Interagency Autism Coordinating Committee logo


Main content area.

Comments from Request for Information NOT-MH-08-021, Interagency Autism Coordinating Committee Draft Strategic Plan for Autism Spectrum Disorder (ASD) Research is Available for Comment

Comments have been redacted for Personally Identifiable Information

From: [redacted personally identifying information]
Sent: Wednesday, August 20, 2008 10:14 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00001] RFI identifier NOT-MH-08-021

As a licensed psychologist and certified school psychologist, I’ve enjoyed working with children who have behavioral disorders and developmental delays, including Autism spectrum disorders, for more than 30 years. My staff and I have created successful treatment programs for children from 18 months through age 21, working collaboratively with their parents and teachers, to help them develop age-appropriate behavioral and social skills using the EPSDT (Medicaid) funding stream. It’s available in all 50 states, and it has a solid track record of success. More research should be directed to finding effective treatment models, not just seeking causes!

Our outcome data from over 500 treatment records of children with Autism and other developmental concerns between 2002 and 2007 show success rates between 74% and 82% addressing physical aggression, communication deficits, personal safety issues, compliance with adult prompts and socialization deficits. The data was analyzed independently by researchers at the University of North Carolina at Chapel Hill who confirmed that we have created a remarkable new treatment modality. Additional research is clearly called-for; we have developed a treatment method that has tremendous promise for success.

One example may help clarify what we have accomplished: A child who had extremely severe autism symptoms is now enrolled in a “regular” education program, no longer carrying an Autism diagnosis, and his parents tell me that they and Dr. Stanley Greenspan, one of the world's foremost authorities in the field of autism treatment, attribute much of his success to our work, spanning five years and funded 100% through the EPSDT mandate of Medicaid at no cost to the parents whatsoever.

Since any child with a disability is automatically eligible for funding to receive these services as part of the Federal Medicaid program under the EPSDT mandate that is applicable in all 50 states, this treatment modality is widely available. We can do the work necessary to enable any child to get Medicaid benefits if they don't already have them in Pennsylvania (where any child with a disability can get Medicaid benefits, regardless of family income), and I would like to help other professionals in other states to understand this system so that they could replicate our success.

A Power Point presentation that describes [redacted personally identifying information] is available for download and distribution at www.ibc-pa.org. [redacted personally identifying information] would like to help other licensed mental health professionals in Pennsylvania and elsewhere to learn how to do what [redacted personally identifying information] been doing successfully in Pennsylvania for the past 16 years.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Thursday, August 21, 2008 12:34 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00002] comments: draft Strategic Plan for ASD Research

Introductory Material (including the Introduction, Vision Statement, Mission Statement, Core Values and Cross–Cutting Themes)

Core values–Sense of urgency. Public Service Announcement to refer people to screening tool.

  1. When Should I Be Concerned?
  2. Uniform early detection screening(multi–lingual) tools used routinely and as frequently as necessary completed by parent, care givers, pre–schools and physician at early childhood well baby check ups and as recommended. Delays⁄concerns should be automatically referred for further evaluation. Take the “subjectivity” out of the screening. (Too many times doctors wait to initiate referrals). When a family registers to take screening tool, they would be assigned a personal tracking number to use for subsequent screenings. You might also have section of survey⁄screening to capture family & pregnancy history through targeted questions. Maybe results could be entered electronically through a 3rd party on-line screening and tracking can be done electronically, similar to an on–line survey. Based on result of screening a list of recommendations can be made including contact information in your area⁄state for “what next” – where to go for further evaluation. Screening would only indicate “at–risk” and refer for additional evaluation. This could initiate more self referrals for screening. Results could be emailed to doctor and parent and tracked through this central database.

  3. How Can I Understand What Is Happening?

  4. What Caused This To Happen And Can This Be Prevented?

  5. Which Treatments And Interventions Will Help?
  6. As child develops and further screening are done, on–line screening can ask appropriate developmental and medical questions including what medications ⁄supplements alternative treatments or interventions are being used. This can be useful in collecting data for “off–label” treatments that are not tracked otherwise. Even anecdotal information might assist in targeting research.

  7. Where Can I Turn For Services?
  8. Central data base can be maintained to refer for further evaluation⁄services. This can be done based on zip code..

  9. What Does The Future Hold?
  10. Development Process for the IACC Strategic Plan for Autism Spectrum Disorder Research References

    [redacted personally identifying information] (and Parent of son with ASD diagnosis) [redacted personally identifying information]

This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the system manager. This message contains confidential information and is intended only for the individual named. If you are not the named addressee you should not disseminate, distribute or copy this e–mail. Please notify the sender immediately by e–mail if you have received this e–mail by mistake and delete this e–mail from your system. If you are not the intended recipient you are notified that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited.

From: [redacted personally identifying information]
Sent: Thursday, August 21, 2008 4:10 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00003] IACC input

According to the directions we are suppose to put input under one of the headings. I chose this one. What do you think of this for input?

[redacted personally identifying information]

IV. Which Treatments and Interventions Will Help?

I am the Research Coordinator for [redacted personally identifying information] as well as the mother of 5 children (one adopted) who use to have autism. I have done countless hours of research on reports from parents and doctors who have been successful at ridding autism. What I have found was immune dysfunction. Ridding pathogens and toxins corrected this immune dysfunction. Various techniques are used from diets, vitamins, minerals, anti–fungals, anti–virals, anti–bacterials, detoxers, chelators, anti–inflammatories, etc. World famous doctors who have long waiting lists who are publicized as being successful at ridding symptoms of autism and in causing complete recoveries are saying what I have just mentioned. Some of these doctors are showing a preference for bacterial infections, specifically borrelia as possibly the main cause of the immune dysfunction leading to the stock-piling of pathogens and toxins these children are displaying. There is already research on brain inflammation and white blood cell abnormalities, specifically natural killer white blood cells, as well as GI abnormalities. These children are testing positive for many opportunistic infections: Borna virus, HHV6, CMV, C. Difficile, Candida Albicans, etc. Thus, it is my opinion and desire that research be done to cover such isssues.

[redacted personally identifying information]

It’s only a deal if it’s where you want to go. Find your travel deal here.

From: [redacted personally identifying information]
Sent: Thursday, August 21, 2008 10:46 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00004] NOT-MH-08-021

Hi all,

I am the parent of 2 boys with autism, [redacted personally identifying information], 11, and [redacted personally identifying information], 9.
Somewhere in

IV: Which Treatments And Interventions Will Help?

and/or

VI: What Does The Future Hold?

I would like to emphasize the importance of the SIGNIFICANT cost savings of early intervention.

In a nutshell: My autistic son [redacted personally identifying information], 11, is non–verbal.

When [redacted personally identifying information] was young, he had one word (“dog”) , which he lost by the age of 3.

We paid $1,500 for Play Project therapy ($250/hour) for [redacted personally identifying information] when he was 5 years old. He did speak a new word. He lost the word when we could not afford to continue the therapy.

We paid $5,000 for 2 weeks of another therapy this year. [redacted personally identifying information] said a word, “yeth” for “yes”. We were so happy. With a head shake for “no”, and “yeth” we could have some kind of conversation with him. When we discontinued the therapy because we couldn't afford it, he lost the word.

We are back to having an 11 year–old non–verbal son.

The government is going to have to pay thousands of dollars for his care for the rest of his life because we couldn”t afford a couple of thousand dollars up front. (We have 2 insurances, both HAP, and Medicaid. They don't cover therapies that work.)

Not only is [redacted personally identifying information] quality of life significantly reduced, [redacted personally identifying information] will be a heavy burden on taxpayers for the rest of his life. All for a couple thousand dollars. We can argue all we want about who should pay what forever, but the fact remains – for lack of early therapy, the government will have a dependent for life.

[redacted personally identifying information] is only one of thousands of kids with autism in the same boat.

So, somewhere in the report, I would like a cost–benefit analysis, showing the significant cost savings of early intervention. In [redacted personally identifying information]’s case, it could’ve made the difference between lifetime government support and outpatient care.

[redacted personally identifying information]
[redacted personally identifying information]’s mom

It's only a deal if it’s where you want to go. Find your travel deal here.

From: [redacted personally identifying information]
Sent: Friday, August 22, 2008 2:56 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00005] NOT-MH-08-021

Section V

Where Can I Turn for Services

When a 17 year old male with behavioral issues ( mainly in School) needs to be placed somewhere because loving parents can no longer handle, there needs to be an easily accessible placement option. It should not take a family that is in CRISIS 2 months to place an autistic young man. When you go on www.autisminpa.org. and view the Autism Task Force’s Report the 15 pages specific to adolescents with autism) that was prepared in December, 2004; it clearly indicates that “it is not unusual for autistic adolescents to develop aggressive behaviors”. We need a safe place with autism specialization for these boys – – NOT CONTINUE TO ALLOW THEM TO BE PLACED IN WHAT MAINLY A DRUG AND ALCOHOL DETOX FACILITY because there is no other place that would accept him! This is an outrage! Our son never had drug nor alcohol issues and lead a very sheltered life with CONSTANT ADULT SUPERVISION & TSS SERVICE WHEN HE LIVED AT HOME.

Here it is almost a year later and now we face another nightmare of trying to transition from the RTF to a group home specializing in autism. Different funding sources for each makes this a huge problem. Instead of the same funding source, we must wait on a PUNS list for several months. We need a SEAMLESS and COLLABORATIVE WAY TO GET SERVICES FOR ADOLESCENTS WITH AUTISM.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Friday, August 22, 2008 7:02 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00006]

Please be advised that I am raising an issue paramount to the ASD community. First and foremost any Mental Health Legislation should acknowledge that those on the Spectrum are not to be confused with the MR population. Case in point: My son is a seventeen year old non–verbal individual with exceptional capabilities in academics. The core of his challenges remain in communication and socialization. Hence he has, in his past history (4 years ago), a test of non–verbal intelligence which he scored very low on. This test is given to the ASD populations although it is aimed at assisting a person whose disability is that they are non–verbal (only). This non–verbal IQ test does not allow for the inability of an Autistic person to respond appropriately to the examiner or their inability to respond in a manner that will be universally understood by the examiner. Although the Doctor who administered the exam issued a diagnosis of Autistism, my state utilized my sons score on the exam to label him Mentally Retarded and denied him the medicaid assistance we had applied for. The sister program for the MR population, which we did not apply for has a waiting list of 50 YEARS. The ASD population does not benefit by the Government trying to lump them into categories with the MR population or the DEAF population. I beleive a diagnosis of ASD should come from a MENTAL HEATH PROFFESIONAL WHO SPECIALIZES IN ASD and not from some unqualified Medicaid Worker. My son has been HIT by a proverbial Bat from every angle. He deserves respect for his accomplishment and a compassionate recognition of his limits. With the numbers of children receiving a ASD diagnosis today ,ASD appropriate mandates are paramount. This very capable group of individuals could very well be the new majority and we should all be prepared to deal with it. Thank you in advance for your attention to this matter.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, August 25, 2008 12:06 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00007] parent input and public transparency-from [redacted personally identifying information]
  1. Why isn’t the meeting open to the public? What is the benefit of secrecy???
  2. Why is there no discussion of vaccines??? I find this to be incredible. Over 50% of parents believe vaccines triggered their child’s autism. I watched my healthy baby regress horribly after receiving 7 vaccines in one day. A minuscule amount of money has been spent on objective vaccine safety studies. Parents are not satisfied and do not trust that our aggressive immunization program is safe. That isn’t even an opinion, it is a fact. Look at the falling immunization rates all over this country. The IACC cannot hide from this issue any longer.
  3. Where is a focus on GI disease and regressive autism? We desperately need more studies on this subject. As of now children like mine exist in horrible pain until a doctor who understand how to treat this condition is found. I literally had to travel the country to find a pediatric GI who could help my son. It isn’t even that complicated, he suffers from severe IBD and needs to stay on a strict diet and his pain has been greatly lessened by anti-inflammatories. Still very little research has been funded on the subject. This is inexcusable. Pain relief should be the #1 priority. If we can do nothing else we should succeed there.
  4. Where are SafeMinds, TACA, the NAA and Generation Rescue? These orgs comprise a huge % of the parent community, far more than many of the other orgs involved. TACA and the above orgs organized the first ever autism demonstration down Independence Avenue to a rally on Capital Hill. 8,000 people attended, from all 50 states! ! ! In order to be successful the IACC must respectfully include ALL stakeholders, not just institutional research orgs or governmental bodies. Autism Speaks is important but it is only one, meanwhile there is so much overlap among govt. bodies on the IACC.

I look forward to hearing a response to these inquiries.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Wednesday, August 27, 2008 12:41 PM
To: IACC Services (NIH/NIMH)
Subject: [Comment 00008] RFI notice NOT-MH-08-021

My quick comments:

The spectrum includes individuals with ASD who are nonverbal and cannot live independently, and others who find gainful employment and live independently. This implies that someone who is nonverbal is at the low end of the spectrum and cannot live independently. In fact, there are many people with autism who are non-verbal who use augmentative communication systems who can function independently.

With multiple causes and symptoms, there likely will be multiple ways and approaches to intervene (e.g., medical, behavioral, nutritional, etc.)It’s good that nutritional treatments are being acknowledged as legitimate. Technically, though, they are a subset of medical.

Lifespan Perspective
Yes. See [redacted personally identifying information] report at
http://www.coachmike.net/special_report.php which highlights the need for the federal government to include people with autism in their hiring of people with disabilities.

causation is generally thought to involve some forms of genetic risk interacting with some forms of non-genetic environmental exposure (e.g., hormonal and reproductive factors, paternal age, birth weight, stress during preconception/pregnancy, infections, and toxicants). The balance of genetic risk and environmental exposure likely varies across the spectrum of ASD. Good that you acknowledge the role of the environment, but bad that you fail to point out environmental pollutants as factors even on a general level (pesticides, mercury, etc.) and instead focus on factors based on the person rather than external factors that can affect the person.

Numerous epidemiological studies have found no relationship between ASD and vaccines containing the mercury based preservative, thimerosal (Immunization Safety Review Committee, 2004).Others have found a relationship and mercury isn’t the only controversy. At least define the controversy – the MMR shot for example – getting three jabs at once of proteins from live viruses into kids with weak immune systems – is also part of the controversy. It’s intentionally misleading to say “mercury doesn’t cause autism so therefore vaccines don’t cause autism” since that’s only part of the controversy.

There are other treatments in wide use that have not been studied in randomized controlled trials. These include nutritional supplements and diets (e.g. gluten-casein free diets), and chelation.I have a hard time believing that GFCF and chelation have not been studied in randomized controlled trials. Start these trials then. Or use different trials that are conducive to validating the types of treatments that are out there.

One such treatment, the neuropeptide, secretin, that had been reported to improve symptoms of ASD was studied in a placebo–controlled trial and found to be ineffective (Esch & Carr, 2004). If you’re going to mention a treatment that supposedly didn’t work then why not focus on some that did work?

ASD poses economic and social costs for individuals, families, and society at large.I skimmed through this quickly but didn’t find anything on health care parity for autism. There should also be mention of the disparity in the ability of poor families to get services and the fact that services need to be made available.

There is little information about the number of adults with ASD within the criminal justice system.Good. There should be also a mention of the need to study the homeless.

[redacted personally identifying information]

Get ideas on sharing photos from people like you. Find new ways to share. Get Ideas Here!

From: [redacted personally identifying information]
Sent: Thursday, August 28, 2008 11:49 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00009] NOT-MH-08-021

Human pheromones probably cause autism. Adult male facial skin surface lipid in quantities of 150 mg p.o. should be tried to ameliorate symptoms.

[redacted personally identifying information]

Coined “Inclusive” and “Inclusive Democracy” concepts from math term.

Original creator of “Lights On! Tampa!” art display/contest.
Proposed “Floating Riverwalk” for Tampa
Proposed Lee Roy Selmon Expressway extension to St. Pete w/rail link.
Developed simple chewing gum cure for delinquency, criminal behavior Proposed GA's HOPE Scholarship Program ( precursor to Bright Futures) Proposed Law & Rule Obeying Gays in the Military executive order & 1st thing timing Proposed Tuskeegee Presidential Apologies and NIH Victim Restitution. Presidential advisor to Presidents Bubba “Bill” Clinton and Hillary Clinton, 1972.

Presidential advisor to Presidents George W. & G. H. W. Bush, 1971 (George H.W. Bush led the plumbers in killing JFK &many others) Wrote poems for Dead Poets Society (& sax solo) lyrics (Light and Day) Spotless Mind speeches for Braveheart, Independence Day, Armageddon, Deep Impact Titanic, Good Will Hunting, Cast Away, LOR trilogy, Wag the Dog, V for Vendetta, Pirates of the Caribbean trilogy, 300, Night in the Museum, Borne trilogy, Austin P owers trilogy, National Treasure, Back to the Future trilogy, Sky Captain and the World of Tomorrow, There Will Be Blood, Mystic River, many others

From: [redacted personally identifying information]
Sent: Friday, August 29, 2008 4:26 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00010] NOT-MH-08-021

Hello

I have a comment about which treatment will help. We have had our son in ABA therapy for just over a year now. Unfortunately it is not covered by insurance in Washington State. It has been very helpful. It has helped our son with social interactions and communication as well as in some academic areas. We average about 6 hours a week of ABA therapy with our 9 year old son.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Friday, August 29, 2008 9:17 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00011] Plan for autism research

I am a integrative pediatrician and therefore, many autism patients have found their way into my office. There stories intrigue me and have sent me searching for more answers than are really available. For me, the biggest research questions that need to be answered is who are our “at risk population” and how can we prevent progression of this disorder? I do not believe that the profession's insistance that “regressive” autism is a diagnostic category that should be studied separately from “autism”. If we believe that regressive autism is “triggered” by some noxious insult then, why can the insult not be possible in the first year of life? As clinicians regressions in that period would be nearly impossible to catch.

From: [redacted personally identifying information]
Sent: Saturday, August 30, 2008 10:27 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00012] autism comments

Sirs:

As a pediatrician in the largest pediatric group in the Northeast US, I implore you to devote some effort to combatting the media insanity surrounding the alleged link between autism and vaccines. The totally unsupported positions taken by such celebrities as Jennie McCarthy that are clearly scientific nonsense, have caused many of us caring for both normal and autistic kids untold amounts of grief, lost time and professional burnout combatting their high publicized, yet basically irrational campaign of disinformation. This campaign has literally drained hours from our time every single day providing medical care that is wasted reassuring frightened parents about vaccine safety. Many physicians are so frustrated with this position that it has compromised and poisoned our attitude to parents, groups, and even the misguided professionals who endorse it . The anger level of pediatricians toward such groups cannot be over–estimated. I find it impossible to do any kind of work for autistic kids when I am constantly assaulted and attacked over this non–issue. Unless some concerted public relations effort is made to combat it, I fear that the overall care of autism will be severely compromised as main stream pediatricians become increasingly disinclined to engage families in this unproductive and time wasting discussion.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 02, 2008 3:00 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00013] NOT-MH-08-021
Attachments: NOT-MH-08-021.pdf

Attached is my response to the Request for Information (RIF) for comments on the IACC Strategic Plan. I do hope my comments will be carefully considered and discussed by members of the IACC.

Sincerely,

[redacted personally identifying information]

Memorial Research Initiative To seek understanding of brain system impairments in autism.
[redacted personally identifying information]

Comment on the IACC draft strategic plan NOT–MH–08–021
[redacted personally identifying information]

Introduction

Auditory system impairment should be added to the core clinical characteristics of children with autism, especially as an impediment to language development. Evidence of disturbed auditory function in children with autism has been provided by many research studies. The inferior colliculi (in the midbrain auditory system) have higher blood flow and metabolism than any other area of the brain and are vulnerable to any factor that disrupts aerobic metabolism, including toxic substances like mercury and lead [1]. Research on auditory problems should be prominently sought in the IACC plan, and research on oxygen insufficiency at birth should be a focus for some of the following reasons:

  1. Prominent lesions of the inferior colliculi were part of a pattern of symmetric damage within the brainstem caused by six or more minutes of total oxygen deprivation at birth in experiments with monkeys [1].
  2. Loss of the ability to comprehend spoken language following injury of the inferior colliculi has been described in several case reports [1, 2]. How much more serious impairment of function of the inferior colliculi should be for an infant [3].
  3. Brain maturation did not follow a normal course in monkeys subjected to asphyxia at birth, and many of the areas of the brain that did not develop normally correspond to brain regions now found in fMRI scans reported to represent under–connectivity [1].
  4. Monkeys subjected to asphyxia at birth displayed initial lack of motor control from which they appeared to recover. Poor manual dexterity remained into adulthood [1].

Vision: The plan needs to seek understanding of the increased prevalence of autism.

Mission: The mission must include measures to identify preventable environmental hazards.

Core values: Collaboration should include discussion of written comments submitted for IACC meetings. Obstetric complications are associated with development of autism and effects of birth injury must not be ignored [1, 3, 4, 5].

Cross–cutting themes: The final common pathway in the brain affected by all etiological factors (genetic and environmental) associated with autism should be looked for [1]. The following comments are based on [redacted personally identifying information] suggestion that umbilical cord clamping within seconds following birth should be investigated as cause of the increased prevalence of autism during the past 20–25 years [redacted personally identifying information]:

  1. When Should I Be Concerned?
  2. Was your baby crying (or breathing) before the umbilical cord was clamped?

  3. How Can I Understand What Is Happening?
  4. Language is learned “by ear” and may be difficult for a child with any impairment of the auditory system.

  5. What Caused This To Happen And Can This Be Prevented?
  6. Prospective parents should refuse umbilical cord blood banking, and they must insist that a birthing plan be adhered to that includes waiting for pulsations in the umbilical cord to cease before clamping. Plans should be made in advance for resuscitation with the umbilical cord attached.

    Comment on the IACC draft strategic plan NOT-MH-08-021

  7. Which Treatments And Interventions Will Help?
  8. Efforts to help a child hear the boundaries between syllables and words may be helpful [1]. Children with Kanner autism often learn to read early, which may represent a strategy taken by the child to hear syllable and word boundaries. This was the case with my own first–born son, whose first diagnosis was “mild” cerebral palsy.

  9. Where Can I Turn For Services?
  10. Long-term care insurance is more important than universal health care insurance. An effort must be made to make long–term care insurance mandatory for every child born [1].

  11. What Does The Future Hold?
  12. The current protocol for clamping the umbilical cord immediately at birth is a clear medical error. The obstetric profession is beginning to recognize this, but the obstetric clamp ought to be scrapped. Statistics for “respiratory depression” at birth are similar to those for autism. Respiratory depression at birth implies oxygen insufficiency at birth with risk of auditory system impairment.

Development Process for the IACC Strategic Plan for Autism Spectrum Disorder Research

Since the Autism Summit in 2003, I have tried to urge investigation of oxygen insufficiency at birth as a possible cause of auditory and language problems in many cases of autism. I submitted comments for both the May and July meetings of the IACC this year, but see nothing in the draft strategic plan that addresses complications at birth.

Is there any way that well–educated parents might have a chance for greater participation in the focus of research for the IACC? [redacted personally identifying information] research into developmental language disorder began 44 years ago, when [redacted personally identifying information] 2-year-old son who had been diagnosed with “mild” cerebral palsy was severely dysarthric. Three years later his younger brother, [redacted personally identifying information], was diagnosed as autistic, and he was a classic case of Kanner autism with fluent echolalic speech and excellent pronunciation. [redacted personally identifying information] needed to be resuscitated at birth, which is why my focus has been on brain impairments resulting from oxygen insufficiency.

References

  1. Simon EN (2000-2008) http://www.conradsimon.org/
  2. Pan CL, Kuo MF, Hsieh ST. Auditory agnosia caused by a tectal germinoma. Neurology. 2004 Dec 28;63(12):2387-9.
  3. Simon EN. Auditory agnosia caused by a tectal germinoma. Neurology. 2005 Jul 26;65(2):339 [letter]; author reply 339. Online at http://www.neurology.org/cgi/eletters/63/12/2387
  4. Cederlund M, Gillberg C. One hundred males with Asperger syndrome: a clinical study of background and associated factors. Dev Med Child Neurol. 2004 Oct;46(10):652–60.
  5. Glasson EJ, Bower C, Petterson B, de Klerk N, Chaney G, Hallmayer JF. Perinatal factors and the development of autism: a population study. Arch Gen Psychiatry. 2004 Jun;61(6):618–27.
From: [redacted personally identifying information]
Sent: Tuesday, September 02, 2008 4:40 PM
To: [redacted personally identifying information]
Cc: IACC (NIH/NIMH)
Subject: [Comment 00014] Autism Tissue Program (ATP) Monthly Report – August 2008 and IACC info
Attachments: ATP August 2008.doc

Dear Friends/Colleagues, here is the ATP Report for August and a preliminary response to the IACC.

The Interagency Autism Coordinating Committee (IACC) has requested input to a draft strategic plan*.

This statement appears in the draft and needs to be corrected: Some progress has been made to establish the necessary infrastructure for the collection and preservation of post-mortem tissue from individuals with ASD, through the efforts of the National Autism Brain Bank, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Brain and Tissue Bank, the Autism Tissue Program and the Autism Brain Project. In addition, advocacy organizations such as Autism Speaks have made efforts in the U.S. and internationally to promote tissue donation.

  • The ‘National Autism Brain Bank’ is the Harvard Brain Tissue Resource Center (HBTRC) as designated at the IACC meeting in 2003.
  • The NICHD Brain and Tissue Bank for Developmental Disorders collects ASD tissues.
  • The Autism Speaks Autism Tissue Program is in place currently to 1) promote brain donation to the HBTRC of affected ASD and unaffected donors* *, 2) do home visits for diagnosis and other clinical phenotyping as well as family support, 3) support a Tissue Advisory Board to review tissue requests and make recommendations to distribute tissue to approved investigators and 4) track projects and research data in the informatics portal (www.atpportal.org).
  • I don’t know what the ‘Autism Brain Project’ is.
  • Autism Speaks has made efforts to reach the autism community to promote donations over the last ten years; efforts also need to be part of NIH–supported projects too. At a minimum, all subjects entering NIH sponsored ASD projects should be made aware of the ATP (www.autismtissueprogram.org). Past grantors and partners have been ASA, MIND Institute, NIMH, NINDS, ACRE.

I am passing along a comment on the draft by a past [redacted personally identifying information]board member, [redacted personally identifying information]: Looking at the objectives on P 12, [redacted personally identifying information] suggests this goal: Increasing awareness among the autism spectrum community of the potential value of brain & tissue donation to further basic research. At least twice the current number of donors is needed to have the power to reduce the variability of findings described in promising preliminary research.

* IACC Draft Strategic Plan for ASD Research is Available for Comment. The purpose of this time–sensitive RFI is to seek comments on the draft Strategic Plan from ASD stakeholders such as individuals with ASD and their families, autism advocates, scientists, health professionals, therapists, educators, officials of state and local programs for ASD, and the public at large. Please see the official RFI notice NOT-MH-08-021 at http://grants.nih.gov/grants/guide/notice-files/NOT-MH-08-021.html for more information and instructions for responding by the deadline of September 30, 2008. Responses should be directed to iacc@mail.nih.gov

* *except in southern California counties where Medical Examiners are happy to assist families with consented donations to the UCLA brain bank for which they have long–standing contracts.

[redacted personally identifying information]

Autism Tissue Program (ATP) Monthly Report August 2008

This month: Cumulative total

DONORS:

REGISTRANTS 4 31044
Autism 0 102
Asperger 0 3
Autism in Family 0 32
Other Disorder 0 13
Non–affected 0 9
Total 1 159

TISSUE INQUIRES: 2 268
TISSUE PROPOSALS: 0 154
PROJECTS APPROVED: 3 87

PROGRAMMATIC ACTIVITIES

Donations. [redacted personally identifying information]

      Donor 159. Adult female, unaffected, to Harvard Brain Tissue Resource Center

Data – [redacted personally identifying information]. [redacted personally identifying information] provided the statistics for the monthly report. [redacted personally identifying information] and [redacted personally identifying information] consulted with [redacted personally identifying information] on regression items in the ADI-R and posted a donor case list to the portal under ATP project #999. It lists donors whose histories indicate regression and gives an explanation of the ADI–R items and scores that denote regression. This report will be updated each quarter.

[redacted personally identifying information] participated in NDAR (National Database for Autism Research) Webinar on the 27th. The agenda for the meeting was to provide a status on NDAR and obtain community feedback on planned capabilities for NDAR in 2008 as well as NDAR objectives for 2009. ATP Informatics Portal would theoretically be part of the federated databases on NDAR in the future; currently, NDAR is working on ADI–R and ADOS clinical data and is a long way from dealing with ATP data.

Tissue Advisory Board (TAB). Three proposals were approved at the third quarterly meeting on 8/22. Abstracts and supporting publications are on www.atpportal.org under Research Projects and Findings.

P# 1678, Ikuko Mohri; Osaka University Graduate School of Medicine A possible important role of hematopoietic prostaglandin D synthase in the pathogenesis of autism

P# 1698, Wolfgang Sadee; Ohio State University Functional genetic variants of serotonergic signaling in autism spectrum disorder

P# 1721, James Millonig; UMDNJ (University of Medicine & Dentistry in NJ) ENGRAILED 2 mRNA/protein levels in cerebellar post-mortem samples

New Publications Citing ATP as Brain Source.

[redacted personally identifying inforamtion] Palmieri L, Papaleo V, Porcelli V, Scarcia P, Gaita L, Sacco R, Hager J, Rousseau F, Curatolo P, Manzi B, Militerni R, Bravaccio C, Trillo S, Schneider C, Melmed R, Elia M, Lenti C, Saccani M, Pascucci T, Puglisi–Allegra S, Reichelt KL, Persico AM. Mol Psychiatry. 2008 Jul 8. [Epub ahead of print]

Altered calcium homeostasis in autism–spectrum disorders: evidence from biochemical and genetic studies of the mitochondrial aspartate/glutamate carrier AGC1.

Autism is a severe developmental disorder, whose pathogenetic underpinnings are still largely unknown. Temporocortical gray matter from six matched patient-control pairs was used to perform post–mortem biochemical and genetic studies of the mitochondrial aspartate/glutamate carrier (AGC), which participates in the aspartate/malate reduced nicotinamide adenine dinucleotide shuttle and is physiologically activated by calcium (Ca(2+)). AGC transport rates were significantly higher in tissue homogenates from all six patients, including those with no history of seizures and with normal electroencephalograms prior to death. This increase was consistently blunted by the Ca(2+) chelator ethylene glycol tetraacetic acid; neocortical Ca(2+) levels were significantly higher in all six patients; no difference in AGC transport rates was found in isolated mitochondria from patients and controls following removal of the Ca(2+)–containing postmitochondrial supernatant. Expression of AGC1, the predominant AGC isoform in brain, and cytochrome c oxidase activity were both increased in autistic patients, indicating an activation of mitochondrial metabolism. Furthermore, oxidized mitochondrial proteins were markedly increased in four of the six patients. Variants of the AGC1–encoding SLC25A12 gene were neither correlated with AGC activation nor associated with autism-spectrum disorders in 309 simplex and 17 multiplex families, whereas some unaffected siblings may carry a protective gene variant. Therefore, excessive Ca(2+) levels are responsible for boosting AGC activity, mitochondrial metabolism and, to a more variable degree, oxidative stress in autistic brains. AGC and altered Ca(2+) homeostasis play a key interactive role in the cascade of signaling events leading to autism: their modulation could provide new preventive and therapeutic strategies.

[redacted personally identifying information] this mortality report from Denmark. ATP California data–mining had similar results and read further for [redacted personally identifying information]’s remembrance of [redacted personally identifying information] to honor [redacted personally identifying information] and highlight SUDEP.

Mouridsen SE, Brønnum-Hansen H, Rich B, Isager T. Autism. 2008 Jul;12(4):403-14. Mortality and causes of death in autism spectrum disorders: an update.

This study compared mortality among Danish citizens with autism spectrum disorders (ASDs) with that of the general population. A clinical cohort of 341 Danish individuals with variants of ASD, previously followed over the period 1960–93, now on average 43 years of age, were updated with respect to mortality and causes of death. Standardized mortality ratios (SMRs) were calculated for various times after diagnosis. In all, 26 persons with ASD had died, whereas the expected number of deaths was 13.5. Thus the mortality risk among those with ASD was nearly twice that of the general population. The SMR was particularly high in females. The excess mortality risk has remained unchanged since our first study in 1993. Eight of the 26 deaths were associated with epilepsy and four died from epilepsy. Future staff education should focus on better managing of the complex relationships between ASD and physical illness to prevent avoidable deaths.

ATP Outreach/Friends of ATP/Science Ambassadors – [redacted personally identifying information] & [redacted personally identifying information]

UC Davis Summer Neurodevelopmental Institute. [redacted personally identifying information] staffed an AS exhibit booth. The conference was attended by approximately 600 national/international professionals and parents. A student in [redacted personally identifying information]’s lab has started an autism club at UCDand is interested in assisting with ATP outreach; we will report further on student neuroscience clubs. Other activities: espeaks had a piece on the [redacted personally identifying information] family and their dedicated involvement in marathon training and fund-raising for Autism Speaks. [redacted personally identifying information] said that he “began running largely for [redacted personally identifying information] and we're channeling our passion for helping other families through Train 4 Autism as well”. The Long Beach Marathon is 10/12/08.

[redacted personally identifying information], sent this information about [redacted personally identifying information], who attended CVPH Medical Staff grand rounds on the 15th and gave out information about the ATP. Thanks [redacted personally identifying information] for the great help.

Another [redacted personally identifying information] Ambassador, [redacted personally identifying information], talked with [redacted personally identifying information] about [redacted personally identifying information] plans to participate on the panel of the Autism & Epilepsy Conference at UMDNJ (University of Medicine and Dentistry, New Jersey) next month.

[redacted personally identifying information] took advantage of a trip to Mayo Clinic to put out ATP flyers.

[redacted personally identifying information], was promoted to [redacted personally identifying information] at CryoLife and continues to help communicate the interest of the ATP to partner with organ and tissue agencies with experience in brain recovery.

[redacted personally identifying information] remembered her daughter with this message:

    Four years ago, August 26, is the day my darling daughter [redacted personally identifying information] died from secondary causes due to Autisms (SUDEP, Sudden Unexpected Death due to Epilepsy). [redacted personally identifying information]’s brain was donated to the Autism Tissue Program so that she could continue to help others, as she help us while she lived. If you want to know more about [redacted personally identifying information] visit her My Space page at [redacted personally identifying information] (check out her pics). If you are an organ/ tissue donor, please consider donating your brain too [redacted personally identifying information]. It is a separate donation. Please visit the ATP site (www.autismtissueprogram.org) and consider donating your brain toward autism research. Further… I intend to have an ice cream cone, rather than a martini in [redacted personally identifying information]'s honor. Please consider having a cone in her honor too. Or better yet, treat a child to a cone in her honor. I do. Thank you. A Bereaved Mom.

Other Program Activities

ATP Staff Change. [redacted personally identifying information], resigned from Autism Speaks effective August 15. In [redacted personally identifying information] year of service, [redacted personally identifying information] was instrumental in securing a contract with Upstate New York Transplant Services, a tissue bank in the northeast, to partner with the Autism Tissue Program (ATP) on brain donation and also organized medical equipment suppliers to support our partner agencies. We thank [redacted personally identifying information] for [redacted personally identifying information] contributions to Autism Speaks and wish [redacted personally identifying information] well in his future endeavors. Should you have any questions, please direct them to [redacted personally identifying information].

Upcoming Meeting & Conferences

Sep 6-9 AATB – American Association of Tissue Banks, 9/8 ATP presentation - Chicago
Oct 11-14 American Academy of Pediatrics AAP – Boston
Oct 16-20 Society for Developmental and Behavioral Pediatrics (SDBP) – Cincinnati
Oct 29 -Nov 1 Contemporary Forums Clinical Issues in Pediatrics - San Francisco, CA
Nov 11-15 American Society of Human Genetics (ASHG) – Philadelphia
Nov 5-8 Child Neurology – Santa Clara
Nov 15-19 Society for Neuroscience (SfN) (TAB 11/15 morning) - Washington DC
2009 May 7-9 IMFAR – Chicago
Jun 25 IDEAS (chromosome 15q duplication) - Indianapolis
Oct 17-21 Society for Neuroscience (SfN) – Chicago

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Wednesday, September 03, 2008 3:28 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00015] NOT-MH-08-021

Wed.

Dear IACC:

I was thrilled to be able to review the IACC draft Strategic Plan submitted 8/15/2008 and distributed to me through my membership in INSAR. I am a neurologist in private practice and have a daughter with autism and intractable seizures. I have also been on the [redacted personally identifying information] Advisory Board. I have two suggestions:

Regarding Section II, Page 10, regarding tissue research, the organization of centers may need to be revised. I am sure the Harvard Brain Bank, in Belmont, MA, would like to be included as they were among the first to develop a standardized protocol for collecting tissue. I emailed [redacted personally identifying information] about this section and I'm sure she could update the IACC as to the status of these projects. (email: [redacted personally identifying information]

The second comment addresses Section IV; treatments. Under the research opportunities “Methods of treating co–existing medical or psychiatric conditions” I would ask that we add specifically seizure control. Most of the research on epilepsy and autism to date has been observational, with few prospective studies, and no databases or registries to generate hypotheses for further targeted research. If autism affects 1 in 160 births, and 1 in 3 with autism are affected also by seizures, then autism could be considered one of the leading causes of pediatric epilepsy, probably second only to cerebral palsy/mental retardation. The behavioral problems associated with autism make it difficult to evaluate side effects of the antiepileptic drugs; for instance agitation in someone with autism could be due to a change in the environment or addition of a new medication, e.g. levetiracetam. I frequently deal with other questions in the office such as whether addition of a psychotropic medication (risperidone) will cause an increased risk of seizures. I have to tell the patient and family that it probably will not, but we simply do not know.

Under objectives, I would add: “Establish a registry or consortium of registries to track seizure control, medication use and adverse effects related to treatment.”

A long term goal would be to support prospective trials of commonly used antiepileptic medications in well defined groups of patients with autism or Asperger syndrome. Examples would be Lamotrigine versus Levetiracetam, (two new drugs), Carbamazepine versus Levetiracetam (a popular old drug versus a new drug). Other treatments which might be studied include the Vagus Nerve Stimulator (popular because there is no sedation) and even the Ketogenic Diet.

I would be happy to be involved in a process to develop longer term research goals through my membership in the Epilepsy Foundation and the American Epilepsy Society.

Thank you for your hard work on these issues. We've come a long way!

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Wednesday, September 03, 2008 5:58 PM
To: IACC (NIH/NIMH); NIMH IACCPublic Inquiries (NIH/NIMH); AMERICANVOICES@mail.house.gov
Cc: [redacted personally identifying information]
Subject: [Comment 00016] I WANT THE EFFECTS OF ALLOF THESE VACCINES ON TINY BABIES STUDIED

IT IS CLEAR MEDICINE HAS BEEN ACCEPTING TOTALLY WHAT DRUG PROFITEERS TELL THEM. AND THE DRUG PROFITEERS HAVE TAKEN OVER MEDICAL AGENCIES IN THE UNITED STATES. THEY ARE MAKING BIG BIG MONEY OUT OF INJECTING MERCURY, FORMALDEHYDE, SOY, ALUMINUM AND OTHER METALS INTO OUR BABIES. MERCURY IS STILL NOT OUT OF THE FLU SHOT TOTALLY.IN ADDITION OUR VACCINES ARE BEING MANUFACTURED IN CHINA, HOME OF POISON DRUGS. NOBODY IS WATCHING THIS WHOLE VACCINE ISSUE AND THE HARM THAT IT DOES.

WE MUST TOP ADVOCATING INJECTIONS OF VACCINE UNTIL WE DO STUDIES OF THE MASSIVE GROWTH IN VACCINES THAT ARE MANDATORY. OUR GOVT AGENCIES HAVE BEEN PUPPETS OF THE DRUG INDUSTRY PROFITEERS AND DOING A NUMBER ON OUR KIDS.

AUTISM IS AN OUTGROWTH OF A BOUGHT AND PAID FOR AGENCY MANDATING ALL OF THESE VACCINES WITHOUT ANY ADEQUATE SAFE KNOWLEDGE OF EXACTLY WHAT IT IS THAT THEY DO. THE NEGLIGENCE IN THIS WHOLE PROJECT HAS BEEN ENORMOUS.

WE MUST BAN VACCINES UNTIL WE HAVE SAFE, HONEST INFORMATION. WE DO NOT HAVE THAT AT THIS TIME AT ALL. THE SLIME IN WASHINGTON DC HAS PERMEATEDTHIS AGENCY AND OTHERS WHERE DRUG PROFITEERS RUN THE SHIP IN CONTRAVENTION OF SAFETY AND HEALTH.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Thursday, September 04, 2008 2:32 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00017] Yo, NIH! You guys should stick to the peer reviewed methods that work

Yo, NIH! You guys should stick to the peer reviewed methods that work


From: [redacted personally identifying information]
Sent: Thursday, September 04, 2008 2:32 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00018] I know you are getting pressure about vaccines, please don’t cave

I know you are getting pressure about vaccines, please don’t cave


From: [redacted personally identifying information]
Sent: Thursday, September 04, 2008 4:43 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00019] NOT-MH-08-021

Dear IACC members,

I am writing as an autistic self advocate as well as a mother of an adult on the autism spectrum. Please think about that for a moment. The IACC has been acting as if they believe that most autistics are children (they are not) and that there are “parents” on the one hand and “autistic people” on the other hand.

If you will take a moment to think about it, autism is the most highly heritable of all known mental or developmental disorders. I’ll repeat that. Autism is the most highly heritable of all known mental or developmental disorders. That doesn’t mean that all the parents of autism spectrum children are themselves autistic, but it would tend to mean that many of them are. But when the IACC invites “parents” to sit on their panels they do not invite autistic people who are parents, they invite the very worst that the autism community has to offer. This is your track record up until now, your “parent” advocates are really advocates for toxic–tort law firms and fringe conspiracy theorist led groups. You need to get your act together and pay attention to what the real parents of autistic people are saying, not these politician backed know–nothings and self–centered egotists who want nothing but to have never had an autistic child to burden their otherwise “glamourous” lives.

Apart from the fact that you are being influenced by anti–scientific egotist parents and their lawyers, here are my concerns about future autism research.

It frightens me the way it is accepted that earlier and earlier identification of autism is a good thing. What I have seen is that over the past few years, more children are being falsely diagnosed with autism because they are given the label too early. There is no way of telling if a particular child who is a late talker and may have some odd behaviors will merely grow out of these autistic like traits if given decent parenting, normal experiences and normal health care. But what I see is that behaviorists and "biomed" quacks want to claim that they are curing these children of autism. It will make them rich, as they will seem “successful” as they will have more and more “false positive” babies to “cure”.

I read the first–person accounts of parents writing to Internet groups. Some of these are putting their 12 month old babies into hyperbaric oxygen chambers and having their babies given intravenous chelation and injected with high doses of methyl B12 over long periods of time (which can cause cancer by methylating cancer suppressor genes). This is not a safe world in which to diagnose a baby with autism. It's not even safe for older children. This is in part because some IACC members have encouraged this kind of insane quackery by including promoters of these therapies on your panels! This is deadly serious. You people (Dr. Thomas Insel, for one) need to quit giving credibility to quacks before more children are killed by autism quackery and antivaccine extremism. So extreme caution must be used before entering into this grand new age of early, early autism diagnosis. Early, early autism diagnosis may get more children killed than you “save” from developmental delays.

You also need to be willing to fund studies that start off by acknowledging the amazing strengths of autistic people an not just delve deeper and deeper into their weakness to see exactly how weak and and bizarre they are. Autistic people are fantastic people. If you start from that standpoint, you will give their lives honor. You will find just as many fascinating things, but not end up making autistic people seem like they are nothing more that side–show freaks, merely a collection of pathetic flaws and desperate errors. By emphasizing strengths and understanding them more completely you are more likely to enable autistic people to have jobs and become tax payers as opposed to shunting them off to the side of society and sob over what tragic, “empty shell” (thank you, [redacted personally identifying information]) burdens they all are.

Please do not fund any more research on vaccines and autism. This idea is a dead horse. It is beyond dead. It is a rotten, bloated, beaten to a quivering pulp of a stinking corpse of a horse. You don’t need to listen to hysterical parents, some of whom are outright liars, tell you about how their baby descended into the hell that is autism within minutes, days, weeks, or months following a vaccine.

You have to realize that there is no reason for communities to reach out to include, or help support, autistic people if you are funding research that is written in a way that demonizes autistic people as worthless tax burdens. If a grant proposal begins with, “autism is a devastating disease that is causing a massive tax burden which will cripple our State and Federal governments and thus leave our fair nation open to being overtaken by terrorist hordes,” variations of which I have seen in published papers on autism, then refuse to fund their study. If a grant proposal can show you that the results may improve the lives of autistic people and you sense that the researchers aren’t going to put out press releases that damn and demean autistic people, then by all means grant them money if the research seems solid.

[redacted personally identifying information]
autistic advocate and mother of an autistic adult
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Thursday, September 04, 2008 7:11 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00020] NOT-MH-08-02, RFI input for the Draft Strategic Plan for the IACC

Dear IACC memeber,

following is some feedback for the draft Strategic Plan, per the RFI recently posted.

Unfortunately much of the advocacy involved with public input for the Strategic Plan is likely to center around the issue of vaccines. In regards to this topic in specific, and all topics in general, I would like to ask that the IACC please stay with the scientific method in evaluating specific parts of the Strategic Plan and its implementation. This is one of the strengths of the NIH and NIMH and should be followed in autism research.

The Institute of Medicine in their report on vaccines and autism rejected the theories that vaccines cause autism and further stated, “the committee recommends that available funding for autism research be channeled to the mostpromising areas.” Truly, we need to insure that limited money, time and researcher resources be applied to the most promising areas. The vaccine/autism theory does not meet that standard. This has been made even more clear by the study of Hornig et al., which has clearly shown that science doesn’t support the idea of MMR causing autism. The CDC website notes that a thimerosal/autism study is due out this month (September 2008) as well. Should this study also not support the autism/vaccine hypothesis, the idea should be put on a “watch” list, rather than an “active research” list.

The Strategic Plan allows for updates to respond to new research. The current plan to monitor the literature in case new, relevant research comes forward indicating that the autism/vaccine question should be pursued. This is the appropriate approach.

I am the parent of a young child with autism. Even with that perspective, I feel that adult issues are the most important and subject area that the IACC could concentrate upon. The time lines for studies in “what does the future hold” are far enough out that real results could be expected by the time that adolescents and even children are adults. Our children will spend most of their lives as adults. Much of their adult lives will be spent after we, the parents, have passed on. There is a very high probability that adults with autism are currently vastly undercounted. Should the true incidence be relatively flat across age groups, adults make up the majority of people with autism.

Much more effort should be focused on adults than is in the current Plan.

One goal of the Plan is “Conduct at least two clinical trials to test the efficacy and cost–effectiveness of interventions, services and supports to optimize daily functioning (e.g., educational, vocational, recreational, and social experiences) for adolescents, adults, or seniors living with ASD by 2012.” Two clinical trials seems quite small when divided amongst three age groups (adolescents, adults or seniors) and multiple areas of daily functioning. These are areas which could use much higher levels of support.

One goal not often mentioned is to bring new researchers into the autism field. Autism is a long–term project and capturing the best researchers possible is a goal unto itself.

Another area which I see in the Plan but is worth stressing more is the idea of diverse populations. The data available make it clear that a serious undercounting of autism likely exists amongst minority groups and people outside of urban centers. It would seem urgent to find out why this is occurring and seek methods of correcting it.

Therapies and treatments for people with autism should be based on research. Unfortunately, there is much alternative medicine practiced in the autism community. While one goal could be to research these practices, we do not have infinite resources of time, money and research groups. Topics must be chosen using a firm basis in science and the peer–review process, with an eye towards protecting the rights of the autistic individuals who would partake in these studies. To that end, emphasis must be placed on treatments which have biological plausibility. Therapies, such as chelation, which are based on concepts which are not plausible should not take time and money away from projects which have some plausibility. Popularity amongst alternative–medicine practitioners should not be a criterion for using scarce resources.

I appreciate your time in this matter,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Friday, September 05, 2008 10:42 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00021] RFI identifier, NOT-MH-08-016 Response to Autism Strategic Plan

Dear Coordinating Committee Chair:

Thank you for the opportunity to respond to the draft Autism Strategic Plan by the Interagency Autism Coordinating Committee.

Having participated in the early stages of the draft plan, including the Ballston meeting in January, I was surprised by the lack of emphasis on animal and cellular model systems to investigate the biological causes of autism, as well as model systems for evaluating treatments. While mention was made in four places, there was only one brief Objective, on page 20:

“Standardize and validate three model systems (e.g. cellular and/or animal) that replicate features of ASD and will allow identification of specific molecular targets or neural circuits amenable to existing or new interventions by 2012.”

Restricting the goals to three model systems will not even begin to address the many compelling hypotheses about the causes of autism. A large number of candidate genes will need to be evaluated in animal models. Hypotheses about immune dysfunctions, environmental toxins, etc. will require independent model systems. Three will not be anywhere near sufficient to discover and evaluate proposed treatments. Treatments for distinct endophenotypes in autism will require a variety of model systems for preclinical testing.

A simple fix for this serious problem is to change the word “three” to “multiple”, to read “Standardize and validate multiple model systems that replicate…” If a number needs to be stated, then “at least 20 robust model systems by the year 2012” might be appropriate.

NIH and private foundations are right to focus on clinical studies and address immediate needs of families with autistic individuals. However, NIH must be the primary source of funding for basic research to discover the true biological causes of autism(s). Parent advocacy foundations have a much harder time in funding basic research. The mission of NIH is on bench to bedside research, particularly the use of animal and cellular model systems for basic research. Please correct this unfortunate lack of emphasis in the Autism Strategic Plan.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 09, 2008 3:43 PM
To: IACC (NIH/NIMH); IACC Services (NIH/NIMH)
Subject: [Comment 00022] RFIs: Draft Strategic Plan for ASD (NOT-MH-08-021 ) & Priorities (NOT-MH-08-016)

Dear Interagency Autism Coordinating Committee:

I am pleased to provide the following feedback based on your RFIs (NOT–MH–08–021 & NOT–MH–08–016).

A few years ago, my son had daily ADHD incidents and dyslexia. At first, we followed the officially accepted treatments. The results were disappointing; however, when I found alternative treatments that use the same techniques [redacted personally identifying information] used in [redacted personally identifying information] profession to remove capacity bottlenecks in large computers, [redacted personally identifying information] achieved breakthrough results for those conditions. His last ADHD incident was nearly two years ago. Today, we have a very different, normal child.

Intrigued by these experiences and the lack of interest by officials and scientists, [redacted personally identifying information] began [redacted personally identifying information] private research initiative. An initial finding was that there are many indicators of good to breakthrough treatment results (particularly for dyslexia). Strangely enough, this doesn’t appear to be seen within the scientific community. It leads to the following questions: (A) Why is this not being noticed? (B) Why doesn’t desperately–needed research get off the ground? As I hope to make clear below, the answers to these questions are highly relevant to ASD.

For somebody familiar with capacity management, here is one issue that relates to the phenomenon of capacity bottlenecks: Whenever an architect designs a complex system such as a new airport terminal, a skyscraper, or computer, there must be a lot of attention paid to avoiding capacity bottlenecks. Otherwise the system may/will not work properly. We typically experience the consequences of a bottleneck in a traffic jam, such as where three lanes reduce to two. The consequence is a queue. Strangely enough, when it comes to what some consider to be the most complex system we know of (the brain), this phenomenon doesn’t appear to get attention.

For example, at the International Meeting for Autism Research (IMFAR 2008) I attended, I did not come across a single remark suggesting capacity bottlenecks had been considered. Moreover, capacity management techniques are well known. Yet to this day, I haven’t come across any references suggesting the consideration of capacity management techniques for treating mental disorders. More information is available from the paper “Hypothesis: Capacity bottlenecks cause mental conditions and disorders” [1]. With this, a first answer for question “A” emerges: There is an obvious knowledge, experience and research gap of critical importance.

In addition to the capacity bottleneck hypothesis, [redacted personally identifying information] research initiative involves an information management model. The model outlines – in theory and based on fundamental architectural criteria as seen in the brain – how, at the neuron level, information management could happen inside the brain. By adding bottlenecks to it, the model also explains how bottlenecks in different locations lead to different symptoms – symptoms that are associated with dyslexia, ADHD, autism, etc. Based on this [redacted personally identifying information] proposing how, in theory, certain autism symptoms could develop at the neuron level [2]. [redacted personally identifying information] author [redacted personally identifying information] is a specialist in autism.

Regarding the relevance of the model, I would like to note that it is developed and published to a level of detail that it can be programmed. In a next step, its relevance needs to be confirmed. Then simulations must be done – for example, simulating autism symptoms. The model has been presented to scientists with various backgrounds in brain research. So far, nobody has pointed to any reasons why the model would not provide a reasonable explanation as to how the brain processes information and how symptoms develop.

The immediate challenges are to get [redacted personally identifying information] published, funding approved and research started. The obstacles, however, seem insurmountable. But that is no surprise; it is common for anything considerably different from the general line of thinking. In this case, the capacity bottleneck theory and the model address the brain as a single, complex dynamic system. The approach also assumes that in a complex dynamic system, there may be no exact answers. On the other hand, brain research is highly fragmented, and it appears there is a strong focus on finding exact answers. As a consequence, the model and the capacity bottleneck theory don’t fit into a research discipline. Yet another major obstacle is procedural requirements, whether for research funding or acceptance for publication.

Of course, [redacted personally identifying information] biased on this topic, and it is only a theory at this time. But is it that simple? The fact is that at IMFAR2008, some 750 oral and poster presentations took place. Moreover, 15,000 abstracts are submitted each year to the annual conferences of the Society of Neuroscience. This gives an indication of the number of research projects done each year (which must be much higher). Despite this enormous number of projects, breakthrough understandings of the brain and of autism have not been achieved. This alone gives reason to argue that the breakthroughs may come from unexpected places, and that breakthroughs may look extremely different from where research is focused today.

Moreover, I see that there is mention of the biological basis of ASD in the strategy paper. But what about the information management basis of ASD? This by itself is an enormous area for causing all sorts of abnormalities. Today, this area seems to be too challenging to address. I disagree. Ref. [2] [redacted pending information].

The main point I hoped to make through the examples above is this: There is a realistic possibility that the breakthroughs will come from unexpected places and will not fit into today’s thinking. In today’s environment, however, extremely few people can be expected to go through the enormous challenge of overcoming what appear to them as insurmountable obstacles. Consequently, the new research strategy should make absolutely sure obstacles that prevent breakthroughs from taking place are removed.

With deeply embedded procedures, protocols, working practices, etc., this is no easy task. The straight-forward solution would be to extend the existing strategy to contain a space specifically for innovative and even radically different proposals. Ideally, the only thing that matters in this space should be reasonable indicators of breakthrough potential (with or without scientific background). As long as health risks from proposed treatments are equal to or lower than those from existing treatments, any other requirements should be low priority. What is also needed is proactive support. This means that one top priority should be on funding and providing supporting structures (inclusive mentoring) for such proposals. Why not make one–third of the budget available for this purpose?

Most importantly, as a father who has experienced firsthand how a breakthrough treatment made a dramatic difference in our family, I urgently appeal to the IACC to support and ensure the creation of an environment that enables breakthroughs to surface and become available as soon as possible. Of course, I’d be happy to answer any questions and provide additional information.

Kind regards,

[redacted personally identifying information]

References

[1] E. Oetringer and M. Fitzgerald: Hypothesis: Capacity bottlenecks cause mental conditions and disorders. Bioscience Hypotheses, doi:10.1016/j.bihy.2008.02.002

[2] [redacted pending publication] Submitted

From: [redacted personally identifying information]
Sent: Wednesday, September 10, 2008 10:57 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00023] NOT-MH-08-021 How Can I Understand What is Happening

To Whom It may Concern:

I am a high functioning unemployed autistic man and I would like to write some suggestions to the IACC. If researcher lauren mottron is getting funding from the federal government I urge that this be discontinued immediately. He has an employee named [redacted personally identifying information] in his lab who undermines the nobel goal of finding a cure for autism that was emphasized under the combatting autism act. Also, Morton Anne Gernsbacher an autism researcher who wrote an essay entitled autistics need acceptance not cure should not be allowed to engage of peer review of scientific articles that have been funded under the combating autism act. Also, Mark Blaxill and Lynne Redwood’s membership on the IACC should be discontinued immediately as they continue to believe in the disproved hypothesis of thimerosal causing autism and will only undermine scientific advancement into finding a cure for autism.

Psssst…Have you heard the news? There’s a new fashion blog, plus the latest fall trends and hair styles at StyleList.com.

