Cent4dent Blog

Dr. Shuren is the head of the FDA Medical Devices Committee, and is the one, I’m told is responsible for the delay in acting on the ban or partial ban of mercury fillings.

Here is the email I sent him today:

Can you tell me what the hold-up is in banning, or partially banning the use of mercury in the mouths of Americans? With all of the evidence presented, doesn’t it seem like the pro-amalgam forces are the ones with anecdotal evidence, because THEY haven’t proven that it’s safe for everyone? Who are the sinister forces, at work behind the scenes, making sure that we continue to poison Americans, not just by placing mercury fillings, but by making dentists think they’re doing no harm. It’s time for a ban, and for regulations regarding the removal of fillings so that more people aren’t poisoned by this process.

I know a lot of dentists ready to make a fortune off of the panic created, but none of them uses a rubber dam, and other IAOMT recommended safety procedures. The public needs to be made aware that strident precautions are needed for removal.

Physicians need to be made aware of symptoms of mercury toxicity that might be related to other entities that they’re treating with Rx’s, and that appropriate testing for heavy metals is needed, and then a referral to a mercury-safe dentist combined with chelation for mercury, rather than the thousands of pills Americans are swallowing.

This is 2012 Dr. Shuren, not 1850. It’s time that those “quacks” who began the process, and today are ADA dentists understand that dentistry used to be done only by MD’s. While dentists are trained to be “physicians of the mouth”, those sinister forces behind the scenes are trying to keep the rank and file dentists as unwitting poisoners of Americans, especially young children who are most succeptible.

Time to get off your butt, and act as an agent of change rather than a puppet of big business. Your job is to protect and defend. Please explain your lack of attention to this issue?

FDA Webview, 01/04/2012

Despite publicly asserting several times that he hoped to take action on petitions to reconsider the safety of dental amalgam by the end of 2011 after the World Health Organization called for a phase-down, CDRH director Jeffrey Shuren has let that informal deadline pass unmet. When asked what the new timeline goal is, FDA spokesperson Morgan Liscinski responded that there isn’t one.

FDA’s history of regulating dental amalgam is tortuous. For 32 years it refused to publicly warn about its neurotoxic risks until compelled in 2009 by federal court action to classify it. Even then, the agency’s action – declaring it as safe under Class 2 for everyone over age 6 who is not allergic to mercury – was immediately faulted by dental activists as weak and based on selective reading of the scientific literature on the topic.

Dr Markus has now addressed the FDA on three separate occasions, and they promise to move forward, but there must be more sinister forces underlying this issue, because they refuse to act. Here is a link to Dr. Markus’ and others speeches before the FDA Panel at the end of 2010.

Within two months of the rule’s publication in the Federal Register, two citizen petitions asked the agency to reconsider it, and a month later a World Health Organization expert group agreed in concept for a worldwide phasing down of dental amalgam. Goaded by such pressures, FDA eventually agreed to ask an advisory panel in December 2010 to examine the latest science; it voted to recommend a ban on amalgam’s use in children.

Still the agency hesitated, sending Shuren to a series of town hall meetings around the country at which he heard so much criticism of the agency’s amalgam policy that he began saying he hoped for agency action on it by the end of 2011.

Liscinsky’s comment suggests that after waiting 35 years on the amalgam safety issue, not to mention its similar delay on deciding not to move against food animal use of tetracycline and penicillin, FDA sees no need to hurry now.

National counsel for Consumers for Dental Choice Charlie Brown commented:

“At Jeff Shuren’s Center for Devices, politics wins. Science loses. Thirteen months ago, FDA’s own advisory panel of handpicked scientists told FDA to stop amalgam use for children and pregnant women.

“But Shuren fails to heed the scientists – even though, since September, he repeatedly announced that he intended to act on amalgam in 2011. Every day that Shuren fails to act, more children are subjected to this mercury product, which – FDA’s own rule concedes – can have ‘neurotoxic effects’ on the ‘developing neurological systems’ of children and unborn babies.”

