by revere, cross-posted at Effect Measure
Everyone knows newspapers are struggling, which means cutting back on everything, including investigative reporting. So it is nice to acknowledge that there is still some wonderful reporting going on. A particular standout has been Susanne Rust and her colleagues at the Milwaukee Journal-Sentinel, whose investigation of FDA’s handling of the bispheonal A (BPA) episode has been superlative. Yesterday they hit paydirt again. The FDA is currently considering an August draft report of a task force convened last April to re-examine the safety of BPA. The draft report says BPA is safe. BPA, a component of the hard plastic polycarbonate and used in food packaging, water and baby bottles, dental sealants and many other places, has come under increasing suspicion after mountains of laboratory evidence pointed to biological effects at levels commonly encountered in the environment. In September the NIH’s National Toxicology Program (NTP) released its own review which raised significant questions about the safety of BPA. This comes in the setting of Health Canada’s decision to consider BPA a toxic agent and their move to ban the sale, import and advertising of childrens’ product, including baby bottles, containing BPA.
When last we visited this issue the Rust and her team at the Journal-Sentinel had discovered that the task force’s chairman also had a risk assessment institute that received a $5 million gift from a notorious anti-regulation nutcase who also strongly advocated BPA’s safety. The FDA denied this was a conflict of interest on the grounds the task force chairman’s institute salary was not involved. You can read our view of this here. Now Rust has more dirt. The FDA draft report seems to have been written largely by the industry:
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. (Suzanne Rust and Meg Kissinger, Milwaukee Journal-Sentinel)
The task force was assisted in preparing their report by ICF, a consulting company whose other clients include the American Chemistry Council and the American Petroleum Institute. While neither ICF nor FDA would say what role ICF played in all this, Rust, Kissinger and their team reviewed previous ICF reports and found the substance of the task force findings in those previous products. Now several congressional committees want to see all communications between FDA and ICF. They’ll probably not get them under this administration whose idea of following the law is not to follow it, but in less than 90 days there will be a new administration. Then maybe we’ll find out more. At the moment we have to make inferences from information like this:
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.
How does the plastics industry respond to these revelations?
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.”
Just like anyone else? Hahahahahahaha.