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Donation raises questions for head of FDA’s bisphenol A panel

A retired medical supply manufacturer who considers bisphenol A to be "perfectly safe" gave $5 million to the research center of Martin Philbert, chairman of the Food and Drug Administration panel about to make a pivotal ruling on the chemical's safety.

Philbert did not disclose the donation, which is nearly 25 times larger than the $210,000 annual budget of the University of Michigan Risk Science Center, where he is founder and co-director. FDA officials learned of the link from the Journal Sentinel.

Donor Charles Gelman, once labeled the second worst polluter in Michigan by the state's Department of Natural Resources, said in an interview that he considered the chemical, which is used to make baby bottles and aluminum can liners, to be safe. Worries about health problems that may be caused by the chemical are exaggerated by "mothers' groups and others who don't know the science," Gelman said.

He said that he had made his views clear to Philbert in "several conversations."

Philbert denied that.

"At no time have the Gelman family or any other interested/disinterested person, persons, corporations or other entity contacted me or attempted to influence my scientific judgment on the matter," Philbert said in an e-mail response to questions from reporters.

Norm Fost, director of the bioethics program at the University of Wisconsin, said Philbert should have disclosed the donation.

"The public has a right to know about those connections whether they have any effect on the outcome or not," Fost said. "It sounds like a conflict of interest."

Philbert was chosen to chair the FDA's subcommittee on bisphenol A by Barbara McNeil, head of the FDA's Science Board. She selected him from a list of 12 scientists on her board. Philbert then filled out a conflict of interest statement but did not list Gelman's donation.

McNeil said she could not recall exactly when she picked Philbert to head the committee, but she thought it was sometime in July.

Gelman's donation to the Michigan center was made in July.

Philbert's committee is expected to release its opinion this month. It will advise the FDA on whether to accept, reject or amend a draft released by the agency in September. That draft found that products made with bisphenol A are safe for food storage.

The decision of Philbert's committee is being watched carefully by chemical-makers and is expected to have huge implications on the regulation and sale of the chemical in items such as baby bottles, reusable food containers and plastic wraps.

Developed originally as a synthetic form of the hormone estrogen, bisphenol A is used to make hard clear plastic in water bottles, baby bottles and other household products. It is also used as a liner in aluminum cans and in many dental sealants. The chemical has been detected in the urine of 93% of Americans tested.

In the late 1990s the FDA and other government agencies discovered that bisphenol A was leaching from baby bottles. It was also migrating into liquid infant formula from cans.

Since then, a host of studies have found that the chemical causes cancer, heart disease, obesity, reproductive failures and hyperactivity in laboratory animals.

In April, Canada proposed classifying bisphenol A as a toxin and banning its use in baby bottles and other products for children. A number of manufacturers, such as Wal-Mart, Nalgene and Toys "R" Us, have said they will begin phasing out its use.

The National Toxicology Program, formed to advise the FDA, released its report in September citing some cause for concern about the chemical's impact on the development of children, infants and fetuses.

The discrepancy between the FDA and its advisory program has been confusing to consumers.

Last year, the Journal Sentinel reviewed 258 research papers and found that a large majority of those studies showed bisphenol A was harmful to lab animals. Those that didn't find harm overwhelmingly were paid for by the chemical industry.

Gelman, a retired manufacturer of syringes and medical filtration devices, has fought against government regulation of pollutants for years.

He is an anti-regulation activist and an outspoken supporter of organizations including JunkScience.com, the Cato Institute and the Competitive Enterprise Institute that attack the credibility of government and academic scientists on such topics as global warming and hazardous chemicals.

Gelman said he and Philbert talk often. He said Philbert eventually told him that he did not want to have any more discussions on the subject of bisphenol A because he was concerned about the appearance of impropriety. But, Gelman said, "He knows where I stand."

Norris Alderson, the FDA's associate commissioner of science, learned of the link from the Journal Sentinel. He looked into the matter and said he was satisfied there was no conflict of interest because Philbert's salary is not paid by the donation.

Still, the connection troubles scientists familiar with the chemical controversy.

"This definitely raises some red flags," said Sarah Vogel, a post-doctoral fellow at the Chemical Heritage Foundation in Philadelphia who did her dissertation on the politics of bisphenol A. "Is there an expectation that Dr. Philbert would vote one way or another?"

Philbert serves as co-director of the University of Michigan's Risk Science Center, which he helped develop in 2003 to assess health risks from environmental agents.

Gelman said he hopes his grant money to Philbert's center will get people to consider risks of chemicals outside a highly charged political atmosphere.

"Too often politicians are responding to what they think a small part of the public wants," Gelman said.

Philbert said Gelman's gift was made with the understanding that it conformed to the rules and policies of the Standard Practice Guide of the University of Michigan.

"No influence may be exerted on the Center, its management, direction or on the statements made by members of the Center," Philbert said.

He steadfastly denied any conflict of interest.

"Until today, no question has been raised with respect to my impartiality in this matter," he said in an e-mail to the Journal Sentinel. "I am not open to any undue influence and have taken on this (unwelcome) task with all due diligence and seriousness."

The announcement of the Gelmans' gift was hailed in university publications as a way to position the University to become the nation's premier center to determine health risks from environmental agents. Philbert was pictured with Gelman and his wife, Rita, in publicity press about the donation.

The FDA draft has been criticized by environmental groups for relying on two industry-funded studies and for selecting Philbert, who has no expertise or background in bisphenol A.

There are seven members of Philbert's subcommittee. Two are from the Science Board and five were picked by Philbert and McNeil. One of those five is a faculty member at Philbert's Risk Science Center.

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