A former senior consultant with the Food and Drug Administration (FDA) has criticized that agency's close relationship with the pharmaceutical industry. In an interview with the British Medical Journal, he attacked the FDA's decision to allow the re-marketing of a controversial drug.

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, hospitalization, surgery, and deaths.

Glaxo Wellcome (as the company was named at that time) 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 pressured to "help get this drug back on the market."

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 the U.S. is likely to determine whether the company pursues approval for the drug elsewhere in the world.

Over the last 10 years, eight drugs have been approved by the FDA and subsequently withdrawn for safety reasons, prompting calls for an end to industry funding of FDA drug reviews.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.