The Yin Yang of the Bisphenol A Controversy
Posted by
Armand RossettiSeptember 17, 2008 4:29 PMTags: JAMA,
Bisphenol A,
liver,
enzymes,
shana,
swan,
epidemiologist,
risk,
safety,
plastics,
heart,
disease,
diabetes,
BPA,
FDA,
consumers,
study,
danger
The Yin:
As the old saying goes, there are two sides to every story. Today, an article appeared in the Journal of the American Medical Association (JAMA) raising new concerns about a unexpected link between Bisphenol A, a chemical found in plastic used to make baby bottles, soda can lining and CD disks, and cardiovascular disease.
The retrospective JAMA study included 1,455 US men and women ages 18 to 74. They were divided into four groups based on the levels of Bisphenol A detected in their urine. However the study was not conclusive that Bisphenol A was the cause of the increased risk of disease.
Nevertheless, those subjects with the largest amount of Bisphenol A in their urine were 2.9 times more likely to have cardiovascular disease than those with the lowest levels. The risk was 2.4 times higher for diabetes. In addition, subjects with higher levels of Bisphenol A had higher liver enzymes, pointing to liver toxicity.
The findings are consistent with those of prior animal and human studies, and Shana Swan, an epidemiologist at the University School of Medicine and Dentistry and Rochester, New York said that the new JAMA findings will make it impossible for the FDA to conclude that Bisphenol A is safe for humans.
However, the FDA has chosen to overlook the ramifications of the JAMA study and to permit business as usual.
The Yang:
An article entitled, Agency Affirms Plastics Safety, as Study Raises Questions appeared in today’s New York Times. The article reported that federal regulators defended their assessment that Bisphenol A is safe, despite the JAMA report that has indicated otherwise.
The FDA contents that there is a margin of safety adequate enough to protect consumers, including infants and children, at the current level of exposure. In fact, Senior FDA scientist, Laura Tarantino has endorsed Bisphenol A’s safety before an expert panel that the FDA has asked to provide a second opinion on the agency’s assessment.
Evidently, two Dartmouth College analysts, Drs. Lisa Schwartz and Steven Woloshin have also indicated that the JAMA study presented no clear information about what might have caused heart disease or diabetes in those subjects with the higher urine Bisphenol A levels. Dr. Schwartz stated the following:
“Measuring who has disease and high BPA levels at a single point in time cannot tell you which comes first,”
The Dartmouth doctors criticized the JAMA investigators for conducting a broad search for diseases that might show an association, generally providing weaker evidence. There was no reason to suspect that heart disease might be linked to Bisphenol A. And the JAMA investigators used statistical modeling to make their comparisons. For example, fatter subjects had higher levels of Bisphenol A, and researchers attempted to correct for that with statistics.
The Unity of Opposites:
In Chinese philosophy, the yin-yang combines two complimentary qualities, also called polar effects. Therefore, the yin-yang when put together is the entire phenomenon. When the FDA chooses one polar effect over the other, or decides to endorse the opinions of two doctors over the results of the JAMA study, and do so when neither of the two provides the entire answer, the FDA has not adequately addressed consumer safety.
In the interest of safety, the FDA should err to the side of caution and at least not endorse Bisphenol A as being safe, when nobody really has a handle on its safety. After all, who determines what level of exposure is safe, and who provides the reason that a certain level is safe. There are too many exposed variables to make a clear choice that Bisphenol A is safe.
Instead, the FDA should have issued a statement expressing caution, and suggesting that consumers lower their consumption of food distributed in containers made with Bisphenol A. If the FDA had made a statement of that sort, and added a call for timely studies to determine the extent of any actual danger, that course of action might have been a better approach to solving the problem.