Number range CHAPTER **[SUMMARY OF SCIENTIFIC EVIDENCE
QUESTIONING]{.underline}**

**[THE CONTINUED USE OF MERCURY AS A COMPONENT OF]{.underline}**

**[DENTAL FILLING MATERIAL]{.underline}**

(This was drafted in 1993 and filed in the Appendix to the reply brief
in Foundation for Toxic Free Dentistry, et al, vs. Food and Drug
Administration, which is a petition for writ of mandamus asking the
court to force the FDA (a) to require manufacturers of mercury/silver
fillings to warn both dentists and patients of the problems of
hypersensitivity and (b) to certify and give a classification to the
final product mercury/silver fillings. Heretofore they have only
certified the component parts (1) dental mercury and (2) amalgam alloy.)

This summary of the scientific evidence questioning the continued use of
mercury as a dental filling material was prepared for the United States
Court of Appeals, District of Columbia, in anticipation of an FDA
argument that there is no proof that the use of dental mercury and
mercury/silver fillings is dangerous. Quite the converse is actually
true. There is no proof that mercury fillings are safe and a very open
and unanswered question as to the extent it contributes to or causes
sub-clinical effects and specific diseases. Referenced citations are
supplied principally via footnotes. The attachments of all these
references would be unduly bulky. To the extent the Court wishes to
review any or all of the references, they will be provided upon request.

It is important to note that the Petition for Writ of Mandamus does not
seek to prove, in any way, that mercury should be banned from its
present use as a dental filling material, even though many of the
petitioners believe it should be banned. Rather the Petition seeks to
require the FDA to warn of hypersensitivity which they themselves
acknowledge. These warnings should be given both to the dentists and
their patients. In addition, the Petition seeks to require the FDA to
certify mercury/silver filling material as a device or implant and to
give it an appropriate classification.

**SCIENTIFIC STUDIES AND CLINICAL EVIDENCE**

**CALL INTO SERIOUS QUESTION THE SAFETY**

**OF MERCURY/SILVER FILLINGS**

Mercury/silver fillings, commonly called amalgams, have been in use for
approximately a century and a half in this country. There has always
been a debate about the safety of using a substance as toxic as mercury
for this purpose.

The Dental Products Panel of the FDA convened March 15, 1991 to consider
the issue of safety versus toxicity from mercury/silver fillings and
included Alfred Zamm, M.D. who stated, \"The belief that a small amount
of mercury is not clinically significant is the result of a major error
in analysis.\"^1^ The panel in discussing the issue seemed to conclude
that mercury was safe unless proven otherwise, and that there was not
sufficient proof of its harm to consider taking any action to insure
safety to the public. But in so doing, they totally ignored the
testimony of many, including the testimony of one of the world\'s
foremost and eminent authorities on mercury, Lars Friberg, M.D., Ph.D.
of the Karolinska Institute, Stockholm, Sweden,:

\"In conclusion, we consider that dental amalgam, from the strictly
toxicological point of view, is an [unsuitable dental filling
material]{.underline}. It is our opinion that,in the future, steps
should be taken to use, as far as possible other material than amalgam.
\*\*\* In the interim we find it highly appropriate to classify the
mercury used in dentistry as a class III device.\"FDA Transcript
3/15/91, p. 81.

Dr. Friberg\'s testimony was followed by Dr. Zamm who concluded his
remarks as follows:

In summary, dental mercury is a dangerous substance. It was a 170-year
old anachronistic mixture of crude coin fil\[l\]ings and mercury that
has been grandfathered in without scientific proof of safety. It is a
dangerous substance that is 170 years old and should be banned. FDA
Transcript, 3/15/91, p.138.

A review of the transcript reveals that the FDA Panel seemed more
concerned about dispelling public fear of mercury/silver fillings than
they were in insuring public safety.

A survey of all the available information has found nothing which will
survive scientific rigor supporting the safety claims for dental mercury
and/or mercury/silver fillings. The information relied upon by the FDA
and others is a claim of 150 years of use without incident and various
articles which either cite no primary research or are basically flawed.
This is, in essence, anecdotal evidence of the worst kind.^2^

**A. [SCIENTIFIC EVIDENCE]{.underline}**

In contrast, there is a great body of valid scientific literature
impugning the safety of mercury/silver fillings^3^ This is accentuated
by the findings of the World Health Organization (WHO) in 1991 regarding
the contribution of mercury/silver fillings showing that a vast majority
of the average body burden of mercury came from those fillings.^4^ Dr.
Friberg, in his testimony to the FDA, presented a number of studies to
support WHO\'s findings.^5^ The ADA has attacked this position
repeatedly despite the fact that earlier autopsy studies (Eggleston;
Nylander), both in this country and Europe, supported WHO\'s
conclusions.^3^ Three recent studies make WHO\'s conclusions
unassailable.^6^ The only one of these published in this country was by
Aposhian, et al, which appeared in the April, 1992 edition of the FASEB
Journal. Despite the fact that the study consisted primarily of people
in the 18-29 age group, thus having little time to accumulate a
significant body burden, Aposhian found, \"It appears that two-thirds of
the Hg in the urine of students with amalgams originated from mercury
vapor that initially had been released from the amalgams in their
mouths.\" (page 2474), and went on to state:

\"Certainly as far as dental amalgams are concerned, the [mystery as to
the degree of toxicity]{.underline} and whether this causes clear
systemic effects or symptoms in the most sensitive groups in the general
population will continue until more sensitive biological markers of
mercury exposure can be developed.\"

Researchers (Grant, 1969^7^ ; Landrigan, 1982^8^) have suggested that
the full extent of how Hg interacts with humans and the en vironment is
only partially understood, but it is known that Hg is a cumulative
poison with insidious symptoms which can be subacute, acute or chronic.
One average-sized amalgam filling contains enough mercury to exceed the
USEPA adult intake standard for non-dietary mercury for more than 100
years.^9^ Dental amalgam has been scientifically proven to be unstable
for over 100 years, because it becomes a battery when placed in
electrolytes such as saliva.^10^ Documented scientific research has
proven that patients with dental amalgam fillings are constantly exposed
to mercury throughout the lifetime of the fillings and that
amalgam-derived mercury builds up in the patients\' bodies with
time.^11^ Exposure to methylmercury from fish is not more dangerous.
Heintz, Edwardsson, Durant and Berkhed (1983), reported that they were
able to show that dental amalgam was changed to methylmercury by oral
streptococci. Thomas W. Clarkson, Ph.D., M.D. of the University of
Rochester, another of the world\'s eminent authorities on mercury has
written:^12^

\"The release of mercury from dental amalgams makes the predominant
contribution to human exposure to inorganic mercury including mercury
vapor in the general

The US EPA banned indoor paints containing mercury because of an
[inadequate margin of safety]{.underline} for painters and residents,
especially children.^12^ Paint obviously contributes much less to the
total mercury body burden than do mercury/silver fillings. Why has the
FDA persisted with the use of dental mercury? Reviewing the evidence
which was produced in the FDA Dental Products Panel hearing in 1991 it
is hard to imagine how one can conclude that mercury/silver fillings are
safe. The Dental Products Panel was so weighted with people involved in
the dental profession and the American Dental Association which
apparently brought about the presumption that fillings were safe unless
proved otherwise.

Mercury in the environment is clearly one of the most toxic naturally
occurring elements, considered much more dangerous to human health than
arsenic, lead or cadmium.^13^ Personal opinions to the contrary, no one
can dispute that human exposure to even the lowest doses of mercury
should be prevented when possible. A specific no-observed- effect-level
(NOEL) cannot and has not been established, either by the World Health
Organization or the United States Environmental Protection Agency.^14^
\"Experiments in primates clearly demonstrate that Hg released from
\"silver\" tooth fillings concentrates in body tissues in amounts
sufficient to alter cell function.\"^15^

Studies have demonstrated that mercury/silver fillings can cause
periodontal disease, oral lichen planus, increased resistance to
antibiotics, and loss of kidney function in test animals, and, in all
probability, in humans.^3^ These problems (presented to Commissioner
Kessler June, 1992) alone are sufficient to determine that the use of
mercury as a filling material is unsafe.

Additionally, autopsy results have shown high levels of mercury in the
brains of individuals who died from Alzheimer\'s disease.^16^ Since then
there has been a study which has shown that mercury (Hg2+) induces a
brain reaction in rats similar to those observed in Alzheimer\'s
patients.^17^ The University of Kentucky now has a grant to study the
possible relationship between Alzheimer\'s disease and mercury/silver
fillings. Numerous scientists have concluded that dentists and their
staff are being poisoned by dental mercury. An increased incidence of
spontaneous abortion and decreased fecundability^18^ are just two
glaring examples of how women working in dentistry are injured because
of the FDA failure to properly regulate or ban this implant material.
Kidney function of dentists is worse than their comparative workers in
cadmium industry.^19^ In addition, a variety of scientific^5^ and
clinical evidence exists implicating mercury from fillings in other
health conditions, including neurological disorders.

The dental establishment has been highly critical of the research team
of Lorscheider, Vimy and Hahn^3^ for using sheep in their studies of the
effects of mercury/silver fillings. The criticism revolves around the
fact that sheep are ruminants who make heavy use of their teeth and
because of the regurgitation process, those teeth are also subject to
stomach acids to some extent. What the dental establishment ignores is
the fact that sheep were used as a worse-case model and that the
fillings were in place in those animals for a very short period of time,
particularly when compared to a human life span. Had the experiments
with sheep proven no potential for harmful effects from the mercury, but
then there would at least be a pretext of scientific research showing
the safety of mercury/silver fillings. Unfortunately, such was not the
case. The study showed extensive deposition of mercury in such critical
organs as the kidney, liver, and brain. Follow-up studies with sheep
showed significant depositions of mercury in the fetus and transmittal
via mother\'s milk. There was an additional and somewhat ludicrous
criticism in that the studies did not measure for background levels of
radio-active mercury. What those critics failed to take into account was
the fact that there is no naturally occurring radio-active mercury so
there was no necessity in checking for background levels. The sheep
studies were followed by studies in 1990 using primates (Dansher;
Hahn).^3^

B. **[CLINICAL EVIDENCE]{.underline}**

A great deal of clinical evidence exists showing that many health
conditions improve upon removal of the mercury/silver fillings and
replacement with non-mercury containing materials. A recent Swedish
study titled \"Amalgam Exchange - A Road to Better Health?\"
demonstrated a 33% reduction in annual sick leave just by replacing
mercury/silver fillings. The study was conducted by the Health Insurance
Bureau in Stockholm County to evaluate the potential of \"amalgam
exchange\" to reduce total health care costs. Of 383 patients (with
mercury/silver fillings) who were chronically ill and on sick leave
approximately 65 days a year, seventy-three (73%) percent had their
mercury/silver fillings replaced with non-mercury materials. This group
demonstrated improvement in all previously reported health symptoms. By
the end of the second year after replacement of mercury/silver fillings,
annual sick leave had dropped from 65 to 44 days a year.

