25 Member Advisory Panel Rejects FDA Safety Report on Mercury Fillings
You can now read at http://www.fda.gov/ohrms/dockets/dockets/06n0352/06n0352.htm Comments to the FDA that are in the process of being posted. It may take awhile for your post to show up as there are close to 3000 comments. This link will take you off the MercuryPoisoned web site.
March 2008- The last time I looked the FDA had stopped posting comments as of January 10, 2007. They didn't post my comments and they didn't post the entire 3,000 comments.
September 26, 2006
by Marie Flowers
October 9, 2006--You can now see the complete transcripts from the FDA hearings on September 6, 2006 and September 7, 2006 at http://www.fda.gov/ohrms/dockets/ac/cdrh06.html#dentalproductspanel. Look under the section "September 6 and 7, 2006 with Peripheral & Central Nervous System Drugs Advisory Committee."
Mercury Fillings Safe? Mercury Fillings Unsafe?
It's all been in the news lately, "FDA Says Mercury Fillings Safe!"
Then less than a week later headlines proclaimed, "FDA Advisors: Safety of mercury fillings needs more study" or "Caution Urged on Mercury Fillings" or "Safety of Dental Fillings Questioned" or "Group Rejects Government's claim that mercury fillings are safe."
Are you confused? Did you understand the headlines about mercury fillings being unreasonable? Did you understand what you local paper reported about the "FDA not objectively and clearly presenting the current state of knowledge about mercury dental fillings?"
The FDA hearings were held at the Holiday Inn Ballroom at Gaithersburg, Maryland.
Some news reports were very confusing, since people did not understand the questions that were being answered by the FDA advisors. Some reports were fair and others had gross inaccuracies. A reporter from the Wall Street Journal concentrated more on quoting what the ADA spokesman had to say, even though the FDA and American Dental Association's position on amalgam's safety had just been rejected! She completely missed the significance of what had just taken place at the FDA hearings since it appears she only sought information from the pro amalgam ADA. Dr. Mackert from the ADA told her it would take 265 to 312 amalgam fillings to reach toxic levels of mercury exposure. Another dentist from the ADA said it would take 500 fillings, all in the mouth at one time, to cause a person to be poisoned.
But realize what was happening back at ADA headquarters. Consumers for Dental Choice reported on their website---
A.D.A. HQ in Panic Mode Over Vote of Two FDA Scientific Panels
Admitting that the FDA Panels vote against the safety of mercury fillings "continue[s] to generate heavy press coverage," the pro-mercury American Dental Association has sent out a panicky e-gram asking members to rally around mercury fillings. The ADA even sends members talking points based on the ADA ridiculous position that mercury is safe only when dentists use it. This pro-mercury trade group "which hides from the public the facts that it has pay-to-play endorsement contracts with amalgam manufacturers and owns at least two amalgam patents" admits to its worst nightmare: "The panel of advisers did recommend, however, that the report be rewritten, and that could will [sic] fuel efforts to restrict or ban amalgam use." I am writing my impressions of what happened at the FDA hearings, along with testimonies of people opposing the use of amalgam, or mercury dental fillings. If you want to read the ADA position, go to the ADA website. You can also download slides of pro amalgam speakers off the FDA website. The FDA web address is at the bottom of this page. So here goes.
What Really Happened at the FDA Hearing on Dental Amalgam?
On September 6 and 7, 2006 two panels to the FDA (a dental panel and neurology panel), made up of distinguished scientists convened for the sole purpose of addressing the neuro-toxicity of mercury amalgam dental fillings, better known as "silver" fillings. One panel was primarily physicians such as neurologists, MDs and a cardiologist, and the other panel was primarily dentists. There was an array of scientist-consultants (professor of biostatistics, consultant for anti-epileptic drugs, toxicologists.) All of them are credentialed in their fields, and all must pass FDA ethics requirements before being appointed.
I testified before the 25 Member panel on September 6th as one of the victims of mercury poisoning from "silver" amalgam dental fillings, which are actually 50% mercury and only 25% silver, along with zinc, tin and copper . Except for one holistic BIOLOGICAL dentist from Durham, NC, Dr. Michael Fleming, the panel of outside advisors to the FDA consisted of traditional (not alternative) doctors.
We are very blessed to have Dr. Fleming on the dental advisory panel for the next 3 ½ years. This is the very first time the FDA has had any dentist that is not pro amalgam. To date, the FDA has not issued any warnings about dental amalgam because their dentistry branch is made up of ADA dentists who maintain the old party line that silver fillings are safe, because "We have placed billions of them, and we have been using them for over 150 years."
Charlie Brown, general counsel for Consumers for Dental Choice (www.toxicteeth.org) brought lawsuits against the FDA for failing to classify dental mercury as safe. Brown quotes in his petition to the FDA to ban mercury fillings in pregnant women, "Based on the latest Centers for Disease Control data, scientists for the US Environmental Protection Agency have found that one American woman of childbearing age in eight already has so much mercury in her body she is at risk of having a brain-damaged baby."
Dental devices are supposed to be tested and classified as safe before they are placed on the market, but in the case of amalgam fillings, they were "grandfathered" into use without ever being tested by the FDA. Yet the American Dental Association has their "seal of acceptance" on the silver fillings and has patents on them.
Charlie Brown of Consumers for Dental Choice, Press Release
In a press release Brown said, "The FDA staff presented a White Paper consisting of shopworn rhetoric, selected studies (some of whom were misinterpreted) and out-of-date conclusions about mercury toxicity; in short, the staff paper argued that mercury fillings are safe. By two votes of 13 to 7, this panel decisively rejected the FDA staff position. It is highly unusual for a panel to disagree with staff.Charlie Brown
National Counsel for Consumers for Dental Choice
The questions presented:
"Does the draft FDA White Paper objectively and clearly present the current state of knowledge about the exposure and health effects related to dental amalgam?"
Yes 7
No 13.
"Given the amount and quality of information available for the draft FDA White Paper, are the conclusions reasonable?"
Yes 7
No 13.
