Get_involved_2By Jim Moody, Esq.

An “early draft” of the strategic plan for autism research: NO epidemic and NO urgency, NO priority for treatment and environmental triggers, and NO research budget.

The requirement in the Combating Autism Act (CAA) for a Strategic Plan (SP) with a budget for autism research gives the community a unique and unprecedented opportunity to influence the conduct of federal autism research.  The future of NIH-funded autism research will be decided in the next couple months as the strategic plan nears completion and submission to Congress.  The entire autism community must again unite to fight for an effective plan.  An “early draft” of the SP has been completed and will be presented Tuesday morning 10 AM - 1 PM  EDT at a teleconference meeting of an outside “workgroup” for review (register HERE)  and listen here [888-455-2920, code 3857872], and at a public meeting on the NIH campus in Bethesda on July 15 9 AM - 4 PM of the Inter-Agency Autism Coordinating Committee (IACC), register HERE. 

The community must act quickly and in unity to ensure that the CAA research money is spent in a way that will be of greatest benefit to families already dealing with ASD and to the prevention of future cases.

The autism community worked tirelessly to enact the unprecedented Combating Autism Act (CAA) of 2006, P.L. 109-416.  The CAA authorized $640 million over five years to expand and intensify autism basic and clinical research conducted by NIH to “investigate the cause (including possible environmental causes), diagnosis or rule out, early detection, prevention, services, supports, intervention, and treatment of autism spectrum disorder.”  Congress directed the IACC to develop, submit, and annually update a comprehensive Strategic Plan (SP) with a budget for the conduct of this research.  But appropriations to carry out this plan must be passed by Congress each year, especially reserved for autism, so that the research set forth in the plan doesn’t get ignored amidst the cockfight over the $28 billion or so allocated generally to NIH.

The process for development of the SP began at the IACC meeting November 30.  See AOA: What’s So Secret About Autism Science? (HERE.)  Unfortunately, serious process failures and a cloak of secrecy shrouding the development of the SP violate both the letter and spirit of the CAA.  Based on what’s happened so far at IACC this spring, the SP will: be little more than a listing of general research projects (similar to the 2003 roadmap); NOT present a research plan and implementation strategy with any sense of urgency justified by the size and cost of the autism epidemic; NOT contain the research budget that Congress demanded; NOT contain a specific plan for vaccine research, even though mandated by CAA; NOT propose a funding process that is accountable and provides for considerably greater community participation (also required by CAA and used successfully in the tiny but highly regarded autism research program conducted by DoD and separately funded by Congress); and NOT reprioritize research in favor of effective treatments and eliminating environmental triggers (despite suggestions from IOM and a previous evaluation of the “roadmap”).

The Process So Far.

Briefly, the process to date has been as follows: The IACC, newly reauthorized by CAA, held its first meeting November 30.  The NIMH staff presented a tentative plan to gather public and scientific input for the SP with over 500 comments filed by January 5.  However, comments and/or summaries have not been made public.  Over seventy scientists met in groups January 15-18 and generated 41 general research topics.  These meetings were closed to the public and the 41 initiatives have not been made available to the public.  An initial workgroup met on February 21.  The IACC met again on March 14 and expressed a need for historical funding information and a consensus for a new workgroup to conduct detailed analysis and begin the process of drafting the SP.  The newly organized workgroup met on April 21 with public access available via telephone.  The workgroup reached a consensus that it needed clarification of its mandate from IACC and several more meetings to complete the task of drafting the SP.  A huge townhall meeting was held in Sacramento on May 3.

During their most recent meeting on May 12, the IACC again expressed a strong consensus that the workgroup should reconvene for further analysis and development of the SP, as well as expanding the workgroup as an ongoing subcommittee similar to the Services Subcommittee.  Despite repeated requests by the IACC for more information and for a continued role for the workgroup in drafting the SP, most of the drafting has been captured by NIMH staff with little practical input from the IACC, or the workgroup.  The NIMH has consistently failed to follow the guidance of the IACC and the workgroup regarding ways to improve the quality and oversight of the SP.  The “early draft” was sent to IACC and the workgroup, but only a brief opportunity for “review” (with insufficient time for real collaboration or drafting) has been scheduled for July 8.  The draft SP will be presented to the IACC on July 15.

