The Surprising 32-Year Scandal That's Kept This Toxic Substance in Your Head
By Dr. Mercola

The United States Food and Drug Administration (FDA), once the world's "gold standard" for food, drug, and device regulation, has evolved from industry regulator to industry captive.

Political scientists are not surprised. The evolution from tough regulator to passive regulator to industry captive is a pattern in Washington. Unless an agency engages in a major system of reinvigoration, the spiral continues. But the FDA seems comfortable being the hand-maiden for industry; it has brought big bucks to the agency and lucrative jobs after time at the FDA.

The big bucks are in the FDA's pay-to-play approval system. Drug companies pay seven-figure amounts into FDA coffers to gain approval of their drugs.

FDA staff knows that the cash means higher salaries and more perks in the agency budget. The drug companies know the high fees prevent small competitors with good ideas from getting their products to market. The coziness between the FDA and major drug and device companies gets tighter, while innovative entrepreneurs are shut out and the public loses twice: good drugs aren't being considered, and controversial drugs are rubber-stamped.

FDA: Captive of Corporate America
Another bitter legacy of federal regulation is the "revolving door," where insiders bounce between well-paid positions in industry, to high-ranking FDA positions that regulate that industry.

Those in the political party out of power hold cushy jobs awaiting their return to power, at which point – in the game of Washington musical chairs – those in the party leaving power in turn take the high-paying jobs in industry. The current FDA Commissioner, Margaret Hamburg, coming to FDA from Henry Schein, Inc., the largest seller of dental products and a major seller of medical products too, is a perfect example. Hamburg was a high official in the Clinton Administration, so Schein's CEO Stanley Bergman, an active Democrat, tapped Hamburg for the light work of being a board member during the Bush II years, paying her millions of dollars to likey sit in meetings and file occasional reports.

When Bergman's party returned to power in 2009, he escorted Hamburg back through the revolving door – as Commissioner of the world's most powerful food and drug regulator, the FDA.

FDA Covers Up Amalgam's Mercury from Consumers – for 32 Years
The dirty secret of conventional dentistry is this: those "silver fillings" aren't silver. They are mainly mercury – and mercury, of course, is a virulent neurotoxin that can kill babies in the womb, can cause permanent brain damage to children, and can cause irreversible kidney damage in adults (among many other things).

When industry is engaged in a cover-up of a health problem, the solution for the past century in America has been to turn to the U.S. FDA. But on amalgam, like on many health issues affecting our lives in recent years, FDA has been AWOL – focusing on blocking Americans' access to products Americans want and need and which are not harmful, instead of doing its legal duties.

In the case of amalgam, the violation of law was flagrant and continuing – and ultimately resulted in sharp language and a direct order from a United States federal judge. In 1976, Congress directed the FDA to classify (determine the risk of) every medical device. Dental fillings are a medical device. The FDA proceeded to classify all filling materials except the most common one – and the most controversial one – mercury amalgam.

Despite letters, petitions, Congressional hearings, and a lawsuit, the FDA refused to budge. The FDA had no intention of doing what, by law, it was required to do.

Why?

Because by classifying amalgam, the FDA would have to address the dirty little secret of dentistry ---they FDA would have to tell the American people that amalgam is mainly mercury. So instead of letting parents know that their child is getting a dose of the most toxic and the most volatile of the heavy metals, the FDA stood as the silent partner of the pro-mercury American Dental Association. For 32 years, from 1976 to 2008, the FDA defied the law. And they would still be doing so had not Charlie Brown and Consumers for Dental Choice sued them.

In 2008 Charlie Brown sued the FDA. United States District Judge Ellen Huvelle convened a hearing, and demanded to know why the FDA was refusing to classify amalgam. When the FDA's lawyer said the agency was working on it, the Judge was incredulous -- and ordered the parties into mediation to set a date to classify.

Since the FDA had not really started its work, and since its rule was still in the public comment phase, requiring clearance of all legal hurdles would require over a year. Hence, the FDA agreed to re-write its website in addition to classifying by August 2009. FDA Associate Commissioner Randall Lutter and Charlie Brown negotiated the website line by line, and, for the first time, the FDA issued this frank and serious warning about amalgam:

Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
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For anybody considering the removal of their mercury amalgam fillings - please read this article!

At the time my wife and I had ours done seven years ago, we contracted TB in that same period, and have always been at a loss of why our Immune systems when wonky on us. Now at least I have an answer, coz as a vegetarian and health nut, it was the last thing I expected!!


