From: BULLELKMAN@aol.com
Sent: Thursday, July 29, 2004 12:59 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 16, 2003

            

Marian Blevins, Contracting Officer,  Via fax, 301.480-8308

Norman S. Braveman, Ph.D., Assistant to the Director,  Via e-mail, and fax 301.480-0964

National Institute of Dental and Craniofacial Research

 

Re:  Protest noncompetitive bid on mercury fillings
 

Dear Ms. Blevins and Dr. Braveman:

 

We object to the noncompetitive, secretive, sweetheart consulting subcontract on mercury fillings that Dr. Braveman is trying to hoist on the taxpayers.  We ask you to cease at once from signing it, or if you have signed it, to repudiate it.

 

The issue of mercury dental fillings is now one of intense controversy and extreme public importance and urgency.  The health risks posed by material that is half mercury, and which constantly emits toxic mercury vapors, is drastically in need of attention from federal regulators, who have ducked the issue for three decades.[1]  To his credit, Dr. David Feigal, the Director of the FDAs Center of Devices, promised an independent review of the scientific literature on mercury fillings, untrammeled by previous agency pronouncements.

 

Instead of doing an independent review, (1) you did not bid the contract; (2) you sought out a contractor who does unrelated work for NIDCR; (3) you created an entirely new task for that contractor, knowing it must pick a subcontractor; (4) you manipulated a subcontract through that contractor; (5) you then picked your favored party.  When I asked each of you for an explanation, Dr. Braveman would not return my phone call,[2]  and Ms. Blevins refused to answer, stating I must put the question in writing.  The favored contractor plans no public hearings, and intends to exclude from the reviewing panel those experienced researchers who have found that mercury fillings are not safe.[3]  

 

By picking the contractor secretly and in violation of federal bidding laws, you are sabotaging Dr. Feigals efforts.  The favored party you chose has numerous corporate clients with business before federal regulators, such as Philip Morris.  Based on NIDCRs pro-mercury fillings record, it appears you sought out a contractor who will maintain the agencys agenda.  Keep America smoking.  Keep America using mercury fillings.

 

[1] Federal inaction allows the American Dental Association to sign promotional contracts with mercury manufacturers, then advertise the fillings under the deceptive term silver.

[1] NIDCR employees confirm you, Dr. Braveman, do not return phone calls and are generally inaccessible.  Your voice mail indicates you are only in your office half the time.  You did not respond to a written inquiry whether you are a full-time or a half-time government employee.

[1] In addition to handpicking the consultant, you are involving only those agencies that have long supported mercury fillings -- thus excluding EPA, National Academy of Sciences, and the Agency for Toxic Substances and Disease Registry.

 

NIDCR has an abysmal and outrageous record of shoveling taxpayers money to contractors to pretend to study mercury fillings.  In the past 30 years, NIDCR has awarded grants for 543 contracts for research on the safety and effectiveness of mercury amalgam dental fillings.  It has published one (1!) peer-reviewed study in the past ten years. NIDCR would rather reward amalgam friendly contractors and pretend to study the issue rather than learn if mercury fillings are safe.[4]  A federal or Congressional inquiry into your general contracting practices is clearly due.

 

            We hereby protest this sweetheart deal.  We will not stand by idly while, once again, NIDCR protects the American Dental Association instead of the American people.  Dr. Braveman, your efforts to manipulate bidding statutes are clever, but will not succeed.

 

            We ask you to provide us a copy of the draft of this proposed noncompetitive subcontract immediately.  Our fax number is 202.822-6309.

 

We are filing a complaint with (1) the Department of Justice via the United States Attorney for the District of Maryland, and (2) the Burton subcommittee on Capitol Hill.  It is time that NIDCR complies with the laws requiring open and competitive bidding, operates in the sunshine, and starts doing unbiased research about mercury fillings instead of furtively paralleling the pro-mercury agenda of organized dentistry.

 

                                                                                    Sincerely,

 

 

 

                                                                                    Charles G. Brown

 

ccThe Honorable Dan Burton, Chair, and the Honorable Diane Watson, Ranking Member, U.S. House Subcommittee on Wellness and Human Rights

ccThe Honorable Frank Lautenberg, United States Senate

ccU.S. House Commerce Committee: Alan Slobodin

ccThe Honorable Thomas M. DiBiagio- United States Attorney, District of Maryland

ccGeneral counsel for NIH and NIDCR

ccDr. David Feigal and Dr. Lee Joseph, FDA 

 

 

[1] For example, Dr. Braveman is also project director of the ill-fated Portugal and Boston study, which involves putting large quantities of mercury into the mouths of Portuguese orphans and U.S. Hispanic, African-American, and poor white children (referred to in NIDCRs research data base as Childrens amalgam studies).  The two leaders of the Portugal study are dentists from Seattle who, two years ago, appeared at a public government hearing along side the ADA to proclaim their support for mercury fillings.   This study by the biased dentists (a toxicologist has his name on the study but tells us he has only a minor role in it) will no doubt conclude to ratify what the dentists already have lobbied for in Washington state; and, will no doubt lead to more requests by NIDCR for research grants.  But of course researchers will not place large amounts of mercury into white middle-class American children.  Experimenting on Portuguese orphans and Americas racial minorities is acceptable to keep organized dentistrys financial bandwagon rolling along.



--------------------------------------------------------------------------------

[1] Federal inaction allows the American Dental Association to sign promotional contracts with mercury manufacturers, then advertise the fillings under the deceptive term silver.

[2] NIDCR employees confirm you, Dr. Braveman, do not return phone calls and are generally inaccessible.  Your voice mail indicates you are only in your office half the time.  You did not respond to a written inquiry whether you are a full-time or a half-time government employee.

[3] In addition to handpicking the consultant, you are involving only those agencies that have long supported mercury fillings -- thus excluding EPA, National Academy of Sciences, and the Agency for Toxic Substances and Disease Registry.

[4] For example, Dr. Braveman is also project director of the ill-fated Portugal and Boston study, which involves putting large quantities of mercury into the mouths of Portuguese orphans and U.S. Hispanic, African-American, and poor white children (referred to in NIDCRs research data base as Childrens amalgam studies).  The two leaders of the Portugal study are dentists from Seattle who, two years ago, appeared at a public government hearing along side the ADA to proclaim their support for mercury fillings.   This study by the biased dentists (a toxicologist has his name on the study but tells us he has only a minor role in it) will no doubt conclude to ratify what the dentists already have lobbied for in Washington state; and, will no doubt lead to more requests by NIDCR for research grants.  But of course researchers will not place large amounts of mercury into white middle-class American children.  Experimenting on Portuguese orphans and Americas racial minorities is acceptable to keep organized dentistrys financial bandwagon rolling along.