Drug Regulators Admit Error Tossing Lilly Critic From Panel
The Food and Drug Administration decided to eject panel member Sanjay Kaul after Lilly contacted the agency, said Janet Woodcock, director of the FDAs Center for Drug Evaluation and Research. The Indianapolis-based drugmaker complained about research articles written by Kaul that questioned the safety and effectiveness of the drug, called prasugrel, she said.
The FDA “disinvited” Kaul because of concerns he might be biased against the drug, said Woodcock, who called the dismissal a “mistake.” The panel on Feb. 3 backed prasugrels approval in a 9-0 vote, after the advisers in attendance downplayed the potential risks of bleeding and cancer. John LeCroy, an analyst with Nataxis Bleichroeder in New York, described the meeting as a “love fest” in a note to investors.
Kaul “would have been a very valuable member of the committee,” said John Jenkins, director of the FDAs Office of New Drugs, in a telephone interview yesterday. “He was asking the right questions.”
Sandy Van, a spokeswoman for Kaul, director of a heart research laboratory at Cedars-Sinai Medical Center in Los Angeles, said he wasnt available to comment. Lilly spokesman Mark Taylor didnt return a telephone call for comment.
Prasugrel, if approved, may take up to 20 percent of market share from Plavix, which generated $8.1 billion in 2007 for Bristol-Myers Squibb Co. and Sanofi-Aventis SA. Prasugrel was cleared by European regulators yesterday to be sold under the name Efient. Lilly will split revenue from the drug with Daiichi Sankyo Co. in Tokyo.
Not Invalidated
The FDAs Woodcock said the agency doesnt believe Kauls absence from the meeting “invalidates the results.”
The controversy over Kauls dismissal may mean “a small delay” in prasugrels final approval, said Tim Anderson, an analyst at Sanford C. Bernstein & Co. in New York, in a note to clients yesterday. “It would seem to be perfect material” for investigation by critics of the FDA in the U.S. Congress.
“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,” said Sidney Wolfe, director of Washington-based Public Citizens health- research group, in a letter to the FDAs Center for Drug Evaluation and Research on Feb. 19. “On the contrary, he is free from any financial conflicts of interest, which are not uncommon on FDA Advisory Committees.”
Several small mistakes led to the decision to keep Kaul off the committee, which was made during the weekend before the meeting without the knowledge of senior FDA staff, Woodcock said.
“This is not the correct procedure,” she said. “This is not going to happen again.”