What Should Be In The SP?

The community can enthusiastically support a SP that ensures progress toward Congressional goals with all deliberate speed.  Therefore, the SP must be much more than an unprioritized listing of interesting research topics relating to autism (as was the “autism roadmap” developed in 2003). 

The SP must address at a minimum: (1) a mission statement incorporating the goals set by Congress; (2) specific goals; (3) analysis of past and present research, accomplishments, and gaps (including unfunded projects as a measure of demand); (4) a prioritized plan for present and future research initiatives that specifically includes a focus on environmental causes including vaccines; (5) changes to the funding process to reduce delay, rely on mechanisms such as special emphasis panels with defined budgets and research targets, and increase community participation in funding decisions; (6) transparency, accountability and performance metrics; (7) a justified research budget driven by scientific opportunity and demand; and (8) collaboration and partnerships with non-NIH public and private research funders.

The SP must strategically justify necessary resources, prioritize research questions, is accountable and transparent.  The community must have an effective plan to take back to Congress to obtain the necessary appropriations.

Why Is The Strategic Plan  Important?

This particular battle might seem like a small and irrelevant silliness, just a piece of paper, but it is of the utmost importance.  Advances in treatment and prevention depend on sound science in biomedical/environmental and behavioral areas.  Much of the really useful science to date has been funded by parents and private philanthropy and is being conducted “informally” (one kid at a time) in tens of thousands of households and in the offices of courageous, dedicated, and over-stressed DAN! docs and in leading institutions such as MIND, Thoughtful House, and the Rimland Center.  Success in vaccine court depends absolutely on science to show a biologically plausible connection between vaccines and autism.  Sound science must inevitably defeat the Government’s now tiresome refrain is that the kids’ case isn’t even close to this standard of proof, and is based on little more than “junk science” and mere speculation put forth by Sallie Bernard, et al, with respect to  mercury, and by Wakefield, with respect to MMR.  The SP sets the “official” agenda for what’s important (for example, spending a gazilion on the search for the elusive autism gene) and what’s unimportant (spending money on vaccine safety research or to determine whether there’s an association between vaccines and autism) which will drive both public spending and private philanthropy.  The future (recovering kids and preventing new cases) depends on the research funded under this plan as well as that privately funded.  If the Government refuses to look for possible triggers for autism in vaccines, then, obviously, they won’t find them and squander millions looking elsewhere.  New cases will continue to skyrocket.  In one example of stalled but crucial research, NIH has had a chelation clinical trial on the books for two years but hasn’t enrolled a single child; implementation has been held up for “political” reasons masquerading as safety concerns. 

Time to Act Up!

The SP is an unprecedented opportunity to influence federally funded research that can make a difference.  The community risks having little influence over federally funded autism research if we end up with a lame SP because it will have the imprimatur of the CAA, the IACC (with its six voting members from the community), and the blessing of an outside workgroup.  The community must come together, once again, to fight for a strategic plan that will actually matter in the treatment and prevention of autism.  We fought hard for this money and will have to fight again in the appropriations process to actually get the money allocated for autism.  The SP must be an effective marketing document, justifying why we need hundreds of millions for autism research and how it will be spent in a manner that is both effective and accountable.  Stay tuned here following the Workgroup meeting today for a further report and an action plan to include community-wide and individual letters.  Working together, we can craft a plan that will make a difference.

Jim Moody is a Board Member of SafeMinds and the National Autism Association and chairs the government affairs committee of SafeMinds. He is the founder of Citizens for a Competitive Economy. Jim is a practicing attorney and is active in cause-related advocacy for children with autism



Kevin, many people on all sides of the autism debate, both treatment based and pure acceptance based have worried mightily that this might be the goal of all the genetics research. I wrote a HuffPo piece where I questioned whether the "Cure" for autism was going to be the same as the "Cure" (marked decrease) in Down Syndrome, that is to say, pregnancy termination following testing.

