New Haven, CT – Congresswoman Rosa L. DeLauro (CT-3), in her on-going effort to return science-based decision making at the Food and Drug Administration, pressed FDA Commissioner Andrew von Eschenbach to restart the agency’s review of Bisphenol A. Recently reports have surfaced about conflicts of interest involving the FDA decision-making process regarding the safety of BPA.

“I remain very concerned about the reports of conflicts of interest involving the FDA decision-making process regarding the safety of Bisphenol A (BPA),” DeLauro writes in the letter. “I strongly urge the FDA to cancel the release of the BPA report, and the portion of the Science Board meeting that will focus on BPA scheduled for Friday, October 31, and to remove Dr. Martin Philbert and Dr. Howard Hu from the Science Board subcommittee on the safety of BPA. I also urge the agency to re-start the evaluation process for BPA and to consider all previous FDA reports on this issue to be null and void.”

The letter continues, “There appears to be a complete undermining of the decision-making process at FDA on the BPA issue and I fear that this case demonstrates that the conflict of interest standards governing scientific advisory panels are inadequate. This also appears to be yet another case of the agency’s preference for biased industry data rather than a reliance on research from independent scientists.”

Below is the text of the letter.

October 28, 2008

Andrew C. von Eschenbach, M.D.

Commissioner

U.S. Food and Drug Administration

U.S. Department of Health and Human Services

5600 Fishers Lane

Rockville, MD 20857

Dear Dr. von Eschenbach:

I remain very concerned about the reports of conflicts of interest involving the FDA decision-making process regarding the safety of Bisphenol A (BPA). Because of several pending issues that require additional scrutiny, I strongly urge the FDA to cancel the release of the BPA report, and the portion of the Science Board meeting that will focus on BPA scheduled for Friday, October 31, and to remove Dr. Martin Philbert and Dr. Howard Hu from the Science Board subcommittee on the safety of BPA. I also urge the agency to re-start the evaluation process for BPA and to consider all previous FDA reports on this issue to be null and void.

There appears to be a complete undermining of the decision-making process at FDA on the BPA issue and I fear that this case demonstrates that the conflict of interest standards governing scientific advisory panels are inadequate. This also appears to be yet another case of the agency’s preference for biased industry data rather than a reliance on research from independent scientists.

The Science Board should not re-schedule a meeting to discuss the BPA issue until the following pending issues are addressed.

Dr. Martin Philbert, chair of the FDA's Science Board subcommittee on the safety of BPA, has conflicts of interest that should have disqualified him immediately from participation in any aspect of FDA's decision-making process. He is the founder and Acting Director of the University of Michigan Risk Science Center.

According to a recent op-ed written by Dr. Philbert, the Center has grants totaling $15 million from Dow Chemical, one of the major manufacturers of BPA. In addition, Charles Gelman, a retired medical device manufacturer who has publicly defended the safety of BPA, has donated $5 million to the Michigan Risk Science Center. Regarding the safety of BPA, Mr. Gelman has been quoted as saying that “he made his view clear to Philbert in several conversations.” In various news reports, Dr. Philbert has either denied having these conversations with Mr. Gelman, or claimed that Mr Gelman's views did not influence him. Neither of these conflicts were made public by the FDA, and instead were revealed by media reports after the FDA subcommittee's public meeting in September.

According to the roster on the FDA web site, there are only two members of the BPA subcommittee, and five advisors. Of the five advisors, three are government scientists and only two are academic researchers. Of those two academic researchers, Dr. Howard Hu also is a faculty member from the University of Michigan Risk Science Center. This means that the same Center has provided the chair (one of only 2 members of the subcommittee) and half (one out of two) of the non-governmental advisors.

Based on information revealed by the House Energy and Commerce Committee, the FDA hired a private consulting group with strong industry ties to perform some of its analyses of BPA. This finding could explain why the agency relied on two industry studies and virtually ignored the data from more than 100 independent peer- reviewed studies.

During the meeting on BPA that the FDA convened in September, numerous scientists criticized the agency’s analysis for various fundamental flaws. For example, the FDA's assumptions about the levels of BPA in cans of infant formula was based on a small sample of only 17 cans of formula, all from Washington, DC area supermarkets in the early 1990's. More recent research on national samples of infant formula have revealed much different levels of BPA in infant formula, and have also indicated that these levels vary widely, from negligible to very high.

The implications are clear – the levels of BPA in cans of infant formula are not being carefully regulated, and infants could be exposed to much more BPA than the FDA assumed in their analysis. Similar problems are likely for Americans consuming other canned foods and beverages because the companies involved are not carefully controlling BPA levels in those food containers.

The Science Board is intended to be an objective, additional source of information and advice. BPA is used in a wide variety of FDA- regulated products including baby bottles, the lining of food cans, and medical devices, including implanted devices such as breast implants. More than 90 percent of Americans have BPA in their bodies, according to the Centers for Disease Control and Prevention. The health of millions of Americans could potentially be adversely affected by BPA, and the FDA’s review of BPA must be of the highest integrity and scientific standards. So far, the FDA has completely undermined the credibility of this process.

Peer-reviewed independent research by well-respected scientists suggests that BPA may harm brain functions and could increase the risks of breast cancer and prostate cancer. Research published in the Journal of the American Medical Association in October found that adults with higher levels of BPA in their bodies were more likely to have heart disease or diabetes.

The University of Michigan and the FDA have claimed that Dr. Philbert has no conflict of interest, because his salary is not paid by Dr. Gelman's grant. Neither the FDA nor the university has publicly commented on the conflicts of interest posed by the Dow Chemical grants. The exact source of Dr. Philbert's salary is not a relevant issue. The founder and director of a research center has a responsibility and presumably a dedication to attract funding for that Center, to pay for the salaries and functioning that keep that Center in existence. Participating in activities that are in direct conflict with the wishes of the Center's major donors would put the Center's survival at risk. By failing to recognize this, the FDA clearly has no understanding of conflicts of interest among academic researchers.

Dr. Howard Hu's participation as a faculty member for the University of Michigan Risk Science Center also is very disconcerting. As one of only two non- governmental advisors to the FDA's supposedly independent Science Board subcommittee, his participation additionally undermines the integrity of the FDA's review of the safety of FDA, regardless of exactly which entities pay his salary or the salary of others working with him.

Unlike most products regulated by the FDA, the use of BPA in food and beverage containers affects almost every American. It is FDA’s responsibility to assure Congress and the public that this matter is being taken seriously, and that protections will be put in place to ensure that this never occurs again.

Sincerely,

ROSA L. DeLAURO

Chairwoman

House Appropriations Subcommittee on Agriculture

Rural Development, Food and Drug Administration,

and Related Agencies