From: BULLELKMAN@aol.com Sent: Friday, July 23, 2004 2:09 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 ******************************************************** 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 Elias H. Zerhouni, M.D., Director National Institute of Health – fax 301.402-2700 Re: NIDCR violates competitive bidding laws and contines cover-up of Mercury Fillings by handpicking tobacco consultant to do study. Dear Director Zerhouni: NIDCR is posed to accept and praise a report that it illegally contracted for. In defiance of the Federal Acquisition Act, NIDCR's Norman Braveman handpicked a tobacco consultant to write a report that covers up the health risks of Mercury Fillings. Braveman, working with Susan Runner of FDA and a third person from PHS, now deceased, met secretly and secured an agreement with an existing contractor, Betah Associates, who agreed to act as straw person in exchange for half the money. Betah in turn picked LSRO, Inc., a company with a wide range of corporate clients such as Big Tobacco. LSRO proceeded to conducted a sham study and issue a report that intentionally ignores the studies showing Mercury Fillings are a health risk. LSRO’s procedures were opposite NIH’s standards: no one on the panel had published material on Mercury Fillings; the panel met repeatedly in secret; outside reviewer Thomas Clarkson had already served as a major participant (two conflicting roles); the panel didn’t write the report; and the draft by LSRO staff contains false claims about Mercury Fillings. The result is all junk science; a whistleblower who has read the report calls it an unscientific document. Braveman’s secretly handpicking LSRO, through the straw person Betah Associates, violates the Federal Acquisition Regulation, requiring transparency and competition. See 48 CFR Parts 5 and 6. Even if not bid, negotiated contracts require competition, not handpicking one’s favorite Beltway Bandit. 48 CFR 15.002. Betah selected LSRO in a procedure that also violates the Federal Acquisition Regulations requiring approval under strict standards by the agency. 48 CFR 3.502. LSRO Contractor Betah and subcontractor LSRO then violated the kickback statute, 41 USC 51-58, because (according to fragmentary information released to us) LSRO got only 49% of the money while running the project. How much did everyone make? It’s a secret, according to NIDCR, who is hiding the cash aspects of the deal from a Freedom of Information Act request. Sir, we cannot even get our FOIA requests granted by NIDCR, so intent is Braveman and company to get this sham study completed. Norman Braveman is a phantom employee. His voice mail says (or said) he is at work only half time. Employees at NIDCR say he never returns phone calls. He put himself in the ethically-charged position of naming himself as a co-author of a study by his grantees. Was this a quid quo pro by the grantees to boost Braveman’s credentials? Or was Braveman taking time away from taxpayers business to immerse himself in the project? Either answer begs for an inquiry. We ask that NIH and NIDCR withhold approval of the LSRO so-called study. It was done in secret; it was fraught with conflicts of interest; and it is the fruits of the poisonous tree's illegal NIDCR-Betah-LSRO contract. In no way should the federal government accept the report as authentic. NIDCR views the report as a major step in its march toward covering up, forever, the health risks of Mercury Fillings. NIDCR and FDA’s Dental Devices section work closely together toward a goal of enacting a regulation that will prevent consumers from ever learning the known health risks of amalgam. Indeed, FDA won’t even stop the American Dental Association from deceptively promoting the device as “silver” fillings. The report is unrelated to any quest for the truth. It is part of NIDCR's agenda of protecting organized dentistry instead of protecting the children of America. If NIH and NIDCR proclaim this study as valid before checking into these serious allegations, it will show the recent attempts by Congress to clean up NIH has meant nothing. You cannot expect Director Tabak to be concerned about this problem. He presides over Braveman’s dysfunctional program of doling out millions of dollars to friendly pro-ADA dentists who either don’t or can’t finish their work, and who assuredly never seriously explore the damage Mercury is doing to the children of America. In the Children’s Mercury Experiment on Portuguese orphans – a project certain to be compared with the Tuskegee experiment in its absence of disclosures and the amount of toxic materials inserted into human bodies – the leaders are dentists who proclaimed at a public hearing at the start of the project that Mercury Fillings are safe. All other health professions and 100% of American scientists know the virulent toxicity of Mercury, while NIDCR keeps pretending Mercury in children’s bodies is safe. We ask you to demonstrate your continued concern to clean up the mess at NIH by forwarding this letter to the Inspector-General. Sincerely, Charles G. Brown cc-- Lawrence Tabak, DDS, Director, NIDCR – fax 301.402-2185 Chairman Barton Chairman Greenwood Chairman Burton Ranking Member Watson