Subject: AIDS Patients Press FDA for New Drugs 
Date: Published: 3/16/89 (82 lines)
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology & Medicine:  
    AIDS Patients Press FDA for New Drugs
    Due to Rise of Viruses That Resist AZT
    ----   
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    The rise of drug-resistant strains of the AIDS virus is
 causing an increase in the pressure on pharmaceutical
 companies and U. S. regulators to speed up testing and
 approval of alternative treatments.
    Patients and advocacy groups have reacted swiftly to the
 news this week that the virus is mutating to elude Wellcome
 PLC's AZT, the only drug against acquired immune deficiency
 syndrome that has won the approval of the the U. S. Food and
 Drug Administration.
    "This highlights the fact that the medical establishment
 and the FDA in particular have been slow in pursuing sister
 drugs to AZT," said Peter Staley, a spokesman for the AIDS
 Coalition to Unleash Power (ACT UP) in New York.  "My own
 community has been lax in pressing the point on DDC and DDI,"
 he added, speaking of two experimental compounds being
 developed by Hoffmann-La Roche Inc. and Bristol-Myers Co. 
    "We'd like (FDA Commissioner) Frank Young to take DDC and
 DDI as seriously as he's taken two grapes from Chile," said
 Mr. Staley, in a reference to the current panic over
 cyanide-laced fruit.  "We need these drugs on the fast track."
    But the FDA reacted testily to any suggestion the agency
 is dragging its heels.  DDC and DDI "are already on the fast
 track," said spokesman Brad Stone.  "They are in clinical
 trials.  Despite the misunderstanding or misrepresentation by
 some AIDS groups, our intent has always been to develop these
 drugs as fast as possible."
    Companies too insist they've pulled out the stops.  "We're
 moving full speed ahead right now," said David Pizzuti,
 associate director of antiviral research at Hoffmann-La Roche
 in Nutley, N. J. He described the FDA's attitude as "very
 responsive."
    Added a spokeswoman for Bristol-Myers, "We have been and
 are operating under a sense of great urgency in developing
 {DDI} and have worked with the FDA to expedite the studies."
    While Commissioner Young has publicly declared his
 commitment to cut red tape for AIDS drugs, some doctors have
 privately wondered whether that commitment has trickled to
 lower agency personnel.
    Scientists say the best strategy for dealing with drug
 resistance in AIDS, as in cancer, is to combine or alternate
 drugs.  "Judicious use of combinations of drugs makes it
 difficult for the virus to become resistant to any one of the
 component drugs in the regimen," explained Samuel Broder,
 director of the National Cancer Institute, who is testing a
 regimen alternating AZT and DDC. 
    The vice president for research at Wellcome's Burroughs
 Wellcome Co. unit, David Barry, said his company is testing
 combination regimens combining AZT with either DDC or
 interferon.  In addition, he said the company is cooperating
 with Vical Inc. of La Jolla, Calif., to develop a new
 formulation of AZT that circumvents drug resistance.
    Meanwhile, patients go from clinic to clinic, taking what
 drugs are available, knowing each has its limits.  Mr. Staley
 of ACT UP, who suffers from AIDS-related complex, is taking
 low-dose AZT and looking for a new treatment.  "I'm very aware
 that as time goes by, this drug is going to be less effective
 for me."
    A Rhode Island AIDS patient, who asked anonymity, said he
 took AZT successfully for two years before suffering a
 relapse that his doctors attributed to a drug-resistant
 virus.  "It was scary having to come off AZT. Whether or not
 it kept me alive, I felt it did," he said.  "What choice did I
 have but to try something new?  "
    Now enrolled in a DDI test group, the patient said, "my
 energy's back up and my blood count has stabilized.  I'm back
 to training horses and skiing."

[This article is made available here by Dow Jones Co. for the 
personal and non-commercial use of callers to this bbs, in the 
hope that it will be of some help to those who are suffering 
from the disease and others who are seeking to help them.]