Summary of 16 issues related to violations of Federal contracting regulations or inherent conflicts of interest in the NIDCR contract with LSRO and BETAH Associates.
— Issue #1: Did NIDCR officials Lawrence Tabak, Norman Braveman, and Marion Blevins attempt to circumvent the competitive bidding laws?
Instead of doing an RFP, considering bids, or even having open negotiations, Tabak’s assistant Braveman met secretly with LSRO, drafted a contract, and exchanged e-mails with Tabak, Runner, and others about what changes were needed to seal the deal. The process was kept so secret that the principals even circulated e-mails to ensure no one responded to ongoing inquiries about the process from this organization, Consumers for Dental Choice – to whom Dr. Feigal of FDA had promised an open process with substantial public input. After contracting specialist Blevins entered the picture, NIDCR decided to bring in strawperson contractor BETAH – a conference planning company not qualified to do scientific studies, but possessor of an existing NIH contract – to act as the “contractor,” while LSRO, the principal, was shoehorned in as “subcontractor.” (It should not go unnoticed that BETAH is a company dependent on NIDCR for current and future conference-related contracts.)
— Issue #2: Did Tabak, Braveman, and Blevins generally engage in activities designed to cover up their violations by creating a façade of legality?
After trying to hire LSRO directly as contractor, then apparently being informed that it was illegal to hire a contractor without a bid, Tabak, Braveman, and Blevins enlisted strawperson contractor BETAH, a company totally unqualified to conduct the study, with sub silentio instructions to BETAH to enlist LSRO as “subcontractor.” As BETAH’s existing contract was limited to providing support services (electrical hookups, nametags, leasing vehicles, etc.) for NIH conferences, the group falsely and deceptively concocted contract language to pass this major scientific study off as a “conference.”
— Issue #3: Did Tabak, Braveman, and FDA’s Runner put together an “outcome biased” study?
At the outset, NIDCR designated the result they wanted – right in the draft contract! They defined amalgam by listing mercury as the seventh [!} element in the mixture, when in fact mercury is 50% of amalgam, by far the dominant element. They stated that their governmental in-house review in 1993 gave amalgam a totally clean bill of health – it was “inappropriate to restrict the use of dental amalgam,” then claimed, falsely, that the World Health Organization “reaffirmed this conclusion” in 1997. (Although a rogue dentist-dominated committee of W.H.O. once supported amalgam use, the organization’s position is that there is no safe level of mercury; NIDCR leaders know or should know this.) This blueprint stayed in the contract until the next-to-final draft, when it was adroitly removed, presumably so the casual reviewer would never know about it. NIDCR handpicked LSRO – a company with a history of selecting panels favorable to special interests (e.g., tobacco companies, health-food supplement producers, baby formula manufacturers) – and even allowed LSRO to make a “pre-proposal” (meaning the contractor was advising the government on the terms rather than the legal way to do it). NIDCR insured that the panel would not operate independently – drafts of the contract (again, cleverly removed at the end) had NIDCR selecting the literature to be reviewed and the speakers for the opening hearing. NIDCR insisted that zero panelists have experience researching mercury amalgam – Braveman belittled such a request from Consumers for Dental Choice in an e-mail to the others. Indeed, control was so tight that Braveman e-mailed the cabal that the panel should do nothing until it had been “oriented.” Marching in lockstep with NIDCR’s blueprint and following a strategy it had used in the past, LSRO brought in as chief witness and as a key panel member an outspoken apologist for mercury-based products, and packed the panel with people with absolutely no experience doing research on amalgam.
— Issue #4: Did Director Tabak provide false or deceptive testimony to Congress about the LSRO/BETAH deal?
