Generation Rescue’s Vaccinated/Unvaccinated Study

8 Jun

Generation Rescue and other groups have been calling for an independent study of health outcomes comparing vaccinated and unvaccinated populations. They recently announced at the AutismOne conference that they had announced that they had procured funding for the project. They had been trying to get funding for this project from a settlement from a lawsuit against Airborne. The funds from that lawsuit have not been distributed yet. So if Generation Rescue has funding, it is from some other source.

That said, documents filed in Generation Rescue’s bid for the Airborne settlement money gives us a chance to see their proposed study design. Let me pull some of the highlights out for discussion.

The “purpose” of the grant is listed as:

Funding for study on vaccinated verse (sic) unvaccinated children to ensure the safely and well being of children worldwide.

They request $809,721 for the project.

Here is a segment of the statement of the problem to be addressed:

The U.S. and many other countries appear to be experiencing a silent pandemic with 1 in 5 children now suffering from learning disabilities, sensory deficits, and developmental delays. Neuro-developmental disorders such as autism, attention deficit hyperactivity disorder (ADHD), mental retardation, and cerebral palsy, are increasingly common, very costly, and cause lifelong disability. In 2003, the National Survey of Children’s Health reported that 0.5% (I in 200) children ages 6-17 had autism, 11.5% had learning disabilities, 8.8% had ADHD, and 6.3% had behavior problems. By 2007, the prevalence of autism in the U.S. had risen to 1 in 150 children (Rice et aI., 2007). There are a number of physical ailments that children with Childhood Neuro-developmental Disorders (NDs) typically manifest including: food allergies and eczema, general gastrointestinal distress, constipation and diarrhea, yeast overgrowth, immune system deregulation, sleep disturbances, and high levels of environmental toxins.

Why study vaccines? According to the proposal:

What could be causing these increases in NDs and disability among children in the US.? Hypotheses proposed to explain these increases have included changes in diet coupled with reduced physical activity and/or increased sedentary behavior, low birth weight, stress, medication use in pregnancy, infections and environmental toxins. Although it remains widely debated, certain routine childhood vaccinations have been suggested as contributing to the increase in neuro-developmental disorders. A recent examination of the vaccinating practice of other countries showed that the United States vaccinates children on average double that of all other first world countries; the U.S. uses 36 compared to 18 at other countries. In fact, the United States utilizes more vaccines than any other country in the world yet it has the worst mortality rate among children 5-years-old and under of the top 30 developed countries. Coincidently, some of the countries with the lowest vaccination rates also report the lowest rates of autism. It has been theorized the child’s body is overwhelmed by the combination of heavy metals (mercury, lead aluminum), live viruses (particular from their vaccines), and bacteria. These serve to slow or shut down normal biochemical pathways leading to NDi physical and mental manifestations.

I believe the “recent examination of the vaccinating practice” mentioned in the above paragraph refers to the pseudo-study Generation Rescue generated “AUTISM AND VACCINES AROUND THE WORLD: Vaccine Schedules, Autism Rates, and Under 5 Mortality”, which I discussed at length here. Generation Rescue’s “examination” was amazingly manipulative. For example, they compared a recent study on the autism rate in the U.S. for children born in 1994 to a French study from 1997 on children born between 1976 and 1985. Of course the rate in the US was higher than the rate in France. That doesn’t have anything to do with their current vaccine schedules.

What are Generation Rescue’s research credentials?

Research Programs: With some of the top scientists in the world, research is dedicated to finding more of the causative factors and treatment approaches for children with NDs.

Sort of vague there. I note that Generation Rescue decided not to tout their phone survey as an example of their research efforts. Given that in many cases the survey showed exactly the opposite of what Generation Rescue claimed in their cherry-picked publicity, this is understandable. It is still interesting that Generation Rescue seems to realize that the survey was not an asset.

That said, who are “some of the top scientists in the world”? Although not named in the proposal, it is worth checking who these “top scientists” might be. From their website, here is s Generation Rescue’s “Science Advisory Board”?

Richard Deth, Ph.D.
Professor, Department of Pharmacology, Northeastern University, Pharmaceutical Sciences

Brian Hooker, Ph.D.
Principle Consultant
Brian Hooker Consulting

Jerry Kartzinel, M.D.
Pediatric Partners of Ponte Verde

Woody R. McGinnis, M.D.
Research Coordinator, Behavioral Nutrition

I’ll leave it to you to look these gentlemen up, but they are perhaps not what most people would call “top scientists in the world”. Their papers are not very highly cited autism. Also, Generation Rescue does not appear to be using their “top scientists” for this project. Which begs the question: what is the actual project?

