Amazing news from FDA

Amanda Just of Waterford has finally been able to speak directly to federal regulators looking into the health effects of mercury in dental fillings.
Just, who claims to have been made ill by mercury released during a botched dental procedure several years ago, had four minutes before a U.S. Food and Drug Administration panel this week in Gaithersburg, Md.

The panel, convened by the U.S. Food and Drug Administration to look into the safety of amalgam dental fillings containing mercury, advised the agency Wednesday to reevaluate the use of the material in children and pregnant women.

At the end of two days of hearings in Gaithersburg, Md., the advisory panel said new data brought to light Tuesday and Wednesday shows that some dental patients may experience medical problems related to amalgam, a mix of metals that generally contains about 50% mercury. Anti-mercury advocates say amalgam can lead to a variety of neurological disorders, such as Alzheimer's, Parkinson's, multiple sclerosis and Lou Gehrig's disease and may be a factor in a rise of kidney and periodontal disease.

"We need to see where the science is and if there are gaps," said panel Chairwoman Marjorie Jeffcoat, a University of Pennsylvania researcher and dental authority quoted by CNN.

Bob Reeves, a Lexington, Ky., attorney who has been fighting against amalgam for nearly 30 years, said the panel's findings, if accepted by the FDA, would likely require the agency to re-categorize amalgam as a Category 3 material, which is for substances considered most dangerous to human health. Category 3 requires manufacturers to prove amalgam is safe, which Reeves said would effectively end its use as a filling material.

"This was a big carving away of the myth of safety of mercury in fillings for all people," Reeves said in a phone interview immediately after the panel's consensus decision. "That myth was destroyed."

Just, an East Lyme Middle School teacher, said she was thrilled to have been part of the decision-making process.

"This is historic," she said in a phone interview after the panel's decision.

Just said she saw testifying as her responsibility to her students and children throughout America.

"Why is this poisonous element being drilled into the mouths of pregnant women and children?" she asked the FDA panel during her four-minute presentation. "I'm certain that any loving and caring teacher would protect children from exposure to mercury vapor ... and so would a government that cares about the future of its country."

The FDA ruled 18 months ago that amalgam was safe for children and women of childbearing age. But public pressure brought by citizens such as Just and organizations such as the International Academy of Oral Medicine and Toxicology led the FDA to convene a panel to re-examine the issue.

The FDA, which has about six months to respond to the panel's findings, does not have to accept its recommendations.

Reeves, the Kentucky attorney who has filed suits in the past to press the case against amalgam, called the panel "amazingly fair-handed," and predicted that the FDA would not be able to ignore this group, as it did a previous advisory body in 2006, partly because the mercury issue is getting so much more media attention this time around.

Still, Reeves said he was surprised at how quickly the panel moved to agree that subpopulations such as pregnant women, mercury-sensitive adults and children up to the age of 12 should receive special consideration in deciding whether amalgam is safe.

Dentists who testified before the FDA panel said they believe amalgam was safe. The panel said the FDA's decision to approve amalgam last year — after a short period when the agency temporarily recommended against its use in pregnant women and young children — had been based on the best information available at the time.

The FDA panel could not decide on one of the key issues before it: What level of exposure to the mercury vapors emitted by amalgam fillings would be considered safe for humans? The panel decided that not enough data existed to make a determination.

"This morning was highly, highly charged," said Just, the Waterford schoolteacher, who protested outside her hotel Tuesday wearing a hazardous-materials suit.



This article comes from http://www.usatoday.com/yourlife/health/2010-12-18-fda-debates-mercury-affects_N.htm