From: BULLELKMAN@aol.com
Sent: Wednesday, December 15, 2004 1:32 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

 

Case #2004-99: Fourth submission to OMA Director Servis:

 

Admission by LSRO of BETAHs Irrelevancy = Prima Facie Evidence that Latter Is Strawperson

 

I.  Admission by LSRO:  Contractor is Irrelevant
            In its pell-mell effort to release its bogus report on mercury fillings while still under investigation, consultant LSRO made a serious admission against interest.

 

            In its news release, LSRO said it prepared its report at the request of the Trans-Agency Working Group on the Health Effects of Dental Amalgam.[1]  Four paragraphs later, LSRO claims it was tasked to do the report.  Taken together, LSRO is asking the press to infer that it was LSRO whom NIDCR contracted with.  Indeed, that is exactly what the Atlanta Journal-Constitution and San Diego Union Tribune reported:  LSRO conducted the research on behalf of the National Institute of Dental and Craniofacial Research.

 

            But a key name is missing entirely from the news release:  the contractor!  BETAH Associates is the contractor, not LSRO.   LSRO is merely the subcontractor, which by law would require it be hired solely by the contractor and to work under the latters direction.  But BETAH, being a qualified conference coordinator but unqualified to do scientific studies, is in no position to field press calls about science.  Plainly, LSRO -- and no doubt BETAH too -- dont want the press to know that BETAH was involved, and risk exposure that the contractor lacked credentials to do the study.

 

            BETAH was hired by NIDCR to coordinate conferences, and we have no doubt they do a fine job setting up phones, getting the vans, printing ID cards, and greeting participants.  But BETAH lacks expertise to run a scientific study.  And who -- by omitting their name entirely from the press release about the study  now concedes that contractor BETAH is irrelevant?  None other than LSRO, the subcontractor.

 

            To qualify, BETAH used the legerdemain of pretending this entire event was just another conference.  It prepared a contract substituting the word conference for study  making a claim about the work that all conspirators well knew was patently false.  See Exhibit S of our submission of evidence.

 

            BETAH Associates, while qualified to set up a conference, is absolutely unqualified to be the contractor for a scientific study.  So LSRO hid its1very existence from the public.

II. Tabaks Dilemma:  the Law OR the Facts

            When responding to Congress, and when responding to the investigators, Lawrence Tabak has a dilemma.  Does he explain the facts truthfully  showing a violation of law  or does he change the facts to try to show compliance with the law?  

 

            Heres the irony:  while LSRO is conceding that it (not BETAH) is the principal, Dr. Tabak is doing the opposite.  To Congress, he assiduously claimed that BETAH was hired as contractor first, and then, he wrote Congresswoman Watson, claimed BETAH identified LSRO to be subcontractor.  

 

Tabak knows that the only way he can stay out of legal trouble is to claim that BETAH came first, was a bona fide contractor qualified to do this project, identified LSRO, and hired LSRO for assistance.  The trouble with Tabaks story: the facts are otherwise.  On August 16, and again on October 26, we submitted a major work product with over 20 exhibits, making clear that Tabak knew that Braveman was negotiating with LSRO for months before BETAH entered the picture. 

 

            Because their goals have temporarily diverged, the targets of this investigation are now unmasked.  The subcontractor must represent itself as the principal in order to keep BETAH away from the press.  The NIDCR director, on the other hand, needs to stop further investigating by Congress and get NIH Case No. 2004-99 over quickly, so he must create facts to shoehorn the contract into a faade of legality.  For Tabak, then, BETAH emerges, like Phoenix, as the principal.

 

  a.. LSRO Inc.
LSSO wants to convince the press and public that it, LSRO, did it all, and that BETAH is therefore irrelevant.  This claim is factually true, but means the contract violates the law -- there was no competitive bid or RFP, NIDCR chose their consultant to do the study and negotiated a contract, then NIDCR had to backtrack and corral in an unqualified consultant simply because it was available (having an existing, unrelated contract), then the parties pretended its all a conference.  In addition to violating FAR and HHSs own regulations, the federal kickback statute is being violated:  the contractor is getting paid for being available, while the essence of the work is being done by the subcontractor designated by NIDCR.  All this is coming unwound because LSRO now admits to the irrelevance of BETAH.

 

  a.. Lawrence Tabak 
To protect his position as NIDCR Director, Tabak needs to convince Congress and the Investigators of the opposite:  that BETAH is the substantive contractor, and that BETAH identified LSRO.  His smooth letter to the House Subcommittee makes that claim.  But the FOIAd records make clear that Braveman was negotiating with LSRO for months, through several draft contracts  and ccing Tabak and Kleinman of NIDCR, and Runner of FDA  before anyone thought to consider legal requirements.  Then, after Blevins examined their work, they inserted BETAH as, quote, contractor, unquote, for a quote, conference, unquote.  Tabak testified deceptively:  NIDCR  not BETAH -- identified and chose LSRO.

 

Why did this pro-organized dentistry group bend every rule to engage LSRO?  LSRO, a favorite of Big Tobacco, has a history of bringing in biased panelists and taking the side of the funding entity.   This group knew an INDEPENDENT study of the literature would show health risks associated with mercury fillings, a point almost every government but ours already accepts.  But this would unmask their decade of kowtowing to organized dentistry and deceiving the American public.  So they brought in LSRO.  To be sure, they (1) wrote out, in the early drafts of the contract, the result they wanted; and (2) insisted that no panelists have any experience researching mercury fillings (Braveman in an e-mail joked about the latter move).  To no ones surprise, the pliant LSRO eagerly provided that very result, at times even verbatim.

 

            Attached is an excerpt from our submission of August 16, showing the four phases of this conspiracy to deceive the American public and assault the integrity of the National Institutes of Health:

      Phase One: With no competitive bidding, no request for proposal, and no public notice, NIDCR and FDA officials secretly chose a consultant with ties to the tobacco industry. 

      Phase Two: BETAH Associates was enlisted as straw person contractor.

      Phase Three: The conspirators erected a faade of legality to try to cover their tracks.

      Phase Four: LSRO proceeded, predictably, toward the delivery of a biased, unscientific product.[2]

 

Charles G. Brown

December 13, 2004

 

 

Attachments:

-- LSROs News release.  We ask that it become our Exhibit CC.

 

-- Inquiry to decide if research contract awarded properly, San Diego Union Tribune, December 10, 2004.  We ask that it become our Exhibit DD.

 

-- Excerpts from submission of August 16 to NIH:  Re:  NIHs investigation of the NIDCR/FDA contract with LSRO/BETAH to conduct an independent scientific study of the literature on mercury amalgam fillings.

 

-- List of Sixteen Issues for Case No. 2004-99  (Issues are analyzed in our submission of October 26).  We ask that this list become our Exhibit EE.

 

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[1] A body dominated by dentists inside government with close ties to organized dentistry, people who use their positions to promote the agenda of the pro-mercury American Dental Association.  The group has a decade-long record of distributing misleading and unscientific materials on mercury amalgam.

[2] The Exhibits referenced therein can be found as attachments to both our submission of August 16, and to our submission of October 25 providing the 16 Issues that need to be examined in this investigation.