Current BPA Study May Involve Conflict of InterestOct 15, 2008 | Parker Waichman LLP
Federal Health Officials To Review Possible Conflict Of Interest
Federal health officials announced that they would review a possible conflict of interest involving a prominent toxicologist who is heading a bisphenol A (BPA) review. Some lawmakers say the controversy could minimize the credibility of the Food and Drug Administration's (FDA) BPA assessment while an FDA official argued that nothing improper occurred. The FDA says BPA is safe; however, some scientists see it as a cancer risk, consumer groups want it banned, and another federal agency says its risks cannot be completely ignored. BPA is a highly ubiquitous estrogen-mimicking chemical that is found in many durable plastic products and has been in the news lately for its links to cancer, heart disease, hormonal and liver function disturbances, and diabetes.
University of Michigan professor Martin Philbert heads an FDA advisory panel that is presumably delivering an independent BPA risk assessment; however, the independence of that assessment is now in question. It seems Philbert is also acting director of a risk science center at Michigan that received a $5 million pledge this summer from Charles Gelman, a university alumnus who ran a successful manufacturing company that was involved in a pollution case in the 1980s with Michigan authorities. Gelman is openly skeptical of BPA's risks. According to news reports this weekend, Philbert did not disclose the donation when the FDA reviewed his finances in preparation for his role in the advisory panel.
FDA Reviewing Philbert's Financial Disclosures
Philbert said the gift was made to the university, not to him and that he does not stand to profit from it since none of his salary is paid from it, and he is only serving as director of the center temporarily. "I don't declare any of the gifts given to the university. I don't benefit from this financially; therefore, it just doesn't occur to me as a conflict…. I have complied with the letter and the spirit of the law, from the point of view of the FDA and the university," he said, adding that he refused to talk about BPA with Gelman. FDA spokeswoman Judy Leon said that the FDA is reviewing Philbert's financial disclosures and all relevant federal regulations.
Government rules require outside advisers to disclose conflicts, and the FDA bars experts with a financial interest in a company from voting on recommendations that may affect it. "That said, we have no reason to believe that Dr. Philbert has done anything other than act in good faith on this matter," Leon said. But, many wonder if such a donation can bias one’s judgment.
Representative Rosa DeLauro, Democrat-Connecticut. who oversees the FDA budget, described the situation as "very disturbing," adding that "Mr. Philbert's role in determining the safety of BPA should be re-evaluated. If the FDA fails to address this issue, I would urge Mr. Philbert to recuse himself." Michigan Democratic Representatives John Dingell and Bart Stupak, leaders of the Energy and Commerce Committee, said they would investigate the potential conflict.
Philbert’s BPA safety report is expected at the end of the month.
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