http://www.iaomt.org en-us http://www.iaomt.org/index.asp?intReleaseID=340&month=8&year=2010 From The Jakarta Globe:Fidelis E Satriastanti 8/3/10Moves to Outlaw Mercury Use in Indonesian Medical SectorJakarta.  Environmental health activist Yuyun Ismawati is hardly a fan of mercury, so it came as a shock to her to find out that her dental fillings contained high concentrations of the heavy metal. “The WHO [World Health Organization] lists dental amalgam as the biggest non-industrial mercury vapor source,” said Yuyun, a director at Bali Fokus Foundation, a toxic chemicals watchdog. “The biggest contributor is still the industrial sector, due to the use of coal and natural gas, but the contribution from the health sector is considerable.” Mercury is a common by-product of mining, cement production and coal-fired electricity production. It is also used in some cosmetics and present in fish caught in polluted waters. However, an often overlooked source of mercury is the health sector, including dentistry and health equipment such as thermometers, Yuyun said. Mercury can have a devastating impact on human health, causing allergic reactions, pneumonia and liver and heart damage. Mercury poisoning can also cause death. The WHO estimates that 5 percent of the mercury released through waste water comes from medical facilities. Such facilities are responsible for 10 percent of the mercury vapor released through waste incineration. Wiwik Wahjoeni, an official from the Health Ministry, said it was difficult to get accurate figures for mercury use in medical appliances in Indonesia. “We should monitor the use of mercury-based dental amalgams, because not all dentists are aware of the dangers of this substance, particularly those at community health centers,” she said. Rasio Ridho Sani, the assistant for toxic and hazardous substances at the Environment Ministry, said his office was currently drawing up a national action plan to ban the use of mercury, starting with the medical sector. “It’s not a simple issue, given the ubiquitous use of mercury in everything from heavy industry to the medical sector,” he said. “We’ve decided to start with the health sector because it affects people most directly, and we want all medical practitioners to realize this. Most of them don’t know that they’re harming their patients through their ignorance of the dangers of mercury.” Faye Ferrer, from international health care watchdog Health Care Without Harm, pointed out that most developed countries now ban or strictly regulate the use of mercury in the medical sector. “The European Union has banned mercury thermometers and is considering alternatives for blood pressure devices, too,” she said. Ferrer called on developing countries like Indonesia to be wary of donations from developed countries in the form of medical equipment, as some countries might attempt to dump non-conforming equipment here. http://www.iaomt.org/index.asp?intReleaseID=339&month=8&year=2010 After a month-long lock-in at a Spanish hospital and a bold hunger strike, Professor Servando Pérez has won the right to detoxification treatment for his dental mercury poisoning. As president of the Spanish amalgam-poisoned patient association Mercuriados, and First Vice President of the World Alliance for Mercury-Free Dentistry, Servando is a well-respected leader of the mercury-free dentistry movement. His Spanish court case established that Spain’s public health care system is required to pay for the chelation of amalgam-poisoned patients.  When the hospital attempted to subvert the court’s decision, Servando refused to leave the hospital until he received treatment.  Harassed and pressured by hospital staff, he declared a hunger strike last week to protest this egregious denial of treatment.  People from around the world contacted the hospital administrators and the Spanish government, voicing their support for the Gandhi of the mercury-free dentistry movement. Finally, the hospital relented late last week.  Servando was referred to a toxicologist for treatment – a step hospital administrators should have taken over a month ago.  