Dear friends,

The third negotiating session for the world mercury treaty was held October 31-November 4 in Nairobi, Kenya. The World Alliance for Mercury-Free Dentistry, the ever-expanding coalition we founded in 2010, brought a skilled team of professionals from five continents: I led five dentists, a biologist, an international attorney with a background in human rights, and four nonprofit leaders with environmental expertise to represent our cause at the third negotiating session. Working together as a team, we participated in six grueling days of sessions, briefings, and working groups.

While no treaty language was agreed to, developments in Nairobi have moved our cause forward substantially. We have come a long way since the first session in Stockholm in 2010, when the cause of mercury-free dentistry was met with reactions ranging from indifference to hostility. Here are some of our latest accomplishments on the international front:

First, we have regions as well as national governments now openly advocating for “robust” treaty language addressing amalgam. For example, thanks to the efforts of our Amalgam-Free Africa Campaign, Africa vocally supports the phase-out of amalgam. And in the wake of our intense Australian campaign, Australia now supports the position of the United States – which supports addressing amalgam in the treaty. We continue to provide information, expertise, and recommendations to governments in both developed and developing nations.

Second, we have been able to build on the major breakthrough we achieved with the World Health Organization (WHO). It had appeared that WHO’s traditional opposition to mercury-free dentistry would prevail when WHO staff released a paper in 2010 promoting amalgam as the “material of choice.” As you might recall, we organized a worldwide protest that highlighted the glaring errors in the paper; we asked for an investigation. The paper was withdrawn. Last month the final corrected report was issued – it was a complete turn-around. Now WHO commits itself to “facilitate the work for a switch in use of dental materials” away from amalgam. Its key findings: Amalgam raises “general health concerns”, amalgam releases a “significant amount of mercury” into the environment, and “materials alternative to dental amalgam are now available.”

Third, our World Alliance for Mercury-Free Dentistry has gained a wide range of allies from the nonprofit organization community. Dentists, scientists, and environmental experts volunteer to serve as regional vice presidents and national chapter leaders for the World Alliance for Mercury-Free Dentistry in Oceania, East Asia, South Asia, the Middle East, Africa, the Americas, and Europe. In addition to our regional and national leadership, other professionals have volunteered to serve in technical and advisory roles. For example, Dr. Graeme Munro-Hall, president of IAOMT-Europe, is chairman of our Training and Transition Task Force, which is charged with demonstrating that alternatives to amalgam are effective, affordable, and available even in developing countries. These highly qualified individuals are now reaching out to more governments, more dentists, and more dental consumers all around the globe.
Treaty talks require tactics entirely different from the ones used to challenge federal or state agencies in the United States. As we prepare for the fourth negotiating session to be held next summer, our experienced international team will continue to navigate strategically this delicate diplomatic arena. We will continue our steady – and to date successful – march toward securing a treaty that aggressively addresses amalgam.

Charlie
16 November 2011

P.S. A special thank you to each of you who contributed financially this past fall during our matching campaign to help our united worldwide team. We couldn’t do it without you!

Charles G. Brown
National Counsel, Consumers for Dental Choice
President, World Alliance for Mercury-Free Dentistry

For more information, visit the Mercury Issues page of our website.

Rick Perry’s gaffe the other day led to a posting on his website, RickPerry.org calling for public feedback on which agencies need to be closed. The write in at the bottom requires the sending of an email to forgetmenot@rickperry.org – This is what I wrote:

The FDA has to be one of the most corrupt in DC. They are so willing to listen to influence peddling. There is no rationale behind the ongoing use of mercury in American’s heads. These fillings were judged dangerous when they were introduced in this country — IN 1850! I am providing you with 2 links about my testimony before the FDA (twice) and to issues of corruption that made the FDA fail to act on these issues in recent years.

http://www.cent4dent.com/html/mercury_issues/links.html

http://blog.cent4dent.com/category/mercury-toxicity-information/

I would heartily endorse a Republican candidate who would take a look at this, and the fact that the ADA is derived from a trade guild of itinerant dentists in the 1800’s that believed this substance, known at that time to cause neurotoxicity (Mad Hatter’s Disease back then). I welcome your feedback after learning the facts.

