Six on FDA stent panel have ties to device firms
WASHINGTON -- Six physicians with financial ties to Johnson & Johnson and other heart-device makers will be advising US regulators whether to restrict the use of some products because of potentially lethal side effects.
The doctors will serve this week on a Food and Drug Administration panel in Washington reviewing blood clots linked to stents, tiny devices that prop open arteries. The panel members, listed on an FDA website Nov. 22, will include Robert Harrington, who runs a Duke University research institute funded by stent makers J&J and Boston Scientific Corp.
To allow the doctors to participate in the review, the FDA is waiving rules that bar panelists from serving in matters affecting companies in which the experts have stock ownership or consulting contracts. Regulators say expert researchers often consult for makers of products under review. Agency critics, including Republican Senator Charles Grassley of Iowa, say only advisers without financial conflicts should be chosen.
"I could think of 100 people who could qualify," said Herman Gold, a cardiologist at Massachusetts General Hospital in Boston and a Harvard Medical School associate professor. "The FDA has been asleep at the switch with regard to the safety" of stents, Gold said in an interview Nov. 28.
Gold, 65, said he plans to present research to the FDA panel explaining how coatings on some stents raise blood-clot risk. Last year, stents coated with drugs designed to keep arteries from reclogging accounted for 43 percent of sales for Boston Scientific, which is based in Natick, and 5.2 percent for J&J, based in New Jersey.
The risk of blood-clot formation is raised as much as fivefold in heart patients who receive drug-coated stents compared with those getting bare-metal ones, according to a Cleveland Clinic Foundation analysis released Wednesday .
The study is the latest to raise concerns that drug-eluting stents are more likely to cause clots leading to heart attacks and strokes.
Some members of Congress, including Grassley, and consumer groups such as Public Citizen in Washington have criticized the FDA in past cases for selecting panelists with financial ties to companies whose drugs or devices are under review.
Ten of 32 members of the FDA advisory group on painkillers such as Vioxx, the drug withdrawn by Merck & Co. in September 2004 because of cardiac risk, had financial ties to makers of the medicines, according to a study last year by the Center for Science in the Public Interest, a Washington-based advocacy group.
The panel voted 17-15 to allow Vioxx back on the market. Nine of the 10 panelists with financial ties to the makers of this class of drugs voted with the majority, according to the advocacy group. The FDA later rejected the advice.
