By Charlie Brown, JD
The FDA used to be the world’s gold standard health regulator. However, it has recently spiraled into a Byzantine phalanx of independent centers providing hasty approvals of high-risk products, without oversight, and inconsistent regulations.
A powerful example is its regulation of mercury amalgam fillings. The FDA has done nothing until compelled to act by court order.
To be FDA’s new Commissioner, President Obama chose former New York City Health Commissioner Margaret Hamburg, M.D. The Harvard-educated physician was confirmed May 18th without controversy or opposition.
The FDA Protects Animals from Mercury but Not Humans
A good way for Dr. Hamburg to begin would be to reverse years of FDA inaction on mercury amalgam – a step she assured Senator Mike Enzi (R-Wyo.) she would take in response to his question during the confirmation process. Inexplicably, the FDA zealously protects animals from mercury exposure, while taking almost a laissez-faire approach to human exposure to mercury.
In 2002, the agency pulled from the market a mercury-containing ointment for horses, and proclaimed zero tolerance for mercury in any product used to treat an animal. The FDA ruled that mercury is so toxic to mammals, it had no duty to prove its presence actually harms horses.
When it comes to mercury-containing products marketed to the humans however the FDA’s zeal evaporates. The FDA requires mercury critics to prove actual and widespread harm -- the shocking opposite of its position on protecting animals. Interestingly, the FDA policies ignore warnings from the Environmental Protection Agency that one in seven American women of childbearing age has so much mercury she is at risk of having a brain-damaged child.
Mercury Amalgams (Silver Fillings) Are Archaic, Deceptive, and Dangerous
Nowhere is the FDA’s failure to protect humans from mercury more blatant than in the field of dentistry. Amalgam fillings are 19th century devices containing 50% mercury.
However, the FDA continues to allow unregulated amalgam use in assembly-line clinics and institutions – including, sadly, the military – despite the fact that modern dentists have switched to safer alternatives like resin. A national dentist poll published in the June edition of The Wealthy Dentist states that slightly over 50% of dentists are mercury-free, meaning the 19th-century-style dentists – the mercury-users – have declined to less than half of all US dentists!
The FDA never even acted to stop use of the deceptive term “silver fillings” to describe amalgam. As a result, a Zogby poll conducted three years ago found that more than three in four Americans could not name mercury as amalgam’s main component.
FDA Successfully Sued
I run a small national consumer group, and have sparred with the FDA for seven years, first coaxing, then suing, to get the agency to do what is legally required. After my organization, Consumers for Dental Choice, sued the FDA, the agency retracted its claims of amalgam’s safety from its website and issued a stark advisory: Mercury from amalgam fillings “may have neurotoxic effects on the nervous systems of developing children and fetuses.”
As a result of my lawsuit against the FDA it must, by court order, classify amalgam – that is, issue a regulation deciding the degree of risk it poses for the general public and for vulnerable subpopulations – by July 28, 2009. In anticipation, public officials are imploring the FDA to protect dental consumers.
The State and Local Public Officials Mercury-Free Caucus, a coalition of state lawmakers, mayors, and other public officials from eleven states, wrote a letter asking that FDA “act decisively to protect Americans, especially children and young women, from mercury by limiting, then phasing out the use of amalgam.”
Then, on May 14, Congresswoman Diane Watson (D-Calif.) and Congressman Dan Burton (R-Ind.) sent a letter urging the FDA to steer consumers to safer materials. Co-signed by 17 other Members of Congress, it emphasizes that mercury from amalgam can “threaten the development of the fetus” and “pass into breast milk of the lactating mothers.” Thus, the FDA must not only ensure that all consumers know about the mercury, but the FDA must also “protect women and children from the harmful effects of mercury fillings.”
The End of Silver Fillings May Be Near!
As the FDA approaches its duty to classify, manufacturers and pro-mercury dentists are increasingly feeling the heat. In May, a religious-consumer-environmental coalition, led by Sister Valerie Heinonen, Ursuline Sisters of Tildonk, presented a resolution to the annual meeting of Danaher, the #1 manufacturer of toxic mercury fillings. Calling for Danaher to consider exiting amalgam, one-sixth of all shareholders (forty-three million shares) voted for it, an extraordinary outcome for a first-time presentation.
But it isn’t just activists weighing in – it’s Wall Street itself. A financial analysis by Bank of America Securities advises that Dentsply, the #2 manufacturer, would be more profitable if mercury fillings are banned. And where manufacturer liability looms, the trial lawyers won’t be far behind. My article in the Idaho Trial Lawyers Association Journal provides a preliminary road map for such litigation.
An industry analysis by J.P. Morgan predicts that the FDA will finally stop mercury amalgam fillings from going to children and pregnant women. It’s about time. The Canadian government took this action thirteen years ago.
You Can Make a Difference
For all players, the upcoming FDA rule on July 18, 2009 will mark the watershed moment in dental history.
- For the average person, it means empowerment, access to the information we need to reject mercury fillings – and switch to mercury-free dentists.
- For the bitter-ender pro-mercury dentists, as represented by the American Dental Association, it means the chance to recognize that the FDA’s rule will mark the beginning of the end of mercury fillings – or surely these dentists and their trade group will fall on their collective swords for toxic mercury.
- For the Obama Administration’s FDA, it means the first and best opportunity to return to the path toward becoming the world gold standard health regulator.
- If you want to be a volunteer to help in the next phases of the removal of mercury from the US write us at firstname.lastname@example.org
Charles G. Brown is National Counsel for Consumers for Dental Choice (www.toxicteeth.org), Washington, D.C.