From: BULLELKMAN@aol.com
Sent: Wednesday, December 15, 2004 1:30 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
Excerpt from Our Submission to Director Zerhouni, Aug. 16, 2004
************************************
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.
At the outset of the process, Tabaks assistant Braveman, Runner, one Dr. Lireka Joseph (now deceased), and one or two other persons formed a committee or task force to name the consultant for the study.  Exhibit F.  Tabak was kept apprised, e.g., through being ccd on e-mails.  On November 21, 2002, Braveman met with a representative of the tobacco consultant, LSRO.  Based in Bethesda, Maryland, LSRO s research activities in defense of tobacco companies made it the perfect candidate. On November 22, Braveman told LSRO to submit a proposal.  Exhibit H (bottom e-mail).
After huddling with LSRO, these government officials then wrote, or caused to be written, a second draft contract dated January 14, 2003, that calls for a Contractor to do the work instead of the government.  The agreement specifies meetings to be held with the Contractor at LSROs headquarters location in Bethesda.  Exhibit I.
Astonishingly, this draft plainly states the biased agenda of the parties drafting the contract: Their two previous literature reviews opined that amalgam is safe, and now we have handpicked you, LSRO, as the independent contractor to repeat the process and come up with the same results.  Reading that contract leaves little doubt about what conclusion these government officials wanted LSRO to reach. LSRO  which had performed so eloquently for the tobacco interests  was sub silentio directed to give amalgam a clean bill of health.
This end point, it would appear from the correspondence, LSRO understood well.  In an e-mail dated December 3, 2002, and addressed as Dear Norm (Braveman) and Lireka (Joseph), LSRO sent, in the words of the writer,[1] a pre-proposal.  Exhibit H.  In decidedly unscientific language, LSRO described the project as right down our alley.  In its own words, LSRO made clear they understood what the trick is to producing the kind of study these government officials desired.
Braveman apparently then passed this contract on to Tabak, Runner, and others, asking for comments.   On January 23, Braveman e-mailed them, saying he had reviewed their comments on the contract, rejecting some and including some.  Exhibit J.  In this memo, he made clear that the secret decision to hire LSRO had been made:
Lets keep in mind that this document is intended to be passed to our contracting people so that we can get a cost associated with whats been outlined.  It is definitive only in the sense that it is intended to outline in a broad way the activities that wed like to have the contractor handle.
These officials violated several sections of the Federal Acquisition Regulation (FAR): no request for proposal, no publication of a desire for a contractor, no competitive bidding, and no open negotiations.  Immediately after Director Feigal announced the need for a study in late November 2002, the contracting process focused solely on LSRO, and within a matter of weeks, the terms of the contract were being finalized.  By January 2003, Braveman and Runner, along with Tabak, had agreed to contract with LSRO.  The entire process was conducted in secret and, as shown below, kept secret from public scrutiny through an orchestrated series of deceptive acts and practices.
In the third draft, Exhibit K (January 23), Tabak, Runner, and associates made a major change in the terms.  They decided that they, the government, would determine what literature the independent panel would read, precluding the possibility that an inquisitive panel member might venture into uncharted territory (for NIDCR) and that the most up-to-date and thoroughly researched scientific evidence might inadvertently be considered.
The government will separately identify and define the initial scope of the literature to be reviewed, and will manage all logistic activities relating to expert panel members. 
A question naturally arises about what is meant by logistic activities within the context of scientific research.  And what criteria did the government intend to use to define the scope of the literature to be reviewed?  Would the criteria include the warnings resulting from major studies by the governments of Norway, Sweden, Canada, and Germany?  Or would these warnings and other scientific studies suggesting health risks to pregnant women and young children be minimized or ignored?  Between January 23 and May 1, despite repeated FOIA requests, Consumers for Dental Choice was denied access to e-mails, or other information that might have shed light on these questions by both NIDCR and FDA.  To date, we have received no e-mail responses from FDA at all.
Phase Two: BETAH Associates was enlisted as straw person contractor.
            In the fourth draft (February 23, 2003), LSRO remained the Contractor, but a new name suddenly appeared: BETAH Associates, Inc.  Exhibit L.  BETAH, also based in Bethesda, Maryland, has an existing three-year contract with NIDCR to do provide management and logistical services associated with running conferences.  Exhibit M.  None of BETAHs services are remotely related to scientific research, and nothing in the NIDCRs contract with BETAH pertains to scientific studies  an area in which BETAH has no qualifications whatsoever.  In this draft, BETAH is charged with submanaging logistic activities within the Governments responsibilities.
            In the fifth contract draft (March 21, 2003), Exhibit M, BETAHs responsibilities became separated from those of the Government.  Exhibit N.  LSRO was given 10 major delegated responsibilities, Betah just one peripheral responsibility.  But in the eyes of Tabak, Runner, and associates, BETAH had the one qualification that LSRO lacked: an existing NIDCR contract.
            Enter NIDCRs Marion Blevins.  Exhibit O.  As the contract officer, she was charged with putting the veneer of legality on the arrangement.  At this point (May 1), through a tortuous distortion of Dr. Feigals original order, the conference-planning support company BETAH became the Contractor designated to conduct the independent scientific review. On May 13 (Exhibit P), Blevins wrote an authorization for BETAH to hire LSRO as a subcontractor.
