Editor's choice

Science, industry, and politics at the FDA

From BMJ USA 2002;November:589

In this issue, the Australian journalist Ray Moynihan reports on the FDA decision to reintroduce alosetron (Lotronex) for irritable bowel syndrome despite serious side effects (BMJ USA p 633). He asserts that the FDA looked the other way, ignoring warnings from its advisory committees and FDA staff, under pressure from private industry and advocacy groups.

The cover photo of the September 14 BMJ, in which his article first appeared, showed the FDA building in Rockville, Maryland, above the provocative caption, "Who owns the FDA?" A news report in that issue quoted a former FDA consultant: "[the agency has become] a servant of the industry, where dissenting voices are intimidated and ostracized" (BMJ 2002;325:561).

In this issue, Janet Woodcock, an FDA official cited by Moynihan, responds with a commentary defending the Lotronex decision (BMJ USA p 637). She concludes by asking what is wrong with the FDA's responsiveness to advocacy organizations that represent patients with irritable bowel syndrome, the very people to be helped or harmed by Lotronex. "The FDA can be accused of listening to, and being influenced by, the needs of patients and practitioners," she writes. "Many thoughtful people would not have it any other way."

Woodcock does not react to speculation that drug money influences the FDA. Moynihan estimates that in 2002 the FDA will receive $162 million from industry under the Prescription Drug User Fee Act. An editorial by Michel Lièvre notes that banner ads from drug companies "sponsor" the web sites of IBS advocacy groups (BMJ USA p 597).

Lately, politics seems the more blatant interloper at the FDA. The front page of the September 17 Washington Post detailed efforts by the Bush administration to eliminate scientific advisory committees' "coming to conclusions at odds with the president's views." An FDA committee was eliminated as it tried to restrain the marketing practices of the genetic testing industry. Elsewhere in government, environmental health and childhood lead poisoning committees had been reconstituted with members tied to the chemical and lead industries, respectively (Washington Post, October 21). A bioethics panel was made "more conservative and prolife" (Philadelphia Inquirer, September 22). The obstetrician nominated to chair an FDA advisory panel on reproductive health drugs is supported by antiabortion groups, opposes contraceptive use, and has written books emphasizing the "restorative power of Jesus" in treating gynecological disorders (Time, October 14).

Politics threatens the objectivity of health information given to the public. Government web sites have been edited to remove undesirable content, such as fact sheets about the effectiveness of condoms and sex education (Washington Post, October 21). For now, patients and professionals can trust the impartiality of scientific health information from the government, but not so if this trend continues.

Articles cited in Editor's Choice are listed below, beginning with their BMJ USA page number

BMJ USA p 633 Alosetron: a case study in regulatory capture, or a victory for patients' rights? (Moynihan), http://bmj.com/cgi/content/full/325/7364/592

BMJ USA p 637 Commentary (Woodcock), http://bmj.com/cgi/doi/10.1136/bmjusa.02110002

BMJ USA p 597 Alosetron for irritable bowel syndrome (Lièvre), http://bmj.com/cgi/content/full/325/7364/555