3 mai, 2005 23:36
Women's groups urge probe into FDA implant review
Associated Press
WASHINGTON — Six women's groups are asking Congress to investigate the U.S. Food and Drug Administration's review of silicone-gel breast implants, citing an agency email that they say suggests officials were under inappropriate pressure to approve the devices.
Inamed Corp. and Mentor Corp. want the FDA to lift a 13-year ban on most use of the gel implants.
Two weeks ago, FDA's scientific advisers concluded that Mentor had proved its devices safe enough to resume widespread sales under certain conditions, but that Inamed needed to do more research. The FDA is considering that advice as it completes its own review.
However, a month before that panel met, an aide to FDA Acting Commissioner Lester Crawford emailed the agency's medical device chief an unsigned "Update on Silicone Gel Breast Implants" that said the devices were safe and that criticism of them amounted to "junk science."
"I got this from an outsider who is interested in seeing us come out okay on the b.i. (breast implant) issue," says the email from Susan Bond, Crawford's scientific policy director. "Can you take a look at this and tell me your thoughts?"
In his response, FDA medical device chief Dr. Daniel Schultz wrote, "The truth lies somewhere in between this very positive perspective and the totally negative viewpoint of the other side."
The National Organization for Women and five other women's groups — who oppose silicone breast implants — sent copies of the email to members of Congress on Thursday, asking that it and a list of other complaints about implants be investigated.
"This email implies the FDA had a predetermined interest in approval even before the FDA advisory panel met," they wrote.
The Senate Health, Education, Labor and Pensions Committee, which oversees the FDA, is reviewing the groups' letter, a spokesman said.
FDA spokeswoman Julie Zawisza said the emailed "update" was not an FDA document and didn't represent the agency's position.
"We receive a lot of input from a lot of parties," she said.
Schultz said in an interview Friday that it is routine for agency officials to seek each other's reaction to outside opinions such as the emailed document, and said he felt no pressure to influence his decision.
"Absolutely not," he said. "We get these things all the time."
