From: BULLELKMAN@aol.com
Sent: Monday, July 26, 2004 12:26 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

 

                                                                                    June 9, 2003

 

David W. Feigal, Jr., M.D., M.P.H., Director

    Center for Devices and Radiological Health

Food and Drug Administration

Rockville, MD 20850 -- Via fax 301. 594-1320, and e-mail: dwf@cdrh.fda.gov; lzk@cdrh.fda.gov; 

lpj@cdrh.fda.gov; BravemanN@de45.nidr.nih.gov; axb@cdrh.fda.gov.  

 

Re:  Independent Review of Mercury Fillings Literature
Being Run by Biased and Secretive Group
 

Dear Dr. Feigal:

 

            Thank you for initiating a review of the literature on mercury fillings, as you promised you would do in October.  You demonstrate you are a person of your word, as you earlier fulfilled your commitment to revoke the flawed Consumer Update of February 2002 on mercury fillings and re-issue one reflecting agency policy.

 

            I must apprise you, however, of the growing evidence that persons under you at FDA, and from NIDCR, are sabotaging your goal of conducting an independent review of whether mercury fillings are safe.   

 

            Consider:

 

(1) The agencies participating are the same group who did such an inadequate review in 1997:  FDA, PHS, NIDCR.  Why not include agencies who have recently studied mercury, but whose agenda may not so closely mirror that of the ADA:

      National Academy of Sciences

      EPA, which issued a study about mercury in 2003;[1]

      Agency for Toxic Substances & Disease Registry (who issued the 600-page report in 1999 that your staff, in the 2002 draft rule, pretended does not exist); 

      Also, please include the AMA.  It is time that scientists and physicians took over this issue, and relegated dentists out of it.

 

(2) The study is being run by the same persons who have already decided that mercury fillings are safe, and have proclaimed so in public statements.[2]

(3) Dr. Braveman at NIDCR, apparently with the consent of his teammates at FDA, is secretly picking an outside party (his vague word) to oversee the process.  I have been denied, under the FOIA, the right to learn the bid specs or any other information until after Dr. Braveman picks this person, whose agenda presumably will mirror the agenda of Drs. Braveman and NIDCR.[3]

 

I ask you to stop this secretive process immediately and to bring what they are doing into the sunshine.  The public will have no confidence in a consultant who is secretly handpicked by Dr. Braveman and NIDCR.[4]

 

 (4) The timing and implementation of the public notice was, to say the least, curious.  The letter was signed by the Deputy Director on May 1, but it was conveniently not published until May 9, the day after the Burton hearings.  Then, it was not posted on the FDA web site for weeks, and it was issued in a slightly incorrect manner such that many people are unable to submit testimony.  A month extension has somewhat eased the situation.

 

 

It is our impression that Chairman Burton and Congresswoman Watson of the Wellness and Human Rights Subcommittee plan to have additional hearings about whether federal agencies are re-directing their energies away from organized dentistry and toward protecting children and other consumers from mercury fillings.

 

 

            Dr. Feigal, we ask that you do a truly independent review not tied to the biases of the past.  For this to happen, we ask you to:

 

 

  1.. Open up this closed process by inviting in the following agencies and organizations: 
    1.. National Academy of Sciences 
    2.. American Medical Association 
    3.. EPA 
    4.. Agency for Toxic Substances & Disease Registry.  
 

 

  2.. Open up the contract process so Dr. Braveman does not secretly choose a contractor acceptable to organized dentistry.
 

 

  3.. Conduct public hearings.  Let the public know what is going on.  Its time this process proceeded in full public view instead of just within the purview of organized dentistry.
 

 

  4.. Show us that this is not a re-hash of 1997.  Remove people who have already made up their minds through public statements and letters  e.g., Dr. Runner, Dr. Joseph  and put in people ready for a fresh look.  Have toxicologists and chemists, not dentists, do this review.  FDA dentists limit their research to the biased and non-peer-reviewed JADA.  It is time to separate those with a vested interest in the result from having any role in its outcome.
 

