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IACC Meeting Wednesday to Finalize Federal Autism Research Plan

Important date By Jim Moody

It has taken over a year to write the first-ever strategic plan for federal autism research, but this long and tedious ordeal may come to an end at the meeting of the Interagency Autism Coordinating Committee (IACC) this Wednesday in Washington.  The public meeting will be held today 9-2:30 at the Neuroscience Center (NIMH), Conference Room C, 6001 Executive Blvd., Rockville, Md. 

In-person attendees should register (HERE), and the meeting will be telecast on 888-455-2920, access code 3857872. 

Slides can be viewed on a webinar (HERE)

The agenda (HERE) includes final decisions on the content of the Plan and the autism research budget, both of which are required under the Combating Autism Act of 2006.  General information about IACC, including charter, members, and documents can be found on its home page (HERE).

This is a crucial meeting as many of the topics to be discussed will determine whether the research spending will actually make a differencer in finding the cause and effective treatments for autism.  The draft strategic plan (HERE), backgrounddocuments relating to development of the plan (HERE), and the 148 public comments (HERE) received in September can be reviewed online.

Most of the revisions and additions to be discussed will make the plan an aggressive response to the national health emergency presented by the autism epidemic.  The present draft basically continues business as usual and failed to even propose spending the minimum authorized by Congress in the CAA, about $640 million over the next three years.

The two topics on the agenda are completion of the edits to the Introduction for the Plan and assignment of budgetary amounts to the 35 research projects grouped into six broad categories with short- and long-term objectives for each.

Autism Must Be Declared a National Health Emergency.

The necessary changes in the Introduction primarily relate to the themes that impact the entire research enterprise.  The Plan must declare autism a national health emergency driven by the rapid rise in prevalence, the burden on individuals, families, and society, and the opportunity that answers provided through research can have an immediate impact on function, quality of life and prevention of disability.  The autism epidemic deserves a crisis-level response with direct leadership from the White House, as promised by President-Elect Obama.  Why is CDC so quick to deny the epidemic of autism cases when it is reasonably competent at tracking down SARS, salmonella, pet food and toys from China, E. Coli outbreaks, and even 131 cases of measles?  The recently released study from the MIND Institute (HERE) demonstrated with rigorous analysis that the rapid rise in cases reported in California data was real and not simply the result of better counting, awareness, and changes in diagnostic practices.  CDC remains awash in ignorance about autism, claiming “it is unclear how much of this increase is due to changes in how we identify and classify ASDs in people, and how much is due to a true increase in prevalence,” although CDC does concede that ASDs are “urgent public health concern.”  This deliberate ignorance must be replaced by concerted action.

The ability of basic and clinical research to have an immediate impact justifies a research agenda responsive to crisis.  To the extent that services, interventions and treatments promise real hope for recovery or gain of functionality, improvement in behavioral symptoms, and restoration of physiological health, these must be developed through research and implemented with all deliberate speed.  To the extent that autism is triggered by particular environmental factors, their identification and elimination offers the hope of a significant reduction in new cases.

Autism Is a Complex Biological Disorder.

The Plan must acknowledge that autism is a disorder of the whole body.  Autism is at present defined and diagnosed behaviorally, but it is driven by biological mechanisms that we need to better understand.  We therefore need to consider the wide range of dysfunction in multiple bodily systems as potential targets for research and treatment.  Areas deserving further research focus include unusual brain growth, widely and unevenly distributed patterns of lasting neurogliosis and pervasive disruption in connectivity, mitochondrial dysfunction, immune system disregulation, sleep disturbances, gastrointestinal pathology, and disruption of metabolism. Making rapid progress in elaborating the mechanisms for these pervasive problems will require collaborative efforts across disciplines.  We need to focus research on the real-time development of this disorder in the brain and in other body systems.

Environmental Factors Play a Crucial Role in Causation.