While there remain concerns over the quality of treatment he will receive, this achievement is nonetheless a momentous leap forward in the battle to help amalgam victims. Clara Valverde, President of the Spanish environmental illness association Liga SFC, issued the following statement on behalf of Servando: “We want to thank all the scientists, doctors, associations and individuals who, all over the world, during Servando’s lock-in and hunger strike, have contacted the Spanish and the Galician [provincial] authorities to protest for Servando's situation and who have shown support for our fight. We hope to continue to count on your support.” News from Consumers for Dental Choice http://www.iaomt.org/index.asp?intReleaseID=338&month=8&year=2010 From the Chemical Sensitivity Network, of Germany:As of yesterday, July 26, 2010, Professor Servando Perez, President of Mercuriados Spain (people affected by chronic mercury intoxication), has began a hunger strike. Prof Perez was diagnosed two years ago as having Chronic Mercury Intoxication and Multiple Chemical Sensitivities (MCS). His case went to the highest court in Spain and a judge ruled that Prof. Perez had chronic mercury intoxicaton due to dental fillings and that the Spanish public health care system (Social Security) should treat his condition with chelation or refer him to a private clinic to do so and pay the costs. This was an incredible legal precendent. Needless to say, Professor Perez has not been treated yet and the Social Security has been doing everything possible to make sure that he, as with other MCS, Chronic Fatigue Syndrome/Myalgic Encephylitis and Fibromyalgia patients in Spain, do not receive proper medical services from the public health care system. Because of this, Mercuriados Spain and many other associations, have been carrying out campaigns, popular initiatives, lobbying, legal suits, and many other strategies to change this situation, but with no positive results. Professor Perez’s health has deteriorated and a month ago he went to emergency at the Santiago de Compostela University Hospital. They refused to attend him and he said he would not leave the hospital until the judge’s order for a chelation was carried out. In the past month, at the hospital, Prof Perez has endured all kinds of harassment and pressures to leave. He has even been “diagnosed” as having a psychiatric illness despite the fact that his illness is organic. We, the Spanish MCS, CFS/ME and FMS associations have mounted a campaign to support Prof Perez with emails, phone calls to the hospital, press, etc. And now, the latest harassing strategy by the hospital is to refuse to give him food without additives. Faced with all of this, Servando Perez has started a hunger strike. Yes, he could try to get a bank loan and pay for a private chelation, but this would not help the rest of us ill people in Spain waiting to get treatment in the public health care system. The hospital says that they refuse to refer him to a private clinic (and pick up the tab) because it would set a precedent, and soon all the people with chronic heavy metal intoxication in Spain would have to be treated. And they don’t want to do that with tax money. Servando Perez has opted for the brave and hard road to try to change the desperate situation we live with in Spain, those of us with these illnesses, and we are proud of Servando’s action. We write you to inform you and to ask you for your support. Please write or phone the Vice director of the Hospital Santiago de Compostela, Dr Jose-Ramón Gómez at jose.ramon.gomez.fernandez@sergas.es or phone him at (34) 98.1950970. We all are Servando Perez! Thank you, Clara Valverde President Liga SFC (CFS/ME League, Spain) www.ligasfc.org - http://www.iaomt.org/index.asp?intReleaseID=337&month=8&year=2010 The United Nations Environmental Program is in the process of designing a new international treaty to limit international trade and transportation of mercury. It was becoming apparent that dental mercury was going to be sidelined in these negotiations, so Graeme Hall, BDS, our long time IAOMT fellow in the UK, and Charlie Brown, chief counsel for Consumers for Dental Choice, rushed to attend.  With the help of Michael Bender, of the Mercury Policy Project, they pushed dental mercury back to center stage.  Here is Graeme's report:UNEP STOCKHOLM  Mercury Programme. June 6-11, 2010. Report and proposal by Graeme Munro-Hall BDS FIAOMT In the 20+ years I have been a participant in the amalgam struggle, this UNEP (United Nations Environment Programme) meeting was one of the most important meetings I have attended. I went at the invitation of Charlie Brown and his newly formed umbrella organisation, World Alliance of Mercury-Free Dentistry, also representing the IAOMT. Charlie had registered World Alliance as an NGO (Non Governmental Organisation) with UNEP. My task was to counter any arguments from the FDI (World Dental Federation). They had at the interim meeting in Washington talked about the safety and viability of amalgam. The recently published book “Toxic Dentistry Exposed” authored by myself and Lilian Munro-Hall gave me a credibility that was certainly apparent the Stockholm meeting. I had very little time to prepare a submission, about a week, but I prepared a submission and a short power point presentation. Both are available on www.munro-hallclinic.co.uk. I put the submission