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FDA Says Chemical with Links to Reproductive Problems Is Safe for Humans

More than 100 government and university studies have found the chemical Bisphenol-A to be harmful even at low levels.
 
 
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On September 16, the FDA did something completely expected: it declared the chemical Bisphenol-A (BPA) safe for human consumption. This announcement flies in the face of the overwhelming majority of the scientific literature on this chemical, including the recent and highly-publicized studies out of the National Institutes of Health and a report released this week from the American Medical Association linking BPA and heart disease.

Earlier this year, Canada said it would ban the use of the chemical in baby bottles because its own research showed it leached into formula and breast milk at a level that could affect behavior and the brain in children, as well as reduce survival and birth weight in fetuses (when the chemical was ingested by the mother). In the U.S., the National Toxicology Program, a division of the National Institutes of Health, announced in its draft report that there was "some concern" that BPA could produce the physiological and neurological changes cited by Canada, as well as cancer. California is currently considering a ban on the chemical in baby bottles and food containers. BPA is commonly found in plastics, most notably food containers, including baby bottles. More than 100 government and university studies have found the chemical to be harmful at even low levels; it mimics estrogen (it was, in fact, developed out of the search for a synthetic estrogen), has been linked to increased breast cancer cell growth and disrupted neurodevelopment in fetuses, and is found at detectable levels in the urine of 95 percent of Americans. Newborns and infants seem particularly vulnerable to the chemical.

And yet the FDA has considers the BPA safe. It seems curious, until you consider that the source for the scientific research the agency based this finding on came not from a university or another government research program like the National Toxicology Program. Instead, it came directly from the American Plastics Council, an industry group that represents plastics manufacturers, for whom the use of BPA is a do-or-die proposition. By utilizing only two industry-funded studies on BPA to determine this controversial chemical's safety, particularly in baby bottles, the FDA has finally jumped the shark.

The tortured machinations of the FDA have been documented in great detail over the last eight years: political appointments to top positions within the agency, the hiring of former employees of pharmaceutical companies, making decisions about drugs based on political beliefs, often over the objections of the agency's scientific advisers, and the use, and often exclusive use, of industry research studies to determine whether a product is safe. The New England Journal of Medicine accused the FDA of making "a mockery of the process of evaluating scientific evidence" and that it had "squandered the public trust and tarnished the agency's image." USA Today found that while federal law prohibits the FDA from using experts with staked interest in companies seeking approval, the agency has waived that law nearly a thousand times since 1998. And earlier this year, several members of Congress asked about conflicts of interest at the FDA after the agency's spokesman, who previously worked as a public relations representative for pharmaceutical companies, used agency email to attack the research of an independent scientist who had published a study suggesting diabetes drug Avandia could increase the risk of heart attacks.

These stories come and go with whatever news cycle they happen to hit. But the BPA story might stick. The baldness of the FDA's embarrassing failure here as a regulatory agency combined with the combustible passions parents have for the well-being of their children could, and should, lead to demands for answers and accountability from the agency. It should disturb every consumer in this country that the agency charged with determining the safety of consumer products, including pharmaceuticals and plastics, takes industry's word for its own products' safety. Given industry's track record in massaging, obscuring, buying, or inventing the science in their research, it's an unconscionably ineffective approach to protecting consumers.

The FDA protests that it is too underfunded to do independent research and must, out of necessity, rely on industry research. The FDA needn't do independent research, at least on BPA. Independent research on this chemical abounds, and the science is clear. One can't help but ask why the FDA would make such an important decision, one that flies in the face of thousands of pages of research coming from disinterested scientists with nothing to gain besides tenure, and rely instead on two industry studies completed by scientists on the plastics industry's payroll. The answer is that the FDA is inextricably bound to the industries it regulates, and it is for the reason that the agency should be replaced with one that does not base decisions on industry research, is adequately funded, and is free from political appointments to leadership positions.

The FDA has all the trappings of authority, but none of the qualities one expects from an authority: trustworthiness, deep knowledge of its subject, unbiased judgment, immunity to politics and industry. Because it uses science provided by the manufacturers of the very products they are charged with regulating, rather than the huge amounts of independent research that is readily available, the FDA has clearly demonstrated that it has outlived its usefulness and is now in danger of becoming worse than irrelevant: it is fast becoming a menace to the very people it is charged with protecting.

Ashley Shelby is a writer based in Minneapolis. Her first book, "Red River Rising: Anatomy of a Flood and the Survival of an American City," was published in April 2004. She blogs at www.scienceforsale.com.

 
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