Archive | IACC RSS feed for this section

IACC Strategic Plan: Good for us?

6 Mar

By ‘us’ I mean my idea of what the neurodiversity community is.

The IACC released their strategic plan for the future direction of autism research yesterday. This is the basic plan that will form the basis of US (and probably world) autism research for the next 10-20 years. It sets out what it thinks the problems are, what should happen to address those problems and what specific research targets should be set to help address those problems.

So, is it good for us?

On one hand it is. In some places the document makes a clear distinction between the need to address the disabling issues that autism can bring and leaves aside cure language:

It is critical for research to identify the methods and approaches that can be used to prevent the challenges and disabilities of ASD.

Cool. Fine by me. And yet later on in that same paragraph:

Having sound research on the risk factors and the environmental triggers for ASD ultimately may allow us to achieve the goal of prevention: preventing the development of the disorder in some people at risk or reducing the degree of severity in those affected.

Hmmm. Possibly less good. I don’t even really quibble at the ‘reducing the degree of severity’ phrase but prevention? Even researchers as established and august as Simon Baron-Cohen and Tony Attwood have suggested this is not such a great idea. I also don’t believe its a great (or necessary) idea.

There’s lots of good talk about support and education for adults and the need to recognise that autism is not a childhood condition. Amazing that such talk is needed when adults clearly make up the larger percentage of the autism population.

I’m not sure this is a cure-based document. I do think its a define-autism-as-a-medical-condition document which is again not such an accurate idea.

And so we turn to the ‘v’ word. Vaccines are given fairly short shrift in the plan. I didn’t think so at first. When I read this paragraph I was dismayed:

To address public concerns regarding a possible vaccine/ASD link, it
will be important over the next year for the IACC to engage the
National Vaccine Advisory Committee (NVAC) in mutually informative
dialogues. The NVAC is a Federal advisory committee chartered to
advise and make recommendations regarding the National Vaccine
Program. Communication between the IACC and NVAC will permit each
group to be informed by the expertise of the other, enhance
coordination and foster more effective use of research resources on
topics of mutual interest. Examples of such topics include: studies of
the possible role of vaccines, vaccine components, and multiple
vaccine administration in ASD causation and severity through a variety
of approaches; and assessing the feasibility and design of an
epidemiological study to determine whether health outcomes, including
ASD, differ among populations with vaccinated, unvaccinated, and
alternatively vaccinated groups.

This is in section III under the heading ‘what needs to happen’. As I say at first I thought this was terrible. But then I read it again and noticed that what the plan is actually saying is that the IACC and NVAC should talk about these things. They’re not committing money to them.

Vaccines in fact feature nowhere as a short or long term objective in the whole plan and are mentioned again once as a possible research opportunity for people to keep an eye on any developing science.

Overall its a mixed bag. Good on vaccine stuff, good on recognition of need for services, good for recognition of adults but ambiguous at best on its intent for the idea of curing autism.

Advocacy Success: NIMH Use of Stimulus Money Includes Services-Research

5 Mar

If you’ve read what I’ve written on the IACC process, and been able to get past my annoyance with the political maneuverings, you know that I’ve had great hope for the research into areas involving services and adult issues.

Given that, you can imagine that I was quite pleased to get this email from Ari Ne’eman of ASAN (the Autistic Self-Advocacy Network), discussing recent RFA’s (Requests for Applications) for research topics in specifically these areas.

Hello,

Recently, the National Institute of Mental Health released several Request for Applications (RFAs) on services-research topics relevant to autistic people and our families as part of a broader effort to identify NIMH’s priority areas for use of stimulus funds. The RFAs utilize funds specifically allocated under the recently passed American Recovery and Reinvestment Act (aka: the Stimulus bill). As you may be aware, the Autistic Self Advocacy Network and the broader autistic and disability communities have been lobbying for increased representation of services-research and bioethics issues in the NIH research agenda for some time. We’re pleased to share with you these RFAs, which hopefully will yield research that will have a positive impact for our community.

04-MH-104 Access to services by individuals with autism and their families. Engage well-characterized subjects and families in existing autism research activities in preliminary studies exploring variations in access to and use of services, identification of targets for services interventions, and exploration of how variations in service use affect family functioning in diverse populations. Contact: Denise M. Juliano-Bult, M.S.W. 301-443-3364, djuliano@mail.nih.gov

02-OD(OSP)-104* Ethical Issues in the Translation of Genetic Knowledge to Clinical Practice. Genetics and genomics have great promise for the development of personalized medicine, yet the ethical, legal and social implications of both the research and application of genetic and genomic knowledge and technology are far reaching. Studies are needed to better understand the factors that influence the translation of genetic information to improved human health and the associated ethical issues. Examples of studies include those to address ethical issues related to broad sharing and use of new genetic information and technologies for research to improve human health, human subjects protection in genetic and genomic research, the identifiability of genetic/genomic information and how our understanding of identifiability is evolving, return of research results and incidental findings to subjects, alternative models of informed consent for broad data sharing for research, and the impact of intellectual property (IP) issues on development of new technologies. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NIMH Contact: Jean Noronha, Ph.D., 301-443-3367, jnoronha@mail.nih.gov

