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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.

Are autism organizations acting in good faith?

19 Jan

As one might imagine, this is a follow up post to Kev’s post, Did the IACC act in bad faith?

Obviously, much damage control is ongoing right now. Some autism organizations were hoping for a document from the U.S. Federal Government indicating that vaccines might be implicated as a causal factor in autism. No surprises there. They managed to get some language and a possible research project into an early approval stage for inclusion in the IACC’s Strategic Plan.

Now, these same autism organizations are crying foul that the vaccine language was removed. Autism Speaks has pulled support for the Plan under the cover story that they are upset at the process–that a “previously voted-on decision” was revisited without “forewarning”.

Autism Speaks today decried a vote by the Interagency Autism Coordinating Committee (IACC) to reverse a previously voted-on decision to approve objectives relating to vaccine safety research as part of its deliberations for the Strategic Plan for Autism Research. The decision to debate removing these objectives was not posted on the meeting’s agenda, nor were the public members given any forewarning that this section of the plan – which was resolved at the previous IACC meeting in December—would be revisited. As a result, Autism Speaks is withdrawing its support for the Strategic Plan.

Bob Wright, founder of Autism Speaks, stated “Because of this surprise tactic, we now have a plan that is tainted and cannot be supported by the autism community.”

So, this wasn’t on the agenda, so it is a “surprise tactic” and this is why the process is “tainted”. Somehow, this just didn’t ring true to me when I read it.

Anyone else check the actual agenda? In case you don’t want to click on the link, here it is:

Time Event
8:00 Registration
9:00 Call to Order and Opening Remarks
Thomas Insel, M.D.
Director, National Institute of Mental Health and Chair, IACC
9:05 Brief Introductions of IACC Members
9:10 Review and Decisions: IACC Strategic Plan for ASD Research: Introduction
Thomas Insel, M.D.
Director, National Institute of Mental Health and Chair, IACC
10:40 Break
10:45 Continuation – Review and Desicisons: IACC Strategic Plan: Budget Recommendations
12:15 Lunch
12:45 Continuation – Review and Decisions: IACC Strategic Plan: Budget Recommendations
1:15 Review and Decisions: IACC Strategic Plan: Finalizing the Plan
2:00 Break
2:10 Open Session for Public Comment
2:30 Closing Comments and Adjournment

What are the main parts of the agenda? “Review and Desicisons: IACC Strategic Plan: Budget Recommendations” and “Review and Decisions: IACC Strategic Plan: Finalizing the Plan”

Pretty broad agenda item there. Definitely broad enough to cover revisiting the vaccine proposals. Not a “surprise tactic”, not something outside the agenda. Just an action that probably saved the Strategic Plan from being voted down.

TACA is stating that the IACC “rescinds vaccine research initiatives”. Makes it sound like there was a hard commitment to the research initiatives. There wasn’t: the Strategic Plan wasn’t finalized. They also play the “it wasn’t on the agenda” card, like Mr. Wright.

SafeMinds is stating that the action by the IACC defies “wishes of its own scientists”. No kidding, they say that. They say that it also defies the wishes of “Congress”. As Kev has already pointed out, where does the Combating Autism Act state that vaccines should be researched? (hint, it doesn’t). I guess a couple of people speaking in a Colloquy are all of Congress? Because, that’s the only place where this vaccine language is included related to the CAA–the Colloquy–a couple of short speeches given after the Act was voted upon. There were also arguments made before the CAA was voted on about vaccines, including a lot of lobbying by these same autism organizations that are now crying “foul!”

That tells this reader one very important fact: Congress specifically did not include vaccine language in the Combating Autism Act. Seriously, we likely wouldn’t have a CAA if the vaccine language was included. They wouldn’t have had the votes to get it passed. But, hey, that doesn’t make a good press release, does it?

SafeMinds has gone so far as to pull its support for the Strategic Plan. If SafeMinds’ very own Lyn Redwood would like to follow the example set by Alison Tepper Singer and resign (in this case, from the IACC), I’ve got a few really good suggestions for who could fill the seat.

But pull it all together: Autism Speaks, TACA, NAA…all these press releases are damage control. OK, that and they are jockeying for position to complain to the new U.S. administration about how they have been “marginalized”. But, are they being truthful? Are they, as supposed representatives of the “Autism Community”, using their position wisely?