and the presentation on 20 USB sticks to give to interested delegates. I was invited to speak at the “Products” meeting but only given 3 minutes. The talk (see attachment – Talk) was well received, the FDI spokesperson actually walked out during my speech. I was in fact on holiday in Spain but gave up the time to attend the meeting flying to and from Spain. I flew in Saturday for the Sunday meetings, the official opening was on Monday and I left Wednesday night with the meeting having two days still to go. UN meetings are officially from 10 till 1 then 3 to 6, this is the main “Plenary” meeting where nations can speak and NGOs attend but not speak unless asked to by the chair. Groups of nations such as Africa, Asia, EU nations, Middle East, Eastern Europe, JUSCAN (Japan/USA/Iceland/Switzerland/ Canada) and so on meet separately from 8 till 10 and 1-3. Specialist meetings such as Products, Transport, Waste etc. take place 6-8 (usually 10pm). The specialist meetings are open but the nation groups are by invitation (or not in my case, I just went) and sometimes NGOs are excluded if a nation objects to them. Typically Armenia, Azerbyjan and Iran. I was informed by other NGOs that Iran is suspicious of all NGOs believing them to be agents of the CIA. I found them very polite and interested in the subject. Meals are taken on the run, if at all, and it is very one on one, eyeball to eyeball type of event. Charlie gave a 5 minute talk to the whole assembly at the beginning of the meeting. Charlie Brown was extremely effective in his talking, his lobbying, strategy and meetings. I could not praise Charlie enough for all that he did. He attended the full length of the conference. We were on the go from morning until night. Between us we put amalgam at the top of the agenda and hopefully neutralised the FDI, at least at this time. There are to be meetings in 2011 (Tokyo) and 2012 (Burkino Faso probably) but this meeting set the agendas and the tone. If amalgam had been relegated to a side issue here it would never have been possible to raise it up the agenda at later meetings. In the beginning the main issue was ASGM (Artesinal Small-scale Gold Mining) and the mercury used by the miners; mercury from amalgam was an also ran. That was on the Sunday. By Wednesday, amalgam was firmly in the conference agenda mainly thanks to our Swedish hosts, Charlie and myself. This UNEP Mercury conference was the best attended conference of any UN meeting in the last 20 years, there is major worldwide interest in mercury from all sources. UNEP started by refusing to discuss the pathology of mercury stating that was already established and no further discussion was either necessary nor allowed. UNEP had a mandate from their governing council to make a worldwide treaty banning mercury and its products by 2013. The main mover of this was the new US Government. The Bush Administration had stalled and wanted voluntary agreements ((i.e. keep the status quo). The Obama Administration had done a 180^0 turn and forced the issue into UNEP. This alone had given the mercury issue traction and made the meeting possible. Charlie had organised a small stand which we gave out information he had printed up in many different languages. The Swedish hosts were excellent. At the opening ceremony the Swedish Minister of the Environment stated: “All Swedish lakes were contaminated with mercury, mercury was a global issue and the mercury from dental amalgam was a major polluter in the lakes. It was the mercury found in every lake in Sweden which made us act. This is an environmental rather than a health issue. (This cuts the legs from under the FDI and ADA.) Sweden followed Norway in the ban of amalgam as well as other mercury products, thermometers, blood pressure devices etc. and where the Nordic countries led the rest of the world should follow. All mercury used eventually ends up as waste and this either pollutes the water or is airborne, travels miles from its point of origin before descending to earth and polluting the environment and damaging health.” This put the amalgam ball into the arena, Charlie and I just ran with it. At the products meeting originally there was to be a dentist from the Swedish Health Board talking about amalgam but he had written against Boyd’s work so was hardly representative of a neutral amalgamist. I was to be used head to head against him, however, the Swedish patient organisation managed to persuade the Minister via a personal contact that this would be a bad idea i.e. might make them look bad in a head to head, so he changed it to someone from the Swedish Chemical Agency. The agency gave a brief outline of the practical steps of how they organised the elimination of amalgam. They said that research showed that