Application to Dismiss Application (Exhibits thereof)

[It is recommended to see the original pdf instead by clicking here.]

CLINICAL NEGLIGENCE (in part)
IN THE HIGH COURT OF JUSTICE CLAIM NO. HQ11X01668
QUEENS BENCH DIVISION
between:-
ROBIN PHILIP CLARKE
Claimant
and
THE DEPARTMENT OF HEALTH
/ THE CHIEF DENTAL OFFICER
Defendant
APPLICATION TO DISMISS APPLICATION
EXHIBITS:
RPC1: “Pro-Amalgam Report Withdrawn”
http://iaomt.org/news/archive.asp?intReleaseID=357&month=1&year=2011
RPC2: Complaint about WHO 2009 from Mercury Policy Project
RPC3: Complaint about WHO 2009 from Associazione Malattie da
Intossicazione Cronica e/o Ambiente – Italy
RPC4: Complaint about FDA 2009 from Consumers for Dental Choice
RPC5: Mutter J, Journal of Occupational Medicine and Toxicology 2011
RPC6: Mats Hanson critique of SCENIHR
RPC7: Letter from Dr Whittington in 1977 (=KH7)
RPC8: Advice from CDO to dentists, 1998
RPC9: Email from Claimant to Dental Hospital, 2004 (=KH8)
RPC10: Letter from Claimant to CMO, January 2007 (=KH9)
RPC11: US Court of Appeal decision, Cloer v Secretary of Health, 2010
RPC12: Pages 71-72 of Amalgam Illness by Andrew Hall Cutler
(blank)
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UN Mercury Council To Meet in Japan; Pro-Amalgam Report
Withdrawn
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1/24/2011
United Nations Urged to Ban Mercury Fillings
--International Delegates Meet in Japan--
Champions Gate, FL, January 20, 2010—Mercury, the main ingredient in “silver” or
amalgam fillings, will be the subject of a United Nations conference to be held in Chiba,
Japan on January 24-28.
Members of various non-governmental organizations (NGOs), as well as dentists and
scientists from groups such as the International Academy of Oral Medicine and Toxicology
(IAOMT), will be attending and urging a ban on products containing mercury, including
dental amalgam. The deliberations serve as the second of five intergovernmental
negotiating committee (INC) meetings planned with the purpose of creating worldwide
mercury regulations by 2013.
These meetings are the result of an agreement made by the Governing Council of the
United Nations Environmental Programme (UNEP) in 2009, when it was deemed necessary
to create global standards addressing risks related to mercury, a toxic element phased out
of many consumer products but still used in dental amalgam fillings. On its website, UNEP
cites reasons for recognizing the impact of mercury on human health: “Mercury can
produce a range of adverse human health effects, including permanent damage to the
nervous system, in particular the developing nervous system…[M]ercury can be transferred
from a mother to her unborn child, [and] infants, children and women of child bearing age
are considered vulnerable populations.”
The IAOMT will be represented by Dr. Graeme Munro-Hall, of the UK, and by Dr. Lillian
Lasaten Ebuen, of the Philippines, who represent a growing number of dentists and
scientists from around the globe concerned about the toxic effects of mercury in silver
amalgam fillings. Dr. Munro-Hall asserts, “International pressure to rid our world of toxic
mercury will hopefully convince the FDA, CDC, NIH and ADA to acknowledge the perils of
placing poison into the mouths of Americans.”
Attorney Charles Brown, President of the World Alliance for Mercury-Free Dentistry, based in
Washington, DC, made an impact on the first INC meeting in Stockholm last year and will
also speak in Chiba. In a recent message to the World Health Organization, Brown stated,
“UNEP has identified amalgam as one of the five major products contributing to the global
mercury problem, so action is urgently needed.”
Scientific studies substantiating the hazards of mercury fillings will be discussed by various
international experts and organizations. Research that links autism to fetal exposure from
maternal fillings will be provided by Mark Geier, M.D., Ph.D. Data collected by Joachim
Mutter, M.D., published last week in the Journal of Occupational Medicine & Toxicology, will
also be presented. Dr. Mutter’s findings relate mercury fillings to various neurological
diseases, ranging from Alzheimer’s to multiple sclerosis.
At an FDA Dental Products advisory panel meeting in December, it was recommended that
FDA consider banning and/or issuing stringent warnings for mercury filling use in children,
pregnant women and an unclassified hypersensitive population. Countries such as Sweden,
Norway and Denmark have already banned the use of mercury in dentistry.
Contact: Freya Koss, Publicist, IAOMT cell (267) 290-7685, (610) 649-2606 frekoss@aol.
http://iaomt.org/news/archive.asp?intReleaseID=357&month=1&year=2011 (1 of 2)12/07/2011 16:59:35
RPC1
IAOMT News
com
Kym Smith, IAOMT (863) 420-6373 info@iaomt.org
Charlie Brown, reporting from Chiba (Japan), January 24, 2011:
The W.H.O. has withdrawn the notorious Petersen Paper , a propaganda project of its inhouse
dentist to claim that phasing out amalgam is not feasible and that amalgam is a safe
product.
After a constructive meeting of many amalgam stakeholders in 2009 , where an agreement
was reached to "phase down" amalgam, WHO dentist P E Petersen was assigned to write up
the notes. Instead, Petersen secretly assembled three other pro-mercury dentists, all from
developed countries, and produced a paper denying progress could be made on amalgam
and making a series of provably false claims about amalgam and about the progress of that
stakeholder meeting.
After those attending the meeting proved that the Petersen Paper in no way reflected what
occurred there , a world uproar ensued, led by leaders of the World Alliance for Mercury-
Free Dentistry. The United Nations Environmental Programme (UNEP) showed great
integrity, insisting that the Petersen Paper be withdrawn or else all reference to UNEP
removed. Upon my written request, WHO's Assistant Director-General, Dr Ala Alwan,
agreed to investigate the Petersen Paper, and to his credit, had the paper withdrawn.
It is being rewritten, and -- nota bene, my friends -- all claims that amalgam is safe are
being withdrawn! Likewise, all participants in the meeting are being asked to comment on
the paper before it will be issued again. The new report of the stakeholder meeting of 2009
will likely be an honest project, and devoid of propaganda favoring Petersen ally the World
Dental Federation.
Our movement for mercury-free dentistry has achieved a stunning victory.
Charlie Brown, President, World Alliance for Mercury-Free Dentistry
Chiba, Japan, 24 January 2011
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http://iaomt.org/news/archive.asp?intReleaseID=357&month=1&year=2011 (2 of 2)12/07/2011 16:59:35
Re: WHO Meeting Report on the Future of Dental Restorative Materials
26 November 2010
Dear Dr. Petersen,
As meeting participants, we are writing regarding the World Health Organization (WHO)
Meeting Report on the Future of Dental Restorative Materials. While we thought the
meeting was generally congenial, a positive exchange of information and a forward
thinking approach to moving forward, we were most disappointed to read the WHO
meeting report which is so at variance with what actually occurred.
Our distinct recollection, as you can see in our attached meeting notes, was that the
purpose of meeting was to discuss alternatives to amalgam, and not debate the
safety of amalgam. Yet the report takes every opportunity to confirm that amalgams are
safe. Unfortunately, contrary to your recent email, the gross inaccuracies and biases
reflected in the report are already being diffused on various pro-amalgam websites, as
everyone can see:
http://www.ada.org/news/5082.aspx, and
http://www.adavb.net/#zomaUQ6HCSLv
While the meeting report states who the authors are and that they are responsible for the
views expressed in the publication, the report is clearly presented as a meeting report. As
mentioned already above, what the report now includes is not the full picture of what was
discussed, but rather a biased distortion. In addition, since the report came out as a WHO
publication, it is evident that this is how it will be used and not as a private writing of the
authors.
Furthermore, although it is mentioned that ‘all reasonable precautions have been taken
from WHO to verify the information in the publication’, the most simple one,
circulating a draft to the participants before publication, has not occurred. As a
result, we question the overall validity of this report, as we consider it misleading in the
way it is presented, and in terms of content many important points are missing from the
description and discussions, including factual elements that could have been very
interesting for the reader on what is going on in the regions. Consequently, we hold
WHO directly responsible and liable for fostering this kind of premeditated and clearly
misleading meeting report information.
This deception is perpetuated by the inclusion the statement in Annex 1, entitled
"consensus statement on amalgam,” (which is not even a WHO policy document) for the
express purpose of demonstrating the safety of amalgam is both misleading and
irresponsible. However, this statement is not from the actual meeting, was not discussed
during the meeting, but in fact is more than 10 years old! Yet this is almost exactly the
same wording that was used in the 1997 WHO report Dental Amalgam and Alternative
Direct Restorative Materials :”The views expressed in documents by named authors are
RPC2
2
solely the responsibility of those authors.” Including such references is rather a step
backwards and the opposite of the spirit in which discussions took place during the
November 2009 meeting.
Clearly, it appears that this subsequent meeting report intends to be utilized by its
authors as was this 1997 report, which was extensively used to influence politicians and
other decision makers world wide and convince them about the safety of dental amalgam,
http://www.fdiworldental.org/sites/default/files/statements/English/WHO-consensusstatement-
on-dental-amalgam-1997.pdf . When this report and the resulting consensus
statement became known questions were raised that the claims of amalgam safety were
actually made by WHO as an organization.
Therefore, it’s important to seek clarification on the legal status of these kinds of WHO
meeting reports. The Swedish journalist Monica Kauppi (Heavy Metal Bulletin)
contacted the WHO Legal Department and this is what Legal Officer of the WHO at that
time in 1997 stated in the interview:
“Expert groups, whatever the form, are usually set up as ad hoc groups, and what
they have in common is that they are only set up in order to provide advice to the
WHO. This means that any statements or recommendations made by the group or
individual experts are not in any way binding for WHO, or for any other body for
that matter, they are only made as advice to WHO. Also, WHO is in no way
responsible for the advice provided by the experts.” (Note: see attached article.)
Furthermore, as already discussed, even though there is some small print somewhere in
the report that states that only the authors are responsible for the report, the postings on
the websites (see above) are already blatantly disregarding this, and many readers will
assume that the report is the consensus of all the participants, which is clearly not the
case.
Consequently, we believe that it is incumbent on WHO to correct the inaccuracies,
misleading and incorrect statements and bias in this meeting report and to honor the
statements that were made to participants during the meeting. In developing our
comments below, we have consulted extensively from our contemporaneous notes which
we took meticulously during the meeting, and believe are an accurate representation of
what actually transpired during the meeting. We would urge WHO to carefully review
and utilize this document when revising its meeting report.
I. Conference Notes
(A) Transition out of mercury-containing tooth fillings
A key and central theme discussed during the meeting was on how to transition out of
amalgam into mercury-free tooth filling materials. The notes make clear why a transition
out of amalgam is needed, and why at least some meeting participants voiced reasons
why a transition to mercury-free tooth filings should occur:
· The continuing use and subsequent release of mercury from amalgam is a major
pollution source. Mr. Bakken of UNEP; Dr. Narvaez of UNEP: worked past the
3
relative impact to address the point that all major uses of mercury must eventually
be curtailed.
· Dental mercury pollution is not just limited to what spills in the dental office,
because most of it is implanted and later enters the environment through multiple
pathways, including through cremation (Professor Hylander);
· Amalgam, whose vapors can be dangerous to dental workers, is a major
occupational safety issue (Professor Phantumvanit; Dr. Meyer; )
· Amalgam alone destroys good tooth matter, whereas composite and “ART”
“preserve the tooth structure.” (Dr. McConnell, Dr. Dahl).
· Amalgam has externalized costs to governments and society due to the mercury
pollution that it creates and costs in terms of subsequent environmental health
impacts (Mr. Maxson, Dr. Van den Heuvel)
· The world is working on a treaty and all uses of mercury must be addressed (Dr.
Narvaez, Mr. Bakken);
· WHO lists mercury as one of 10 chemicals of most concern globally (Dr. Vickers
of WHO);
· Amalgam-free, or virtually amalgam-free dentistry, is prevalent from Norway to
Indonesia to Japan. There was evidence from the presentations that mercury free
dentistry is growing in use in the developing countries.
· Some meeting participants from the developing world expressed support for an
amalgam phase-down, and wondered what was holding up the rich countries
(Professor Phantumvanit; Dr. Sudeshni).
(B) The concrete steps available now for an amalgam phase-down
While no vote was taken, the meeting ended with no expressed objections that there is a
need for a phase-down of the use of amalgam. What was abundantly clear from the
meeting notes is that “phase-down” means concrete steps to reduce amalgam, and indeed
a large number of quite specific and realistic phase-down strategies were proposed.
Throughout the two days, the meeting was alive with a huge variety of ways to approach
a phase-down in the use of amalgam; the speakers were both supporters and opponents of
amalgam:
· End amalgam use for routine care, preserving it only for the unusual cases (Dr.
Dr. Van den Heuvel);
· Change third-party payment systems to cover alternatives in all teeth( Dr.
Pedersen, Dr. Valencia, Professor McConnell, Dr. Meyer, Dr. Soucy);
· Health providers must contribute to the amalgam phase-down (Dr. Petersen);
· Educate dentists about the risks as well as benefits of amalgam (Mrs. Lymberidi-
Settimo);
· Switch from amalgam use to ART in lower-income nations, which is both cheaper
and involves less expertise (Dr. Williams, Dr. Honkala, Dr. Soucy,);
· Amalgam is not necessarily a lower price than composite -- composite is less in
some markets (Mr. Maxson), and as controls begin mercury’s price will rise and
hence amalgam’s price will rise (Mrs. Lymberidi-Settimo);
· Stop its use for children (Dr. Soucy; Professor Bian Jin You, Mr. Maxson, Mrs.
