Insider speaks out against the FDA
Alosetron (Lotronex)
a drug for irritable bowel syndromewas
withdrawn from sale in the United States in late 2000 after reports of
serious adverse events, but six weeks later the special joint advisory
committee to the United States Food and Drug Administration (FDA)
recommended its remarketing. A senior advisor from the committee has
warned of more deaths if the drug is relaunched, and a former insider
of the FDA says that the agency has become a servant of the
pharmaceutical industry. On p 592 Moynihan charts the path of the
drug and examines the truth or otherwise of inappropriate corporate
influence in drug licensing.
(Credit: MARTY KATZ)
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- Alosetron: a case study in regulatory capture, or a victory for patients' rights?
- Ray Moynihan
BMJ 2002 325: 592-595.[Extract] [Full Text] [PDF]
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