the alternatives to amalgam were: 1. Effective 2. Affordable 3. Available. Therefore there was no need to continue with the use of amalgam as a dental restorative material. Our pitch to the delegates was the same, effective, affordable and available. The downstream costs of using amalgam in terms of environmental and personal health problems made the cost of using amalgam very high. This was part of our pitch. I offered IAOMT expertise on any part of the “amalgam problem” to the UNEP Secretariat and the delegates. . I gave away all the USBs to various delegates. Sevandes, the leader of a Spanish amalgam patient organisation and someone of Charlie’s Spanish speaking group contacted the Cuban group to see if we can get them to agree to a mercury free zone somewhere in Cuba with our help, advise and expertise. Then using this zone as an example to spread it over the whole island. Similarly I spoke to the Iranians with the same idea. These countries are not beholden to dental authorities or commercial pressure and could be used as examples for the rest of the world to follow. The Nordic countries are seen as rich enough to afford going mercury free whereas Tanzania, for example, may have problems rolling out such a programme. ( Tanzania was one of many delegates whom I approached and now understands about amalgam! Cost was their main concern). IPEN is an NGO umbrella group of environmental organisations. Charlie had contact with their leader, a chemical engineer from the Lebanon. Charlie will write a proposal for a Lebanese mercury free zone. IPEN Lebanon will massage the proposal so that it can receive funds. A conference for the interested parties would be organised and Govt. Policy makers brought in to change policy on mercury in line with UNEP recommendations. Once again this can be made to be an example to the rest of the world. I would sort speakers for the conference within the Lebanon, the policy makers would be on board and force the issue and we could implement a mercury free zone. What this entails for dental offices, monitoring compliance and emissions are areas for IAOMT expertise. Egypt is another strong possibility in this regard (I am invited to Cairo!) as they are an important player in the UN Basel Waste Treaty Organisation (DDT etc.). And so on and so forth. Busy, busy! I spoke to the FDI representative, Julian Fischer (English). He claimed that the FDI were not far away from our position. (!) In Sept. 2010 they will come out with a new cavity classification instead of Black’s classification which is, to quote: “A new paradigm in dentistry, no more drill, bill and fill but concentrate on oral medicine and new materials”. (They are asking the pharmaceutical industry for money!) This is I believe just to change the subject away from amalgam, they want the amalgam issue to fade slowly away so they are not held responsible for the consequences. Until they acknowledge that mercury from amalgam is an immediate and urgent problem and set dates for the cessation of the use of amalgam, they cannot be considered sincere. I doubt that they will ever do this. They are already lobbying WHO behind the scenes for delay in phasing out amalgam and money for research into new materials. Why do we need more research? This is a familiar ploy on their part to stall for time. They want “All dentists to work together” but as Charlie said to UNEP in his opening, the FDI only represent a shrinking proportion of the working dentists and are beholden to large commercial interests. One only has to see their involvement at the ADA midwinter meeting in Chicago where the UNEP Problem was on the agenda to realise this. Details of which I have if anyone wants. Until the FDI 1. Set a date for amalgam cessation 2. Acknowledge the mercury problem from amalgam is pressing (even if only environmentally) then we should regard them firmly as the opposition and restrict any cooperation between us. I will contact and put a proposal to them with these conditions and see how they respond. I will offer them a way out that may reduce their coming legal quagmire but whether they will take it is extremely doubtful. I met with the US delegates and spoke to the FDA “Minister of Health” (her description, her proper title is Director International Harmonisation and Multilateral Relations Office) Ms. C. Michelle Limoli who was largely ignorant about amalgam. She is not so ignorant now after I had a talk with her and said that the products division would contact me about details of how to move away from amalgam. We shall see what, if anything, happens. The UK delegates seemed to think that I was the Devil Incarnate and were frightened to be seen talking to me. Their leader, J Roberts, was most uncomfortable speaking to Charlie and me