From: [redacted personally identifying information]
Sent: Wednesday, September 10, 2008 8:29 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00024] NOT-MH-08-021-Research Opportunities and Section III and IV

Dear Staff of the IACC

As the mom of an autistic child living outside the USA I appreciate the possibility of sharing my personal concerns that this open question for feedback allows, internationally. I will focus in three areas III. What Caused This To Happen And Can This Be Prevented?, IV. Which Treatments And Interventions Will Help? And the Research opportunities.

There are several aspects that need attention in several areas (social, education, advocacy and family) but I am very much concerned now about biological concomitant medical problems (BCMPs&41; to the diagnosis of ASD and how they are tested, diagnosed and finally treated. Personal experience gave me the negative experience of having an ordaly to get the proper attention to the testing/diagnosis and treatment of the gastrointestinal, immune and autoimmune, sensorial, nutritional, toxicological, biochemical, metabolic– –and mitocondrial– –problems my son demonstrated to have. It was extremely difficult in the context of the current paradigm of what is considered autism and the lack of training, knowledge and attention given by peditricians/gastroenterologists/neurologists/generalists to these problems related to ASD patients. Especially when there are concomitant several problems of this kind that are not clear or are presented as subclinical in key steps of a toddler development, without the clinical presentation of an infectious disease. There are three steps that need urgent attention

  1. the Testing: Involving controversial areas such as
  2. a–Bioaccumulation of toxic and essential elements, deficiency of key essential ones

    Even when the anecdotic evidence of imbalances in toxic and essential elements in autism is overwhelming, they are seen always in the minor status of anecdotical and non–systematized evidence and remain unanalyzed as such. However, there is no available test for bioaccumulation of Hg, Al, Pb, As, Cd and/or imbalances in Ca/Mg/Zn/Fe/Cu properly considered in a protocol of testing of BCMPs in ASD, after the diagnosis. Even more, there is no controlled trial of the impact of protein restriction without Se or aminoacids supplementation, in the status of Ca/Mg/Zn/Fe/Cu/Hg/Al/Pb/Cd/As in urine, blood, and Fecal stool every 1/2 months on time on a protein–restricted diet, such as a gluten free casein free and soy free diet.

    With the information about the lack of homeostasis in aminoacids/proteins many autism subgroups have and with the importance of aminoacids (proteins) /Se/glutathione system in the transport and management of toxic and essential elements, this controlled trial would give information about the importance of the protein avoidance as a test to know about potential impact of endogenous mismanagement of proteins from food in the essential and toxic elements metabolism. There should be increased efforts to develop a toxic elements/essential elements bioaccumulation test, avoiding the so called provocation test using chelating agents, which is controversial and whose “normal Ranges” are debatible and controversial, in blood, urine and fecal stool.

    The dietary restrictions should be enough studied, proposed and deeply researched based on the known metabolic and biochemical imbalances that are present in many autism subgroups and not based in the use and the behavioral aspects only. Clinical research and the goal of the characterization of biomarkers of systemic and physiological BCMPs in ASD should be the rule.

  3. Coinfections of fungal, bacterial and viral–chronic or persistent or cyclic–and their role in ASD
  4. There has been no systematic effort to characterize the coinfections of fungal infections (candida albicans and others), bacterial infections (wild such as clostridia, GABHS, mycobacteria, giardia, klebsiella, staphylococcus and related to vaccine composition– –DtaP and others) and viral infections.– –RNA/DNA viruses of vaccinal–measles, mumps, rubella, HepB– –or wild origin–the previous plus herpes such as HV1, HZV,CMV, EBV, HH–6, HH–7– –in combination and their role in ASD.

    In the case of the bacterial aspects, not only the infection per se but also the consequences in a dysbalanced/dysfunctional immune system or the potential adverse effects– –such as the impact in the angiotensin–renin system in the case of the DtaP– –have not been deeply researched. In the case of the viral aspects, there is a need of the search for unknown or not considered before situations, looking at the known status of the art of the implicances of persistence–in the case of the hypothesis of such– –in terms of viral replication, mutation, recombination, immune evasion and secondary impact of the lack of viral cleareance– –beyond antibodies generation– –and the consideration of the immune/nutritional status of the host at the time of the wild/vaccinal postnatal exposure (Selenium defficiency, vitamin A/vitamin D defficiency, liver dysfunction or immune immaturity). The need of the use of sophisticated techniques to test for unknown viral species– –instead of the comparison with known strain primers– –and the reformulation of the questions is of paramount importance especially considering coinfections and persistence in tissues (gut for example) with the state of the art knowledge. Testing in fluids and tissues should be done after the formulation of more sophisticated questions than before, using techniques for unknown viral species and for the definition of the importance of coinfections of virus with fungus and bacteria (chronic or persistent and/or cyclic vs acute) in ASD vs non– –autistic controls…

c-The development of a protocol for testing BCMPs in ASD

A coherent and consensuated protocol of testing should be present to detect the BCMPs to an ASD diagnosis considering the state of the art. Today the protocol is part– –many times– –of a familiar private effort– –talking internationally– –to get the best combination of tests considering the best doctor you can get– –able to read about the topic and to research on the individual situaton. The protocol should be able to detect genetic metabolic conditions– –beyond the genetic reasons of ASD such as X fragil or MR X linked– –,autoimmune and immunological conditions, gastrointestinal problems and nutritional imbalances, mitocondrial and biochemical/metabolic imbalances in the management of minerals, vitamins and aminoacids and toxicological bioacumulation of toxic and essential elements using non-invasive procedures (tests of blood, urine and fecal stool) as much as possible.

II. the Diagnosis of BCMPs

The diagnosis of the kind of medical situations many autistic children/teens and adults have requires knowledge about how to search, what to search and how to analyze the results. The average peditrician or doctor does not have this kind of knowledge in front of an autism diagnosis– –even an specialist– –that many times comes from the neurology/the genetics, the pshychiatry or the pshycology– –but not from the biochemistry/general clinic medicine or the molecular biology field. The result is the lack of testing, of diagnosis and of treatment of BCMPs– –not related to specific genetic conditions such as phenylketonury or succinic semialdehyde dehydrogenase deficiency– –to an ASD diagnosis. Even many metabolic genetic conditions are not tested in the current paradigm of the approach to ASD

III. The treatment of the BCMPs- Beyond the “autism cure” and for a better life quality of the today’s autistic my son is and for the treatment and/or prevention of medical problems related to environmental exposures to xenobiotics and wild/vaccinal exposures. After the development of proper testing tools and a Search protocol, an effort to the development of the best approach to treat them should be done, looking at the risks/benefits and focusing in the well being of the human being the autistic person ( /toddler/child/teen/adult) is. The use of pharmacology to control behavior should be the last resource, after the proper testing and consideration of underlying metabolic, nutritional, immunologic– –viral/bacterial/fungal– –gastroenterologic, biochemical, mitocondrial and toxicological aspects that could be related to certain behavior because of pain, sensorial disturbance or neurological impact of these conditions– –esulting in brain dysfunction– –in combination or not..

The need of the detection of a potential subgroup of children prone to adverse reactions to vaccines in accumulation– –considering full vaccination schedules and full composition– –should be properly considering taking into account

  1. the (epi) genetic aspect and the immunological, gastrointestinal, nutritional and developmental changes (from the xenobiotics management system to the mucosal immunity) that take place the first 2 years of life
  2. b) considering the kind of nutrition/protection the brain receives during this key step of a human being life– –from birth to 3 years– –and how vaccine schedule could compromise the gut-brain axis in susceptible individuals– –especially with the current pediatric management of childhood (age of the introduction of solid food and bottled milk and the use of antibiotics for the wild infections) and
  3. analyzing the systemic and mitocondrial/metabolic/gastrointestinal/immune/inflammatory impact the full vaccination schedule has in autistic vs non–autistic children– –beyond antibodies generation.

This way, with the new knowledge this approach may give, precautionary measurements could be included to avoid, to prevent or to properly treat if and when happen the adverse reactions to vaccines and not years after the adverse event, when the impact of them is potentially not reversible, depending on the individual situation.

Thank you for your attention
[redacted personally identifying information] (Mom of an autistic child–PhD Chemistry) and
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Thursday, September 11, 2008 5:35 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00025] Response to RFI NOT-MH-08-021
Attachments: ResponseToStrategicPlan.doc

Please find attached my comments in response to RFI NOT–MH–08–021, Strategic Plan for Autism Spectrum Disorder Research.

Regards,

[redacted personally identifying information]

<<ResponseToStrategicPlan.doc>>

[redacted personally identifying information]

On page 9, under short term objectives, first bullet

Developing at least one diagnostic instrument, based on existing tools should not require three years. Deadline should be by 2010, not 2011.

On page 9, under short term objectives, second bullet

There is a deadline of 2012 proposed for validating existing screening tools. I believe such validations should be on–going, never–ending process as our knowledge–based understanding changes by time. For example, validate in every 4–5 years?

On page 9, under short term objectives, second bullet

It is proposed to develop five measures of … It should not be limited by five. Better wording would be “at least five measures…”

Page 11, What do we need?

One of the greatest difficulties in diagnosing the ASD, treating it and accepting it in the community is the absence of a clear–cut boundaries between ASD (especially high–functioning Asperger’s syndrome) and neurotypical individuals. Unlike, for example, Down’s syndrome whereas one either has it or not, all behavioral and cognitive features of ASD exist in all individuals at varying degree.

We need to introduce a concept of “ASD trends” and some measuring tool of such trends.

Page 15, Research opportunities

Besides the environmental factors listed in bullet 5, ordinary metabolites should be also studied on the subject of having exaggerated, even if only short–term, effects in manifesting the ASD symptoms. Essentially, all metabolites which are transferred into neurotransmitters, or have any other effect in synaptic activity, should be studied.

Page 16, Long–Term Objectives

In bullet 3: Year 2014 may not be realistic for identifying genetic risk factors in at least 50% of
children. Indeed, ASD doesn’t seem to be caused by malfunction of a single or even few genes. Interaction of multitude of genes and of many genes with environmental factors is shaping up to be the case. Such short target as 2014 may put undue pressure on providing the results that may not be feasible scientifically.

Pages 17, 18

Language in this section implies that currently existing medications may or may not help. It is enormously important to give parents and staff working with ASD individuals more realistic picture. Namely, that some medications can lead to disastrous results. Tools are needed to aid such individuals (especially the parents) to properly evaluate risk/benefits
ratio for any proposed medication.

Page 20, Long–Term Objectives

Add one more bullet:

Complete randomized controlled studies of long-term (10+ years) effects of the intervention
methods.

Page 22, Long–Term Objectives

Add a bullet:

Community education programs aimed at resolving perceptual conflicts that too much resource is allocated for too few special children. It needs to be explained that in the long term, it is much more economically prudent to help ASD individuals become more self-sufficient and potentially tax–paying members of the community rather than 100%–dependent.

From: [redacted personally identifying information]
Sent: Thursday, September 11, 2008 9:02 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00026] Comments on IACC Autism Strategic Plan
Attachments: IACC 2008 report reviewfinal.doc; ATT7448512.txt

To the IACC,

Thanks for your hard work. Attached are my critical comments on this document.

[redacted personally identifying information]

Review of “Interagency Autism Coordinating Committee Strategic Plan for Austism Spectrum Disorder Research” dated August 15, 2008.

[redacted personally identifying information]

Overall, this report proposes a relatively comprehensive strategic plan that addresses a wide range of concerns of the families affected by autism spectrum disorders (ASD). There is some attempt at balance of objectives covering the needs for research into basic science, etiology, prevention, biomarkers, diagnosis, services, intervention, and treatment. However, some of the areas are much better covered than others, and therefore, in this review, I have focused on deficiencies or areas in need of further development in the plan. Whereas many elements of the strategic plan are rational and sound, the gaps or inadequate development of certain fields of inquiry may hinder progress that otherwise would be feasible in the short– and long–term.

Major concerns:

The principal areas of deficiencies in this report are the plans and objectives related to basic biology (primarily in Section II, “How Can I Understand What is Happening?”) in relationship to the core features of autism, and environmental factors as etiologic agents (primarily in Section III, “What Caused This to Happen and Can This Be Prevented?”).

  1. Basic Biology.
  2. Section II on p.12: The Short–Term Objectives related to the underlying biology of autism are a bit vague, and rather inadequate to the task ahead. The second bullet point is “Support at least four research projects to identify mechanisms of metabolic and/or immune system interactions with the central nervous system that may underlie the development of ASD during prenatal-postnatal life by 2010.” A crucial question is: what constitutes a ‘research project.’ If there were only four individual focused investigations nationwide, it would be quite pitiful. Furthermore, metabolic mechanisms should be separated out from the immune mechanisms, as the hypotheses are rather different, involve different organ systems, and by and large, different expertise and groups of researchers. Fortunately, more than four projects are already underway, and in some cases, results are appearing in the literature. What would truly advance the field would be four major programmatic efforts in each of several areas. Three potential areas (this is not an exhaustive list of course) might be: oxidative stress/metabolism, immune dysfunction, and hormone disruption, e.g., thyroid or sex steroids. To do justice to any of these areas and put them at the level of their proper importance, a ‘research project’ would then need to be defined as a program of research involving multiple arms, such as a focus on immune function using a combination of: human developmental, behavioral phenotype, and molecular studies: or clinical evaluations of inflammation, MRI imaging/brain growth, and animal models.

    Moreover, without a truly major effort – far more than what is called for in this draft strategic plan, the objective for biomarkers in section I (p.9) is very unlikely to succeed or else the markers developed may end up only marginally useful. Biologic markers with adequate specificity and sensitivity to be useful in prediction or if not prediction, then in elucidation of mechanisms, need to be based on a much–expanded program of research into biologic systems that interact with the developing brain. Biomarkers can only be developed from sound, well–funded science. Thus a greater commitment to discovering the basic biology of autism spectrum disorders will strengthen activities in other domains.

  3. Environmental Factors.
  4. The discussion of “What do we know” under Section III is rather scattered, the examples are uneven, the slow progress in identifying susceptibility genes is not acknowledged, and the interpretation of genetic research omits important frameworks related to geneXenvironment interactions. The Short Term Research Objectives with regard to environmental causes of autism are too modest to move the field forward in any significant way. The Long-Terms ones for environment may be unrealistic. None of the Objectives broaches the critical importance of tackling geneXenvironment interactions.

    “What do we know?” Though this may seem like quibbling, the examples of non–genetic environmental exposure are somewhat questionable. The literature on maternal age is at least as strong, if not stronger than that on paternal age, but the former was not even mentioned. Moreover, paternal age could be argued to represent primarily genetic and chromosomal influences and therefore is not a best example of a nongenetic factor, whereas maternal age may represent, in addition to genetic/chromosomal factors, a wide array of physiologic, immunologic, hormonal and other environmental influences on the fetus. Birth weight is a very complex and exceedingly heterogeneous and nonspecific marker that is hard to classify as an exposure per se, as there are small adults, small children and small babies for whom nothing is aberrant at all. Birth weight independent of gestational age is even less meaningful and a shift in mean birth weight can occur with no resulting impact on perinatal health (See, e.g., Wilcox & Russell 1986, Sanderson et al 1994, Adams et al 2003). On the other hand, dietary factors and medical exposures are two huge classes that deserve to be included in any strategic plans for evaluating environmental factors. Regarding toxicant exposures, these occur through such a broad range of human activities that some elaboration would be appropriate, e.g., based on chemical classes, on routes of exposure – air, water, food, household products – or on expected uses or activities through which human interaction takes place. Additionally, the final sentence of the first paragraph appears to be pure speculation (that the balance of genetic and environmental contributions likely varies across the spectrum); at this stage, one could argue for either direction of that ‘balance’ or that the balance may be totally unrelated to severity.

    It is stated that defining environment is difficult. It should be pointed out that defining genetics is also difficult: the critical distinction between hereditary and genetic is glossed over in the second paragraph of this section. Gene expression and epigenetics indicate the complexity of how genetics can/should be defined. Whether this complexity has hampered progress in genetics research is probably open to discussion, but in any event, there is no reason to limit the problem of definitions to environment. This second paragraph, which is devoted to genetics, also refers to ‘spontaneous” deletions as possible “causal factors of ASD” but these spontaneous events may be hypothesized to occur in response to environmental exposures of one type or another. Perhaps the lesson here is that geneticists and environmental scientists need to come together to unravel this problem! Unfortunately, the flavor of this exposition does not serve to point the research community in the direction of such collaboration.

    The third paragraph provides one perspective on the implications of genetic research to date, but another view is also possible. One might interpret the findings as indicating the importance of common polymorphisms (hence the small number of high penetrance genes identified) that each may confer mildly increased risk that only manifests in the presence of multiple moderately risky alleles and/or the right combination of environmental factors. At the recent IMFAR meeting, this perspective was made explicit by one of the plenary speakers (Bourgeron), who discussed the trade–off between specificity, high relative risk and low impact on the one hand vs. low relative risk but high actual impact on the other. If the IACC prefers to emphasize the former as a strategy, perhaps because the gains seems more within reach, then at least the wider universe should be acknowledged with some perspective on when and how other avenues might also be pursued.

    Whereas some advances in identifying susceptibility genes have been tangible, given the huge resources invested, the progress has been slow. At the same time, advances have also been made with regard to environmental risk factors. For instance, the paragraph on p.14 should mention several studies that suggest a potential role of pesticides in the development of autism or autistic behaviors (Eskenazi et al 2007 and Roberts et al 2007). (Again paternal age is cited as an environmental factor – see comment above).

    Under “What do we need?” it is stated that “few studies have ruled in or ruled out specific environmental factors.” This is indisputable, but the more pertinent fact is that few studies have been funded to address the role of specific environmental factors. This paragraph argues that the lack of consensus on how to define environment has hampered research. Where is the evidence of this? Moreover, the difficulty in defining environment has not prevented progress in research on cancer, birth defects, asthma, other respiratory conditions, cardiovascular disease risk and numerous other important health outcomes, thus it should not be held up as a serious obstacle to the field of autism etiologic research. The lack of resources and the failure to attract knowledgeable experts on environmental health into this area have been far greater obstacles.

    This section of the strategic plan asserts the importance of longitudinal approaches; it should also assert the critical importance of case–control studies, especially in the relatively young stage of knowledge on autism etiology. Recommended language might include:

    “As in most health outcomes research, especially for relatively rare (<5% prevalence) conditions, case–control studies are an effective first line of inquiry to begin accruing data, both focused and broad, on disorders with multifactorial etiology. The CHARGE (Hertz–Picciotto et al 2006) and CADDRE (SEED) Studies are good examples of case–control investigations where the environmental exposure and biologic pathways along with genetics, are being (or will be) examined, while database–driven approaches for this design have also contributed new knowledge (Roberts et al 2007, Hultman et al 2002). Case–control studies are less expensive for the same level of statistical power and often quicker in producing results than the large cohort studies. Although the exposure information can be of lower quality, this is not entirely the case, and when existing records or monitoring systems providing objective exposure data that can be linked to cases and controls on an individual basis, the case–control design can be exceedingly efficient and powerful in both the lay and statistical meanings of those words.

    Under “Research opportunities” (p.15), case–control studies of ‘unique subpopulations’ are suggested. It’s not clear what is intended by this language, nor why any populations of persons with ASD should be excluded from study.

    A very modest “Short–Term Objective” is proposed with regard to environmental factors:

    “initiate studies on at least five environmental factors identified in the recommendations from the 2007 IOM Report “Autism and the Environment: Challenges and Opportunities for Research.”

As [redacted personally identifying information], and [redacted personally identifying information], to that IOM report, I can say that currently in the CHARGE Study [redacted personally identifying information] investigating no fewer than eight environmental factors. Thus, this objective could be considered met, and no further work would need to be initiated. That conclusion would be a terrible mistake. Besides understating what is possible and appropriate, this objective suffers from having lumped all environmental factors into one objective. Instead, distinctions would underscore the breadth of areas where new knowledge can and should be generated.

An alternative to what is in this draft would be the following objective(s):

  • Studies be launched to address a variety of environmental domains: (a) at least ten environmental chemical toxicants, (b) at least five medical exposures, (c) at least five nutritional or metabolic factors, and (d) at least three hormonally relevant hypotheses. Alternatively, it could be worded in terms of not numbers of exposures but numbers of studies launched.
  • This proposed Short Term Objective is eminently feasible. Notably, because virtually no funds have been invested in geneXenvironment hypotheses, there has been no progress on this front. The state–of–the–art and the infrastructure already exist, in which advances are possible. The strategic plan ought to take this as a challenge for the upcoming period and include a further short–term objective

  • Initiate efforts to expand existing large case–control and other studies so as to enhance capabilities for targeted geneXenvironment research
  • An additional objective should also be included, which would be the way to meet the modified (first) objective of this section (which I’ve outlined above, to include multiple types of environmental exposure domains)

  • Support new and existing case–control studies with enrollment of broad ethnically diverse populations affected by ASD
  • With regard to the “Long Term Objectives,” it’s difficult to definitively determine effects of environmental chemicals, and for any specific exposure, it may take 3 or 4 well–conducted studies. Thus, the first objective may not be realistic, and perhaps needs rewording such as:

  • “Generate high quality data in at least two investigations of the effects from each of at least five environmental factors…by 2012.”
  • The point here is that replication will be needed and that high quality leads can be generated quickly to spark further focused studies. The additions to the Short Term Objectives would make this long term one realizable. Currently there is insufficient funding to follow–up leads that have emerged.

    To fulfill the need for integration of the genetic and environmental research efforts, a further Long–Term Objective should be included:

  • Maintain and increase sample sizes of existing comprehensive case–control studies to ensure that they can effectively address geneX environment interactions for moderately common exposures and genes with prevalences of 5–15% or vice versa, moderately common genes and exposures with slightly lower prevalences.

Lesser points:

p.3: The “Vision Statement,” by focusing on those with ASD, could seem to be omitting the need for prevention. I’m sure this was not the intention, and certainly, any success in prevention should result in increased resources available for each individual with ASD. Moreover, prevention appears on the next page.

p.5: Under “Resources,” the point regarding well–trained researchers is weakly stated. An emphasis on attracting new researchers into the field of autism research is needed. Specifically, suggested language might be:

“Attracting a cadre of rigorously trained scientists, including those who come from outside the area of autism research, will assist in bringing innovative ideas and inter–disciplinary approaches into this field and should be viewed as a priority.”

From: [redacted personally identifying information]
Sent: Friday, September 12, 2008 9:26 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00027] NOT-MH-08-021

IV: Which Treatments And Interventions Will Help?

I am not a medical professional – – I can only speak from personal experience. My 3–yr–old twin grandsons were both obviously developmentally delayed, and in spite of speech and play therapy sessions several times a week (not covered by insurance! ) since they were 18 months old, neither of them was making any noticeable progress. Then last January, [redacted personally identifying information] was diagnosed as autistic and [redacted personally identifying information] was diagnosed with ASD (autism spectrum disorder). Their pediatrician essentially said “Sorry – nothing to do but continue therapy and hope for the best. Expect them to live in a group home when they grow up.”

Fortunately for my grandsons, their parents were not satisfied with that response, so they began to research other options. We are not a family given to alternative anything – – but in this case, the alternatives were the only options available. Since the boys have been tested for nutritional deficiencies (tests not covered by insurance; they both had plenty of those, in spite of appearing healthy and well–fed) and being started on nutritional supplements (not covered by insurance!) plus a casein–free, gluten–free diet, they have both shown amazing improvements in their development. [redacted personally identifying information] is now testing very near his age group in most markers, and [redacted personally identifying information] has made huge strides in speech, as well as cognizant and social skills.

They continue to receive speech and other therapies, along with their public school curriculum. It has been a financial struggle for the family, since their Mom cannot work and also get them to all the places they need to be for their various therapies. The therapies and the special diet are costly, and the nutritional supplements cost them hundreds of dollars each month. The fact that virtually none of their treatments are covered by insurance has been a terrible drain on the family finances. I pity any single parent who has to go through this -- I can't imagine how they can manage it.

If these so–called alternative treatments were recognized as valid treatments by the medical community, then the insurance companies would surely be required to cover at least some of this extraordinary cost. And parents who are not saavy enough to do their own research could also be given the hope that just maybe there is something that they can do that will help their child to reach his or her full potential. To be told by their doctor that there is nothing that can be done is to give the child no hope for a decent future. THERE IS HOPE, and it should be made available to anyone who needs it.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 15, 2008 9:29 AM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00028] RFI Notice NOT-MH-08-021
Attachments: MagellanResponse to NIMH RFI(2).doc

Good morning:

On behalf of Magellan Health Services, thank you for the opportunity to provide comments on NIMH’s Request for Information regarding the issues surrounding services and support to individuals with Autism Spectrum Disorders (ASD). Attached, please find Magellan’s comments for your review and consideration. Thank you, [redacted personally identifying information]

***Confidentiality Notice***This electronic message transmission contains information belonging to Magellan Health Services that is solely for the recipient named above and which may be confidential or privileged. MAGELLAN HEALTH SERVICES EXPRESSLY PRESERVES AND ASSERTS ALL PRIVILEGES AND IMMUNITIES APPLICABLE TO THISTRANSMISSION. If you are not the intended recipient,be aware that any disclosure, copying, distribution or use of this communication is STRICTLY PROHIBITED. If you have received this electronic transmission in error, please notify us by telephone at [redacted personally identifying information]. Thank you.

Magellan’s Response to the National Institute of Mental Health (NIMH) Request for Information Related to Autism Spectrum Disorders (ASD)

Magellan Health Services, Inc. (Magellan) welcomes the opportunity to respond to NIMH’s Request for Information regarding the issues surrounding services and support to individuals with Autism Spectrum Disorders (ASD). Magellan, the nation’s leading manager of behavioral health and substance abuse services, currently offers assistance focused on the unique needs of this population to individuals with ASD and their families through a network of approximately 60,000 behavioral health providers. The variety, intensity, and comprehensive nature of services needed by individuals with ASD – – as well as professional involvement from various disciplines – – requires coordination, experience and a comprehensive approach that is goal oriented and sensitive both to the individual and the family.

Magellan’s program includes comprehensive, coordinated care to children with ASD and their families by coordinating care with pediatricians and developmental specialists for evaluation and diagnosis, Early Intervention Services for ages 0 – 3, and pediatric specialists who treat children with ASD for medical issues. Magellan refers to behavioral health providers to address behavioral issues such as aggressive or self–injurious behavior and non–compliance and for high functioning individuals with ASD for behavioral therapy sessions to promote improved function and address co–morbidities.

In addition to the core behavioral health services that Magellan provides to the public sector and health plans, Magellan is also currently involved in locally–based, advocacy activities related to promoting the principles of consumer involvement and empowerment. Since early 2007, 26 [redacted personally identifying information] families of children with ASD have been able to make purchases to help them achieve resiliency goals such as keeping children safe and furthering their children’s socialization and communications skill due to Magellan’s self–directed care program. Government and industry leaders have recognized that self–direction is a key component of mental health recovery. Self–directed care programs address the goals of improved functioning and quality of life.

Magellan would like to offer the following recommendations related to ASD research as well as other recommendations related to ABA training and federal legislation.

Recommendations

Intervention Research

Magellan supports additional research focused on behavioral therapies, such as Applied Behavior Analysis (ABA), including randomized controlled trials and trials that compare ABA to other techniques. More treatment research is needed with strict empirical designs that can allow for sound inferences regarding the parameters of treatment effectiveness and can answer current questions about features of children who are most likely to respond.1 To date, most of the published literature on ABA involves studies that have several methodological problems, including lack of a clear definition of the ABA treatment and its protocols (e.g., many studies refer to using the Lovaas method manual and video), lack of control groups using established treatment alternatives, poorly chosen or poorly specified samples, outcomes measured only in limited areas (e.g., IQ), and outcome measures giving little information regarding the totality of the treatment impact. Use of a battery of assessments, both specific and global, is needed to give a comprehensive and detailed picture of treatment effects.1, 2 Additionally, most research on ABA programs has centered on preschoolers with autistic spectrum disorders and therefore research on comprehensive programs for older children and adults with autism is needed.

As outlined in the RFI, Magellan agrees that intervention research should focus on the mode of delivery, intensity, duration and dose as well as unique characteristics of the individuals with ASD in an effort to develop more personalized interventions, treatments, and services.

Outcomes Tools

According to a review article published in CNS Spectrums, Outcome Measures for Clinical Drug Trials in Autism, Aman et al 2004, there are no universally accepted outcome measures developed for measuring changes in core symptoms of ASD from treatment. Magellan supports funding for clinical trials to determine which current instruments could be adapted for use or to use the research findings from the clinical trails to develop a specific instrument to be used by providers to measure changes in the core symptoms. According to the article, the biggest challenge with cognitive measures is finding tasks that are flexible enough that individuals with a wide range of abilities will be able to perform them.

Medical Management – Psychopharmacology

Magellan adopted the American Academy of Pediatrics’ Practice Guideline on the Management of Children With Autism Spectrum Disorders for use as its Clinical Practice Guideline in 2008. The AAP Guideline indicates that the Food and Drug Administration (FDA)–approved atypical antipsychotic risperidone is now widely used to treat symptomatic irritability, aggressive behavior, deliberate self-injury and temper tantrums in children and adolescents with autism. The atypical or second-generation antipsychotic (SGA) drugs aripiprazole, olanzapine, quetiapine and ziprasidone currently are being investigated for use in treating such behaviors as hyperactivity, impulsivity, inattention, aggression and explosive outburst and self–injury.1 In a recently published review of antipsychotic treatment of autism, Posey et al. note that with the widespread use of SGA agents, the use of conventional antipsychotics, like haloperidol, became and continue to become less frequent, although prior randomized controlled trials have shown that they too are efficacious in young children with autism.3 Most of the clinical studies on the use of conventional antipsychotics occurred in the decade spanning 1965–1975. These studies were well–designed controlled studies of haloperidol in doses of 1 to 2 mg/day, where the drug was found to be more efficacious than placebo for withdrawal, stereotypy, hyperactivity, affective labiality, anger and temper outbursts.4 Posey concludes that while multiple studies found haloperidol efficacious for improving a variety of behavioral symptoms in young children with autism, there was less robust evidence for the efficacy of other conventional antipsychotics. Posey concludes that since haloperidol treatment frequently leads to acute dystonic reactions, withdrawal dyskinesias and tardive dyskinesia, this high risk of extrapyramidal symptoms has limited the use of these medications to only the most treatment–refractory patients.14

Magellan supports further research and clinical trails targeted at determining the efficacy of other conventional antipsychotics for improving the behavioral symptoms in young children with autism. Magellan also supports further research aimed at the assessing methods of treating co–existing medical or psychiatric conditions and assessing how the methods affect ASD symptoms and severity.

ABA Analyst Training

There is currently a small number of certified ABA providers nationally which has lead to a model where a supervisor or master’s level therapist develops the behavioral treatment plan for a child and then provides indirect supervision of an ABA specialist (Bachelor’s level education) or tutor who engages in the one-on-one treatment with the child. The specialists are certified but the tutors are not certified by the Behavior Analyst Certification Board nor are they licensed or regulated by states, such as required to pass criminal background checks or required to complete standardized education.

In addition, there is no oversight of ABA business entities by states. Not including tutors in provider networks, however, will reduce the ability the likelihood of an adequate network of ABA providers to provide for the large number of children who need such therapy. It is difficult to find certified ABA providers in most areas, but especially in rural areas. It is critical to provide services to this vulnerable group of individuals without potentially exposing them to risk. It is critical that national standards be established for an ABA tutor–equivalent provider class.

Magellan recommends the creation of strategies to improve the availability and access to ABA services for individuals with autism by increasing the number of qualified ABA providers who may provide consulting, training, behavioral plan development and supervision of ABA tutors. Magellan also recommends that education is offered to psychiatrists and psychologist be become trained to supervise specialists and tutors.

Licensing Requirements and Regulations

Magellan believes that legislation should address the differences in policies and resources that result in marked differences in the treatment of ASD across geographic areas and the types of services and support that are received. Absent state licensing or regulation of ABA providers, federal legislation should establish minimum requirements for licensure/regulation of ABA providers, including specialists and tutors, to provide consistency on a national basis.

Information Technology

Magellan agrees that it would be beneficial if databases that house data from healthcare, education and social services administration should be merged to facilitate the longitudinal study of whether early diagnosis, entry to services, and type of intervention affects the course of ASD over a lifetime.

  1. Screibman L, Intensive Behavioral/Psychoeducational Treatments for Autism: Research Needs and Future Directions, Journal of Autism and Developmental Disorders, Vol. 30, No. 5, 2000.
  2. Eikeseth S. Outcome of comprehensive psycho–educational interventions for young children with autism. Res Dev Disabl (2008), doi: 10.1016/j.ridd.2088.02.003.
  3. Posey DJ, Stigler KA, Erickson CA, McDougle CJ. Antipsychotics in the treatment of autism. J. Clin. Invest. 118(1): 6-14 (2008).
  4. McDougle CJ, Posey D. Genetics of Childhood Disorders: XLIV. Autism, Part 3: Psychopharmacology of Autism. J Am Acad Child Adolesc Psychiatry, 41:11, 1380–1383 November 2002.
From: [redacted personally identifying information]
Sent: Tuesday, September 16, 2008 11:29 AM
To: IACC (NIH/NIMH); IACC Services (NIH/NIMH)
Subject: [Comment 00029] coments on IACC autism draft
Attachments: Dear IACC.doc

Dear IACC, I wish to comment on the draft strategic plan for autism. Please note the attachment. Kindly confirm the receipt of this document.

Regards,

[redacted personally identifying information]


Psssst…Have you heard the news? There’s a new fashion blog, plus the latest fall trends and hair styles at StyleList.com.
(http://www.stylelist.com/trends? ncid=aol[redacted personally identifying information])

[redacted personally identifying information]

September 16, 2008

Dear IACC,

I was on the phone for the entire April 21st IACC Strategic Planning Session. I have read the IACC Strategic Plan for Autism Spectrum Disorder Research. I wish to comment on the draft.

I have been involved in the field of autism research as both an advocate and philanthropist for about 15 years. I [redacted personally identifying information] the National Alliance for Autism Research and attended most of its SAB’s. [redacted private support] has been a major supporter of the Autism Genome Project (AGP), as well as other scientific and community based projects. I [redacted personally identifying information] the Executive Council at the Yale Child Study Center.

I want to complement the committee on the creation of this very impressive document. It is by far the most comprehensive and well articulated strategic plan for autism that I have seen. Undoubtedly, it could not have been done without the hard work and collaboration of many people.

I know that dollar numbers have yet to be attached to the research priorities. The committee’s intention to enhance accountability by using SMART is admirable. However, throughout the discussions on April 21st and this draft there is no mention of the potential “impact factor” of each of the priorities. Aspiration goals are noble, and while the pace of discovery may be unpredictable, there may be more objective measures or parameters that can be established that can help to prioritize your funding. This may be particularly true of translational projects. I do believe that if your committee spent some time trying to evaluate the impact of success in each area prior to your final budget, that you may have an enhanced method to prioritize your spending. The vote by the committee members on April 21st has limited value in the absence of the discussion of the impact on the autism community of obtaining success in a given area.

In response to your request on comments for priorities, I would like to point out an enormous unanswered question: How many adults are there with autism? As [redacted personally identifying information] of a local ARC, our executive staff have speculated that as many as 25% of residents currently classified as mentally retarded, are actually on the autism spectrum. I think that attempts to quantify this number will have an enormous impact on the allocation and direction of research.

I think that a higher priority needs to be given to detailing the strategic plan for federal resources to promote best practices for adolescences and adults as they transition out of IDEA supported placements. A “Quality of Life Rating Scale” would help guide parents and professionals on best practices for adult living as well empower parents to develop programs with more progressive and cost–effective methods.

Employment concepts are also underrepresented. NIH should consider enlisting the corporate sector as a partner in job initiatives with a particular interest in monitoring mental health support.

Finally, I think that the strategic plan should include measuring and enhancing the neural plasticity and adaptive brain reorganization of adolescents and adults with ASD. The current document emphasizes early intervention. But research from traumatic brain injury cases shows that the brain can be retrained even in later years. I would like to see research opportunities that incorporate training protocols successfully used with traumatic brain injuries adapted for adolescents and adults with autism.

Respectfully submitted,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Wednesday, September 17, 2008 8:40 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00030] Autism

I am responding to your study

Our son is a 9 year old autistic

Read your report draft. It is lengthy and pretty much details a lot of what is going on in autism. We will continue to monitor your study and participate with the various aspects of autism research in an effort to help our son and others.

What is minimized is the educational, cognitive aspect of autism. We have dropped ABA in favor of the Rapid Prompting Method, Soma-Halo.org. Our son went from buttoning a shirt to learning age appropriate lessons and communicated on a letter board. Who do I contact in reference to educational treatments. I would like to communicate with someone to exchange autism educational therapies and protocols. Not sure where to go from here.

Thanks

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Wednesday, September 17, 2008 12:00 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00031] RFI Comments: IACC Strategic Plan
Importance: High
Attachments: Comments on RFI 1 Draft Proposal from IACC_09132008.doc

RE: Request for Information (RFI): Interagency Autism Coordinating Committee Draft Strategic Plan for Autism Spectrum Disorder (ASD) Research is Available for Comment

To Whom It May Concern:

Please find my comments regarding the IACC’s draft Strategic Plan for ASD Research attached. If you should have any questions, please contact me at [redacted personally identifying information] or by email.

Sincerely,

[redacted personally identifying information]

Introductory Material

  • On pg. 2 it says that “Over the past decade, research addressing all aspects of ASD has expanded significantly.” While several aspects of ASD have and continue to be studied, many topics have not been researched at all. Several of these topics, including #s 2, 3, 4, and 5 listed below are important for policy makers and administrators to gauge the extent to which services are needed, to assess the distribution of funding, and to determine which systems are responsible for providing services to the ASD population.
  1. Efficacy of interventions for teens and adults using randomized controlled trials (*which is mentioned later as a goal in the “What Does the Future Hold” section)
  2. Rate of misdiagnosis (especially of adults now living in state hospitals, mental health facilities, or prison)
  3. The incidence of individuals living with ASD involved in the juvenile or criminal justice systems
  4. The incidence of individuals living with ASD who are homeless or unemployed.
  5. Where funding for services is currently spent (and how much), considering that individuals with ASD are served through multiple service systems, including medical, education, mental retardation/intellectual disability/developmental disability, long–term care, vocational rehabilitation, early intervention, medical assistance, and mental health.
  6. Reasons for staff turnover and factors that improve retention of staff.
  7. The needs of family members/caretakers of teens and adults with ASD, and the availability of services and supports for them through state or local resources
  1. When Should I Be Concerned?
    • On pg 7, a video glossary of early red flags is mentioned, but there is no indication that it is available through the Autism Speaks website. If parents or other interested ASD stakeholders read this document seeking information they will want to know how to access this valuable resource.
  2. What Caused This To Happen and Can This Be Prevented?
    • On pg. 15, the 2007 IOM report on environmental challenges is mentioned in regard to the 5 environmental factors that will be studied. A list of the possibilities outlined in the report would be very helpful.
  3. Which Treatments and Interventions Will Help?
    • On pg. 19, it says that five randomized controlled trials (RCTs) of early intervention for infants and toddlers will be conducted by 2011, and that three RCTs of interventions for school–aged and/or adolescents will be launched by 2012. An explanation of which interventions will be studied (i.e., ABA, RDI, floortime, social skills training, TEACH, etc.) would be very helpful.
    • Is it possible to make another short–term goal to conduct RCTs of interventions for adults as well within the next few years? Several states are struggling to determine which interventions they should fund for adults with ASD because there is almost no research on efficacy of interventions for this older population. Current interventions used are often designed for other disability populations, including those with mental illness and mental retardation/intellectual disability alone, and do not meet the unique needs of individuals with autism. In the absence of evidence-based standards, inappropriate service delivery will continue. Many of these adults are in dire need for appropriate supports to prevent frequent hospitalizations or entry into the criminal justice system.
  4. Where Can I Turn For Services?
    • On pg. 21 it states that “children with ASD have a much more difficult time accessing appropriate care than children with other special healthcare needs.” Can you also include some information on the severe lack of services and/or appropriate services for adults with autism? Below is an extremely helpful resource on this topic, using Pennsylvania as an example:
      Thomson Medstat. (2006, July). Expanding home and community–based
      services for persons with autism in Pennsylvania
      . Retrieved May 6, 2008, from
      www.dpw.state.ps.us.
      *direct link: http://www.dpw.state.pa.us/Resources/Documents/Pdf/Publications/MedstatAutismReport-July28.pdf
  5. What Does The Future Hold?
    • On pg. 25, one of the short–term goals talks about assessing and characterizing variation in adults living with ASD by 2011. Will this address involvement in local, state, and federal programs, unemployment, housing, and other factors justifying the need for new programs?
    • Also on pg. 25, another short-term goal looks at conducting “at least two clinical trials to test the efficacy and cost–effectiveness of interventions, services and supports…for adolescents, adults, or seniors living with ASD by 2012. Thank you for including this. It is badly needed. Is it possible to target all three categories, rather than focus on just one? It is difficult to prioritize the need for research across these groups.
From: [redacted personally identifying information]
Sent: Wednesday, September 17, 2008 4:09 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00032] NOT-NH-08-021

Comments on Section III: What Caused This To Happen And How Can This Be Prevented?

  • Perhaps it should be explicitly stated that “it is still not known whether any specific factor is necessary or sufficient to cause ASD” or how environmental factors may modify the phenotypic expression of ASD. We often take too narrow of a view about the role that environmental factors may play…and this consequently limits study designs and analyses.
  • It may be useful to make an explicit distinction between environmental factors that are likely to 1) either be documented in medical records or can be queried as possibly in the awareness of parents vs 2) toxins in our environment which require environmental sampling or biologic assays. The latter group poses very different challenges for data collection.
  • Under long–term objectives, the multi–site study of subsequent pregnancies should probably either include a control group or, be conducted in some way in synch with the National Children’s Study so that a control population for biologic sampling and other data collection can be constructed from that large study…that is to say, some comparability of methods between a subsequent pregnancy study and NCS. It seems inevitable that when the results of a multi–site subsequent pregnancy study are being analyzed, important questions will arise that can only be adequately addressed with pregnancies from non–ASD affected families.
  • I would think that exposure monitoring for environmental toxicants possibly relevant to autism should be included, perhaps in the subsequent pregnancy study.
  • In general, there needs to be more emphasis on incorporating the capability to evaluate gene- environmental interactions and evaluating phenotypic subgroups.

Thank you.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Wednesday, September 17, 2008 5:09 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00033] NOT-MH-08-021

September 16, 2008

Attention: Strategic Plan for ASD Research RFI Office of the Director
National Institute of Mental Health
6001 Executive Boulevard, Room 8235, MSC 9669
Bethesda, MD 20892-9669

To whom…:

This letter is in response to the request for comments on the draft for the IACC Strategic Plan dated August 15, 2008. This letter is from GRASP, the Global and Regional Asperger Syndrome Partnership, a 501c3 non–profit that is the largest organization in the world of adults who are diagnosed along the autism spectrum.

Other than our proven support and advocacy networks (providing supports to currently over 3,600 subscribers), our educational outreach, and our role as an informational clearinghouse on autism-related issues, what separates GRASP are the stipulations GRASP must adhere to in accordance with our bylaws–That the Executive Director, 100% of the Advisory Board, and 50% of the Board of Directors of GRASP must all be diagnosed along the autism spectrum.

That said, however, GRASP is not an isolationist organization. GRASP has many professional affiliations and works in tandem with parents’ organizations, universities, service agencies, research institutions, larger autism organizations, advocacy organizations, and we enjoy a four–year old contract working with the New York Public Schools working with their autistic teens.

Unlike other organizations, we also maintain open channels, and converse frequently with organizations with whom we have differences of opinion (such as Autism Speaks).

But our mainstay are those regional support groups (currently 17 of them) that are all run by people on the spectrum. These provide not only the therapeutic quality of shared experience, but also the means for self–advocacy as more information on our diagnoses is distributed with a positive attitude.

We are deeply concerned, however, with the IACC's inability, or lack of willingness, to address what we see as several deficits:

  1. Almost all of the research funding is geared towards bio–medical study, or towards developing future educational and developmental strategies. This is perhaps wonderful for future generations, but the disproportionate bypassing of those who are desperately in need of services now…we believe this to be without merit. It benefits the careers of some great minds but does almost nothing to stem the tide of suffering endured by the living, most especially the adults who live with the condition. More evidence and data based research seems more than "long overdue." We would highly encourage the IACC towards funding studies to determine how many people are out of work, how many need housing, and how many families are without services for their children. Armed with this type of information, more funding could argued for at higher government levels.
  2. We beg the IACC to take a stand and stop funding investigations into areas that seem to be dead arguments, such as the vaccine controversy, or in areas of dubious practice such as chelation therapy. The IACC has historically allowed itself to be bullied by what is a very loud minority of people who (to cite one example) believe that vaccines caused autism in their children. This wastes money that could be spent on infinitely worthier endeavors, wastes taxpayer money, and perpetuates the unnecessary alarmism that keeps those faithful followers of vaccine theory from being able to truly move on. To be clear, we do the zealouts no favors either, by stringing them along in this manner.
  3. We applaud the inclusion of Stephen Shore (a GRASP Advisory Board member) onto the main table of the IACC. It took a long time for the IACC to include people on the spectrum in this capacity and when Stephen was asked to join, we cheered. But Stephen can’t remain the only one, lest the gesture will resonate as tokenism. GRASP has received compliments from several officials at the NIMH, yet collectively we have felt ignored. And there are at least two dozen noteworthy people on the spectrum (that I can think of) whom would qualify for a another chair. We understand there was a regrettable incident in November, but that shouldn’t cause the IACC to shut the door on future involvement from people on the spectrum. The measuring stick of intent these days is whether or not folks like us are consulted for our experiences, or for our opinions. There is the danger of lip service surfacing as the IACC’s collective motivation, and knowing some of the individuals in your building as I do, this just doesn’t seem fair to their reputations when these are good, good people.

In short, we find the IACC to have consistently responded to extremists from all sides, acting almost as pollsters, and we ask that this change. We ask instead that the IACC lead, not follow; to work hard not for the dreams of those whose children already have their services paid for, but instead for those who are in great need. Research and services have their connections, and we ask that the IACC take this into much stronger consideration as it develops further. There’s too much progress going on outside of seratonin levels, that is causing most of the autism world to develop ethically better strategies. The IACC should pitch in. We would applaud some catchup herein by the IACC; and then for you to pass the crowd, and lead.

Thanking you for your time and consideration, [redacted personally identifying information]

Sincerely yours,

[redacted personally identifying information]
GRASP
The Global and Regional Asperger Syndrome Partnership, Inc.
[redacted personally identifying information]
www.grasp.org

Help GRASP make a difference. Donate now by clicking the link below:
http://www.nycharities.org/donate/charitydonate.asp? ID=2223

From: [redacted personally identifying information]
Sent: Friday, September 19, 2008 1:08 PM
To: [redacted personally identifying information]
Cc: [redacted personally identifying information]
Subject: [Comment 00034] Office of Dietary Supplements (ODS) Responding to NIMH's request for information

Dear [redacted personally identifying information]

In response to [redacted personally identifying information] email of August 21, 2008 for comment on the IACC Draft Strategic Plan for ASD Research and the Priorities for the Interagency Autism Coordinating Committee Services Subcommittee for Autism Spectrum Disorders, ODS reviewed the information provided with the two RFIs and the IOM document “Autism and the Environment: Challenges and Opportunities for Research.”

The Office of Dietary Supplements remains interested in co–funding research projects that delve into the role of nutrition, diet, and dietary supplements as environmental factors in ASD causation and/or development as well as possible effective prevention or therapeutic approaches. However, at this time it seems that considerable basic neurological research, epidemiological study, and better diagnostic consensus, as well as exploration of treatment modalities will need to transpire before nutrition, diet, and dietary supplement approaches merit funding. ODS will continue to keep abreast of advances in the ASD research agenda.

[redacted personally identifying information]
Office of Dietary Supplements
National Institutes of Health
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 22, 2008 10:52 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00035] Response from WV Team Autism
Attachments: Response to IACC Strategic Action Plan.docx

Attached is a short response from West Virginia Team Autism. We appreciate the opportunity to comment.

[redacted personally identifying information]
WV Autism Training Center
Marshall University
[redacted personally identifying information]

Response to IACC Strategic Action Plan
Submitted by:
[redacted personally identifying information] on behalf of the members of West Virginia Team Autism

Contact Information:                  [redacted personally identifying information]

Date:      September 19, 2008
The West Virginia Team Autism membership includes representatives of the WV Department of Education–Office of Special Education, parents of children on the spectrum, WV Birth to Three, the West Virginia Autism Training Center, the Autism Services Center, the WV Office of Behavioral Health, universities and colleges throughout the state, private providers and other individuals who are invested in improving and maintaining quality services for individuals on the autism spectrum and their families. We are submitting our response to the Interagency Autism Coordinating Committee’s Strategic Plan for Autism as a team.

SECTION COMMENT
Introductory Material: No specific suggestions were generated. We do note that the core values are commendable. The IACC has provided the opportunity for public comment on the plan – and has disseminated the opportunity to respond widely which enforces the core value of “consumer–driven.”
Which Treatments and
Interventions Will Help?
Consensus of WV Team Autism was that the short term objectives appeared to be somewhat biased in favor of medical interventions. A broader view of evidence–based interventions (e.g. as addressed throughout the Journal of Applied Behavior Analysis) should be at least equally reflected in the short term objectives. The long term objectives do not address behaviorally–based interventions at all.
References: The Journal of Applied Behavior Analysis is not represented at all in the references.

From: [redacted personally identifying information]
Sent: Monday, September 22, 2008 3:30 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00036] NOT-MH-08-021
Attachments: Crisis Prevention Institute Comment NOT-MH-08-021.doc

Please accept the attached on the behalf of [redacted personally identifying information] the Crisis Prevention Institute. Thank you and your Subcommittee for allowing for public input on the Subcommittee’s research priorities in the upcoming years.

If you or the subcommittee have any questions or you would like further clarification on the comments we have provided on the attached letter, do not hesitate to contact me directly. I can be reached by phone at [redacted personally identifying information] or by return email to [redacted personally identifying information].

Sincerely,

[redacted personally identifying information]
Crisis Prevention Institute, Inc.
[redacted personally identifying information]
www.crisisprevention.com

“To be angry is easy. But to be angry at the right person, at the right time, for the right reason, with the right amount of anger, is not easy.” Aristotle

The content of this communication may be confidential and proprietary. If you have received this message by mistake, are not the intended recipient or are not an agent responsible for delivering it to the intended recipient, please inform the sender of the error by email reply, and delete it from your system. You may not retain, copy, or disseminate this message, or disclose its contents to anyone without the express written consent of the author. Thank you.

Crisis Prevention Institute, Inc.
[redacted personally identifying information]

September 22, 2008

Attention: Strategic Plan for ASD Research RFI
Office of the Director
National Institute of Mental Health
6001 Executive Boulevard, Room 8235, MSC 9669
Bethesda, MD 20892–9669

Dear Director:

On behalf of the Crisis Prevention Institute (CPI), I commend the Interagency Autism Coordinating Committee Services Subcommittee for Autism Spectrum Disorders (ASD) on its efforts to advance research for individuals affected by ASD. It is with keen interest that I respond on CPI’s behalf to the recent draft of the Subcommittee’s strategic plan, dated August 15, 2008, given that many of the professional staff who work directly in support of individuals affected by ASD turn to CPI to learn crisis management skills. These professionals come from a variety of settings, frequently providing direct and daily care to individuals with ASD and their families.

I am encouraged by the Subcommittee’s efforts to include research on Community Integration for people with ASD. Given that the diagnostic rate for individuals with ASD is estimated at 1 in every 150, it is likely that nearly everyone within a given community will be in contact with someone on the spectrum. Having been made aware of a paucity of training available for people throughout a community with less frequent contact with individuals affected by ASD, CPI has developed an instructional seminar intended to provide information on how to recognize, relate and respond to a person with ASD. These professionals include: emergency responders, educators, police, librarians, retail associates, dentists, or anyone who will provide some sort of common service to individuals with ASD in their community.

Our expertise in developing training has focused on programs designed for delivery to staff providing direct care, education, and services to individuals with ASD. The research base for training programs for staff is still emerging, and, as such, we ask that the Subcommittee’s research priorities be expanded or clarified to include interventions designed as such. Quantitative and qualitative research designs examining quality of care indicators, as well as topics such as staff confidence before and after training, have been effectively used to help gauge the effectiveness of such training implementations. We are also aware of the increasing value in research producing practice-based evidence and ask that the Subcommittee invite these designs as well.

Any questions members of the Subcommittee might have concerning interventions intended to implement training for professionals who frequently – or only occasionally – provide services for individuals with ASD can be directed to me through my associate, [redacted personally identifying information]. He can be reached by phone at [redacted personally identifying information] or by email at [redacted personally identifying information] Once again, I commend you and your Subcommittee on its excellent work to help provide for better outcomes for individuals with ASD.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Wednesday, September 24, 2008 2:23 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00037] RFI identifier NOT-MH-08-021
Attachments: Interagency Autism Coord Comm Comment Sept 2008.doc

Please see attached.

[redacted personally identifying information]

Occupational Therapy: Living Life To Its Fullest

September 9, 2008

Interagency Autism Coordinating Committee

Re: Request for Information: Comment on Draft IACC Strategic Plan for ASD Research

The American Occupational Therapy Association (AOTA) represents the interest of more than 100,000 occupational therapists, occupational therapy assistants and students of occupational therapy. We appreciate the opportunity to provide information to the Interagency Autism Coordinating Committee (IACC) regarding the draft strategic plan for research about Autism Spectrum Disorders (ASD).

AOTA is pleased that occupational therapy is acknowledged as an intervention that is appropriate for children and adults with ASD, and we would like to comment on Section IV of the Strategic Plan, “Which Treatments and Interventions Will Help?”

The strategic plan states that occupational therapy addresses problems with sensory integration and motor planning (p.17). While this is true, we would like to clarify that occupational therapy strives to improve functioning in everyday activities. While many individuals with ASD have sensory processing disorders or sensory integration problems, occupational therapists would address these sensory issues if it was negatively influencing an individual’s ability to perform daily activities such as eating, bathing, dressing, learning, and participating in family and community activities. This clarification is in keeping with the focus of the profession and the way occupational therapy is dedicated to the improvement of function and performance so that individuals can lead more productive, satisfying lives.

A systematic review of occupational therapy related interventions used for autism revealed that many interventions used by occupational therapists are effective for promoting social interactions, academic performance, self–care, play, and participation in society (Case–Smith & Arbesman, 2008). One of the key findings from this review is the importance of developing individualized interventions through analysis of performance and behavior so that interventions are appropriate for the individual’s developmental level and addresses the underlying variables influencing performance. Occupational therapists are skilled at analyzing performance, considering environmental modifications, and customizing interventions to developmental age, parents’ goals, and context. However, customizing interventions for each individual and family makes designing large–scale studies difficult. We respectfully request that research opportunities (p. 19) include observational study designs because randomized controlled trials are not always feasible for sustained customized therapies such as occupational therapy.

One of the research opportunities refers to “interventions that improve functioning and quality of life for older children and adults with ASD.” AOTA is pleased that the IACC is addressing the needs of older children and adults with ASD, but we seek clarification on the term “functioning”. Occupational therapists frequently use function to refer to performing tasks, but other disciplines use function to refer to specific capacities. If the intent is to focus on the function in daily life activities, AOTA would support this broader view of function. Indeed, the systematic review discovered that there are very few studies of adolescents’ and young adults’ performance in work and independent living settings. Families desire to know how individuals with ASD can work and live in the community as independently as possible.

Another research opportunity to consider is studying interventions that enable children with ASD to learn and perform academic tasks, as well as their ability to transition to another educational setting. School is a context in which many children with ASD face challenges. Occupational therapists utilize the strengths of children with ASD, such as visual perception, to address areas of concern, such as maladaptive behavior, which may be related to sensory modulation problems. We would like to see more studies that measure physiological and performance effects to determine the causal mechanisms through which sensory–based interventions influence behavioral and performance outcomes.

In summary, AOTA lauds the IACC’s work in developing this strategic plan and would like to recommend:

  • Clarifying occupational therapy’s role in treating individuals with ASD; occupational therapists enable individuals’ ability to perform daily activities and participate in society to their fullest.
  • Including observational studies to examine the effectiveness of therapies.
  • Clarifying the term “functioning” for older children and adults with ASD; we need research on adolescents’ and young adults’ performance in work and independent living settings.
  • Considering studies that measure both physiological and performance effects to determine the mechanisms through which sensory-based interventions influence behavioral and performance outcomes.

Again, we thank you for this opportunity to share our thoughts related to the IACC’s Strategic Plan for ASD Research and look forward to continuing to work with the committee and member organizations in support of our common research agenda.

[redacted personally identifying information]
The American Occupational Therapy Association

From: [redacted personally identifying information]
Sent: Thursday, September 25, 2008 11:04 AM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00038] Response to IACC Strategic Plan for ASD
Attachments: Response to IACC Strategic Plan.pdf

Office of the Director:

Please find attached a .pdf file detailing my comments on the IACC Strategic Plan for Autism Spectrum Disorder Research.