There are a number of reports published by Godfrey Hanson, Huggins,
Pleva, Siblerud, Stortebecker, Taylor, Zamm, Ziff, etc., in books and
journals, many of which are not generally recognized as authoritative by
the medical-scientific community, but which nevertheless provide insight
into the types of problems which seem to be related to the presence of
and alleviated by the removal of mercury/silver fillings.^20^

Two unpublished studies by dentists, Dr. Pierre Larose in Canada and Dr.
Tandlage Henrik Licktenberg in Denmark, also support the conclusion that
removal of mercury/silver fillings has beneficial health results. The
Danish study included \"120 patients suffering from many symptoms that
are classically associated with chronic mercury intoxication\" who
elected to have their mercury/silver fillings replaced with composite
fillings in the period 1985-1990. Both a control group and the subjects
of the study completed a subjective questionnaire stating their
symptoms. For the group which had their mercury/silver fillings removed,
88% of their symptoms either improved or were eliminated.^21^ The
Canadian study was similar in that it involved a questionnaire and
expands on the results of a report of eighty (80) patients before and
after amalgam removal published in [Dental & Health Facts]{.underline},
Volume 2, No. 1, 1989. Fifty-seven of eighty patients (71%) who
requested the removal of their mercury/silver fillings reported, three
months later, some form of improvement in their symptoms.^22^

The FDA Medical Devices Division now has over 700 reports of adverse
reaction to mercury/silver fillings. Statements have been made that
these reports present a very confusing picture because the symptomology
is undifferentiated. That, of course, is to be expected as over 200
signs and symptoms are caused by mercury according to the scientific
literature.^23^ Medical texts including Goodman and Gilman, [The
Pharmacological Basis of Therapeutics]{.underline} and Kaye, [Handbook
of Emergency Toxicology]{.underline}, list some of the classic symptoms
of mercury toxicity as tremors, depression, insomnia, tachycardia,
weight loss, anxiety, lack of self-confidence, memory loss, kidney
problems, lack of concentration, loss of energy, constipation, diarrhea
and sensitivity to light. A summary of \"Symptom Analysis of Patient
Adverse Reaction Reports,\" complied by the Foundation For Toxic Free
Dentistry (Reply App. 107) noted startling, consistent improvement of
these symptoms upon removal of mercury amalgam fillings. For example, of
165 cases of depression, 155 were improved or cured after amalgam
removal. Removal improved memory loss 102 out of 109 times. Kidney
problems were improved in 12 out of 12 cases. Similar results were
reported by virtually every reported symptom of mercury toxicity.

This is compounded by the fact that in all probability many toxins act
in synergistic fashion. Every person in this country who has
mercury/silver fillings in their mouth is exposed not only to mercury
and alloyed metals but to some extent they are exposed to the plethora
of chemicals in our environments which are potentially toxic and most
assuredly to lead, considering lead\'s ubiquitous nature due to past
intensive use in gasoline. The synergism, including the potential
differentiation in symptoms which may be caused by this chemical and
metal soup, is not well understood. It is, however, clear that there is
a potential for a great deal of synergism in the toxic effects of lead
and mercury.^24^ When you couple the Adverse Reaction Reports with the
clinical information of the previous paragraph it presents a picture
which should be given very serious consideration. While the ADA and
other proponents of mercury/silver fillings label this information
anecdotal, it is the kind of clinical evidence which should be given
credence under the first principle of the scientific method:
observation. In this regard the following quote from an editorial in the
[New England Journal of Medicine]{.underline} (April 1987) is most
appropriate:

> \"Science is a hard taskmaster, and in the light of mounting evidence
> that suggestions of toxicity are for the most part ultimately
> confirmed by painstaking scientific inquiry, perhaps it is time to
> re-examine whether scientific standards of proof of causality - and
> waiting for the bodies to fall - ought not to give way to more
> preventive health policies that are satisfied by more realistic
> conventions and that lead to action sooner.\"

After years of evidence as to the potential toxicity, we have finally
dealt with the issues of asbestos and lead. It took approximately a
century after the first questions were raised about the use of mercury
in teething powders before mercury was recognized as the cause of
acrodynia.^25^ Isn\'t it time we apply the above quote to the use of
dental mercury? Recently the National Research Council, a part of the
National Academy of Sciences, restated the above principle in a much
different way in its 1992 publication [Environmental
Neurotoxicology]{.underline} (National Academy Press, Washington DC 1992
at page 3:

> \"Anecdotal reports of neurotoxicity in humans need to be pursued
> vigorously with clinical surveillance and follow-up. The incorporation
> in surveillance systems of the concept of sentinel health events
> (SHEs) specifically for neurotoxic illnesses should be encouraged.\"

