At the end of the two-day hearing to evaluate the safety of amalgam, FDA’s own scientific panel – including neurologists, toxicologists, epidemiologists, and environmental health specialists – told the agency to stop amalgam use in children, pregnant women, and hypersensitive populations.
After reviewing the available scientific studies and the presentations of researchers, experts, dentists, and injured consumers, the scientists concluded that – contrary to the claims of FDA’s in-house dentist Susan Runner – amalgam is not safe for everybody. According to the panel, FDA’s amalgam risk assessments were not adequate to protect hypersensitive adults, children, and unborn babies. Repeatedly, panel members expressed their concern about amalgam use in children. Pediatric neurologist Dr. Suresh Kotagal of the Mayo Clinic summed it up for the entire panel: “There is really no place for mercury in children.” Other panelists went on to explain that dental mercury is like lead. The panel urged FDA to quickly contraindicate amalgam for these vulnerable populations and insisted that FDA provide consumers with labeling containing clear warnings.
The press heard the scientists loud and clear. According to the well-respected trade publication FDA Webview, the panelists “suggested the agency should ban the device’s use in children and pregnant women.” * Reuters announced that “Use of fillings in kids, pregnant women biggest concern…Enough uncertainty surrounds silver-colored metal dental fillings with mercury that U.S. regulators should add more cautions for dentists and patients, a U.S. advisory panel said.” **
At the end of the hearing, presiding FDA official Anthony Watson, Director of the Division of Dental Devices, announced that FDA would act quickly in response to concerns raised by the panel. But already FDA is ignoring the scientists. FDA’s official summary of the hearings reads like the American Dental Association press release that was issued the day before, simply noting that more research is needed.*** The summary does not even mention the scientists’ vocal cry for contraindications and restrictions to protect vulnerable populations. And even though panelists insisted that FDA has a responsibility to provide clear labeling for consumers, the summary twists their comments to absolve FDA of all responsibility – it claims that the panel only suggested the need for informed consent within the dentist-patient relationship.
We cannot let FDA get away with rewriting history and ignoring the scientists as it has done so many times before. Please write Anthony Watson at anthony.watson@fda.hhs.gov
Tell Mr. Watson of FDA:
• Since FDA’s own panel of scientists advise that amalgam should “definitely not” be implanted in children, pregnant women, and hypersensitive people, how soon will you take action to protect these vulnerable populations from this toxin?
• Since FDA has a duty to tell consumers that amalgam contains mercury that can damage the neurological systems of unborn babies, children, and hypersensitive populations, when does FDA intend to clearly state this warning on its consumer website and in consumer labeling?
• Since Commissioner Hamburg claims FDA is committed to transparency, how does FDA plan to keep the public updated on its progress with regard to the amalgam issue?
Thank you to all who came out to testify at the hearings, participated in the demonstration, and submitted comments to FDA! We’ve gotten this far, let’s keep it up.
– Charlie
Charles G. Brown
National Counsel, Consumers for Dental Choice
President, World Alliance for Mercury-Free Dentistry
316 F St., Suite 210, Washington DC 20002
MY RESPONSE TO MR. WATSON:
To: Watson, Anthony
Subject: FDA Hearings
As one of the presenters before the ADA Hand-picked panel, led by the former editor in chief of the ADA Journal, I am writing to let you know that simply banning fillings in the mouths of pregnant women and childrend does not go far enough. I had already written the ADA (I mean FDA – but it seems on the mercury issue they’re one and the same) in 2008, about this after they questioned me about their plans. The answer I wrote them is attached.
Until there is a way to determine who is “sensitive” to mercury from fillings everyone must be treated as such. Similarly, in 1988 there was a paradigm shift in dentistry where we had to treat all patients as if they had AIDS (universal precautions). We need another paradigm shift now.
When I watched you oversee the hearings, I felt there was promise for change. The murmurings I’m hearing from others who haven’t been able to believe the level of influence-peddling that is downright sinister, is that once again, the FDA will succumb to the ADA lobby. What power do they hold over your institution to be able to make your government agency look so corrupt?
Steve Markus
The Centre for Dentistry at Haddon
209 White Horse Pike
Haddon Heights, NJ 08035
www.SmileSouthJersey.com
856 SMILE S J
HIS RESPONSE TO ME:
Dear Dr. Markus,
All I can say is don’t lose hope. It has only been three weeks. We are still making sense of the panel and what to do within our authority. I have received numerous e-mails regarding the panel and it seems like many people have already come to the conclusion that we have completed our work and nothing else will be done. The truth is, we are not done. Mr. Markus, I am an optimist by nature so I believe we will take some affirmative action. I am also certain that someone will not be happy with our decision. It always seems that there is an unhappy constituent. The e-mails I have been getting all reflect a wide range of possible actions that people believe we ought to take. This begs the complexity of the issue and the need for deliberate approaches to decision-making. Thank you again for your e-mail and have a great day.
Anthony D. Watson, BS, MS, MBA
Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Phone: (301) 796-6296