From: BULLELKMAN@aol.com
Sent: Friday, July 23, 2004 2:14 AM
To: FDADockets@oc.fda.gov; brownchas@erols.com
Cc: FreKoss@aol.com; sandyduffy@comcast.net
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

                                                                                                December 1, 2003

Amy M. Brownawell, Ph.D., Staff Scientist
Life Sciences Research Office
9650 Rockville Pike
Bethesda, MD 20814      brownawella@lsro.org 



Dear Dr. Brownawell: 

 

            We object to your hearing on Dec. 12.  You are allowing only one hour of public comment about mercury fillings, are hosting it in a tiny room, and are pre-ing up rebuttal to which the public tactile qualities.  You have assured yourselves that no scientists will come, because there isnt time for their message.  You have picked panelists with track records of approving controversial products, ones that do not question existing products  a position that fits your companys record perfectly.  It is certainly obvious to LSRO,  as it positions itself for the next lucrative contract from FDA, that you were handpicked to approve mercury fillings (Dr. Faulk told our Development Director,  Ms. Freya Koss she may not like the results), and you are proceeding surreptitiously but rapidly toward that goal.

 

            We object to the sleazy process that steered this government contract to you.  You did not bid.  You did not contract directly.  Instead, working with Drs. Braveman, Runner, and Joseph  who are on record as adamant supporters of mercury fillings  you got in through the subterfuge of a subcontract on a totally unrelated existing contract.   The FDA has since managed to use that fiction as a basis to exclude valuable information about your arrangements of the contract and your relationship with them.

 

You have created a process to ensure that the committee does not get a vetting of the toxicity issues surrounding mercury fillings.  You have no amalgam experts.  Instead, your firm  a professional grant recipient picked to approve products  has picked professional government panelists who are being fed a carefully plotted plate of information to lead to a pre-determined conclusion.  You excluded scientists with expertise on mercury fillings from your panel.  That ensures that no dissenting opinion will issue.

 

A. Questions about LSRO

 

1. You claimed LSRO was handpicked by Drs. Braveman, Runner, and Joseph because of your experience.  Judging from your vast corporate portfolio getting money from tobacco companies and the like, what I think you mean is experience in approving products.  You could not name a single instance when an LSRO-conducted  review found a product should be removed from the market.  Thus I re-ask the question that stumped you and even Dr. Faulk:  When is the last time, if ever, that you found a product should be recalled or removed from the market?

 

2. How much is LSRO being paid for this project?

 

3. If you believe in the integrity of government contracts  as Im sure you do  why did you participate in this sleazy, hush-hush process of getting handpicked through the thin faade of Braveman, Runner, and Joseph picking a totally unconnected existing contractor who has no expertise in mercury toxicity whatsoever?

 

4. Astonishingly, Dr. Faulk told Ms. Koss You might not like our results.  This suggests you are in charge of the results, and the committee a mere ratifier.  What is the role of the Advisory Committee vs. LSRO in making the decisions?

 

 

B. Questions about the committee 

 

5. Is this an advisory committee?  If not, what is it, and what is its authority?

 

6. What is the committees role?

 

7. Is the committee going to be asked to approve the pro-mercury fillings classification regulation proposed by the FDA Dental Devices staff in February 2002?

 

8. Why did you handpick a panel with such close corporate ties?

 

9. Why did you exclude scientists who have studied mercury fillings?

 

10. Will you increase the size of the committee to include scientists who have studied mercury fillings and found them to be a health risk?

 

11. Why have you ignored Commissioner McClellans policy that the committees have diverse viewpoints?

 

12.  Why did you defy Dr. Feigals promise and exclude our group from recommending panelists, while accepting a contract where Braveman, Runner, and Joseph were given primacy in recommending them?

 

13.  Why did you bend your rules and accept the ADA submissions after the deadline?  They had given you no studies, zero  presumably comfortable in knowing where you are going.  Then you arranged to accept their studies post deadline.  But you refused to accept our pre-1997 studies, saying that was outside your scope.  Thus, you have signaled to one and all that the ADA gets what it wants -- in the process and presumably in your report.

 

14.  How much is each committee member being paid?

 

15.  Did you ask the committee members for conflict-of-interest statements?  Please send them to me:  fax 202.822-6309.

 

16.  Have you hidden from the committee members that the sponsors have a long record of advocating for mercury fillings?

 

 

 

C. Questions about the hearing

 

17.  Why did you limit this incredibly important issue to one hour for external input?   Clearly you know more time is needed to address the scientific toxicity questions.

 

18.  Will you have a second hearing for the scientists?

 

19.  Are you going to exclude the scientists like Haley, Lorscheider, Aposhian, Chang, Summers, et al., from this process?  If not, how will you involve them?   Please do not insult them and me by saying they could have eight minutes during the one-hour public presentation.

 

20. We are greatly concerned that you INVITED pro-mercury fillings spokespersons to a separate hour to advocate their use.  You did not invite academicians who have found mercury fillings to be toxic, but you invited the ADA, the pro-mercury advocates to defend them.   Dr. Faulks pro-mercury bias is palpable.  You defended this bias by saying the committee  wanted it, but upon my further questioning, you then said the committee has never met.  Either you lied when you said the committee wants this session, or you lied when you said the committee has never met.  Why are you giving equal time to the issue of the beneficial qualities of mercury fillings as a dental restoration material?  Why is that closed off to public comment?  Why did you mislead me by saying the committee wants it when the committee has not met?  Are you also going to have a session with the committee on the range of safe alternative dental restoration materials that make amalgams obsolete?  We would be happy to provide you the names of mercury-free dentists and materials scientists who could provide the committee with this information.21. Will you address the social justice issues?  Mercury fillings are no longer given to middle-class white adults, increasingly being the domain of children, people of color, and the working poor.

 

22. Why is the committee meeting in secret?  Isnt it required to meet in public? What is your legal authority for these secret public meetings?

 

23.  Who else attends the secret committee meetings in addition to the committee members?  Does Dr. Faulk or you?  Why? 

 

24.  How many discussions have you and Dr. Faulk had with representatives of the American Dental Association during this process?

 

25. Why did you pick such a tiny room for this event?  Dr. Faulk boasted to Ms. Koss that the 16th person will be turned away at the door.  We have thus told an interested press person that she will be barred by Dr. Faulk if she is not one of the first 15 to arrive.  

 

26. Why are you trying to keep this issue away from the public while bending over to give the ADA a special hour to promote the qualities of toxic mercury fillings?

 

27. Are you going to exclude the press if the tiny room is already full when they arrive?

 

Sincerely,

 

 

Charles G. Brown

National counsel

 

ccSenator Lautenberg (Cindy Bethell); Chairman Burton (Mark Walker); Congresswoman Watson (Richard Butcher); House Commerce Committee staff (Alan Slobodin); Consumers for Dental Choice (Freya Koss).