On Nov. 8, Leo Cashman, DAMS (support group) wrote:
"There has been no written FDA statement confirming that amalgam is a class III device. So, let's be cautious and keep our actions focused."

The whole message:
Dear DAMS Board & networkers,
We have probably all seen recently broadcast e-mails declaring a huge
win, saying that FDA has declared that amalgam is a class III device and
that the use of amalgam is already now technically illegal under the new FDA
classification.
But there has been no definitive declaration about these matters from the
FDA itself and Charlie Brown, who is much closer to the center of the action
with the FDA, is unwilling to make such a declaration of victory.
In October, Anne Ferreira, Charlie, Carol Ward and others met with Dr.
Feigel, who is head of devices at FDA, and ranks above Susan Runner, DDS and
her ADA oriented minions. It seemed to be a good meeting and promising, but
there has been no written confirmation yet (as of Nov 4, 2002) of what
Feigel and the FDA is doing about the Class III question.
The other promising development occurred in connection with the Senate
Health Committee's hearing and approval of Dr Mark McClellan, MD, as the new
FDA Commissioner. Dr. McClellan was "boxed in" on the amalgam issue by being
asked questions by Sen. Ted Kennedy and others about the mercury amalgam
issue. He made the following commitments:
1) yes, he promised to consult with the White House Task Force on Mercury in
dealing with the amalgam question, and
2) yes, the FDA's rule on amalgam would need to be consistent with other FDA
policies on mercury, and
3) yes, the FDA's rule on amalgam would have to be based on up-to-date
science.

Credit goes to Rep. Diane Watson for using her democratic connections for
getting the necessary questions raised in the hearing for Dr. McClellan.

But, there has been no re-write of the FDA's "Consumer Update" on amalgam's
safety - yet. There has been no written FDA statement confirming that
amalgam is a class III device. So, lets be cautious and keep our actions
focused.

The above developments points to the interplay between our congressional
activism and the positive developments at the FDA. We must not stop our
currents efforts, but rather continue them, focused on the November 14th
hearing in the Committee on Government Reform. We would be seriously
mistaken to presume the we have achieved the end of amalgam now through a
presumed victory via the FDA.
Instead, we must keep activists focused on educating Congress members on the
dental mercury issue so that perhaps we can have an FDA victory and a
victory in other ways. On Burton's committee, there are certain key states:
California, Florida and New York each have five members on this committee.
Charlie and Freya are preparing a memo asking for all activists to focus
right now on contacting the 40 members of Congress who sit on Burton's
committee. Freya will list the contact information for these 40 members.
Charlie is also asking for those who can to attend the hearing at the US
Capitol and, while there, stop by the offices of their Congress members and
Senators and lobby them and their staff (bring literature and written
statements to leave with them).

Leo Cashman, manager DAMS

November 2, 2002

BURDEN OF PROOF SHIFTED TO AMALGAM MANUFACTURERS & ADA TO PROVE SAFETY

Dr. Susan Runner, Centre for Devices & Radiological Health at the FDA thought that the old argument, “mercury had been used safely for 100 years” would be all that was required to prove the safety of dental amalgam when she moved dental amalgam from it’s previous status as a ‘grandfathered, non classified material’, to a ‘Class III Medical Device’. The plan was to use this old tired argument to have dental amalgam moved to Class II status, where it would have been used and marketed as ‘SAFE’.

But the plan fell apart when the acting Director of the FDA determined in his wisdom that Runner’s argument did not hold water. As a result mercury dental amalgam will remain a Class III device in the USA, and cannot regain its’ previous grandfathered status, until such time as the safety and effectiveness of mercury dental amalgam is proven with peer reviewed published studies.

Apparently, now in a dramatic turn of events, the FDA is in the process of establishing a new review panel, which will consist of Dr. Boyd Haley among others, who’s responsibility it will be to review the validity of science submitted, supporting the purported safety of dental amalgam. But until then, it appears that in the USA, that mercury dental amalgam can only legally be used in University Sponsored Investigational Review Board studies or in life threatening situations.

FDA PROPOSED RULE

Media Inquiries Contact
Communications Department
Talk International.com
communications@talkinternational.com
www.talkinternational.com

Showing real chutzpah, the ADA has adopted a new legal strategy: sue our dentists, not us!

The ADA is facing lawsuits in half a dozen states for its seminal role in implanting mercury into the bodies of American children. In Maryland, lawyers for the ADA and the Maryland State Dental Association have filed papers saying that dentists, not the dental associations, would be the proper parties for injured consumers to sue. Thus, instead of acting to protect its dues-paying members, the ADA gives a green light in its court filings to sue them!

