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Autism research funding: who is paying and how much?

21 Jul

Ever wonder who is funding autism research and where the money is being spent? If you were watching/listening to the IACC meeting this week, you would have answers to a lot of these questions.

To answer the most basic question, the current annual expenditure on autism research in the U.S. is $225,000,000.

Most of us assume (and we are right) that in the US, the Government is the biggest source of research funding. But as it turns out, fully 35% of the research funding for autism in the U.S. is from private sources. That works out to over $78M in autism research funding is from private sources. Pretty impressive.

Anyone want to venture a guess as to who is the largest private source? Autism Speaks would be a good guess. It was mine. A.S. is a respectable second with $31M, but the number one private source of autism funding is the Simons Foundation, with $43M per year.

In case you want to see the entire breakdown of funding sources, here it is:

Autism Funding by Agency

Autism Funding by Agency

So, now we know where the money is coming from. The next question is “where is it going?” There are pages of detailed information on that in the research portfolio discussed at the IACC, but let’s take the summary view. In specific, NIH collated the research by category. They used the categories from the Strategic Plan:

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

All of these categories are important and each of us will have a different view on the priorities. The issues I want to see get more funding involve figuring out how best to support autistics. In order to do so, I feel the research community has to fill a big gap in their knowledge when it comes to adult autistics.

Or, to put it in Strategic Plan categories, I think category V (where can I turn for services) and, mostly, VI (What does the future hold) need more attention and funding. As autism research funding grows, we should be expanding funding in these areas.

How is funding divided now? Well, here’s a pie chart:

Pie chart showing how autism research funding is distributed.

Pie chart showing how autism research funding is distributed.

Obviously the funding agencies don’t agree with me on priorities. Category V gets 1% of the funding, and category VI gets 5%.

Let’s put this another way: there are by some estimates roughly 1.5M autistics in the U.S. (I know that’s debated, but let’s go with it for a rough estimate). We are spending about $9M on understanding adults with autism. Roughly, $6 per autistic. Does that make sense?

Or, to put it another way, we have 300M people in the U.S.. Each of us is spending, what, $0.005 (one-half cent) a year on studying adults with autism? Surely we can do better than that.

It is worth stopping for a moment to acknowledge that the Strategic Plan is just getting started. The funding levels shown in the pie chart are going to change as the Plan is implemented. But, will research on adults be given high priority?

There are a lot of blog posts and news stories lately talking about how we as a society are not prepared for the “tidal wave” of autistics about to become adults. If that is your position, why not call for better research on adults? Why not call for the sorts of papers that will help you and your soon-to-be-adult children advocate for better services?

Care Clinics and Doctors Data sued

17 Jul

An alternative medicine clinic specializing in autism, Care Clinics of Austin Texas was recently raided by the FBI and the IRS and appears to be shut down.

According to the Quackwatch website In another action, Care Clinics and Doctor’s Data are being sued:

CARE Clinics, of Austin Texas, its owner Kazuko Curtin, its subsidiaries, and Chicago-based Doctor’s Data have been sued for fraud, negligence, and conspiracy

The complaint is being brought by an adult, apparently not autistic, who claims to have been misdiagnosed for heavy metal poisoning. In a step that could have a big impact on the autism alternative-medicine community, the petitioner is charging that the method of testing for heavy metals, specifically that used by Doctors Data, is fraudulent.

It’s worth repeating: it is hard to underestimate the impact of a successful suit against challenge testing to “diagnose” mercury poisoning.

FBI and IRS shut quack clinics

16 Jul

Readers may remember the investigations by health insurers of CARE clinics. Now the FBI have become involved and CARE clinics have shut.

CARE Clinics, an autism clinic on Bee Cave Road that was being investigated by insurance companies over insurance claims, was raided by the FBI and IRS agents today.

The clinic has been closed, perhaps permanently.