The rapid increases in autism rates demands a high priority on investigating the etiological role of environmental factors. These factors can interact with susceptibility genes. We need to take on a more innovative view of the interactions between genes and the environment in order to make research on both genes and the environment more productive. Timing of exposure during development is also an important consideration, and relevant environmental exposures can occur from the preconception, prenatal, and infancy periods with the changes in the brain and other bodily systems being most notable after infancy. Some show early signs of autism but others develop normally as infants and then regress. In light of the increases and the observations seen in children, it’s important to leave no stone unturned in the investigation of environmental exposures. Research on environmental factors must include the potential role of vaccines (including components such as mercury and aluminum) in the etiology of autism.  Studies of vaccines in animals and in humans (especially the crucial vax/unvax comparison) were added to the research projects set forth in the Plan at last month’s IACC meeting (HERE)

Such research should resolve remaining uncertainty while preserving confidence in the vaccine program.  Even low level exposures can result in alterations to development that can lead to symptoms of autism.  Research on the role of environmental agents can be a fruitful approach for both treatment and prevention.  The Plan must consider the best ways to inform epidemiology with toxicology, while also developing the disciplines of predictive toxicology, in order to get answers rapidly.

Treatment:

The Plan should emphasize a broad range of treatments (biomedical and behavoiral/educational) leading to recovery of function and loss of diagnosis.  Individuals with an ASD diagnosis are unique.  Children and adults with ASD can lead independent lives; expand their capacity to learn, grow and develop; play a productive role in society; and enjoy mutually satisfying and loving relationships as they desire.  Individuals diagnosed with autism have biologically-based differences that can lead to both disability and superior ability, and that cannot be viewed purely as behavioral or psychiatric in nature.  Substantial gains in function, quality of life, and health are possible across the lifespan through targeted interventions developed through careful assessment of each person. Thus personalized treatment parity across all domains, including medical, educational, and behavioral, must be made a high priority for research in the Plan.

Implementation.

The value of this Plan will be lost without proper implementation, even if the Plan succeeds in adopting good doctrine and a comprehensive list of research projects.  Key features of this implementation include mechanisms for accountability and oversight, a substantially increased research budget, and community involvement in decisions relating to scientific merit and programatic relevance. 

Public Participation in Research.

The CAA instructed IACC to increase public participation in all decisions relating to autism; therefore, this must be an express goal of the Plan.  Such participation is consistent with the Plan’s goals of consumer focus, partnerships, and accountability.  Close collaboration between parents, scientists, and clinicians, working through private organizations and providing input to public agencies, has been a hallmark of rapid progress of ASD research and in the development and deployment of both behavioral and biomedical interventions.

As an example, the Autism Research Program as recommended by the Institute of Medicine and administered by the Department of Defense Congressionally Directed Medical Research Program incorporates significant community participation in decisions relating to both scientific merit and programmatic relevance.  Community participation in that program has been instrumental in serving to remind basic scientists of the human component of disease and to focus research toward projects with high impact and leverage.  A similar process must be implemented with respect to research under the Plan.

Autism Advisory Board.

 The CAA requires that the Plan be updated annually.  This process will require evaluation of completed and ongoing projects, reallocation of resources among existing initiatives, the creation of new initiatives, and the preparation of annual updates to the Plan.  In passing the CAA, Congress encouraged the establishment of an Autism Advisory Board comprised of scientists, clinicians, and advocates.  Working together both formally and informally, collaboration among these groups has already proven an effective tool in advancing research and treatments for autism.  The community has repeatedly asked for an AAB in comments and letters.  The Plan should establish an AAB immediately. 

Funding Process.

Consistent with the demand for an urgent response to this crisis and the cross-cutting nature of much of the ASD research portfolio, IACC should immediately convene a workgroup to re-engineer the funding process to meet this crisis.  Subjects to be addressed include allocation of the research initiatives among a limited number of special interest panels who will provide funding on a continuous basis through program announcements and other innovative grant-making initiatives, and an “innovation fund” and process for immediately responding to new research and treatment opportunities.  Accountability, transparency, and oversight must be hallmarks of this process to ensure that progress on the research objectives is timely and effective.

Research Budget.

