Heart disease and diabetes are twice as common in adults exposed to higher levels of a chemical used in plastic bottles, food-storage containers and the lining of cans, new research shows.
The study released by the Journal of the American Medical Association boosts concern that the chemical bisphenol A, or BPA, causes health risks. The findings were presented today to U.S. Food and Drug Administration advisers for review. The advisers have been studying an FDA report that found the chemical was safe for consumers.
The new research is the largest to link bisphenol A with risks in people after animal studies reviewed by the National Toxicology Program this year suggested exposure could alter development of fetuses and young children. Consumer groups and researchers critical of the FDA's stance said the new study shows why the widely used chemical should be restricted.
``Further evidence of harm should not be required for regulatory action to begin the process of reducing exposure to BPA,'' said University of Missouri biology professor Frederick S. vom Saal and John Peterson Myers, founder of the nonprofit group Environmental Health Sciences in Charlottesville, Virginia, in an editorial in the medical association journal.
The FDA panel, made up of outside experts who advise the agency on science issues, heard presentations from researchers and industry and consumer groups at its meeting in Rockville, Maryland. The panel doesn't have a deadline by which it must report back to the FDA. The agency usually takes the advice of its panels, though it isn't required to do so.
`Margin of Safety'
``A margin of safety exists that is adequate to protect consumers,'' said Laura Tarantino, the FDA's head of food additive safety, at the meeting. The agency hasn't yet reviewed the new BPA study from the medical association journal, she told reporters.
``Obviously if we thought it was not safe, if any new information changes that, then we would take action,'' Tarantino said.
The American Chemistry Council, an industry group based in Arlington, Virginia, supports the FDA's assessment, saying ``bisphenol A is not a significant health concern at the trace levels present in some consumer products,'' according to an e- mailed statement.
Bisphenol A has been used for decades in epoxy resins that coat metal cans and in polycarbonate plastics that make up many baby bottles, food-storage containers, compact discs and medical devices. The chemical can leach into food and drinks and was declared ``toxic'' by the Canadian government in April. Canadian and U.S. lawmakers are considering proposals to ban its use.
National Toxicology Program
The National Toxicology Program released its final report on bisphenol A this month, concluding the chemical's risks for children ranked in the middle of a five-point scale. The group, which like the FDA is part of the Health and Human Services Department, was created in 1978 to assess the health effects of chemicals in the environment.
Several studies in that review weren't considered by the FDA because they didn't meet the agency's standards for ``good laboratory practices,'' which the critics said were more often used by industry-funded groups than by researchers supported by the National Institutes of Health. The FDA doesn't consider funding of research and relied mainly on two industry-sponsored studies in its review, Tarantino said.
Lawmaker's Questions
Senator Charles Grassley, an Iowa Republican, asked for an explanation of how the FDA's task force chose studies and what communications it had with industry groups, in a letter today to Commissioner Andrew von Eschenbach.
``I am concerned that the FDA by its actions is determining that NIH-funded studies do not merit a review by the FDA safety panel on BPA,'' Grassley wrote in his letter, requesting a response by Sept. 30.
An estimated 93 percent of Americans have bisphenol A traces in their urine, according to the U.S. Centers for Disease Control and Prevention in Atlanta.
In the new study, David Melzer, a professor of epidemiology and public health at the Peninsula Medical School in Exeter, U.K., and his colleagues analyzed bisphenol A concentrations in urine samples take from 1,455 adults surveyed in 2003-2004 by the CDC.
People whose level was in the top quarter of those tested were more than twice as likely to have cardiovascular disease or diabetes compared with those in the lowest quarter. Higher concentrations were also associated with abnormal amounts of three liver enzymes. Future studies should aim to confirm the link through repeated measurements over weeks, months or years, the authors said.
Need for Proof
``If the findings are replicated and it is clear that BPA is causing the problems we have identified, then safe limits would need to be reviewed,'' Melzer said in an e-mailed statement. ``Government agencies need to make this decision based on an overview of all the human and animal evidence, not just our analysis.''
The study's ``very indirect approach'' can't provide proof of a causal risk, said panel member Garret FitzGerald, a professor of medicine and pharmacology at the University of Pennsylvania School of Medicine, at the meeting. ``I wouldn't take that so seriously.''
Energizer Holding Inc.'s Playtex Infant Care unit and Thermo Fisher Scientific Inc., the maker of Nalgene sports bottles, have already stopped using BPA in their new products because of the health concerns. Eastman Chemical Co. plans to boost production during the next two years of its new Tritan plastic as demand surges for it as an alternative to bisphenol A.