The responses of Dr. Stephen J. Markus, who addressed the FDA in September of 2006 (link to: http://www.cent4dent.com/html/mercury_issues/fdaletter.htm) on the issues of mercury amalgam toxicity are included, after the >> symbol, below:
For the agency’s future analysis of benefits and costs of the regulatory options for dental amalgams, FDA also requests comments, including available data, on the following questions:
(1) How many annual procedures use mercury amalgams? What are the trends?
>>The figures I’ve heard is that there are still at least half of the dentists in the US who believe mercury fillings are the best and safest. The trend is that those numbers are decreasing.
(2) What are the differences in cost between amalgams and alternative materials (e.g., composite, other metals, ceramics, etc.)?
>> Composites take more time, are more technique sensitive and are a superior service, therefore they cost more by about 50%. Of course, as I told the FDA, the costs of treating patients who have symptoms of mercury toxicity but physicians who don’t recognize it may well result in an overall saving of health care dollars.
Are there differences in replacement lives?
>> Yes. Foremost is the technique sensitivity part. At the FDA hearings you heard me tell the panel that the statement by the representative of dental school faculty, who contended that it would be impossible to train the dental students to perform these procedures was a fallacy. Dental students are there to learn and gain dexterity. The problem would be in re-training the dinosaurs and ostriches on the dental school faculties.
Dental mercury fillings, because of the coefficient of thermal expansion tends to crack teeth. Composite restorations do not. I have been placing only composite restorations in my practice for almost 20 years. When done properly, they have the same or better longevity than mercury.
(3) What are reimbursement rates for dental amalgam and the alternative materials?
>> I suspect that the insurance lobby has been behind the promotion of the use of mercury fillings because they are far less expensive. Our practice was forced to eliminate the acceptance of any dental insurance because the carriers were attempting to drive a wedge between my patients and my practice.
In actuality it means more out-of-pocket for those with insurance because the insurance industry has truly controlled dentistry. When I first started practicing, in the late 70’s the maximum reimbursement from dental insurance was between $750 and 1000 a year. Thirty years later, things haven’t moved much, although dental technology has. Actuaries have stated that benefits today, to have kept pace with medical benefits, and with inflation, and with the changed practice environment should be about 10X higher than it was back then. The insurance industry (for the most part) has also refused to pay for composites because a less expensive option was available (amalgam). In this manner they have held the profession in check, because most patients think with their wallets instead of their heads. And so, my profession has not been able to evolve away from this toxic material because insurance companies don’t want to part with their dollars. Even though their losses are delimited by the policy annual maximum, the widespread use of amalgam alternatives would only cut into their profits.
(4) How would labeling describing the risks of amalgam for certain subpopulations (e.g., children under age 6>>the issue here is eradicating decay by getting children on better diets and educating mothers. Where did you come up with the age of 6? At the age of 6 the permanent teeth start coming into the mouth. So is what you’re saying: “We want to make sure that baby teeth that fall out don’t have any mercury in them, but those teeth that are going to stay in an American’s head the rest of their life will be fine with mercury fillings in them. Your panel already heard, in September of 2006 that the effects sometimes do not manifest themselves for over three decades.
, pregnant >> how many fillings are place in the mouths of women who don’t even know they’re pregnant (and not educated about the material either)? Shouldn’t this be for all women until they’re post-menopausal? Doesn’t this once again speak to the need for a ban, since it is sexually discriminating?
and lactating women, hypersensitive >> As your panelists in 2006 explained, this is not a hypersensitivity reaction – it is a reaction to the most toxic naturally-occurring substance on the planet surface. This is poisoning, and as Dr. Boyd Hailey discussed, those who have an aberrant allele, the APO E-4 rather than APO E-2 do not have the transport mechanism in place to remove mercury in nerve tissue, which it rapidly destroys, thus the neuro-toxicty issue. Please be sure to Google Boyd Haley (Chairman of the Department of Chemistry at University of Kentucky) and Amalgam. The research is out there, you just have to read it.
Don’t miss: www.chem.unep.ch/mercury/2001-ngo-sub/sub11ngo-att1.pdf
or immunocompromised individuals) affect the demand for, and use of, mercury amalgam?