I am currently [redacted personally identifying information] of a human tissue repository that supplies a significant amount of post–mortem tissue for ASD research.

[redacted personally identifying information]

Response to IACC Strategic Plan for ASD Research

September 25, 2008

[redacted personally identifying information]

Underlined sections are suggested changes:

Page 5: RESOURCES

Add to end – Donations of post–mortem biospecimens from individuals who have the disorder are limited. This limitation impacts both the scale and quantity of medical research possible. A comprehensive and robust outreach campaign focusing on tissue donation is essential. Donor registration is important, but by itself cannot overcome the shortfall of this resource. Securing the cooperation of medical examiners and coroners is critical to obtaining post-mortem tissue from both controls and individuals with ASD.

FOOTNOTE: For over the past 15 years, the NCHD Brain and Tissue Bank has been accepting tissue donations from both affected and unaffected individuals. Regardless of the thousands of donor registrants, only a small number of these actually become tissue donors. ASD individuals are not pre–eminently disposed to succumb to the disorder. On the contrary, the death of ASD individuals is most frequently caused accidentally, without warning to family and medical professionals. For this reason, we have begun to educate medical examiners and coroners about the need for post–mortem tissue from controls and individuals with ASD. Their cooperation is essential to increase the availability of post-mortem tissue. A well funded, robust, and far reaching campaign targeted at these professionals throughout the U.S. can dramatically increase the availability of ASD post–mortem tissue.

Page 10: II: What do we know?

“Exploring the neuronal basis … post–mortem tissue from controls and from individuals with ASD, through the efforts of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD Brain and Tissue Bank and the Autism Tissue Program.”

FOOTNOTE: To the best of my knowledge, the “National Autism Brain Bank” was discussed in 2003/4, but never created. I have never heard of the “Autism Brain Project.” The NICHD Bank and the Autism Tissue Program are the only source of post–mortem tissue from ASD and controls for the general research community. Tissue from a few autistic donors reside in private collections but are not readily available.

Page 11: II: What do we need?

“Many in the field have highlighted the need to establish nationally coordinated strategies for the collection and preservation of post-mortem tissue from both individuals with and without ASD. The existing brain and tissue bank resources cannot satisfy the high demand and the continuously increasing demand for post–mortem tissue by scientific investigators. Currently, the numbers of well–preserved brains is limited, and the specimens include a number…”

FOOTNOTE: The perceived limitation of post-mortem tissue is very much based on the relative demand for this tissue. Currently, the NICHD Brain and Tissue Bank repository houses brain and some systemic tissue from 33 autistic donors and 66 control cases. We have distributed over 3,000 tissue specimens to more than 50 autism researchers. These numbers are significant, but the numbers in and of themselves do not tell the full story. The demand for this type of tissue through a wide range of developmental ages is so great and with increased research funding, is expected to increase dramatically, surpassing availability. Therefore, a proportionally greater commitment of resources needs to be committed to retrieval of post–mortem tissue for autism research.

Page 12: II: Short–Term Objectives. Point 1

“Establish an international network of brain and systemic tissue acquisition sites with standardized guidelines for phenotyping, collection and distribution of tissue by 2010.”

Strategy for Distribution of ASD and matched Controls

FOOTNOTE: The nature of the non–brain tissue to be collected for autism research is driven primarily by researchers who wish to explore new hypotheses. Although general guidelines can be provided, it is at the level of the individual bank and researcher that new tissues needs are identified. It is suggested that the term “protocols” be replaced by “guidelines“ since the sectioning and processing of tissue is dependent on specific research protocols that cannot be met by one set of protocols.

Likewise, guidelines for distribution will assure that issues of 1) importance of proposed research, 2) experience, 3) supportive funding, 4) feasibility and 5) IRB approval are addressed. However, the decision of what project to support also involves such issues as 6) how much tissue is requested, 7) the amount of region available for distribution, and 8) how it will impact on other tissue requests. Our experience has been that we spend a significant amount of time clarifying tissue requests with investigators. This means that the minimum amount of tissue is distributed from regions most likely to answer the research question without impinging on the tissue needs of others. It also requires an acute awareness of the tissue in our collection. This is complex since each hemi–coronal section may have been sampled multiple times for project specific areas. It is difficult to convey the specific tissue availability to a central committee. Furthermore, to assure the feasibility of a project we may supply non–critical samples for preliminary work. These types of decisions are best made at the local tissue repository level and will enable a timely distribution of tissue.

From: [redacted personally identifying information]
Sent: Friday, September 26, 2008 3:17 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00039] IACC draft research comments NOT-MH-08-021

To: Interagency Autism Coordinating Committee

From: [redacted personally identifying information] parent of a child with vaccine-induced autism [redacted personally identifying information]

re: SUGGESTIONS for Draft Strategic Plan for Autism Spectrum Disorder (ASD) Research

Regarding III: What Caused This To Happen And Can This Be Prevented?

SUGGESTION – – Make vaccine injury the number one source to investigate, based on thousands of reports to VAERS, thousands of cases in the National Vaccine Injury Compensation Program and the Federal Omnibus Autism Proceedings, and thousands more undocumented anecdotal reports of vaccine injury nationally.

Regarding IV: Which Treatments And Interventions Will Help? –

SUGGESTION – – Prioritize clinical testing of children’s blood, urine, hair and stool and biopsies where appropriate to detect mitochondrial dysfunction, toxic levels of heavy metals such as mercury, vaccine strain measles in the GI tract, antibodies to myelin basic protein, etc.

SUGGESTION – – Direct funding toward replication of medical treatments found at Thoughtful House in Texas, Rimland Center in Virginia, the ARCH Clinic in Franklin, Wisconsin, and others that treat gastrointestinal problems, immune disorders and nutritional deficiencies in ASD children.

SUGGESTION – – Provide funding to chemist Andrew Hall Cutler, PhD, PE of Sammamish, Washington to do a study on his mercury chelation protocol. See his technical manual “Hair Test Interpretation: Finding Hidden Toxicities.” http://www.noamalgam.com/hairtestbook.html Here is an interview with Dr. Cutler by Mark Schauss of Carbon Based, a laboratory testing company. Scroll to the bottom and click on “Download audio file” http://labinterpretation.com/content/track01–mark–schauss–andrew–cutler

###

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 3:00 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00040]

iacc@mail.nih.gov

Dear IACC:

Thank you for asking for input on the autism strategic plan. I was happy to see that on page 14 you recognize that there is no relationship between autism and vaccines and was pleased to note that no recommendation is made for studying vaccines as a possible cause of autism. Thank you for that. I fully support the genetics research priorities. The recent genetics findings with regard to Fragile X and TSC look very promising.

Sincerely,

[redacted personally identifying information]


Stay up to date on your PC, the Web, and your mobile phone with Windows Live. http://clk.atdmt.com/MRT/go/msnnkwxp1020093185mrt/direct/01/

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 5:29 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00041] IACC Strategic Plan Feedback - Spectrumites Response
Attachments: IACC Strategic Plan Feedback.pdf

Spectumites Autistic Rights Group
Website:http://www.spectrumites.com Email: admin@spectrumites.com

To whom it may concern,

The attached document is a feedback response to the IACC’s strategic plan, on behalf of the Spectrumites group.

Spectrumites is a worldwide group of autistic individuals, and family & friends of autistic individuals, who have been brought together for a common cause – we believe that autism is a natural neurological difference that has strengths as well as weaknesses, and we therefore believe that autistic people should be helped, rather than cured or eliminated.

With regards to our viewpoint on autism funding, we believe the following points:

  • That all autism funding be directed towards initiatives thathelp autistic people and their supporters, and no funding be awarded towards the elimination of autistic people.
  • That funded treatment programs be solely aimed at skill development, help with co–morbid conditions, or support programs. No funding should be awarded to programs that are aimed at eliminating harmless behaviors, or otherwise “normalizing” autistic people.
  • That funding should be redirected away from researching the causes of ASD due to concerns over eugenic usage, and also with a view towards using all funds to help autistic people.
  • That the autistic community be consulted on all autism–related policy decisions.
  • That a significant amount of funding be directed towards the prevention of autism–related human rights abuses.
  • That a significant amount of funding be directed towards support services for adults on the autistic spectrum.
  • That a significant amount of funding be directed towards combating the negative stereotypes of autism perpetuated by anti-autistic organizations such as Autism Speaks.

The following response to the IACC strategic plan is a direct application of the above points.

Thank you for your time.

Yours sincerely,

[redacted personally identifying information]

IACC Strategic plan – feedback

We recommend the following alterations to the IACC strategic plan.

Introductory material:

  1. Introduction The heading “What caused this to happen and can this be prevented” should be removed, as projects funded under this heading could only be used for eugenic elimination of autism, or autism reversal – neither of which is a desirable goal. This funding could be redirected towards the more positive goal of assisting autistic people, rather than eliminating us.
  2. Vision Statement
    No changes necessary.
  3. Mission Statement
    No changes necessary.
  4. Core Values
    No changes necessary.
  5. Crosscutting Themes

The title “Prevention” should be altered to “Treatment Strategies”, as helping autistic people should be the goal, not removing autism. In the same spirit, the phrase “prevent the development of the disorder”should be removed.

Under the “Earlier Detection” title, references to biomarker research should be removed, as such research will inevitably lead to the eugenic elimination of autistic people. Emphasis should instead be placed on identification via behavioural research of young autistic children.

Under the “Data Sharing” title, references to genomic sequence should be removed.

With these alterations, the document becomes a model for helping autistic people, rather than eliminating or normalising autistic people. Every funding dollar that is not directed towards the elimination of autistic people can become funding for much–needed support services, education grants, work placement programs, or treatment of co–morbid conditions.

  1. When should I be concerned?
    Under the “What do we know>” heading, the word “epidemiological” should be removed. There is no medical model that supports the idea that autism is a viral disease, and to use disease terminology is both incorrect and derogatory.
  2. Under the “What do we need?” heading, again, references to “biomarkers” and “biologic approaches” should be removed.

    Under the “Research Opportunities” heading, the bullet point regarding genetic testing should be removed.

    Under the “Long–Term Objectives” heading, the bullet point regarding biomarkers should be removed, and references to biological heterogeneity should be removed from the next bullet point.

  3. How can I understand what is happening?
    This section should emphasise understanding of what autistic people are experiencing and which challenges autistic people may experience, rather than determining the biological bases of ASD’s.
  4. Under the “What do we know?” heading, given their status as an organisation dedicated to eliminating autism, references to Autism Speaks should be removed.

    Under the “What do we need?” heading, references to “determining the biological bases of ASD” and examining biomedical trajectories should be removed.

    Under the “Research Opportunities” heading, references to “potential biological targets”, biological features of females with ASD’s, and acquisition of biomaterials should be removed.

    Under the “Short–Term Objectives” heading, references to pre–natal identifiers should be removed due to eugenic concerns.

  5. What caused this to happen and can this be prevented?
    This entire section should be removed – no projects relating to this section will result in helping autistic people. This entire section is devoted to the unethical goal of eliminating autism, rather than helping autistic people.
  6. Which treatments and interventions will help?
    Under the “What do we know?” heading – The practice of 25–40hr/week ABA has widely been used for “normalisation” therapy rather than skills development, as the majority of this time is devoted to the removal of harmless behaviour (such as stimming), or the enforcement of unnecessary behaviour (such as forced eye contact). This extra time is therefore an exercise in “reinforcing socially acceptable behaviour” rather than “improving social skills”.
  7. We therefore recommend that the reference to ABA as effective in improving social skills be removed, and that if the reference to improving language is included, then the reference to “25–40 hours” should be removed.

    We also recommend that no form of ABA using aversive therapy be funded, as there are many alternatives that work even for severe self–harm.

    Furthermore, we recommend a study of whether ABA is effective in flexible skill development at all, or merely a device for automatic triggered behaviour.

    References to chelation should also be removed, as medical authorities are unanimous in stating that the theories behind chelation are not valid.

    References to removing “core” symptoms should be removed, as core autistic characteristics involve both strengths and weaknesses.

    References to removing “associated” symptoms are fine, as this emphasises co–occurring issues, and thus reinforces the idea that while autism often has co–morbid issues that should be looked at, core autism itself is not negative or positive, just different – in the same way that breast cancer is negative, but “femaleness” is not.

    Under the “Research Opportunities” heading, references to “prevent the development of ASD’s” should be changed to “prevent the co–morbid issues associated with ASD’s”.

    Under “Short–Term Objectives”, research projects aimed towards identifying biological signatures should not be funded.

    Also, an emphasis on projects helping with sensory issues should be included.

  8. Where can I turn for services?
    Under the “What do we know?” heading, as well as mentioning children, support services for autistic adults should also be emphasised – while these things are mentioned in the next section, it’s also important to mention adults under the this section, as support services are not limited to children.
  9. Alternatively, this section could be retitled “support services for children”, and the next section could be retitled “support services for adults”.

  10. What does the future hold?
    As per the previous sections points, this section seems to be about support services for adults, rather than “the future”. It may be better to either retitle these two sections to reflect this, or to simply merge the two sections into a single “support services” section.
From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 11:50 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00042] NOT-MH-08-021 Responses to IACC Strategic Plan
Attachments: Responses 9.29.08.doc

To Whom It May Concern,

Attached are my responses to the IACC strategic plan.

Thanks,

[redacted personally identifying information]

NOT–MH–08–021

Responses to the IACC Strategic Plan 9.29.08

    Q1.

  1. There is still a need to clarify the definition of “regressive autism” and apply it consistently across all research being done. There is tremendous heterogeneity of what parents consider to be regressive and it often involves symptoms like sleep problems and gastrointestinal problems that go beyond the traditional core symptoms of ASDs.
  2. In the discussion of early detection, it would be helpful to develop a validated tool that is usable by parents as well as pediatricians.

    Q2.

  1. Include some comparative male/female studies – not just “stand alone” female studies.
  2. Give more funding to the metabolic and mitochondrial function issue. Give greater funding to the immune piece and see how it relates to family history of allergy and autoimmunity.

    Q3.

  1. Suggest an effort to categorize candidate genes into clusters of metabolic pathways that they affect. It is looking more and more like many children are being affected by multiple small genetic hits and this might help clarify the situation.
  2. Similar to the above, research needs to be done into how the leading environmental candidates (heavy metals, PCB’s, pesticides, etc.) might be interacting with the leading candidate genes. We need to be looking for patterns of developmental interference – not just individual genes.
  3. On the question of genetic mutations, we need to be addressing what could be causing them, not just saying, “Wow, these are more common in autism”.
  4. The Somali clusters suggest a vitamin D issue. SNPs on the Vitamin D receptor predispose to lead poisoning. What else might they predispose to in terms of environmental susceptibility?

    Q4.

  1. On the question of co–occurring conditions, we need a study to see if rates of food allergy anaphylaxis and asthma are more common in ASDs.
  2. Since the chelation study has been shelved in kids, we need to do it in primates with whatever behavioral measures and biomarkers we can establish as a model for ASDs.
  3. Include acetyl–l–carnitine and methyl–b12 on the list of small studies that need to be followed up.

Thanks,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 1:44 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00043] RFI identifier NOT-MH-08-021

Dear, National Institutes of Health (NIH) :

Please know that I totally support SafeMinds.org and the fact that they had identified major deficiency in your National Institutes of Health (NIH) Strategic Plan for Autism Research. Further, I agree on each and every summarized and grouped points that they have made below. For ONCE, just ONCE listen to the people that know best… the parents of kids with Autism… which I am as well!

Sincerely,

[redacted personally identifying information]

Acknowledge The Epidemic

Autism is nothing less than a national emergency. The current draft of the plan lacks statements acknowledging its increase and the urgency needed in addressing it. With the explosion in the rate of childhood autism and related disorders in the United States, no reliable or responsible method exists to interpret autism's increase and continued rise as anything other than a true increase in its occurrence. There is no persuasive evidence indicating that the rise can be explained by expanded criteria, improved diagnostics or heightened awareness, anymore than the cause could be solely genetic. Data dictates that policy must be precautionary and that autism merits the urgency that any major health problem would generate with similar prevalence increases. Autism must be considered a global health crisis, requiring the utilization of significant resources, diligent investigation of its increasing frequency and aggressive management. Autism’s growth is real and must be recognized with the primary goals being the rapid creation of effective treatments to assist those affected today and determining its cause(s) in order to prevent its occurrence in the future.

Needed Changes to the Draft Strategic Plan:

  1. Prevent new cases of autism by eliminating major causal contributors, leading to a 90% reduction in new cases of autism among 2014 births.
  2. Implement a rigorous autism prevalence study among U.S. adults to measure the rate of increase and determine if the characteristics of autism have changed over time.

Essential – Investigate the Role of Mercury and Vaccines

The public, via town hall meetings, and IACC public members and workgroup members have repeatedly requested that the role of mercury and vaccines in autism causation be investigated. The current draft of the strategic plan is devoid of any investigation specific to these concerns and fails to accomplish one of the primary tenets of the Combating Autism Act – research on mercury and vaccines. The growing evidence of a link and the continued controversy surrounding this subject and its effects on immunization policy must be addressed for the autism community to support any strategic plan put forward by the NIH IACC.

Needed Change to the Draft Strategic Plan:

Add comprehensive and unbiased studies that investigate the role of vaccines and mercury in autism causation and severity, to be implemented as a short term research objective and accompanied by appropriate budget allocations.

Find the Cause of Autism: Intensify Environmental Research

For the last decade, genetics has been the leading priority in autism causation research conducted by the NIH and other funding organizations. Genetic research has gobbled up the lion’s share of etiology dollars even though the evidence is clear that environmental factors play a major role. In fact, the investments in autism genetics have not yielded results that will lead to the urgent breakthroughs required in addressing the autism epidemic. This type of research is well funded by private organizations such as the Autism Consortium and the Simons Foundation, and NIH should not duplicate these efforts. Identifying and understanding the mechanisms of environmental factors involved in autism represents a far more effective use of NIH etiology research dollars. For these reasons, genetics should not command the lead in NIH funding of autism research. The strategic plan should reflect a sharp redirection of priorities towards environmental investigations, including an understanding of how environmental triggers interact with genetics that increase susceptibility to harm. A report by the NIH IACC noted that the role of the environment in autism research had received insufficient attention to date and remains an understudied area of investigation. More importantly, researchers have identified that children with ASD may be more vulnerable to environmental toxins secondary to inadequate or faulty body chemistry and organ systems. Even more significantly, efforts to support these impaired pathways and treat underlying pathology have resulted in marked improvement in many children to the point where they have lost their diagnosis of ASD.

Certain environmental toxins have been shown to produce autism-like symptoms in animals. The IOM workshop on Autism and the Environment identified an extensive list of potential environmental triggers and ways to investigate them. The workshop proceedings and a review of scientific literature identify an extensive list of categories for promising research, including:

  • Environmental toxins such as pesticides, benzene, and especially metals like lead, aluminum, mercury, and cadmium, including concern of synergistic toxicity of multiple exposures
  • Medical interventions like vaccines, antibiotics, pitocin, immune globulins, valproic acid, and ultrasounds
  • Substances in food, drink, and consumer products that have increased dramatically in the past 20 years such as glutamate (e.g. in MSG), artificial dyes, and cosmetic ingredients
  • Manufactured chemicals ingested by humans due to inclusion in certain products, similar to bisphenol A, which is used in baby pacifiers, baby bottles, and the inner lining of soda cans
  • Pathogens like viruses and bacteria

To properly investigate this array of environmental factors and redress a decade of insufficient spending on the environment, extensive resources and effort must be immediately applied to this domain, far more than the current Strategic Plan calls for. For example, the plan only directs research to 5 environmental factors and assigns this as a long term project rather than a short term one, so that answers on just these 5 factors would not be delivered until 2012. Families with autism cannot wait this long only to have such limited answers to their concerns.

Needed Changes to the Draft Strategic Plan:

  1. Reallocate strategic plan funding of Genetic/Genomic research into Environmental Risk Factors and Environment X Gene Interaction
  2. Vastly increase the absolute spending on short term projects that focus on these areas.

Make a Difference in Quality of Life

The draft plan is woefully inadequate in the area of treatment research. The total recommended spending for this domain is just $88.8 million over 5 years, or a mere $17.7 million per year! With 1 in 150 children affected and an undetermined number of untreated adults, would this level of spending ever be considered if the disease were, say, diabetes or asthma? As an example, the plan calls for just 3 clinical trials on co–morbid conditions, when it is well known that autism is associated with a large array of such conditions: sleep problems, GI dysfunction, anxiety, depression, seizures, obsessive–compulsive disorder, phobias, hypotonia, cognitive differences and eating problems, to name a few. Another example: the plan calls for study of just 5 widely used interventions in autism, when it is common knowledge that parents and professionals are using an innumerable array of interventions (diets, supplements, chelation, antipsychotics, antidepressants, anti–inflammatories, and sleep medications, to name but a small subset), and they are all in need of rigorous study. Investigations are needed across a wide variety of subgroups, from likely responders to those across the spectrum and across the lifespan. It is illogical to assume that an effective treatment research program that is supposed to last for 5 years could be accomplished with the resources and projects described in the current draft plan.

Needed Change to the Draft Strategic Plan:

Quadruple the budget and number of projects currently in the strategic plan for treatment.

The Process – Public Participation and Necessary Expertise Sidelined

A provision of the Combating Autism Act requires public participation in the strategic planning process. NIH has included "outreach" efforts to the public at a few points along the way, mostly after the major decisions have already been made and with public input manipulated to fit the NIH’s view of research priorities. True participation and honest incorporation of the public’s concerns have been elusive. A blatant example of ignoring the community’s concerns is the deliberate omission of investigations on mercury and vaccines. Documents from the community asking that the autism epidemic be recognized in the plan and for the plan to provide resources to adequately address it were never acknowledged. Representatives from federal agencies, all beholden to NIH, outnumber public representatives on the primary decision–making body, the IACC, by a 2 to 1 margin. Invitations extended to the public to participate in the planning process have been highly selective: key autism organizations have been excluded from important workgroups while academic institutions which receive NIH funding have been invited to make the funding decisions that benefit themselves, despite obvious conflicts of interest. Of special concern, expertise in toxicology as it relates to autism was absent from critical meetings, resulting in inadequate funding and leadership for this important work. This lack of expertise severely limits pursuit of promising areas of research necessary to address the autism epidemic, as outlined earlier. Conversely, the field of genetics had over–representation, thus it is not surprising that funding for this field is self–perpetuating in the current draft plan. Inadequate measures were put in place for accountability and evaluation of the plan once it is launched. Responsibility for carrying out most of the plan components was arbitrarily distributed by NIH to various federal agencies and a handful of private organizations without mechanisms to ensure that the work is done and is having an impact. Responsibility for many plan components, including several critical environmental ones, was not accepted by any agency or organization at all, so the NIH was forced to consign them to a mysterious “ACC” team and a few were left unassigned. The Autism Research Institute volunteered for a number of treatment related initiatives but was rebuffed by NIH so that it could delegate oversight to a federal agency.

Needed Changes to the Draft Strategic Plan:

  1. Institute a public participation model in the planning process similar to the exemplary Department of Defense Autism Research Committee.
  2. Create an Autism Advisory Board made up primarily of consumer members with responsibility for carrying out the plan and to ensure accountability and evaluation as the plan is executed over the next 5 years.
  3. Upgrade the IACC from NIH’s rubber stamp committee to a true external advisory body by expanding public representation to a majority of seats relative to government agency insiders.
  4. Reconstitute the Strategic Plan Workgroup to include expertise and public advocacy in the field of environmental factors and autism.

be good!

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 2:12 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00044] NOT-MH-08-021

Dear NIH Representative:

I have worked as a school psychologist for twenty–five years. Part of my job responsibility is to diagnose autism. I assure you, the rate of autism has increased dramatically, and has now reached epidemic proportions. Where I once diagnosed one or two cases a year, I now see dozens per year. What is causing this epidemic? Please use your research dollars to identify unequivocally the factors contributing to the increase, many of which MUST be environmental.

Time after time I have listened to heart–broken parents recount how they took bright, happy, sociable toddlers in for their well–baby shots and then watched in horror as their children descended into the anxiety and isolation of autism. There MUST be something to these stories. They bear a common thread. Please do the necessary research to confirm or refute once and for all whether or not there is a vaccine (specifically, thimerosal)–autism link. The public’s confidence will not be restored until solid, direct research results are compiled and publicized.

Autism is the most serious health crisis facing our nation today. Please confront it. Please be resolute and tireless in your efforts to understand what is causing it and to find effective ways to treat it. Generations of children are depending on you.

Thank you,

[redacted personally identifying information]
School Psychologist
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 2:57 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00045] NOT-MH-08-021

As an occupational therapist in the school system I want to stress to you that the language of the strategic plan for autism research is not comprehensive enough. I do believe the plan should be stronger for research to be valid to all interested persons. I believe that the groups involved in the input for research should be broadened to include advocate groups who will bring a focused, clear vision to the plan and only add to the scientific groups already involved.

There should be an urgency about your plan to swiftly eliminate contributing causes and even suspected causes in order to effectively and drastically reduce the number of autism.

Funding should be increased to address enviromental suspects in the contribution to autism. If funding is not increased here it most certainly will be in the schools and state run adult programs as they are overloaded with a unique group of disabled persons. And that increase will have to continue their lifespan and as more and more persons are added to this group of disability.

There should be far more consumer groups invited to participate in this plan as they have firsthand experience with the extreme difficulties and recognize the urgency of addressing this swiftly.

More and more parents of typical children are realizing they dodged some unknown bullet and new parents are going to refuse vaccinations (and there are an insane number of vaccinations) for their little ones as they realize autism is lifelong whereas the illness their child may get could be short and survivable. More and more are going to take their chances with this unless they see that there is swift, strong action. Your plan does not measure up yet to swift and strong.

[redacted personally identifying information]
Occupational Therapist

Looking for simple solutions to your real–life financial challenges? Check out WalletPop for the latest news and information, tips and calculators.

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 3:18 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00046] Autism Research: Public Input

IACC and NIH:

I am writing in regard to your plan and budget on autism research. I am the mother of a 7 year–old boy whose body and mind are being healed from an autism disorder. When he was born at 36 weeks, he was a healthy 6.8 pound baby. The following day, he received the Hep B vaccine and immediately reacted badly, requiring external supports. When his father and I went to the NICU to see him and saw the x–ray of his intestines, full of bubbles, we immediately asked why his intestines looked like that. The nurse told us, “Some babies have a bad reaction to the vaccine.” At his 2–month well–baby visit, the immunologists readministered the same vaccine. When asked why, they replied that they wanted to make sure he had it, and we were told this was routine.

After years of searching for answers to some of his behaviors, he was diagnosed with PDD–NOS in 2005, and we were given a grim outlook on his future. As is likely the case with untold numbers of parents, we were advised to take him to counseling and hope for the best: that with years of therapy he would be able to manage a functional life.

After a predictably unsuccessful experience with counseling and a nightmare of an experience with an overstimulated child in the classroom setting, we were fortunate enough to be acquainted with a sensory integration certified occupational therapist who is the DAN! and Yasko Protocol contact in [redacted personally identifying information]. In a year of DAN!, we watched our son calm down and achieve such progress in the mainstream classroom that his personal aide was switched to a classroom aide, and that aide was eventually used for other students in other classrooms. He was able to function independently with minor accommodations. This year, he is in the mainstream classroom with no aide.

When we began to implement the suggestions from Yasko’s Nutrigenomic Testing, we saw fast, extreme results. From addressing his inability to detoxify, our son stopped flapping or “stimming” for the first time in his life. This was a major achievement. His friendships tightened. His personality went from being one plagued by defensiveness and self–doubt to one of gregariousness and activity. He was even nominated for an award “for being a role model to his peers.” Now those who work with him believe his PDD–NOS diagnosis is no longer valid, though he does appear to warrant a diagnosis of ADD/ADHD, which is one click lower on the autistic spectrum. Being a former teacher and very familiar with the behaviors of children with attentional difficulties, I agree. While we are well aware he is not out of the woods, we see significant, life–changing progress that is too strong to dismiss as coincidental.

With existing research indicating mitochondrial dysfunctions in the population are 1 in 200 (this number is from merely researching 10 of 37 possible mutations– –what will that number be when the other 27 possible mutations are researched?) AND the recent court concessions that Hannah Poling’s “autistic symptoms” were caused by vaccines aggravating an underlying mitochondrial dysfunction, we are both angered and saddened the NIH and other agencies are not rigorously pursuing finding the susceptible populations in this area. These children could be tested and treated as the high injury–risk and susceptible beings making up the explosive numbers of autistic diagnoses.

The science is there, but it is being ignored. Those children and families damaged while your agencies pursue red herrings will be judged harshly by history. The line of research NOT relying solely on “finding a gene responsible” for this epidemic must be included in further research. Our story is not unique. There are thousands of families achieving success by treating their children for environmental injuries. We understand there is a genetic component to the injuries our children sustained; we reject the theory of genetic causation. In human history, there is no tale of genetic epidemic. Know that we are aware there is not one now.

Please reconsider the focus of your research, the unacceptably low funding, and the lives at stake if you choose not to take the right path.

Sincerely,

[redacted personally identifying information]

Find phone numbers fast with the New AOL Yellow Pages!

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 3:50 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00047] autism money

To Whom It May Concern:

Please, please we need more funding for autism research. This disease is rapidly on the rise in this nation of over–immunized children. Let’s consider this funding for autism preemptive. If we can prove the cause it may prevent the federal government from having to pay up from supporting individuals with autism who cannot support themselves. Thank God we are able to support our son and his $1,000 a month requirements of supplements, speech therapy, special diet, and doctor bills not covered by Blue Cross, but what about the thousands out there who cannot? Autism is touching many more lives than ever before. Let’s put the money into research before it hits your family. Thanks you and God bless you,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Saturday, November 29, 2008 3:58 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00048] Federal Autism Spending

To Whom It May Concern:

As the parent of a 13 year old son who reacted to his 15 month vaccinations and developed autism, I very much agree with the article set forth in the Age of Autism website about Federal Autism Spending. I copied the article below. I would very much appreciate it if you would carefully examine the suggestions set forth in the article. It's bad enough our kids now have autism; do our grandkids have to have it as well?

Thank you!

[redacted personally identifying information]

The process for developing the SP began at a meeting of the Interagency Autism Coordinating Committee (IACC) last November 30. A summary of the major events in the development of the SP is here (HERE). Age of Autism reported on the process, “What’s So Secret About Autism Science” (HERE), January 12, “The Strategic Plan for the Combating Autism Act” (HERE), July 8, and “The Strategic Plan for the Combating Autism Act” (HERE), July 14. Consult these articles and information on the IACC website (HERE) for more background. Information on deficiencies in the plan can also be found in Safeminds’ July 7 letter to Secretary Leavitt (HERE) , IACC member Lyn Redwood’s August 5 letter to Dr. Hann (current head of the Autism Team) (HERE) and Autism Speaks’ August 14 letter to IACC Chair Insel (HERE)

What’s Wrong With the Plan.

Where to start? There’s so much wrong with the plan that it is probably best to just start over. Basically it is a rehash of the 2004 “autism matrix” or research roadmap (HERE). The plan proposes 35 broad research initiatives grouped into six categories, and is organized as follows:

Introductory Material (including the Introduction, Vision Statement, Mission Statement, Core Values and Cross-Cutting Themes)

  1. When Should I Be Concerned?
  2. How Can I Understand What Is Happening?
  3. What Caused This To Happen And Can This Be Prevented?
  4. Which Treatments And Interventions Will Help?
  5. Where Can I Turn For Services?
  6. What Does The Future Hold?

Development Process for the IACC Strategic Plan for Autism Spectrum Disorder Research References

Although Congress asked for a plan leading to cause (prevention) and treatment, the draft has all the urgency of molasses on a cold day. It fails to recognize the paradigm shift from autism as a psychiatric disorder to autism as a whole–body disease caused by environmental exposures and treatable. Set forth below are some ideas that might help your comments.

The Plan Must Articulate Adequate Doctrine to Guide Research.

The most crucial flaw is failure to adequately set forth guiding principles and doctrine. The plan must recognize that autism is a national health emergency and propose research with a genuine sense of urgency, similar to our response to threats like SARS and bird flu. The plan must recognize that the ten–fold increase in diagnosed cases over the past two decades represents a real increase in the frequency of this disorder – a genuine epidemic – rather than simply better labeling or increased public awareness. The research agenda responsive to an epidemic is much different than research directed against a disorder that has been here since the beginning of time, especially since it would focus aggressively on identifying and removing environmental triggers and on treatment of those already affected. The plan must expressly state a strategic goal of preventing new cases of autism. Without such a goal and research focused on identifying and eliminating environmental triggers, the over–emphasis on gene research in the current draft risks future reliance on eugenic abortions as the government’s “solution” to the autism problem rather than a genuine effort to identify and eliminate etiologic environmental triggers.

The plan largely embodies the old paradigm of autism as an inherited genetic disorder. Recent research has failed to provide evidence supporting the heritability hypothesis. While investigation of inherited factors in autism have contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore don’t deserve the funding priority they have heretofore received. The plan must state a strategic goal that research be conducted provide benefits to children and adults living with autism.The plan should focus research on environmental causation. Such research must include “controversial” topics such as vaccines as a potential cause. The legislative history of CAA singled out vaccine research for special emphasis yet the draft plan lumps this (without specific mention) into the general category of environmental research. An environmental factor or combination of factors contributes to disease causality. These factors can interact with susceptibility genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre– or post–natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention.

The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. While there may be no “cure” for autism, we cannot turn back the clock to reclaim the time lost to developmental injury. We also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts. Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism. Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function. Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, significant improvement in function is likely. Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation). The plan should expressly recognize that recovery of function is possible with early and effective treatment. The plan must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.

The Plan Must Include Community Participation in All Decisions Relating to Autism Research.

A second major flaw is that it completely fails to re–engineer the grant–making process. Crucial here is the inclusion of community participation at all levels of decisions relating to autism research, especially on matters of scientific merit and program relevance. The Congressionally–mandated program for autism research conducted by the Defense Department (HERE) does a much better job of incorporating meaningful community participation. Greater participation ha been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.

The Budget is Woefully Inadequate to Solve the Challenges Posed by the ASD Epidemic.

Although initially reluctant, the Autism Team eventually accepted the requirement in the CAA that it provide a research budget as part of the SP. How much should be spent on autism research? Not to be flip, but the answer is simple: as much money as is needed to effectively treat existing cases and prevent new ones. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. Ironically, the same general sort of analysis is used to “justify” each new vaccine in terms of the “benefits” of preventing an infectious disease. The budget must also consider the demand from the scientific community for funding for autism–related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money. This information was requested but never provided to IACC.

A couple of examples will illustrate the inadequacy of the funding. A list of the proposed initiatives with proposed funding as of August 8 is here (HERE). Five projects relating to environmental cause are proposed for the next five years at a funding level of $24 million. Why limit these studies to only five (without even specifically mentioning vaccines)? The plan should propose as many as are needed to identify the pre–natal and post–natal exposures that trigger ASD without arbitrary limits. The budget proposes a handful of treatment studies and clinical trials over five years. But this falls far short of studying the effectiveness of the dozens of behavioral and medical interventions currently used by parents. It’s hard to have confidence in NIH’s treatment research agenda in light of the recent cancellation of a clinical trial of chelation. Although thousands of parents are using various forms of chelation, NIH had its own trial on the books for two years and finally dropped it allegedly for safety reasons. Although most likely a pretext, the fact that so many parents are using chelation more than justifies rigorous study of this intervention especially if there are legitimate safety concerns.

Process Failures Contributed to a Deficient Plan.

You might also wish to comment on the many errors that have infected the planning process. The details are too numerous to discuss here, but, without major revision, anything approved by IACC is subject to legal challenge and a restart of the process. Some of the more serious examples include: appointment of Joyce Chung, wife of legendary epidemic–denier Roy Grinker, as head of the Autism Team (see “Grinker’s Stinker: His Wife Runs the IACC” (HERE), January 15); members of science workshops and workgroups were not appointed by IACC, the six c ommunity members of IACC were prohibited from collaborating outside formal meetings; secret email voting and discussions; “public” comments not made public; refusal to provide background information necessary to formulate the plan; community input was ignored; selection of workshop and workgroup members with disqualifying bias and lack of diversity; abrogation of IACC’s obligation to make key decisions to an internal bureaucracy; and “community” participation in making crucial decisions regarding funding priorities and specific initiatives was limited to organizations and interests that privately fund autism research (especially relating to genetics).

Next Steps.
The next meeting of IACC will be held November 21 in Washington (HERE). As has been the case for three of the SP workgroup meetings, hopefully this will be available on a conference call and on the web (slides) so that the broader community can listen. Hundreds of millions in research funding are at stake. It is also important that the broader community have the first–hand opportunity to assess how effectively the six IACC “community” members are representing the community

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 5:21 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00049] Strategic Plan for Autism Research

To whom it may concern,

I don’t like the way my tax dollars are being spent with regards to the activities of the Interagency Autism Coordinating Committee (IACC). I am the father a 17 year old child with autism. [redacted personally identifying information] was born to a mother who was only 30 years old at the time; had a normal gestation (exactly 40 weeks); no medication of any kind was used during labor (as it was only 3 hours and 45 minutes long); [redacted personally identifying information] was breast fed for most of his first 12–15 months and had a very healthy appetite; he hit all his milestones for physical and mental development (e.g., he crawled and started speaking ahead of the averag); then something happened. At around 18 months of age he stopped progressing entirely (shortly after his MMR – – like many others). He stopped picking up new words. He stopped making eye contact. He stopped smiling. He started banging his head. He’s 17 years old. He still bangs his head (we just went to the hospital last week because he cut his head open – – again).

I do not believe that his autism was inherited (i.e., genetic) as no one in either my wife’s family or mine has any history of this type of illness. I do not believe that the increase in the incidence of autism is due to better diagnosis. My son is on the mild end of the spectrum but you don’t have a child like this and not get a diagnosis. If this had happened 30 years ago he would have had some kind of diagnosis. If the increase is due to better diagnosis, then I would expect that there was a decline in some other, related, diagnosis. No such decline exists. The current incidence rate is at 1 in 150 with four times as many boys affected. This is not true in our adult population. Our children are becoming ill in hugely epidemic proportions. YOU MUST DO SOMETHING ABOUT THIS NOW! Further studies into to genetics, while useful, aren’t going to help identify the cause and possible preventions (other than through abortion).

If you talk to parents in the autism community you’ll hear the same basic story over and over and over again. If you do not add research to investigate the possibility that vaccines had something to do with this epidemic then you are violating the direction of Congress and condemning more children to the same fate. It is painfully clear that there is some component of the current vaccine program involved in the majority of autism cases. A study to compare vaccinated vs unvaccinated populations would help shed light on this issue and help people to understand what needs to be done. The current policy of ignoring this issue is only going to prolong the issue and put innocent children at risk of preventable diseases (the AAP, CDC, etc. telling people that they need to just shut up and take their shots isn’t working – – because mother’s aren’t stupid, and there are 5 kids on their street that have autism – – and THAT really scares them, as it should). Studies on general environmental exposures aren't going to get the job done.

Do not limit the areas in which research is done on recovery therapies. I and my wife have been at this for 15+ years. We have tried numerous therapies, many of which had no effect. We have encountered a number that have had dramatic effects. These aren’t things that our insurance will cover because no one has done any double–blind placebo controlled studies to prove that they work – – but we saw it with our own eyes (FYI, my wife and I are both college educated and very familiar with the scientific method). The things that worked for our son did not have the same effect on other children that we know who tried the same things. AND, other therapies worked on some of these other children that did not work on our son. We need to look into as many areas as we can otherwise we’ll miss something that will help a significant portion of the population.

Financially this should be a no-brainer. The estimated cost to taxpayers for the support of people with autism is estimated at approximately $2–3M over the course of their lives. There are currently over 250,000 people with autism in this country. And, we are adding approximately 72 new diagnosed cases of autism per day. The $700B bailout program that Congress is currently working on pales in comparison.

Finally, where is the transparency in this Committee? You are working for the taxpayers (i.e., me). You need to make your entire operation open to the public. You need to allow the members to converse freely with each other and the community at large. You are not working on the Manhattan Project – – although the magnitude of this task is greater – – if you haven't figured that out yet. Open the process and you’ll start making progress.

Respectfully,

[redacted personally identifying information]
Father of [redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 5:25 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00050] Comments on strategic plan for autism research

As a parent with a child who has recovered from autism spectrum disorder and Sensory Processing disorder and who knows 5 other children with autism among my close family and social circle, not to mention the children from our church and preschool whom I have encountered with autism, I am keenly aware that this disorder is on the rise and should be considered an epidemic and national crisis. This is evident through FOIA information from the Department of Education and the military TRICARE insurance program tell us that the CDC out dated number of 1 in 150 is really 1 in 67 children with autism.

Given the prevalence of parents reporting a regression in their children sometime during the toddler years and after normal along with the existence of GI, immune and mitochondrial dysfunction among so many of these children, it is time that our view of autism as a psychiatric disorder shifts to recognizing autism as a whole–body disease caused by environmental exposures and as treatable.

I would like to see this plan direct funding to research that studies the idea that children with autism may have a genetic susceptibility triggered by some event such environmental exposure and vaccines.

Studies should look at timing of exposure during development is also an important consideration, and relevant exposures may occur pre– or post–natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism and sensory processing disorders. Again, because of the reported regressive nature of so many cases of autism a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases should be a priority.

This plan should absolutely include research to evaluate children with autism, to determine when their symptoms evolved, what other medical issues the children have along with identifying genetic markers that might have been the trigger. By doing so we may find children with specific susceptibilities. Knowing these susceptibilities should help us understand environmental exposures that these children should avoid, such as certain general toxins in the environment or the traditional vaccine schedule or components in vaccines.

The plan also should, re–engineer the grant–making process. Crucial here is the inclusion of community participation at all levels of decisions relating to autism research, especially on matters of scientific merit and program relevance. The Congressionally–mandated program for autism research conducted by the Defense Department does a much better job of incorporating meaningful community participation. Greater participation ha been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.

From a budgetary perspective as much money as is needed to effectively treat existing cases and prevent new ones should be included in the budget. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. Ironically, the same general sort of analysis is used to “justify” each new vaccine in terms of the “benefits” of preventing an infectious disease. The budget must also consider the demand from the scientific community for funding for autism–related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money.

Thank you for the opportunity to comments,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 7:14 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00051] NOT-MH-08-021

Please excuse my technical difficulties! The email I meant to send appears below.

Dear Members of the Interagency Autism Coordinating Committee

My comments pertain to Section IV (Which Treatment and Interventions Will Help). I just wanted to mention that there are research–supported therapies besides ABA that have been shown effective in children with autism, particularly in the under 3 age grouping. These therapies are often referred to as “child–directed,” though this is not entirely accurate since it is still an adult who is creating an environment where social learning can take place and applying very specific techniques.

The particular therapy I have in mind, Responsive Teaching, I have been using with my own son, aged 22 months. It was developed here in Ohio at Case Western Reserve University and is both effective and cost-effective. Once I was trained I was able to implement the program at home with my son for the recommended 20 hours a week, eventually bringing in a college student to help me who also attended the training.

There is another approach known as Play Project, about which I know less, but the research studies indicate its effectiveness as on a par with those for ABA. I feel it is important to mention these both in order to present a more balanced view and because some parents may feel ABA is not perhaps the best choice for their child but be uncertain where else to turn for reliable guidance.

Here is a link to an abstract on Play Project:
http://www.playproject.org/about_research_abstract.php

And here to research findings for Responsive Teaching:
http://www.responsiveteaching.org/findings.php

I cannot emphasize enough what a difference this approach has made for my son.

Thank you for investing your time and efforts on behalf of individuals with autism!

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 7:52 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00052] comments

As a Mom of a severely regressive and sick child I want research into how combination vaccines affect babies’ central nervous systems

I would also like to see research on how multiple vaccines, like Pentacel, affect 2 month olds developing brains and immune systems. How do we know that babies can tolerate so many viruses and preservatives at once? My baby could not tolerate 5 separate shots at that age and had a terrible adverse reaction. Are their plans to use animal models, like rhesus monkeys, to examine the effects of both our vaccine schedule and the additive combinations such as: aluminum, ammonia, formaldehyde, etc. They are all widely used.

[redacted personally identifying information]
Mom to [redacted personally identifying information] age 7

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 8:14 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00053] NOT-MH-08-021

My comments pertain to Sections I through V. My interest is in the area of social cognition. Communication and relationship problems are among the core aspects of ASDs, yet we know very little about the role, nature or extent of social cognitive deficits in individuals with ASDs. Social cognition involves how individuals understand and think about the multifaceted social world. Generally, social cognition involves thinking about the self, thinking about others and thinking about relationships. While arguably more difficult to operationalize than other skills such as specific social skills such as eye–to–eye contact, some measures and programs pertaining to social cognition do exist. I believe social cognition or social thinking research may be very important for our comprehensive understanding of individuals on the autistic spectrum. Social cognitive deficits or social problem–solving may be fundamental to the communication and relationship problems of many individuals with ASD.

As more individuals with verbal IQs >70 are identified and as we’re learning that social skills interventions are not leading to as much generalization or social successes as one would hope, researchers should look deeper into what drives social competence. I suggest that significant focus be put to researching social cognitive deficits in individuals with ASD. Furthermore, successful intervention for complex social problems are virtually non-existent. We know little about how to intervene for social cognitive deficits. What works? Since social competence becomes more complicated and more important, as the individual ages, intervention programs must be designed to remediate the various levels of social thinking and social problem–solving. Furthermore, these must be designed to address the social needs and interests of the various age groups just as remediation programs for older dyslexic students involved easier to read materials but with content that was age–relevant. In short, research on social cognition is complex but necessary.

Studies of the various components (e.g. Theory of Mind, Central Coherence) of social cognition suggest that social cognitive deficits are indeed common in individuals with ASD. Among others, MIchelle G. Winner (2002) believes social cognitive deficits result from a syndrome of weaknesses that comprise social cognitive knowledge. She cites 3 major theories with relevance to the development of social skills in individuals with ASD: Central Coherence Theory (Frith, 1989; Happe,1994), Executive Dysfunction Theory (Ozonoff, Pennington & Rogers, 1991) and Theory of Mind ( Baron–Cohen, 1995). Central Coherence Theory speaks a weakness in gestalt–style processing that can limit a person’s ability to understand the meaning of subtle cues in a social situation (Winner, 2002). Problems with executive functioning such as planning, organizing or prioritizing of socially important information or events could also lead to social or relationship problems. Finally, Theory of Mind, sometimes called perspective taking, involves a person’s ability to monitor and consider the thoughts and feelings of others and to respond to the social cues/social needs of their communicative partner (Winner, 2002).

We should not only focus some research efforts to identify the role of social cognition in individuals with ASDs, we should develop effective interventions that target and remediate social cognitive deficits. We need effective programs in schools and in the private sector. For a starting point, Michelle G. Winner is currently developing an assessment measure identifying the various levels of perspective taking. She has published numerous materials proffering an remedial curriculum for ages 3 through adulthood that integrates these 3 theoretical views (www.socialthinking.com). Furthermore, in the Social Thinking Clinic of Silicon Valley (San Jose, Ca.) has a long history of implementing this program and while there is a great deal of anecdotal evidence to support this work, the work remain largely under-studied. Perhaps there are others in the field working to understand the role and nature of social cognitive deficits in ASD. Ms. Winner's work is the most comprehensive that I have found to date. If nothing else, it could be a starting point.

While we continue to progress in areas of early identification, early intervention, genetics, physiology and other biological areas involved in people with ASDs, we still have great need for understanding and interventions that address the barriers to successful functioning for individuals with ASD. We need considerable research aimed at deconstructing the complexities of social thought and social problem-solving throughout the lifespan of individuals on the spectrum. Thank you for considering this suggestion.

[redacted personally identifying information]
Parent of 17 yr. old with ASD
Psychologist

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 8:47 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00054] Federal money for autism research--a suggestion for the IACC

IACC,

You’re making this harder than it has to be, and as a concerned and informed mother with three children, two of whom were vaccine–damaged, I do have some suggestions.

We’ve been asking for vaccinated vs. unvaccinated studies for decades.

Study the vaccines, study what happens to animals when you vaccinate them according to the current childhood schedule, study the kids who were okay and then regressed.

Study the kids with autism who don’t have the identifiable genetic markers, and see what kinds of cumulative exposures they have in common with one another of the known neurotoxins that cause brain damage. Start with mercury and aluminum, and don’t forget to calculate prenatal as well as post–natal exposure.

Note that the 80% to 90% of non–genetic autism we–re currently experiencing can be prevented by reducing prenatal and post–natal exposure to toxins, and this can most easily be done by adjusting the vaccine schedule.

So study the vaccine schedule and make some recommendations for changing it, including elimination of the Hep B vaccine at birth, no flu shots, no mercury in any shot, no more than one shot per 6–month period. And shots should start no sooner than age 2, per Dr. Donald Miller, Jr. (His full recommendations are available at www.generationrescue.org).

Thank you.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 9:43 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00055] Comments

Hello Knuckleheads,

I wrote you idiots last year and explained how to cure autism. You dumb [redacted inflammatory language] didn’t pay attention and decided to just waste more time so you won’t have to hurt the drug companies by telling the general public the truth. I know you are aware that thimerosal caused all of this autism. You’ve been told enough times.

So why do you persist with your obnoxious delaying tactics? Children, and now adults, are suffering with autism because you bunch of [redacted inflammatory language] won’t simply tell the truth. You wrote up some [redacted inflammatory language] plan that calls for looking at some bogus studies 4 to 6 years from now when you know those studies are a waste of time.

I told you last year that you should ask Andrew Hall Cutler, PhD to teach you [redacted inflammatory language] how to cure autism. Did you call him and ask for his help? Did you bother writing back to me so I could explain it to you over the phone without wasting any more time on needless studies? No, you can’t be bothered to hear from anyone who has already cured this [redacted inflammatory language] nightmare because you’re just jacking all of these kids around so you can avoid the truth. The truth is that you [redacted inflammatory language] will propose doing studies until after all of these kids are dead so you don’t expose the pharmaceutical industry for the [redacted inflammatory language] they are for poisoning our babies.

Well [redacted inflammatory language] IACC. There’s no point in being polite with you [redacted inflammatory language]. It’s incredibly obvious that you [redacted inflammatory language] will never tell the truth. Your delaying tactics are allowing people to suffer who should already be cured. Don’t bother asking for comments again. I know you are just doing that as a ruse to make some naive people think you will actually do anything useful. Every [redacted inflammatory language] cent you spend on autism is wasted. All you have to do is admit that thimerosal caused the problem and tell people Andy Cutler can help. Just tell every parent of an autistic kid to go see what Andy has to say and stop wasting our tax dollars on your [redacted inflammatory language].

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 9:03 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00056] Federal Autism Spending

As the mother of two sons with autism I would like the money spent on a three-pronged approach: prevention, education and long term planning.

  1. Spent more money on prevention. Research environmental causes, including an open and honest investigation of vaccines as a causal factor. My two typically developing sons became autistic two weeks after routine vaccinations. All previous government sponsored research has been biased and faulty. More important than cover ups or liability is figuring out why so many previously normal children are becoming autistic. It has and will continue to cost our country tremendously both in monetary and non-monetary terms. Every child that we can stop from developing autism saves us money.
  2. Research bio–medical interventions including DAN (Defeat Autism Now). One of my sons almost recovered with only ABA (behavior modification therapy) but the other needed bio–medical intervention to retain any skills and make any progress. Why would bio–medical make a difference for one and not the other?

  3. Develop a general ABA (Applied Behavior Analysis) curriculum in collaboration with a university program that is certified by the Behavior Analysis Certification Board http://www.bacb.com/. This curriculum would have standard behavior programs written that all school districts, parents and other educators could access. Along with web videos of BCBA (Board Certified Behavior Analysts) doing drills with autistic children. Additionally, the school or parent could pay for video conferencing with BCBAs because in some states there is not a single Board Certified Behavior Analyst. These programs could be based on the ABLLS™–R: The Assessment of Basic Language and Learning Skills–Revised http://www.behavioranalysts.com/ and would therefore be individualized to each child’s deficits. Thus individual school districts would not have to recreate the “wheel” and free up that money for specialized training or more aids.
  4. While all strong programs are individualized for each child, a program designed to teach a child to tie his shoes or put on his clothes is often the same but with different prompting hierarchies. If every school district had access to several hundred programs the money they would have spent on writing these programs could be more efficiently used.

    I don’t make these suggestions because I don't value an individualized program, rather I feel that every child should have access to well written programs and have a chance at recovery.

    Giving more children access to a 40 hour a week ABA program will significantly decrease the severity of symptoms in many children some children recover enough to enter a typical Kindergarten class without any additional services.

  5. Develop long term community centers. Spent money on job training. These children have a normal life span and will need a place to live and something to do. Develop swimming programs and exercise programs. We need to plan for their integration in society and for when their parents will die. Consider their medical and dental care. Most doctors and dentists are not trained to care for our children’s health and as a result it suffers

Feel free to contact me for more suggestions. I urge you to spend the money where it can do the most good. One of my sons is significantly impaired and will never live independently or hold a job and there are tens of thousands like him. Put money into programs for 3 to 7 year–olds. Give children who live in rural areas or towns that does have anyone qualified to set programs an opportunity to adequately educate the children they are responsible for. And give the adults a place to live and something to do.

Thank you,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 10:10 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00057] NIH Research Agenda

Dear Sirs~

You asked for parents opinions, and so you are going to get it.

As a parent of two autistic children, now lasting into my second decade (son 27, daughter 21), I ask you to completely revamp you research programs to the following agendas, per my two decades of research on the causes.

  1. BIRTH PROCESS and Autism, how this could cause autism by Immediate Cord Clamp / Birth Drugs like Terbatuline/pitocines, and high levels of C sections (IMFAR)
  2. INFECTIONS in utero, aka, ANY virus, any immune deranging bacteria, including lyme, syphilis, STD’s, flu viruses, and even vaccines given mothers.
  3. Antipyretic use during those infections in utero, and vaccine fevers (see www.rollingdigital.com/autism)
  4. VACCINES, overuse, toxins, immune shifters, toxins, adjuvant, does autism occur more often in the vaccinated, answer yes
  5. FOOD SUPPLY, MILK, WHEAT, CORN, SOY, BT TOXINS, GMO FOODS, PESTICIDES–the set up for autism? Answer, YES.
  6. The continual pollution – aka MUNICIPAL FLUORIDE in Water which makes aluminum more toxic in the brain, aluminum coming from childhood vaccines and other sources.
  7. The Continual pollution of Flame Retardants, Dioxins, Molds, Pesticide traces on foods, MSG in food supply, Plastics, etc
  8. Mothers failing thyroid glands, autoimmunity, high leptin levels. The other set up for autism.
  9. Mothers amalgam fillings as possible neurotoxic source of mercury, and or her diet of fish and or polluted skies.
  10. Mitochondrial disorders, both inherited and acquired from being exposed to mercury, infections like lyme disease what constitutes a true mito injury, and one has to look towards genetic medical linkages, such as cancers, anemias, seizures, etc in family members and or test the mom before pregnancy or at first weeks of pregnancy, administering mitochondrial cocktails.
  11. Obesity causing autism, as in high leptin levels found in mothers of autistic children, and their children, along with this, low levls of VIT D or the ability to absorb VIT D correctly.
  12. High levels of IRON in our food supply may be causing autism, as in prenatals, formula and cereals. Check for hemachromatosis as a prenatal genetic screen.
  13. Check for iron levels in brains of boys, calcium in girls brains. Answer, these two are the biggest oxidative stressor.
  14. What constitutes oxidative stress, and what constitutes a contraindication against vaccines (aka, dogs and cats have more than our children). Actually take a PCR sample of what is in random vials of vaccines, and behold the retroviruses and contaminations, even mycoplasma. Opting out of vaccines, SHOULD BE EVERY PARENTS RIGHT based upon these preconditions.
  15. Prenatal exams should include, is mother dealing with autoimmune issues and gestational diabetes (another sign of iron overload), does she have a present infections and is being treated for them no matter what (lyme, EBV, Herpes 6a, CMV, etc/, does she have mitochondrial issues, should she ingest iron prenatals if she is already overloaded, are we checking her B-12/Folic/B–6 levels/homocystein and CHOLESTEROL (and no not for high cholesterol, I mean LOW because this impacts a baby’s myelin sheath), is she eating correctly and avoiding MSG?
  16. Bottom line, infections, too many vaccines, immune system gone awry, toxins, birth process, what we are exposed to more than ever…get the picture?

