The following article sheds light on the misleading statements from organized dental organizations to government health committees. Please peruse the science section of our website for a sampling of studies Dr. Frederick Eichmiller is unaware of or forgot to mention.
Association testifies before expert panel on amalgam safety - 2003
Bethesda, Md. — "The overriding body of scientifically valid and peer-reviewed research supports only one conclusion: that dental amalgam is a safe, affordable and durable material."
So testified Dr. Frederick Eichmiller, director of the ADA Foundation's Paffenbarger Research Center, Dec. 12 to an independent, third-party expert panel commissioned by the federal Food and Drug Administration, Centers for Disease Control and Prevention and National Institutes of Health. Its task: to analyze the peer-reviewed, scientific literature published since 1996 on potential adverse human health effects caused by dental amalgam.
"In fact," he added, "over the years, the major U.S. and international scientific and health bodies, including the National Institutes of Health, U.S. Public Health Service, Food and Drug Administration, Centers for Disease Control and Prevention and World Health Organization, among others, have all stated that dental amalgam is a safe restorative material."
Dr. Frederick Eichmiller has mistakenly state that the World Health Organization (WHO) endorses the continued use of amalgam. It is a wide spread misconception that the WHO, has declared mercury fillings safe. They have not.
The source of this misinformation seems to be a policy statement made by the FDI World Dental Federation with the title WHO Consensus Statement on Dental Amalgam.
This policy statement has incorrectly and extensively been used by dental organizations to convince politicians and other decision makers that the WHO has declared mercury fillings safe.
In March 1997 the WHO Oral Health section, the dentists within WHO, gathered a number of external experts to a consultation on the matter. It is pointed out in the report that the statements made by the experts in their written contributions are solely the responsibility of the authors. Furthermore the subtitle of the resulting report is WHO Consultation on Dental Amalgam and its Alternatives, Geneva, 3-7 March 1997 indicating that this is not a decision taken by the WHO. (Mjör IA, Pakhomov GN . Dental Amalgam and Alternative Direct Restorative Material. Oral Health Division of Noncommunicable Diseases World Health Organization. Geneva 1997.)
It almost happened again in 2010
Charlie Brown, President of
the World Alliance for Mercury Free Dentistry
explains why the World Health Organization
retracted the Peterson Paper
Charlie Brown, President of the World Alliance for Mercury Free Dentistry, announced to the stakeholders attending INC2 that the World Health Organization rescinded the document known as the "Petersen Paper." The Notorius Petersen Paper was a propaganda project of the World Health Organization's in-house dentist. In his paper, Petersen claimed that phasing out amalgam was not feasible and amalgam was 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. includes Juliet Pratt and Lillian Lasaten Ebuen DDS
Here is what the World Health Organization ("WHO") says currently (2011) in its re-released, long-awaited report on dental amalgam. In Future Use of Materials for Dental Restoration, WHO urges "a switch in use of dental materials" away from amalgam.
The report describes three of these reasons in detail:
WHO determines that amalgam releases a "significant amount of mercury": WHO concludes that amalgam poses a serious environmental health problem because amalgam releases a "significant amount of mercury" into the environment, including the atmosphere, surface water, groundwater, and soil. WHO says "When released from dental amalgam use into the environment through these pathways, mercury is transported globally and deposited. Mercury releases may then enter the human food chain especially via fish consumption."
WHO determines that amalgam raises "general health concerns": While the report acknowledges that a few dental trade groups still believe amalgam is safe for all, the WHO report reaches a very different conclusion: "Amalgam has been associated with general health concerns." The report observes, "According to the Norwegian Dental Biomaterials Adverse Reaction Unit, the majority of cases of side-effects of dental filling materials are linked with dental amalgam."
WHO concludes that "Materials alternative to dental amalgam are available" – and cites many studies indicating that they are superior to amalgam. For example, WHO says "recent data suggest that RBCs [resin-based composites] perform equally well" as amalgam. And compomers have a higher survival rate, says WHO, citing a study finding that 95% of compomers and 92% of amalgams survive after 4 years. Perhaps more important than the survival of the filling, WHO asserts that "Adhesive resin materials allow for less tooth destruction and, as a result, a longer survival of the tooth itself."
IS THAT REALLY WHAT THEY SAY ?
Consumers for Dental Choice
Explains the lawsuit that forced the FDA
to finally classify mercury amalgam fillings after 33 years of inaction.
So does the FDA really endorse the continued use of amalgam as safe, strong, inexpensive material for dental restorations?
Both yes and no.
For 33 years the FDA dodged properly classifying dental amalgam as it was grandfathered in without proof of safety. Manufacturers of amalgams have never performed any safety studies on this product. In 2008 Charlie Brown of Consumers for Dental Choice sued the FDA. United States District Judge Ellen Huvelle convened a hearing, and demanded to know why FDA was refusing to classify amalgam. When FDA's lawyer said the agency was working on it, the Judge was incredulous -- and ordered the parties into mediation to set a date to classify. What came about was an agreement that the FDA would post on its website the following.
"Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
The FDA lost a 2007 lawsuit which forced them to classify amalgam (determine safety), but the final rule of the classification (delivered in 2009) was a huge disappointment as it declared the mercury vapor released from amalgam fillings to be safe for anyone and everyone, without regard to age, reproductive status, or any of the known factors that make a person unusually susceptible to the effects of mercury exposure.
Attorney, Jim Love
International Academy of Oral Medicine and Toxicology
Explains the "Petition for Reconsideration"
submitted to the FDA in 2009
Although the FDA ruling purported to be a 'risk assessment', the document was nothing of the sort as it did not comply with the standards of practice endorsed and espoused by the professional risk assessment community. The International Academy of Oral Medicine and Toxicology and several concerned scientists found over 27 glaring mistakes in the ruling and submitted a "petition for reconsideration" to the FDA.
This petition pointed out the inaccuracies, inconsistencies and flawed science the FDA relied upon and urged them to reconsider their ruling. In December 2010, The FDA convened a new dental products panel meeting specifically to further investigate and re-evaluate the issues brought up in the petition for reconsideration and will come out with a new rule amalgam sometime in 2011.
Additionally, in their amalgam rule, the FDA cited an ill-defined and unsubstantiated estimate of absorbed mercury exposure from dental amalgam of 1 to 5 μgs/day that supposedly relates to the presence of between 7 and 10 amalgam fillings.
This conclusion is attributed to a report by the Public Health Service published in 1993 (PHS, 1993). This cited report did not contain or conduct a detailed quantification of mercury exposure but based its estimates on the review of other yet older reports.
In fact, PHS(1993) acknowledged that estimates of mercury exposure from amalgam span 1 μg/day to 29μgs/day (see PHS, 1993, Appendix III), with higher estimates appropriately acknowledged for the sizable population of persons who have more than ten amalgam fillings.
This means that the Public Health Service (PHS) quotes published levels of mercury exposure for those with amalgams far above and beyond that of all other exposures (air, food, water) combined. But yet they came to the conclusion that dental mercury was safe to leave on the market.
FDA reviews conducted in 1993 and 1998 both determined the available evidence does not show that exposure to mercury from amalgam restorations poses a serious health risk in humans. Components in dental restorative materials, including amalgam, may in rare instances result in local side-effects or, in other words, allergic reactions.
As recently as Oct. 30, 2003, a paper in the New England Journal of Medicine concluded that exposure to mercury from dental amalgam, as well as from fish consumption and vaccines, is not associated with adverse health effects.
"These studies uniformly reaffirm that dental amalgam is a safe material," Dr. Eichmiller told panel members.
The ADA Council on Scientific Affairs continues to monitor the scientific literature on the safety and effectiveness of products commonly used in dentistry, including amalgam.
Dr. Eichmiller also testified on the effectiveness of amalgam, which he said remains a valuable restorative option for dentists and patients, even with the availability of newer composite resins and other materials. He cited, among other properties, amalgam's toleration of moisture during placement — important for fillings in areas difficult to keep dry, such as below the gum line.
Amalgam, he said, is the strongest and most durable direct restorative material for large, load-bearing restorations on posterior teeth. Gold and porcelain may also be suitable, but they are considerably more expensive. Banning amalgam, he cautioned, would have a dramatic effect on oral health care.
Frequent Causes of Amalgam Failure and its Effect on Teeth
"I want to be clear," Dr. Eichmiller declared, "the ADA does not support one restorative material over another. Amalgam is one valid choice among several, depending on clinical and other factors. We believe the ultimate decision about what filling materials to use is best determined by the patient in consultation with the dentist.
"The ADA and its members are proud of our commitment to scientifically sound dental practice as an integral component of our responsibilities as health professionals and citizens," he concluded.
By Mark Berthold
The American Dental Association Foundation's (ADAF) dental research enterprise at the Paffenbarger Research Center (PRC) has been hailed as one of the most productive in the world. ADA and ADAF research scientists have engaged in cooperative dental and medical materials research with government scientists since 1928. This collaboration at the National Institute of Standards and Technology (NIST, formerly NBS, the National Bureau of Standards, a government research laboratory managed by the U.S. Department of Commerce) has in many respects revolutionized the practice of dentistry.
The Paffenbarger Research Center (PRC), located on the campus of the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland, an agency of the American Dental Association Foundation (ADAF) and a Department of the Division of Science. PRC scientists conduct basic and applied studies in clinical research, dental chemistry, polymer chemistry and cariology, and are the crown jewels of the ADA.
PRC was founded as a dental research group at the National Bureau of Standards (NBS) in 1919 by the U.S. Department of Commerce, in response to the Army's desire for a standard for dental amalgam. In 1928 the ADA became involved with the NBS through the NBS Research Associates program, forming a relationship that continues to this day. The research center was renamed the Paffenbarger Research Center in 1985, after Dr. George C. Paffenbarger, who was instrumental in fostering the U.S. government-ADAF collaboration into one of the most productive long-term dental research centers in the world.
The work of the scientists at the Paffenbarger Research Center has led to the creation of the electric drill, tooth colored composite filling material, the panoramic x-ray machine, orthodontic bracket bonding materials, and the calcium phosphate bone cements and adhesives that revolutionized dentistry. The 26 researchers at PRC are currently at work in the areas of polymer chemistry, dental chemistry, cariology, and clinical research.