Critics slam chemical report: Scientists note flaws in bisphenol A study; lawmaker wants ban ... (Milwaukee Journal Sentinel) Oct. 24, 2008

[Guest guest]

http://www2.jsonline.com/story/index.aspx?id=809667

Critics slam

chemical report ( Milwaukee Journal Sentinel) 10/24/2008 2:14:54 AM Critics slam chemical report Scientists note flaws in bisphenol A study; lawmaker wants ban By SUSANNE RUST and

MEG KISSINGER srust@...

Posted: Oct. 24, 2008 Lawmakers, scientists and advocacy groups

intensified their criticism Thursday of a government report declaring bisphenol

A to be safe. • A group of 36 international scientists

issued a blistering assessment of the Food and Drug Administration report,

calling it seriously flawed. • A congressman whose committee oversees

the FDA wrote the commissioner, renewing his call for a ban of the

controversial chemical. • An advocacy group demanded that the

FDA cancel its meeting next week to discuss the draft. The Journal Sentinel reported Thursday that

the draft was done primarily by representatives of the plastics industry and

those with an interest in downplaying concerns about the chemical. Bisphenol A,

used in baby bottles and other hard plastic, has been detected in the urine of

93% of Americans tested. Hundreds of studies have found it to cause health

problems in laboratory animals, including cancer, diabetes, heart disease,

hyperactivity, autism and reproductive failure. The newspaper found reviews of studies in the

FDA draft had been supplied by a consulting firm that also worked for chemical

makers. A review of studies that was included in the draft had been

commissioned by Hentges, executive director of the American Chemistry

Council's group on bisphenol A. The council represents chemical companies and lobbies

Congress on their behalf. The Environmental Working Group, a watchdog

health group, issued a statement Thursday saying the newspaper's most recent

report proves a glaring conflict of interest that should render the draft

meaningless. "An agency that once epitomized

independent, impartial expertise in the service of public health has

degenerated to a disgraced stenographer for the chemical and plastics

industry," said Ken Cook, president of the organization. The report was the second to raise questions

about conflicts of interest regarding the agency. The newspaper reported

earlier this month that Philbert, chairman of the subcommittee reviewing

the draft, is founder and co-director of a science center that received a $5

million donation from an anti-regulation activist who considers bisphenol A to

be "perfectly safe." Gelman, the donor, said he discussed his

views about bisphenol A with Philbert on several occasions. Philbert's subcommittee is expected to release

its review of the FDA draft in the next few days. It is scheduled to meet in

Washington , D.C. ,

on Oct. 31 to discuss the results. Cook's group renewed its request to the FDA

on Thursday to cancel that meeting. The FDA declined to comment. Lawmaker demands ban U.S. Rep. J. Markey (D-Mass.), who

serves on the committee that oversees the FDA, sent a letter to Commissioner

von Eschenbach on Thursday citing the Journal Sentinel reports, and

asking for the agency to follow Canada 's

lead and declare the chemical to be toxic and ban it from use in children's

products. Canada on Saturday became the first country to declare the chemical a toxin. The FDA also declined to comment on Markey's

letter. 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. Article blasts FDA draft Also on Thursday, a group of three dozen

scientists from around the world issued a scathing review of the FDA's draft,

calling it misguided and scientifically flawed. The article, which is published online in the

government-sponsored journal Environmental Health Perspectives, says the draft

used guidelines and protocols that gave an unfair advantage to industry

scientists. The guidelines, known as "Good Laboratory

Practice," give greater credibility to studies that use more animals.

National Institutes of Health guidelines limit the number of animals that can

be tested by government scientists and those who work for many publicly funded

institutions. The FDA's task force report on bisphenol A

dismissed or gave lesser credence to hundreds of studies that showed the

chemical caused harm. These studies were conducted by government and academic

scientists, using state-of-the-art techniques and methods but did not have the stamp

of Good Laboratory Practices. Instead, the agency relied on a handful of

industry-funded studies that had the stamp, even though they were flawed in

other ways. Two of the studies accepted by the FDA were

rejected by its advisory group at the National Toxicology Program. Another industry study, accepted by the FDA

and called the "gold standard" of studies, was criticized by an

earlier review by the National Toxicology Program. That panel said the study

used a strain of rat that was insensitive to the effects of estrogen, and

therefore wouldn't detect bisphenol A, a chemical that was developed as a

synthetic estrogen. Another FDA-approved study, also funded by

industry, used protocols that were out of date and methods that wouldn't screen

for the effects at low doses. "The bottom line is that each of the four

major studies cited by the FDA were flawed," said J. Myers, lead

author of the critical review and chief scientist of the nonprofit group

Environmental Health Sciences.The standard used by the FDA "does not

guarantee quality, reliability or validity in the scientific process," he

said. s, a professor of occupational

and environmental health at Washington University and who was not an author of the review, said the regulatory process clearly is

flawed. "The discord between the National

Toxicology Program, Health Canada and the FDA spotlights the limitation of the FDA's approach," s

said. Sales of the chemical reached $6 billion

worldwide in 2007. Harrington, spokeswoman for the

American Chemistry Council, said her group was unable to respond to the

scientists' article Thursday.