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Conflict of Interest Cloud Hangs Over FDA

For Immediate Release: 
Tuesday, October 14, 2008
WASHINGTON – With yet another conflict of interest swirling around the Bush administration’s assessment of potential health risks from exposure to the toxic plastic chemical bisphenol-A (BPA), Environmental Working Group (EWG) has called on the FDA to halt all further work of the agency’s Science Board BPA subcommittee until a top-down investigation is concluded. 
 
 As reported on October 11 in the Milwaukee Journal Sentinel, BPA subcommittee chair and Science Board member Martin Philbert, Ph.D., failed to disclose to the FDA a $5 million gift from Charles Gelman, the retired head of Gelman Sciences, a medical device manufacturing company, to the University of Michigan Risk Science Center where Dr. Philbert serves as Acting Director.
 
 “As BPA subcommittee chair, Dr. Philbert has a clear conflict of interest that he did not reveal,” EWG Executive Director Richard Wiles wrote to members of FDA’s Science Board.  “The conflict itself and Dr. Philbert’s attempt to conceal it raise serious questions about the integrity of the process and FDA’s entire scientific analysis, which the American people expect to adhere to the highest standards of objectivity and impartiality.” 
 
 In a separate statement to the press, Wiles added, “Dr. Philbert has 5 million reasons to make sure FDA comes down in favor of the chemical industry and against protecting the health of millions of babies. The agency must have a zero tolerance policy for failure to disclose serious conflicts of interest.”
 
 As one of two Science Board members charged with reviewing the BPA risk assessment, Dr. Philbert exercises enormous power over the agency’s decisions on a chemical that represents a $6 billion annual worldwide market, Wiles noted in his letter to FDA.
 
The full letter is attached to this release:
 
                                  ###
 
EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment.  
 
 
October 14, 2008
 
FDA Science Board
c/o Office of Science and Health Coordination
Office of the Commissioner (HF-33)
Food and Drug Administration
Rockville, MD 20857
 
 
We are writing to raise serious concerns about the integrity of the U.S. Food and Drug Administration Science Board subcommittee that is conducting a risk assessment for bisphenol A (BPA) in food packaging.  That subcommittee is expected to present its final recommendation to the FDA Science Board later this month.  The Science Board’s objective review is vital to ensuring the safety of a chemical that the Centers for Disease Control and Prevention has detected in 93% of Americans tested. 
 
As reported on October 11 in the Milwaukee Journal Sentinel, subcommittee chair and Science Board member Martin Philbert, Ph.D., failed to disclose to the FDA a $5 million gift from Charles Gelman, the retired head of Gelman Sciences, a medical device manufacturing company, to the University of Michigan Risk Science Center where Dr. Philbert serves as Acting Director. 
 
As BPA subcommittee chair, Dr. Philbert has a clear conflict of interest that he did not reveal.  The conflict itself and Dr. Philbert’s attempt to conceal it raise serious questions about the integrity of the process and FDA’s entire scientific analysis, which the American people expect to adhere to the highest standards of objectivity and impartiality.  The agency must have a zero tolerance policy for failure to disclose serious conflicts.  The fact that the FDA did not identify and act upon such a grave and unambiguous financial conflict of interest warrants a suspension of all Science Board activities until all Board and subcommittee members are fully screened and audited for financial conflicts and the entire process is thoroughly transparent.
 
Medical device manufacturers such as the company founded by Mr. Gelman have a direct financial stake in the Philbert subcommittee’s deliberations concerning BPA.  In recent years, BPA-based polycarbonate plastics have replaced metals in a range of medical instruments and dental fillings.  Medical devices could pose an even more serious hazard to humans than BPA-laden food packaging, because devices bypass the body’s major detoxification systems and release the chemical directly into the bloodstream.  Recognizing the potential for harm, last week the FDA announced a plan to publish a safety assessment for BPA in medical devices (FDA News Device Daily Bulletin 2008). 
 