[N.B.: (Note well!) Two-thirds of panelist says the position that mercury fillings are safe is not reasonable!] Chicago Tribune Article- Mercury Fillings Enter the Age of 'Unreasonable'
After the vote, each panelist made a statement. Virtually all expressed concern in one or more of the following three areas: (1) the need for informed consent (real informed consent, telling about the mercury and its effects); (2) the need to stop usage for pregnant women and children (as Canada, Sweden, the U.K., etc., already do), and (3) the reality that a substantial number of persons are severely hypersensitive.
Some highly intelligent and educated consumers testified that they had no idea that "silver" fillings are mercury - until it was too late. Please, please never again use the term "silver fillings", and make dentists say the "M" word when describing a material that is so full of mercury.
FDA is itself divided on whether mercury fillings are safe, meaning, in our regulatory system, they are not proven safe (there is no category between safe and unsafe). In short, then, our government can no longer guarantee American parents and young women that mercury fillings are safe for their children and babies. The solution is obvious -- we need an immediate ban on mercury fillings for pregnant women and children under seven -- the Health Canada model. From there, we work to put mercury fillings into the dustbins of history."
[Editor's note: See the draft FDA White Paper. Remember it was REJECTED by the Advisory Panel.]
This is Charlie Brown's speech to the FDA Advisory Panel.
Testimonies of Mercury Poisoned Victims
There were people from many walks of life who were poisoned and testified. This included an attorney, a librarian, a former teacher and prison minister (me), a clinical psychotherapist, a dental assistant who was still very sick and struggled to attend the meeting, an Activist from London, a son of a FDA official who is bringing a lawsuit in Maryland, an environmentalist, a former social worker and insurance professional, a poisoned dentist, and independent film makers, one of whom was the founder of Consumers for Dental Choice.
Carol Ward, Vice President of DAMS, and former librarian, left.
Read Carol's testimony.
London DAMS Activist, Angela Kilmartin, with Dr. Hal Huggins, right
Read Angela's testimony to the FDA. See her slides.
Linda Brocato was the first to testify. Brocato, a former Medical Social Worker and Operations supervisor for an insurance company has mercury induced MS. She never had another MS exacerbation after safely removing her mercury fillings. She can now, after 10 years with an aide, live alone and sit in the wheelchair without falling over. She has not seen a neurologist for MS in 16 years.
She had an interesting sticker on the back of her wheel chair: "Jesus, Don't Leave Earth Without Him."
Linda Brocato, left, from Prospect Heights, Illinois.
Jessica Kerger, an attorney from Ohio, told of her struggle to find out why she was loosing her memory and could no longer continue her legal practice to big companies.
Kerger testified, "I grew up in a medical family. I have a great deal of respect for mainstream medicine. My father and all three brothers are doctors. So is my stepson and his wife is about to join them. My uncle is also a medical doctor, a psychiatrist.I think this all makes me an unlikely plaintiff, but a plaintiff I am. I am the plaintiff in a case against the ADA, the Ohio Dental Association, Johnson & Johnson, Densply & Densply, the manufacturers of Dispersalloy amalgam, which was what was used in my mouth."
"I may have never figured it out, except that a very fine dentist in my town performed a root canal through an amalgam filling, meaning he drilled right through the center of it. That escalated my neurological problem so greatly that I ended up forgetting my infant son on a changing table and going off and doing something else. I wound up in the hospital within a week with heart problems. Somebody while I was there asked me if I had any dental work done. I had said yes, and they said, 'I think you ought to look into that.'"
Dorice Madronero,a former insurance underwriter, works for a non profit environmental organization in New York. Dorice had two miscarriages, each time occurring right after a dental visit where the dentist did dental work involving mercury fillings early in her pregnancies. There was cleaning, drilling and the placing of mercury filling(s) at each visit.
A Poisoned Dentist. . . .
Dr. Andrea Brockman, a dentist from Pennsylvania, exposed her son in the womb to mercury vapor because she drilled out old mercury fillings in her patients. He was hyperactive, asthmatic, a bet wetter, suffered from chronic sinus and digestive problems, periods of depression, difficulty focusing and impulsive behavior. He tested high for mercury. Brockman also had a miscarriage from mercury exposure. She sought advice from the ADA about her exposure to mercury vapor and they said they would get back to her. It has been 25 years and she hasn't heard from them. This is her testimony before the FDA Advisory Panel.
And Two Poisoned Dental Assistants--
Karen Palmer & Karen Burns
Karen Palmer struggled to attend the FDA hearings. She was a dental assistant for years. Karen told me, "I started with all the parasthesia in 2003 and it took a year
of testing till we figured it all out. I was diagnosed as mercury poisoned in 2004. Now I know all about "neurotoxicity" from mercury vapors and all the damage it causes. All those years, working in dentistry and handling mercury everyday..........thinking I
was protected by the mask I wore, never realizing the vapors went right through it and straight to my brain!"Karen is now completely numb on the left side of her body. The dentist she worked for is in denial, even after Karen was diagnosed as mercury toxic.
Karen testified, "It is so sad that people are not given all of the information in order for them to make informed decisions for themselves. Mandatory informed consent would help, and it is a start and some states have it, but not all are on board. Pennsylvania is one of the worst.
As crazy as it sounds, Oprah Winfrey gets quicker results daily with over 40 million viewers just in this country alone, than the entire federal government. How sad."
Karen Burns, from New Jersey, has been a dental assistant both in New Jersey and New York City. She was also poisoned from her dangerous job since dentists and dental assistants are not properly taught in dental school to protect themselves or their patients from mercury vapor. Dental assistants who work for biological dentists are at a definite advantage because these dentists use safe mercury removal protocols in their offices and have safe equipment and ventilation to protect their staff and patients.Karen testified, "When I first started dental assisting, we didn't wear masks or gloves. We had a vial of mercury and silver pellets that we put together by hand. And you want to talk about vapors being in the room! Back then we even had rugs in the rooms because we didn't understand that these vapors were everywhere.
This is a great opportunity for you people [the FDA Advisory Panel]to consider this issue, even though they've been saying for 150 years that this has been a safe product. You must see the damage that it's doing. Even if it's doing it to ten people. Why should ten people--which it's not, it's much more--why should anyone have to suffer this illness when it can be totally eradicated? We don't need to use dental amalgam fillings."