>>Certainly labels and public service announcements that stated the facts fairly would lead to decreasing numbers of patients accepting them. A Zogby survey recently showed that 80% of Americans had no idea their “silver” fillings were in actuality 50% mercury. The majority of those surveyed would therefore refuse mercury fillings.
How would the risks included in the labeling be communicated to those subpopulations? >>Why just subpopulations? Doesn’t that constitute a reverse gag order, of sorts? We wouldn’t have to inform those who haven’t yet developed symptoms of mercury toxicity? There must be informed consent to place mercury in the heads of these subpopulations but not others? Here is my question to you: How is it that the ADA tells dentists that it’s totally safe to place mercury in the heads of Americans, because it becomes inert. Then, out of the other side of their “mouth”, the ADA tells dentists that scrap left behind after a mercury filling should be stored in a sealed glass container, under a high-specific-gravity liquid to prevent the vapor from escaping. LET ME SEE IF I HAVE THIS STRAIGHT ~ THERE ARE TWO SAFE PLACES TO STORE MERCURY FILLINGS, IN THE JAR, AND IN AN AMERICAN’S HEAD. This is why I call my co-professionals “ostriches”. They’ve got their brains in the sand.
(5) What is the current exposure to mercury for patients?
>> High since most dentists follow the ADA diatribe. It will continue until the product is either banned, or dentists are required to hand out a very specific form apprising patients of the risks. Asking dentists to do this voluntarily would be a joke.
For professionals?
>>Higher than they realize
What would be the reduction in exposure associated with the use of alternative materials?
>> Depends on how cautious the dentist is in removing the mercury. We use the IAOMT protocol to maintain our safety. Most dentists, who do not believe in mercury toxicity, are indeed sloppy with technique.
You see, when mercury is removed from a tooth, a slurry is created in the mouth, and mercury vapors are released both there, and from the aerosol created. A rubber dam must be used to prevent uptake of mercury via the sublingual route. Both the patient and the operating staff need to be properly protected.
Our building is equipped with a mercury separator to control the bioburden on waste treatment facilities.
Labeling Controls. For example, how should labeling controls, if any, address the disclosure of composition, including mercury content, and precautions regarding use of the device in sensitive subpopulations>> you don’t want to consider a total ban? This subpopulation idea to me is offensive. composed of individuals who respond biologically at lower levels of exposure to mercury than the general population?
>> This is already in place in California, copy them
If so, which subpopulations should be included (e.g., children under age 6, pregnant and lactating women, hypersensitive or immunocompromised individuals)?
>> How about everyone except those who’ve already lost their minds? Seriously, how do you communicate to everyone that there are serious issues involved in this matter. Until there are tests that are totally inclusive, you put at risk the entire subpopulation of adults who will develop Hg toxicity-related problems later in life.
>>As I stated in my address to the FDA, there was a paradigm shift in the eighties (with AIDS) in dentistry when we started having to sterilize handpieces and prevent blood borne cross infection. All patients had to be treated as if they were infected. So, now, we must treat ALL patients as if they were susceptible to mercury poisoning, because there is currently no known solitary predictor for that.
Should the labeling controls require more specific patient labeling (e.g., informing patients of identified sensitive subpopulations of the mercury content, the alternatives to the device and their relative costs, and health risks associated with the failure to obtain dental care)?
FDA requests comment on whether the two types of special controls proposed by FDA in 2002 (materials and labeling) provide reasonable assurance of the safety and effectiveness of these devices and on whether the special controls FDA described in 2002 should be revised in light of the recommendations and with respect to the discussions by the 2006 joint committee.
>> Certainly the FDA’s reversal of its own white paper points to the need to discard 2002 and re-write the book on Hg once and for all.
>> A massive public awareness campaign needs to be mounted. I have never had a patient ask me to read the label on any of the materials I use. Dental spokespeople on the news all are still afraid to speak-out, and deny the dangers of mercury. But based on what? ADA policy not to open one’s mouth still has a lot of my colleagues afraid to speak out as I have.
>> Most dentists have never even had a lecture in dental school about mercury. It was never considered on its own. It was always, as alloyed in amalgam. The re-education of dentists should also be mandated when the FDA does the right thing for Americans and bans mercury fillings, and mandates appropriate hazardous waste guidelines for its removal and disposal.