Let’s face facts: the Strategic Plan was going to be voted down. The majority of the members didn’t want the vaccine language included. The options were simple: revisit the sections on vaccines now and get the Plan passed or have the Plan go down in flames now and rewrite the sections on vaccines later.

Either way, the vaccine language was going to be out.

Doesn’t make a good press release, though, does it? “We were going to lose anyway, but we want to pretend like they acted improperly”. Somehow I don’t see Generation Rescue, TACA, SafeMinds, or the NAA issuing such a simple, truthful statement.

Paul Offit in the New York Times

13 Jan

Paul Offit is in the NYT today talking about his book:

A new book defending vaccines, written by a doctor infuriated at the claim that they cause autism, is galvanizing a backlash against the antivaccine movement in the United States.

which is true. For the first time in the nearly six years I’ve been blogging about autism and vaccines, things are happening beyond the stale, jargon filled denouncements appended to the end of news pieces about autism and vaccines. Doctors in the US and UK are wising up to the very real health dangers – and dangers posed to autism research – posed by the antivaccine/autism lobby. I’ve seen health experts on TV over here, read many interviews with actual doctors and scientists in both countries and am aware of plans to carry the message much, much further and harder than ever before. Its about time.

Offit again mentions the threats he’s received and Dr. Gregory A. Poland mentions threats his kids, something that Offit has also received, as have I and several other autism parents who don’t believe vaccines cause autism. Some scoff at that according to the NYT article. I would suggest that that displays a level of arrogance and head-burying that is unhealthy.

However, I think some of the scientists involved are naive or simply don’t understand the level of blind fanaticism they are dealing with:

If the surgeon general or the secretary of health or the head of the C.D.C. would come out and make a really strong statement on this, I think the whole thing would go away,” said Dr. Peter J. Hotez, president of the Sabin Vaccine Institute, who has a severely autistic daughter…

With respect to Dr Hotez, thats living in a fantasy world. What would happen is that certain factions would simply do what they try to do to Dr Offit, Dr Poland, Dr Shattuck, him (if he knew it), me, Kathleen, Kristina, Amanda, Orac, Joseph, Do’C (the list goes ever on) and now Josh and Ben from Change.org – they would suggest that the Surgeon General had become a pharma shill. They would wheel out the same tired old statements from ex-heads of NIH etc, people who have no relevance and no ideas and the whole thing would just go around and around.

To be 100% honest, the best thing to do with these people is buy them an island somewhere, transport them to it and let them live out their lives totally organically and naturally. Two birds, one stone.

But seriously, you will never, ever get through to these people. They cannot be reasoned with. To quote Lord Byron:

Those who will not reason are bigots, those who cannot are fools, and those who dare not are slaves.

Leading members of Generation Rescue are quoted in the piece:

We have hundreds of fully recovered children. I’m very frustrated that Dr. Offit, who’s never treated an autistic child, is spending his time trying to refute the reality of biomedical recovery.

He…condemned threats generally, saying he had received some himself. “No one should ever do that to another human being,” he said.

This is a constant source of puzzlement to me as I keep hearing about these ‘hundreds of full recovered children’ (didn’t it used to be thousands?) and yet a search of PubMed for these case studies show nothing at all.

So where are they? Much like David Kirby with his claim HHS have said vaccines caused Hannah Poling’s autism when they have not, this is yet another soundbite with no substance at all to back it up. How long can one keep making such wild claims without a shred of evidence to support them? How long before one’s own conscience starts to trouble you?

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.

I agree. But whilst we live in a society that thinks Jenny McCarthy is capable of offering medical advice and the media love celebs more than people it ain’t going to happen. Medical science needs to carry on fighting and fighting harder.

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…

Why should the strategic plan include vaccines…

14 Nov

…if all the vaccines-cause-autism advocacy organizations can’t ask for it?

I’ve been watching the process for the IACC fairly closely. You may have noticed my obsession. One issue that has come up is…you guessed it, vaccines. IACC meetings have been available to listen to by phone. (thank you NIH!) I’ve listened to long…long…long…speeches about the importance of research on vaccines and mercury. It’s had very broad support from…well…Lyn Redwood and Mark Blaxill. Pretty much silence from the rest of the IACC.

