After hearings raised questions on its paper, opponents say the FDA now has to choose
The Next Step


By Tom Wilmoth, Editor of The Bedford Bulletin in Bedford Virginia
news@bedfordbulletin.com

December 27, 2006

After Marie Flowers of Bedford Country---along with numerous other witnesses--testified before an advisory panel of the U.S. Food and Drug Administration in September, those opposed to the use of dental amalgam fillings came away believing positive steps had been taken.

That panel rejected the findings of a draft document prepared by the FDA touting the safety of amalgam fillings, stating that more research needed to be done before any conclusion could be reached.

Some saw that as a step in the right direction. But four months later, some of those same folks involved in the battle against mercury fillings aren't so sure.

Charles Brown is one of those that was initially encouraged, but now has questions. "Right now (the question) is, is the bureaucracy going to just kill this thing," he said, adding the FDA has been dead set to try and hide any hint of problems of using mercury in dental fillings.

In fact, he said the FDA doesn't even want people to know the fillings contain mercury. "When are they going to tell people," he said, adding the FDA's policy is to not take action. "They do nothing extremely well over at FDA."

Brown, a lawyer, works as national counsel for Consumers for Dental Choice. He questioned the veracity of the White paper that had been prepared on dental amalgam safety. "We have no idea who wrote it. It did not go through the normal FDA procedures. They just fronted it to the press the Friday before Labor Day weekend," he said. "They just thought they could sound authentic."

He doesn't have any confidence that the FDA will follow through on providing the research the panel said was lacking in that document.

Brown said the FDA wants to classify dental amalgam in one of two classifications that assume the safety of its use. He said a Class III designation would mean that the manufacturer would have to prove that it's safe before it's sold.

He said dental amalgam has intentionally not been classified by the FDA for that very reason, though devices used in medical work began being classified 30 years ago.

In the late 1980's, Brown said all other dental filling materials were classified, some that aren't even used any more, but not dental amalgam.

"If they classify it they know it has to be a (class) III. It can't be proved safe. . . It's an implant and it has mercury. . . They just let it keep being sold unclassified."

He said the advisory panel did its job in not rubber stamping the White Paper on dental amalgam safety.

Brown said the goal of Consumers for Dental Choice is easy: to abolish mercury fillings. "I represent a lot of dentists whose free speech rights were being harmed. The dental boards didn't want the secret out. They call them silver fillings (not mercury). Do you think Marie Flowers would have intentionally put mercury into her body. . . The dentists who wanted to blow the whistle were told to keep their mouths shut."

The judicial process is slow--as it was with challenging tobacco, in which it took a long time for those lawsuits to see success. Brown said, "The courts are not created for new theories. You've got to kind of knock the courthouse door down."

He said it's a challenge to get the courts to say that the dentist is putting something dangerous in a patient's mouth.

And there are other problems, even in studies that some claim amalgam fillings are safe, Brown said.

One such study on children was reported earlier this year in the Journal of the American Medial Association. The studies sought to compare children receiving mercury amalgam fillings with hose how received fillings made of composite materials. Brown was critical of the study conducted by Dr. Timothy DeRouen of the University of Washington. That study involved children ages 8 to 10 years old from Portugal. He called the study unethical because it used children without a guardians' approval.

The claim that a dentist would make more not using dental amalgam fillings is a fallacy, Brown said. "They make more money per chair per day doing mercury. The goal, if you're in business, is the time aspect. It's how many you can sell in a time period."

He compared it to a factory line operation. "Economically it's a great thing," He said. "They can do a lot more fillings in an hour (than with an alternate restorative material)."

Brown said the FDA is a main battleground right now. "This stuff has 50 percent mercury which is a neuro-toxin. The dentist is hiding this by calling it silver fillings. Why are they calling it silver fillings. If it is so safe, why are dentists hiding the mercury?"

Dr. Robert Kelly, a spokesman for the American Dental Association from the University of Connecticut School of Dental Medicine disagrees with Brown's assessment of the issue.

Kelly said dental amalgam is safe and the health issue is "settled."

But he said questions will continue until use of the material eventually ends. Kelly said the use of dental amalgam is dropping at a rate of about 3 percent a year. Other materials are getting better he said.

Kelly has no problem, however, with the use of amalgam fillings.

I've got amalgam s in my mouth," he said. "I would put amalgams in my wife's mouth today. It is a safe and effective material. If there was a problem I personally would not be using the material."

He said the confusion is not because there hasn't been research. "It's not for a lack of looking. It's not because dentistry has any hidden agenda or it's protecting the use of this stuff. We honestly think it is a safe material."

But Boyd Haley, Ph. D, a research professor at the University of Kentucky, disagrees. He said there have been studies on cadavers in the United States and elsewhere that show dental amalgam use leads to increased mercury levels in human tissues. He said researchers in Sweden and New Zealand have performed studies on patients with diagnosed neurological disorders that when the dental amalgams are removed, and patients are tested three years later, about 70 per cent report considerable improvements in their health.

"With grams of mercury inches from the brain, giving off mercury vapor every second of the day, it seems implausible that its effects should not be considered at causing or exacerbating Alzheimer's diseases," Haley, who testified before the FDA advisory panel, said. "Yet any study on it seems to be suppressed. When studies are done using appropriate tissues from an Alzheimer's diseased brain, it is mercury and only mercury that produces the aberrant bio-chemistry seen."

The bottom line, Haley said, is that all biological science dedicated to heavy metal toxicity points strongly at mercury for causing Alzheimer's disease, but has been ignored by those performing research in that area.

Haley said genetics provide the difference in whether someone can effectively deal with mercury in their system.

Haley said one problem with this issue is that the refutations of studies touting anything but the safety of dental amalgam receive little press attention, including the FDA advisory panel's rejection of the White Paper in September.

The FDA, he said, is hiding from the facts "and trying to have the issue die with a whimper. Their job is to test amalgams for mercury release and decide whether or not they are safe. The FDA has refused to do this for decades because they know the amalgams will not pass a safety testing."

Organized dentistry makes a lot of money placing amalgams, Haley said.

"I am supporting fighting the dental amalgam issue at the state level, just like New York fought the transfat issue at the city level. My opinion is that the FDA sells out to commercial interests and cares little for the citizens. All publications on products that contain transfats show them to be toxic, yet the FDA approval they got years ago still stands and is the major claim that maker of transfats use to argue that they should be allowed to continue to sell these products. This is regardless of the known science and this is the same with mercury and dental amalgams."

Haley said people should be concerned if they have a family history of a neurological illness that would put them into the genetic susceptible group most likely to be affected by mercury exposure.

He said funding has not been adequate at the federal level to study this issue.

"Anytime you keep going to a dentist who is placing amalgams, you are donating to a group who think it is their God-given right to place one of the most toxic metals into your mouth."

Haley's work dates back to the late 1980's and early 1990s studying Alzheimer's disease. He said the studies led him to look for environmental factors related to that disease which led him to mercury.

He said the debate on the safety of dental amalgams need to be on a level playing field, with dentists who believe that amalgams release mercury and are a major concern not having to fear losing their license to practice dentistry. "Then the American people will make a decision based on what is in their best interests," he said. "They will not believe that a material that is treated as a toxic waste when outside the mouth is safe when in the mouth. They will not like the idea that before they can be cremated their amalgams may have to be removed to prevent environmental mercury contamination, as in the case in certain locations."

He said people should study the issue.

"Take the time to read the pro and con arguments and you will see how lopsided the arguments are against any mercury exposure," Haley said.