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
