Six doctors with financial ties to the pharmaceutical industry, including stock holdings or speaking fees, will be among members of a U.S. advisory panel on the use of a GlaxoSmithKline Plc diabetes medicine linked to heart risks.
The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn’t say how many members the committee will have.
The FDA was criticized by lawmakers for allowing conflicts of interest among members of an advisory panel in 2005 that concluded benefits outweighed risks for pain drugs, including Merck’s Vioxx, which already had been withdrawn, and Pfizer Inc.’s Celebrex and Bextra. Ten members of that 32-person panel had financial ties to companies whose products were examined. Without their votes, the panel recommendations would have been reversed for Vioxx and Bextra.
Some members of the panel on Avandia own stocks through mutual funds, collect speaking fees or advise drugmakers that compete against companies whose products are to be discussed at the meeting. In addition to Avandia, the panel is expected to discuss similar medications, including Takeda Pharmaceutical Co.’s Actos.
The FDA’s documents for Thomas Pickering, a professor at Columbia University Medical Center in New York, said he was paid less than $10,001 a year for serving on a drugmaker’s advisory board and had stocks in drug companies.
Pickering, 67, who is a voting member of the panel, said in an interview that he served earlier this year on an advisory board to Bristol-Myers Squibb Co., a New York-based drugmaker, and holds mutual funds that invest in pharmaceutical companies. The financial ties won’t affect his recommendations, Pickering said.
Another voting member, David S. Schade, a professor at the University of New Mexico School of Medicine in Albuquerque, received less than $10,001 a year as a member of a speaker’s bureau for a drugmaker whose products compete with those to be discussed at the panel meeting, according to the FDA. He also received less than $10,001 a year as a consultant to a pharmaceutical company on an unrelated product. The names of the companies were expunged on the documents made public. Schade didn’t return a phone call.
Morris Schambelan, a professor of medicine at the University of California, San Francisco, received less than $10,001 a year as a member of a drugmaker’s “complications committee” that focuses on side effects of antiviral medications, according to the FDA. Schambelan, a voting member, was out of the country and didn’t return phone calls.
John R. Teerlink, another Avandia panel member, holds stock in a health-sector mutual fund, according to the FDA. Teerlink, director of the heart-failure clinic at the San Francisco Veterans Affairs Medical Center, also received $10,001 to $50,000 a year as a study reviewer for a drugmaker, which he identified as Bristol-Myers. The FDA paperwork doesn’t make clear whether Teerlink will vote.
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