We have said for years that the ADA can't serve two masters who send it money, the mercury amalgam manufacturers and the dentists. When it's crunch time, we see which side the ADA saddles up to.

Actually, the American Dental Association IS to blame for this situation: Dentists who join must subscribe to the ADA code of ethics, including its notorious gag rule about the risks of mercury fillings.
If the dentist initiates a conversation to warn the patient or the parent about the virulent toxicity of mercury (even manufacturer warnings), then he/she could violate the gag rule, or a state dental board interpretation thereof.
If the dentist stands silent, he/she stands naked to lawsuits for failing to warn the patient or parent about the risks. In other words: Talk, and the ADA goes after you. Don't talk, and get sued. For us, the moral solution is obvious: patients are more important than the ADA. The ADA, too, has a simple solution for its Gordian knot: Sue the dentists!

Charlie Brown, Lawyer

The evidence: Quotations from the briefs. From the Brief by the ADA, October 17, 2002, to the Circuit Court for Baltimore County, footnote 5: "Even if she could recover for Dr. (name omitted)'s offer to 'redo' her dental amalgam, (injured plaintiff)'s pregnancy at the time that he made this offer illustrates why Plaintiffs' claims must fail. Dental amalgam manufacturers warn dentists that 'amalgam fillings should not be placed in patients with known allergies to mercury, in patients with severe renal deficiency, in children six years of age or lower, or in expectant or nursing mothers.' (Second Amended Complaint, at para. 18). Yet even though Dr. (name omitted) may have disregarded this warning by offering to redo Ms. (patient)'s dental amalgam, Plaintiffs ask this Court to hold the ADA liable for his actions."

From the Brief by the Maryland State Dental Ass'n (MSDA), page 17: "As previously pointed out, the only allegations of misrepresentations and omissions as to the Plaintiffs relate to the alleged misrepresentations and omissions made by their dentists. . Any alleged misrepresentations or omissions on the part of the identified dentists, and any alleged reliance by the Plaintiffs thereon, cannot be binding on the MSDA, a nonprofit dental trade association."

Press Release Uppsala 16th Oct. 2002

Breakthrough for the Bionic Man

New Swedish biomaterial integrates with human tissue

Background:
In October 2000, the new directly applicable ceramic dental material, DoxaDent, was launched, a material that needs no cement for its application, which gave new hope to many sensitive patients world-wide. Information was published in the Heavy Metal Bulletins No. 2 & 3, 2000. Now a group of Swedish researchers, including those behind DoxaDent have produced a completely new biomaterial with unique properties. The new material integrates with bone tissue so that no join is visible even down at atom level. Sounds almost too good to be true...See press release below.

A group of Swedish researchers have produced a completely new biomaterial with unique properties.
Tests show that the new material integrates with bone tissue so that no join is visible even down at atom level.
"This is one of the most important advances since it was discovered that the human body will accept titanium implants," comments Professor Peter Thomsen of the Department of Biomaterial Science, Sahlgrenska Academy at Gothenburg University.

Many parts of the body can be replaced or substituted by artificial components made of biomaterials. At present this is done using metals, various plastics, bioceramics and similar materials.

The major difficulty up to now has been getting the body to accept implants and above all, to get them to stay firmly in position. However, five months ago, a team of researchers at Doxa AB led by Professor Leif Hermansson found the unique solution. Their discovery involves total integration of the biomaterial with bone tissue - an integration taking place directly in the body.

Historic Discovery

"This is a historic discovery with enormous potential. For instance, the technique lends itself naturally to dental restoration, where the composites in use today can shrink after a while, resulting in secondary caries. The new material cannot shrink or cause a gap against the tooth wall because it integrates with the tooth," adds Professor Peter Thomsen.

"Odontology, orthopaedics and plastic surgery are areas where this technology can usefully be applied. In cases of osteoporosis or fractures, the innovative technique can help produce new bone which is much stronger than using any currently available materials. Furthermore, patients suffering from rheumatism or cancer causing orthopaedic implications, will also benefit from the technique," Lars Magnus Bjursten concludes, Professor of Bio-implant Research at Lund University.

Doxa's discovery is a directly applied ceramic material known as the "CAH-HAP system," CAH referring to calcium-aluminate and HAP to hydroxyl-apatite, the mineral found in bone.

The unique reaction takes place when calcium-aluminate interacts with body fluid or water containing phosphate to form the body's own ceramic - apatite. All the fluid enveloping the calcium-aluminate is used up in the reaction resulting in all the water-filled areas being replaced by solid material. In consequence, a compact body is formed, making it impossible to discern any boundary between bone tissue and the implant.

