IRB Approval and the New Thimerosal Study
May 20, 2008 by Kristina Chew, PhD
Filed under Health
The Pathophilia blog looks carefully at IRB Approval of Geier Autism Study: Yes or No?—–this would be the new study on thimerosal and neurodevelopmental disorders which lists David A. Geier and his father, Dr. Mark Geier, as two of the three co-authors. Aside from noting conflicts of interest, Pathophilia notes:
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: [read more at Pathophilia]……..
If they didn’t have IRB approval, the paper will have to be retracted.
bmartin on Pathophilia also notes that
Seems that the Geiers were, at one point, informed that they were not to proceed further with the VSD data and so with their study.
Why do you suppose they were not allowed to use the VSD data? I think the answer is quite obvious. It’s been said “the truth shall set you free”. True. But the truth also damns others.
The answer is obvious. It is because they tried to steal the data in such a way that they could have broken the confidentiality and identified individual patients.
That is a gross breach of ethics and a clear violation of HIPAA privacy laws. To allow the Geiers access to the data after what they did in trying to breach the confidentiality would be malpractice and a violation of law.
The HMO becomes liable if it allows the Geiers access to the patient information.
http://www.ama-assn.org/ama/pub/category/11805.html
Why would anyone risk civil and criminal prosecution by allowing the Geiers to touch their data? Most medical professionals are not unethical, or stupid. You would have to be both to allow the Geiers access to the data.
The exchange of letters on the VSD issue
http://www.aapsonline.org/vaccines/geierirb.pdf
I don’t see from that chain of letters that the prohibition was rescinded. Was it?
It’s funny that their response states, as a header, that merging datasets is an impossibility. Apparently, that was something ascertained empirically during their visit.
Having some experience with these things, I have some comments regarding their rebuttal, quoted here:
“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, ICD-9 code and date of diagnosis assigned,
maternal age, APGAR score at birth, birthweight, gestation and race. 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 CDC to allege that we have violated the
protocol is disingenuous since we have not even been allowed to finish our analysis.”
The above does not address in any way whether or not they violated the stated protocol…whether the analysis is complete or not doesn’t matter. When it comes to violations or crimes or breaking promises or cheating, you’re either in the middle of doing it or you’ve done it. Either way, you’re culpable.
“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 DtaP vaccines in general.”
If this were part of the study, it would clearly have been stated as such in the protocol hypotheses and rationales, and the specificity of looking at DtAP vaccines and “not acellular DtAP in general” would also have been included. Specific products, in my experience, must be named specifically if there is such an intent. Every step, every intent, every use of data…it all has to be laid out clearly with appropriate rationale for approval, and you’re not allowed to wander willy-nilly outside of that approved protocol, not even a smidge, strictly speaking.
Hi, I just received word today from the Kaiser IRB office, which responds, “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.” There is no more information as to how the objections were resolved. The CDC is evidently still working on an official response to the latest Geier study.
Thanks for the update, Dr. Martin.
Also, over at Respectful Insolence is Orac’s take on the latest from the Geiers and here’s, too, what Epi Wonk has to say.