Elissa Meininger |
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| MERCURY MADNESS - FDA STILL IN DENIAL Elissa Meininger November 7, 2006 NewsWithViews.com The Dental Amalgam Issue “a terrible sin against humanity” --Dr. Alfred Stock, 1926 Some months ago, I learned that the Food and Drug Administration (FDA) was going to stage another hearing about the safety of dental amalgam (aka mercury) fillings scheduled for September 6 and 7, 2006. Immediately, like thousands of other victims of mercury poisoning who had monitored the last major FDA hearing in 1991, I wondered if this time the hearing would be objective, or if we would experience the same attempt to cover up what we all knew was a major health crisis fifteen years ago. When the hearing began, we learned that the FDA had convened two panels of scientists to address the neuro-toxicity aspect of mercury amalgam dental fillings. One panel was made up primarily of physicians. The second panel was made up primarily of dentists. Both panels included an additional array of scientist-consultants. All the panelists were credentialed in their fields and had passed the FDA’s “sniff test” regarding ethics requirements. Prior to the hearing, the FDA staff had touted an official White Paper, which it then presented at the hearing, and which turned out to be a collection of 34 scientific studies selected to prove that mercury fillings were safe. As Charles G. Brown, the national counsel for Consumers for Dental Choice, an anti-Amalgam consumers’ group, said in an e-mail to his constituents, the paper consisted of “shopworn rhetoric, selected studies (some of whom were misinterpreted) and out-of-date conclusions about mercury toxicity; in short, the staff paper argued that mercury fillings were safe.” Despite the FDA’s careful planning for this two-day hearing, which included inviting and paying for pro-amalgam “experts” to testify, while anti-amalgam witnesses had to pay their own way, the two panels convened and after two days of riveting testimony summarily rejected the White Paper. Two specific votes the panelists took in replying to two separate questions said it all. The questions were: 1. “Does the draft FDA White Paper objectively and clearly present the current state of knowledge about the exposure and health effects related to dental amalgam?” 2. “Given the amount and quality of information available for the draft FDA White Paper, are the conclusions Reasonable?” In both instances, seven panelists voted “YES” and thirteen voted a resounding “NO.” In a memo sent after the hearing to his anti-amalgam consumer group, Charles Brown, summarized the statements made by the panelists after the vote, saying, “Virtually all expressed concern in one or more of the following three areas: (1) the need for informed consent (real informed consent, telling about the mercury and its effect); (2) the need to stop usage for pregnant women and children; and (3) the reality that a substantial number of persons are severely hypersensitive. Some highly intelligent and educated consumers testified that they had no idea that “silver” fillings are mercury – until it was too late.” Interestingly, wire service reports of the hearing were almost universally upbeat, displaying misleading headlines like, “Study Finds Silver Filling Not Harmful,” which were picked up and used, often verbatim, by leading newspapers around the country. For people just skimming the headlines, the actual rejection of the FDA’s White Paper and position on mercury filling safety was entirely missed. (However, some TV headlines were more to the point. The CBS website blared the headline, “FDA Panel: Filling May not be Safe” and MSNBC’s was “FDA At Odds Over Safety of Mercury Fillings.”) Victims of mercury poisoning have long endured an uphill battle in their efforts to expose the risks of dental mercury fillings against the entrenched dental and medical establishment and the government agencies this establishment appears to control. So, this time around, members of the venerable victims support group, Dental Amalgam Mercury Syndrome (DAMS), considered the hearing a victory of sorts. It is, in fact, the first time the FDA and the American Dental Association have not been able to hide behind misleading and/or misreported science to “prove” that amalgam fillings are safe. In fact, the DAMS group, fully prepared to witness another FDA effort to whitewash the problem again, came out swinging -- publishing an exhaustive review of two well-touted and notorious studies called “The Children Amalgam Trials” in their own publication, Dental Truth. In the months leading up to the hearing, both these notorious studies had been headlined in the JAMA and the ADA News as proof that mercury amalgam fillings are safe. Having seen whitewash campaigns