This Procedure Ruins Your Body's Ability to Detoxify Itself
By Dr. Mercola
With Consumers for Dental Choice

Dr. Dave Simone works with Consumers for Dental Choice to fight amalgam because he fully appreciates how deviating amalgam fillings can be to your health. Dental amalgam emits mercury vapor even after it is placed in your mouth. This mercury is bioaccumulative and endangers your health in many ways, which we'll review below.

I urge you to watch the interview I did with Dr. Simone in its entirety, or at least read through the transcript, as he covers far more than what this summary contains. For example, he explains how mercury actually inhibits its own elimination mechanism:

"[Y]ou make glutathione in the mitochondria of your cells. It's one of your 20 amino acids. Glutathione is your heavy metal detox amino acid. It grabs on to mercury, finds its way to your large intestine… you excrete mercury that way… [But] mercury inhibits the manufacturing of glutathione, so mercury stops its own elimination mechanism. [Hence] it bioaccumulates in your body. It also affects the Krebs cycle. So you're not producing ATP, your energy source."

Amalgam Endangers Your Neurological Health

The mercury in amalgam is a neurotoxin – and pro-mercury dentists are placing it an inch from your brain!

Vulnerable populations – such as children, especially unborn ones, hypersensitive individuals, and people with kidney impairments – are known to be particularly susceptible to the neurotoxic effects of dental mercury.

That is why the U.S. Food and Drug Administration's advisory panel on dental amalgam in December 2010 warned against the use of amalgam in vulnerable populations and insisted that FDA had a duty to disclose amalgam's risks to parents and consumers. As panelist Dr. Suresh Kotagal – a pediatric neurologist at the Mayo Clinic – summed it up, there is "no place for mercury in children." The FDA panelists are not alone. Other countries are already working to protect vulnerable populations, especially children, from exposure to amalgam.

For example:

The 47 nations of the Council of Europe just passed a resolution calling on the nations to start "restricting or prohibiting the use of amalgams as dental fillings,"1 explaining that "amalgams are the prime source of exposure to mercury for developed countries, also affecting embryos, fetuses (through the placenta) and children (through breastfeeding).
Exposure to mercury can seriously affect the health of both patients and dental professionals, and early exposure to low doses of mercury (during pregnancy and through breastfeeding) increases the risk of a decrease in the intelligence quotient (IQ) among children.… According to the World Health Organization in 2005, certain studies show that mercury may have no threshold below which some adverse effects do not occur."2
Australia's National Health & Medical Research Council (NHMRC) says amalgam should be avoided in pregnant women, nursing mothers, children, and people with kidney disease.3 As the government of the state of Queensland explains,

"Amalgam is now generally avoided for filling children's teeth. Growing children tend to be more sensitive to the effects of exposure to any chemical substance in their environment… High level exposure to mercury (which is present in silver fillings) may affect the kidneys. Therefore, the NHMRC, suggest people with kidney disease may be more concerned than others to minimize exposure to mercury."4

Health Canada directed its dentists to stop using amalgam in children, pregnant women, and people with impaired kidney function – way back in 1996.5

Amalgam Endangers Your Reproductive Health

It is known that the mercury from amalgam can cause reproductive harm – dental mercury even crosses the placenta and accumulates in unborn babies. Due to mercury exposure from amalgam in the workplace, dental workers – including dentists, dental hygienists, and dental assistants – are at particular risk for suffering reproductive harm. Studies have shown that dental workers have elevated systemic mercury levels.6 Many of these dental workers are women of child-bearing age, which makes them particularly susceptible to the occupational hazards associated with handling mercury.

Few dental workers employed by pro-mercury dentists are given protective garb or air masks to minimize their exposure to mercury. Many dental workers are not even aware of the risks of occupational mercury exposure. As a result, dental workers have reported serious health problems – especially reproductive failures and birth defects caused by amalgam in the workplace.7 Interestingly, both the American Dental Association and the amalgam sellers have admitted that amalgam endangers dental workers, and attempted to profit from it.