I. Project’s Primary Purpose, and the Need it Addresses. The goal of this project is to test the association between vaccinations and both acute and chronic neuro-developmental disorders and the efficacy of preventive health strategies. This will be achieved by conducting a retrospective cross-sectional study comparing the incidence of chronic illnesses (i.e., asthma, obesity, and eczema), neuro-developmental disorders (i.e., autism, ADHD and learning disorders), and overall health and well-being among a random sample of vaccinated and unvaccinated children (5-18 years of age). The study will obtain information from a random sample of two populations: I) children being horne-schooled and belong to the National Horne Educational Research Institute (NHERI); and, 2) children among the 30,000 unvaccinated patients being provided health care at the Homefirst Health Services in Chicago. Data will be collected from medical charts and parental reports via website health surveys and the standardized measures including the Autism Diagnostic Questionnaire.

The project proposal is vague and very brief. But let’s consider some details presented.

Not surprisingly, they chose to work with the Homefirst clinic in Chicago. Homefirst comes up quite often in discussions of proposed vaccinated/unvaccinated studies. This results largely from the fact that the director of Homefirst, Dr. Mayer Eisenstein has stated with no equivocation that there are zero autistic children who were born in his clinic and didn’t receive vaccines.

There is some confusion about how many of Homefirst’s patients are actually unvaccinated. Generation Rescue states that 30,000 are unvaccinated, but this is actually the estimate for all the children at Homefirst, vaccinated and unvaccinated:

“We have a fairly large practice. We have about 30,000 or 35,000 children that we’ve taken care of over the years, and I don’t think we have a single case of autism in children delivered by us who never received vaccines,” said Dr. Mayer Eisenstein, Homefirst’s medical director who founded the practice in 1973.

For the moment, let’s take Dr. Eisenstein at his word. What possible biases are there that they should be working around? One example–we don’t know the status of patients who have left Homefirst. Consider the parents who joined Homefirst specifically to avoid autism. After their child is diagnosed, is it conceivable that they not return to Homefirst and would find a different clinic? How do they plan to control for this? Also, one can not minimize the fact that Dr. Eisenstein has a lot riding on the reputation that he has built on the “no vaccines, no autism” slogan.

Even without this, researchers I have been in contact with have questioned how useful clinical notes such as these could be in screening, much less diagnosing, autism. From what I can see, Dr. Eisenstein’s practice does not include psychologists or other staff to test for autism, so that would not be directly included in the notes.

As an aside, the lack of autistics in his practice hasn’t stopped Dr. Eisenstein from joining the alternative treatment of autism. The Chicago Tribune discussed Dr. Eisenstein, his somewhat troubled past and his foray into treatments like Lupron in Autism doctor: Troubling record trails doctor treating autism.

NHERI is a new name to me. I have not heard much about them or their founder in autism discussions before. As an aside, one quote from the NHERI website was quite interesting–“”Whoever has the data controls the policy.” Kay Coles James, Virginia State Cabinetmember”.

The “Autism Diagnostic Questionnaire” is not a standard diagnostic instrument by any means. In fact, it is difficult to find out what it is at all. A google search for “Auism Diagnostic Questionnaire” gives only two hits (or did before I published this piece). The questionnaire appears to be this worksheet from the Autism Research Institute (DAN). I can find no information on how it is scored or how accurate it is.

One thing missing in this proposed study is actual contact with the children. “Standard measures” could mean a lot of things, but if they were planning on screening children and then testing probable cases using an ADOS and ADI-R (which one might argue would be “standard”), wouldn’t they mention that? If so, wouldn’t they mention who would perform such tests. None of the staff assigned to this study appears to be a psychologist, for example. The Staff for the project are listed as:

Project Stafjing: The Project Director will have a Masters’ degree and will be responsible foroverseeing the implementation, quality assurance and reporting of this project. Dr. A. Mawson is Professor of Pediatrics and Medicine at University of Mississippi Medical Center (UMMC), and Principal Investigator of the Mississippi Study Center for the National Children’s Study. Dr. B. Ray is President of the National Home Education Research Institute and an experienced researcher in home education. Dr. S. Buttross is Professor and Chief of the Division of Child Developmental Disorders in the Department of Pediatrics; UMMC; and Dr. W. May is Professor of Biostatistics, Department of Medicine, UMMC. The combined experience of these investigators ensures the highest standards of quality and scientific rigor.