Lymberidi-Settimo);
· For amalgam phase-down but we need to establish the timeline (Dr. Meyer)
4
· Prevention: Many speakers pointed to preventing cavities as one of the means to
reduce amalgam use.
· Provide information to the consumer about alternatives to amalgam (Dr.
Petersen).
(C) Success stories on countries phasing out amalgam
The meeting gave reports on how the nations and regions of the world were doing, and
outcome it was mixed. . That is, success stories about ending amalgam use, or getting
amalgam use under 10%, came from all over the world:
.
· Norway, zero %: According to Dr. Dahl of the University of Oslo: For dentists,
“the ban of 1.1.2008 did not create any problems.” They had already ceased
using amalgam!
· Indonesia: 5% amalgam. Indonesia, the world’s larges Muslim nation, uses
ART.
· Vietnam: 5 to 10% amalgam.
· Guangxi province, China: 8 to 10% amalgam.
· Finland, 5%
Dr. Van den Heuvel, in his presentation, noted that Sweden, in 1978-79, had 74%
amalgam usage. (Most participants were aware that Sweden, like Norway, has ended
amalgam, so the number was probably presented to show a nation can go from high usage
to zero usage.)
Professor McConnell of Ireland’s dental school stated that, in Ireland, the dental schools
focus on resin; it is recognized that amalgam is “going down.” Dr. McConnell doubts
that amalgam will be used in the future.
In an indication that it is children who are most at risk, the meeting noted that on three
continents steps have been taken to stop amalgam use for children: in Canada; in Dalian,
China; and in the Scandinavian region.
II. Opening Statement to Meeting Participants
In the opening statement, it was stated that: “Alternatives to amalgam: that’s what this
meeting is about” and were an active participant in phase-out discussions throughout and
concluded with the following statements. With the meeting concluding on a high note;
you stated that the “phase down” approach provided a “platform to move forward.”
III. The Meeting Report
As others have already pointed out, some of the claims in the meeting summary are just
plain wrong. Your paper says that Sweden’s usage of amalgam is 74%. The meeting
notes make clear it was a figure from 32 years ago!
Unexplainably, the meeting report proceeds to disregard all phasedown strategies.
Insurance was repeatedly stressed as a strategy at the meeting; it is virtually ignored, as
5
are limits for children, as is making ART or composite the routine filling and amalgam
the exception.
The report pretends that catching the amalgam dentists spill solves the problem. First,
developing countries have no way to set up this system, as there is no hazardous waste
collection or infrastructure in place to manage mercury-containing wastes. Furthermore
the effectiveness of amalgam separators was not mentioned in the meeting report, though
it was discussed in the meeting; meaning that the real effectiveness may not be the same
after installation if routine maintenance does not occur regularly. Second, 80 to 90% of
the mercury is walking out of the office – and ultimately into the environment either
when fillings are drilled out and replaced, or when the person dies. It also gives no
weight to workplace risks, nor to another amalgam downside, that placement of amalgam
damages good tooth matter more than other restorative materials.
Another problem with the WHO report is that it presents dentistry as a monolithic group
opposed to an end to amalgam, when in fact multitudes of dentists worldwide are
opposed to dental mercury or are embracing the growing exodus toward mercury free
alternatives. Thus the 2009 meeting attitude of “we can do it” is turned on its head in the
report to “we cannot do it.” For example, about Europe, you state: “Many dentists feel
amalgam cannot be entirely replaced.” It could easily have said, equally truthfully,
“Many dentists feel amalgam can be entirely replaced.” Many of the points under
summary of conclusions are as well presented in a rather negative way when they refer to
alternatives, clearly demonstrating a bias in promoting amalgam.
The section of the meeting report on the various national initiatives is not accurate either
– and not just the Swedish example presented above. Rather than the success stories, the
paper talks about failure nations, and states instead that nothing can be done. In addition,
the meeting report failed to acknowledge other key countries updates, including ignoring:
· Indonesia, with 5% amalgam use and instead chose to spend a page on Canada,
population one-eighth of Indonesia
· Japan, with amalgam at 5%. Japan is hosting the next INC.
· Vietnam, 5 to 10% amalgam on caries.
The report appears to make Norway look like the outlier, with anyone else not able to end
amalgam. Hence it conceals East Asian and Southeast Asian success stories: Indonesia,
Japan, and Vietnam. The presentations have shown that alternatives are used also in other
regions even if not widely spread at the moment, such as Africa and in Latin America the
insurance system is even reimbursing resin for front teeth restorations. It says Norway is
the only country where amalgam is phased out, without naming Sweden too, and without
noting the entire Nordic Council of Ministers supporting an amalgam ban.
One conclusion only is possible: the report appears to suggest that dentists have no good
reason to start using substitutes, not even for routine cavities, whereas during the meeting
the issue of environmental impacts of dental amalgam were discussed and recognized.
Instead, the report casts blame on nations, parents, and consumers for the existence of
cavities, and adamantly insists says that dentists will continue to use mercury materials to
fix them instead of using interchangeable, nontoxic substitutes.
6
In conclusion, the meeting report claims are repeatedly contrary to the positive spirit and
discussions of the meeting as well as our contemporaneous notes -- it is incontrovertibly
biased toward amalgam. It pretends that only one nation has succeeded in phasing out
amalgam when several in Asia and Europe have.
Therefore, for these reasons and the ones mentioned above, we respectfully request that
WHO revise the report based on the comments received and through consulting the
attached meeting notes and with the meeting participants. Once this occurs, we look
forward to seeing a revised, fair and unbiased meeting report that accurately reflects what
transpired during the meeting. Thank you.
Sincerely,
Michael Bender, Director, Mercury Policy Project
Elena Lymberidi- Settimo, Project coordinator ‘Zero Mercury Campaign’, European
Environmental Bureau.
Zero Mercury Working Group Co-Coordinators
November 2010
Associazione Malattie da Intossicazione
Cronica e/o Ambientale – Italy
Sent: Wednesday, December 22, 2010 12:53 PM
Subject: Petersen's Paper: Propaganda for a Pro-Mercury Trade Group?
To Dr Ala Alwan
Assistant Director-General
Noncommunicable Diseases and Mental Health
WHO
Dear Dr Ala Alwan,
we are writing to you about the Report of the Meeting on "Future Use of Materials for Dental Restoration"
held in Geneva in November 2009 which presents serious lacks on relevant issues on the systemic
adverse health effects in the amalgam bearers.
According to some participants, such as two representatives of the Zero Mercury Working Group, the
report doesn't show the complexity and plurality of positions on amalgam that were presented at the
meeting.
The partiality of this report is quite evidenced also in the references by the relevant number of journals
edited by dental organizations, such as JAMA, Dental Clinics of North America, J Public Health Dent,
Journal of American Dental Assoc., Acta Odontologica Scandinavica and others. The dental organizations
are clearly in a situation of conflict of interest and, in fact, the evidence about the adverse health effects of
amalgam can be found more in publications about toxicology, neurology, immunology and bio-chemistry.
In the Petersen's report we could not find a single line about the toxicological studies based on the socalled
"chewing-gum test" for the evaluation of metals in saliva, not a line about the lymphocyte immunoassay
test for the evaluation of systemic allergy to metals, not a line about the toxic burden of the jaw
bone, which is a major target of amalgam toxic overload, not a line about the typization of apolipoprotein-E
gene which is responsible for susceptibility to the toxicity of mercury.
In Dr Petersen's report we can read the a-critic quotation of a sentence from the Consensus Statement
WHO Consultation (3-7 March 1997): "controlled studies have been published demonstrating systemic
adverse effects from amalgam restorations. At present, there is no scientific evidence showing that
general symptoms are relieved by the removal of amalgam restorations". This sentence is totally false.
There are several studies about the improvement of neurological symptoms as weel as the improvement
of symptoms in MS, ASL, CFS, MCS and auto-immune disorders after the correct removal of amalgam
fillings. The adverse health effects are so many that also Dr Math Berlin's overview of scientific literature
published in
1997–2002 on amalgam, for the Swedish Government, concluded that, in case of a systemic chronic
multi-systemic disease, the evaluation of amalgam poisoning should be accomplished for excluding this
case.
Moreover, we would like to remind you that the Consensus Statement was unanimously approved by the
participants of the WHO Consultation, at Geneva on 3-7 March 1997, but it does not represent an official
position of WHO, as we can clearly read on the Statement itself: "Experts groups, whatever the form, are
usually set up as ad hoc groups, and what they have in common is that they are only set up in order to
provide advice to WHO. This means that any statements or recommendations made by the group or the
individuals experts are not in any way binding for WHO, or for any other body, for that mater, they are only
made as advice to WHO. Also, WHO is in no way responsible for the advice provided to it by the experts".
We believe that Dr Petersen's a-critical quotation of WHO 2007 Consultation on amalgam, puts the WHO
in a position of responsibility for promoting as "WHO official position" a report which was only reflecting
the personal opinion of some external experts.
For all these reasons we are here asking you to withdraw immediately Dr Petersen's report on November
2010 meeting in Geneve, with a public press conference, and we also ask you to let all the partecipants at
RPC3
Geneve meeting to review and to subscribe the report of the meeting in a democratic and transparent
way.
WHO has a huge moral and legal responsibility in protecting the health of present and future generations
from the adverse health effects of amalgam poisoning and we would strongly raccomend you to control
very carefully the transparency of any decision making before promoting position papers and official
reports also because there are already several legal actions going on in Europe for the compensation for
amalgam injury.
Sincerely yours,
Francesca Romana Orlando
Vice President of AMICA
Associazione Malattie da Intossicazione Cronica e/o Ambientale
(Association for Environmental and Chronic Toxic Injury)
P.O. Box 3131
00121 Rome - Italy
www.infoamica.it
Jean Huss
President AKUT asbl
Member of Health Committee
Council of Europe
Parliamentary Assembly
Rapporteur for Health hazards of heavy metals
AKUT asbl
137, rue de Mühlenbach
L-2168 Luxembourg
Reinhard Lauer
President of BBFU e.V.
Federal Association of information centres for environmental toxins,
in particular amalgam, heavy metals and wood preservatives
61440 Oberursel, Germany
Mats Hanson
Science Director & Director of the Swedish Association of Dental Mercury Patients
Tf (6000 members)
1
Consumers for Dental Choice
316 F St., N.E., Suite 210
Washington DC 20002
Phone 202.544-6333; fax 202.544-6331
www.toxicteeth.org
Working for Mercury-Free Dentistry
Office of Inspector General
Department of Health and Human Services
PO Box 23489
Washington, DC 20026 – via e-mail: HHSTips@oig.hhs.gov
Complaint to the Inspector General, Department of Health and Human Services
To the Honorable Daniel Levinson:
FDA’s amalgam rule – unabashedly against disclosure of amalgam’s mercury
content to parents and dental patients – is manifestly tainted by (1) Commissioner
Margaret Hamburg’s surreptitious involvement while intertwined with the nation’s top
amalgam seller (whose stock jumped after the rule was unveiled and whose CEO
thereafter announced appreciation to Dr. Hamburg for her “insights”) and (2) wellpublicized
charges that Director Daniel Schultz was pressuring for the approval of unsafe
devices under industry influence.
Background: FDA’s Amalgam Rule
On August 4, FDA published a rule that allows amalgam sellers to conceal from
consumers the fact that amalgam’s major component is mercury. FDA won’t even
require disclosure of this highly relevant information to young women and parents –
despite admitting that children and the unborn are more susceptible to mercury’s
neurotoxic effects and conceding that no study indicates that mercury amalgam does not
pose these known neurological risks to these subpopulations.1 Not only does FDA’s new
rule cover up the mercury in amalgam from American dental patients, but it withdraws an
accurate FDA consumer website that advised parents and young women that dental
mercury can cause neurological harm to children and unborn children.2 Instead, FDA
hands amalgam sellers carte blanche authority to market mercury amalgam under the
deceptive term “silver fillings”3 (the phrase that has for so long confused dental patients,
most of whom, according to surveys, would choose an alternative based solely on
awareness that amalgam is mainly mercury).4 The rule is so callous toward children and
so deferential toward amalgam sellers that it actually states an aspiration to reverse a
decline in mercury exposure5 even though FDA acknowledges that mercury exposure can
lead to neurological damage, kidney problems, and similarly-severe injuries.6
The rule was such an outlier in favor of amalgam industry giants like Henry
Schein, Inc. that it shocked Wall Street, which had advised investors that
contraindications were coming for pregnant women and children.7 It defied the
expectations of a bipartisan group of Representatives, led by Congresswoman Diane
Watson (D-CA) and Congressman Dan Burton (R-IN), who wrote the agency in May
asking for a rule providing clear disclosures of the mercury to all, as well as additional
protections so pregnant women and children would not be subjected to amalgam.8 The
RPC4
2
more than 50% of American dentists who have already abandoned this pre-Civil War
device in favor of modern alternative filling materials9 were no doubt stunned. Even
FDA employees were surprised that the agency would go this far in favor of industry.10
Clear evidence exists that a bias toward industry led to this shockingly unbalanced
rule. The following six factors demonstrate a troubling nexus between the egregious
amalgam ruling, Commissioner Hamburg’s unethical handling of the rule, and Dr.
Schultz’s involvement:
(1) Margaret Hamburg had an ethical problem that should have prevented her from
being involved in the amalgam rule
Not until mid-July, after being pressed by a trade news reporter, did
Commissioner Hamburg admit that she had to recuse herself from the amalgam rule
“based on the requirements of federal ethics laws and the standard of ethical conduct.”11
She refuses to explain what led to her recusal, but it was believed to have been her
intertwining relationship with dental products colossus Henry Schein Inc.,12 a
relationship that began in 2003, existed until the day before the rule was announced on
July 27, 2009, and caused Schein’s CEO to boast the morning after the rule was
published on August 4.
