FDA Admits Error In Barring Doctor From Panel

Wed, 02/25/2009 - 4:04am
By MATTHEW PERRONE AP Business Writer WASHINGTON (AP) — An influential cardiologist who criticized an experimental Eli Lilly drug should not have been barred from a panel that evaluated the drug's safety, federal health officials said. Earlier this month, nine members of the Food and Drug Administration's cardiology panel unanimously voted in favor of prasugrel, a highly anticipated blood thinner under FDA review. Missing from that vote was Dr. Sanjay Kaul, who had criticized Lilly's studies of the drug. Kaul was pulled from the meeting roster days before by FDA officials, who said he had the "appearance" of a conflict of interest. But in an unusual move Monday, FDA officials said they were wrong. "That's not the correct procedure," said Dr. Janet Woodcock, director of FDA's drug division. Woodcock said higher-level officials should have been consulted on the decision, and the agency has since ruled that Kaul did not have an unreasonable bias. According to Woodcock, Lilly contacted the FDA days before the meeting and suggested Kaul had "an intellectual bias" against the drug. Lower-level officials decided it was too late to properly assess the issue and decided to exclude him. "At every step of the way errors were made by multiple parties not following the correct way of doing things, and that led to Dr. Kaul being disinvited from the advisory committee meeting," Woodcock said. The FDA relies on advisory panels to provide expert advise on whether to approve drugs and medical devices. It is not required to follow panelists' advice, though it usually does. The agency has been criticized in recent years for allowing too many experts to serve despite financial relationships with companies. A 2006 study found that more than one-fourth of the experts relied on for advice on drugs reported such conflicts of interest. But the agency's decision to pull Kaul lends weight to another frequent criticism: that the FDA is too willing to accommodate the companies it regulates. Lilly said it was simply making the FDA aware of Kaul's history regarding prasugrel. Company spokeswoman Tammy Hull said in a statement, "We were well prepared to answer any and all questions from the panel regardless of who the members were." Prasugrel, which won European approval on Monday, has had a protracted review at FDA, which has twice delayed making a decision. While prasugrel clearly lowers the risk of heart attack in patients with acute heart problems, it also raises the risk of internal bleeding. Eli Lilly argued the drugs' risks could be minimized if it isn't given to certain high-risk patients, including those older than 75 and under 130 pounds. But Kaul criticized the company's evidence and in November he made a series of presentations on the issue at the American Heart Association meeting. He predicted the drug would at best be a "niche" product. Kaul, a specialist in evaluating clinical trials, is a research director at Cedar Sinai Medical Center in Los Angeles. Officials at the center Tuesday could not provide comment. Lilly developed prasugrel with Japanese drugmaker Daiichi Sankyo Co., and the two companies will share revenue. If approved in the U.S., it would be marketed as Effient and could reach an estimated $1 billion in annual sales. It would be the first serious competitor to Plavix, the world's second best-selling prescription medicine. The drug had U.S. sales of $4.9 billion last year and is marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis.



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