Saturday, July 2, 2011

Eleven dead research subjects in a fake study

Everyone knows how Parke-Davis (now part of Pfizer) made billions by marketing Neurontin, a seizure drug, for off-label uses ranging from migraines to ADHD.  Less well-known is the fact that Parke-Davis also marketed Neurontin through so-called "seeding trials."  Seeding trials are fake studies.  They masquerade as clinical trials, but in fact their purpose is not to generate an answer to a legitimate scientific question, but rather to make doctors familiar with a new drug.

It's an old marketing tactic that ordinarily attracts little attention.  What makes the Neurontin seeding trials different is the window on the tactic opened by litigation.  As three expert witnesses in the Neurontin litigation recently wrote in The Archives of Internal Medicine, 73 patients in the Neurontin seeding trials had serious adverse events, 997 had side effects and 11 patients died.  That's eleven deaths in the service of a marketing campaign.  Pfizer was able to settle the off-label marketing lawsuit for $420 million.  Why hasn't it been forced to answer for these eleven deaths?

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