Sue Ann Taylor, founder of Blue Heron films, taped the whole hearing. She told that she had been poisoned from mercury dental fillings. While she was researching mercury toxicity, she found the reason her son became violent and dropped from a straight A student to a failing student. He had broken some teeth and a dentist had placed nickel posts in his mouth to repair the damage. After the nickel posts were removed the child recovered. Two members of her family were victims of modern dentistry!
Sue explains what she did next, "I started Consumers for Dental Choice and got Jim Turner and Charlie Brown involved and helped them raise the initial money to get things rolling. I was most shocked by the fact that a dentist could GO TO JAIL for telling me that my son's mental health and medical problems could have any connection with his dental materials - That is what sent me to Washington - No one believed me when I told them that a dentist was not allowed, no matter what he or she knew, to tell you that your symptoms could be caused by dental materials or procedures."
[Dr. Hal Huggins warns of nickel in dental materials at www.halhuggins.com. The chrome caps (stainless steel) that dentists place in children contain lots of nickel. Huggins says nickel is a carcinogen, can cause children to need thick lenses, and cause violent behavior in children.]
Michael Burke of Illinois, was the saddest witness. Michael testified for his wife Phyllis, age 50, who smiled but said very little. Phyllis was diagnosed with early onset Alzheimer's in 2004 when she was 47. She had been showing symptoms around the age of 44 to 45. She tested positive for the APO-E4 genotype which meant she was not able to excrete mercury. Michael said two mercury fillings triggered her Alzheimer's. The APO-E gene has 4 receptor sites, where cysteine can attach and pull heavy metals out of the cerebrospinal fluid. People with the APO-E4 gene do not have ANY cysteines on their receptor sites. Michael testified that he had spent over 3,000 hours doing research to try to help his wife.
Michael and Phyllis were a wonderful couple and when my husband and I ate lunch with them, we prayed for Phyllis to have a miraculous recovery. She just needs a miracle, that is all! Michael was so loving and attentive to his wife. I told Michael I would ask our church to pray for her.Michael was quoted in the news, "Do the right, decent, honorable and God-loving thing. There needs to be an immediate embargo on mercury fillings for everyone, or at least pregnant women and children, because they are our future."
[Dr. Boyd Haley, former Chair of the Chemistry Department from the University of Kentucky, explains, "Specifically, a reduction of APO-E gene types carrying cysteines decreases the ability to remove mercury and other thiol-reactive toxicants from the cerebrospinal fluid. This increases brain exposure to thiol-reactive toxicants and the risk of Alzheimer's disease (AD). It is reasonable to propose that exposure to mercury is one of the major toxic factors involved in early onset AD. Further, that simultaneous exposures to other toxicants or factors enhance the toxicity of mercury and hasten the onset of AD, especially in those individuals who are genetically susceptible.
The work by Rose's group at Johns Hopkins University implicates APO-E genotype as a "risk" factor with APO-E2 being protective and APO-E4 being a major risk factor. APO-E2 has the ability to protect the brain from mercury by having two additional thiol-groups to bind mercury appearing in the cerebrospinal fluid whereas APO-E4 does not have this additional capability. This may explain the proven genetic susceptibility to AD of the APO-E4 carriers."
Dr. Donald Miller reports in his article Mercury on the Mind, "Most important, however, is one’s genetically programmed ability to rid the body of mercury. The brain has a house-cleaning protein that removes dangerous waste products, which comes in three varieties: APO-E2, APO-E3, and APO-E4. The APO-E2 protein can carry 2 atoms of mercury out of the brain; APO-3, one; and AOP-E4, none. The genes we acquire from each parent determine which two we have. People with two APO-E4 proteins (and thus no APO-E2 or -E3) have an 80 percent chance of acquiring Alzheimer’s disease. And according to one study, autistic children have a huge preponderance of APO-E4 protein in their brains."]
Kathleen Nelson, a federal civil servant, came all the way from Austin, Texas to testify to the FDA Advisory Panel about her mercury poisoning ordeal. Kathleen told me in private about her acute vertigo when she was poisoned. "I had a severe vertigo episode at 3 o'clock in the morning that raised me out of a deep sleep. It sounded like a tidal wave of water going through my head. It immediately made me nauseated. When I tried to get to the bathroom, I couldn't walk because I had very little sense of what was up, down or sideways. I couldn't sit either.
I vomited over and over for hours and was not able to move off the bed. I couldn't open my eyes. It made it worse. I could get in no position on the bed that helped. I felt like I was in shock. I shook and was very weak.
The sound was too loud and light was too bright. You know how you feel when you are frightened to death and your adrenaline flows, fight or flight? That's what I felt all the time. That experience was dreadful.
Antivert, a antihistamine, was the only thing that immediately helped manage the symptoms of the vertigo and dizziness. My peripheral nervous system was strained. Weeks later, I went to rehab to try and acquire some balance and muscle strength back. This did nothing. I did not know at this time that I was mercury poisoned."
She told the Advisory Panel, "This question to use mercury or not to use mercury in dental products is simply absurd to me. The question defies common sense. It does not take a doctorate in chemistry or toxicology to understand that mercury is a known neurotoxin and degrades our health."
Freya Koss is very well known as an activist against mercury dental fillings. She has worked with Consumers for Dental Choice, the International Academy of Oral Medicine and Toxicology and has now organized the Pennsylvania Coalition for Mercury-Free Dentistry. Freya coordinated all the anti mercury speakers that spoke before the FDA Advisory Panel and coordinated dinners where we could all gather and get to know one another.
Freya showed the Advisory Panel her well known picture of what her face looked like after her dentist used liquid mercury to fill a tooth instead of using an amalgam capsule. Freya refused to accept the diagnosis of her doctors and started doing her own research to find out why she had double vision and was so suddenly struck with so many symptoms. "I learned from the research of Swedish neurologist, Patrick Storetebecker, that the route for transport from the upper teeth to the brain amounts to less than 10 centimeters, and that neurotoxins from the oral cavity can cause neurological symptoms such as ptosis or drooping eyelids, sclerosis, epilepsy, and myasthenia gravis."