In his letter to Congresswoman Watson, Tabak falsely claimed that BETAH “identified” LSRO for NIDCR. In reality, Tabak’s assistant Braveman had been meeting with LSRO for weeks and had drawn up several draft contracts, advising Tabak via e-mail of these developments. Only later was strawperson BETAH enlisted to circumvent competitive bidding rules. Tabak made three other false claims in that letter: that BETAH used criteria to select LSRO (in fact LSRO has been selected by the Braveman team months before BETAH was contacted); that “the methodology and approach used, including the number of meetings held, … were in no way dictated or influenced by the government” (in fact, the draft contract did list the number of meetings, and stated the government would determine the initial literature to be used and the types of research to be examined); and the government “stay[ed] at arm’s length from the process and those involved” (a laughable claim for anyone reading the barrage of e-mails between LSRO’s Falk and NIDCR’s Braveman).
— Issue #5: Did NIDCR take over what was really an FDA project?
David Feigal, Director of FDA’s Center on Devices (since retired), announced the project in October 2002. He announced to a Congressional hearing that the project would be FDA’s, and promised Consumers for Dental Choice in a letter that, “[i]n this reassessment, we will employ a broad array of experts from across government and the outside scientific community.” Feigal’s promise was sabotaged. No broad array of experts on mercury amalgam were put on this panel; indeed, not one. NIDCR’s Braveman became chair of the committee and effectively took control away from FDA.
— Issue #6: Did Braveman – along with Runner, “subcontractor” LSRO, and “contractor” BETAH – shut interested citizens and consumer groups out of the process, despite assurances to the contrary?
Braveman sent an e-mail indicating his intention to block all information to “Charlie Brown” (the undersigned), who was filing FOIA requests in an attempt to find out what was going on. The panel was picked with no public input — another promise of Feigal’s broken. Despite assurances of transparency, there was virtually none: LSRO’s Falk barred the public from all but one-half of one meeting.
— Issue #7: Did BETAH willingly accept its role as the strawperson contractor, in light of its lack of expertise to do scientific studies, or was it pressured into going along with the scheme out of fear of losing other NIH business?
BETAH – whose expertise is conferences, not scientific studies – should never have accepted this contract. BETAH saw the drafts unfold and understood that it was “contractor’ in name only, with only one significant duty: to provide the appearance of legality by pretending to be the “contractor” and to “hire” LSRO as a “subcontractor.” In BETAH’s defense, it is clear that Braveman and Blevins put intense pressure on BETAH to participate. A series of e-mails on June 3, 2003, may be instructive. BETAH was hesitating, perhaps for legal reasons, to agree to the contract, so LSRO’s Falk says to Braveman, “I wouldn’t blame you [for] pushing [BETAH].” Braveman then e-mails BETAH at 10:24 pm in language that can only be interpreted as strong-arming: “We … need to know that there is a subcontract between you and LSRO in place.” After noting that BETAH had had a proposed contract from LSRO for two weeks, he requested, redundantly, that BETAH “expedite the processing of this as quickly as possible.” The law says contractors – not government officials — decide with whom contractors subcontract, with the government’s role limited to approval or disapproval.
— Issue #8: Did the participants misrepresent the contract as a “conference” instead of a “study”?
Here we see primary evidence of a conspiracy by NIDCR officials to represent the contract as something it was not, in order to pretend that NIDCR was simply appending a new duty to BETAH’s existing activities.
— Issue #9: Did LSRO secretly negotiate a contract, even though it was neither an existing contractor, nor a sole source supplier, nor the winner of a competitive bid?
Since LSRO has had numerous government contracts, the company is certainly aware of the Federal Acquisition Regulation. Yet LSRO had numerous meetings with Braveman, never bid for the job, responded favorably to draft contracts with it as the contractor, and was integral to the illegal “handoff” of the contract to BETAH, with the clear understanding that LSRO, although nominally the “subcontractor,” was the real party of interest.
— Issue #10: Did LSRO conduct an “independent” scientific inquiry?
LSRO picked a panel without a single scientist who had done research on amalgam fillings. One panelist, Dr. Brent, is an outspoken advocate of the position that parents should stop being concerned about environmental toxins, as their effect is de minimis. LSRO hired Dr. Thomas Clarkson – a well-known pro-amalgam advocate – to perform dual, and conflicting, roles. Clarkson was designated both as chief witness of the last hearing and as outside reviewer, being allowed therefore “independently” to review his own testimony!
— Issue #11: Were the violations at the low level or did they involve higher-ups?