In a brochure on occupational health in dental offices, the American Dental Association (ADA) explains that:

"Exposure to mercury is a potential hazard for anyone in the dental profession who handles mercury or mercury-containing compounds….Office spaces may be contaminated with mercury from leaky amalgam capsules and from the lingering effects of spillage. High speed handpieces and ultrasonic compactors that vaporize mercury can lead to unsuspected inhalation." The brochure goes on to list the symptoms of dental mercury exposure, including "[g]rowing irritability, mood swings, and appetite loss…insomnia…tremors or numbness in the fingers…" But "[w]aiting for these symptoms to appear is far too late."

According to the ADA brochure, the solution is for dentists to buy an annual subscription to the ADA Mercury Testing Service for $75.00 per employee.

An advertisement from Henry Schein Inc., the leading amalgam seller, explains that amalgam's "toxic vapor is quickly absorbed and accumulated within your body's system, giving proven, long-term harmful side effects." The flyer urges dentists to "protect yourself now from the harmful effects of mercury vapor" by purchasing new amalgam storage containers for $60.99 or $26.49.

Of course, the most effective – albeit perhaps less profitable – solution is to prevent dental workers from being exposed to this unnecessary source of mercury in the first place.

Amalgam Endangers Environmental Health

Even if you do not have amalgam in your mouth, your health is still at risk from amalgam. Amalgam leaches into the environment via multiple pathways, polluting our water via dental clinic releases and human waste; our air via cremation, dental clinic emissions, sludge incineration, and respiration; and our land via landfills, burials, and fertilizer. Once in the environment, dental mercury converts to its even more toxic form, methylmercury, and becomes a major source of mercury in the fish people and other animals eat.

The environmental health effects of amalgam are well known, and have recently been reiterated by the United States Environmental Protection Agency: brain damage and neurological problems, especially for children and the unborn babies of pregnant women.

Amalgam Endangers Your Oral Health

In addition to all the neurological, reproductive, and environmental harm caused by amalgam, it turns out that amalgam even endangers oral health. It is well known that placing amalgam requires the removal of a significant amount of healthy tooth matter. This removal, in turn, weakens overall tooth structure, which increases the need for future dental work.8 On top of that, amalgam fillings, which expand and contract over time, can crack teeth and create the need for still more dental work.9

Superior modern alternatives preserve healthy tooth structure and actually strengthen teeth, leading to better oral health and less extensive dental work over the long-term.10

"These tooth-friendly features of resin-based composites make them preferable to amalgam, which has provided an invaluable service but which, we believe, now should be considered outdated for use in operative dentistry," concluded a recent study of composite use.11

Additionally, the mercury in amalgams can interact with other metals in your mouth, such as gold fillings and crowns, causing an increased rate of reduction and oxidation that results in overall higher levels of toxicity. The other challenge is the electric current generated by having two dissimilar metals in your mouth, which essentially creates a battery that has more current than the circuits in your brain. This current has actually been given a name and is called biogalvanism.

The Alternatives to Amalgam

Far from being an essential dental product with no viable alternatives, amalgam is interchangeable with many other filling materials – including resin composites and glass ionomers – which have rendered amalgam completely unnecessary for any clinical situation. In fact, the mercury-free alternatives are so advanced that entire nations, such as the Scandinavian countries, have stopped the use of amalgam.12 Already, about half of U.S. dentists are mercury-free and 77 percent of consumers who are told that amalgam contains mercury choose mercury-free alternatives.13

One of the most popular alternatives to amalgam is resin composite. Resin composite is made of a type of plastic reinforced with powdered glass. It is already common throughout the U.S. and the rest of the developed world, offering notable improvements over amalgam, as it:

Is environmentally-safe: Composite, which contains no mercury, does not pollute the environment. This saves taxpayers from paying the costs of cleaning up dental mercury pollution in our water, air, and land – and the costs of health problems associated with mercury pollution.

Preserves healthy tooth structure, because, unlike amalgam, it does not require the removal of significant amounts of healthy tooth matter. Over the long term, composite preserves healthy tooth structure and actually strengthens teeth, leading to better oral health and less extensive dental work over the long-term.

Is long-lasting: While some claim that amalgam fillings last longer than composite fillings, the science reveals this claim to be baseless. The latest studies show that composite not only lasts as long as amalgam, but actually has a higher overall survival rate.14
A lesser known alternative is increasingly making mercury-free dentistry possible even in the rural areas of developing countries. Atraumatic restorative treatment (also called alternative restorative treatment or ART) is a mercury-free restorative technique that has been demonstrated a success in a diverse array of countries around the world, including Tanzania, India, Brazil, Zimbabwe, Turkey, South Africa, Thailand, Canada. Panama, Ecuador, Syria, Hong Kong, Mexico, Sri Lanka, Chile, Nigeria, China, Uruguay, Peru, and the United States.

