Joined: 24 Jan 2005
Location: Here Now. Somewhere Else Later
|Posted: Tue Jul 28, 2009 12:31 pm Post subject: Beginning of the end for mercury in your mouth
|Beginning of the end for mercury in your mouth
Watershed event in history of mercury fillings coming this week
The turning point of our movement comes this week. Because of our landmark lawsuit, the U.S. Food and Drug Administration must now set the ground-rules for the use of mercury fillings, an action that agency refused to take for 30 years until we filed the case of Moms Against Mercury et al. v. Von Eschenbach.
Due to our years of work -- your work, my work, this movement’s work -- our moment has arrived. FDA no longer sits in the hip pocket of the American Dental Association on this issue. We are going to get a regulation that moves us to the middle of the playing field. Don’t get your hopes too high -- neither side will get the victory each seeks. But the mercury secret -- hidden for years by manufacturers, the American Dental Association, and the FDA -- will be out this week.
Consumers for Dental Choice has a ten-point plan to try to turn this event into the beginning of the end of mercury fillings -- we will challenge manufacturers and distributors, insurance companies and Medicaid agencies, Wall Street and trial lawyers. If the American Dental Association realizes this is the end of the road for its 19th-century foundation-stone, fine. If not, it can fall on its poisonous sword.
For the past six months, we have executed an aggressive program to keep the issue front-and-center at FDA, via work on Capitol Hill and with the media. And we challenged the Commissioner herself. I wrote two letters of objection to FDA Commissioner Margaret Hamburg about her five years as a board member of Henry Schein Inc., the colossal dental products distributor. My challenge succeeded: Commissioner Hamburg recused herself from participating in the rulemaking!
Remember how desperate things were when we started, in the mid-1990s? Dentists were silenced by the gag rule… almost all consumers were unaware that “silver fillings” are mainly mercury… the system was held in place by the Iron Triangle of the ADA, the FDA, and state dental boards. Two true visionaries -- one in the East, one in the West -- created Consumers for Dental Choice: Bob Jones of Colorado (now Texas) and Sue Ann Taylor of Georgia. Inspired by Hal Huggins, we began.
In the first phase of our movement, we knocked out the notorious gag rule in state after state -- Pennsylvania, Arizona, Florida, California, Oregon, Iowa, Alabama, Maine, Minnesota, Connecticut, and Washington. This trailblazing work was done by consumer activists like Carol Ward, the late Maz Levy, and Joyce Van Haaften; lawyers like Jim Turner, Sandy Duffy, Sandy Keech, and Shawn Khorrami, filmmakers like Sue Ann Taylor; writers like Mark Genrich, dentists like Terry Lee, Andy Landerman, Milt McIlwain, Mark Breiner, and Ada Frazier; and dental board members like Ron King and Jessica Saepoff. Dentists could finally advocate, advise, and advertise mercury-free dentistry.
The second phase was about informing consumers: we gained fact sheet laws and ensured their enforcement (often the more difficult task). In California, we created a political tsunami by shutting down the dental board, an act that sent shock waves to every other state dental board. Led by Anita Vazquez Tibau, advised by consultant Pete Conaty, and chronicled by filmmaker Kelly Gallagher who is producing a movie about this movement, we had activists like Bill Magavern and dentists like Ward Eccles on the outside and new dental board members Chet Yokoyama and Kevin Biggers on the inside. The Philadelphia fact sheet project was led by Freya Koss; in Maine it was Pam Anderson; in New Hampshire Rosie Cronin; and in Connecticut Mark Mitchell and media guru Mike London. Outstanding lawmakers wrote these laws: Diane Watson of California, Mike Michaud of Maine, Hal Lynd of New Hampshire, and Blondell Reynolds Brown of Philadelphia.
The third phase of our work involved taking on FDA: With state laws implemented, with the dental board threat to our dentists fading, with our movement having national respect, we could have real impact -- and we did. Attorney Johann Wehrle, at the time a law student, designed a plan to challenge the agency, first via petitions, then a lawsuit. In between petitions and lawsuits was the dramatic September 2006 hearing of the FDA Scientific Advisory Committees where the scientists, led by Dr. Mike Fleming, voted 17 to 7 that FDA staff was wrong when it said mercury fillings are safe. After that vote, Dr. Rich Fischer led a team of scientists to urge FDA staff to change their position. All along, our friends in Congress, led by Diane Watson and Dan Burton, were holding FDA's feet to the fire by insisting that the agency follow the law.
But the inertia continued. So we filed suit in December 2007 and moved for an injunction in April 2008. At a hearing in May, Judge Ellen Huvelle ruled that we were entitled to a regulation by FDA on a date certain, but to no other relief; she ordered the parties into mediation. At an intense negotiation session, we insisted on warnings in the interim between then and the classification date. We got them in the website --- the best advisories issued by any national health agency on dental mercury’s irreversible damage to children: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses." The overwhelming and positive worldwide press response made clear that FDA had crossed its own Rubicon on the mercury amalgam issue.
The plaintiffs in this landmark litigation who stayed the course were Moms Against Mercury (Amy Carson and Angela Medlin), Connecticut Coalition for Environmental Justice (Dr. Mark Mitchell), Oregonians for Life (Mary Starrett), Michael Bender, Senator Karen Johnson, Linda Brocato, Dr. Andy Landerman, Anita Vazquez Tibau, and of course Consumers for Dental Choice.
We didn’t get this far by ourselves. We built broad alliances. Michael Bender of the highly effective Mercury Policy Project leads the environmentalists; Ed Hogan and Emmitt Carlton reached out to minority communities; Sandy Duffy recruited civil libertarians; and Sister Valerie Heinonen linked us to the faith community. And we have had volunteers who have logged hundreds of hours, such as Barbara Pierson, Mary Ann Newell, Linda Brocato, Elizabeth Wright, and Karen Burns, to name a few.
With the FDA rule, we will enter our fourth -- and I firmly believe, final -- phase: the demise of amalgam fillings. The momentum is ours.
The key to the upcoming rule, not surprisingly, will be the fine print: the new Special Controls. That will tell us if the rule is strong or weak. My focus is the children: if we can protect boys and girls, if we can protect the unborn, we have prevented amalgam from going to the most vulnerable. From there, we can build toward ultimate victory.
If the FDA rule is abysmal -- if it contradicts its own website advisory for children and pregnant women that we negotiated to settle the lawsuit -- we intend to appeal. But, first we must see the rule FDA is unveiling this week ...
27 July 2009
Charles G. Brown, National Counsel
Consumers for Dental Choice
316 F St., N.E., Suite 210, Washington, DC 20002
Ph. 202.544-6333; fax 202.544-6331
Working for Mercury-Free Dentistry
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