316 F St., N.E., Suite 210-B

Washington DC 20002

March 24, 2010

Joshua Sharfstein, M.D. Principal Deputy Commissioner

U.S. Food and Drug Administration –

via e-mail JMSharf1@fda.hhs.gov and fax 301-847-3531

Re: FDA should not try to block state and local amalgam fact sheet laws

Dear Deputy Commissioner Sharfstein:

We regret that last year the Food and Drug Administration chose to adopt a rule allowing amalgam to be sold without even informing dental patients and parents that it is mainly mercury. Fortunately, legislatures in several states and some city councils feel otherwise, and have mandated fact sheets be distributed so dental patients and parents will know about the mercury and know they have alternatives such as resin.

We understand you are writing a letter to the City of Philadelphia about its fact sheet.

We urge you to respect the right of states and political subdivisions to write consumers protection laws that differ from your personal views about disclosure. Any effort by FDA to block state legislatures and city councils from making disclosures about amalgam continues to take our country down the wrong path, and may be of questionable legality. Instead, we urge you to focus on rewriting the rule you adopted last year.

Sincerely,

Hon. Daylin Leach, State Senator, Pennsylvania

Hon. Blondell Reynolds Brown, Councilwoman, Philadelphia (author, Philadelphia

amalgam fact sheet ordinance)

Hon. Jay Goyal, State Representative, Ohio

Hon. Michael J. London, Councilman, Trumbull, Connecticut

Hon. Marvin L. Van Haaften, former Director, Iowa Governor’s Office of

Drug Control Policy (“Drug Czar”); and former Sheriff, Marion County, Iowa

Hon. Ann Clifton, RN, BSN, former Assessor, Thurston County, WA

Hon. Charles G. Brown, former Attorney General, West Virginia

Hon. Ron King, DDS, former Member, Minnesota Board of Dentistry

Hon. Kevin Biggers, former Member, Dental Board of California

Hon. Chester L. Yokoyama, DDS, former Member, Dental Board of California

Recently, an agreement in concept was reached by a World Health Organization convened international expert group meeting, supporting the phase-out of dental mercury use worldwide. Dental Tribune Group Editor Daniel Zimmermann spoke with Prof. Lars Hylander, Associate Professor at the University of Uppsala in Sweden who attended the meeting, about the agreement and strategies for future biomaterials use in dentistry.

Daniel Zimmermann: Prof. Hylander, you recently attended a joint meeting of the World Health Organization (WHO) and the United Nations Environment Programme (UNEP) that aimed to assess the latest clinical evidence on dental restorative materials. Could you tell us about the outcome of this meeting?

Prof. Lars Hylander: Most participants agreed that amalgam should be phased out or at least phased down. Dr Poul Erik Petersen, Responsible Officer for Oral Health at the WHO, however, raised several good questions, such as what to tell people in poor countries who cannot even afford dental amalgam fillings. At this point, the room grew rather silent.
A similar consultation was held more in Geneva than ten years ago. What has changed since then
concerning the manner in which dental restorative materials are perceived?

Allergic reactions from amalgam fillings in some patients have been acknowledged by proamalgamists.

Mercury leakages and emissions from dental amalgam into the environment have been fully acknowledged, particularly after dental amalgam was banned in Norway and Sweden, and restricted in Denmark and other places. Proof of methylmercury formation in wastewater from dental clinics is a third factor that makes the continued use of amalgam less justified. Another factor is that alternative tooth filling materials are now available or in development.

What has been decided regarding dental amalgam?
The WHO has not been as quick as Norway, who instituted a ban on dental amalgam in less than six months after the proposal of a ban was presented in the country. Thus far, nothing has been decided, but the WHO can hardly ignore the decision made by the world’s governments within the UNEP to negotiate a mercury treaty, which will begin in Stockholm next June. There was some consensus that mercury use in dentistry should be phased down. A suitable way to do this is to begin teaching alternative restoration techniques, other than dental amalgam, in dental schools.