I'd prefer that my girls did not have autism, I think I make that quite clear. But I was offered the chance to terminate Bella. I was. My OB knew the stress I had with Mia and Gianna, who were 4 and 5 when I found myself pregnant again (what 36 year old woman has an "oops?" LOL!) I didn't consider it for an instance. And my OB's heart was in the right place in telling me "I had an option."

If Autism Speaks is truly headed for this goal, I think the world should know it, as it's tragic. My girls bring me great joy and I wouldn't trade them, or the path they have led me to, for anything. Not even an easier, richer ($$) life.


Kevin Barry

It's long past time for autism-genetics research to be called what it is: research into markers for genetic counseling, i.e abortion.

For years, the CDC/NIH and Autism Speaks/CAN/NAAR have been quietly spending the vast majority of their dollars on abortion research. Period.

Talk of "gene therapy" is bullshit. Gene therapy does not apply to multi-gene conditions.

From the Human Genome Project website:

“Multigene disorders - Conditions or disorders that arise from mutations in a single gene are the best candidates for gene therapy. Unfortunately, some the most commonly occurring disorders, such as heart disease, high blood pressure, Alzheimer's disease, arthritis, and diabetes, are caused by the combined effects of variations in many genes. Multigene or multifactorial disorders such as these would be especially difficult to treat effectively using gene therapy.”

Even for single gene disorders,

…..“The Food and Drug Administration (FDA) has not yet approved any human gene therapy product for sale. Current gene therapy is experimental and has not proven very successful in clinical trials. Little progress has been made since the first gene therapy clinical trial began in 1990. In 1999, gene therapy suffered a major setback with the death of 18-year-old Jesse Gelsinger. Jesse was participating in a gene therapy trial for ornithine transcarboxylase deficiency (OTCD). He died from multiple organ failures 4 days after starting the treatment. His death is believed to have been triggered by a severe immune response to the adenovirus carrier. “

How are hundreds of millions of federal dollars going to be spent on abortion research?

Teresa Conrick

Damn..I missed this all but it sounds like it went well..right?

Thanks Jim, Mark, and Martha Herbert...and Kelli Ann for your play by play!

I think the *genes only* folks are losing but not without a fight so we need to keep eloquently kicking butt--

Kelli Ann Davis

Mark’s closing remarks:

“To date, no disclosure regarding input rec’d from community” -- Insel’s colleague responded that they are currently in the process of getting the information up on their website.

He cautioned that the IACC was not prepared to deal with the difficult process of implementing a Strategic Plan and made the argument that the IACC delegate the task to individuals who would be more suited to carry out the charge.

Insel responded by saying that “we need people at the table who have the understanding on what/how it needs to be done” and they will be discussing this at the IACC meeting next week.

Suffice to say, Mark should definitely be one of the individuals at the table.

"This is Kelli Ann Davis reporting, over and out." (That was fun to say -- made me feel like a mini-Dan or David ;-)

Craig Willoughby

From the sounds of this meeting, it looks to be going very well. I couldn't join in on the call, unfortunately (Work...ya know how it is), but I would love to read a transcript of it if that is possible. Thanks Kelli for the updates, and thank you Mark and everyone on the call for your hard work.


Did they provide and e-mail address for public comments? I missed it if they did.

Kelli Ann Davis

From Geri Dawson (AS) on Interventions:

"There appear to be effective interventions and we need to understand the mechanisms and why they are effective" and we need to be "learning from them and informing the science."

And she stressed that "the voices of the families" need to be "active participants in the process."

Kelli Ann Davis

Mark is talking about making sure to get the "tone" right in regards to recovery and treatment so as not to continue on in the "disqualifer" mode; i.e; "parents do this BUT...."

Tom Insel agreed and said that "behavioral recovery" has been something they've been hearing about and "very little research has been done on it till now." He is agreeing with Mark that "we need to make sure the tone is not dismissive of the experience of parents and families."


Thank you so much for this post. It's crucial that we all continually audit the activity of the federal government with regard to innovative autism research.

