From: BULLELKMAN@aol.com Sent: Tuesday, July 27, 2004 2:17 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 ________________________________________________________________- -----Original Message----- From: sandyduffy@comcast.net [mailto:sandyduffy@comcast.net] Sent: Wednesday, June 23, 2004 9:43 PM To: mhk@pitt.edu; sberent@umich.edu; rbrent@nemours.org; bruckner@rx.uga.edu; jdoull@kumc.edu; megershwin@ucdavis; gmatanos@jhsph.edu; Raphael.rubin@jefferson.edu; Bernard_weiss@urmc.rochester.edu Subject: Amalgam Review Report To: The Amalgam Review Committee Meryl Karol, Ph.D., Chairwoman Stanley Berent, M.S., Ph.D. Robert Brent, M.D., Ph.D James V. Bruckner, M.S., Ph.D. Genevieve Matanoski, M.D., Dr.P.H. Raphael Rubin, M.D. Bernard Weiss, Ph.D John Doull, M.D., Ph.D. M. Eric Gershwin, M.D. Ronald D. Hood, M.S., Ph.D. , (we have no e-mail address for Dr. Hood. May we ask that Chairwoman Karol or another panelist forward him this e-mail?) Dear Amalgam Review Panel: I understand that the Report of your Panel will be issued soon. As an activist for mercury-free dentistry, I am quite familiar with the very large body of scientific studies which address mercury generally, and mercury amalgam specifically. Over 3000 studies were submitted to you by activists and scientists. These same studies have led Sweden to stop reimbursing the costs of amalgam as part of its state dental insurance program. Norway recently adopted guidelines which discourage the use of amalgam fillings. Numerous other countries limit the use of amalgam, especially in children, pregnant women, the allergic, those with kidney problems, those with braces and other vulnerable populations. Even American studies show very low levels of chronic mercury exposure results in adverse health effects (ex. Echeverria’s studies showing neurological damage at <4ug/l mercury in the urine). On the other hand, the pro-amalgam camp came up with 175 “studies,” which were submitted by the ADA (after a solicitation to do so by the FDA). Of those 175 “studies” (predominantly reviews written by dentists, or “consensus statements” created by dental-industry-dominated federal agency committees or task forces). None of the 175 submissions support a conclusion for the safety and effectiveness of dental amalgam. Any Report which concludes that the evidence of health harm from mercury amalgam dental fillings is “insufficient to limit the use of amalgams IN ANY DENTAL PATIENT except those hypersensitive to mercury”, is not supported by the evidence submitted to you, and is a knowing and willful false statement intended to cover up the risks of mercury toxicity from mercury amalgam dental fillings. Dr. Falk has refused to reveal to us the database of studies that were reviewed by the Panel. He may not have even allowed you to see all of the relevant studies which were submitted. We know it was literally impossible for all of you to have reviewed all of the material provided. You, as members of the Amalgam Review Panel, are being used to perpetuate a scheme to keep American dental consumers in the dark about amalgam toxicity and to use the clout of federal agencies (Public Health Service, FDA and NIDCR) to convince public health agencies, state dental boards, state dental associations and American dentists of the safety of amalgams when there is no credible scientific evidence to support such a conclusion. In fact, studies date back into the 19th century which conclude that mercury and amalgam are harmful to the human body. You should carefully consider whether you want to have your name on the Report which will be issued. By pushing this Junk Science report in front of you, Drs. Falk and Brownawell want you to further the pro-Mercury Fillings agenda of organized dentistry, at the expense of the children of America. As such, you, as members of the Amalgam Review Panel, risk being used as the props to perpetuate keeping American dental consumers in the dark about amalgam toxicity. No credible scientific evidence exists to support a conclusion that Mercury Fillings are safe, and none was presented to you. All Falk, Brownawell and the ADA apologists for Mercury Fillings could give you to support their position are opinions -- and opinions are inconsequential compared to peer-reviewed studies. FDA Dental is charged with protecting the public from unsafe dental devices. A statement that mercury amalgams are safe for all dental consumers, except those with a hypersensitivity to mercury, is materially false, and if the Panel’s Report makes such a statement it is falsifying, concealing and covering up material facts (amalgams are toxic to humans and are the primary source of human mercury body burden). It is no longer out of the question to suggest that Panel Members consider seeking the advice of their own counsel. In summary, we have (1) a report (we are told) which concludes contrary to the peer-reviewed research; it follows on the heels of (2) a no-bid contract and (3) clever subcontracting through an intermediary; plus, (4) all players -- NIDCR, LSRO, and Betah -- refuse to disclose the amount of taxpayers' money that LSRO is receiving; and, finally (5) the review procedures violate the Federal Advisory Act (among other things, consumerswho signed up for email notice of meetings never received such notices). A statute that a lawyer may want to examine is 18 USCS Section 1001 (set out below). Respectfully submitted, Sandra Duffy Consumers for Dental Choice NW Lake Oswego, OR 18 USCS § 1001 (2004) § 1001. Statements or entries generally (a) Except as otherwise provided in this section, whoever, in any matter within the jurisdiction of the EXECUTIVE, legislative, or judicial branch of the Government of the United States, KNOWINGLY and WILLFULLY-- (1) FALSIFIES, CONCEALS, or COVERS UP by any trick, scheme, or device a MATERIAL FACT; (2) MAKES any materially FALSE, fictitious, or FRAUDULENT statement or representation; or (3) MAKES or uses any FALSE WRITING OR DOCUMENT knowing the same to contain any materially FALSE, fictitious, or FRAUDULENT statement or entry; shall be fined under this title or imprisoned not more than 5 years, or