Rushing Ddi To Market

For four years, the list of approved drugs for AIDS patients began and ended with AZT. The drug, also called zidovudine, can extend a patient's life-span, but not everyone can tolerate its side effects, which may include nausea and severe anemia. Now, after billions of dollars of research and constant pressure from AIDS activists, the Food and Drug Administration has bypassed some of its usual requirements to approve another medication, didanosine, known as DDI.

Developed by Bristol-Myers Squibb, DDI resembles AZT in that it interferes with replication of the AIDS virus. Whether it will extend the life of patients remains unknown, but it has been shown to boost levels of disease- fighting T cells. Last week's approval, granted with unusual speed, will enable doctors to prescribe the drug to those who cannot tolerate AZT -- about half of AIDS patients.

Though AIDS activists were delighted with the decision, there are several concerns. About 23,000 people have been receiving the pills for free, as a humane gesture. Now they are expected to pay $2,000 a year for the treatment. Bristol-Myers says, however, that it will continue to offer free pills to those who cannot afford the drug or obtain insurance coverage. Another worry is side effects, including inflammation of the pancreas, numbness in the hands and feet, and diarrhea. Most important, DDI has yet to pass the rigorous testing usually required by the FDA. "We are giving DDI a status it has not earned, and we are lowering the scientific standards for drug approval," complains Dr. Deborah Cotton of Harvard, who reviewed the DDI approval application. FDA chief David Kessler justifies the decision by saying that "people are dying." Whether DDI can forestall their deaths will be clearer within six months, when the results of clinical trials are in.