Alosetron: a case study in regulatory capture, or a victory for patients' rights?

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Editorial p 555 News p 561 Senior members of the FDA's advisory committee warn of more deaths if alosetron (Lotronex) is relaunched, as a former insider speaks out about the US regulator's close relationship with Big Pharma In April this year, a special joint advisory committee to the United States Food and Drug Administration (FDA) recommended remarketing GlaxoSmithKline's controversial drug for irritable bowel syndrome, alosetron (Lotronex), which was once considered a potential top seller but was voluntarily withdrawn in late 2000 following serious adverse events, including deaths. Because of the drug's modest benefits and major harms, a key condition of the committee's recommendation was the introduction of a “risk management programme.” Committee members emphasised during their deliberations that the drug should be prescribed only by doctors who had been trained and certified to use it. They explicitly rejected a weaker company proposal to allow prescribing by doctors who “self attested” to competency. #### Box 1: The Lotronex timeline RETURN TO TEXT Just six weeks later, on 7 June, the FDA formally re-approved marketing, but it announced that prescribing would be based on …