before, the DAMS group put these studies under a microscope to determine their accuracy. This project turned out to provide a bonanza of interesting information, showing how studies can be designed to support the pre-existing position desired by the study’s sponsors, and then later used to “prove” that position regardless of the facts involved. In fact, these two children’s studies, one undertaken in Portugal and one in the U.S., were so poorly designed and executed, that the International Academy of Oral Medicine & Toxicology, (an anti-amalgam group of scientists, dentists and doctors), has filed ethics complaints with Harvard University, the University of Maine, Boston Children’s Hospital, The New England Research Institute, and the University of Washington, which conducted these studies. The substance of these complaints, were, a) that the two studies were “designed to fail” to detect mercury fillings’ long-term effects on young children, and, b) that they failed to obtain informed consent. Taxpayers take note. These two studies were funded to the tune of million in taxpayer-funded grants from the NIH’s historically pro-amalgam National Institute of Dental and Craniofacial Research (NIDCR). The DAMS report also revealed that, in addition, several investigators in the Portuguese study received funds from dental amalgam manufacturers. While I found the flaws in both studies as outrageous as DAMS and IAOMT found them to be, I found the Portuguese study particularly appalling in terms of how the children used for the study had been selected. What happened was that the people conducting the Portuguese study recruited 507 disadvantaged children between the ages of eight and ten. Many were blind, deaf, or had other disabilities. The average IQ of the group was 85. A hundred of them were orphans. All were students at the Casa Pia school system in Lisbon. After being recruited, these children of limited mental function were asked to sign a consent form that did not even explain that the fillings some of them would be receiving had mercury in them which could permanently damage their brains and kidneys, and that children, in particular, are more sensitive to these effects than older people. During the study, two children with amalgam fillings died, but no information was sought to determine the cause of their deaths. In response to DAMS’ questions about this, the head of the study stated that he didn’t know if any autopsies had been performed. He added that, in any event, he would not have had access to the autopsy findings. Let me re-phrase this…..two children in an amalgam toxicity study died and nobody knows or apparently cares to know if these deaths may have been amalgam-related. As it happened, a major scandal broke out in the Case Pia school system during the trial. It seems that many of the children at Casa Pia had, for years, been routinely sexually abused by school employees who also made these children available for sexual favors to politicians, media personalities, academics and others. International media coverage of the scandal reported criminal indictments of ten high-profile people and indicated that an estimated 100 Casa Pia children were victimized. While the conduct of the Portuguese trial was sorry enough, the American study ignored classic mercury toxicity symptoms many of the amalgam group were reportedly suffering from once the fillings were placed. The mind-boggling details provided by DAMS as to the other flaws in this study are so numerous, that, rather than attempting to report them here, I suggest anyone interested in reviewing these details refer to the actual report itself (see address below), keeping in mind that JAMA, the FDA and ADA News tried to use these studies as “proof” that mercury fillings are perfectly safe. Among the superstars of the many anti-amalgam witnesses at the FDA hearing, was U.S. Representative Diane Watson. In her testimony, Watson told the committee that, during her 20-year stint as a California legislator, 17 as head of the state’s health and human services committee, she promoted passage of a law in California known as “the Watson Law.” The intent of this law was to force the state’s dental board to issue a brochure informing patients of the materials found in dental fillings. In the end, it took 12 years, and the eventual firing of all members of the dental board by Gov. Gray Davis, followed by the appointment of a complete slate of new members, to get the dental board to comply with the law. Like a number of other witnesses at the FDA hearing, she has taken the fight to ban mercury fillings into other venues as well. Watson, along with Congressman Dan Burton, a longtime supporter of banning mercury in dentistry and in vaccines, has formally requested an investigation of the FDA for