Cent4dent Blog

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

From a Friend’s Blog:

TV’s Dr. Oz certainly has an entertaining show, but I would caution you to not take everything he says as science. Two recent pieces of advice he has given have many dentists, me included, scratching our heads and saying “huh?”.
First he suggested to stay away from more expensive and proven, teeth whitening techniques and “do it yourself.” His suggestion was to use a mixture of lemon juice and baking soda. Honestly, kind of a bone-headed idea. The lemon juice has a pH of about 2,which is highly acidic and will leach the calcium and minerals from your healthy enamel, causing irreversible damage. Baking soda is way too abrasive to be used regularly, again irreversibly damaging your teeth. His suggestion to chew raisins is also a head scratcher. Raisins are very sticky and very high in sugar, definitely not a tooth healthy suggestion. Yes they will stimulate saliva, but may I suggest a piece of Xylitol sweetened gum, or a Xylitol mint.
Another recent show discussed the dangers of dental xrays and thyroid cancer. First be assured that all of us in the dental community want to minimize any risk our patients receive from radiation. That’s why many dentists, including our practice, have gone to digital radiography for our xrays. This technology drastically cuts the amount of radiation used. We take only those radiographs that are necessary. To compare the amount of radiation you receive from a dental radiographic exam is 0.008 Millisieverts., just daily exposure from natural background radiation is 5.6 millisieverts. I’m not a mathematician but that ratio is miniscule. The benefit of these xrays in diagnosing dental disease in its early stages, and thus preventing local and systemic infections, extraction of teeth, pain and suffering, and the creation of dental cripples, far outweigh their minimal risk.
To summarize, when you have questions about a dental procedure, or technique, ask a dentist. We really did go to school for this stuff, and practice everyday. Don’t venture into the land of Oz, leave that for Dorothy, Toto, and the Scarecrow (who had no brain).

Mercury Fillings May Pose Health Risks, FDA Panel Says

Mercury Fillings may cause medical problems for some CNN reports

FDA Panel Calls for Safety Review of Mercury in Dental Fillings

For further information, visit the mercury links page at www.cent4dent.com

A pregnant woman’s number of amalgam filling is associated with risk of
autism.

Results of two studies:

1. “The mothers in the autistic group had significantly higher
levels of mercury exposure through Rho D immunoglobulin injections and
amalgam fillings than control mothers.”

Reduced levels of mercury in first baby haircuts of autistic children.
Holmes AS, Blaxill MF, Haley BE.
Int J Toxicol. 2003 Jul-Aug;22(4):277-85. Link to Article

2. “Subjects [ie, autistic children of mothers] with 6 or more mercury amalgam fillings were 3.2-times
more likely to be diagnosed with autism (severe) in comparison to ASD
(mild) than subjects with 5 or less amalgams.”
A prospective study of prenatal mercury exposure from maternal dental
amalgams and autism severity.
Geier DA, Kern JK, Geier MR.
Acta Neurobiol Exp (Wars). 2009;69(2):189-97.
Link to Article

For further information, visit the mercury links page at www.cent4dent.com

FDA hearings on the toxicity of mercury fillings, at which I addressed the panel. read

Mercury and Alzheimer’s Disease Linked. Read And Another Article

Interesting commentary from citizens in the Washington Post.

For further information, visit the mercury links page at www.cent4dent.com

DrBicuspid.com reporter.
Day one:

Day two:

For further information, visit the mercury links page at www.cent4dent.com

My first 4 minutes of remarks regarding the history of the use of mercury fillings in the US – watch here

For further information, visit the mercury links page at www.cent4dent.com

Thank you for allowing me to speak before you today. My name is Stephanie Bernier-Adamson and I traveled from Fullerton, California to be here and my mother, Gabriella Harsh, a nurse, traveled from Athens, Georgia.

In January 2010, I was diagnosed with mercury poisoning, and at the recommendation of my primary care physician, decided to have the only mercury-emitting device in my body, my silver fillings, removed in February.

