IRB Approval of Geier Autism Study: Yes or No?
The idea that thimerosal-containing vaccines are associated with the development of autism has been broadly and compellingly refuted (see, for instance, authoritative conclusions rendered by the Institute of Medicine and the CDC). Moreover, autism rates have continued to climb, despite the removal of the ethylmercury preservative from routine childhood vaccines since 2001.* Nevertheless, the editorial board of the Journal of the Neurological Sciences, a self-described peer-review journal, finds it necessary to revive the debate in arguably unnecessary fashion by publishing a study that was funded by the Autism Petitioners' Steering Committee and written by plaintiffs' consultants in vaccine litigation.
Talk about your potential conflicts of interest. Given the well-known positions of the study's coauthors—in particular, those of Mark R. Geier, MD, PhD, and his son David Geier (see, for instance, a 2005 profile of the duo by the NYT and a considerable amount of research conducted by Kathleen Seidel at the neurodiversity blog)—it is not surprising that the authors concluded an "association between increased Hg exposure from Thimerosal-containing vaccine and neurodevelopmental disorders."
But the article and additional investigation raise several questions that go beyond the merits of the study itself (which will be discussed in another post). For instance:
- Was the study protocol, which drew on Kaiser HMO data from the CDC's Vaccine Safety Datalink (VSD), in fact, approved by Kaiser's institutional review board (IRB) as described?
- What was the decision process among the editorial members of the Journal of the Neurological Sciences that led to the publication of such a questionable study?
- What exactly is the nature of the body of work conducted by Geier and Geier?
For now, I will address (in as much as I can) the first and second questions.
In the article's Materials and Methods section, the authors claim, "The study protocol employed was approved by the US Centers for Disease Control and Prevention (CDC), the Institutional Review Board (IRB) of Kaiser North-West, and the IRB of Kaiser Northern California." However, an online source suggests that this may not be so, or that there was at least a hitch in the approval of the study given the conduct of its researchers.
In a February 2004 letter to the IRB administrator of Kaiser of Northern California, the then Acting Associate Director for Science of the National Immunization Program at the CDC, Jeanne Santoli, MD, warned Kaiser of "potential breaches in confidentiality and execution of analyses that were not approved in advance," when Mark and David Geier visited the CDC Research Center in Hyattsville, MD, in October 2003 and in January 2004 to collect data from the VSD.
Kaiser's IRB administrator, Leigh Pruneau, RN, PhD, then wrote a letter the following week, informing Mark Geier that his research project was suspended pending his response to the CDC allegations. The letter advised Geier that "you and your co-investigator are prohibited, until notified otherwise, from accessing VSD data derived from Colorado Kaiser Permanente and Northern California Kaiser Permanente institutional officials," and continued:
Federal regulations and KPNC/IRB policy prohibit conduct of research that has been suspended by the IRB. The IRB is required to report, and will proceed to report, the suspension of this study to the CDC and Kaiser Permanente institutional officials.
The following actions are required:
- You must immediately cease all activities which involve Kaiser Permanente data, as it is required by federal regulations and KPNC IRB policy.
- You must inform the IRB of any research-related activity continued beyond this notification of study suspension, providing the reason(s) for continuation.
- You must provide written notification of study suspension and the required cessation of all research activities to the co- and sub- investigators, if any, participating in this research within five business days of receiving this notification.
The IRB requires that you provide your response to the CDC's letter to KFRI via e-mail to KPNC IRB on Lotus Notes, or KPNC.IRB@kp.org, or by U.S. Mail by noon on March 8, 2004, for review at the March 18, 2004 IRM meeting.
It is currently unknown to me if the CDC's allegations were resolved or even addressed by Geier and his coinvestigator or if Kaiser ever gave the go-ahead to continue the study. An inquiry to the CDC reveals that the current Acting Director of the CDC's Immunization Safety Office, John Iskander, is aware of the published study, and that the CDC is preparing a response. E-mails sent to Kaiser's public relations office and its IRB office regarding Kaiser's approval of the study are, so far, unanswered.
On the flip side, Ed Silverman at Pharmalot published yesterday a less-than-thoughtful piece on the study's publication, which frankly reads like a press release from the study's researchers and/or the Autism Petitioners' Steering Committee. Beginning with Silverman's graf 7, the steering committee chides the Federal government, the vaccine makers, and the HMOs for not conducting any studies in the VSD database, and claims that the study's investigators were hampered in their mining of the VSD data:
First, the government refused to produce the automated data in a way that would have allowed the investigators to link vaccine-mercury exposure to outcome data in individuals...
Second, the government and the HMO’s refused to permit access to any data entered after the year 2000, which meant that the maximum follow up period of the neurodevelopmental disorders for some children was only to four years of age. Specifically, for children born in 1997 or later, this restriction to access prevented any examination of true prevalence rates for those later birth cohorts.
Third, only three of the eight HMO’s participating in the taxpayer funded database permitted even this limited access (Northern California, Colorado, and Oregon Kaiser plans). Other HMO’s blocked access to the data on hundreds of thousands of additional children.
The steering committee then alleges that plaintiffs' families have been denied access to the "taxpayer-funded" VSD by the government and the courts. Regardless of what the steering committee believes, their statements do not address the IRB approval of the study and, in fact, suggest unresolved issues with respect to the use of the VSD data by the study's authors.
Nevertheless, it is certainly possible that the CDC's alleged confidentiality breaches from 2004 were resolved by Geier and that the study protocol as published in the Journal of the Neurological Sciences was, in fact, ultimately approved by the CDC and the respective Kaiser IRBs; however, if this is not the case, the study's claim of IRB approval would be seriously undermined and suggest poor judgment on the part of the journal's editorial board to publish the work.
To that end, I e-mailed Robert Lisak, MD, the journal's editor (as well as chair of the Department of Neurology at Wayne State University and a highly regarded neurologist), asking for any comments on the study's publication. His response was disappointing and of ultimate brevity: "None."
05/21/08 update: An e-mail reply from the Kaiser IRB office provides the following information. "The objections stated in the referenced letter were resolved and the study was ultimately approved by the IRB—as is stated in the published article." How the objections were resolved is not described.
*Thimerosal has not been used as a preservative in routinely recommended childhood vaccines since 2001, with the exception of some influenza vaccines.
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