FDA is ignoring its own scientists' warnings about amalgam
In December 2010, for the second time, FDA convened its scientific advisory panel on dental amalgam – and for the second time, the scientists told FDA that the agency was wrong. Amalgam use in children, pregnant women, and hypersenstive adults needs to stop, the scientists said.
Here’s the FDA scientific advisory panel in its own words: Dr. Kotagal said there is “no place for mercury in children,” Dr. Ismail said “children less than 6 years of age, I would restrict it significantly,” Dr. Thompson said “definitely not in pregnant women and definitely not in those below 6 years of age,” Dr. Fleming said we need contraindications for pregnant women, and Dr. Burbacher said, “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.” Not a single panelist agreed with FDA's 2009 rule that permitted unrestricted amalgam use in children and pregnant women. FDA has heard that message before: in 2006 its advisory panel concluded – by a 13 to 7 vote – that amalgam is not generally safe for everybody.
But FDA did nothing. Then in September 2011, dentists, consumers, and scientists confronted FDA Center Director Jeff Shuren – who is in charge of the amalgam issue – at an FDA-hosted “town meeting” in San Francisco. In response to California physicist Robert Cartland’s testimony, Shuren publicly stated that FDA would make “an announcement by the end of the year.”
The year ended; FDA made no announcement. An FDA press spokesperson told an inquiring reporter that there was no announcement and no timetable for action on amalgam. Now every day FDA fails to act, children's developing neurological systems are unnecessarily exposed to this major source of mercury, a known neurotoxin.
It’s time for Congress to step in and tell FDA to listen to its scientists. Which means…it’s time for you to telephone your Congressman or Congresswoman and ask that he/she write FDA to find out what is going on. Find the name of your Member of Congress by clicking here. Then phone Congress at 202-224-3121 and ask for your Member’s office. Here are some talking points:
Over a year ago, the scientists on FDA’s advisory panel told FDA that dental amalgam is not safe for children, pregnant women's unborn babies, and hypersensitive adults.
Now FDA is refusing to protect these vulnerable populations. Dentists are still using amalgam even in children.
- Would the Congressman/Congresswoman please write FDA to find out why FDA is failing to protect our children – in spite of warnings from its own scientists?
It sometimes takes a second call or a follow-up email, but talking to Congress works. Over the years, we've seen Senator Patty Murray of Washington write FDA at the request of Ann Clifton…Congressman Jim Moran of Virginia write at the request of Dr. Rich Fischer...Senator Mike Enzi of Wyoming write at the request of Dr. Rebecca Painter. As a few additional examples, Senator Richard Lugar of Indiana, Congressman Adam Schiff of California, Congressman (now Senator) Mark Udall of Colorado, and our long-time friend Congressman Dan Burton of Indiana all have written FDA about amalgam on behalf of constituents in the past.
Thank you for calling your Member of Congress today!
14 February 2012
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Charles G. Brown
National Counsel, Consumers for Dental Choice
President, World Alliance for Mercury-Free Dentistry
316 F St. NE, Suite 210 Washington, DC 20002 USA