05-MH-101* Leveraging Existing Healthcare Networks for Comparative Effectiveness Research on Mental Disorders and Autism. Existing large integrated healthcare networks are needed to more efficiently conduct large-scale effectiveness trials in “real-world” patient settings. The NIMH solicits individual or collaborative, linked grant applications from researchers with experience conducting studies within large integrated healthcare delivery systems to develop and test infrastructure to efficiently conduct trials on the effectiveness of treatment, preventive and services interventions to improve care for people with mental disorders and autism. Applicants can propose studies to 1) demonstrate the ability to identify, recruit and enroll large patient populations into clinical trials, 2) harmonize electronic medical record data across multiple integrated systems for research use, 3) pool data for common analyses, and 4) build capacity for the collection and storage of biologic material. Contact: David Chambers, D.Phil., 301-443-3747, dchamber@mail.nih.gov

05-MH-103* Collaboration with AHRQ Comparative Effectiveness Research Program
In FY09 and FY10 the Agency for Health Research and Quality (AHRQ) plans to support research grants (PA-09-070) on comparative effectiveness of clinical treatments and services as authorized in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) Section 1013. MMA section 1013 mandates two mental health categories: Depression and other mental health disorders; and Developmental delays, attention deficit hyperactivity disorder and autism. NIMH is interested in funding ancillary studies including but not limited to: 1) studies on the comparative effectiveness of important new or existing technologies; and 2) assessment of the comparative effectiveness of treatments that are commonly administered to children but have been evaluated for safety and effectiveness in adult populations. Two year studies will contribute to successfully implement the mental disorders components of MMA Section 1013 by utilizing AHRQ networks ( e.g. EPCs, DEcIDE, CERTs, PBRN, ACTION, etc) to generate information for health care decision-making. Contact: Agnes Rupp, Ph.D., 301-443-3364, arupp@mail.nih.gov

04-MH-105 Developing interventions and service delivery models for the transition to adulthood. Conduct pilot studies to develop and test developmentally appropriate, evidence-based prevention interventions and service delivery models for youth with who are at high risk for, or experiencing severe mental illnesses who are transitioning to adulthood. Studies would propose strategies to address discontinuities in service systems and health care financing. Contact: Joel Sherrill, 301-443-2477, jsherril@mail.nih.gov

Furthermore, NIMH also released the funding of the Inter-Agency Autism Coordinating Committee (IACC) Strategic Plan as an RFA. ASAN has been active in lobbying for the inclusion of quality of life oriented research in the IACC’s priorities since this IACC’s inception in 2007. While having both positive and negative components, the IACC Strategic Plan includes services- and quality of life-research components, including research on meeting the needs of autistic adults. It can be found below.

04-MH-101* Autism: Addressing the challenge. Target research gap areas identified by the Inter-Agency Autism Coordinating Committee (IACC) Strategic Plan for Autism Spectrum Disorder Research, including biomarkers, novel interventions, and new tools for screening, among other topics. Contact: Ann E. Wagner, Ph.D., 301-443-5944, awagner@mail.nih.gov

We encourage you to transmit this information to your contacts in the research and scientific communities, encouraging them to apply for funding for projects that will positively impact the lives of autistic people while working with the self-advocate community to ensure inclusive and participatory models of research, as we practice through our partnership with the Academic Autistic Spectrum Partnership in Research and Education (AASPIRE). Please feel free to e-mail us at info@autisticadvocacy.org with questions on ASAN’s research advocacy and how you can get involved. If you are a researcher, interested in interfacing with ASAN and our research partner AASPIRE on research priorities, design and implementation, we encourage you to contact ASAN Board Member and AASPIRE Project Co-Director Dora Raymaker at dora@aaspireproject.org.

Regards,
Ari Ne’eman
President
The Autistic Self Advocacy Network
1660 L Street, NW, Suite 700
Washington, DC 20036
http://www.autisticadvocacy.org
732.763.5530

Send feedback before tomorrow's IACC meeting

3 Feb

The next IACC meeting is tomorrow. One subject sure to come up is the proposed vaccine initiatives. These are projects that were added to the plan (outside of the normal procedure) and later removed. Instead of actual initiatives (planned research), vaccines are now discussed in the Plan as something the IACC needs to get further input on–from the vaccine experts.

If you think, as I do, that the Plan has been delayed long enough by the organizations promoting vaccine causation, let the IACC know. You can email the IACC at iacc@mail.nih.gov.

Alternatively, as discussed in a comment here a web based form has been set up here to allow you to give feedback easiliy.

You can go to that site, enter your information and message and send feedback to the IACC and Dr. Insel, director of the NIMH and chair of the IACC.

The form has a default message, which I have copied below.

Dear Dr. Insel,

As you are well aware, some initiatives were inserted into the IACC’s Strategic Plan in December which would budget for vaccine related research. As you yourself noted in the January meeting, those initiatives did not go through the standard procedure and were not cleared by the science subcommittees.

I approve of the move to submit those initiatives to a re-vote in the January IACC meeting, and agree with the majority of the IACC members that it is inappropriate to keep these initiatives in the Plan at this time.

In addition, I would like to express my concern that the Strategic Plan process has been significantly delayed already by attempts to incorporate vaccine language, and I would urge you to not allow these delays to continue. Now is the time for the first Strategic Plan to be submitted to congress and for the research called for in the Combating Autism Act to begin.

Respectfully submitted.

It appears that groups such as Generation Rescue are fine with research being delayed as long as it keeps hope alive for the vaccinated/non-vaccinated comparison study.

That’s who the IACC is hearing from right now. Do you want that to be the only opinion they hear?

Autism research is being delayed. Are you angry yet?

3 Feb

The Strategic Plan–the document which outlines how the HHS agencies are supposed to conduct autism research in the next few years–has been seriously delayed by repeated attempts to insert vaccine language.

The Plan is basically ready to be finalized. Months later than it should be because, well, people (read: Lyn Redwood) keep monopolizing the time for the meetings to discuss vaccines.

