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.
IV. “Unprecedented” public outcry against FDA’s amalgam rule
Consumers worldwide reacted harshly to 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 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, 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 FDA was considering its options.
FDA threatened to retaliate against the leader of this grassroots opposition; its chief press officer wrote Commissioner Hamburg and Deputy Commissioner Joshua Sharfstein that FDA needed to mount an “end game re: [Charlie] Brown.”
V. Enter the 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, 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 FDA retreated, announcing it would reconsider the amalgam rule it had issued only ten months earlier. FDA announced it would convene a scientific panel in December to determine what changes need to be made.
VI. December 2010 hearings
Two days of testimony that were alternatively scientific and emotional were utterly convincing, even to scientists handpicked by FDA. With no dissent, they recommended that FDA promptly (1) make sure that all consumers and all parents know that amalgam is mainly mercury; and (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 FDA is determining the health risk of amalgam.
VII. FDA Town Meetings
But 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 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 need 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.”
VIII. Help Consumers for Dental Choice Fight 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!
Please consider a donation to Consumers for Dental Choice, a 501(c)(3) non-profit organization dedicated to advocating mercury-free dentistry.
Donations can be made online at http://www.toxicteeth.org/donate.cfm. Checks can be mailed to:
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