The issue of the corruption in the Food and Drug Administration (FDA) is so huge, this is the first of several articles I’m writing to expose the agency’s large contribution to “the swamp” in Washington.
By Elissa Meininger – Health Policy Analyst
The swamp Trump promises to clean up. If you have even one “silver” filling in your teeth, this one’s for you.
Below is part of a 2011 article posted by Charlie Brown, head of Consumers For Dental Choice , and mastermind behind years of legal action to force the FDA to follow the law. It offers a bird’s eye view of how the FDA operates.
FDA’S Thirty Two Years of Concealing Amalgam’s Mercury From You...
I. Captive of corporate America: the US Food & Drug Administration
The United States Food and Drug Administration, 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 FDA seems comfortable being the hand-maiden for industry; it has brought big bucks to the agency and lucrative jobs after time at FDA.
The big bucks are in 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 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.
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 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, FDA.
II. FDA covers up amalgam’s mercury from consumers – for 32 years…
The dirty secret of traditional 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 irrevocable 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 US Food and Drug Administration. 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 FDA to classify (determine the risk of) every medical device. Dental fillings are a medical device. 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, FDA refused to budge. FDA had no intention of doing what by law it was required to do.
Why? Because by classifying amalgam, FDA would have to address the dirty little secret of dentistry — 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, FDA stood as the silent partner of the pro-mercury American Dental Association. For 32 years, from 1976 to 2008, FDA defied the law. And they would still be doing so had not Charlie Brown and Consumers for Dental Choice sued them.
In 2008 Brown sued FDA. United States District Judge Ellen Huvelle convened a hearing, and demanded to know why FDA was refusing to classify amalgam. When 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 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, 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, 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.”
III. FDA’s New Commissioner enters from boardroom of nation’s #1 seller of dental amalgam
During the time between the court settlement and final action, enter Margaret Hamburg as Commissioner – coming straight from the boardroom of America’s largest seller of amalgam.
To get appointed, Hamburg was required to sign an agreement promising (1) to sell her Schein stock and stock options and (2) not to participate in regulator matters affecting Schein while owning these options. Sign she did, but she apparently had her fingers crossed.
Selling her stock, Hamburg retained her stock options, which in a few weeks gained from being “under water” (no value) to having market value. Promising to cut her ties with Schein, she continued regular correspondence with Schein’s general counsel on her private e-mail. Charlie Brown wrote her June 1, 2009, to inquire whether she had recused (disqualified) herself from working on the amalgam rule. Not even answering, she convened a meeting with the American Dental Association’s best friend at FDA, dentist Susan Runner. On July 1, in a meeting whose notes are heavily expunged from public records requests, Henry Schein alumna Hamburg and pro-amalgam dentist Runner put together a disgraceful rule on amalgam, one that allowed continued concealment of the mercury, buried the warnings for children and unborn children so deep in the rule no one would find them, and allowed Runner to be FDA’s spokesperson to proclaim amalgam safe. At the end of July, Runner unveiled this monstrosity of a rule, along with a website that concealed all the language that Brown and Lutter had agreed to (Lutter by then having been shipped to another agency by Hamburg). Immediately after Runner’s announcement, Schein’s general counsel wrote Hamburg that Schein is “indebted” to her for her work as Commissioner.
Appalled at the ruling and Hamburg’s obvious ethics violations, Charlie Brown appealed to Senator Grassley, Head of the Senate Finance Committee, for an investigation. In his request, Brown provided all the sordid details but nothing came of it. In short, Commissioner Hamburg got away with hiding the previous cautionary warning and declaring mercury fillings perfectly safe.
It is important to note, Hamburg was head of the agency during the time when scientific “proof” that dental amalgams were safe was being sought for upcoming safety hearings, which involved conducting a study on 500 retarded orphans in Portugal victimized by pedophiles. The $11 million study was not just seriously flawed, but had major Nuremburg Code violations that resulted in Consumers for Amalgam Mercury Solutions filing a complaint at the Criminal Courts at the Hague.
Mercury Fillings Have Always Been A Sleazy Business of Concealment…
The arguments over whether mercury amalgams are safe go back to the 1830s when two French adventurers, now known in dental history as “the Crawcour brothers”, came to America to seek their fortune. By calling the mercury filling material they were promoting “royal mineral succedaneum” which the public associated with gold, they set up shop to revolutionize American dentistry and at the same time conceal the fact these “silver” fillings were actually mostly mercury.
At the time, the use of mercury in medicine was already a public fight between the pro-mercury allopathic physicians who founded the American Medical Association in 1847 and the anti-mercury homeopaths, who had founded The American Institute of Homeopathy three years earlier. Samuel Hahnemann, founder of homeopathy, made it quite clear just how bad mercury was to the human body. In his “Organon of Medicine” still a basic text for homeopaths he said:
“When physicians of the old school (allopaths) do not know what to do in a chronic disease, they treat it blindly with …..the horrible mercurialia (calomel, corrosive sublimate and mercurial ointment)….which they allow to act in such large quantities and for so long a time on the diseased body….that at last the health is by destructive effects completely undermined….”