Freya continued in her presentation, "The FDA has allowed the continued implanting of mercury in the body, the second most non-radioactive metal, solely based on the anecdotal claim of its 150 years of use, without classification or proof of safety or efficacy.
Neither the FDA nor the ADA have done actual research on the safety of amalgams but claim they are safe. One must wonder, is the mouth the only safe haven for mercury?"
More Important Speakers
The Honorable Congresswoman Diane Watson, in pink suit, Charlie Brown on left.
Congresswoman Diane Watson (D-CA), sponsor of HR4011 to ban mercury dental fillings testified how she had the Watson Law passed in California while she was a state legislator. This law required dentists in California to give patients a fact sheet on dental materials and post warning signs in their offices that mercury causes birth defects. It took 12 years before the California Dental Board would comply with the law and write the fact sheet. At one point the whole dental board was fired by the governor and a new one was appointed. The FDA allowed Watson to testify as long as she wished and she is always a forceful speaker. We gave her a standing ovation.
Dr. Rebecca Painter, a lovely Internal Medicine doctor from Gillette, Wyoming, came to Maryland on a divine mission. She told us at dinner, "The Holy Spirit has drawn us all here together." She has treated over 80 patients for mercury toxicity from dental fillings.
Dr. Rebecca Painter (middle) with her husband, Dr. Ernest West (left) and Dr. Hal Huggins (right).
Painter became acquainted with toxicity from dental fillings after attending a seminar by Dr. Hal Huggins. She said after that she was able to help many more patients who had failed to respond to treatment.
She testified that the original Quacks were dentists who placed mercury fillings in Germany. The word Quack comes from the old German word quacksalver, the German word for mercury.
I saw online news reports from Wyoming that Dr. Painter is being criticized by the Wyoming Dental Board and dentists in her hometown of Gillette for testifying at the FDA hearings. But of course they do not mention her name.
Dr. Boyd Haley presented a paper to the FDA which evaluated the science done by the FDA staff who prepared the "white paper." He said their evaluation contained a "fatal flaw" in that urine and blood mercury levels are well known not to be good measures of mercury exposure or danger. "It is well known that high urine and blood levels are a sign of ability to excrete mercury and have no reflection on total mercury exposure. The FDA staff totally missed this point as it serves the pro-amalgam groups' agenda of implying that amalgams do not contribute to mercury body burden---which is totally incorrect."
Dr. Haley is the former Chair of the Chemistry Department at the University of Kentucky and has testified before Congressional hearings and the NIH as an expert witness concerning mercury in dental fillings and vaccines. He told the Advisory panel his research shows that the same tangles that are in the brains of Alzheimer's patients, occur when mercury, and no other heavy metal but mercury, is placed on brain tissue in the lab. Haley told how much mercury was emitted from mercury fillings and it was far more than what was considered safe by the EPA.
You can see Amalgam Mercury: The Effects of Retention Toxicity, Synergistic Toxicities and Genetic Susceptibility, Dr. Haley's slide presentation to the FDA on this link. Haley was only given seven minutes to give his speech. This was the same amount of time as non scientists like me. The FDA did not even invite him as an expert witness! The FDA invited scientists and dentists came at government expense and had 20 minutes or more to testify.
Dr. Hal Huggins is the pioneer in this third amalgam war. At one time he was the darling of the American Dental Association and often was a speaker for them. Then Huggins wrote the classic book It's All in Your Head, the book that caused him to lose his dental license in Colorado in 1996 for speaking out against dental mercury and toxic root canals and refusing to place them in patients. See his biography at his website (www.halhuggins.com.) It cost him $3.5 million to fight against the dental system. He told us at dinner, "They took everything but my mortgage away from me". Huggins presented his Coors study to the Advisory Panel which showed lowered cholesterol after mercury fillings were removed. You can see Dr. Huggins' slides here.
Testimonies of Biological Dentists
They Came from New Jersey, California, Georgia, and Washington, DC.
Dr. David Kennedy is the former president of the International Academy of Oral Medicine and Toxicology (IAOMT). You can see the website of his Preventive Dental Health Association at SaveTeeth.org. Note the IAOMT protocol for safe removal of mercury fillings on his site.
Kennedy presented a power point version of "Mercury/Silver Amalgam Fillings and Neurotoxicity." He showed that the brain and body burden of mercury were in direct correlation to the number of amalgam fillings in the mouth. He showed many slides including one of the sheep and monkey studies which showed mercury throughout the body of the animal after scientists did a whole body scan. Other materials presented by Dr. Kennedy and the IAOMT include:
Table of Contents of Submissions
Mercury a Neurotoxin
Suitability of Mercury
20 Years of funding Peer Scientific Research has produced a prodigious body of empirical evidence
Dr. Wayne King is an outspoken Christian dentist who attends the Mount Paran Church of God in Georgia. He testified, "I am really not supposed to be here. One year ago, my aortic aneurysm blew out in my doctor's face." He publicly testified that Jesus had saved his life. King said there was a paper published in '76 that showed a connection between mercury exposure and dissecting aneurysm.
King was obviously upset as he explained to the panel, "I was going to show you the mask that I wear, but they took it away from me. They probably thought it would scare you! Mercury miners must use NIOSH approved masks. Why don't the dental schools tell dentists they should wear these masks while mining mercury from out of patients' mouths?"Dr. Wayne King and wife
He blamed his breathing mercury without the proper mask on his aneurysm in his chest.
"I wanted to mix a mercury filling for you, and test it for mercury vapor with my Mercury Vapor analyzer, but they confiscated my amalgam capsule also, and my vapor analyzer!"
To the right--At the Congressional briefing in March 2006, volunteers were tested for mercury vapor levels.
It was not a good day for Dr. King because the security had taken away all his props, but if he had dropped the mercury on the carpet, the hotel would probably have been evacuated. Yet the amalgam capsule would have been considered safe by the dental establishment to put in a patient's tooth. You can see the type of mask King planned to show the panel in this picture. It is the one the IAOMT sells to their biological dentists.