Generation Rescue and others have often called for an “independent” research. Left unvoiced is whether “independent” means “independent of the government and pharmaceutical companies” or whether “independent” includes being free from ties to the vaccines-cause-autism groups.

The “Project Director”, Dr. Mawson, is a vocal supporter of Andrew Wakefield. Below is a letter by him you can find in multiple places on the web. Note this was not included in the research proposal:

Dear Dr. Crippen,

I would like to point out that Trisha Greenhalgh’s assessment of Andrew Wakefield’s paper was itself seriously flawed!

You do a disservice to Wakefield and the scientific community by perpetuating this myth of the flawed study and the paper that should have been “rejected” by The Lancet.

The paper is actually excellent–a superb case study that will join the ranks of other famous case studies, such as the link between rubella infection and congenital rubella syndrome (Gregg 1941) and between exposure to thalidomide and embryopathy (McBride 1956).

Greenhalgh states that the paper set out to test a hypothesis that was unstated –of a causal relationship between exposure to MMR and autism — and the design of the study was all wrong. She starts out with an incorrect assumption about the nature of the study and then continues to build on her incorrect foundational argument. Her argument may look impressive to the layman and most medical practitioners perhaps, but not to anyone who knows anything about study design, i.e. epidemiologists, and the reviewers of the paper for The Lancet, who clearly understood that the paper was not an hypothesis-testing paper but a hypothesis-generating paper. It was, in short, a case series analysis.

The paper, once understood in this light, as case series analysis, is truly remarkable, well written and brilliantly documented. It concluded by stating the hypothesis, based on parents’ reports, that the children’s’ signs and symptoms were temporally connected to MMR vaccination. Subsequent studies may not have substantiated the hypothesis; but that does not detract from or invalidate the merits of the paper as a case series and as, essentially, a hypothesis paper.

Anthony Mawson.

I’d be interested in Prof. Mawson’s take on the quality of the Wakefield Lancet article now that it has been retracted. More to the point, the fact that the study is not a true “case series” in the fact that the subject selection was highly biased. There is an “Anthony Mawson” who is a signatory on the “We Support Andy Wakefield” website.

Dr. B. Ray is the President of NHERI, the homeschooling group involved in the research and is not a medical professional nor an epidemiologist.

Dr. Susan Buttross appears to be rather reasonable. The website for a clinic she is affiliated with has links to sites like the CDC and the AAP when discussing vaccines and autism. She worked on the Mississippi Autism Task Force, whose report can be found here. That report does not discuss vaccines one way or the other. It does discuss that toxins have been “implicated”:

To further complicate the findings, there is mounting suspicion that environmental factors play a role in many cases. A genetic predisposition may cause certain individuals to be more sensitive to environmental toxins. Specific environmental toxins have not yet been identified, however, lead, mercury, and other chemical toxins have been implicated. There has been concern that certain dietary components may be a causative factor in some cases. Viral infections including rubella, measles, and CMV (cytomegalic virus) have also been linked to ASD. Illicit drugs and alcohol used by the mother during pregnancy are also known to increase the risk of a child developing ASD.

Interviews with her can be heard here, here and here.
Mississippi Autism Task Force

Dr. W. May is, I believe, Warren May. I have no real details on what connection he may have to the autism communities and to the question of vaccines.

In the introduction I pointed out that Generation Rescue was attempting to get funding for this project from the Airborne settlement. The Ariborne suit was brought by the Center for Science in the Public Interest (CSPI). CSPI was not supportive of the Generation Rescue proposal, noting that the project was vague and the sample groups likely heavily biased and that Generation Rescue was not actually conducting the study, but was managing it, building in overhead costs that might not be warranted.

I tend to agree with CSPI that the proposed study is far from being strong enough to be very convincing, one way or the other, on the question of vaccines and autism. There are some potentially reasonable people associated with this proposal. But I would think that any active involvement by Dr. Mayer Eisenstein would seriously taint the study. Further, should Dr. Mawson still support Andrew Wakefield, given Wakefield’s multiple ethical lapses and clearly biased study design, I would think that too would cast somewhat of a pall on the study.