The violations were at the very top level of NIDCR. Director Tabak was cc’d on e-mails from the start, and his assistant Braveman chaired the process.
— Issue #12: Were the violations inadvertent or intentional?
Failing to bid, failing to write RFPs, providing a written blueprint of the desired result, providing false scientific claims in that blueprint, shoehorning in an unqualified existing contractor as strawperson, calling the study a “conference” in order to get that contractor into the process, providing false and misleading information to Congress about how LSRO was identified – these are the marks of a conscious and concerted effort to award an illegal contract to a compliant consultant. As with any investigation, the question of motive looms: why go out and recruit a favored company to do the work instead of bidding it, and why risk violating the law by covering it up by layering on an unqualified additional consultant? And why deceive Congress about it all? The motivation, we suggest, goes to the heart of what NIDCR has been doing for years: Protecting mercury amalgam on behalf of organized dentistry instead of doing objective and diligent scientific studies. Accordingly, it is both relevant and timely to address four further issues about the way Tabak has run NIDCR and the way Braveman has run the contracts.
— Issue 13: Is NIDCR engaged in a pattern of paying dentists to conduct sham studies on amalgam that rarely, if ever, get completed or published? How many millions of dollars have been wasted in the process?
According to its own web site, NIDCR has authorized over 200 studies of amalgam over decades; only one has been published. Commonly, those receiving grant money for NIDCR research on amalgam are acknowledged pro-amalgam dentists who are not qualified to measure the influence of exposure to toxic materials on the whole body. The two main recipients of the multimillion-dollar Portuguese orphan experiment, DeRouen and Martin at the University of Washington, testified at a public hearing that mercury fillings are safe BEFORE they had examined the data. Neither is a toxicologist; the only toxicologist employed in the project admits to a de minimis role. Critics such as Senator Lautenberg estimate that NIDCR has wasted more than $30 million on what amounts to pseudo-scientific amalgam research – with virtually nothing to show for it.
— Issue 14: Is NIDCR contracting with dentists and failing to provide proper disclosure of risks in its mercury experiments in other studies, e.g., on Portuguese orphans and low-income American children?
In the most expensive (i.e., most lucrative for NIDCR grantees), proper disclosure of health risks of exposure to mercury is being withheld from the parents of minority children in Boston and the rural white children in Maine, while the children are given “candy money” to keep coming in. No disclosure of even the presence of mercury is given to the Portuguese orphans, the site of a sensational child pedophile scandal that alone should have caused the project to be canceled.
— Issue #15: Is having NIDCR contract with dentists to do “independent” studies of amalgam an inherent conflict of interest, as critics such as Senator Lautenberg maintain? Or does it create, at a minimum, the appearance of a conflict of interest?
The American Dental Association endorses mercury amalgam and has long-standing financial contracts with amalgam manufacturers. Because the amalgam manufacturers pay the ADA under these contracts, no one can seriously suggest the ADA is neutral on this issue. With their trade association declaring the product to be “safe and effective,” people with professional ties to organized dentistry cannot objectively address this issue. At a minimum, the dentists involved in NIH’s “independent” studies cannot claim that they are unfettered by private interests.
— Issue #16: Is having dentists – instead of toxicologists – in charge of NIH studies to determine the toxicological effects of mercury on the neurological system and body organs an imprudent misuse of taxpayer-funded research?
Dentists are trained to address oral health, not the impact of a powerful toxin on the nervous system or other parts of the human body. To the extent that they have such knowledge, it pales in significance to that of toxicologists or physicians. Thus – in an issue raised emphatically by Senator Lautenberg in a letter dated October 20 to Director Zerhouni — it is essential that studies be run not by dentists but by toxicologists, and that the grant-giver not be NIDCR or any Institute that is so heavily influenced by pro-amalgam interests. II.
EVIDENCE for the 16 ISSUES PRESENTED
The evidence presented here is culled from replies we received from NIDCR, FDA’s Center on Devices, and publicly available sources of information. Despite a plethora of Freedom of Information Act requests and follow-ups, we received limited and heavily edited information from the files of the government officials. It is probable that we received nothing from the files of Lawrence Tabak, Susan Runner, or DeShandra Kleinman. And of course we received nothing from private contractors LSRO and BETAH, whose files would be closed to us, but not to NIH investigators.
