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photo of elashoff michael elashoff, ph.d.

A biostatistician, Michael Elashoff was a drug reviewer for the FDA from 1995 to 2000. Elashoff says he found himself marginalized at the FDA after he voiced his concerns about a new flu drug called Relenza. In this interview, Elashoff speaks out about the culture of the FDA's drug approval process and why he felt Relenza should not have been put on the market. This interview was conducted on Feb. 19, 2003.

photo of galson steven galson, m.d.

Steven Galson is the acting director of the FDA's Center for Drug Evaluation and Research. The CDER oversees the drug approval process and monitors drugs after they are already out on the market. In this interview, Galson discusses this monitoring process, explains how the Prescription Drug User Fee Act helps the FDA, and recounts the Baycol recall. This interview was conducted on Feb. 19, 2003.

photo of kelly john kelly, m.d., ph.d.

John Kelly is senior vice president for scientific and regulatory affairs and a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's lobbying organization. He tells FRONTLINE that the industry is pleased with the way user fees, introduced under the 1992 Prescription Drug User Fee Act (PDUFA), have made the drug review and approval process more efficient, and notes that Congress has decided that user fees are the best way to fund this part of the FDA's activities. This interview was conducted on Feb. 12, 2003.

photo of lutwak leo lutwak, m.d.

Leo Lutwak is a retired FDA drug reviewer. An endocrinologist specializing in obesity, Dr. Lutwak taught at Cornell University before joining the FDA in 1989. While with the FDA, he 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 lead to the recall of this drug. This interview was conducted on Nov. 3, 2002. Lutwak has since been retained by plaintiff's counsel in the ongoing litigation surrounding these drugs.

photo of rich stuart rich, m.d.

Stuart Rich is a professor of medicine and director of the Rush Heart Institute Center for Pulmonary Heart Disease in Chicago. In January 2004, he will become the chief medical officer at United Therapeutics Corporation, and will continue at Rush on a part-time basis. In this interview, he recounts his role in the international study of pulmonary hypertension associated with the diet drug Redux, which was published in The New England Journal of Medicine in 1996. The interview was conducted on Nov. 19, 2002.

photo of seligman paul seligman, m.d., m.p.h.

Since July 2001, Paul Seligman has been the director of the Office of Pharmacoepidemiology and Statistical Sciences and director of the Office for Drug Safety in the FDA's Center for Drug Evaluation and Research. The Office for Drug Safety monitors the safety of drugs after they go on the market, and receives as many as 1,000 MedWatch alerts a day. In this interview, Seligman explains how his office manages these alerts and how it conducts risk management when adverse events are reported. This interview was conducted on Nov. 4, 2002.

photo of wolfe sidney wolfe, m.d.

Among the most outspoken and vigilant critics of the FDA and the pharmaceutical industry, Sidney Wolfe has been the director of Public Citizen's Health Research Group -- an independent, nonprofit consumer-advocacy organization -- since it was founded in 1971. He is also an adjunct professor of internal medicine at Case Western Reserve University School of Medicine. "Within the FDA," he tells FRONTLINE in this interview, "there's a very dangerous, unhealthy tension that results in drugs being approved that shouldn't be approved, and drugs staying on the market much longer than they should." He goes on to discuss the reforms that he thinks are needed. This interview was conducted on Nov. 4, 2002.

photo of woosley sidney woosley, m.d.

Raymond Woosley is vice president for Health Sciences at the University of Arizona and was a top candidate to become FDA commissioner in 2002. From 1988 to 2000, he was chair of Georgetown University's department of phamacology. He tells FRONTLINE in this interview that the FDA's drug safety efforts are underfunded and understaffed, and stresses that the country needs independent analysis of drugs' safety and effectiveness. "The market," says Woosley, "is going to find out what's good about medicines. It's never going to ask all the questions about what could be wrong." This interview was conduced on Oct. 25, 2002.

 

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posted november 13, 2003

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