Would you like to see autism research move forward? Would you like to see the Combating Autism Act money actually appropriated and spent? Or, would you like to see future meetings continually monopolized by this one question?

If you are like me, you would like to see good research start. I’ve listed some of the initiatives that are stalled below. Good stuff. If you would like those projects to start sooner rather than later, send an email to Dr. Tom Insel, director of the NIMH and chair of the IACC. Let him know that it’s time for the IACC

Here are some points–

1) The Strategic Plan process has been significantly delayed by vaccine-oriented autism organizations

2) The proposed vaccine initiatives have not been checked by science subcommittees. I.e. they were inserted outside of the regular procedure.

3) Combatting Autism Act funded research has been stalled by the political maneuverings of the vaccine-oriented autism organizations.

4) It is time to put the CAA to work.

Here, I’ll make it easy for you: click here

Edit the email however it suits you. Hit send. Let the IACC know that CAA funded autism research should no longer be stalled by people pushing for vaccine research over all else.

Just in case you aren’t annoyed enough, here are some research initiatives that could be starting if the Plan were finalized rather than still in the tedious discussions by those who would rewrite it:

$5M on research for adults, seniors and adolescents:

Conduct at least two clinical trials to test the efficacy and cost-effectiveness of interventions, services and supports to optimize daily functioning for adolescents, adults, or seniors living with ASD by 2012. Estimated cost: $5,000,000 over 5 years.

Study quality of life for adults with ASD:

Launch at least two studies to assess and characterize variation and quality of life in adults living with ASD by 2011. Estimated cost: $1,500,000 over 3 years.

Randomized controlled trials–for both the very young and older kids. Yep, finally the RCT studies for

Conduct five randomized controlled trials of early intervention for infants and toddlers by 2011. Estimated cost: $15,000,000 over 5 years.

Launch three randomized controlled trials of interventions for school-aged and/or adolescents by 2012. Estimated cost: $14,000,000 over 5 years.

Genetic studies, anyone?

Identify genetic risk factors in at least 50% of people with ASD by 2014. Estimated cost: $30,000,000 over 6 years.

Coordinate and implement the inclusion of approximately 20,000 subjects for genome-wide association studies, as well as a sample of 1,200 for sequencing studies to examine more than 50 candidate genes by 2011. Estimated cost: $40,000,000 over 4 years.

And there is a lot more. A lot more including environmental factors, gene-environment interactions, biological markers–all stuff that is supposed to be near and dear to the hearts of the vaccine-orgs. One could understand them stalling the Plan if it was all genetics and adults and other subjects they find uninteresting, but the Plan is chock full of exactly what these orgs have been asking for.

Heck, I don’t see why their membership isn’t up in arms that these projects are being stalled. Just goes to show that the vaccines are really far and away the number one topic. Not surprising, but it is interesting to see them stall their “own” research projects for this one issue.

The vaccine-autism org spin on the IACC

2 Feb

The vaccine-oriented autism orgs are claiming that the IACC acted improperly when they removed the vaccine initiatives from the Strategic Plan. They claim that this wasn’t on the agenda. Uh, yeah.

Let’s take a second look at this, eh? Because, from what I can see, not only is there a lot of spin being added to this story, the spin is filled with hypocrisy.

These vaccine initiatives were added at the December IACC meeting. Here’s the agenda for that meeting. I don’t see where it says, “Add new initiatives”.  And, yet, here they are in the draft of the Plan.  Note that the vaccine initiatives are in all red–they were added at that meeting.

That’s not “according to procedure”, if we take the SafeMinds/TACA/GR/NAA spin where it has to be clearly in the agenda.

It isn’t even “according to procedure” in the real sense.  Science based initiatives are supposed to be generated by subcommittees who vet them based on need and whether they have a reasonable scientific basis.

Or, to put it another way–vaccines were added to the Plan at the last minute as part of an end-run around the system by Lyn Redwood. And, now, she and the vaccine-orgs are complaining that the removal of these initiatives is part of a “improper action” or some such nonsense because it wasn’t in the agenda.

Not merely a weak argument, but hypocritical as well.

Let’s take a look at some similar actions.  The January IACC meeting included an attempt by Lyn Redwood to basically rewrite the introduction to the Plan. (By the way, one of the IACC members called Lyn Redwood out (politely) on her constant attempts to rewrite the Plan, noting how this has delayed the entire process considerably. Thank you, whoever you are.)

Let’s take a look at the agenda for the January meeting. Do you see any mention of rewriting the introduction in there? I don’t. So, what do we have here? We have Lyn Redwood attempting to circumvent the procedure and introduce new initiatives outside of the process. Then, when they are removed, she cries foul, claiming that others are working outside of the process?!?

Clearly, this is a political move.  Adding vaccines to the Plan was a political move, not a scientific move.   The complaints lodged against the removal of the vaccine initiatives are political, not reality based.

And, while all this plays out, good research is stalled.

That’s a complete shame.

Strategic Plan: fact and fiction

2 Feb

If you’ve been reading some of the autism blogs lately, you’d think that the only question that the NIH has to consider on autism is whether to study vaccines. That’s because, it’s all the autism organizations seem to be talking about with respect to the IACC and the NIH.

Yes, I’ll admit I’ve contributed to the pervasiveness of the vaccine discussion by responding to those blogs. Just to get that out.

The big stink lately is the fact that the vaccine-specific initiatives were voted out of the IACC’s Strategic Plan in January. Autism Speaks and the small groups like Generation Rescue, NAA, TACA and SafeMinds (as an aside—why are there so many clone orgs? Do they really represent different views?) all issued statements or harsh words about this change.

