Failures on Drug Safety and Conflicts of Interest Shake Confidence in FDA

Interview with Linda Marsa, journalist and author, conducted by Scott Harris

Before its recall, the painkiller Vioxx had been used by more than two million people in more than 80 countries. But Merck & Co., the maker of Vioxx withdrew the drug in September after studies confirmed earlier indications that the painkiller increased the risk of heart attack, stroke and death. Since then other drugs, including the painkiller Celebrex and the attention disorder medicine Strattera have come under scrutiny.

But, more importantly, confidence in the regulatory process supervised by the U.S. Food And Drug Administration has been shaken. The FDA reports that adverse drug reactions among Americans has more than doubled from 1995 to 2003 -- and risen by more than fourfold since 1990. Questions have been raised about the standards used by the FDA in testing the safety of new drugs and about the regulatory agency's relationship with the pharmaceutical industry it monitors. The recent announcement by the drug-maker's top lobby group, PhRMA, that its new president would be retiring 13-term Republican Congressman Billy Tauzin of Louisiana, who chaired the House Energy and Commerce Committee, further raised alarm about the revolving door between government and industry.

Between The Lines' Scott Harris spoke with journalist and author Linda Marsa, who examines the recall of drugs like Vioxx, and the relationship between the FDA and the pharmaceutical industry.

Linda Marsa's article, "Sleep For Sale," can be read online at www.motherjones.com. Marsa's 1997 book about the pharmaceutical industry, "Prescription for Profits," is published by Scribner.

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