From: BULLELKMAN@aol.com Sent: Thursday, July 29, 2004 12:55 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 ******************************************************************************************** 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 18, 2003 Mark McClellan, M.D., Commissioner -- Via fax 301. 301-443-3100 David W. Feigal, Jr., M.D., Director, Center for Devices -- Via fax 301. 594-1320 Daniel Troy, General Counsel, -- Via fax 301.827-3054 United States Food and Drug Administration Dear Commissioner McClellan, Director Feigal, and General Counsel Troy: The National Institute for Dental & Craniofacial Research is secretly trying to implement a noncompetitive contract – thus circumventing federal bidding laws – to handpick the consultant to review the science on mercury fillings. Because it was the FDA who announced the study in the Federal Register and initiated an interagency effort, we are bringing it to your attention to determine the involvement, if any, of your agency. Dr. Norman Braveman, assistant to NICDR Director Lawrence Tabak, decided to hire a consultant to do the work, but did not bid out the contract, as federal law generally requires. Instead, he designated an existing contractor (working with NIDCR on an unrelated project), and added a new task that appeared to be beyond the capabilities of the original contractor. Suddenly, out of these complex maneuvers, a subcontractor emerges to be awarded the work -- and the money -- without even submitting a bid. (The subcontractor, Life Sciences Research Office, Inc. (LSRO), represents numerous major corporations regulated by FDA, raising the specter of conflicts of interest as well.) FDA officials may well be involved in this cronyism. The FDA announcement in the Federal Register states that FDA dentist Susan Runner has a prominent role in this project. And according to her e-mail to me, Dr. Lee Joseph, from PHS but assigned to FDA, is working with Dr. Braveman on implementing the project. Both Dr. Runner and Dr. Joseph have a long record of ignoring the emerging science and staying in step with the American Dental Association. Reportedly, they crafted the notorious FDA Consumer Update of February 2002, the prime political paper used by the ADA to fight the national movement to abolish mercury fillings – until Dr. Feigal revoked it in December. Dr. Runner gives press interviews and, only last month, told a citizen who called her that mercury fillings are safe. As they have shown no reluctance to immerse themselves in the process to protect mercury fillings, it is appropriate to determine if they participated in the process of choosing LSRO as part of reinforcing their staked-out position. On June 16, I wrote (1) the United States Attorney asking for a Justice Department investigation, and (2) Dr. Braveman and NIDCR contract officer Marian Blevins, asking them not to go forward with this shady deal. Both letters are attached. Sincerely, Charles G. Brown National counsel