Gift to Center Headed by FDA Panel Chairman Raises Questions
Monday, October 13, 2008
A retired medical supply manufacturer who considers bisphenol A to be "perfectly safe" gave $5 million to the research center headed by the chairman of a Food and Drug Administration panel about to rule on the chemical's safety.
The July donation from Charles Gelman is nearly 50 times the annual budget of the University of Michigan Risk Science Center, where Martin Philbert is founder and co-director. Philbert did not disclose the donation to the FDA, and agency officials learned of it when reporters asked about it.
Norris Alderson, the FDA's associate commissioner for science, looked into the matter and said he was satisfied that there was no conflict of interest because Philbert's salary is not paid by the donation.
Gelman said he considers the chemical, which is used to make baby bottles and aluminum can liners, to be safe. Worries about health risks posed by the chemical are exaggerated by "mothers' groups and others who don't know the science," Gelman said.
He said 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 wrote in an e-mail.
Philbert's committee is expected to release its opinion this month. It will advise the FDA on a draft assessment 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 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.
Since the late 1990s, studies have linked bisphenol A to cancer, heart disease, obesity, reproductive failures and hyperactivity in laboratory animals.
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 such as 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."
Philbert steadfastly denied any conflict of interest.
"Until today, no question has been raised with respect to my impartiality in this matter," he wrote in an e-mail. "I am not open to any undue influence and have taken on this (unwelcome) task with all due diligence and seriousness."