The autism research budget set forth in the Plan has been increased during the past few months to approximately reflect the amounts authorized during the three years remaining under the CAA.  However, the rapid rise in prevalence, the necessity of an urgent and coordinated response to this national health crisis, and the time-sensitive opportunities for prevention and treatment demand a considerable and immediate increase in the research budget. The CAA authorizations must be regarded as a floor, not a ceiling.   IACC should immediately convene a workgroup and appropriate workshops to (1) increase funding for the research initiatives (with emphasis on increased priority for environmental and treatment research which has been under funded in the past) at least to the level of the CAA authorizations; and (2) develop a coherent justification for a substantial increase in the research budget based upon a “cost of disease” model and on the opportunity in the scientific and clinical communities (measured in part by grant proposals that have merit but remain unfunded) to perform high-quality research in support of the mission and vision of this Plan.

The importance of this Plan cannot be over-emphasized.  It (along with annual updates) will direct all federal autism research.  Attendees and listeners should pay particular attention to how the six community members advocate and vote for the necessary improvements in the Plan.

In the end, the Plan is just words on paper.  Its true value will depend on whether its implementation can be measured in new cases of autism prevented, in meaningful treatments for existing cases, and in services and supports that have a useful impact for those with ASD. 

Previous AoA articles on the strategic planning process:

1/5/09: Kirby, Top Federal Autism Panel Votes for Millions in Vaccine Research http://www.huffingtonpost.com/david-kirby/top-federal-autism-panel_b_155293.html.


12/13/08: Walker, When Autism Leads to Advocacy http://www.ageofautism.com/2008/12/when-autism-lea.html.

12/11/08: Moody, IACC Meeting Friday to Finalize Federal Autism Research Plan http://www.ageofautism.com/2008/12/iacc-meeting-fr.html.

12/11/08: Community research organizations’ concensus statement “Concerns on IACC Strategic Plan Discussions” http://www.ageofautism.com/files/iacc_sp_community_concerns_121108_final.pdf.

11/20/08: Listen Live Friday to the Federal Plan for Autism Research http://www.ageofautism.com/2008/11/listen-live-fri.html#more.

11/13/08: Autism Community “United in Expressing Our Disapproval “ of the NIH Strategic Plan for Autism Research (first consensus letter urging that the plan communicate a sense of urgency driven by the rapid rise in prevalence, allocate sufficient resources to achieve its goals, increase resources devoted to environment and gene-environment research, provide for accountability and oversight, create an Autism Advisory Board, and represent the diverse views in the community) http://www.ageofautism.com/files/iacc_strategic_plan_community_concerns.pdf.

9/29/08: Moody, Reminder - This is Your Chance to Influence Federal Autism Spending - Comments Due Tuesday [http://www.ageofautism.com/2008/09/reminder---this.html].
09/10/08: Budget Recommendations from Aug. 8 and Sept. 10 strategic planning workgroup meetings http://www.ageofautism.com/files/iacc_funding.pdf.

9/9/08: Safeminds Reminds: IACC Budget Meeting Wed., Sept. 10 http://www.ageofautism.com/2008/09/safeminds-remin.html.

8/25/08: Davis, NIMH Flip-Flops on Pivotal IACC Workgroup Meeting http://www.ageofautism.com/2008/08/nimh-flip-flops.html.

8/14/08: Autism Speaks’ letter to Chairman Insel (urging clearly defined objectives tied to well-specified budget, greater emphasis on research into environmental factors and gene-environment relationships, potential role of vaccines in the etiology of autism, and inclusion of diverse viewpoints from the entire community) http://www.ageofautism.com/files/autism_speaks_letter.pdf.

8/12/08: Dunkle (Hanah Poling’s aunt), Boost Vaccine Safety http://www.ageofautism.com/2008/08/the-matter-is-u.html.

7/14/08: Davis, Congressional Oversight Committee Presses for Vaccine Research http://www.ageofautism.com/2008/07/congressional-o.html.

7/14/08: Letter from House Science and Technology Committee to IACC (noting concerns over process and calling for vaccine research) http://www.ageofautism.com/files/71408_miller_to_leavitt_re_iacc.pdf.

7/8/08: Moody, The Strategic Plan for the Combating Autism Act [http://www.ageofautism.com/2008/07/the-strategic-p.html].

7/7/08: Safeminds’ letter to Secretary Leavitt Download Safeminds leavitt letter

4/28/08: Invitation to California Autism Advocates (to attend town meeting to gather input for strategic plan) http://www.ageofautism.com/2008/04/nih-invitation.html.

