Thursday, June 30, 2011

Clinical Test Of Epilepsy Drug May Not Be Ethical - Health News - redOrbit

A clinical trial of gabapentin, an epilepsy drug, may have been a “seeding trial” that was used by the pharmaceutical company purely for promotional purposes and to increase prescriptions, according to researchers from Yale School of Medicine.

Joseph Ross, M.D. and his colleagues at Yale describe a seeding trial as “a clinical trial conducted primarily for marketing purposes and intended to promote the drug and increase prescribing by exposing physician-investigators to it.”

Researchers from the study had access to all documents related to the clinical trial “Study of Neurotonin: Titrate to Effect, Profile of Safety (STEPS).” These included internal and external correspondence from the company as well as reports, presentations, depositions obtained in legal proceedings of Harden Manufacturing v. Pfizer, and Franklin v. Warner-Lambert.

“We found that STEPS was a seeding trial posing as a legitimate scientific study,” Ross says.

“The trial itself, not trial results, was part of a marketing strategy used to promote gabapentin and increase prescribing among investigators without informing trial patients or investigators.”

Posted via email from Jack's posterous

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