On October 23, the Endocrine Society, the world’s largest and most established organization dedicated to hormone research and endocrinology in the medical field, organized a virtual webinar to discuss the Food and Drug Administration’s (FDA’s) position on the CLARITY-BPA study. The CLARITY-BPA study, or the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, was organized by the FDA, the National Institute of Environmental Health Sciences (NIEHS), and the National Toxicology Program (NTP) in response to growing concern over the toxicology of bisphenol-A, also known as BPA. BPA is commonly found in plastics, food containers and resins. The FDA has asserted multiple times that the dose of BPA which consumers of these items are exposed to is safe and does not produce any significant health risks . However, many scientists disagree and point out numerous holes in the data collected throughout the study and how it is interpreted.
The Endocrine Society’s virtual conference featured two key scientists: Endocrine-disrupting Chemical Advisory Group members Laura N. Vandenberg, Ph.D., and CLARITY-BPA investigator Heather Patisaul, Ph.D. . The speakers discussed recent data from CLARITY-BPA’s Core Report and other published results from academic partners involved in the study.
Dr. Heather Patisaul reviewed some of the history behind the CLARITY-BPA study and why it was needed. In 2014, the FDA compiled over 300 academic studies about the effects of BPA and reviewed the strengths and weaknesses of each experiment . Based on this evaluation, the FDA decided which studies were valid to analyze the toxicity of BPA and which studies were not reliable for analysis. Through this method, the FDA in essence picked and chose which data to accept and which data to simply ignore, leaving out key scientific information that could lead to wrong conclusions and an erroneous overall picture of BPA’s effects . In addition, the FDA’s methods for their selection appear to be corrupted; for example, when analyzing BPA’s effects on neurotoxicity, only one study was selected out of thirty-six. This study happened to be industry-funded, potentially indicating a conflict of interest which could influence results and conclusions . The lens that the FDA chooses the view and integrate data should thus be called into question due to past corrupt behavior.
While the FDA did not adequately synthesize prior information on BPA toxicity, it became clear through the analysis of other agencies that more information was needed to form a definite conclusion regarding its effects. The CLARITY-BPA study, which involves the work of agencies such as the FDA and National Institute of Environmental Health Sciences and independent academic researchers, was created to foster collaboration between scientists collecting data and regulatory agencies making decisions based on such data. However, early on in the study, the FDA made an initial claim that BPA is safe for consumers, causing disharmony between the organization as it resisted changing its public opinion and researchers as more and more information became available indicating BPA’s harmful effects.
One reason why the FDA ignores the blatantly harmful effects of BPA in rats is that such data is only seen for low doses of BPA. For example, increases in the incidence of mammary adenocarcinoma (a type of cancer) were observed in rats given a low dose of BPA, and inflammation of the prostate was seen in male rats that were exposed to continuous doses of low BPA . Females exposed to lower doses also experienced kidney neuropathy ( at a continuous 2.5 µg/kg/day) and increased body weight (at a continuous 250 µg/kg/day) . However, while these effects were not seen as strongly in the groups exposed to higher doses, the FDA dismissed these results, assuming that if one was exposed to more poison, then more poisonous effects should be observed. However, this relationship is not observed for hormonal effects. BPA mimics the hormone estrogen, causing hormonal changes that can lead to reproductive effects and tumors. These toxic effects increase with increasing dose up until a certain amount, at which point they begin to decrease with increasing dosage . It is important that the FDA interprets the data based on the specific data trends expected for toxins of the endocrine system and not to erroneously assume a linear relationship. As a matter of fact, these low doses are most reflective of the level of exposure children receive from BPA in plastics
While resources would be required to enforce BPA regulations, Dr. Vandenberg noted that the current resources used to treat health conditions caused by BPA exposure are astronomical. According to Dr. Vandenberg, the European Union alone spends an approximated £157 to £270 billion on the treatment of such preventable health effects . While regulation is needed on a federal and global level, change begins with the individual. The effects of BPA toxicity can be rapidly reversed in consumers by avoiding plastic products with BPA and purchasing items such as food containers that contain glass instead. Regardless of federal regulation, the power lies with each citizen: the power to seek being a conscientious consumer and avoid becoming a patient.
Kate Lee is a contributor to The Daily Campus opinion section. She can be reached via email at Katherine.firstname.lastname@example.org.