FDA hearings on the toxicity of mercury fillings, at which I addressed the panel. read
Mercury and Alzheimer’s Disease Linked. Read And Another Article
Interesting commentary from citizens in the Washington Post.
For further information, visit the mercury links page at www.cent4dent.com
DrBicuspid.com reporter.
Day one:
For further information, visit the mercury links page at www.cent4dent.com
My first 4 minutes of remarks regarding the history of the use of mercury fillings in the US – watch here
For further information, visit the mercury links page at www.cent4dent.com
Thank you for allowing me to speak before you today. My name is Stephanie Bernier-Adamson and I traveled from Fullerton, California to be here and my mother, Gabriella Harsh, a nurse, traveled from Athens, Georgia.
In January 2010, I was diagnosed with mercury poisoning, and at the recommendation of my primary care physician, decided to have the only mercury-emitting device in my body, my silver fillings, removed in February.
I started oral chelation with DMPS shortly thereafter and have experienced a continuous and measurable improvement in my health as a result.
I have been suffering from numerous autoimmune and mystery illness for many years. Most recently, I have been managing symptoms of fibromyaglia, ADHD, periferial neuropathy, chronic fatigue, Celiac Disease, in addition to 81 other food allergies. I threw up every day for months.
I also struggle with embarrassing and debilitating symptoms including agoraphobia, spontaneous lactation, chronic staph infections on my face, untriggered panic attacks, heart palpitations, vision disturbances, ringing in my ears, facial numbness and twitching, slurred speech, uncoordinated movements, and short term memory loss that was so severe, I would have trouble finishing my sentences.
The most troubling aspect of this controversial issue, for me personally, was the lack of informed consent.
As consumers, patients, taxpayers, and citizens, we Americans depend on the FDA’s expertise and foresight to protect us from dangerous products and practices. You are the only buffer between we citizens and the pharmaceutical industry.
It’s quite a noble feat that you have been tasked with: evaluating and regulating products to protect more than 300 million people.
Knowing the dangers of mercury and its well-documented health consequences, I have to ask, why would a government body continue to allow its use in medicine?
Placing mercury into the mouths of patients is reckless and dangerous, and I am proof of that.
I understand that mistakes happen in the medical and dental communities, but as the FDA, it is your duty to make certain that any product that causes dire consequences, in any form, should be removed from the market.
It is hard for me to believe that anyone who understands the extensive neurotoxic effects of this metal would give consent to it use.
As such, the issue of mercury was never mentioned in any dental office where I was a patient, and as a result, my quality of life has been affected immensely.
It is my hope that you do what is right for the health of the American people and ban the use of mercury in the dental community.
For further information, visit the mercury links page at www.cent4dent.com
Robert Lowes
December 18, 2010 “An advisory panel to the US Food and Drug Administration (FDA) concluded this week that there are no huge scientific flaws in the agency’s 2009 finding that mercury-based dental fillings, known as dental amalgam, are safe for adults and children aged 6 years and older.
However, at the end of its 2-day hearing, the agency’s dental products panel recommended that the FDA look at more data “and the latest data “on the possible health risks that the filling material poses to pregnant women and their fetuses and to young children, particularly nursing infants whose mothers have these fillings. The panel also said the agency should consider adding warnings for these groups to the material’s product instructions.
In one sense, the outcome of the hearing temporarily preserves the status quo for dental amalgam “so much so that the American Dental Association immediately issued a press release praising the expert panel’s recommendations. The American Dental Association maintains that dental amalgam is safe and warrants no further regulation by the FDA as a medical device.
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.”
An attorney for the International Academy of Oral Medicine and Toxicology (IAOMT), which advocates mercury-free dentistry, told Medscape Medical News that he was encouraged by the consensus positions of the panel (no formal votes were taken).
“There was a lot of support that risk assessment needs to be done again,” said Jim Love, the attorney for the group. “I thought it was a very constructive dialogue.”
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 thatclinical 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.
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.
“Industry Will Go Crazy if That Reference Level Gets Moved”
By weight, dental amalgam is composed of roughly 40% to 50% liquid elemental mercury and a powdered alloy of mostly silver, copper, and tin. Much of the 2-day hearing focused on how much mercury is absorbed by people with these fillings, and what should be the reference exposure level (REL), or safety threshold, for the mercury vapor that the fillings release. Because mercury doses can be calculated from vapor exposure levels, an REL can establish a permissible dose. At the end, the advisory panel recommended that the agency take a second look at its positions on these issues.