Yet even this fragmentary response presents a compelling case of contract law violations, a cover up involving several key officials, an orchestrated program to ratify the pro- amalgam position of NIDCR, all the time promoting this sham project as an “independent” study by “qualified experts.”
The stakes of your contract review are enormous, for three reasons.
First, NIDCR continues to claim that a product that is 50% mercury is safe, even for children and pregnant women, despite overall NIH policy – and 100% scientific consensus – that mercury causes significant neurological damages (NIH even has a Mad Hatter program against mercury). NIDCR is in an institutional conflicted position – the American Dental Association endorses mercury amalgam, hiding from the public its fee-for-service contracts with amalgam manufacturers. ADA has an abysmal record of doling out millions of dollars to dentists – not toxicologists – who take the money and almost never publish anything.
Second, NIH must assure the public that its studies have no bias or appearance of bias, and are being done by the most qualified persons. Neither claim can be made for the dentists with whom NIDCR contracts.
Third, NIH must be able to assure Congress and the American public that its contracts follow the legal and ethical standards of the Federal Acquisition Regulation – that it does not handpick compliant consultants, lead them to pre-determined results, or attempt to cover up its procedures.
The question must be asked: If NIDCR wants an “independent” scientific inquiry into amalgam, why was there a deliberate and complex effort to circumvent Federal regulations? Why did Director Tabak (1) sanction the above activities (he was fully informed about each step of the process via e-mails; and (2) deceive Congress both about how the LSRO contract was made and how it was carried out? We believe the answers go to the heart of what NIDCR has been doing for years: failing to meet NIH standards for expertise and objectivity in addressing mercury-based amalgam, a product endorsed by the American Dental Association and shielded from serious scientific study in the United States by organized dentistry.
Exhibits A-X and AA-BB follow this report. They are abbreviated herein as by the abbreviation “Exh.”
NOTE: Issues 1 through 12 involve the contract at hand and its cover up.
Issue #1: NIDCR officials Lawrence Tabak, Norman Braveman, and Marion Blevins attempted to circumvent the competitive bidding laws.
The entire process began by choosing the consultant via secret meetings, then working out a contract with that consultant.
- It all grew out of closed meetings between Braveman and Falk, Exh. H, followed by draft contracts and continued e-mails between them. Exh. R.
- Each draft identified FASEB, the headquarters of LSRO, as the place for meetings (Exh. I, p. 2; Exh. K, p. 2), so it was understood the contract was to be with LSRO.
- Braveman even allowed LSRO to submit a “preproposal,” Exh. H, a gratuitous and extralegal approach to government contracts.
- No one else was considered: Braveman circulated a contract and appeared to mention LSRO (the word is deleted from our materials) liberally. Exh. J.
- All participants – Tabak, Runner, Kleinman, Braveman, et al., – were made aware of this handpicked contractor with no bidding, Exh. J, but none objected.
- Braveman made a special effort to keep the public from learning about the process, boasting in e-mails about his ability to stonewall. Exh. R (first page).
At the end (see Issue 2), the participants cleverly shoehorned in an unqualified existing contractor, so their handpicked choice could be “subcontractor.”
There was no RFP. No competitive bid. No general publication of solicitations.
- Federal Acquisition Regulation (“FAR”), 41 USC §1 et seq., governing virtually all federal agencies’ purchasing decisions, mandates an open and competitive system. Implemented by thorough set of regulations.
- 48 CFR §6.000 states that the fundamental policy is one of full and open competition;
- 48 CFR §6.102 states that this system covers basic and applied research, and specifically includes “a peer of scientific review”;
- 48 CFR §6.303 states that no agency may depart from this basic requirement without a written “justification for other than full and open competition,” with mandated criteria.
- 41 USC §253 (c) and (f). 48 CFR §5.002 requires contracting officers to publicize contract actions;
- 48 CFR §5.102 requires solicitations be made available to the public.
