From: BULLELKMAN@aol.com Sent: Thursday, July 29, 2004 12:51 AM To: FDADockets@oc.fda.gov; brownchas@erols.com Cc: FreKoss@aol.com; sandyduffy@comcast.net Subject: Docket Number # 03N-0169 Dear FDA, Please post this e-mail to Docket Number # 03N-0169. It is imperative that this important information becomes part of public record on mercury dental fillings. By recording this e-mail to Docket Number #03N-0169, it becomes information that will be available to the "public" to include the American public, elected officials and the media because of Freedom of Information Act. It is critical that the "public" has access to this information. Thank you, Mary Ann Newell Manager of the Files for Consumers for Dental Choice ******************************************************************** Consumers for Dental Choice 1725 K St., N.W., Suite 511 Washington, DC 20006 Ph. 202.822-6307; fax 822-6309 www.toxicteeth.org June 16, 2003 The Honorable Thomas M. DiBiagio United States Attorney for the District of Maryland United States Department of Justice 101 W. Lombard St., Suite 6625 Baltimore, MD 21201 Dear Mr. United States Attorney: On an issue of major public significance, Dr. Norman Braveman, Assistant to the Director, National Institute of Dental and Craniofacial Research, is disregarding federal competitive bidding requirements by creating a subcontractor slot to an unrelated project. (The National Institute of Dental and Craniofacial Research is an arm of the National Institutes of Health, Bethesda, Maryland.) Dr. Braveman has engineered this rather interesting subterfuge via several steps: (1) going to an existing contractor whose tasks are unrelated to studying mercury fillings; (2) adding this new major task to the contract: review the science to determine if mercury fillings are unsafe; thus (3) compelling the contractor to add a subcontractor; and finally (4) having the contractor appoint a subcontractor[1] -- who is almost assuredly Dr. Braveman’s designee. While this sweetheart deal process was being undertaken, neither Dr. Braveman at NIDCR nor Dr. Lee Joseph at FDA (on assignment from U.S. Public Health Service) would tell us what they were doing (see enclosed e-mails). The stakes are huge. The issue is whether it is safe to use mercury dental fillings. Known to scientists as amalgam,[2] the fillings are about 50% mercury, a virulent neurotoxin. Because mercury is the most volatile heavy metal, its toxic vapors emanate from the teeth.[3] The Director of Devices of the Food and Drug Administration promised a no-holds-barred study of the science, and in good faith intends for such a study to occur. Because we have seen a plethora of research indicating mercury fillings are unsafe, especially for children and pregnant women, we welcome the study. Militating against an objective study, however, are government personnel whose careers are built on holding the line that mercury fillings are safe. Among them are leaders at the National Institute of Dental and Craniofacial Research and the dental section of the Center on Devices at FDA. To declare mercury fillings unsafe would upset organized dentistry and these officials inside government who repeatedly have advocated for them. According to an announcement in the Federal Register, Dr. Braveman is working on this project with officials from the FDA and the Public Health Service who likewise declare mercury fillings to be safe. Although we know the three agencies are working in tandem on the scientific review, we do not know if officials from FDA or PHS are also collaborating in steering the noncompetitive contract to the favored party. As of last week, the contract had been agreed to but not signed. NIDCR has wasted millions of dollars by pretending to do studies on mercury fillings. Amidst hundreds of studies in the past decade, only one got published. Effectively, NIDCR has chosen to pretend to study the issue, funneling money to favored researchers who never produce results (or who produce results NIDCR doesn’t want published). In any case, the taxpayers are having their money spent on no work product at all, which could be due to negligent nonfeasance or intentional malfeasance. Sincerely, Charles G. Brown Counsel Attachments -------------------------------------------------------------------------------- [1] The subcontractor would be Life Sciences Research Office, Inc. (known as “LSRO”), Bethesda, Maryland. The contractor reportedly is Betah Associates, also in Bethesda. [2] Unfettered by compliant government regulators, the American Dental Association deceptively promotes the fillings as “silver.” [3] Mercury vapors from the teeth go to the brain, a particular risk for children, whose brains are still developing; to the fetus, because mercury goes through the placenta; and to the nursing child, because mercury goes through breast milk.