ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Monday, November 25, 1996 TAG: 9611250146
SECTION: NATIONAL/INTERNATIONAL PAGE: A-5 EDITION: METRO
DATELINE: ASSOCIATED PRESS
SOURCE: GAITHERSBURG, Md.
Scientific advisers deadlocked Friday over whether to allow AIDS patients to buy a new drug, citing conflicting evidence over whether it works and who should use it.
Pharmacia & Upjohn had argued that delavirdine would help kill the HIV virus in early-stage patients' blood and slightly boost their immune system when used in combination with older medicines.
But the improvement was so slight - and the drug failed to do any good for late-stage patients - that advisers to the Food and Drug Administration were left wondering how any doctor would know how to prescribe delavirdine.
``We're in a tough position,'' said Dr. Wayne Greaves of Howard University Hospital, before the panel voted 4-4 on whether the drug should be approved. ``There are still patients who need additional drugs.''
``A year ago, I would have viewed this very differently,'' said Dr. Christopher Mathews of the University of California, San Diego, who questioned approving a drug that showed such minimal effect when just this year three powerful new medicines began selling, promising patients significant improvement.
But the panel urged the FDA not to make a final decision until doctors finish analyzing an additional study, due in mid-January, to confirm the drug's impact.
The tie vote came after mothers tearfully protested that Pharmacia, like almost every AIDS drug manufacturer, had not even begun testing to determine whether delavirdine would help HIV-infected children.
The mothers accused drug makers and the FDA of ignoring children's desperate need in the race to sell AIDS medicines to adults.
LENGTH: Short : 41 lines KEYWORDS: 2DAby CNB