The National Research Council went on to state at page 4:

> \"Recognition of the possible environmental origin of neurologic and
> psychiatric disease is hampered by the inadequate training of most
> physicians and other health providers in occupational and
> environmental medicine.\"

This quote, \"\...inadequate training of most physicians and other
health providers\...\" may help explain how we have used mercury/silver
fillings for 150 years and have so little knowledge, either as to its
safety or deleterious effects. This is accentuated by the ubiquitous
symptomology presented by mercury and the lack of clear laboratory
indications of its presence in excess. While most physicians are
inclined to rely on blood and urine levels, it is very clear from the
literature that this is not well placed.^3,26,27,13^ There appears to be
little correlation between levels in urine, blood or hair and its toxic
effects.^27^ Another confounding problem presented by mercury poisoning
is that at least in one disease there is a remarkable variation in
individual susceptibility as Thomas W. Clarkson, Ph.D., M.D. (Hon.)
points out:

> \"This characteristic was probably responsible for the long delay in
> identifying mercury as the causative agent of acrodynia. As long ago
> as the 19th century, pediatricians were well aware that thousands of
> children were ingesting calomel (mercurous chloride) in teething
> powders, as a cathartic agent, and in anthelmintic preparations, and
> that their diapers were often washed with mercury compounds added as
> fungicides and disinfectants. In the late 1940s pediatricians finally
> made the connection between mercury and acrodynia. After having been a
> common childhood scourge, acrodynia became rare\... \"^28^

C. **[NEUROLOGICAL DISORDERS]{.underline}**

There are a number of very serious neurological disorders for which the
cause is mysterious. The clinical pictures of several of these are most
interesting when considered in light of the documented neurotoxicity of
mercury and the potential for neurotoxicity from mercury/silver
fillings.

1\. **MULTIPLE SCLEROSIS**

An interesting example is presented by multiple sclerosis. Multiple
sclerosis was first identified in the 19th century during the time in
which mercury/silver fillings came into common use. Unpublished
anecdotal evidence would seem to indicate that a significant number, but
certainly not all, MS victims who have their mercury/silver fillings
removed resolve (spontaneous remission) or improve gradually. Of the
fourty-two victims of MS sending in Adverse Reaction reports 4 were
cured and 29 improved. The Multiple Sclerosis Society debunks this
theory but, there is toxicological evidence that chronic mercury
poisoning (from sources other than fillings) and multiple sclerosis
share similar patterns of symptomology. The [Encyclopedia of
Occupational Health and Safety]{.underline} discusses the symptoms of
chronic mercury poisoning in part as follows:

> \"Nervous system involvement may occur with or without
> gastrointestinal symptoms, and may evolve in line with two main
> clinical pictures: (a) fine-intention tremor reminiscent of that
> encountered in persons suffering from multiple sclerosis.

\*\*\*

> The most frequently encountered symptoms resemble those presented by
> persons with multiple sclerosis except there are no nystagmus and the
> two conditions have a different serology and different clinical
> courses.\" ^29^

Can the other heavy metals which are components of mercury/silver
fillings, the silver, copper, tin and zinc, be causing this difference
in serology and clinical course? No one knows.

In 1966, Baasch concluded, based on sometimes severe neuroallergic
reactions in acrodynia and his own observations on neurologic patients,
that multiple sclerosis was an adult form of acrodynia and a
neuroallergic reaction, in most cases, caused by mercury from amalgam
fillings.^30^

In great detail, Baasch demonstrated that facts concerning the
geographical and age distribution, pathological development and
symptomology of MS are all consistent with amalgams as the primary cause
of the disease. He reported several specific cases and cited ongoing
studies that showed cessation of progression and improvement of
resolution of MS after removal of amalgam fillings. In a very detailed
study published in 1978,^31^ a strong correlation (P\<0.001) between MS
death rates and dental caries was established. The data show that it is
extremely unlikely that this is a chance correlation, and that numerous
dietary factors could be ruled out as causative agents.

A hypothesis presented in 1983 by T. H. Ingalls M.D.^32^ proposed that
slow, retrograde seepage of mercury from root canals or amalgam fillings
may lead to multiple sclerosis in middle age. Based on his personal
experience, he proposed a correlation of unilateral multiple sclerosis
symptomology with ipselateral amalgam-filled teeth. He also re-examined
the extensive epidemiological data that show in the US and other
countries a linear correlation between death rates from MS and numbers
of decayed, missing and filled teeth. Ingalls^33^ suggested that
investigators studying the causes of MS should carefully examine the
patients\' dental histories. Furthermore, Dr. Ingalls\' hypothesis
included other environmental exposures to mercury. In 1986, he published
data supporting his hypothesis that clearly demonstrate endemic
clustering of MS in time and space over a fifty year time span that
could be directly correlated to exposure to mercury.^34^

Another study (1987) found that multiple sclerosis patients had eight
(8) times the normal level of mercury in their cerebral spinal fluid as
compared to neurologically healthy controls.^35^