The FDA currently holds that an individual with 7 to 10 amalgam fillings absorbs 1 to 5 μg of mercury per day. Amalgam opponents say this dose can be 4 times as high, meaning that tens of millions of people with these fillings are at risk for health problems, based on the current REL in place. The advisory panel’s advice to the FDA is to study mercury doses for various population categories.
“We have virtually no data on fetuses,” panel chairwoman Marjorie Jeffcoat, DMD, a professor at the University of Pennsylvania School of Dental Medicine, told Medscape Medical News. “It’s important to subset out the different populations.”
Also in dispute is the REL for mercury vapor. The FDA uses an REL of 0.3 μg/m3, set by the US Environmental Protection Agency (EPA). The EPA refers to this safety threshold as a “reference concentration” (RfC), which is an REL for inhaled, as opposed to swallowed, chemicals. This REL or RfC of 0.3 μg/m3 translates into a permissible dose that lies in the same range as the actual amalgam-derived dose assumed by the FDA.
The IAOMT told the panel that the REL for elemental mercury should be lower than 0.1 μg/m3 and cited a study it commissioned as proof. That study, whose lead author is Canadian biologist G. Mark Richardson, PhD, states that the EPA based its REL in part on studies of industrial workers exposed simultaneously to mercury and chlorine gas, with the gas acting to reduce mercury exposure, thus skewing the numbers. He notes that Health Canada, the Canadian equivalent of the US Department of Health and Human Services (and his former employer), set an REL of 0.06 μg/m3 by relying on studies free of this distortion.
The panel did not fully agree with Dr. Richardson’s critique and called his chlorine gas argument a “red herring.” Nevertheless, it advised the FDA to reexamine the scientific literature to reassess the REL and develop its own, noting that “the EPA RfC needs to be updated with the latest studies,” according to an FDA hearing summary.
In essence, the panel wants the FDA to determine whether the REL really protects vulnerable populations, Dr. Jeffcoat told Medscape Medical News. “Tiny children can’t speak for themselves,” she said.
However, any lowering of the REL for elemental mercury has enormous consequences that extend far beyond the dentist’s office, IAOMT attorney Jim Love told Medscape Medical News. The EPA, he said, uses this REL to regulate how much mercury that heavy industry can put into air and water, as well as to designate waste sites for its Superfund clean-up program. A lower REL means higher environmental protection costs — think billions of dollars — all around.
“Industry will go crazy if that reference level gets moved,” said Love.
Need to Acknowledge Amalgam Benefits
The panel also revisited the question — raised in the FDA’s 2009 deliberations — of whether clinical studies point to a causal relationship between dental amalgam and adverse health events. The panel reaffirmed that the literature at that time failed to do so, but only in terms of the general population. Again, it recommended that the agency continue to study the issue, particularly in terms of “susceptible subpopulations.”
The panel grappled with how to best spell out the possible health risks of dental amalgam in the product instructions that dentists receive. It finally suggested adding warnings for young children, pregnant women, and individuals with metal allergies, and making the reference to limited scientific data about such individuals more explicit.
Panel members also stressed the need for dentists to discuss this information with patients. A number of individuals who spoke at the hearing complained that their dentists never mentioned mercury-associated risks for amalgam fillings, which they blamed for serious illnesses.
A model for warning language, incidentally, lies north of the border. Health Canada states on its Web site that although dental amalgam generally does not pose a health threat, the primary teeth of children should be filled with a nonmercury material when feasible. Pregnant women, individuals allergic to mercury, and those with impaired kidney function should avoid mercury-based fillings, according to Health Canada.
Tempering the panel’s recommendations on Wednesday was an acknowledgment that amalgam’s risks must be weighed against its benefits — namely, its superiority over tooth-colored composite fillings for restoring multiple surfaces, and its greater durability. In addition, although the use of amalgam has drastically declined during the last few decades as a result of patients choosing more cosmetically attractive alternatives, its lower price has made it the default material for poorer patients, who might not be able to afford more expensive fillings if amalgam were banned.
“It’s nice for us to talk about risk and benefit and choice,” said panel member Thomas Burbacher, PhD, a professor of environmental and occupational health sciences at the University of Washington in Seattle. “But if you don’t have a choice, that discussion is meaningless.”
