NEJM editors file amicus alleging drug makers withheld info from FDA

WASHINGTON A group of 10 former and current editors and authors of The New England Journal of Medicine allege that drug makers Merck, Wyeth and Bayer Healthcare withheld information from the Food and Drug Administration about the safety of certain drugs, resulting in tens of thousands of deaths.

The editors and authors have filed an amicus brief in the United States Supreme Court upcoming preemption case, Wyeth v. Levine. Wyeth is appealing a decision by the Vermont Supreme Court to uphold a $6.8 million award to Diana Levine, a musician whose arm had to be amputated after Wyeth’s anti-nausea drug Phenergan (promethazine HCl) was administered improperly.

The brief highlights drugs such as Merck’s Vioxx (rofecoxib), Bayer’s Trasylol (aprotinin) and Wyeth’s Redux (dexfenfluramine) and fen-phen—all of which were withdrawn from the market for safety reasons.

The Journal of the American Medical Association also published an article earlier this year charging that Merck withheld mortality data related to Vioxx before the FDA approved it, while Merck employees ghostwrote and guest-wrote articles about the drug.