Pfizer Used Docs Accused of Misconduct to Prep Geodon Submission to FDA

Last Updated Sep 22, 2009 10:50 AM EDT

Pfizer used three physicians who have since been accused of misconduct to prepare submissions to the FDA for the approval of the antipsychotic Geodon, according to a whistleblower lawsuit brought by a Harrisburg, Pa., doctor.

Dr. Stefan Kruszewski claims he witnessed Pfizer sales reps (and the doctors they paid) promote Geodon off-label for children, downplaying side effects such as weight gain and neurological disorders. Pfizer paid a child psychiatrist to promote Geodon to other docs, Kruszewski claims -- as Geodon is only approved for adults, that physician's "presence alone" constituted off-label marketing.

Pfizer said in a statement:

Pfizer denies all federal, state and qui tam allegations, with two exceptions. We acknowledge certain improper actions related to the past promotion of Bextra and Zyvox. Beyond those two exceptions we deny all federal and state and qui tam claims.
Kruszewski names three doctors who he claims were disciplined for misconduct after they worked on the Geodon NDA submission to the FDA, per the suit:
Dr. Richard Borison: received notice of debarment by the FDA in November 2002. Borison is not allowed to participate in or supervise any clinical drug trials for a minimum period of ten years. Borison, a psychiatrist who previously worked at the Medical College o[ Georgia and conducted a huge number of clinical trials for ziprasidone, was indicted for embezzlement and research fraud and is currently serving a minimum 15 year jail sentence in Hancock State Prison, Sparta, Georgia.
Dr. Bruce Diamond, a psychologist and pharmacologist, was indicted for research misconduct and embezzlement. Like Borison, he was found guilty and served time in Georgia state prison system. He received a notice from the FDA on or about November 26th, 2002, to debar him from participation in or provision of any services to any clinical drug trial for ten years.
Dr. Louis Fabre, a psychiatrist from Houston, Texas, who conducted and supervised several hundred clinical drug trials, including those for Geodon, was sanctioned by the Texas Board of Medical Examiners in October 2006 tor research misconduct.
Geodon was approved in 2000. Kruszewski claims the NDA was "intentionally misleading" regarding cardiovascular effects and that concerns about Borison and Diamond were known in 1996.

Kruszewski received $29 million as his share of the $2.3 billion Bextra settlement that Pfizer recently signed.