These issues are not minor, or far out of the park, in fact, with my surveys of many mothers of autistic children, THESE ARE OUR CONCERNS, and should be yours, because we know exactly what happened to our children, and how we got here. It is somewhat surprising that NIH/CDC refuses to look at obvious things, and still work around the outskirts of what is really happening ever present in the lives of our families clinically and not just intellectually, when we have tests and numerous evidences of these connections. If only I could set the agenda, mobilize forces, fund independent researchers, I guarantee, the answer to autism would be shortly revealed. Instead, [redacted inflammatory language] around, and wasting time/money on large agendas of genetics (which are influenced by off and off genes which are influenced by oxidative stressors and our diet and our environment, and help you to not implicate "products"). It is a pure waste or our time, when children, as much as 1-67 are finding themselves in dire autism straits. Instead of the kickbacks, and the shady deals behind doors, open parents up to this process and see where it takes you…and I guarantee, it won't be pretty for all concerned. Implications can simply scare NIH more than it is willing to admit. Let's get real science back into this disease, not agendas of unknown origins. Parents have only the interest of their children at heart, what is NIH's?

If we think this current financial crunch will hit us, wait until all these children hit the SSI system which will require lifetime support and assistance! Where are our priorities!!? ? Hire me, consult with me, be honest with me, and others, and I will make sure parents are not shafted any more. I will make sure THEIR voices are heard as well as their children's. Make us want to believe your research, which so far, has been thwarted, twisted, manipulated, forced to go in stupid directions and junked. Genetics doesn't explain an epidemic, or rising number, as you so call put it.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 10:20 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00058] RFI identifier NOT-MH-08-021

To Whom It May Concern,

As a mother of two girls in preschool, I have seen the affects that Autism has on many children. I am fortunate to have healthy children but know three autistic children in my small circle of mom friends. I find this to be too many that I should know. My awareness of autism has been heightened in the past two years especially because of my close friend’s daughter.

The amount of work, dedication, money and love that these parents have to pour into their children in an attempt to heal their children is remarkable. Their stress level is a lot higher than parents like myself who only have to worry about the basics of caring for our children. I think that this is a global issue and one that is a concern for many people outside of the 'parents of autistic children.’

I realize that this is a huge effort to make changes in treatment, research and prohibiting certain chemicals to be omitted in the air from industry and lifestyle. On the other hand, the fact that many of us are not touched personally doesn't mean that something shouldn't and can't be done to improve the odds of ensuring healthy births. This is no longer to someone else's problem. We don't who Autism will strike next. Will it be my unborn child, will it be yours? Will it be our nieces or grandchildren? Will the odds keep increasing at a rapid rate?

Because the odds are increasing, there needs to be change for better treatment and research. As far as genetics playing a large role—if they are in fact behind the increase in autistic children, what has changed in the atmosphere or our lifestyle to make that happen? We should find out before we can't do anything about it.

Thank you for reading my concerns and thank you for your efforts to ensure the best health for everyone's children and their future.

My Best,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 11:19 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00059] Autism funding
Follow up Flag: Follow up
Flag Status: Yellow

As a single father of an Autistic boy, I am ashamed at the minimal funding that is allocated for research. This is a national tragedy that must not continue. My son, and all the other people affected either directly, or as family members, deserve better. We, as a nation, waste so much money on useless governmental pork barrel projects, that it is long since time to put the money that is required where it will do so much good – into the future of our children. Thank you…

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 11:19 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00060] Comments: Strategic Plan for Autism Spectrum Disorder Research

To Whom it May Concern,

Please consider the following comments as you move forward in developing and implementing a meaningful strategic plan for autism research.

The Plan Must Articulate Adequate Doctrine to Guide Research.

The most crucial flaw is failure to adequately set forth guiding principles and doctrine. The plan must recognize that autism is a national health emergency and propose research with a genuine sense of urgency, similar to our response to threats like SARS and bird flu. The plan must recognize that the ten-fold increase in diagnosed cases over the past two decades represents a real increase in the frequency of this disorder – a genuine epidemic – rather than simply better labeling or increased public awareness. The research agenda responsive to an epidemic is much different than research directed against a disorder that has been here since the beginning of time, especially since it would focus aggressively on identifying and removing environmental triggers and on treatment of those already affected. The plan must expressly state a strategic goal of preventing new cases of autism. Without such a goal and research focused on identifying and eliminating environmental triggers, the over-emphasis on gene research in the current draft risks future reliance on eugenic abortions as the government’s “solution” to the autism problem rather than a genuine effort to identify and eliminate etiologic environmental triggers.

The plan largely embodies the old paradigm of autism as an inherited genetic disorder. Recent research has failed to provide evidence supporting the heritability hypothesis. While investigation of inherited factors in autism have contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore don't deserve the funding priority they have heretofore received.. The plan must state a strategic goal that research be conducted provide benefits to children and adults living with autism.

The plan should focus research on environmental causation. Such research must include “controversial” topics such as vaccines as a potential cause. The legislative history of CAA singled out vaccine research for special emphasis yet the draft plan lumps this (without specific mention) into the general category of environmental research. An environmental factor or combination of factors contributes to disease causality. These factors can interact with susceptibility genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre- or post-natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention.

The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. While there may be no “cure” for autism, we cannot turn back the clock to reclaim the time lost to developmental injury.

We also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts. Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism. Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function.

Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, significant improvement in function is likely. Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation). The plan should expressly recognize that recovery of function is possible with early and effective treatment. The plan must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.

The Plan Must Include Community Participation in All Decisions Relating to Autism Research.

A second major flaw is that it completely fails to re-engineer the grant-making process. Crucial here is the inclusion of community participation at all levels of decisions relating to autism research, especially on matters of scientific merit and program relevance. The Congressionally-mandated program for autism research conducted by the Defense Department (HERE) does a much better job of incorporating meaningful community participation. Greater participation ha been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.

The Budget is Woefully Inadequate to Solve the Challenges Posed by the ASD Epidemic.

Although initially reluctant, the Autism Team eventually accepted the requirement in the CAA that it provide a research budget as part of the SP. How much should be spent on autism research? Not to be flip, but the answer is simple: as much money as is needed to effectively treat existing cases and prevent new ones. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. Ironically, the same general sort of analysis is used to “justify” each new vaccine in terms of the “benefits” of preventing an infectious disease. The budget must also consider the demand from the scientific community for funding for autism-related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money. This information was requested but never provided to IACC.

A couple of examples will illustrate the inadequacy of the funding. A list of the proposed initiatives with proposed funding as of August 8 is here (HERE). Five projects relating to environmental cause are proposed for the next five years at a funding level of $ 24 million. Why limit these studies to only five (without even specifically mentioning vaccines)? The plan should propose as many as are needed to identify the pre-natal and post-natal exposures that trigger ASD without arbitrary limits. The budget proposes a handful of treatment studies and clinical trials over five years. But this falls far short of studying the effectiveness of the dozens of behavioral and medical interventions currently used by parents. It’s hard to have confidence in NIH’s treatment research agenda in light of the recent cancellation of a clinical trial of chelation. Although thousands of parents are using various forms of chelation, NIH had its own trial on the books for two years and finally dropped it allegedly for safety reasons. Although most likely a pretext, the fact that so many parents are using chelation more than justifies rigorous study of this intervention especially if there are legitimate safety concerns.

Thank you for the opportunity to provide comments.

[redacted personally identifying information]
MS Civil and Environmental Engineering, emphasis on chemical fate and transport, risk based clean-up of contaminated soil and groundwater

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 11:54 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00061] Strategic Plan for Autism Research - Suggestions

The revised plan must recognize that autism is a national health emergency and propose research with a genuine sense of urgency, similar to our response to threats like SARS and bird flu. The plan must recognize that the ten-fold increase in diagnosed cases over the past two decades represents a real increase in the frequency of this disorder – a genuine epidemic – rather than simply better labeling or increased public awareness. The research agenda responsive to an epidemic is much different than research directed against a disorder that has been here since the beginning of time, especially since it would focus aggressively on identifying and removing environmental triggers and on treatment of those already affected. The plan must expressly state a strategic goal of preventing new cases of autism. Without such a goal and research focused on identifying and eliminating environmental triggers, the over-emphasis on gene research in the current draft risks future reliance on eugenic abortions as the government’s “solution” to the autism problem rather than a genuine effort to identify and eliminate etiologic environmental triggers.

The current plan largely embodies the old paradigm of autism as an inherited genetic disorder. Recent research has failed to provide evidence supporting the heritability hypothesis. While investigation of inherited factors in autism have contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore don't deserve the funding priority they have heretofore received.. The plan must state a strategic goal that research be conducted provide benefits to children and adults living with autism.

The new plan should focus research on environmental causation. Such research must include “controversial” topics such as vaccines as a potential cause. The legislative history of CAA singled out vaccine research for special emphasis yet the draft plan lumps this (without specific mention) into the general category of environmental research. An environmental factor or combination of factors contributes to disease causality. These factors can interact with susceptibility genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre- or post-natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention. The new plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. While there may be no “cure” for autism, we cannot turn back the clock to reclaim the time lost to developmental injury.

We also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts. Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism. Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function. Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, significant improvement in function is likely. Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation). The new plan should expressly recognize that recovery of function is possible with early and effective treatment. It must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Monday, September 29, 2008 11:59 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00062] NOT-MH-08-021
Attachments: Utah Autism Research Program comment.doc

Dear Interagency Autism Coordinating Committee:

On behalf of the Utah Autism Research Program, I would like to respond to your request for information (NOT-MH-08-021) regarding the IACC draft dated August 15, 2008, for the Strategic Plan for Autism Spectrum Disorder Research. For over 20 years, we in Utah have contributed the research literature on autism. Over the years, members of our research team have participated in studies of the epidemiology, genetics, endophenotypes, immunology, treatment, brain imaging and adult outcome of autism spectrum disorders (ASD). We welcome this opportunity to respond to your request for information. As specified in your RFI, our comments are organized by the sections in the draft document.

Introductory Material

We applaud the clarity of the draft introduction. In particular, the six critical questions asked by individuals and families living with ASD provide a clear and concise backbone for the overall document. Your statements of vision, mission and core values provide import orientation for our research field. The crosscutting themes section offers well articulated domains for research efforts over the near and distal future.

We are particularly enthusiastic about the two themes of heterogeneity and lifespan perspective. We agree that the concept of heterogeneity applies to the ASD phenotype(s), genetic risk factors and outcome. In the 1980s, we participated in the UCLA-University of Utah epidemiology study that found 241 individuals statewide, who met DSM-III criteria for autism. We found that roughly 10% of cases also were affected with other developmental disorders. We also found a subset of families with more than one affected individual. We have subsequently enlarged our family studies by searching the Utah Population Database, a computerized set of genealogic records to build extended pedigrees by identifying common ancestors for individuals not previously known to be related. Currently, we are engaged in follow-up studies of the 241 individuals diagnosed with autism in the 1980s. By using the Utah Population Database, we have preliminary evidence for diverse outcome. For example, 10 individuals are deceased and 17% have driver’s licenses. We have directly assessed 41 individuals, and found that some function fully independently with good social and economic outcome, while others are nearly fully dependent. We believe that the life span approach will accelerate progress on understanding genetic and environmental risk and protective factors by delineating trajectories that define subsets of ASD.

  1. When Should I Be Concerned? We strongly endorse the aspirational goal that children at risk for ASD be identified by 24 months (page 8). We agree that effective screening instruments for community settings are quite important. We also strongly support the effort to develop biomarkers and protocols for genetic testing. However, we strongly recommend that genetic testing research efforts occur in conjunction with bioethics efforts. While we agree that genetic testing may be helpful, we have concerns that the potential for harm is great.
  2. In addition, we advocate for measures of ASD symptoms and severity are needed across the life span.

  3. How Can I Understand What Is Happening? The opportunities and objectives are well-stated and well-founded. However, we believe that the long- term objective (three comprehensive longitudinal studies of change over time by 2020) sets too distant a horizon. We believe our statewide sample of 241 children born in the years 1960-1984 could well contribute to at least one such study in the very near future.
  4. What Causes This To Happen And Can This Be Prevented? This section sets ambitious but important objectives. We endorse the grand scale.
  5. Which Treatments And Interventions Will Help? We agree with the overall goal and objectives. We believe that launching four studies identifying biologic signatures of improvement across the lifespan is a very good short term objective. However, we would suggest that similar identification of biologic signatures for decline over the lifespan would be complementary and may be as important scientifically.
  6. Where Can I Turn For Services? We agree with the goal and objectives. We believe that cost-effectiveness across the life span can and should be done. We believe that Utah could contribute significantly to the “state of the states” survey.
  7. What Does The Future Hold? We strongly endorse the need for diagnosing ASD in adults. We also believe that the goal of at least two studies of adult outcome by 2011 can be achieved.

In conclusion, we strongly support the IACC draft. We look forward to the progress that it envisions.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 12:01 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00063] NOT-MH-08-021
Attachments: nimh 9-30.doc

Please accept the following comments on the sraft of your strategic plan. I have attached them, as well as pasted them in below in case you have difficulty with the attachment.

Thanks--[redacted personally identifying information]



Introductory Material (including the Introduction, Vision Statement, Mission Statement, Core Values and Cross-Cutting Themes)

We can all agree on the importance of community engagement, earlier detection, lifespan perspective, and prevention. However, I would like to see the IACC put a greater emphasis on lifespan perspective research instead of prevention research, and wish this could be stressed in the Introductory Material.

  1. When Should I Be Concerned?
  2. What do we need? Research into faster delivery of services once screening/diagnosis achieved. Also, research into how there can be a faster track for setting up and moving through the various screening/diagnosis appointments and wait times.

  3. How Can I Understand What Is Happening?
  4. Please prioritize services before genetics.

  5. What Caused This To Happen And Can This Be Prevented?
  6. Please prioritize services before cause.

  7. Which Treatments And Interventions Will Help?
  8. Stress intervention research across the lifespan.

  9. Where Can I Turn For Services?
  10. Stress implementation science research across the life span, especially from a participatory action model.

  11. What Does The Future Hold?
  12. I fully concur that there is a critical need for information about the current landscape for adults with ASD. More information on trajectories of ASD across the lifespan, with particular attention to transitions.

    Development Process for the IACC Strategic Plan for Autism Spectrum Disorder Research The draft mentions that the Second Strategic Planning Workgroup in 3-08 prioritized the list of 41 research opportunities. Has this prioritized list been made public? If not, doing so would aid the general public tremendously in being able to offer feedback on which we feel should be moved to the top of the list, etc. If it has already been made public, might it be publicized more widely so it is more readily available to more people?

References
None.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 12:12 AM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00064] NOT-MH-08-021

Introductory: I am among the biomed doctors and laypersons who are [redacted personally identifying information] of the [redacted personally identifying information] MINDD Foundation. I have specialized in ASD for [redacted personally identifying information] years, authored [redacted personally identifying information] books [redacted personally identifying information]. (MINDD hosts an annual International Forum in Australia – last year of 4 days, with 3,000 attendees). [redacted personally identifying information]. My colleagues and I, among us, now have case histories of some 5,000 children. These include many restored autistic children, originally and properly diagnosed with regressive autism. Many now reversed in only five to eleven months with biomedical intervention.

  1. Your Strategic Plan, ASD syndrome description, does not include gastro-intestinal symptoms seen in 50% - 75% of ASD children (Dr Tim Buie of Harvard described (2002) in his study of 400 children at the Massachusetts General Hospital, as “behaviors and actions as potential symptoms of intestinal complaints”. He found more than 50% of the autistic children suffered this way. We find the same, but a higher percentage – 79%. And one census study of 57 of our children, 84% with some form of bowel malfunction and dysbiosis. Biomedical treatments are very successful in reversing this problem, and in so doing, more than 70% of our families report significant behavioral and other ASD symptom improvements. We hold hundreds of outcome reports that support these findings. Despite the clinical findings of now many hundreds of biomedical doctors, and the records held by the San Diego Autism Research Institute of some 36,000 children, where a gluten-free and dairy-free diet alone produced a parent rating report (n 933) of 63% “got better” – pediatricians in the United States and Australia tell parents that “there are no studies to prove this and only minimal anecdotal reports” . Whereas, the clinical truth supports the ARI findings on a daily basis for ten years, in our practices alone.
  2. REQUEST: Please contact Clinics that treat biomedically to verify the (1) high percentage of repairable G.I.T. problems and (2) the resultant broad-spectrum of ASD symptoms and signs that resolve. This has not been done by the NIH.

    Surely, the logical place to begin your stated ‘urgent’ investigations for ASD interventions is among clinicians who can actually show you their positive outcomes? And, with this one tool (GF & CF free diet) – you can expect a favourable response of some 50%-60%.

  3. Your Strategic Plan does not mention the commonality of basic nutritional deficiencies + metal toxicities, so widely reported by biomed doctors among ASD children. Common deficiencies and excesses, as published by several ASD treating facilities and laboratories, and well known by all biomeds treating ASD children include:Calcium, Selenium, Zinc Magnesium, iron, lithium, iodine, cysteine, sulfate, taurine, B12, B-6, lysine, methionine, essential fatty acids, and vitamins C, D, E and A.

Excesses (found post-challenge by use of chelating agents): aluminium, arsenic, lead, mercury, copper, cadmium, antimony.

Since the essential nutrients are just that, essential - an urgent priority should be measures to find how widespread are these deficiencies? And excesses. But, the measurements should be taken not by blood only, but also by a reputable laboratory using Hair Tissue Mineral Analysis whose accuracy of reporting has been well-tested by clinician results (such as Doctors Data, Chicago or Great Plains, Kansas).

REQUEST: a study into the nutritional status of some 2,000 autistic and other ASD children.

(Note: From your track-record to date, neither of the above requests will even be considered - as no pharmaceutical drugs are necessary in our treatments. Thus, what I and other biomeds write will be totally ignored. And children will be further unnecessarily damaged. Q.E.D.)

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 12:45 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00065] NOT-MH-08-021

Dear Sirs:

Prevention: If this is indeed a serious goal of the IACC as it should be you will need to increase the amount of research and funding for environmental factors. Given the rate of ASD it would appear that the genetic predisposing factor is relatively common in the general population. Therefore, prevention will necessitate the removal of the environmental trigger(s).

Community Engagement in ASD Research: IACC needs a better strategy for utilizing the first-hand experience of indiviuals with ASD, their parents and caregivers. A better strategy is also needed whereby parents can request specific research and share first hand experiences pertinent to autism research. I personally recommend the establishment of a dedicated phone number and email address that is available to the public at all times so we can make requests, and submit concerns and insights. Staff would be needed to categorize the incoming data and then this should be periodically presented to the IACC and should be considered in the shaping of the research agendas.

Another recommendation would be creating a database similar to or in coexistance with IAN that would periodically send evaluation forms to participating members. The evaluation forms should be particularly assessing participating community members appreciation and concerns with current research agendas and processes. This is a simple yet very effective procedure used by most medical establishments, businesses etc. to better gain an understanding of the community they are serving.

A third and final recommendation would be the establishment of a panel of community members who can represent the ASD community. Such a panel could oversee the two above mentioned projects as well as provide insight and assistance in how to best disseminate new research information to the autism community. A website and forum dedicated to representing the ASD community and the disemination of results of research would be greatly appreciated. The IACC should be willing to take suggestions from the general public for individuals appointed to such a panel.

II. HOW CAN I UNDERSTAND WHAT IS HAPPENING?

*Human and animal studies that examine immune, infectious and environmental factors in the occurrence of ASD. No Short term or long term objectives have been identified for this proposal. Please consider giving this area of research significant funding and present clearer goals to the public.

Short Term Objectives
*Support at least four research projects to identify mechanisms of metabolic and/or immune system interactions with the central nervous system that may underlie the development of ASD during prenatal-postnatal life by 2010. This goal I would wish to see increased to at least 10 studies. Studies such as this have the potential to develop an understanding of the biological process of the disorder thus moving us more quickly into the realm of discovering effective treatments that are noneducational. I also think that it should also be included in Long Term Objectives as well.

III. WHAT CAUSED THIS TO HAPPEN AND CAN THIS BE PREVENTED?

*Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g., ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies. As a parent of an autistic child who is my eldest and was vaccinated and four NT children three of whom are unvaccinated I currently refuse to have my children vaccinated and will continue to refuse vaccinations until a well controlled study is done comparing vaccinated and unvaccinated children and assessing the ASD prevalence rates. Failure to conduct such a basic study to identify what role immunizations may or may not have in the development of ASD constitutes negligence to provide the general public and parents of ASD children the benefit of a scientifically sound immunization program. This topic has become increasingly controversial in the public arena as well as in the medical and scientific communities. By refusing to clearly address a debate that has become highly publicised you invite the suspicion of the public and ongoing criticism of the vaccine program as it relates to ASD.

Scientific studies have been done addressing the MMR and Thimerasol, but to date no definitive research has been done assessing the rates of ASD in vaccinated and unvaccinated populations. This is basic epidemiology that should be an urgent priority if you are really interested in the concerns of parents of regressive autistic children, and if you value the confidence of the public in the vaccine program. Scientific study of this nature would indicate whether there is a potential causal relationship between vaccines or not. I am requesting such a study so that I can truly make an informed choice based on science as to whether to have my children vaccinated or not.

I also request a second study in which the more than a thousand children who have received compensation for neurological damage due to vaccination by the vaccine court would be evaluated for ASD. To date, vaccines have been the most dominating environmental concern being voiced by parents of ASD children and to ignore that voice by giving only general monitoring of scientific literature as your best offer is to indicate a lack of concern for not only us but our ASD children and constitutes failure to address our need. We stand in need of basic science to either lay our concerns to rest or validate them. Research has revealed elevated levels of cytokines in the spinal fluid of autistic children indicating inflamation of the brain. Inflamation of the brain may be causal to the increased head growth that appears to take place in early childhood in some ASD populations. It is biologically plausible that vaccine induced encephalopthy results in autism and disrupts normal brain development. Another potentially ASD causal vaccine ingredient is aluminum. Its purpose as an imflamatory stimulant to the immune system should be more thoroughly studied as well as the effect of multiple aluminum containing vaccines being given simultaneously to young infants should be considered suspect. I also strongly encourage active research of pesticides, ultrasound, PBDE's etc.

Short-Term Objectives

*Initiate studies on at least five environmental factors identified in the recommendations from the 2007 IOM report "Autism and the Environment: Challenges and Opportunities for Research" as potential causes of ASD by 2010. I would recommend initiating studies on at least 10 or more environmental factors identified. The scientific community has for years has been guilty of a reluctance and even denial of the impact of the environment as it relates to ASD. Given the prevalence of ASD it is highly likely that the genetic predisposing factors are very common to the general population. Therefore the eliminating of the environmental triggers is going to be necessary to the prevention of the disorder.

Determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development by 2012.

Identify genetic risk factors in at least 50% of children with ASD by 2014.

The two above statements clearly indicate your strong bias towards funding and research for genetic risk factors versus environmental factors. Lead poisoning unfortunately remains one of the greatest threats still in existence to American children today. It affects children cognitively causing loss of IQ and produces aggressive behavior. Its impact on children is based solely on exposure, not genes. I would appreciate a willingness on the part of the IACC to more seriously pursue the environmental factors in ASD. Genetic mutations are likely also be the product of an environmental insult. The old proverb "An ounce of prevention is worth a pound of cure." applies.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 1:07 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00066] Specific Plan for Autism Research draft comments

Dear Sir or Madam,

I have read the draft and will add my comments below. I would first like to state that I am a mother of four children, one of whom is severely autistic, having made little progress in earlyintervention in our public school system in Virginia since the age of three.

I would also like to preface my comments by saying that the draft seems to lack the urgency that the statistics it includes would suggest. The tale is told, this is an "epidemic" and the plan should treat it assuch. If one of every 150 American children were being abducted the public would be outraged. People would take action. That is exactly what is happening each day across this country. My son was perfect, normal, met every milestone, then began regressing around 18 months. He is only a shell of a boy now. Every dream we had for him all but gone. Now, as middle-class parents of three other children, we have to figure out how to care for him for the remainder of his life, while also providing a quality of life (college education) for our other children.

The most crucial flaw in this plan is failure to adequately set forth guiding principles and doctrine. The plan and everyone involved in its creation must recognize that autism is a national health emergency and propose research with a genuine sense of urgency, similar to our response to threats like SARS and bird flu. The plan must recognize that the ten-fold increase in diagnosed cases over the past two decades represents a real increase in the frequency of this disorder – a genuine epidemic – rather than simply better labeling or increased public awareness. The research agenda responsive to an epidemic is much different than research directed against a disorder that has been here since the beginning of time, especially since it would focus aggressively on identifying and removing environmental triggers and on treatment of those already affected. The plan must expressly state a strategic goal of preventing new cases of autism. Without such a goal and research focused on identifying and eliminating environmental triggers, the over-emphasis on gene research in the current draft risks future reliance on eugenic abortions as the government’s “solution” to the autism problem rather than a genuine effort to identify and eliminate etiologic environmental triggers.

The plan largely embodies the old paradigm of autism as an inherited genetic disorder. Recent research has failed to provide evidence supporting the heritability hypothesis. While there may have been a genetic factors that came into play when my son developed autism, I do not believe that was the sole cause. Something else or a myriad of factors came together to trigger this event. While investigation of inherited factors in autism have contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore don't deserve the funding priority they have heretofore received. The plan must state a strategic goal that research be conducted to provide benefits to children and adults living with autism.

The plan should focus research on environmental causation. Such research must include “controversial” topics such as vaccines as a potential cause. An environmental factor or combination of factors contributes to disease causality. We know this it is proven time and again with other common medical conditions like heart disease. These factors can interact with susceptible genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre- or post-natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention.

The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. While there may be no “cure” for autism and cannot turn back the clock to reclaim the time lost to developmental injury, we also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts.

Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism.

Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function. Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, and the financial backing for families to employ these methods, significant improvement in function is likely.

Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation). The plan should expressly recognize that recovery of function is possible with early and effective treatment. The plan must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.

How much should be spent on autism research? The answer is simple: as much money as is needed to effectively treat existing cases and prevent new ones. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. Your budget is woefully inadequate.

As I am listening to the news on the probable $ 700 billion dollar bailout this week, it occurred to me how unfair it is that people on Wall St. can get "bailed out" at such a cost, but lawmakers have yet to provide the funding autism needs. When will you help us and our children? When will the NIH get a clue? Will it be when all of your children or grandchildren or someone you love are affected? When you are living with this pain and watching your child disintegrate in front of you, then will you wake up? God help you all if it comes to this.

I hope that you are actually taking the public comments to heart and treating them as you should. We are the people living with this disorder and it is devastating. I pray that things will change in this country and not only will we be able to get help for our son, but that we can rest knowing he will come into adulthood and be treated with the dignity he deserves.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 1:08 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00067] NOT-MH-08-021

Thank you for this opportunity to provide input to the IACC Strategic Plan process.

Regarding composition of the IACC and workgroups, although NIMH has solicited input from members of the autistic community through RFIs, comment times at IACC meetings, and opportunities for written commentary, a commitment needs to be made to place more individuals on the autism spectrum in workgroups, meetings on funding decisions, and on the IACC committee itself. Future Strategic Planning processes need to include autistic individuals at all levels of the planning process in order to ensure that research priorities accurately reflect the needs of individuals on the autism spectrum.

One area that needs more attention is the services research section under the treatment heading. Aproximately 1.6 million dollars has been budgeted for research into services. Since autism is a lifespan condition, a much higher priority needs to be given to research in this area.

Research into interventions and treatments, such as behavioral interventions and augmentive/assistive communication needs to focus not only on already-studied areas like PECS and ABA, but on new and innovative approaches.

Focus not only on visual communication systems like PECS but also on the needs of individuals who can use written language but are nonspeaking, either completely or partially, or who are limited in speaking but not in writing/typing. Education of autistic individuals, parents, and professionals who work with them should be an implementation aspect of research into communications systems.

Although ABA seems to be the most-studied behavioral intervention system, there are reports from within the autistic community indicating that it can have unintended consequences, or simply be a poor fit for certain individuals. Rather than focusing on changing autistic behavior to emulate non-autistic behavior, research needs to be done on how to best help the autistic individual develop to his or her full potential, as an autistic person.

Regarding prevention and preemption, no research should be conducted with the goal, either stated or implied, of eliminating autism by eliminating autistic people from the gene pool.

Language used by professionals and researchers often refers to autism as "a devastating disorder," making no attempt to clarify that autism is a spectrum condition and that not all (or perhaps even most) individuals are "devastated" by the conditions associated with autism. Part of improving the lives of people on the autism spectrum is accurate education of parents and the public about the heterogeneity of autism, including not only the difficulties but also the strengths associated with autism. Rather than using dehumanizing terms, neutral language that avoids hyperbole and exaggeration will help to make the world a more welcoming place for people on the autism spectrum. NIMH and IACC committee members should take the lead role in accurate and informative public education.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 1:30 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00068] Fwd: Spending Recommendations

Dear Sirs and Madams,

I am writing in regard to spending on autism research over the next five years. As a college teacher who has taught high school as well, I can say that students with IEPs for autism spectrum conditions do not grow up to be typical adults, but do grow up to be great people: I have had a number of them in both my high school and my college classes. I would hate to see spending relegated primarily to children. I have taught atypical adults as well, in both face to face and online courses. Here are a few of the places where I see needs:

  • Research into hidden curricula at older adult level (over age 30), and the development of materials which autistic adults can read or view to learn more about how typical people view a great variety of social interactions, well beyond what is currently taught to children, adolescents, and younger adults [employment, romance, more than passing adult friendship, and more].
  • Funding for professional development for educators and employment counselors to understand work–related issues of adults on the spectrum.
  • Grants and incentives to companies who hire adults on the autism spectrum. In particular, in going through any evaluation, these same people may have difficulty in learning the social rules that are specific to the company fast enough to meet the unwritten rules of the company, and therefore, may be terminated or pressured to leave, before they can be viewed as the valuable employees they are. There may be sensory issues and other issues that are “reasonable” and easy to accommodate, if anyone is willing to make the effort. (These issues will be specific to each individual.)
  • Grants to offer specialized legal counsel to people with autism who are involved at all levels of the criminal court process, either as defendants or as victims, since lack of social skills impairs communication particularly badly in situations like these. In particular, all judges should be informed that lack of eye contact, and fear at the strange process, in no way indicate guilt in a person with autism. All police should be informed of this as well, and I would like to see money set aside to educate law enforcement on the great differences between how a person with autism reacts and how a person without autism might react, under identical conditions.
  • Research into the differences between men and women with any of the pervasive developmental disorders. I have read that many women on the spectrum are undiagnosed, because they present quite differently.
  • Money targeted to aid all who desire to live independently, and become tax-paying citizens, rather than be residents in facilities.
  • Grants to support the purchase or access to a computer with online capability for every literate autistic person in the country, over the age of 12. (There are children's and teen groups for those under 18.) This could include money for training on internet safety, because certainly, someone could prey on anyone who is more naive and trusting. If someone has difficulty speaking, the ability to get online and learn and interact makes an amazing difference to him or to her. Online, these kinds of difficulties are far less noticeable, and in some cases, cannot be discerned at all unless the person discloses.
  • Grants for adults, as well as children, to purchase software to aid in learning to read facial emotion, or other assistive technology.
  • Grants to individuals or organizations to purchase books for their libraries, to help educate themselves or their members in relationship to autism spectrum conditions.

Next, I will list things I would not want to see supported:

  • I would hate to see eugenics supported. If what I have read is correct that Einstein and many other geniuses were on the autism spectrum, then I have to recall the foloowing proverb:
    The stable is clean when there is no ox inside it, but much good is derived from the strength of hte ox,
    I think we have a significant number of people that society classifies as "great innovators", who in fact were or are on the autism spectrum. I am sure their parents did not always have an easy time taking care of them when they were young. Would anyone really feel good about aborting any of them? A prenatal test will likely lead to a very high percentage of babies being aborted, even though the test cannot be certain (there are pairs of identical twins where one developed an autism spectrum condition, and the other apparently did not).
  • I would hate to see more money spent to apply aversives. I live in New Hampshire, where aversives are illegal. There are equally effective techniques that work. Aversives can cause any number of other psychological problems, and have led to a number of fatalities.

Thank you for your consideration.

Respectfully submitted,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 2:02 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00069] NOT-MH-08-021
Attachments: iacc31nov08.doc

To Whom It May Concern,

I wish to submit the following statement to the IACC in response to NOT-MH-08-021. I have included my statement in the body of this email, and as an attachment. Thank you very much.

Sincerely,

[redacted personally identifying information]


Statement to the IACC
RFI notice NOT-MH-08-021
[redacted personally identifying information]

The following comments are submitted to the Interagency Autism Coordinating Committee regarding its Draft Strategic Plan for Autism Spectrum Disorder (ASD) Research.

My name is [redacted personally identifying information] and my 11-year-old son, [redacted personally identifying information],has autism. Via [redacted personally identifying information] blog, I communicate [redacted personally identifying information] with many autistic individuals, parents and teachers of autistic persons, and other stakeholders in the autism communitys. I am also a [redacted personally identifying information] at [redacted personally identifying information].

[redacted personally identifying information]'s autism can be considered severe: He is minimally verbal, is far beyond his peers in his academic skills (he is not able to read or perform simple arithmetic), and has a history of severe (self-injurious) behaviors. [redacted personally identifying information] has benefited greatly from the emphasis on early diagnosis and intervention and I cannot underscore the need for the public to know about the early warning signs of ASDs, as noted in the Draft Strategic Plan (Section I, p.8).

[redacted personally identifying information] was born in [redacted personally identifying information]. By [redacted personally identifying information], he was in an intensive home educational program based on Applied Behavior Analysis (ABA), which has been continued to be the mainstay of his education. We tried a number of biomedical and alternative treatments (the gluten–free casein–free diet, anti–fungal therapy, cranial–sacral therapy, etc.). While these sometimes offered immediate results, none have provided the long–term progress that an educational program, individualized to [redacted personally identifying information]’s specific learning needs, has. Thus, guidance about safe and effective treatments that can truly be (as noted in Section IV, on p. 19) "effective for reducing both core and associated symptoms, for building adaptive skills, and for preventing the disabilities associated with ASD" is much needed. Desperate parents can put too much store in novel, untested interventions that offer limited results.

As the parent of a child who is fast growing up– – – my son has entered puberty and is three inches taller me– – – I was heartened to see two sections of the Draft Strategic Plan focus on services and the delivery and implementation of these, and on the long-term needs of autistic individuals who will require full–time support and staff to work and live. The emphasis on these being of “high quality,” “evidence–based,” and “cost effective” (Section V, p. 22) speaks to the need for providing autistic individuals with the best services possible throughout their lifespan, while also being realistic about the costs of such services.

To underscore why I believe the above goals are so important, I wish to describe one experience that our family had in seeking to provide [redacted personally identifying information] with, as the sixth Aspirational Goal states, a “fulfilling and productive life in the community” (Section VI, p. 25).

In 2003, my husband, [redacted personally identifying information] and I, bought a house in a mid-sized town in [redacted personally identifying information] and thought we would live in it for the rest of our lives. [redacted personally identifying information] was the site of some of [redacted personally identifying information]’s greatest triumphs, where he learned to swim and ride a bike. But it was also the place where the school district refused to provide [redacted personally identifying information] with the right kind of education that we and our doctors and [redacted personally identifying information]’s therapists knew was right for him.

In [redacted personally identifying information], as [redacted personally identifying information] was turning 8 years old, his behaviors problems had intensified to the point that he had become a danger to himself and to others. He was in effect expelled from the public school programs. Some thirteen miles away from [redacted personally identifying information], another school district had created an excellent in-district autism program and it would not have been too hard for the administrators in [redacted personally identifying information] to find out about this program and create one like it. But our school district insisted that [redacted personally identifying information] be sent wherever an opening could be found.

On the south-east corner of [redacted personally identifying information] and not far from an after-school program for developmentally disabled children and adults run by the ARC (Association for Retarded Citizens) [redacted personally identifying information] – – –the program was housed in a warehouse–like space furnished with old, beat–up furniture and a cement floor; the staff smiled and talked to each other– – – –the organization Safe Minds had [redacted personally identifying information] at [redacted personally identifying information]. Safe Minds is one of the main proponents of the hypothesis that mercury causes autism. This belief has at times dominated public discussions about autism and distracted attention from the real needs of real autistic persons today; from the need for educational and other support services. [redacted personally identifying information] and I had been initially glad to know that an autism organization was associated with [redacted personally identifying information] and we were ultimately disappointed that this organization's agenda is so focused about one hypothesis about autism.

[redacted personally identifying information] school district had, then, failed to face its moral obligation to provide [redacted personally identifying information] with an appropriate education. We ended up moving to [redacted personally identifying information]. Today, [redacted personally identifying information] is a happy school boy who looks forward to the school bus and is flourishing in an ABA classroom in our town's middle school. Safe Minds is no longer in [redacted personally identifying information] but the fact that it was, and that its presence did not improve educational programs for autistic children, has come to symbolize for me how searching for a cause and cure of autism can siphon attention from taking care of autistic individuals.

We need to devote as many resources as we can to autistic individuals who are here today. I’m always interesting in finding out more about the causes of autism, and especially about genetic causes (Section III). But I’m not sure resources are best used to find out how to prevent autism in children who have yet to be born, when so many children don’t have enough services and don’t have the right kind of educational program. That’s when life with autism feels hopeless and endlessly awful. Perhaps it seems like a small thing to talk about “better services.: But I really am convinced that, not too long ago, [redacted personally identifying information] would have been packed off to a residential placement relatively early in his life. I think, I hope, we’re slowly on our way to developing solutions to enable autistic individuals to be educated and be included in as many ways as possible in their communities and at home; to make it possible for us to tuck our children into their own beds at night, in our own homes. And this is something to aspire to indeed.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 2:47 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00070] Autism Research Spending

Please increase the funding for autism research and focus on similarities in the kids that develop autism then look for precursors/genetic predispositions, etc. in the general population that might accurately predict the likelihood of a child developing autism. Along with much safer vaccines and parental choice as to which vaccines a parent chooses for each of their children, having the above knowledge will influence parents to make better decisions for their children and hopefully decrease the amount of money being spent on sick children in the future.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 3:09 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00071] RFI identifier NOT-MH-08-021

September 29, 2008

[redacted personally identifying information]

IACC

RE: Strategic Plan for ASD Research

To Whom It May Concern:

My name is [redacted personally identifying information]. My grandson was recently diagnosed with autism at two years old. I have been forced to educate myself in a short four months about the woeful world of autism. So I am going to now educate this committee. There is no time for candor.

Number one, you must quickly coordinate and accelerate the pace of scientific discovery in ASD. A commanding urgency must be demanded of all members. You must make it clear, this is a massive epidemic. Dr. Doreen Granpeesheh, physiologist and founder of The Center for Autism and Related Disorders, who earned her degree under the guidance of Dr. Ivor Lovaas, provided some shocking information at the Anaheim, California DAN conference held in 2007. When she began her work in the 1970’s autism occurred in 1 in 15,000 children. Now she faces much higher numbers. She stated, that if you combine autism, with aspergers, PDD, and ADHD the numbers rise dramatically. She now faces numbers as high as 1 in 6 children. Are you paying attention?

Number two, you need to step onto the battlefield. This is our country’s future at stake. Everywhere I go I am met by children and families without resources, facilities, and needed professionals to help them deal with this epidemic. The numbers of children are overwhelming the available facilities and personnel. You must coordinate the parents and professionals that are in the field and build a network of support. By using their hard won knowledge you could create a powerful force to overcome this epidemic. Pay attention to their successes in healing their children and do the research that has the potential for healing these kids. We cannot languish any longer with inaction. There is no room for niceties in collaboration. The researchers must approach this as a united team helping recover children with autism.

Number three, vaccines do cause autism. My grandson was a happy developing boy until he received his MMR and Varicella vaccine. Within two days, he was spinning like a top. He received twenty-one vaccines by the time he was fourteen months old. My own children received ten vaccines by the time they were six years old. The CDC citing medical studies that only had twenty–five children studied, all of which had autism prior to their MMR vaccination is not an honest attempt at research. The community of autism will not tolerate this kind of deception. You cannot have research solely aimed at genetics. No epidemic in history ever was a result of genetics. What will you do, have half of the nation not having children, because of a genetic link that only becomes a problem when it is assaulted by a vaccine? I cannot excuse the medical professionals that have recommended these cocktails of destruction and I pray that you will not allow a conflict of interest in regards to any research. There should be no one allowed to do research that has an interest in any vaccines profits or in any way is funded by a pharmaceutical company.

Number four, identifying children is not that difficult when it comes to autism. My grandson’s parents and I recognized something was wrong very quickly. The only trouble we had was with his pediatrician recognizing the signs. She delayed his diagnosis. It is amazing how disinterested or uneducated the medical establishment seems to be. To reinforce this point let me tell a little story. I went to an autism meeting that was a series of events being held across our state by one of our representatives. This particular meeting was held at one of the largest hospitals in the state. Not one medical professional or insurance representative was there. This is a perfect example of the blatant disregard for this epidemic being shown by mainstream medicine and health insurance industry. After my grandson's diagnosis, his parents were handed a booklet and sent on their way.

Number five, Biomedical Treatments combined with ABA therapy does work. This is an important key to solving this epidemic. DO NOT DISMISS THIS! My grandson’s diarrhea ceased, he stopped losing weight and has gained weight, he no longer was sick with colds, he stopped drooling, his asthma stopped, he regained much of his eye contact, he has begun to play with toys appropriately, he has spoken an occasional word after losing all of his words, and he has calmed down tremendously. And I want to point out that the biomedical treatment was his only therapy for the first couple of months. We have been treating him since June of this year.

You should not ignore the rant of this grandmother, because there are many more in the wings. I have yet to meet one person (except medical professionals) who has been in disagreement with anything that I have written to you today. The numbers of voices are growing everyday and with each injured child, they scream louder and louder, “Enough!” I want actions taken to correct the pain and suffering being inflicted on these children by a medical establishment that can’t see the forest for the trees. There is a clear right and wrong path for this committee to take and I again pray to God that you realize the huge responsibility that rest on your shoulders. The children of this county are innocent and they deserve a true accounting of the past fifteen years of pain that has been inflicted on them. My Grandson should have never been given twenty–one vaccines this is truly insanity. There is a reasonable approach to vaccinations and there is an unreasonable approach. Let common sense be the guiding factor in your effort to heal the many, many sick children with autism in this country. Please allow the real research we need to heal our kids take place, don’t waste another second of another child’s life.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 3:17 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00072] Response to RFI NOT-MH-08-021

My name is [redacted personally identifying information]. I am an Asperger adult, father of a 17yo autistic son, [redacted personally identifying information], and a 19yo daughter in the broader autism phenotype, [redacted personally identifying information]; their nonautistic mother, [redacted personally identifying information], and I have been married for almost 21 years. [redacted personally identifying information] the Asperger’s Association of New England (http://www.aane.org); [redacted personally identifying information] the Autism National Committee (http://www.autcom.org); [redacted personally identifying information] chapter of the Autism Society of America; and [redacted personally identifying information] Autism Network International (http://www.ani.ac).

Here are my comments, organized by sections of the Draft Strategic Plan:

  1. WHEN SHOULD I BE CONCERNED?
  2. My experience with autistic individuals from all points across the spectrum leads me to the firm conclusion that *establishing a reliable and respected means of communication* must be Job 1 as soon as it is clear that there is a lack of development of expressive speech. Alternative/augmentative means of communication (AAC) in lieu of expressive speech may range from keyboarding to sign language to picture–boards and – books that can be pointed to. Where apraxia is a barrier to pointing or other motor activity needed to use the AAC, support and training to overcome the apraxia is necessary. The ability to communicate needs, desires, fears, preferences, etc. makes all the difference in the world: without it, the individual is reduced to behavior that is often maladaptive in order to effect change or control in his/her environment; with it, communication and negotiation become available better alternatives to maladaptive behavior to achieve those ends. A means of expressive communication of some kind is also a fundamental necessity for interactive education and measuring progress in education.

    IACC should sponsor outcome studies to better document and quantify the effect of the availability of a reliable and respected expressive communication medium, and to develop best practices in providing same to individuals with deficits in expressive speech. The effect of the age at which individuals gain access to AAC to this end should be one aspect of such studies.

  3. HOW CAN I UNDERSTAND WHAT IS HAPPENING?
    (also relevant to IV. WHICH TREATMENTS AND INTERVENTIONS WILL HELP?, V. WHERE CAN I TURN FOR SERVICES?, and VI. WHAT DOES THE FUTURE HOLD?)
  4. The public perception and characterization of autism is fraught with misconceptions. Parents new to a diagnosis or suspecting autistic development in their children are bombarded with worst–case horror stories and a bizarre bazaar of interventions and promises-of–“cure”, often with dire warnings about the urgency of undertaking such interventions “before it’s too late”. They aren’t given enough of an insight into possible adult outcomes, much less contact with a representative range of adults on the spectrum whose experiences can help them understand their children’s potential trajectories, and can help them prepare to provide support and advocate for constructive resolution of the issues their children will face as they age into adolescence and adulthood.

    Better, more reliable, more objective best–practice information needs to be made available to parents and families, including the perspectives of adult self–advocates living the life. The autistic–run and autistic–friendly organizations in which autistic self–advocates have come together and have found their voice, such as the Autism National Committee, Autism Network International, GRASP (http://www.grasp.org), and the Autistic Self–Advocacy Network (http://www.autisticadvocacy.org), and others, most of which are small and scantily–funded in contrast to the big established autism organizations such as ASA and Autism Speaks, and hence likely not yet on the radar of the IACC’s purview, should be brought into the creation and dissemination of such information.

    A critical part of such improved information is a comprehensive, objective set of questions that parents and families can ask about prospective interventions and their goals and methodologies. Such a framework of questions should clearly delineate the distinction between autistic ways of being, and handicap or disability concomitant or secondary to autism, with an emphasis on forming goals and strategies for the mitigation of the latter while recognizing and educating about aspects of the former that are not intrinsically disabling, or disabling only because of lack of acceptance or accommodation by the mainstream society.

    IACC should sponsor studies of the effect on outcomes of the availability of such a critical framework of best–practice information and questions to ask about prospective interventions and their goals and methodologies; and studies of the effect on outcomes of the availability of contact and interaction with adult self–advocates.

    IACC should engage adult self–advocates in the process of designing and executing implementation–science oriented studies, along the lines of the Community Based Participatory Research model promulgated by the AASPIRE project (http://aaspireproject.org).

    One area of particular concern for autistic individuals is getting adequate mainstream medical care for *non–autism–related* medical issues. The barriers that exist in that regard need much more attention and study. Difficulties in communicating what is wrong, difficulties in interacting with providers, lack of knowledge and experience among providers in working with the autistic population, are all concerns. Also a concern is the confounding factor of “biomedical” interventions of dubious provenance which purport to address physiological problems such as gastrointestinal disorders that should really be getting attention from mainstream medical providers in the same manner that they would get attention in a non-autistic patient.

  5. WHAT CAUSED THIS TO HAPPEN AND CAN THIS BE PREVENTED?
  6. I am very concerned about the low standards of quality and ethics in much of the literature being put forth to support various alleged environmental causes of autism, and to support various “biomedical” interventions purporting to remedy such alleged causes. IACC should develop, promulgate, and help enforce high standards for autism research and publication: of peer review, of expectations that experimental models and collected data actually support conclusions drawn in publications, of ethical institutional review practices, and of correction of errata, on a par with those in “hard” scientific fields.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 3:49 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00073] urgencey!!! Autism

Kids are rapidily breaking out with autism. Look at all the causes. Vaccines included. I am not anti vaccine. I am anti toxins in people and animals. I agree there are to many toxins in everything. Its time to get rid of them all. From our food to the vaccines and any other products that contain toxins that could destroy lives. I hope and pray for an end to this big mess. My daughter is 14 yrs old. She was diagnosed with autism in 1998. Today she is basically recovered though she still has some issues. Nothing like she was in 1998 though. Look into the Defeat Autism Now treatment. One size does not fit all and it does take time. Thank you sincerely, God bless you and lead and guide you.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 6:47 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00074] comments to proposed plan

Please do not forget the older person with autism in the proposal

I have been a member of our states UCEDD and have been concerned that there has not been interest in disability categories unless research dollars are connected with it

In the autism area there is a lot of focus on early intervention and young children. this is wonderful but we need to remember that there are millions of individuals over the age of 13 that are suffering with autism–they are suffering because of inadequate health care supports as well as poorly educated/trained teachers.

Children and adults with autism deserve the same focus in this plan as do young children My name is [redacted personally identifying information]. I live at [redacted personally identifying information] and my phone number is [redacted personally identifying information].

Find phone numbers fast with the New AOL Yellow Pages!

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 7:03 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00075] autism research

I would like to see research on environmental exposures (mercury and aluminum).

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 7:30 AM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00076] My Son

I feel that there should be more spending by the government to help with theorpy and other high expences that are not covered by insurance and more help to the families to take care of bills and special diets for the children. I say this because I’m a single parent struggling to take care of my son.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 7:33 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00077] federal spending on autism

PLEASE help our kids!!! Every day practically another child I know personally is diagnosed with Autism I live in a small [redacted personally identifying information] town in [redacted personally identifying information] county and the numbers are staggering. Why???? Do I blame myself???? Does every parent I know have something to do with it??? I highly doubt it. Research is desperately needed. Desperate times call for desperate measures. Why not chelation??? Thanks for your consideration, I have to close and run after my son (with autism) for the 10th time this morning.

Thank you

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 7:38 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00078] Restrictions on insurance for Autism diagnosis

Please influence the insurance companies to stop their non coverage policies for an Autism diagnosis. When therapy can cost as much as $1000 a month, it makes it very hard for the average family to afford. .

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 7:59 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00079] Comments Autism Spending

Dear Sirs:

I want to see a study of peer mimicking in self–contained classrooms.

I want to know why there is no Federal law stating the school district must prove the IEP valid and not the parent? They are the experts, right?

I cry that my child is 14 but I can’t get any services because he is too old. Where are the programs for us?

How is it possible that I make $1,000 too much for financial assistance as a single mother? Do you know how much extra I have to pay for child care, swimming lessons, camp, and anything else typical children do.

And yes, I even have to pay for friends.

You see, what is the point of all of this early intervention when the student gets into a regular education classroom and does well but the district refuses to provide a para to help the students stay on task. These students are pushed out of the regular ed classroom and into sped which leads to no diploma or dropping out. We fight the schools but have the burden of proof and no reimbursement for expert testimony. We have nowhere to turn. We are forced to homeschool. Thanks for nothing.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 8:42 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00080] autism research

There is an urgent need to provide research funding to develop testing methods to identify adults who have escaped thru the cracks and not been identified as having autism. These adults will continue to have trouble until the base cause autism is addressed. Also we need research on appropriate programs to support adults with autism. Many need case management, social support, housing and employment support. There are few systems of care to address the needs of adults. Appropriate care is cost effective care but too many states fragment care and provide prisons or homelessness instead of addressing the needs of those with autism.

As an example my son with autism is a college graduate with a BS in Environmental Science earned in four years with honors but no one will hire him. He does need minimal support but could be very productive with help. An autistic friend of his who recently earned a college degree started a job only to be fired because of following the rules too closely and because he was “odd”. I know the man and he is a great guy and has a lot to offer an intelligent employer. Now he has no income and will have to move back home with his parents.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 8:37 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00081] Autism research

AS A CONCERNED MOTHER OF A FIVE YEAR OLD SON DIAGNOSED WITH AUTISM, THIS ISSUE NEEDS TO BE ADDRESSED AND MORE RESEARCH NEEDS TO BE COMPLETED, AS THESE YOUNG CHILDREN 1 IN 150 WILL GROW INTO ADULTS AND THEN WHAT!!!!

REGARDS

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:02 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00082] AUTISM SPENDING

THIS IS AN EPIDEMIC that warrants as much attention as AIDS.

I am not a doctor but my own research reveals that Autism is an immunlogical disease similiar to AIDS. While there may be a genetic factor there is absolutely NO DOUBT that there is an environmental factor which most urgently needs to be investigated. I am a mother of twins who were developing normally until they were vaccinated. My daughter experienced a rather bad reaction and was dehydrating. Her body was able to clear it out and she recovered. My son, however, could not. She is typical and he is not. You don’t have to be a rocket scientist to realize something is wrong with our immune systems and vaccination just bring it out. I am not anti–vaccine but I do think we need to slow down the process and try to figure out which children are most at risk for immune disease problems

Like breast cancer, this epidemic is most prevelant on Long Island, New York. We urgently need funding for independent studies like those being done at THOUGHTFUL HOUSE for CHILDREN in Austin, Texas.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:02 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00083]

I am all for autism research funding but the federal government wastes too much money on education, welfare, and themselves. Look at how the House of Representatives voted down an economic bailout but will vote to rename federal buildings. THank you Speaker Pelosi!

[redacted personally identifying information]
The Postmaster General with Autism of [redacted personally identifying information]

John 9:1–4
Ephesians 3:20

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:14 AM
Subject: [Comment 00084] Autism Research

A study of the vaccinated versus unvaccinated is long overdue. Not just looking at the incidence of autism, but of other autoimmune disorders, and neurological disorders in general. Asthma, alzheimers, chronic fatigue.

I wouldn’t trust it in the hands of the CDC, any pharmaceutical company, or Autism Speaks.

I have no children diagnosed on the spectrum, just a child who was evaluated for autism at about age three and who, at age fourteen or fifteen came to me while researching Porphyria for a school science paper and said to me “mom I think I have lead poisoning” and when I said “no I don’t think so dear” she paused and then said “well then I think I have mercury poisoning”. This was years before either of us had any concerns about vaccines. (Her medical records look like a description of mercury poisoning symptoms)

Please. Look at the health of unvaccinated individuals. An unbiased look at how it compares with the vaccinated population.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:18 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00085] Comments on the Strategic Plan for Autism Research

During this time of economic hardship, there is an urgent need to spend tax dollars on autism research in the most prudent manner. However, more important than the dollars, are the lives of the children and families suffering with autism. They deserve to have those monies spent on the best science possible. Unless this happens there will be no effective treatments. To continue the current course is to sacrifice science to politics and will only ultimately hurt the credibility of the US scientific community.

The Plan Must Articulate Adequate Doctrine to Guide Research.

The most crucial flaw is failure to adequately set forth guiding principles and doctrine. The plan must recognize that autism is a national health emergency and propose research with a genuine sense of urgency, similar to our response to threats like SARS and bird flu. The plan must recognize that the ten–fold increase in diagnosed cases over the past two decades represents a real increase in the frequency of this disorder – a genuine epidemic – rather than simply better labeling or increased public awareness. The research agenda responsive to an epidemic is much different than research directed against a disorder that has been here since the beginning of time, especially since it would focus aggressively on identifying and removing environmental triggers and on treatment of those already affected.

The plan must expressly state a strategic goal of preventing new cases of autism. Without such a goal and research focused on identifying and eliminating environmental triggers, the over–emphasis on gene research in the current draft risks future reliance on eugenic abortions as the government’s “solution” to the autism problem rather than a genuine effort to identify and eliminate etiologic environmental triggers.The plan largely embodies the old paradigm of autism as an inherited genetic disorder. Recent research has failed to provide evidence supporting the heritability hypothesis. While investigation of inherited factors in autism have contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore don’t deserve the funding priority they have heretofore received.

The plan must state a strategic goal that research be conducted provide benefits to children and adults living with autism.The plan should focus research on environmental causation. Such research must include “controversial” topics such as vaccines as a potential cause. The legislative history of CAA singled out vaccine research for special emphasis yet the draft plan lumps this (without specific mention) into the general category of environmental research. An environmental factor or combination of factors contributes to disease causality. These factors can interact with susceptibility genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre– or post–natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention.

The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. While there may be no “cure” for autism, we cannot turn back the clock to reclaim the time lost to developmental injury. We also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts. Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism. Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function. Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, significant improvement in function is likely. Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation). The plan should expressly recognize that recovery of function is possible with early and effective treatment. The plan must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.

The Plan Must Include Community Participation in All Decisions Relating to Autism Research.

A second major flaw is that it completely fails to re–engineer the grant-making process. Crucial here is the inclusion of community participation at all levels of decisions relating to autismresearch, especially on matters of scientific merit and program relevance. The Congressionally–mandated program for autism research conducted by the Defense Department does a much better job of incorporating meaningful community participation. Greater participation ha been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.

The Budget is Woefully Inadequate to Solve the Challenges Posed by the ASD Epidemic.

Although initially reluctant, the Autism Team eventually accepted the requirement in the CAA that it provide a research budget as part of the SP. How much should be spent on autism research? Not to be flip, but the answer is simple: as much money as is needed to effectively treat existing cases and prevent new ones. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. Ironically, the same general sort of analysis is used to “justify” each new vaccine in terms of the “benefits” of preventing an infectious disease. The budget must also consider the demand from the scientific community for funding for autism–related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money. This information was requested but never provided to IACC.

