Flaws in FDA BPA StudyOct 29, 2008 | Parker Waichman LLP
Negative Effects Of Bisphenol A
We have been reporting for some time on the negative effects of bisphenol A—BPA—as well as some slanted reporting used by the U.S. Food and Drug Administration (FDA) in their assessment deeming BPA safe. Now, according to a report by a panel of U.S. independent scientific advisors, health regulators failed to properly assess the potential safety risks posed by BPA.
According to the group, FDA staff failed to provide “reasonable and appropriate scientific support'' for its finding that the public was not at risk from BPA. BPA has been used for decades to strengthen plastic used in baby bottles and food storage containers and has long been linked in a wide variety of studies to diabetes, heart disease, developmental changes in children, hormonal issues, problems with liver function test results, and interference with chemotherapy treatments. The recent reproach adds to the long-running dispute among U.S. government scientists over BPA’s risks, yet the FDA does not budge from its position and continues to deem BPA safe as recently as August, relying heavily on two controversial industry studies for its data. That announcement sparked a fury of criticism from consumer groups and lawmakers given that the findings conflicted with at least one separate report issued from the National Toxicology Program that found BPA poses a risk to children. The group, which is part of the Health and Human Services Department, ranked the risk level for children in the middle of a five-point scale.
How poorly the agency has handled its review of BPA
The advisory panel's findings show “how poorly the agency has handled its review of BPA and the significant work that lies ahead in improving the agency's performance,'' Representative Rosa DeLauro, a Connecticut Democrat, said of the FDA yesterday. Also, in their report, the advisors also said FDA staff had not sufficiently considered independent studies suggesting BPA isn't safe at current levels. Consumer groups and lawmakers have said the review relied too much on the industry-funded research, but FDA staff maintains that the industry studies met stricter scientific guidelines. Despite the FDA’s assertions, the report states that FDA staff “considered, but rejected for various reasons, a number of potentially relevant studies,'' a subcommittee of the agency's Science Board stated in the report. The safety data the staff relied upon was “inadequate,'' the panel noted.
Over 90 percent of Americans have traces of BPA in their urine, according to the Centers for Disease Control and Prevention (CDC) and BPA was declared “toxic'' this April by the Canadian government, which announced earlier this month its plans to ban baby bottles made with BPA. Meanwhile, lawmakers, including DeLauro, also have raised questions about ties between Martin Philbert, acting director of the Risk Science Center at the University of Michigan, and the chemical industry. The Center received grants totaling $15 million from Dow Chemical Company, a manufacturer of BPA, DeLauro has said. Also, in a move that the Washington Post said could be "seen as less than fully independent," Philbert did not disclose a $5 million donation from Charles Gelman to the Center. Gelman is the retired head of a medical device manufacturing company and a known BPA supporter; Philbert is heading the FDA’s advisory committee on the safety and risks of BPA.
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