I started oral chelation with DMPS shortly thereafter and have experienced a continuous and measurable improvement in my health as a result.

I have been suffering from numerous autoimmune and mystery illness for many years. Most recently, I have been managing symptoms of fibromyaglia, ADHD, periferial neuropathy, chronic fatigue, Celiac Disease, in addition to 81 other food allergies. I threw up every day for months.

I also struggle with embarrassing and debilitating symptoms including agoraphobia, spontaneous lactation, chronic staph infections on my face, untriggered panic attacks, heart palpitations, vision disturbances, ringing in my ears, facial numbness and twitching, slurred speech, uncoordinated movements, and short term memory loss that was so severe, I would have trouble finishing my sentences.

The most troubling aspect of this controversial issue, for me personally, was the lack of informed consent.

As consumers, patients, taxpayers, and citizens, we Americans depend on the FDA’s expertise and foresight to protect us from dangerous products and practices. You are the only buffer between we citizens and the pharmaceutical industry.

It’s quite a noble feat that you have been tasked with: evaluating and regulating products to protect more than 300 million people.

Knowing the dangers of mercury and its well-documented health consequences, I have to ask, why would a government body continue to allow its use in medicine?

Placing mercury into the mouths of patients is reckless and dangerous, and I am proof of that.

I understand that mistakes happen in the medical and dental communities, but as the FDA, it is your duty to make certain that any product that causes dire consequences, in any form, should be removed from the market.

It is hard for me to believe that anyone who understands the extensive neurotoxic effects of this metal would give consent to it use.

As such, the issue of mercury was never mentioned in any dental office where I was a patient, and as a result, my quality of life has been affected immensely.

It is my hope that you do what is right for the health of the American people and ban the use of mercury in the dental community.

For further information, visit the mercury links page at www.cent4dent.com

Robert Lowes

December 18, 2010 “An advisory panel to the US Food and Drug Administration (FDA) concluded this week that there are no huge scientific flaws in the agency’s 2009 finding that mercury-based dental fillings, known as dental amalgam, are safe for adults and children aged 6 years and older.

However, at the end of its 2-day hearing, the agency’s dental products panel recommended that the FDA look at more data “and the latest data “on the possible health risks that the filling material poses to pregnant women and their fetuses and to young children, particularly nursing infants whose mothers have these fillings. The panel also said the agency should consider adding warnings for these groups to the material’s product instructions.

In one sense, the outcome of the hearing temporarily preserves the status quo for dental amalgam “so much so that the American Dental Association immediately issued a press release praising the expert panel’s recommendations. The American Dental Association maintains that dental amalgam is safe and warrants no further regulation by the FDA as a medical device.

At the same time, the panel’s quest for more scientific data about vulnerable populations acknowledged the concerns of dental amalgam opponents, who link mercury exposure to dozens of diseases ranging from autism to Alzheimer’s disease. At high enough levels, mercury exposure can damage the brain and kidneys.

“We have to recognize that some patients should not have amalgam,” said panel member Amid Ismail, BDS, DrPH, a professor and dean at the Kornberg School of Dentistry at Temple University in Philadelphia, Pennsylvania.

“There is really no place for mercury in children,” added Suresh Kotagal, MD, a pediatric neurologist at the Mayo Clinic in Rochester, Minnesota. “The bottom line is, do no harm.”

An attorney for the International Academy of Oral Medicine and Toxicology (IAOMT), which advocates mercury-free dentistry, told Medscape Medical News that he was encouraged by the consensus positions of the panel (no formal votes were taken).
“There was a lot of support that risk assessment needs to be done again,” said Jim Love, the attorney for the group. “I thought it was a very constructive dialogue.”