A couple of examples will illustrate the inadequacy of the funding. A list of the proposed initiatives with proposed funding as of August 8 is here. Five projects relating to environmental cause are proposed for the next five years at a funding level of $24 million. Why limit these studies to only five (without even specifically mentioning vaccines)? The plan should propose as many as are needed to identify the pre–natal and post–natal exposures that trigger ASD without arbitrary limits. The budget proposes a handful of treatment studies and clinical trials over five years. But this falls far short of studying the effectiveness of the dozens of behavioral and medical interventions currently used by parents. It’s hard to have confidence in NIH’s treatment research agenda in light of the recent cancellation of a clinical trial of chelation. Although thousands of parents are using various forms of chelation, NIH had its own trial on the books for two years and finally dropped it allegedly for safety reasons. Although most likely a pretext, the fact that so many parents are using chelation more than justifies rigorous study of this intervention especially if there are legitimate safety concerns.

Process Failures Contributed to a Deficient Plan.

The appointment of Joyce Chung, wife of legendary epidemic–denier Roy Grinker, as head of the Autism Team; members of science workshops and workgroups were not appointed by IACC, the six community members of IACC were prohibited from collaborating outside formal meetings; secret email voting and discussions; “public” comments not made public; refusal to provide background information necessary to formulate the plan; community input was ignored; selection of workshop and workgroup members with disqualifying bias and lack of diversity; abrogation of IACC’s obligation to make key decisions to an internal bureaucracy; and “community” participation in making crucial decisions regarding funding priorities and specific initiatives was limited to organizations and interests that privately fund autism research ( especially relating to genetics).

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:23 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00086] RFI identifier NOT-MH-08-021

Dear NIH,

I am writing today as an advocate for my autistic daughter. I am very excited about your works in learning the causes of this horrible disorder that is now becoming and epidemic. I however share concerns with many about the flaws of your current plans. I would like to acknowledge that I find much of what Coalition for Safe minds has presented to you to also be concerns of mine. I have outlined them below (I have copied much information from their institute as I find they have worded it exactly as I would have):

  1. Acknowledge The Epidemic : Autism is a national emergency. The current draft of the plan lacks statements acknowledging its increase and the urgency needed in addressing it. There is no persuasive evidence indicating that the rise can be explained by expanded criteria, improved diagnostics or heightened awareness, anymore than the cause could be solely genetic. Data dictates that policy must be precautionary and that autism merits the urgency that any major health problem would generate with similar prevalence increases.
  2. Needed Changes to the Draft Strategic Plan: Prevent new cases of autism by eliminating major causal contributors, leading to a 90% reduction in new cases of autism among 2014 births.
  3. Implement a rigorous autism prevalence study among U.S. adults to measure the rate of increase and determine if the characteristics of autism have changed over time.
  4. Essential – Investigate the Role of Mercury and Vaccines: The public, via town hall meetings, and IACC public members and workgroup members have repeatedly requested that the role of mercury and vaccines in autism causation be investigated. The current draft of the strategic plan is devoid of any investigation specific to these concerns and fails to accomplish one of the primary tenets of the Combating Autism Act – research on mercury and vaccines.
  5. Needed Change to the Draft Strategic Plan: Add comprehensive and unbiased studies that investigate the role of vaccines and mercury in autism causation and severity, to be implemented as a short term research objective and accompanied by appropriate budget allocations.
  6. Find the Cause of Autism: Intensify Environmental Research: Genetic research has gobbled up the lion's share of etiology dollars even though the evidence is clear that environmental factors play a major role. In fact, the investments in autism genetics have not yielded results that will lead to the urgent breakthroughs required in addressing the autism epidemic. This type of research is well funded by private organizations such as the Autism Consortium and the Simons Foundation, and NIH should not duplicate these efforts. The strategic plan should reflect a sharp redirection of priorities towards environmental investigations, including an understanding of how environmental triggers interact with genetics that increase susceptibility to harm.

A report by the NIH IACC noted that the role of the environment in autism research had received insufficient attention to date and remains an understudied area of investigation. More importantly, researchers have identified that children with ASD may be more vulnerable to environmental toxins secondary to inadequate or faulty body chemistry and organ systems. Even more significantly, efforts to support these impaired pathways and treat underlying pathology have resulted in marked improvement in many children to the point where they have lost their diagnosis of ASD.

Certain environmental toxins have been shown to produce autism–like symptoms in animals. The IOM workshop on Autism and the Environment identified an extensive list of potential environmental triggers and ways to investigate them. The workshop proceedings and a review of scientific literature identify an extensive list of categories for promising research, including: Environmental toxins such as pesticides, benzene, and especially metals like lead, aluminum, mercury, and cadmium, including concern of synergistic toxicity of multiple exposures

  • Medical interventions like vaccines, antibiotics, pitocin, immune globulins, valproic acid, and ultrasounds
  • Substances in food, drink, and consumer products that have increased dramatically in the past 20 years such as glutamate (e.g. in MSG), artificial dyes, and cosmetic ingredients
  • Manufactured chemicals ingested by humans due to inclusion in certain products, similar to bisphenol A, which is used in baby pacifiers, baby bottles, and the inner lining of soda cans
  • Pathogens like viruses and bacteria

To properly investigate this array of environmental factors and redress a decade of insufficient spending on the environment, extensive resources and effort must be immediately applied to this domain, far more than the current Strategic Plan calls for. For example, the plan only directs research to 5 environmental factors and assigns this as a long term project rather than a short term one, so that answers on just these 5 factors would not be delivered until 2012. Families with autism cannot wait this long only to have such limited answers to their concerns.

  • Needed Changes to the Draft Strategic Plan: Reallocate strategic plan funding of Genetic/Genomic research into Environmental Risk Factors and Environment X Gene Interaction Vastly increase the absolute spending on short term projects that focus on these areas.

Make a Difference in Quality of Life

The draft plan is woefully inadequate in the area of treatment research. The total recommended spending for this domain is just $88.8 million over 5 years, or a mere $17.7 million per year! With 1 in 150 children affected and an undetermined number of untreated adults, would this level of spending ever be considered if the disease were, say, diabetes or asthma$ As an example, the plan calls for just 3 clinical trials on co–morbid conditions, when it is well known that autism is associated with a large array of such conditions: sleep problems, GI dysfunction, anxiety, depression, seizures, obsessive–compulsive disorder, phobias, hypotonia, cognitive differences and eating problems, to name a few. Another example: the plan calls for study of just 5 widely used interventions in autism, when it is common knowledge that parents and professionals are using an innumerable array of interventions (diets, supplements, chelation, antipsychotics, antidepressants, anti–inflammatories, and sleep medications, to name but a small subset), and they are all in need of rigorous study.

  • Needed Change to the Draft Strategic Plan: Quadruple the budget and number of projects currently in the strategic plan for treatment. The Process – Public Participation and Necessary Expertise Sidelined A provision of the Combating Autism Act requires public participation in the strategic planning process. NIH has included “outreach” efforts to the public at a few points along the way, mostly after the major decisions have already been made and with public input manipulated to fit the NIH’s view of research priorities. True participation and honest incorporation of the public’s concerns have been elusive. A blatant example of ignoring the community’s concerns is the deliberate omission of investigations on mercury and vaccines.

Of special concern, expertise in toxicology as it relates to autism was absent from critical meetings, resulting in inadequate funding and leadership for this important work. This lack of expertise severely limits pursuit of promising areas of research necessary to address the autism epidemic, as outlined earlier.

Inadequate measures were put in place for accountability and evaluation of the plan once it is launched. Responsibility for carrying out most of the plan components was arbitrarily distributed by NIH to various federal agencies and a handful of private organizations without mechanisms to ensure that the work is done and is having an impact. Responsibility for many plan components, including several critical environmental ones, was not accepted by any agency or organization at all, so the NIH was forced to consign them to a mysterious “ACC” team and a few were left unassigned. The Autism Research Institute volunteered for a number of treatment related initiatives but was rebuffed by NIH so that it could delegate oversight to a federal agency.

Needed Changes to the Draft Strategic Plan:

  • Institute a public participation model in the planning process similar to the exemplary Department of Defense Autism Research Committee.
  • Create an Autism Advisory Board made up primarily of consumer members with responsibility for carrying out the plan and to ensure accountability and evaluation as the plan is executed over the next 5 years.
  • Upgrade the IACC from NIH’s rubber stamp committee to a true external advisory body by expanding public representation to a majority of seats relative to government agency insiders. Reconstitute the Strategic Plan Workgroup to include expertise and public advocacy in the field of environmental factors and autism.

Please take my letter to your institution seriously. I have a daughter suffering from autism. I have used MANY biomedical treatments not conventionally used AND have seen results. I would really like a good study from your organization to refer to.

Thank you,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:23 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00087] My Comments on the strategic plan (SP) for autism research

Dear NIH, I have read over your plan and I find it inadequate in many ways. I have pasted below and article by Jim moody at “Age of Autism” because no one can say it better and I would like to use his voice to speak for me. As a family who battles autism everyday with the research I have done on this matter myself, I feel like you are all just trying to put a band aid on the issues and hoping it will go away. But the facts are that it is not going to go away especially with the plan you have set forth. Until you take it seriously our children’s children will be affected many times over the amount we are seeing today. This means you very own grandchildren may be diagnosed with autism in the future. We are in danger as a species; if we keep ignoring the signs we will come to a point of no return. This autism epidemic should take precedence over anything and everything that our government is planning for with future spending.

Sincerely,

[redacted personally identifying information]

Where to start? There’s so much wrong with the plan that it is probably best to just start over. Basically it is a rehash of the 2004 “autism matrix” or research roadmap (HERE). The plan proposes 35 broad research initiatives grouped into six categories, and is organized as follows: Introductory Material (including the Introduction, Vision Statement, Mission Statement, Core Values and Cross–Cutting Themes)

  1. When Should I Be Concerned?
  2. How Can I Understand What Is Happening?
  3. What Caused This To Happen And Can This Be Prevented?
  4. Which Treatments And Interventions Will Help?
  5. Where Can I Turn For Services?
  6. What Does The Future Hold?

Development Process for the IACC Strategic Plan for Autism Spectrum Disorder Research References

Although Congress asked for a plan leading to cause (prevention) and treatment, the draft has all the urgency of molasses on a cold day. It fails to recognize the paradigm shift from autism as a psychiatric disorder to autism as a whole–body disease caused by environmental exposures and treatable. Set forth below are some ideas that might help your comments.

The Plan Must Articulate Adequate Doctrine to Guide Research.

The most crucial flaw is failure to adequately set forth guiding principles and doctrine. The plan must recognize that autism is a national health emergency and propose research with a genuine sense of urgency, similar to our response to threats like SARS and bird flu. The plan must recognize that the ten–fold increase in diagnosed cases over the past two decades represents a real increase in the frequency of this disorder – a genuine epidemic – rather than simply better labeling or increased public awareness. The research agenda responsive to an epidemic is much different than research directed against a disorder that has been here since the beginning of time, especially since it would focus aggressively on identifying and removing environmental triggers and on treatment of those already affected.

The plan must expressly state a strategic goal of preventing new cases of autism. Without such a goal and research focused on identifying and eliminating environmental triggers, the over–emphasis on gene research in the current draft risks future reliance on eugenic abortions as the government’s “solution” to the autism problem rather than a genuine effort to identify and eliminate etiologic environmental triggers.The plan largely embodies the old paradigm of autism as an inherited genetic disorder. Recent research has failed to provide evidence supporting the heritability hypothesis. While investigation of inherited factors in autism have contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore don’t deserve the funding priority they have heretofore received.

The plan must state a strategic goal that research be conducted provide benefits to children and adults living with autism. The plan should focus research on environmental causation. Such research must include “controversial” topics such as vaccines as a potential cause. The legislative history of CAA singled out vaccine research for special emphasis yet the draft plan lumps this (without specific mention) into the general category of environmental research. An environmental factor or combination of factors contributes to disease causality. These factors can interact with susceptibility genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre– or post–natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention.

The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. While there may be no “cure” for autism, we cannot turn back the clock to reclaim the time lost to developmental injury. We also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts. Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism. Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function. Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, significant improvement in function is likely. Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation). The plan should expressly recognize that recovery of function is possible with early and effective treatment. The plan must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.

The Plan Must Include Community Participation in All Decisions Relating to Autism Research.

A second major flaw is that it completely fails to re-engineer the grant-making process. Crucial here is the inclusion of community participation at all levels of decisions relating to autism research, especially on matters of scientific merit and program relevance. The Congressionally-mandated program for autism research conducted by the Defense Department (HERE) does a much better job of incorporating meaningful community participation. Greater participation ha been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.

The Budget is Woefully Inadequate to Solve the Challenges Posed by the ASD Epidemic.

Although initially reluctant, the Autism Team eventually accepted the requirement in the CAA that it provide a research budget as part of the SP. How much should be spent on autism research? Not to be flip, but the answer is simple: as much money as is needed to effectively treat existing cases and prevent new ones. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. Ironically, the same general sort of analysis is used to “justify” each new vaccine in terms of the “benefits” of preventing an infectious disease. The budget must also consider the demand from the scientific community for funding for autism-related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money. This information was requested but never provided to IACC.

A couple of examples will illustrate the inadequacy of the funding. A list of the proposed initiatives with proposed funding as of August 8 is here (HERE). Five projects relating to environmental cause are proposed for the next five years at a funding level of $24 million. Why limit these studies to only five (without even specifically mentioning vaccines)? The plan should propose as many as are needed to identify the pre–natal and post–natal exposures that trigger ASD without arbitrary limits. The budget proposes a handful of treatment studies and clinical trials over five years. But this falls far short of studying the effectiveness of the dozens of behavioral and medical interventions currently used by parents. It’s hard to have confidence in NIH’s treatment research agenda in light of the recent cancellation of a clinical trial of chelation. Although thousands of parents are using various forms of chelation, NIH had its own trial on the books for two years and finally dropped it allegedly for safety reasons. Although most likely a pretext, the fact that so many parents are using chelation more than justifies rigorous study of this intervention especially if there are legitimate safety concerns.

Process Failures Contributed to a Deficient Plan.

You might also wish to comment on the many errors that have infected the planning process. The details are too numerous to discuss here, but, without major revision, anything approved by IACC is subject to legal challenge and a restart of the process. Some of the more serious examples include: appointment of Joyce Chung, wife of legendary epidemic–denier Roy Grinker, as head of the Autism Team (see “Grinker’s Stinker: His Wife Runs the IACC” (HERE), January 15); members of science workshops and workgroups were not appointed by IACC, the six c ommunity members of IACC were prohibited from collaborating outside formal meetings; secret email voting and discussions; “public” comments not made public; refusal to provide background information necessary to formulate the plan; community input was ignored; selection of workshop and workgroup members with disqualifying bias and lack of diversity; abrogation of IACC’s obligation to make key decisions to an internal bureaucracy; and “community” participation in making crucial decisions regarding funding priorities and specific initiatives was limited to organizations and interests that privately fund autism research (especially relating to genetics).

Next Steps.

The next meeting of IACC will be held November 21 in Washington (HERE). As has been the case for three of the SP workgroup meetings, hopefully this will be available on a conference call and on the web (slides) so that the broader community can listen. Hundreds of millions in research funding are at stake. It is also important that the broader community have the first–hand opportunity to assess how effectively the six IACC “community” members are representing the community.

http://www.ageofautism.com/2008/09/reminder– – – this.html#more

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:28 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00088] Federal Autism Funding - Comments

Hello,

I am a registered nurse and mother of 2 sons on the autism spectrum. I hope that you will take my following comments into account when considering upcoming Federal Autism Funding.

  1. Autism must be viewed as a national health emergency, and responded to with the urgency that SARS and bird flu were. It is an epidemic that we must get a grip on. As we all know, epidemics aren’t caused from genetics alone, but from environmental triggers or a combination for both. So, The research agenda must reflect this urgency and have a strategy to stop new autism cases from occurring as well as to come up with benefits for those individuals (children and adults) who are already living with autism. The research must be open minded and explore all possible causes of autism – including the controversial vaccine issue and explore possible treatments to help recover as much as possible from the autism related deficits. Emphasis must be placed on early intervention to recognize autism and reduce its affect on children as soon as possible. Groups of people where autism is non-existence must have reliable, trustworthy studies done on them – like the Amish.
  2. I have learned that the grant-making process related to autism funding must be greatly overhauled, with the inclusion of community partici pation at all levels of decisions relating to autism research, especially on matters of scientific merit and program relevance.
  3. Here is how it has been stated to me in better words than I can come up with myself, but to which I totally agree. The Congressionally–mandated program for autism research conducted by the Defense Department (HERE) does a much better job of incorporating meaningful community participation. Greater participation ha been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.

  4. As with most healthcare research/treatment issues, it appears that the Budget is significantly inadequate to solve the challenges posed by the ASD Epidemic. Enough funds must be dedicated to “effectively treat existing cases and prevent new ones”. Like the old TV auto care ad says, “Pay me now or Pay me later”. When the majority of kids with autism reach adulthood and need to be receive SSI/Medicaid, can’t volunteer for military service, can’t hold down significant paying jobs to help contribute to the country’s and world economy, etc, we all would have wished we would have taken more notice of and listened to “those crazy parents back in the 1990s and early 2000s” and done more to get this epidemic stopped.

Thank you.

[redacted personally identifying information]

Find phone numbers fast with the New AOL Yellow Pages!

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:30 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00089] IACC comments due 9/30

I just found out about this today–is there anyway to put me on you email list for future action alerts? My general comment on the strategic plan is regarding effective treatment. I would strongly recommend for consideration “Educating Children with Autism” at www.nap.edu. This was a national study of interventions proven clinically effective for treatment of autism. Both our NJ early intervention and special education guidelines for autism were developed based on this document.

Thank you,
[redacted personally identifying information]

Find phone numbers fast with the New AOL Yellow Pages!

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:31 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00090] RFI identifier NOT-MH-08-021

Introductory Material (including the Introduction, Vision Statement, Mission Statement, Core Values and Cross–Cutting Themes)

Your mission and core values MUST include an authentic commitment to uncover and curb the causes of ASD. It must be done without bias to any industry or governmental interest or initiative. The science and methodology used must be able to stand up to international, non–biased standards.

  1. When Should I Be Concerned?
  2. How Can I Understand What Is Happening?
  3. What Caused This To Happen And Can This Be Prevented?
  4. If the Genetic evidence only points to 10 – 20% of the ASD population, then what will be the focus on the MAJORITY – – the other 90 – 80% of the ASD population. I believe more than genetics is at play here. Immune system weakness, shear toxic overload.

    To ignore the fact that so many parents and families are sure that vaccinations triggered the onset of ASD is ill advised. It is imperative to gain the trust of the ASD community, all groups – – as diverse as it may be. A feat that will not present itself as an easy accomplishment. However, at least an attempt to remain neutral until the science is really completed regarding vaccines and other toxic triggers would be appreciated.

    My son [redacted personally identifying information] is a regression kid, and it happened after vaccinations. In terms of prevention, the manufacturing process and ingredients of vaccines should be reviewed and brought into the age of modern medicine and manufacturing. Toxic substances should be eliminated from vaccines, therefore restoring the general public’s overall confidence in the vaccine program.

  5. Which Treatments And Interventions Will Help?
  6. It is truly disappointing that the success of the biomedical approach is so quickly dismissed or lightly assessed do to the overwhelming bias towards behavioral approaches and medicine. There MUST be a more open mechanism for the sharing of information and results obtained with the DAN! (Defeat Autism NOW) protocol and other approaches that are “outside the box” of the American Academy of Pediatrics (AAP) approach of behavioral therapy/drugs. I look at it this way, would you like your child to learn to “behave” and use drugs to “reduce” symptoms? Or would you like your child to recover – – To rid their body of infection and toxins and allow the gut and brain to function properly?

  7. Where Can I Turn For Services?
  8. The AAP MUST open dialog with doctors currently using the DAN protocol and all pediatricians should be educated and aware of the possibilities of alternative treatment. The “STATE OF THE STATE” will be bankrupt if they have to care for ASD patients over the course of their whole life. The huge burden to the school system and then the social welfare system is already known. Yet another reason to explore the possibility of recovery through DAN!

    The costs of therapies – – speech, OT, ABA, etc – – are crippling for family budgets. My family has gone bankrupt. I know others that are in similar situations. Can someone help with these costs? Insurance cover more? Providers charge LESS? Some fees are outrageous, and most parents I know end up paying for the hope that it will help their child.

  9. What Does The Future Hold?
  10. Development Process for the IACC Strategic Plan for Autism Spectrum Disorder Research References

    [redacted personally identifying information]

    “Live so that when your children think of fairness and integrity, they think of you.”
    H. Jackson Brown, Jr.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:31 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00091] autism spending

Please allocate federal tax money for biomedical research. This is an immense area that has been left unstudied. The moms who are with these kids day in and day out all notice similiar symptoms. Someone needs to pay attention to the conditions the moms are reporting. These include: vomiting, diarhea, irritability, sensitivity to texture, light and sound. These are symptoms of an underlying cause. They should not be dismissed anymore. What is the harm of studying this area? It may solve the autism crisis that our country is facing today.

Sincerely,

[redacted personally identifying information]
mom of [redacted personally identifying information] 5 year old with autism
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:35 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00092] Autism - Funding Available?

My beautiful grandson, [redacted personally identifying information] has been diagnosed with Autism. He is nine years old and totally non–verbal. He attends a public school in [redacted personally identifying information], which claims they give him the appropriate services he is entitled to. When he attended school in [redacted personally identifying information], he had a 1:1 Para–professional shadowing him all day while at school, and his IEP states that he will have the identical services in [redacted personally identifying information], but in [redacted personally identifying information] they will not provide him with a 1:1, saying that he ALMOST has a 1:1 with him during the day. For his safety and his need to learn, he should have a 1:1 Para–professional at his side… why does [redacted personally identifying information] refuse to do this. Also, our Attorney General, [redacted personally identifying information] was very instrumental in my grandson obtaining a DYNAVOX, which would be a perfect learning tool for him, but again the [redacted personally identifying information] school system refuses to be trained on this tool and refuses to let [redacted personally identifying information] use it at school. They claim they have a “better” tool – GO–TALK, but when my daughter was at the PPT meeting on Monday, 9/29 she asked to observe what the GO–TALK was like,… but the GO–TALK was not programmed, and also did not have batteries installed, which tells me that this so–called “better tool” has never been used, nor have people been trained to use it.

My daughter is fighting a losing battle with the [redacted personally identifying information] School system, because all she wants for her son is a “fighting chance” for him to learn and maybe one day live an independent life. The school has banned her from being inside and still refuses his 1:1. This is a safety issue as well as a violation of his rights, which he is entitled to. What can be done and how can more dollars be spent on taking care of my grandson. If [redacted personally identifying information] still refuses to offer [redacted personally identifying information] all the services he is entitled to for him to get an appropriate education and remain safe, then my daughter should be allowed to send him to an appropriate school which will meet all of [redacted personally identifying information]’s needs, outside of the [redacted personally identifying information] School district. Please forward this on this anyone that can offer a solution and please advise if there are any “scholarship” funds available so my grandson can start his learning and growing process. Also, how do we find out about any available dollars and scholarships for special schools?

Thank you for listening to a very concerned grandmother and mother.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:39 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00093] comments on Dev. process for the IACC Strategic Plan for Autism Spectrum Disorder Research References

Official comments on the Development Process for the IACC Strategic Plan for Autism Specturm Disorders:

  1. The plan must recognize that autism is a national health emergency and prospose research with a sense of urgency, similar to the governments response to SARS and Bird Flu. It must recognize the ten-fold increase in diagnosed cases over the past two decades and that this suggests a possible epidemic. The assumption that the increase in autism is due to better labeling is just that, an assumption. There needs to be a genuine investigation as to whether the numbers have actually increased. An effective plan simply cannot be formulated until we know for a fact which we are dealing with, as research priorities for an epidemic vs. a static genetic condition would be quite different.
  2. The plan must expressly state a strategic goal of preventing new cases of autism. The plan, as it is currently written, I believe, over–emphasizes gene research at the expense of identifying environmental triggers. The plan must state a strategic goal that research conducted benefits children and adults already living with autism.
  3. The plan should focus on research into potential environmental causation, including vaccines as a potential trigger in susceptible individuals. Research should look into whether environmental triggers interact with the genes of susceptible individuals to trigger autism. Timing of exposure during development should be looked into, whether pre or post natally.The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases.
  4. The plan must identify treatment and recovery mechanisms such as speech, occupational therapy, Applied and Verbal Behavior Analysis, and Relationship Development Intervention. Recovery and improvement can be measured.
  5. Medical Intervention must be recognized. Presently autism is listed in the DSMV as a psychiatric disorder, which is why, except for a few state mandates, parents can not get insurance coverage for their autistic children. The categorization of autism needs to be altered in the DSMV to reflect recent findings about autism. Autism is not merely a psychiatric disorder, but a neuro–biological disorder. This is reflected in the fact that more than half of all people with autism have severe gastrointestinal issues. Until autism is acknowledged as a neuro–biological disorder, those with the condition will remain unable to be treated and covered for their medical issues.
  6. The plan, in its current state, fails to re–engineer the grant-making process. There should be inclusion of the autism community and parents at all levels of decision making related to autism research and program development.
  7. The old “study section” model should be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should include the establishment of a permanent Autism Advisory Board, as recommended by Congress and the CAA. This board should include scientists, clinicians, and advocates.
  8. In determining the budget a cost of disease analysis should be performed to help determine how much should be spent. An analysis of the direct and indirect fiscal cost to society that autism requires should guide the budgetary allotment. The budget should consider the demand from the scientific community for funding autism research. This should include a review of proposals that were submitted to the NIH in recent years, but turned down due to lack of resources.
  9. Process Failures Contributed to a Deficient Plan, in its current state: Some of the more serious examples include: appointment of Joyce Chung, wife of legendary epidemic–denier Roy Grinker, as head of the Autism Team, members of science workshops and workgroups were not appointed by IACC, the six community members of IACC were prohibited from collaborating outside formal meetings; secret email voting and discussions; “publicE2 comments not made public;” refusal to provide background information necessary to formulate the plan; community input was ignored; selection of workshop and workgroup members with disqualifying bias and lack of diversity; abrogation of IACC’s obligation to make key decisions to an internal bureaucracy; and “community” participation in making crucial decisions regarding funding priorities and specific initiatives was limited to organizations and interests that privately fund autism research (especially relating to genetics). Any plan to address autism needs to be done with openness and transparency. Therefore, the plan should be reconsidered with these concerns in mind.

[redacted personally identifying information]

The next meeting of IACC will be held November 21 in Washington (HERE). As has been the case for three of the SP workgroup meetings, hopefully this will be available on a conference call and on the web (slides) so that the broader community can listen. Hundreds of millions in research funding are at stake. It is also important that the broader community have the first–hand opportunity to assess how effectively the six IACC “community” members are representing the community.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:47 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00094] NOT-MH-08-021: . IACC Services RFI . re: IACC Strategic Plan RFI

[redacted personally identifying information]

Dear IACC Committee,

Thank you for the work you have done since 2003 to further the ASD agenda. I attended the Autism Summit conference and remember how proud I felt when Margaret L. Bauman, MD and Stephen Shore, MEd addressed the group. They are my heros and have done a lot to educate, treat, advocate and care for individuals with an ASD in my local community, as well as nationally, and internationally. They are an excellent example of team work as Dr. Bauman is a pioneer in autism research, and Mr. Shore has been a source of inspiration and together they both provide knowledge and perspective to ASD that cannot be matched by any other team. I believe any research they are involved with brings credibility to the project.

A new health services research field of implementation science is emerging to: (a) evaluate the effectiveness of interventions in community settings; (b) identify the most effective means of disseminating research into widespread clinical practice; and, (c) define the best ways for research to inform policy on ASD services and supports. Integral to success, will be community engagement in shaping, participating, and disseminating ASD research.

What do we need?

I feel we need a person and family centered approach to health care services for persons with ASD. Since people with an ASD have a communication deficit, proper health care is practically impossible without a parent or advocate present at doctor’s appointments. Since ASD is a medical based disability and should be diagnosed by a medical professional not an educator, we need to design health care services supports to better understand and treat these individuals. It strikes me as very unfair that under Section 504 of IDEA, a student is entitled to a FAPE, while at the same time the current medical model makes it difficult to receive appropriate health care. A fifteen minute appointment is not enough time for a typical appointment. When my son was young and low–verbal, it took 18 picture exchange symbols to break down the steps for toilet training. He is verbal now but does not fully understand how to communicate with people without visuals, a script, prompts and cues, and a lot of practice and role playing to prepare him for specific situations. A doctors visit is relatively easy now as we are very fortunate to have health insurance for our son where he can be to to a world class autism research and treatment center that provides clinical and therapeutic services to hundreds of families. They get it and they get us. We would be lost without this clinic and our son would be too. But what frightens me more than anything else in the world is the thought of my son turning 18 and his medical needs not being met if I am out of the picture. Health care is very crucial and should be included in the SP as these children and adolescents are growing up, and the parents are growing old– –very quickly.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:48 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00095] NOT-MH-08-021 Comments

The most crucial flaw is failure to adequately set forth guiding principles and doctrine. The plan must recognize that autism is a national health emergency and propose research with a genuine sense of urgency, similar to our response to threats like SARS and bird flu. The plan must recognize that the ten–fold increase in diagnosed cases over the past two decades represents a real increase in the frequency of this disorder – a genuine epidemic – rather than simply better labeling or increased public awareness. The research agenda responsive to an epidemic is much different than research directed against a disorder that has been here since the beginning of time, especially since it would focus aggressively on identifying and removing environmental triggers and on treatment of those already affected. The plan must expressly state a strategic goal of preventing new cases of autism. Without such a goal and research focused on identifying and eliminating environmental triggers, the over–emphasis on gene research in the current draft risks future reliance on eugenic abortions as the government’s “solution” to the autism problem rather than a genuine effort to identify and eliminate etiologic environmental triggers.

The plan largely embodies the old paradigm of autism as an inherited genetic disorder. Recent research has failed to provide evidence supporting the heritability hypothesis. While investigation of inherited factors in autism have contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore don't deserve the funding priority they have heretofore received. The plan must state a strategic goal that research be conducted provide benefits to children and adults living with autism.

The plan should focus research on environmental causation. Such research must include “controversial” topics such as vaccines as a potential cause. The legislative history of CAA singled out vaccine research for special emphasis yet the draft plan lumps this (without specific mention) into the general category of environmental research. An environmental factor or combination of factors contributes to disease causality. These factors can interact with susceptibility genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre– or post–natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention. The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. While there may be no “cure” for autism, we cannot turn back the clock to reclaim the time lost to developmental injury. We also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts. Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism. Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function. Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, significant improvement in function is likely. Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation). The plan should expressly recognize that recovery of function is possible with early and effective treatment. The plan must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.

A second major flaw is that it completely fails to re–engineer the grant–making process. Crucial here is the inclusion of community participation at all levels of decisions relating to autism research, especially on matters of scientific merit and program relevance. The Congressionally–mandated program for autism research conducted by the Defense Department does a much better job of incorporating meaningful community participation. Greater participation ha been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.

Although initially reluctant, the Autism Team eventually accepted the requirement in the CAA that it provide a research budget as part of the SP. How much should be spent on autism research? Not to be flip, but the answer is simple: as much money as is needed to effectively treat existing cases and prevent new ones. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. Ironically, the same general sort of analysis is used to “justify” each new vaccine in terms of the “benefits” of preventing an infectious disease. The budget must also consider the demand from the scientific community for funding for autism–related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money. This information was requested but never provided to IACC.

Five projects relating to environmental cause are proposed for the next five years at a funding level of $24 million. Why limit these studies to only five (without even specifically mentioning vaccines)? The plan should propose as many as are needed to identify the pre–natal and post–natal exposures that trigger ASD without arbitrary limits. The budget proposes a handful of treatment studies and clinical trials over five years. But this falls far short of studying the effectiveness of the dozens of behavioral and medical interventions currently used by parents. It’s hard to have confidence in NIH’s treatment research agenda in light of the recent cancellation of a clinical trial of chelation. Although thousands of parents are using various forms of chelation, as I am for my son, NIH had its own trial on the books for two years and finally dropped it allegedly for safety reasons. Although most likely a pretext, the fact that so many parents are using chelation more than justifies rigorous study of this intervention especially if there are legitimate safety concerns.

Many errors have infected the planning process. Some of the more serious examples include: appointment of Joyce Chung, wife of legendary epidemic–denier Roy Grinker, as head of the Autism Team; members of science workshops and workgroups were not appointed by IACC, the six community members of IACC were prohibited from collaborating outside formal meetings; secret email voting and discussions; “public” comments not made public; refusal to provide background information necessary to formulate the plan; community input was ignored; selection of workshop and workgroup members with disqualifying bias and lack of diversity; abrogation of IACC’s obligation to make key decisions to an internal bureaucracy; and “community” participation in making crucial decisions regarding funding priorities and specific initiatives was limited to organizations and interests that privately fund autism research (especially relating to genetics).

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:57 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00096] autism spending

I am a physical therapist and parent of two vaccine injured children. I would like to express my extreme disappointment in the lack of proposed funding directed at environmental causes of autism. Vaccines, in particular, are an area that should be carefully looked at. Thousands of parents have the same story. They had normal kids. They vaccinatred their children, and symptoms of autism set in. How many more children have to be vaccine–damaged before you guys do the ethical thing and actually do the proper research?!

I, like thousands of other parents, have healed my kids using biomedical treatments such as diet, supplements, and chelation. Why you don’t look more closely at treatments that actually work is beyond comprehension. I really wonder how you all sleep at night, knowing what unethical decisions are being made regarding autism research at the govenment level. It’s truly criminal!

I will make this short and to the point. I have totally lost faith in our government to supervise our vaccine program. Until there is a proper study done (by independent researchers) of VACCINATED VS NEVER-VACCINATED CHILDREN my family will not be getting any more vaccines. Our CDC appears as corrupt as those in Washington and Wall Street who have caused our current financial disaster. The studeis they’ve done so far are pathetic, as there is no way to determine if vaccines have played a role (yet they have no trouble miseading the public and telling them “vaccines have been proven safe beyond a doubt” which is a bold lie).

The autism community is watching what you do here, very closely, regarding appropriating funds to proper studies. You must know you have a serious “public trust”issue here. If you fail, yet again, to properly address the most important issues in autism research, you can be sure that trust will plummet even further. You will have no one to blame but yourselves if vaccination rates continue to fall.

Vaccines are important, but not worth the sacrifice of so many children.

Do the vaccinated vsnever vaccinated study for starters!!! I’d think any idiot could see that's where you need to start. Should be a pretty simple study, which I know is what you”re all afraid of.

Have the guts to do the right thing for a change. This is not just a purely genetic problem. There is an environmental trigger.

Thank you for your time.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 10:03 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00097] Federal Spending on Autism

While it is a well known fact that Autism is out of control (1 in 150 kids per the CDC), one thing that is being overlooked when it comes to a lot of “the talk” is what to do for those that have already been diagnosed or are being diagnosed later in life. Kids age out of most medical/therapeutic facilities at age 12…just when they are reaching puberty and need social skills training, etc., even more. Schools are not effectively meeting the needs of these children. And, let’s not forget the adults (those over 18 years) that are being diagnosed. Most cannot even tap into government benefits such as MRDD, etc., because they “survived” adolescence. Many are ending up in trouble with the law – in a system that is not prepared to deal with them either!

Non–profit groups such as ours need help!!!

[redacted personally identifying information]
Part of Autism Society of America
[redacted personally identifying information]


Parent Support Group – Support Group assisting parents of children with Asperger Syndrome, high functioning Autism, and PDD/NOS. Meets the 3rd Tuesday of each month from 6:30–8:30pm.

Adult Support Group – Support Group for those 18 years old and older with a diagnosis of Asperger Syndrome, High Functioning Autism, and PDD/NOS. Meets the 1st Thursday of each month from 7:00–900pm.

[redacted personally identifying information]

Looking for simple solutions to your real–life financial challenges? Check out WalletPop for the latest news and information, tips and calculators.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 10:06 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00098] autism funding.

Please spend more money and attention on adult Aspergians, Many of us have NEVER had any assistance with our challenges, and were indeed condemned and stressed out by the people who were supposed to help us (mental health therapists) for being exactly what God made us to be. This happened to me many times! :( I was told, “You would have friends if you would just quit being so rude.” They did not realize what my difficulty was. My cold faced “rudeness” was just my not being able to read facial expressions or respond to them or even noticing there was such a thing as facial expressions. They flash by too quickly for me. I haven’t a chance. Telling an Aspergian, “You would have friends if you weren’t being so rude, so quit being rude!” is just as crazy–making and self–esteem destroying as telling a dyslexic child, “You would read better if you just read better. So start reading better!”

Also please understand our gut problems. What we have is a PHYSICAL disorder that effects how our brain works, not a psychiatric disorder that can be solved merely with “behavior modification.” Some Autists are in so much gut pain we self–mutilate to distract ourselves from the agony! Putting such a person, if he or she is nonverbal and can't explain why he is doing what he or she does, into restraints and what have you, without addressing the fact the person is in AGONY is cruel beyond measure, and yet it happens all the time.

Chemically strait jacketing us with antipsychotics also happens frequently. They keep us calm so we can’t fuss or fight about our physical pain, sensory issues and depression. But they do not relieve us of those agonies. So we are still in agony but too calm to fuss about it. That is not right. Antidepressants can sometimes help us but antipsychotics are worse than worthless. We are not crazy. We are not out of touch with reality like a Schizophrenic but too much in touch with reality.

Schizophrenics and Aspergians may both go for rides in space ships but Schizophrenics go because Little Green Men abduct them. However Aspergians go because we design and build them. Half the people who work for NASA are probably slightly autistic.

But not all of us are intelligent enough to become Scientists. Some of us are just smart enough that it makes us come across as even more weird, so we are socially rejected and there is no help out there for us. I am in that category. I would do better socially if I were dumb!

And the plight of Female Aspergians is even worse. Unlike the Males we try to be sociable, but fail so badly at it, and just come across as “crazy.” Mental health workers fail to diagnose females because we don’t have exactly the same behaviors and issues as the males. We have more sensory issues and less failure to want friends. But wanting to doesn’t mean we can make them.

I did without badly needed medical care for decades for sleep apnea, severe digestive problems and endocrine problems, because my “weirdness” made Doctors think I was just crazy so they would just tell me to go to a psychiatrist and didn’t bother to run any tests. When I did go to one he saddled me with a diagnosis of simple schizophrenia which was completely erroneous. The fact I believe in God and am devout and my Doctor was an Atheist was a big factor. I have my Hashimotos thyroiditis and adrenal fatigue and it was only diagnosed a couple of years ago. I’m 51 years old. And I am having to self treat through internet pharmacies because I can’t afford to be treated by a Doctor and the one I did go to ignored the tachycardia that was being caused by lack of attention to my adrenals. His advice was to just go off the thyroid treatment. :(( I did and gained back 40 pounds. :(( I knew more about my condition than he did but was not believed due to my “weirdness.” :( So I ended up just self treating. That isn’t right!

Also however it happened, vaccines, “silver” fillings or the mercury given off from coal burning power plants, or exposure to sludge fertilizers many of us have heavy metal poisoning. I belong to several autism support groups and this is so common it is beyond belief that it could just be a coincidence. Chelation can help us if glutathione supplements are given with it concurrently. But only IF. My first attempt at chelation was a disaster because my lack of glutathione enzyme was not taken into account. The recent study of chelation in children failed to give any of them glutathione supplements concurrently.

They have replaced the mercury in most vaccines with aluminum which is just another neurotoxin. And now they are recommending pregnant woman get a flu shot and that children get a flu shot every year. Flu shots still contain mercury. So Children are getting more mercury injected into them than ever, plus now all the aluminum. Plus every live virus shot contains glutamate which is also a neurotoxin. Just eating something with glutamate causes me to have melt downs and insomnia. And it hides in the food supply under 30 different names including “natural flavoring.” Because of all the different names it hides under it took me decades to figure out why I was having the melt downs that cost me the love and respect of my parents and made me a recluse. I turned down five marriage proposals because I knew I couldn’t be a fit wife or mother. I know there are people in jail and prison because of MSG caused melt downs and they put it in our children’s shots!

Please put more money into biological research of our problems. Genetics isn’t accounting for all of it. Or if genetics is a factor what we are inheriting is a larger inability to handle the toxins in our environment.

There is so much more society could do to help us, if it just would. And please pray for us!

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 10:09 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00099] Urgent information for IACC vote today

TO: Interagency Autism Coordinating Committee, NIH
RE: Strategic Plan for Autism Spectrum Disorder Research
SUBJECT: Urgent need to investigate the role prenatal ultrasound plays in autism

Since the Interagency Autism Coordinating Committee (IACC) vision is to “inspire research” and its mission is to “accelerate high quality research and scientific discovery,” then it must aggressively investigate the role that prenatal ultrasound may be playing in causing the autism epidemic. There is significant scientific evidence that ultrasound is implicated in autism spectrum disorders, such as:

  • Prenatal ultrasound causes disruptions in neuronal migration in mice consistent with those found in autopsied autistics (Ang, et al, Proc Natl Acad Sci, 2006). Yale neuroscientist Pasko Rakic, who was the lead scientist in the mouse study, is in the midst of an ongoing study of the behavior of primates that were exposed to prenatal ultrasound; while still unpublished, the IACC should consult the Yale team and find out everything they know or suspect about the impact of prenatal ultrasound on primate brains and behavior.
  • Ultrasound can cause changes in mitochondria (Dumontier et al, 1977; Pincuk et al, 1971; Hrazdira & Havelkova, 1966; Harvey et al, 1975) or irreparable damage to mitochondria (Stephens et al, 1978; Karduck & Wehmer, 1974), which is significant since mitochondrial disorders are emerging as a cause of autism. In Hannah Poling’s case, the mitochondrial disorder was inherited from her mother, but other cases of mitochondrial disorders are apparently de novo. What was the prenatal ultrasound exposure for such children in terms of gestational age, duration of exam, acoustic output, type of equipment, type of ultrasound (i.e., 3-D, 4.D, Doppler or color contrast), and is there a common denominator?
  • Low–exposure pulsed ultrasound can cause changes in the ultrastructure of cells, which could affect receptor topography (WHO Environmental Health Criteria 22 Ultrasound, 1982). Since many medications used to treat autism involve chemical uptake, anything that could cause receptor malfunctions or irregularities should be vigorously pursued. Specialists in neurobiology should investigate whether the thermal affects of prenatal ultrasound can result in a life–long change in the temperature at which chemical signaling occurs in the brain.
  • Ultrasound has known bioeffects such as thermal effects, cavitation (a harmonic affect that cause such rapid vibrations that cells are destroyed), microstreaming and shearing, to name only some, many of which are not well understood. Could one or a particular combination of these bioeffects be causing myriad genetic deletions and extra copies that appear to be associated with autism? This could explain the wide variety of non–inherited genetic damage that is being discovered. Could one or more of these bioeffects be what causes devastating gene expressions in families with genetic tendencies that sometimes, but not always, result in autism?
  • The thermal effects of prenatal ultrasound may be responsible for a life–long alteration of the temperature at which important chemical signaling takes place in the brain. Many therapies that help decrease autistic symptoms involve an increase in the autistic’s metabolism, such as prescription stimulants or amphetamines, caffeine intake of any kind, heavy exercise (NYT Aug. 2006) and fever (Zimmerman, et al, Pediatrics, 2007) – all of which suggest that autistic behavior is caused by temperature–related problems in chemical signaling. Could thermal exposure beneath the amount of heat known to cause birth defects be damaging chemical receptors, resulting in neurological disorders?
  • Vaccine-autism connection: Some genes associated with autism are also associated with heat shock genes. If heat shock genes were damaged by the thermal effects of prenatal ultrasound, it would explain why some children who experience high fevers after vaccinations regress into autism, as the heat shock genes would be unable to perform their protective function.
  • Ultrasound can causes increases in sister chromatid exchanges (SCE), which are believed to lead to mutations. The experiments that discovered this effect were done before many changes in ultrasound technology have taken place such as an aeight-fold increase in acoustic output, Doppler ultrasound, 3–D and 4–D imaging, the use of color contrast agents, etc. Experiments should be done to observe sister chromatid exchanges under the new conditions that apply to current ultrasound use.

LACK OF SAFETY STUDIES

There is little data regarding the safety of prenatal ultrasound. A 1982 WHO review of literature found existing studies to be so flawed, their conclusions were “invalidated.” A 2002 report by the National Council on Radiation Protection and Measurements (NCRP) found that there were no safety studies based on data collected after the FDA allowed an eight–fold increase in acoustic output in 1991. The only study published since then (Newnham et al, 2004) has no control population that was not exposed to ultrasound and was based on ultrasound scans conducted after 18 weeks of gestation – when today, many women undergo ultrasound as early as five or six weeks. An abstract of a review and meta–analysis that found ultrasound safe presented in August of 2008 at the World Congress on Ultrasound in Obstetrics and Gynecologists meeting in Chicago was based on old, insufficient data, which sheds no light on the urgent questions women face today regarding current applications of ultrasound.

COMMON DENOMINATOR

The rate at which autism has increased far outpaces any normal rate of change in the gene pool, so there must be an environmental trigger. Ultrasound is the common denominator in obstetrical care worldwide, whereas other environmental factors such as diet, environment, building materials and household cleansers, are very different in different regions. Any common denominator such as prental ultrasound that could affect fetal development must be the subject of meticulous examination.

WHAT MUST BE DONE

The IACC plan to “Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g., ultrasound … ” is not enough, especially with what one expert called an “appalling” lack of such literature. This is not just an oversight; historically, scientists who have applied for funding of relevant safety studies have been turned down. The IACC must make examininng prenatal ultrasound a priority, aggressively launch retrospective and prospective studies and insure the accuracy of results to find out what whether this fetal imaging technique is harming children. To do any less would be a lack of due diligence and could cripple efforts to get to the bottom of autism's etiology.

Respectfully submitted,

[redacted personally identifying information]

EMAILING FOR THE GREATER GOOD
Join me

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 11:01 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00100] NOT-MH-08-021: . IACC Services RFI . re: IACC Strategic Plan RFI

[redacted personally identifying information]

Dear IACC Committee,

These are my comments on the strategic plan.

I thank you that you are targeting “the health and well being of every individual on the autism spectrum across the lifespan.” Autism is a spectrum disorder, with a variety of causes and concerns, and strengths.

I am concerned that you are interested in prevention. I’m not sure if there will be any viable prevention any more than there is for other conditions, such as down syndrom, bipolar disorder, etc. Please focus more on treatments and early intervention. Help the children and adults who have autism now. They are voters and have voting family members.

Please rewrite:

Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g., ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies.

to

Monitor the scientific literature regarding possible associations of environmental factors (e.g., ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies.

Vaccines have been shown not to be associated with autism in general, and we should not include one very very small subgroup over and above all others. Why are children such as Hannah Poling more important than my son, whose autism appears genetic? Additionally, the only things that have conceded it could have been a vaccine, were because the vaccine caused reaction, often similar to symptoms of the various diseases vaccines prevent. So if more children are not vaccinated, more of those children could get a disease that could trigger just as much as people think the vaccine triggered. We KNOW if a pregnant woman contracts rubella, her child has a greater chance of congenital rubella and autistic symptoms. It seems to me that Vaccines prevent autism more than they would cause it.

I want treatments to be covered.

I want research into treatments that cover not just Aspergers and Classic Autism. Not a single piece of research that I have read would have included a child like my son, who is severely autistic, but not a ‘typical’ autistic child (for example he is fascinated with faces, but does not have Williams Syndrome, and is still autistic). So we don't have any evidence based therapies, and we are left to experimenting on him. I do not want to experiment with my son. I do not want other parents to have to experiment with their children.

Autism needs to be further categorized so that the right treatments are applied to the right children.

I also think more work needs to be looked into sensory issues. Every parent I’ve spoken with or read about with a child with autism has some sort of sensory issue. The general public seems to link these with autism, yet they are not part of the diagnosis in the DSM IV that discusses sensory issues. Sensory dysfunction is not an officially diagnosable disorder. But I know, from watching my son, it was his sensory seeking that caused him to regress. As he did not regress after a cold, or after a reaction to a vaccine but after walking, in which he proceeded to do nothing but run around. He lost language, which had been advanced. He no longer fed himself with a spoon, etc, etc. I think research into whether sensory issues are really a part of autism, or a comorbid disorder, or even really a disorder is necessary, and it seems it would assist a larger number of autistic people than research into vaccines would. Also research needs to not just address the sensitive, as not all autistic people are sensitive.

I think research needs to be done into other, comorbid disorders and autism. We need to clearly know what symptoms are autism, and what symptoms are caused by another disorder. There are a number of people with children with epilepsy, or other seizure disorders, that link the seizures to autism. But seizures are not a part of autism. My son, for example has no seizures. There are people with children with allergies and sensitivities that link it to the autism (and then urge others to try diets that won’t help, and may even hurt a child with no allergies or sensitivities). I think people need to understand that if a separate, underlying disorder is treated, then of course the autistic symptoms will improve. A typically developing person who is sick, or not feeling well is not going to communicate as well as when they are well. If that is true for a typical person, how ever more true will it be for an autistic one.

We need to be able to separate comorbid disorders from autism, identify them, and treat them, and not just attribute everything to autism.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 11:02 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00101] NOT MH–08–021
Attachments: IIG to IACC Sept 08.docx

See the attached.

[redacted personally identifying information]

September 30, 2008

Thomas R. Insel, M.D., Chair
Interagency Autism Coordinating Committee
Office of the Director
National Institute of Mental Health
6001 Executive Boulevard, Room 8235, MSC 9669
Bethesda, MD 20892–9669

Dear Tom:

I appreciate the opportunity to comment, in my individual capacity, on the Committee’s draft Strategic Plan for ASD Research. [redacted personally identifying information] endophenotypes in psychiatry, [redacted personally identifying information] the prevalence and genetics of autism since the mid–1970s and [redacted personally identifying information] interested in the scientific and public understanding of this condition. I currently [redacted personally identifying information] he CDC regarding Thimerosal and autism spectrum disorder.

With respect to Question 1, I notice and commend the Committee’s observation that over time, there has been a change in the propensity of clinicians to classify certain behaviors as autistic. Much public confusion has arisen out of the misconception that there has been an “epidemic” of autism, whereas the evidence for that is scanty (Gernsbacher). The Committee’s interest in identifying biomarkers for ASD may be well served by applying the endophenotype model to proposed markers.

Similarly, I concur with the Committee’s recognition in Question 3 that genes play a major role in the development of ASD. The persistent lay belief in vaccines as an important environmental factor is a distraction which should not influence the research agenda. I agree that large–scale, but theoretically–informed, genomic studies will be key to illuminating the genetic factors that play into the development of autism.

The discussion of Question 4 cites chelation as a treatment that is widely used yet unstudied, and the list of Research Opportunities under this question implies that chelation and similar therapies should be studied. I know the Committee is aware that a clinical trial designed to test chelation for autism was very recently cancelled on patient safety grounds. Enthusiasm for settling questions like those surrounding the efficacy of chelation must not be allowed to place autistic individuals at risk of harm. I wish I could give advice on how to avoid uninformed pressures from the Congress.

Questions 5 and 6 describe proposed research on the provision of autism services and the long–range prospects of people with autism. These are important issues. I might suggest adding as a specific research objective an assessment of the difference, if any, in outcomes between individuals who did and did not receive popular therapies or services, such as Applied Behavior Analysis, as children.

The draft Strategic Plan is a fine document, science–driven and carefully crafted. I am optimistic that the Committee’s activities will inure to the benefit of autistic individuals.

Cordially,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 11:11 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00102] NOT MH–08–021

I suggest that the group review and incorporate the following two issues in the resaerch plan

Safety and Security

Many individuals affected with Autism are growing older and will be living longer. Some on the milder end of the spectrum may be able to step out of their homes and walk the local streets and then return home. Some of these may become lost.

We need research and solutions to ensure the safety of these autism effected individuals. What mechanisms are already there which can be incorporated in their care?

What newer technologies can be implemented to track those who are lost?

How can those who are lost and then found be returned to their families?

What kinds of data bases are needed and who should have access to these data bases?

Long Term Care

Many of the children affected with autism will grow through adolescence into adulthood. They will need social services, safety, healthcare etc.

Who will pay for these services?

How will these services be paid for?

Can the government create or authorize tax deferred savings account, privately funded by parents and grandparents for this care? (This can be modeled after the 529 savings account for the college education). As a grandparent we put away money for our grandson?s college education. Now that he has developed Autism, can this money be turned into such a tax deferred plan to provide for his care, safety and security over his life time?

Thank you

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 11:29 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00103] federal funding for autism

I have just learned about this issue of Federal Autism Spending, that it it still based on an EXTREMELY outdated model of primarily treating autism as a psychiatric, genetic condition. This amazes me. There has been so much evidence published in scientific peer reviewed journals on the environmental factors associated with autism. With this terrible crisis the nation faces regarding the hundreds of thousands afflicted with autism, I would hope that the Federal response would become RAPIDLY up–to–date on the problem and how to best address it. There was a Congressional hearing on the issue last week arranged by Congresswoman Maloney. You can access the transcript of the meeting at: http://www.ageofautism.com/david_kirby/index.html

Parents need desperate financial help now with the treatments that are recovering these children!!!! Please help.

[redacted personally identifying information], mother of seven year old son with autism

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 12:06 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00104] Autism Research

I am quite concerned that the Strategic Plan for Autism Research is fatally flawed if it fails to adequately address the absolute necessity of investigating environmental causation. Specifically, vaccines. It is this total lack of investigation by un–involved researchers that is the basis of so much anxiety among parents and relatives of autistic casualties. If it can be established, scientifically, that vaccines play no role in causation of Autism it would end all controversy on this subject and allow scientist to focus their research on other possible areas of concern. It would also allay fears among many parents in vaccinating their children according to recommended schedules.

Please be sure no plan is authorized that does not address the vaccine issue or the entire project will be tainted and useless.

Sincerely,

[redacted personally identifying information]

Looking for simple solutions to your real–life financial challenges? Check out WalletPop for the latest news and information, tips and calculators.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 12:06 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00105] Strategic Plan ( SP) for Autism

SP suggestions:

  1. Research needed on the innate ability (no formal education)some on the spectrum have…eg, the Goodwins Talking Typewriter of the mid 1960s; current facilated communications, et al.
  2. More research…follow up…on “the intense world syndrome”…Supercharged Brain…ie;
    “a unifying hypothesis where the core pathology of the autistic brain is hyper–reactivity and hyper–plasticity of local neuronal circuits. Such excessive neuronal processing in circumscribed circuits is suggested to lead to hyper–perception, hyper–attention, and hyper–memory, which may lie at the heart of most autistic symptoms.”

Please see references.

[redacted personally identifying information]
parent of spoiled only child 43 year old daughter w/classic autism (before spectrum autism)
[redacted personally identifying information]

refs xxxxxxxxxxxxxxxxxxxxx [nothing redacted here]

The intense world syndrome...an alternative hypothesis for autism Henry Markram, Tania Rinaldi and Kamila Markram *

Brain Mind Institute, Ecole Polytechnique Fédérale de Lausanne (EPFL), Switzerland

Autism is a devastating neurodevelopmental disorder with a polygenetic predisposition that seems to be triggered by multiple environmental factors during embryonic and/or early postnatal life. While significant advances have been made in identifying the neuronal structures and cells affected, a unifying theory that could explain the manifold autistic symptoms has still not emerged. Based on recent synaptic, cellular, molecular, microcircuit, and behavioral results obtained with the valproic acid (VPA)rat model of autism, we propose here a unifying hypothesis where the core pathology of the autistic brain is hyper–reactivity and hyper–plasticity of local neuronal circuits. Such excessive neuronal processing in circumscribed circuits is suggested to lead to hyper–perception, hyper–attention, and hyper–memory, which may lie at the heart of most autistic symptoms. In this view, the autistic spectrum are disorders of hyper–functionality, which turns debilitating, as opposed to disorders of hypo–functionality, as is often assumed. We discuss how excessive neuronal processing may render the world painfully intense when the neocortex is affected and even aversive when the amygdala is affected, leading to social and environmental withdrawal. Excessive neuronal learning is also hypothesized to rapidly lock down the individual into a small repertoire of secure behavioral routines that are obsessively repeated. We further discuss the key autistic neuropathologies and several of the main theories of autism and re–interpret them in the light of the hypothesized Intense World Syndrome.

For rest of story pls goto:
http://frontiersin.org/neuroscience/paper/10.3389/neuro.01/1.1.006.2007/html/

Supercharged Brain
http://groups.yahoo.com/group/DDRIGHTS/message/4215

Children who develop autism have *supercharged* brains that are so clever and sensitive that they make everyday experiences utterly overwhelming, new research claims.

Looking for simple solutions to your real–life financial challenges? Check out WalletPop for the latest news and information, tips and calculators.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 12:25 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00106] NOT–MH–08–021

I recommend that the Strategic Plan for ASD Research RFI include:

  • a comprehensive study comparing total health outcomes, including risk of autism, in vaccinated populations in the United States with such outcomes in unvaccinated populations in the United States.
  • the study should include populations that had traditionally remained unvaccinated (such as the Homefirst medical practice and Amish and conservative Mennonite populations)

My recommendations and proposal are echoed in [ http://thomas.loc.gov/cgi–bin/bdquery/z?d110:h.r.02832: ] H.R. 2832 introduced by Carolyn Maloney in the 110th Congress 1st session 2007.