While on the corporate side of the revolving door, between stints in the Clinton
Administration and the Obama Administration, Dr. Margaret Hamburg served on the
board of directors for Henry Schein, Inc., receiving, for example, $282,365 in 2006 and
$249,151 in 2007 for the handful of hours generally involved in being a corporate
director. With a court settlement requiring FDA to classify amalgam within the first 75
days of her taking office,13 Dr. Hamburg’s remaining interest in Schein – including stock
options held until July 27, just 24 hours before the rule was announced – should have
resulted in her immediate public recusal from the amalgam rulemaking.
(2) Hamburg was involved in the rulemaking despite her ethical problem
Dr. Hamburg denies participating in the decision-making for the amalgam rule,
but we have three reasons for believing she was nonetheless involved in spite of her
ethical problem.
First, when Senator Enzi, as part of the confirmation process, asked Dr. Hamburg
two written questions about the amalgam rulemaking, she failed to disqualify herself or
disclose her conflict even though she had been briefed on the issue enough that the
conflict should have been apparent. Instead, she expressed her intention to review the
amalgam rule and to work on it with staff.14
Second, Dr. Hamburg failed publicly to recuse herself upon taking office, and in
fact did not announce her recusal until two months later, even though the issue was raised
at the start of her tenure. Consumers for Dental Choice wrote Dr. Hamburg to notify her
of a possible conflict in early June. That letter was ignored. We kept writing. In
response to our second letter, she said she “decided not to participate”; the legal meaning
of such terminology is unclear. Two weeks after our third letter, FDA’s Chief Counsel,
just four days before the rule was due, notified us that she was recused.
3
Third, her legal defense appears to concede that she participated. FDA’s Chief
Counsel asserted on July 28 that Dr. Hamburg’s participation was not “personal and
substantial.” Apparently, we are supposed to accept Dr. Hamburg’s view of the facts on
faith.
In response to Dr. Hamburg’s loophole defense – participated, but in her opinion
not both personally and substantially – we express two concerns:
• The Inspector General, not Dr. Hamburg, should determine whether the sum of
her actions – including ratifying what others in her employ were doing –
constitutes “personal and substantial” participation.
• That Dr. Hamburg concedes the ethical issue and retreats to a legalistic defense is
profoundly disappointing. It is against the spirit of ethical government that
President Obama brought to Washington. For the American people hoping for
change at FDA, it is an inauspicious start.
(3) Hamburg is evasive about her role and recusal
We thrice sought details about Dr. Hamburg’s ethical problem and the amalgam
rulemaking, and were thrice refused. Then in response to intense media criticism of her
Schein relationship and the amalgam rule, Commissioner Hamburg, through the FDA
press office, issued a non-responsive statement on August 18.15 While specifically
explaining the Schein stock options that she was still holding until the day before the rule
issued (we already knew she had an ethical problem), she appears to be avoiding the
more important question – her role in the rulemaking.
Commissioner Hamburg maintains that she is recused from the rulemaking
currently, but is likewise evasive when we ask for specific information about her recusal.
She won’t say when exactly she recused herself from the amalgam rulemaking (the first
time recusal was mentioned so far as we know was two weeks before the rule was
announced). She won’t provide written proof of her earlier recusal. She won’t advise us
of the status of the rule when she recused herself – for example, whether it was already in
the final form when she recused herself. She will not tell us when Principal Deputy
Commissioner Sharfstein took charge of the rule.
Dr. Hamburg says she did not participate in the decision-making, but she will not
tell us, for instance, whether she approved the decision-making, whether she determined
which staff members continued to work on it, whether she clarified to staff which agency
leader was overseeing this rule, and how she is defining participation that is not “personal
and substantial.”
If Commissioner Hamburg has done nothing unethical, why does she continue to
undermine public confidence in agency decisions by stonewalling legitimate questions
about her public work?
4
(4) Hamburg left Center for Devices Director Daniel Schultz in charge of the
amalgam rule without proper oversight despite awareness of corruption
FDA scientists and FDA critics, Margaret Hamburg among them, were troubled
by Dr. Schultz’s reputation for pressuring his staff to approve unsafe devices, apparently
in response to industry influence. The media widely reported that the Center for Devices
and Radiological Health’s review process was “corrupted and distorted by current FDA
managers, thereby placing the American people at risk.”16 Having been briefed by a
former FDA Commissioner who told her that the Center was “dysfunctional” and “in
meltdown,” Dr. Hamburg was aware of the trouble at the Center for Devices, telling a
reporter back in June that “There obviously have been some problems.”17
Despite this admission, Commissioner Hamburg allowed Dr. Schultz to remain at
FDA until a week after the amalgam rule was published, arranging for the Director to end
his tenure abruptly on August 11. FDA staff believes that amalgam was among the
products that were approved under Dr. Schultz’s leadership despite reservations about
safety. One FDA employee, speaking with a reporter off the record, commented,
“Why continue to use and recommend mercury amalgam when there is safer
composite alternative?...I really question FDA’s motivation here. It seems to
be more responsive to industry than human health.”18
Dr. Hamburg’s defense that she “took no action” on the amalgam rule, apparently
just rubber stamping it along as it proceeded to approval, is meaningless when she knew
that under these egregious circumstances all she had to do to produce a rule favoring
Henry Schein was “take no action” to stop the pro-industry Dr. Schultz. The amalgam
rule needed a strong leader to counter the Center for Device’s corruption. However, not
only did Commissioner Hamburg fail to provide this leadership due to her own ethical
issue, she refused to recuse herself and turn the rule over to Principal Deputy
Commissioner Sharfstein soon enough to allow him to intervene effectively before the
amalgam rule issued. As a result of Dr. Hamburg’s bungled management of her ethical
problem, the amalgam rule was written by a staff under pressure to find products safe for
industry with insufficient oversight and support from unbiased FDA leaders.
(5) The rule resulted in benefits to the amalgam industry at the expense of consumers
The rule has resulted in at least three benefits to the amalgam industry. As these
perks are actually harmful to consumers, they are inexplicable unless industry influence,
such as Dr. Hamburg’s connection to Henry Schein, is considered.
First, in an apparent effort to keep patients and parents ignorant and thereby boost
amalgam sales, FDA refused to require that patients be informed of amalgam’s mercury
content before it is implanted, despite the obvious relevance of this information to
patients’ decisions about their dental care. An overwhelming number of consumers
surveyed (92%) believe that they should be informed of their alternatives before fillings
are placed, and the majority of consumers (over 77%) say that they would rather pay
more for an alternative filling material than have mercury-containing fillings.19 If FDA
had chosen to require disclosure, clearly amalgam sales would have dropped
precipitously.
5
Second, FDA goes so far in its efforts to protect amalgam sales that it removed
accurate information that might discourage amalgam use from its consumer website. To
settle a lawsuit with Consumers for Dental Choice, Moms Against Mercury, Connecticut
Coalition for Environmental Justice, and Oregonians for Life among others,20 FDA
Commissioner Andrew Von Eschenbach agreed to maintain this advisory on FDA’s
consumer website: “Dental amalgams contain mercury, which may have neurotoxic
effects on the nervous systems of developing children and fetuses.”21 FDA removed this
advisory from the consumer website at the time of the rule’s announcement, not even
waiting until the date the rule was published.22 The agency concedes the truth of the prerule
advisory, but now buries it deep in the Special Controls in language intended for
dental professionals only, making it almost impossible for consumers to find.23
Third, perhaps because the President’s executive order disfavors rules that
preempt private remedies, the amalgam rule inserts sentences that appear specifically
designed to help corporations defend themselves before judges and juries, such as the
outrageous statement that the term “silver fillings” merely refers to the color.24 Usually,
the term “silver” refers to the material (the first definition of “silver” in the dictionary
refers to the material; the color, by contrast, is typically listed fourth or lower). More
importantly, according to surveys, the vast majority of consumers understand “silver” to
refer to the filling material and not the color.25 It is a reasonable assumption on the part
of consumers since other filling materials are identified by their main components (for
instance, gold fillings are primarily gold and resin fillings are made of resin). FDA has a
duty to correct deceptions by industry – not to give industry a blueprint for maintaining
industry-instigated consumer misconceptions! By endorsing this deceptive marketing
practice, FDA not only enables amalgam sellers to push their product onto patients who
would reject it if they knew its true contents,26 but this statement could be used by
amalgam sellers to defend their deception in lawsuits brought by consumers who are
injured by the product. FDA’s protection of the term “silver fillings” serves no purpose
other than to benefit industry at the expense of consumers, and as such it is another
example of how industry connections, such as Dr. Hamburg’s stock options, tainted the
amalgam rule.
These corporate benefits raise the question of partisan motivation. By refusing to
disclose the mercury content to consumers, reversing the pro-consumer website of
Republican Commissioner Von Eschenbach, and writing industry defenses to consumer
lawsuits right into the ruling, the Democrats seem to be signaling to FDA regulatees that
their pro-consumerism is mere campaign rhetoric and that they are even more willing
than their predecessors to favor corporate interests over child protection and consumer
disclosure.
(6) The FDA amalgam rule benefited Henry Schein
Henry Schein’s stock value jumped $2/share the week the amalgam rule was
announced (July 28-31).27 Then, the morning after the rule was published, Schein CEO
Stanley Bergman boasted during an earnings call with analysts about the work Dr.
Hamburg did for Schein as a director (this being months after she left the board) and
thanked her for the “insights” she provided “throughout the years.”28 For Americans
hearing the CEO issue a public thank-you to the Commissioner right after the publication
6
of a rule that so benefits the company, answers are needed about the relationship between
Margaret Hamburg and Henry Schein Inc. if the rulemaking process is going to have
even the appearance of integrity.
Conclusion
The consequences of the amalgam rule – children and unborn children willfully
and needlessly exposed to the dangers of mercury – are tragic. That such an unbalanced
rule could issue while the Commissioner (i) comes into office from the largest amalgam
seller, (ii) still holds an interest in that company the month the rule is announced, (iii)
refuses to divulge details of her role in the rulemaking, (iv) refuses to state the date of her
recusal from the rulemaking, and (v) ratifies the continued participation of a Center for
Devices Director whom she has reason to suspect is approving unsafe devices,
significantly taints the rule and as such, cries out for investigation.
While Dr. Hamburg deems public ignorance – of both her ethical issues and the
toxic content of amalgam – the best policy, we believe the public has a right to know.
Since Commissioner Hamburg has repeatedly denied us information to which we have a
right, we request that the Inspector General investigate (1) Commissioner Hamburg’s role
in the amalgam rulemaking process and (2) the effect of inappropriate industry influence
on the rule under the leadership of former Center Director Schultz.
Respectfully submitted,
Charles G. Brown, National Counsel
20 August 2009
1Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and
Amalgam Alloy – Guidance for Industry and FDA Staff,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm073311.htm (“The developing neurological systems in fetuses and young children
may be more sensitive to the neurotoxic effects of mercury vapor. Very limited to no
clinical information is available regarding long-term health outcomes in pregnant women
and their developing fetuses, and children under the age of six, including infants who are
breastfed.”)
2 The pre-rule consumer website advised that “Dental amalgams contain mercury, which
may have neurotoxic effects on the nervous systems of developing children and fetuses.”
3http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/De
ntalAmalgam/ucm171094.htm (“Dental amalgam fillings are also known as “silver
fillings” because of their silver-like appearance.”)
4 http://www.toxicteeth.org/Zogby%20Poll--Results%202006.pdf
7
5 Final Rule for Dental Amalgam,
http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/DentalPr
oducts/DentalAmalgam/UCM174024.pdf (p.89) (“[T]he daily potential exposure to
mercury vapor originating from dental amalgam is expected to decrease gradually in the
absence of the final rule.”)
6http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/De
ntalAmalgam/ucm171094.htm (“High levels of mercury vapor exposure are associated
with adverse effects in the brain and the kidneys.” )
7 The Bank of America and J.P. Morgan reports predicting warnings for women and
children are available at http://www.toxicteeth.org/RB__565608.pdf and
http://www.toxicteeth.org/JPMorgam-2008.pdf
8 http://www.toxicteeth.org/Mercury%20Letter%20to%20FDA-5-2009.pdf
9 http://www.thewealthydentist.com/SurveyResults/16_MercuryAmalgam_Results.htm
10 As one employee commented in response to the amalgam rule, “Why continue to use
and recommend mercury amalgam when there is safer composite alternative?...I really
question FDA’s motivation here. It seems to be more responsive to industry than human
health.” Jim Dickinson, A ‘Shocking’ Decision – Bias Seen in Dental Amalgams Rule,
FDA WEBVIEW, 31 July 2009.
11 Jim Dickinson, Hamburg Recuses Herself From Dental Mercury Rulemaking, FDA
WEBVIEW, 14 July 2009.
12 Alicia Mundy, New FDA Chief Must Divest Several Stock, Fund Holdings, WALL
STREET JOURNAL, 26 May 2009.
13 http://toxicteeth.org/settlement%20agreement.PDF
14 “Dental amalgam:
[Senator Enzi:] Q: FDA has a court-ordered deadline to issue a regulation placing
dental amalgam in one of three device classes. That deadline is fast approaching.
FDA's current proposal is to classify encapsulated amalgam and its components as
class II devices with special controls (materials and labeling.) Is this regulation on
schedule to be issued this July? Will you make a commitment that if the regulation
will not be issued by the deadline that you will tell me why not, and when you do
expect to issue the regulation?
