Dental News
W.H.O. Withdraws Petersen Paper
Chiba, Japan, 24 January 2011Charlie Brown, reporting from Chiba (Japan)
The W.H.O. has withdrawn the notorious Petersen Paper, a propaganda project of its in-house dentist to claim that phasing out amalgam is not feasible and that amalgam is a safe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 The United Nations Environmental Programme (UNEP) showed great integrity, insisting that the Petersen Paper be withdrawn or else all reference to UNEP removed.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Assistant Director-General, Dr Ala Alwan, agreed to investigate the Petersen Paper, and to his credit, had the paper withdrawn.
It is being rewritten, and -- nota bene, my friends -- all claims that amalgam is safe are being withdrawn!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
FDA Hearing on Mercury-Based Dental Fillings
December 18, 2010
The FDA convened the hearing after the IAOMT and other antiamalgam groups and individuals petitioned the agency to reconsider its 2009 decision to reclassify the material from a lower-risk class I device to a moderate-risk class II device. That reclassification entailed revising product instructions to state in part that
* clinical studies have not established a causal link between dental amalgam and health problems for adults and children aged 6 years and older,
* the developing nervous systems of fetuses and young children "may be more sensitive to the neurotoxic effects of mercury vapour," and
* little or no clinical data are available regarding long-term health outcomes for fetuses, children younger than 6 years, and breast-fed infants.
At the same time, the panel's quest for more scientific data about vulnerable populations acknowledged the concerns of dental amalgam opponents, who link mercury exposure to dozens of diseases ranging from autism to Alzheimer's disease. At high enough levels, mercury exposure can damage the brain and kidneys.
"We have to recognize that some patients should not have amalgam," said panel member Amid Ismail, BDS, DrPH, a professor and dean at the Kornberg School of Dentistry at Temple University in Philadelphia, Pennsylvania.
"There is really no place for mercury in children," added Suresh Kotagal, MD, a pediatric neurologist at the Mayo Clinic in Rochester, Minnesota. "The bottom line is, do no harm."
The petitioners urged the agency to either ban dental amalgam, as Norway, Sweden, and Denmark already have done, or else reclassify it as a high-risk class III device with more restrictions on its use.
Costa Mesa - First City in US to Ban Mercury Amalgams
October 2010
Costa Mesa, California has set the precedent by becoming the first city in the United States to pass a resolution to immediately ban the use of mercury amalgams in dentistry.
This success story was made possible by a trio of Orange County, California activists who distributed flyers explaining the hazards of amalgam (unfortunately, most people are still not even aware that "silver fillings" contain mercury). They allied with health professionals and green businesses for support.
They organized an extensive petition drive, collecting signatures from individuals asking city council to ban amalgam - both by asking people directly to sign, and by enlisting friendly health professionals and business people to keep the petitions in their front offices.
They surveyed all the city's dentists, and presented certificates to dentists who are mercury-free.
Mercury Amalgam Tooth Fillings: FDA Changes Stance - Review to Take Place - Dec. 2010
The US Food and Drug Administration (FDA) seems to have changed its stance on dental amalgam fillings. In a legal settlement signed in 2009, the FDA has changed the information on its Web site about amalgam fillings to say that they “may have neurotoxic effects on the nervous systems of developing children and fetus” and that pregnant women “should not avoid seeking dental care, but should discuss options with their health practitioner.” Till now they were not so harsh on the neurotoxic effects of mercury fillings. FDA’s rule making body will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses. The FDA also agreed to decide by next year whether mercury fillings need more regulation.
Dental amalgams contain mercury, when amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. There have been routine warnings about not using the amalgam in patients known to be allergic to the amalgam. This is because of the relatively high percentage of mercury it contains (almost as much as in a mercury thermometer). Mercury is a known neurotoxin which may have harmful effects on the nervous systems of developing children and fetuses. The manufacturers say it should not be used in children age 6 and under, or in pregnant women.
Anti-mercury activists have for long been engaged in pushing the industry to develop substitutes like composites or resins and several other types of dental fillings, that are now available in the market. They've also been persuading people to have their fillings ripped out and replaced by substitutes. But they've been lacking support from official government agencies. The FDA's new approach is just what they wanted for it is sure to give strength to their battle against mercury tooth fillings.
Detailed information on the topic is available at FDA's official website.More recently, on June 11, 2010 the Dental Products Panel of the Medical Devices Advisory Committee of the FDA announced that it is planning meetings in the Washington, D.C. area in December 2010 (Dec. 14-15). These discussions are centered on developing recommendations related to scientific issues raised in petitions received by the FDA concerning last year's final ruling.
The petitions submitted to the FDA question the adequacy of the risk assessment performed by the FDA at the time the dental amalgam was classified as a Class II medical device. The petitioners would like to see dental amalgam banned.
FDA release:
June 10, 2010
FDA Advisory Panel to Review Dental Amalgam
Agency to consider risks to vulnerable populations
"The U.S. Food and Drug Administration today announced plans to hold an advisory panel on Dec. 14-15, 2010, to discuss several scientific issues that may affect the regulation of dental amalgam, used for direct filling of carious lesions or structural defects in teeth. The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.
Used to treat tooth decay, dental amalgam is a mixture of metals, composed of liquid mercury and a powdered amalgam alloy, composed primarily of silver, tin, and copper.
On July 28, 2009, the FDA issued a final rule that reclassified dental mercury from a class I device to class II, classified dental amalgam as a class II device, and designated special controls for dental amalgam, mercury and amalgam alloy. The special control for the devices is a guidance titled, "Class II Special Controls Guidance Document: Dental Amalgam, Mercury and Amalgam Alloy."
Since that time, the agency has received several petitions raising various issues relating to the final rule and special controls.
The concerns raised include the adequacy of the risk assessment method used by the FDA in classifying dental amalgam, the bioaccumulative effect of mercury, the exposure of pediatric populations to mercury vapor, and the adequacy of the clinical studies on dental amalgam. In addition, a recent report on risk assessments issued by the National Academy of Sciences, titled "Science and Decisions: Advancing Risk Assessment, NAP 2009," proposes new approaches to conducting risk assessments. These may be some of the issues the agency asks the advisory committee to review."
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Doctor of Dental Surgery Fellow of International College of Cranio-Mandibular Orthopedics Holistic Dentist 1293 Carlsbad Village Drive Carlsbad, CA 92008 Phone: 760-730-1600 |
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