One of the biggest scandals in American health care is coming to a head this March 27th, 2007. In the United States Court of Appeals for the District of Columbia, a case, called “Moms Against Mercury, et al., v. FDA” will get its time in the sunlight, and the Defendant, the United States Food & Drug Administration (FDA) isn’t doing well in its Defense.
The case is simple. Citizens are suing the FDA for NOT, during the last THIRTY YEARS, ruling on the safety, or danger, of mercury amalgam tooth fillings. The Plaintiffs want mercury amalgam tooth fillings banned completely, and forever.
And, the FDA has virtually no defense…
The US anti-amalgam movement, an aggressive division of the North American Health Freedom Movement, has for years, chipped away at “official dentistry’s” promotion of mercury amalgam tooth fillings, pointing out, correctly, their inherent dangers. But “official dentistry” doesn’t listen, and in fact, actively punishes dentists that shy away from, or actively advertise the removal of, mercury amalgam fillings. The war has been active for a long time.
With this legal assault the anti-amalgams have adopted an effective offense. In essence, you might say, the anti-amalgam people, armed with silver bullets, have found the secret entrance to the FDA’s dungeon, climbed down into the sanctuary during the daylight hours, opened the coffins of the FDA’s sleeping staff dentists, sprinkled holy water over them, and driven wooden stakes through their hearts. So to speak.
This case can be the decisive blow – for the FDA attorneys don’t have very good answers. The case reads:
SUMMARY OF ARGUMENT
Thirty years after being directed to classify all devices, 20 years after classifying all other dental fillings materials, 13 years after being mandamused to classify but winning on exhaustion grounds, nine years after specifically promising (in writing) to classify, four years after pleading no excuses to Congress for not classifying, it’s clear that FDA’s policy is not to classify encapsulated mercury amalgam. To say FDA ignores this issue is incorrect: FDA’s public relations machine is has been in high gear, as the Center for Devices bobs and weaves about its duty to classify through three “literature reviews,” three “consumer updates,” one “white paper,” and a plethora of sound bites.
The decision not to classify – a plain violation of the statute – is thus a reviewable decision.
FDA’s choice of cheerleader for amalgam, instead of regulator of amalgam, is not acceptable. FDA otherwise bans, limits, and warns against other products, drugs, or foods containing mercury, while other federal health agencies and the health regulators of other nations condemn mercury amalgam.
FDA not only ducks classifying, but also refuses to do an environmental assessment, which would plainly indicate the need for an environmental impact statement. Nor will FDA seek a timely and valid panel recommendation – the previous one being too old (1994), procedurally invalid (no statement for departing from Class III), and sub silentio overruled in September 2006. The writing is on the wall in both cases: An environmental assessment will plainly indicate the need for an environmental impact statement, which report would show alternatives to toxic mercury can be used in fillings, thereby eliminating the major source of mercury in the nation’s wastewater – amalgam. In September, the FDA panel decisively rejected the FDA staff’s pseudo-science about amalgam (e.g., it is safe because it’s been used for a long time), so FDA ducks asking the panel for formal action.
FDA keeps amalgam on the market via a sham substantial equivalence test, pretending that a powder half-device containing no mercury equates to a full device capsule that is 50% toxic mercury. When asked by Senator Kennedy why this practice is allowed, Commissioner Von Eschenbach in writing denied that FDA considers the two devices to be substantially equivalent. Since the staff has ten times approved amalgam under this test in the past six years (and many times before that), perhaps the Center for Devices is engaged in rogue activity unknown to the Commissioner’s office.