With news that U.S. FDA Commissioner Margaret Hamburg, M.D., has removed herself from the agency's latest rule-making efforts regarding dental amalgam, there is speculation that the FDA might not make its much-anticipated July 28 deadline to reclassify encapsulated amalgam alloy and dental mercury.
In June 2008, the FDA settled a lawsuit filed by Moms Against Mercury, Consumers for Dental Choice, and other plaintiffs that sought to have mercury fillings banned from the U.S. market. While not agreeing to a ban, the agency said it would add warnings regarding amalgam use in some patient groups, and would complete a review that could lead to more stringent regulation of the substance. The settlement also included a requirement that the agency formally reclassify dental amalgam by July 28, 2009.
But now that Dr. Hamburg has recused herself, the agency is likely to miss its July 28 deadline, according to Charles Brown, national counsel for Consumers for Dental Choice. In a letter dated July 8, FDA Acting Chief Counsel Michael Landa told Brown that Dr. Hamburg "has decided not to participate in this rule making" and that all further inquiries regarding the rule-making efforts should be referred to Joshua Sharfstein, M.D., principal deputy commissioner of the FDA.
FDA's current stance on amalgam
The U.S. FDA has struggled for years to reach a definitive conclusion on amalgam fillings. The agency first proposed to classify encapsulated amalgam and dental mercury as class II medical devices back in 2002. As such, these products would be subject to "special controls" that could include, among other provisions, recommendations and guidance for product labeling, according to the FDA.
But in 2004, an FDA panel determined that there was no evidence of risk from dental amalgam -- even to pregnant women. Two years later, a 2006 Center for Devices and Radiological Health advisory panel disagreed. Even so, the language on the FDA Web site regarding the safety of dental amalgam remained vague, noting only that "the possibility that dental amalgam could pose health risks that are not yet scientifically known."
Then came the lawsuit by Moms Against Mercury and Consumers for Dental Choice, which led to a May 2008 settlement between the plaintiffs and the FDA. In addition to agreeing to revisit the reclassification issue and make a firm decision by July 28 of this year, the FDA agreed to alter the language on its Web site:
Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner.
When asked why Dr. Hamburg had stepped away from the process, FDA Assistant Commissioner for Public Affairs George Strait told FDA Webview on July 14 that it was "based on the requirements of federal ethics laws and the standard of ethical conduct."
According to Brown, the issue is that, prior to joining the FDA, Dr. Hamburg served for five years on the board of Henry Schein. In fact, a Forbes magazine article noted that Schein paid Dr. Hamburg $285,365 in 2007, Brown said. In letters to Dr. Hamburg dated June 9 and July 1, Brown questioned her relationship with Henry Schein and its potential influence on the rule-making process surrounding the pending reclassification of dental amalgam. But Dr. Hamburg did not respond to his queries, Brown said.
"If FDA delays classifying [dental amalgam] due to commissioner Hamburg's conflict of interest based on her affiliation with Henry Schein, FDA becomes a full partner in concealing the mercury in amalgam from America's parents and pregnant women," Brown said in a statement to DrBicuspid.com.
However, according to Peper Long, FDA spokesperson, "The FDA certainly intends to adhere to the July 28 deadline for a final rule."
And many dispute that dental amalgam poses risks to patients. The ADA supports the FDA's proposal to reclassify dental amalgam and believes "the current evidence does not support a link between dental amalgam and systemic diseases or risks to children, pregnant women, or developing fetuses," according to its Web site. "The ADA supports ongoing research on the safety of existing dental materials and in the development of new materials. However, the ADA continues to believe that amalgam is a valuable, viable, and safe choice for dental patients."
And in 2008, writing in the Journal of Dental Research (February 2008, Vol. 87:2, pp. 101-102), Derek Jones, professor emeritus of biomaterials at Dalhousie University and chair of the International Standards Organization's Technical Committee on Dentistry, noted the following:
For the past 20 years, the public has been bombarded by sensational, confusing, and misleading media reports about health issues related to dental amalgam. The public opinion on this issue has been modified by minority, nonscientific views driven and supported by media sensationalism. It is important that governments adhere to scientific principles and base health and environmental policies on sound scientific knowledge.
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