Dear Justices, Before You Rule on Preemption, this just in: Pfizer manipulated studies related to Neurontin

Jean Martin
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Posted by Jean MartinOctober 08, 2008 12:43 PM

Experts have concluded that Pfizer manipulated scientific studies to bolster the use of the epilepsy drug Neurontin for other uses. This report comes from experts who are reviewing documents for plaintiffs in a a lawsuit against Pfizer. Apparently Pfizer delayed the publication of some negative studies, downplayed and mischaracterized negative data, and bundled some negative data in with positive results to neutralize the findings. Pfizer now stands in the long line of pharmaceutical companies who have been accused of manipulating and controlling scientific data in order to protect the sales of their products.

I do not enjoy reporting this news. As our U.S. Supreme Court stands ready to hear a case regarding the preemption of drug liability lawsuits on the basis of FDA approval of the product, it is scary to realize our long-held fears that drug companies are controlling the studies related to their drugs and are mishandling the data coming from those studies, and perhaps misrepresenting the data to the FDA. Limiting or preventing lawsuits on behalf of those injured by drug products and medical devices is not the answer, especially as we learn that the drug companies are manipulating the science and mispresenting the safety of their drugs.

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Henry Greenspan
Posted by Henry Greenspan
October 09, 2008 12:08 PM

Here is what I believe is most relevant to preemption in this instance. As far as I know, FDA itself had the data and relevant studies. It was the journals (and thus physicians and patients) who were defrauded.

Unless journal articles are being used (directly) as promotional materials, I do not think FDA has any regulatory control whatsoever related to their editorial policies.

Thus, here is the kind of circumstance in which substantial and serious fraud can be committed, the company shielded by preemption, yet have committed the fraud in an arena entirely outside the purview of FDA.

How's that for a power grab?

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