An Uproar over AIDS Drugs

By Jay Branegan

Racing against the clock, scientists develop a drug that is at least partly effective against AIDS, and the Food and Drug Administration okays it in record time. Instead of applause, the approval of Retrovir (formerly known as AZT) has provoked outrage in some quarters. On Wall Street last week, 300 demonstrators led by gay activists chanted slogans, blocked morning traffic and hanged an effigy of FDA Commissioner Frank Young. Their complaints: Retrovir's manufacturer, Burroughs Wellcome, is gouging AIDS victims by charging around $8,000 for a year's worth of the capsules. Meanwhile, the protesters claimed, the FDA is dragging its feet on approval of potentially more effective AIDS drugs. "Why aren't they available?" asked Playwright Larry Kramer, a rally organizer.

FDA officials defend their record, noting that all AIDS drugs have been placed on a special fast track. Retrovir went from initial clinical testing to final approval in less than 21 months, in contrast to the usual 8.8 years. Last month the agency proposed rules that would allow doctors to use experimental drugs in life-threatening situations. Says Young: "That is a breakthrough. It's a very propatient orientation."

Ironically, the crash program for developing Retrovir may have contributed to its high price. To make the drug available as quickly as possible, "we have literally turned our company upside down," said Burroughs Wellcome Vice President Thomas Kennedy at a press conference last week. The company says it takes seven months to make the drug and that the high price is needed to offset development and manufacturing costs. Burroughs Wellcome officials also contend that by reducing the need for medical care, Retrovir could, despite its expense, slash the annual cost of treating an AIDS patient from an estimated $43,500 to $32,600.

Retrovir is a palliative, not a cure, and frequently causes serious side effects. Nonetheless, demand is expected to be strong, not only from the nation's 14,000 AIDS patients but from an even larger number with ARC (AIDS- related complex). The question before them: How to pay? About 40% of AIDS patients are covered by Medicaid. In New York and California, Medicaid officials have already decided to reimburse the cost of Retrovir treatment, but other states may choose not to pay for the drug.

While private insurers appear to be willing to pay for Retrovir, what worried many at last week's rally was the large number of AIDS patients who / have no insurance. Democratic Congressman Henry Waxman of California shares the concern: "I don't think it's right to let someone die because they don't have private insurance or the financial resources to pay for the drug." Waxman is seeking $60 million in the 1988 budget, and $30 million this year, to help purchase drugs for indigent AIDS victims. If approved, these funds could help patients like Archie Harrison, 32, of New York City, who is caught in a vexing Catch-22. Harrison took part in a Retrovir trial and is now well enough to resume his career as an actor. But if he works, he may lose his Medicaid benefits. "AZT has gotten me to the point where I can think about a normal life," he says. "I don't want to have to decide not to take the drug."

With reporting by Christine Gorman and Jeannie Park/New York