For further information, visit the mercury links page at www.cent4dent.com
Dr. Markus to Address the FDA
about the toxic nature of
Mercury in Dental Fillings
This is something that effects everyone of your readers who has a silver filling in their mouth, for nobody can ascertain whether they are susceptible to the 50+% of that “silver” filling that is the most-toxic naturally-occurring substance on the planet: MERCURY
As a result of hearings in 2006, the FDA has reclassified dental amalgam as a Class II device. That did not go far enough. They are about to hold hearings once again to reconsider whether these fillings should continue to be placed in the mouths of Americans.
Dr. Steve Markus, of Haddon Heights, NJ is a long-time opponent of the use of this material which causes neurotoxicity in humans, and a member of the International Academy of Oral and Medical Toxicology (IAOMT) had addressed the FDA several years ago, and has been a crusader for a ban on the material.
“Not only doesn’t it belong in the heads of humans, but its removal has to be handled in a very specific manner. Dentists are extremely cavalier about the use of this known toxin, and most don’t recognize the fact that many individuals develop problems because their systems don’t have the proper enzymes to aid the body to excrete mercury. Instead it deposits in tissue and causes problems such as memory loss, tremors, fatigue, headaches to name just a few.”
The failure of the FDA to act on its own resolutions has prompted several class-action lawsuits. Under pressure from the international community, the FDA has begrudgingly agreed to open these hearings. Dr. Markus first addressed the FDA in 2007, and was a keynote speaker for the anti-mercury contingent. The learned panel voted 13-7 against the adoption of their own white paper.
While the panel is supposed to discuss whether these fillings should be banned from use in children under the age of 6 and in pregnant women, Dr. Markus believes that this doesn’t go far enough. To learn more, contact Dr. Markus.
Information regarding the politics of the upcoming hearings, and the text of Dr. Markus’ intended three minute speech is on the blog of www.SmileSouthJersey.com (link in the lower left corner). Depending on the depth you want to research this topic, read the blog, and/or the mercury issues pages of www.SmileSouthJersey.com or www.DentalWellness4U.com
For one hundred and eighty years this neurotoxin has been placed in the heads of Americans, and speakers are being limited to one hundred and eighty seconds to speak! This one microcosm of government, the FDA, has shown how special interests can prevail over rational thought. This is something that effects everyone of your readers who has a silver filling in their mouth, for nobody can ascertain whether they are susceptible to the 50+% of that “silver” filling that is the most-toxic naturally-occurring substance on the planet: MERCURY
Near-final Draft:
Let me explain why we are here: collectively we are here because around 1830 MDs in this country advocated against the use of mercury in anyone’s head because of the newly imported technique of the use of dental amalgam. The blacksmiths and barbers who also treated oral pain therefore formed a guild whose support of mercury could today be compared with the ADA. The ADA has in its Code of Ethics the fact that it is Unethical to speak out against the use of fillings which contain mercury. Perhaps that is why so many dentists don’t even bother thinking about the consequences of their continued use of mercury.
Personally, I am here because my eyes were opened, and my head came out from the sand when I read about the Vimy study, performed in Canada over 20 years ago. Using a radioisotope of Hg in amalgams placed in sheep Vimy sought to prove that the the mercury became inert To his surprise he found that it distributed to all organ systems,… but crossed the blood- brain barrier much more than it distributed to the body. It crossed the placenta to an even greater degree. The guild disputed the results by claiming sheep were different than humans. Vimy’s results were then repeated in primates.
You, the panel are here because despite the last panel’s rejection of your own white paper in 2006, and the admission by the FDA’s author of said white paper that the reason all information presented to that panel was so one-sided and pro-amalgam was that, “he was only following orders!”. The FDA is under the influence of sinister forces that are trying to undermine health. Whose? The guild’s?
I know as both a citizen and a dentist, the decision last year by the FDA not to modify the protocols used, not just for the placement of mercury amalgam, but also to advocate for a safe removal process smacks of corruption.
The FDA asked me after the last time I spoke here, what I though about a ban against the placement of Hg fillings in the heads of children under 6 years old, and in pregnant women? I told them it was a start, but did not go far enough. All the teeth in the head of a child at age six have begun to fall out. So what that proposed regulation did was permit the placement of Hg fillings into teeth that were going to remain in the body forever.
