Stop FDA from Using Children as Guinea Pigs for Mercury Exposure

August 18, 2015
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Consumers for Dental Choice Battles FDA Head-On

According to the FDA, the problem with amalgam fillings is not the mercury. The real “problem,” said FDA Assistant Commissioner for Public Affairs back in 2011 “is that there will be no end to [Charlie] Brown” of Consumers for Dental Choice.

FDA’s solution? Do “a communications end game re: Brown.” But the FDA’s attempt to silence Charlie and Consumers for Dental Choice failed.

Charlie continued to exercise his First Amendment right to challenge FDA’s callous failure to protect the public from mercury. And that FDA Assistant Commissioner for Public Affairs? He was out of FDA within the year.

In September, Consumer’s for Dental Choice will launch an ambitious plan to tackle the FDA, and they need your help to do so. I will be matching every donation dollar for dollar. The goal is to raise $100,000.

Donations are tax-exempt and can be made online, or by mailing your check to: Consumers for Dental Choice, 316 F Street, N.E., Suite 210, Washington, DC, 20002

The Campaign for Mercury-Free Dentistry

The sole mission of Consumers for Dental Choice is to end the use of mercury fillings. Back when this non-profit advocacy organization was founded in 1996, dentists had their licenses threatened – or even taken away – because they were speaking out for mercury-free dentistry.

But Consumers for Dental Choice’s executive director, attorney Charlie Brown, argued that their speech was protected by the First Amendment right to free speech, and the courts agreed.

Then Consumers for Dental Choice launched a grassroots strategy to obtain laws requiring dentists to distribute amalgam fact sheets to patients, and succeeded in passing fact sheet laws in Maine, Connecticut, California, New Hampshire, and the city of Philadelphia.

Building on this success at the state-level, Consumers for Dental Choice turned to the national colossus: the FDA. For more than three decades, the FDA refused to issue a rule on dental amalgam, even though it was legally required to do so.

Without a rule, there was nothing to protest. It was just endless meetings with low-level FDA administrative staff saying they would continue to study the issue... and then study the issue some more.

So Consumers for Dental Choice organized plaintiffs and sued FDA in 2008. And won! The court ordered FDA to issue a rule on dental amalgam by the court-mandated July 2009 deadline.

Reluctantly, FDA did issue a rule a few hours before that deadline. The resulting FDA rule was a severe – although not unexpected – disappointment. It failed to ban amalgam use or acknowledge many of the serious problems caused by amalgam.

But in its rule, the FDA did concede one thing: amalgam puts children and unborn babies at risk, stating:

“The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor.”

Furthermore, the FDA admitted there is no scientific evidence that amalgam is safe for these most vulnerable populations:

“Very limited to no clinical information is available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed.”

And that’s when a new phase of the cover-up began...

FDA’s Long History of Suppressing Warnings About Mercury Fillings

Having buried the warnings about risks to children and unborn babies deep in its wordy amalgam rule, the FDA failed to highlight these warnings in its media roll-out of the rule, so very few dental consumers or parents found out about them.

Needless to say, there was a lot of protest from the public. This resulted in the FDA holding a two-day hearing to re-evaluate its rule on mercury fillings in December 2010. There, FDA’s own hand-picked panel of scientists – including neurologists, toxicologists, epidemiologists, and environmental health specialists – told the agency to stop amalgam use in children, pregnant women, and hypersensitive populations.

Panelist after panelist laid out their concerns: Dr. Kotagal said there is “no place for mercury in children”... Dr. Ismail said “in children less than six years of age, I would restrict it significantly”... Dr. Thompson said “definitely not in pregnant women and definitely not in those below six years of age”...

Dr. Fleming said we need contraindications for pregnant women... Dr. Burbacher said, “why put amalgams in children if we know they're going to live with that for the rest of their lives? And we don't know what that's going to do.”

Not a single panelist agreed with FDA's 2009 rule that permitted unrestricted amalgam use in children and pregnant women. FDA has heard that message before. In 2006 its scientific advisory panel concluded – by a 13 to 7 vote – that amalgam is not generally safe for all. And now that FDA was hearing it a second time, presiding FDA official Anthony Watson announced the FDA would act quickly in response to concerns raised by the panel. Instead, the FDA failed to do anything at all.

So in 2011, Consumers for Dental Choice took yet another approach. The FDA was attempting to garner good publicity for itself by convening town hall meetings in Texas, Florida, and California. Presiding, appropriately, was the FDA official in charge of reconsidering FDA’s abysmal amalgam rule: Center for Devices Director Jeff Shuren. Consumers for Dental Choice flooded the audience at each meeting with mercury-free dentistry supporters demanding that FDA change the amalgam rule.

In response, Dr. Shuren admitted that:

"Now, the [FDA scientific] panel did … point out that there may be certain populations who are more sensitive to dental amalgam, like young children and pregnant women."

Adding:

"We may decide to change our current regulation and that could include changing the status of dental amalgam, which means it comes off the market or has other controls on it or we may decide to leave things as they are."

Finally, he stated that FDA would make “an announcement by the end of the year.” That deadline passed. Then another three years. No announcement ever came. Every day the FDA fails to act, children are unnecessarily exposed to this source of mercury, a known neurotoxin. That is why Charlie Brown and Consumers for Dental Choice are not only battling FDA head-on... they’ve launched a multi-pronged attack to overcome FDA’s horrific policy.

Consumers for Dental Choice End-Runs FDA with the Minamata Convention

While directly challenging FDA’s ongoing scheme to protect amalgam use, Consumers for Dental Choice is also going around the FDA. Five years ago, Consumers for Dental Choice learned about an amazing new opportunity: the nations were negotiating an international treaty dedicated solely to addressing mercury. But so far, amalgam was not in the treaty as a mercury product whose use needed to be reduced. Consumers for Dental Choice was determined to change that.