failing in its duty to protect the public from harm caused by exposure to mercury dental fillings. Watson has also introduced legislation in Congress (along with Rep. Dan Burton and Rep. Mike Michaud) to ban mercury fillings outright, and after the hearing, she took her testimony to the public arena by publishing an article on The Huffington Post in which she outlined the four recommendations she made at the hearing. These four recommendations include: (1) Disclosure: The FDA must immediately take the simple step of requiring dentists to inform their patients that amalgam is 50% mercury, it constitutes exposure to a neuro-toxin, and alternative fillings are available. (2) Environmental Impact: The FDA has the legal duty to conduct an environmental impact study of dental amalgam, which it has never done, before properly classifying the material. (3) Proof of Safety: Manufacturers of amalgam should have the burden of proving its safety. To date, they have never sought nor been given pre-market approval for their product. The FDA must hold amalgam manufacturers accountable. (4) Children and Pregnant Women: Ten years ago, Health Canada directed[issued a guideline to] its dentists to cease placing mercury fillings in the teeth of children, pregnant women, and persons with kidney disease, mercury hypersensitivity, or braces. The FDA should implement a similar ban in the U.S. Another fireball witness, Charles Brown, head of Consumers for Dental Choice, has used the courts for years to sue dental boards across the country to protect dentists and the public. Now, he has filed a federal lawsuit against the FDA because he is convinced that the FDA has not, and most likely will not, honor laws that Congress has already passed. As Brown puts it, if the FDA “were not dodging its legal duty to enforce the law, mercury fillings would no longer be on the market…a quarter of a century of deceiving the public promising to regulate is long enough.” The lawsuit charges that the FDA is violating several federal laws, in that it refuses to classify mercury fillings, it won’t produce an economic impact statement, and it approves mercury fillings without requiring proof of their safety. In closing, I’m delighted to report that, thanks to the unwavering commitment of so many people down through the years, we may now be seeing the beginning of the end of mercury in dentistry. As for me, it’s long overdue. According to a medical journal article entitled, “Injurious Effects of Amalgam Fillings” published over a century ago in 1893 by Charles Taft, a professor of dental surgery and therapeutics at Hering Medical College, it was common knowledge back then among BOTH allopathic and homeopathic doctors that chronically ill patients with amalgam fillings would not get well until their fillings had been removed. A WORD OF CAUTION: If you believe that you or someone you care about may have health problems due to mercury fillings, I urge you to call DAMS at the phone number listed below. DAMS is the premier source of information for victims of mercury poisoning in both Canada and the U.S. DAMS volunteers can provide you with FREE information, lists of resources in your area and one-on-one conversations about your concerns. Their services are free and since the organization exists on donations and sales of over 50 books on their booklists, if you see a book listed below that you may want to buy, please consider purchasing it through DAMS. AND…..most important of all, DO NOT immediately rush out to your local dentist to have your fillings removed. There are serious health risks involved with filling removal and you will need expert help to protect you from further harm. Dental Amalgam Mercury Syndrome (DAMS) 800-311-6265 www.dams.cc OTHER RESOURCES 1, DAMS Report on "The Children Amalgam Trials" 2, IAOMT Ethics Complaint Regarding "The Children Amalgam Trials" 3, DAMS member's blow-by-blow eyewitness account of the FDA hearing: 4, Transcripts of the FDA hearing: 5, Rep Diane Watson's Anti-Amalgam Projects [Read] and [Read] and [Read] 6, Lawsuit against FDA to Ban Mercury Fillings 7, Uniformed Consent -The Hidden Dangers of Dental Care All the medical tech info you need to know that your dentist can't tell you. 8, Tom Warren - How he cured his own diagnosed case of Alzheimer's by getting rid of his mercury amalgams. Great details on the whole mercury issue! [Read] and [Read] and [Read] 9, Organizations and others behind the "ban amalgam movement" [Read] and [Read] and [Read] and [Read] and [Read] 10, "Lies Your Dentist is Forced to Tell You" © 2006 Elissa Meininger - All Rights Reserved Original story along with live hyperlinks to further resources can be found here: http://www.newswithviews.com/Meininger/elissa3.htm | ||
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