If it was a “contract by negotiation, that set of rules is violated too; for example, the process was kept closed by Braveman, and there was no RFP. Plainly does not permit a “choose your favorite contractor” potion. Contract by negotiation requires conducting negotiations with a range of qualified applicants, because factors other than fees matter. Contract by negotiation is “a process designed to foster an impartial and comprehensive evaluation of offerors’ proposals” (emphases on s’ and s added to indicate that “negotiating” means more than one proposal is being evaluated). 48 CFR §15.002. By definition, “negotiating” mandates a “tradeoff process” to reach “the best value.” 48 CFR §§15.101-1 and –2. Written information or, in lieu thereof, oral presentations, are required. 48 CFR §15.102. Not a single-source contract Tabak admits so in letter to Congresswoman Watson. Exh. V.
Issue #2: Tabak, Braveman, and Blevins engaged in activities designed to cover up their violations by creating a façade of legality.
Three drafts of contract illegally have LSRO as contractor (see above). After contracting expert Blevins enters, then comes BETAH, who is unqualified to do a study but possesses an existing contract. Exh. L, Exh. M. BETAH is immediately sent LSRO’s request to contract, leaving BETAH without the choice that the law requires contractors to have. Exh. O. NIDCR paid little heed to the contractor-subcontractor relationship. See 48 CFR §44.202 and 48 CFR §44.203. BETAH’s responsibilities were de minimis, raising questions of the whether the Anti-Kickback statute is violated. The “Anti-Kickback Act of 1986,” 41 USC §§51-58, prohibits compensation to prime contractor from subcontractor, as does 48 CFR §3.502-2, the Code of Federal Regulation implementing language. These government officials may have directed a violation of the Anti-Kickback Statute, in that BETAH may be getting paid primarily for being an existing contractor through the deal made with LSRO, instead of for actual work consistent with the payment made.
Issue #3: Tabak, Braveman, and FDA’s Runner put together an “outcome biased” study. NIDCR designated the result they wanted – right in the draft contract, Exh. I, page 1 “Background.” This presents a threefold problem: it contained false information, it contained deceptive information, and it led contractors to the result. (1) Deceptive: Defined amalgam by listing mercury as the seventh [!} element in the mixture, when in fact mercury is 50% of amalgam, by far the dominant element. (2) False: Claimed the World Health Organization takes the position that no limits should be placed on amalgam. (3) Leading: Stated that their own governmental in-house review in 1993 gave amalgam a totally clean bill of health – it was “inappropriate to restrict the use of dental amalgam.” For a no-bid handpicked contractor, doesn’t that suggest the desired result? Kept the language in draft after draft, removing it at the end (apparently assuming no one would read the discarded drafts). If never detected, this legerdemain of putting it in drafts and taking it out of the final would have accomplished the devious goal of advising the contractor what result NIDCR wants while preventing the Congress or the public from finding out the contractor knew. Chose LSRO because of its history of putting together panels to support the position of its sponsor. Exh. BB. Panel to be composed of not one person who has researched amalgam. Exh. S, Exh. V. Braveman ensured panel was “oriented” by NIDCR before it decided additional literature to review. Exh. J. NIDCR picked initial literature to review. Exh. K. This would ensure the panel never seriously examined the Health Canada position against amalgam, Exh. A, or the EPA concern about preventing mercury exposure for women of childbearing age, or about manufacturer warnings about amalgam. Exh. B, Exh. C, Exh. T. NIDCR to pick initial speakers. Exh. L.