Can an study comparing outcomes of unvaccinated and vaccinated populations be performed? Like any study, a lot depends on how definitive the answer you want is. Prometheus at the Photon in the Darkness blog has discussed the limitations of these studies and, also how they could be done. One early example is in his post “Let’s put on a Study!” Dr. David Gorski goes into the details as well in The perils and pitfalls of doing a “vaccinated versus unvaccinated” study. I agree with his conclusions:

Still, if the government caves and decides to do such a study, it is up to us in the scientific community to make sure that it’s done by no one but the best epidemiologists, in other words, that it’s a proper study that correctly controls for confounders and can answer the question being asked, not the dubious study custom designed to have the maximal chance of a false positive result, which is of course what the anti-vaccine movement really wants.

The questions raised by a vaccinated/unvaccinated study are far to important to be handled by anything less than the best researchers with access to the best data. I fear that Generation Rescue’s plan doesn’t meet either count.

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18 Responses to “Generation Rescue’s Vaccinated/Unvaccinated Study”

  1. passionlessDrone June 8, 2010 at 04:10 #

    Hi Sullivan –

    Nice post. I don’t have time to digest a lot of it now, but while I think that this is an important topic to study, the people listed are likely not smart enough to realize that if you do this study poorly, they’re hurting more than they help. Similarly, I’m not at all convinced they are smart enough to do it well, in fact, I lead towards the opposite.

    We are doomed.

    – pD

  2. Rogue Medic June 8, 2010 at 14:47 #

    Didn’t Jenny McCarthy get boatloads of money out of Jim Carrey for Generation Revenue while they were together?

    • Sullivan June 8, 2010 at 14:54 #

      Rogue Medic,

      Generation Rescue was able to fund at least one ad in USA Today with donations from Jenny McCarthy and Jim Carrey. That’s about US$200,000.

  3. Catherina June 8, 2010 at 20:16 #

    The project *director* will have a Master’s degree?! I bow to their superior quality control!

  4. Stephen June 9, 2010 at 05:47 #

    Why do so many people ‘poo poo’ the idea of such a study. If there was nothing to be concerned about, i.e. a possible connection, then these people shouldn’t give a damn. It’s about time we get a study such as this. And just maybe those not-so top notch scientists haven’t been biased by Pharma already, so I see that as a good thing.
    If there was nothing to hide there would not be such a stink about it.

    • Kev June 9, 2010 at 08:22 #

      Stephen, its not a case of hiding anything. As Sullivan says in his blog entry, a study like this is very very difficult to do and do well. Many of us fear a badly designed study that will just tell those bankrolling it what they want to hear.

  5. David N. Brown June 9, 2010 at 06:22 #

    “If there was nothing to hide there would not be such a stink about it.”
    The ones making a stink are “vaccine blamers” whose claims have already been rejected by science. They are also the ones who, on conducting an actual survey, committed outright fraud. (See “Stupid Like a Fox” at Evil Possum.) They, in short, are the ones with things to hide.

  6. Squillo June 9, 2010 at 19:23 #

    Forgive my ignorance, but why wouldn’t GR set up a foundation to fund such research rather than attempting to direct it themselves? They clearly don’t have the in-house expertise, and anyone they bring on board directly is likely to be tainted–fairly or unfairly–as biased.

    Wouldn’t a grant be more likely to attract real experts to design and conduct the study? Via a grant process, GR could ensure the study design was to their liking and relatively free of the COIs they object to in other research.

  7. Dawn June 9, 2010 at 19:45 #

    @Stephen: most respectable medical researchers “poo-poo” a prospective vax/unvax study because doing one prospectively, with double-blinded researchers and participants, is very unethical. It is against the Treaty of Helsinki to withhold the “usual and recommended” medical care from a participant without their knowledge.

    So, right away you would get a group that is either self-selected to have vaccines or not have vaccines. And it would be almost impossible to randomize the groups, so they would not be equal. This would mean a lot of potential confounders that would skew the results.