The story being propagated is basically this: “All the money is going into genetic research. We asked for this small thing and they blocked it”

So, let’s do something different than the vaccine-orgs, eh? Let’s look at some of the initiatives that are still in the Plan. Let’s discuss what is really happening on that front. There is a lot more to discuss about the reality of the Plan, but I figure since no one wants to actually look at the initiatives, it’s fertile ground.

The Plan is divided into section (think chapters) according to “questions”. Let’s look at a few sections and pick a few initiatives out to consider.

Question 1: When should I be concerned?

Identify a panel of biomarkers that separately, or in combination with behavioral measures, accurately identify, before age 2, one or more subtypes of children at risk for developing ASD by 2014. Estimated cost: $30,000,000 over 5 years.

Develop at least five measures of behavioral and/or biological heterogeneity in children or adults with ASD, beyond variation in intellectual disability, that clearly relate to etiology and risk, treatment response and/or outcome by 2015. Estimated cost: $40,000,000 over 5 years.

Holy Moly! I’d expect end-zone victory dances over something like that–$30M for biomarkers? Another $40M that includes biological heterogeneity? Isn’t this exactly what these organizations claim they want—recognition and research into the biological underpinnings of autism?

Instead of victory dances, we get silence from the vaccine-orgs on these initiatives. It’s all “what happened to vaccines!”

Here’s one that I wouldn’t expect them to trumpet, but my eye was captured by this:

Validate and improve the sensitivity and specificity of new or existing screening tools for detecting ASD through studies of the following community populations that are diverse in terms of age, socio-economic status, race, ethnicity and level of functioning by 2012. Estimated cost: $5,000,000 over 3 years.

My eye was captured, but that’s because I am really into the idea of identifying underserved populations like adults, and racial and ethnic minorities. I don’t expect the vaccine-orgs to support this since admitting there are underserved populations threatens the “epidemic”, so I didn’t expect the vaccine-oriented organizations to comment on that.

OK, let’s move on to the next “question”:

Question 2: How can I understand what is happening?

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. Estimated cost: $6,000,000 over 4 years.

Whoa! Did I read that correctly? $6M for studies on immune system interactions in the development of ASD? And, from the vaccine-orgs that called for this research? The sound of one hand clapping?

OK, the really big study for this section is this one:

Complete a large-scale, multi-disciplinary, collaborative project that longitudinally and comprehensively examines how the biological, clinical, and developmental profiles of children, with a special emphasis on females, youths, and adults with ASD change over time as compared to typically developing individuals by 2020. Estimated cost: $50,000,000 – $100,000,000 over 12 years.

Again, they are tracking the “biological” side of autism. Not a word of welcome from the vaccine-orgs.

The study above is one of the most critical that the Plan can call for, in my most humble opinion. How many times have we all asked or read others ask, “how will things look into the future?” Wouldn’t that really help answer questions about who “recovers”? Won’t Seriously, wouldn’t it be nice to understand how many people show large gains? Although lets face it, it happens even without “biomed”.

And, yes, I am very glad to see the extra emphasis on adults and females as well, by the way.

Question 3: What caused this to happen and how can it be prevented

This is the section where the vaccine initiatives were shoehorned in. Let’s take a look at what is still in.

Check out this big one:

Support ancillary studies within one or more large-scale, population-based surveillance and epidemiological studies, including U.S. populations, to collect nested, case-control data on environmental factors during preconception, and during prenatal and early postnatal development, as well as genetic data, that could be pooled (as needed), to analyze targets for potential gene/environment interactions by 2015. Estimated cost: $40,000,000 over 5 years.

Wow! $40M in gene/environment interactions. How much closer to the supposed agenda of the vaccine-orgs can one get? And yet, once again, the vaccine-orgs aren’t talking about it.

How about two more initiatives:

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 2015. Estimated cost: $10,000,000 over 5 years.

Conduct a multi-site study of the subsequent pregnancies of 1000 women with a child with ASD to assess the impact of environmental factors in a period most relevant to the progression of ASD by 2014. Estimated cost: $10,000,000 over 5 years.

Another $20M on environmental issues.

I think the point is made—just in this list there are something like $100M to $200M in funding for the biology of autism and environmental factors.

Why don’t the vaccine-orgs talk about these initiatives? One could speculate that it hurts their political maneuvering complaining about the removal of the vaccine initiatives. “Senator, they gave us $100M for exactly what we asked for, but we didn’t get everything”. Doesn’t sound so good, does it?

But, and this is important, these same vaccine orgs weren’t trumpeting the inclusion of all these biology and environment initiatives even before the vaccine initiatives were removed.

That’s why I keep referring to them as “vaccine-orgs”. It seems vaccines are the one and only issue they care about. Sure, they gave some lip-service to environment and biology. But now it’s as if these initiatives don’t exist and aren’t important. If you listen to their spiel: “Poor us, we asked for this small vaccine initiative, but all we got was genetics”.

Genetics? Yep, it is in the Plan. And rightly so, I will add. There is real evidence for genetic links to autism. If we are to understand autism, even environmental causes, we need to have the genetic information. Take this initiative, for example:

Identify genetic risk factors in at least 50% of people with ASD by 2014. Estimated cost: $30,000,000 over 6 years.

That’s a big project, and that’s what the vaccine-orgs would like everyone to think is the core of the Strategic Plan. But, as we’ve seen, it just isn’t fair to paint the Plan as emphasizing genetics while ignoring environment and biology.

