From: BULLELKMAN@aol.com
Sent: Tuesday, February 22, 2005 1:53 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





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 16, 2005

Norka Ruiz Bravo, Ph.D.
Deputy Director for Extramural Research

National Institutes of Health

 

Re:  Case No. 2004-99:  Investigation of NIDCR contract with LSRO/BETAH:  Objection to your letter exonerating NIDCR while independent investigation is ongoing.

 

Dear Dr. Ruiz Brava:

 

            Your letter to a member of the public concerning wrongdoing in NIDCRs mercury fillings contract to BETAH/LSRO, peculiarly, spends two pages exonerating

NIDCR from wrongdoing, then in the last paragraph notes that NIH is conducting an independent investigation of NIDCR.  You went so far as to make following claim:  NIDCR-supported research grants and contracts go through the same rigorous peer review as those awarded by other NIH components.  This claim is not only unsupportable; it is incorrect.

 

            Doctor, you have been receiving false and misleading information from Lawrence Tabak and NIDCR  but you are not alone.  Last summer, Tabak wrote Chairman Dan Burton and Congresswoman Diane Watson a letter covering up the fact that it was his own assistant who handpicked the contractor to do the mercury fillings study.  (The assistant kept Tabak in the loop by ccing him on the e-mails.)  Tabak falsely stated that the strawperson contractor, BETAH, identified subcontractor LSRO, when he well knew (1) it was his assistant Braveman who identified LSRO, and (2) NIDCR initially wanted LSRO to be the contractor, even drafting a contract with LSRO, long before BETAH got involved.  BETAH was identified and drafted in months later, after someone at NIDCR decided this was a way to sneak in LSRO.  BETAH was totally unqualified for the mercury fillings study:  it is a conference coordinator with no expertise whatsoever to do a scientific study, but conveniently was there to take money for playing a pass-through role for Tabaks choice, tobacco consultant LSRO.  

 

We are disappointed you would take a conclusions first, facts later, position re Tabak, NIDCR, and Case No. 2004-99.  When high-ranking officials mount a public defense of NIDCR before the facts are in, we have grounds to fear that the independence and integrity of the allegedly independent investigation of Case No. 2004-99 is being compromised.  NIH must not whitewash Tabak  who subverted the bidding process to protect the American Dental Associations pro-mercury fillings policies.  His deal with LSRO-BETAH is probably the tip of the iceberg, as he doles out contracts putting dentists in charge of studies which should be run by toxicologists, and specifically dentists with demonstrably close ties (as he has) to organized dentistry and its pro-mercury amalgam position.

 

You may have seen the recent news about the investigation of mercury policies at EPA, where that agencys Inspector-General concluded that the agency put politics ahead of science.  Regarding mercury in dental fillings, so did Lawrence Tabak.  Senator Lautenberg charges that an inherent conflict of interest exists when a dentist-run institute examines the material heartily endorsed by the ADA.  As the Senator further notes, dentists are the wrong profession to be in charge of the studies.  The issue is not how the fillings fit, but whether they harm the brain.  Those in charge should be toxicologists and physicians  and not toxicologists handpicked by the dentists to whom Tabak awards millions of dollars.

 

            For the LSRO/BETAH deal, the facts show, prima facie, a concerted effort to violate the competitive bidding laws, steerage of the result to ratify NIDCRs pro-amalgam position, and a cover up of wrongdoing in communications to Congress.

 

1)      The contractor was plainly unqualified.  Read BETAHs web site.  They set up conferences for NIH  get vans, write nametags, set up phones.  They have never run a scientific study, nor could they.

 

2)      In a letter to Chairman Burton and Congresswoman Watson, Director Tabak claimed the work was within the scope of the BETAHs contract.  The existing contract permits no such legerdemain.

 

3)      Subcontractor LSRO, a consultant for Big Tobacco, was handpicked by Tabaks top staff  and was initially scheduled to be the contractor -- rather than the legal way of doing it.  Braveman and LSROs Falk had meetings, and then NIDCR drew up a draft contract.  It was only later, when Blevins showed they couldnt simply contract with whom they please, that they started a second level of their wrongdoing  to cover up their plan to handpick LSRO.

 

4)      Tabaks staff laid out, in advance, the results they wanted from LSRO.   Braveman and dentists at FDA (Runner) and NIDCR (Kleinman) handed LSRO a blueprint saying mercury fillings are safe.  Then removing that evidence, the deleted the desired result from the final contract  so LSRO knew what was wanted but the auditors would not see it.  

 

5)      Tabak falsely told Congress that contractor BETAH identified subcontractor LSRO -- when in fact Tabaks staff picked the subcontractor, then shoehorned in unqualified BETAH to be contractor.  Tabak was ccd on this process by Braveman.  Perhaps Dr. Tabak feels he has no duty to provide truthful and nondeceptive testimony to Congress.  

 

6)      Tabaks staff insisted on panelists with no experience with mercury  the opposite of whom should be such a panel.  (It is important to emphasize, as we have on numerous occasions, that this was no Advisory Committee, something FDA must create before proceeding further.)

 

7)      NIH promised the report would not be released during the pendency of the investigation.  We have evidence that NIDCR provided a green light -- probably in violation of Director Zerhounis instructions  to release the report prematurely.

 

At this point, only the Inspector-General can conduct the kind of impartial and thorough investigation needed for this level of wrongdoing.   We ask you and Director Zerhouni to make such a request to the I-G.  We ask you, too, to reconsider your views that Tabak uses rigorous peer review, unless you mean like-minded ADA dentists sitting down together with him to ratify the ADA economic position.  (The ADA seal of acceptance is a pay-to-play scheme with manufacturers; the ADA agrees to promote mercury fillings without ever testing them for safety.)  The NIDCR and ADA positions on amalgam are identical even in their choice of terminology.

 

Lawrence Tabak and his staff handpicked a tobacco consultant without a bid or an RFP, conspired to violate the Federal Acquisition Regulation by hiring a strawperson contractor, hid it from the public, and engineered the result they wanted and that his organized dentistry colleagues insists on.  Then, via his letters to Congress and his own proclamation to the media, he covered it up.

 

The question now is whether NIH will join the cover-up  or let the chips fall where they may.

 

Sincerely,

 

 

 

Charles G. Brown, Counsel

 

cc:        Elias Zerhouni, Director

Suzanne J. Servis, Director, Office of Management Assessment, NIH

Office of Inspector-General, HHS

 

Attachments:  your e-mail to Mr. Levy; Sixteen Issues For Case No. 2004-99; our letter to Director Zerhouni; letter from Senator Lautenberg