Corruption in the FDA? Really? Who woulda-thunk?
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
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.
[From JS Online: Plastics industry behind FDA research on bisphenol A, study finds ]
Not surprising, but despicable. The FDA should be ashamed, and those corrupt officials who are behind this latest travesty should lose their jobs, and be banned from working for any plastic-related corporations for 20 years.
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.
See also
Plastic fantastic