Agents are removing dozens of boxes of documents, but they declined to say what they are looking for. They directed inquiries to Special IRS Agent Mike Lemoine, who did not immediately return a call.
[…]
CARE clinics mainly treated children with autism using alternative therapies typically frowned on by mainstream doctors. Though some parents who brought their children to CARE Clinics say they’ve seen improvements in their child’s autistic behaviors, critics say the clinic uses therapies that lack strong scientific evidence. The clinic commonly uses intravenous chelation on patients, a controversial treatment that introduces a chemical solution into the body to bind with a metal or other substance to be removed.

Ritalin and the Health Ranger

5 Jul

According to the Natural News Network they “focus on providing empowering content for intelligent readers.” A recent example is a report on research into potential dangers from ritalin and similar stimulants that are prescribed to an increasing number of children and adolescents for the treatment of ADHD. According to the American Journal of Psychiatry an estimated 2.5 million children and teens in the USA are taking these drugs and their use amongst adults is increasing. So it is important to assess their safety.

Whatever their intelligence, readers are unlikely to feel empowered after reading Mike Adams’ (aka the Health Ranger) recent article for Natural News Network, “Ritalin ADHD Drug Linked to 500 Percent Increased Risk of Sudden Death in Children.”

He tells us that

According to scientific research funded by the FDA and the National Institute of Mental Health, drugs such as Ritalin increase the risk of sudden death by five hundred percent among children and teens

And that is all he tells us. There is nothing else about the research in the article, not even a reference or a web link to the research. We are told that according to other research (again no references are provided) “ADHD drugs stunt the physical growth of children while impairing brain development.”

Then we get the usual tirade about ADHD being a fictitious disease, invented by the drug companies in order to boost profits from drug sales. And of course they are in cahoots with the FDA and the psychiatric profession. This wholesale chemical poisoning of our children in the name of profit is, of course, a holocaust and children are dying day by day while the mainstream media remains silent.

The media are so compromised that our trusty Lone Ranger had to use all his ranger skills to unearth this story. Well no. Actually he set up a Google news alert and read it in the Washington Post and on ABC News. So much for the media conspiracy of silence.

Of course he had to rely on the media because the drug companies are busy supressing negative research and hiding it away in obscure journals aided and abetted by “Corrupt, dishonest psych doctors “ Except that the paper is published in the American Journal of Psychiatry and it is open access so anyone can read it for free.

This conspiracy of silence seems even more unlikely when you read that the study was supported in part by a contract from the Food and Drug Administration and a grant from NIMH (R01-MH56250) and many of the study’sauthors have received funding from drug companies.

Dr. Walsh has received research support from AstraZeneca. Dr. Duan has received research support from Pfizer. Dr. Olfson has received research funding from Eli Lilly and AstraZeneca and has worked as a consultant for AstraZeneca and Pfizer and as a speaker for Janssen. Dr. Greenhill has received research support from Johnson & Johnson, Otsuka, and Forest. The remaining authors report no competing interests.

The study did something very simple.

Mortality data from 1985–1996 state vital statistics were used to identify 564 cases of sudden death occurring at ages 7 through 19 years across the United States along with a matched group of 564 young people who died as passengers in motor vehicle traffic accidents. The primary exposure measure was the presence of amphetamine, dextroamphetamine, methamphetamine, or methylphenidate according to informant reports or as noted in medical examiner records, toxicology results, or death certificates.

So the research team compared deaths in traffic accidents, on the assumption that children’s medication status would have little bearing on survival rates in such circumstances, with other instances of sudden death. They found that the rate of methylphenidate usage for unexplained sudden deaths was five times more than for deaths in road accidents. So does this mean that Ritalin will make your child five times more likely to die unexpectedly than a child who is not taking Ritalin?

Not exactly. The study did find a clear difference in rates of medication between the two groups and subsequent statistical analysis indicated that this difference was significant and not just an artefact. But what does it signify?