King's website is outstanding and explains all you need to know about safe dentistry. See his story in Christian Life Magazine on his site at www.MercuryFreeDentistry.com.
Dr. Steve Markus
from New Jersey gave a boldstirring speech-I would almost call it a fervent sermon- saying he stopped using dental mercury immediately after reading the sheep and monkey studies by Levy and Lorscheider . Whole body scans showed mercury in the jawbone, kidneys, liver, and stomachs of the sheep and monkeys one month after radioactive mercury fillings were inserted into the animals' teeth. This report was featured on CBS's 60 Minutes in 1990 where the ADA spokesman said about mercury fillings, 'It's not gonna cause a problem."
Dr. Markus' website: www.CENT4DENT.com
During his testimony Dr. Markus commented on some of the other speakers' remarks. "Pro-mercury dentists argued yesterday, that composite fillings are less durable, that dental schools can't teach it. This is all ludicrous. Dental schools teach dexterity and technique. They also insist on the use of the rubber dam. It's not the training of the students; it's the retraining of some of the dinosaurs that may still be teaching that is the obstacle."
Dr. Markus poked a hole in the pro amalgam position that it would be too expensive to stop using mercury fillings. Dr. Markus pointed out that the argument of increased costs is not the most important point to consider. "Many pro-mercury dentists argued about the cost of eliminating mercury from their armamentaria. But nobody asked what the financial burden is on the medical system for symptoms resulting from the use of mercury implanted in people's skulls."
Dr. Paul Gilbert, DDS practices in East Brunswick, New Jersey. His speech was titled
Amalgam, It no Longer has Benefits that are Worth the Risks. His website is www.drpgilbert.com.
Dr. Felix Liao, DDS who practices in Washington, DC and Virginia testified and told about one of his patients, Mary Puff, who was poisoned from mercury dental fillings.
Foreign Experts Invited by FDA Showed America was Behind the Times
The FDA invited expert witnesses from Sweden and Canada. They helped our cause by telling how their countries limited or banned the use of amalgam fillings in pregnant women and children and practiced the Precautionary Principal. In other words, they chose to "err on the side of caution." If you don't know if it is safe or not, don't use it.
Dr. Arthur Conn, Dental Advisor from Health Canada, spoke on the scientific basis for the regulation of dental amalgam in Canada. He told how amalgam is banned for pregnant women, children six and under, those with kidney disease and those with braces or with allergies. See his slides.
Dr. Lennart Philipson, Medical Devices Director, Medical Products Agency in Sweden discussed the regulatory process which had some similarities and some differences from the US regulatory system. Sweden classifies medical/dental devices into four classes. Dental fillings are class III.
Sandy Duffy summarized his speech, "He told the panel that Sweden would ban amalgam for everyone on January 1, 2007, except in very extraordinary circumstances which allows hospitals to place amalgam if there is no alternative. Since there is an alternative for every filling, that circumstance should never exist. He said that they were not waiting for absolute proof beyond a reasonable doubt before banning mercury fillings but were instead recognizing the Precautionary Principle." See his slides.
Though foreign countries are not coming out and saying mercury fillings poison, they advise against the use of dental mercury because of the Precautionary Principle and stress the importance of not polluting the environment with dental mercury.
John Rowe is a kind gentleman who organized three Congressional hearings on mercury dental fillings at the nation's capitol. You can read transcripts from the 2003 Congressional hearing on "Informed Consent and Full Disclosure in Dentistry" on this MercuryPoisoned.com website.
Mr. Rowe was the public relations man for the Congressional briefings concerning dental mercury in March 2006, and has lobbied for the International Academy of Oral Medicine and Toxicology. Rowe
spoke briefly, "It recently came to my attention that there's controversy in the European Union about the transport of amalgam from the manufacturer to the warehouses and to the dental offices. Restrictions on the transport of hazardous materials is interfering with the free flow of the amalgam to its place of use because it's so hazardous." The EU is the world's biggest exporter of mercury. The Commission intends to propose a ban (by 2011) on the export of mercury from the European Union (EU).
From the European Union website: The main source of exposure in developed countries is through inhaling mercury vapour from dental amalgam; furthermore, methyl mercury (its most toxic form) collects and concentrates especially in the aquatic food chain (fish, seafood, etc.). This is why the European Food Safety Agency (EFSA) is to carry out a study into dietary exposure in vulnerable population groups (pregnant women, children, etc.), particularly people who eat a lot of fish and seafood. The strategy also foresees regular communication of additional information concerning mercury in food.
Reference: http://europa.eu/scadplus/leg/en/lvb/l28155.htm
Sandy Duffy, President of Consumers for Dental Choice testified towards the end of the hearings. She warned the Advisory Panel, "The FDA is telling you that your job is to decide to agree with its white paper, or to tweak it in some minor way." She went on to explain that the FDA had tried in the past to "warn patients of amalgam's zinc content, not its mercury content. That's shocking for a health agency, isn't it?""We urge you to call a meeting promptly, to take up the classification issue, and the only one you can do, with the state of the science today, is a class three. Today, you can act on a narrower question. Ban mercury fillings for pregnant women."
"FDA's failing to act on this issue is scandalous. FDA refuses to classify. It has never classified encapsulated mercury amalgam. It has never done an environmental impact statement on this, the largest source of mercury in wastewater treatment plants."
76% Do Not Know Dental Amalgam Contains Mercury
Michael Bender of the Mercury Policy Project (www.MercuryPolicy.org) testified that, "even though amalgam is 50 percent mercury, 76% of Americans do not know this, according to a recent Zogby poll. It is not due to lack of consumer interest; indeed, the poll shows over 90% of consumers believe they have a right to know about mercury in dental fillings."
Amalgam Manufacturers Warn of Dangers
Bender of Mercury Policy Project showed slides to the panel of encapsulated dental amalgam that arrives at a dentist's office with skull and cross bones affixed next to the words "Poison, contains metallic mercury." Mercury, the warning states, is a "potentially hazardous substance" with "neurotoxic/nephrotoxic effects"; "a chemical known to the state of California to cause birth defects or other reproductive harm."
