AZT-FIRSTAIDSDRUG-UMROLE

March 14, 2002: 15th anniversary of AZT – world’s first AIDS drug – commemorated
March 19th -- University of Miami School of Medicine faculty played a banner role

Rebecca Riordan
(305)243-5671

         Amid the raging AIDS epidemic of the mid 1980s, there was no treatment. Not until March 19,
         1987, when the FDA approved the first AIDS drug, AZT. The 15th anniversary of AZT’s arrival is
         being commemorated March 19, 2002.

         The University of Miami School of Medicine was a major contributor to that first treatment and
         today AZT is still one of the most prescribed AIDS medications. Margaret Fischl, M.D., professor
         of medicine and director of UM’s AIDS Clinical Research Unit was an original AZT investigator
         and lead author of the study report that led to the drug’s FDA approval.

         "Fifteen years ago, AIDS patients saw their diagnosis as a death sentence," says Dr. Fischl. "But
         AZT offered hope and we began to view AIDS as a treatable disease." AZT’s approval came only
         six months after the Phase II clinical trial was halted early at the recommendation of an NIH
         independent data safety and monitoring board. Early data showed a significant reduction in deaths
         among patients who were taking AZT, compared to those who had received a placebo. And that
         first approved dosage had significant side effects. Subsequent studies indicated that the drug was
         just as effective at half its original dose and it became much more tolerable for patients.

         Emergence of this first drug began the quest for more drugs to improve patient outcomes.
         Introduction of a new class of drugs called protease inhibitors in 1996 was a major turning point
         and again, UM was in the lead. Dr. Fischl was an investigator on that initial trial, as well as the
         senior author of the New England Journal of Medicine article that documented their effectiveness.
         Triple combination therapy with AZT, 3TC and a protease inhibitor was the first potent
         antiretroviral therapy, often referred to as the "AIDS cocktail."

         "I remember the first time I had a patient who was feeling so well with his combination therapy he
         went back to work," says Dr. Fischl. "The patient’s insurance company called me and was talking
         very quietly on the phone, so I asked, `Why are you whispering?’ They said, `People with AIDS
         don’t go back to work.’ I said, `That was yesterday. This is today.’"

         Seven years later, AZT was approved for use to prevent transmission of the AIDS virus from
         HIV-positive women to their newborns. Studies showed that AZT reduced the rate of transmission
         by about two-thirds and for the first time, AZT was saving lives by preventing transmission of the
         virus. Participants in this study and co-authors of the research article published in the New England
         Journal of Medicine in 1994 were Mary Jo O’Sullivan, M.D., UM’s director of high risk
         pregnancy, and Gwendolyn Scott, M.D., UM’s director of pediatric infectious diseases.

         Since the first cases of HIV were observed 20 years ago, the University of Miami emerged as one
         of the nation's epicenters of HIV treatment and research. Today, in excess of $20 million of the
         University's research budget is dedicated to projects related to HIV and AIDS. Locally and
         nationally, UM faculty were among the first to sound the alarm about the threat this virus
         represented. UM research was instrumental in securing FDA approval for AZT and today
         continues that groundbreaking progress with combination drug therapies and AIDS vaccine
         development.

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