There was a focus on the oral cavity, which thus ignored the environmental aspects such as mercury emissions from crematoria and leakage of mercury into wastewater from dental clinics and the wearing of amalgam surfaces due to everyday chewing. The American Dental Association demonstrated this most clearly in the presentation by Dr Daniel Meyer, in which it was stated that of the 35 tons of amalgam used annually in the US, only a few hundred kilograms are emitted into the environment.
Which restorative materials were considered to have the most potential for use in developed and developing countries?
Composites and other white filling materials have replaced amalgam in several developed nations. Even in countries without any ban, such as in Japan, less than 4 per cent of the fillings are now fabricated with amalgam, for aesthetic reasons. In addition, many patients do not find it sensible to have as toxic an element as mercury just a few centimetres from their brains.

Composites and glass ionomers are also widely used in many developing countries. The question of why such developments progress so slowly in the big nations of the rich world was raised. Atraumatic restorative treatment with glass ionomers and using only hand tools is a promising alternative, not only for developing countries. In countries in which glass ionomers or composites are produced locally, the cost of these fillings is lower than that of amalgam.
Thank you very much for the interview.

Dr. Wakefield has always recommended single antigen vaccines. He hypothesized that the three live viruses given together in the MMR vaccine are the source of potential problems in at least SOME children.

Learn more: http://www.cent4dent.com/html/mercury_issues/vaccines.html
Read the whole article: http://drtenpenny.com/Wakefield_Inquisitioners_Have_their_day.aspx

controls?

bill domb

New autism treatment shows promise

April 9th, 2008

When University of Louisville researchers pulsed a low-frequency
magnetic field around the brains of people with autism, the patients
later experienced less severe symptoms.

The treatment, transcranial magnetic stimulation, is still in early
testing stages, but has potential to become an effective treatment for
the major symptoms of autism, said neuroscientist Manuel Casanova.

Members of the UofL research team placed a coil on the scalps of 10
people with autism to create a low-frequency magnetic field, which they
then pulsed by reversing the field’s polarity. After receiving a
20-minute treatment twice a week for five weeks, patients showed fewer
symptoms of hyperactivity, sensory overload and repetitive behaviors,
said psychologist Lonnie Sears, a project collaborator.

Full story at:

http://php.louisville.edu/news/news.php?news=1143

By Steve Markus, DMD FACE
Haddon Heights, NJ
www.cent4dent.com
Abstract: Vaccines and Thimerosal
The death penalty is off the table. The worst you can get is life in prison without parole now in New Jersey. State Health and Senior Services Commissioner Fred Jacobs, New Jersey Department of Health has promoted, and had signed into law four additional vaccinations for pre-school and school age children. Because there are known links between autism and thimerosal (a derivative of mercury, used as a preservative in vaccines) this law potentially imposes a life sentence on the parents of inoculated children. Dr. Mark Geier, a Maryland geneticist and vaccinologist, and his research partner and son, David Geier, estimate the lifetime cost of caring for an autistic person at between $5 million and $10 million. ( 28 ) It also affects the quality of life of the child. But it doesn’t stop there. Because adults can be affected as well (MS-like symptoms and Alzheimer’s Disease have been linked to mercury), this document is intended to educate the public (especially the parents and grandparents living here in New Jersey) about what they need to know about to make an educated decision about what is right for them. Your pediatrician will belittle your concerns. Become an educated parent, before you are spending too much of your time trying to learn how to deal with a normal child who, because of vaccination, has become autistic. It can happen, at the drop of a hat, to anyone.
To read the entire article, click here.

Decay Story:

• Tooth decay in primary teeth of children aged 2 to 5 years increased from 24 to 28% – a 16% increase from the 88-94 period vs the 99-04 period
• Significant disparities along racial, ethnic and economic lines – Hispanics 6-11 showed 31% fill rate in permanent teeth vs 29 % non-Hispanic/white kids
• Three times as many children living below the poverty line ages 6-11 had unfilled cavities compared with those with incomes above the poverty line.
• Adults 20-64 showed a 4% decrease in dental visits at least once a year when comparing the same 88-94 vs 99-04 date parameters – tie into oral/systemic link