but we spoke to him a number of times (would not let him escape, that was fun!). UNEP asked NGOs for partnership in specific areas as they acknowledge that they are lacking expertise in these areas. I gave them our book, “Toxic Dentistry Exposed” and the USB of course to get them up to speed on the amalgam issue. The most useful partnership areas for us are: 1. Products 2. Waste I will register IAOMT-Europe as a partner in products. There are meetings in Geneva at least once a year and I can attend to keep amalgam issue relevant and on track. Waste is a big issue that we can influence such as separators, recycling especially in developing countries etc. Of course even with a treaty in place, individual countries may not ratify it but first things first. My suggestions are as follows: 1. Work with Charlie Brown using the World Alliance for Mercury Free Dentistry. Most of the European groups have agreed to this, AKUT, environmental medical groups, patient groups etc. This gives us more credibility on the world stage. I have seen this in action and it works. Nothing is involved other than support for mercury free dentistry. 2. Become partners with UNEP on the three subject areas. (Products is already underway). The mechanics of how this is implemented we can sort out later. 3. Send an IAOMT representative to Tokyo and eventually to the Burkino Faso UNEP meetings. Have on USBs proposals for implementation of the cessation of amalgam that delegates can grasp and use to persuade their home ministries to set up mercury free zones. Tell them the problem and offer solutions We have a chance to sideline the FDI/ADA and using environmental concerns about mercury. This is an excellent opportunity to fulfil the primary goal of the IAOMT of having amalgam banned. After this we should consider how to address the aftermath of amalgam i.e. the patients still affected by mercury poisoning and environmental cleanup that will be required. http://www.iaomt.org/index.asp?intReleaseID=336&month=6&year=2010 For Immediate Release Contact: Michael Bender, 802 223 9000, 802 917 4579, mercurypolicy@aol.com. As Mercury Treaty Talks Start, W.H.O. Lauded for Highlighting “Phase Down” of Amalgam & Stopping Mercury Use in Skin Cosmetics [Stockholm, Brussels – 11 June 2010] –World governments, under the auspices of the United Nations Environment Programme, today completed the first step towards a legally binding treaty to control mercury pollution at the first Intergovernmental Negotiating Committee (INC) meeting, in Stockholm, Sweden. These initial discussions will provide a strong basis for developing the text of the treaty, starting at the next INC meeting in Tokyo, Japan, January 2011. “The participation of 132 countries’ reaffirmed the importance and international commitment to address the global mercury problem”, said Elena Lymberidi–Settimo of the European Environmental Bureau and the Zero Mercury Working Group. “We hope that this first round of discussions covering all issues will open the way to more substantive discussions on legally binding control measures in order to minimise and, where feasible, eliminate mercury from use, supply and emissions globally.” “We applaud the World Health Organization’s (W.H.O.’s) statement during the INC to stop the production of skin lightening cosmetics containing mercury, as they present a serious exposure risk worldwide,” said Michael Bender of the Zero Mercury Working Group. “We also welcome W.H.O. interest in “phase downing” the use of dental amalgam. This may be of particular interest in the U.S. as the FDA decided yesterday to review dental amalgam and in particular risks to vulnerable populations.” During the meeting countries expressed their views on potential targeted control provisions on mercury issues such as supply; storage; use in products and processes; artisanal small scale gold mining; trade; atmospheric emissions; waste and contaminated sites; as well as on compliance, Countries and regions also expressed their opinions on how discussions should unfold during the upcoming INCs. “We now look forward to engaging in focused discussions in areas such as supply, trade and storage of surplus mercury where substantial progress can be made,” said Susan Keane of the Natural Resources Defense Council. Rico Euripidou, of the South African NGO groundwork, Friends of the Earth South Africa, noted: “We have made a good start towards establishing a treaty to control mercury pollution that will ultimately protect the fish we eat from this poison.”Mercury is a dangerous neurotoxin that makes its way up the food chain into humans,and puts developing foetuses and young children most at risk. Five Intergovernmental negotiating committee meetings are foreseen to take place to complete the