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 - the 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."
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
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 allegedly 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 the 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 the 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.
"Unprecedented" Public Outcry Against the FDA's Amalgam Rule
Consumers worldwide reacted harshly to the FDA's decision to continue the amalgam cover-up. Such a massive number of letters, e-mails, telephone calls, and faxes were generated that a leading journalist in the trade press, Jim Dickinson of FDA Webview, wrote:
"No final rule in FDA's modern history, or perhaps ever, has attracted this kind of organized opposition."
The American Dental Association sought help from the FDA to overturn state and local fact sheets that plainly warn of amalgam's risks, but Consumers for Dental Choice turned back a second assault on our right to know. In early 2010, in a dramatic confrontation in Philadelphia, the FDA backed off any suggestion it sought to weaken that city's fact sheet – and in fact asked the city to hold off acting because the FDA was considering its options.
The FDA threatened to retaliate against the leader of this grassroots opposition; its chief press officer wrote Commissioner Hamburg and Deputy Commissioner Joshua Sharfstein that the FDA needed to mount an "end game re: [Charlie] Brown."
Enter Negotiations for a Worldwide Treaty Addressing Mercury
Things turned our way in 2010. The nations of the world began a series of meetings to hammer out a treaty addressing all mercury. To its great credit, the United States not only was an active participant, but a leader as these negotiations began – negotiations to address all major uses of mercury, including amalgam.
With the Department of State, the Environmental Protection Agency, and the White House Council on Environmental Quality all seeking ways to phase out or at least reduce mercury in our society, the FDA became odd man out.
A noted attorney, Ellen Brown, called the breach between the FDA's protection of amalgam and the Obama Administration's stand the "Mercury Mischief."
Her article in the Huffington Post was headlined: "As Obama Warns of Hazards, The FDA Approves Mercury Dental Filling."
In June 2010 the FDA retreated, announcing it would reconsider the amalgam rule it had issued only 10 months earlier. The FDA announced it would convene a scientific panel in December to determine what changes need to be made.
December 2010 Hearings
Two days of testimony that were alternatively scientific and emotional were utterly convincing, even to scientists handpicked by the FDA. With no dissent, they recommended that the FDA promptly:
1. Make sure that all consumers and all parents know that amalgam is mainly mercury
2. Stop amalgam use for children and pregnant women
As panelist Dr. Suresh Kotagal – a pediatric neurologist at the Mayo Clinic – summed it up, there is "no place for mercury in children." Unprecedented press coverage accompanied these hearings, with every network and most major newspapers writing stories that the FDA is determining the health risk of amalgam.
FDA Town Meetings
But the FDA still did not act.
Instead, Jeff Shuren, director of its Center for Devices (amalgam is a device), organized three "town meetings" in 2011 to hear concerns about FDA policies.
At both Dallas and Orlando, the turnout was overwhelmingly about amalgam, and about the FDA's cover-up. Again, major press coverage about FDA inaction accompanied these meetings.
The third "town meeting" will be in San Francisco on September 22; if you live in northern California and would consider going, write Charlie Brown, email@example.com
On July 29 Director Shuren signaled he may act soon. In a letter to those who had petitioned FDA to act, Shuren wrote:
"We agree that the Panel [of scientists in December] raised issues concerning uncertainties with previous risk assessments on mercury vapor and sensitivities in certain populations to mercury released from dental amalgam. Note that we are currently considering our regulatory options for determining what steps the agency will take to address these concerns."
Mercury Free Dentistry Week: 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, firstname.lastname@example.org 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
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 email@example.com
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…[B]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.
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 firstname.lastname@example.org
Last but certainly not least, I encourage you to contribute to Consumers for Dental Choice. The Natural Health Research Foundation, founded by me, Dr. Mercola, will double match whatever you give this week. I believe that strongly in the mission, the commitment, and the quality of work of Consumers for Dental Choice and its Campaign for Mercury-Free Dentistry.
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