The new ceramic material has numerous positive properties. It is very durable and chemically stabile. It displays thermic properties similar to those of cortical tissue, is both biocompatible and environmentally friendly. The ceramic is also easy to form and work with, and is formed directly in situ in the body at normal body temperatures.

Peter Bramberg, CEO Doxa

Further information will be provided a.s.a.p on this website.

New study
Heavy metals in autism

Monday, July 22, 2002 4:01 AM
Subject: The SCHAFER AUTISM REPORT

Scots Study On Autism Poses New Question of MMR Link

A scientist in Scotland presented new research which could indicate a link between autism and the MMR vaccine by showing that
autistic children have abnormally high levels of toxins, such as lead, aluminium and antimony, in their bodies and therefore may not respond properly to the MMR vaccine. Levels of antimony in autistic children were five times above the
normal maximum range and levels of lead and aluminium were three times higher. Antimony can cause fatigue, hypotension, angina, and immune dysfunction. All 24 children with autism who took part in the study were found
to have antimony present above the recommended maximum values, compared to 50% of the eight non-autistic children tested, and 40% of the five children with Asperger's Syndrome. The study raises hopes that autism may not be genetic and instead be a physical, and therefore potentially treatable
http://click.topica.com/maaarZuaaSSXba4L83ob/

DO SOMETHING ABOUT AUTISM NOW
Subscribe, Read, then Forward the Schafer Autism Report.
To Subscribe http://click.topica.com/maaarZuaaSSXda4L83ob/
                   No Cost!

Amalgam & autism
First case filed in the U.S. linking mercury dental amalgams to autism. In the suit, lawyers for Kathy Galeano allege that her nine amalgam fillings released enough mercury into her system during her pregnancy to help cause her son Daniel, now 5, to develop severe autism.
http://www.khorrami.com/

Anti-amalgam breakthrough in Norway

This message originates from "Maryanne Rygg", Norway.
Datum: Fri, 31 May 2002 08:54:52 +0200
Subject: Anti-amalgam breakthrough in Norway

A long-awaited breakthrough in the war against amalgam was announced on
Norwegian radio this morning (31 May). The Norwegian Directorate of Health
and Social Welfare has announced that it will be sending its new guidelines
for use of dental materials out for hearing in a couple of weeks, and
expects them to take effect from 1 January 2003.

The director for the Norwegian Directorate of Health and Social Welfare was
interviewed, and said that the health authorities now recommend that
dentists no longer use amalgam on their patients. He said that the new
guidelines are based on newer research that has revealed how mercury leaks
from amalgam in the mouth of patients. The announcement was called a
"turn-about" by the Norwegian radio. The current president of the Norwegian
Dental Association was also interviewed, and said that the Norwegian Dental
Association was satisfied that the guidelines stop short of a full ban on
amalgam, and that freedom of choice is still possible. He also said that
there has been controversy around the use of amalgam for 100 years, and that
the Dental Association would not defend amalgam "at any price". The current
president of the Norwegian Dental Association works in an amalgam-free
dental practice, and has not used amalgam for many years.

Unfortunately, the 10-page document is still labelled as confidential, until
it is sent out for hearing in a couple of weeks. In the meantime, I intend
to use time to carefully translate it to English. We have been told that it
will be published (in Norwegian) on the website of the Norwegian Dental
Materials Adverse Reaction Unit (http://www.uib.no/bivirkningsgruppen/), but
it has not appeared there as yet. I expect it will also be published on the
website of the Norwegian Dental Patient Association (www.tenneroghelse.no)
as soon as possible.

My own comment is that this document contains many statements that our
anti-amalgam movement has claimed for years, and that we have repeatedly
asked the Norwegian health authorities to publicly endorse. Now they have
done so, although there are still a few sentences in the 10-page document
that will continue to be disputed. Although the document states that the
overall aim is to phase out the use of amalgam, the guidelines do stop short
of a complete ban on the use of amalgam. It will still be possible for
adult patients who insist on amalgam, to receive an amalgam filling.
However, when the statements about amalgam which are contained in this
document are made public, it would surprise me if anyone would still choose
to have amalgam installed in their mouth.

Maryanne Rygg
Norway

Dentists in Norway encouraged to use less amalgam!