To accomplish this goal, coordination was key. Consumers for Dental Choice helped found the World Alliance for Mercury-Free Dentistry as the umbrella coalition uniting non-governmental organizations dedicated to phasing out amalgam. For three years, the World Alliance for Mercury-Free Dentistry has grown steadily as a talented team of non-governmental organization leaders worked in every region of the world to make this treaty a turning point for the mercury-free dentistry movement.

It was three years of countless one-on-one meetings with government officials around the world... letters to governments... detailed memos on effective amalgam phase out steps... strategy sessions... regional meetings... economics studies... workshops for stakeholders... consultations with experts... late night international telephone conferences... scientific literature searches... research summaries... outreaches to other non-government organizations... submissions for delegates... and coalition-building.

Then the team on the ground worked with governments from around the world, literally night and day, at the five negotiating sessions (the meetings went until past 3 AM some mornings) to ensure the treaty included requirements for amalgam. And all that hard work paid off! Now the new Minamata Convention on Mercury requires every nation signing it to phase down amalgam use. The U.S. has ratified the Convention, which takes effect after 50 nations sign (which usually takes a few years). So the FDA is going to have to act in order for the U.S. government to live up to its treaty promises.

Consumers for Dental Choice Shows FDA Is an International Embarrassment

The FDA’s refusal to protect even children from the toxic mercury in amalgam fillings is an international embarrassment that continues to grow. Already many other nations – including Canada, Australia, and Denmark – are warning dentists and parents about the risks of amalgam fillings in children. And now the European Union is joining them. For the first time, the European Commission’s scientific committee on health is recommending the use of mercury-free dental fillings instead of amalgam for children’s baby teeth and in pregnant patients.

In its final opinion on amalgam, the European Union government’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) concluded that “use of amalgam restorations is not indicated in primary teeth, in patients with mercury allergies, and persons with chronic kidney diseases with decreased renal clearance.”

Additionally, “it can be recommended that for the first treatment of primary teeth in children and for pregnant patients, alternative materials to amalgam should be the first choice.” We’ve come a long way since 2008, when this same EU scientific committee had promoted amalgam as safe for all. How did so much change in seven years? Here are a few factors:

SCENIHR specifically cites the Minamata Convention as a rationale, explaining that its position will “reduce the use of mercury-added products in line with the intentions of the Minamata Convention.”
European organizations, experts, and Consumers for Dental Choice devoted countless hours to submitting studies, delivering comments, and following up to make sure that this opinion protected vulnerable populations.
This step forward came right on the heels of last month’s announcement that the people of Europe – including many of you! –overwhelmingly voted to phase out amalgam use in the European Union during a public consultation.

This new scientific consensus clearly has the potential to protect millions of children, unborn babies, pregnant women, and people with kidney disorders from dental mercury exposure. But as we know from experience in countries like Sweden that have ended amalgam use, it is also an important step toward eliminating amalgam use entirely.

FDA’s Director Shuren – still in charge of the dental amalgam rule at FDA – backed himself into a corner when comparing the European and U.S. regulatory systems. He infamously claimed, “Under the EU system, the public are being used as guinea pigs… We don't use our people as guinea pigs in the U.S.” But the European Union is starting to protect its children while FDA’s own amalgam rule promotes using children as guinea pigs for a mercury product that FDA knows can cause harm and admits is not proven safe for children.

That Jeff Shuren felt compelled to deny that FDA uses Americans as guinea pigs for corporate profits begs the question. On amalgam, indeed, there can be no doubt that American children are being treated as guinea pigs. FDA admits it does not know if a 50 percent mercury device implanted an inch from the brain is safe for children under six. Yet FDA green-lights its use with no warnings, no disclosures – and even says it’s fine to deceive parents by calling these mercury products “silver fillings.”

Consumers for Dental Choice Is Reforming the Dental Marketplace

Moving the mercury-free dentistry movement forward isn’t just about battling the FDA. There are also marketplace barriers that block consumer access to mercury-free dentistry. For example:

Dental apartheid: Connecticut Medicaid mandates mercury fillings in molar teeth. Connecticut is the richest state in America, but apparently also the stingiest. Mercury-free dentists are ordered to send away parents who bring their children in for dental care. Working with Consumers for Dental Choice, Councilwoman Cynthia Jennings of Hartford is challenging that despicable practice, via an op-ed in the Hartford Courant and a public hearing scheduled for August 27 to spotlight this dental apartheid: Choice for the rich, mercury for the poor.
Fine print: Oregon Medicaid is better: if you read the fine print, the choice of mercury-free fillings is allowed. But hardly anyone knows that! Working with Consumers for Dental Choice, Commissioner Mary Starrett of Yamhill County is launching a campaign to make sure dentists inform Medicaid families that they too have a right to mercury-free dentistry.
Penalties: Many Aetna dental insurance plans charge a penalty for consumers who want mercury-free dentistry. So if you accept amalgam, your dental plan will pay for the whole thing, but if you insist on mercury-free fillings in back teeth, then you have to pay more out-of-pocket. Aetna knows that many families cannot afford the extra charge and has no problem consigning them to getting mercury in the mouth. Consumers for Dental Choice has launched a petition drive to end this practice, which we encourage you to sign. Insurers must quit pushing consumers to get mercury fillings!
The “silver fillings” deception: “Silver fillings” is the great deceiver. About one-fourth of Americans, quite understandably, think that amalgam’s main component is silver, not mercury. Thus, deceptive marketing works, unfortunately! We must stop the dental industry from using this term, and Consumers for Dental Choice’s campaigns can do that!

In the year ahead, with your help, Consumers for Dental Choice will continue to fight to break down these barriers so all consumers have access to mercury-free dentistry.