Press Releases: 11.21.05
For further information, contact:
Consumers for Dental Choice
Charles G. Brown, National Counsel
E-mail: email@example.com Phone: 202.822-6307
Consumers for Dental Choice, a nonprofit group focused on a transition to mercury-free dentistry, has filed a series of formal and informal petitions calling for FDA to stop hiding the fact that amalgam fillings expose children and pregnant women to toxic mercury. Although deceptively promoted by the American Dental Association as “silver” fillings, amalgams are about 50% mercury by weight and less than 30% silver.
The petitions contrast the anomaly that FDA (1) bans mercury in all drugs,www.fda.gov/oc/po/firmrecalls/equine05_02.html , and (2) bans mercury in all veterinary products,www.fda.gov/cvm/July_August.htm#2241, but won’t even give warning to pregnant women or children about mercury amalgam. Both WHO and Health Canada call amalgam the #1 exposure of humans to mercury, while the Centers for Disease Control calls it (in its 2005 report on environmental toxins) a “major” human exposure.
The heart of the problem, says Consumers for Dental Choice, is dentist self-regulation – astoundingly, the dentist-run Dental Devices Branch decides whether mercury vapor from these fillings is a health risk to the developing fetus, the child’s brain, and the adult’s kidneys. Pointing to a letter from Senator Frank Lautenberg, which calls dentist control both an “inherent conflict of interest” and unwise policy – since toxicologists and physicians are well-trained to determine toxic effects on the brain and fetus while dentists are not – one petition (Dkt #2005P-0462/CP1) calls for removal of dentist control of the process. Another petition (Dkt #2005P-0465/CP1) calls for withdrawal of a proposed rule on amalgam, a rule not just encouraging but mandating concealment of warnings that amalgam constitutes a major mercury exposure.
Consumers for Dental Choice (“Consumers”) filed a 21-page report, with 33 Exhibits, to the Office of Internal Affairs, calling for an investigation of a contract where FDA’s Dental Devices Branch helped handpick a tobacco consultant to do an “independent” review of amalgam studies, provided it a blueprint of the desired result, inserted the consultant as subcontractor, and appointed an unqualified strawperson as contractor. The study is a total departure from the results of reviews in other countries that call for total phase-outs. Consumers calls on FDA to revoke a Consumers Update it calls deceptive and done based on ex parte contacts, and to retract letter with false information provided to Senator Smith and Senator Murray about mercury amalgam.
A Zogby poll of Connecticut voters shows three in five are not aware that “silver’ fillings have mercury – and only 1 in 30 knows that mercury is the major component. “This information is hidden because FDA wants to keep it that way,” says Charles G. Brown, national counsel for Consumers. “FDA assigns dentists with ties to the ADA to control the process, makes its so-called ‘Consumer Updates’ a joint enterprise with the American Dental Associations, and covers ups the plethora of contraindications emanating from other nations about mercury exposure.” Pointing to a horse medicine banned solely because it has mercury, Brown adds: “When it comes to mercury, FDA favors protecting horses over protecting children, born and unborn.”
Of particular concern to Consumers is that the dentist-run branch created an “Amalgam Vigilance” committee. As its name suggests, this extra-legal group rounds up like-minded dentists in other health agencies to make policy supporting amalgam use, keeping regulators at the top of FDA in the dark about developments in Canada, Sweden, Germany, and other nations who give either red-light contraindication warnings for children and pregnant women or call for outright bans. “The vigilance of FDA’s Amalgam Vigilance committee is to protect the American Dental Association at the expense of the American public,” Brown adds. “When it comes to amalgam, FDA has abandoned its Gold Standard reputation.”
- Letter to FDA Special Agent Thomas Doyle - Nov. 2, 2005:
Request to investigate FDA’s agreement with LSRO Inc. / BETAH Associates, including actions of LSRO, of BETAH, of CDRH’s Dental Devices Branch, and of its Director, Dr. Mary Susan Runner
- Memorandum to FDA Office of Internal Affairs - Nov. 4, 2005:
FDA’s LSRO/BETAH Contract
- Letter to FDA Senior Advisor for Consumer Affairs - Nov. 8, 2005:
Request that FDA Retract and Reissue the Dec. 2002 FDA Consumer Update on Amalgam
- Citizen Petition to FDA - Nov. 9, 2005:
Transfer Regulatory Responsibility from Dental Devices to General, Restorative, & Neurological Devices; transfer Classification Responsibility from Dental Products to Clinical Toxicology Devices Panel
- Citizen Petition to FDA - Nov. 10, 2005:
Withdraw Draft Regulation on Mercury Amalgam; To Proceed Is Contrary to Law, Science, and Public Policy – and Would Create a Gross Appearance of Impropriety
- Letter to Associate Commissioner Lutter and other FDA officials - Nov. 12, 2005