Other medical groups such as the Eclectics (part anti-mercury allopath, part natural herbal medicine), Thomsonians (natural herbalists) , plus vegetarian groups, several religious groups that promoted prayer and natural healing modalities, all ran the other way when it came to consulting mercury-promoting allopathic physicians.
“Some thirty years ago I was very sick, and was considered fast wasting away with consumption. At that time I became so low that it was with difficulty I could walk about. I was all the while under the allopathic practice, and I had taken so much calomel (mercury) that my system was said to be poisoned with it; and I had lost many of my teeth from the effect. My symptoms were those of any consumptive; and I had been told that my liver was affected and my kidneys diseased, and that my lungs were nearly consumed. I believed all this, from the fact that I had all the symptoms, and could not resist the opinions of the physician while having the [supposed] proof with me. In this state I was compelled to abandon my business; and, losing all hope, I gave up to die—not that I thought the medical faculty had no wisdom, but that my case was one that could not be cured.”
Eddy had suffered bouts of chronic illness so severe she was often bedridden, so, once healed by Quimby, she founded Christian Science. She and her followers shunned allopathic physicians completely and chose to heal themselves and others by spiritual means. Mormons and Seventh Day Adventists, now the backbone of the natural dietary supplement products business, also openly shunned the use of mercury in medicine.
In the dental community, responsible dentists organized the American Society of Dental Surgeons (ASDS) in 1840 and made members sign a pledge never to use mercury fillings. They were unable to hold back the wave of dentists who liked these new, easy to place “silver” fillings and in 1859, pro-mercury filling dentists formed the American Dental Association (ADA).
Since then, the American Dental Association rose like the Phoenix as the great champion of mercury fillings, a position they still hold today, continuing to promote and defend mercury fillings as safe, still backed by the FDA, thanks to the handiwork of Commissioner Margaret Hamburg.
Despite the demise of the ASDS, many dentists continued to be very concerned about the safety of mercury fillings. In 1882, E.S. Talbot published a major article in the Ohio State Journal of Dental Science covering the history of amalgam fillings.
Over the years, Talbot reported case after case where removal of the fillings resolved the patient’s distress and how exposure to mercury was well known to “cause wasting, ptyalism (excessive salivation), necrosis (cell death) of bones, trembling, impaired intellect, and, in women, abortions.”
Talbot then described a series of experiments he and a professor of chemistry from Rush Medical College conducted, to see if mercury vapor was dangerous. The dental community believed that once mercury fillings were placed, they did not give off mercury vapor, the defense they used well into the late 1900s. Talbot’s studies included testing amalgam exposure to bugs (that died), near living plants (that died) and a guinea pig that suffered emaciation, trembling and cold limbs before he died after two weeks of constant exposure to amalgam filling material.
Talbot pointed out that according to eminent scientists, by inhaling mercury into the lungs, the vapor is then carried throughout all parts of the body. Let me translate this for you….Bolen Report’s own dental expert, David Kennedy, DDS, in his now world famous experiment showing mercury vapors. Check this out for yourself. Seeing is believing, except it appears the FDA and the ADA are both blind.
Talbot summarized from published scientific records that long exposure to mercury caused all sorts of havoc in the system including the digestive system, something that is still a controversy today as it relates to mercury in vaccines. Also noted, mental debility, neuralgic pains, and loss of memory was mentioned as mercury vapor was often the culprit.
Just so you know, back then, Ohio State Journal of Dental Science published over 880 pages of articles documenting how mercury fillings were extremely toxic, that amalgams were not stable and using them resulted in bad health and death.
While Talbot’s report was allopathic medical information, and based on simple bio-chemistry studies, by 1893, homeopathic doctor and dentist, Charles H. Taft, a professor of dental surgery and therapeutics in Herring Medical College in Chicago, wasn’t happy with mercury fillings either. He published a paper that he had presented to the Massachusetts Dental Society, covering the homeopathic point of view.
Taft’s paper, steeped in homeopathic technical jargon, boiled down to explaining energetic principles related to physics and the vital force, not chemistry or biology. In short, the energy resonating in just one filling was sufficient to make people sick, so the standard homeopathic procedure for chronically ill patients was to remove all mercury fillings from the teeth.
The most detailed paper ever written about what mercury vapor-caused symptoms are like, please read Dr. Alfred Stock’s famous paper published in 1926. Dr. Stock was one of Germany’s leading research chemists. In 1950, the German chemical industry established a prize in his name in recognition of his pioneering achievements in inorganic chemistry. Among his published work were 50 papers on various aspects of mercury and mercury toxicity..
Where Are We Now in the Great Mercury Fight?
