Letters

Alosetron for irritable bowel syndrome

BMJ 2003; 326 doi: http://dx.doi.org/10.1136/bmj.326.7379.51/b (Published 04 January 2003) Cite this as: BMJ 2003;326:51

Senior vice president of GlaxoSmithKline responds

  1. James B D Palmer, senior vice president, new product development ([email protected])
  1. GlaxoSmithKline, 5 Moore Drive, Research Triangle Park (RTP), NC 27709, USA
  2. Forest Laboratories, 909 Third Avenue, New York, NY 10022, USA

    EDITOR—As the senior doctor at GlaxoWellcome and GlaxoSmithKline who participated in all of the key meetings that resulted in the withdrawal of Lotronex (alosetron) and the subsequent approval for reintroduction, I feel compelled to reply to both the article and editorial on alosetron. 1 2

    Moynihan sees a complex web of intrigue where none existed, at least from the viewpoint of GlaxoWellcome and GlaxoSmithKline.1 Here are the key elements of the story from our position.

    We had a medical disagreement with the Food and Drug Administration about the aetiology of the serious adverse events occurring in patients taking alosetron. In November 2000 we had several meetings with the administration, which led to a meeting on 28 November where we realised we could not come to agreement …

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