 

  5.. Do not limit the review of the science to peer-reviewed publications from 1997 to present.  The FDA notice, in so limiting the review, seems to be using as a foundation for this inquiry the prior FDA reviews that concluded amalgam was safe based on all research to that date.  Pre-1997 studies include many peer-reviewed studies showing very serious health harm from mercury and amalgams.  This new panel should be allowed to reassess those studies and not take the biased conclusions of prior panels.  Furthermore, the review should not be limited to peer reviewed studies inasmuch as the NIDCR has paid for 527 studies on the safety and effectiveness of mercury amalgam since 1972.  We have compared the NIDCR studies from the last decade to the PubMed publications on line and find only one of those NIDCR funded studies have been published!  These 527 studies, even though not peer reviewed or published, should be reviewed by the new review panel for their contribution to the body of science on the safety and effectiveness of amalgam. [5]
 

 

  6.. Allow us to recommend distinguished scientists and renowned physicians to participate in this review.   If you insist on including dentists, allow us, too, to recommend respected dentists who vehemently disagree with the ADAs pro-mercury position.  How may we do so, and to whom do we send names?
 

 

  7.. Stop the ADA, at once, from promoting mercury fillings as silver (e.g., in the brochure I believe we showed you).  FDA (at least the rest of FDA except for dental devices) opposes deceptive labeling.  Were mercury fillings not self-regulated by organized dentistry and instead eyeballed by tough consumer-oriented regulators that are omnipresent at FDA, the ADA would surely shrink from such deceptive claims.
 

Sincerely,

 

 

 

Charles G. Brown

Counsel 

 

cc:  Chairman Burton, Congresswoman Watson, Senator Lautenberg, House Commerce Committee

--------------------------------------------------------------------------------

[1] EPA said one U.S. woman of childbearing age in 12 already has so much mercury in her body that she is at risk of having retarded children.  Such women should NEVER receive a mercury filling.  Yet the ADA, spurred forward by its monetary agreements with mercury amalgam manufacturers, continues to advocate mercury fillings even for those women; and, apparently,  Dr. Runner and your dental devices section would not even want to warn them!

[2] The group you are relying on failed you before, issuing absurd and deceptive statements in the Consumer Update and proposed rule in February 2002 -- claiming there is no literature showing mercury fillings are unsafe; mythically asserting that the FDAs failure to classify a decade ago was inadvertent (in your testimony before the Burton committee you said nothing in the records of that period could determine if the non-action was intentional or not); mischaracterizing the position of Health Canada and European countries who point to the health risks of mercury fillings; and issuing a Consumer Update that they knew (or should have known) would be the major political document used by the ADA as it lobbied before state legislatures against disclosing the health risks of mercury fillings.

[3] Attached to the faxed hard copy are (1) the e-mail from Dr. Joseph, who declined to talk to me and referred me to Dr. Braveman; (2) the e-mail from Dr. Braveman, who likewise declined to talk to me but gave the tantalizing vagary about the party that may conduct the review;  (3) my letters to Dr. Braveman; and (4) my letter to the FOIA officer.

[4] Again, this issue is far too important to allow dentists to be the self-regulators.  NIDCR is embedded with the ADA.  NIDCR loudly proclaims mercury fillings are safe, but (ignoring the word research in its title) has never determined if mercury fillings are safe.  Instead, it sends taxpayers money to persons who do not publish their results (either because they cant meet peer-reviewed standards or because the results are against NIDCR ideology).  This issue was addressed in testimony before the Burton subcommittee on May 8.  Dr. Braveman is currently overseeing a study with huge amounts of U.S. taxpayers money (over $11,000,000 with requests for more money to extend the follow-up period) in Portugal, where the two overseers have already publicly proclaimed their allegiance to mercury.  Both Dr. Martin and Dr. DeRouen testified at a public government hearing in Seattle in February 2002 that mercury fillings are safe, and sat with the ADA on the pro-mercury side of the argument.  The study claims to be engaging a toxicologist, Dr. Wood, but when I brought the irregularities and biases to Dr .Woods attention, he told me that he has only a minor role -- that the dentists are running it.  The study is at an orphanage (how convenient!  no permission is needed from parents even though up to 20 mercury fillings are poured into unsuspecting eight-year-olds) and in a country where fish is the main protein diet  fish being, as ATS&DR pointed out in 1999, the other main source of mercury besides fillings.  The pre-ordained results of the Portugal study will have no public credibility.

[5] For the record, we note that an independent review can only be an intermediate step.  To classify mercury fillings, you need to convene a new scientific advisory panel.  It is absurd to suggest that a panel which last met ten years ago, and which did not include the diversity of thinking promised by the Commissioner, could justify a rule.  Numerous studies in the past decade show mercury fillings are unsafe. Meanwhile, as the dental devices subgroup of the Center pretends mercury is safe, other national governments and U.S. states enact prophylactic and disclosure actions.