work on a mercury treaty before 2013. For more information, see:www.zeromercury.orgwww.mercurypolicy.orgThe Zero-Hg Working Group (ZMWG) is an international coalition of more than 80 public interest environmental and health non-governmental organizations from over 45 countries from around the world that strives for zero supply, demand, and emissions of mercury from all anthropogenic sources, with the goal of reducing mercury in the global environment to a minimum. http://www.iaomt.org/index.asp?intReleaseID=335&month=6&year=2010 http://www.ada.org/news/4282.aspxJune 11, 2010Court allows dental malpractice claim involving amalgam to move forwardBy Jennifer GarvinNew York—A New York appellate court has upheld a lower court ruling allowing a malpractice claim against a dentist to go to trial.The Appellate Division of the Supreme Court of New York, First Department, June 8 affirmed a ruling denying Dr. Hadley Bach's motion requesting summary dismissal of claims by a former patient that Dr. Bach committed dental malpractice by using bulk amalgam for a restoration instead of using encapsulated amalgam, allegedly resulting in mercury poisoning.According to court documents, lawyers for patient Freya Koss, a Pennsylvania-based anti-amalgamist, claim that Dr. Bach "deviated from accepted standards of care by employing an amalgam that contained mercury, resulting in the patient suffering mercury poisoning, rather than using a pre-mixed, precapsulated amalgam filling."The court ruled that based on reports from three expert witnesses on Ms. Koss' behalf, the witnesses "sufficiently raise a triable issue of fact as to whether defendant departed from the standards of accepted dental practice, and whether such deviation was a proximate cause of the patient's injuries."The court considered that the experts "relied on such objective factors as the failure to use pre-mixed dental amalgams, and the high levels of gaseous mercury that the vapor testing found in plaintiff's mouth."The court's ruling does not mean that there has been a definitive ruling on this subject. Rather, the court only concluded that a sufficient factual question has been raised to warrant a trial.In 2009 the ADA Council on Scientific Affairs reinforced the Association's longtime position that "dental amalgam is considered a safe, affordable and durable material that has been used to restore the teeth of more than 100 million Americans."To see that statement in its entirety, visit www.ada.org/1741.aspx.= http://www.iaomt.org/index.asp?intReleaseID=334&month=6&year=2010 In a big win for safer dentistry, the Food and Drug Administration today effectively put on hold its rule declaring mercury–containing dental fillings to be safe for the entire population, in response to several “petitions to reconsider,” including one filed by the International Academy of Oral Medicine and Toxicology (IAOMT). The Final Rule classifying dental mercury and dental amalgam was published in the Federal Register on August 4, 2009 (74 FR 38686). A spokesman for the FDA, noting that it is exceedingly rare for such petitions to be granted, made it clear that the petition submitted by the IAOMT was the one that influenced FDA policy makers to take this action. “You confronted us based on the science,” he said, particularly on issues of risk assessment for mercury exposure from dental amalgam. IAOMT President, Dr. Michael Jackson, of Fort Worth, Texas, said in response to today’s news, “We believe the weight of scientific evidence demonstrates that there are unacceptable health risks posed by this product. The IAOMT position has always been that dental amalgam-- the primary source of mercury exposure in the general population-- should be discontinued, especially now that safer materials are so well established in dental practice.”The FDA has scheduled a meeting of an advisory panel of scientists on December 14-15, 2010, to discuss and make recommendations concerning the scientific issues raised. A docket for public comment to the forthcoming panel will be open soon. Comments can be submitted at http://www.regulations.gov, docket number FDA-2010-N-0268- (The docket is not ready for viewing at this time. We will let you know as soon as we get this information).The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.The IAOMT (www.IAOMT.org) is an academy of medical, dental, and research professionals dedicated to integrity and safety in health care. Safer dentistry has been its main thrust since its founding in 1984. FDA webview writes:FDA Panel to Re-review Dental Amalgam Rule06/10/2010Opponents of FDA's position on dental amalgam are moving one step closer to a possible agency redress of last August’s controversial final rule (see earlier story) declaring mercury-based dental