That said, I can’t say I am not surprised that an 11th hour attempt to change the process. Yes, according to a letter sent to members of the IACC, “we as a community community” are “united” expressing disapproval for for the Strategic Plan in the current form. This isn’t new. In person and in letters, members of these organization have co-opted my rights into an “autism community” that supports their vaccine/mercury agenda.

But, it’s worth taking a look at the letter. Alternatively, you could trust me to tell you what I found. Better yet, let me tell you what I didn’t find: vaccines. No mention of the word vaccines…or mercury…or thimerosal…or immunization…or epidemic. I seriously had to check that the search function was working as I read that document.

Why point this out? To jab a little fun at our good friends? No, there is a much more important message here:

Take a look at the organizations that signed this letter:

Autism New Jersey
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

If they can’t agree on including “vaccine”, “mercury”, “epidemic” or any variation of those words—

WHY SHOULD THE IACC INCLUDE THOSE WORDS IN THE STRATEGIC PLAN????

Seriously, there has been a big push to get the IACC to make a strong statement on the vaccine issue. And yet, these words are missing from their own letter.

So, I’ll say it again: if Generation Rescue, SafeMinds and the rest can’t agree to put “vaccines” or “epidemic” in a letter, why should the IACC bow to their wishes and include these terms in the Strategic Plan?

Vocational Rehabilitation and Autistic Adults

13 Nov

I recently saw a paper in the Online First section of Journal of Autism and Developmental Disorders called “Use of Vocational Rehabilitative Services Among Adults with Autism“. I knew I had to read it. It comes from one of my favorite research groups, that of Prof. David Mandell. I’ve been carrying this paper around in my pocket for a month now. It is folded, tattered and filled with highlight marks.

The reason for the delay: how to condense this paper into a meaningful blog post without essentially copying the entire paper? As it stands, this will be a series of excerpts. The reason for blogging it: papers on issues directly related to adults with autism are few. This one looks at what I consider to be a very important question: training to get employment for adults with autism.

One other note: I will skip over the data analysis section. This will be a long post already, and I want to concentrate on the discussion of the results. But, rest assured, they did their due diligence and analyzed the data thoroughly.

So, even though this may not be the best presentation of the study, if I don’t do it now, it may never get done.

Here’s the abstract:

This study examined the experiences of individuals with autism spectrum disorders (ASD) in the US Vocational Rehabilitation System (VRS). Subjects included all 382,221 adults ages 18–65 served by this system whose cases were closed in 2005; 1,707 were diagnosed with ASD. Adults with ASD were more likely than adults with other impairments to be denied services because they were considered too severely disabled. Among those served, adults with ASD received the most expensive set of services. They and adults with MR were most likely to be competitively employed at case closure. Post hoc analyses suggest that their employment was highly associated with on-the-job supports. The results suggest the importance of the VRS in serving adults with ASD.

If you are interested, here is the first page (for free).

The paper points out that adults with ASD require considerable supports, with possibly only 15% achieving independence, and another 20% “functioning well in the presence of community based support.” This points out the great need for studies such as this one. We need a better understanding in order to improve the situation for the estimated 65% who are not independent or “functioning well”.

In the United States, the vocational rehabilitation system falls under the Department of Education, and helps with assessments, diagnosis, counseling, job search assistance, assistive technology and on-the-job training.

The outcomes include “Competitive employment”, which involves integrated settings (with supports as needed) and wages at or above the minimum required by law. Alternatively, Non-competitive employment can be paid below the minimum wage, and can include sheltered employment.

Results were compared for people with ASD, Mental Retardation, Specific Learning Disability (SLD) and Other Impairment Cause (OIC).

Individuals with ASD’s have “markedly different vocational needs than individuals with other developmental disabilities”. And “the small body of research in this area suggests that services provided through vocational rehabilitation programs are less than optimal for individuals with ASD.”

The authors stress, repeatedly, the value of employment. The concluding paragraph starts with the statement, “Work is among the most valued social roles in our society. Many individuals with ASD can achieve successful employment outcomes, despite questions about access and cost-effectiveness.” The value of employment is also spelled out in an earlier section:

Our findings are also important in light of research indicating that supported
employment through vocational rehabilitation programs may improve cognitive performance of adults with ASD (Garcia-Villamisar and Hughes 2007) and generally improves quality of life (Garcia-Villamisar et al. 2002).

