Foreordained Conclusions · 2006-03-08 17:45

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Much attention has been paid this past week to Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines, by David A. Geier and Dr. Mark Geier, published in the Spring 2006 issue of the Journal of American Physicians and Surgeons.

Authors of a gaggle of articles alleging a causal connection between vaccines and autism, the Geiers conducted an analysis of data from the Vaccine Adverse Events Reporting System (VAERS) and caseload statistics from the California Department of Developmental Services (CDDS). Their conclusion:

The present controlled assessment of VAERS and CDDS databases shows that very specific NDs [neurodevelopmental disorders] are associated with TCVs [thimerosal-containing vaccines].

The article was heralded several days prior to its publication by UPI’s Dan Olmsted. Shortly thereafter, a press release was issued by the Association of American Physicians and Surgeons. The press release was picked up by several online news sites specializing in medicine and right-wing politics. Vaccine-litigant groups, including the National Autism Association, promptly issued their own press releases announcing the results of the Geiers’ study, and calling for a Congressional investigation into the CDC’s conduct of the National Immunization Program. Articles about the study also appeared in local newspapers around the country.

I will focus my attention here on several notable problems; and in order to save the best for last, will begin at the end of the article.

Past Imperfect

The Geiers disclose their potential conflicts of interest:

David Geier has been a consultant in vaccine/biologic cases before the no-fault Vaccine Injury Compensation Program (NVICP) and in civil litigation. Dr. Mark Geier has been an expert witness and a consultant in vaccine/biologic cases before the no-fault NVICP and in civil litigation.

Although this disclosure is worded in the past tense, in fact, Dr. Mark Robin Geier was recently named as an expert witness in the Petitioners Initial Disclosure of Experts filed with the Office of Special Masters of the Omnibus Autism Proceeding on February 14, 2006. The pending rather than closed nature of these cases is a significant potential conflict of interest that should have been disclosed.

Vexing VAERS

The Geiers rely upon data from VAERS and the California Department of Disability Services for their analysis. The influence of litigation-related reports on trends in possible adverse event reports to VAERS has been discussed at some length in the February 2006 article, Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies. The article’s authors, Michael Goodman and James Nordin, concluded that:

This review shows a previously undisclosed rise in the number of reports to the VAERS related to pending litigation for vaccine injury.

Methodological concerns raised by the use of VAERS data in this study have been extensively addressed by Orac at Respectful Insolence (which contains a lengthy comments thread), and also at the new blog, Good Math, Bad Math.

Comparing California Oranges & Avocados

In their article, the Geiers state that:

The CDDS recognizes only professionally diagnosed individuals with mental retardation, autism, epilepsy, cerebral palsy, and conditions similar to mental retardation as conditions eligible for services. Persons diagnosed with one of the other Pervasive Developmental Disorders, including Pervasive Developmental Disorder Not Otherwise Specified, Asperger’s Disorder, Rett’s Disorder, and Childhood Disintegrative Disorder, are not eligible for regional center services.

They go on to refer to:

...the total new number of autism reports received by the CDDS...

The term “autism reports” is misleading, because the CDDS tracks statistics not of autism prevalence, but of individuals receiving services funded by the state, a subset of individuals with an autism diagnosis.

Further, the Geiers fail to factor into their analysis the 2003 institution of more restrictive thresholds for qualification for services from the California DDS. According to the Schafer Autism Report:

In July 2003 California adopted a new additional “substantial disability” criteria for eligibility into California’s developmental services system. Not only must persons with mental retardation, epilepsy, cerebral palsy, and autism be professionally diagnosed (and in the case of autism receive a diagnosis of full syndrome DSM IV autism, not including any other autism spectrum disorder such as PDD, NOS, or Asperger’s Syndrome), they now must demonstrate “significant functional limitations in three or more of the following areas of major life activity:

1. Self-care
2. Receptive and expressive language
3. Learning
4. Mobility
5. Self-direction
6. Capacity for independent living
7. Economic self-sufficiency

Since the implementation of the new law in July 2003 there has been a decrease in the number of new intakes in all four categories of disabilities in California’s system. In some categories the decrease in the number of new intakes has been substantial.

Institution of these criteria has resulted in a documented reduction not in the numbers of individuals diagnosed with autism, but in the numbers of individuals qualifying for services from the California Regional Centers.

Curious to learn about the impact of these changes, on March 7, I called the Harbor Regional Center in Torrance, California, and asked whether they were keeping track of numbers of applicants being denied services following institution of the more restrictive criteria who would have been eligible under the previous, less-restrictive criteria; and if so, whether those statistics are reported to CDDS. A staff member there told me unequivocally that the Harbor Regional Center does not tabulate or report this information.

If one assumes that the same would be true for every regional center, and that the California DDS has no system in place to monitor how many formerly-eligible applicants have been denied services since July 2003, one must conclude that post-July 2003 statistics cannot be accurately compared with those gathered prior to July 2003.