There is a big push right now to stall the Strategic Plan (as though it hasn’t been delayed enough already by the constant attempts to rewrite the Plan by Lyn Redwood. If you think I am the only one who thinks this, listen to the last IACC meeting.) Yes, the same organizations who called for research into the environment and gene-environment interactions are willing to stall that research for one reason: vaccines.

Who thinks that TACA or Generation Rescue or any of the other small orgs would sit quietly by and see all this research stalled if it weren’t for the possibility of getting vaccines into the Plan?

Why should the rest of us sit quietly and let them stall progress towards a Strategic Plan that includes good research projects on topics like lifespan issues?

We shouldn’t.

Did the IACC act in bad faith?

17 Jan

A slew of Press Releases from Safe Minds and the NAA appeared today decrying the IACC’s re-vote on two pieces of autism/vaccine research. SafeMinds say:

In a highly unusual departure from procedure, government representatives to the Federal Interagency Autism Advisory Committee (IACC) voted this week against conducting studies on vaccine-autism research despite approval of the same studies at their prior meeting. The research was supported by numerous autism organizations and requested by IACC’s scientific work groups and Congress

NAA said:

In an unprecedented move on Wednesday, the Interagency Autism Coordinating Committee (IACC) removed previously approved vaccine safety research from the Strategic Plan for Autism Research objectives…. The committee’s action is in direct opposition to the majority of its public members who support vaccine research, and to the Congressional directive of the Combating Autism Act of 2006 (CAA) which specifically called for research into “potential links between vaccines, vaccine components, and autism spectrum disorder.”

So, there’s a number of issues that need addressing. Lets take them in the easiest to address first.

1) The allegation that the re-vote is ‘highly unusual’ or a ‘departure from procedure’ or ‘unprecedented’.

Well, it may well be unprecedented. Thats because this is only the second time that vote was taken on this issue. The first time they voted one way, this time they voted another. If this was the 300th vote then NAA might have a point. As it is, they don’t. They’re using these as Scare Words to make the situation sound alarming.

I’ve talked to a number of people who attended the IACC meetings both in person and via the phone. The claim that the re-vote was a ‘highly unusual departure from procedure’ is rubbish. Why? *Because there is no procedure* . One person I spoke with said:

[There is]…no requirements other than to vote on approving or not approving the plan. There is not even a requirement to vote on individual initiatives!

Another person said:

[T]here are some rules–e.g they can’t hold a meeting later than the agenda says. In December, Lyn [Redwood] was calling for people to work into the night, but Insel canned it saying the rules are very clear on that.

But in the matters of voting, re-voting etc everyone was in total agreement. There is no procedure. This puts an instant black mark against the NAA and Safe Minds c;aims and reveals it as an attempt to hype up the situation by using Scare Words.

2) The claim that the CAA specifies vaccine specific language

The NAA say in their press release that:

The committee’s action is in direct opposition to…the Congressional directive of the Combating Autism Act of 2006 (CAA) which specifically called for research into “potential links between vaccines, vaccine components, and autism spectrum disorder.”

This is quite simply not true. Nowhere in the CAA is that sentence used. In fact, nowhere in the CAA do the words ‘vaccine’, ‘vaccination’, ‘immunize’, ‘immunization’, ‘inoculate’, inoculation’, ‘thimerosal’, ‘mmr’ etc appear. Don’t take my word for it. Download the Act and search for yourself. I guess somehow, the NAA made a terribly unfortunate accident and confused the CAA itself with this Senate discussion _about_ the act. A discussion which has no bearing whatsoever on the legal _contents of the Act itself_ .

3) The insinuation that because _they_ voted for vaccine specific research, that they speak for the majority of the autism community

The NAA’s press release quotes a Ms. McIlwain as saying:

It’s no wonder parents around the country are questioning vaccines when government agencies refuse to investigate legitimate vaccine safety concerns

Safe Minds Lyn Redwood said:

“Advocacy groups and legislators have been marginalized in this process.”

As we’ve seen, legislators have not been marginalised. Certain advocacy groups may well have been. Boo-hoo. Its about time we asked ourselves the question: do these co-called advocacy groups actually accurately represent individual opinion?

In the Summer of 2008, the NIMH asked for public comments about the IACC’s Strategic Plan. This was following the NIMH’s Director Tom Insel statement to Lyn Redwood of SafeMinds during the Nov 21st 2008 IACC meeting:

We’ve received public comments on both sides and comments that make it clear that vaccines have no place in this report.

If one visits the public comments page (see link above) and does a search for the word ‘vaccine’, this is what you get:

Out of 148 total responses, 52 (35%) specifically mention vaccines, asking for research. 18 (12%) specifically mention vaccines, asking for the IACC in various ways to discount the vaccine idea. This leaves 78 (53%) who are so uninterested in the vaccine idea they don’t even mention it.

Or, to put it another way, 65% of responders did not ask for vaccine research.

I think this is pretty clear. When 65% of people who are interested enough in autism to respond to a request for public comments don’t ask for vaccine research then the 35% who do cannot claim to be in the majority, or to hold the leading opinion on the matter.

So lets recap. The re-vote was not unprecedented. It did not go against procedure. The CAA does not mention vaccines anywhere in the entirety of the bill. The majority of people who are interested in autism aren’t interested in vaccine research.

I object! (Part 3)

20 Nov

If you’ve been reading these past few days, you know that I find a recent letter sent to the IACC by a number of autism organizations to be, well, objectionable (hence the post titles!). I’ve noted that I don’t like the way they claim backing from a united “autism community”. I don’t like the way they are presenting their arguments in their letter (here and here).