4/20/08: IACC Meeting Listen In Via Conference Call http://www.ageofautism.com/2008/04/iacc-meeting-li.html.

1/15/08: Handley, Grinker’s Stinker: His Wife Runs the IACC http://www.ageofautism.com/2008/01/grinker.html.

1/12/08: Moody, What’s So Secret About Autism Science http://www.ageofautism.com/2008/01/whats-so-secret.html.

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Comments

Marie-Anne Denayer

The government better start paying really close attention.
My daughter Stephanie became autistic in 1988 at a time when no "expert" had ever seen a previously "perfect baby girl"(to quote our pediatrician)become autistic over a period of 4 months.
Fast forward 20 years, an entire generation.
After 18 years in our school system, Stephanie is now an "adult". She continues to live at home, her older brother and younger sister are in college. In order to care for Stephanie, I work days and my husband works nights.
I was able to enroll her in an adult program (ARC)that runs from 9:30 AM to 3:00 PM. I bring her to her program in the morning before heading for my office and my husband picks her up in the afternoon. As soon as I return home after caring for my adult MS patients, my husband an ER physician is out the door to work a 12-hour night shift.
In order for Stephanie to attend any adult program she had to be enrolled in Medicare and Medicaid.
Here in an easy algebra problem for our government and other experts: Knowing that in 1988, the statistics for autism were at most 1 in 10,000 and in 2009 1 in 150, calculate how many 21 year-old with autism will have been enrolled in Medicare and Medicaid by 2030. Staggering isn't it?

Marie-Anne Denayer, M.D.

PS: The 4:1 boys to girl ratio everyone keeps quoting held true for the NON-EPIDEMIC "autism" (Fragile X syndrome was identified by an astute geneticist who wanted to find out why "mental retardation" in general was more prevalent in boys than girls).
From attending parents' meeting over the years I have concluded that this male preponderance does not hold true for the alas increasingly more prevalent EPIDEMIC ACQUIRED AUTISM as it should-in my humble opinion-be called.

Stagmom

Dr. Denayer, thank you. Wow. A neurologist? Wow. Thank you.

KIM

Marie-Anne Denayer

First step in identifying kids potentially at risk of becoming autistic in relation to vaccination is to stop administering vaccines "blindly" ,that is without first testing the recipient for the presence of antibodies against the infectious agent the patient is being vaccinated against.
All this requires is a physician willing to order the antibody titer(s).

Marie-Anne Denayer M.D.
Adult neurologist.
Daughter Stephanie age 21 became autistic in 1988, onset of regression at age 15 months.

Cathy

If they refuse to fund vaccine safety research, they should prepare for us to continue to debate to safety of vaccines. End of arguement!
Do you think we are stupid?

Heidi N

Here's my summary of the IACC meeting:

As a representative of the LIA Foundation and as a mother who recovered her children from autism, I listened in to the Interagency Autism Coordinating Committee (IACC) Stategic Plan for Autism Spectrum Disorder Research that was open to the public for listening via over the telephone. The IACC is under the U.S. Department of Health and Human Services. The IACC was formed in accordance with the Congressional Combating Autism Act and falls under Public Law 109-416 http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_public_laws&docid=f:publ416.109.pdf It was a listen-only type of situation for us "public". Although, there was one parent at the meeting of a child with autism, she did not speak much during the meeting, so I was not able to interpret her input. What was noticeable and stood out was the issue of vaccines. The previous meetings I listened in on also spent the most time discussing or rather disagreeing on vaccine research. As a matter of fact, things seemed to run along smoothly except for two issues: one being the public's input into scientific research, and the other being vaccines. It appeared to me that whenever these two subjects were brought up, much, long, almost heated discussion then erupted.