The two largest amalgam manufacturers -- Kerr and Dentsply advise dentists away from placing amalgam in pregnant women, nursing mothers, children under six and anyone with kidney disease. Kerr, the largest mercury amalgam manufacturer in the American market, warns dentists: "The health authorities of the various countries, including Canada, Germany, France, the United Kingdom, Norway and Austria have recommended against the placement or removal of an amalgam in certain individuals such as pregnant and nursing women and persons with impaired kidney function." Michael Bender picture taken at the March 2006 Congressional briefing to stir support for HR 4011
Mercury Girls and Mercury Children
Bender and his science advisor Dr. Rachael Obbard also showed seven minutes of a documentary from Norway called Mercury Girls which showed historical film of Norwegian dental nurses (assistants) working with amalgam in their bare hands. In 2005 the Norwegian Broadcasting Company examined complaints of dental nurses who had high levels of mercury. The reports of high mercury exposure were shocking. After the dental nurses saw the documentary in Norway and Denmark, they reported that their offspring was affected too, and a second documentary was produced, entitled Mercury Children. Bender's said common sense would recommend that 1) amalgam placement needs to be banned during pregnancy and 2) dental assistants should be placed on leave during pregnancy.
The Study Results of the Dental Nurses
In the study results between the dental nurses and a control group, the results even surprised the scientists. 25% of the dental nurses reported having neurological problems. 36% of the dental nurses had tremors compared to 8% in the control group. 14% of the dental nurses had problems with memory vs. the control group having NO problems with memory. 18% of the dental nurses were depressed compared to 4% in the control group. 21% of the dental nurses had heart and lung problems, compared to 5 % of the control group.
Professor Bente Moen, Head of the Section for Occupation Medicine at the University of Bergen in Norway had the oversight for this project.
When opponents said this could not happen at the level of mercury exposure the nurses were exposed to Professor Nils Gjerdetat, from the Faculty of Dentistry at the University of Bergen conducted experiments following the procedures used in the past in dental offices. They heated amalgam under a hood and then measured the vapors. The results were staggering. Every time amalgam was prepared the meter read 1000 mg/m3, the maximum limit the device could measure.
The response after the document aired was overwhelming. 394 women called the Norwegian television station. A pattern emerged. Many worked while pregnant and were also breast feeding. A high number reported children born with birth defects, learning difficulties, immunological, and muscular/skeletal problems. The mothers had severe bleedings and multiple late spontaneous abortions.
New Zealand nurses were also exposed to similar levels of mercury. In 1974, authorities discovered nurses in New Zealand were ill with mercury poisoning. They were given paid leave until their levels "normalized." A study there found a statistically significant result. 25 % of the dental nurses had had a hysterectomy compared to 6 % in the control group.
After Mercury Girls was aired in Denmark, more than 1650 dental nurses called the Danish Trade Union, expressing concerns for both their health and the health of their children. In response, the Danish Trade Union launched a new website: www.kviksoelv.dk. The Danes are working collaboratively with Parat, and the Norwegian Trade Union. www.parat.com
Norway now actively discourages dentists from placing amalgam, because 1) it takes away from the life of the tooth. (More of the tooth structure has to be drilled away in order to place an amalgam filling compared to a composite filling.) 2) Levels of mercury in pregnant women and children are too high, and Norway chooses to follow the precautionary principle. The principle of product substitution is, when available, use less toxic materials. Amalgam placement is banned during pregnancy. Pregnant dental nurses in Norway are placed on paid leave.
The two women, Kjersti Knudssøn and Synnøve Bakke, who made this documentary, received the Norwegian Press Award for Outstanding Investigative Journalism. The judges said, "After the two journalists’ impressive and extensive work, our perceptions of what 10,000 dental nurses were exposed to in their workplace has been changed forever."
You can see all of Bender's slides with more information at this link.
How to Obtain the Documentaries for TV Airing by Broadcasting Companies
Information about the Norwegian Broadcasting documentaries can be found at:
Mercury Girls (If the picture in this link does not show up, you can post the address in your browser later.
From the tv2world website: "They mixed mercury with their bare hands. They spilled it on the floor. They heated it over open fire. This was the daily routine for 10,000 Norwegian dental-assistants until the mid -80`s. Nobody told them it was dangerous. The authorities assumed the mercury levels were low. Today many of the women are ill, and unable to work. They have classical symptoms of neurological damage caused by mercury but never the less the health care system treats them as mentally ill.
This is the unknown story of the dental-assistants, and the children they gave birth to after handling mercury every day.
The Norwegian government has initiated a research-project based on these documentaries."
Mercury Children
Anyone interested in airing the documentaries should contact TV2 WORLD DENMARK, www.tv2world.com. Their email addresses is as follows
sales@tv2.dk
tel+45 65 21 22 23
Please go to these websites for Mercury Girls and Mercury Children. It is unbelievable.
The FDA, at First, Refused to Place the Mercury Girls Documentary into the Records
Sandy Duffy, attorney for Consumers for Dental Choice told me, "Michael Bender came up to me and Charlie Brown after his presentation and said that the FDA clerk would not take the documentary as evidence because he hadn't shown all of it. I told him to go tell the FDA clerk that he/she HAD to take it because otherwise there was not a physical record of the presentation. They finally took it."
Duffy continues, "I'll bet the FDA didn't want that in the public domain. It was devastating. I'm sure the ADA and FDA will say - oh, well, it was just bad hygiene in the old days, now we have encapsulated amalgam. But it definitely shows how the learning curve on mercury is long and often wrong. It is now taken as truth that there is NO safe level of lead. That is where we are going with mercury. It is at LEAST 40 times more toxic than lead."
The Advisory Panel--Concerned about Mercury Exposure to Women and the Unborn
Panelist were very concerned about the health effects on the fetuses, such as drilling out a filling or placing a filling in a pregnant woman. Lynn R. Goldman, PhD, a professor of environmental health sciences at Johns Hopkins University in Baltimore, MD said, "We have a major data gap in terms of the sensitivity of the fetus. I come out of this very uneasy about what we don't know, about both the exposure levels during dental procedures, what the transfer of that might be to the fetus and what the impact of that might be on the developing brain. Everything that we know about other forms of mercury, methylmercury, the time that seems to be the critical time is during brain development, in utero. And so that would be the most important thing to know in terms of assessing safety, and we don't know it."