Around 4% of American children are currently taking prescribed medications like Ritalin for ADHD. So you would expect that if Ritalin was not a factor in sudden deaths amongst children, we could expect to find around 4% of such children on Ritalin or similar medications. That works out at around 45 children or 22/23 in each group. In fact they only found 12 children on such medications – 10 in the sudden death group and 2 of the victims of traffic accidents.

Rather than Ritalin increasing the likelihood of sudden death, it is plausible to argue from these figures that Ritalin protects against sudden death. Instead of an expected figure of 22/23 Ritalin users they found only 10. and for traffic accidents the figure is even more dramatic – 2 instead of 22/23.

The authors point to all sorts of reasons why their results hould treated with caution: the small sample size; recall bias amongst parents; the rarity of sudden unexplained deaths in children; even the idea that Ritalin protects against sudden death by making children less likely to engage in potentially life threatening actiivities.

If our intrepid health ranger had read the study he would have known this. He would have also known that he has completely misrepresented its findings. Actually, if he had only read the press reports that he links to, he would have known that he has completely misrepresented its findings. I think he does know this and has deliberately misrepresented this study. Either that or he is the victim of his own conspiracy theoryand is totally impervious to any evidence that contradicts his preconceptions.

Whatever the case may be, anyone studying at the University of Google is more likely to get a D minus than a PhD if they rely on the Health Ranger and Natural News for their information. Though to be fair he does do a nice line in organic hair care products from The Valley of Longevity and he will even help you to buy real estate in the actual Valley in southern Ecuador.

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Autism and aspergers are essentially the same

26 Jun

Interesting new study in the upcoming issue of Journal of Autism and Developmental Disorders which examines the historical emergence of the classification of autism alongside the emergence of the classification of Aspergers. Abstract is:

The histories of autism and Asperger’s Disorder (AD), based on original contributions by Kanner and Asperger, are reviewed in relation to DSM-IV diagnostic criteria. Their original articles appear to have influenced the distinction between AD and autism made in the DSM-IV. Based on up-to-date empirical research, however, it appears that AD and autism are not qualitatively distinct disorders, but are different quantitative manifestations of the same disorder. The differences between AD and autism may be a function of individual variability in these areas, not the manifestation of qualitatively distinct disorders. The DSM-IV criteria for AD and autism need to be considered with their historical developments, and based on empirical evidence, the DSM-IV diagnostic criteria may be subject to critical review.

The whole paper is a fascinating and accessible read but its overall conclusion is difficult to resist. Despite certain peoples beliefs that autism (by which I mean classic/severe/whatever) and aspergers (and the artificial construct of HFA) are very different, there is, in reality, very little difference between the two and, as the author argues, are simply slightly differing manifestations of the same ‘thing’.

Sanders (the author) makes the excellent point that the fact that these are seen as two different things is almost certainly due to the fact that Aspergers paper was only introduced into the USA in 1981, one year after the introduction of DSM III. It was further not fully translated into English until 1991. Amazing.

There is apparently talk of separating autism and aspergers in the new revisiion of the DSM. Based on the contents of this paper I’d say that is very premature.

It’s new! It’s spam! It’s revitaPOP: The MB12 Lollipop

23 Jun

I just got a nice spam email from Stan Kurtz, inventor. See, he invented this lollipop with methyl B12 in it to cure…well…almost everything.

Actually, I am a bit confused on that point. I often am from claims in alternative medicine. You see, from his website, Mr. Kurtz states

MB12 is a very unique vitamin and deficiency can affect vision, intestinal function, the ability to protect against infections and toxins, nerve functioning, and DNA replication.

Dang, it protects against DNA replication!?! Does that sound, well, problematic to anyone else? (see comments below. I mis-read the above statement.)

On his website, Stan Kurtz himself tells us that:

What I can tell you is that MB12 truly changed my life. I suffered for years with irritable bowel symptoms, chronic viral infecitons and ADHD and after I took this product I felt better. Since then I’ve personally observed hundreds of people’s lives change through the supplementation of MB12.