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Taking Action!!


Help Consumers for Dental Choice Fight the FDA

Consumers for Dental Choice is challenging the world's most powerful health regulator and the well-funded corporate interests that back it -- and you can help!

During this Mercury-Free Dentistry Awareness Week, I urge you to take action.

Here's what you can do:

Americans: Our number one problem is the Food and Drug Administration (FDA), which has partnered with the American Dental Association (ADA) to cover up the mercury; to make you think you are getting silver instead of toxic mercury in your mouth. The FDA intentionally conceals the warnings about amalgam deep in its regulation -- so parents will never see them. On its website, the FDA gives dentists the green light to continue to deceive consumers with the term "silver fillings"

"Americans are ready for the end of amalgam." This was the theme of the testimony to the U.S. Department of State on August 18 by former West Virginia state Senator Charlotte Pritt. Yes, Americans are ready. But FDA is not. So let's send them a message.Nine months ago, FDA scientists advised the agency to disclose the mercury to all patients and parents, and to stop amalgam for children and pregnant women. Yet FDA sits – sits actually in the pocket of the American Dental Association – ignoring its own scientists.

Please write the Director of FDA's Center for Devices, Jeff Shuren, jeff.shuren@fda.hhs.gov Ask Dr Shuren why the FDA continues to ignore scientists and covers up the mercury from American parents and consumers. Ask when the FDA is going to get in step with the world on mercury.

Dr. Jeff Shuren, Director
Center for Devices, U.S. Food & Drug Admin.
10903 New Hampshire Ave.
WO66-5431, Room 5442
Silver Spring, MD 20993-0002
Telephone: 301-796-5900
Fax: 301-847-8149
Fax: 301-847-8109

Californians: Dr. Shuren is coming to San Francisco for a "town meeting" on September 22. We urge Northern Californians to attend. It will go from 8 am to 12 noon, at the Embassy Suites Hotel, San Francisco Airport (telephone: 650.589.3400)

In Southern California, Consumers for Dental Choice is organizing a city-by-city attack on amalgam --- and needs volunteers. If you wish to help with the grassroots work of organizing for city council hearings, gathering petitions, and telephoning, volunteer by writing announcements@toxicteeth.org

Australians: Your government, Aussies, is now in last place on the mercury treaty, asking the world to throw in the towel instead of working to phase out dental mercury. A great new group has started, Australians for Mercury-Free Dentistry, led by dentist Lisa Matriste and consumer activist Anna Priest. We urge you to go to its website and join: http://www.mercuryfreedentistry.com.au/

Canadians: The chief dental officer of Health Canada doubles as a lobbyist for the pro-mercury World Dental Federation. Pretty outrageous, eh? We ask that you write Minister of Environment Canada Peter Kent at Minister@ec.gc.ca, and tell him that you as a taxpayer are amazed that Environment Canada is letting someone with such a conflict of interest influence the nation's treaty policy on amalgam. Ask him why Environment Canada is silent on amalgam, and if this is due to the fact that Canada's Chief Dental Officer was at the treaty sessions boasting that he "wears two hats," paid government employee and lobbyist for a special interest group.

Brits and other Europeans: The Parliamentary Assembly of the Council of Europe passed a resolution this spring calling for the end of amalgam. The Council of Europe is not the European Union -- it is every European nation, all 47 of them. Deputy Jean Huss drafted the meticulously-researched report upon which this resolution was based. This ground-breaking report explained that "[A]malgams are the prime source of exposure to mercury for developed countries, also affecting embryos, fetuses (through the placenta) and children (through breastfeeding)… Exposure to mercury can seriously affect the health of patients and dental professionals…etween 60 and 90 tonnes of mercury from dental surgeries are released into and contaminate Europe's atmosphere, surface waters and soil every year." Please thank Deputy Huss for his excellent work at Jhuss@chd.lu.

[b]Folks worldwide: If you aren't on that list, there's plenty to do – for example, Dominique Bally, an outstanding young advocate from the Ivory Coast, runs the Amalgam-Free Africa Campaign. If you want to help somewhere, anywhere, and there's nothing on the list above for you, write Charlie Brown at charlie@toxicteeth.org