They found that at the end of VR training, 42.2% of those with ASD were competitively employed, whith 2.1% employed in a sheltered setting. The remaining (55.7%) were not employed. These results are better than those for the other groups. The numbers for those competitively employed were, 39.4% (mental retardation), 37.5% (SLD) and 35.1% (OIC).

They found that 4.3% of individuals with ASD had cases closed for having a disability “too severe to benefit from services”. Compare this to 2% for those with mental retardation, 0.4% for those with SLD, and 2.2% for those in other categories. So, people with ASD were more likeley to be denied services for this reason. They state that this “hints at the possibility” that “some people with ASD’s may never explore the use of VR services because they (or their families) do not see it as a viable option or are discouraged from seeking services.” This could affect the numbers found for those achieving competitive employment.

The costs were compared:

VR expenditures were much higher for individuals with ASD than for those with other impairments except people with MR. This difference may be due to the additional needs of people with ASD (Muller et al. 2003). Alternatively, the VR system may not be structured to provide services to individuals with ASD in the most cost-efficient manner (Hillier et al. 2007). Both potential explanations beg for additional research on the most cost-effective strategies for achieving competitive employment.

The median costs? $2,380 (ASD), $2,160 (mental retardation), $1,108 (SLD), $1,280 (OIC).

So, yes, the numbers were higher for the ASD group. But even $2,160 per person to me sounds like a pretty darned good investment to get a sizable fraction of a group employed.

The authors noted:

VR expenditures were much higher for individuals with ASD than for those with other impairments except people with MR. This difference may be due to the additional needs of people with ASD (Muller et al. 2003). Alternatively, the VR system may not be structured to provide services to individuals with ASD in the most cost-efficient manner (Hillier et al. 2007). Both potential explanations beg for additional research on the most cost-effective strategies for achieving competitive employment.

There is a lot more valuable information in this paper. One thing that is missing is who funded the research. I’d love to hear that this is the sort of research NIH is sponsoring, and will continue to sponsor through the IACC process.

I’ve already quoted part of the conclusion. I think it worth quoting it in whole here:

Work is among the most valued social roles in our society. Many individuals with ASD can achieve successful employment outcomes, despite questions about access and cost-effectiveness. Individuals with autism and their families should seek out supports and employment; other support providers should emphasize employment as a possible social role; and policymakers should continue to examine ways in which they can enhance the variety and accessibility of supports for adults with autism, including vocational services, in order to ensure that they have opportunities to live and contribute in their communities.

ResearchBlogging.org
Lindsay Lawer, Eugene Brusilovskiy, Mark S. Salzer, David S. Mandell (2008). Use of Vocational Rehabilitative Services Among Adults with Autism Journal of Autism and Developmental Disorders DOI: 10.1007/s10803-008-0649-4

Kirby launches torpedo at Verstraeten, sinks Geier

8 Oct

The thimerosal/autism study by Thomas Verstraeten is one of the big targets for those with the vaccines/mercury cause autism agenda. For what it’s worth, Autism’s False Prophets goes into the history of the Verstraeten study and clearly explains the history of that study.  Not surprisingly, the answer is somewhat different than you might find in, say, Evidence of Harm.

In his recent briefing on Capital Hill,  David Kirby took another jab at the Verstraeten study. He tried to assert that (a) the NIEHS claimed that the Vaccine Safety Datalink was unusable for autism studies and that (b) the CDC agreed. He was incorrect, and, luckily, a staffer caught Kirby at it.

Mr. Kirby is trying to explain his actions in a blog post in which he posts an open letter to that congressional staffer.

Let’s consider something here: the congressional staffer, an M.D., knew enough about the subject to catch David Kirby misquoting the NIEHS. I wouldn’t have been quick enough on my feet to catch the misquote.  Now, David Kirby wants to educate this gentleman. Frankly, the information should be flowing the other way. If Mr. Kirby had shown himself open to such education, say when EpiWonk made it abundantly clear (twice) what Mr. Kirby’s mistakes were, perhaps it would be worth the staffer’s time to discuss this with Mr. Kirby. That said, let’s take a look at Mr. Kirby’s letter.