And now, for the last part of their letter.

Bullet point (d), or, we want a bigger say

Provisions for accountability and evaluation for the research spending are absent. Adoption of oversight, review and evaluation mechanisms, such as an Autism Advisory Board and a Department of Defense grant review model, should be added to the plan.

They are asking for an “advisory board” or AAB and a grant review system. Generation Rescue attempted (and apparantly failed) to get an AAB put in place by lobbying he Secretary of Health and Human Services. Now they are pushing the IACC to institute an AAB and also add DoD grant review model.

Let’s look at these proposals one at a time, starting with the AAB.

This is not the time to institute the Autism Advisory Board. President-elect Obama will soon be in office. He has specific ideas on autism and disabilities in general. These include an “autism czar” to coordinate autism activities. Let Mr. Obama and his team make the next changes in the structure of how autism research activities are conducted.

Second, the IACC is already an advisory board. Why are people asking for a second layer, when the IACC process has been working well? OK, you got me, it’s a good bet that these people don’t think the process has been working well. If I were to venture a guess, they are unhappy about the lack of a prominent statement about the “epidemic” and/or “vaccines” within the Plan.

Would an Advisory Board change that? Let’s look at how the Advisory Board is mentioned in the report that accompanied the CAA (note that the “autism advisory board is not mentioned within the CAA language itself):

[congressional report] The committee further re-examined the Interagency Autism Coordinating Committee (IACC). In particular, the committee wanted to increase the amount of public participation (from two individuals) to at least six. In addition, the IACC has been tasked to make recommendations to the Secretary regarding the public participation in decisions relating to autism spectrum disorder. For instance, the committee notes that the IACC may recommend providing other, additional, formal mechanisms, such as an Autism Advisory Board, to provide additional public feedback and interaction. Further, the Secretary may opt to provide such a mechanism without the recommendation of the IACC.

The committee expects that the IACC will be the primary mechanism for the coordination of all research, surveillance, and early detection activities within the Department of Health and Human Services. As agencies implement specific activities related to autism spectrum disorder, they should strongly consider those activities outlined in the Autism Research Matrix.

So, even if an Advisory Board were formed, it would still be the IACC that has the task of coordinating autism activities within HHS.

That would seem to me to be a potential reason why they are now asking for something akin to the DoD grant review process–to add some actual power–oversight and control–to the new “advisory” groups they are proposing.

Again, perhaps someone can correct me here in what I am about to say. But from my perspective I can’t see why the NIH needs a second layer of grant review. For the DoD, an agency that is not primarily involved in medical research, I can see a review board. For the NIH, an agency whose functions already include a peer-review grant process, I don’t see that the case is very clear at all for an additional review board. Let the NIH do what it is chartered to do.

Let’s look at that last bullet point from the letter:

[Letter]The planning process diminished the voices of important segments in the autism community. Future activities related to the SP should ensure integral participation of the diverse community representing families and individuals with autism.

First, I’d switch the wording in that last sentence to “….representing individuals with autism and their families.” (and I wouldn’t object at all to people who would change it to “…representing autistics and their families”)

Second, the very segments of the autism community who are signing this letter were given ample opportunities to be heard. IACC meetings have been dominated by a very few with a vary narrow message. An entire “Town Hall” meeting was held on the West Coast to obtain more input. Letters have been sent, investigations mounted and pressure applied. It is quite a stretch to state that voices were “diminished”.

Having your voice “heard” and having your requests acted upon are very different things, however. And that is the flaw in the logic of this letter: the voices were heard, but it appears that they carried a message that didn’t meet the basic criteria for inclusion in the Strategic Plan: a basis in sound science.

To take a recent example: People can say over and over, “we want research into chelation”. But, if (a) there is no reason to suspect chelation would help as autism is not heavy metal poisoning, (b) there is a possibility that chelation could hurt as demonstrated by recent rodent studies

Conclusion, or, tell them again

[letter]We ask that the IACC approve these specific action items: (a) adoption of amendments to the plan responsive to the above 5 concerns; (b) specification that research spending be at least the CAA minimum and establishment of a workgroup to be convened in January 2009 to develop recommendations to the IACC for increasing the research spending to at least that minimum and adding objectives which will bolster research on the environment, gene-environment and treatment; (c) inclusion of oversight provisions including an AAB and DOD-model review process; and (d) specification that oversight bodies and workgroups have strong and diverse community representation.

Which pretty much summarizes the bullet points above. My eye was drawn to the idea that a workgroup be convened in January 2009. Why? Could it be that they would like this workgroup to be a fait accompli when President Obama takes office? Again, let Mr. Obama put his plans into action.

The final short paragraph caught my eye as well:

[letter]Each day, decisions are being made on autism research by NIH and other federal agencies which are outside of the SP. It is imperative that the plan be improved in the areas noted above at the November 21, 2008 IACC meeting.

The strategic plan (SP) is not approved yet. By definition, decisions are being made that are outside of the Plan. Also, I sincerely hope that decisions continue to be made outside of the Plan. Who can predict what may happen in the next few years that may require action outside of the Plan? As the old saying goes, if we knew what the answers were going to be, it wouldn’t be “research”. I really have a hard time figuring out why they included that sentence in this paragraph.