Phase Three: The conspirators erected a faade of legality to try to cover their tracks.
            BETAH Associates started as a non-participant, then took on an inconsequential role doing logistics, and finally was designated as the contractor. LSRO started as the contractor, then was shifted to subcontractor, although it was doing all the substantive work.  So LSRO was slipped in through the back door, while BETAH received a handsome payment in return for going along with the deal.
            Aware that public comment was supposed to be an important part of this study, and faced with the potential undoing of their scheme, Braveman and Blevins began to pressure BETAH to speed up the process  and get the contract finalized.  Exhibit Q, series of e-mails May 21 to June 4.
            On May 29, Braveman made clear to his co-conspirators that he would continue stonewalling requests for information until the contract was completed.  Exhibit R.  In an e-mail titled Charlie Brown (presumably referencing the counsel for Consumers for Dental Choice, the undersigned), he referred to an attached letter he had written to Brown (not released under FOIA), but which he would hold . . .
until all of the is are dotted and ts crossed in the contract between [sic] LSRO.  I cant send it until we know for sure that everything is ok with the contract.  Ill let you know when that happens.
            One more step remained  to shoehorn the work of LSRO into BETAHs existing contract.  Through utterly shameless verbal manipulation, the language of the approved contract named the conference-planning company BETAH as the contractor to conduct a study on the critical issue of potential health risks from exposure to mercury in dental amalgam.  To complete the fabrication, the contract said that BETAH, not the government, identified LSRO as a subcontractor, and described LSROs independent scientific study as a conference.
By means of this obviously deceptive mechanism, BETAH was awarded the NIDCR contract.  Neither before   nor after  is this work characterized as a conference.  LSROs activities became a conference only momentarily, in the rigged language of a sham contract designed to mislead the public and produce predetermined results in the guise of an independent scientific study.
            Tabak, his assistant Braveman, Runner, et al., conspired to create the appearance of engaging an existing contractor already doing similar work.   In a cynical distortion of government contracting regulations, they identified LSRO as a safe consultant whose track record indicated a willingness to deliver findings consistent with the agenda of the client, drafted a contract of duties, then found an existing contractor  one doing totally unrelated work  on which to piggyback the deal.  This Byzantine scenario shows, prima facie, that Tabak, Runner, et al., consciously took a carefully scripted set of steps to corrupt the bidding process in order to handpick LSRO as a compliant consultant.
As government officials at agencies that regulate or study the potential benefit or harm of a variety of products, these officials abused their responsibilities by sabotaging the order of FDA Center Director Feigal to conduct an independent study of the literature on health risks associated with mercury in amalgam fillings.
            They embarked on a conspiracy to (1) handpick a tobacco industry consultant experienced in using scientific verbiage to create a veneer of authenticity, (2) enlist an existing contractor as straw person to hire that consultant as subcontractor; and (3) erect a faade of paper legality in an effort to cover their tracks in the first and second steps.  Meanwhile, (4) they worked to keep their activities secret from the public and from consumer advocates.
Phase Four: LSRO proceeded, predictably, toward the delivery of a biased, unscientific product
The study  or what the BETAH contract with NIDCR defined as a conference  proceeded predictably.  It turned out to be neither a study nor a conference. LSRO conducted its independent study from start to finish in the most unscientific manner imaginable.  Not one panelist had expertise or even substantial experience in researching mercury-based dental amalgam products.  From the outset, one participant was openly dismissive of risks related to mercury.  He went so far as to air his views in a published article and sat for a major newspaper interview.[2]
            In June 2004, LSRO sent the draft to outside reviewers, one of whom had appeared as its chief witness in favor of amalgam fillings.  At this point, another reviewer who recognized the need to play the role of whistleblower, alerted Consumers for Dental Choice about a host of irregularities and omissions in LSROs conduct of its independent study: no mention of major international studies on new evidence of health risks associated with amalgam, deceptions and mischaracterizations of the literature, an unscientific report with results plainly predetermined  in short, findings that simply echo the positions advocated by organizations that have a financial stake and/or  a vested interest in amalgam.
            For example, the report claims that the government of Canada has no problems with mercury amalgam fillings, when the opposite is true.  That government advised every dentist in the country in 1996, via a personal letter, not to place mercury-based fillings in children, pregnant women, or people with kidney problems.
            During the last week of June, Michael Falk, chief executive officer of LSRO, advised Consumers for Dental Choice that LSRO would complete its work by June 30 and turn the work over to the government.  We have attempted to find out if this has occurred, but have received no replies to repeated requests.
--------------------------------------------------------------------------------
[1] LSRO Inc.s principal is never identified.  In an artful decision of dubious legality, his name was redacted every time.
[2] Dr. Robert Brent, a member of the panel, told The New York Times on July 13, 2004, that parents should stop worrying about environmental toxins like mercury.  With his public position so clear, it is obvious Dr. Brent is an advocate of Mercury fillings.