You see, it doesn’t “treat” anything, but it changes your life if you have certain disorders. Also, mB12 is “involved in” a whole host of disorders. No direct claims that mB12 supplementation “treats” the disorders. Just a great big implication.

But, then there is the disclaimer. Always a disclaimer. Gotta have a disclaimer.

These products are not intended to diagnose, treat, cure or prevent any disease

No use spending a lot of time on the contradictory nature of claims made by people touting supplements. Mr. Kurtz didn’t invent this sort of doublespeak, and he won’t be the last to use it.

Still, I thought this “revitapop” thing was odd, so I checked a few things out. Like, Stan Kurtz’s otehr website which touts the benefits of MB12, but also states:

Stan has chosen not to sell or profit from the use of this vitamin.

I guess it depends on your definition of the word “sell” or “profit”? $35 for 30 lollipops sounds like there could be room in there for profit.

What also caught my eye was this: “* patent pending”. It caught my eye because I thought, “How can someone patent this?”

I can’t find the patent application for the lollipop version of MB12, but I did find the patent application for his MB12 nasal spray. Patent application US29012039A1.

Claim one of the patent describes the vast number of disorders that are “treated” with this nasal spray:

A method of treating a psychological or neurophysiological disorder, comprising nasally administering methylcobalamin, or a pharmaceutically acceptable salt thereof, to a person in need of such treatment in an amount sufficient to treat the disorder in the person, wherein the disorder is selected from the group consisting of:attention deficit hyperactivity disorder (ADHD), anxiety, depression, stress and chronic stress, socialization problems, mood problems, behavior problems, memory problems, dislexia, depth perception problems, color viewing problems, visual and auditory processing problems, light modulation problems, night vision problems, speech problems such as finding words, apraxia, and articulation problems, sleep regulation problems, eye or muscle movement problems, chronic fatigue problems, digestion problems, sensitivity to chemicals, viral infection, inflammatory conditions such as rheumatoid arthritis, sciatica, and fibromyalgia, asthma, irritable bowel, colitis, tinnitus, migraines, nail biting, and autoimmune problems.

Typical of alternative medical treatments–they treat everything. Always a warning sign, if you ask me. It is interesting to me that autism is not specifically mentioned in the patent. There must be a reason for that.

Is this really new, or novel, as they say in the patent business? It seems that that there is already a patent on nasal sprays to administer Vitamin B12, Vitamin B12 nasal spray and method of use. Filed in 2006, and it mentions mB12.

There is a phrase in patent law: obviousness. Taking one invention, say, mB12 nasal spray, adding it to another supposed invention, treating certain disorders claimed to respond to mB12 is, well, obvious. As they say, anyone “skilled in the art” would put those together.

Even if this doesn’t meet the definition of non obvious, I still think this patent has little chance of success. Consider this paragraph from the US Patent office:

In order for an invention to be patentable it must be new as defined in the patent law, which provides that an invention cannot be patented if: “(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent,” or “(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country more than one year prior to the application for patent in the United States . . .”

(emphasis mine)

Mr. Kurtz’ patent application was field March 17, 2008.

mB12 nasal sprays–as touted by Mr. Kurtz himself–have been discussed online since at least 2005. I guess Mr. Kurtz is counting on the patent examiner not checking the AutismOne website for Mr. Kurtz’ own talk on nasal spray mB12 in 2006. But, even without that, Mr. Kurtz’ own website has discussions of the nasal spray from March 16, 2006– that predates his patent application by 1 year. 1 year and 1 day. Ironic, that.

It will be interesting to see the lollipop patent application. I mean, there are vitamin B12 lollipops already, too. I wonder when Mr. Kurtz first publicly discussed his lollipop invention? Did he shoot himself in the foot here too?

