FDA Advisor: "Ignore breast implant vote"

FDA Advisor: “Ignore breast implant vote”

Wed, 5 Nov 2003

Dr. Thomas Whalen, Chairman of FDA’s advisory committee that had voted on Nov 3 to approve with restrictions the resumption of silicone breast implants, wrote a letter to FDA Commissioner, Marc McLellan, urging him to ignore the committee’s vote and not approve.

Dr. Whalen said he took the unusual step because “I felt morally compelled.” Let us hope that more physicians will begin to feel morally compelled to do no harm.

In today’s medical culture this often requires going against industry driven practice guidelines that promote the use of drugs often resulting in more harm than good. For example, doctors are prescribing psychotropic drugs for children whose behavior is bothersome but normal. Those drugs have risks of severe adverse effects–including the risk of precipitating aggression and suicidal acts. Thus, doctors who have yet to feel “morally compelled” to put patients’ interests above industry’s sales objectives are putting children in harm’s way.

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FDA advisor: Ignore breast implant vote

WASHINGTON (AP) –In a highly unusual move, the chairman of a government advisory panel that reluctantly backed resuming sales of silicone gel breast implants now is urging federal health officials and lawmakers to disregard that advice.

“I really have a lot of angst” about the panel’s vote, said Dr. Thomas Whalen of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School. “I felt morally compelled — it sounds corny, but morally compelled — to do something about it.”

Silicone gel implants were highly popular until 1992, when fears that leaking silicone caused serious diseases prompted the Food and Drug Administration to end routine sales. Now one manufacturer is seeking an end to the ban, arguing that silicone implants have been exonerated of causing serious diseases like cancer or lupus.

Last month, the FDA asked outside scientists for advice. In a two-day meeting, dozens of women blamed silicone implants for permanent disfigurement and dozens more begged for access to them.

The advisers recommended, on a 9-6 vote, the sale again of implants but only under very strict conditions. These include additional safety tests and warnings to recipients about lingering safety questions and the frequent need for repeated operations because of painful scar tissue and other problems.

As the panel’s chairman, Whalen could not vote unless there was a tie. But in a letter obtained Tuesday by The Associated Press, he wrote FDA Commissioner Mark McClellan and five members of Congress about his “very strong reservations concerning this vote.”

“Long-term safety, the concern that prompted the removal from the market 11 years ago, was clearly not demonstrated,” Whalen wrote.

Also “extraordinarily troubling,” he added, is the enormous costs that women face for additional surgeries and removal of broken or painful implants. “This is a public health issue of no small import that must be addressed should the FDA second this misguided panel decision,” Whalen said.

The FDA said it had received and would consider Whalen’s comments.

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Copyright 2003 The Associated Press. All rights reserved.

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