FDA Scientific Panel Urges FDA to Stop Amalgam Use in Vulnerable Populations – Will FDA Listen?
We all know that the human body is nothing to be meddled with, pardon my pun, and we all know that metals such as lead or mercury are poisonous. It would seemingly be common sense then that such poisons are kept out of our bodies, yet all over the world people have mercury directly adhered to their teeth by dentists to fill holes left after drilling cavities. Having trusted that the FDA and medical care providers wouldn’t put them in harms way, many now suffer from mercury poisoning due to amalgams.
In December the FDA held a two day hearing to evaluate the safety of amalgams during which the agencies own scientists urged that the use of amalgams in children, pregnant women and those who may be hypersensitive be stopped immediately. Why stop at children though? Most anything that can poison a child can also poison an adult. Whatever age, we are made of the same physiological structures, and poison is poison.
Amalgam fillings contain approximately 50% mercury, 30% copper, 14% each of tin and silver, and 1% zinc. All five of these metals are toxic and when they react they form 16 more toxic corrosion products. The EPA safety limits for mercury vapor exposure is 0.01 mg per day but numerous studies have shown that mercury fillings release up to 0.029 mg per day, nearly 3 times higher than the limit. Vapor exposure is highest when the amalgams are being placed or removed, but as long a person has them, they will be inhaling mercury 24 hours a day. The mercury vapor by the amalgam increases every time they chew anything, are exposed to hot liquid, or whenever they are brushed.
Exposure to mercury will effect kidney function and cause brain dysfunction, reproductive disorders and birth defects; like x-rays and other heavy metals, it causes damage to the lining of arteries. More than 100 million amalgam fillings are placed in the United States every year and the metal composites are not even effective in creating a healthier mouth half the time. Dr. Gary Schumacher, a dentist and chief of clinical research at the ADA Health Foundation’s Paffenbarger Research Center referred to amalgam fillings as “probably the biggest problem facing most dentists today”. He estimates that more then half of the fillings done cause a secondary tooth decay.
The major findings of the national poll are as follows:
- Most Americans (76%) don’t know mercury is the primary component of amalgam fillings.
- Americans overwhelmingly (92%) want to be informed of their options with respect to mercury and non-mercury dental filling materials prior to treatment.
- The majority (77%) of Americans would choose higher cost fillings that do not contain mercury if given the choice.
- Close to half (47%) of all Americans think mercury pollution poses a serious problem for the environment.
Those figures are a strong message that the FDA is not fulfilling their duties to their public and instead continue to downplay the harmful effects.
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 the FDA’s in-house dentist Susan Runner – amalgam is not safe for everybody. According to the panel, the 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 the FDA to quickly contraindicate amalgam for these vulnerable populations and insisted that the 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 the FDA would act quickly in response to concerns raised by the panel. But already the FDA is ignoring the scientists. The FDA’s official summary [PDF] 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 the FDA has a responsibility to provide clear labeling for consumers, the summary twists their comments to absolve the FDA of all responsibility – it claims that the panel only suggested the need for informed consent within the dentist-patient relationship.
We cannot let the FDA get away with rewriting history and ignoring the scientists as it has done so many times before. Please write Anthony Watson at firstname.lastname@example.org .
Tell Mr. Watson of the FDA:
- Since the 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 the 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 the FDA intend to clearly state this warning on its consumer website and in consumer labeling?
- Since Commissioner Hamburg claims the FDA is committed to transparency, how does the 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 the FDA! We’ve gotten this far, let’s keep it up.
Charles G. Brown
National Counsel, Consumers for Dental Choice
President, World Alliance for Mercury-Free Dentistry
316 F St., Suite 210
Washington DC 20002
Note: Since receiving this email, we heard further news from Charlie:
Joshua Sharfstein, the FDA Principal Deputy Commissioner who approved the abysmal amalgam rule after Commissioner Margaret Hamburg claimed to be recused, has resigned. Sharfstein’s exit allows new FDA leadership to take a fresh look at amalgam, and we will continue to hold their feet to the fire.
- Dental Composites for Kids: Even Worse Than Mercury Amalgam? Dental Composites Linked To Behavioral Issues In Children Research...
- Vaccine Genetically Engineers People to Stop Smoking: Planned for Children An upcoming vaccine contains a genetically engineered virus designed...
- The Power of Being an Introvert in a World That Can’t Stop Talking “Mom, you’re reading that, too!?” My 23-year-old-son, home for...
Related posts brought to you by Yet Another Related Posts Plugin.