amalgam safe. FDA says it is holding an advisory committee meeting 12/14-15 to discuss several scientific issues that may affect the dental amalgam regulation.A Federal Register notice publishing 6/11 acknowledges several petitions the agency has received about the rule raising concerns on the adequacy of the risk assessment method used to classify 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, the agency says, adding that "(t)hese may be some of the issues the agency asks the advisory committee to review."Last month, FDA Webview reported that FDA might be preparing to admit its mistake on the final rule. One big factor shaping the agency's advisory committee review is "new" data that were not available when the final rule went to press. The data reportedly aren’t really that new — they just weren’t considered by FDA’s amalgam rule lead reviewer Susan Runner before the rule was finalized. These data, on extreme toxicity reactivity in infants implanted with amalgam — underpinned a Health Canada decision to recommend against amalgam use in 1995, according to a 9/15/09, 47-page petition, one of two against dental amalgam that are under review at the agency.Speaking for the International Academy of Oral Medicine and Toxicology, Oklahoma attorney Jim Love (Titus Hills), author of one of the pending petitions, told FDA Webview 6/10 that while "sorely disappointed in the FDA’s final rule issued in July 2009, we are pleased and encouraged that FDA has seen fit to reconsider its position by a holding new hearing before an advisory panel of experts. We believe there is already adequate science available to demonstrate the unacceptable health risks posed by the use of this product. As we have said for many years, dental amalgam — the primary source of mercury in the general population — is unsuitable for use as a dental restorative material and should be discontinued." FDA NOTE TO CORRESPONDENTSFor Immediate Release: June 10, 2010Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.govConsumer Inquiries: 888-INFO-FDAFDA Advisory Panel to Review Dental AmalgamAgency to consider risks to vulnerable populationsThe 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.Details about the advisory panel meeting will be published in the Federal Register on June 11, 2010 and is available for advanced viewing today only.For more information: http://www.iaomt.org/index.asp?intReleaseID=333&month=6&year=2010 Here's an interesting piece of research from the Department of Epidemiology and Public Health, University College, London: http://www.iaomt.org/index.asp?intReleaseID=332&month=5&year=2010 Body’s Own Stem Cells Can Lead to Tooth Regeneration source link Work at Columbia University College of Dental Medicine Holds Promise for a Biological Substitute for Dental Implants, According to Latest Journal of Dental Research NEW YORK (May 19, 2010) - A technique pioneered in the Tissue Engineering and Regenerative Medicine Laboratory of Dr. Jeremy Mao, the Edward V. Zegarelli Professor of Dental Medicine at Columbia University Medical Center, can orchestrate stem cells to migrate to a three-dimensional scaffold infused with growth factor, holding the translational potential to yield an anatomically correct tooth in as soon as nine weeks once implanted. People who have lost some or all of their adult teeth typically look to dentures, or, more recently, dental implants to improve a toothless appearance that can have a host of unsettling psycho-social ramifications. Despite being the preferred (but generally painful and potentially protracted) treatment for missing teeth nowadays, dental implants can fail and are unable to “remodel” with surrounding jaw bone that undergoes necessary changes throughout a person’s life. Human molar scaffolding from the lab of Dr. Jeremy Mao An animal-model study has shown that by homing stem cells to a scaffold made of natural materials and integrated in surrounding tissue, there is no need to use harvested stem cell lines, or create an environment outside of the body (e.g., a Petri dish) where the tooth is grown and then implanted once it has matured. The tooth instead can be grown “orthotopically,” or in the socket where the tooth will integrate with surrounding tissue in ways that are impossible with hard metals or other materials. "These findings represent the first report of regeneration of anatomically shaped tooth-like structures in vivo, and by cell homing without cell delivery,” Dr. Mao and his colleagues say in the paper. "The potency of cell homing is substantiated not only by cell recruitment into scaffold microchannels, but also by the regeneration of periodontal ligaments and newly formed alveolar bone." This study is published in the most recent Journal of Dental Research, the