They wanted to prevent it’s placement in pregnant women. I told them that regulation should have begun at first menstruation, ended after menopause, and was also sexually discriminatory.
So what the FDA did was nothing. The status quo. I have seen enough patients’ conditions of depression, memory fog, Meniere’s Disease, fatigue and more, eliminated after the proper protocols are followed to remove the mercury. I have seen others, where the dentist acceded to the patients’ request for Hg filling removal, and their conditions worsened because proper protocols for removal were not followed.
You had the opportunity to correct a 150 year old wrong last year, and the powers that be succumbed to this 150 year old sinister plot to poison Americans whose dental care is governed by a 150 year old guild, of which I am a member, through the unquestioned use of a material that 150 years ago was known by medicine to cause neurotoxicity.
How can I have any trust in government and any faith in the FDA when important decisions requiring simple protocol changes are not advocated for by a government organization that is supposed to have the best interests of its citizens, not sinister lobbies, at the forefront of their resolutions?
FDA Accused of ‘Rigging’ Advisory Panel to Favor Amalgam
by Jim Dickinson
FDA is frequently accused of “stacking” advisory committees to maximize the chances that they will vote the way agency staffers want them to (see, for example, two recent stories here and here). FDA rarely dignifies such complaints with a response. So it is again with next week’s (12/14-15) meeting of CDRH’s Dental Products Panel. Two petitions the meeting will discuss accuse the mercury in amalgam of being a cause of Alzheimers Disease, multiple sclerosis and other hard-to-study diseases affecting human fetuses and infants through maternal blood and milk. FDA found amalgam safe and effective in a controversial rulemaking 8/09, provoking the two petitions, one of which trashed the caliber of FDA science. The American Dental Association, whose membership stands to face professional liability lawsuits if FDA condemns amalgam’s safety, thanked FDA commissioner Margaret Hamburg for the rule and reportedly has two members on next week’s advisory panel.
Consumers for Dental Choice national counsel Charlie Brown told FDA Webview 12/6 the meeting represents “another way” for FDA “to pretend mercury fillings never hurt anyone.” In an email message, he said FDA is limiting public testimony at the meeting to three minutes. “Some people are begging for more time, while others are canceling their trips. These are people who are intent on telling the scientific panel how mercury from amalgam has had devastating impact on them and their families.
“FDA originally discouraged testimony by telling everyone who asked, (1) we may have a lottery, and (2) no one will be told until early December. For the average American, who can get to Washington only on cheap airline tickets and by making plans far in advance, the combination of the lottery threat and the very late answer (they could have done rolling acceptances instead) discouraged testimony.
“Now FDA says: You get three minutes. That should mean, under the FDA original plan of two four-hour periods of public testimony, that 160 people asked to testify. I smell a rat. I believe FDA condensed the time for public testimony – in order to invoke its cruel three-minute limit. Certainly, FDA knows this limit means many people will cancel when they are told their big trip to Washington — those not already deterred by the ‘lottery’ letter.”
FDA is declining to release the attendance list before the meeting, or to say how many speakers there will be. Press officer Karen Riley would say only that three-minute limits “are not uncommon.”
In an 11/15 email to CDRH advisory committee designated federal officer Olga Claudio, Pennsylvania Coalition for Mercury-Free Dentistry founder and president Freya Koss gave one example of why she wanted to know in advance if all intending public presenters at the meeting would be both allowed to speak and given more than three minutes to tell their stories.
Her star witness against amalgam, Koss wrote, was one Linda Brocato “who resides in Chicago [and] has been in a wheelchair for more than 20 years because she developed multiple sclerosis and lost the use of her legs due to mercury toxicity from her fillings. She must make travel arrangements for herself and an aide to accompany her. Despite the fact that she wrote to you explaining her disability and told you of her situation, you apparently responded by informing her that she would have to wait until November 29 to learn whether she would be able to speak or not, in spite of her condition. No consideration whatsoever was given to Linda. The longer she waits, the higher the airfares. It would seem that FDA would consider Linda’s disability and hardship and accommodate her. You might be interested in reading a recent news articles about Linda: You can see she is extremely disabled but very capable of speaking her mind about what’s right and wrong.”