PRESS RELEASE FROM THE NORWEGIAN DIRECTORATE FOR HEALTH AND SOCIAL WELFARE
Post Box 8054 Dep, N-0031 Oslo, Norway
Telephone: (+47) 2416 3000
Fax: (+47) 2416 3014
www.shdir.no

THE DIRECTORATE FOR HEALTH AND SOCIAL WELFARE ENCOURAGES DENTISTS TO REDUCE
THE USE OF DENTAL FILLING MATERIAL AMALGAM

The Directorate for Health and Social Welfare is now in the process of
sending out for public comments a draft "Directive for the use of dental
filling materials" that are to be used in dental health services. In this
directive the Directorate for Health and Social Welfare encourages dentists
to reduce the use of amalgam as much as possible. This is to be done by
considering if it is possible to use an alternative to amalgam every time it
is necessary to install a filling. The Directorate does not encourage
replacement of existing amalgam fillings.

This request to use less amalgam is not based on one single research report,
but rather on an overall assessment of research and experience that has been
collected since the former Health Directorate published guidelines for
dental filling materials in 1991.

The Directorate for Health and Social Welfare has considered public health
and the environment to be vitally important when formulating the directive.
This directive shall ensure the public good dental care with safe materials
that satisfy present-day demands. Newer materials require removal of less
tooth substance than amalgam when a filling is to be installed. This means
that use of newer materials conserves tooth substance in a satisfactory
manner. A lower mercury burden for the general population and less mercury
released to nature will be the long-term gains.

The deadline for written comments is 1 October 2002, and the directive is
expected to take effect 1 January 2003. The draft directive may be found on
the Directorate's website at http://www.shdir.no/index.db2?id=1430 (in
Norwegian).

News Release 

For Immediate Release


High Profile Law Firm Seeks Justice for Mercury Amalgam Dental Filling
Victims

2/4/2002 9:44:44 A.M. - Victims cases are now being reviewed for
consideration for immediate filings across the U.S.A.

If you have been injured by mercury fillings, or have had mercury fillings placed without your consent or without knowing of the potential adverse health effects, now is your opportunity to have your case heard. The science and the experts are on side.

Of particular interest are cases where specific dentists have provided misinformation, about mercury dental fillings, but all potential claimants are invited to submit application/questionnaires. Attorneys will be in touch with all applicants immediately after receipt and review of questionnaires as they are submitted.

Questionnaires may be obtained at http://www.talkinternational.com/hg_filling_questionnaire.pdf and may be faxed to (705) 788-7364, or sent by regular post to the address provided.

These are not class action suits. Legal actions are being selected and filed on an individual basis. Only those who have completed in full and submitted questionnaires in the form provided to us will be considered for participation.

Wayne Obie
Media & Public Relations
Talk International.com
http://www.talkinternational.com/
communications@talkinternational.com

In a bold and exciting move, Governor Gray Davis has picked Dr. Chet Yokoyama to the California Dental Board. Chet, a prominent and reputable mercury-free dentist in L.A., is a member of all three major dental societies who oppose mercury dental fillings: the Int,l cademy of Oral Medicine & Toxicology, the Am. Academy of Biological Dentistry, and the Holistic Dental Ass,n.

It's been such a great summer for the cause of mercury-free dentistry.
Therefore, I am happy to present the summer's top ten accomplishments (as is the current custom, in ascending order).
Let me say I am proud of our great movement and the men and women who are part of it! The drum roll -- and here we go:

10) Ohio news conference continues momentum.

In front of several TV cameras, Representative Annie Key announces bill to ban mercury fillings for Ohio children and pregnant women, making Ohio the 8th state to have such a bill.

9) ADA wimps out in lawsuit against Khorrami.

Amidst great braggadocio, the ADA sued Shawn Khorrami, the nation's top anti-mercury lawyer for daring to say mercury fillings are dangerous for children. But the ADA was too timid to serve him, waiting four months until a reporter smoked them out. The ADA bigwigs don't want to face Shawn in court - they just want to talk about it.

8) State legislators across USA renew efforts against mercury fillings.

Assemblyman Dick Dickerson (R-Calif.) introduced a resolution against the FDA regulation (see (3), below). Representative Johnny Rogers (D-Ala.) promises major action in 2003, as do Rep. Bob Holmes (D-Ga.), Reps. Karen Johnson & Debra Brimhall (R-Ariz.), and Rep. Mary Flowers (D-Ill.) Sen. Mike Michaud (D-Me.) and Rep. Hal Lynde (R-N.H.) passed their bills this year. And there's more: Mike Michaud won his party's primary for the United States Congress, and could become the East Coast Diane Watson if he wins. You can find Mike at 213 Lisbon St., Lewiston, ME 04240.

7) Litigation against ADA marches forward.

Cases are now filed against the ADA in several states, including California, Maryland, and Georgia. The ADA and the state dental associations have lost every single motion they have made to dismiss the cases.

