FDA advisory panel on drug-eluting stents to include physicians with industry ties

Dec 5 2006

FDA will waive rules that prohibit advisory panel members from having financial ties to companies whose products are being reviewed to allow six physicians with ties to Johnson & Johnson and other heart device manufacturers to serve on a panel examining the possible health risks of drug-eluting stents, Bloomberg/South Florida Sun-Sentinel reports (Goldstein, Bloomberg/South Florida Sun-Sentinel, 12/5).

The panel on Thursday and Friday will examine whether drug-coated stents, which are sold in the U.S. by Boston Scientific and J&J, increase the risk of life-threatening blood clots and whether the potential risk outweighs the benefits of the stents for some patients.

Recent studies have suggested the devices might increase the risk of thrombosis compared with bare-metal stents.

The panel might examine whether FDA should require longer studies of drug-coated stents and might recommend that FDA restrict the use of drug-coated stents already on the market.

In addition, the panel might recommend that patients who receive the devices take Plavix for longer than the current recommendation of six months or less.

Plavix is marketed by Bristol-Myers Squibb in the U.S. and Sanofi-Aventis in the rest of the world (Kaiser Daily Health Policy Report, 12/4).

Some consumer groups and members of Congress have criticized the inclusion of experts with financial ties to the drug and medical device industries on FDA advisory panels.

However, regulators say researchers often consult for companies that make products under review (Bloomberg/South Florida Sun-Sentinel, 12/5).