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September 9, 2005

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FDA Lets Scientists With Drug Company Ties Evaluate New Insulin Product

The Food and Drug Administration (FDA) is under fire again today for allowing scientists with direct financial ties to a drug manufacturer to serve on an advisory committee charged with evaluating that company's product.

At a meeting today of the Endocrinologic and Metabolic Drugs Advisory Committee that considered the safety and efficacy of Pfizer's proposed insulin inhaler, at least three of the committee's nine members had direct ties to Pfizer, the product's manufacturer, or its technological partner, Nektar Therapeutics. One other member-the acting chairman-holds stock in Pfizer.

Dr. Talmadge E. King of San Francisco General Hospital has consulted with Nektar in the recent past. He was granted a complete waiver to participate in the meeting. Dr. Dara P. Schuster of Ohio State University has consulted and spoken on behalf of Pfizer. He also was granted a complete waiver. Dr. Nelson Watts, usually the committee's chairman, was allowed to participate in the meeting without a vote despite earning $5,000 to $10,000 a year for serving on Pfizer's speakers bureau. And Dr. Paul Woolf, who chaired the meeting, was granted a "de minimus" waiver for owning under $25,000 in stock in Pfizer.

According to today's FDA presentation, the data behind Pfizer's claim that insulin inhalers will be safe and effective for people with Type I diabetes is unclear. Yet the ease and desirability of switching to an inhaler from subcutaneous injections will make this product extremely attractive to millions of Americans suffering from diabetes, whether Type I or Type II. That's why it is critical that the advice given the FDA by its advisory committees be free from conflicts of interest or even the appearance of conflict of interest, according to the Center for Science in the Public Interest (CSPI).

"The public's faith in the integrity of the process is undermined when one-third of an advisory committee's membership has significant financial ties to the company seeking the product's approval," said Merrill Goozner, director of the Integrity in Science project at CSPI.

In the past, the FDA has claimed that it cannot find suitable expertise without ties to industry and that all of the most qualified people have such ties. Yet every medical school in the country has experts who both practice and conduct research in the fields of endocrinology and pulmonary medicine (relevant here because they were considering the safety of the chronic use of inhalers).

"It is ludicrous that the FDA could not find highly qualified experts in these fields who did not have ties to the manufacturer," said Goozner.

Because of the FDA's use of conflicted scientists on its advisory panels, the House of Representatives in June voted to require the FDA to end the practice and seek out unconflicted advice. The Senate should pass a similar measure next week when it considers the FDA appropriations bill.