Dr Paul Stolley joined the FDA in July 2000 to look into the post-marketing safety of alosteron (Lotronex), a treatment for irritable bowel syndrome manufactured by GlaxoSmithKline. Within months he was writing to his superiors about a rising toll of adverse incidents, including ischaemic colitis, hospitalisation, surgery, and deaths.
Glaxo Wellcome (as the company was then) voluntarily withdrew alosteron in November 2000, but almost immediately patient groups were pushing for its return. Stolley claims that his superior, Dr Janet Woodcock, accused him of "brow-beating" colleagues about the drug's risks. He also says other colleagues concerned about the drug's safety were pressurised to "help get this drug back on the market". Woodcock, however, says that alosetron is an example of how difficult it is to provide access to a risky drug for those in greatest need. On Stolley himself she says: "It's our responsibility to be dispassionate and not develop emotionally based positions".
In April a special advisory committee recommended that alosetron be remarketed on the condition that it was prescribed only by specially certified doctors. Six weeks later, however, the FDA formally re-approved marketing based only on "physician self attestation of qualifications".
A number of the committee members are now publicly warning of a risk of more deaths and another withdrawal if the drug returns to the market later this year. What happens in America is likely to determine whether the company pursues approval for the drug elsewhere in the world.
Over the last ten years eight drugs have been approved by the FDA and subsequently withdrawn for safety reasons, prompting calls for an end to industry funding of FDA drug reviews. "It's getting its money from industry now and it's afraid to offend those companies", says Stolley. Glaxo and the FDA deny any inappropriate influence over regulatory decision making.