The whole meeting was spoken in eloquent, politically correct language, but it wasn't difficult to notice a few statements, such as when it was boldly stated that one of the participants was trying to re-write the proposal. This statement was followed by Lynn Redwood, defending herself, who did what I feel was a fantastic job of speaking up for the public and the need for vaccine research. Unfortunately, not many agreed with her. As a matter of fact, there was much steering going on. As they were treading along, deciding if things need to be re-worded, all of a sudden it was mentioned and then voted upon that it was unnecessary to continue since it was imperative to get the proposal completed. Thus, they did not continue forward, but went backwards instead. Instead of stopping as they voted to do, a switch was made to revisit vaccines. What followed was a re-wording of vaccine research, even though the specific wording had already been agreed upon at the prior meeting. This really stood out to me. They did not have time to finish considering re-wording the proposals that the science writers had interjected from the public's input, but had plenty of time to go back and re-write the vaccine research sections that they had already previously been agreed upon and voted on. The result was that vaccine research went from being along side other needed areas of research to a much smaller area of importance. With the areas of research towards the causes of autism being very limited, this leaves one wondering what funding vaccines will get, if any. I feel with all the flack vaccines are getting from successful lawsuits, privately-funded research, parents, and alternative doctors, one would hope that vaccines were in the spotlight for research, even if for no other reason than to comfort parents.

As much as voting took place to decide events, it also appeared that most of those voting had direct ties to vaccines. Thus, in my opinion, we can not have good research where financial ties are very strong. I believe changes to the system need to be made. Under Public Law 109-416, most meeting members of the IACC are required to be from specific government agencies, who coincidently also happen to have vaccine ties. I wonder if this inherently results in a steering away from any research in areas that may lead to unfavorable results, reflective to those agencies. I remember a time when conflict of interest was taken very seriously. Do we still have those laws? Were they changed, or do we just not pay attention to them any more? How and why did we stop accounting for conflicts of interest when setting up our governmental agencies? They say this meeting was recorded. Thus, any member of Congress could listen for themselves, and form their own view of things. I say, without eliminating such strong conflicts of interest, we will continue to get unsatisfactory results.

Sincerely,

Heidi Noyer, MS
Research Coordinator, LIA Foundation

Twyla

This is most distressing.

jruch

Any chance the timing of a strong arm review of a 5 month old book and the vote were coincidental?

"Many doctors now argue that reporters should treat the antivaccine lobby with the same indifference they do Holocaust deniers, AIDS deniers and those claiming to have proof that NASA faked the Moon landings."

replace reporters with voters.

16 million in research in the search for truth down the tubes. Not just vaccine research, but the search for susceptible populations. disgraceful.

Any chance this is a last ditch effort to make a point before many of them are swept out by the new administration?

Garbo

I am deeply concerned, between this and Tom Daschle's comments in his confirmation hearing the other day about the importance of vaccines, and Obama's seeming willingness to follow the party line about the vaccine program, that there is any hope of positive movement anytime soon. The corporo-governmental pharma complex is as big as an aircraft carrier and as difficult to turn around.

Kevin Barry

Bad news from DC. I just spoke with Jim Moody who attended today's IACC meeting.
Jim told me that the IACC members voted to strip the vaccine research language from the strategic plan.

This part is bizarre. Jim said Alison Singer of Autism Speaks voted with the federal members on the IACC - and against all of the other autism community members - to strip the vaccine research language.

I sincerely hope Singer's vote was not an effort to gain the favor of the federal members in order to become President Obama's "Autism Czar".

In my opinion, because Singer's vote appears to be so foolish, there is danger here. You would think Alison would pretend to support vaccine research, since there were enough federal member votes to strip the language without her vote. Why would she put Autism Speaks in a difficult position, unless it would advance her personally in some way?

Something smells here. The last thing we need is Alison Singer as "Autism Czar". Alison could cause even more damage to autism research if she worked for the federal government than she currently does at Autism Speaks. Be on guard.

I never thought I'd say this - but I hope Alison stays at Autism Speaks.

Kevin

PS- This is the language voted out, from David Kirby's article last week:

"In fact, two vaccine-autism studies have been approved by the IACC, which has proposed spending $16 million to:

1) "Study the effect of vaccines, vaccine components, and multiple vaccine administration in autism causation and severity through a variety of approaches, including cell and animal studies, and understand whether and how certain subpopulations in humans may be more susceptible to adverse effects of vaccines by 2011. Proposed costs: $6,000,000


2) Determine the feasibility and design an epidemiological study to determine if the health outcomes, including ASD, among various populations with vaccinated, unvaccinated, and alternatively vaccinated groups by 2011. Proposed costs: $10,000,000"

LHRYDEN

This is my first time to post here. I am a parent and advocate, with a background for 20 yrs in the medical diagnostics industry.

