FDA Backs Down Over Deadly Mercury Amalgams

[Guest guest]

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

Opinion by Consumer Advocate Tim Bolen  

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 " 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.

 

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.

 

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[Guest guest]

Thanks for this Loretta. Are you keeping in touch with the outcome

of this court case? I was aware of it sometime ago but with one thing

and another the last few months lost track of what was happening. It

is good to know it is still going strong. I am keeping my fingers

crossed on this one! Would you know of an url which I can keep

checking for updates by any chance? I am still trying to catch up

after being off the computer of 2 months - I now have first hand

knowlegdge of the foolishness of downloading unknown programs when

one has bad brainfog.

best wishes

Shan

, " Dr. Loretta

Lanphier " <LorettaLanphier wrote:

>

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

> Opinion by Consumer Advocate Tim Bolen  

> Monday, March 19th, 2007