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

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

Advocate  Tim Bolen  

http://www.bolenreport.net/feature_articles/feature_article053.htm

Monday, March 19th, 2007

 

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 "

http://www.toxicteeth.org/Brief-MAM-FDA.pdf 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,â€

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.â€Â 

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 fillingsâ€; 

“

constantly changing scientific evidence†exists on mercury amalgam; 

“complex

issues and intense disagreement [exist] about the scientific evidence

regarding mercury and its potential health effectsâ€;  “the complexity of

the issue

and the lack of conclusive scientific evidence on the health effects of dental

amalgamsâ€;  “the lack of … definitive scientific evidence.â€

 

Let's see what happens next. 

 

Stay tuned...

 

Tim Bolen  - Consumer Advocate