Causes of increased decay

• Access to care issues, and the fact that so few dentists participate in Medicaid system, which is frought with problems:
o Payment is very small
o Patients don’t keep appointments
o Limited numbers of procedures – eg Hg vs composite
 Talk about California and Maine, and soon, other parts of the US
• Entitlement mentality
o If I don’t have dental insurance I don’t go to the dentist
o Boss is responsible for whether my family and I keep my teeth – this is a quality of life decision, not a quality of job decision
• The managed care system
o Babies don’t come with owner’s manuals – baby bottle syndrome used to be a precautionary lesson, I think today it’s glossed over
o Baby teeth are not expendable.
o Parental and grandparental coping mechanisms are not in place, priorities are misplaced, many mothers out in the workplace and therefore cannot control the diet children are getting during the day.
• A nation of over-indulged children and adults – check out love and logic.com
• Misplaced dollars – toys (child and adult), consumer debt, pampering (nails grow back, teeth don’t).
• Study faulted bottled water – this IMHO is not the case. Fluoridation has not been shown to be effective. In many areas water is not fluoridated. Osteosarcoma in adolescent males. Fluoride needs to be applied topically, not taken systemically.
• Baby teeth decay very rapidly
• Spaces between baby teeth are there so that there’s room for the larger permanent teeth. Sticky candies, like jelly beans get stuck between, and start the decay process. Also get stuck in grooves of teeth. This is something that is seldom taught to parents – How to brush your child’s teeth.

Effects of increased decay
• Invasive treatment on infants is scary both for the child and the dentist.
• Creates dental anxieties that can take decades, even a lifetime to overcome
• Budgetary changes which can lead to a lack of care, or undercare.
• Lack of access to care led to the death of a 12 year old in Maryland, so this simply isn’t only about teeth, it is a life and death issue.
• Many children’s decay is so severe that the children need to be treated under sedation or general anesthesia. This poses a substantially added risk to a situation that could have been avoided, had the proper nutritional and preventative information been given the parents.

What can parents do?

• The causes of decay in children must be understood. The cause of rampant decay like we see here in this child was baby bottle syndrome – there should be nothing but water in a bottle in the child’s mouth when it goes to sleep or for a nap. Sugar is present in juices, formula. It lays on the teeth and if not removed, starts the decay process. Once the decay starts, it gets deeper in the enamel and then it hits the underlying layer, the dentin which is 60 times softer than the enamel. From there it spreads like wildfire to the nerve of the tooth.
• Too many sweets that are sticky lock into the grooves in the top of teeth, and between spaces in the teeth, and again, spread like wildfire.
• Soda and fruit juices with sugar are major culprits – children should be encouraged to rinse and spit after ingesting these foods.
• Jellybeans and other sticky candies should never be used as rewards without an immediate toothbrushing by the parent.
• Children should not be entrusted to their own toothbrushing until around age 8 or 9.
• Parents should sit cross-legged on the floor so that they have visual access to all tooth surfaces and brush them. This position also trains the child for their first dental visit which will be in a dental chair, with them lying down.
• As soon as the teeth begin to erupt into the mouth, parents should start at least wiping the erupting teeth down with a gauze square.
• Children’s first dental visit should be around age 1 or 2.
• Dietary information and a whole lot of other information about this is available on our website at: http://www.cent4dent.com/html/treatment/kids_teeth.html
• If there is an older sibling who is a good dental patient, bring the younger sibling in, to observe the procedures and gain trust, take a ride in the dental chair.
• Sealants on permanent molars as soon as they erupt into the mouth.

When I first started practice, in 1976 I set up next door to a pediatrician so I saw a lot of child patients. The parents of these patients were well educated by the pediatrician, and it was backed up by the preventative procedures we used on them. I thought that we’d make life really easy for these kids, by providing them with regular, preventative services. Many of those children are now bringing their children into the practices, and understand what it takes to keep their teeth.

However, parents whose parents didn’t place these priorities on them while growing up are now facing large dental and financial problems because the knowledge was not passed forward. Hoping that the access to care for patients below the poverty line is going to get better is not going to eliminate this problem. Many dentists simply will choose, as we have, not to participate in a program where they are not being reimbursed and patients do not respect our time. Many of us get involved in various charity programs to assuage our guilt of not participating in government programs. In our office, we often will provide treatment for our patients of record who have fallen on hard times and cannot afford the treatment their children need. We do not do this for people outside the practice, because I get at least 3 emails a week from people searching for a dentist to treat them for free.