A Premature Pronouncement

The Geiers’ study was mentioned by Robert F. Kennedy, Jr. in his extensive essay, Tobacco Science and the Thimerosal Scandal (upon which his shorter article, Deadly Immunity was based):

A soon-to-be published study by Drs. Mark and David Geier shows rates of autism and other neurodevelopmental disorders declining nationally following the elimination of thimerosal from most vaccines.

Tobacco Science and the Thimerosal Scandal was published on June 22, 2005. A footnote indicates that Kennedy personally interviewed David Geier in the course of his research; one would assume that this occurred at least a month or two before he published his article.

Yet, according to the Geiers’ report,

The online public access VAERS database (updated through August 31, 2005) was examined using Microsoft Access… The total new number of adverse event reports for each type of ND received on a reporting-quarter basis… for 36 consecutive reporting quarters from January 1, 1994 through December 31, 2002, and for 14 consecutive reporting quarters from January 1, 2002 through June 30, 2005, were evaluated in VAERS.
The online public access CDDS database (updated through October 4, 2005) was examined using Microsoft Access. The total new number of autism reports received by the CDDS from 36 consecutive reporting quarters (from that starting on January 24, 1994, through that ending on January 6, 2003), and for 15 consecutive reporting quarters (from that starting on January 3, 2002, through that ending on October 4, 2005), were analyzed.

If Kennedy’s report is accurate — that is, if David Geier had, in fact, told him prior to the June 22, 2005 publication of Tobacco Science and the Thimerosal Scandal that their

soon-to-be published study… shows rates of autism and other neurodevelopmental disorders declining nationally following the elimination of thimerosal from most vaccines.

— one must conclude that the Geiers determined the results of their study prior to conducting their analysis of data upon which it was based.

Comments


  1. I have to agree with your conclusion (and everything else in an excellent piece). Perhaps that explains why their data does not even begin to support their conclusions.

    — Mike Stanton    2006-03-08 18:09    #

  2. ...and I have enough firsthand and secondhand experience of the California Regional Center system to know that their diagnostic practices are ridiculous anyway and depend on many factors.

    (For instance, some regional centers are known for seeing autism where it isn’t, and others are known for not seeing autism where it is.)

    — Amanda    2006-03-08 21:43    #

  3. A great article and one I agree with wholeheartedly. Working from a conclusion to try and get a justification for it makes for terrible science. To borrow a term from political satire, the Geiers smack of “truthiness” but not of truth. Or, as George Orwell put it, “We are all capable of believing things which we know to be untrue, and then, when we are finally proved wrong, impudently twisting the facts so as to show that we were right.”

    — Ari    2006-03-08 23:50    #

  4. I once had to do some work at a construction site in rural Texas and, thinking it would require most of the day, I was dropped off with an arranged pick-up time. I finished sooner than expected and decided to enjoy the sunshine by lying out on top of a pile of plywood. I fell asleep and got a nasty sunburn and I awoke to the sound of my ride. When I opened my eyes I saw several vultures circling much lower and closer than I had ever witnessed, it was obvious they thought I was dead or dying. Another few hours and they may have been rewarded, vultures are known for their prescience – The early scavenger gets the fresh meat.

    — clone3g    2006-03-09 09:00    #

  5. The NIH orders ethics classes to be given to all graduate students in programs using NIH money (which is pretty much all of them). Too bad this was only started a few years ago.

    — Bartholomew Cubbins    2006-03-09 09:50    #

  6. What’s sad is that if there weren’t people like Sally Bernard paying them for their help, they’d move on to some other quack stomping grounds. The really awful ethics comes from the parents and their lawyers in this case, and they scream the loudest about how evil and sloppy in thinking everyone else is.

    That’s projection.

    — Ms Clark    2006-03-09 14:56    #

  7. It is also possible that the Geiers had already done analysis which supported their conclusion and relayed to the “esteemed” RFK, Jr. Not that I think the Geiers are right or anything – in fact, I would be stunned if they didn’t go into said study with a predetermined outcome in mind.

    — anonimouse    2006-03-09 15:17    #

  8. I think there would be a delicious bit of irony if it came out that the Geiers “massaged” the data to get the result they wanted, and there were emails and a secret meeting in a hotel conference room to back that theory up.

    — anonimouse    2006-03-09 15:19    #

  9. It’s the same story as with Wakefield: they always know what the research will find before they do any research. Boils down to a word that begins with f, and isn’t a profanity.

    — Ellie Smith    2006-03-12 17:53    #

  10. I agree, mercury isnt really dangerous. And I don’t think those kids are sick anyway – and if they really are sick its all in their head. On the other hand it is interesting that no-one seems to think there might be a reason for these neurodisorders. All disease just happens then I guess..? Poison just isnt what it used to be

    — Martin Rost    2006-05-18 10:38    #

  11. Mercury Martin – Your fascilitation of this rubbish that has been disproven….is wasting time and resources needlessly… work that science might get to…..were they not busy defending your baseless claims of harm.

    — m    2006-05-31 18:51    #