6) Burton, Watson to host Congressional hearings.

Folks, Congressman Dan Burton will soon be presiding over hearings on this issue, probably in early October. Congresswoman Diane Watson, a member of his committee, is assisting in preparing for this potentially momentous event.

5) Kelly Gallagher documentary on the brink.

This independent film-maker has chronicled the movement for the past two years, and is completing a movie about it.

4) "Dentist the Menace" report shows mercury's #1 source in wastewater is dental offices.

Michael Bender of the Mercury Policy Project, joined by the Sierra Club and Health Care Without Harm, unveiled a major report showing that the #1 cause of mercury in our wastewater is (but you already know this) dental offices. The report received major coverage in many of the nation's leading newspapers.

3) Consumers for Dental Choice organizes campaign against FDA rule.

The FDA is trying to cover up the risks of mercury fillings, and we are organizing the truth squad. Mary Ann Newell is receiving all submissions, to make sure the FDA hears from us. Submissions are due Sept. 16.
Friends, this is a major -- a gargantuan, in fact - barrier to our movement. If you have not written the FDA, you must do so now. Address your concerns to the FDA, and e-mail them to Mary Ann Newell, Vancouver, Washington: BullElkMan@aol.com.

2) Dental Board Committee Chair Yokoyama proposes California recommend no mercury fillings for children, pregnant women.

The president of the new California dental board, Dr. Alan Kay, appointed Dr. Chet Yokoyama, a mercury-free dentist, to chair a committee to write a consumer-friendly "fact sheet" about the risks of mercury fillings. At the August meeting in San Francisco, Dr. Yokoyama proposed that the Board recommend that children and pregnant women not receive mercury fillings. He will hold hearings on this issue in November in Los Angeles.

1) NAACP national conference endorses ban for children, pregnant women.

In a historic breakthrough, the annual convention of delegates of one of our nation's oldest and most respected organizations endorsed the Watson-Burton bill, and called for a ban on mercury fillings for children, pregnant women, and nursing mothers. Meanwhile, standing up to huge
pressure from organized dentistry, the National Black Caucus of State Legislators stood firm on its resolution supporting Watson-Burton. To witness the leadership by African-American organizations in pointing the way - certainly something we have seen before in our recent history - is gratifying indeed.

Summary:
Prohibition of the utilization and commercialization within the Italian territory of not predosed dental amalgam; because

• the emission of mercury vapours during the use of the not predosed dental amalgam could compromise the health of both dental workers and the patients
• there is a risk of of mercury over-dosage in the fillings when amalgams are not prepared from the predosed capsules
• the existence on the market of predosed amalgams enables to reduce the emissions of mercury vapor during the preparation of the dental amalgam and to standardize the quantity of mercury.

Precautionary measures and warnings to be included with dental amalgams sold in Italy, because

• certain groups of the population have higher susceptibility (children, pregnant women, etc.) and need a higher level of safeguard,
• the exposition to mercury can become elevated as a result of certain situations where higher levels of mercury exposition are reached
• for the general population there exists multiple sources of mercury exposition (such as
  food, environmental pollution, drugs, etc.)

there is a need for dental workers as well as patients should be informed of the
precautionary instruction to be adopted;

Art. 2
The following information should be reported in the instructions regarding the use of dental amalgam sold in Italy:

a) keep the amalgam capsules stored in a cool and well aired place;
b) work in aired rooms with no carpet/moquette on the surfaces
c) the cutting and polishing with the dental drill must always be done with irrigation (cold water) and protection with rubber dam
d) do not use ultrasound condensators; the amalgam will be condensed
manually, with the classical means.
e) do not insert dental amalgam nearby other metallic restorations as to
avoid risks of corrosion;
f) avoid, as a precautionary measure, to insert or drill an amalgam in
patients with allergy to amalgam, in pregnant patient or in breastfeeding
mothers, in children under 6 years of age, in patients with serious
nephropaties;
g) in those cases where local reactions to the material appear,
particularly lichenoid lesions nearby an amalgam, or in those cases where
an allergy to the material has been clearly established, amalgam
substitution is suggested.

This law came into force the day after its publication in the "Gazzetta
Ufficiale Repubblica Italiana" paper.

Rome, October the 10th, 2001, the Minister: G. Sirchia

01A11862

This information was forwarded to us by Lorenzo Acerra, Italian Dental Patient Organization.

Editor and Publisher: MONICA KAUPPI
Editorial office: Hägerstensvägen 134
S-126 49 Hägersten, Sweden
Tel/Fax: +46 8 18 40 86
heavymetal.bulletin@swipnet.se