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Chemical Reaction
As it decides the fate of a widely used compound, the FDA has to be mindful of a potential conflict.

Thursday, October 16, 2008

A DRAFT REPORT on bisphenol A (BPA) from the Food and Drug Administration last month determined that it was safe for food storage, rejecting claims that the chemical, which is used in the manufacture of baby bottles and to line aluminum cans, causes cancer, obesity and heart disease. A special agency subcommittee will release a recommendation this month advising the FDA on whether to accept, reject or amend that determination. But there's concern that its conclusion will be seen as less than fully independent.

The FDA subcommittee is chaired by Martin Philbert. He is the acting director of the University of Michigan's Risk Science Center, which received a $5 million donation in July from Charles Gelman, the retired head of a medical device manufacturing company and an ardent defender of BPA. Mr. Gelman told the Milwaukee Journal Sentinel, which reported the story, that he discussed his views with Dr. Philbert. Dr. Philbert told us that he put the kibosh on any discussion of BPA with Mr. Gelman once the context of his interest became clear.

Dr. Philbert did not disclose to the FDA Mr. Gelman's gift to the Risk Science Center. Dr. Philbert told us that the FDA form asked for disclosure of gifts from which the recipient personally stands to gain. The donation was made to the university with a stipulation to endow professorships and student scholarships at the center. The money won't start flowing until next year, when a permanent director is expected to be in place. Dr. Philbert is not under consideration for the post.

FDA spokeswoman Judy Leon said Tuesday that the agency would look into Dr. Philbert's actions. She said that "we have no reason to believe that Dr. Philbert has done anything other than act in good faith on this matter." But surely she understands why many perceived a conflict of interest.

In announcing the gift to the Risk Science Center, the university noted that Mr. Gelman's "personal experience" influenced his donation. To be specific, the Michigan Department of Natural Resources once dubbed Mr. Gelman the second-worst polluter in the state. In 1992, Mr. Gelman's manufacturing company settled a long battle with the Michigan DNR to clean up lagoons and fields near his factory after groundwater near it was found to be contaminated with 1,4-dioxane, a carcinogen. Mr. Gelman is on record as having said that BPA is "perfectly safe."

Dr. Philbert's subcommittee won't have the final say on BPA. That will rest with the FDA itself. The agency must make every effort to ensure that not only are its opinions based in fact but also that they are free of undue influence or even the appearance of such.

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