When we hear top NIH officials admit that this type of research has not been conducted because the researchers fear the outcomes, it is time for a change in direction! Let’s seek the truth now, where ever it leads and what ever the outcomes.

[redacted personally identifying information]
PA Families for Safe Birth
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 12:53 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00107] IACC Strategic Plan Comments

September 30, 2008

Interagency Autism Coordinating Committee
iacc@mail.nih.gov Attn: Dr. Thomas Insel, Chairman

Dear Dr. Insel,

Upon review of the current draft Strategic Plan for ASD Research (SP), the National Autism Association (NAA)respectfully submits the following comments in response to the Request for Information from NIMH.

This draft does not succeed in establishing the initiatives necessary to provide meaningful help to individuals affected by autism. The document fails to sufficiently address the dramatically increasing incidence in autism diagnoses and the urgency of addressing this epidemic as a national emergency. Our children (and society as a whole)are facing a crisis, yet the SP is a woefully tepid response to an inadequately specified problem. The SP wholly fails to propose research driven by the stated “urgency” guiding principle. We know that our science enterprise is capable of responses to urgent problems, like SARS and bird flu, but the draft proposes business as usual with a research pace that can only be described as glacial. Studies focusing on etiology, mechanism, and treatment are particularly anemic. For example, the SP should clearly state a goal of identifying the major environmental triggers of autism so that they can be eliminated within the next five years, and do whatever number of studies are necessary to achieve this goal. Parents are using dozens of medical and behavioral interventions, but are often criticized for using “unproven” science. Yet, your draft, by proposing a pathetic handful of studies, does nothing to either validate the vast majority of treatments in use or to devise new and more effective ones.

While the strategic plan acknowledges that autism is likely caused by genetic susceptibility factors, paired with environmental exposures, it does not stress the urgent need to direct significant resources toward environmental research to reach the goals of prevention and development of effective treatments for those already affected. The plan does not indicate an intention to increase resources allotted to treatment and prevention in accordance with the severity of this ongoing crisis, nor does it review past performance of research investments made to date to assist in determining future objectives.

The need for research on environmental factors, specifically including vaccines and vaccine components has been clearly established by the Combating Autism Act which will provide funding to implement the strategic plan. Advocates within the Autism community worked diligently to obtain the passage of the Combating Autism Act and expect the funding to be utilized by exploring the most promising areas of research to help those affected. With Congress, stakeholders in the Autism community, and the American public demanding vaccine safety research as it relates to the causation of ASD, the failure to place an emphasis on this important topic in the plan is both concerning and disappointing.

The need for specific vaccine–ASD research was repeatedly stressed in the initial round of public comments, in “gap” initiatives submitted to IACC, and in the town hall meeting held in Sacramento, yet this public input is completely ignored in the plan. Vaccines and their components were the only specific research topic identified in the CAA legislative history. CDC took the position at the July 15 IACC meeting that the science is all “done” and there is no ongoing issue. This could not be further from the truth;. There are NO safety studies looking at chronic vaccine”caused illness, including vaccines, yet there is an emerging scientific consensus that a large portion of chronic illness may be vaccine–caused. The burden of demonstrating safety is on government and industry, and not on the autism community to demonstrate a lack of safety. The SP must contain a separate section addressing this issue, beginning with a retrospective and prospective comparison of the health outcomes, including autism, of vaccinated versus unvaccinated children. ASD vaccine research should also include intensive study on immune dysregulation, animal models, and toxicity of vaccine components such as mercury and aluminum.

Under the plan’s Research Opportunities, the only reference to vaccines is the monitoring of the scientific literature. This is meaningless and completely unacceptable in our view. Based on the recommendation of the IOM Workshop on Environmental Factors in Autism, vaccines must be explored as a possible causative factor in ASD.

The most fundamental flaw in the plan is to adequately set forth broad and governing principles. These must include the following:

  1. ASD must be regarded as a national health emergency with a research agenda driven by this crisis.
    The sense of urgency must be driven by a recognition that we are facing a real rise in cases – an epidemic – and not an artifact of better labeling or increased public awareness. ASD must no longer be regarded as an inherited condition, but one triggered by environmental factors in genetically susceptible children. The research focus must therefore be on identifying these factors so that they can be reduced or eliminated preventing new cases.
  2. The SP must be based on the new paradigm for ASD which recognizes that it is an acquired
    biological condition not an inherited psychiatric disorder. Our children are sick, not crazy. The SP must recognize that ASD can – and should be – prevented in new cases. The existing overemphasis on genetic research is not likely to yield usable results (until the environmental triggers can be isolated)and will likely lead to eugenic abortions (as is the current practice e.g. in Downs Syndrome). Prevention of new cases through identification and elimination of environmental triggers – rather than eugenic abortions of potential ASD’s – must be an expressly stated goal of the SP.
  3. Recovery is possible with effective treatment. The SP proposes a small handful of treatment studies
    yet parents are using dozens of behavioral and medical interventions. Parents are often criticized for using treatments that are not evidence–based yet the SP does little to address these concerns. All of the major interventions used by parents must be studied. The SP should include an aggressive collaborative program with treating clinicians at Defeat Autism Now! and ATN to mine their existing data, work toward uniform systems, and implement a wide range of multi–center trials. Significant investment must also be made in new and innovative treatments.

The proposed budget is completely inadequate to address the emergency, especially since new (and preventable)cases are rising and because treatment is more likely to be effective based on early intervention. The budget should be based on a “cost of disease” analysis and on the opportunity to do good research.

A second major flaw is that the SP completely fails to re–engineer the grant–making process. Crucial here is the inclusion of community participation at all levels of decisions relating to autism research, especially on matters of scientific merit and program relevance. The Congressionally mandated program for autism research conducted by the Defense Department does a much better job of incorporating meaningful community participation. Greater participation has been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB will be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.

Process Failures Contributed to a Deficient Plan.

Process failures have contributed to an inadequate plan. Without major revision, anything approved by IACC is non–responsive to the CAA and to the repeatedly expressed needs of the community. Some of the more serious examples include: appointment of Joyce Chung, wife of legendary epidemic–denier Roy Grinker, as head of the Autism Team; members of science workshops and workgroups were not appointed by IACC, the six community members of IACC were prohibited from collaborating outside formal meetings; secret email voting and discussions; “public” comments not made public; refusal to provide background information necessary to formulate the plan; community input was ignored; selection of workshop and workgroup members with disqualifying bias and lack of diversity; abrogation of IACC’s obligation to make key decisions to an internal bureaucracy; and “community” participation in making crucial decisions regarding funding priorities and specific initiatives was limited to organizations and interests that privately fund autism research (especially relating to genetics). There are three large representative parent organizations, NAA, TACA and Generation Rescue, that were completely excluded from the workgroup process even though they (and many other community groups)spend money on autism research and treatment. Limiting participation in crucial decisions to “pay to play” (especially when exclusions are made arbitrarily and there is an over–inclusion of gene researchers)severely limits the responsiveness of the plan, and its implementation, to the crisis. There must be true community participation.

With the steady, continuing increase in ASD diagnoses and lack of progress made toward prevention and treatment through autism research funded to date, we are extremely concerned that the research opportunities identified represent a plan that would continue to direct funding toward traditional and often unproductive status quo areas of research. We implore the committee to direct its energy and resources into new and promising areas of research including immune system dysfunction, detoxification pathways and reducing toxic body burden, mitochondrial disorders, methylation abnormalities, the establishment of biomarkers and promising treatments of comorbid conditions with all speed and determination. We believe it is of utmost importance to increase the number of environmental triggers investigated to the full list recommended by the IOM Workshop, “Autism and the Environment” and make this critically needed study span a short term vs. a long term with a maximum of two years.

Sincerely,

[redacted personally identifying information]
National Autism Association


[redacted personally identifying information]
http://www.nationalautism.org
Think Autism. Think Cure. ®

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 1:09 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00108] “If you don’t like the way your tax dollars are being spent, or not spent, on autism research, this is your chance to speak up and take action.”

In particular, as a mom of a 9 year old with asperger syndrome, I would like to see more grants available to parents who aren’t able to afford intervention services or services that the schools deny based on results from their “average” test scores, and when dipping into their budget is just out of the question.

thank you, i know i am only one person, but if 99 more feel the same and 99 of their friends feel the same, maybe someting positive can happen!

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 1:51 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00109] NOT–MH–08–016: . IACC Committee . re: IACC Strategic Plan RFI

[redacted personally identifying information]

Dear IACC Committee,

I would like to thank the IACC and the subcommittees for their efforts. It is obvious that a lot of time and care went into drafting the Plan.

I realize that is can sometimes be difficult to balance a “sense of urgency” and a need for innovation with the requirements that research projects be based on sound principles. However, there are limited funds and, worse, limited researcher resources. There are many projects which are promoted as being “innovative”, but which do not appear to have the foundations to pass peer–review. Projects such as those do not meet the need for a “sense of urgency”. Much the opposite, they would likely waste precious resources. I urge the NIH to stay with their core principle of peer review.

Section 1: When should I be concerned?

I greatly appreciate the effort to identify children by 24 months. First, this could help reduce family stress earlier. Second, there is an administrative shift in service agencies (from early–start to school district)at 36 months. Children identified near 36 months can see delays in the start of services.

The goal to target a more diverse population is an excellent one. It is clear from the available data that there is a large variation in the identification rates with ethnicity and geography. Reducing those variations should be a high priority.

Section 2: How Can I understand what is happening?

This section has some very good goals, and could provide families with valuable information. The emphasis on investigating females is a particularly good idea. Goals on metabolic/immune system interactions demonstrate the IACC's responsiveness to the various constituencies in the autism communities.

Section 3: What caused this to happen and how can it be prevented?

This sections demonstrates the IACC’s broad focus on autism issues. I appreciate the emphasis on genetic, gene/environment and environmental causes of autism and how this represents the goals of various groups within the autism communities.

I would strongly urge the IACC to reconsider including any mention of vaccines or immunizations within the Strategic Plan. During IACC meetings, I did not hear support for this line of research from the vast majority of IACC members. The Plan itself notes that the research favors a rejection of the vaccine/autism hypothesis, and this has only been strengthened by recent research (Hornig et al.). Inclusion of vaccines in the Plan, even to the current level, appears to be an attempt by a minority to make the PLan a political and, possibly, litigation driven statement. If so, this would be highly inappropriate.

Section 4: Which treatments and interventions will help?

I appreciate greatly the IACC’s commitment to look a the various interventions currently in use. I would urge a focus on some of the less strict DTT methodologies which have not been researched with great detail (e.g. floortime). I would like to see if measures of success other than IQ could be used. IQ gains and terms like “indistinguishable from peers” are one measure, but improvements in self–sufficiency can be as much or more important to the individuals involved.

Some of the goals in this section are quite ambitious. I believe this is worth noting as it demonstrates the IACC’s commitment to the urgency of the need with autism.

Section 5: Where can I turn for services?

I am greatly encouraged to see an emphasis on interventions for all ages in this section. Also, an effort to search for services with an eye towards cost–effectiveness. Many interventions are beyond the reach of parents, and, frankly, beyond the reach of school districts. This puts both parents and schools in the situation of trying to create a balance: in the case of parents, the balance is between improving a child’s abilities vs. setting aside money for a child later in life.

The idea of “state of the states” assessments is excellent. I would like to see that this includes evaluations of adults with autism.

Section 6: what does the future hold?

As the parent of a young child with autism, I can say without reservation that this is the most important section of the Strategic Plan. Autism has been for too long considered a “childhood” disorder, and we need to understand the needs of the adults with autism. We need to appropriately serve the large number of adults who are likely unidentified now. We need to learn what the appropriate supports are so the children of today be taken care of. We need to give parents an eye towards what the future holds for their children.

I would question the title of this section, as it does seem to come from a “childhood disorder” view of autism. The future is now for likely 1 million American adults with autism.

Again, I would like to thank the IACC for its time and efforts in developing the Strategic Plan. The Plan as a whole shows the efforts of the experts consulted during the process and the commitment of the IACC to work with respect and a sense of urgency for the needs of the various autism communities.

I thank you for your time in this matter,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 5:30 AM
To: IACC (NIH/NIMH)
Subject: [Comment 00110] RFI identifier NOT–MH–08–021

As a country we knew about autism in the fortys. Countries over seas knew something about mercury and the connection to AUTISM and banned mercury in vaccinations. President BUSH had to realise something was wrong with DRUGS because he made it impossible for the autism world to sue pharmasticles.

As a world a whole generation of children have had there brains poisened!!!! As a world TAXPAYERS have to pay to support all of the children that have been diagonesed with autism for there entire lives!!!! The governments will pay but the DRUG companies will not!!!! tHIS SICKENS ME TO THE CORE!!! I wish everyone involved with politics had to take care of a severly autistic child for a week and then VOTE! as OF NOW we have very limited support services and help. PLEASE,we need all of the help we can get, monatery, emotionally, physically, etc! If we don»t start to try to change, we as a country, USA THE LEADING NATION! we will go broke paying for mistakes that were made by politiciations before we ever have a universal healthcare system.

A MOTHER WARRIOR FOR AUTISM
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 2:31 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00111] NOT–MH–08–021

The plan must recognize that autism is a national health emergency and propose research with a genuine sense of urgency. The plan must expressly state a strategic goal of preventing new cases of autism.The plan must state a strategic goal that research conducted must provide benefits to children and adults living with autism. The plan should focus research on environmental causation. Such research must include controversial topics such as vaccines as a potential cause. The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. The plan should expressly recognize that recovery of function is possible with early and effective treatment. The plan must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.

The Plan Must Include Community Participation in All Decisions Relating to Autism Research.

The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA, composed of scientists, clinicians, and advocates. A “cost of disease” analysis should be performed and included in the plan to determine how much should be spent. The budget must also consider the demand from the scientific community for funding for autism–related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 2:32 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00112] Plan for ASD Research
Attachments: IACC reply.pdf

Dear Committee Members:

I am enclosing my suggestions for music therapy for ASD intervention as a PDF file. It is my understanding that the NIH no longer accepts Mac documents.

Sincerely,

[redacted personally identifying information]

Reply to IACC Draft Strategic Plan For ASD Research

In this “decade of music and the brain research” and multiple books and articles supporting the use of music as a positive intervention for autism, the IACC should take a look at the current research, and particularly Auditory Integration Training(AIT). Not only is AIT generally effective, it is also the best treatment as a dollar-for dollar return on investment compared to the expensive and labor-intensive alternative of Applied Behavior Analysis (ABA).

As a member of the American Music Therapy Association and a Berard–certified AIT practitioner of the AIT Institute, I have been able to compare both methods. Most AIT children need only one ten–day course of treatment, and the results continue to be measurable for up to a year. Equally important, improvements do not extinguish themselves when AIT is stopped.

In comparison, The [redacted personally identifying information] School in [redacted personally identifying information], is a representative exampleofa residential ABA facility and its costs. The yearly tuition is $59,000.00 for fewer than twelve months, and research has shown that amount to be one of the lower ones advertised on the Internet. When ABA treatment is stopped, the children often lose the improvements–the television show 20/20 featured two brothers who suffered such a setback during the two–week Christmas vacation.

I use the Digital Auditory Aerobics (DAA) equipment for my AIT treatment protocol. It costs $5,000.00. The cost of treatment ranges from $1,200.00 to $2,000.00 depending on each practitioner and travel and housing costs. I can offer proof of the rapid transformations of my clients, both in written case studies and in DVD footage taken during the course of AIT treatment. Two such cases, [redacted personally identifying information] and [redacted personally identifying information], can be viewed on my website, [redacted personally identifying information]. I would further recommend the website www.aitinstitute.org, where treatment protocols and parent testimonials can be read.

I am prepared to assemble qualified researchers to conduct double blind studies pre–and–post AIT treatments with improvements in brain wave patterns captured by EEG tests. I would urge the IACC to fund a pilot project for this purpose, which would pave the way for widespread implementation across the United States.

I offer you a bibliography for further reference sources. In addition I will answer both e–mail and phone requests if any questions about AIT remain. If necessary I would be willing to come to Washington, D.C. to meet with the IACC. I am totally committed to this cause.

Contact information:
[redacted personally identifying information]

References

Abou-Setta, A. (2006). Auditory Integration Training (AIT) for Autistic Children.
International Journal of Child Neuropsychiatry, 3(1), 39–47.

Berard, G. (2000). Hearing Equals Behavior. Chicago: Keats Publishing.

Brockett, S. (2006). auditory integration training is an educational intervention.
the sound connection, 6(4), np.

Doidge, N. (2007). The Brain That Changes Itself: Stories of Personal Triumph from
the Frontiers of Brain Science. Boston: Penguin (Non–Classics).

Levitin, D. (2007). This Is Your Brain on Music: The Science of a Human Obsession.
New York: Plume.

Rimland, B., & Edelson, S. (1994). "The Effects of Auditory Integration Training in
Autism . American Journal of speech language pathology, 5, 16–24.

Sacks, O. (2007). Musicophilia. New York: Knopf.

Sarkamo, T. (n.d.). Music listening enhances cognitive recovery and mood after
middle cerebral artery stroke Särkämö et al. 131 (3): 866
Brain. Retrieved Sep. 29, 2008, from
http://brain.oxfordjournals.org/cgi/content/abstract/131/3/866?eaf.

Stehli, A. (2004). Sound Of Falling Snow: Stories of Recovery from Autism and Related
Conditions. New York: Beaufort Books.

Stehli, A. (1991). The Sound of a Miracle. New York: Doubleday.

Whipple, J. (2003). Music in Intervention for Children and Adolescents with Autism: A
MetaAnalysis. Tallahassee: Florida State University.

[redacted personally identifying information]
9/30/08

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 2:34 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00113] NOT–MH–08–021
Attachments: VFV to IACC 0908.pdf

Please find attached a letter from Voices For Vaccines responding to the Committee’s request for information related to its Strategic Plan for ASD Research.

Thank you,

[redacted personally identifying information]

VOICES
FOR VACCINES

[redacted personally identifying information]
www.voicesforvaccines.org

Thomas R. Insel, M.D., Chair
Interagency Autism Coordinating Committee Office of the Director
National Institute of Mental Health
6001 Executive Boulevard, Room 8235, MSC 9669
Bethesda, MD 20892–9669

September 30, 2008

Via E–Mail

Dear Dr. Insel:

On behalf of Voices For Vaccines, a national nonprofit organization that advocates for clear, evidence–based communication about immunization, I would like to thank the Interagency Autism Coordinating Committee for composing and sharing the well-thought-out Strategic Plan which is the subject of this letter.

Because vaccines have been linked with autism by anti–vaccine groups and some news media, we have had occasion to acquaint ourselves with the landscape of autism advocacy. We have learned that a significant portion of the autism community regards focusing on vaccines as an unjustified diversion of resources away from needed research on the cause or causes of autism and on the effectiveness of therapies, as well as for the services that will improve the lives of children with autism. While the parents, scientists, and autistic adults who hold these views have historically been less aggressive in promoting them, we urge the Committee not to disregard them as it attends to its cross-cutting theme of community engagement in ASD research.

We strongly support the Committee’s intent to identify the biological bases and markers, as well as the natural history, of ASD (Questions #2 and #6), Success in these areas will remove the confusion which has permeated public awareness of autism and has led to suspicion of vaccines.

[redacted personally identifying information]

The background discussion for Question #3 states that genetic structural abnormalities known to be associated with ASD explain only 10–20% of cases. It may be clearer to specify that these figures estimate the proportion of ASD which is attributable to discrete diagnostic entities such as Rett syndrome, because we understand the role of genetics overall in autism is thought to be considerable, given the studies comparing autism concordance among monozygotic versus dizygotic twins. The medical literature regularly reports discoveries of autism–related genes; this suggests that genetics is an extremely fertile field of research for understanding etiology and beginning to conceptualize treatments.

With respect to environmental factors, we appreciate the Committee’s acknowledgement that thimerosal–containing vaccines have been examined and eliminated as a potential cause of ASD This was illustrated particularly clearly by researchers in California, the state with the most extensive records available for study, who found that rising rates of autism were unaffected by the withdrawal of thimerosal from childhood vaccines. Exhaustive pre–and post–licensure safety testing of vaccines is required by the Food and Drug Administration’s Center for Biologics Evaluation and Research; after vaccines are approved for use, the Immunization Safety Office within the Centers for Disease Control and Prevention monitors their safety through the Vaccine Adverse Event Reporting System (VAERS, a program shared with FDA), the Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment Network. VAERS is particularly useful as a rapid indicator of adverse effects too rare to appear in clinical trials, and to generate hypotheses for testing through a system such as the VSD Thus, for example, shortly after the rhesus rotavirus vaccine was introduced in 1998, VAERS detected a slight increase over the baseline level of intussusception cases that occurred among recipients, and this warning was borne out by later research In addition, scores of original studies and reviews have specifically attempted to find a link between vaccines and autism, and all the credible results have been negative. We would submit that, in light of the overwhelming body of evidence against the vaccine hypothesis, and considering the substantial federal resources already devoted to vaccine safety, it is not an efficient use of autism research resources for the Committee to continue looking for connections between vaccines and autism. Even though the resources that would be devoted to this task appear to be minimal, the needs of autistics are so broad and so time-sensitive that no funds at the Committee’s disposal should be misdirected.

Similarly, although some parents of children with autism have not been convinced by the science which has shown no association between vaccines and autism, the Committee should not continue to promulgate a failed hypothesis by citing these unfounded fears as part of the backdrop to its priorities on etiological research.

As a final note on Question #3, it might be beneficial for the Strategic Plan to note the known and suspected roles of vaccine–preventable prenatal viral infections (rubella and influenza, respectively) in causing autism. This would provide a contextually appropriate reminder of the consequences of deterring vaccination. Deaths and permanent disabilities still occur in the United States every year due to vaccine–preventable diseases. It is unnecessary and unacceptable that misconceptions about the safety of vaccines should cause even one such injury.

[redacted personally identifying information]

I hope that the preceding observations will be useful to the Committee, Voices For Vaccines applauds the Committee for having produced a Strategic Plan which is comprehensive, scientifically grounded, and most of all, oriented to the real needs of autistic people, We fully expect that this Plan will form the basis of important advances in the science of ASD and the lives of those affected by it.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 2:48 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00114] Citizen Response to RFI NOT–MH–08–021

September 30, 2008

To the Members of the Interagency Autism Coordinating Committee:

I am mother to two young adults, one diagnosed with Asperger Syndrome, and have other family members with autistic spectrum diagnoses and traits. I am writing to offer several observations about the Committee’s August 15, 2008 draft Strategic Plan for Autism Spectrum Disorder Research.

The draft Strategic Plan cites a “sense of urgency” as the first “core value” underlying the Committee’s work. I fully support the development and implementation of effective, compassionate and respectful responses to the needs of autistic individuals and their families. However, I would caution the Committee to avoid allowing anyone’s “sense of urgency” to justify abandoning scientific rigor or exposing autism research subjects to greater than minimal risk in the absence of any evidence of potential for direct benefit to them. This is especially important given the Committee’s support for the development of “clinical trials that assess the safety and efficacy of widely used interventions that have not been rigorously studied for use in ASD populations.” Although some of these “widely used interventions” such as the gluten–free casein–free diet may be relatively innocuous, others such as extended administration of chelation drugs are associated with significant and well–documented risks. Certain entrepreneurs may have successfully marketed autism treatments that are not well–supported by scientific evidence and are premised on speculative hypotheses of autism causation, and may have persuaded parents of autistic children to consent to invasive, potentially traumatic diagnostic testing, blood draws, injections and intravenous infusions; however, the risks of such treatments and procedures should not be downplayed, or the strength of supporting evidence overplayed, in any autism research that is federally supported.

Although the draft Strategic Plan states that “numerous epidemiological studies have found no relationship between ASD and vaccines containing the mercury preservative thimerosal,” vaccines subsequently and inexplicably appear first in a list of possible environmental factors deserving further monitoring. The only conceivable reason for the inclusion of this recommendation is to placate plaintiffs’ advocates such as IACC members Mark Blaxill and Lyn Redwood, whose organization SafeMinds exists to support and publicize only those studies that validate their pre–existing conclusions about autism causation, and to influence the outcome of vaccine–injury litigation. The IACC must focus public resources on autism research that is rationally justified, rather than spend taxpayer dollars in a futile attempt to mollify activists who alternate their demands for “more science” with expressions of suspicion against scientists whose research is supported by the federal government or the pharmaceutical industry, and condemnation and ridicule of scientists and studies with conclusions different from their own.

Please resist the efforts of vaccine–injury plaintiffs’ advocates to define themselves as representatives of “the autism community.” There are many people affected by autism spectrum conditions, many different theories of causation, and many different perspectives on appropriate ways to address the medical, cognitive, educational and social challenges faced by people on the autistic spectrum. There is no unified “autism community.” The IACC should therefore refrain from using the phrase “autism community” in its publications.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 2:59 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00115] NOT–MH–08–016: . IACC Committee . re: IACC Strategic Plan RFI

[redacted personally identifying information]

Dear IACC Committee,

I’d like to begin by thanking the IACC for all their efforts to date. It is well documented that forming unified actions in the autism community is extremely difficult, and I respect the IACC for the draft version of the Strategic Plan.

I am a stakeholder in the autism community, as two of my three sons have been diagnosed with Autism Disorder at Children’s Hospital of [redacted personally identifying information]. I encourage continued emphasis lifespan issues. This is a primary concern, as it seems today’s media &#$0;which, unfortunately does have an impact on funding decisions)seems to view autism as some sort of new childhood–only disease. I also place great value in the concept of community engagement. I also feel that the ongoing study of autism as a heterogenous condition are worthwhile. It is apparent that the lived experience of persons with autism can vary dramatically, and I’d like to see research support for persons all along the spectrum.

I support the early childhood screening for autism. As a parent of two autstic kids, I can vouch for the benefits of early diagnosis. We were much more easily identify our third son’s early signs due to our experience with our oldest sos, and have therefore much more rapidly adjusted our parenting style and tapped into support resources to help the little guy along. Early screening and diagnosis, if accurate, can be of great help.

Please consider a strong move away from the vaccine etiology view of autism disorder. I need not rehash all of the lasting problems this failed hypothesis has created in the autism community, but I will appeal to your better judgment in terms of how we can put this issue to rest as quickly as possible. It has become apparent that no amount of new scientific findings will convince the small but very vocal group of parents of autistic kids that vaccines are not to blame. I think a direct departure from this research direction citing existing science as evidence would create a starting point for the autism community to heal itself from this tremendous rift. Please do not allow an agenda–driven element of our community to further derail productive avenues of research in the search for their elusive vaccine “smoking gun”. Our intellectual capital and money could be invested much more wisely in any number of other areas.

Thanks for listening to this “autism dad”, and I look forward to seeing the results of the powerful collaboration of expertise on the IACC.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 2:50 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00116] NOT–MH–08–021
Importance: High

For the official record, the following letter was sent to Dr. Tom Insel on August 15, 2008. This correspondence represents our feedback on the IACC Draft Strategic Plan for Autism Spectrum Disorder (ASD) Research.

August 14, 2008

Thomas Insel, MD
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard
Room 8235, MSC 9669
Bethesda, MD 20892–9669

Re: Public Comment on IACC Strategic Plan for Autism Research

Dear Tom:

We are writing to express concerns that we strongly believe should be addressed before the Strategic Plan (SP)is finalized.

First, we want to stress that, until the SP has clearly defined priorities and objectives and a well–specified budget, the SP will not be effective in accelerating science as intended by the Combating Autism Act (CAA). We trust that clearly defined priorities and objectives, tied to a well–specified budget, will be developed and there will be appropriate time for stakeholder feedback after these elements are incorporated into the SP.

Second, as we expressed in our letter of July 9, 2008, there are still several key issues advocated by the IACC, and included in the CAA, that are not represented in the current draft of the SP. Specifically, the CAA and several IACC members urged a stronger emphasis on environmental factors, gene–environment interaction, and prevention of autism. Of particular concern is that the SP does not explicitly mention that the investigation of the potential role of vaccines in the etiology of autism is needed.

As you are aware, many stakeholders in the autism community remain concerned about the potential role of vaccines in the etiology of autism. While the weight of the evidence does not currently support this hypothesis, several recent developments (e.g. Hannah Poling concession, Dr. Bernadine Healy statements)suggest that more research is warranted. In addition, the legislative history of the CAA very clearly states that more emphasis on exploring the role of environmental factors, including vaccines, is needed. We feel that scientific inquiry into the questions that many stakeholders have regarding the potential role of vaccines in the etiology of autism is the best way to ensure that confidence and trust in our vaccine program is restored and maintained.

Finally, we are aware that many stakeholders in the autism community have concerns with regard to the strategic planning process. Much like the heterogeneity of autism itself, there is a diversity of viewpoints across the spectrum of autism stakeholders. While there have been efforts to engage as many viewpoints as possible, including the town hall meeting that was part of the planning process, concerns remain among some stakeholders that their views have not been adequately included in the process. We strongly urge you to continue to look for ways to include a diversity of viewpoints and to emphasize to the community when these viewpoints have been solicited and represented during the SP process so that the final SP will accelerate and inspire research as it is intended to do.

We appreciate your thoughtful consideration of these points that will impact the success of the Strategic Plan for Autism Research.

Very truly yours,

[redacted personally identifying information

Thank you.

[redacted personally identifying information]
Autism Speaks
[redacted personally identifying information
| www.autismspeaks.org

Autism Speaks does not provide medical or legal advice or services. Rather, Autism Speaks provides general information about autism as a service to the community. The information provided in this email is not a recommendation, referral or endorsement of any resource, therapeutic method, or service provider and does not replace the advice of medical, legal or educational professionals. Autism Speaks has not validated and is not responsible for any information or services provided by third parties. You are urged to use independent judgment and request references when considering any resource associated with the provision of services related to autism.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 3:00 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00117] IACC Autism Strategic Plan Public Comment

As a parent who has dealt with autism, I am deeply disturbed by several elements of the proposed research and spending agenda outlined in the current plan as presented. I believe that it is in need of a major overhaul that reflects the current state of knowledge and theory in the world of autism rather than relying on past models.

First, and most importantly, it is an embarrassment that Joyce Chung has been appointed as head of the Autism Team. None of the important work on autism that needs to be done is likely to be done effectively and transparently if it is done under the auspices of someone who is married to a published autism–epidemic denier. This appointment sends exactly the wrong signal to the very people whose concerns you are supposed to be addressing – – it is cynical and unacceptable. If Ms. Chung cannot herself see this egregious conflict of interest and recuse herself from this panel, then she must be involuntarily removed and replaced with someone who approaches these serious problems with an open mind, a clean public record and no ideological or financial conflicts of interest.

The panel needs to change the way the government views autism and autism research.

First, it must approach the problem of autism with the fundamental notion that it is a biomedical disorder or series of disorders, rather than a psychological disorder. The primary focus of research must be medical rather than psychological and should fall under the purview of the medical scientists rather than psychiatric specialists. Rather than spending money studying use of existing psychological drugs in treating autism, study the underlying causes for the disease. In light of the Hannah Poling case it stands to reason that mitochondrial function in autistic populations is a ripe area for study.

Second, it must acknowledge that autism spectrum disorders are growing at epidemic levels of increase, and that such increases are not due to better diagnosis because there are not hundreds of thousands of diapered autistic adults, and that such an increase cannot be the result of sudden genetic changes but must be the result of environmental factors. The primary focus of research must be on these potential environmental factors, including dental amalgams, food, air and water exposure to heavy metals and other toxins, and with explicit focus on vaccines separate from other environmental factors.

Third, it is important to devise safe studies of currently popular treatements for autism, including chelation therapy and antiviral therapy, to determine their efficacy. Devising studies that are unsafe, only to later cancel them, is skirting the issue and abdicating public responsibility. Use the currently used substances that have been determined to be safe for use in chelation treatment for lead poisoning, such as DMPS and CaEDTA, and follow the DAN protocols for vitamin and mineral supplementation to ensure safety for all study participants.

Fourth, with regard to vaccines, the studies need to be independent of conflicts of interest or influence from industry and from the regulators who have so far failed to properly address the public’s concerns. They must be medical rather than epidemiological studies. We need to compare vaccinated vs. unvaccinated populations for overall health outcomes including autism, obesity, diabetes, asthma, severe food and other allergies, bowel disease and other autoimmune disorders. We need further studies of thimerosal/mercury accumulating in the brain, to further Burbacher’s work. We need independent and unbiased studies of aluminum hydroxide and other aluminum adjuvants, to determine safety and whether they might contribute to immune and/or motor coordination problems, following on the work of Shaw et al. We need a safety study of the entire vaccine schedule as recommended, in combination, rather than safety studies done one vacccine at a time. We need vaccine approval studies reviewed and replicated, ensuring that the testing control group receives saline rather than aluminum adjuvant as the “control” dose. (I’m talking here about Gardasil specifically.)We need a study that determines if giving aluminum adjuvenated vaccines at the same time as mercury–containing ones creates a dangerous cross reaction between these two substances that aren’t supposed to be mixed. We need a study that determines whether combining two aluminum adjuvenated vaccines at the same time creates unexpected immune reactions and/or mitochondrial dysfunction. We need a study of various adjuvants to determine which of them is safest. We need a study that tracks both efficacy and health outcomes with regard to timing of vaccine doses, and a specific study of Hep B shots and whether birth doses are dangerous. We need for the complete original data sets from all of these publicly–funded studies to be public, not just the conclusions, so that the studies may be properly analyzed.

Fifth, every effort must be made to follow up VAERS reports and vaccine court settlements with lengthy health history questionnaires, including medical testing where indicated, to gain an understanding of the biological similarities among those who develop autism, in the hopes that a profile or test might emerge that would be able to screen susceptible populations and prevent the disorder from developing.

Finally, there must be continuing transparency by this committee, and continuing public inclusion – – and not just pharma shills in disguise but actual leaders in the autism community such as Safe Minds, Generation Rescue, USAA and ARI/DAN. This is the only way to mitigate deep and abiding public mistrust that exists in the autism community.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 3:08 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00118] RFI NOT–MH–08–021
Attachments: RFI NOT–MH–08–021.doc

Response to RFI # NOT–MH–08–021

The New England Center for Children (NECC) appreciates the opportunity to respond to this RFI and have a voice in the decision–making processes of the IACC. With the enactment of the Combating Autism Act of 2006, our government has taken a very important step towards addressing the needs of children and families affected by autism. In the generation of the Strategic Plan for Autism Spectrum Disorder Research, the IACC has done an admirable job of constructing a comprehensive outline of areas in need of further research. As a school that has served individuals diagnosed with autism and related disorders for over 30 years, the Strategic Plan is of great interest to NECC. Below, we have included comments on select areas of the Strategic Plan.

Introductory Material (including the Introduction, Vision Statement, Mission Statement, Core Values and Cross–Cutting Themes)

Heterogeneity
The heterogeneity clearly present in ASDs is an issue that we believe is of utmost importance and that this should be considered in all stages of the development of an autism research agenda. This varied presentation is readily apparent to educators of individuals diagnosed with autism from the youngest to the oldest persons served. In fact, the most effective educational and clinical interventions take this heterogeneity into account by tailoring the teaching and therapy to the particular learning styles and needs of each individual.

Keeping this heterogeneity in mind, we suggest that the IACC explicitly promote single-subject treatment and education research in which the effects of experimental manipulations are examined at the level of individual participants to identify the conditions and subject characteristics necessary for treatment effectiveness. The ultimate scale of such research should include multiple replications of intervention effectiveness across many individuals such that groups of responders to distinct treatment strategies can be identified.

Earlier Detection
Although biomarkers are particularly discussed in the section on Earlier Detection, we suggest also discussing the need for further research on methods of detecting behavioral symptoms and on training doctors, teachers, and caregivers to detect behavioral symptoms.

Resources
We suggest that the IACC encourage partnership in research with established schools and treatment centers for individuals diagnosed with autism. These institutions will be better placed to provide a sufficiently trained and qualified staff and administration to promote research efforts. Many studies of intervention effectiveness are of questionable utility given a lack of uniformity in training and experience in direct care staff and supervisors.

I: When Should I Be Concerned?
We suggest an increased emphasis on research evaluating methods for early identification of behavioral symptoms of autism. We also suggest that the IACC promote research examining effective methods for training doctors, teachers, and caregivers to identify behavioral symptoms of autism.

IV: Which Treatments And Interventions Will Help.
The heterogeneity of ASDs has implications for treatment selection. Large scale RCTs may not be appropriate for detecting relations between treatment effectiveness and individual characteristics and the most effective interventions are individualized to the needs of each client or consumer. We suggest that the IACC promote single-subject research examining methods for identifying effective treatments and interventions particularly for remediating critical deficits such as joint attention and communication for individual participants.

V: Where Can I Turn For Services?
There is a continuing need for the development and dissemination of comprehensive curricula for teaching individuals diagnosed with autism. We suggest that the IACC promote research on the evaluation of teaching procedures and the production of a comprehensive curriculum of teaching procedures for individuals diagnosed with autism. We also suggest that the IACC promote examinations of methods of training caregivers to implement effective teaching procedures with individuals diagnosed with autism.

Again, NECC appreciates the opportunity to respond to this RFI. We hope that our comments will be found to be useful to the IACC. We have been encouraged by the work done by the IACC thus far and we hope that the committee continues to be receptive to feedback provided by schools, educators, and clinicians.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 3:45 PM
To: Tim.Bishop@housemail.house.gov; IACC ( NIH/NIMH)
Subject: [Comment 00119] Fw: Federal Funding for “Strategic Plan for Autism Research”
Attachments: Letter to Michael Leavitt re. Strategic Plan for Autism Reserch 30 Sept 08.doc

Herein, and, as an attached file, is a letter to Michael O. Leavitt, Secretary, Health & Human Services re. Federal Funding for the “Strategic Plan for Autism Research”– –:

[redacted personally identifying information]

September 30, 2008

RE: Federal Spending for Strategic Plan for Autism Research

Hon. Michael Leavitt
Secretary, Health & Human Services
200 Independence Ave. SW
Room 615–F
Washington, DC 20201

Dear Secretary Leavitt,

As far as I can see the comprehensive “Strategic Plan” ( SP) for autism has been highjacked by the NIH to the detriment of our ASD kids. It’s proceeding at a glacial pace while the house is burning down–while our kids are not getting the help they need and deserve, and, the environmental causes ( including vaccines( remain unexplored. You are wasting precious time while the rate of autism continues to increase. Research is still geared more on genetics than in looking at the environment.

It’s a process that’s marred by a lack of transparency (and, at best, by a very limited transparency as to be counter–productive).

The autism community needs an active role; and, whatever role they had so far has been relegated to zip.

In reality, for the most part, it’s business as usual. Not what Congress had intended in the Combating Autism Act.

The letter to you from “SafeMinds” dated July 7, 2008 sums up what has transpired to date and what needs to be done: I quote it in part:

“…The SP must address at a minimum: ( 1) a mission statemen incorporating the goals set by Congress; ( 2) speicific goals; ( 3) analysis of past and present research, accomplishments, and gaps (including unfounded projects as a measure of demand); ( 4) a prioritized plan for present and future research initiatives that specifically includes a focus on environmental causes including vaccines; ( 5) changes to the funding process to reduce delay; rely on mechanisms such as special emphasis panels with defined budgets and research targets, and increase community participation in funding decisions; ( 6) transparency, accountility and performance metrics; ( 7) a justified research budget driven by scientific opportunity and demand; and ( 8) collaboration and partnerships with non–NIH public and private research funders…”

I refer you to the letter from SafeMinds in its entirety as it comprehensively sets out all the problems that exist and how they can be remedied.

Very truly yours,

[redacted personally identifying information]

Cc: Representative Tim Bishop; Senator Hillary Clinton; Senator Chuck Schumer

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 3:44 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00120] We Need Help

Please help families affected by Autism. We need funding for research.

Looking for simple solutions to your real–life financial challenges? Check out WalletPop for the latest news and information, tips and calculators.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 4:16 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00121] Re: Autism Research

Sir

I am the proud grandfather of a lovable nine year old, nonverbal boy, who “regressed” and was diagnosed autistic just prior to three years of age. Many of these “regressed” children suffer physical problems, such as, colitis, gasteronitis, inflamed upper and lower tracts…and…when treated, the more bizarre behaviors they exhibit, such as, spontaneous outbursts, stimming, sleepless nights for weeks on end, head banging, etc. etc…lessened considerably. Indeed, our family believes our little guy must have been suffering a lot of pain that he was unable to express to us…because when treated…his “behaviors” improved noticeably. Critical research into what “caused” the many physical problems these children have in common is long overdue.

I also implore you to begin urgent research in the critical area of our universal childhood vaccine policies.

I would respectfully request you re-visit the 1931 Nobel Prize Award acceptance speech given by Charles Richet on “Anaphylaxis” which can be accessed at:

http://tinyurl.com/3eey7p

Almost one hundred years ago, this eminent scientist found each individual immune system is as unique to that individual as are their DNA and fingerprints. Unless Dr. Richet”s award winning research has been thoroughly disproved over one hundred years of opportunity to do so…the scientific likelihood that a universal “one size fits all” vaccine can be manufactured is highly improbable.

In addition, there should be no doubt the widespread and growing numbers of parents who are challenging our universal public health vaccine schedules is due almost entirely to their growing distrust over the safety of the vaccines their child is required to receive. These parents demand to know why the most heavily vaccinated generation in our nation’s history…is so sick…with autoimmune disorders that were uncommon in previous generations. Indeed, parents want to know what “caused” the CDC to report that 1 in every 6 American child suffers some type of early childhood development disorder, such as, autism, allergies, asthma, juvenile type 1 diabetes, juvenile rheumatoid arthritis, ADD, ADHD, etc.

Immediate pressure should be made on elected federal legislators to pass a pending bill that seeks to provide the funds for a scientific, independent study of “vaccinated vs. unvaccinated” populations to ascertain if BOTH populations have suffered the same inexplicable, dramatic increase in autoimmune disorders.

The time has long passed for a truly independent study of vaccines and the early timing that demands a newborn infant be given the HEP B vaccine within hours of birth, ostensibly to protect that infant from a disease that is primarily spread through unprotected, promiscuous sexual relations or the sharing of contaminated drug paraphernalia. This particular vaccine should be immediately stopped…research immediately begun to ascertain just how much damage it has caused…not the least of which may be the inexplicable infant mortality rate is higher than some undeveloped third world countries.

Immediate critical research must address the recent mitochrondial “concession” by the best “experts” the Health and Human Services could find…that found vaccines triggered “symptoms of autism” in Hannah Poling. How many children have mitochrondial challenges that cannot tolerate the numerous vaccines those children are being inundated with? Whatever the small number of children “pre–disposed” to mitochrondial failure…public health officials have a great responsibility to identify them PRIOR to requiring they receive vaccines. After all, vaccines ought not be dispensed expecting parents to “hope” their child is not one of the “unlucky few” who will have their entire lives destroyed.

Thank you for any consideration you may give my comments and observations.

Please, do SOMETHING to end the disastrous autoimmune disorders this generation of children are suffering.

[redacted personally identifying information]

Looking for simple solutions to your real–life financial challenges? Check out WalletPop for the latest news and information, tips and calculators.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 4:17 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00122] Comments: Interagency Autism Coordinating Committee Draft Strategic Plan for Autism Spectrum Disorder Research
Attachments: September 30.b2.doc

September 30, 2008

To: The Interagency Autism Coordinating Committee
Email address iacc@mail.nih.gov

Re: Comments - Strategic Plan for Autism Spectrum Disorder Research

Ladies and Gentlemen:

I respectfully submit comments (See attached Microsoft Word document September 30.b2.doc) regarding the Strategic Plan for Autism Spectrum Disorder Research.

It has come to my attention that various vaccine shots for adults still contain mercury, present as a component containing 49% mercury by weight in the vaccine preservative Thimerosal. One list showing vaccines that contain mercury is found at http://www.vaccinesafety.edu/thi-table.htm.

I call your attention to the fact that people, including expectant mothers, after receiving 25 micrograms of mercury in one of these vaccines, would receive levels that exceed the USEPA mercury reference dose. The USEPA established the level of “0.0001 mg/kg/d based on developmental neurologic abnormalities in human infants.” That means that a clear and present risk is presented to both the mother and the child by the act of receiving these levels of mercury injected into their bloodsteams.

Also, according to the USEPA, “mercury compounds to prevent bacterial and fungal growth” for latex paint were discontinued after 1990. See http://www.epa.gov/ttn/atw/hlthef/mercury.html.

In view of these facts, it is intolerable that the Interagency Autism Coordinating Committee (IACC) continues a policy that studies the practice of injecting this toxic heavy metal into human beings without first warning the public of the risks.

It is with great concern that I therefore request that the IACC include warnings in the strategic plan, under “SECTION III. WHAT CAUSED THIS TO HAPPEN AND CAN THIS BE PREVENTED?” Until further studies warrant otherwise, the warnings should clearly state that no person should receive any vaccinations with mercury containing preservatives.

In addition, I request that the IACC correct a serious omission in the draft plan. It states:

“Numerous epidemiological studies have found no relationship between ASD and vaccines containing the mercury based preservative, thimerosal (Immunization Safety Review Committee, 2004).”

Too often this incomplete statement regarding the scientific literature on Autism is quoted in press articles. It misleads the reading public into thinking that there are no other studies to the contrary.

For instance, Dr. Verstaeten stated “The CDC screening study of thimerosal–containing vaccines was perceived at first as a positive study that found an association between thimerosal and some neurodevelopmental outcomes. See http://pediatrics.aappublications.org/cgi/content/full/113/4/932. He then states that since a second study on a different group of children didn’t show the same results then the totality of the two studies on different sets of children is neutral. This is not neutral. If ½ of the study for one set of children shows a risk of autism and the other ½ of the study for another set of children is unable to find a risk – then ½ plus zero equals ½, not zero, not null, and not “neutral.” None the less he did say “more study is required.”

The “half truth” of this draft Strategic Plan present wording on Autism studies is, as Alfred Lord Tennyson said in his poem The Grandmother, a “harder matter to fight.”

Therefore I request that the omission be corrected and all studies that have indicated risk of autism from Thimerosal be referenced anddiscussed.

Finally, before more study is conducted, urgency and diligence require every effort to warn the public to not receive vaccines that contain any levels of mercury. And it is unconscionable that these vaccines are still administered to children and pregnant women.

I await your response to my request with keen interest. I know you see this as an urgent issue due to the harm that these heavy metals are known to cause to human brain tissue. Thank you.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 4:17 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00123] NOT-MH-08-021
Attachments: IACCLetter.pdf

Dear Dr. Insel,

I am the assistant to [redacted personally identifying information] of the Immunization Action Coalition (IAC). Per [redacted personally identifying information]’s request, I am attaching IAC’s letter for the consideration of the Interagency Autism Coordinating Council regarding the Strategic Plan for ASD Research. Feel free to contact us if you have any questions. Thank you.

[redacted personally identifying information] Immunization Action Coalition
[redacted personally identifying information]

Immunization Action

[redacted personally identifying information]

September 30, 2008

Thomas R. Insel, MD.
Strategic Plan for ASD Research RFI
Office of the Director
National Institute of Mental Health
6001 Executive Boulevard, Room 8235, MSC 9669
Bethesda, MD 20892–9669

Dear Dr. Insel:

[redacted personally identifying information] the Immunization Action Coalition, a nonprofit organization [redacted personally identifying information] creates educational materials about vaccines for health care professionals and the public. Because the provinces of immunization and autism have come to overlap in many parents’ minds, I have some thoughts to offer on the Interagency Autism Coordinating Committee’s draft Strategic Plan for ASD Research.

As I know the Committee is aware, for several years a vocal group of autism parents have espoused the view that vaccines– –either the MMR vaccine or thimerosal–containing vaccines– –made their children autistic. This frustrates those of us who advocate for immunization, because not only do vaccines need to pass exhaustive safety testing before they are approved for use and before each batch of vaccine can be distributed, but existing methods of detecting vaccine adverse effects could and would easily signal a link, if one existed, between vaccines and a phenomenon as common as autism. In addition to these structural safeguards, a number of studies have explored the possibility of such a link, but no credible evidence of one has ever emerged.

I would like to call to the Committee–s attention the unfortunately real consequences of the illusory danger touted by anti–vaccine parents. Reported in the CDC Morbidity and Mortality Weekly Report of August 22:

    Among the 131 measles patients, 123 were US. residents, of whom 99 (80%) were aged <20 years Five (4%) of the 123 patients had received I dose of MMR vaccine, six (5%) had received 2 doses of MMR vaccine, and 112 (91%) were unvaccinated or had unknown vaccination status. Among these 112 patients, 95 (85%) were eligible for vaccination, and 63 (66%) of those were unvaccinated because of philosophical or religious beliefs.

These findings clearly illustrate the dangers of vaccine refusal. Measles is perhaps the most contagious of the infectious diseases, and is poorly controlled in much of the world, so it is unsurprising that measles has been the first vaccine–preventable disease to make an alarming comeback following years of unfounded, yet persistent, public uncertainty about the safety of vaccines.

I emphasize this to make the point that in crafting this Strategic Plan, the Committee has a choice to make which has serious implications for public health, I am pleased to see that the current draft correctly characterizes the scientific invalidity of the hypothesis that thimerosal–containing vaccines cause autism and outlines only minimal plans to monitor the literature for new findings related to vaccines and autism, However, because any mention of this hypothesis tends to instill in the minds of laypersons the possibility that it could be plausible, I suggest that the Committee relegate it to the class of autism theories inhabited by “refrigerator mothers”–that is, acknowledge that it is a concept that serves only to harm, and elect not to give “vaccines cause autism” further life

To the extent the Committee wishes to address the beliefs of autism parents who remain concerned about vaccines, I suggest that the Committee coordinate with federal agencies already tasked with public communications on vaccines and autism, such as the National Center for Immunization and Respiratory Diseases and the National Center on Birth Defects and Developmental Disabilities, and recommend an effort to be more direct about the lack of a connection between vaccines and autism. This will conserve Committee–administered funds for productive research while meeting the public's needs. I commend the Committee for the thoughtful and thorough work it has done in organizing the pressing research needs of the world of autism. From its emphasis on researching the best ways of providing autism support services, to its recognition of the lifelong nature of autism, the draft Strategic Plan calls for focused scientific rigor without losing sight of the real people it is meant to benefit

Respectfully submitted,

[redacted personally identifying information]

The Immunization Action Coalition (JAC) works to increase immunization rates and prevent disease by creating and distributing educational materials for health professionals and the public that enhance the delivery of safe and effective immunization services

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 4:20 PM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00124] NOT-MH-08-021 Interagency Autism Committee Draft Stategic Plan

Although I wish to follow instructions and list my comments by sections of the proposed strategic plan, I find that my comments do not fit neatly into a category. Therefore, I will make the comments and you may consider them wherever you find appropriate.

First: Providing the public with only 30 days to read, digest and prepare comments is inadequate. I am fairly new to the autism community as my grandson was diagnosed only 12 months ago, but to the best of my knowledge, the availability of the plan and the request for comments was not widespread. I saw it only last week in the Autism Society newsletter. I saw nothing from Autism Speaks.

Second: The above lack of communication/cooperation is a huge concern that you do not address. It appears that we have two national competing organizations that do not communicate, let alone cooperate. How much money is being wasted by this lack of interaction? Why is this not addressed or even mentioned in the plan? Is this committee yet another “competing” organization?

Third: You have specifically laid out research topic, after research topic. What you failed to specify is how you intend to work with other organizations such as Autism Speaks and the Autism Society or other scientific communities so as to avoid duplicate work and duplicate expenditures.

Fourth: Most importantly, you have completely failed to address the one immediate source of help to families facing ASD. Very simply, it should be a national mandate by law that medical insurance companies must pay for treatments for children diagnosed with Autism. You specifically sited three therapies (speech therapy, occupational therapy and ABA) that are effective, but they are systematically denied payment in most of the United States. In my own state of Michigan, the AFL/CIO, Ford Motor Company, leading Chambers of Commerce, among others, are mightily fighting against mandated coverage. Absurdity– – this should NOT be a state by state issue.

Your plan completely fails to address this issue. Mandated medical coverage for proven brain abnormalities should be first in your list of priorities…it is so basic. It would be fantastic to find a “cure”, BUT if families cannot afford to pay for the treatment, then what has truly been accomplished? If there had been adequate time, 1000 families (and growing ) in Michigan would have written to you in regards to the failure to address this issue in the strategic plan.

I applaud very much of the plan but the above issues are equally important. Thank you.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 4:25 PM
To: IACC (NIH/NIMH); Insel, Thomas (NIH/NIMH) [E]
Subject: [Comment 00125] NOT-MH-08-021
Attachments: ASANCoalitionDoc-Final[1].pdf

The Autistic Self Advocacy Network Coalition Comments on Interagency Autism Coordinating Committee Request for Information NOT–MH–08–021

September 30, 2008

This joint comment on the Draft Strategic Plan is submitted by The Autistic Self Advocacy Network and the undersigned organizations. Our combined organizations collectively represent thousands of citizens with disabilities, including individuals on the autism spectrum, as well as well as family members, professionals and other allies of citizens on the autism spectrum. The Autistic Self Advocacy Network aims to empower autistic people across the lifespan, by focusing on supports, service delivery, and education research. As such, we have an interest in the inclusion of autistic adults in all aspects of IACC's decision-making process, research topic selection, research design and research implementation.

The Autistic Self Advocacy Network applauds the efforts of the IACC to develop a Strategic Plan that will address the needs and concerns of individuals on the autism spectrum and our families. We are especially encouraged by the invitation extended by IACC members to listen to the viewpoint of autistic people, because our viewpoint frequently departs from the traditional concern with causes, cures, and prevention of all autism spectrum conditions.

The Autistic Self Advocacy Network and our supporting organizations suggest several areas of concern to be addressed in the draft Strategic Plan:

  1. All federally–funded researchers must consider the impact that their research will have on autistic citizens’ human rights, their dignity, and the quality of their lives, from prenatal life forward.
  2. Research focused on early detection and intervention, prevention/preemption, pharmaceutical interventions, prenatal treatments, and the like needs to be conducted with the human dignity and rights of the individual as the foremost concerns.

  3. Implement a research agenda that addresses services and supports for people on the autism spectrum throughout the lifespan. Change the emphasis of research away from prevention and cure and toward effective supports for community inclusion.
  4. Currently (as of May 12, 2008), only 1% of NIMH’s $127 million budget for autism research addresses the area of services and support. More resources should be allocated to this area. We share the committee’s “sense of urgency” when we speak about quality–of–life issues for people on the autism spectrum, such as education, employment, and housing needs.

    For example, a more aggressive agenda must be pursued for researching alternative and augmentative communication technology and other assistive communication technologies. The only augmentive/alternative communication technology mentioned in the Strategic Plan is PECS; however, PECS is not always appropriate or even useful to many people on the autism spectrum, particularly for those with visual processing difficulties, or those who need more sophisticated assistive technologies. Lower–cost communications devices need to be researched and tested to enable more people on the autism spectrum to communicate with their families and communities. New modes of alternative communication and augmentive communication that take advantage of autistic individuals’ processingstrengths andstate–of–the–art technology should be pursued.

    Interventions other than Applied Behavior Analysis must be studied. Because research on ABA has shown only limited positive outcomes, other methods must be studied, keeping in mind the heterogeneity of the autistic population. Not all people on the autism spectrum will respond positively to a single approach. As Dr. Catherine Lord of the University of Michigan Center for Human Growth and Development says, in her Omnibus Autism Proceedings testimony, “We know that behavioral treatments make some difference but it’s a relatively small amount of difference.”

    Emphasis should also be placed on identifying the optimal and often unique ways that autistic people think, learn, communicate, and remember. Such research will help parents of autistic children and professionals who work with autistic children to better understand and meet those children’s’ needs. Examples from other areas illustrate this concept: Hearing parents of deaf children are often well served by learning to sign. Sighted parents of blind children are often well served by learning to read Braille. The same principle applies to parents of autistic children; parents deserve attention and intervention alongside their children. Right now, our interventions merely force autistic children to learn, think, behave, and communicate like non–autistic children. Instead, they should be taught how to learn, think, behave, and communicate like autistic children, so that they can maximize their capabilities.

    Longitudinal studies that address quality–of–life and satisfaction–with–life issues need to be undertaken, including research on access and utilization of services in community settings. Research into living arrangements, employment options, relations within the community, guardianship questions, and other aspects of daily life need to be conducted. These are the issues we consider to be of greatest urgency.

  5. Conduct research into unique strengths of autistic individuals and positive experiences of living with autism.
  6. Much research and fundraising language emphasizes “costs to society” and uses the disrespectful rhetoric of “burden.” The National Center on Disability and Journalism strongly recommends against describing persons with disabilities, or their disabilities, as burdens because “portraying [persons] with disabilities as a burden to family, friends, and society can dehumanize them.” We strongly agree.