And yes, Mark is doing a fantastic job as I listen in... as are Peter and Martha H.

Kelli Ann Davis


One of the rare opportunities to hear him in action -- and yes, he *is* one of the most diplomatic and eloquent speakers I know. It's why he's always in any important meeting in DC because he's just that good.

So far during this conference call, Mark, Martha Herbert, Issac Pessah, David Amorall (sp?)have been stressing the need for including the need to expand and clarify the need for environmental/biomedical research.

Peter Bell is talking right now about the CAA specifically asking for research into environmental factors and the need to research vaccines specifically.

Peter is saying we need to answer the vaccine question. "Clearly it's intended from the legislation itself that this is an issue that needs to be addressed."


If there is an action called, I'll be there, though I confess to being deeply cynical about the route which CAA has taken so far, about IACC and especially about the NIMH. The following are excerpts from an IACC report which the author attended in 2006. The panel wasn't as dastardly as some have been. What concerns me is if the following is what was made PUBLIC from IACC's deliberations-- in which specific antipsychotics are repeatedly mentioned and referred to as "efficatious" without mention of the studies showing the quarter century decrease in lifespan (20 year Finnish study), massive rates of TD, fatal metabolic disorders, suicide or the fact that this class of drugs, like most, cause or worsen the very mitochondrial dysfunction implicated in autism-- we can just imagine what goes on behind closed doors. The tone of this report, by recommending drugs without mentioning risks, is no different than an AAP meeting in which vaccine risks are never broached. The priorities here are very clear just by the order of panel recommendations (drugs first, environment last). I've heard that psychopharmaceutical drug front groups have been invited to at least one of those "secret" meetings.

Until pharma's death grip can be taken off CAA, I'm not sure what progress can be hoped for, though I'll pitch in to fight for it anyway.

Evaluating Progress on the IACC Autism Research Matrix


"Significant progress has been made in identifying efficacious pharmacological interventions directed at target symptoms.
o Double-blind placebo controlled trials have found risperidone to be an efficacious treatment for irritability and aggression.
o Methylphenidate has been found to reduce hyperactivity in some children with autism and other pervasive developmental disorders.
o Trials are underway examining aripiprizole for its effects on irritability and aggression; olanzapine for its effects on irritability; and escitalopram for its effects on interfering repetitive behavior.

Psychopharmacologists and behavior therapists have begun to interact in meaningful ways. For example, one large-scale study is comparing the effect of risperidone treatment alone versus risperidone plus parent management training on irritability and associated noncompliance.

Although there have been some preliminary attempts at developing treatment algorithms, with some including both behavioral and psychopharmacological approaches, the development of algorithms depends upon having a much fuller range of effective treatments; therefore, evaluation of progress on this element is premature.

The majority of targeted children and adults in schools and communities are also going to be on psychopharmacological treatments. Educational and community interventions need to be better integrated with psychopharmacological interventions.

Pharmacological interventions, particularly for core symptoms of social and language dysfunction, and greater involvement of the Food and Drug Administration (FDA) and the pharmaceutical industry in drug discovery and development".

And last but really least:
"Exploration of the role of the environment".


Mark is eloquently laying it down... I actually got choked up at one point.

Damn, he's good.

Kelli Ann Davis

Mark Rocks!

5 minutes out of the gate and he's already laying it on the line!

"In strategic planning the importance is on where the ship is *heading* not in the details" and he went on to talk about environmental triggers, vaccines, etc...

Whooo hooo.


Listening in right now. Mark is speaking.

Kelli Ann Davis

I encourage everyone to try and participate in today's conference call. It's extremely important that NIMH understand we support Mark (Blaxill) and his valuable input!

I find it absolutely mind-boggling that an agency like NIMH wouldn’t jump at the chance to fully utilize the talents of one of the best strategists in this country (Mark was a Senior VP for Boston Consulting Group for 25 years) and incorporate his ideas into the process!

It’s unacceptable and yes, we need to unite to make sure the mandates from Congress are followed. Jim, you can count me in!

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