Autism and gender identity

16 Jun

Two abstracts from IMFAR (the International Meeting for Autism Research) caught my eye as they discussed an area I haven’t seen discussed much (if at all): gender identity and autism.

The 2008 paper was from the Autism Research Centre (ARC), R.M. Jones first author, and Simon Baron-Cohen‘s group:

Female-to-male transsexuals and autistic traits.

The second paper had first author I. L. J. Noens ( Katholieke Universiteit Leuven) with collaborators from the Netherlands.

Co-Occurrence of Autism Spectrum Disorders in Individuals with Gender Dysphoria

It isn’t surprising that the ARC paper was looking for support for the Extreme Male Brain theory of autism. They tested transsexuals, female-to-male and male-to-female, “typical” [edit: typical is their term in the abstract] males and females and people with Asperger syndrome. They used the Autism Quotient test. What they found was that male-to-female transexuals and “typical” males and females scored about the same. Female-to-male transexuals scored significantly higher than these groups in AQ, but significantly lower than people with Asperger syndrome. The concluding sentences in the abstract stated:

We speculate that these biological females, being masculinized in their autistic traits, may have had difficulties socializing with a female peer group and therefore found it easier to identify with a male peer group. This research illustrates how carefully selected groups in the population (e.g., congenital adrenal hyperplasia) can inform the extreme male brain (EMB) theory of autism.

I think this speculation is just that–speculation. I am not really comfortable with the speculation either. However, the idea of studying gender identity and autism stayed with me. So, I was very interested when I saw the abstract for the Noens study in the 2009 IMFAR abstracts.

Noens et al. took a different approach. They tested people for autism who were referred to the Amsterdam Gender Identity Clinic.

From April 2004 to December 2007, all children and adolescents referred to the Amsterdam Gender Identity Clinic were screened for ASD features.

Their preliminary results?

Preliminary results indicate that at least 6 % of the 233 referred children and adolescents has an ASD. This percentage remains almost the same for the referrals with a confirmed Gender Idenity Disorder (GID) or Gender Identity Disorder-Not Otherwise Specified (GID-NOS) diagnosis. The group of individuals with ASD and GID (seven adults included) is heterogeneous in various respects: sex (both male and female), GID classification (GID, GID-NOS, transvestic fetishism), ASD classification (AD, Asperger syndrome, PDD-NOS), age of onset of GID (before or after puberty), and developmental trajectory (cross-sex behavior temporary or persistent).

Pretty interesting, if you ask me. 6% of people referred to the clinic had an ASD. Unlike the results from the ARC group, there appears to be similarity in the male and female subgroups.

6%–about 6x the prevalence of autism in the general public. That is worth following up on.

There is, of course, another study one could consider: how many people with ASD’s have GID’s?

Note: I hope I have treated gender identity with respect. If I have made any disrepectful comments, I would welcome suggestions for correction.

2-Fatality HBOT Fire

14 Jun

Admittedly, the future for Francesco Martinizi (the boy who was very badly burned in a fire/explosion in a Florida HBOT clinic while apparently being “treated” for Cerebral Palsy), looked quite uncertain.

As I wrote previously:

Yes, this accident (fire/explosion) is tragic, very tragic. If Francesco indeed survives the injuries he’s apparently sustained, the next couple of months are likely to be very very rough. The situation certainly isn’t helped by the fact that there probably isn’t much in the way of good scientific evidence to support the notion that little 4 year-old Francesco should have ever been in such a facility in the first place.

His future is certain now. Francesco died Thursday.

Media reports:

Child Hurt In Chamber Explosion Dies In Hospital

Boy critically burned in Broward oxygen chamber explosion dies

Boy dies from injuries in hyperbaric chamber blast in Lauderdale-by-the-Sea

Boy injured in hyperbaric chamber blast dies

Previous entries at LBRB:

Fire, Fatal Injury, and Claims of Certification in an Independent HBOT Clinic

HBOT quackery maims 4 year old

Woman and child hurt in HBOT explosion

In Pace Requiescat, Francesco.