    Similarly, many NIH–funded researchers and staff speak of autism as “a devastating disorder.” However, many individuals on the autism spectrum do not feel that they are leading lives that are less worthy or more filled with suffering than those of other citizens. Moreover, a growing body of research literature demonstrates that the autistic spectrum profile can be accurately characterized by documented strengths, including the ability to focus on details and qualities such as intense interests, which can sometimes be channeled into productive employment. Research must also address education of the public, including parents, about traits that are often seen as “impairments,” but which, in reality, are often innocuous or compensatory mechanisms.

  7. Require that individuals on the autism spectrum be actively involved as collaborators and participants on all IACC subcommittees.
  8. Most of the recent IACC workgroups, including the treatment and services workgroup, did not have adequate participation from members on the autism spectrum. If future workgroups are convened, every attempt must be made to include autistic individuals in more than a token way. Comparisons can be made to other fields in which persons affected by the research are involved in the research, such as deaf scientists who study deaf language and culture. As MacArthur Fellowship recipient Harlan Lane articulated with regard to deaf research: “…involve deaf people themselves at all levels of the undertaking. Federal agencies … should require the projects they sponsor to turn preferentially to the deaf community for advisers and collaborators in research design and implementation, for assistance in data collection and analysis, for guidance in interpretation of results.” We strongly recommend that the federal agencies that fund autism research endorse this socially responsible position and mandate the involvement of individuals on the autism spectrum in all aspects of the research process.

[redacted personally identifying information]
The Autistic Self Advocacy Network
[redacted personally identifying information]
http://www.autisticadvocacy.org

[redacted personally identifying information]
American Association of People with Disabilities

[redacted personally identifying information]
TASH
http://www.tash.org

[redacted personally identifying information]
Autism National Committee

[redacted personally identifying information]
The Autism Acceptance Project
www.taaproject.com

Compiled by ASAN Board Member [redact personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 4:47 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00126] Public Comment to the IACC Plan

Dear IACC members:

As a parent of a young child on the autism spectrum, I applaud the work of the committee in drafting this plan. In general, I am pleased to see that the plan commits to rigourous, high–caliber science to carry through on the goals contained within. All research conducted in this plan should be the result of competitive applications, triaged through the traditional NIH study section and peer-reviewed by experts in the field. This will insure integrity and prevent political interference.

However, I do have some specific concerns about the plan as written.

In section III, under the aspirational goal of discovering the causes of ASD, a series of bulleted research opportunities follows. The following bullet is of great concern to me:

“Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g., ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies.”

I strongly urge the committee to remove the word ‘vaccines’ from this bullet. As written, it appears to lend credence to the scientifically unsupported claim that vaccines are a risk factor for autism. The bullet will be misunderstood by many to indicate that the IACC is concerned about vaccines. This will only serve to further undermine vaccination rates. Study after study finds no association. The word ‘vaccine’ deserves no mention, much less a predominate, special, mention as the leading environmental factor in this goal. I urge the committee to consider how alarmist and scientifically out–of–step this goal appears.

In Section IV on treatments and interventions, the following goal appears:

Test safety and efficacy of five widely used interventions (e.g., nutrition, medications, medical procedures, etc.) that have not been rigorously studied for use in ASD by 2012.

I would respectfully suggest that unless there is considerable scientific rationale, this goal is inconsistent with a commitment to high–caliber science. I have witnessed what can only be described as a debacle and embarrassment with the NIMH’s effort to study chelation. The trial design itself (exclusion criteria) was a testament to the absurdity of placating the public by evaluating quackery. The last minute cancellation of this trial in light of the finding that chelation led to cognitive decline in animal models, should underscore how perilously close NIMH investigators were to harming children to evaluate this worthless intervention. The political pressure to test such alternative therapies must be resisted. It puts vulnerable children at risk with little chance of benefit and is a waste of precious funding resources. I urge the IACC to remove this goal from the plan.

Lastly, I am greatly concerned about the welfare of vulnerable children in clinical trials. Another NIMH intramural trial (minocycline in regressive autism) currently being conducted calls for participants to consent to lumbar puncture. Children on the spectrum have difficulty communicating and are often subjected by well–intentioned but misguided parents to all manner of medical procedures. How can a toddler possibly understand much less consent to this procedure? Moreover, the rationale and history of minocycline in neurologic diseases undermines the rationale for this trial. I am greatly concerned that out of a sense of urgency, clinical investigators have lost perspective and compassion for these children and instead get caught up in the anguish of parents who cannot accept their child’s diagnosis. I am mystified that an IRB approved this trial.

I make this point because in section IV on treatments and interventions another of the expressed goals is to:

Complete randomized controlled trials in humans on three medication targeting core symptoms by 2014.

There are just too many questions to answer before such trials can go forward. Genotype/phenotype correlations will need to be rock solid to insure proper inclusion/exclusion criteria. A much improved understanding of the underlying biological causes of autism and its core symptoms must be gained. Animal models must be developed. Translational and pre-clinical work must be completed. There is little chance that unless the scientific community grasps at straws like minocycline that this goal will be accomplished. There should be no time stamp on the completion of clinical trials.

In closing, I want to reiterate that the overall plan is thoughtful. I realize a lot of hard work went into it. I thank you for your efforts and for letting me comment.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 4:56 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00127] Draft Strategic Plan for ASD – Recommendations
Attachments: IACC.response to RFA.9.30.08.doc

Please see the attached document with recommendations.

<<IACC.response to RFA.9.30.08.doc>>

[redacted personally identifying information]
Autism Services Division
Department of Developmental Services
[redacted personally identifying information]

September 30, 2008

Interagency Autism Coordinating Committee (IACC)
Re: Comments for the IACC Draft Strategic Plan for Autism Spectrum Disorder Research

Introduction: The [redacted personally identifying information] Connecticut Department of Developmental Services, Division of Autism Services wishes to submit comments regarding the draft strategic plan of the IACC. The primary focus of the division has been a pilot program to provide services and supports to adults who have autism spectrum disorders and do not also have mental retardation. The vision of the pilot is to establish a statewide program that enables eligible adults with autistic spectrum disorder (ASD) who do not have mental retardation to lead lives that are functional and independent.

In response to your request for comments on the IACC Draft Strategic Plan for Autism Spectrum Disorder (ASD) Research, we are recommending the following be included:

Section V: Where Can I Turn for Services?:

  • State funded services delivery systems
    The recommendation is for establishing or highlighting models of service delivery systems for individuals with autism including those with a behavioral health dual diagnosis. Models should include cost, creative use and integration of funding streams, best practices for service delivery, and provider workforce development. Many states, families and individuals are struggling with issues related to appropriate resources and methodology to create these systems.
  • Housing
    The recommendation is for models of safe, community based affordable housing that meets the needs of individuals with autism. We often see affordable housing programs situated in areas that would put some of the adults who are most vulnerable in an unsafe environment.
  • Employment
    The recommendation is to develop state models for successful competitive employment for adults with autism spectrum disorders. We would like to recommend new models of vocational rehabilitation that are designed to address the needs of this population and meet outcomes of successful competitive employment.
  • Safety
    The recommendation is to develop awareness training and strategies for criminal justice, law enforcement and first responder systems regarding individuals with autism spectrum disorders. Research into areas that can improve safety for autistic people throughout the lifespan and in different situations needs to be undertaken. An area to focus on is keeping people on the autism spectrum safe if they have a tendency to wander or do not understand dangerous situations. Education of parents, professionals, first responders, and people with autism should be undertaken, and the best methods for ensuring safety should be addressed by research in this area. Sometimes autistic people can appear unusual in behavior, which attracts attention from law enforcement and other personnel. Training for professionals in aspects of autistic behavior that might not be understood is a crucial area to address in order to promote the safety of all.
  • Aging adults and adults with aging parents
    The recommendation is to develop models of service delivery to address the aging population both aging adults with autism spectrum disorders and aging parents of individuals with autism spectrum disorders. There is a group of adults with autism spectrum disorders who have been underserved or not served at all during their adult lives. Parents have been the only supports to these adults. As parents are aging and incurring their own medical problems and passing on, these adults with ASD are abandoned or placed with siblings who are not prepared to provide the needed supports.
  • Healthcare Access
    Access to health and medical services, particularly for adults on the autism spectrum is of paramount importance for research funding. Current studies that focus on diagnosis and treatment of children do not address the very real need for healthcare access for autistic adults who may not have insurance and may have communication and other difficulties that prevent them from obtaining adequate care. Education of health care professionals so that they can interact knowledgeably with autistic patients/clients is one area for research into services and supports.
  • Transition to Adult Life
    Research into the most effective transition options needs to be undertaken. Parents and young adults on the spectrum often have nowhere to turn after they age out of the school environment. A clearinghouse of options should be researched and developed so that families will have resources already in place by the time their child ages out of school services.

Sincerely,

[redacted personally identifying information]
Division of Autism Services
Connecticut Department of Developmental Services

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 5:04 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00128] NOT-MH-08-021
Attachments: RFI response _2_.pdf

Good afternoon,

Please accept the attached document, submitted on behalf of Ohio’s Interagency Work Group on Autism, in response to the Request for Information for comments on the IACC’s Draft Strategic Plan for ASD Research.

Thank you–

[redacted personally identifying information]
Ohio Department of MR/DD
Office of Children and Family Supports
[redacted personally identifying information]

The mission of ODMRDD is continuous improvement of the quality of life for Ohio citizens with developmental disabilities and their families.

All or part of this electronic mail transmission may contain confidential information. If you are not the intended recipient, you are hereby notified that any retention or dissemination of this information is strictly prohibited. If you have received this e–mail in error, please notify [redacted personally identifying information] and delete all copies of this e–mail from your system.

NOT-MH-08-021
Request for Information
Interagency Autism Coordinating Committee Draft Strategic Plan for Autism Spectrum Disorders Research
Submitted by: Ohio’s Interagency Work Group on Autism

Under the leadership of the Ohio Department of Mental Retardation and Developmental Disabilities, an Interagency Work Group on Autism was convened in January 2008. The Work Group, comprised of representatives from the Governor’s Office, Cabinet agencies (including the Ohio Departments of: Health, Education, Mental Health, Job and Family Services, Budget and Management, and Mental Retardation/Developmental Disabilities), the Rehabilitation Services Commission, and the Ohio Center for Autism and Low Incidence, works to assure that Ohio’s plan to serve individuals with autism is effective, broad-based, and an integral part of the State’s efforts for all individuals with developmental disabilities. Several of the Work Group’s priorities parallel the research opportunities outlined in the IACC Strategic Plan. Ohio’s Interagency Work Group on Autism submits the following comments in response to the six questions addressed in the IACC’s Plan.

  1. When should I be concerned?
  2. Ohio has recently committed state funds for a pilot project to develop mechanisms to train the medical community around more standardized developmental screening practices. Additionally, the pilot will serve to increase the knowledge base of medical, clinical, educational, and community service providers in recognizing early signs that may indicate the need for further clinical diagnostics for autism. The pilot mirrors the IACC’s long and short-term objectives targeting the need for improving efficacy and sensitivity of existing screening tools and diagnostic instruments. It is hoped that the IACC considers in its plan a process that includes ways to integrate such instruments and protocols into general medical and clinical practice which will result in more standardized, responsive, and cost-effective methods of early identification of autism across states.

  3. How Can I Understand What is Happening?
  4. What Caused This to Happen and Can This Be Prevented?
  5. The need for intensive, multi–disciplinary studies, starting at early ages is supported in Ohio. This is evidenced most recently by research efforts in the state focusing on the interplay of biological, psychosocial and social aspects of individuals having a dual diagnosis of mental illness and an intellectual disability. Interpreting multi-determined factors into medical, psychological, educational and behavioral interventions has ramifications not only for this distinct population being studied, but extends also to those with ASD and other developmental disabilities. A balance should be struck between research targeted at determining causation and prevention of autism, and the urgent and present need of research around effective interventions.

  6. Which Treatments and Interventions Will Help?
  7. Ohio shares the IACC’s “sense of urgency” to create rapid responses to the challenges of families affected by ASD. It is critical that a focus be maintained on applied research that will inform the service system to promote intervention models built on sound, valid, and effective practice. Applied research, with investigation to acquire new knowledge, needs to be directed primarily towards a specific practical aim or objective. Families are placed with a huge burden to navigate the complexities of intervention strategies that may or may not have clinical validity. Translating research into practice is vital.

    Also, consideration should be given to refine assessment strategies that result in the mapping of a specific plan of interventions tailored to the unique abilities of individuals with ASD. The IACC’s focus on multi–disciplinary approaches mirrors Ohio’s efforts to explore the feasibility of developing unified service plans for individuals that encompass goals and objectives across multiple service domains, and are driven by a comprehensive assessment process.

  8. Where Can I Turn for Services?
  9. As outlined in the IACC’s plan, Ohio also shares a commitment to implement high quality, evidenced–based, and cost effective services and supports. Data indicates that nearly 81% of Ohio’s population resides in 7 metropolitan and 8 micropolitan areas of the state, leaving 19% residing in rural Ohio. Significant disparity with regard to availability and accessibility of services from county to county is the result of this spread. Much work is currently underway within the state to define and develop provider networks to work collaboratively through regional partnerships to create capacity in more heavily populated areas as well as reach underserved, less populated areas of the state. Thus, Ohio supports the IACC’s focus on studies that explore service utilization patterns in community settings, specifically related to regional systems of care.

    Of equal importance are cost–effectiveness studies of intervention models. The state is continually challenged to develop creative financial solutions to support services and programs that are affordable and equitable across the state for families. Studies with a focus on outcomes and evidence will result in families better able to make informed choices about treatment for their family members with ASD, and the state will have a well articulated and consistent message for covered services. Research to facilitate the development of blended and braided financial mechanisms to remove silo-based barriers to effective and timely interventions, that represent a truly integrated continuum of care, are needed.

  10. What Does the Future Hold?
  11. Transition from school to work or higher education has been identified as one of Ohio’s Interagency Work Group’s priorities. Through multi-agency efforts, the state is building baseline data on the service and employment needs of adolescents and adults with ASD. Simultaneously, cross system training strategies aimed at improving transition and employment opportunities are underway. Additional work is being conducted to develop innovative employee/employer incentive programs to create integrated work settings, thereby providing employers with the opportunity to build a productive and sustainable workforce leading to long term impact on the entire system of supports to individuals with developmental disabilities. Underlying these efforts is the recognition of the importance of social skills training across the lifespan. Research aimed at infusing social skills training throughout all phases of development, from infancy on, is paramount and should be embedded in the IACC’s planning efforts.

    Questions regarding this submission can be directed to [redacted personally identifying information] Ohio Department of Mental Retardation and Developmental Disabilities at [redacted personally identifying information] or [redacted personally identifying information].

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 5:40 PM
To: [redacted personally identifying information]
Cc: IACC (NIH/NIMH)
Subject: [Comment 00129] Re: NIH Research Agenda

Yes.

There was a monkey porn study by Duke University where monkeys were rewarded looking at other monkey’s butts. How will this kind of research help our kids???

Our son, [redacted personally identifying information] was born normal in 1985 and regressed into autism after getting the MMR vaccine. How can you reverse this damage where he has no speech and has aggressions where he is drugged with 5 drugs in a residential center. I know of a 13 year old with aggressions and autism in NJ who was put in a residential center in PA. Our son is in a residential center in DE. Another older couple in our community came crying to us about their son who is 23 and has autism with seizures and aggressions. They can’t get a home for him.

What will your research do for our kids and the generations of lost males that will follow??? Who will cover the expenses to pay for all these kids over their lifetime.

[redacted personally identifying information]

– – – – Original Message – – – –

From: [redacted personally identifying information]
Date: Monday, September 29, 2008 10:10 pm
Subject: NIH Research Agenda
To: iacc@mail.nih.gov

Dear Sirs~

You asked for parents opinions, and so you are going to get it…

As a parent of two autistic children, now lasting into my second decade (son 27, daughter 21), I ask you to completely revamp you research programs to the following agendas, per my two decades of research on the causes.

  1. BIRTH PROCESS and Autism, how this could cause autism by Immediate Cord Clamp / Birth Drugs like Terbatuline/pitocines, and high levels of C sections (IMFAR)
  2. INFECTIONS in utero, aka, ANY virus, any immune deranging bacteria, including lyme, syphilis, STD’s, flu viruses, and even vaccines given mothers.
  3. Antipyretic use during those infections in utero, and vaccine fevers (see www.rollingdigital.com/autism)
  4. VACCINES, overuse, toxins, immune shifters, toxins, adjuvant, does autism occur more often in the vaccinated, answer yes
  5. FOOD SUPPLY, MILK, WHEAT, CORN, SOY, BT TOXINS, GMO FOODS, PESTICIDES–the set up for autism? Answer, YES.
  6. The continual pollution – aka MUNICIPAL FLUORIDE in Water which makes aluminum more toxic in the brain, aluminum coming from childhood vaccines and other sources.
  7. The Continual pollution of Flame Retardants, Dioxins, Molds, Pesticide traces on foods, MSG in food supply, Plastics, etc
  8. Mothers failing thyroid glands, autoimmunity, high leptin levels. The other set up for autism.
  9. Mothers amalgam fillings as possible neurotoxic source of mercury, and or her diet of fish and or polluted skies.
  10. Mitochondrial disorders, both inherited and acquired from being exposed to mercury, infections like lyme disease what constitutes a true mito injury, and one has to look towards genetic medical linkages, such as cancers, anemias, seizures, etc in family members and or test the mom before pregnancy or at first weeks of pregnancy, administering mitochondrial cocktails.
  11. Obesity causing autism, as in high leptin levels found in mothers of autistic children, and their children, along with this, low levls of VIT D or the ability to absorb VIT D correctly.
  12. High levels of IRON in our food supply may be causing autism, as in prenatals, formula and cereals. Check for hemachromatosis as a prenatal genetic screen.
  13. Check for iron levels in brains of boys, calcium in girls brains. Answer, these two are the biggest oxidative stressor.
  14. What constitutes oxidative stress, and what constitutes a contraindication against vaccines (aka, dogs and cats have more than our children). Actually take a PCR sample of what is in random vials of vaccines, and behold the retroviruses and contaminations, even mycoplasma. Opting out of vaccines, SHOULD BE EVERY PARENTS RIGHT based upon these preconditions.
  15. Prenatal exams should include, is mother dealing with autoimmune issues and gestational diabetes (another sign of iron overload), does she have a present infections and is being treated for them no matter what (lyme, EBV, Herpes 6a, CMV, etc), does she have mitochondrial issues, should she ingest iron prenatals if she is already overloaded, are we checking her B–12/Folic/B–6 levels–homocystein and CHOLESTEROL (and no not for high cholesterol, I mean LOW because this impacts a baby’s myelin sheath), is she eating correctly and avoiding MSG?
  16. Bottom line, infections, too many vaccines, immune system gone awry, toxins, birth process, what we are exposed to more than ever…get the picture?
  17. These issues are not minor, or far out of the park, in fact, with my surveys of many mothers of autistic children, THESE ARE OUR CONCERNS, and should be yours, because we know exactly what happened to our children, and how we got here. It is somewhat surprising that NIH/CDC refuses to look at obvious things, and still work around the outskirts of what is really happening ever present in the lives of our families clinically and not just intellectually, when we have tests and numerous evidences of these connections. If only I could set the agenda, mobilize forces, fund independent researchers, I guarantee, the answer to autism would be shortly revealed. Instead, [redacted inflammatory language] around, and wasting time/money on large agendas of genetics (which are influenced by off and off genes which are influenced by oxidative stressors and our diet and our environment, and help you to not implicate “products”). It is a pure waste or our time, when children, as much as 1–67 are finding themselves in dire autism straits. Instead of the kickbacks, and the shady deals behind doors, open parents up to this process and see where it takes you..and I guarantee, it won’t be pretty for all concerned. Implications can simply scare NIH more than it is willing to admit. Let’s get real science back into this disease, not agendas of unknown origins. Parents have only the interest of their children at heart, what is NIH's?

    If we think this current financial crunch will hit us, wait until all these children hit the SSI system which will require lifetime support and assistance! Where are our priorities!!?? Hire me, consult with me, be honest with me, and others, and I will make sure parents are not shafted any more. I will make sure THEIR voices are heard as well as their children’s. Make us want to believe your research, which so far, has been thwarted, twisted, manipulated, forced to go in stupid directions and junked. Genetics doesn’t explain an epidemic, or rising number, as you so call put it.

    [redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 5:46 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00130] NOT-MH-08-021
Attachments: IACC Sep Strategic Plan Ltr.doc

[redacted personally identifying information]
Association for Behavioral Health and Wellness

Advancing benefits and services
in mental health, substance use
and behavior change.

September 30, 2008

I am writing on behalf of the Association for Behavioral Health and Wellness (ABHW – formerly the American Managed Behavioral Healthcare Association) in response to your request for comments on the draft Strategic Plan for Autism Spectrum Disorder (ASD) Research. ABHW is an association of the nation’s leading behavioral health and wellness companies. ABHW members cover over 147 million people across the country in both the public and private sectors.

As requested, our comments are organized by the sections of the draft Strategic Plan, our comments are as follows:

When Should I be Concerned?

ABHW supports NIMH’s goal of identifying children with or at risk for ASD with appropriate interventions, including funding research opportunities to develop screening instruments and approaches for use in community settings to identify individuals who require diagnostic evaluation and to develop sensitive clinical diagnostic tools for diagnosing ASD in widely diverse populations, including underrepresented racial and ethnic groups, females, and younger and older age groups.

Which Treatments and Interventions Will Help?

ABHW also supports NIMH’s goal of developing interventions that are effective for reducing both core and associated medical symptoms, building adaptive skills, and preventing the disabilities associated with ASD. We support large scale studies that compare interventions and combinations of interventions to identify what works best for which individuals. In addition, we support the use of randomized controlled trials that address co–occurring medical conditions associated with ASD. ABHW is also interested in research opportunities that assess methods of treating co–existing medical or psychiatric conditions and assessing how such methods affect ASD symptoms and severity.

Where Can I Turn for Services?

With respect to the whole concept of cross cutting themes and services integration, the issue of program data is critical. In particular, ABHW suggests that the Strategic Plan include development of a standard template of data that could be gathered from programs across states and systems of care. Cross-discipline data is particularly important to understanding autism and its correlates, incidence and causes, as stressed in the 2005 Autism Report to Congress. In order to establish effective system of care models, we need understandable and comparable data. There are so many disciplines involved in the treatment of these populations, including medical, neurological, mental health, special education, juvenile justice, etc., that the data template becomes that much more critical.

We would also like to reinforce, as we have stated in previous comment letters, the importance of identifying effective evidence based interventions. The research in this area is critical to help find proven technologies that help treat Autism Spectrum Disorder. AHBW is pleased to have the opportunity to once again provide input to the IACC and we look forward to working with the Committee and others to find an effective way to deliver services to the ASD population.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 6:16 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00131] Planned autism research

It is crucial that any research on autism undertaken include identification of those for whom vaccinations are too risky, compared to the benefit. And I am not speaking only of mitochondrial disorders.

    Gupta S, Aggarwal S and Heads C (1996). Dysregulated immune system in children with autism: beneficial effects of intravenous immune globulin on autistic characteristics. Journal of Autism and Developmental Disorders 26(4): 439–52.

    Summary by William Shaw, PhD:

    “Studies done by Reed Warren Ph.D. at Utah State University, Sudhir Gupta M.D.PhD., a clinical immunologist at the University of California at Irvine Medical School, and others indicate most children with autism have substantial immune abnormality of some type. Reported defects include myeloperoixase deficiency, severe combined immunodeficiency, IgA deficiencies (partial and complete), IgG subclass deficiencies in 20%, and deficiencies in complement C4b.

    In Gupta’s study, 20% of the children with autism had a deficiency of IgA and 8% lacked it completely. Reed Warren and his colleagues also found that 20% of individuals with autism had low serum IgA compared with none of the normal individuals used as controls.”

I have a PhD myself in biology from [redacted personally identfiying information] University, and I also have Common Variable Immunodeficiency requiring maintenance gamma globulin. Despite our informing their pediatricians, two of my grandsons were immunized with live virus vaccines and developed pervasive developmental disorders, in one case, high–functioning autism. Our family is also sensitive to mercury, like the mice in Mady Hornig, PhD’s article who were “lupus–prone.” Both myself and my daughter (mother of one of the two grandchildren), develop anti–nucleolar antibodies in response to mercury and other chemical exposures. We were both diagnosed with lupus. Autoimmune diseases in the the mother are another risk factors.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 7:56 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00132] Funding for an Epidemic

Please review the following. This is really an epidemic. I challenge anyone to find anyone in their sphere to find not one autistic child. They are everywhere but unseen because they look like typical children. These children are being left on the wayside and will be hampered for all their lives due to the lack of treatment and funding for reasons and cures for the epidemic increase of this illness.

When these children are on their own only the government will be able to supply even basic care for these “new” adult autistic people. The cost of care alone should galvanize action now to help to prevent both personal suffering and taxpayer (governmental) cost of care for a lifetime.

Most people cannot afford treatment programs and can only rely on information provided in the media (pitifully little) and the public library again pitifully little.

Now is the time to act. Please don’t let these generations of children down, you are their only hope.

This issue is more important than anything that can possibly be found on the “normal” agenda of congress.

We must act now to prevent a catastrophic future for these children, adults, and disability expense to the government.

Thank You,

Grandma of a beautiful autistic boy who needs all the help only you can provide.

His name is [redacted personally identifying information] and he is trying so hard, please help him and all the other children and adults with autism. You must know that insurance companies do not provide any coverage for these children. Only the intercession of congress can correct this despicable behaviour. You are our only hope. This problem supersedes anything that is happening on Wall St. or ever will happen there.

You must act now to prevent a catastrophic future for these children, adults, and disability expense to the government.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 8:12 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00133] (no subject)

I am not sure if this is where I was supposed to send this to. But I wish there was more funding for intervention for those parents who can not afford it themselves and when the schools have exhausted all there funds. What are parents supposed to do when they do not have the money?? Just let there children there babies slip into another world just bc they do not have the money, is that fair? If you were diagnosed with cancer would someone help you there or just let you fade away in all that pain and suffering. Autism is just as important to have funds for is it not or should those children just be left to suffer. Well that is what I would like to see more funds and help for those families that are really in need and have no other alternative…

Thanks for listening

[redacted personally identifying information]

Looking for simple solutions to your real–life financial challenges? Check out WalletPop for the latest news and information, tips and calculators

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 8:47 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00134] NOT-MH-08-016: . IACC Committee . re: IACC Strategic Plan RFI

[redacted personally identifying information]

Dear IACC Committee,

I want to thank you for your putting up with various and sundry cranks, crackpots and pressure groups and for obviously working hard to include the perspective of autistic people, a perspective that was entirely lacking in earlier documents from the IACC.

However, I am concerned, still, that parents are necessarily seen as “normal” when for a fact autism is the most heritable of all developmental/mental disorders and therefor it is extremely likely that one or both of the parents of a given autistic child are on the autism spectrum themselves. This isn’t just a hunch there is a whole body of literature about the ways that parents of autistic kids differ from parents of non-autistic kids. The parents, as a group, are not “typical.” It is totally foolish to pretend that they are.

What this tells you, also is that there has been no autism epidemic since the “hidden horde” (coined by the mercury phobic, public health opposing, egomaniacal Mark Blaxill) are not so hidden they are there bringing the children into the clinic! Or they are home while the more typical parent is bringing the child to the clinic.

Please, get real about who is autistic and how common it is and how long autism has been around. It is plainly ignorant to pretend that autism is a “new thing,” a brand–new “gut thing” a brand–new “immune thing”. Looking at autism the way the “biomed" parents do is totally a waste of time, it assuages their fears that their own genes caused their child's autism but it is a dead end.

Further, you WILL be funding research that harms autistic children if you don’t QUIT buying into the SAFE MINDS, Autism Speaks, Autism Society of America hystrionics!.

I would like to quote [redacted personally identifying information] here:

“… I would caution the Committee to avoid allowing anyone’s ‘sense of urgency’ to justify abandoning scientific rigor or exposing autism research subjects to greater than minimal risk in the absence of any evidence of potential for direct benefit to them.”

The hystrionics and borderlines of the “parent groups” are driving research in a dangerous direction and the NIH has allowed it to happen. I am totally shocked that you have allowed Dr. Susan Swedo to experiment on and plan to experiment on children in shocking and totally scientifically unfounded ways, and on this extremely vulnerable group of human subjects.

Her “brain inflammation” study that she is still recruiting for is nearly worthy of Dr. Mengele. You are going to ask children if they want to be transformed into typical children, and then say the way to that transformation is through multiple spinal punctures and pills?

How dare you allow this, NIMH? How dare you allow this, Dr. Insel? How dare you do this to these children as young as three? Because of idiotic pressure groups? Because some lousy politician called you from Washington and said, “Do it.” It’s unconscionable.

But this is the shameful future of Federally funded autism research if you don’t stop listening to these foolish people with their totally ignorant, immoral and unscientific agendas. (See: Lyn Redwood)

Autistic adults such as myself may not be subtle, but we tend to tell the truth and you need to include more of us and not in just a token way. Many of us are parents. Many of us ARE parents. We can see this from the side of having an ASD and from the side of being a parent, and up until now you have assiduously avoided listening to us and including us, with few, almost token exceptions.

You can see what autism across the lifespan looks like. Look at adults! See what has worked for us.

The goal of identifying autistic children younger and younger is a very dangerous one. Right now quack Defeat Autism Now! doctors are chelating mere babies. If you identify 12 month old babies as potentially autistic that only puts them in danger of being harmed by therapies that have not been tested, including behaviorism which consistently gets a “pass” as being wonderful and never is examined as to what kind of harm it actually does. And it does harm children. You need to see that for what it is. ABA is a quack industry that operates on people continually repeating the falsehood that ABA is scientifically backed. No it is not. It is not. It’s just packaged ans sold as if it is.

The few studies of ABA where children were assigned randomly to a control group did not show any benefit for ABA. Behaviorism is not beneficial for autistic children. We don't know what kind of teaching is best for autistic children. It hasn’t been studied adequately. Stop blindly supporting behaviorism as if it has the science behind it merely because it has staked a claim on autism. Please.

The effect of stress and stress hormones on the health of autistic children and adults has been almost entirely avoided in research, and yet there must be tons of low hanging fruit there. It is already known that stress affects autistic children differently than it does typically developing children. See the work of Blyth Corbett of the UCD MIND Institute. And yet even though we know that autistic children have more and longer lasting exposures to health-damaging cortisol, instead of looking at stress as a possible cause of “gut problems” and “immune problems” in autistic children, you will look for the “zebra hoofbeats” of a thousand different xenobiotics, particularly vaccines, as if they might cause constipation and diarrhea. Start with stress. This is so obvious, it’s painful to think of how it’s been ignored.

Stress is a huge problem and people continually throw autistic people into stressful situations and expect them to take it. If the person has a “meltdown” they you want to drug him or her. That’s just wrong. Study the effects of stress and the peculiar stressors of autistic people. Please, this is vital.

It is vital that there be research carried out into the effect of bias, stigma and stereotyping of autistic adults. We can’t get work, we are even beaten and killed because we don’t look “right,” we don’t act “right.” How can this be mitigated?

You have no need to “monitor literature” for clues into xenobiotics, including vaccines, as a cause of autism. This is language that has been placed in the plan to help litigant parents in their court cases. Please, don’t include the word “vaccines” any variant of it in the final plan. It’s a ridiculous concept and was based on a totally false premise to begin with. (See: Andrew Wakefield and Lyn Redwood).

Alternatives to the vaunted, “early intensive, 40 hours a week behavioral” mantra must be found. This is inhuman, overly stressful for everyone and absolutely foolishly expensive. There is no reason to do this to children based on no science. Parents need to be taught how to communicate with their children. The work of Marian Sigman is stellar in this area. Anything related to Lovaas and Smith needs to be approached with caution and suspicion because it is being sold as if it is necessary, when it clearly is not, and not supported by real science.

Again, study stress and ways to reduce stress in autistic children to a reasonable level, using objective measurements like cortisol levels in saliva or heartrate and sweating. You can not merely look at the face of an autistic child and say if he is stressed or not, this is borne out by the work of Blythe Corbett at the UC Davis MIND Institute.

I think if an intervention is being touted by “Defeat Autism Now!” or other quackery oriented groups you should avoid giving it some kind of air of legitimacy by studying it. The NIH does not need to cater to quackery and harm autistic children just to please politicians and a few loud–mouthed activists. This is what you have been doing (the chelation study, the “brain inflammation study,” both supervised by Susan Swedo) to some extent and it is wrong. It must stop.

Make services truly accessible to autistic people keeping their special needs in mind. You wouldn’t hand printed literature to a blind person, but you would get the literature translated somehow. Don’t expect autistic people to be able to cope with some kinds of application processes. Some services are totally out of the reach of autistic people because of the way they must be applied for (in a noisy office, too many people to face and talk to, with too much paperwork, etc).

Look at ways to make it easier for communities to accept and understand autistic people. Do not fund groups that stigmatize autistics and demonize autism (such as Autism Speaks and DAN! does now). Do not fund groups that promote the “epidemic” this is a very damaging lie that impacts the lives of autistic people negatively. Don’t help promote it.

Please look at the bodily effects of stress on autistic children and adults.

Please realize that you are throwing parents and babies to the lions if you diagnose 12 month olds now when so many dangerous and needless and expensive therapies are being offered. Babies may die if you diagnose them now. You need to get the “therapy” end of things under control before you throw more babies into the lion’s den of “therapy.”

Please make applying for services truly accessible, otherwise there’s no point in offering them.

Please continue to work with genetics and dysmorphology, this is an excellent way to understand autism.

Please recognize that the parents themselves are likely to be on the autism spectrum. Please include parents who are on the spectrum in the decision making process, don’t exclude us in favor of extremist, duplicitous and demanding activists (see: Mark Blaxill, Sallie Bernard, Lyn Redwood, Jim Moody, Kelli Ann Davis…)

Penalize, not reward, researchers who demonize autism and stigmatize autistic people and promote the “autism epidemic” concept in their papers and applications for grant money.

Research the effect of bias, stigma and stereotyping of autism and atuistic people. This is an area of social psychology that is vital to explore, and yet so far the NIMH and CDC has tended to contribute to the stimgatization of autistic people rather than diminish it. (See: the “Autism Alarm” and Dr. Insel’s previous remarks about autistic people being “lacking personhood.”

Thank you for considering my thoughts. Please include them in the final draft. I have had contact with the autistic adult community for years now, I know what our priorities tend to be. But people such as myself (with the exception of Wolf Dunaway have been excluded. Stephen Shore comes across as more or less a mouthpiece for the litigant/biomed parent groups. He is not well respected by his peers in the autistic adult community, neither is Valerie Paradiz, for the same reason.

Thank you again,

[redacted personally identifying information]
autistic self–advocate
autism advocacy blogger

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:33 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00135] recommendations for autism plan

First and foremost, biomed research needs to be funded, and results assessed. The Autism Research Institute and the DAN protocol need to be studied, because THEY ARE EFFECTIVE!!!

We need to ensure that the ACCESS (MA) card covers DAN doctors, vitamin supplements, hyperbaric oxygen therapy, chelation, and other tests, both genetic, and tests for levels of heavy metals, etc. It should also cover other alternative things, such as massage, cranial sacral, vision therapy, Tomatis or Berard, etc.

New model needed as another option instead of traditional hospitalization or therapeutic foster care, or residential placement, or institutions: Hospitalization which is primarily biomed should be available (when parents believe that it is needed) while a child is doing biomed, or when a child is doing traditional medical treatments, such as prescription drugs. It should be hospitalization that is responsive to the needs of the parents and the family, and with the family being equal partners with the doctors. It is commonly accepted that when children try different supplements, they may have severe behavioural reactions, and when they are going on or off prescription meds, or changing meds, or adjusting the dosages, they may also have severe behavioural reactions–mood swings, violent or agressive tantrums, etc. Yet, parents are left to fend for themselves, dealing with potentially dangerous, and extremely stressful events, trying their best to keep their child with autism, and other members of the family safe, and trying to keep the house from being trashed, and everything from being broken, or keep the child from running away, or hurting him or herself. Parents should have the option of having the children stay in a safe hospital environment, with personnel who can assist when needed– and it would be great if it was set up like apts or hotels, so that the rest of the family could stay there too. Parents could continue to take their children to school, therapy, church, the regular routine of activities when they are stable, and have some one to help when they are not. It would probably be a fairly short–term situation, just during the crisis period, or the transition period, and not all children would need it, but it would be a godsend to those who do, and keeping the family together, and allowing the child to continue the parts of the regular routine which are working will provide continuity, and help them to have a faster recovery. We also need to provide more support for parents!!!

Other areas to look at: removing lead, mercury, arsenic, aluminum, antimony, etc. safely and effectively. Evaluate Dr. Andrew Hall Cutler’s low dose protocol, chlorella, clay, etc. Also, look at the effects of anti–biotics, and yeast problems in the children, and in THE MOTHERS (things like long–term courses of anti–biotics given for infections or acne, birth control pills, etc.), and the possible effects on the fetus. Look at the (OVER) use of pitocin at delivery.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:48 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00136] NOT-MH-08-021
Attachments: IACC Commentsfinal.pdf

Thank you for the opportunity to comment.

[redacted personally identifying information]
Illinois Autism/PDD Training and Technical Assistance Project
[redacted personally identifying information]
www.illinoisautismproject.org

THE ILLINOIS AUTISM / PDD TRAINING
AND TECHNICAL ASSISTANCE PROJECT

I thank the Interagency Autism Coordinating Committee for their impressive work on the Strategic Plan for Autism Research and the opportunity to comment. While the need for increased research into the cause of autism and reasons for the increase and potential prevention is vital, there is an overriding need for resources for families who are struggling today with the many challenges of this disability and its impact on their lives. As [redacted personally identifying information] of a project that focuses on supporting families and schools to assist individuals with autism to lead high quality lives in the community, I would like to focus on the last three critical questions that frame your plan.

Which Treatments and Interventions will help?

When a child is diagnosed with autism, it affects the entire family. Often, at least one parent must leave their job to order to take care of the child with autism but then the cost to provide therapies can be more than the family single income can bear. Or even worse, when the family is headed by a single parent, a job may be out of the question when the child with ASD requires fulltime care and therapies. We know that early diagnosis and intensive early intervention can be critical to a child with autism and his/her family. Research is showing that children with ASD who receive good early intervention make more gains and family health and stability is improved. Currently, the burden for providing services for children with autism, especially young children, falls to the family.

Early Intervention, Education and School Personnel Training

In 2001, the National Research Council published its extensive report “Educating Children with Autism.” The committee states that a child who is seriously considered to have an autism spectrum disorder should begin intervention at once. The committee also identifies “criticalfeatures”of what that intervention should involve, including full day programming 5 days aweek(at least 25hours) that engages the child actively and intensively in repetitive, organized teaching, a low student/teacher ratio of no more than two children with ASD per adult, parent involvement and training and ongoing program evaluation as critical components of effective programs.

With the increase in children with autism in our schools, the need for training for teachers and all the other personnel who work with children with autism is growing rapidly. A common comment I hear from parents that their child’s Early Intervention Specialist or teacher (or para–professional) has no training on autism and effective strategies. Another concern is that the largest numbers of children are still in their early elementary school years. Sometimes schools have worked hard to get personnel trained and programs in place in early childhood and early elementary grades, only to have the children fall apart when staff in middle elementary schools do not have the same understanding of strategies that work. The middle and high schools have not seen the increases yet and will need much training and support as these children reach their school doors. With the continuing increase in numbers, the gap between the demand for trained personnel and those who are trained in working with children with autism is widening. It is clear that more resources will need to be devoted to personnel training and technical assistance to meet these needs.

The training needed has been recommended by the National Research Council: a three-tiered approach beginning with initial training on best practices for working with individuals with ASD, then ongoing training and mentorship and finally technical assistance. The National Research Council sites the directory of the Network of Autism Training and Technical Assistance Projects (NATTAP) that is published annually. More recently, NATTAP has collaboratively developed both competencies for professionals who work with individuals with ASD and a national conference that focuses on evidence based practices on supporting individuals with ASD. As schools and agencies work to provide effective education and support for individuals with ASD, it will be important to standardize those competencies and the efficacy of strategies and interventions. Then training for professionals from early childhood to adulthood must be funded and sustained. What we know is that strategies and interventions must be individualized based on what skills and symptoms are present for that person and how he or she learns. Research must continue into what strategies are most effective based on particular symptom clusters, learning styles, and skills to be taught.

Where can I turn to for services?

With the advent of the internet, it seems as though families must know how to find and access all services. Still, there continues to be a disconnect between families finding the services their children need and how to access competent professionals. A national database of services and professionals that agencies and families can easily and confidently search is a critical component of the IACC.

What will the future hold?

In addition to the stress families have while their child with ASD is in school, they are often even more stressed about what will happen to them as adults. Individuals with ASD are adults much longer than they are children. As our children with autism leave the school system, they may be faced with no recreation, no job and no place to live except home. Most adults with ASD need support to obtain or hold jobs. Many adults who could live semi-independently in the community cannot because of the lack of supports. Many adult service agencies and employers have no understanding of ASD. We must educate and support these agencies and employers if we are going to be prepared for the numbers of people who will need those services in the future.

Conclusion

The growing numbers of individuals with ASD will have an increasing impact on the country’s schools, families and economy. After we develop a good understanding of what services and interventions will help, families, schools, adult service agencies, employers and community members will need extensive training and support to make a difference in the lives of individuals with ASD. That will make a difference in what the future will hold. We know that when appropriate services are provided early, children make more progress and the need for and costs of services later is reduced. Families need funding and support for therapies and interventions for their child with ASD and to maintain a life for their family. Early intervention services and schools need more funding for personnel training and technical assistance in order to effectively educate the growing numbers of children with ASD. Options for adult services and employment must be developed for individuals with ASD as they leave the secondary school system.

Sincerely,

[redacted personally identifying information]
Illinois Autism Training and Technical Assistance Project
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 9:50 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00137] NOT-MH-08-016: . IACC Committee . re: IACC Strategic Plan RFI

[redacted personally identifying information]

Dear IACC Committee,

Thanks to all of you involved at the IACC for developing a strategic plan for ASD research,

I am an autistic adult with and autistic child so research is important to me. Both my son and I are high functioning. I live with my wife and we have another son who is developementally delayed and will likely be diagnosed with an autistic disorder in the next year. We think it is important that all forms of autism should be given equal attention. We think it is also important that they each be looked at separately because there may be treatments and therapies that help for each separate subgroup. We are glad there will be a focus on heterogeneity.

We are also glad you will be looking into lifespan issues and not just viewing autism as a childhood disease. We think that there should be more research into services and treatments for adults like myself and for my son/sons when they get older.

We hope that you include as much input from autistic adults as you can. We are happy that you have included Wolf Dunaway in the implementation committee. We would like to see you continue to seek that kind of input from autistic people.

We think it is good that one of you goal will be to develop ways to identify and diagnose autistic children by 24 months or earlier. In some areas there can be a waiting list to receive early intervention. It is because of this that earlier diagnoses is important.

We would also like it if there were better more effective diagnoses of minorities and individuals who are in older age groups including adults who may have not been diagnosed as children. We believe there are many autistic adults who are undiagnosed or possibly diagnosed with other disorders but have underlying autistic disorders.

There are subgroups that may respond differently to treatments and therapies. Research into which therapies work best for each different subgroup should be done. Also some things that work better for boys than girls and vice versa. This should be looked into as well. It should be determined what therapies are the most effective for each subgroup.

We think too much time and money has been spent into researching vaccines as a cause of autism. There has been a lot of research already that has rejected that hypothesis. It is unlikely that those who believe in vaccine causation will ever be convinced that there is no connection no matter how many studies there are that find no relationship between vaccines and autism.

We would like to see more studies on brain imaging. We believe that many answers will be found in our genetic make up. We would like to see that research used for the developments of treatments.

We have read that there may be some things that occur in utero like prenatal testosterone exposure. This should be studied.

We have also read that there may be higher rates of autism in children born to fathers over or around the age of 40. This should be studied

We have also heard that premature birth and low birth weight increases the risk a child will have an autistic disorder. Our son was full term but just over 5 pounds and we think research into this would also be promising.

Of course we think it is important that treatments and interventions be studied to see which work best and which ones work best for each subgroup. We like your goal of cunducting five randomized controlled trials of early interventionfor infants and toddlers by 2011. This will be good for people who are trying to decide what treatments they would like their children to have. We wonder how this will be determined. Treatments should not be deamed beneficial on the basis of making autistic people seem more typical. Treatments should also be determined successful if they effectively nuture natural talents autistic people may have.

We think it is great that studies to determine the effectivenesss of treatments and threrapies for infants an toddlers but we think there also needs to be a lot of focus on what treatments and therapies may help school age children and teenagers. We are glad you will be doing randomized controll studies on older kids.

We are glad to see that you plan to test the efficacy and cost-effectiveness of three evidence–based services for people with ASD of all ages in community settings and the cost effectiveness of interventions and services for individuals with ASD across the lifespan. I am really happy to see that you are inculding autsitic people of all ages in those studies.

Your goal to initiate a “state of the states”; assessment of existing state programs and supports for people and families living with ASD by 2009.sounds like a good idea. We are hoping to see best practices for adults be a part of this.

We think that the following studies contain very important goals. They should really help autistic kids who are growing up now.

Launching at least two studies to assess and characterize variation in adults living with ASD (e.g. social and daily functioning, demographic, medical and legal status) by 2011.

Conduct at least two clinical trials to test the efficacy and cost–effectiveness of interventions, services and supports to optimize daily functioning (e.g., educational, vocational, recreational, and social experiences) for adolescents, adults, or seniors living with ASD by 2012.

Develop at least two community–based interventions with individual specificity that improves outcomes, as measured by educational, occupational, and social achievements by 2015.

Thank you for taking the time to read our letter and I hope you will consider our advice helpful to you in developing your strategic plan.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 10:03 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00138] NOT-MH-08-016: . IACC Committee . re: IACC Strategic Plan RFI

[redacted personally identifying information]

Dear IACC Committee,

Thanks for your efforts to figure out how to direct autism research. I appreciate that you have emphasized the diversity of presentations. My own son has Asperger's Syndrome, and is high functioning, but we have friends with children who may never be able to live independently. Therefore I think your emphasis on issues faced by autistics throughout their lives, not just as children, is very useful.

Simpler methods of identification (biomarkers) is a good goal, although given the breadth of the autism spectrum may be difficult to achieve.

I see that the plan mentions monitoring the literature for possible reports of associations with vaccines and other environmental factors. Given that lots of people will monitor the literature for possible associations anyway, it’s not clear that this statement belongs in a research plan. Given that there has never been any plausible association reported between vaccines and autism, and that every credible study attempting to find such an association has found none, I’m not sure why there should be special mention of the topic in the plan – unless it is to mention that there is no particular reason to press further into this issue. I certainly would hate to see research that looks for a link with vaccines crowd out more scientifically grounded research.

I think the focus on testing evidence–based services for autistic children (and adults) is good. I can say that we personally have been very satisfied with the help our son received through our school district. I certainly hear stories of others not being so lucky, so I support trying to extend good services nationwide.

In closing, I’d like to commend the generally science- and evidence–based focus of the document so far. Please do not be pressured into throwing money at hypotheses that are implausible or have already been discredited (of course I refer, again, to a link with vaccines, for which there has never been any credible evidence).

Thanks again for your efforts.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 10:14 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00139] Response to NOT-MH-08-021

I would like to thank the Committee for its efforts to include autistic self–advocates and our concerns in the planning process this year. Here are my views on the Draft Plan:

Section 1: I agree that research aimed at developing better methods of identifying autism in young children would be useful. At present, there is a great deal of ignorance and misunderstanding of autism, which has led to confusion and worry among parents of young children. In addition to improving diagnostic tools and educating parents and professionals on early signs of autism, I would like to see a much stronger emphasis on making sure that parents receive accurate information as soon as a child is diagnosed. No parent should ever be told by any professional that their young child will never be able to go to college, live independently, marry and raise a family, or other such stereotyped predictions. It is simply not possible to make accurate predictions of what any child will be like when he or she grows up, and those ugly old prejudices are harming children and families.

Section 2: There is definitely a need for more understanding of how autistic people develop and change over time. All too often, parents and professionals assume that if an autistic child or adult has a problem, it must be because of the autism. This mistaken assumption can cause serious health problems unrelated to autism to be overlooked, or conversely, autistic people may be assumed to have health issues that they do not in fact have (such as the urban myth of inability to digest wheat and/or dairy). More factual information is needed about what autism biologically is and is not.

Section 3: I am glad to see that “prevention” is specifically defined here as preventing challenges and disabilities, rather than developing a prenatal test or other eugenic ways to “eradicate” (to use Suzanne Wright’s term) the autistic population. However, I believe that the best way to prevent difficulties from occurring is to gain more knowledge of how autistic people learn. Instead of spending so much time and money on abstract questions of causation that provide minimal benefit to the autistic population, we need more funding for studies in cognitive and educational psychology, so that autistic children can be better taught in ways that develop the natural strengths and abilities of the autistic brain.

Section 4: Randomized controlled trials of various therapies can be useful in sorting the worthwhile ones from the hype. Please keep in mind that autistic children have been subjected to an appalling number of unproven and potentially harmful treatment programs. Be extremely careful to ensure that all such research is conducted with the highest regard for the human rights of the study subjects and that no child is put at risk by unnecessary and dangerous medical procedures that have no reasonable scientific basis (e.g. chelation). Autism research should always be required to meet the same ethical standards as any other type of research.

Section 5: I would like to see much more research funding allocated to the effective provision of services, which are desperately needed by so many people. This should include not only studies of cost–effectiveness and best practices but also detailed quality of life assessments, which should be based on thorough and respectful interviews with the recipients of the services. It is vital that autistic individuals actively participate in defining what is meant by effective services, rather than being viewed as passive objects of care.

Section 6: Longitudinal studies would be very helpful to combat unfounded fears and misconceptions about the lives of autistic adults, which often cause the autistic population to be viewed as a burden to society, rather than as a productive and diverse part of society. Unfortunately, this section of the Draft Plan perpetuates the view of autistic citizens as a burden by quoting an unhelpful study that reduces each autistic individual to a lifetime cost, without accurately taking into account our many contributions to society. Would you describe any other minority group in this manner? I’d like to see an economic study that provides an estimate of the cost of inadequate education and employment discrimination.

In closing, I would ask that the IACC make more efforts to enable autistic citizens to be involved in its workgroups and at all levels of the process. Those who will be affected by this research should participate in setting priorities for it.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 10:21 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00140] Autism Research - my comments
Attachments: Autism Research.doc

Hello,

My name is [redacted personally identifying information] and I am mother of a child who is affected by ASD.

Attached are my comments regarding the strategic plan for autism spectrum disorder research.

Thanks,

[redacted personally identifying information]

"Women are like tea bags--you never know how strong they are until you drop them in hot water." Eleanor Roosevelt

Autism Research

So, the question to answer is how to most efficiently use the $640 million research fund. There are many unanswered questions surrounding prevention, causes and possible treatments. So, where to start? How about starting with these three areas?

First of all, we need to agree that autism is not a mental condition but instead a very complex disorder that not only affects the brain development but also affects other parts of the body. We also need to agree that there is more than one type of autism: classic autism and regressive autism. The symptoms, challenges and medical conditions vary from individual to individual, and this makes the autism question a very complicated one.

The incidence of classic autism is still only 1 or 2 kids in 10,000 while the incidence of regressive autism has exploded to a national statistic of 1 in 150 kids. About twenty years ago, the only type of autism known was “classic” autism; it was a rare disorder. So, we have to ask ourselves, what has changed so dramatically over the last two decades that now we have these many kids affected by this disorder? Statistics show that every 20 minutes a kid, in the USA, is diagnosed with Autism Spectrum Disorder (ASD).

Yes, there is more awareness about autism and we have better diagnostic tools, but these do not justify the annual growth of 17% that we are experiencing at a national level. Interestingly, what we are not seeing is annual growth on funds allocated to study the causes, treatment and prevention of ASD. Just to have a frame of reference, muscular dystrophy affects 1 in 20,000, and it gets a funding of $175 million. Pediatric AIDS affects 1 in 8,000, and it gets a funding of $394million. Juvenile Diabetes affects 1 in 500, getting a funding of 130; while autism affects 1 in 150 and only gets a funding of $15 million. The numbers paint a very serious situation, and clearly, autism research is not where it could or should be.

In the prevention realm, it would be beneficial to not only focus on discovering the “autism gene”, but also in identifying genetic predispositions that could lead to regressive autism. Once these environmental triggers (e.g. toxins, heavy metals, etc) are identified they could managed or eliminated. Doesn’t that sound logical?

Looking for causes for autism should not be a finger–pointing exercise, but instead should be about scientifically formulating a hypothesis, conducting research, then reviewing findings and reaching a conclusion. A lot of us suspect that the ingredients within the vaccines (e.g. preservatives and other fillers) had something to do with our kids’ regressive autism. I am sure that many of us feel that this is a valid question that deserves an answer. If we look at the growth of autism in the USA, we could clearly see that there is a correlation between the amount of vaccinations that the kids receive before the age of two and the incidence of autism. Once again, what needs to be looked at is the amount of preservatives (e.g. thymerosal) that are contained in vaccinations. If every human being is considered unique, then, why are we assuming that every person has the same detoxification ability to flush out toxic agents from their bodies? So, why are we giving every child the same amount of vaccines’ preservatives/ingredients?

Finally, we have to think about the recovery and rehabilitation of those experiencing autism. We are not only talking about ABA therapy, O/T, P/T and S/T; we are also talking about addressing the other medical conditions that our kids have to deal with on a daily basis. Most kids are suffering from serious gastrointestinal issues, nutritional deficiencies as well as high levels of toxic agents due to their inability to naturally detoxify their bodies. Currently, conventional medicine does not offer many options to treat either the symptoms of autism or its underlying medical conditions. Many of us are turning to the DAN! Protocol (Defeat Autism Now). The Protocol approach is based on real hard sciences such as biochemistry and neurochemistry.

I really hope that this is the beginning of a long and a fructiferous dialogue. In the end, we all want what is best for our kids.

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 10:36 PM
To: IACC Services (NIH/NIMH); IACC (NIH/NIMH)
Subject: [Comment 00141] IACC RFI NOT-MH-08-021

RE: NOT–MH–08–021

Dear IACC members:

Thank you for the opportunity for stakeholders to provide input into this RFI process and Strategic Plan process. I am a dyslexic individual who is the parent of a spectrum individual.

Part of the IACC’s expressed Vision Statement is to “accelerate and inspire research that will profoundly improve the health and well being of every individual on the autism spectrum…” To even begin to address attempting this goal, you must begin the process within your own organization [NIH/NIMH]; in which case you must stop the damaging language (diaper–wearing; burdensome; robbed of personhood) you persist in using about autistic individuals. Director Tom Insel needs to publicly apologize for his several disparaging comments toward autistic citizens as he has set a tone that is damaging. Most specifically, Director Insel should apologize for the overall doltishness of the following comment: “[Autism] really robs a child and a family of the personhood of this child.” If the Director of the NIMH actually believes this about an entire group of oppressed individuals whom it is part of his job to help and protect, then he really needs to step down. [Note: Personhood reference: http://www.neurodiversity.com/autism_and_personhood.html ]

The IACC’s Mission Statement states that the purpose of the Strategic Plan is “to focus, coordinate, and accelerate high quality research…in partnership with stakeholders to answer the urgent questions and needs of individuals on the autism spectrum and their families.“ First, the actual stakeholders need to be appropriately determined. Because right now it seems, from someone who attended the Sacramento Town Hall meeting; at least one phone conference meeting and read every word on–line the IACC has released, that the deck has been stacked in favor of those PARENTS who have an ANTI–VACCINE BIAS and have been leading the IACC, the NIMH and Director Insel around by the nose. Please! These .ORGs have had their say. They have diverted time and money to the detriment of all autistic citizens. Is there ONE PERSON in the NIH/NIMH who can stand up to them? Is there ONE PERSON in the NIH/NIMH … within the IACC… who can tell these pseudo–scientific, faux–charity groups that they”ve had their time on the stage; they've have had their say; their voices have been heard by all the top government scientists, but NOW we – – as a public entity – – need to let other voices, voices of the actual oppressed, be heard. IS this possible? Or does the NIH/NIMH/IACC need to keep placating the scare-mongers? – –>Ref: "So many moms have said to me…” http://www.autismvox.com/pressure-to-study-chelation/ – &ndash – Yes, I realize that the chelation trial was [finally!] canceled. Does Director Insel realize that the ‘moms’ reporting to him were self–selecting? Only those that had little care that he classified those on the spectrum as missing their person hood, plus his being a near-apologist for Lyn Redwood and Co. would have contacted him in the first place.