The letter is then signed:

Autism New Jersey (formerly COSAC)
Autism Research Institute
Autism Society of America
Autism Speaks
Generation Rescue
National Autism Association
Organization for Autism Research (OAR)
SafeMinds
Southwest Autism Research & Resource Center (SARRC)
Talk About Curing Autism (TACA)
Unlocking Autism

Much speculation could be had about what tradeoffs were made in order to get all these groups to sign the above letter. It isn’t much of a stretch to say that the letter doesn’t go nearly as far as many of the signatories would have gone on their own in the area of mercury and vaccines.

It is notable that Autism Speaks signed on to a letter with a number of groups that have been quite negative towards AS (to put it mildly). It is also notable that at least one, and this one major, autism research organization is not represented on this list.

I realize it is just one rather short letter, and my responses have been rather long in comparison. I also realize that many of these points are probably obvious to those at NIH and/or working on the IACC. And, yet, I somehow had to do this!

On to more important topics soon!

I Object! (Part 2)

19 Nov

It’s amazing that a relatively short letter could be so objectionable as to take multiple blog posts to discuss.

And, yet, here I am, on my third post. You can read the other two, I Object (Part 1) and Why should the Strategic Plan include vaccines.

Continuing on with bullet points (b) and (c)…

Bullet point (b), or “you are leaving money on the table”

[Letter](b) The plan fails to allocate commensurate resources. The CAA authorized $645 million for NIH research over five years. The plan falls short by close to $200 million. Given the urgent situation, we consider the CAA allocation to be a minimum requirement for federal agencies and feel that even greater resources are needed.

Who is going to say no to “we should apply more resources to the situation”? Certainly not I. But I’m not an MBA. I count resources in terms of how many good research groups are doing quality research in relevant areas. Counting the money, that comes second.

This is similar to the method used by the IACC. People tend to think–and this letter helps perpetuate–the idea that the CAA appropriated money and that the IACC worked from that budget to create the Plan.

Both ideas are incorrect.

First, in admittedly confusing language, the CAA authorized the appropriations. The CAA states, “…there is authorized to be appropriated..”, not, “this amount is appropriated”. Another way to look at it is to see how often “subject to the availability of appropriations” is used in the text of the CAA. It isn’t as though there is a bank account with $645M waiting to be tapped into.

Second, the IACC did not work from a budget and then decide on a Plan. They didn’t say, “Well, we’ve got $645 million, how will we spend it?” What they did was say, “what needs to get done?”. Near the end of the process, they passed the Plan on to the implementation subcommittee to draft the budgets for the various projects.

This sounds like the much more defensible method. The IACC can go to congress and say, “this is what we need to get the job done.” Had they come up with a budget higher than the CAA allocated, they would have been in a good position to ask for more. They are (I hope) in a good position to get their budget fully funded–they can defend why they came to the total cost in their budget.

That said, of course I’d like to see more research funded. But, I’d like to stay on a friendly partnership with the NIH too. Presenting their actions inaccurately (as this letter appears to do) doesn’t accomplish that in my mind.

let’s look at what the CAA authorized to be “appropriated“:

[Combating Autism Act]`SEC. 399EE. AUTHORIZATION OF APPROPRIATIONS.
(a) Developmental Disabilities Surveillance and Research Program- To carry out section 399AA, there are authorized to be appropriated the following:

`(1) For fiscal year 2007, $15,000,000.
`(2) For fiscal year 2008, $16,500,000.
`(3) For fiscal year 2009, $18,000,000.
`(4) For fiscal year 2010, $19,500,000.
`(5) For fiscal year 2011, $21,000,000.

`(b) Autism Education, Early Detection, and Intervention- To carry out section 399BB, there are authorized to be appropriated the following:

`(1) For fiscal year 2007, $32,000,000.
`(2) For fiscal year 2008, $37,000,000.
`(3) For fiscal year 2009, $42,000,000.
`(4) For fiscal year 2010, $47,000,000.
`(5) For fiscal year 2011, $52,000,000.

`(c) Interagency Autism Coordinating Committee; Certain Other Programs- To carry out section 399CC, 409C, and section 404H, there are authorized to be appropriated the following:

`(1) For fiscal year 2007, $100,000,000.
`(2) For fiscal year 2008, $114,500,000.
`(3) For fiscal year 2009, $129,000,000.
`(4) For fiscal year 2010, $143,500,000.
`(5) For fiscal year 2011, $158,000,000.’.

So, the $645 million number comes from section c. Two things to notice. First, there are large sums in sections (a) and (b) as well. I hope they are getting appropriated. Second, notice that there is money budgeted for 2007 and 2008 in that number. Remember that the CAA hasn’t been funded yet? Has NIH been sitting on their hands, waiting for the budget before they do autism research? Hardly.

The NIH budget for autism in 2007 is estimated at $127 million ($27M more than the CAA called for all IACC sponsored research, which includes CDC and other agencies). Similarly, $128M is the estimated budget for 2008 ($14M above the IACC budget).

Perhaps I am missing something. It is quite possible. But it appears to me that the NIH is working in good faith here.

Again, given the urgent need–to identify and serve the underserved in this country–I would consider there to be a great reason to increase resources applied by the IACC. I just don’t think that is want the signators of that letter had in mind. Consider the next point they make:

Bullet point c, More environmental research, or, what happened to the “V” word?

[Letter]Research on the environment, gene-environment interaction, and treatment are underrepresented in the draft plan. The plan should apply additional resources to these areas.

As already discussed, I found this statement interesting for what it doesn’t say, far more than what it says. What it doesn’t say explicitly is “mercury” or “vaccines”. As noted in that previous blog post: if the signatories of that letter are OK with this wording, it should be OK in the Strategic Plan.