[Dr. Hamburg] Answer: It is my understanding that the regulation is on schedule to be
issued in July. Although I do not expect the regulation to be delayed, in the event that
an unforeseen delay does occur, I will be happy to let you know the reasons for the
delay and update you on the timeframe for its issuance. I will also be happy to keep
you informed of its progress.
Q: FDA’s website states that “[d]ental amalgams contain mercury, which may have
neurotoxic effects on the nervous systems of developing children and fetuses.”
8
Furthermore, the agency raises concerns about the safety of dental amalgam for many
other vulnerable demographics, including pregnant women, the hypersensitive,
“individuals with existing high levels of mercury bioburden,” children under age 6,
lactating women, immunocompromised individuals, dental patients generally, and
dental professionals. Will the forthcoming classification take into account FDA’s
professed concerns about the impact of mercury amalgam on these vulnerable groups?
Answer: I have not been briefed on all the substantive details of this matter. If
confirmed, I will undertake a review of this and all other pending regulatory matters,
and work with agency staff to be as responsive to your concerns as possible.”
15 Jim Dickinson, FDA: Lawyer’s Charges Against Hamburg ‘Incorrect,’ FDA
WEBVIEW, 18 August 2009
Associate Commissioner George Strait’s statement to FDA WEBVIEW (reprinted in full):
The claims you have published regarding the FDA’s recent rule on dental amalgams and
Dr. Hamburg’s connection to it are incorrect.
First, as we have told you before, Dr. Hamburg was not involved in the decision making
for the dental amalgam rule and is recused from it.
Second, allegations that Dr. Hamburg had a vested interest in the dental amalgam
decision because she would profit from the Schein stock that she held are false. By May
20 (six days before she took office as FDA Commissioner), Dr. Hamburg had divested
all her Schein stock and all Schein options which had any market value, and by July 27
she had no interest whatsoever in Schein. In fact, Dr. Hamburg lost hundreds of
thousands of dollars on the sale of Schein stock and options.
th
th
These are the details. Dr. Hamburg was confirmed by the Senate on May 18th, but did
not take office until May 26th. In the days following her confirmation and BEFORE she
took office, Dr. Hamburg resigned her position as a Board Director at Schein, sold all of
her Schein stock, exercised all the Schein options she owned that had monetary value (so
called in the money), and immediately, that same day, sold all of that resultant stock.
At that time, Dr. Hamburg also forfeited unvested restricted Schein stock worth
$262,000. By the close of the markets on May 20th, she did not own any Schein stock.
The only Schein interests she had left were non-transferable out-of-the-money Schein
options, which according to her statement from Fidelity had zero value.
During July, the market went up and some of those options gained valued (came into the
money). On July 16th, in order to continue to immediately divest herself of any Schein
interests as rapidly as possible, she exercised all of the options that had value and sold the
resultant stock for a profit of $2,593.73. The profit on the sale was less than one percent
of what it cost Dr. Hamburg to forfeit the unvested Schein stock when she resigned from
the board on May 20 . During that same period she contacted Schein to see if there was
some way to get rid of the remaining non-transferable options before they were due to
expire in August. On July 27th, Schein canceled the remaining options.
th
9
To reiterate, by May 20 Dr. Hamburg had divested all Schein stock and all Schein
options which had any market value, and by July 27th, she had no interest whatsoever in
Schein. In addition these stock forfeitures and stock option sales and cancelations
resulted in a loss to Dr. Hamburg of over $200,000.
th
16 Alicia Mundy & Jared A. Favole, FDA Scientists Ask Obama to Restructure Drug
Agency, WALL STREET JOURNAL, 8 January 2009.
17 Alicia Mundy, FDA Chief Eyes Device Group, WALL STREET JOURNAL, 17 June 2009.
18 Jim Dickinson, A ‘Shocking’ Decision – Bias Seen in Dental Amalgams Rule, FDA
WEBVIEW, 31 July 2009.
19 http://www.toxicteeth.org/Zogby%20Poll--Results%202006.pdf
20 Moms Against Mercury et al. v. Von Eschenbach, et al.
21 The settlement agreement is located at
http://toxicteeth.org/settlement%20agreement.PDF
22 Originally, FDA had excluded from its post-rule consumer website even universally
accepted facts about the effects of mercury on the human body, which resulted in a
“Potential Risks” section that did not actually explain any of the risks. After consumer
outcry, FDA apparently recognized that this blatant omission went too far. It placed a
new statement on its consumer website on August 11: “High levels of mercury vapor
exposure are associated with adverse effects in the brain and the kidneys.” FDA's
consumer website still contains no reference to the fact that any mercury exposure poses
a higher risk to children and the unborn even though the agency acknowledges that the
risk is higher because these subpopulations may be more susceptible to mercury’s
neurotoxic effects.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalA
malgam/ucm171094.htm
23 Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and
Amalgam Alloy – Guidance for Industry and FDA Staff,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm073311.htm (“The developing neurological systems in fetuses and young children
may be more sensitive to the neurotoxic effects of mercury vapor. Very limited to no
clinical information is available regarding long-term health outcomes in pregnant women
and their developing fetuses, and children under the age of six, including infants who are
breastfed.”)
24http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/D
entalAmalgam/ucm171094.htm (“Dental amalgam fillings are also known as “silver
fillings” because of their silver-like appearance.”)
10
25 A Zogby poll indicates that 76% of Americans cannot identify the main component of
amalgam. http://www.toxicteeth.org/Zogby%20Poll--Results%202006.pdf
26 http://www.toxicteeth.org/Zogby%20Poll--Results%202006.pdf
27 http://apps.cnbc.com/view.asp?uid=stocks/charts&symbol=HSIC
28 Henry Schein CEO Henry Bergman stated during an earnings call with investment
analysts:
"So as a closing comment, I would like to extend on behalf of the company,
our Board and our shareholders our sincere thanks to Dr. Margaret Hamburg,
who has served as the Director of Henry Schein Company's Board since 2003.
As has been known in public announcements, Dr. Hamburg left our Board
following her confirmation as Commissioner of the U.S. Food and Drug
Administration. We would like to thank Dr. Hamburg for the insight she
shared with the Henry Schein Board throughout the years and wish her
continued success."
Q2 2009 Earnings Call; August 4, 2009, http://seekingalpha.com/article/153742-
henry-schein-inc-q2-2009-earnings-call-transcript?page=-1
REVIEW Open Access
Is dental amalgam safe for humans?
The opinion of the scientific committee of the
European Commission
Joachim Mutter
Abstract
It was claimed by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)) in a report
to the EU-Commission that “....no risks of adverse systemic effects exist and the current use of dental amalgam
does not pose a risk of systemic disease...” [1, available from: http://ec.europa.eu/health/ph_risk/committees/
04_scenihr/docs/scenihr_o_016.pdf].
SCENIHR disregarded the toxicology of mercury and did not include most important scientific studies in their
review. But the real scientific data show that:
(a) Dental amalgam is by far the main source of human total mercury body burden. This is proven by autopsy
studies which found 2-12 times more mercury in body tissues of individuals with dental amalgam. Autopsy studies
are the most valuable and most important studies for examining the amalgam-caused mercury body burden.
(b) These autopsy studies have shown consistently that many individuals with amalgam have toxic levels of
mercury in their brains or kidneys.
(c) There is no correlation between mercury levels in blood or urine, and the levels in body tissues or the severity
of clinical symptoms. SCENIHR only relied on levels in urine or blood.
(d) The half-life of mercury in the brain can last from several years to decades, thus mercury accumulates over time
of amalgam exposure in body tissues to toxic levels. However, SCENIHR state that the half-life of mercury in the
body is only “20-90 days”.
(e) Mercury vapor is about ten times more toxic than lead on human neurons and with synergistic toxicity to other
metals.
(f) Most studies cited by SCENIHR which conclude that amalgam fillings are safe have severe methodical flaws.
Dental amalgam is the main source of mercury in
human tissues
SCENIHR (Scientific Committee on Emerging and
Newly Identified Health Risks) from the European Commission
claim [1]: “Exposure to mercury is difficult to
measure. The indications for mercury exposure are
therefore normally obtained by measuring mercury
levels in urine and blood of individuals.”
SCENIHR did not cite any autopsy studies, which are the
most reliable studies for assessing mercury levels in tissues.
An approx. 2-5-fold increase of mercury levels in
blood and urine in living individuals with dental
amalgam as well as a 2-12 fold increase in several body
tissues was observed in deceased individuals with dental
amalgam [2-21]. Additionally, studies with animals have
confirmed the fact that dental amalgam leads to significantly
increased levels in the tissues [22-28].
According to these studies, dental amalgam is responsible
for at least 60-95% of mercury deposits in human
tissues. This was not acknowledged by SCENIHR.
No organic mercury compounds through dental
amalgam?
SCENIHR [1] state that “there is no evidence that biotransformation
of amalgam derived mercury takes place
Correspondence: jm@zahnklinik.de intra-orally in association with bacterial activity.”
Department of Environmental and integrative medicine Lohnerhofstraße 2,
78467 Constance/Germany
Mutter Journal of Occupational Medicine and Toxicology 2011, 6:2
http://www.occup-med.com/content/6/1/2
© 2011 Mutter; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
RPC5
In contrast to this claim studies have shown that mercury
(Hg) from dental amalgam is transformed into
organic mercury compounds by microorganisms in the
human gastrointestinal tract [29-31]. Leistevuo et al.
(2001) found a three-fold increase of methylmercury
levels in saliva of individuals with dental amalgam compared
to individuals without amalgam, although frequency
and kind of fish consumption were identical in
both groups. Mercury levels in saliva exceed mercury
limits for sewage in 20% of individuals with amalgam
[30]. The form of methylmercury derived from dental
amalgam may be much more toxic (up to 20 times)
than the form of methylmercury found in fish (see section
“toxicity of mercury”).
Toxic mercury levels in vitro and in vivo
Inorganic mercury levels of 0.02 ng Hg/g (2 μl of 0.1
μMolar Hg in 2 ml substrate) led to the total destruction
of intracellular mircrotubuli and to the degeneration
of axons [32]. In other experiments inorganic
mercury levels of 36 ng Hg/g (0.18 μMol Hg) led to
increased oxidative stress as a prerequisite for further
cell damage [33,34].
Mercury vapor inhalation in doses which also occur in
humans with many amalgam fillings and chewing led to
pathological changes in the brains of animals after 14
days [35,36].
No toxic mercury levels in humans through
dental amalgam?
In a recent autopsy study, it was found that individuals
with more than 12 amalgam fillings have more than 10-
times higher mercury levels in several tissues including
the brain, compared to individuals with only 0-3 amalgam
fillings [11].
The average mercury level in the brain of EU citizens
with more than 12 amalgam fillings was 300 ng Hg/g
brain tissue [11], which is well above mercury levels proven
to be toxic in vitro on neurons (0.02 -36 ng Hg/g)
(see above).
In another autopsy, individuals with more than
10 amalgams have 504 ng Hg/g in their kidney tissues
(0-2 amalgams: 54 ng Hg/g) and 83.3 ng Hg/g in the
liver (0-2 amalgams: 17.68 ng Hg/g) [5].
Mercury levels in thyroid- and pituitary glands were
55 ng Hg/g and 200 ng Hg/g respectively and again,
these levels correlates significantly with numbers of
amalgam fillings [37].
Because the levels found in these studies are only
average levels, a significant portion of individuals with
dental amalgam have more than twice (standard deviation)
these toxic mercury levels in their body tissues. It
is important to note that mercury levels found in subcellular
fractions like microsomes, mitochondria and
other cell compartments even exceed the average levels
of the brain samples analysed in these studies [38].
Toxic mercury levels in Alzheimer’s disease
The average mercury load in brain tissues of individuals
with Alzheimer`s disease was 20 to 178 ng Hg/g; in
some cases the load exceeded up to (236- 698 ng Hg/g).
In 15% of the human brain samples the mercury load
was above 100 ng Hg/g [39-41]. The average mercury
load in the pituitary gland was 400 ng Hg/g [42]. These
levels are again well far above established toxic levels
(see above).
Pathological changes, caused by mercury, in most
german human brains?
About 20% of individuals in the age group of 20 years,
50% of individuals in the age group of 50 years, and
90% of people in the age group of 85 years living in
Germany show pathological changes in their brains that
are typical for Alzheimer’s disease [43] and mercury
toxicity. This coverage of pathological brain changes
caused by very low levels of mercury in experiments
and not by low levels of other metals (like lead, iron,
aluminum, copper, manganese, chromium, cadmium)
[32,36] resembles the frequency of dental amalgam fillings
implanted in humans: About 80-90% of people living
in Germany have dental amalgam over decades. It
must be noted that about 30-50% of german people
above the age of 85 years have Alzheimer’s disease (AD)
and there are many hints that mercury plays the major
pathogenetic role in AD [44].
Maternal amalgam as the main source of mercury
in infant tissues
Maternal amalgam fillings lead to a significant increase
of mercury levels in fetal and infant body tissues including
the brain [6]. Furthermore, placental, fetal and infant
mercury body burden correlates with the number of
amalgam fillings of the mothers [6,45-52].
Mercury levels in amniotic fluid [53] and breast milk
[54-56] also significantly correlate with the number of
maternal amalgam fillings.
Mercury in infant tissues: Increased risk of
neurodevelopmental disorders?
Drasch et al. found mercury levels of up to 20 ng Hg/g
in German infant brain tissues which were mainly
caused by dental amalgam fillings of their mothers [6].