Issue #4: Director Tabak provided false or deceptive testimony to Congress about the LSRO/BETAH deal. Tabak’s letter to Congresswoman Watson is Exh. V. In that letter to Congresswoman Watson, Tabak falsely claimed that BETAH “identified” LSRO for NIDCR. In reality, Tabak’s assistant Braveman had been meeting with LSRO for weeks and had drawn up several draft contracts, advising Tabak via e-mail of these developments. Only later was strawperson BETAH enlisted to circumvent competitive bidding rules. Exh. H, Exh. I, Exh. J, Exh K, Exh. L, Exh. M, Exh. N, Exh, O, Exh. P, Exh. Q, Exh. R. Note that for three drafts of the contract, LSRO was the contractor, and BETAH isn’t even mentioned. Tabak is cc’d in an e-mail showing he saw the previous draft and the current one, Exh. J, so his claim to Congresswoman Watson that BETAH “identif[ied] LSRO is false, and knowingly false. Tabak made three other false claims in that letter: (1) that BETAH used criteria to select LSRO: In fact LSRO has been selected by the Braveman team months before BETAH was contacted – see Exhibits cited above; (2) that “the methodology and approach used, including the number of meetings held, … were in no way dictated or influenced by the government”: In fact, all initial draft contracts did list the number of meetings, and stated the government would determine the initial literature to be used and the types of research to be examined – Exh. I, Exh. K, Exh. L, Exh. N; and (3) that the government “stay[ed] at arm’s length from the process and those involved”: a laughable claim for anyone reading the barrage of e-mails between LSRO’s Falk and NIDCR’s Braveman: Exh. H, Exh. Q, Exh. R. The control by NIDCR was so airtight that Braveman insisted the new panel not select the literature to review until it is “oriented” by NIDCR. Exh. J. Tabak is cc’d on this e-mail.
Issue #5: NIDCR wrongly took over what was really an FDA project. Exh. F: Braveman and NIDCR are in control, not FDA, writes Dr. Joseph on June 5, 2003. Compare to what Dr. Joseph wrote seven months earlier, Dec. 12, 2002, Exh. D, where – writing on behalf of Dr. Feigal — she said FDA was initiating the study, and what Dr. Feigal promised Congress, Exh. E: “FDA Planning Another Review of Mercury in Dental Amalgam.
Issue #6: Braveman – along with Runner, “subcontractor” LSRO, and “contractor” BETAH – shut interested citizens and consumer groups out of the process, despite assurances to the contrary. Braveman sent an e-mail indicating his intention to block all information to “Charlie Brown” (the undersigned), who was filing FOIA requests in an attempt to find out what was going on. The panel was picked with no public input and, despite assurances of public participation, LSRO barred the public from all but one-half of one meeting. Exh. R. Almost all sessions by LSRO were closed to the public, apparently per NIDCR instruction in the contract. Exh. S. By having LSRO, a private entity, choose the panel, Exh. S, NIDCR found a way to keep public input out, and to violate Dr. Feigal’s promise that public participation would be allowed in the process. Exh. D, Exh. F.
Issue #7: BETAH – whether willingly or because of pressure from NIDCR – became strawperson contractor, despite a lack of expertise to do scientific studies and with de minimis duties. The first two drafts of the contract were for LSRO only, who was (illegally) designated as the contractor; BETAH’s name was not present. Exh. I, Exh. K. BETAH’s name creeps in in the third draft, Exh. L, merely to do one item on behalf of the government; LSRO is still the contractor. In the fourth draft, Exh. N, BETAH has only one duty, that being to do its traditional work of arranging transportation logistics. Only in the fifth draft does BETAH become the contractor, with several duties, all of them de minimis. Exh. S. That contract, Exh. S, makes clear that all substantive work – which is, after all, the purpose of the contract – will be done by subcontractor LSRO. BETAH has no expertise or experience in doing scientific studies; see its web site, www.betah.com; its selling point is “communications.” Ergo, BETAH was inserted as strawperson contractor to create a façade of legality. SUBCATEGORY: Did Braveman strong-arm BETAH into becoming the contractor? It is unclear whether BETAH was a willing or unwilling participant. As a major contractor, it was in a difficult situation to refuse NIDCR or blow the whistle on the illegal activity. The e-mails we have – and there are certainly others not released to s – show that Braveman and Blevins of NIDCR and Falk of LSRO were pushing BETAH hard for a contract. Exh. O, Exh. P, Exh. Q. Exh. R (4 pages long) is a series of e-mails, where Braveman and Falk plot on how to pressure BETAH to return a contract for Falk to sign, with Braveman then writing BETAH an e-mail near midnight asking not IF they will sign, but when.
