PLASTICS INDUSTRY BEHIND FDA RESEARCH ON BISPHENOL A, STUDY FINDS

Milwaukee Journal Sentinel
October 22, 2008

By Susanne Rust and Meg Kissinger srust@journalsentinel.com
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 Stephen 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

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Sidebar: Bisphenol A Timeline

April 14: FDA convenes a task force on the safety of bisphenol A.

Aug. 15: The task force releases its draft saying that bisphenol A is
safe.

Sept. 3: The National Toxicology Program releases its report finding
some concern for the chemical's effects on children, infants and
fetuses.

Sept. 16: An FDA subcommittee meets to consider whether to amend the
task force draft.

Oct. 15: A congressional committee launches an investigation of
possible conflicts of interest after the Journal Sentinel reveals a $5
million donation to the subcommittee chairman's science center by an
advocate for bisphenol A.

Oct. 18: Canada declares bisphenol A toxic and announces a move to ban
the sale, import and advertising of baby bottles and other children's
products containing the chemical.

========================================================

The Journal Sentinel reported earlier this month that subcommittee
chairman Martin 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,
Charles 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 Douglas Beck declined to comment on his company's
involvement in the study of bisphenol A..

FDA spokesman Michael 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 Andrew 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 David 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.

Tiffany 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."

Copyright 2005-2007, Journal Sentinel Inc.

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