I listened to end of the IACC meeting this afternoon, and was very happy to have heard Katherine Walker speak about the necessity of environmental research and less focus on genetic research. Let's face it...we have spent millions on genetic research into autism and come up with no commonality that occurs in all of the ASD population. I attend a few molecular genetics conferences per year, and the diagnostic companies and reference labs are clamoring to see who can offer the first "autism genetic panel." As I met with these researchers and company representatives, I asked them how many ASD cases they have been able to 'catch' with their genetic profiles. They answered an optimistic 10%.

I will say that I have a concern that the IACC possibly does not understand which biomarkers are needed for testing for autism, and that there seemed to be an opinion in the meeting today that we need substantial research into finding these biomarkers. Well, that is partially correct because we are learning more about the immune system impairments in autism.
However, why don't we use the biomarkers that we have today for diagnosis and monitoring treatment?
Examples- homocysteine, amino acids, GI markers, viral load/ blood virus testing, metal screens, glutathione

These are all tests which exist today, and they are mostly protein markers and not genetic markers. Learning the results of these tests has helped provide answers for my own son, and helped to guide his recovery.

In addition, these tests already have CPT codes and are reimbursed by insurance in most cases.

Unfortunately, many pathologists and physicians are not yet aware of how these markers can be used as diagnostic tools for autism spectrum disorder. Of course, many are also unaware that autism is treatable and recovery is possible. My own son is speaking in sentences now after years of being nonverbal.

Sincerely,
Lisa Hunter Ryden

Kathy Blanco

I noticed when I wrote them, they took about ten of my critical comments into their mainstream "thought pattern"....give me a break, they didn't think of this stuff because it implicates products, services etc. It took my ten years to research these itmes thoroughly as the causes or initiators of autism. A parents job? I don't think so, but we are forced to, because no one is looking after our children.

I am sure NIH and CDC will do nothing about this information...it would take bilions of dollars to research. If there isn't an end product in mind (a pharmaceutical), most studies don't get funded. Studies that implicate things are often privately funded, and then told, they are biased by the funder. Even if, there is no financial motivation involved. Even if, the ONLY motivation is to cure or prevent autism.

Our world is truly a messed up globe...we have no compassion or will anymore to do the right thing...

Blame that on fluoride and mercury and lead toxicity, and the like...we are melded into the BORG of people who want us to be useless drones and non thinkers and non questioners.

My life was forever changed by this Borg mentality...I no longer do anything for "the good for all", I selfishly now, have to go my own way, and find the cure, cause and treatment for autism....thanks researchers, NOT. *(and by the way, it's a no brainer what or why we have this epidemic...but they are too dumb or too indifferent or have too many stakes to make that revelation public)

Twyla

Thank you so much to all those who have worked and fought so hard for two years to ensure that this plan reflects autism as we know it. Prayers and best wishes for a successful day.

Ray Gallup


Back in the 1990's and early 2000's I went personally went to the NIH in Maryland to request funding for Drs. Jim Oleske, Vijendra Singh and Andrew Wakefield.

I accomplished nothing because this research is verboten at the NIH. I was up against the US equivalent of the Berlin wall.

I wish parents the very best in their efforts at IACC but don't be totally surprised if you get the same results I did.

Ray Gallup

nhokkanen

Thank you, Mr. Moody, for this comprehensive explication of the IACC focus and process.

The articles linked at the bottom describe the number of obstacles thrown in the path of progress by those with nefarious interests. We all need to keep the pressure on the contrarians on this commitee, to ensure vaccine safety research and biomedical treatments for our children remeain key components of the plan.

Ray Gallup


For those that expect that the IACC will stop the autism epidemic by looking into the vaccine issue, can expect the following as Khrushchev once said:

"Those who wait for that must wait until a shrimp learns to whistle.”

http://en.thinkexist.com/quotes/nikita_khrushchev/3.html

Khrushchev is the right person to quote because the IACC (and their associates)is like dealing with the old Soviet Union.

Ray Gallup

Kevin

Help me understand. This was supposed to be "Combat" however, here we are 2 years later and we're still on 1.0 of the PLAN???? Hello. Can they complete this sometime this quarter????

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