To cut to the chase scene, the most recent “amalgam war” as it is often called, started anew in the 1980s when the late Hal Huggins, DDS, sounded the alarm and started training dentists on how to safely remove fillings. Dentists were cowed into not talking about what was in those “silver” fillings. Those who stood up found themselves relieved of their licenses to practice. Carolyn Dean, MD/ND and I wrote an article about this in 2005 called, “Lies Your Dentist is Forced to Tell You” . By then, the International Academy of Oral Medicine and Toxicology had organized in 1984 and a volunteer group named Dental Amalgam Mercury Solutions, had also organized around that time to push for change. Pressure from these groups forced the FDA to hold the first of two hearings on the safety of amalgam fillings in 1991.
In 1990, I conducted the first national study among dental amalgam victims in preparation for that hearing.
What I was looking for was to find out what people where doing to find a proper diagnosis and what they were doing to improve their health. Since “mainstream” allopathic doctors still don’t have a clue what this is all about, those who consulted MDs in my study, often ended up having all kinds of expensive, sometimes invasive treatments that only made matters worse. Most people, like me, ended up taking our business elsewhere.
The wide array of misdiagnoses I found in my study suggests to me that we have a nation of sick people who are either a big burden on our health care system or, more interestingly, are the basis of a massive “health freedom” movement that rises up, from time to time, to take on the political establishment to promote passage of laws to protect access to natural healing arts products and services.
I will expand upon this issue in future articles but what I want to say here is that I believe that there are countless people institutionalized today because their symptoms included neurological dysfunctions that were given medical names like bipolar disorder (aka manic depression), which the one doctor I consulted in the 1980s tried to hang on me. God knows how many others are diagnosed with mental disorders and are walking around in public drugged to the gills with buckets of psychotropic drugs that only fill the coffers of Big Pharma. These costs, of course, are never calculated as part of the fallout from the ADA and the FDA refusing to be honest about the dangers of mercury fillings.
Amalgam fillings are the number one source of mercury toxicity in America. Mercury exposure of most people with fillings exceeds government health standards and levels found to cause adverse health effects.
There is a Resolution to this Mercury filling Fight – and You Can Help…
While preparing this article, I contacted Charlie Brown for up-to-the-minute info on this issue and here’s what you need to know.
Currently, the FDA still maintains mercury fillings are safe and the agency is making no effort to promote the idea that dental patients have the right to know what’s in those “silver” fillings. Some states have passed laws requiring dentists to hand out information about what is in the fillings but, it appears that dentists are ignoring these laws.
Despite the stall tactics of Commissioner Hamburg, the future of mercury amalgams ended up in the hands of the United Nations. A treaty called the Minamata Convention on Mercury was created to protect human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds. President Obama signed the treaty in November of 2013.
Charlie has just issued an action alert (see below) for people to sign a petition urge the FDA to comply with the treaty.
European Parliament votes to ban amalgam
for children, pregnant women, and breastfeeding mothers…
By an overwhelming 663 to 8, the European Parliament voted last week for a comprehensive package to reduce mercury use, as required by the Minamata Convention on Mercury. Under this new European Union regulation:
Amalgam use in children under age 15 will be banned on 1 July 2018.
Amalgam use in pregnant women will be banned on 1 July 2018.
Amalgam use in breastfeeding mothers will be banned on 1 July 2018.
Each country in the European Union will be required to develop a national plan by 1 July 2019, laying out how it will reduce its amalgam use.
The European Commission must decide by mid-2020 whether to move forward with plans to phase out dental amalgam completely in the European Union.
This progress is the result of our team’s seven years of toil: building a united European coalition…meeting after meeting with government officials…submitting comments to one scientific committee after another…presenting testimony at a half dozen public hearings…organizing the grassroots… finding the right experts…and collecting signatures for petitions.
When we started, the European Union was the largest user of amalgam in the world – but that will change dramatically when this new regulation goes into effect in 2018. As the European Parliament explains in its press release, this new regulation “aims to phase out the use of mercury in dental amalgam by 2030.”
But we’re aiming to finish off this primitive, polluting mercury product even sooner – including in the United States. (After all, if we can win in the complicated European Union system, we can win anywhere!)
Today, Consumers for Dental Choice filed a petition that calls on the U.S. Food and Drug Administration (FDA) to act. It points out that while the European Parliament is taking steps to protect European children from amalgam, FDA’s 2009 amalgam rule fails to protect American children. To solve this problem, our petition urges FDA to follow the European Union’s example: ban amalgam use in children under age 15, pregnant women, and breastfeeding mothers….and then take the lead in championing a mercury-free future!
Now FDA needs to hear from you too! Please sign this online petition* telling FDA to catch up with the European Union. Then share it with your friends, colleagues, patients, and family.
Banning amalgam use in children and pregnant women was the step that led to the ultimate phase out of all amalgam use in Sweden. Now that the European Parliament has taken that first step, there’s no going back in Europe….and if we pull together, we can take this most crucial step in the United States too!
28 March 2017
By Elissa Meininger – Health Policy Analyst