Claudio stiffly responded two days later:
“Dear Koss,/ As indicated in the meeting announcement for the Dental Products Panel of the Medical Devices Advisory Committee (75 FR 33315), interested persons have until November 29, 2010 to notify FDA of their interest to speak during the open public hearing. The number of requests that FDA has received is therefore subject to change until November 29, 2010. [Bolding in original.] FDA will notify interested persons regarding their request to speak as soon as possible after the November 29, 2010 deadline, but no later than December 1, 2010 (as stated in the FR notice).”
Interesting that Claudio would choose to address Mrs. Koss as Dear Koss, because my response to her about this lottery was that if they’re going to delimit us to 3 minutes (last time we had 6), these speakers should be drawn equally from both sides of the issue. She addressed my response to Mr. Markus rather than Dr. Markus, when my email to her clearly stated I was a dentist. [sjm commentary to this]
An article recently published in the Journal of Alzheimer’s Disease, presenting a large scale systematic review of the literature, makes the case that mercury exposure is significantly associated with the incidence of AD.
Fox News picked up on the report in a news item viewable on YouTube:
Vaccines & Dental Fillings Cause Alzheimer’s
FDA Panel to Weigh Health Risk of Dental Amalgam Again
http://www.medscape.com/medscapetoday
December 7, 2010 ” An advisory panel of the US Food and Drug Administration (FDA) next week will weigh a study claiming that 67 million Americans with mercury-based dental fillings are exposed to mercury levels exceeding those considered safe by the US Environmental Protection Agency (EPA).
The study, commissioned by an organization committed to mercury-free dentistry, also calls the EPA’s safety threshold too high. It estimates that 122 million Americans with such fillings would be exposed to unsafe levels of mercury based on what it calls a more realistic threshold used by the California Environmental Protection Agency.
The advisory panel hearing, scheduled for December 14 and 15, promises to be another skirmish in this country’s ongoing scientific war over the health risk of mercury-based cavity fillings ” known as dental amalgam ” that dates back to the mid-19th century, when it divided the dental profession. Declining dramatically in use during the last several decades, dental amalgam accounts for roughly 30% of all fillings as alternate materials have gained popularity, according to the American Dental Association (ADA). Nevertheless, the traditional filling still sparks controversy. Opponents blame it for causing the likes of autism, schizophrenia, and Alzheimer’s disease.
Silver-colored dental amalgam is composed of roughly 40% to 50% elemental metallic mercury, as opposed to the organic mercury compounds found in fish, or inorganic mercury compounds such as those used in batteries. The other ingredients of dental amalgam are silver, zinc, copper, and tin.
Elemental mercury releases mercury vapor that at high levels can damage the brain and kidneys, according to the FDA. However, the agency has maintained that dental amalgam is safe for filling cavities for adults and children aged 6 years and older. The ADA agrees, noting that combining mercury with other amalgam metals renders it stable and nontoxic.
A number of consumer and dental organizations do not share these views, however, and instead advocate banning dental amalgam, as Sweden, Norway, and Denmark have done. Even the FDA recently has tightened its controls over the material, which comes under the agency’s regulatory oversight as a medical device. In July 2009, the agency bumped up its classification of dental amalgam from a lower-risk class II device to a moderate-risk class II device. That reclassification entailed label recommendations such as what dentists should tell patients about amalgam benefits and risks, including the risk of inhaling mercury vapor.
Among other things, the prescribed message states that “the developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor,” although clinical information is scarce as to the long-term health outcomes. The agency has concluded that infants are not at risk if they are breast-fed by women exposed to mercury vapors from dental amalgam.
Amalgam opponents have petitioned the FDA to revisit its 2009 decision, which led to the scheduling of next weeks’ hearing. The agency states that the dental products panel, part of its medical device advisory committee, will focus particularly on potential risks to pregnant women, fetuses, and young children. Issues that may come before the panel include the biocumulative effect of mercury and the adequacy of past clinical studies on dental amalgam.
The hearing next week raises the stakes for the product, considering how opponents have asked the agency to either ban it or classify it as a class III device — one that poses the highest risk to patients. The FDA has stated that class III designation probably would spell the demise of dental amalgam, because manufacturers would likely pull their products from their market instead of going through the time and expense of obtaining FDA premarket approval, as is required for class III devices. In essence, the premarket approval process would force them to prove that dental amalgam is safe.
The FDA can either accept or reject any recommendations that the dental advisory panel issues on the basis of its hearing next week.
