Alosetron for irritable bowel syndrome
James B D Palmer and Robert H Palmer
BMJ 2003; 326: 51.

EDITORAs 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. Moynihan (1) 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 on certain key matters. Reluctantly, we decided that we had no viable option but to withdraw the drug voluntarily. Having withdrawn the drug, we had no intention of reintroducing it. But thousands of patients contacted both us and the Food and Drug Administration to emphasise the benefits of the drug. It was these pleas that led GlaxoSmithKline and the Food and Drug Administration to try to find common ground to reintroduce the drug. This culminated in April 2002 in an advisory committee, where a full and transparent review of all available data was undertaken. Over the past 20 months we have worked with the Food and Drug Administration to find a way forward for this drug that will balance safety concerns and practicality in prescribing with the clear desires of patients to have an effective treatment for irritable bowel syndrome. People who were at the advisory committee could not fail to have been moved by testimonies from patients whose lives had been changed by alosetron. The implication that we were somehow in collusion with the Food and Drug Administration is not true. The pharmaceutical industry is highly regulated, and everyone in industry accepts and respects the Food and Drug Administration's authority. The articles by Moynihan and Lièvre (2) have clouded the subject of the reintroduction of alosetron by misrepresenting the facts. I hope this helps clarify what happenedat least from our point of view. Also, let's not forget who is the ultimate beneficiarythe patient with irritable bowel syndrome for whom alosetron is an effective treatment.

1. Moynihan R. Alosetron: a case study in regulatory capture, or a victory for patients' rights? BMJ 2002; 325: 592-595 (14 September.)
2. Lièvre M. Alosetron for irritable bowel syndrome. BMJ 2002; 325: 555-556 (14 September.)