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

doi:10.1136/bmj.325.7364.592

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Ray Moynihan, journalist (ray_128@hotmail.com)

Australian Financial Review, GPO Box 506, Sydney 2201, NSW, Australia

Correspondence to: R Moynihan, 4/1312 21st Street NW, Washington, DC, 20036, USA

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irritable bowel syndrome, alosetron (Lotronex), which was once considered a potential top seller but was voluntarily withdrawn in late 2000 following serious adverse events, including deaths.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

16 November 1999—First FDA advisory committee recommends approval of alosetron hydrochloride (Lotronex), a 5-HT₃ receptor antagonist made by GlaxoWellcome.
9 February 2000—FDA approves alosetron for treating women with “diarrhoea-predominant irritable bowel syndrome”
27 June 2000—Second FDA advisory committee meeting discusses mounting toll of serious adverse events, but votes to keep alosetron on the market
1 July 2000—Dr Paul Stolley joins FDA as “senior consultant”
16 November 2000—Dr Paul Stolley is joint author of internal FDA memo on failure of “risk management” strategies to prevent harms and deaths
28 November 2000—GlaxoWellcome and FDA meet; company withdraws alosetron
December 2001—GlaxoSmithKline seeks to re-market alosetron with restrictions
23 April 2002—Third FDA advisory committee recommends re-marketing, with restrictions
7 June 2002—FDA re-approves alosetron, ignores key committee recommendation on eligible prescribers

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 …