FDA will look into scientist's possible conflict

[October 15, 2008]  WASHINGTON (AP) -- Federal health officials said Tuesday they will look into a possible conflict of interest involving a prominent toxicologist who is heading up a review of a sensitive safety issue.

Several lawmakers said the controversy could undermine the credibility of the Food and Drug Administration's assessment of bisphenol A, or BPA. The chemical, used to make plastics, is found in consumer goods from soup cans to baby bottles, and seen as a health risk by some.

But a Food and Drug Administration official said there is no reason to believe that University of Michigan professor Martin Philbert did anything improper.

Philbert heads an FDA advisory panel that is supposed to deliver an independent risk assessment of BPA. The FDA says the chemical is safe, but some scientists see a cancer risk, and consumer groups want it banned. Another federal agency says its risks can't be completely ruled out.

Philbert is also acting director of a risk science center at Michigan. That center received a $5 million pledge this summer from a wealthy businessman who is openly skeptical of BPA's risks. Philbert did not disclose the donation when the FDA scrutinized his finances as he prepared to take charge of the advisory panel, the Milwaukee Journal Sentinel reported on Sunday.

In an interview, Philbert said the gift was made to the university and not to him. He does not stand to gain from it, since none of his salary is paid from it, and he is only serving as director of the center temporarily. "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 the donor.

FDA spokeswoman Judy Leon said that the agency 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. "It is also worth noting that Dr. Philbert was not in a position to benefit."

The key question is whether a donation to a university can sway the judgment of individual faculty experts. "We have had discussions with senior Michigan officials who have reassured us that the university has strong protections to prevent donors from exercising undue influence over faculty," said Leon.

But Rep. Rosa DeLauro, D-Conn., who oversees the FDA budget, called the situation "very disturbing."

"Mr. Philbert's role in determining the safety of BPA should be re-evaluated," said DeLauro. "If the FDA fails to address this issue, I would urge Mr. Philbert to recuse himself."

Michigan Democratic Reps. John Dingell and Bart Stupak, leaders of the influential Energy and Commerce Committee, said they would investigate the potential conflict.

The grant to the university came from Charles Gelman, an alumnus who ran a successful manufacturing company. In the 1980s Gelman's firm was embroiled in a pollution case with Michigan authorities.

Philbert was part of a group from the university that made presentations to Gelman to ask for money. On several occasions, Gelman tried to bring up the subject of BPA safety, Philbert said. But the professor said he cut the conversation off. "As soon as I comprehended the substance, I interrupted politely and said this is inappropriate," Philbert said.

Philbert said Gelman's gift to the university did not strike him as relevant under the FDA's conflict of interest rules. "I don't declare any of the gifts given to the university," he said. "I don't benefit from this financially, therefore it just doesn't occur to me as a conflict."

His committee's bisphenol safety report is expected at the end of the month.

[Associated Press; By RICARDO ALONSO-ZALDIVAR]

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