FDA "Backs Down(?)" Over Deadly Mercury Amalgams...

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.

The correct recourse is not a mere order to classify, allowing an unclassified, unregulated device – with 50% mercury and for which substitute materials are legal and available for any dentist to place – to remain in commerce, but to remove it from commerce temporarily until FDA complies with its legal duties.

CONCLUSION

This Court must direct FDA to start being amalgam’s regulator instead of amalgam’s cheerleader. Whether by intention or lethargy, FDA’s Center for Devices has protected the marketing of mercury fillings by doing none of its regulatory duties – neither classifying nor requiring proof of safety nor doing an environmental assessment nor seeking a valid recommendation from the scientific panel. Since they have ducked and dodged classifying encapsulated amalgam after classifying all other dental filling materials in the 1980s, the mercury apologists at the Center for Devices by now realize that completing any of these tasks will lead straight to the end of mercury in dentistry.

Thus, an order to classify is not enough. The legal prerequisites (environmental impact statement and Panel referral) mean the process will take months; the record of bad faith suggests it will take years. Amalgam is illegally in commerce. It must be removed from commerce forthwith, temporarily, until FDA chooses to complete its regulatory duties.

What was the FDA's response to this legal action?

Not much.

Charlie Brown, two-time elected Attorney General for the State of West Virginia, and now attorney for the Plaintiffs, says of the case:

Our case, filed April 27, 2006, by 9 petitioners (names below)* charges FDA with illegally allowing the sale of mercury fillings. For thirty years, FDA has defiantly refused to classify amalgam -- even though this step is required as the legal prerequisite to sale of any implants. Even the repudiation of its pseudo-science by two FDA Scientific Panels on September 7, 2006 has not deterred FDA, who is making false and deceptive claims to mask the vote of these Panels.

Faced with standing before a federal court, FDA now departs from its role as chief cheerleader for mercury fillings. In its brief, FDA admits, five times, that it does not know if mercury amalgam is safe or unsafe!

The nine petitioners who sued FDA: Four organizations: Moms Against Mercury (Amy Carson, Angela Medlin), Connecticut Coalition for Environmental Justice (Mark Mitchell, M.D.), Oregonians for Life (Mary Starrett), and California Citizens for Health Freedom (Frank Cuny); two state officials: California Dental Board Public Member Kevin J.Biggers, and Arizona State Senator Karen Johnson; three individuals: Dr. Andy Landerman, Linda Brocato, and Anita Vazquez Tibau.

This is a breakthrough not thought possible a year ago. To repeat, FDA now admits that the evidence is “changing,” thus the safety of mercury fillings is not “definitive” and is “the subject of intense disagreement.” Quotations from FDA’s brief, containing those admissions, are below.**

FDA’s admissions in its brief to the US Court of Appeals: “there is a lack of conclusive evidence regarding the health effects of mercury fillings”; “constantly changing scientific evidence” exists on mercury amalgam; “complex issues and intense disagreement [exist] about the scientific evidence regarding mercury and its potential health effects”; “the complexity of the issue and the lack of conclusive scientific evidence on the health effects of dental amalgams”; “the lack of … definitive scientific evidence.”

Let's see what happens next.

Stay tuned...

Tim Bolen - Consumer Advocate