FDA Names

7 “High-Risk” Groups in the USA

That Should Avoid Receiving

Mercury Fillings

Informed consent is a cornerstone of health freedom and when there is a cover up of a hazard such as dental mercury, which is still allowed in the USA, it is a violation of valid informed consent.  Informed consent can occur only when patients know the truth. Here Leo Cashman writes about the latest news developments in the USA by the FDA and its regulation of dental amalgam mercury fillings.

On September 24, 2020, the US Food and Drug Administration stunned dentistry in America by issuing a Press Release and Statement calling for the avoidance of the use of dental amalgam fillings, which are about half mercury, in pregnant women, women who are planning to become pregnant, nursing mothers, and children. The statement also called for avoidance of amalgam in people with neurological disease, impaired kidney function and heightened sensitivity (allergy) to mercury.

Our analysis of the seven groups listed as being “high risk” gives us an estimate that, after eliminating overlaps and double-counting, the FDA is calling for the elimination of amalgam use in at least 176 million Americans, or at least 55% of the entire population. This calculation is based on a mathematical model that includes all women who are pre-menopausal, because any of them might get pregnant, and all people who have anxiety, depression or other neurological problems. That population now, under the stress of COVID, makes up more than 30% of all adults. It is unclear how the FDA’s new recommendations will be implemented by the rank and file dentists and, for example, how they would be enforced by state dental boards. Dental Boards enforce the “standards of care” through investigation of complaints and disciplinary actions taken against dentists.

The reaction within the biological dentistry and holistic health community was jubilation at the FDA’s break from its long history of stonewalling on the mercury amalgam filling issue.  The FDA has long ignored the published science of animal studies, human studies and clinical evidence, all showing that mercury from amalgams is not only harmful to pregnancies and to the unborn fetus, but also to people of all ages because of mercury’s ability to cause damage to the nervous, immune, endocrine, and cardiovascular systems.

The fact is the FDA’s list of vulnerable groups is seriously incomplete because every patient getting an amalgam filling will get an unhealthy mercury exposure, and the only sensible public health measure is a complete ban. “Mercury causes a bio-chemical train wreck,” biochemist mercury researcher Boyd Haley, PhD, has often said; every other mercury researcher agrees, saying that all unnecessary mercury exposures should be avoided. Mercury causes or contributes to every leading cause of disability and death, including the leading three, heart disease, cancer, and stroke.

Based on a renaissance in mercury research about thirty years ago, dental amalgam fillings should have been banned at that time. But the American Dental Association (ADA) has exerted and undue influence on the FDA, and the FDA has, until now, failed to provide even a hint of a warning that amalgams are a health hazard. In year 2009, FDA came out with a long awaited “rule” on the dental amalgam product.  In disregard for the vast scientific evidence of harm, FDA’s 2009 rule classified amalgam as a Class II, which is the “moderate risk category”, as opposed to putting it in Class III (most hazardous).  Class III would have required rigorous examination and a proof of safety. 

FDA’s unhelpful 2009 rule included a “guidance document” which discussed the question of whether to impose curbs on the use of amalgam in pregnant women, nursing mothers, or other vulnerable groups.  But the 2009 rule’s guidance document rejected all such curbs. It did not even call for dentists to inform the patient that amalgam contains mercury before placing the half-mercury product in the patient’s teeth. So, the FDA’s 2009 rule did not even call for the minimal amount of information needed by most patients so as to have some informed consent.  

FDA’s 2009 rule was a sweetheart present for the ADA, conforming to ADA’s central tenet that amalgam mercury fillings are safe to use.  To get an idea of how wedded the ADA is to its “dental mercury is safe” dogma, consider its early history.  Back in the 1840s before there was an ADA, amalgam mercury fillings were condemned by the American Society of Dental Surgeons when mercury was first starting to be used.  Amalgams were condemned because of the harmful effects that mercury was obviously causing. But a faction of renegade dentists refused to quit using mercury and they formed their own group which became the ADA. The ADA was formed by the renegade, mercury-using faction in dentistry and its mission has always been to convince its member dentists and everyone else that mercury in your mouth is safe.               

