Despite admitting that amalgam causes mercury exposure -- and despite knowing that mercury causes neurological harm to developing brains -- Sharfstein rejects putting on contraindications for amalgam, rejects putting on warnings on amalgam and even rejects a requirement that dentists tell patients that amalgam is mainly mercury.
Sharfstein even withdraws the FDA’s website warning that dental mercury can cause permanent neurological harm to children and unborn children. Sharfstein’s rule actually says the FDA wants to stop a decline in amalgam sales. At Joshua Sharfstein’s FDA, commerce trumps safety.
The FDA doesn’t even defend its rule on the science. The FDA admits it does not know if mercury fillings are safe for children 6 and under, for pregnant women, or for nursing mothers whose mercury goes through breast milk.
No, it’s not science -- it’s about commerce. The FDA wants Americans to keep buying amalgam.
The children of America have lost. Another generation will be mercury toxic.
Hopefully you will get a chance to review my video interview with Charlie Brown, who is the leading consumer protection attorney in the United States with respect to mercury. He is the stealth behind-the-scenes champion for consumer protection.
Most Americans are absolutely unaware of what he and his organization has tirelessly been doing for the last ten years by seeking to eliminate the use of mercury in dentistry in the US.
If you feel half as strongly as I do about the use of mercury in dentistry, I strongly encourage you to watch all of these videos so you can understand the problem and, more importantly, actively participate in the process to eliminate mercury in dentistry in the US.
Circulating throughout Washington is the question: How could the Food and Drug Administration (FDA) issue a rule that allows the sale of mercury amalgam even to children and pregnant women when it acknowledges that it does not know if the product is safe?
Even Wall Street had predicted limits on amalgam’s use.
Worse, how could the FDA allow amalgam sales without even warning consumers of the mercury in this implant, or even disclosing the existence of the mercury, when it gives warnings about the mercury in our tuna?
And why would the FDA remove from its website an accurate warning about amalgam’s risk of neurological harm to children and fetuses?
By covering up the mercury, the FDA is allowing untrammeled sales of amalgam, even though President Obama wrote a law (while a Senator) banning mercury exports and now is negotiating a treaty to phase out all man-made mercury. How could the new FDA Commissioner go against the anti-mercury policies of the President who appointed her?
Emerging in recent days is evidence that Commissioner Margaret Hamburg’s relationship with the nation’s top amalgam seller may have played a role in this dismal result.
Another Industry Shill at the FDA?
Dr. Hamburg served on the board of dental products colossus Henry Schein Inc., drawing an annual income of a quarter million dollars a year, according to the Wall Street Journal. In May 2009, when she took office as Commissioner, she was still holding Henry Schein stock options, which she did not cash until July, the month the amalgam rule issued. In fact, she was still holding Schein stock options until July 27, the day before the FDA rule was announced.
Instead, in response to a question from Senator Enzi during the confirmation process last May, she announced that she was preparing to work on the amalgam rule.
In the weeks leading up to the rule, Charlie Brown, legal counsel for the Consumers for Dental Choice, which is a nonprofit corporation whose purpose is to educate the public about the health and environmental dangers of mercury fillings and to ensure more effective government oversight on amalgam, challenged this conflict of interest.
He wrote the FDA three times, the first letter being ignored, the second and third getting a response but no answers to his questions. Correspondence is at http://toxicteeth.org/FDA_letters_JunJul2009.pdf and http://toxicteeth.org/FDA_letters2_Jul2009.pdf
The FDA agrees that Margaret Hamburg had an ethical problem that led to her recusal, but neither she nor anyone else at the FDA will say what work she did on the rule or when she stopped working on it. Her legal defense is based on a technicality that her work was not “personal and substantial.” In any case, her late exit from the process could well have signaled her trusted lieutenant, Joshua Sharfstein, that this rule was about more than protecting health.
The resulting rule is a bonanza for Henry Schein, who can sell amalgam to anyone and everyone without even disclosing that it is mainly mercury.
Why is the FDA Still Claiming Mercury Fillings are Safe?
A simple breakdown of the facts compiled by Consumers for Dental Choice paints a very clear picture:
Margaret Hamburg served on the Schein board from 2003-2009, earning a quarter million dollars a year. After becoming Commissioner in May -- with the amalgam rule to be issued in July -- she retained her Schein stock options. She cashed some of those options on July 16, and held the others until July 27 -- the day before the amalgam rule was to issue. Dr. Hamburg claims to have recused herself at some point, but continues to stonewall requests for written proof that she actually did recuse herself, and on what day she did so.
- The FDA’s new amalgam rule has neither contraindications for children and pregnant women, nor the lesser requirement of warnings for children and pregnant women.
This is in spite of the fact that the FDA concedes that children and the unborn are more susceptible to mercury’s neurotoxic effects and that no study indicates that mercury amalgam does not pose these known neurological risks to this subpopulation.
- As pointed out in the Watson-Burton letter to FDA, signed by 19 Members of Congress, most consumers and parents still don’t know that amalgam is mainly mercury, due to its marketing under the deceptive term “silver fillings.”
