The FDA approved AZT in a record 20 months, a move that remains controversial today.
HIV was first reported in 1981, but it wasn’t until six years later—in March 1987—that a drug to fight the virus was approved by the Food and Drug Administration (FDA). On the 30th anniversary of this milestone, Time magazine takes a look at the story behind the controversial med azidothymidine, commonly known as AZT.
Also known as Retrovir or zidovudine, the compound AZT was not originally created with HIV in mind but was developed in the 1960s to battle cancer. Decades later, scientists at pharmaceutical giant Burroughs Wellcome made a version of AZT to fight HIV.
To fast-track the med, the drugmaker conducted a trial with 300 people who had AIDS. After 16 weeks, it was halted because those taking AZT were doing so much better than those not on the med. The results were considered a breakthrough, and the FDA approved the drug on March 19, 1987, in a record 20 months, according to Time.
The approval was granted despite many questions remaining unanswered—for example, how long did the benefits last?—and despite other issues surrounding the trial itself. In fact, Time notes, the trail remains controversial today.
Then came a bigger controversy: the price tag. At about $8,000 a year ($17,000 in today’s dollars), AZT was unattainable to many.
Today, we have more than 41 drugs to treat HIV, many in combo form and with much fewer side effects.
A similar HIV milestone occurred in 1996. For more about that, read “Antiretrovirals: A Success Story—Celebrating 20 Years of Effective Treatment” and “Milestones in the Era of Effective Treatment.