In allowing the physicians to be a part of the review, the FDA is waiving its own rules that prevent panel members with financial ties to companies that are affected by panel decisions from serving. Critics say that because the panel will be making important safety decisions on stents -- many of which have been found to dramatically increase the risk of heart attack and stroke -- the doctors' financial ties to stent makers is unacceptable.
"Once again we see the FDA violating basic ethical standards by recruiting decision makers who have strong financial ties to the very companies impacted by their decisions," said health author and FDA critic Mike Adams. "It demonstrates just how deeply the FDA is financially intertwined with the profits of drug companies and medical device manufacturers.
"Essentially, the FDA has become the marketing department for those firms, and simultaneously an opponent of the public," Adams said.
A Nov. 29 study by the Cleveland Clinic Foundation found that stents coated with anti-clotting drugs increased recipients' risk of stroke and heart attack as much as fivefold.
According to Sanjay Kaul, director of the cardiology fellowship program at Cedars-Sinai Medical Center in Los Angeles, blood clots caused by drug-coated stents kill 2,160 patients in the United States each year. Kaul's study was published online on Oct. 11 by the American College of Cardiology. Stent makers Johnson & Johnson and Boston Scientific both claim that their drug-coated stents are no more dangerous than uncoated metal stents.
The FDA defended its decision to waive its conflict-of-interest rules for the panel members, claiming that the six doctors' expertise on heart disease outweighs their financial conflicts of interest with stent makers.
However, Dr. Herman Gold, a cardiologist at Massachusetts General Hospital and an associate professor at Harvard Medical School, said he "could think of 100 people who could qualify" as heart disease experts, without financial conflicts of interest. "The FDA has been asleep at the switch with regard to the safety" of stents, Gold said.
The panel will meet Dec. 7 and 8 in Gaithersburg, Md., to determine whether or not cardiologists implant too many coated stents, as well as how long companies should be required to test new models prior to approval. The panel's decisions could affect the FDA's guidelines on the $6 billion stent industry.