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

DATE: THURSDAY, August 18, 1994                   TAG: 9408180108
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-11   EDITION: METRO 
SOURCE: Cox News Service
DATELINE: WASHINGTON                                LENGTH: Medium

FDA DISMISSED CANCER WARNINGS

The Food and Drug Administration dismissed warnings from one of its own safety officers in 1992 that participants in a large-scale breast cancer experiment were being misled about the risks of taking daily doses of a drug known to cause some types of cancer.

In a memorandum to other FDA officials, safety officer Paul Goebel warned that a consent form women were required to sign downplayed the risks and overstated potential benefits of taking tamoxifen, a drug some researchers think will be useful in preventing breast cancer.

Goebel said the form could lead volunteers to erroneously believe that if they developed uterine cancer after taking tamoxifen, the disease could be easily ``cured.''

On Oct.28, 1992, the date Goebel wrote his critique, four uterine cancer victims from an earlier tamoxifen trial already had died of the disease, although neither Goebel nor any other FDA official appears to have known it at that time.

Despite Goebel's warnings, the consent form was not changed. More than 10,000 women volunteered to take tamoxifen, told in the consent form that ``no deaths from uterine cancer were reported'' among women in previous tamoxifen trials and that ``the uterine cancers that have occurred have been at an early stage and are thought to be curable ...''

Goebel's memorandum was not made public by FDA but was appended to a recently published report by the House Government Operations subcommittee on human resources, which held hearings in 1992 on the $68 million government-funded Breast Cancer Prevention Trial.

The consent form that Goebel criticized listed expected benefits and risks of taking tamoxifen pills daily for five years. Chief goal of the experiment is to determine if tamoxifen will prevent women from developing breast cancer.

The trial is one of a series of breast cancer experiments that have been managed for the National Cancer Institute by the National Surgical Breast and Bowel Project, a group of researchers at the University of Pittsburgh Medical School.

Early this year, the Pittsburgh scientists amended the consent document to disclose for the first time that some uterine cancer victims from an earlier trial had died. Like the prevention trial, the earlier tamoxifen trial was sponsored by the National Cancer Institute and managed by the Pittsburgh group.

The Pittsburgh scientists said they had not discovered the deaths and an elevated overall incidence of uterine cancer among more than 3,000 participants in the earlier trial because data from the trial had not been analyzed until recently.

An FDA official acknowledged Tuesday that had the agency pursued Goebel's warnings, it might have discovered that some women had not been ``cured'' of uterine cancer. Instead, Goebel's objections were dismissed as ``matters of opinion or semantics,'' and the FDA approved the consent document.

``In retrospect, if we had known that one of the patients had died, the statement that there were no deaths would not have been allowed,'' said Dr. Gregory Burke, head of an FDA office that oversees research on cancer drugs.

by CNB