Amalgamdebatte auf Englisch

THE DEBATE CONTINUES

The fact that the FDA has agreed to classify encapsulated dental amalgam does not guarantee that it will be classified as a Class III device as many of us would prefer. Here are some quotes between Congressman Dan Burton and Dr. David W. Feigal, M.D., M.P.H., Director, Center for Devices and Radiological Health, Food and Drug Administration. The exchange took place during a hearing of the House Committee on Government Reform and Oversight on November 14, 2002.

MR. BURTON: "Based on today's standards at the FDA, if mercury amalgams were new and were submitted for approval as a dental device, using the existing published research today, would you approve it?"

DR. FEIGAL: "I think we would approve it as a restorative, yes I do."

MR. BURTON: "Do you? And what class of device would you call it?"

DR. FEIGAL: "It would still probably be a Class II device because most of the evidence would not have to come from clinical evidence."

MR. BURTON: "Now, after you do that study I asked you about a while ago, if it shows that there is an inordinate amount of vapor leeching into the body, would you maybe reconsider?"

DR. FEIGAL: "What we would have to know is what the significance was of the release of the vapor. And it comes back to the point I must not have made very clearly before, which is it is not the exposure which is at issue. It is the clinical significance of the exposure. That is what needs to be established."

Dr. Feigal seemed to be dismissive about the dangers from mercury toxicity and bioaccumulation raised by Boyd Haley, Marc Richardson, Rich Fischer and others. He said, "It is the clinical impact though that is the standard for taking action on medical devices, not the toxicology, not the ability to take preventive actions, but the actual observed effects."

That "observed effects" comment and a reference he made earlier to allergic reactions suggests that he focuses only on problems that occur in the dentist's office at the time that amalgams are placed. Follow-up problems down the line form bioaccumulation are no part of his knowledge or concern.

Dr. Feigal also made it clear that the FDA ignores the dangers of mercury to dental personnel. He said that is OSHA's concern. The FDA doesn't care about the toxic nature of amalgam scraps and removed teeth with amalgams. That is the EPA's concern. He also said that the FDA rarely intervenes in the way that products are described or presented in informed consent. "That is the practice of medicine which the FDA is asked not to get involved in." (I found that statement to be rather hard to believe, but that is what he said).

In response to questions from Congressman Ben Gilmore, Dr. Feigal said, "The misconception I think about safety in FDA is that we certify products as safe. We do not. All products have risks."

So, on subject, after subject the FDA spokesman testified that they don't care. The FDA does not care about health risks to dental personnel, they don't care about toxic waste disposal, they don't care about informed consent, and they don't care about health problems that show up after patients leave their dentist's office.

You and I care about all of those things, but the FDA witness made it clear that none of those concerns has any effect whatsoever on how the FDA will classify amalgam! At least, that was the attitude in November, 2002.

Practically the only thing he indicated that the FDA cares about is labeling. At one point during the hearing he said, "The FDA's authority on information about products has to do with the labeling of products." the FDA does indeed exercise their authority on the labeling of prescription drugs, over the counter drugs, and nutraceuticals. But, and this is a huge but, they do not exercise their authority when it comes to amalgam.

Consider this. Encapsulated dental amalgam is shipped from manufacturers to dental offices with a skull-and-crossed-bones affixed next to the words: "POISON, CONTAINS METALLIC MERCURY." The amalgam manufacturers Kerr, Vivadent and Dentsply, among others, advise dentists against placing amalgam in the teeth of pregnant women, nursing mothers, children under six, and anyone with kidney disease. The European Union guidelines call for manufacturers to include the skull-and-crossed-bones with the word "toxic" and the picture of a dead tree with the phrase "dangerous for the environment." The labels also say "Toxic by inhalation", "Danger of cumulative effects" and "very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment."

But all of that information is withheld from US dental patients under the guidance of the ADA and with the concurrence of the FDA. In my opinion, that grievous miscarriage must be corrected.

The FDA's request for comments give us an opening here. In their question 4 they ask, "How would labeling describing the risks of amalgam for certain subpopulations (e.g., children under age 6, pregnant and lactating women, hypersensitive or immunocompromised individuals) affect the demand for, and the use of, mercury amalgam? How would the risks included in the labeling be communicated to those subpopulations?"

My personal answer would be that use among the subpopulations cited above would be curtailed sharply. The information should be conveyed via posters prominently displayed in every dental office with warnings similar to California's Proposition 65 warnings, or those on the manufacturers' Material Safety Data Sheets, including the skull-and-crossed-bones. You may have a better answer.

Have things changed since the 2002 hearing? Well, there have been personnel changes. Several European countries have acted appropriately to reduce the use of amalgam. The FDA was embarrassed at the joint advisory panel hearing in 2006. They have been battered in the press on numerous food and drug safety slip-ups. Several IAOMT members have worked at developing better relationships with appropriate FDA officials. The FDA had to make some embarrassing admissions in court on two occasions. They also had to remove some ADA boilerplate language about amalgam from the FDA Website. So, yes, some things have changed since November of 2002. In a normal world, all of these things would suggest that the FDA might moderate their stance. But there is nothing normal about the FDA's world.

Am I saying don't bother to submit your comments? Absolutely not! Quite the opposite. I sincerely hope that most IAOMT members who have not already done so will submit their comments to the FDA Docket. Instructions can be downloaded at the IAOMT Website at: http://www.iaomt.org/news/archive.asp?intReleaseID=270 .Simply download and open the attached PDF file and follow the instructions.

The IAOMT Scientific Advisory Board submitted powerful factual comments for the record. Additional persuasive comments will be submitted on behalf of the IAOMT as a whole.

Please consider joining this important effort. If you can find any cracks in the brick wall that the FDA has thrown up to prevent any shaft of light from illuminating the truth about the human cost of installing a virulent neurotoxin a couple of inches from the brain please do so. But even if you can't, submit your comments anyway. We must show the FDA that there is so much interest in this subject that they must act responsibly. The FDA has to be taught that opposition to mercury-containing amalgam is not going to go away.

Source
International Academy of Oral Medicine & Toxicology