FDA Swayed by Drug Industry, Former Insider Charges
September 13, 2002 08:33:19 AM PST, Reuters
A former senior consultant for the US Food and Drug Administration ( news - web sites) (FDA) charges in the latest issue of the British Medical Journal that the agency may be inappropriately influenced by patient groups and the drug industry in making decisions that affect Americans' health and safety.

The FDA engaged Dr. Paul Stolley in 2000 to look into reports of adverse events associated with GlaxoSmithKline's irritable bowel syndrome drug Lotronex (alosetron). He claims that the agency appeared to buckle under pressure from patient groups in deciding to return the drug to the market after it had been withdrawn due to safety issues.

Stolley also maintains that the agency took special precautions to avoid antagonizing Glaxo. He believes that the funding the FDA receives from drug firms in the form of user fees compromises its objectivity in reviewing medicines.

Glaxo voluntarily withdrew Lotronex from the US market in November 2000 after the firm and the FDA failed to reach an agreement on an appropriate risk-management plan to address a growing number of reports of serious side effects. The reports included hospitalizations and even some fatalities.

The company resumed discussions with the FDA in January 2001, following an outcry from patients who were upset that they had lost access to the drug. Glaxo now expects to relaunch Lotronex this year under a comprehensive risk-management plan limiting its use to patients with severe, diarrhea-predominant disease who have failed conventional therapy.

But in an interview with Reuters Health, Stolley said that if the FDA had made its decision based purely on science, it would not have approved the reintroduction even with the risk-management provisions.

Irritable bowel syndrome is not life threatening, and Lotronex's benefit doesn't justify its risks, Stolley asserted. He noted that the FDA and Glaxo were not able to determine which patients are at greatest risk of serious side effects.

In general, Stolley said he supports the idea of risk-management programs for important drugs that raise safety concerns, but he maintains that Lotronex is a poor candidate for such a program "because the complications are so unpredictable.

"My own opinion is that the drug should not come back except for compassionate use," he noted.

The FDA does not deny that its decision to allow the Lotronex reintroduction was influenced by patient groups. "Our mission is to serve people who need medicines," Dr. Janet Woodcock, who heads up the agency's Center for Drug Evaluation and Research, pointed out in an interview with Reuters Health.

Woodcock said that it makes little sense to use the Lotronex story as an example of the industry's influence over the FDA, because Glaxo actually was reluctant to continue distribution of the drug in the US.

She said the FDA does not allow drug sponsors to influence its decisions. Even the user fees it collects are designed to help patients in that they speed the review of important medications and allow the FDA to more actively participate in drug development programs, she maintained.

Woodcock acknowledged that the Lotronex reintroduction is likely to result in a number of adverse event reports, despite the risk-management program. The FDA will monitor the reports and modify the program as needed, she said.

She added that the agency probably would report its experience with the reintroduction at a future advisory committee meeting when there is more concrete data available to evaluate the decision.

"People commonly disagree on what to do," she noted. On one hand, the FDA is under constant pressure to allow patients to make informed decisions, but on the other hand, doing so opens the agency to criticism that it has failed to uphold its public-health mission, she said.

In the case of Lotronex, Woodcock said such criticism fails to take into account that a doctor is part of the equation. "We are not putting it over the counter," she emphasized.

A spokeswoman for Glaxo told Reuters Health that when the company decided to withdraw the drug, it had no intention of bringing it back. The decision to try to reintroduce Lotronex was spurred by requests from patients, she said.

She added that it will be years before Lotronex is expected to turn a profit and the firm doesn't consider the drug to be commercially significant.