"I'm taking it more seriously that there could be exposures, acute exposures."
Dr. Margaret (Peggy) Honein, PhD, Master of Public Health and Epidemiologist for the Centers for Disease Control and Prevention Atlanta, Georgia stated, " Yes. I just wanted to share Dr. Goldman's concern about fetal exposures and that being a fairly significant research gap. What we do understand is what effect it might have, especially during early development. And to that end, I was wondering if the practicing dentists on the committee could shed any light on the standard of care for pregnant women in the U.S. currently?
Is it only emergency care for things that cannot wait until after pregnancy? Is it fairly typical to be removing and installing fillings during pregnancy? What would be the typical standard of care?"
Dr. Michael Fleming, a non voting Consumer Representative on the panel, and biological dentist from NC answered, "Well, I can tell you this. I will give you an example of the unique situation that's in the hygiene department of your practice. I personally would never think of replacing, removing or installing anything in a woman who was pregnant. That's my personal view.
The issue in hygiene departments is that the hygienist will take a prophylaxis cup, if the patient has amalgams, and they'll polish those amalgams and the mercury release rates are dramatically increased. That's the acute "hit" that they get. Not to mention the "hit" that the hygienist gets in the field around the oral cavity.
So the big problem I think that you face with pregnant women is not so much the installation removal in the pregnant woman, but it's in the maintenance that's often emphasized during their pregnancy.
For example, dentists are very quick to recommend that they need to be cleaned because they can get pregnancy gingivitis and things of that sort. So the cleanings are emphasized. So I think some attention needs to be given to keeping that prophylaxis cup off that amalgam."
Dr. Richard Burton, DDS, Professor of Oral and Maxillofacial Surgery at the University of Iowa College of Dentistry gave the view of pro amalgam dentists. "I guess my comment would be a little different. I haven't practiced general dentistry for a while but I've managed large dental clinics, both in the military and where I'm currently at, where we have both a number of hygienists and a number of general dentists.
And my thought would be that there really is not particularly, in terms of providing general dental care, which is what I would put this under, whether you're replacing initial restorations or replacing restorations, there's really not a restriction that I'm aware of, that I've ever had in any of those facilities. So at least potentially, if someone came in and they've broken a filling, they're always very acute--or during a pregnancy are more aware of their overall health and well-being, and I can honestly say I know that those are replaced.
And in our particular state, where we also take care of a number of Medicaid and Title 19 patients, interestingly enough, some of them become eligible for care because they're pregnant.
So they will come in and get large amounts of treatment done during their pregnancy because it becomes covered during that period.
So I guess I would say, you know, in answer to your question, yes, I think that the standard of care--and I'm not trying to describe what that is--but I would say I'm not aware of anything out there that says no, you would not treat them, you limit care, those kind of things.
So they are going to be exposed to either initial restoration placement or potentially replacement during the time that they're pregnant."
Panelists said more study was needed on whether mercury fillings give off more vapors when they're being placed or removed. We already have that information. Dr. David Kennedy, DDS states "during the removal or placement of amalgam the patient can be exposed to amounts which are a thousand times greater than the EPA allowable concentration. Once the drill touches the filling the temperature increases immediately vaporizing the mercury component of the alloy."
[Cooley RL, Barkmeier WW: Mercury vapor emitted during ultra speed cutting of amalgam. J Indiana Dent Assoc 57:28-31, 1978]
(http://www.saveteeth.org/mercury/iaomt.htm)
The ADA-Unconcerned About Mercury Exposure to Women and the Unborn
I checked the ADA website and found out the ADA thinks it is just fine to drill out a mercury filling or to place a new one during pregnancy.
Why Did the Advisory Panel Reject the FDA Safety Report?
My answer is because the FDA-invited scientists couldn't answer elementary questions!
These were the two questions the Advisory panel had to answer:
1) Does the draft FDA White Paper objectively and clearly present the current state of knowledge about the exposure and health effects related to dental amalgam?In a vote of 13 to 7, the Advisory panel voted, No, the FDA did not clearly present the evidence about the exposure and health effects related to dental amalgam. And in another vote of 13 to 7, the Advisory panel voted, No, the conclusions are not reasonable that the dental amalgam fillings are safe based on the draft FDA white paper.
2) Given the amount and quality of the information available for the draft FDA White Paper, are the conclusions reasonable?
The Advisory panel did not say the fillings were always unsafe and they needed more information, much more than the FDA provided, in order to make a decision.
Panel members were concerned because they had only limited access to journal articles (those handpicked by the FDA) and the FDA had not used multiple search engines in compiling the studies.
"There are too many things we don't know, too many things that were excluded," said Michael Aschner, a professor of pediatrics and pharmacology at Vanderbilt University and a panel consultant. He cast two "no" votes.
Dr. Roger Porter, a panel member, and a consultant in the development of anti epileptic drugs, called the FDA's study "very deficient" because it didn't address how the human body absorbs, distributes, processes and eliminates mercury.
A Little Bit of Humor.....It Actually Happened!
I almost laughed when one of the Panel members asked a FDA speaker this question, "Why didn't you include FOREIGN RESEARCH in the studies for us to review? (The foreign countries are the ones who are banning or limiting the use of mercury.)
The FDA official replied, "Because that was what I was ordered to do."
Then a Panel Member asked the ADA spokesman, "Why were the mercury urine levels so high in the studies done on people in the military?"
The ADA spokesman said, "Because they were in the military and had free dental care, so they had more dental fillings."
Moral of the Story: Join the Military so You Can Load Up on MERCURY DENTAL FILLINGS!
Leaking Mercury, Blue Lines Around Gums and Oral Galvanism
The ADA's position is, in rare cases, people have allergic reactions to the mercury in amalgam. The ADA says that fewer than 100 cases of this type of allergy have ever been reported. The ADA and the FDA were throwing around the word allergy and hypersensitivity at the hearing.