The FDA wants to keep the mercury unknown, and has gone so far as to justify the marketing of amalgam under the deceptive term “silver fillings.” The FDA's claim that it is permissible because of the color is belied by the fact that all other filling materials are known by their main component (gold, resin, porcelain). Of course, the FDA knows the term "silver fillings" deceives American parents and consumers, yet the agency outrageously blesses this scheme.
To its extreme discredit, the FDA under Commissioner Hamburg actually pulled off the consumer website a warning that was prudently posted by Commissioner Von Eschenbach: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.”
The only beneficiary of this secretiveness is the amalgam industry, which raises even more concerns.
There is well-publicized corruption at the Center for Devices and Radiological Health, which was charged with the amalgam rulemaking. Recently, Center for Devices Director Dan Schultz (part of the group that has given carte blanche to amalgam sales with no disclosure) resigned “by mutual agreement” with Dr. Hamburg, amidst complaints that he pressured staff to approve devices that they did not think were safe in order to benefit industry.
FDA staff believe amalgam to be one of these devices; an employee commented thusly off the record to a reporter on the amalgam rule:
“Why continue to use and recommend mercury amalgam when there is safer composite alternative? ... I really question FDA’s motivation here. It seems to be more responsive to industry than human health.” (A ‘Shocking’ Decision – Bias Seen in Dental Amalgams Rule, FDA Webview, 31 July 2009).
Your Dentist Does Not Have to Warn You
Since there is no requirement that dentists tell patients amalgam is mainly mercury, I want to set the record straight right now.
Folks, dental amalgam fillings are made from about 50 percent mercury and the rest an amalgam of silver, tin, copper, zinc and other metals.
Mercury is a potent toxin that can damage your brain, central nervous system and kidneys. Children and fetuses, whose brains are still developing, are most at risk, and that is why it’s especially dangerous for pregnant women to get an amalgam … but really anyone can be impacted. Again, those most at risk include:
- Pregnant and nursing women
- People with already high levels of mercury bioburden
- Those who are sensitive to mercury exposure
In the event you need a filling, seek out a biological dentist who can recommend a truly inert material that will not harm your health.
For those of you who already have mercury fillings, I recommend that you have them removed … but avoid making the mistake I did 20 years ago by having it done by a non-biological dentist. You see, when you have these fillings removed you can be exposed to significant amounts of mercury vapors if the dentist doesn’t know what he or she is doing.
It’s also for this reason that I suggest you get healthy BEFORE having your fillings removed, as you want your detoxification mechanisms optimized prior to removal.
Resources for Finding a Mercury-FREE Dentist:
- Dental Amalgam Mercury Solutions: e-mail firstname.lastname@example.org or call 651-644-4572 for an information packet
- Consumers for Dental Choice
- International Academy of Biological Dentistry and Medicine
- International Academy of Oral Medicine and Toxicology
- Holistic Dental Association
- International Association of Mercury Safe Dentists
How You Can Make a Difference Now
Please write Deputy Commissioner Sharfstein and ask him to reconsider the amalgam rule-making entirely, this time without the stench of corruption that surrounds this rule.
His e-mail address is JMSharf1@fda.hhs.gov
You can call him, too, at 301.796-5040.
In response to the moral travesty that is the FDA’s new amalgam rule, Charles Brown and Consumers for Dental Choice have also filed a complaint with the U.S. Inspector General asking for an investigation into the FDA Commissioner’s ethics.
It is a public document and may be circulated, re-published, or sent to your Member of Congress. Please consider writing the Inspector-General at HHSTips@oig.hhs.gov with your views about the need for such an investigation.
Please also ask your Congressman or Congresswoman to look into this underhanded dealing.
You can find out who your Representative is and how to contact him or her at this link. If you prefer to phone him or her, the House of Representative switchboard is 202.224-3121 or 202.225-3121 -- or you can look up his or her phone number online.
If you live outside the United States and want the FDA to do the right thing, which will certainly accelerate change in your country, you can write two champions of the anti-amalgam cause, Representative Diane Watson, Democrat-California and Representative Dan Burton, Republican-Indiana.
In your message, ask your Representative to write FDA Commissioner Hamburg to get answers to these questions:
When Senator Enzi asked Dr. Hamburg a written question about the amalgam rule, why did she not then disclose the stock and say she would be disqualified from participating?
Why, when taking office as Commissioner and still holding stock options, did she not recuse herself from participating in the rule-making right away?
On what date did Margaret Hamburg recuse herself?
Did Margaret Hamburg approve any draft of the rule or approve which staff would draft it?
Since Commissioner Lester Crawford was forced out of office in 2005 for conflict of interest involving stock ownership, why does Commissioner Hamburg believe this situation is different, and why does she believe she should remain in office?
Why is the amalgam rule so incredibly favorable to Henry Schein and so unfavorable to America's children, giving Schein the right to untrammeled amalgam sales without even a requirement that patients be told of the mercury in amalgam?
Unlike dental products colossus Henry Schein, the children of America can’t put anyone on a board of directors. They need you to speak up for them so that they, too, will not suffer the health-damaging effects of silver mercury fillings.