Healthy Skepticism Library item: 7144

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Publication type: news

FDA Stents Panel Filled with Conflicted Physicians
Ingegrity in Science 2006 Dec 4
http://www.cspinet.org/integrity/watch/200612042.html

Full text:

FDA Stents Panel Filled with Conflicted Physicians

The Food and Drug Administration gave financial conflict-of-interest waivers to six physicians who will sit on the advisory panel that meets Thursday and Friday to evaluate the safety of drug-eluting stents made by Johnson & Johnson and Boston Scientific. Recent studies have shown that drug-eluting stents, which have been inserted in 4 million Americans with heart disease over the past three years, increase the risk of heart attacks compared to bare-metal stents, which are one-third the cost.

Five of the waivers went to physicians with direct ties to stent manufacturers or makers of drugs used in stents. They included: Richard Page of the University of Washington, who has unrelated consulting agreements with a manufacturer of a drug-eluting stent; George Vetrovec of Virginia Commonwealth University, who has a consulting deal with a manufacturer of drug-eluting stents; Clyde Yancy of the University of Texas Southwestern Medical Center, who has a consulting agreement with a company that makes a drug being tested for use with drug-eluting stents; and Judah Weinberger of Columbia University, who owns stock in companies that manufacture drug-eluting stents. The company names were blacked out in the publicly-released waivers. The FDA also gave JoAnn Lindenfeld of the University of Colorado Health Sciences Center a waiver because she is “recognized as an expert noninvasive cardiologist and heart failure expert and has traditionally served as a useful and thoughtful counterweight to the interventional cardiology perspective.” Her waived financial ties included consulting arrangements with an unnamed stent manufacturer and a firm with a competing technology. Earlier this year, she refused to explain to a New York Times reporter her earlier criticism of a cardiovascular device, which had been carried on the specialist-oriented Heartwire.

The other financial tie the FDA chose to overlook was Duke University researcher Robert A. Harrington’s consulting arrangements with several drug manufacturers with a stake in continued use of drug-eluting stents. “His views on stent thrombosis and possible mitigation of this devastating complication will be extremely valuable,” the FDA waiver said. Earlier this year, Harrington participated in an American College of Cardiology online continuing medical education program that suggested clopidogrel (Sanofi-Aventis’ best-selling blood thinner drug Plavix) plus aspirin was better than aspirin alone for preventing blood clots in patients with clogged heart arteries. He disclosed that he or his institution received research grants from 11 firms, including Sanofi-Aventis. A recent New England Journal of Medicine review of the stent issue pointed out that “many physicians now recommend extended or lifetime prescriptions of aspirin and clopidogrel for patients receiving drug-eluting stents.”