FDA Says Doctor Should Have Been on Prasugrel PanelFeb 24, 2009 | Parker Waichman LLP
Eli Lilly’s drug Prasugrel might be facing additional problems since a prominent cardiologist was bumped from a panel determining the drug’s fate, reports Dow Jones. U.S. federal regulators agree. Lilly’s experimental anti-clotting drug has been mired in controversy over dangerous bleeding and cancer risks, said Bloomberg News.
The U.S. Food and Drug Administration (FDA) said that to “dis-invite” Dr. Sanjay Kaul, from the panel was a “mistake,” quoted Dow Jones. Dr. Kaul is a cardiologist and heart research scientist at Los Angeles’s Cedars-Sinai Heart Institute and was scheduled to participate in the FDA’s meeting about Prasugrel on February 3, said Dow Jones and Bloomberg. The meeting was conducted to determine whether or not to recommend Lilly’s drug for FDA approval. The members voted in a unanimous 9-0 vote for recommendation, said Dow Jones.
But, just a few days before the meeting was scheduled to take place, Lilly called the FDA and mentioned its concerns over Dr. Kaul’s attendence, said Dow Jones, complaining about articles he authored, said Bloomberg. Dr. Kaul has written research articles questioning Prasugrel’s safety and efficacy, said Bloomberg.
The FDA is legally allowed to exclude members from participating in such meetings if it is found that a financial or intellectual conflict of interest is present, said Dow Jones, which noted that financial conflicts include if a member has received consulting fees from an involved company. So-called “intellectual bias” is a bit more challenging to determine, said Dow Jones, noting that this type of bias involves if a member has pre-determined if a drug should or should not be allowed on the market. FDA officials, said the paper, admitted that a variety of mistakes led to Dr. Kaul’s ejection.
Dr. Janet Woodcock, FDA’s drug division director, said that Dr. Kaul was only asked about financial conflicts during the screening process, reported Dow Jones, noting that no financial conflicts arose. Dr. Kaul was never asked about intellectual biases and Woodcock and other key FDA officials were not advised that Dr. Kaul was told not to attend the Maryland meeting until after the fact, said Dow Jones. "At every step of the way there were errors by multiple parties," Woodcock said. The FDA has yet to conduct a formal review to determine Dr. Kaul’s intellectual bias, if any.
"In my own personal opinion I didn't see anything in [Kaul's] writings ... that would preclude him from serving on the committee," said John Jenkins, FDA's director of the Office of New Drugs. "I think he would have been a very valuable member," quoted Bloomberg. “He was asking the right questions,” he added. Sidney Wolfe, director of Washington-based Public Citizen’s health- research group and a member of the FDA’s drug safety committee wrote in a letter to the FDA, dated February 19, “It is unclear how the conclusions Dr. Kaul came to regarding the efficacy and safety of prasugrel suggest any bias, as opposed to well-reasoned scientific inquiry. On the contrary, he is free from any financial conflicts of interest, which are not uncommon on FDA advisory committees.”
Meanwhile, Dr. Kaul was not consulted, Prasugrel is not yet on the market, and an approval decision is pending, said Dow Jones, but Bloomberg notes that the drug might face delays given the admitted mistake of removing Dr. Kaul. As a matter-of-fact, said Bloomberg, according to an analyst with Nataxis Bleichroeder—Jon LeCroy—the controversy could postpone action until later this year. It seems that advisors also “downplayed” the bleeding and cancer risks posed by the Lilly drug, said Bloomberg, with LeCroy describing the meeting as a “love fest” that ended with the FDA possibly only adding stricter warning labels to the drug’s packaging, if and when, it makes it to market.