2\. **AMYOTROPHIC LATERAL SCLEROSIS (ALS) OR LOU GEHRIG\'S DISEASE**

Another interesting neurological disorder with unknown etiology is
amyotrophic lateral sclerosis (ALS), more commonly known as Lou
Gehrig\'s disease. Like MS, some with ALS have found that their
condition improved dramatically upon removal of their mercury/silver
fillings. The correlation to mercury exposure was first suggested by
Brown in 1954. Footnote: Brown, I.A. Chronic Mercurialism, a cause of
the clinical syndrome of amyotrophic lateral sclerosis. AMA Arch. Neurol
Psych 72:674-681, 1954. A 1961 study of eleven cases of chronic
mercurialism from consumption of bread treated with a mercury-containing
fungicide presented neurological pictures akin to amyotrophic lateral
sclerosis with some more closely resembling progressive muscular
atrophy. The paper concluded:

> \"1. Since the same causative factor was operative in all these cases,
> it would appear that amyotrophic lateral sclerosis and progressive
> muscular atrophy are probably nosologically identical.
>
> 2\. Amyotrophic lateral sclerosis should not be considered a disease
> entity but rather a syndrome of variable etiology.
>
> 3\. [Chronic mercurialism is a possible etiologic factor in
> amyotrophic lateral sclerosis]{.underline}.\" (emphasis added) ^36^

Two subsequent reports are noteworthy. A 1978 report by Barber involved
two employees in a mercury oxide manufacturing plant who developed
neurological changes resembling ALS.^37^ In a 1983 report in JAMA a
54-year-old man had symptoms resembling ALS after a brief but intense
exposure to elemental mercury which resolved afterwards.^38^

From this we cannot say absolutely that mercury from fillings causes
either MS or ALS, but it certainly appears to be a factor. To those who
have seen their symptoms improve or resolve this may seem ridiculous but
the available scientific evidence is inconclusive and more research must
be done. More importantly, the converse cannot be proven. That is, that
mercury/silver fillings are safe. Congress has placed a burden upon the
FDA and the manufacturers which they have not met.

D. **[HYPERSENSITIVITY OR ALLERGIC REACTIONS]{.underline}**

It will probably be some years before medical scientists have unraveled
all the harm which mercury from dental fillings is causing. That is not
surprising considering its ubiquitous nature as a poison and the fact
that most medical doctors have been exposed only to the positions of the
ADA and FDA on the safety of mercury/silver fillings. Apparently there
are second thoughts within the FDA, as you can see from the newspaper
article containing statements (Reply p.2) of Dr. Don Galloway of the
FDA\'s Center for Devices & Radiological Health.^39^ The ADA and FDA,
while ignoring the evidence of toxicity, admit that 1% of the U.S.
population may be hypersensitive to mercury/silver fillings. Although
their figure is invalid and not based on any scientific study or
epidemiological data, utilizing their statement would still place
upwards of a million people at risk. Scientific studies demonstrate at
least a 5-11% allergic response to mercury and perhaps much higher.^40^
We must be aware that no studies have been found about the sub-clinical
toxic effects of mercury, particularly in this sensitive group. However,
as Lars Friberg, M.D., Ph. D., has testified on this issue to the FDA:

> \"A special problem is the fact that mercury can give rise to allergic
> anti-immunotoxic (sic) reactions which are partially genetically
> regulated.\" ^41^

Manufacturers of mercury/silver fillings and the FDA face a dilemma
regarding this evidence of hypersensitivity to mercury. The percentages
are so high that action is required but apparently there is no standard
of care within dentistry or medicine for testing for
hypersensitivity.^42^

**[THE DENTIST\'S DILEMMA]{.underline}**

A 1973 textbook on oral pathology states:

> \"A toxic reaction from absorption of mercury in dental amalgam has
> been reported on a number of occasions.\"^43^

Yet the ADA persists in assuring the public, dentists, and particularly
its members that the scientific evidence indicates amalgam fillings are
safe with statements such as the following:^1^

> \"Why is the ADA so confident that amalgam is safe? The strongest and
> most convincing support we have for the safety of dental amalgam is
> the fact that each year more than 100 million amalgam fillings are
> place in the United States. And since amalgam has been used for more
> than 150 years, literally billions of amalgam fillings have been
> successfully used to restore decayed teeth.\"^44^

Most dentists rely on the standard of care to protect them, but the
alternative theory known as the \"material risk approach\"^46^ and
specific cases on informed consent raise serious questions as to whether
or not this will suffice on the question of the use of dental mercury
with an individual patient. Two cases have suggested that when faced by
a direct question by the patient, the health care provider must research
the question and disclose to the patient current scientific information.
In other words, a disclosure of reasonable, foreseeable risk is not
sufficient if the patient inquires concerning any and all risks, at
which time a complete disclosure is required.^45^

Given the fact that individuals with mercury/silver fillings receive a
considerable dose of mercury,^3;6^ a highly toxic heavy metal, it is
important to limit that exposure. Since mercury/silver fillings have a
limited longevity, removal and replacement is foreseeable. From the
literature there appears to be a significant exposure both at placement
and removal of mercury/silver fillings, but the level of that exposure
has not been adequately quantified. There are concerns about the lack of
a standard of care in both the placement and removal of mercury/silver
fillings in order to minimize exposure. The American Dental Association
calls for the use of water spray and evacuation, however, it cannot be
said that that is necessarily the standard of care. Many dentists simply
grind out mercury/silver fillings with an amalgam removing diamond
drill, which tends to pulverize the material, releasing a great deal of
mercury and maximizing exposure. Obviously methods of isolation, debris
removal and high volume evacuation can limit patient exposure.48 Because
of the lack of a clear efficacious standard of care it is incumbent upon
the FDA and the manufacturers of mercury/silver fillings to establish a
protocol for its removal which will minimize exposure to the patient.