Issue #8: The participants misrepresented the contract as a “conference” when all know it to be a “study”. Exh. S (second page, numbered “1” at bottom, under Project Synopsis, the project is described as “convening a conference.” That is blatantly false; everyone knew it was, but it was the way for BETAH to become the contractor, as BETAH was doing conferences for NIDCR. Here we see primary evidence of a conspiracy by NIDCR officials to fool future contract auditors into thinking the project was something it was not – in concert, the conspirators would pretend that NIDCR was simply appending a new duty to BETAH’s existing activities.
Issue #9: LSRO secretly negotiated a contract, even though it was neither an existing contractor, nor a sole source supplier, nor the winner of a competitive bid. Since LSRO has had numerous government contracts, the company is certainly aware of the Federal Acquisition Regulation. Yet LSRO had closed sessions with Braveman, Exh. H (bottom half of page); said it knew the “trick” to satisfy what Braveman and NIDCR wanted, Ibid.; had the gall to submit its own “preproposal” (having the contractor tell the government what is will do is a reversal of what the law requires), Exh. H (top half of page); never bid for the job, Exh. J; corresponded with Braveman during the entire course of negotiating its subcontract with straw contractor BETAH, Exh. R (second page, but numbered “1” at bottom of page); and urged Braveman to start “pushing” BETAH to get the subcontract signed, Exh. R (third page), allowing essentially a pincer movement on BETAH from above and below.
Issue #10: LSRO failed to conduct an “independent” scientific inquiry. LSRO picked a panel without a single scientist who had done research on amalgam fillings. One panelist, Dr. Brent, is an outspoken advocate of the position that parents should stop being concerned about environmental toxins, as their effect is de minimis. Exh. X. LSRO hired Dr. Thomas Clarkson – a well-known pro-amalgam advocate – to perform dual, and conflicting, roles. Clarkson was designated both as chief witness of the last hearing and as outside reviewer, being allowed therefore “independently” to review his own testimony. LSRO has a history of picking biased panelists who support the position of the government agency or major corporation who is paying LSRO. See Exh. BB, a page one story in the Washington Post.
Issue #11: The violations came from the top of NIDCR. The violations were at the very top level of NIDCR. Director Tabak was cc’d on e-mails from the start, Exh. J, and his assistant Braveman chaired the process, Exh. F.
Issue #12: The violations were willful, not inadvertent. Failing to bid, failing to write RFPs, providing a written blueprint of the desired result, providing false scientific claims in that blueprint, shoehorning in an unqualified existing contractor as strawperson, calling the study a “conference” in order to get that contractor into the process, providing false and misleading information to Congress about how LSRO was identified – these are the marks of a conscious and concerted effort to award an illegal contract to a compliant consultant. –
Issues 13 through 16 address broader issues of Tabak’s and NIDCR’s policies and activities to protect mercury amalgam from objective and diligent scientific scrutiny; all were addressed in Senator Lautenberg’s letter to Director Zerhouni, Exh, AA.
For these final four issues, Consumers for Dental Choice is still preparing its evidentiary submission, and will present it to NIH in the near future. Issue 13: NIDCR engaged in a pattern of paying dentists to conduct sham studies on amalgam that rarely, if ever, get completed or published.
Issue 14: NIDCR is failing to provide proper disclosure of risks in its mercury experiment on Portuguese orphans and low-income children in New England.
Issue #15: Having NIDCR contract with dentists to do “independent” studies of amalgam is either (a) an inherent conflict of interest, or (b) the appearance of a conflict of interest.
Issue #16: Having dentists selected by NIDCR – instead of toxicologists selected by NIEHS – in charge of NIH studies to determine the toxicological effects of mercury on the neurological system and body organs is an imprudent misuse of taxpayer-funded research. III.
SUGGESTED REMEDIES A) The study and the contract:
1. The NIDCR contract with LSRO / BETAH should be revoked. To allow the contract to be fulfilled would be to say that NIH has no remedy when upper echelon government employees are engaged in unethical or illegal conduct. To reward LSRO and give the NIDCR officials who engineered this deal a slap on the wrist would send a message that such behavior will be tolerated, and NIH will accept it.
