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« 'Tis the season of giving...to EWG, of course! | Main | Taking pollution personally »
Conflicts of interest at the FDA...again
Last Tuesday, under fire from Congress and consumer groups, the U.S. Food and Drug Administration promised to investigate ties between a key science advisor and business interests maneuvering to avert a federal ban on bisphenol A (BPA), a ubiquitous toxic plastics chemical, in baby bottles, food packaging and medical devices.
The very next morning, however, the FDA announced that an advisory board meeting on the BPA issue would go forward on Oct. 31, as previously scheduled. And the scientist whose apparent conflict of interest is at issue -- Martin Philbert, a University of Michigan toxicologist – remains chair of the two-man panel and is poised to play a pivotal role in the agency’s upcoming decision on BPA.
Federal ethics inquiries take months and sometimes years. So it seems the FDA intends to investigate Philbert’s apparent conflict of interest after he renders his advice on BPA – a synthetic estrogen and plastics component whose manufacture generates global annual revenues estimated at $6 billion.
The agency’s decision to rush ahead with its Oct. 31 Science Board meeting on BPA policy is, quite simply, an act of defiance of the many thoughtful lawmakers, scientists and health and consumer advocates concerned about the continued exposure of Americans to BPA, linked in more than 200 animal studies to cancer, brain, nervous system and behavior problems, hormone disruption and reproductive system damage.
The Environmental Working Group has called on the FDA to halt the work of the Science Board and its BPA subcommittee, which Philbert heads, until questions are resolved about Philbert’s relationship with a retired medical device manufacturer and persistent critic of environmental regulators who recently made a $5 million gift to a University of Michigan scientific research center directed by Philbert.
The Milwaukee Journal Sentinel reported Oct. 11 that Philbert did not disclose the gift to the FDA, even though it came within weeks of his appointment as chair of a two-person subcommittee assessing the risk of BPA for the regulatory agency. According to the Journal Sentinel, donor Charles Gelman acknowledged he had had “several conversations” with Philbert about his view that BPA is “perfectly safe” and that he believed concerns about the chemical had been exaggerated by "mothers' groups and others who don't know the science."
Philbert has been quoted as saying that Gelman tried to discuss BPA with him but that he rebuffed these conversations as “inappropriate.” We have no reason to doubt that assertion. Still, it’s an implicit confirmation that Philbert knew very well where Gelman was coming from.
For all we know, Philbert may not agree with Gelman about BPA. Indeed, he may have no opinion at all: he is a veteran and respected researcher whose expertise has nothing to do with BPA, plastics or food safety. (His lack of depth in the thorny science of low-dose BPA exposure raises other questions about why, exactly, FDA put him in charge of the BPA review.)
But back to his relationship with Charles Gelman. Here, there is an untenable appearance of a conflict of interest. Gelman's gift may not have paid Philbert's salary, as FDA officials insist. But it certainly promises to add considerable luster to Philbert's career. The University of Michigan's press release boasted that the Gelman gift would "position the University to become the nation's premier comprehensive resource for assessing, quantifying and communicating risks to public health." If you man the helm of any institution that aspires to be the "nation's premier" in any field, a generous gift that puts that ambitious goal within reach is a glittering prize.
By ignoring questions about this contretemps and steaming ahead with its decision-making process on BPA, FDA is only undermining its own credibility.
Not that it has much credibility left: under the current administration, the agency has time and again tolerated minor to egregious conflicts of interest on its numerous advisory bodies. For that reason, EWG is urging the FDA to conduct a rigorous audit and screening of all Science Board members and advisors.
Several members of Congress, including Reps. John Dingell and Bart Stupak, D-MI, Edward J. Markey, D-MA, and Rosa DeLauro, D-CT, have also called for a full investigation of FDA’s handling of the Philbert-Gelman matter.
If FDA fails to heed reasonable calls for truly independent, science-based regulation of BPA, it will chalk up one more reason for a top-down overhaul. We can do better than this.
Photo by Mommyof4Ruggies
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