**[ENVIRONMENTAL IMPACT]{.underline}**

Dental mercury has a tremendous negative environmental impact which was
ignored at the time of its classification in 1987. Estimates are that
two million pounds of mercury has gone into the environment of the
United States over the last 15 years. This amounts to over 130,000
pounds per year and over 350 pounds per day.^49^ A most frequent
recipient of this mercury is the waterways of this country.
Unfortunately, in aqueous systems, mercury\'s presence is magnified by
aquatic life as the small organisms & fish filtrate the water, they also
filtrate the mercury. As a consequence, mercury can be toxic at
extremely low levels. Clean Water Action has recently published a report
pointing out that one pound of mercury is sufficient to contaminate a
lake with an eighteen square mile surface area. Dental mercury
contributes approximately 350 pounds per day. For the sake of argument,
assuming that one-half of that amount is dispersed in a lake, it would
contaminate a lake with over 3,000 square miles of surface area each
day.^50^

Perhaps the strongest evidence of this lack of proof of safety comes
from statements made by an FDA official as excerpted from a newspaper
September 25, 1992:

> Despite safety reassurances from the dental profession and two federal
> panels, leading toxicologists yesterday said evidence still points to
> mercury in amalgam dental fillings as a potentially serious health
> threat.
>
> A Food and Drug Administration official, speaking at a Seattle meeting
> of the Society of Toxicology, drew parallels between the evidence
> against lead poisoning 20 years ago and the evidence against mercury
> today. Lead has since been proven harmful to humans and removed from
> paint, pipes and many other materials.
>
> New evidence indicates a need for more vigorous study of the possible
> risk posed by the release of mercury vapor from \"silver\" amalgam
> fillings, said Dr. Don Galloway, a scientist with the FDA\'s Center
> for Devices and Radiological Health in Rockville, Md.
>
> Making an analogy to lead poisoning, he said the rule of thumb for
> safety in lead exposure used to be the point at which exposure caused
> obvious physical symptoms. But studies have since shown that chronic
> exposure to even low levels of lead, especially in children, can cause
> significant developmental and neurological damage.
>
> Lead was removed from paint in 1971, Galloway said. Mercury was
> removed from paint in 1991, he noted, asking the toxicology group
> meeting at the Washington State Convention and Trade Center yesterday
> to consider if there is a 20- year lag between understanding mercury
> toxicity compared with lead toxicity. \*\*\*
>
> There are some striking similarities in the history, he said.^39^

Two conclusions must be drawn from this statement. The first is that
studies need to be done regarding the possible risks of mercury/silver
fillings. The second, naturally following from the first, and more
chilling aspect is that the safety of mercury/silver fillings has not
been proven as Congress intended in the Medical Devices Act of 1976 and
the FDA persists in doing nothing about it.

Given the plethora of scientific data calling into question the
continued use of mercury/silver fillings it is hard to see how the
manufacturers, the American Dental Association, the National Institutes
of Health, including the National Institute of Dental Research have
continued to allow the use of mercury in dentistry without at least
explicit warnings regarding the potential for hypersensitivity. At the
time of the approval by the FDA of dental mercury in August of 1987 the
panel made reference only to three (3) articles dealing with
hypersensitivity, ignoring other articles dealing with toxic or
hypersensitive reaction and also ignored many other articles that called
into question the use of dental mercury on other grounds. As Dr. Thomas
W. Clarkson has said, \"Many important medical questions concerning
mercury toxicity remain to be answered.\"^28^ We know the use of
mercury/silver fillings is unsafe, we just do not know to what extent.

**[FOREIGN ACTION]{.underline}**

An ad hoc committee (called the Expert Commission) of imminent
scientists, formed by the Swedish government to consider this issue,
found that mercury/silver fillings were unsuitable from a toxicological
standpoint and suggest its use be discontinued in pregnant women. The
Expert Commission went on to recommend that all use of mercury/silver
fillings be discontinued when a suitable replacement could be found. In
1990 the Swedish government passed a law requiring the National Health
Insurance System to pay part of the costs of replacing mercury/silver
fillings when medically indicated. Recently the Swedish Public Health
Department submitted a plan to the government calling for all use of
mercury/silver fillings to be stopped by 1997.

Germany, on March 1, 1992, published a special directive limiting the
use of mercury/silver fillings to chewing surfaces in posterior teeth;
eliminating the use of mercury/silver fillings for root or retrograde
fillings; stopping the placement of mercury/silver fillings in children
up to 6 years of age and in the teeth of pregnant women; and stipulating
that mercury/silver fillings should not be placed in the teeth of anyone
with kidney problems.