top-rated, peer-reviewed scientific journal dedicated to the dissemination of new knowledge and information on all sciences relevant to dentistry, the oral cavity and associated structures in health and disease. Dental implants usually consist of a cone-shaped titanium screw with a roughened or smooth surface and are placed in the jaw bone. While implant surgery may be performed as an outpatient procedure, healing times vary widely and successful implantation is a result of multiple visits to different clinicians, including general dentists, oral surgeons, prosthodontists and periodontists. Implant patients must allow two to six months for healing and if the implant is installed too soon, it is possible that the implant may fail. The subsequent time to heal, graft and eventually put into place a new implant may take up to 18 months. The work of Dr. Mao and his laboratory, however, holds manifold promise: a more natural process, faster recovery times and a harnessing of the body’s own potential to re-grow tissue that will not give out and could ultimately last the patient’s lifetime. Jeremy Mao, D.D.S., Ph.D. “A key consideration in tooth regeneration is finding a cost-effective approach that can translate into therapies for patients who cannot afford or who aren’t good candidates for dental implants,” Dr. Mao says. “Cell-homing-based tooth regeneration may provide a tangible pathway toward clinical translation.” Dr. Ira B. Lamster, dean of the College of Dental Medicine, stated: “This research provides an example of what is achievable when today’s biology is applied to common clinical problems. Dr. Mao’s research is a look into the future of dental medicine.” This research was supported by NIH ARRA Funding via 5RC2 DE020767 from the National Institute of Dental and Craniofacial Research. Columbia has filed patent applications relating to the engineered tooth and, through its technology transfer office, Columbia Technology Ventures, is actively seeking partners to help commercialize the technology. http://www.iaomt.org/index.asp?intReleaseID=325&month=5&year=2010 Here's an interesting tie-in with the Philadelphia fact-sheet story.  The "47 page petition" mentioned in this story was the work of  IAOMT.From FDAwebview.com:FDA Ready to Reverse Itself on Amalgam?05/19/2010 FDA has never been known to admit it made a mistake, but it may be preparing to do so now on last August’s final rule declaring mercury-based dental amalgam safe. One big factor holding it back is likely to be how to save face — how to dress-up its reversal in the armor of legal consistency and “new” data that were not available when the final rule went to press. The data reportedly aren’t really that new — they just weren’t considered by FDA’s amalgam rule lead reviewer Susan Runner before the rule was finalized. These data, on extreme toxicity reactivity in infants implanted with amalgam — underpinned a Health Canada decision to recommend against amalgam use in 1995, according to a 9/15/09, 47-page petition, one of two against dental amalgam that are under review at the agency. “That we’ve taken so long to examine those petitions is a good sign for you,” a CDRH staffer reviewing them reportedly told one of the petitioners recently. Another sign, according to Consumers for Dental Choice national counsel Charles G. Brown, is the agency’s reported failure to recommend to the City of Philadelphia, as requested, that it not accede to local dental associations’ efforts to repeal a bylaw requiring dentists to issue fact sheets to patients warning of possible neurological damage from mercury before amalgam is implanted in their teeth. Instead, Philadelphia Board of Health chairman Donald Schwarz, reportedly a friend of FDA principal deputy commissioner Joshua Sharfstein who had final sign-off responsibility for the final rule, announced to the board at its 5/13 meeting that FDA had requested he remove no warnings from the fact sheet. “We won several other important victories,” Brown said in a memo to his membership this week. “The board promised it would make no clandestine attempts to change the fact sheet without public hearings. The dentist member of the Board of Health — a pro-mercury dentist who appears to read from a script handed to her by the ADA — excused herself from the meeting altogether, appropriately recusing herself from future considerations of the issue. “Furthermore, the board publicly condemned dentists who were misrepresenting the fact sheet as a consent form for amalgam and then denying treatment when parents refused to sign.” What form FDA’s amalgam-is-safe reversal might take is a closely held secret. In January, the agency tersely denied that it was considering a possible proposal to repeal last August’s rule.