As described above, mercury levels of 0,02 ng Hg/g led
to degeneration of axons [32]. Furthermore, the mercury
levels found in the brains of infants whose mothers were
dental amalgam bearers are sufficient enough to inhibit
the function of the important enzyme methionin synthetase
[57,58]. Methionin synthetase is crucial for
Mutter Journal of Occupational Medicine and Toxicology 2011, 6:2
http://www.occup-med.com/content/6/1/2
Page 2 of 17
methylation, a central step for most important metabolic
reactions the the body, including the development of the
brain, the maturation of nerve cells and the production
of neurotransmitters.
Maternal amalgam fillings also increase significantly
mercury levels in cord blood [59,60]. The risk for
delayed neurodevelopment of children was 3.58- times
increased when mercury levels in cord blood were
higher than 0.8 ng Hg/ml [61]. It is important to note
that mercury levels of 0.2 - 5 ng Hg/ml cord blood are
considered “normal” in Germany [62], thus leaving
many infants with mercury levels that may cause neurodevelopmental
deficits.
No correlation between mercury in urine or blood
and in body tissues
The SCENIHR report is based on studies which have
measured mercury levels in biomarkers such as urine
for the assessment of clinical symptoms or mercury
body burden. However, the WHO states (1991) that
“Mercury typifies a “retention” toxicity and much of
the mercury taken into the body is absorbed by the
solid tissues. The amount in urine represents mercury
being excreted. However, the main question is
how much is being retained in the different body
tissues”.
It has been shown in experiments with animals
and men that in spite of normal or low mercury
levels in blood, hair and urine high mercury levels are
found in critical tissues such as brain and kidney
[7,13,20,22,25,28,46,63,64]. A recent study on deceased
individuals confirm that there exists no correlation
between inorganic mercury levels in urine or blood and
mercury levels in brain tissues [37].
Drasch and coauthors have shown that 64% of individuals
occupationally exposed to mercury vapor and having
typical clinical signs of mercury intoxication had
urine levels of mercury below 5 μg/l, which represent
the No Observed Adverse Effect Level (NOAEL). The
same results were found for mercury levels in blood and
hair [65-67].
Paradoxical association between mercury levels in
urine and clinical symptoms
There is even a paradoxical correlation between mercury
levels in urine, blood or hair and clinical symptoms:
Subjects with highest urine levels of mercury showed
best recovery rates from neuropsychological complaints
after removing their amalgam fillings [68]. Also children
with highest mercury levels in hair showed better performance
in developmental tests [69]. Another study
indicates that in spite of a significantly higher exposure
to mercury in their mothers` womb autistic children
had up to 15-times lower mercury levels in their infant
hair than healthy children [46]. Furthermore, the lower
the mercury levels in infant hair, the higher was the
severity of autism [46].
Despite higher mercury body burden, a “amalgam
hypersensitivity” group showed slightly lower levels of
mercury in their saliva, blood and urine [70]. Even after
provocation with the mercury chelator DMPS, the
“amalgam hypersensitivity” group excreted in mean only
7,77 μg Hg via urine in 24 h whereas healthy amalgam
bearers excreted 12,69 μg Hg/24h [70].
Furthermore, studies confirm that the ratio of fecal
to urine excretion is 12 to 1 [13]. This proves that the
majority of excreted mercury leaves through the bilary
transport system of the liver via the fecal route. Urine
mercury therefore represents a minor excretory route
of less than 8% of mercury being excreted. Also, urine
mercury is a measure of mercury being excreted
by the kidney—not a measure of total mercury body
burden.
Safety levels for mercury?
In view of the data presented above, it is impossible to
determine any safety levels below which adverse effects
can be excluded [71]. SCENIHR used safety limits which
were deduced from studies with workers occupationally
exposed to mercury. However, these limits cannot be
applied to individuals with amalgam fillings and must be
critically evaluated:
a) Frequently, mercury exposure of workers in the
chlorine-alkali industry is used for comparison
although the simultaneous exposure to chlorine considerably
diminishes the absorption of mercury into
the body tissues of animals by 50-100% [72].
b) Workers exposed to mercury usually represent a
group whose mercury-exposure starts only with
adulthood (for about 8 hours a day, 5 days a week),
while amalgam bearers can be exposed to mercury
in the womb through maternal amalgam fillings during
their childhood and until death at a rate of 24
hours per day, 7 days per week.
c) Workers are a selected healthy group, while pregnant
women, infants, children and individuals with
illnesses (such as multiple sclerosis, autoimmunity,
cancer, psychiatric diseases) do not start working at
all either due to industrial safety regulations or to
early health problems during working.
d) Despite mercury exposure below “safety limits”,
significant adverse health effects were found in most
studies in workers exposed occupationally to mercury,
even several years after the exposure had
ceased [73-81].
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Body half-time period of mercury
SCENIHR state that the body half-time (of mercury) is
“20-90 days”.
Particularly in the brain, mercury has a significantly
longer half-time of more than 17 years [63,64,82-87].
Toxicity of mercury
SCENIHR did not mention the specific toxicity of mercury
vapor coming off dental amalgam fillings. This
should be mentioned in a risk analysis:
Mercury has been shown to be 10 times more toxic
than lead (Pb) in vitro [88-90]. Mercury is the most
toxic non-radioactive element. Mercury vapor is one of
the most toxic forms of mercury along with some of the
organic mercury compounds. This extraordinary toxicity
is also determined by the following properties:
a) Mercury is the only metal representing a volatile
gas at room temperature, which is readily absorbed
(80%) by the respiratory system.
b) Mercury vapor from amalgam penetrate into tissues
with great ease, because of its monopolar
atomic configuration.
c) Once inside the cells, mercury vapor is oxidized
to Hg2+, the very toxic form of mercury which binds
covalently to thiol groups of proteins inhibiting their
biological activity.
d) Hg2+ is more toxic than Pb2+, Cadmium (Cd2+)
and other metals because it has a higher affinity due
to “covalent bond” formation with thiol groups
(cysteines in proteins) causing irreversible inhibition.
Other metals form reversible bonds with proteins
and are therefore less toxic.
e) Hg2+ does not bind tightly enough to the carboxylate
groups of natural organic acids (natural chelators
like citrate) for its toxicity to be prevented.
f) Chelating agents, like EDTA, which normally inhibit
the toxic effect of heavy metals like lead, have no
inhibitory effect on the toxicity of mercury or may
even increase it [91,92]. Other chelating agents
(DMPS and DMSA) inhibit the toxic effect of Cd2+
and Pb2+, but not of Hg2+ [93]. DMPS, DMSA or
natural chelators like vitamin C, glutathione or
alpha-lipoic acid are not able to remove mercury
from nervous tissues [94]. DMPS or DMSA may
even increase the inhibitory activity of Hg2+ and Cd2
+on enzymes but not of Pb2+ [95]. Furthermore,
DMPS in animals led to an increase of mercury concentrations
in the spinal cord [96].
The toxicity of methylmercury which is bound to
cysteine in fish seems to be far lower (only approx. 1/
20) than methylmercury compounds usually used in
experiments [97].
Furthermore, marine fish represents a significant
source of selenium and essential omega-3-fatty acids,
which are known to protect effectively against mercury
toxicity. Nevertheless, methylmercurychloride, which
proved to be more toxic than methylmercury in fish,
showed less neurotoxicity for the growing nervous system
in vivo than did mercury vapor [98].
Investigations by Drasch et al. show similar correlations:
The population of a goldmining area, which was
exposed to mercury vapor, showed significantly more
neurological symptoms of mercury intoxication than a
control group which mainly was exposed to methylmercury
from fish consumption, despite their mercury levels
in hair and plasma being higher compared to the individuals
exposed to mercury vapor [65,66]. Another study
also points to smaller neurotoxicity of methymercury
from fish compared to iatrogenic mercury sources
(amalgam, thimerosal) [46]. Here, in contrast to the
numbers of dental amalgam in the mothers, no correlation
between maternal fish consumption during pregnancy
and the risk of autism for their children was
found.
In summary, mercury vapor coming off dental amalgam
or methylmercury derived from amalgam in the
gastrointestinal tract has not reacted with anything yet
and has the full toxic potential. On the other hand,
methylmercury in fish has already reacted with fish proteins
and other protective molecules or atoms in fish tissues
such as glutathione or selenium, which are
enriched in fish. Furthermore, newest studies confirm
that most individuals with dental amalgam fillings are
exposed to toxic mercury levels [99,100].
Synergistic toxicity of mercury to lead (Pb)
Some scientists try to argue that results gained by animal
or cell testing are overestimated and not comparable
to the situation of the human body. However, in
contrast to test animals in experiments, humans are
exposed to many other toxins simultaneously, thus the
effects add up or are even synergistic [101,102]. For
example, it has been proven that the combination of the
Lethal Dose 1% of mercury (LD1Hg) together with the
LD1 of lead (Pb) results in the death of all animals, so
the following toxicological equation can be assumed:
LD1 (Hg) + LD1 (Pb) = LD 100 [101].
In this context, it must be considered that modern
humans have more mercury and between 10-1,000-
times more lead in their body tissues than ancient
humans.
In other experiments, the addition of aluminumhydroxide
(often in vaccines), antibiotics, thimerosal (sometimes
in vaccines) and testosterone increased the
toxicity of mercury [108,109]. The synergistic toxicity of
testosterone explain the observation, that much more
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males than females suffers from autism or amyotrophic
lateral sclerosis.
No adverse effects through dental amalgam?
SCENIHR states “It is generally concluded that no
increased risk on adverse systemic effects exists and we
do not consider that the current use of dental amalgam
poses a risk of systemic disease” and “....some local
adverse effects are occasionally seen with dental amalgam
fillings, but the incidence is low and normally readily
managed”
SCENIHR has neglected numerous scientific studies
which find significant adverse health effects from dental
amalgam:
Cytotoxicity of amalgam in comparison to
composites
SCENIHR compare the toxicity of amalgam with composites.
However, in most experiments, even inorganic
mercury, which is much less toxic than mercury vapor
(because inorganic mercury is not able to penetrate
easily into the cells), was proven to be much more toxic
than any composite compound: Mercury was shown to
be 100-800- fold more toxic than composite components
for human cells [110-114].
Genotoxicity, oxidative stress, cancer
Dental amalgam fillings have been found to cause DNA
damage in human blood cells. [115]. Even low levels of
inorganic mercury lead to significant DNA damage in
human tissue cells and lymphocytes [116]. This effect,
which trigger cancer, has been found with mercury
levels below those normally causing cytotoxicity and cell
death. Furthermore, aberrations of chromosomes can be
provoked by amalgam in cell cultures [117]. Amalgam
bearers show significantly increased oxidative stress in
saliva [118,119] and blood [120,121]. The increase of
oxidative stress correlates with the numbers of amalgam
fillings. Mercury levels normally seen in tissues of individuals
with amalgam fillings lead to increased oxidative
stress and reduction of glutathione levels, thus inducing
cellular damage [33,34]. Significantly elevated mercury
levels have also been observed in breast cancer tissues
[122]. Mercury deposited in the tissue is mostly bound
to selenium, which means that the this selenium is no
longer available for the body. Therefore, amalgam may
aggravate a latent deficiency of selenium, particularly in
countries with suboptimal selenium supply (e.g. in Central
Europe) [123,124].
Antibiotic resistance
It has been shown that mercury from dental amalgam
can induce mercury resistant bacteria [125-127]. This
leads to a general antibiotic resistance in oral bacteria
and in other body sites [127], which is particularly true
when the antibiotic resistance genes are contained
within the same mobile element as the mercury resistance
operon [128,129]. Mercury resistance is common
in human oral bacteria [130,131]. Monkeys with dental
amalgam also showed an increase in antibiotic resistant
bacteria in their stools [127,132].
Penetration of amalgam in tooth bone and jaw
Experiments on monkeys and sheep have shown that
mercury from amalgam penetrates easily into the dentin
roots as well as into the jaw bone [25,26]. The fact that
this was also shown for humans [133] confirms an alternative
route of mercury exposure caused by amalgam.
Skin
There is a correlation between atopic eczema and IgElevels
and the body burden of mercury [134]. Amalgam
fillings can induce lichenoid reactions [135-139]. In
more than 90% of the cases, these lesions have been
found to recover upon removal of amalgam, no matter
whether an allergy patch test was positive or not. Granulomatosis
improved likewise [140]. Also, other forms of
dermatitis seem to be related to dental amalgams
[141,142].
Autoimmune disorders and mercury
hypersensitivity
Constant low-dose mercury exposure, as is common in
amalgam bearers, has been considered a possible cause
for certain autoimmune diseases, e.g. multiple sclerosis,
rheumatoid arthritis or systemic lupus erythematosus
(SLE) [135,143-152]. These effects occur with exposure
below mercury safety limits [153]. Recent research has
shown that mercury and ethylmercury have the ability
to inhibit the first step (phagocytosis) in the innate and
acquired immune response of humans at very low levels
[154]. This shows that mercury exposures quite below
the average exposure through amalgam exposure can
cause disruption of the immune system at all ages.
Only “rare cases of proven allergic reactions"?
SCENIHR only accept the “proof” of allergic reactions to
amalgam, which is a positive cutaneous patch test. However,
it has been shown that in more than 90% of the
cases with mucosal reactions these lesions have been
found to recover by removal of amalgam, no matter
whether a cutaneous patch test was positive or not
[137,139,140]. Therefore the relevance of the cutaneous
patch test in detecting sensitivity or allergy to mercury
implanted in the oral cavity without any epicutaneous
contact has been severely questioned [155].
The results with another validated test system
reveal that there are more than just “rare cases” with
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immunological complaints due to dental amalgam
[148,150,152,156-162].
There may also be a correlation between atopic
eczema, IgE-levels and the body burden of mercury,
which is also not detected by means of cutaneous patch
tests [134].