**[CONCLUSION]{.underline}**

No scientific data has ever been presented which has established liquid
mercury as a safe implant material. A number of studies are ongoing that
will probably provide further support for the scientific argument
against the use of mercury in dentistry. The scientific and clinical
information should be considered in light of the guiding principle of
medicine - \"first do no harm.\"

This document was prepared by:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Robert E. Reeves

REEVES & GRADDY

167 W Main Street Suite 300: now 1310

Lexington KY 40507

\(606\) 252-8539: now 226-0700

.OJoff

(Copies of the reference documents have not been attached becauseof
their bulk, but will be provided to the Court if requested.)

^1^ FDA Transcript 3/15/91, p.81

^2^ IAOMT response to the positions taken by the ADA. IAOMT, PO Box 458,
Ortonville, Michigan 48462.

^3^ A short list of the most important references found in regard to the
question of safety of mercury/silver fillings is attached.

^4^ World Health Organization (1991) \"Environmental Health Criteria
118: Inorganic Mercury\", Geneva.

^5^ FDA Transcript 3/15/91, pp. 67-70.

^6^ Aposhian HV et al. Urinary mercury after administration of 2,3-
dimercaptopropane-1 sulfonic acid: Correlation with dental amalgam
score. FASEB J 6(6):2472-2476, April 1992.

Zander D. et al. Studies on human exposure to mercury .3. DMPS induced
mobilization of mercury in subjects with and without amalgam fillings.
Zentralblatt fur Hygiene und Umwelmedizin 192(5):447-454, Feb 1992.

Skare I, Enqvist A. Amalgam restorations - an important source of human
exposure to mercury and silver. LAKARTIDNINGEN 15:1299-1301, 1992.

^7^ Grant, N. (1969). Legacy of the mad hatter.
[Environment]{.underline}, [11]{.underline}, 18-23, 43, 44.

^8^ Landrigan, P.J. (1982). Occupational and community exposure to toxic
metals: Lead, cadmium, mercury and arsenic. [The Western Journal of
Medicine]{.underline}, [137]{.underline}, 531-538.

^9^ Craig, RG;et al. Dental Materials: Properties and Manipulation. pg.
78 CV Mosby. St. Louis. 1975

^10^ Chase, HS, M.D., D.D.S. Some Observations and Experiments Connected
With Oral Electricity. Amer J. Dental Science. Vol. 12:18-23. 1878-79.\]
\[Phillips, RW. Skinner\'s Science of Dental Materials. 7th Ed. WB
Saunders Co. 1973\]

^11^ Clarkson TW, Friberg L, Nordberg GF, Sager PR, eds. Biological
monitoring of toxic metals. New Yorik: Plenum Press, 1988. National
Academy of Sciences, \"An Assessment of Mercury in the Environment\",
Washington, D.C. 1978, p. 84.

^12^ see footnote #28 the fallowing was cited erroneously: Agocs, M. M.
et al Mercury exposure from interior latex paint. New England J Med
1990; 323:1096- 1100.

^13^ Sharma RP and Obersteiner EJ. Metals and Neurotoxic effects:
Cytotoxicity of slected metallic compounds on chick ganglia clutures. J.
Comp. Path. Vol 91:235-244, 1981.

^14^ Mercury Health Effects Update: Health Issue Assessment.
EPA-600/8-84-019F. Aug 1984.

^15^ Letter from Drs. Lorscheider and Vimy, Vol. 337: May 4, 1991, [The
Lancet]{.underline}, page 1103.

^16^ (a) Wenstrup, D; Ehmann, Wd; Markesbery, WR Trace Element
Imbalances in Isolated Sub cellular Fractions of Alzheimer\'s Disease
Brains. Brain Research. 553:125-31. 1990

\(b\) Ehmann, W.E., et al. Biol. Trace Elem. Res. 13:19-33. 1987

\(c\) Ehmann, W.D. et al. Brain Trace Element Analyses with instrumental
NNA Neurtoxicology. 7:197-206. 1976

^17^ Duhr E. et al, FASEB 75th Annual Meeting, Atlanta, Georgia, April
21-25, 1991. Abstract #493.

^18^ Rowland A, Baird D, Weinberg C, Shore D, Shy C and Wilcox A Reduced
Fertility Among Dental Assistants with Occupational Exposure to Mercury;
National Institute of Environmental Health Sciences, Research Triangle,
NC (Abstract The Toxicologist 31st Annual Meeting Vol 12 #1 February
1992).

^19^ Verschoor MA, Herbert RFM, Zielhuis RL; Urinary mercury levels and
early changes in kidney function in dentists and dental assistants;
Community Dentistry and Oral Epidemiology Vol 16 #3 June 1988.

^20^ These citations are not listed here but will be furnished to the
Court and/or copies of the articles upon request.

^21^ Lichtenberg, Tandlaege Henrik, Torvet 1A, 3400 Hillerod, Denmark,
Elimination of Symptoms by Removal of Dental Amalgam from Mercury
Poisoned Patients, as Compared with a Control Group of Average Patients.
(Unpublished) Copy attached.

^22^ Larose, Dr. Pierre, St-Laurent, Quebec, The Effect Of Amalgam
Removal on 37 Health Symptoms In Humans (1992 - unpublished). Copy
attached.

^23^ See pp. i-iii of a mercury bibliography with approximately 12,000
references is available for \$43.00 including shipping from Bio-Probe,
Inc., P.O. Box 608010, Orlando, FL 32808-8010. If requested this will be
furnished to the Court of Appeals at no charge.

