Education And Debate

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

BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7364.592 (Published 14 September 2002) Cite this as: BMJ 2002;325:592
  1. Ray Moynihan, journalist (ray_128@hotmail.com)
  1. Australian Financial Review, GPO Box 506, Sydney 2201, NSW, Australia
  1. 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irritable bowel syndrome, alosetron (Lotronex), which was once considered a potential top seller but was voluntarily withdrawn in late 2000 following serious adverse events, including deaths.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 …

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