Because mercury from maternal dental amalgam is
one of the main sources of mercury body burden in
fetal and infant tissues, postnatal atopic eczema disappear
after mercury detoxification of the infants [163].
Heart diseases
Mercury may cause hypertension and myocardial infarction
[164].
Significant mercury accumulation (22,000 times higher
than controls) has been found in heart tissues with a
form of heart insufficiency [165].
Urinary system
SCENIHR cited only one review performed by a dentist
and published in a dental trade journal [166] as well as
5-7 year studies on initially healthy children, also performed
mainly by dentists, to back up their argument
that “there is no evidence that dental amalgam fillings
affect kidney function in humans”. However, there are
many other studies suggesting quite the opposite:
In animal experiments, an impairment of renal functions
due to amalgam fillings has been observed
[23,146,167]. Humans with amalgam fillings show more
signs of tubular and glomerular damage when compared
to individuals without dental amalgams [15]. The frequently
mentioned children amalgam trial study found
first signs of kidney damage (microalbuminuria) [168]
even after only 5 years of amalgam exposure.
Alzheimer’s disease (AD)
SCENIHR questioned that mercury may contribute to
the development of AD. As a proof of this statement
they cited only one study [41] published in the trade
journal of the world-wide leading American Dental
Association (ADA) [102]. In contrast, other studies have
shown that mercury play a major pathogenetic role in
AD [108,109,169,170]. A new systematic analysis of the
literature regarding the role of mercury in AD found a
significant association [124].
Parkinson’s disease (PD)
Heavy metals have long been suspected to be a cause of
PD, with several studies showing a relation, including
epidemiological studies [171-180]. Elemental mercury
has induced PD [175], and in a case report, the condition
of PD substantially improved after treatment with a
mercury chelator [173] and remained unchanged during
a 5-year follow-up period [173]. In another study,
significantly elevated blood mercury levels were found
in 13 of 14 patients with PD compared to healthy controls
[172]. This supports the conclusion of a previous
study which found a correlation between blood mercury
levels and PD [176]. Another study found significantly
higher amalgam exposure in individuals with PD compared
to healthy controls [179].
Adverse health effects in dental staff?
SCENIHR state that “the incidence of reported adverse
effects [in dental staff and dentists] is very low”.
A simple literature research reveals quite the opposite:
Dentists working with amalgam have an increased mercury
exposure [17,181,182]. In most studies available,
mercury exposure in dental clinics resulted in significant
adverse health effects in dental workers. In some studies,
the clinical outcome was not correlated with mercury
levels in urine or blood, and some authors falsely concluded
that mercury was therefore not the cause of the
adverse effects. However, this is not scientific since
urine- or blood mercury levels did not correlate with tissue
levels (see above). Lindbohm et al. (2007) found a
two-fold increased risk for miscarriage through occupational
exposure to mercury (OR 2,0; 95% CI 1,0- 4,1).
The effect from mercury exposure was stronger than
from exposure to acrylate compounds, disinfectants or
organic solvents [199].
Even 30 years after cessation of mercury exposure,
dental nurses showed significant adverse health effects
[200]. In spite of the fact that 85% of the dentists and
dental technicians tested showed mercury related toxicities
in both behavior and physiological parameters, and
15% showed increased mercury induced neurological
deficits with polymorphism of the CPOX4 gene
[186,188,201], SCENIHR still maintain that amalgams
do not cause any significant medical problems in dental
workers, because urine and blood levels are below
“safety limits”.
Infertility
SCENIHR stated that “There is no evidence of any association
between amalgam restorations and either male
or female fertility or obstetric parameters”. As a proof of
this statement, SCENIHR cited just one study, which
examines only semen parameters in men. However,
other studies point to the opposite direction, especially
when examining women:
Female dental assistants exposed to amalgam showed
a higher rate of infertility [198]. Women with more
amalgam fillings or increased mercury levels in urine
(after mobilization with DMPS) had a higher incidence
of infertility [202-204]. Heavy metal detoxification led to
spontaneous pregnancies in a considerable part of the
infertile patients [203]. Exposure to mercury also lead to
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decreased male fertility [205-207]. A Norwegian study
which is often cited as a proof that mercury exposure
in dental clinics does not cause infertility suffers from
methodological flaws insofar as only women were
included who had already given birth to at least
one child. Women without children were excluded.
Such a study certainly cannot answer the question if
working with amalgam leads to infertility or not.
Moreover, the exposure time to amalgam was not calculated
and thus not included as a covariate into the
study.
Multiple Sclerosis (MS)
A 7,5-fold increased level of mercury was found in the
cerebrospinal fluid (CSF) of MS patients [208]. It would
be difficult to speculate that the presence of this
increase in the CSF would not at least exacerbate the
problems associated with MS or any other neurological
disease. The prevalence of MS has been shown to be
correlated with the prevalence of caries [209,210] and
the prevalence of amalgam [211,212]. Several MS epidemics
occurred after acute exposure to mercury vapor
or lead [213]. In animal models inorganic mercury
caused a loss of Schwann cells which build the myelin
sheaths and stabilize the axons of neurons [214]. Autoimmune
pathogenesis, including antibodies against myelin
basic protein (MBP), can be provoked by mercury
and by other heavy metals [148].
MS patients who had their amalgam fillings removed
showed fewer depressions, less aggression and less psychotic
and compulsory behaviors when compared to a
group of MS patients with amalgam fillings [215]. They
also had significantly lower levels of mercury in blood
[216]. After amalgam removal, pathological oligoclonal
bands in the CSF disappeared in MS patients [217].
Removal of dental amalgam also led to a recovery in a
significant proportion of MS patients [147]. A retrospective
study on 20,000 military individuals revealed a significantly
higher risk for MS in individuals with more
amalgam fillings [218]. This risk was underestimated,
because the study cohort which was selected by means
of medical examination consisted exclusively of individuals
with good health at the time of joining the military
[218]. Another problem occurring in some studies
is the absence of documentation of the dental status
before or at the time of the onset of multiple sclerosis.
In spite of these limitations [219] a reanalysis found a
3.9- fold increased risk for multiple sclerosis in individuals
with amalgam compared to individuals with no
amalgam. A recent systematic review also found an
increased risk for MS caused by dental amalgam in
spite of the fact that most studies did not use proper
amalgam-free controls [220].
Amyotrophic Lateral Sclerosis (ALS)
SCENIHR state that “there is no evidence for a relationship
between Amyotrophic Lateral Sclerosis (ALS) and
mercury”
In contrast to the statement of SCENIHR, there are
many studies which suggest that mercury may play a
pathogenetic role in ALS:
Mercury vapor is absorbed by motor neurons [221]
where it leads to increased oxidative stress. In experiments,
mercury vapor was found to promote motor
neuron diseases such as ALS [222-226]. It was proofed
that mercury enhances glutamate toxicity in neurons,
which is one factor in ALS. Case reports show a correlation
between accidental mercury exposure and ALS
[227,228]. There is a reported case of a Swedish woman
with more than 34 amalgam fillings who suffered from
ALS. After removal of these fillings she recovered [229].
A retrospective study reported a statistically significant
association between an increased number of amalgam
fillings and the risk of motor neuron diseases [218].
“Amalgam disease” and markers of sensitivity
Among the most frequently reported symptoms due to
amalgam fillings are: Chronic fatigue, headache,
migraine, increased susceptibility to infections, muscle
pain, lack of concentration, digestion disorders, sleeping
disorders, low memory capacity, joint pain, depression,
heart sensations, vegetative disregulation, mood disorders
and many more [161,215,216,230-234].
Until recently it was not possible to differentiate
between „amalgam-sensitive” and „amalgam-resistant”
persons by their mercury levels in blood or urine or an
epicutaneous test (patch test) [9,21]. However, it could
be shown that subjects could react to a mercury patch
test with psychosomatic complaints, although there was
no allergic reaction of the skin [235]. In addition, neutrophil
granulocytes in amalgam-sensitive subjects react
differently compared to those in amalgam-resistant subjects
[236] and different activities of the superoxide dismutase
could be found [237].
Increased susceptibility to mercury and amalgam
SCENIHR did not mentioned any susceptibility parameters
which make a significant proportion of the population
more susceptible to mercury from dental amalgam:
a) Abnormal porphyrine profiles due to mercury exposure
It is known that mercury exposure leads to aberrant
urine porphyrine profiles in dentists [238] and autistic
children and that this aberrancy was reversed by treating
these children with a mercury chelator [239-241].
A genetic polymorphism of coproporphyrinoxidase
(CPOX4) [188,201] leads to increased susceptibility to
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mercury and thus to a higher risk for neurobehavioral
complaints [242].
The critical question here is the effect of mercury
vapor exposure on brain porphyrine profiles since an
aberrancy in brain heme has been associated with the
inability to remove beta-amyloid protein from brain
cells, which in turn may lead to Alzheimer’s disease
[243].
It should be noted that porphyrins lead to heme, and
heme is critical for several biochemical mechanisms: (i)
heme is the oxygen carrying cofactor for haemoglobin,
(ii) heme is a critical cofactor for the P450 class of
enzymes that are responsible for detoxifying xenobiotics
from the body, (iii) heme is a necessary cofactor for one
of the complexes in the electron transport system of
mitochondria and therefore ATP-synthesis.
Therefore, mercury inhibition of heme production
could have a multitude of secondary effects causing
human complaints and illnesses.
In spite of the fact that 85% of the dentists and dental
technicians tested showed mercury related toxicities in
both behavior and physiological parameters, and 15%
showed an increase of mercury induced neurological
deficits with polymorphism of the CPOX4 gene, organized
dentistry and SCENIHR still maintain that amalgams
do not cause any significant medical problems
because the urine and blood levels are below safety
limits.
b) Brain derived neurotrophic factor
Another genetic polymorphism of the brain derived
neurotrophic factor (BNDF) increases also the susceptibility
to very low level mercury exposure [186,187].
c) Apolipoprotein E diversity
It could be shown that amalgam sensitive persons are
significantly more likely to be carriers of the apolipoprotein
E4-allel (APO-E4) than symptom free controls and
that they are less likely to carry the APO-E2 [231,234].
APO-E4 is known to be the major genetic risk factor for
Alzheimer’s disease, whereas APO-E2 decreases the risk.
It has been postulated that this is due to the difference
in capacity to remove heavy metals from the cerebrospinal
fluid [44,92,102,124,231,234,244]. APO-E2 possesses
two cysteines with metal binding sulfhydryl-groups
whereas APO-E4 does not have any cysteine residues.
d) Glutathione metabolism
Reduced glutathione (GSH) is the main natural chelator
for heavy metals in the body due to its sulfhydryl-containing
cysteine. Only mercury, which is bound to glutathione
(or selenium), is capable of leaving the body via
urine or biliary excretion. Thus, a high level of glutathione
is crucial for mercury metabolism. It has been
described that polymorphisms in genes leading to
impaired GSH production cause higher retention of
inorganic and organic mercury in the body. Other factors
which may increase susceptibility to low dose mercury
exposure, e.g. low levels of selenium, abnormal
reaction of neutrophil granulocytes, activity of super
oxide dismutase, D4-receptor positive methionine
synthetase and impaired methionine transulfurationand
methylation pathways (about 15% of the population),
led to decreased mercury protecting agents, like Sadenyl-
methionine, cysteine, GSH and metallothionine
[44,245-247].
Improvement after removal of amalgam
Significant improvement of health and above mentioned
diseases (including Multiple Sclerosis and other autoimmune
diseases) have been reported after amalgam
removal (in most studies with elaborate protective
measures to minimize mercury exposure) [68,147,149,
150,159,161,217,230,233,234,248-251].
No neurodevelopmental disorders through
mercury?
SCENIHR stated that “There is no evidence of a causal
relationship between dental amalgam and autism” and
“... that no link has been yet established between vaccines,
thimerosal and autism”.
Nonetheless other authors come to opposite conclusions:
“...mercury exposure altered cell number and cell
division; these impacts have been postulated as
modes of action for the observed adverse effects in
neuronal development. The potential implications of
such observations are evident when evaluated in
context with research showing that altered cell proliferation
and focal neuropathologic effects have
been linked with specific neurobehavioral deficits (e.
g., autism).” [252]
Cheuk and Wong (2006) in patients diagnosed with
attention-deficit hyperactivity disorder and Desoto
and Hitlan (2007) in patients diagnosed with autistic
disorders found significant elevations in blood mercury
levels in comparison with controls [253,254].
Adams et al. (2007) observed significant increases in
the mercury levels of baby teeth in infants with
autistic disorders in comparison with controls [255].
Mercury in baby teeth mirrors mercury exposure in
the womb.
Recent brain pathology studies have revealed elevations
in mercury levels and mercury-associated oxidative
stress markers in patients diagnosed with autistic disorders.
The level of mercury in the urine of autistic
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children shows an increase of 3-5 times after appropriate
treatment with the mercury chelator DMSA compared
to healthy children [259]. Autistic children also
excrete higher concentrations of coproporphyrine which
is specific for mercury intoxication [239,240,260,261].
Detoxification of mercury with DMSA normalizes the
abnormal coproporphyrin levels in autistic children
[239,240] and led to improvement of symptoms [262].
Additionally, experimental as well as epidemiological
studies indicate that mercury exposure is responsible for
autism or a deterioration of the disease. Prenatal exposure
to maternal amalgam [46,263], maternal thimerosal
[46,264] and postnatal sources (mercury from vaccines
for the child) together with a genetic sensitivity may
trigger autism. In animal experiments vaccination with
thimerosal led to symptoms similar to autism [265]. Epidemiological
studies confirm a significant association
between low-dose mercury exposure and neurodevelopmental
disorders [266][267][268][269][270][271]. Autistic
children show decreased levels of the natural
mercury chelator glutathione [272]; it is known that
mercury is capable of causing this phenomen [273]. In
some preliminary therapy studies with chelation therapy
led to improvement of symptoms [263]. The Autism
Research Institute therefore lists chelation as the most
effective therapeutic approach among 88 therapies
including 53 medications [274].
