Texans confront FDA Center Director Shuren

Texans confront FDA Center Director Shuren
. . . now it's your turn

The U.S. Food & Drug Administration convened a Town Meeting in a Dallas suburb on March 10 – and our movement gave FDA a Texas-size welcome. Several dentists, a dental hygienist, and a number of victims of mercury toxicity turned out. Although the Town Meeting was open to any subject, amalgam dominated. The huge press coverage – the major Dallas TV stations and the Fort Worth Star-Telegram – was exclusively about mercury fillings!*

Presiding was the very man in charge of reconsidering FDA’s abysmal amalgam rule: Center for Devices Director Jeff Shuren. Dr. Shuren told the Texas press:

"Now, the [FDA scientific] panel did …point out that there may be certain populations who are more sensitive to dental amalgam, like young children and pregnant women."

and

"We may decide to change our current regulation and that could include changing the status of dental amalgam, which means it comes off the market or has other controls on it or we may decide to leave things as they are."

So FDA's point man on amalgam has announced that FDA is seriously considering protecting children and unborn babies from amalgam. Kudos goes to our outstanding Texas team:

• The organizer of it all was Carol Ward, vice president, Dental Amalgam Mercury Solutions. Thanks to Carol’s outreach, we had at least seven witnesses, including former president of the International Academy of Biological Dentistry and Medicine Dr. Bill Glaros, who came all the way from Houston.
  
• The press director was Virginia Pritchett of Mineral Wells, Texas. With her strong journalism background, Virginia secured a plethora of press.**
  
• Texans who made this event a success include hygienist and author Carol Vander Stoep of Austin; dentists Dr. Bill Glaros of Houston, Dr. Allen Sprinkle of Arlington, and Dr. Daniel Strader of Dallas; and consumer advocates Randy Staudt of Austin, Kathairein Magdalena of Irving, and Elizabeth Hong of Dallas.

The FDA scientific panel has spoken: End amalgam now for children, end amalgam now for pregnant women. The people of Texas have spoken: Stop treating the children of America like guinea pigs. Now it’s your turn.

Please write Center Director Jeff Shuren at Jeff.Shuren@fda.hhs.gov or phone him at 301-796-5900, and ask him: When, Dr. Shuren, are you going to stop amalgam use in children and pregnant women, as the scientific panel advised? Here are some talking points:

• Dr. Shuren, you recently stated that “Under the EU [European Union] system, the public are being used as guinea pigs….We don't use our people as guinea pigs in the U.S.” But FDA’s own amalgam rule promotes using children as guinea pigs for a mercury product that FDA knows can cause harm and admits is not proven safe for children.
  
• FDA concedes that amalgam puts children and unborn babies are at risk: “The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor.”
  
• FDA admits that there is no scientific evidence that amalgam is safe for children and unborn babies: “Very limited to no clinical information is available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed.”
  
• FDA’s own scientific panel repeatedly told FDA to stop amalgam use in children and pregnant women: For example, Dr. Kotagal of the Mayo Clinic says “There really is no place for mercury in children”; Dr. Ismail says “children less than 6 years of age, I would restrict it significantly”; Dr. Thompson says “definitely not in pregnant women and definitely not in those below 6 years of age”; Dr. Fleming says we need contraindications for pregnant women; and Dr. Burbacher says “why put amalgams in children if we know they're going to live with that for the rest of their lives? And we don't know what that's going to do.” In other words, stop using children as guinea pigs for amalgam.

-- Charlie

Charles G. Brown
National Counsel, Consumers for Dental Choice
President, World Alliance for Mercury-Free Dentistry
16 March 2011

* Links also available at http://www.nbcdfw.com/news/health/FDA-Hears-Concerns-Over-Dental-Fillings-117766113.html & http://www.star-telegram.com/2011/03/10/2913105/concerns-over-amalgam-fillings.html#tvg

** Link also available at http://www.wfaa.com/news/health/Group-confronts-CDRH-over-mercury-in-dental-amalgam-fillings-117773213.html