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Fight FDA mercury amalgam rule




FDA has issued its rule on mercury fillings. There are no limits on amalgam use. Dentists and manufacturers still do not have to disclose the mercury to consumers. FDA agrees that disclosure of risks will reduce amalgam sales, and will reduce mercury exposure in children -- then FDA, astoundingly, decides it will take steps to increase the use of amalgam (I’m not making that up -- FDA said on page 89 that amalgam sales will decrease and mercury exposure decrease without a rule, so FDA is writing a rule to stop the decline from happening). FDA admits it doesn’t know if amalgam is harmful to children under six, pregnant women, and nursing mothers -- then doesn’t do a thing to protect them.


In a double-cross to the consumer movement, FDA even pulled from its website the neurological risk advisory that had become kind of famous over the past year: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.”.


FDA has delivered a heavy blow. Let’s not sugar coat it. But it’s not a knockout punch. Far from it. It is reminiscent of several times when we faced moments of deep despair with no seeming exit -- and triumphed.


While the rule is an outrage, it has some provisions that we will take advantage of:
  1. Because FDA admits amalgam is a risk, Wall Street analysts have ratcheted up the pressure on amalgam manufacturers to cease production; see, e.g., a report from the respected firm NorthCoast Research. Hence, we will redouble our work to show Danaher and Dentsply shareholders that their management is foolishly putting the companies at risk by continuing to manufacture amalgam.

  2. Any dentist who continues to implant mercury in children and young women is now at great legal risk because FDA said it doesn’t know if the fillings are safe for them. In January I published two articles in trial lawyer association journals. We will continue to educate the litigators on the economic potential of cases against manufacturers and dentists who implant mercury fillings.

  3. The state and local fact sheets are alive and well. FDA specifically said they remain in effect -- all over New England, in California, in Philadelphia.
    -- all over New England, in California, in Philadelphia.


What went wrong?


First, the new FDA Commissioner, Margaret Hamburg, made a million bucks over the past five years from #1 dental products distributor Henry Schein. She still owned stock in the company when she became Commissioner, failed to recuse herself from the rulemaking immediately, and now will not tell us the nature of her involvement with the rule. I filed repeated written protests throughout June and July, and will provide you more (much more) on this in the very near future.


Second, Commissioner Hamburg and the Principal Deputy Commissioner, Joshua Sharfstein are avowedly trying to convert FDA from a regulatory agency (one that decides safety and warns about risks, the role the law requires), into a “public health” agency (where they will decide what information we get to know and what information we don’t get to know, a role without a legitimate basis).


Third, the agency accepts and approves two-tiered dentistry, where the elite get all the information they need and have the money to choose what they want, while the public is told that amalgam sales are a good thing and little sacrifices (children) must be made to maintain the flow of commerce for pro-amalgam dentists.


Because of the ethically-challenged Commissioner Hamburg, children will be getting an unnecessary dose of mercury, which will cause many of them permanent neurological harm. Because she and Deputy Commissioner Sharfstein are transforming FDA into a Big Brother that tells us only what they want us to know, unborn children will be exposed to mercury, causing an immeasurable number to die in the womb. FDA knows this to be true -- it was even on their website until last week.


This week, folks, we begin the grassroots campaign to challenge FDA. In a series of upcoming e-mails, I will ask you to contact various public officials with a specific message. May I ask that, at each point, you consider taking action.


To paraphrase Churchill, we will fight FDA on the law, we will fight FDA on the science; we will fight FDA on the ethics; we will fight FDA on the policy. We have just begun to fight.


In more scientific language, an increase in permeability of the intestinal mucosa to luminal macromolecules, antigens and toxins associated with inflammatory degenerative and/or atrophic mucosal damage. Once in the blood stream our immune system is the last line of defense to deal with these substances and it will eventually get overwhelmed if a Leaky Gut is not rectified.


---Charlie

5 August 2009




Michael Biamonte holds a Doctorate of Nutripathy, and is a New York State certified Clinical Nutritionist. He is a professional member of the International and American Association of Clinical Nutritionists,The American College of Nutrition and is a member of the Scientific Advisory Board for the Clinical Nutrition Certification Board. He is listed in "The Directory of Distinguished Americans" for his research in Nutrition and Physiology.

For an appointment, contact our office at:

Michael Biamonte, C.C.N.
139 Fulton St.
Suite 507
New York, NY 10038
(212) 587-2330


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