SunToads Health News 281. Mercury - Amalgam - Fillings - FDA

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At 10:47 PM 7/15/07, you wrote:

Source:

http://www.bolenreport.net/feature_articles/feature_article067.htm

 

Bolen

Report

ARCHIVES

 

 

 

Majority DDSs (52%) now

mercury-free - Tipping point at hand!

 

 

By Charles G. Brown, National Counsel, Consumers For

Dental Choice

 

Monday, May 21st, 2007

 

The tipping point against mercury fillings, my

friends, has arrived. A dentist magazine surveyed its dentist

readers, and finds that 52% of American dentists now are

mercury-free.

www.toxicteeth.org/Mercury%20survey.pdf

Wow.

 

This new dentist majority brings colossal

ramifications upon America ’s protectors of mercury fillings -- the

American Dental Association and the Food and Drug Administration.

 

 

I wrote the head of the ADA to inform him that the ADA

has missed the boat by not exiting the mercury fillings business last

year. (I even went to Chicago in December to hand them a graceful

exit plan.) Choosing instead to stay mired in the

19th century, ADA ’s pro-mercury members are likely to be

picked off via lawsuits, one-by-ones. The ADA , I advised Dr.

Bramson, will morph into a numerical shadow of itself, as its members

wake up to the fact that this rallying around mercury has been a sham;

www.toxicteeth.org/52%25%20mercury-free,%20Dr.Bramson.pdf

With this new evidence, if the ADA refuses to warn its dwindling band

of pro-mercury dentists to abandon mercury, the ADA likewise will be

sitting in the litigation dock.

 

Our legal team -- Bob Reeves, Sandy Duffy, Kele

Onyejekwe and I – was on the brink of filing the re-match lawsuit in the

U.S. District Court, (Moms Against Mercury v. FDA II). But

FDA lawyers agreed at the 11th hour to a meeting. On May

10, they assembled a number of top officials, and I brought the nation’s

#1 food and drug lawyer on the consumer’s side, Jim Turner. We had

what diplomats describe as a “frank” session. By letter afterwards,

I asked FDA to meet with IAOMT ’s Science Advisory Board (see our web

site, www.toxicteeth.org,

third item); IAOMT ’s liaison, Dr. Rich Fischer, is following through.

 

 

As the summer opens, we begin a short intense period

where FDA will decide whether to abandon its policy protecting mercury

fillings and comply with the law, adhere to the science, and apply plain

common sense (the precautionary principle of health care) – or continue

its position that the health of children and pregnant women rank below

professional courtesy to the dental establishment. My fellow

lawyers join me in assuring you our powder is dry.

 

The press corps that cover FDA are closely following

our battle; see

www.toxicteeth.org/natCamp_BNA-FDAMAM.cfm

and www.toxicteeth.org/FDA%20Week%204.20.07.pdf

 

For your community (regardless of whether it has reached the magic 51% threshold), this development is huge. Regardless of whether you are a health professional or a consumer, please call in to talk shows; write a letter to the editor; write a letter to your state and federal lawmakers and your state dental board, with a message like this:

A majority of dentists are now mercury-free! Why are the old-fashioned dentists sticking with this primitive 19th-century device in the 21st century? It’s time to stop using mercury in dentistry.

 

Charlie Brown, 5/16/07

 

Charles G. Brown, National Counsel,

Consumers for Dental Choice

1725 K St., N.W., Suite 511, Washington DC 20006

Ph. 202.822-6307; fax 822-6309

charlie, www.toxicteeth.org

+++++++++

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

Bolen Report ARCHIVES

 

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.

Stay tuned...

Tim Bolen - Consumer Advocate

 

 

Copyright 2007 by Bolen Report

 

 

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