BMJ 2002;325:592-595 ( 14 September )

Education and debate

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

Ray Moynihan, journalist. 

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

Correspondence to: R Moynihan, 4/1312 21st Street NW, Washington, DC, 20036, USA
ray_128@hotmail.com

Editorial p 555 News p 561

The first 150 words of the full text of this article appear below.

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irritable bowel syndrome, alosetron (Lotronex), which was once considered a potential top seller but was voluntarily withdrawn in late 2000 following serious adverse events, including deaths.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

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