Even now, after listing seven sizable groups of the population that amalgam should not be used for, in the second half of its recent statement the FDA backtracked from its message of curbs and cautions and echoed the ADA’s dogma in saying the following:

The FDA is not recommending anyone remove or replace existing amalgam fillings in good condition unless it is considered medically necessary because removing amalgam can cause a temporary increase in exposure to mercury vapor….potentially resulting in more risks than benefits.  (From FDA’s Press Release and Statement)

Translated, FDA seems to be saying: “don’t you dare get your amalgams replaced, because amalgam removal is too risky and will likely do you more harm than good.” This is the same scare talk that the ADA has always been putting out and it seriously mis-informs the public on the serious issue of safe amalgam removal.  The truth is that Amalgam removal can be done safely but that is when and only when it is done by a “holistic,” “biological” dentist, who has the training and the equipment to do it safely.  Amalgam removal does carry risks when it is done by dentists – such as the typical ADA dentists – who are not properly trained in amalgam removal.

The ADA, a private professional association, and also the FDA, do not want to acknowledge the existence of holistic and biological dentistry, as these are the leading critics of ADA and FDA’s cover-ups. The views of the ADA-FDA nexus gives its critics the impression that it wants to keep the public unaware of the truth about dentistry and health that is offered by the biological dentists and their non-profits. The public is supposed to be kept in the dark about the ADA’s toxic influence. In part, the ADA’s influence is wielded by its (undeserved) privilege of being the institution that must accredit every dental school in America, thus controlling what is taught to dental students in the classroom – the books used, the curriculum and the top professors. ADA also maintains some out-sized influence on government by its political PACs, with their well-paid lobbyists and with their financial contributions to legislatures and governors. Realize that it is the state governors who appoint the dentists and the lay persons who will serve on the powerful state dental boards.  These boards have all too often in the past, attacked holistic dentists for being outspoken in their criticism of dental mercury.

Any dental patient who has health challenges that may be caused in part by existing mercury fillings has good reason to consider amalgam removal as long as it is safely done, as part of the treatment and recovery program. For a patient who is currently healthy but who has amalgams, it is also reasonable to consider amalgam removal, as long as it is done safely with elaborate protections used by a biological dentist.

 

The FDA’s defective and misleading 2009 amalgam rule will surely need to be revised in order to incorporate the FDA’s new recommendations spelled out in their press release statement.  But it is now apparent that the FDA is not about to put the amalgam product into Class III (most potentially hazardous) which would require a proof of safety.  Being in Class III and having to produce a proof of safety would be the death knell for the use of amalgam in the USA. But the FDA has clearly told us in a private email that it has no intention of banning amalgam or re-classifying amalgams.  Our only conclusion is that the FDA’s amalgam mercury cover-up continues, with all the continuing harm that it will do to America.

Some people ask “why now?” as far as timing of the FDA’s recent announcement of dental amalgams curbs.  We don’t entirely know.  But perhaps it was an attempt to deal in a quiet, less noticeable way given the pressure from the fact that now a dozen countries of the world have already banned mercury amalgams or else are in the process of doing so. There surely has been pointed pressure from the curbs that the entire European Union imposed as of July 1, 2018.  Beginning then, the EU placed a ban on the use of amalgams for children under 15, pregnant women and breastfeeding mothers.  This was not a recommendation in the EU, it was a firm ban!  In comparison, the FDA probably feared that it appeared callous and negligent in protecting women and children in the USA from a major mercury exposure.

So, where do consumers in America go from here?  For one, consumers can realize that the FDA has been seriously negligent in protecting dental patients in the past and is still not coming clean on the major toxic exposure from dental mercury in our mouths. Second, realize also that there is probably pressure to  

continue the cover-up from other agencies and players who have colluded in the cover-up; this pressure would flow from the entire public health establishment, going from the Center for Disease Control and the state health departments, down through the complicit news media.  Of course, the ADA itself might implode if the dental mercury cover-up were truly to unravel, with its seal of approval losing its value and reputation tattered.   Consumers are best off disregarding that media/public-health chain of propaganda and misinformation and, instead, look to independent non-profits that have integrity and are able to put out truthful scientific facts. A poison like mercury is not good for us and that is true even when a dentist puts it in our mouths. Aided by the truth, and all the necessary facts, all dental patients can make a safe escape from mercury amalgam fillings and other toxic mistakes, and become the healthier, happier people they are meant to be.  In a new era of awareness, all dentists can become “biological,” “holistic” dentists, ones who strive to avoid the dental poisons and to protect a patient’s health.

Leo Cashman is the executive director of DAMS, Dental Amalgam Solutions and he also serves on the board of National Health Freedom Coalition. DAMS has a web site amalgam.org, and is reachable at the e-mail dams@usfamily.net or by calling 651-644-4572.