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Problem: Conflicts of Interest
The FDA's advisory boards, which vote on drugs and devices, are intended to represent a broad spectrum of physicians, researchers and patient advocates -- not stockholders. But a study published in JAMA in 2006 found that in 22 percent of advisory board meetings, more than half the members had direct financial interests in the companies whose medical products they evaluated, or their rivals.The agency says it's doing the best it can. Because drug companies underwrite most clinical research, even at universities and hospitals, some say it's difficult to find top medical experts with no ties to industry.
What's Being Done
Congress has decided to roll up the red carpet. Over the next five years, the FDA will have to cut by 25 percent the number of advisory committee members with financial ties to a product under review. Consumer groups had hoped for an outright ban but say this is a step in the right direction.
• Problem: Muzzled Experts
Dr. Graham, in the FDA's drug safety office, says that a few years ago he was ordered to soften his assessment of a drug he thought should be withdrawn because it could cause liver failure and death. "Industry is our client," a supervisor told him.
"It may be your client," Dr. Graham says he replied, "but it will never be mine."
When told this story, FDA spokeswoman Julie Zawisza said, "Our client is really the public."
Still, other agency scientists share Dr. Graham's concerns. Drug reviewer Rosemary Johann-Liang, MD, suggested two years ago that the diabetes drug Avandia carry a black box on its label (the agency's strongest warning), alerting patients and doctors to its cardiac risks. Instead, Dr. Johann-Liang says, her supervisors reprimanded her and deep-sixed her report.
Last August the agency did finally issue an urgent warning about the drug and placed a black box on its label. But by then Dr. Johann-Liang had resigned -- and millions of Avandia prescriptions had already been filled.
Many agency staffers say they've felt similar pressure to soft-pedal product dangers. In a poll of 1,000 FDA scientists, conducted in 2006 by the Union of Concerned Scientists, 20 percent said agency decision makers had asked them explicitly "to provide incomplete, inaccurate or misleading information to the public, regulated industry, media or elected/senior government officials." And 40 percent said they could not publicly express concerns about public health "without fear of retaliation."
The tone has been set from the top. Last year Andrew von Eschenbach, MD, the FDA commissioner, told a roomful of staffers to stop making their gripes public. "If they don't follow the team," he said, "the first time, they'll be spoken to; the second time, they'll be benched; and the third time, they'll be traded." (FDA spokeswoman Zawisza says Dr. von Eschenbach has no desire to limit dissent.)
The tangled story of Ketek, a once-promising new antibiotic, illustrates what can happen when the agency's scientists feel marginalized.
What's Being Done
Last year Congress created the Office of Chief Scientist of the FDA, to give staff members a forum for debates and improve the quality of research. The new law also gives in-house staffers the right to publish their critiques in medical journals and makes sure their assessments, even if overruled, are made part of the public record.
Money alone won't solve the FDA's morale problem. In recent years, dozens of career scientists and senior managers have left the agency, a much higher turnover than that of the National Institutes of Health or the Centers for Disease Control and Prevention. Public trust in the agency has slid from 67 percent in 2001 to 36 percent in 2006.
Without change at the top, longtime agency watchers say, there's no assurance that officials will get tough on industry scofflaws. In fact, from 2000 to 2005, FDA enforcement against drug, vaccine and medical device manufacturers dropped by more than 50 percent, according to a recent investigation by California Congressman Henry Waxman.
A discouraging sign: One of the first regulations the agency proposed this year is intended as a shield, according to some Congressional leaders, designed to protect drug companies from lawsuits brought by people who believe they've been injured by drugs or medical devices.
But having stronger tools and the right leadership could gradually restore the FDA to what it once was -- a highly respected band of medical detectives, apolitical and immune to corporate pressure.
There is one bright spot on the horizon, says Jerry Avorn, MD, a professor of medicine at Harvard Medical School and an expert on the drug-approval process. "There is more public awareness of this issue than I've seen in 30 years," he says. "And that can help put the agency's many smart, dedicated people back into the driver's seat. Because a lot of this is really not about very arcane science. It's about common sense. And that's what's been missing, until now."
Read more about what you can do.
See the life cycle of a prescription drug.
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