Question for commenters: What do you think about the mainstream media’s coverage of this fatality?

Citalopram no good for autism

8 Jun

An interesting study for me personally as it involves a crazymed I’m familiar with – Citalopram (the generic name) brand name Celexa in the US and Cipramil over here in Blighty.

Citalopram is an anti-depressant of the class SSRI which means ‘selective serotonin reuptake inhibitors’. In plain english an SSRI based crazymed stops serotonin being reuptaken and therefore your neurons wallow for longer in it. This is, apparently, good. Why? I don’t know, I am not a scientist, I am a user 🙂 Well, I’m not anymore, I take a different sort of anti-depressant crazymed called Venfalaxine which is an SNRI. I don’t know how that works either but it does and thats good enough for me. Hopefully it has plenty of formaldehyde and monkey kidneys in it.

Anyway, I had no idea that Citalopram was used off-label for autism and when I heard about this study my first thoughts were ‘what the hell did they expect it to do?’ Shortly followed by ‘Citalopram is some serious shit’.

What the hell did they expect it to do? They expected it to reduce repetitive behaviours.

Seriously.

They put these kids on heavy duty SSRI’s because they flapped their hands and rocked back and forth. Excuse me for being a little rude here but so fucking what?

Apparently

Side effects were more common in the children taking Celexa, the researchers found. Those on Celexa were more likely to have increased energy levels, impulsiveness, decreased concentration, hyperactivity, mechanical repetition of the same movement or posture, and sleep problems.

Oh wait, all the symptoms of the beginnings of what to me sounds like hypomania. Which is (gasp!) a side-effect of most if not all SSRI’s.

Because they flapped and rocked and swayed and liked routine. Good call.

“A medication that we thought would be helpful for these repetitive behaviors was no better than placebo,” he [Bryan H. King] says. “That calls into question how or if we should use [Celexa] or even related medications for this purpose.

Yeah? Does it? How about we call into question the necessity of drugging the shit out of a kid because s/he likes to rock and flap?

I have to wonder, I really do. How the hell did this study – which to me sounds more like torture – ever get past an IRB?

Apologies for the rant but this is appalling to me.

A vaccinated vs unvaccinated study

6 Jun

For as long as I can recall, this has been one of the clarion calls of the autism/antivaccine/pro-disease groups – that the only way to know if vaccines cause autism is to do a ‘simple’ study of vaccinated vs unvaccinated populations. Indeed, Generation Rescue carried out an ill-fated phone survey that in reality meant absolutely nothing so badly was it put together and carried out. But even if it _had_ been well designed and carried out the results were not good for pro-disease anti-vaccine autism believers:

Number of boys and girls with Aspergers
Unvaccinated: 1% of total
Partially vaccinated: 2% of total
Fully vaccinated: 1%
Fully and Partially combined: 2%

Conclusion: you are 1% more likely to have Aspergers if you have been partially vaccinated than unvaccinated. If you are fully vaccinated your chance of being Aspergers is no greater than if you were unvaccinated.

Number of boys and girls with PDDNOS
Unvaccinated: 2% of total
Partially vaccinated: 2% of total
Fully vaccinated: 1%
Fully and Partially combined: 1%

Conclusion: you are 1% more likely to have PDDNOS if you are unvaccinated. If you are fully vaccinated your chance of being PDDNOS is 1% less than if you were unvaccinated.

Number of boys and girls with Autism
Unvaccinated: 2% of total
Partially vaccinated: 4% of total
Fully vaccinated: 2%
Fully and Partially combined: 2%

Conclusion: you are 2% more likely to have autism if you have been partially vaccinated. If you are fully vaccinated your chance of being autistic is no greater than if you were unvaccinated.