Although the Philbert subcommittee’s primary focus is the issue of BPA in food packaging, we believe its advice on the appropriate toxicity studies and methods of calculating risk will inevitably influence the agency’s assessment of BPA-containing medical devices.  The FDA also appears to share that view:  the agency’s conflict-of-interest form distributed to scientists participating in the FDA review specifically asks about financial ties to medical device manufacturers, as well as other affected industries (FDA 2008).
 
The timing and magnitude of the Gelman gift, which represents a 25-fold increase in the Risk Science Center’s funding, are particularly troubling.  Announcing the donation in July -- the same month Dr. Philbert was named to lead the BPA subcommittee -- the University of Michigan declared that the Gelman donation “will position the University to become the nation's premier comprehensive resource for assessing, quantifying and communicating risks to public health” (University of Michigan 2008).  The Milwaukee Journal Sentinel quoted Mr. Gelman as saying that he and Dr. Philbert discussed Mr. Gelman’s opinion that BPA poses no risk to human health (Rust and Kissenger 2008).  
 
It is surprising that the FDA did not discover the Philbert-Gelman relationship during the requisite check of his and other Science Board members’ financial holdings, employment, research grants and contracts.  The press release disclosing the $5 million dollar donation was clearly posted on the Risk Science Center’s website, and Mr. Gelman’s company could be easily identified as a medical device manufacturer.  Nor did the FDA appear to notice that Dr. Howard Hu, one of five advisors to the BPA subcommittee, is Dr. Philbert’s subordinate at the Risk Science Center and also benefits from Mr. Gelman’s $5 million donation.
 
As one of two Science Board members charged with reviewing the BPA risk assessment, Dr. Philbert exercises enormous power over the agency’s decisions on a chemical that represents a $6 billion annual worldwide market. 
 
We are concerned that Norris Alderson, the FDA’s associate commissioner of science, told the Milwaukee Journal Sentinel that he saw no conflict because Dr. Philbert’s salary is not paid by the donation.  Such a narrow definition of “conflict” is inconsistent with FDA’s interpretation of the types of remuneration that could present, at minimum, the appearance of a conflict of interest.  According to the FDA web site, members of FDA advisory committees are asked to provide “detailed information regarding financial holdings, employment, research grants and contracts, and other potential conflicts of interest that may preclude membership” (FDA 2007).  The agency does not limit its inquiry to “salary” but rightly exercises a much more expansive definition of conflict of interest. 
 
Since this is not the first such conflict of interest to plague FDA, we call on the agency to conduct a thorough and transparent investigation of financial and other potential conflicts of all Science Board members.  The agency must also rigorously review all subcommittee members for conflicts of interest.  Until this review is completed, the FDA must halt the BPA review process. 
 
We thank you for your attention to this matter and look forward to working with you to ensure that FDA’s scientific evaluations reflect the utmost integrity and scientific objectivity.   
 
 
Sincerely,
 
 
Richard Wiles
Executive Director
 

References:

EWG. 2008. Environmental Working Group Comments to BPA Subcommittee. Sept 12, 2008. http://static.ewg.org/files/BPA_091208.pdf.

FDA. 2008. Conflict of Interest Disclosure Acknowledgment for Participation at the Subcommittee Public Meeting on the Draft Assessment of BPA (Bisphenol A) for Use in Food Contact Applications. Food and Drug Administration, September 2008.

FDA News Device Daily Bulletin. 2008. “Devices with BPA added to FDA’s ‘Hot Topics’ list” Oct 8, 2008. Vol. 5, No 197. http://www.fdanews.com/newsletter/article?issueId=12023&articleId=111040 last viewed Oct 13, 2008.

Rust S, Kissinger M. 2008. “Donation raises questions for head of FDA’s bisphenol A panel” Milwaukee Journal Sentinel. October 11, 2008. http://www.jsonline.com/story/index.aspx?id=805074, last viewed Oct 13, 2008.

University of Michigan. 2008. Press Release: Gift positions U-M as national leader in studying risks to public health, July 1, 2008. http://www.ns.umich.edu/htdocs/releases/story.php?id=6630, last viewed Oct. 14, 2008.

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