Lancet challenges FDA's integrity

The British medical journal Lancet released a stinging commentary on Friday accusing the FDA of putting the interests of pharmaceutical companies ahead of public health. Lancet editor Richard Horton charged that FDA's handling of GlaxoSmithKline's irritable bowel therapy Lotronex alosetron, which was withdrawn in November 2000 because of concerns that it caused fatal side effects, demonstrates a "fatal erosion of integrity" at the agency. He also contends that the Lotronex case "reveals not only dangerous failings in a single drug's approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research (CDER) in particular, has become the servant of industry." Horton recommends a congressional audit of the FDA's drug approval activities since the enactment of the Prescription Drug User Fee Act, the cessation of "all covert private communications between senior FDA officials and industry," and greater transparency in the conduct of approvals and safety reviews. ...