Zahir et al. (2005) described that the access of mercury
“...to man through multiple pathways air, water, food,
cosmetic products and even vaccines increase the
exposure. Fetuses and infants are more susceptible to
mercury toxicity. Mothers consuming diet containing
mercury pass the toxicant to fetuses and to infants
through breast milk. Decreased performance in the
areas of motor function and memory has been
reported among children exposed to presumably safe
mercury levels [...] Mercury has been found to be a
causative agent of various sorts of disorders, including
neurological, nephrological, immunological, cardiac,
motor, reproductive and even genetic. Recently heavy
metal mediated toxicity has been linked to diseases
like Alzheimer’s, Parkinson’s, Autism, Lupus, Amyotrophic
lateral sclerosis, etc.”[275].
Some studies which found no associations between
mercury exposure and autism have severe methodical
flaws [245].
Severe methodical flaws in studies cited by
SCENIHR as a proof of the safety of dental
amalgam
In order to study toxic effects it is necessary to compare at
least two samples: one that was exposed to the substance
in question and one that was not. One of the main
problems in most of the amalgam studies is that the vast
majority did not incorporate a true control group that had
never been exposed to dental amalgam. Even when comparing
samples with and without dental fillings, the sample
without dental fillings had been exposed to dental amalgam
earlier in life. The studies cited frequently not only by
SCENIHR as a proof of the putative harmlessness of amalgam
do not use “proper” non-amalgam control groups.
There is a prominent example to describe:
The Swedish twin study [276] actually only compared
57 twin-pairs in a co-twin analysis, and not 587 as mentioned
by the authors and many governmental institutions.
As the average age of the sample was 66 years,
25% had no teeth at the time of investigation, many had
missing teeth and an unknown number had crowns
using other dental materials. Root fillings with amalgam
and amalgam fillings under crowns were not calculated.
As an allegedly “non-amalgam” group, they were compared
with individuals who still had teeth with amalgam
fillings. The authors found that individuals with more
amalgam fillings (which means also more own teeth)
had a better health status. It is fair to assume that individuals
with few or no teeth or teeth that have been
restored with crowns or bridges had probably had dental
amalgam previously. As mercury accumulates in body
tissues, this “amalgam free group” might have a higher
mercury body burden than the “amalgam group” with
currently existing amalgam fillings.
SCENIHR also cited Zimmer et al. (2002) as a proof of
the safety of amalgam. But this study compared two
groups exposed to amalgam (all female, one group of
patients who claimed to be suffering from symptoms
they related to their amalgam fillings and the other
group which did not report any association between
complaints and their amalgam) in terms of mercury
levels in body fluids and psychometric tests. The mean
number of amalgam fillings was identical in both
groups. They found equal mercury levels in both amalgam
groups. Zimmer et al. (p. 210) conclude: “Thus,
mercury released from amalgam fillings was not a likely
cause of complaints reported by the amalgam sensitive
subjects” [21]. It is not clear why these authors come to
such a conclusion. Furthermore it is known from animal
experiments and pharmacological studies that individuals
given equal amounts of a toxin might react differently.
An example for this is that not every smoker
develops lung cancer, although smoking is now accepted
as a main cause for cancer.
“Children amalgam trials”
SCENIHR based their statement about the safety of dental
amalgam also on two children amalgam trials. These
studies show severe methodical flaws:
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In two randomised trials on children it was evaluated
whether mercury containing dental amalgam had
adverse neuropsychological or renal effects [277,278].
Healthy children were randomised to either amalgam or
composite surface restoration. Two children in the
amalgam group died (one possibly by committing suicide)
and were excluded from the study.
Power calculation (binomial - adverse event versus no
event) indicates that psychological illness, having prevalence
of 6.7% in the composite-treated children, would
have to have had a prevalence of at least 14.5% in the
amalgam group to have an 80% chance of being proven
statistically (observed was 9.0%). Similarly for neurological
illness, observed prevalences in the composite group
(0.4% composite, 1.5% amalgam) would have needed at
least 4.5% prevalence in the amalgam group to be significant.
From the authors it was concluded that “there is
no reason to discontinue use of mercury amalgam”
[277] and that “dental amalgam [...] emits small amounts
of mercury vapor” [278].
The first conclusion is a classic error: Due to its lack
of power, the study provides false reassurance that mercury
is ‘safe’. To effectively evaluate the effect sizes seen,
the trial should have been much larger (1500-2500/
group).
Urine porphyrin profiles and markers of oxidative
stress, which are elevated in individuals with dental
amalgam [19,119] were not measured. Also, genetic
polymorphism, which increase the susceptibility to mercury,
like BDNF-Polymorphism [186,188] and Glutathion-
S-Transferase gene polymorphism [279] were
not measured either. Furthermore, the real exposure
level of mercury (mercury vapor emitted in the oral cavity)
was not determined, which questions the ethics of
such a study. Research has demonstrated that the emission
of mercury vapor was much higher than what has
been “estimated” by dentists. Chew et al. (1991) showed
that 43.5 microgram/cm2/day mercury was released
from a “non-mercury releasing amalgam” and this
remained constant over the study period of 2 years
[280].
Mean mercury urine levels were significantly higher in
the amalgam groups [277,278], although in years 3 to 7
the levels of mercury in the urine of the amalgam
bearers continuously dropped until they approached the
levels of the amalgam free children [278]. But restorative
treatment was used in years 6 and 7, which should have
increased or at least maintained the urine mercury
levels. This needed explaining. In the Chew study above
[280], the amount of mercury released was steady for
2 years (the length of the study). It is known that amalgam
do not stop releasing mercury vapor within 7 years.
The question therefore is what the drop was caused by
after year 2? Urine mercury levels are a measure of the
amount of mercury being excreted via this route.
Therefore, after two years of mercury exposure the
route of kidney excretion of mercury appears to be
becoming less effective. This is consistent with the wellknown
fact that increased mercury exposure inhibits its
own excretion. It has been published and verified that
over 90% of mercury excreted by humans leaves through
the biliary transport system of the liver and is excreted
in the feces, not in the urine [13]. The conclusion of
Bellinger et al. [277] that “there is no reason to discontinue
use of mercury amalgam” is amazing, because possible
adverse effects may need more than five years of
mercury exposure to develop. If mercury is involved in
the pathogenesis of Alzheimer’s disease, the disease may
need up to 50 years to be diagnosed clinically [44].
One of the included criteria for the two studies was
“no interfering health conditions” including neurodevelopmental
disorders. The Centers for Disease Control
and Prevention (CDC) in Atlanta (USA) reports that 1
in 6 American children have a neurodevelopmental disorder.
However, above mentined papers conclude that
amalgams should remain a viable clinical option in dental
restorative treatment [278] and they did not exclude
use on children with neurodevelopmental disorders -
exactly the type of child, however, which they excluded
from their studies. As mercury exposure during pregnancy
may be the prime cause of neurodevelopmental
disorders [46,61,245], this conclusion from the children
amalgam is unsafe for the public.
Amalgam for mercury pollution
There has been an alarmingly increase of mercury in
our environment [281] and human bodies [282] over the
last decades. The UNEP reports on a 3-5 fold increase
over the last 25 years [281].
In the European Union (EU) the usage of amalgam
amounts to 120 tons yearly. Dentists are the 2nd largest
user group in the EU [283,284].
Recent calculations done by Hylander [284,285] show
that there are 40 tons of mercury in teeth with dental
amalgam of Swedish people, which results to the excretion
of 100 kg of mercury per year in wastewater. 1300
to 2200 tons of mercury in dental amalgam is present in
the teeth of citizens in the EU (27 countries) [284], and
for the USA the respective figures are about 1000 tons.
In the US, dental amalgam is the 3rd most significant
source of environmental mercury [286]. In contrast to
the EU, removed amalgam is not separated from the
wastewater of dental clinics in the US. But even in most
EU-countries, where such separators are in use, parts of
the dental amalgam leaks into the environment [284].
This mercury from dental amalgam (i.e. mercury
emissions from dental clinics in wastewater, excreted
mercury emissions from amalgam in living individuals,
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mercury emissions from elevated mercury deposits in
tissues of deceased and cremated humans with dental
amalgam) enter into the environment. When including
environmental costs into the economic calculation
(except costs from amalgam related diseases), amalgam
is the most costly dental material as was shown by
Hylander and Godsite [283].
The role of organized dentistry in SCENIHR and in
defending amalgam
The SCENIHR amalgam expert group consisted of one
engineer (chairman), four dentists, a toxicologist and
two veterinarians. The chairman has tight contacts to
the industry. No experts for medicine or environmental
medicine were included. One must wonder why it were
the dentists who represented the strongest party in
SCENIHR.
Due to their education and clinical experience, dentist
are not able to judge medical systemic adverse side
effects caused by dental amalgam, like multiple sclerosis,
autism, autoimmunity, Alzheimer’s disease, psychiatric
diseases etc. Usage of dental amalgam may increase
worldwide (increasing caries epidemic in undeveloped
countries which constitute the highest percentage of the
world`s population ). Today, dental organisations are
the only trade group of health professionals who
endorse the use of a product that is primarily made of
mercury. Every amalgam patent has been produced
according to dental organisations specifications
[287,288]. This may indeed be a critical point, because
organized dentistry, which has always support the use of
dental amalgam, are responsible for adverse side effects
[287,288]. Therefore, the strategies of organized dentistry
used to influence science and politics over the last
decades [287-290] may be analogous to other well
known topics with existing conflicts of interest, where
effective measures have been applied to influence
science and politics regarding dangerous products
[291-295].
Competing interests
The author declare that he have no competing interests.
Received: 23 March 2010 Accepted: 13 January 2011
Published: 13 January 2011
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doi:10.1186/1745-6673-6-2
Cite this article as: Mutter: Is dental amalgam safe for humans? The
opinion of the scientific committee of the European Commission.
Journal of Occupational Medicine and Toxicology 2011 6:2.
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Page 17 of 17
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1
2008-02-22
To the SCENIHR report on ”The safety of dental amalgam and alternative
dental restoration materials for patients and users”.
We do not agree with the report which is more distinguishing for what it has left out than for
what it contains.
The report does not reflect curent knowledge of mercury and amalgam and seems to be 30
years out-of-date.
The report seems to reflect the opinions and wishful thinking of industry and dental schools.
The report relies heavily on blood and urine levels of Hg which at best can be useful in acute
poisonings, useless for chronic poisoning and irrelevant for immunological/immunotoxic
effects. Mercury research has failed to find a correlation between exposure (blood/urine) and
severity of symptoms. At higher levels of exposure more persons get ill but tells nothing
about how ill they are. Since studies has shown elevated blood levels into industrial ranges
after use of nicotine chewing gums, does the EU intend to restrict the use of chewing gums?
We are surprised that a report which claims to be scientific can include references like Bratel,
Herstrom, Dodes and others. For instance it is not possible to claim psychic causes for
somatic symptoms when mercury has as a major effect psychic and cognitive disturbances,
known since ages.
We can not find any reference to the Swedish Dept. of Health report Dental Materials and
Health (SOU 2003:53) and the risk evaluation by M. Berlin, former chairman of the IPCS
Environmental Health Criteria 118, Inorganic Mercury. The report from the Dept. of Health
must have been known at least by the scandinavian participants. Likewise we find no
information on the studies in Norway which show clear-cut late damage to dental assistants
health.
Lichen is known to become malignant in one to a few % of cases, enough reason to ban
amalgam. For lichen the report discusses the generally positive effects of amalgam removal.
Not so for other health effects of amalgam, there are now quite a number of studies showing a
positive health effect in 70-90 % of patients (addendum: saner2-e.pdf). We must assume that
the omission is deliberate. A hallmark of side effects of drugs is the concept Challengedechallenge-(
rechallenge). This obvious measure has not been used in the clinics established
to handle side effects of dental materials. Patients in both Norway and Sweden have
repeatedly complained to the health authorities about the way they have been (badly) treated
and their reports on health changes after amalgam removal have been ignored.
We can find no discussion on the malpractice of placing amalgam in contact with gold with
ensuing severe corrosion. To cite Skinner’s Science of Dental materials 3rd Ed 1948: ”.. such a
condition is always a hazard to the health of the patient”.Many other sources inform about the
severe effects of gold-amalgam corosion cells. This malpractice is however common practice.
Dentists seem to be completely ignorant on corrosion.
This ”greenwashing” report will not be accepted in Scandinavian countries where the
awareness of amalgam toxicity is widespread and the report is more akin to the ”science”
produced by the tobacco industry.
Commentary by Dr Mats Hanson:
RPC6
2
The fact that alternative materials also contain toxic substances is no excuse for continuing
with amalgam. Rather it is a shame for dentistry that they put on the market untested materials
with toxic content and use the population as guinea-pigs. We demand that dental materials
should be handled much like medical drugs.
The Swedish Association of Dental Mercury Patients, Tandvårdsskadeförbundet, Tf (6000
members) and recognized as a handicap organisation with state support.
Mats Hanson, deputy director
e-mail mercapto@telia.com
e-mail to central office of Tf info@tf.nu
16
RPC167
(blank)
To: General Dental Practitioners
General Medical Practitioners
Chief Executives of NHS Trusts
29 April 1998
Dear Colleague
DENTAL AMALGAM
1. We are writing to advise you of publication on 30 April of the enclosed statement from
the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment
(COT) on the toxicity of dental amalgam. COT last considered the safety of dental amalgam
in 1986 when they noted that dental amalgams containing mercury had been used for 150
years and concluded that their use was free from risk of systemic toxicity and that only a
very few cases of hypersensitivity occurred. In their latest statement the committee state that
these conclusions remain unchanged.