In regards to Mr. Kirby’s misquotes, he has recently “clarified” his position.  He is writing to the Doctor who corrected him in his briefing here:

As you rightly pointed out (and as I concurred that day) I omitted an important detail in regards to Dr. Gerberdings’s letter to the Committee. I regret that, and never meant to mislead people in the room.

It was a rather artless sin of omission.

I think the lesson for me here is that, when you try to cram a two hour presentation into 25 minutes, it is wise to not include very complicated and, as you put it, “somewhat arcane” details that are difficult to explain in such a short period of time. In retrospect, I probably should have focused solely on the NIEHS report itself, and left the Gerberding letter out of the presentation entirely.

Mr. Kiby iscorrect, it is a confusing situation.  There are two documents–an NIEHS report and Dr. Gerberding’s response for the CDC. But, does that excuse misquoting the head of the CDC in his legislative briefing?

Here’s what David Kirby in his capital hill briefing “quoted” the NIEHS report as saying:

NIH: “We identified several areas of weakness that were judged to reduce the usefulness of the VSD for addressing the potential association between exposure to thimerosal and risk of ASD.”

That isn’t in either the NIEHS report or Dr. Gerberding’s response.  Here’s what Dr. Gerberding actually agreed to:

The panel identified several serious problems that were judged to reduce the usefulness of an ecologic study design using the VSD to address the potential association between thimerosal and the risk of AD/ASD.

Emphasis is mine.  But, we’ve already discussed that: Dr. Gerberding didn’t claim that the VSD has reduced usefulness in addressing the thimerosal/autism question. It made a claim that the ecological studies using the VSD had limitations. But, the recipient of Mr. Kirby’s letter would know that.

Back to Mr. Kirby’s open letter: David Kirby is now presenting his own interpretation of the NIEHS report, in place of Dr. Gerberding’s.

As I interpret things, the panel concluded that the database itself suffered from several weaknesses and limitations, which in turn reduced its usefulness for studies of autism risks from thimerosal (ie, Verstraeten) AND ALSO reduced the feasibility of future studies (ie, ecological ones) that are based on data collected within the VSD.

As EpiWonk aptly pointed out, Mr Kirby’s assertion is not the case. The NIEHS panel suggested a number of possible studies on autism using the VSD.  From the NIEHS report:

An alternate future study design that was viewed positively among panel members was a study of a high risk population, defined, in this instance, as siblings of individuals diagnosed with AD/ASD. A sibling cohort from the VSD would allow comparison of AD/ASD risk in siblings as a function of their thimerosal exposure through vaccination and the sample size would lend itself to supplemental data collection. A related study design based on sib-pairs or sets could be used to address discordant ASD/AD status in relation to thimerosal exposures. Another possibility that generated support by the panel was an expansion of the VSD study published by Verstraten et al (2004). The availability of several additional years of VSD data was seen as an opportunity to provide a more powerful test of any potential association between thimerosal and AD/ASD and would enable reconsideration of some aspects of the original study design (e.g., exclusion criteria). A related idea was to conduct a VSD retrospective cohort study using California-based MCOs linked with the California DDS, which would improve the diagnostic data and provide more complete ascertainment. For each of these designs, the ability to link medical records from mothers with those of their children was deemed critical.

As this reader interprets things, NIEHS seems to find that there is quite a bit of value in the VSD for studying autism, including an expansion of the Verstraeten study.

EpiWonk made the point first, but how can the NIEHS say that Verstraeten study design is not a good and that future use of the VSD is not useful, while at the same time suggest expanding Verstraeten?

The bottom line is that there are limitations to using the VSD alone in ecological studies of autism. One can overcome these limitations by going to chart reviews and other methods–as used in Verstraeten et al. and, more importantly, by VSD studies ongoing at CDC (one of which looks at autism).  As noted by Dr. Gerberding:

The VSD currently has a number of priority studies underway to address a range of important immunization safety questions, none of which utilize an ecologic study design. Instead, these current studies, including one study evaluating associations between thimerosal-containing
vaccines and autism, all evaluate individual-level data. This typically involves the review of individual medical charts to confirm the vaccines each individual received as well as the outcomes being studied. Studies using individual rather than group data provide stronger scientific evidence.

