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the fda - hazardous to your health?
A look inside the FDA, its recent record, and the debate over whether our nation's drug safety system is broken.

`Safe and Effective'?

How good is America's drug safety system? Since 1997, more than a dozen prescription drugs have been taken off the market due to serious side effects -- in some cases after hundreds of injuries and even deaths have occurred. Is the Food and Drug Administration, which is responsible for approving and monitoring the safety of the medications we take, up to the task? Here are excerpts from FRONTLINE's interviews with the FDA's Steven Galson and Paul Seligman, Public Citizen's Sidney Wolfe, and Raymond Woosley of the University of Arizona.

related features
how independent is the fda?

Is the FDA too close to the industry it regulates? Critics argue that industry funding of the drug review and approval process gives pharmaceutical companies, and their lobbyists, too much influence over decision-making and policy. To address these issues, in excerpts from FRONTLINE's interviews, are Public Citizen's Sidney Wolfe, the FDA's Steven Galson, the University of Arizona's Raymond Woosley, and pharmaceutical industry lobbyist John Kelly.

interview: leo lutwak, m.d.

"The FDA is wholly dependent on trust -- on trusting [that] the company is providing all the truth all the time," says Leo Lutwak, a retired FDA drug reviewer specializing in obesity. Dr. Lutwak was the chief medical reviewer for weight-loss drugs and was at the center of the Fen Phen controversy. In this interview, Dr. Lutwak recalls the role he played in the review of Redux and provides insight into the sequence of events that led to the recall of this drug. (Since the time this interview was conducted, Lutwak has been retained by plaintiff's counsel in the ongoing litigation surrounding these drugs.)

interview: michael elashoff, ph.d.

"I think it was pretty well understood," say former FDA scientist Michael Elashoff, "that if you were advocating turning a drug down -- particularly if it was from a large pharmaceutical company -- that that wouldn't be good for your career." A drug reviewer for the FDA from 1995 to 2000, Elashoff says he was marginalized within the agency after he voiced his concerns about a new flu drug called Relenza. Here, Elashoff speaks out about the culture of the FDA's drug approval process.

interview: steven galson, ph.d.

"We think we can run a high-quality independent program, regardless of the source of the resources," says the FDA's Steven Galson, acting director of the Center for Drug Evaluation and Research, "as long as, of course, the resources aren't linked to performance goals that are going to interfere with our independence." In this interview, Galson discusses the FDA's drug safety system and explains how the Prescription Drug User Fee Act helps the FDA.

Interview: Paul Seligman, M.D., M.P.H.

"The fundamental point," says Seligman, director of the FDA's Office of Drug Safety, "is that no drug -- even having gone through this long period of development, testing, and review -- is 100 percent safe." Seligman explains how his office handles adverse-event reports from pharmaceutical companies and through the MedWatch system, and discusses various areas in which the agency's drug safety program could be improved.


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posted november 13, 2003

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