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2008-09-17 10:10:52
By Will DunhamTue Sep 16, 8:41 PM ET
A major study links a chemical widely used in plastic products, including baby bottles, to health problems in humans like heart disease and diabetes, but U.S. regulators said on Tuesday they still believe it is safe.
The chemical bisphenol A, or BPA, is commonly used in plastic food and beverage containers and in the coating of food cans.
Until now, environmental and consumer activists who have questioned the safety of BPA have relied on animal studies.
But the study by British researchers in the Journal of the American Medical Association found that among 1,455 U.S. adults, those with the highest levels of BPA were more likely to have heart disease, diabetes and liver-enzyme abnormalities than those with the lowest levels.
U.S. Food and Drug Administration officials said they would review the new findings, which were not yet published when the agency issued a draft conclusion in August that BPA is safe at current exposure levels.
"We have confidence in the data that we've looked at and the data that we're relying on to say that the margin of safety is adequate," FDA official Laura Tarantino said at a meeting of experts advising the agency on whether it made the right call.
"There are things you can do if you choose to reduce your level of bisphenol A," Tarantino said. "But we have not recommended that anyone change their habits or change their use of any of these products because right now we don't have the evidence in front of us to suggest that people need to."
Panel chairman Martin Philbert declined to say what the committee's next move would be.
BPA is used to make polycarbonate plastic, a clear shatter-resistant material in products ranging from baby bottles to medical devices.
BPA can mimic the hormone estrogen in the body.
LEACHING INTO LIQUIDS
People can consume BPA when it leaches out of the plastic into baby formula, water or food inside a container. Some retailers and manufacturers are moving away from products with BPA. Canadian officials have concluded BPA was harmful.
Steven Hentges of the American Chemistry Council, an industry group, said the study's design did not allow for anyone to conclude BPA causes heart disease and diabetes.
"On the other hand, though, bisphenol A has been very intensively studied in a very large number of laboratory animal studies. And the weight of evidence from those studies ... continues to support the safe use of products containing bisphenol A," he said in a telephone interview.
The British researchers, who acknowledged their findings are not proof that the chemical is causing the harm, analyzed urine samples from a U.S. government health survey of adults ages 18-74 representative of the U.S. population.
The 25 percent of people with the highest levels of bisphenol A in their bodies were more than twice as likely to have heart disease, including heart attacks or type 2 diabetes, compared to the 25 percent with the lowest levels.
At the FDA panel meeting, several scientists and activists said the FDA ignored animal studies finding health concerns and some called for the chemical to be banned in food containers.
Democratic U.S. Rep. John Dingell of Michigan, who heads the House Committee on Energy and Commerce, said the FDA has "focused myopically on industry-funded research."
Iowa Republican Sen. Chuck Grassley, ranking member of the Committee on Finance, released a letter he wrote to FDA Commissioner Dr. Andrew von Eschenbach asking why the agency has not appointed a safety panel to review BPA.
Tarantino said nothing was ignored but industry-funded studies finding no harm were important in the conclusions. The panel is expected to present its advice to the FDA next month.
Tarantino, head of the FDA's office of food additive safety, said there is talk of government scientists doing their own BPA safety studies, but that could take years to conduct.
(Additional reporting by Michael Kahn in London; Editing by Maggie Fox and Bill Trott)
Scientists raise new concern over plastic containers
by Jean-Louis SantiniTue Sep 16, 4:33 PM ET
A new study released Tuesday linked a controversial chemical widely used in baby bottles and plastic food containers to diabetes, heart disease and liver abnormalities in adults.
The report published in the September 17 issue of the Journal of the American Medical Association (JAMA) reviewed the effect on adults of the chemical known as bisphenol A (BPA).
It found that adults with the highest concentrations of BPA in their urine had nearly triple the odds of cardiovascular disease, compared with those with the least amounts of the compound in their systems.
Of 1,455 adults studied, those with the highest BPA levels had more than double the odds of having diabetes, the report found.
"Higher urinary concentrations of BPA were associated with an increased prevalence of cardiovascular disease, diabetes, and liver-enzyme abnormalities," the authors wrote.
The release of the report coincided Tuesday with a Food and Drug Administration (FDA) hearing in Washington into the safety of bisphenol A, which the FDA has so far deemed to be safe in a preliminary report issued in August.
"A margin of safety exists that is adequate to protect consumers, including infants and children, at the current levels of exposure," Laura Tarantino, senior scientist at FDA, told the hearing.
The FDA's August report triggered an outcry from the scientific community and consumer protection groups.
They accused the agency of ignoring the results of studies done on animals showing that small doses of BPA could provoke changes during development in the brain, prostate glands and at puberty for females.
A group of toxicologists at the National Institutes of Health (NIH) also published their concerns about the levels of the chemical found in many food containers, plastic bottles and dental fillings in a study earlier this month.
According to the NIH findings, the chemical could have dangerous effects on the development of the brain and the prostate gland in fetuses and newborn babies.
BPA is said to interfere with estrogen, the hormone which plays a key role in fetal and childhood development.
The authors of Tuesday's study said it was the first to track the prevalence in the human body of BPA, which authorities in Canada plan to outlaw as a health risk and major environmental contaminant.
The compound is found in detectable levels in more than 90 percent of Americans, "primarily through food, but also through drinking water, dental sealants, dermal exposure, and inhalation of household dusts," researchers said.
More than two million metric tonnes of BPA were produced worldwide in 2003, and demand for the compound has increased by between six and 10 percent each year since then, the authors said.
Consumer groups are pushing for the FDA to review its initial conclusions, which they say have been based on industry-funded research.
Elizabeth Hitchcock of the US Public Interest Research Group said she hoped the FDA would take into account the evidence "about the consequences of bisphenol A particularly on children's health" in making its decision.
But the industry group American Chemistry Council said more follow up studies were needed.
"Overall, due to inherent limitations in study design, this new study cannot support a conclusion that bisphenol A causes any disease," said Steven Hentges from the council.
"The weight of scientific evidence continues to support the conclusion of governments worldwide that bisphenol A is not a significant health concern at the trace levels present in some consumer products."