2. As a precautionary measure, however, COT advise that it may be prudent to avoid, where
clinically reasonable, the placement or removal of amalgam fillings during pregnancy until
appropriate data are available. The advice which follows may be helpful in answering
enquiries about the statement.
Advice to women who have undergone dental treatment during pregnancy
3. Mothers may be reassured that COT found no evidence of harm to children from the
treatment of their mothers with dental amalgam during pregnancy. However, it is now
generally accepted that women should avoid unnecessary medical interventions during
pregnancy in order to minimise any possible risks to the health of the fetus. As exposure to
mercury vapour from dental amalgam is greatest during the placement or removal of
restorations, COT believe precautionary advice is warranted. Their advice is based on the
possibility that mercury vapour emitted during the removal or insertion of amalgam during
dental treatment could cross the placenta. There is no evidence of any harm to a fetus but,
until further research is carried out, it may be prudent to avoid, where clinically reasonable,
the placement or removal of amalgam fillings during pregnancy.
RPC8
Advice to pregnant women who require dental treatment.
4. Female dental patients may be similarly reassured that COT concluded that there is no
available evidence to indicate that the placement or removal of dental amalgam fillings during
pregnancy is harmful. COT 's advice is to avoid placement or removal of amalgam fillings
where clinically reasonable. Dentists will normally establish if their patients may be pregnant.
Where a pregnant woman has a dental emergency and treatment with dental amalgam is
indicated, it may be assumed that the health benefits of providing that treatment outweigh
any, as yet, theoretical risk of systemic toxicity. In those cases where it is decided to delay
treatment, dentists will be able to use suitable temporary alternatives. It is not recommended
that other permanent, dental filling materials are routinely substituted for amalgam.
Ultimately it will of course be for the patient to decide how she should be treated in the light
of her dentist's advice.
Advice to dental staff
5. The British Dental Association issue guidance regularly on the handling of mercury in
dental practices. The Department will consult the profession about any further advice
necessary as a result of the COT statement.
Action
6. We should be grateful if
* All doctors , dentists, nurses, midwives and health visitors, who are consulted about
the COT statement, could reassure their patients that there is a long history of safe and
beneficial use of dental amalgam and that there is no evidence of harm to children.
COT's advice is precautionary until further research is carried out.
* GPs could bring this letter to the attention of the nurses, midwives and health
visitors associated with their practices, and
* Chief Executives of NHS Trusts could arrange for it to be circulated among medical,
dental, nursing and midwifery staff working in maternity, gynaecological, paediatric
and dental departments in hospitals and nurses, midwives and health visitors employed
by community trusts.
Enquiries about this letter should, in the first instance, be addressed to Jerry Read in room 325
at this address tel: 0171 210 5743.
We are copying this letter to the attached professional and voluntary bodies.
Robin Wild Jeremy Metters
Chief Dental Officer Deputy Chief Medical Officer
From: "R Clarke" <r-clarke@blueyonder.co.uk>
To: <f.j.t.burke@bham.ac.uk>,
"Peter Marquis" <p.m.marquis@bham.ac.uk>,
<a.c.c.shortall@bham.ac.uk>
<785F15D0BDC7554D942234E5055EA29F493DDA@ds180.bham.ac.uk>
Subject: Comedy section found in Dental Library [at classn. RK519.A4] #H052277
Date: Tue, 20 Jul 2004 12:33:21 +0100
Dear Professors,
Thank you for your only burdening me with five citations in your defence of
your approach to my treatment.
I thought I'd seen it all with the Committee on Toxicity's second "Statement
on Vitamin B6" -- a document VERY carefully contrived to deceive
policymakers for corrupt ends, as I proved beyond doubt in a manuscript of
which the Lancet managed to "lose" all its copies after making three
attempts to get me to castrate it into a 500-word farce-letter.
But now it's clear that that creation of the criminal liar Prof H Frank
Woods has been eclipsed by a greater classic,
"The Future of Dental Amalgam" by Dr B M Eley.
In this case it seems to be comedy rather than crime.
I won't go through every line and space of the great work, just point out
three notable bits.
Page 30: "Thus the recent consensus view .... approximately 1 ug/day."
Referring back to Table 8 on the previous page, one sees, errm, well one
squints a bit and moves one's blind spot a bit .......
Page 37: "These results are shown in Table 12 and it can be seen that .....
0.23-1.08 ug ..... 7% to 16% ..... "
-- and sure enough, with sufficiently powerful
optical aids these figures can be clearly seen in that Table 12
(is 0.79-3.38 ug ..... 25% to 56% close enough?).
Page 51 paragraph four starts off on a sticky wicket. Study no. 123 found
an increase in bacterial resistance to mercury. Studies no. 124 and 125
joined in. But then fortunately study no. 126 comes to the rescue with a
null result, probably because of the high pre-existing level swamping any
change. So we can confidently conclude that "Therefore, there is no
evidence ....... ". Just one little problem. The study no. 126 which
proved so decisively that there was *no* increase, was titled..
"Mercury released from dental 'silver' fillings provokes an increase ......
[etc]".
RPC9
Now, given that that above is what this simpleton reader (too stupid for
admission to a university) has noticed on a brief reading, just what perhaps
more is there in that book that he hasn't noticed yet ?
Also, you forgot to mention the 2003 report of the Swedish Dental Material
Commission www.dentalmaterial.gov.se which states: (among other things)
"amalgam must be considered to be an unsuitable material for dental
restoration. This is especially true since fully adequate and less toxic
alternatives are available." (p 25)
"FOR MEDICAL REASONS, amalgam should be eliminated in dental care as soon
as possible." (p 26)
One does have to wonder what else you may have forgotten to mention.
Aha! At last! Page 32 of Dr Eley's book tells me that "nearly 500
scientific studies were used as a basis" for the US PHS report. So I am
closing in at last on those pesky definitive references which keep squirming
from view as fast as one reaches for them. But I can't help recalling the
distinguished Prof. Woods emphatically reassuring BBC listeners that his
anti- vitamin B6 statement was based on "over 100 studies". I checked out
those studies for myself, and was able to see all too clearly why Woods was
only able to cite a handful of the most ultra-pathetic dregs of the would-be
scientific literature in supposed support of his "authoritative" statement.
He's still chairman of the hugely-important Committee on Toxicity six years
on from my definitively documenting his criminal lying. So why should any
of us believe /anything/ that any of these "authorities" tell us?
Turning now to the other citations you kindly provided....
Eur J Oral Sci 104 (1996) Berglund - Indeed, a group of patients,
hypochondriac-hysterics self-selected by a mere emotional hunch that they
are amalgam-poisoned, proved not to be higher in mercury. Contrast that
with my own case where a certain amount of logic relating to my
self-diagnosis is in evidence. It is well-known that hysteric-inclined
individuals tend to be struck down with whatever disease is currently in
vogue.
Int Dent J 53 (2003) Yip - Hardly constitutes a heavyweight assembly of
literature (five pages, 12 refs). Absence of evidence does not constitute
evidence of absence (except in legal circles perhaps), especially in
respect of appeals to epidemiological data which the Swedish report has
shown to be inherently unable to resolve the issue.
J Dent 32 (2004) Burke - Given that in several of the countries amalgam is
little used or being substantially phased out anyway, it should be no
surprise that they are not bothering to legislate against it. And as a
general principle it makes sense to have more regard to scientific reports
such as the Swedish one above, rather than the outputs from parliaments
which are usually more politically-distorted and corrupted.
Controlled Clin Trials 23 (2002) DeRouen - This future data can hardly prove
anything as of now.
Thanks also for kindly sending the following two items.
Quintessence Int 32 (2001) Wahl - The various key points in this article are
disposed of by the Swedish report linked above and by www.iaomt.com .
BDA handout. This is not so much information as propaganda misinformation.
Its claim that "of course" dentists would stop using a hazardous substance
is laughable given the consistent record of institutions whenever they find
themselves in a hole, always digging themselves in further until the mud
collapses on top of them.
I further note your sentence "This statement is the one that is issued by
the Hospital to patients concerned over the issue". In other words you
confirm the policy of no informed consent and only telling patients in the
event that their concern has already been provoked by others first.
I could go on here, but I think I've said enough for now. I really think
you should put an end to wasting your time and mine and just acknowledge
that the pro-amalgam position is indefensible and you should just get on
without delay in enabling me to have the proper treatment I have indicated.
In closing, you may wish to ponder why the following charts of autism
promptly start to rise just after the introduction of high-copper amalgams
in 1976, and how they relate to the fact that my unchallenged theory
provided a FULL explanation of how mercury binds to dna and thereby causes
exactly the symptom-syndrome that is autism.
http://www.autism.com/ari/editorial/explosion.html
www.zazz.fsnet.co.uk/auttheo.htm
Sincerely,
Robin P Clarke
Robin P Clarke www.smartertech.info
Email: r@rpcc.info
Tel: 0121 449 8994
9 Augusta Rd
Moseley
Birmingham
B13 8AJ
Sir Liam Donaldson, Chief Medical Officer
Department of Health
Room 114, Richmond House
79 Whitehall
London
SW1A 2NF
2nd January 2007
Dear Mr Donaldson,
Dental amalgam, not MMR, caused the increase of autism
I am sending herewith a copy of a scientific paper titled:
“The causes of autism: A theory further confirmed by three predictions; and why
dental amalgams were the cause of increased autism”.
This is based on an unchallenged theory paper published in 1993. It makes clear
that the persisting suspicions that MMR caused the autism increase are
unfounded, and that in reality a type of dental amalgam introduced in the 1970s
was to blame.
But meanwhile there is another element to this which is liable to produce a less
favourable impression.
The author of that spectacular update is himself being seriously poisoned by 20
dental amalgams which he cannot afford to have removed. And it appears that
the NHS is incapable of doing anything to correct the great injury it has caused.
I was given a referral to the Birmingham Dental Hospital 8 months ago but they
have proved utterly useless, just stalling incoherently. It has become clear that
they do not have the competence to deal with my case anyway.
My mercury poisoning is now becoming intolerable and critical. I am costing the
taxpayer nearly ten thousand a year in various disability benefits. Yet if a
smaller sum were spent on correcting the mercury problem, all that taxpayer
expense could cease and I could become a contributing taxpayer instead.
It appears that the only person with the specialist competence for this critical
and complex treatment would be Hesham el-Essawy www.el-essawy.com .
This needs to be arranged urgently as I am now in a critical state.
Yours sincerely,
Robin P Clarke
RPC10
United States Court of Appeals for the Federal Circuit
2009-5052
MELISSA CLOER, M.D.,
Petitioner-Appellant,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent-Appellee.
Appeal from the United States Court of Federal Claims in case no. 05-VV-1002,
Judge Lawrence J. Block.
__________________________
DECIDED: May 6, 2010
__________________________
Before MICHEL, Chief Judge, CLEVENGER and DYK, Circuit Judges.
Opinion for the court filed by Chief Judge MICHEL. Dissenting opinion filed by Circuit
Judge CLEVENGER.
MICHEL, Chief Judge.
Petitioner-appellant Melissa Cloer, M.D., appeals the decision of the United
States Court of Federal Claims. Cloer v. Sec’y of Health & Human Servs., 85 Fed. Cl.
141 (Fed. Cl. 2008). The decision affirmed the Chief Special Master’s report, which
denied Dr. Cloer’s petition for compensation under the Vaccine Injury Compensation
Program (“Vaccine Program”) established by the National Childhood Vaccine Injury Act
of 1986, 42 U.S.C. §§ 300aa-1 to -34 (“Vaccine Act”), because it was time-barred. See
RPC11
300aa-100(a). The Vaccine Injury Table lists vaccines that are covered under the
Vaccine Act. See §§ 300aa-11(c)(1)(C)(ii), 300aa-14. The Vaccine Injury Table also
lists injuries that may arise from these vaccines, which are referred to as Table injuries.
§ 300aa-14. Other injuries, including MS, are not listed in the Vaccine Injury Table and
referred to as non-Table injuries. § 300aa-11(c)(1)(C)(ii).
The Vaccine Act sets forth a statute of limitations:
In the case of . . . a vaccine set forth in the Vaccine Injury Table which is
administered after October 1, 1988, if a vaccine-related injury occurred as
a result of the administration of such vaccine, no petition may be filed for
compensation under the Program for such injury after the expiration of 36
months after the date of the occurrence of the first symptom or
manifestation of onset or of the significant aggravation o such injury.
§ 300aa-16(a)(2). The question in this case is whether the 36 month period
commences where a petitioner experiences the first symptom of an injury, but where the
medical community at large does not recognize that the symptom is related to a vaccine
and the claimant has not received medical information suggesting such a connection. If
so, Dr. Cloer’s appeal is time-barred because she experienced the first symptom of MS
in 1997 but did not file her claim until 2005.
Dr. Cloer argues that her appeal cannot be time barred because the “first
symptom or manifestation of onset,” for the purposes of § 300aa-16(a)(2), is “the first
event objectively recognizable as a sign of vaccine injury by the medical profession at
large.” See Markovich v. Sec’y of Heath and Human Servs., 477 F.3d 1353 (Fed. Cir.
2007). Dr. Cloer interprets Markovich to mean that the medical community at large
needs to recognize a link between the injury and the vaccine for the statute of limitations
to begin running. We generally agree.
2009-5052 6
RPC12

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