by Andrew Bridges, Associated Press
Washington government health advisers rejected a federal report that concluded dental fillings used by millions of patients are safe, saying further study of the mercury-laden amalgam is needed.
A joint panel of Food and Drug Administration advisers did not declare the so-called “silver fillings” unsafe. But in a 13-7 vote Thursday, the advisers said the federal report didn’t objectively and clearly present the current state of knowledge about the fillings.
In a second 13-7 vote, the panelists said the report’s conclusions about safety weren’t reasonable, given the quantity and quality of information currently available.
The FDA had asked the panel of outside advisers to weigh the report, a review of 34 recent research studies.
The report had found “no significant new information” that would change the FDA’s earlier determination that mercury-based fillings don’t harm patients, except in rare cases where they have allergic reactions.
But panelists said remaining uncertainties about the risk of so-called silver fillings demanded further study. In particular, research is needed on the effect of mercury-laden fillings on children and the fetuses of pregnant women with fillings.
“There are too many things we don’t know, too many things that were excluded,” said Michael Aschner, a professor of pediactrics and pharmacology at Vanderbilt University and a panel consultant. He cast two “no” votes.
Panelists also said more study was needed on whether mercury fillings give off more vapors when they’re being placed or removed.
Dr. Ralph Sacco, of Columbia University, said consumers shouldn’t panic and that there was no need to have their amalgam fillings removed.
Consumer activists had pressed the panel to recommend the FDA ban mercury fillings.
“Do the right, decent, honorable and God-loving thing: There needs to be an immediate embargo on mercury fillings for everyone, or at least pregnant women and children, because they are our future,” said Michael Burke, who blamed mercury fillings for the early onset of Alzheimer’s disease diagnosed in his wife, Phyllis, in 2004.
Dr. Michael Fleming, a Durham, N.C., dentist and the consumer representative on the panel, asked the FDA to consider restricting the use of amalgam in children younger than 6 and in pregnant women. Activists- dozens attended the two-day meeting- met his proposal with applause.