From: BULLELKMAN@aol.com Sent: Monday, July 26, 2004 12:23 AM To: FDADockets@oc.fda.gov; brownchas@erols.com Cc: sandyduffy@comcast.net; FreKoss@aol.com 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 ________________________________________________________ Twc30@aol.com Muriel_Klein@urmc.rochester.edu Thomas Clarkson, Ph.D. University of Rochester Re: Re quest You End Conflict of Interest of Double Participation in LSRO’s So-Called “Study” of Mercury Fillings Dear Professor Clarkson: We are astonished to learn that you are designated as one of three scientists doing the “external review” of the cursory literature review by a panel handpicked by Mr. Falk. You were intimately involved in the formation of the record. In good faith, you cannot conduct an independent review after being a lead speaker and participant in the process! According to the record: (1) At the February 17-18 secret meeting of this panel, you were the one and only invited speaker. (2) To keep your presence hidden from the public, Mr. Falk and Ms. Brownawell, the LSRO consultants, refused to post who was speaking until AFTER your appearance, an obvious breach of LSRO's promise of transparency, and an indicator that Falk and Brownawell wanted its handpicked panelists to hear you without any contradiction from those who find Mercury Fillings to be a health risk. (3) To our knowledge (amidst the difficulty of trying to wade through the efforts of LSRO to block information from consumers), you were the last speaker to appear. (4) You appeared amidst a group who obviously are relying on you heavily, as not a single one of them – not Falk, not Brownawell, not a single panelist – had any background in studying the toxicity of Mercury Fillings. We believe it is a clear conflict of interest for you to testify, then be picked as a quote, outside, unquote, reviewer. This entire project has been one conflict of interest after another. The American Dental Association’s top ally at NIDCR, Dr. Norman Braveman, and the ADA’s top ally at FDA, Dr. Susan Runner, handpicked LSRO and Mr. Falk through a secret, no-bid, subcontract under a contract. Mr. Falk then, per agreement, picked a panel of Mercury Filling No-Nothings who would compliantly allow Falk and Brownawell to write a so-called report mirroring the ADA pro-Mercury Fillings position. The only way for you to correct this conflict is to withdraw as one doing the external review. We have one further question, since this is government funds. LSRO refuses to say how much they are being paid to write this pro-ADA report. We call on you to distance yourself from this stonewalling by disclosing (a) hw much are you being paid, and (b) whether you are being paid twice, once for appearing and once for the literature review. Charles G. Brown, June 17, 2004 cc--Meryl Karol, Ph.D., Chair Chairman Dan Burton Congresswoman Diane Watson Congressman Dave Weldon, M.D. Senator Frank Lautenberg Jamie Wolszon, Reporter, FDA Week Les Weinstein, Ombudsman, FDA Center on Devices Charles G. Brown, national counsel Consumers for Dental Choice, and Coalition for Mercury-Free Dentistry 1725 K St., N.W., Suite 511 Washington, DC 20006 Ph. 202.822-6307; fax 822-6309 www.toxicteeth.org