I've Been Sucked Into the Thimerosal-Autism-Geier Vortex

And it's BEAU-TI-FUL.

After Monday's post, which questioned the IRB approval of the Geier study, "Thimerosal exposure in infants and neurodevelopmental disorders," I was notified of a link to the Geiers' 2004 response letter that addressed their alleged confidentiality breaches of the VSD.

Several excerpts from the Geiers' (father and son) response letter to the Kaiser IRB office merit comment, and I admittedly draw on relevant insights made Wednesday by "Emily" at AutismVox.

In their 2004 letter, the Geiers acknowledge the 2 questions stipulated by the IRB-approved protocol: 1) Does acellular DTaP increase the risk for acute adverse event (list of 15 [ICD-9 codes]) within 30 days following vaccination? And 2) Does acellular DTaP increase the risk for chronic adverse event (same list of 15) within 1 year following vaccination?

The Geiers then respond to the alleged deviation from the IRB-approved protocol as follows:

In the brief time we were able to access the VSD data on October 9-10, 2003 CDC allowed us to access datasets with the following information per patient identifier number: specific vaccine and brand name [emphasis added], ICD-9 code and date of diagnosis assigned, maternal age, APGAR score at birth, birthweight, gestation and race.

Here the Geiers seem to imply that identification of the vaccine brand name was part of the IRB-approved protocol, because the CDC allowed access to this information.

The ICD-9 codes were limited to 15 set forth in the approved IRB protocol. We are currently in the process of analyzing the temporal relationship between the administration of the vaccine and these 15 ICD-9 codes. Therefore, for the CDC to allege that we have violated the protocol is disingenuous since we have not even been allowed to finish our analysis.

Interesting. If I'm reading this correctly, the Geiers claim that they did not violate protocol, because they were prevented from doing so in January 2004 after being caught in flagrante delicto by VSD monitors. (See CDC warning letter: "[T]he researchers...on the second visit attempted to carry out unapproved analyses but did not complete this attempt.")

Further, since different brand name vaccines are used, it is not violative of the protocol to examine whether or not an acute or chronic condition is associated with a specific vaccine and not accellular[sic] DtaP vaccines in general.

Now the Geiers appear to contradict their first claim (ie, identification of the vaccine brand was part of the IRB-approved protocol) by asserting their interpretation that the protocol should really allow identification of vaccine brands. Perhaps the Geiers' assertion is based on their reading of the "spirit" of the protocol and not on the literal wording of the protocol. In any event, it seems a very loose interpretation, if not an outright violation. 

If a statistically significant relationship is found based upon the brand of vaccine administered this information should be vitally important to you as well as the CDC.

So the Geiers add, in head-spinning fashion, that Kaiser and the CDC should really be interested in this information anyway, regardless of what the protocol says—an argument that, of course, doesn't defend an alleged violation (or attempted violation) of protocol.*

In the second half of the letter, the Geiers recite a litany of VSD security measures to rebut the claim that they tried to merge VSD datasets in violation of protocol. However, the section reads more like a tirade against draconian government security than a defense against their alleged violation of protocol. The Geiers further imply that the VSD data are being kept from the public in conspiratorial fashion.

They then write:

It is impossible for the datasets given to us by CDC to be merged...It is impossible therefore to construct a dataset that contains any information on one patient that links the vaccines administered to the ICD-9 diagnosis.

As Emily at AutismVox suggests, wouldn't this conclusion have to be drawn empirically, after first attempting to merge the datasets (in violation of protocol)?

It should be pointed out that CDC and its approved external researchers have full access to this type of information, not us.

The Geiers again suggest a government conspiracy to keep the VSD data from the public, and more specifically from themselves.

They then conclude:

[W]e were asked by members of Congress to investigate the VSD, especially with regards to the thimerosal and neurodevelopmental disorder issue. Therefore, we were only doing the study which the Congress asked us to do...

It does appear that certain sympathetic members of Congress facilitated the Geiers' study of the VSD and perhaps even the study's ultimate IRB approval, despite the alleged protocol violations. For instance, in February 2006, 8 congressional members (Senators Joe Lieberman and Debbie Stabenow and Reps. Dan Burton, Dave Weldon, Carolyn Maloney, Joseph Crawley, Chris Smith, and Maurice Henchey) signed a letter to the head of the National Institute of Environmental Sciences, urging the use of the VSD data to examine a potential link between thimerosal and autism (despite the acknowledged conclusion of the IOM in May 2004). Moreover, the congressional members advised the NIES to work with the CDC and external researchers, because "a CDC-led study would be viewed with much skepticism." Now that's a shocking and unmerited slap in the face (and even an implied allegation of corruption) against a government organization that's charged to monitor and guide public health. 

Well the congressional leverage appears to have worked, and perhaps then some. The protocol in the Geiers' published study is considerably broader than that described in 2004. For instance, the original protocol stipulated the examination of 15 ICD-9 codes; however, the published study (Table 2) describes 26 ICD-9 codes for neuro-developmental disorders and 6 codes for "control disorders." Likewise the vaccine database appears to have been broadened to include oral polio, Haemophilus influenza type b, hepatitis B, and whole-cell DTP vaccine data—as well as DTaP data.

*It's interesting that the Geiers focus so heavily in their letter on the identification of vaccine brands in the VSD, an issue not mentioned by the CDC in its warning letter. Of course, the ultimate concern is that identification of individual patients or vaccine brands might be used to inform plaintiff litigation (which is how Dr. Geier earns his keep) against particular companies.

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