    So, you look at retrospective groups – those who didn’t have vaccinations vs those who did. However, you still have to control for confounders. And you need to randomize from groups that are different than those listed in the study. Face it. Most homeschooling families are going to be middle-to-upper income families. (Please – I didn’t say ALL, don’t start a flame war!) And yes,the Healthfirst families are well matched for that. But you are ignoring the fact that, as was pointed out, families with autism/PDD-NOS may not be well represented in either group which again will skew the results.

    I know Prometheus had a good post about how he would do a study.

    Of course, if I had limitless funds and people (and could get this past an IRB – highly doubtful, actually -, here is how I would do it:
    Enroll EVERY child born in a 3 year period throughout the world.
    At every doctor visit, if any, record what care the infant receives and why they are in for a visit (well care, vaccines, ear infection, etc). The recorder will also document exactly what is any vaccines the child gets by listing all ingredients (barring the fetal monkey parts and other gross things…LOL!)
    The child is videotaped monthly at the office or at home for visual documentation of growth and development.
    Follow those children for 5 years (of course, in my ideal world, everyone participates and there are no drop outs…except for deaths. Even in my ideal world, I am rational enough to realize children will die…from disease – vaccine preventable or not, from murder, from accidents, from war…)
    Tally those children and see who has more autism…IF either group has more.

    (End dream world!)

  8. Squillo June 9, 2010 at 19:57 #

    @Dawn,

    Where can I send the check?

  9. Sullivan June 9, 2010 at 22:16 #

    Dawn–

    stay tuned…

  10. Frank June 10, 2010 at 16:47 #

    I’m curious if/when Generation Rescue will be removing the now disproven theory that autism is preventable and is caused by immunizations and vaccines. I’m sure by now we’ve all seen the research that proves autism is genetic and occurs in the womb due to gene mutations and missing bits of DNA.

    Please see this link for reference;

    http://www.ctv.ca/CTVNews/TopStories/20100609/autism-genetic-changes-100609/

    The sooner they correct their misinformation, the sooner we can prevent all the deaths that have been caused from preventable illnesses due to parents not having their children immunized because of their false claims.

    Please stop Generation Rescue from contributing to so many senseless deaths.

  11. Dawn June 10, 2010 at 22:46 #

    @squillo: wrong Dawn. I don’t twitter. You can send the check c/o Sullivan; he’s one of the few who knows who I really am. ;-)

    @Sullivan: stay tuned? OOOOOHHHH! Sounds interesting. Does it have something to do with the emails you sent me a few weekds ago?

  12. Sullivan June 11, 2010 at 01:25 #

    Dawn,

    nothing so exciting. Just this post

    http://leftbrainrightbrain.co.uk/2010/06/nih-funded-research-includes-search-for-possible-vaccine-autism-link/

    which points out that a prospective study of environmental causation (and gene-environment interactions) is nearing completion. That study, by Columbia University, includes vaccination as a factor to be tracked.

    The question is–what does GR hope to do that isn’t being done sooner and better by other groups? Columbia is monitoring a cohort of 10,000 control families and 150-200 autistic kids.

Trackbacks/Pingbacks

  1. Tweets that mention Autism Blog - Generation Rescue’s Vaccinated/Unvaccinated Study « Left Brain/Right Brain -- Topsy.com - June 8, 2010

    [...] This post was mentioned on Twitter by Kim Wombles, Sharon Lopez. Sharon Lopez said: Autism Blog – Generation Rescue's Vaccinated/Unvaccinated Study … http://bit.ly/cP6msv [...]

  2. Science-Based Medicine » Vaccines and infant mortality rates: A false relationship promoted by the anti-vaccine movement - May 9, 2011

    [...] For example, last year Generation Rescue requested $809,721 from the Airborne settlement to set up a “vaxed versus unvaxed” study, despite the known difficulties with such a study and the low likelihood of finding anything [...]

  3. A look at the financials for Generation Rescue and the Strategic Autism Initiative « Left Brain Right Brain - February 15, 2013

    [...] $43k for a study on “vaccination status and health outcomes among homeschool children in the United States”, with Anthony Mawson of Jackson State. Mr. Mawson was named as the lead researcher for this project back when GR was seeking funding from money left over from a class action lawsuit to fund it. [...]

  4. Vax vs. Unvax studies… FIGHT! | The Poxes Blog - March 22, 2013

    [...] did surveys. (Heck, even the anti-vaxers wanted to do surveys.) And, after adjusting for all sorts of biases that surveys present, we found no difference between [...]

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