Representation

Please include several members on the IACC committee and not those who are already entrenched within cure groups and anti-vaccine groups through which they receive their monetary livelihood (this would be all of whom you currently have if I’m recalling correctly). You must work to removed the bias, from which is your very foundation, that comes from those deep-pockets .orgs that have the backing of high-profile professional lobbyists such as a [redacted personally identifying information]. The politics already involved in the IACC have ground the scientific process to a near a halt as it is. It feels, to this taxpayer and citizen, that you all are being dictated to by the politicos. Again: At all times, it is vitally important to hold to the highest standards when speaking of and representing people on the autistic spectrum.

Vaccines

One of my most over–riding concerns with the IACC is their hyper–focus on vaccines and this committees near–allegiance to members of the anti–vaccine and vaccines=poisons mob. Please stop placating these groups, if this is your intent. You are harming science and potentially public health and perhaps the mental health some involved by persisting in perpetuating these damaging and long–lasting myths.

“Vaccine–Injured”

Please do not allow those who are identifying as “vaccine injured” to also identify as ASD and represent themselves as speaking “for the community”. They need to separate themselves out from the ASD community. This needs and must be a separate and distinct issue – – – – removed from the IACC and CAA. They do not speak for the majority but have had the PR and marketing resources (not to mention the lawyering resources) to make it appear that they do. Please do not let any one group use this term “autism community” – – most specifically these groups who are misrepresenting the science and trampling on the civil rights of others.

Human Rights

Please also be aware that there is great prejudice and bias within the mainstream medical community toward those on the autistic spectrum – – – with some health care providers treating ASD pts. with thinly–veiled contempt and giving a different – – – and much lower – – – standard of care. Bottom–line: Their lives are less valued by many scientists and clinicians. The IACC should immediately strive to change this. You will get no help from in those from those in the cure–at–all–cost camp or the anti–vaccine camp because they have fueled it. I‘m concerned that your “sense of urgency” as the “first core value” plays into this aspect of not valuing the lives of autistics as well. The IACC has still really been held hostage by a small group of highly-financed individuals with an extreme p.o.v. Please do not proceed based on information from parents – – – in varying stages of grief [some on the spectrum themselves who don't realize it]– – – – who have the wherewithal to form popular internet–dot–.orgs that have landed them in infamy.

Please, please stay grounded… in science, in human rights, in ethics, in compassion.

Respectfully submitted,

[redacted personally identifying information]
30 September 2008

Please read the Autism Hub !

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 11:20 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00142] NOT-MH-08-021 RFI

To the IACC members,

I am writing to urge the Committee to ground the direction and funding of autism research in basic neurobiological research and to avoid the undue influence of a small number of anti–vaccination proponents.

A vocal and well–funded minority of families who have autistic children believe that either vaccines in general or a specific component of vaccines caused their children to become autistic. This small group includes some very influential citizens and seeks to shift the future of autism research toward investigating the culprit they have predetermined (using research tools such as Google and parent support listserves) as the cause of autism in their families: vaccines and Thimerosal.

Given the dearth of scientific support for their idea, I urge the committee to keep its attention focused on basic neurobiological research empowered by the scientific process and performed by mainstream and skilled biologists and clinicians.

I am a parent of a young child on the autism spectrum and I know firsthand the lure of the quick and magical cure. I have also experienced the guilt and desperation that drives many of these anti–vaccination parents to look for an easy answer. But as a scientist who has dedicated years to the study of gene expression and neuroscience I also understand the power and importance of basic neurobiological research in dealing with disorders and conditions such as Autism.

The American taxpayer should not have to shoulder a financial burden to build evidence – however tenuous – to support an idea generated by lawyers and anti–vaccinationists.

Thank you for allowing me to provide input for this exciting and important effort.

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Wednesday, September 30, 2008 11:22 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00143] DISBELIEF!

To whom it may concern:

How can anyone justify injecting mercury into pregnant women and tiny infants?

You are a morally corrupt person if you continue to allow this practice.

There is absolutely no scientific or medical justification for injecting organic mercury into ANYONE!

Sincerely,

[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 11:48 PM
To: IACC (NIH/NIMH); Insel, Thomas (NIH/NIMH) [E]
Subject: [Comment 00144] NOT-MH-08-021
Attachments: SM 0908 IACC SP Public Comment.pdf; Recommendations for draft IACC SP changes 9-30-08.pdf

Please find attached our public comment with supporting documentation.

Regards,

[redacted personally identifying information]
SafeMinds, www.safeminds.org
[redacted personally identifying information]

The Coalition for SafeMinds is a private charitable nonprofit organization founded to investigate and raise awareness of the risks to infants and children of exposure to mercury from the environment and medical products, including thimerosal in vaccines. The Coalition of SafeMinds supports research on the potential harmful effects of mercury and thimerosal.


NOTICE: This message, and any attachments accompanying it, is confidential and intended for the named recipient(s) and may contain information that is (i) proprietary to the sender and/or (ii) privileged, confidential and/or otherwise exempt from disclosure under applicable [redacted personally identifying information] and Federal law. Parties, other than the intended recipient(s), are prohibited from disclosing, copying, or disseminating the contents or attachments. If you have received this email in error, please destroy this message and inform the sender immediately by telephone, fax or email.

NOT-MH-08-021

September 30, 2008

Dr. Thomas Insel, MD
Chairman, Interagency Autism Coordinating Committee
National Institute of Mental Health
6001 Executive Boulevard
Bethesda, MD 20892–9669

Re: Comments on Draft IACC Strategic Plan for Autism Research.

Dear Dr. Insel,

Safeminds submits the following comments urging significant changes to the draft strategic plan. The autism community worked with Congress to enact the Combating Autism Act (CAA) of 2006, P.L. 109–416. The CAA authorized $744 million over five years to expand and intensify autism basic and clinical research conducted by NIH to “investigate the cause (including possible environmental causes), diagnosis or rule out, early detection, prevention, services, supports, intervention, and treatment of autism spectrum disorder.” Congress directed the Interagency Autism Coordinating Committee to develop, submit, and annually update a comprehensive Strategic Plan (SP) with a budget for the conduct of this research.

Safeminds has worked within the severe constraints imposed on development of the draft SP to achieve the best possible plan responsive to the ASD crisis, the needs of the community for effective treatments, and the mandate from Congress. Safeminds submitted comments in response to the two RFI’s in January, submitted “gap” initiatives, participated in the Sacramento townhall meeting in May, attended all of the public meetings of the IACC and workgroups, submitted (through Ms. Redwood) edits to the July 1 preliminary draft, offered suggestions and critique of process issues, and generally served as a resource for education relating to the crucial research and process issues addressed in the draft plan.

In its present form, the draft is seriously deficient and is an inadequate response to a poorly specified crisis, to the needs of the community, and to the mandate from Congress. This is due in part to serious flaws in the process, violations of FACA, violations of the letter and spirit of CAA, and failure to fully utilize the resources of the community. It is our hope that these substantive deficiencies can be corrected in this round of public comment which might possibly render moot the procedural violations. Safeminds remains committed to work with IACC to achieve the best possible SP, one that is responsive to the tasks set by Congress and meets the needs of the community to harness the power of science and medicine to find the cause of autism, treat and support existing cases, and prevent the factors leading to new cases. Strong community support for the SP is essential for its success.

The community can enthusiastically support a SP that ensures progress toward Congressional goals with all deliberate speed. Therefore, the SP must be much more than an unprioritized listing of interesting research topics relating to autism (as was the “autism roadmap” developed in 2003). The SP must address at a minimum: (1) a mission statement incorporating the goals set by Congress; (2) specific goals; (3) analysis of past and present research, accomplishments, and gaps (including unfunded projects as a measure of demand); (4) a prioritized plan for present and future research initiatives that specifically includes a focus on environmental causes including vaccines; (5) changes to the funding process to reduce delay, rely on mechanisms such as special emphasis panels with defined budgets and research targets, and increase community participation in funding decisions; (6) transparency, accountability and performance metrics; (7) a justified research budget driven by scientific opportunity and demand; and (8) collaboration and partnerships with non-NIH public and private research funders. The SP must strategically justify necessary resources, prioritize research questions, and be accountable and transparent. The community must have an effective plan to take back to Congress to obtain the necessary appropriations. Accordingly, in addition to the above, the SP must address the following major issues:

The SP Must Clearly Express Strategic Doctrine.

The first task in developing the SP should have been development and IACC approval of strategic doctrine in response to the mandate from CAA. Instead, the process launched immediately into a lengthy list of research initiatives of a fairly general and obvious nature, unprioritized, and, in essence, a rehash of the 2004 autism roadmap. At a minimum, in order to be responsive to CAA and to the needs of the community, the SP must begin by clearly articulating the following doctrine: (1) autism is a national health emergency that requires a crisis–level response; (2) autism is a biological disorder triggered in genetically susceptible individuals by environmental factors; (3) new cases of autism can and should be prevented by identification and elimination of environmental causes; and (4) autism is treatable. Based on a recognition of these principles, the research emphasis must be placed on environmental etiology, biological mechanisms and disease process, and treatment.

  1. Autism Is a National Health Emergency Requiring a Crisis–Level Response.
  2. There has been an explosion in the rate of childhood autism and related disorders in the United States. Despite imperfect surveillance systems, less than ideal prospective evidence and a fragmentary base of prevalence surveys, there is no responsible way to interpret the reported rise in disease frequency as anything less than a true increase; an order of magnitude increase in childhood autism rates cannot be explained as a mere artifact of changes in diagnostic practices and greater awareness. No persuasive evidence supports the conclusion that increased autism rates are an artifact of increased awareness, and indeed, any hypotheses to that effect must not be given the benefit of the doubt and assumed as a default policy position but rather require high levels of proof before they can be considered as serious claims. Instead, precaution requires that, in light of these alarming increases, autism be considered a national and global health emergency requiring significant resources, diligent investigation of its increasing frequency and aggressive management. This dramatic rise in prevalence imposes huge and growing direct and indirect costs on society as a whole and on affected families in particular. Ganz (2006) estimated the lifetime cost of care for an individual with autism at $3.2 million and the annual cost to society at $35 billion.

    Strategic goal: prevent new cases of autism and reduce the rate of autism in cohorts of newborn children by over 90%.

  3. Autism is a Biologic Disorder With a Primary Environmental Etiology.
  4. Historically, the leading priority for autism research funded by NIH has been placed on research into inherited genetic risk factors. Although there are many reasons for this, the weight of the evidence suggests that these investments have not yielded results that will provide the kind of urgent breakthroughs required to respond to this health crisis. The increased concordance of autism in monozygotic (identical) twins compared to dizygotic (fraternal) twins has been used to argue for the importance of inherited genetic factors in autism but these findings are based on old studies that examined birth cohorts born before the rapid increases in autism rates. In addition, large investments in full genome scans for autism (most recently the largest genome scan ever conducted, the Autism Genome Project Consortium) have failed to yield reproducible results that support the role for inheritance in any region of the genome. While investigation of inherited factors in autism has contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore does not deserve the funding priority it has heretofore received.

    Strategic goal: conduct research in areas likely to provide benefits to living children and adults.

  5. New Cases of Autism Should Be Prevented By Identifying Environmental Etiology
  6. There is a clear need for a high priority on investigating environmental factors in light of the increases in autism rates. These increases also help explain why there has been so little success in the search for heritable risk factors. We need to take on a more innovative view of the interactions between genes and the environment in order to make research on both genes and the environment more productive. Meaningful exposures can occur from prenatal period through infancy and the changes in the brain are most notable after infancy. Some are born autistic but many develop normally as infants and then regress. In light of the increases and the observations we see in children, it’s important to leave no stone unturned in the investigation of environmental exposures.

    An environmental factor or combination of factors contributes to disease causality. These factors can interact with susceptibility genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre- or post-natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention. This research should include continued investigation of controversial environmental exposures such as childhood vaccines, vaccine preservative and environmental mercury exposures, as well as other environmental toxins such as organophosphates and pyrethrins. We need to consider the best ways to inform epidemiology with toxicology, while also developing the disciplines of predictive toxicology, in order to get answers rapidly.

    The CAA required NIH to “expand, intensify, and coordinate” basic and clinical research to investigate “cause (including possible environmental causes), diagnosis or rule out, early detection, prevention, services, supports, intervention, and treatment of autism spectrum disorder.” 42 U.S.C. 284g. Prevention is an attractive goal in terms of the direct and indirect cost of autism and the burden it imposes on individuals, families and society as a whole. The sharp rise in autism rates can only be fully explained by environmental factor causality (interacting with genetic susceptibility), these environmental triggers can be identified and eliminated, thereby preventing disease spread and potentially ameliorating the condition in existing cases.

    Although NIMH Director Insel stated to Congress[1] that prevention is a goal of NIH autism research, a glaring absence from both the draft mission[2] and vision[3] statements presented by Dr. Insel at IMFAR is an express commitment to “prevention.” This absence reflects the irremediable failure of NIMH to develop an acceptable SP and demonstrates a fundamental need to overhaul the SP exercise. Any acceptable SP must come to grips with the fundamental nature of this disorder. As you clearly articulated during the first IACC meeting on November 30, autism is both preventable and treatable. The SP must incorporate this vision.

    Strategic goal: identify preventable causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases.

  7. Recovery of Function is Possible With Effective Treatment.
  8. There is no “cure” for autism. We cannot turn back the clock to reclaim the time lost to developmental injury. We also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts. Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism.

    Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function. Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, significant improvement in function is likely. Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation).

    Strategic goal: expand therapy and treatment options for all individuals with autism and identify the most effective intervention modalities and regimens in current use.

Comments on Specific Research Questions.

  1. WHEN SHOULD I BE CONCERNED?:
    Regression is only offered as an afterthought and the growth in autism prevalence “explained” as an improvement in diagnosis. Regression is a reality that must be recognized and used in the development of sensitive screening tools to detect subtle development differences to better support epidemiology and risk factor studies. Additionally, inclusion of data from the CDC 2007 surveillance study confirming that existing screening tools are not adequately used by pediatricians at “well baby” check–ups, as recommended by the American Academy of Pediatrics, in effectively screening and subsequently diagnosing children would more accurately describe screening issues to date. Use of these well care screenings with development and use of measurable biomarkers will allow families earlier access to early intervention by 24 months for improved long–term outcomes.
  2. HOW CAN I UNDERSTAND WHAT IS HAPPENING?:
    Use of existing scientific data on medical conditions, such as motor and sensory problems, seizures, metabolic abnormalities, gastrointestinal pathology, mitochondrial dysfunction, inflammation and cognitive disabilities that accompany ASD is nonexistent the this plan (Valicenti–McDermott, Pardo, et al, 2005). Recognition of inquiries underway, such as those by Autism Treatment network (ATN) documenting medical features in 15 academic centers, and need for understanding early medical trajectories are necessary, as well as comparison of ASD individuals to their typical counterparts, to better assess physical and developmental differences to improve outcomes. Also absent in is the need for analyses of genetic interaction with environmental exposures. Multi-disciplinary, longitudinal, biobehavioral studies of children, beginning in infancy, characterizing neurodevelopmental and medical trajectories of development across the multiple axes of ASD phenotypes are necessary in order to identify ASD risk factors, subgroups, and potential biological targets for intervention. Children must be intensively studied during the process of development of the disorder and during phases of regressions in order to fully understand the precise developmental and biological mechanism of this disorder. Such intensive study will include some in–patient time, multiple and repeated neurological, biological, and imaging studies, and the repeated collection of biological and tissue samples.
  3. WHAT CAUSED THIS TO HAPPEN AND CAN THIS BE PREVENTED?:
    The draft is biased toward prenatal onset and should recognize the likelihood of multiple trajectories in autism, including postnatal onset, regression and postnatal influences. Detection should extend to a continuum of time points, and trajectory research should include an understanding of the biology underlying disease/symptom onset.
  4. Historically, the leading priority for autism research funded by NIH has been placed on genetic research, which has yielded no reproducible results, while other research has identified a cause in “rare cases” and there is a growing body of anecdotal evidence of recovery. “Rare” and anecdotal evidence of recovery are not leveraged in this plan, or use these cases as a starting point for new research initiatives. Due to this lower priority, research on environmental risk factors is less well developed. Wording should be revised to recognize the innovative and novel approaches currently in place, or being developed by the field. The current wording suggests that cutting edge developments are only occurring in the area of genetics.

    The most frequently cited environmental toxin is mercury. Numerous studies that indicate a potential role for mercury exposure in autism (Palmer et al, 2006 and 2008, Windham et al, 2006, DeSoto & Hitlan 2008, Holmes et al, 2003, Austin, 2008, Young, 2008), a finding that receives support in animal studies as well (Hornig et al, 2004, Laurente et al 2007). The draft must specifically include vaccine research as this is the only specific research topic addressed in the legislative history of the CAA and the intent of Congress. The document should reference the known shortfalls of the epidemiological studies commonly cited to rule out vaccines in autism and state that the issue is open.

    Environmental research in ASD must build on the substantial pre–existing environmental research infrastructure and informatics, as risk factors are likely to be pertinent to both brain development and chronic systemic features, such as inflammation and oxidative stress (James 2004), in subgroups of ASD.

  5. WHICH TREATMENTS AND INTERVENTIONS WILL HELP?:
    This section must encompass accumulating evidence suggesting that the breadth of this disorder extends well beyond the behavioral diagnosis with multiple systemic issues influencing vulnerability, onset and severity of symptoms and behaviors. Care models like those of the ATN support the possibility that both the core behaviors and medical issues have a convergent mechanistic basis that, if identified, could provide new insights into treatment targets, candidate genes, and strategies for prevention. Large–scale multidisciplinary RCTs to develop and test the efficacy of comprehensive interventions will identify which elements are most effective in reducing or ameliorating symptoms for which children and should be fast tracked to facilitate translational treatment research.
  6. Obstacles to conducting treatment research, such as the review process, need to be addressed. An increase in improved research designs are needed that consider subgroups of responders versus the aggregate treatment response with recognition that treatment response can inform phenotype studies. Shared treatment databases will move the field forward.

Critical Flaws in the Planning Process.

Without major revision, anything approved by IACC may be subject to legal challenge and a restart of the process. Some of the more serious flaws in the development of the SP include: appointment of Joyce Chung, wife of legendary epidemic–denier Roy Grinker, as head of the Autism Team; members of science workshops and workgroups were not appointed by IACC, the IACC community members were prohibited from collaborating outside formal meetings; secret email voting and discussions; “public” comments not made public; refusal to provide background information necessary to formulate the plan; community input was ignored; selection of workshop and workgroup members with disqualifying bias and lack of diversity; abrogation of IACC’s obligation to make key decisions to an internal bureaucracy; and “community” participation in making crucial decisions regarding funding priorities and specific initiatives was limited to organizations and interests that privately fund autism research (especially relating to genetics). Genetics was over–represented while several relevant fields were underrepresented at the science workshops, including immunology, virology, gastroenterology, toxicology, and clinical care. The second workgroup was arbitrarily terminated although it stated its desire to complete and extend its work. “Gap” initiatives were submitted but not circulated to the full IACC for review and basically ignored by the Autism Team. In particular, there was a systematic effort to exclude vaccine-specific research despite repeated public comment and community support that such research was absolutely necessary.

The inclusion of the broader autism community during this process has been severely limited, with consensus from town meetings regarding mercury and vaccines ignored and absent in research objectives. Individuals with autism, their families, their teachers and their caregivers have insights and perspectives needed to inform research design and evaluation and must be integral to this process. Dismissive wording when referring to parent observations should be removed. The final draft of the SP should include an analysis of the cost of disease, recognize the serious increase in prevalence, and calculate the social ROI for the SP initiatives.

The Research Budget Must Be Significantly Increased to Respond to Both Crisis and Opportunity.

CAA tasked IACC to “develop and annually update a strategic plan for the conduct of, and support for, autism spectrum disorder research, including proposed budgetary requirements, and submit to the Congress such strategic plan and any updates to such plan.” 42 U.S.C. 280i–2(b)(5), (6). The Senate HELP Committee report (S. Rep. No. 109–318, emphasis added) was quite specific[4] in the reason for and expected contents of this autism research budget: “To increase the accountability and focus on autism spectrum disorder at the National Institutes of Health (NIH), the committee specifically authorizes a strategic plan related to autism spectrum disorder. In requiring the Director of the NIH to develop a strategic plan for autism spectrum disorder, the committee wants to ensure that this plan provides not only an outline of key research activities and questions but also ties those activities to specific budgetary outlays to improve the transparency of the planning process… In reporting on the expected spending and providing an analysis of what was previously expended, the committee strongly encourages the director to provide such dollar amounts using clear and consistent methods for determining the monetary allocation.”

Despite this clear requirement,[5] the NIMH has repeatedly claimed “there is no new money” and forbidden both the science panels and workgroups from addressing budget requirements. The July 1 draft contained no budget information. Ultimately, the third workgroup proposed budgets for each of the 35 initiatives but these figures were fairly arbitrary and not the product of rigorous analysis, especially given the general nature of many of the initiatives. Arbitrary limits were placed on the number of studies undertaken under each of the initiatives by the workshop chairs and/or the Autism Team. These limitations are severe in light of the crisis of autism and the opportunity to perform good science.

The draft budget released after the September 9th meeting of the third workgroup is woefully inadequate as a response to the challenges and opportunities of the autism epidemic. Although initially reluctant, the Autism Team eventually accepted the requirement in the CAA that it provide a research budget as part of the SP. How much should be spent on autism research? The answer is simple: as much money as is needed to effectively treat existing cases and prevent new ones. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. This is the same general analysis used to “justify” each new vaccine in terms of the “benefits” of preventing an infectious disease and must be similarly used in the creation of a plan addressing the autism crisis. The budget must also consider the demand from the scientific community for funding for autism–related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money. This information was requested but never provided to IACC.

For example, and to illustrate the inadequacy of the funding, five projects relating to environmental cause are proposed for the next five years at a funding level of $24 million. Why limit these studies to only five, none of which specifically mentions vaccines? The plan should propose as many as are needed to identify the pre-natal and post-natal exposures thattriggerASD without arbitrary limits. The budget proposes a handful of treatment studies and clinical trials over five years and in doing so falls far short of studying the effectiveness of the dozens of behavioral and medical interventions currently used by parents. It’s difficult to have confidence in NIH’s treatment research agenda in light of the recent cancellation of a clinicaltrialon the books for two years and then dropped for safety reasons. The fact that thousands of parents are using various forms of chelation with success more than justifies rigorous study of this intervention, particularly if there are legitimate safety concerns.

Notwithstanding the above comments on the need for a significantly increased research budget for ASD with a comprehensive justification, Safeminds has proposed modifications to the research budget within its current format and constraints (reserving our objections) for the guidance of IACC in achieving the best possible allocation of available resources. These budget recommendations and suggested changes in the initiatives are set forth in the accompanying spreadsheet.

The SP Must Specifically Research Vaccines as a Potential Cause of Autism:

The CAA specifically listed 13 scientific fields that should be included in the research plan: pathology, developmental neurobiology, genetics, epigenetics, pharmacology, nutrition, immunology, neuroimmunology, neurobehavioral development, endocrinology, gastroenterology, and toxicology. Both House6 and Senate[7] legislative history singled out a single research opportunity, vaccines, transcending many of these fields. Considerable public input (from the January request for written comments, following the IACC March 14 request to fill any “gaps,” and the May 3 town hall meeting in Sacramento) insisted that the research agenda must include vaccines. However, none of the 41 (revised down to 35) broad initiatives under consideration even mentions this topic.

The SP must not be ruled by implicit censorship or fear,8 but by a sincere commitment to use science to uncover the truth about vaccines and autism. The need for vaccine–autism research is particularly urgent, especially a comprehensive retrospective and prospective comparison of the health outcomes of vaccinated versus unvaccinated children. The present vaccine schedule must be regarded as experimental because its safety with respect to chronic disease has never been validated by a customary double-blinded randomized clinical trial in either an animal or human population. CDC’s comment at the July 15 IACC meeting that the science is all “done” and there is no connection between vaccines and autism is disingenuous, as the safety research has never been done, and there is no follow up for safety beyond 3–6 week is in existing “safety” studies. Whether the burden of chronic vaccine-caused disease, including autism, exceeds the benefits of preventable infectious disease is simply unknown. Dr. Insel’s comment that a separate section on vaccine research in the plan would call too much attention to the issue is compelling evidence that vaccine research will not be done under the general rubric of “environmental” research unless it has a specific set of research initiatives.

Mounting evidence from animal models, especially results presented at the preeminent autism scientific conference IMFAR in May, suggests the expanded schedule is unsafe. That pilot study showed significant neurological impairments and bowel disease in vaccinated macaques versus unvaccinated controls. Even the Institute of Medicine has left open the possibility that vaccines could cause autism in a genetically susceptible population.9 The lead author of the only US epidemiological study relied upon by IOM published a retraction10 of any “no causation“ inference, and called for further research. In addition to the studies cited in the “gap” initiative for vaccine–specific research submitted in March, recent studies (Austin, 2008, Young, 2008) continue to point to a growing consensus that vaccines play a role in the etiology of autism.

The SP Must Include Specific Opportunities for Public Participation.

There must be community involvement in decisions relating to both scientific merit and programmatic relevance, a model used very successfully (encouraged and ratified by the IOM) for the newly–funded Congressionally Directed Medical Research Program for Autism.[11] Adherence to the six “values” adopted by IACC (Sense of Urgency, Spirit of Collaboration, Consumer–focused, Scientific Excellence, Partnerships in Action, and Accountability) requires significant community participation at each stage of funding decisions as well as structural reform to ensure that the “scientific excellence” will actually achieve measurable benefits in finding the cause, prevention, treatment, services, and supports for autism.

The SP Should Re–Engineer the Funding Process to Ensure Transparency and Accountability.

The CAA specifically directed IACC to “make recommendations to the Secretary regarding public participation in decisions relating to autism spectrum disorder.” 42 U.S.C. 280i-2(b)(4). Funding must be re–prioritized to place greater emphasis on environmental factors as potential causes and modifiers and on treatments. IACC's review of progress in achieving the goals of the autism roadmap concluded that these areas in particular had been underfunded. Greater reliance must be placed on RFA's (with specific monetary allocations)[12] with review by special emphasis panels (as opposed to the more generalized study section review of R01 grants)[13] to ensure that crucial scientific questions of greatest urgency and impact are matched with the funding and talent to get answers as quickly as possible.

The SP Should Include the Establishment of an Autism Advisory Board.

The SP should establish an Autism Advisory Board composed of scientists, clinicians, and advocates. This would not in any way duplicate the work of the IACC, which is broadly concerned with coordinating all federal activities relating to autism, including critical activities related to services. Rather the AAB would be concerned with the narrower scientific research agenda and the ongoing CAA mandate to annually measure performance of and update the SP. Both the House[14] and the Senate[15] recognized the usefulness of an AAB in the legislative history for the IACC. The experience of convening scientific workshops and two different workgroups this spring highlights the need for an ongoing body that brings together these three crucial sources of advice.

In closing, considering the numerous deficits within the plan, as well as the process, expressed herein, we request that a meeting of the IACC be convened in October to address these issues. We feel strongly that this additional meeting of the IACC is justified, as it would be impossible for these concerns to be adequately addressed at the IACC’s regularly scheduled meeting in November.

Sincerely,

[redacted personally identifying information]

[1] Statement of Thomas B. Insel, M.D., Autism Research at the National Institutes of Health, Before the Appropriations Subcommittee on Labor, Health, and Human Services, Education, and Related Agencies, United States Senate at 7 (April 17, 2007) (“Ultimately, our goal is prevention, based on early detection of risk, understanding environmental factors that increase or decrease symptoms, and development of effective interventions before behavioral and cognitive deficits appear.”)

[2] Draft Mission Statement: “The purpose of the Strategic Plan is to focus, coordinate, and accelerate high quality research and scientific discovery in partnership with stakeholders to answer the urgent questions and needs of individuals on the autism spectrum and their families.”

[3] Draft Vision Statement: “The Strategic Plan will accelerate and inspire research that will profoundly improve the health and well being of every individual on the autism spectrum across the lifespan. The plan will set the standard for public-private coordination and community engagement.”

[4] Rather than simply a listing of interesting studies, Congress required rigorous analysis of past achievements and future priorities in the SP: “Further, in crafting the specific strategic plan, the committee encourages the director to:

  • Determine and establish priorities among critical scientific questions related to autism spectrum disorder;
  • Specify the short and long–range objectives to be achieved, and estimate the resources needed to achieve these objectives;
  • Evaluate the sufficiency of existing research programs on autism spectrum disorder to meet the specified objectives and establish objectives, timelines, and criteria for evaluating future research programs; and
  • Make recommendations for changes to existing research programs on autism spectrum disorder, including potential consolidation of research activities if such consolidation would improve program efficiencies and outcomes.” S. Rep. 109-318 at 13.

[5] In doubling the President’s budget proposal for FY09 autism spending, Senator Dodd explained:

“It continues to be a challenge to determine how much Federal funding is actually going to study the causes of and treatments for autism. In fact, some estimates are that actual NIH funding for research specific to autism is less than half of what is being reported. That is why this amendment is so critical. It will redouble our Federal commitment to funding autism, the fastest–growing developmental disability in the U.S. At a time when the number of children and families living with autism has grown exponentially, the President’s budget proposes to freeze Federal spending on autism at levels that are insufficient to make the kind of discoveries in autism that are needed… There are so many unanswered questions about autism. And it will require a major scale–up in funding to bring us closer to answering them. We should close no doors on promising avenues of research into the causes of autism and my amendment allows all biomedical research opportunities on autism to be pursued. The amendment I am offering would enable us to redouble our efforts on autism research and treatment services by increasing funding for research, treatments, education and interventions by $197 million in fiscal year 2009 and I urge my colleagues to support the amendment. Again, I emphasize it is the fastest growing developmental disability in our country. The number of children who will be born with autism is increasing every day in this country.” 154 Cong. Rec. S1971 (March 12, 2008).

[6] House Chairman Barton added:

“With respect to possible environmental or external causes of autism, some have suggested a link exists between autism and childhood vaccines… I recognize that there is much that we do not know about the biological pathways and origins of this disorder, and that further investigation into all possible causes of autism is needed. This legislation is not designed to predetermine the outcome of scientific research. Rather, the legislation rightfully calls for renewed efforts to study all possible causes of autism–including vaccines and other environmental causes. Simply put, we should leave no stone unturned in our efforts to find a cure, whether it means exploring possible environmental factors, paternal age, genetic factors, or any other factors that may hold answers.” 152 Cong. Rec. H8787 (December 6, 2006).

[7] Senate HELP Committee Chairman Enzi explained that the CAA research mandate as:

“the bill reported by the HELP Committee contemplates key research activities, including environmental research, that focus on a broad range of potential contributing factors, with meaningful public involvement and advice in setting the research agenda. However, I want to be clear that, for the purposes of biomedical research, no research avenue should be eliminated, including biomedical research examining potential links between vaccines, vaccine components, and autism spectrum disorder… No stone should remain unturned in trying to learn more about this baffling disorder, especially given how little we know.” 152 Cong. Rec. S8772 (Aug. 6, 2006).

[8] Former NIH Director Bernadine Healy explained in a May 12 CBS News interview:

“I think that the public health officials have been too quick to dismiss the hypothesis as irrational… There is a completely expressed concern that they don't want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. First of all, I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show…. What we’re seeing in the bulk of the population: vaccines are safe. But there may be this susceptible group. The fact that there is concern, that you don’t want to know that susceptible group is a real disappointment to me. If you know that susceptible group, you can save those children. If you turn your back on the notion that there is a susceptible group… what can I say?”

[9] Determining causality with population-based methods such as epidemiological analyses requires either a well–defined at–risk population or a large effect in the general population. Absent biomarkers, well–defined risk factors, or large effect sizes, the committee cannot rule out, based on the epidemiological evidence, the possibility that vaccines contribute to autism in some small subset or very unusual circumstances. However, there is currently no evidence to support this hypothesis either.” IOM, Vaccines and Autism at 11 (2004).

[10] “The article does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come… A neutral study carries a very distinct message: the investigators could neither confirm nor exclude an association, and therefore more study is required… The bottom line is and has always been the same: an association between thimerosal and neurological outcomes could neither be confirmed nor refuted, and therefore, more study is required.” Pediatrics, 2004;113;932.

[11] http://cdmrp.army.mil/arp/default.htm. The CDMRP includes consumer input at the beginning of the annual planning cycle and during both levels of proposal review, scientific merit and program relevance, explaining: “Consumer advocates participate in setting CDMRP priorities and making funding decisions. Consumer advocates’ firsthand and personal experiences with a disease provide a unique perspective that complements scientific expertise during proposal review. The Consumer perspective increases awareness of the human side of research and how it impacts survivors. Funding decisions incorporate the concerns and needs of patients, treating clinicians, and survivors, their families, and communities. Conversely, scientists impart a new understanding of the research community to the Consumers on the review panels. The mutually beneficial partnership between Consumers and scientists is a valuable aspect of the peer and programmatic review process at the CDMRP. Through 2007, Consumers have participated in more than 1,700 peer review opportunities.” Strong consumer participation was recommended by the Institute of Medicine and reviewed with approval. See IOM, Strategies for Managing the Breast Cancer Research Program: A Report to the U.S. Army Medical Research and Development Command, National Academy Press, 1993; IOM, A Review of the Department of Defense’s Program for Breast Cancer Research, National Academy Press, 1997, McCaughan, S., The DOD Congressionally Directed Medical Research Program: Innovation in the Federal Funding of Biomedical Research, Clinical Cancer Research, 8:957-62 (April, 2001).

[12] Most recently used by CDC on June 12 to award 2008-R-VAC01, Associations of Vaccine Adverse Events and Human Genetic Variations, 2008-R-VAC01. NIH announced Research to Advance Vaccine Safety (PA-08-256) [http://grants.nih.gov/grants/guide/pa-files/PA-08-256.html].

[13] http://cdmrp.army.mil/arp/default.htm. The CDMRP includes consumer input at the beginning of the annual planning cycle and during both levels of proposal review, scientific merit and program relevance, explaining:

“Consumer advocates participate in setting CDMRP priorities and making funding decisions. Consumer advocates’ firsthand and personal experiences with a disease provide a unique perspective that complements scientific expertise during proposal review. The Consumer perspective increases awareness of the human side of research and how it impacts survivors. Funding decisions incorporate the concerns and needs of patients, treating clinicians, and survivors, their families, and communities. Conversely, scientists impart a new understanding of the research community to the Consumers on the review panels. The mutually beneficial partnership between Consumers and scientists is a valuable aspect of the peer and programmatic review process at the CDMRP. Through 2007, Consumers have participated in more than 1,700 peer review opportunities.” Strong consumer participation was recommended by the Institute of Medicine and reviewed with approval. See IOM, Strategies for Managing the Breast Cancer Research Program: A Report to the U.S. Army Medical Research and Development Command, National Academy Press, 1993; IOM, A Review of the Department of Defense’s Program for Breast Cancer Research, National Academy Press, 1997, McCaughan, S., The DOD Congressionally Directed Medical Research Program: Innovation in the Federal Funding of Biomedical Research, Clinical Cancer Research, 8:957-62 (April, 2001).

[14] Chairman Barton explained:

“The IACC has been tasked with making recommendations to the Secretary regarding the public participation in decisions relating to autism. For instance, the committee notes that the IACC may recommend providing other formal mechanisms, such as an Autism Advisory Board, to provide public feedback and interaction. Further, the Secretary may opt to provide such a mechanism under existing statutory authority, without the recommendation of the IACC. Public participation, especially among the parents and families of those affected by autism, is necessary to emphasize the human side of autism research and to ensure that Federal resources are used wisely. 152 Cong. Rec. H8787 (December 6, 2006).”

[15] “The committee further re-examined the Interagency Autism Coordinating Committee (IACC). In particular, the committee wanted to increase the amount of public participation (from two individuals) to at least six. In addition, the IACC has been tasked to make recommendations to the Secretary regarding the public participation in decisions relating to autism spectrum disorder. For instance, the committee notes that the IACC may recommend providing other, additional, formal mechanisms, such as an Autism Advisory Board, to provide additional public feedback and interaction. Further, the Secretary may opt to provide such a mechanism without the recommendation of the IACC.” S. Rep. 109–318 at 17.

SafeMinds Summary Comments on the Draft IACC Strategic Plan September 30, 2008 (PDF file, 8 pages)

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 7:57 PM
To: NIMH IACCPublicInquiries (NIH/NIMH)
Subject: [Comment 00145] NOT-MH-08-021

[redacted personally identifying information]

Dear IACC Committee,

I am a [redacted personally identifying information] citizen who would like to comment on your strategic plan. I am the parent of a young man with Aspergers Syndrome. I teach children with severe learning difficulties (IQ< 55) many of whom are autistic. I write and lecture on autism. I am writing to you as an individual and not as a representative of any organization. But I am a member of the National Autistic Society and have been [redacted personally identifying information] for the last six years. This experience has shaped my perceptions about autism. I have had the privilege to work alongside people whose experience of autism and attitudes to it vary greatly. Nevertheless we have all been able to work together because our priority is not to debate our differences but to seek ways to work together to make a difference in the lives of autistic people and their families.

I recently attended the NAS International Conference on Autism: Research into Practice. Many eminent figures spoke: Sir Michael Rutter, Simon Baron-Cohen, Rita Jordan etc. But the highlight for me was a workshop addresed by four [redacted personally identifying information] members of the NAS Council: Virginia Bovell, John Dickinson, Josh Muggleton and Steve McGuinness.

[redacted personally identifying information] is the [redacted personally identifying information] of a severely affected child who attends a specialist school based on the principles of ABA. [redacted personally identifying information] spoke honestly about the pressures that autism places upon the whole family, a theme reiterated by [redacted personally identifying information] fellow speakers. [redacted personally identifying information] also discussed the symptoms that are sometimes disregarded by clincians as behavioural manifestations of autism rather than being diagnostic of additional medical conditions and paid tribute to the doctors at the [redacted personally identifying information] who saw past [redacted personally identifying information] son’s autism to treat his gastro-intestinal disorder.

[redacted personally identifying information] spoke about the problems that exist even when the child is high functioning. In [redacted personally identifying information] daughter’s case late diagnosis in early adulthood meant that opportunities to do the right thing had been missed. As an aging parent, [redacted personally identifying information] shared [redacted personally identifying information] concerns for [redacted personally identifying information] daughter’s future after [redacted personally identifying information] death and how this affected her neurotypical siblings.

[redacted personally identifying information], who has Aspergers Syndrome, was also concerned that the needs of siblings should not be neglected. [redacted personally identifying information] knew that autism made life difficult for those around him. [redacted personally identifying information] also knew that other people’s attitudes to autism were also a problem. [redacted personally identifying information] was bullied “because” he was autistic. Or was he? When siblings and parents are bullied is that because of autism or because there is something wrong with the bullies? It need not be overt bullying. Social isolation affects the whole family.

[redacted personally identifying information], who is autistic and the parent of an autistic child, suggested that people with autism are more tolerant of non-autistic people than we are of them. Barriers to inclusion are erected by non–autistic people who lack knowledge and understanding of autism. Autistic people spend their whole lives trying to understand and adapt to societal norms. When they succeed they are given no credit. But when they stumble they are condemned. The media is quick to promote negative images of autism, whether it is the imputed financial burden on the state or the invocation of autism as a reason whenever an autistic person appears in court. Neurotypicality is never invoked as an explanation of criminal behaviour, even though most criminals are neurotypical and not autistic.

I offer this experience, not as a direct commentary upon your plan, but as an alternative perspective to the sustained campaign to influence public opinion and the allocation of research dollars that I have observed in the United States. This campaign is informed by the view that Autism is a public health disaster of unprecedented dimensions that is destroying families and crippling the economy. Moreover, the advocates for this viewpoint make wild accusations against the public health agencies of the US government and the pharmaceutical companies involved in vaccine manufacture, while promoting theories and remedies for autism that have no scientific credibility. This campaign also has an international dimension. Bad Science coming out of self appointed autism advocacy groups in the USA is spreading to Europe and Asia.

As a foreigner I would not presume to specify the details of your national strategic plan for autism. But I would ask you to consider the international dimensions of your work. It would help me greatly if the message from the USA was evidence based and had no truck at all with those who advocate that autism is toxic damage to children that is reversable by dubious alternative therapies. I would like you to take account of the social model of disability and ask whether changes to society were likely to be as effective as trying to change autistic people. By analogy, what is more cost effective: pouring billions into teaching wheelchair users to walk or providing ramps and other forms of disabled access?

Please, do not be panicked or pressured into dubious research initiatives like the recently cancelled chelation study. Talk to autistic adults. Talk to parents. Talk about real sustainable changes to health and education and welfare systems that will deliver qualitative improvements in the lives of autistic people and their families now. Devoting research effort to evaluating effective practical support for families will do so much to ease the burden and enable a fresh dialogue free of mistrust and the destructive adversarial aspects of the “autism wars” currently being played out in the vaccine court, the media and elsewhere in society. – –
[redacted personally identifying information]

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 10:15 AM
To: IACC (NIH/NIMH)
Cc: [redacted personally identifying information]
Subject: [Comment 00146] RFIs: NOT-MH-08-016, NOT-MH-08-021 - AHCA CorrFlow 220958

<<RFI NOT_MH-08-016.docx>>   <<RFI Request NOT-MH-08-021.docx>>

[redacted personally identifying information]
Bureau of Medicaid Services
Agency for Health Care Administration
[redacted personally identifying information]

To: iaccservices@mail.nih.gov
From: [redacted personally identifying information],
Medicaid Services The Agency for Healthcare Administration, State of Florida
Re: Request For Information, 1 of 2, on behalf of the Interagency Autism Coordinating Committee, from The National Institute of Mental Health
Date: 09/08/08
Subject Line: Request Reference Number: NOT–MH–08–021

REQUEST: The IACC requests comments on the draft Strategic Plan for ASD Research (attached). IACC Requests that comments be organized by section of the draft as delineated below.

RESPONSE: AHCA Comments in italics, in bold type and in blue ink

Introductory Material:

  • Vision Statement
  • AHCA: possibly include indication of timeframe for when the Strategic Plan will be accomplished (i.e.: by the end of the decade)

  • Mission Statement
  • AHCA: Is it measurable? (i.e.: in what format or time frame will questions be answered)

  • Core Values
  • AHCA: Might include a component on how we could teach or train other individuals and organizations how to pass on and continue to enhance this plan for action.

  • Crosscutting Themes
  • AHCA: could state that these are “designed to promote an improved quality of life” for those having these disorders

  • Earlier Detection
  • AHCA: Section on Biomarkers – add that another possible result of biomarkers could be in the development of better drugs for the population with autism. Metabonomics (which is a cutting edge technology that examines patterns of metabolites in bio–fluids) could be used to identify features in urine that are distinctive for individuals with autism. If identified, these characteristic urine profiles may potentially be used as biomarkers to confirm an autism diagnosis and to subtype different groups of children with autism, thereby offering indications for treatment opportunities.

When Should I be Concerned?

Define existing tools currently used as diagnostic instruments.

AHCA: Obtaining an accurate diagnosis is of significant concern for the State of Florida. The process of developing an ASD diagnosis is not an exact science and cannot be measured by a physical test. It is currently diagnosed on a specified number of characteristics listed in the DSM–IV in ranges inappropriate for the child’s age. It is difficult to evaluate these characteristics on a child that is still developing and it is particularly challenging to determine an accurate diagnosis on a child in the less severe end of the autism spectrum. Diagnosis is based on a combination of parent interviews, non–medical tests, observation, and professional judgment. Some specialists in autism recommend a multi–disciplinary evaluation that can involve an overtime observation of a child interacting and functioning in a variety of situations. It is essential to assure verification and streamline diagnosis by qualified professionals in order to limit over–diagnosis. Over–diagnosis could overwhelm our sizable state programs which already have stretched resources.

  • Should the diagnosis be made by only a multi–disciplinary team or a specialist with a specified amount of training and/or ASD experience; OR should we allow only primary care physicians to make the diagnosis?

How Can I understand what is Happening?

Early developmental trajectories

AHCA: Will children being researched also receive intervention and therapy?

Support at least 4 research project, large scale, multi–disciplinary, collaborative project?

AHCA: Although the draft strategic plan does not include cost estimates for implementation, cost of large projects such as this must be factored into the process to determine if these large scale interventions are feasible

What Caused This to Happen and Can This be Prevented?

Funding for multi–site studies including pregnant women and what is involved in identifying genetic risk factors for 50% of children by 2014?

AHCA: Are numbers of children estimated as having ASD being accurately portrayed? If so, is the budgetary workgroup accurately considering these numbers for funding estimates? Is this realistic?

Which Treatments and Interventions will help?

Associated Symptoms
Behavioral Interventions
Medications
Nutrition
Sleep studies
Research opportunities
Trial studies

Where Can I Turn for Services?

What types of services should I seek and where can I find them?

AHCA: What about service packages, providers and rates? Behavioral services are particularly challenging as there is a lack of diagnostic and behavioral intervention services available for children with ASD.

Qualifications for providers should be streamlined and verified. Should we use current developmental disabilities professional provider qualifications or should an ASD specialty be sought (board certification, i.e. – Certified Behavioral Analyst)? Could we consider using current qualifications in effect for private insurance currently in state statute?

What is my state or local government doing to provide services?

AHCA: Would funding come from state plan amendments or Medicaid waivers? If so, which would be the overseeing and administering agencies? Agencies with experience should handle and oversee, but each agency would require additional staff resources to deal with the workload of administering and overseeing a new program.

Prevalence in geographic areas, specific communities:

AHCA:

  • If Medicaid waiver is used for funding, may need to limit the geographic area
  • Population estimates should be forecasted based on widely used 1/150 prevalence rate
  • Cost effectiveness:

    AHCA:

  • If Medicaid waiver is used for funding may need to limit the numbers served based on funding/resources
  • If Medicaid waiver is used for funding, must enroll only those who meet an Institutional Care Facility level of care
  • If Medicaid waiver is used for funding, an age limit could possibly be imposed.
  • If Medicaid waiver is used for funding, dollar limit could possibly be imposed.
  • If Medicaid or state plan funding is used, there will be a percentage of the federal benefit rate (i.e.: 150% – 300%) that income eligibility could not exceed, thereby excluding many of those in the ASD range needing services.
  • A waiver could also limit certain diagnosis (i.e. – not considering full spectrum scale)
  • Waitlist considerations and prioritization:
    1. Severity level – Require that the child be screened to see where on the ASD scale the child falls or;
    2. First–come/first serve – based on date of application for services.

What does the Future Hold?

Will the person be successful in adulthood?

AHCA: Transition plans needed for people after reaching the age limit of service plan or program (i.e.: going into school or graduating from school)

Outcomes for adults with ASD

AHCA: How will these personal outcomes be measured?

Developmental Process for the IACC Strategic Plan for ASD Research

Research opportunities and objectives
Workgroups and scientific workshops
Timeline of steps in the planning process
RFI responses
Short term and long term objectives

To: iaccservices@mail.nih.gov
From: [redacted personally identifying information],
Medicaid Services The Agency for Healthcare Administration, State of Florida
Re: Request For Information, 2 of 2, on behalf of the Interagency Autism Coordinating
Committee, from The National Institute of Mental Health
Date: 09/08/08
Subject Line: Request Reference Number: NOT–MH–08–016

REQUEST: The National Institute of Mental Health (NIMH) on behalf of the Interagency Autism Coordinating Committee(IACC), requests input and ideas about high-priority questions and issues surrounding services and supports to people with Autism Spectrum Disorder (ASD) of all ages, and specific research initiatives on ASD services and supports. Information is being sought in areas that impact services and supports across the lifespan such as education services, health and medical services (including dental), housing, transitions, employment, community inclusion, safety, older adults, finances, guardianship, and estate planning:

RESPONSE: The Agency for Health Care Administration (AHCA) of the State of Florida has been legislatively authorized to seek federal approval through a Medicaid waiver or state plan amendment to provide specialized services to individuals who are 5 years of age and under, and have been diagnosed with autism, Autism Spectrum Disorder (ASD) or Down syndrome. The State of Florida has also convened the “Governor’s Task Force on Autism Spectrum Disorders”, who are responding separately to this request for information.

Although authorized to pursue a Medicaid waiver or state plan amendment, AHCA must initially determine the feasibility of this action along with the impending effect. For this purpose, AHCA has formed an internal task workgroup to evaluate state data and research various options in order to determine the best strategy for providing services to these children. Based on a widely recognized 1 in 150 prevalence rate, there are an estimated 8,750 children under age 5 in Florida with Autism Spectrum Disorder. The workgroup seeks to define specific necessary services and supports in order to determine that a waiver or a state plan amendment will provide a viable solution. There is frank concern that a waiver or state plan amendment may only meet minimal population needs and be less timely than needed for implementation.

Obtaining an accurate diagnosis is of paramount concern. ASD cannot be diagnosed by a physical test, but is rather loosely based on a combination of parent interviews, non-medical tests, observation, and professional judgment. There are few medical professionals specifically trained to diagnose autism, so those best qualified are various professionals who have the most experience in making this diagnosis. It is also important to limit over-diagnosis by assuring independent verification by qualified professionals.

Otherwise, the program may become overwhelmed by large numbers of children with questionable diagnoses. This could overwhelm the already stretched resources of our involved state programs. Other concerns and issues include the challenge of narrowing eligibility criteria to insure that we are targeting the intended population, limiting services to medical necessity which must be controlled through development of appropriately narrowed needs–based criteria, and utilization management. There is also concern in setting the income eligibility standard as relates to the federal poverty rate and if by using this rate the intended population would benefit.

Additionally, transition for children enrolled in this program will be challenging as most will have continued therapy and care needs after the age of five. There will need to be a plan and process to assist them after state services end, for example, and they transition into the public school system and into adult vocations.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 1:50 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00147] RFI Identifier NOT-MH-08-021

Attached is the response of Family Network on Disabilities of Florida, Inc. to Request For Information.

Thank you.

[redacted personally identifying information]
Family Network on Disabilities of Florida, Inc.
[redacted personally identifying information]
www.fndfl.org

Family Network on Disabilities of Florida, Inc.
[redacted personally identifying information]
website: www.fndfl.org
[redacted personally identifying information]

Response of Family Network on Disabilities of Florida to Request For Information

Family Network on Disabilities of Florida has held Parent Training and Information center grants (PTI’s) through the U.S. Department of Education for more than 20 years. We are pleased to have the opportunity to be able to submit the following comments on the IACC Draft Strategic Plan for Autism Spectrum Disorder Research. Individuals associated with Family Network are also submitting detailed comments. Therefore, we have limited Family Network’s comments to areas not covered in the other comments. We have organized our comments, as requested, according to the sections of the Draft Strategic Plan.

III. What Caused This To Happen And Can This Be Prevented?

The families and individuals with whom we work are in desperate need of quality, impartial information. They are being bombarded from all directions with massive amounts of information concerning what may cause autism and what can be done for an individual on the spectrum. Family Network feels that a very important issue facing families is the controversy over whether or when to vaccinate, and to what extent. Being able to obtain quality information about these issues, and to come to a resolution about what can or must be done in this area, is crucial to our families and to our society, due to the public health implications of decreasing rates of vaccinations. Richard La Belle, Executive Director of Family Network, serves as a member of Florida Governor Crist’s Task Force on Autism Spectrum Disorders. At the September meeting of the Task Force in Tampa, the Task Force members were provided with a compilation of a number of states’ number of students enrolled in public education vs. those enrolled students who claim, on medical, religious, or philosophical grounds, an exemption from vaccination. The information provided was for the 2006–2007 school year, for both those students in kindergarten and in middle school. Family Network believes that it would be very helpful to individuals and families living with autism, as well as to governmental and public health authorities, to look at these students (in a way that insures absolute privacy) and track whether, and at what rates, these non–vaccinated students are diagnosed as being on the autism spectrum and/or develop other disabilities. Family Network believes that this data, which should be readily available for every state in the union, for as many years as we may reasonably wish, would go a very long way toward settling the issues currently swirling around vaccinations. This information, which is awaiting essentially only collation, should show whether or not there is a link between autism and vaccinations. At the very least, it could give us a very comprehensive, nationwide sample, over time, of many different individuals from varying ethnic and socioeconomic backgrounds.

IV. What Treatments And Interventions Will Help?

Much of the information that is currently available in this area is focused and targeted at young children and their families, with the importance of early intervention being repeatedly stressed. However, there are many individuals with autism who are adults or teenagers. These persons and their families were often told that there was nothing that could be done for them. Many are unaware of the advancements made in recent years in understanding autism spectrum disorders. Further, there is little information about what treatments and/or interventions may be effective for persons beyond childhood. We feel it would be very beneficial to have research focused on those areas.

V. Where Can I Turn For Services?

The availability of services within a state often differs from agency to agency, based on differing definitions used to define autism or the autism spectrum. These differing definitions determine eligibility. Thus, a person diagnosed with autism may literally be eligible for services from one state agency and not be eligible for services from another, based only on the scope of the definitions used. While there may be many reasons behind the use of differing definitions, uniformity should be stressed. This will help eliminate confusion and stress for persons with autism and their families. Research in this area focusing on these issues would be helpful.

From: [redacted personally identifying information]
Sent: Tuesday, September 30, 2008 1:52 PM
To: IACC (NIH/NIMH)
Subject: [Comment 00148] RFI Identifier NOT-MH-08-021

Attached is the response of [redacted personally identifying information] Florida PIRC of FND.

Thank you.

[redacted personally identifying information]
Family Network on Disabilities of Florida, Inc.
[redacted personally identifying information]
www.fndfl.org

Family Network on Disabilities of Florida, Inc.
[redacted personally identifying information]
website: www.fndfl.org

Response of [redacted personally identifying information] Florida PIRC of FND

Introductory Material:

As parents of children affected by Autism, it has been with a collective sigh of relief that we have witnessed the incredible recent wave of societal acknowledgement of the autism spectrum. Unfortunately, still, children and adults affected by autism are not valued, nor are they treated as equal members of our society. It is our wish that all individuals with autism are able to exercise the same fundamental rights afforded to us all—that all individuals with autism be able to live independently, with dignity, and inclusively.

  1. When should I be concerned?
  2. The onset for autism varies in all cases as far as diagnosis is concerned. For the moderate and more severe cases, symptoms of autism may appear as early as six months old; however, it is often diagnosed by the age of three. For mild cases, or high functioning cases, a diagnosis may come years later. There have been cases of individuals diagnosed with autism as late as thirty five years of age because the symptoms were so mild. Parents and pediatricians working together for an early diagnosis is key. Keeping track of developmental milestones and the classic signs of autism is something both pediatricians andparents should be monitoring together. If there is a history of autism in the family, this also increases the odds of having a child with Autism.

  3. How can I understand what is happening?
  4. Information on autism, treatments, and therapies is more readily available today than ever before. The internet, specialists, and Parent Training and Information Centers are all instrumental in assisting to understand information, providing options, and explaining in detail any entitled services.

  5. What caused this to happen and can this be prevented?
  6. Many parents are convinced the cause of autism is vaccine related because the symptoms typically develop around the same time certain vaccines are administered. This is not true in all cases. Many believe that autism is caused by a combination of genetics and environmental factors. This requires much more research and seems more probable, since identifying a single gene has not been possible.

  7. Which treatments and interventions will help?
  8. Since autism can cover such a broad spectrum, it is not possible that a single method or intervention will work for every case. Parents and specialists will need to work together on what treatments are available and that they feel most comfortable trying. The exploration of interventions is extraordinarily time consuming and requires great patience and objectivity. Treatments such as bio–medicaloptions l13ve increased exponentially in the last ten years. Many opt for less invasive treatments, such as natural supplements, chiropractic treatments, acupuncture, etc. Effective interventions such as Behavioral therapy, Speech and Language therapy, OccupationalTherapy, and Physical Therapy have shown great success, and have been utilized in treating every symptom associated with autism. These methods are now starting to be integrated with academic instruction, which is very exciting! Applied Behavioral Analysis (ABA), Floortime, TEACH, Music Therapy, Horse back riding, Water Therapy (Water Play), and othermethods of therapy are being developed daily in order to continue to explore the many ways to treat autism and all of its many facets.

  9. Where can I turn for services?
  10. After the diagnosis, it’s important for parents to research the agencies in their state responsible for providing Early Intervention services.

  11. What does the future hold?
  12. Of all disabilities, autism is one of few disabilities with the greatest uncertainty. Since autism is a highly sensory integrated related disorder, new behaviors and symptoms are manifested and are inconstant and unpredictable. It is difficult to predict the future for a child or adult with autism. Perseverance and continued exploration of treatments and interventions is key. Familiarizing and educating oneself on services, rights, national, state and local agencies, and legislation and policy making is also important. Developing relationships with other parents in the community, the schools, and taking a leadership role in modeling non–combative advocacy creates a dynamic and lasting impact inour society. There is no reason for us to believe that individuals with autism cannot lead independent, productive and successful lives.



HHS Home | Contacting IACC | Accessibility | Privacy Policy | FOIA | Disclaimer | USA.gov | IACC Webmaster

U.S. Department of Health & Human Services • 200 Independence Avenue, S.W. • Washington, D.C. 20201