When I testified, I let the Advisory Panel know I thought it was insulting to call my condition an allergy to mercury. I said, "When my doctor diagnosed me he wrote in his notes, 'Patient's history is consistent with heavy metal toxicity.'
Marie Flowers from Virginia (left)
Marie was poisoned by oral galvanism and breathing mercury vapor, which caused her brain to catch "on fire."
Sandy Duffy, of Oregon, President and Attorney, Consumers for Dental Choice (right).
Duffy became interested in mercury dental fillings when she found they could be a contributing fact to her husband's cancer, since mercury lowers the immune system.
I continued, "He didn't say allergy to mercury or hypersensitivity to mercury. It is insulting to call poisoning an allergy. Ragweed is an allergy. If I were poisoned by arsenic you would not say I was allergic to arsenic. I would be poisoned by arsenic!"
I also told how mercury leaked out of my mercury filling after the dentist placed a crown with dissimilar metals over top of the mercury filling. This caused what is known as oral galvanism, a battery like effect from dissimilar metals. When the mercury leaked out of the filling it made a little blue line around the base of the tooth down in the meat of my gums, around the gum line. This was called an amalgam tattoo.
I tasted metal, was nauseated, spent sleepless nights and felt like I was dying. Metallic taste and blue lines around the gums are just some of the oral symptoms of mercury toxicity.
More Humor, They Couldn't Define Words or List Symptoms
An astute Advisory Panel Member asked, "What is the DEFINITION of allergy, hypersensitivity and poisoning from mercury dental fillings? What is that little blue line called around the gums? Is it allergy? (She had been paying attention to my story.)
The FDA spokesman said, "I don't know."
The Advisory Panel Member asked, "What are the SYMPTOMS of allergy, hypersensitivity and poisoning from mercury dental fillings?"
FDA spokesman said, "I don't know."
How can the FDA, parroting the ADA, say there have only been 100 cases reported of allergy to dental mercury, yet they can not even define or give examples of what an allergy is? I thought that was FUN NEE!
One of our speakers pointed out that maybe the FDA had invited the wrong scientists as their experts. I agree. The FDA- invited experts came at government expense, most of them being pro amalgam except for the foreign speakers, and were allowed to speak twenty to thirty minutes. Our scientists, like Dr. Boyd Haley, PhD was only given seven minutes, the same amount of time that I had.
But even with our seven minute limit per speaker, we still got the message across. I sat and watched some of the panel members with horror on their faces while we told our stories. Maybe THEY had mercury dental fillings too!
The Hotel Thought We Might Be a Security Risk
The FDA had their security at the hotel and the hotel hired its own security in case we became wild and violent. It was really funny.
The hotel had signs posted all around about not allowing protests in the hotel. I had brought my protest signs and my skeleton on a stick since Freya Koss had received permission to bring signs from FDA officials before we came. But once we brought them inside the room people from the FDA came running to say we couldn't use signs. So my skeleton became a "wall flower" and just sat there behind a camera man. Later on we stacked the signs up in a pile on the hotel luggage carrier out in the lobby. Carol Ward and Freya Koss had brought posters of teeth with different captions such as "Shame on the FDA."
I also had my Hal Huggins Toxicity from Dental Mercury - The Three Costumes of Mercury poster showing routes of mercury into the body. Dr. King picked up the poster and used it as a display during his speech. That was the only thing he had left to display after security had confiscated his mask, amalgam capsule and his Jerome Mercury vapor analyzer. 
I was actually glad security was there because they had an opportunity to sit and listen to all the "tall tales" the ADA and FDA told about how "safe" these mercury fillings really were. They also had the opportunity to hear some of the best scientists speak, even though they only had seven minutes. One security person told me he/she did not think that we had all come all that distance, one from London, others from California to Vermont, and places in between, to just get up there and tell lies. The security officer said he/she was getting his/her fillings out!
My husband, who had not always been so happy about my activism, could barely stomach the old tired speeches of the ADA and FDA. He enjoyed meeting Charlie Brown and exchanging West Virginia jokes. My husband became an activist during this trip because he wore his NO MERCURY button.
Charlie Brown and my husband, Kenneth Flowers
Not to be outdone at one of our dinners, Kenneth got up and introduced himself saying, "I came on this trip as my wife's chauffeur." (He was tired of all of us talking about being mercury poisoned.) "I want to tell you that I have been lead poisoned. I have lead in my legs, and lead in my arm," and I inserted, "lead in your butt," and he continued, "lead all over the place from shrapnel in Vietnam." See A Marine's Story, the story of how Kenneth miraculously survived on Hill 881 South in Vietnam after you read this page.
What Can We Expect in the Future?
Charlie Brown and the International Academy of Oral Medicine and Toxicology have written letters to the FDA asking them to reconvene the Advisory panel to take an extensive look at the science on dental amalgam. Since our scientists were only able to testify for only seven minutes, the Advisory Panel did not get to see the real science or hear the presentations fully. A Summary of the hearing tells what the personal recommendations of some members of the Advisory Panel. Unfortunately you may not have heard this on the news. My eyes have been opened to see that what you hear on the news is not the whole story!
Check with Consumers for Dental Choice and the IAOMT for more information.
What you can do: Write your Senator and Representative and ask him to tell the FDA to reconvene the Advisory Panel to hear more evidence about mercury dental fillings, since the Advisory Panel was not satisfied with the information the FDA gave them. They could not make a decision based on the limited scope of 34 studies supplied by the FDA. All the studies need to be examined, not just those studies hand picked by the FDA.
If you are one of the people featured in this story and I have made mistakes, please email me at marieflow (at)aol.com.
I want to thank all those who have contributed to this report with their testimonies and pictures. Also I thank Charlie Brown and Michael Bender for their press releases which helped me to write this story. I thank Dr. David Kennedy for his information from the IAOMT.
October 9, 2006--You can now see the complete transcripts from the hearings on September 6th and 7th at http://www.fda.gov/ohrms/dockets/ac/cdrh06.html#dentalproductspanel.
You will be able to look at the slides of the ADA and their spokesmen.
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4218b1-index.htm (to see the White Paper of studies the FDA presented to the panel)
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