The FDA convened the hearing after the IAOMT and other antiamalgam groups and individuals petitioned the agency to reconsider its 2009 decision to reclassify the material from a lower-risk class I device to a moderate-risk class II device. That reclassification entailed revising product instructions to state in part thatclinical studies have not established a causal link between dental amalgam and health problems for adults and children aged 6 years and older, the developing nervous systems of fetuses and young children “may be more sensitive to the neurotoxic effects of mercury vapour,” and little or no clinical data are available regarding long-term health outcomes for fetuses, children younger than 6 years, and breast-fed infants.

The petitioners urged the agency to either ban dental amalgam, as Norway, Sweden, and Denmark already have done, or else reclassify it as a high-risk class III device with more restrictions on its use.

“Industry Will Go Crazy if That Reference Level Gets Moved”

By weight, dental amalgam is composed of roughly 40% to 50% liquid elemental mercury and a powdered alloy of mostly silver, copper, and tin. Much of the 2-day hearing focused on how much mercury is absorbed by people with these fillings, and what should be the reference exposure level (REL), or safety threshold, for the mercury vapor that the fillings release. Because mercury doses can be calculated from vapor exposure levels, an REL can establish a permissible dose. At the end, the advisory panel recommended that the agency take a second look at its positions on these issues.

The FDA currently holds that an individual with 7 to 10 amalgam fillings absorbs 1 to 5 μg of mercury per day. Amalgam opponents say this dose can be 4 times as high, meaning that tens of millions of people with these fillings are at risk for health problems, based on the current REL in place. The advisory panel’s advice to the FDA is to study mercury doses for various population categories.

“We have virtually no data on fetuses,” panel chairwoman Marjorie Jeffcoat, DMD, a professor at the University of Pennsylvania School of Dental Medicine, told Medscape Medical News. “It’s important to subset out the different populations.”

Also in dispute is the REL for mercury vapor. The FDA uses an REL of 0.3 μg/m3, set by the US Environmental Protection Agency (EPA). The EPA refers to this safety threshold as a “reference concentration” (RfC), which is an REL for inhaled, as opposed to swallowed, chemicals. This REL or RfC of 0.3 μg/m3 translates into a permissible dose that lies in the same range as the actual amalgam-derived dose assumed by the FDA.

The IAOMT told the panel that the REL for elemental mercury should be lower than 0.1 μg/m3 and cited a study it commissioned as proof. That study, whose lead author is Canadian biologist G. Mark Richardson, PhD, states that the EPA based its REL in part on studies of industrial workers exposed simultaneously to mercury and chlorine gas, with the gas acting to reduce mercury exposure, thus skewing the numbers. He notes that Health Canada, the Canadian equivalent of the US Department of Health and Human Services (and his former employer), set an REL of 0.06 μg/m3 by relying on studies free of this distortion.

The panel did not fully agree with Dr. Richardson’s critique and called his chlorine gas argument a “red herring.” Nevertheless, it advised the FDA to reexamine the scientific literature to reassess the REL and develop its own, noting that “the EPA RfC needs to be updated with the latest studies,” according to an FDA hearing summary.

In essence, the panel wants the FDA to determine whether the REL really protects vulnerable populations, Dr. Jeffcoat told Medscape Medical News. “Tiny children can’t speak for themselves,” she said.

However, any lowering of the REL for elemental mercury has enormous consequences that extend far beyond the dentist’s office, IAOMT attorney Jim Love told Medscape Medical News. The EPA, he said, uses this REL to regulate how much mercury that heavy industry can put into air and water, as well as to designate waste sites for its Superfund clean-up program. A lower REL means higher environmental protection costs — think billions of dollars — all around.

“Industry will go crazy if that reference level gets moved,” said Love.

Need to Acknowledge Amalgam Benefits

The panel also revisited the question — raised in the FDA’s 2009 deliberations — of whether clinical studies point to a causal relationship between dental amalgam and adverse health events. The panel reaffirmed that the literature at that time failed to do so, but only in terms of the general population. Again, it recommended that the agency continue to study the issue, particularly in terms of “susceptible subpopulations.”

