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.

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.

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.

“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.”

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.