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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.

When Should I Be Concerned?

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.

How Can I Understand What Is Happening?

What Caused This To Happen And Can This Be Prevented?

Which Treatments And Interventions Will Help?

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.

Where Can I Turn For Services?

Central data base can be maintained to refer for further evaluation⁄services. This can be done based on zip code..

What Does The Future Hold?

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]

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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]

Why isn’t the meeting open to the public? What is the benefit of secrecy???
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.
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.
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]

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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:

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].
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].
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].
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]:

When Should I Be Concerned?

Was your baby crying (or breathing) before the umbilical cord was clamped?

How Can I Understand What Is Happening?

Language is learned “by ear” and may be difficult for a child with any impairment of the auditory system.

What Caused This To Happen And Can This Be Prevented?

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

Which Treatments And Interventions Will Help?

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.

Where Can I Turn For Services?

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].

What Does The Future Hold?

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

Simon EN (2000-2008) http://www.conradsimon.org/
Pan CL, Kuo MF, Hsieh ST. Auditory agnosia caused by a tectal germinoma. Neurology. 2004 Dec 28;63(12):2387-9.
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
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.
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

the Testing: Involving controversial areas such as

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.

Coinfections of fungal, bacterial and viral–chronic or persistent or cyclic–and their role in ASD

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

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
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
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?”).

Basic Biology.

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.

Environmental Factors.

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.

Screibman L, Intensive Behavioral/Psychoeducational Treatments for Autism: Research Needs and Future Directions, Journal of Autism and Developmental Disorders, Vol. 30, No. 5, 2000.
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.
Posey DJ, Stigler KA, Erickson CA, McDougle CJ. Antipsychotics in the treatment of autism. J. Clin. Invest. 118(1): 6-14 (2008).
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.

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)
Rate of misdiagnosis (especially of adults now living in state hospitals, mental health facilities, or prison)
The incidence of individuals living with ASD involved in the juvenile or criminal justice systems
The incidence of individuals living with ASD who are homeless or unemployed.
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.
Reasons for staff turnover and factors that improve retention of staff.
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

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.

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.

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.

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

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:

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.
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.
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:

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.
Vision Statement
No changes necessary.
Mission Statement
No changes necessary.
Core Values
No changes necessary.
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.

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.

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.

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.

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.

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.
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”.

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.

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.

Alternatively, this section could be retitled “support services for children”, and the next section could be retitled “support services for adults”.

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.

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.
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.

Include some comparative male/female studies – not just “stand alone” female studies.
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.

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.
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.
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”.
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.

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.
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.
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:

Prevent new cases of autism by eliminating major causal contributors, leading to a 90% reduction in new cases of autism among 2014 births.
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:

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. 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:

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.

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

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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.

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

When Should I Be Concerned?
How Can I Understand What Is Happening?
What Caused This To Happen And Can This Be Prevented?
Which Treatments And Interventions Will Help?
Where Can I Turn For Services?
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.

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.

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?

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.

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.

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.

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)
INFECTIONS in utero, aka, ANY virus, any immune deranging bacteria, including lyme, syphilis, STD’s, flu viruses, and even vaccines given mothers.
Antipyretic use during those infections in utero, and vaccine fevers (see www.rollingdigital.com/autism)
VACCINES, overuse, toxins, immune shifters, toxins, adjuvant, does autism occur more often in the vaccinated, answer yes
FOOD SUPPLY, MILK, WHEAT, CORN, SOY, BT TOXINS, GMO FOODS, PESTICIDES–the set up for autism? Answer, YES.
The continual pollution – aka MUNICIPAL FLUORIDE in Water which makes aluminum more toxic in the brain, aluminum coming from childhood vaccines and other sources.
The Continual pollution of Flame Retardants, Dioxins, Molds, Pesticide traces on foods, MSG in food supply, Plastics, etc
Mothers failing thyroid glands, autoimmunity, high leptin levels. The other set up for autism.
Mothers amalgam fillings as possible neurotoxic source of mercury, and or her diet of fish and or polluted skies.
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.
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.
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.
Check for iron levels in brains of boys, calcium in girls brains. Answer, these two are the biggest oxidative stressor.
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.
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?
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.

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.

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.

In addition, we advocate for measures of ASD symptoms and severity are needed across the life span.

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.
What Causes This To Happen And Can This Be Prevented? This section sets ambitious but important objectives. We endorse the grand scale.
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.
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.
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.

When Should I Be Concerned?

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.

How Can I Understand What Is Happening?

Please prioritize services before genetics.

What Caused This To Happen And Can This Be Prevented?

Please prioritize services before cause.

Which Treatments And Interventions Will Help?

Stress intervention research across the lifespan.

Where Can I Turn For Services?

Stress implementation science research across the life span, especially from a participatory action model.

What Does The Future Hold?

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.

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.

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%.

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.

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:

WHEN SHOULD I BE CONCERNED?

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.

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?)

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.

WHAT CAUSED THIS TO HAPPEN AND CAN THIS BE PREVENTED?

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 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 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.

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):

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.
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.
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.
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: 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

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)

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

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

The Plan Must Articulate Adequate Doctrine to Guide Research.

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 Include Community Participation in All Decisions Relating to Autism Research.

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.

Process Failures Contributed to a Deficient Plan.

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.

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.
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.

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.

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.

When Should I Be Concerned?

How Can I Understand What Is Happening?

What Caused This To Happen And Can This Be Prevented?

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.

Which Treatments And Interventions Will Help?

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?

Where Can I Turn For Services?

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.

What Does The Future Hold?

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:

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.
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.
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.
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.
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.
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.
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.
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.
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]


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 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.

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
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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.

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]

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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:

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.
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.

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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:

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.
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.
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 costR

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

Autism Tissue Program (ATP) Monthly Report August 2008

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