Pinellas County Fluoride has stopped fluoridating its water. Other areas are falling in line. Here’s what’s behind it all http://www.youtube.com/watch?v=fpc7BxVOVfM&feature=youtu.be

Dear Dr. Shuren:

As someone who has spoken 3 times before the FDA about the obfuscation of calling these fillings “Silver”, and the harm it can have on those susceptible (depleted homocysteine, inadequate APO e2 allele, inability to excrete Hg) which can be manifest in many ways I am once again encouraged by the news from Charlie Brown, that a final decision is coming before the end of the year.

We have been down this road before, however. As I am sure you will remember, the debacle in July of 2009 involving corruption perhaps prevailing over truth.

It is time that the American public learns that not only have their systems been poisoned at the hands of dental lemmings who couldn’t make the connection that their minds were being poisoned by the ADA. How can any dentist assume mercury is safe in the mouth, but not to dump down the toilet? And they’re supposed to be scientists.

The Vimy study was enough for me to stop placing amalgams 30 years ago. “Why?” you might ask.

Because ADA President, Arlen Lackey responded to questions from the NY Times stating, “That research was done on sheep, it wasn’t done on humans.” It opened my eyes and I started investigation. I learned that Dr. Vimy repeated the research on primates with the same results.

Vimy’s study involved the placement of fillings using a traceable radioisotope of mercury and found that the mercury from these fillings distributed to all organ systems in the body, and crossed the blood-brain barrier, and placenta even more readily.

I think everyone in this country knows that Washington needs to take a stand against influence peddling. There can be no other reason for the FDA to act as a sinister body allowing the wanton poisoning of adults, children, pregnant mothers. The ADA (of which I am a member) has tried to influence the FDA by having its speakers say:

1. It would be too difficult to train dental students how to place these composite restorations.
2. The insurance industry cannot afford the curtailment of mercury fillings
3. It’s an impossible restorative material to use on children, and more.

I refuted all this when I first appeared before the FDA in 1997, and then again last year by stating that
1. It’s the dinosaurs teaching in the dental schools that need reprogramming, the students are there to learn science and dexterity.
2. It’s not really insurance, it’s a reimbursement plan that is penurious, and that’s why most conscientious practitioners don’t even accept dental insurance, and
3. If fluoridation were as beneficial as its proponents contend we wouldn’t be dealing, as dentists, with massive amounts of decay in children. Instead, we find that because parents rely on benefits, rather than proper diet to control decay in their children’s mouths, tooth decay in children is still an issue. We need public health education. Because many pregnant women often don’t know they’re pregnant at the time of filling placement, mercury use in women of child-bearing age must be banned, which would then be sexually discriminatory.

To read the full content of my 3 addresses to the FDA, please visit:
1997 text of my speech –
2010 text of my speech -
Videos of presenters, 2010 -

You should also read this treatise on Informed Consent: which the FDA should take a step further, and educate the public who will be clamoring to have their fillings removed that this removal should only be done by a dentist who is taking all precautions needed to safeguard the health of their patient, their staff, and the environment.

Let me know if you need to know anything else.

Steve Markus
The Centre for Dentistry at Haddon
209 White Horse Pike
Haddon Heights, NJ 08035
www.SmileSouthJersey.com
856 SMILE S J

The U.S. Food and Drug Administration’s Director of the Center for Devices has agreed that FDA will issue an “announcement” on amalgam by the end of this year.

Dr. Jeff Shuren, who signed the appalling 2009 amalgam rule, agreed to this timeline as he presided at an FDA town hall meeting in San Francisco on September 22. It was the third FDA town hall meeting this year – and for the third time, our movement showed up in force to confront Dr. Shuren about the dangers of mercury fillings. The first town hall meeting was in Texas, the second in Florida, and now the third in California – these states represent a quarter of the U.S. population!

California grassroots director Anita Vazquez Tibau presented testimony on behalf of Consumers for Dental Choice. She highlighted amalgam’s devastating impact on the Latino community. “Many Spanish speakers told me that their dentists have never ever used the word ‘mercurio’ in a discussion,” Anita explained to Dr. Shuren. “Instead, it is deceptively called la amalgama plata – ’silver fillings.’ I’d like to see you tell everyone that mercury is toxic, and please post it in Spanish as well.”