2. NIH should dissociate itself from the study. The public will rely on any report on dental amalgam that has the imprimatur of NIH. With the overwhelming weight of scientific evidence from nations around the world showing potential health problems related to amalgam for vulnerable populations – particularly pregnant women and young children – NIH is inviting a new round of credibility questions unless it dissociates itself from this study and the conclusions it draws.
3. NIDCR should not be involved in further studies on the general health effects of amalgam. Public health advocates and Members of Congress are increasingly aware that organized dentistry and NIDCR have no business exercising judgment over how mercury-based amalgam affects the fetuses of pregnant women, the developing brains of young children, and the general health of people with a history of kidney problems. A truly independent study on amalgam should be (1) headed by toxicologists with no ties whatsoever to organized dentistry; and (2) conducted, as suggested by Senator Lautenberg, by the National Institute of Environmental Health Sciences, which has a proven record of examining the impact of toxins on children. B) Who should control the research on mercury amalgam:
4. Research on amalgam should be moved from NIDCR and give to NIEHS. All the while that Tabak’s assistant Braveman was carrying out his insider deal, he was e-mailing top-level NIDCR officials – yet no one blew the whistle! For four reasons, NIDCR has forfeited its right to keep this work: i) It chooses dentists over toxicologists to conduct research. To have dentists decide whether mercury fillings could harm the brain makes as much sense as having podiatrists decide whether metals in a foot implant can damage the heart. ii) It chooses researchers like DeRouen and Martin, who publicly advocate their pro-amalgam views – hardly the people to do “independent” studies. iii) Hundreds of times, NIDCR has sent huge sums of money to their colleagues in organized dentistry, with no published results. It’s as if NIDCR is simply pretending to study the potential health risks related to amalgam, but doesn’t want researchers to finish anything. iv) But there’s more than a lack of proper qualifications: pro-amalgam dentists have an inherent conflict of interest – or at least the appearance of a conflict of interest. Senator Lautenberg’s letter to Director Zerhouni states in part: “… Consider the inherent conflict of interest in NIDCR being the lead institute for investigating the adverse health effects of mercury amalgam fillings. Organized dentistry endorses mercury amalgam.
The American Dental Association has given mercury amalgam its Seal of Acceptance. This dynamic does not provide assurance that disinterested scientific analysis will [be] used to settle serious fetal neurodevelopmental health and the potential risks to young children, in conjunction with dental mercury.” (Lautenberg’s letter is Exhibit AA, attached. C) NIDCR officials Tabak, Braveman, and Blevins should be disciplined for their unethical and illegal conduct:
5. Tabak and Braveman presided over this ill-fated contract. The unethical and illegal conduct in the LSRO/BETAH deal included no bidding, secret negotiations, a blueprint in advance for the result, a strawperson as contractor, etc. – but this is hardly an isolated mistake. Dr. Tabak oversees an agency that has wasted millions of dollars of research money on non-scientific studies. Worst of all, he willfully presented false and misleading testimony to Congress to cover up his wrongdoing. As Tabak’s assistant, Dr. Braveman secretly solicited LSRO to be the handpicked contractor; presented a blueprint for the desired result (“no evidence” of health risks) containing false information about the science to date; refused to release information about the process; devised a contract calling for panelists with no experience in researching amalgam – in short, he was the official responsible for executing the process.
6. Ms. Blevins, instead of ensuring that NIDCR followed government contracting regulations, provided information that led to enlisting BETAH as strawperson contractor. It was only after Blevins entered the picture that NIDCR brought in BETAH as strawperson contractor – to create a façade of legality and to cover up the fact that LSRO had already been chosen to do the work. Blevins was fully aware that BETAH was unqualified to be a contractor in the area of conducting a review of scientific literature.
7. As this case raises such series legal questions, and because it also involves officials at FDA, it should be referred to the HHS Office of Inspector General.
16 issues with NIDCR hiring LSRO and BETAH Associates for amalgam review