Mr. Kirby seems to be neglecting the fact that the CDC’s ongoing study (and the Verstraeten study) is not soley dependent on the VSD for the data.  He seems to be arguing that since the VSD, as a single data source, has limitations, the CDC can’t use it for any study. It’s like saying,

But, let’s take a closer look at what this says….and what Mr. Kirby is saying: The VSD on it’s own is not a good source of data to look at the thimerosal/autism question.

Now, anyone remember all the consternation that has been created by the fact that the VSD is not open to just any outside researcher?  Why should the VSD be opened to, say, Mark and David Geier?  Could they do the individual level data collection needed to make a VSD study valuable?

Apparently not. Recall this study by the Heather Young and the Geiers: Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink

This was a study paid for by the petitioners in the Omnibus proceding.   It, on it’s own, was bad enough that EpiWonk disassembled it.  Twice.

The recent Heather Young/Geier paper didn’t look at individual level data.  Any future study by the Geiers almost certainly wouldn’t as well.  Given the argument by the NIEHS, Dr. Gerberding…and David Kirby, the above study and any proposed study by the Geiers on the VSD would be useless.

Some how I doubt Mr. Kirby will make statements confirming that. But, I can’t see how he could hold any other opinion, given the arguments he, himself, has made.

Vaccines on the Hill III

26 Sep

Somehow I never thought there would be a “Vaccines on the Hill II”, much less III. That said, a question from Lisa (from about.autism.com) got me thinking and, well, I’d rather do this a post than a response.

I admit, this isn’t directly related to her comment, who commented on how David Kirby makes a point of stating he is not “anti-vaccine”.

Instead this is about frustrations with Mr. Kirby. As an example, let’s discuss how Mr. Kirby “quoted” a response that the CDC made to an NEIHS report in his congressional briefing. Yes, “quoted” is in quotes for a good reason.

On his presentation, page six, Mr. Kirby “quotes” (there’s those quotation marks again!) the NIEHS report:

NIH: “We identified several areas of weakness that were judged to reduce the usefulness of the VSD for addressing the potential association between exposure to thimerosal and risk of ASD.”

With the response from Dr. Gerberding at CDC of:

Gerberding General Response: CDC CONCURS

What was the real quote?

The panel identified several serious problems that were judged to reduce the usefulness of an ecologic study design using the VSD to address the potential association between thimerosal and the risk of AD/ASD.

Emphasis mine.

Yep. Mr. Kirby left out the fact that the NIEHS was specifically talking about ecological studies.

Makes a BIG difference in how that phrase is interpreted. This was a major part of two epiwonk blog posts, here and here. Mr. Kirby’s original blog post on this was retracted, so Mr. Kirby is well aware of the importance of the fact that the NIEHS limited the statement to ecological studies.

By the way, the real CDC response?

CDC Response: CDC concurs with this conclusion and does not plan to use VSD for ecological studies.

They did most certainly not concur with the statement that Mr Kirby “quoted”. Instead, they see the limitation for ecological studies. There is strength in using the VSD. They don’t see it as valuable for discussing the thimerosal/autism question, as we’ve discussed before.

Here’s the NEIHS report, and here, the CDC response.

Mr. Kirby’s “quote” of the NIH was incorrect. This isn’t incorrect in the way Dan Olmsted thinks that “has” vs. “have” is an important difference. No, the quote by Mr. Kirby completely changed the very meaning of the statement that NIEHS made and implied the CDC concurred with.

It sounds like Mr Kirby was caught red-handed trying it too, by a staffer who obviously came in very well informed. The bright side is that the legislature got an idea of Mr. Kirby’s tactics. The down side, they may not realize that the entire autism community is not represented by Mr. Kirby and his tactics.

This misinformation effort has already had an effect. Mr. Kirby’s original treatment of the CDC response made people think that the CDC position is that the Verstraten study was flawed. As epiwonk makes very clear, the opposite is true. The NIEHS panel suggested expanding the Verstraten study (which was not ecological) with additional years.

And people wonder why I get frustrated with Mr. Kirby.

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