Controversy Swirls Around FDA Meeting on Drug Coated Stents

A planned FDA safety review regarding the use of drug-coated stents is facing intense scrutiny after it was revealed that six doctors on the advisory panel have financial links to stent makers Johnson & Johnson and Boston Scientific. The meeting, set for Thursday and Friday of this week, has been scheduled in order to discuss significant risks of blood clotting associated with the use of drug-coated stents. The FDA granted conflict-of-interest waivers to all six of the physicians in question.

In advance of the meeting, the FDA released documents today related to an FDA staff review that noted that the drug-coated stents “are associated with a small but significant risk of late-stent thrombosis.” Stents are wire-mesh devices used to unclog arteries. The drug-coated stents are intended to prevent scar tissue from forming in the arteries, but preliminary research has determined that the coated stents may increase the probability of adverse events, including heart attacks and strokes.

Agency critics are amazed and appalled that the FDA would allow panel members with significant ties to the companies whose devices are being reviewed. In a statement last month, Merrill Goozner of the Center for Science in the Public Interest said, “The scientists who advise the FDA should be free of all financial ties to firms whose products are under review. The public’s faith in the integrity of the process will be undermined by any reform legislation that allows physicians and scientists with conflicts of interest to continue serving on these committees.”

In response to the latest controversy, Goozner told the Newark Star-Ledger: “There are literally thousands of experts all over this country who are well-schooled in the details of this field. But instead of reaching out to that community to get a totally unbiased look at this question, the FDA appointed a committee on which a substantial fraction have conflicts of interest directly with manufacturers of products being evaluated. It’s almost impossible to have confidence in the outcomes of this kind of deliberation.”

According to Bloomberg News, one member of the advisory panel is Robert Harrington, who runs a Duke University research institute funded by both J&J and Boston Scientific.

Drug-coated stents have been used in 4 million patients and have sales in the $6 billion range annually. They are significantly more expensive than bare stents, but apparently they are more dangerous as well.