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Rules Planned for Industry Ties on F.D.A. Boards
Gardiner Harris | New York Times | 07/24/2006

The Food and Drug Administration is expected to announce Monday an effort to write guidelines detailing the kind of industry ties that are permitted for those who serve on its powerful advisory boards.

The agency is hoping the move will appease some of its critics who have complained for years that those who sit on its boards often have such deep financial ties to drug makers that their advice is tainted. Advisory boards recommend drugs for approval, and their votes can have enormous influence on drug company stock prices.

The new rules, which are being debated internally and will have to go through a public comment period, are an effort to codify how the agency grants “waivers,” which allow experts with financial ties to drug makers to serve on the boards. The agency has almost complete discretion in granting waivers in a process that is mysterious to outsiders and confusing even to insiders.

F.D.A. officials said the rules would make it all but impossible for experts who get money from drug makers’ marketing departments to serve on advisory committees. That would exclude, for instance, anyone who was paid by the marketing departments to promote drugs.

But the rules would loosen other restrictions, they said. Experts whose ties to a drug maker involve only a grant made to their university may not need to get a waiver, they said.

Indeed, agency officials said they had no intention of excluding all advisers with ties to drug makers.

“There are very few academic experts engaged in research who don’t have some ties to industry,” said Dr. Scott Gottlieb, deputy commissioner for medical and scientific affairs at the F.D.A.

Critics contend that the agency must do a better job of keeping its advisory boards free from the drug industry’s financial influence.

“The idea that all the bright people in the medical world are working for industry is just not right,” said Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest.

Still, many will cheer the agency’s effort to bring greater clarity and transparency to the waiver process. Advisory board members have long complained that it is unpredictable and capricious. “A lot of the judgments we make in granting waivers are case by case and not codified anywhere,” Dr. Gottlieb said.

Another problem is that the agency, citing privacy rules, often refuses to disclose its reasoning for granting waivers, F.D.A. officials said. Critics were sometimes left to wonder whether experts permitted to serve on advisory committees had earned $900 or $90,000 from drug makers, and whether they were paid for genuine research or simple marketing efforts.

“We need to be far more transparent,” Dr. Gottlieb said.

The new rules will, for the first time, try to parse the good and the bad in the myriad relationships many academic researchers have with drug makers.

Dr. Robert Temple, director of the agency’s Office of Medical Policy, complained that some experts had been excluded from advisory panels because they served on industry-sponsored drug-safety monitoring boards for human trials. Such boards are charged with checking study results and ensuring that patient health is protected.

“Those are the very best people, and they are anything but patsies,” said Dr. Temple, adding that he wanted to end the requirement that such experts must get waivers.

Dr. Wayne K. Goodman, chairman of the Psychopharmacology Advisory Committee, which examines psychiatric drugs, said in an interview that he needed a waiver because a colleague in the psychiatry department at the University of Florida, where he is chairman, was involved in an industry-sponsored trial.

“One Web site out there characterized me as rife with conflicts,” Dr. Goodman said. “I thought my integrity was insulted.”

Dr. Sidney Wolfe, director of Public Citizen’s health research group, said the problem with the waiver process had nothing to do with excluding capable experts. He pointed out that a study by his group published in April in a medical journal found that the F.D.A. barred advisory board members with conflicts of interest from attending meetings only 1 percent of the time. Twenty-eight percent of advisory board members disclosed a financial conflict, the study found.

“The F.D.A. abuses its discretion by failing to disqualify members with significant conflicts of interest,” Dr. Wolfe said.

An article last year in The New York Times reported that a vote by a crucial advisory committee on whether to remove a popular painkiller from the market would have turned out differently had experts with industry ties been excluded.

The article led Representative Maurice D. Hinchey, Democrat of New York, to sponsor legislation to bar the agency from allowing anyone with industry ties to serve on advisory boards. The legislation passed in the House last year and this year but has not passed in the Senate.

The controversy over waivers reflects the growing influence of industry in medical research and the increasing importance of the advisory boards, which assess new drug applications and weigh drug risks. Many critics contend that the only way to ensure that the F.D.A. gets unbiased advice from its panels is to exclude anyone who has a financial relationship with a drug maker, no matter how small or how old the tie.

“This country is filled with brilliant scientists, doctors and researchers, and there are plenty of them without any stake in device or drug companies,” said Jeff Lieberson, a spokesman for Mr. Hinchey, whose legislation would bar waivers.

F.D.A. officials and outside experts said ending the waiver process would be a mistake. Dr. Goodman said that his experience running clinical trials for drug makers helped him to decipher drug-company results on the advisory committee.

“I could read between the lines,” he said.

Still, Dr. Goodman said the agency should exclude experts who are pocketing money from drug makers at the time of their service. And he said the details of all waivers should be disclosed.

Dr. Gottlieb said that experts who work with the drug industry on scientific endeavors learn unique lessons, and that “we want these experts on our committees precisely because they have this experience.”.