^24^ Schubert, Jack et al - Combined effects in Toxicology - a rapid
systematic testing procedure: Cadmium, Mercury, and Lead, [Journal of
Toxicology & Environmental Health, vol 4:763.776, 1978]{.underline}.

^25^ Warkany, J. Acrodynia - Postmortem of a disease Amer. J. Dis.
Child. 112, 1966. 147-156.

^26^ Bell ZG Jr, Lovejoy HB, Vizena TR. Mercury exposure evaluations and
their correlation with urine mercury excretions. 3. Time-weighted
average (TWA) mercury exposures and urine mercury levels. J Occup Med
1973; 15:501-8.

^27^ (a) Goldwater, LJ, Ladd, AC, & Jacobs, MB. Arch. Envir. Health,
1964)

\(b\) NIDR/ADA Workshop on Biocompatibility of Metals in Dentistry.
Journ. American Dental Assoc. Vol. 109. September, 1984.

^28^ Clarkson, T.W., N. Eng. J. Med. 323:1137-1139 (October 18, 1990).

^29^ [Encyclopedia of Occupational Health and Safety]{.underline}, (3rd
revised edition 1983) Parmeggiani, L., Technical Editor, pp. 1334-1335.

^30^ Baasch, E. Theoretische Ueberlegungen zur Aetiologie der Sclerosis
multiplex. Die Multiple Sklerose eine Quecksilberallergie? Schw. Arch.
Neurol. Neurochir. Psychiat. 98, 1966, 1-18.

^31^ Craelius, W. Comparative epidemiology of multiple sclerosis and
dental caries. J. Epidemiol. Comm. Health 32:155-165, 1978

^32^ Ingalls, T.H. Epidemiology, etiology, and prevention of multiple
sclerosis. Hypothesis and fact. Am. J. Forensic Med. Pathol. 4:55-61,
1983.

^33^ Ingalls, T.H. Triggers for multiple sclerosis. Lancet, xx:160,
1986.

^34^ Ingalls, T.H. Endemic clustering of multiple sclerosis in time and
place, 1934-1984. Am. J. Forensic Med. Pathol. 71:3-8, 1986.

^35^ Britt Ahlrot-Westerlund, \"Multiple Sclerosis and Mercury in
Cerebrospinal Fluid\", Second Nordic Meeting on Trace Elements in Human
Health and Disease, Odense, Denmark 17-21 August 1987.

^36^ Kantarjiam AD: A syndrome clinically resembling amyotrophic lateral
sclerosis following chronic mercurialism. Neurology 11:639-44, 1961.

^37^ Barber TE: Inorganic mercury intoxication reminiscent of
amyotrophic sclerosis. J. Occupat. Med. 20:667-9, 1978.

^38^ Adams CR, Ziegler DK, Lin JT: Mercury intoxication simulating
amyotrophic lateral sclerosis. J. Amer. Med. Assoc. 250:642-3, 1983.

^39^ February 25, 1992 article by Paulson in [Seattle
Post-Intelligencer]{.underline}, \"Danger in Fillings Indicated\"
regarding meeting of Society of Toxicology.

^40^ See references by (a) Djerassi, (b) Miller, and (c) White, per
footnote #5.

^41^ FDA Dental Products - Panel Meeting, March 15, 1991, pp. 72-73.
(The transcript refers to \"anti\"-immunotoxic which is believed to be a
transcription error.)

^42^ NIDR maintains that hypersensitivity is rare, appears within a
relatively short period of time, is usually localized, and \"can be
determined through a skin patch test performed by an allergist or
dermatologist\". (NIDR Research Digest, February 1991). In contrast, the
facts indicate that mercury patch testing has generally been dropped by
physicians, and there never was a clear protocol established for the
patch test when it was in use. (Robert E. Reeves\' personal conversation
July 1992 with William Sellars, M.D., Board Certified Immunologist,
Dallas, Texas.)

^43^ Shafer, WG; et al. A Textbook of Oral Pathology. WB Saunders Co.
Philadelphia. 1973

^44^ J Amer Dent Assoc., [When Your Patients Ask About Mercury in
Amalgam]{.underline}. 120:396. April 1990.

^45^ Council on insurance. Informed consent: a risk management view.
[JADA]{.underline}, Vol. 115:630-635, 1987.

^46^ Herbeson v. Parke-Davis, Inc., et al, 746 Fed 2d 517, 525 (9th
Circuit 1984). Mason v. Ellsworth, Wash. Appl, 474 P.2d 909, 919 (1970).
C & 61 Am. Jur.2d, Physicians, Surgeons, etc., sec. 189.

^47^ Reinhardt, J.W., et al. Exhaled mercury following removal and
insertion of amalgam restrictions. [Journal of Prosthetic
Dentistry]{.underline}, 49:652-656, 1983.

^48^ Bio-Probe Newsletter, September 1992, pages 1-4

^49^ Clean Water Action, Mercury Warning: The Fish You Catch May Be
Unsafe To Eat, Washington, D.C. 1992.

^50^ Neurotoxins: At Home and the Workplace, Report to the Committee on
Science and Technology, U.S. House of Representatives, Chairman, Don
Fuqua, Florida, 1986.

m:scien93.108

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