The panel grappled with how to best spell out the possible health risks of dental amalgam in the product instructions that dentists receive. It finally suggested adding warnings for young children, pregnant women, and individuals with metal allergies, and making the reference to limited scientific data about such individuals more explicit.

Panel members also stressed the need for dentists to discuss this information with patients. A number of individuals who spoke at the hearing complained that their dentists never mentioned mercury-associated risks for amalgam fillings, which they blamed for serious illnesses.

A model for warning language, incidentally, lies north of the border. Health Canada states on its Web site that although dental amalgam generally does not pose a health threat, the primary teeth of children should be filled with a nonmercury material when feasible. Pregnant women, individuals allergic to mercury, and those with impaired kidney function should avoid mercury-based fillings, according to Health Canada.

Tempering the panel’s recommendations on Wednesday was an acknowledgment that amalgam’s risks must be weighed against its benefits — namely, its superiority over tooth-colored composite fillings for restoring multiple surfaces, and its greater durability. In addition, although the use of amalgam has drastically declined during the last few decades as a result of patients choosing more cosmetically attractive alternatives, its lower price has made it the default material for poorer patients, who might not be able to afford more expensive fillings if amalgam were banned.

“It’s nice for us to talk about risk and benefit and choice,” said panel member Thomas Burbacher, PhD, a professor of environmental and occupational health sciences at the University of Washington in Seattle. “But if you don’t have a choice, that discussion is meaningless.”

For further information, visit the mercury links page at www.cent4dent.com

Dr. Markus to Address the FDA
about the toxic nature of
Mercury in Dental Fillings

This is something that effects everyone of your readers who has a silver filling in their mouth, for nobody can ascertain whether they are susceptible to the 50+% of that “silver” filling that is the most-toxic naturally-occurring substance on the planet: MERCURY

As a result of hearings in 2006, the FDA has reclassified dental amalgam as a Class II device. That did not go far enough. They are about to hold hearings once again to reconsider whether these fillings should continue to be placed in the mouths of Americans.

Dr. Steve Markus, of Haddon Heights, NJ is a long-time opponent of the use of this material which causes neurotoxicity in humans, and a member of the International Academy of Oral and Medical Toxicology (IAOMT) had addressed the FDA several years ago, and has been a crusader for a ban on the material.

“Not only doesn’t it belong in the heads of humans, but its removal has to be handled in a very specific manner. Dentists are extremely cavalier about the use of this known toxin, and most don’t recognize the fact that many individuals develop problems because their systems don’t have the proper enzymes to aid the body to excrete mercury. Instead it deposits in tissue and causes problems such as memory loss, tremors, fatigue, headaches to name just a few.”

The failure of the FDA to act on its own resolutions has prompted several class-action lawsuits. Under pressure from the international community, the FDA has begrudgingly agreed to open these hearings. Dr. Markus first addressed the FDA in 2007, and was a keynote speaker for the anti-mercury contingent. The learned panel voted 13-7 against the adoption of their own white paper.

While the panel is supposed to discuss whether these fillings should be banned from use in children under the age of 6 and in pregnant women, Dr. Markus believes that this doesn’t go far enough. To learn more, contact Dr. Markus.

Information regarding the politics of the upcoming hearings, and the text of Dr. Markus’ intended three minute speech is on the blog of www.SmileSouthJersey.com (link in the lower left corner). Depending on the depth you want to research this topic, read the blog, and/or the mercury issues pages of www.SmileSouthJersey.com or www.DentalWellness4U.com

For one hundred and eighty years this neurotoxin has been placed in the heads of Americans, and speakers are being limited to one hundred and eighty seconds to speak! This one microcosm of government, the FDA, has shown how special interests can prevail over rational thought. This is something that effects everyone of your readers who has a silver filling in their mouth, for nobody can ascertain whether they are susceptible to the 50+% of that “silver” filling that is the most-toxic naturally-occurring substance on the planet: MERCURY