The FDA again throws it’s bloated-bureaucratic weight around to protect the chemical companies in direct opposition to the health, well-being and concern of the American people. Canada banned BPA this past weekend, but our U.S. scientists still proclaim it to be generally safe? Come on! Not only do we have the best Congress money can by, we obviously have the best bureaucrats and scientists money can buy!
Critics slam chemical report
Scientists note flaws in bisphenol A study; lawmaker wants ban
By SUSANNE RUST and MEG KISSINGER
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 Stephen 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 Martin 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.” Charles 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. Edward J. Markey (D-Mass.), who serves on the committee that oversees the FDA, sent a letter to Commissioner Andrew 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. Peterson 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.
David Michaels, a professor of occupational and environmental health at George 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,” Michaels said.
Sales of the chemical reached $6 billion worldwide in 2007.
Tiffany Harrington, spokeswoman for the American Chemistry Council, said her group was unable to respond to the scientists’ article Thursday.
That Chemical Cocktail is Killing You: More on BPA by Withonebreath