Sullivan’s take

The order of these two bullet points sends a clear message: The Plan doesn’t use all the money “appropriated” and, yet, the Plan should put additional resources into environment and treatment.

Or, “why don’t you take some of the $200 million and spend it on these areas?”

It would be a good question if that was the way the process worked. (A) the money wasn’t appropriated (so there isn’t $200M sitting unused) and (b) the Plan was built on a “what needs to be done” basis, not “how much do we have to spend” basis. The push for more environment/treatment really needs to be justified in terms of “what needs to be done”.

But, again, I’d agree that more resources would be welcome. And, again, I would suggest attempting to meet the great need of serving the underserved. Research into services like the Taft Transition to Independent Living program comes to mind.

more to follow…

I object! (Part 1)

18 Nov

If you’ve been reading LeftBrainRightBrain lately, you know about “The Letter“. If you haven’t, here’s a quick introduction: A number of autism organizations drafted a letter and submitted it to the members of the Interagency Autism Coordinating Committee (IACC). The letter attempted to invoke “the autism community” (see the AoA blog post for more on that) and that was objectionable to me. Kev took up the idea of Who makes up the autism community. It is clearly an important discussion–there are over 100 comments for those two blog posts.

I’ve been told that the letter marks an achievement in advocacy–bringing together all these groups. And it was–someone got Generation Rescue to accept a document that didn’t explicitly call for research on vaccines. Whatever underling who told the top people there, “this is the best you are going to get” was pretty brave.

But, Let’s get back to the letter itself. Because, believe me, I for one have many more objections to that letter. Going through point-by-point takes some, but I present below my views. I’d suggest this: take a look at the letter, see what you may agree with or disagree with, and check back here to see if you agree or disagree with my take.

I’ll be frank. Every section had something objectionable in it.

Let’s take a closer look at the letter, shall we? I’ll add my thoughts section by section, starting in this post with the introduction and the first bullet point.

Introduction, or, “we are united”

[Letter]November 12, 2008

RE: Concerns on Draft IACC Strategic Plan

Dear Members of the IACC:

The Combating Autism Act required the IACC to prepare a strategic plan for autism research in order to enhance the quality, effectiveness, and overall benefits of autism research spending within HHS agencies. While the 2008 planning activities reflect improvements relative to earlier Autism Matrix efforts, ultimately the draft plan and the planning process have fallen short. Autism advocates have identified a range of deficiencies and each may place priorities on different concerns. Nevertheless, as a community we are united in expressing our disapproval of the draft plan for the reasons outlined here.

Ouch–there it is: “Nevertheless, as a community we are united in expressing our disapproval of the draft plan for the reasons outlined here”. For any confused as to what “community” means can read the title of the Age of Autism blog post, “Autism Community “United in Expressing Our Disapproval” of the NIH Strategic Plan for Autism Research.”

That’s been discussed a lot (feel free to join in) here and here.

But, let’s look at the substance of the Letter. They make a number of bullet points, (a) through (e).

Bullet Point (a), or “no Urgency”

[Letter](a) The plan fails to communicate a sense of urgency reflecting the alarming increase in prevalence and autism as a national health emergency. The beginning pages of the plan should embody urgency and the critical need of the government to apply the resources to address a crisis situation.

Variations on the word “urgent” are used at least 5 times in the Draft Strategic Plan.

What do they want? They want the Plan to specifically state that autism causes “considerable human and financial toll”, as support for the greater need for “prevention and treatment”. Those are speculations, those are statements from SafeMinds in complaining about the “Strategic Plan” in a previous letter.

Sullivan’s take on “urgency”
When I think of “urgent” in regards to autism, claiming an epidemic is not high (or anywhere) on the list. Finding better ways to help people with autism, yes, that would be high. In terms of the “alarming increase in the prevalence of autism”, I also see things differently that the authors of this letter. I see great strides in identification more people with autism. But, I see a job that is not complete. Racial and ethnic minorities are vastly under-represented in the current autism counts. Autism counts vary significantly by geography. Lastly, but certainly not least in importance, there is likely a vast pool of undiagnosed, underserved adults in this country. But, that is a topic where the mantra “absence of evidence is not the same as evidence of absence” is ignored in place of promoting an epidemic.

Ignoring the underserved is a truly shameful position that these organizations have taken.

However, I am pleased to see that within the Plan, ethnicity, race and lifespan issues are prominent. There is even a prominent statement in the introduction of the Plan on lifespan issues:

[Strategic Plan] Lifespan Perspective: Historically, ASD has been characterized as a disorder of childhood. Although most individuals with ASD will not outgrow their diagnosis, their symptoms will change in form and severity over time. There was great support during the development of this Plan for more research on ASD in older individuals, especially the need for practical strategies for increasing the quality of life and functioning of adolescents and adults with ASD. As individuals with ASD advocate for themselves and expand our knowledge of their experiences and needs, they become partners in the research effort.

Does that rise to the level of “urgency”? I don’t know, I’ll take “great deal of support” happily.

Urgency or politics?
The issues noted above highlight what I see as a big problem with this letter: it is attempting to make the Plan a political document, possibly acknowledging the “epidemic” of “vaccine injury” autism. I am not naive enough to think that there are no politics involved in government sponsored medical research, but the backbone of the NIH process is scientific peer review of research proposals. I’d rather see the Plan document stay closer to that ideal than become political fodder in a struggle that is ripping our community apart.

Such a short letter, so much to discuss. And, we are only at the first bullet point! But, even at this point, it is clear that this is a letter that doesn’t come close to representing the views of this member of the greater autism community.

More to follow…

← Older Entries
Newer Entries →