Court declines to rule on merits in Moms Against Mercury v. FDA –

but suggests road map to victory

The U.S. Court of Appeals ruled that it lacks jurisdiction (the statutory authority to rule) in Moms Against Mercury, et al. v. FDA, adding the decision is not a ruling on the merits of our cause and implying a remedy could lie in the U.S. District Court. (Full opinion at www.cadc.uscourts.gov — on right side click “All Opinions”; see Apr. 13, 2007, 4th case).

To win this round, FDA paid an enormous price. To achieve credibility with the court, FDA abandoned its long-time role of cheerleader for amalgam, five times admitting in its court brief that it FDA doesn’t know if mercury fillings are safe or unsafe. (Those 5 admissions at www.toxicteeth.org/natcamp_fedgovt_fda_admits_Mar07.cfm)

That a federal agency continues to allow untrammeled sales of a mercury-based device to pregnant women and children while conceding “the lack of definitive scientific evidence” and “intense disagreement about the scientific evidence” is reckless, contemptible, and immoral. FDA must be hoping that no one outside the Capital Beltway finds out. Or perhaps some of FDA’s protectors of mercury fillings (see next paragraph) intend to disavow those admissions before the ink is dry on the court decision. Suspecting just that, I sent a warning letter to FDA counsel advising that any statements by FDA returning to the status quo ante constitutes a Fraud on the Court. (Letter at www.toxicteeth.org/natcamp_fedgovt_fda_brown_Apr07.cfm)

FDA’s hard-line protectors of mercury fillings include Associate Comm’r Norris Alderson, who presented the “white paper” apologia for amalgam in September, a position soundly rejected by two Scientific Advisory Committee position; Center for Devices Director Dan Schultz, MD, and Dep. Director Linda Kahan, Esq., who together uphold the outrageous “professional courtesy” stand to allow self-interested dentists ignorant of toxicological issues to make the decision, hence giving primacy to dental economics over children and fetal health; Division Director Chiu Lin, who used an unauthorized substantial equivalence test to OK an application for mercury fillings, even though the applicant himself advised Lin that mercury fillings aren’t allowed for pregnant women and children in its home country, the U.K.; and Dental Devices Branch Director Mary Susan Runner, the initiator of the notorious BETAH-LSRO contract and the ADA’s fifth columnist inside FDA.

The astonishing gap between FDA’s position (doesn’t know if it’s safe) and its policy (may be implanted into anyone without even warnings) is setting off a grassroots firestorm. Ken Stoller, M.D., filed a sworn complaint to the New Mexico Board of Pharmacy asking that mercury fillings, no longer certified as safe by FDA, be banned in that state (want to help?–write Ken, hbotnm@netzero.com). Philadelphia Councilwoman Blondell Reynolds Brown plans hearings in early May (want to help?–write Freya Koss, frekoss@aol.com). The latest example of a reckless dentist leaving bottles of mercury for children to get exposed happened in West Virginia; this time, we have a plan to fight back (want to help?–write Sandy Keech Esq., sandraK@toxicteeth.org). In Ohio, the movement is growing to add a mercury-free dentist to a dental board whose policy is to block from consumers disclosures that “silver fillings” aren’t really silver (want to help?–write Jessica Kerger, Esq. JessKerger@aol.com). Congresswoman Watson is closely monitoring these developments in consultation with Members of the House Government Reform Committee (want to help?–write Elizabeth Wright, elizabeth@toxicteeth.org)

Here’s the good news about the Court opinion: It appears to suggest an ongoing violation of law. The Court holds that FDA may not approve mercury amalgam by using a “substantial equivalent” test. But that is exactly what FDA is doing when it approves mercury amalgam applications.

In the days ahead (stay tuned to our web site), we will announce our next step to reign in an FDA bureaucracy that exhibits both contempt for the law and reckless indifference to the health, and very lives, of America’s born and unborn children.

Charlie Brown, 4/14/07

Charles G. Brown, National Counsel

Consumers for Dental Choice

1725 K St., N.W., Suite 511, Washington DC 20006

Ph. 202.822-6307; fax 822-6309

charlie@toxicteeth.org, www.toxicteeth.org