Number of boys and girls with all ASD’s
Unvaccinated: 4% of total
Partially vaccinated: 6% of total
Fully vaccinated: 3%
Fully and Partially combined: 3%

Conclusion: you are 2% more likely to have an ASD if you have been partially vaccinated. If you are fully vaccinated your chance of being autistic is 1% less than if you were unvaccinated.

Overall conclusion: the best way to avoid being diagnosed with an ASD is to be fully vaccinated according to the CDC schedule.

And in September of last year, you may recall the announcement of yet another study that demonstrated there was no link between MMR and autism. During the press conference that launched that study David Kirby asked the lead author – Ian Lipkin – what his thoughts were about a vaccinated vs unvaccinated study. His answer was:

http://webjay.org/flash/dark_player

Very difficult if not impossible.

Given that, the US NVAC vaccine safety group released a draft of their latest thinking on the issue of vaccine safety which touched on the idea of doing this sort of study. The entire section related to this is quoted in full below:

Feasibility study of Vaccinated/Unvaccinated/Alternatively Vaccinated Children

Members of the public, stakeholders, and the Interagency Autism Coordinating Committee (IACC) have articulated interest in a study of vaccinated vs. unvaccinated children to determine if there are differences in health outcomes between groups with varying exposures to vaccines. The Working Group considered drafting a recommendation for an IOM review of the science, epidemiology and feasibility of studies of unvaccinated, vaccine delayed, and vaccinated children. The Writing Group Draft Document on Gaps in Research Agenda further developed this idea. The Working Group wishes to clarify several points on this topic. *First, the Working Group believes that the strongest study design, a randomized clinical trial that includes a study arm receiving no vaccine or vaccine not given in accord with the current recommended schedule, is not ethical, would not pass IRB review, and cannot be done*. The type of study that is being suggested would be an observational study of populations looking at natural variation in vaccination schedules including some children where vaccination is declined through parental intent. All children in the study should be recommended to receive the standard immunization schedule. The Working Group endorses the Writing Group’s recommendation for an external expert committee, such as the Institute of Medicine, with broad methodological, design, and ethical expertise to consider “strengths and weaknesses, ethical issues and feasibility including timelines and cost of various study designs to examine outcomes in unvaccinated, vaccine delayed and vaccinated children and report back to the NVAC.”

The Working Group does not necessarily agree with all of the language in the Writing Group’s statement, but with its general intent. The process should be open and transparent, engaging individuals from a broad range of sectors. Considerations as outlined by the Writing Group and modified by the Working Group are as follows:

– This review should consider strengths and weaknesses, ethical issues and feasibility including timelines and cost of various study designs and report back to the NVAC

– Consideration should be given to broad biomedical research including laboratory studies, and animal studies.

– Consideration should also be given to study designs comparing children vaccinated by the standard immunization schedule with unvaccinated children (by parental intention), and possibly partially vaccinated children or children vaccinated by alternative immunization schedules

– Outcomes to assess include biomarkers of immunity and metabolic dysfunction, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and other developmental disabilities such as epilepsy, intellectual disability and learning disabilities.

– The inclusion of autism as an outcome is desired. This review should also consider what impact the inclusion of Autism Spectrum Disorders (ASD) as an outcome would have on study designs and feasibility, as referenced in the IACC letter to NVAC.

– This review should be conducted expeditiously, in a transparent manner, and involving broad public and stakeholder input.

So, as per a straight ‘vaccinated vs unvaccinated’ study, Ian Lipkin and NVAC Working Group agree that it can’t be done in the most scientifically accurate way and even if it could, it wouldn’t be ethical due to the requirement of excluding children from vaccination.

What they are saying is that a group like the IOM therefore should write up a feasibility study as to how such a study _could_ be done. Without this, its extremely unlikely that a vax vs unvax study will ever fly.

Amusingly, the way that the NVAC Working Group words a possible solution – vaccinated vs unvaccinated via parental choice – sounds pretty much like the Generation Rescue phone survey. And we know how that ended up.

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