ROANOKE TIMES

                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: THURSDAY, February 13, 1992                   TAG: 9202130005
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A7   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                LENGTH: Medium


VOTE LOST ON BREAST IMPLANTS DOCTOR'S BIAS CITED BY FDA

The Food and Drug Administration stripped a Baltimore doctor of his vote on an advisory panel that next week is to consider whether silicone gel breast implants are safe. The reason given was that the doctor was biased.

In yanking Dr. Norman Anderson's vote, the FDA acknowledged Wednesday that he was largely responsible for getting the agency to take another look at the safety of the implants.

Anderson, an associate professor of medicine and surgery at the Johns Hopkins University School of Medicine, had been one of 11 voting members on the panel.

Anderson was quoted in Time magazine this week as telling the FDA that breast implants ought to be removed from the market. He also was highly critical of Dow Corning, a manufacturer of implants that has been accused of concealing data concerning safety risks.

The safety of the implants has become a sensitive subject at the FDA. Consumer groups and lawsuits allege that gel leaking from the implants can cause a host of health problems, including cancer, and damage to the body's immune system.

FDA spokeswoman Susan Cruzan said pulling Anderson's vote "has been necessitated by statements in the mass media which led to an appearance of his inability to render objective advice."

Cruzan did not specify which of Anderson's statements got him in trouble, but this week's Time cited a letter Anderson wrote to the agency saying the implants ought to be removed from the market.

Anderson also referred to the "gentlemanly working relationship" that had existed historically between the FDA and the industry.

This week, Dow Corning released hundreds of pages of internal company memos and studies showing it had heard complaints about the implants for decades.

Anderson was quoted in the magazine as saying the memos left "little doubt of [Dow Corning's] misrepresentation of the facts."

The move by FDA Commissioner David Kessler drew an immediate demand for an explanation from Rep. Ted Weiss, D-N.Y., chairman of the Government Operations subcommittee on human resources.

Weiss wanted to know why Anderson was being singled out.

"All members of this advisory committee expressed their opinion about silicone breast implants at the panel meeting in November," Weiss wrote to Kessler. "Several panel members have publicly expressed their opinions about breast implants since then."

Repeated efforts to reach Anderson by telephone were unsuccessful.



by Bhavesh Jinadra by CNB