Then Anita reminded Dr. Shuren of his own famous boast: “We don’t use our people as guinea pigs in the U.S.” She held high a photograph of a Latino kindergartener whose mouth is filled – top and bottom – with mercury fillings. “FDA admits that amalgam can cause neurological harm in young children. Their developing neurological systems are ‘more sensitive to the neurotoxic effects of mercury vapor’ says FDA. And FDA admits there is no evidence that amalgam is safe in children under age six: ‘No clinical information is available’ says FDA.” So stop treating Latino children like guinea pigs, Anita concluded.

Dr. Shuren responded. “What I can tell you is we intend to come out with an announcement by the end of the year.”

The clock is running: FDA has 97 days left to act.

I congratulate all the Californian consumers and dentists who confronted Dr. Shuren at the San Francisco town hall meeting – and everyone who has spoken up for mercury-free dentistry in their community. It was the grassroots movement rising up all across America that put amalgam at the top of FDA’s “to do” list. Thank you.

So what will FDA do? Will FDA act as its own scientists recommended: (1) end amalgam use in children, pregnant women, and hypersensitive adults and (2) make sure that every parent knows amalgam is mercury, not silver? Or is FDA simply going to “announce” that it will do something at a later date?

As many of you have been doing since 2009, I urge that you write Director Shuren at jeff.shuren@fda.hhs.gov:

First, thank Dr. Shuren for agreeing to act on amalgam this year.

Second, ask Dr. Shuren to take real action this year – don’t just announce that FDA might act sometime in the future. As Anita explained, our children are being subjected to mercury fillings now – they cannot wait another year.

Third, tell Dr. Shuren to take the advice of the FDA scientists he convened in December 2010. Stop amalgam use in children, pregnant women, and hypersensitive adults immediately. And warn every consumer that amalgam is mercury – a neurotoxin.

For More Information Visit the Mercury Issues Page of my Website……

Sept 11, 2011 – Dr. Mercola has wrapped up a week of attempting to increase public awareness of the issues, and corruption at the highest levels that allow the placement of mercury fillings in American’s heads.
Links Mercola – How the FDA has covered this all up.
What is the ADA’s motivation in sustaining this potent neurotoxin?
View Dr. Markus twice addressing the FDA on the neurotoxicity of mercury/silver amalgam fillings.

Today’s installment, an interview with David Simone.

Mercola also raises many salient points. One you might find interesting:

•In a brochure on occupational health in dental offices, the American Dental Association (ADA) explains that:

“Exposure to mercury is a potential hazard for anyone in the dental profession who handles mercury or mercury-containing compounds….Office spaces may be contaminated with mercury from leaky amalgam capsules and from the lingering effects of spillage. High speed handpieces and ultrasonic compactors that vaporize mercury can lead to unsuspected inhalation.” The brochure goes on to list the symptoms of dental mercury exposure, including “[g]rowing irritability, mood swings, and appetite loss…insomnia…tremors or numbness in the fingers…” But “[w]aiting for these symptoms to appear is far too late.”

According to the ADA brochure, the solution is for dentists to buy an annual subscription to the ADA Mercury Testing Service for $75.00 per employee.

•An advertisement from Henry Schein Inc., the leading amalgam seller, explains that amalgam’s “toxic vapor is quickly absorbed and accumulated within your body’s system, giving proven, long-term harmful side effects.” The flyer urges dentists to “protect yourself now from the harmful effects of mercury vapor” by purchasing new amalgam storage containers for $60.99 or $26.49.

Of course, the most effective – albeit perhaps less profitable – solution is to prevent dental workers from being exposed to this unnecessary source of mercury in the first place.

Read the entire article.
Visit the Mercury Links page of my website

Charlie Brown, the lobbyist and attorney for Citizens for Dental Choice (a group that seeks to educate the public about the perils of placing silver/mercury fillings 4″ from the brain) is interviewed in this first of several articles that will be featured by Dr. Mercola this week. Watch and read by clicking here.
As a proud supporter of this organization, I have testified twice before the FDA, trying them to ban the use of mercury in American’s heads. Videos of those events are linked to on my website if you would like to watch them. Watch and read by clicking here.