Group Commissioning Study Advocates Removal of Amalgam Fillings
The fireworks at the hearing next week will likely be supplied by a study commissioned by the International Academy of Oral Medicine and Toxicology, one of several parties petitioning for the new FDA review. Based in ChampionsGate, Florida, the academy not only promotes mercury-free dentistry but also advocates that patients with amalgam fillings have them removed.
The group that conducted the study is the environmental division of a large, publicly traded engineering and construction firm in Ottawa, Canada, called SNC-Lavalin. The lead author, G. Mark Richardson, PhD, has previously authored similar studies for Health Canada, the Canadian equivalent of the US Department of Health and Human Services. That agency states that although dental amalgam generally does not pose a health threat, the primary teeth of children should be filled with a nonmercury material when appropriate. In addition, people with mercury allergies, pregnant women, and those with impaired kidney function should avoid mercury-based fillings, according to Health Canada.
Dr. Richardson’s SNC-Lavalin study estimates mercury exposure for 5 different age groups ranging from toddlers to seniors. Four different exposure scenarios are set forward. The highest-exposure scenario assumes that all restored tooth surfaces are composed of dental amalgam; the lowest-exposure scenario assumes that 30% of persons with filled teeth have no amalgam, and the rest have amalgam in only half their fillings other than nonamalgam crowns.
Using the lowest-exposure scenario, Dr. Richardson estimates that because of the mercury vapor they inhale from dental-amalgam fillings, 67.2 million Americans exceed the mercury dose extrapolated from the reference exposure level (REL) of 0.3 µg/m3 set by the US EPA. However, Dr. Richardson writes that this REL is too high because the EPA based its math on studies of so-called chloralkali workers who make chlorine and caustic soda from brine solutions in a mercury-based process. For them, mercury toxicity would be reduced by simultaneous exposure to chlorine gas.
These chloralkali-worker studies also guided the California EPA in calculating its REL for elemental mercury, although its REL is 10 times lower, at 0.03 µg/m3. Dr. Richardson estimates that 122.3 million Americans with dental amalgam are exposed to mercury levels above this more conservative safety threshold. He notes that the REL set by Health Canada of 0.06 µg/m3 reflects studies of mercury exposure free of concomitant chlorine-gas exposure, making them more reliable.
According to the FDA, a dose that exceeds the REL set by the US EPA “does not necessarily mean that any adverse effect will occur.”
Another recent study about mercury risk that the advisory panel may consider was published in the November issue of the Journal of Alzheimer’s Disease. That study concludes that inorganic mercury, which the authors define as including elemental mercury, may be a cofactor in the development of Alzheimer’s disease. The study, a meta-analysis of 106 other studies, recommended “the removal of mercury from public and ecologic circuits and replacing it wherever possible by less toxic alternatives.”
FDA Must Consider Possible Fall-Out of Ban, Says ADA
The ADA has entered the latest fray over mercury and dental fillings, stating in comments filed with the FDA that “the best scientific evidence continues to support the safety of dental amalgam.” No new research, it contends, has emerged to warrant new regulatory action since the FDA reclassification of dental amalgam last year. Meanwhile, the association faults amalgam opponents for citing research articles that are not peer reviewed or compliant with clinical trial standards, or else focused “solely on subclinical effects at the cellular level.”
To bolster its case, the ADA referred to a report recently published by the World Health Organization that described dental amalgam’s track record for safety in Europe and the United States. However, that report, titled “Future Use of Materials for Dental Restoration,” smacks of faint praise, stating that “dental amalgam remains a dental restorative material of choice, in the absence of an ideal alternative.” The report also recommends that the dental profession help identify safe and affordable substitutes as the use of amalgam is “phased down.” A complete ban, the report states, “may not be realistic, practicable, and achievable.”
The ADA raises similar points in its own defense of dental amalgam. “At present, there is no direct restorative material that works as well as amalgam for large fillings in the back teeth, in very deep fillings, or in fillings below the gum line,” the association states in its FDA filing. Furthermore, current alternatives to amalgam cost more, meaning that a full or partial ban on the material would drive up the cost of dental restorations and price some individuals out of treatment.
“Any rational risk assessment must account for this side of the equation: the cost of regulation,” the ADA states.
Authors and Disclosures
Journalist
Robert Lowes
Freelance writer, St. Louis, Missouri
Disclosure: Robert L. Lowes has disclosed no relevant financial relationships.