Amalgam Foes Seek To Overturnfda Ruling

Amalgam foes seek to overturn FDA ruling
9/2/2009
By: Laird Harrison, Senior Editor

Amalgam opponents plan to formally petition the FDA this week for reconsideration of its July 28 guidelines for the material, part of a four-pronged approach by which they hope to eliminate mercury from dentistry.
They are also demanding an investigation of FDA Commissioner Margaret Hamburg, M.D., for analleged conflict of interest. They're planning legal action against the agency for allegedly violating a settlement in which it issued warnings about amalgam. And they're lobbying members of Congress, said Charles Brown, national counsel for Consumers for Dental Choice.
"We're going to fight and we're going to win," said Brown, author of a lawsuit that forced the FDA to post warnings about amalgamon its Web site last year. "The FDA is not going to get away with this."
Petition
“We're going to fight and we're going to win.”
— Charles Brown, national counsel
for Consumers for Dental Choice
Brown said a coalition of groups opposed to mercury in dentistry would file a petition for reconsideration of the ruling by a September 3 deadline. The petition will argue that the FDA did notadequately consider evidence that mercury in amalgam poses a health risk.
The July 28 guidelines require makers of amalgam filling materials to disclose potential risks from mercury, but only contraindicate it for people with specific allergies to the material. In announcing its decision, the FDA said it had considered more than 200 peer-reviewed studies on amalgam, and had also taken comments fromthe public. Brown argues that the evidence shows amalgam is unsafe and insisted that most of the public comments were on his side.
Consumers for Dental Choice, however, will not be named in the petition because that would undermine its legal status as a party to its settlement with the FDA, Brown said. Instead, other groups will put their names on the petition while Consumers for Dental Choiceseeks to remedy what it sees as a breach of the settlement.
What was the breach? The FDA violated its agreement to post on its Web site a warning that amalgam might pose a risk of neurological damage to "developing children and fetuses," Brown said. The agency now says that the scientific evidence suggests that even these groups may safely have amalgam restorations, but it has maintained thewarning on a page of its site.
Brown is also incensed that the FDA is allowing materials makers to use the term "silver" in describing amalgam, since the primary ingredient is mercury.
Conflict alleged
The FDA's ruling "was a big surprise," Brown said. In seeking to explain it, he points the finger at Dr. Hamburg's relationship with Henry Schein. He has written to the Office of the Inspector Generalof the U.S. Department of Health and Human Services, requesting a formal investigation of those connections, and of "inappropriate industry influence" on Daniel Schultz, M.D., former director of the FDA's Center for Devices and Radiological Health.
Dr. Hamburg served on the Schein board of directors and owned both stock and stock options in the company. Under federal ethics guidelines,presidential appointees are not allowed to receive any outcome or "hold financial interests that conflict with the conscientious performance of duty."
A spokesman for the inspector general said he would not comment on the possibility of an investigation. But Dr. Hamburg "was not involved in the decision-making for the rule on dental amalgams," according to an FDA statement.
Also between her May 18 Senateconfirmation and taking office on May 26, Dr. Hamburg "resigned her position as Board Director at Schein, sold all of her Schein stock, exercised all the Schein options she owned that had monetary value, and immediately, that same day, sold all the resultant stock," the FDA noted in the statement. "At that time, Dr. Hamburg also forfeited unvested restricted Schein stock that was worth...