The first crack in FDA’s armor has appeared, folks. This morning, FDA changed its website, adding this sentence: “High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys.” (Go to http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/ucm171094.htm and scroll down to “Potential Risks”). Prior to this, the website did not explain to consumers the damage caused by mercury at all.
Congratulations to all of us in the mercury-free dentistry movement. FDA realizes that its website, like its rule, is a cover-up of the existence and risk of mercury, so its lawyers are trying to ease FDA into a more defensible position (see e-mail below).
But it is still “the Henry Schein Amalgam rule.” It still allows the nation’s #1 distributor of mercury amalgam, Henry Schein Inc. untrammeled rights to market amalgam for everyone, even pregnant women, without even disclosing the mercury to patients. (As you will recall, Schein paid Margaret Hamburg about a million bucks to be its director during her revolving-door time outside of government.)
The website still does not re-instate the language FDA agreed in writing in 2008 to maintain on its website: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.” In particular the website still fails to inform consumers that young children and unborn children are especially susceptible to the effects of mercury. FDA does not want parents to know about this danger to children even though it admits that this information is true (buried deep in the labeling intended for dentists in the new rule’s special controls, the agency writes that “The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor”).
Now that you had an impact writing Deputy Commissioner Sharfstein. our next step will be to write your Representative in Congress. My next e-mail will suggest talking points and the route to e-mail and to phone him or her.
FDA is covering up the mercury risks, but doing so a little bit less than yesterday. We move forward; they retreat. In the words of our first naval hero John Paul Jones, “We have not yet begun to fight.”
Charlie
11 August 2009
PS—Breaking news: The Director of FDA’s Center for Devices, an accomplice to FDA’s years of covering up mercury resigned today under pressure. Dr. Dan Schultz had repeatedly rebuffed my efforts to get the Center for Devices to change course on amalgam. His exit on the same day that FDA alters its website is more evidence that FDA is being rocked by this egregious mistake over amalgam. FDA minus Schultz means more momentum for our movement.
Charles G. Brown, National Counsel
Consumers for Dental Choice, ,www.toxicteeth.org
Working for Mercury-Free Dentistry
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From: xxx.xxxxx@fda.hhs.gov
Sent: Tuesday, August 11, 2009 8:57 AM
To: Charlie Brown
Subject: FDA website
Mr. Brown, although we have declined to repost the old website as you requested, the agency has modified the language in the current website regarding the potential risks of dental amalgam. You can read the modified language at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/ucm171094.htm
The first full paragraph under the heading “Potential Risks” now states:
“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.”
(A lawyer in FDA’s Office of the Chief Counsel)
for further information visit the mercury links page of my website.