Wednesday, August 26, 2009

Please Call FDA Dep. Commissioner Sharfstein on Thursday or Friday Regarding Amalgam Rule

Please call FDA Dep. Commissioner Sharfstein on Thursday or Friday.

The highly respected publication FDA Webview, edited by Jim Dickinson, says of our battle:  

“No final rule in FDA’s modern history, or perhaps ever, has attracted this kind of organized opposition.”


We have a strong start, but must make a sustained effort.  Because, as FDA Webview further reports, a spokesperson claims the agency is holding firm -- to a rule to cover up the mercury in amalgam, to a rule that gives no consumer warnings, to a rule that blesses the marketing of mercury fillings as ‘silver fillings.’ 


No surprise here.  Commissioner Margaret Hamburg came to FDA straight from dental products colossus Henry Schein Inc., entered office holding at least a quarter million in Schein stock, and received a hearty thank-you right after the rule issued from Schein CEO Stanley Bergman.  Although Schein is tops in amalgam sales, the Harvard-educated Hamburg refuses to disclose when she recused herself, nor will she provide details of her contact with Schein the very day before the rule was unveiled.


While still cashing in Henry Schein stock options, Hamburg handed the issue to Deputy Commissioner Joshua Sharfstein, who entered office as a child advocate but who may not have had time to read the full rule after Hamburg’s orchestrated exit. 


Dr Sharfstein now faces the decision of his career: loyalty to his boss Hamburg or loyalty to the children of America.  If you stand silent, he will stand where he does now -- in favor of the purveyors of mercury.  If you speak up --- if you call him, ask for him by name, and insist that you be allowed to leave a message instead of letting them route you deep into the bureaucracy -- perhaps he will return to being a child advocate.


Deputy Commissioner Sharfstein’s phone # is 301.796-5040

       --- Thursday is phoning day for those in the Central time zone (plus our Mexican and South American friends).

       --- Friday is phoning day for those in the Eastern and Atlantic time zones.

       --- Of course, if you missed calling on Tues. or Wed., please call on Thurs. or Fri., from wherever you are.  And if you’ve run out of nickels, then call FDA at, and ask for Joshua Sharfstein’s office.


Here are suggested questions:

1. On what date did Margaret Hamburg recuse herself?  (Sharfstein knows, because that’s the moment control over the rule passed to him.)

2.  Why, if he is a child advocate, did Dr. Sharfstein sign a rule that allows amalgam sales to cover up the mercury from consumers? 

3. Did Dr. Sharfstein know that Commissioner Hamburg was trading in Henry Schein stock options the very month the rule was being finished?

4. Why does FDA ban mercury in lotions put on horses’ blisters because mercury is so toxic, but say that it’s fine to risk the lives of unborn human babies and the brain development of small human children?



    25 August 2009


PS---No matter what they say, Sharfstein is in charge.  Don’t let them send you to a minion below.  Leave your phone number.  If they want your e-address, give it, but tell them people are sick and tired of FDA’s form letters


PPS----Here is that FDA Webview article referenced above:

Consumer-level Pressure Mounts on Sharfstein Over Amalgam Rule

FDA Webview08/26/2009

Unprecedented consumer-level pressure is attacking FDA’s 8/4 final rule on mercury-based dental amalgams, and its chief critic is claiming he sees “signals” from the agency that it is looking for a way out.  The rule, which essentially declares the neurotoxic heavy element safe as currently used, becomes effective 11/2 — unless FDA finds a way to defer or withdraw it.  Press officer Mary Long, however, tells us that there is “no truth to observations that the FDA is trying to get out of implementing” it.


Consumer-level pressure to do that got a big boost this week when widely published osteopathic physician Joseph Mercola, who operates what he calls “The World’s Most Popular Natural Health Newsletter” posted a three-part video interview with amalgam opponent Charles G. Brown, national counsel for Consumers for Dental Choice.  According to the Web site, by 8/26 the interview had attracted more than 68,000 views.  In it, Brown urges viewers to call and email principal deputy commissioner Joshua Sharfstein with their opinions about the mercury amalgam controversy: “Ask FDA’s Sharfstein why he covers up the mercury in amalgam.”  No final rule in FDA’s modern history, or perhaps ever, has attracted this kind of organized opposition.


As of 8/25, FDA said Sharfstein’s office had received 58 responses, “all of which were answered individually via email with a standard response letter.”


The Brown videos are headlined “FDA’s Mercury Ruling Defies ALL Scientific Reasoning” and appear with a separate newsletter article that has attracted more than 11,500 views and 38 comments, under the headline “The FDA has the Audacity to Claim Mercury is Completely Harmless” and a sub-headline: “Outrageous conflict of interest uncovered in recent FDA ruling on mercury and what you can do to correct it.”  This is a reference to conflict-of-interest allegations, denied by FDA, that Brown has made and repeats in the videos against commissioner Margaret Hamburg.


In the videos, Brown says FDA “is giving a lot of signals that they want to change what they’ve done” in the final rule.  Asked by FDA Webview what those signals are, Brown said they include a post-publication change to FDA’s amalgam Web site to say: “Dental amalgam contains elemental mercury. It releases low levels of mercury vapor that can be inhaled. High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys.”  In addition he, said there have been informal verbal comments by senior FDAers indicating concern about public reaction to the rule, and a media statement earlier this month by FDA press officer Long that indicated her statement “may only be preliminary, as the agency continues to review the criticisms, which come primarily from experts associated with the International Academy of Oral and Medical Toxicology.”


FDA’s seeming discomfort with its position on mercury coincidentally drew additional attention on another Web site 8/25 — an interview on Green’s Echo Childs Play site with former CFSAN scientist Renee Dufault, who recently retired early because, she says, supervisors discouraged her continuing research.  The article says she discovered the presence of mercury in the widely used “natural” sweetener high fructose corn syrup.


“The FDA as an agency had mixed feelings about my results,” Dufault says in the interview.  “Some individuals were not happy with my findings. I think they were afraid.  Some individuals at FDA supported my work and applauded my efforts.  There may have been some things going on behind the scenes to put an end to my work but I do not know this for sure. I did not have to retire early but I was discouraged from doing the field work that I liked doing and in fact told not to continue some of the research that I was doing.  I found myself with lots of time on my hands.  I do not twiddle my thumbs well. I need to be intellectually challenged and I need to feel like I am making a difference.  I was no longer able to meet these basic needs doing my FDA job.”


Dufault said the U.S. should “follow Sweden’s lead and ban the use of mercury in manufacturing processes and products.  Congress needs to provide FDA with substantial funding to conduct its own sorely needed research into product safety.”  

Jim Dickinson, Editor
FDA Webview & FDA Review



Charles G. Brown, National Counsel
Consumers for Dental Choice
316 F St., N.E., Suite 210, Washington, DC 20002 
 202.544-6333; fax 202.544-6331, 
Working for Mercury-Free Dentistry


LNH salutes and supports the good work of Charlie Brown and Consumers for Dental Choice.  We hope that you will take a moment and call Dr Sharfstein's office this Thursday or Friday.

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