Plastics industry behind FDA research on bisphenol A, study finds ... (Milwaukee Journal Sentinel) Oct. 22, 2008

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Industry at root of

BPA study ( Milwaukee Journal Sentinel) 10/23/2008 12:52:08 AM Plastics industry behind FDA research on bisphenol A, study finds By SUSANNE RUST and

MEG KISSINGER srust@...

Posted: Oct. 22, 2008 A government report claiming that bisphenol A is

safe was written largely by the plastics industry and others with a financial

stake in the controversial chemical, the Journal Sentinel found. Although the Food and Drug Administration will

not reveal who prepared its draft, the agency's own documents show that the

work was done primarily by those with the most to gain by downplaying concerns

about the safety of the chemical. That includes Hentges, executive

director of the American Chemistry Council's group on bisphenol A, who

commissioned a review of all studies of the neurotoxicity of bisphenol A and

submitted it to the FDA. The FDA then used that report as the foundation for

its evaluation of the chemical on neural and behavioral development. The

American Chemistry Council is a trade group representing chemical

manufacturers. The FDA's draft, released in August, found no

cause for worry about bisphenol A, which is found in thousands of household

products, including baby bottles, infant formula containers and the lining of

aluminum cans. That finding is at odds with the conclusions of

the FDA's own advisers from the National Toxicology Program. The NTP announced

in September that the chemical is of some concern for effects on the

development of the prostate gland and brain, and for behavioral effects in

fetuses, infants and children. The NTP also found some concern for the

neurodevelopment of young children, infants and fetuses. Last week, the government of

Canada declared that bisphenol A is

a toxin and is banning its use in baby bottles and other products used by

children. The FDA draft finding no harm is under review by

a subcommittee, which will decide if the conclusions need to be amended. That

assessment is expected to be released any day and will be presented Oct. 31 in

Washington The Journal Sentinel reported earlier this month

that subcommittee chairman Philbert is founder and co-director of an

institute that received $5 million from a retired medical supply manufacturer

who said he considered bisphenol A "perfectly safe." The donor,

Gelman, told the newspaper that he has expressed his views to Philbert

in several conversations. Philbert at first denied ever having been

contacted by Gelman about bisphenol A. He now says that he is aware of Gelman's

views but is not influenced by them. Congressional

inquiry A congressional committee launched an

investigation into the connection, citing the newspaper report. Those same congressional investigators are now

looking into other possible conflicts of interest. They are scrutinizing the

role that ICF, a consulting firm whose clients include the American Chemistry

Council and the American Petroleum Institute, had in preparing the FDA draft. Neither ICF nor the FDA would say what role the

consulting firm had in the agency's review of the chemical. But the newspaper

found reports issued to the FDA by the consulting firm from 2000 to 2007. Those

reports included reviews of government and industry studies on the effects of

bisphenol A on animal health. The task force used ICF's reviews in its draft. ICF spokesman Beck declined to comment

on his company's involvement in the study of bisphenol A.. FDA spokesman Herndon is referring all

questions about the draft to congressional investigators. The House Committee on Energy and Commerce and

its subcommittee on Oversight and Investigation has asked FDA Commissioner

von Eschenbach to appear for an interview by committee staff to explain

the agency's decision-making relating to bisphenol A. "Specifically, why industry-funded studies

provide the basis of your regulatory decisions and why the totality of the

science around the chemical continues to be ignored by your science-based

agency," the committee letter said. Investigators want transcripts of all

communication between ICF and the FDA by Wednesday. Poring

over evidence The newspaper reviewed the body of evidence that

the task force considered. It found memos with entire sections blacked out,

reviews commissioned by the American Plastics Council, an arm of the American

Chemistry Council, and reviews completed by consulting firms with clients who

havefinancial interests in the sale of bisphenol A. Many of these reviews of individual studies are

at odds with the NTP's reviews of the same studies. For example, one study funded by the National

Institutes of Health and the Department of Defense looked at the effects of

bisphenol A on prostate development in rats. The FDA called it "severely limited,"

in contrast to the NTP's review, which labeled it of "high utility." Another government-funded study, which also

looked at the effects of the chemical on the prostate, again was considered of

"high utility" by the NTP for its evaluation, and it was deemed

"very limited" by the FDA. Much of the science that the task force

considered was 20 years old or older, including a study commissioned in 1976. The older studies are not as sensitive as modern

tests. They used high doses of the chemical and did not consider the unique

effects on the endocrine system. Bisphenol A was developed in 1891 as a synthetic

estrogen. It came into widespread use in the 1950s when

scientists realized it could be used to make polycarbonate plastic and some

epoxy resins to line food and beverage cans. The chemical is used in a host of products from

dental sealants and eyeglasses to CDs and water bottles. Bisphenol A has been

detected in the urine of 93% of Americans tested. Sales of the chemical reached $6 billion

worldwide in 2007. Last year, the Journal Sentinel reviewed 258

research papers on bisphenol A and found that a large majority showed the

chemical was harmful to lab animals. Those that didn't find harm overwhelmingly

were paid for by the chemical industry. The newspaper also found that the

government was basing its safety recommendations for bisphenol A on outdated

studies performed more than two decades ago. Columbia University professor Rosner, who researches the relationship of

industry and government regulators of toxic substances, has compared the

controversy over bisphenol A to tobacco and asbestos. "It makes sense that we have a process that

is not tainted by corruption," he said. "This looks tainted." A plastics industry spokeswoman defended the

role of Hentges and others in shaping the FDA's task force draft. Hentges was

out of the country on Wednesday and not available for comment. Harrington, spokeswoman for the American

Chemistry Council, said Hentges was acting appropriately in his capacity as an

advocate for the plastics industry. "We are a stakeholder just like anyone

else," Harrington said. "It's part of the process."