From: BULLELKMAN@aol.com Sent: Thursday, July 29, 2004 12:53 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 ******************************************************************** Brown Asks Justice Department and Burton Subcommittee to Investigate Sweetheart NIDCR Contract. Consumers for Dental Choice counsel Charles G. Brown has called for a federal investigation of a hush-hush, noncompetitive contract by the National Institute of Dental and Craniofacial Research (NIDCR). Last fall, Dr. David Feigal, Director of the Center on Devices at the Food & Drug Administration (FDA), promised in good faith to do a new scientific inquiry about the health risks associated with mercury fillings. Unfortunately, the people put in charge are the same old pro-mercury crowd at NIDCR and FDA, many of whom have spent their careers protecting the American Dental Association rather than protecting the well-being of the American public. Heading the study is Dr. Norman Braveman, who runs the notorious Portugal and Boston studies, where mercury fillings (up to 20 per patient) are being poured into Portuguese orphans and American minority and poor white children -- experiments that would never be done on middle-class children. NIDCR has an abysmal record of wasting taxpayers’ money by pretending to do studies on mercury fillings but never publishing the results. Brown has asked the U.S. Attorney to determine whether a pattern of giving money to favored researchers who fail to make their results public is criminal malfeasance or negligent nonfeasance. NIDCR decided to hire a consultant to do the work. But Braveman did not bid out the contract, as federal law generally requires. Instead, he worked out a sweetheart deal with Life Sciences Research Office, Inc. First, he designated an existing contractor (working with NIDCR on an unrelated project), then 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 prize -- and the money -- without even submitting a bid. Presto -- with government bidding rules circumvented, NIDCR and FDA have the consultant they want. Life Sciences Research (like NIDCR, located in Bethesda, Md.) has contracts with many major corporations, such as RJR Nabisco and Philip Morris. Keep Americans smoking. Keep Americans using mercury fillings. On June 16, Brown wrote the United States Attorney in Maryland asking for a Justice Department investigation. He also wrote Braveman and NIDCR contract officer Marian Blevins, urging them not to go forward with this shady deal. He is presenting those materials to the House Government Reform Committee’s Subcommittee on Wellness and Civil Rights, chaired by Congressman Dan Burton (R-Ind.). Burton and Ranking Member Congresswoman Diane Watson (D-Calif.) are conducting hearings into why government agencies are protecting organized dentistry’s continued use of mercury fillings. “These sweethearts deals between NIDCR and their handpicked consultants, who continue to ignore the science on mercury fillings, must stop,” Brown said. Both letters are attached.