From: BULLELKMAN@aol.com
Sent: Tuesday, February 22, 2005 1:49 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

      Subject:
     Director Servis -- Is your investigation of Tabak and the LSRO/BETAH contract a whitewash?
     
      Date:
     2/18/2005 1:33:39 PM Pacific Standard Time
     
      From:
     brownchas@erols.com
     
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            To:
           ServisS@mail.nih.gov
           
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           ZerhounE@mail.nih.gov, Rk25n@nih.gov, Tm77f@nih.gov, popeV@mail.nih.gov, BurklowJ@od.nih.gov, allenMa@od.nih.gov, kingtonr@od.nih.gov, kingtonr@mail.nih.gov
           
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Consumers for Dental Choice

1725 K St., N.W., Suite 511

Washington, DC 20006

Ph. 202.822-6307; fax 822-6309

www.toxicteeth.org

 

                                                                                                February 18, 2005

 

Suzanne J. Servis, Director, Office of Management Assessment

National Institutes of Health 

Rockville, MD  via e-mail and fax

 

Case 2004-99:  NIDCR, LSRO, BETAH

          Why are your investigators refusing to communicate with those 

                   who provided information adverse to NIDCR and Tabak?

 

Dear Director Servis:

 

            NIH Director Zerhouni wrote me in July announcing an investigation of the NIDCR/FDA contract with BETAH/LSRO.  I submitted an extensive report, and Director Zerhouni replied with a thank-you letter acknowledging this information.  I therefore assumed that your office would examine the information we sent, and, after reviewing it, would have questions about the allegations.

 

            As you are certainly aware, we have made five or more substantive submissions directly to you, containing specific allegations based on agency records and statements by NIDCR Director Lawrence Tabak  submissions totaling over 30 pages of single-spaced letters and 30 documents.   

  a.. Despite our submission of detailed information, not once have I been telephoned or written.  It raises the question of whether your office wants to ignore evidence incriminating to the high-ranking Lawrence Tabak, his staff, and his handpicked subcontractor. 
  b.. Furthermore, no one (to our knowledge) has contacted Congresswoman Watson or Congressman Burton, even though they wrote Tabak asking questions, and are most dissatisfied with his response. 
  c.. We are gravely concerned that this in-house investigation is really inside baseball, one where the views of NIH colleagues at NIDCR  Tabak, Braveman, Kleinman and Blevins  plus their handpicked contractors, are given a wide berth for their views, but ours are not being examined.
 

The contract process was corrupt from the outset:

 

      The contractor (BETAH) was plainly unqualified for this task; it is hard to see it any other way. BETAH specializes in arranging conferences  arranging vans, writing name IDs, setting up phones, etc.  but never had done anything like a scientific study.  Tabak falsely claimed, in a letter to Congresswoman Watson, that the contract provided for BETAH to do scientific studies.  Indeed, the conspirators were well aware they could not enlist BETAH except through a subterfuge -- they labeled the contract a conference, well knowing it is not.

 

 

      The subcontractor (LSRO) started out as the purported contractor.  After secret meetings between Tabaks assistant Braveman and LSROs Falk, the NIDCR/FDA pro-amalgam group drafted a contract  after asking Tabak for input on its terms   that provided a written blueprint of the desired result:  that mercury fillings are safe.  Only when Blevins noted there could be no such handpicking of a contractor, with no bid and no RFP, did Tabaks assistant enlist BETAH as strawperson.

 

      The panel, contrary to NIH policies, was directed to have no one with expertise in mercury fillings.  LSRO, with a history of picking a biased panel, repeated this pattern in this panel, and held closed meetings.  NIH promised the report would not be released until the investigation was over, but it was, based on connivance from NIDCR.

 

      Tabak covered up the violations by misleading Congress, stating falsely that BETAH had identified LSRO.   Later, he went on a media offensive, misleading the press by claiming the project was independent of NIDCR. 

 

All of the above allegations have been extensively documented in previous submissions.

 

Under Tabak, NIDCR has a history of letting contracts to colleagues with close ties to the pro-amalgam American Dental Association  with nothing to show for it but shearing the taxpayers of millions of dollars.  Tabak has close ties to organized dentistry, defends amalgam in public, and ensuring that contracts for amalgam studies are controlled by his dentist colleagues, not by independent toxicologists.   In addition to the LSRO-BETAH contract, your investigation needs to address this pattern of protectionism of amalgam of this dentist-run institute.

 

            Does your staff have written or oral questions for us -- or do you plan to ignore our information by paying attention only to the inside-the-agency viewpoint?

 

                                                                        Sincerely, 

                                                                        Charles G. Brown

                                                                        Counsel