Tests Promising; Wide Use of New AIDS Drug Possible

Federal health officials are expected to announce today that an experimental AIDS drug has shown such early promise that it should be made more widely available to those suffering from the deadly disease, according to Department of Health and Human Services sources.

Azidothymidine, or AZT, is the first drug shown to prolong AIDS patients’ survival, although researchers and other health officials stressed that it is neither a cure nor a breakthrough drug, and they are uncertain of its long-term effects.

Further, a critical problem is that only very limited supplies exist for the nation’s estimated 10,000 AIDS patients, department sources said.

“The big debate is whether they can get enough AZT for everyone” and whether it should be made available on a “compassionate use” basis or as part of a large national research program under federal control, one department source said.

It was unclear how the drug would be dispensed or how it would be decided who will receive it, according to another department source.

“We don’t know how quickly more drug can be made available--it takes some degree of time and money,” he said. “ . . . Who’s going to be eligible when a drug is scarce? It’s a tough decision.”

If sufficient quantities of the drug are available, its expanded use will probably encompass AIDS patients first, rather than those suffering from AIDS Related Complex, or ARC, a milder form of the disease, or those who are infected with the virus but have no symptoms, department sources said.

Department officials said they expected today’s announcement to result in an avalanche of inquiries from thousands of the nation’s AIDS patients. “We’ve already been told to set up additional telephone lines across the country,” one source said, presumably linked to existing AIDS and disease information hot lines.

The drug was developed and is manufactured by Burroughs Wellcome Co. of Research Triangle Park, N.C., which has been sponsoring a study in 12 centers nationwide, including four in California. Azidothymidine, also known as Compound S, was originally obtained from fish sperm, mostly herring and salmon, although methods have now been developed to produce it synthetically through genetic engineering.

“The supply situation is improving,” a company officer said earlier this week. “There are some difficulties in producing experimental drugs on a larger scale, but we’ve been working on it for some time and are making significant progress. But it’s not the easiest thing to do--you can’t start with a thimbleful and make chili for a thousand.”

Look-Alike Placebos

The immediate beneficiaries of the drug will be the approximately 140 patients who have been receiving harmless look-alike placebos, or sugar pills, as part of the study’s “control” group. The study includes both AIDS and ARC patients.

Typically, to assure the scientific integrity of experimental drug testing on humans, trials are designed with half of the participants receiving the drug and the other half receiving placebos. Also, they are organized as “double-blind” studies--neither the doctors who administer them nor the patients themselves know who is receiving what.

“It was decided that the placebo (recipients) deserve the same chance as those who have been on AZT,” a department source said.

The decision was made after an independent monitoring board evaluated the first 32 weeks of test data on the first group of patients in the study and concluded that those receiving the drug were living longer than those in the control group.

Mandate of Board

Since February, when the study began on the first group, 16 patients receiving the placebo had died, compared to only one death among the AIDS patients taking AZT, sources said. The 280 patients in the study entered on a staggered schedule, the last in June.

The mandate of the board when it was impaneled was to halt the study immediately if it determined that participants had deteriorated as a result of the drug--or if they had significantly improved.

The board met for the first time in August and decided the study should continue. The board was not scheduled to meet again until October but reconvened last week after “recent data required close evaluation,” a Burroughs Wellcome spokesman said.

The officials stressed that the study’s limited duration makes it impossible to determine exactly how long AZT may prolong survival. “Also, long-term use of this drug could lead to severe toxic reactions--we just don’t know,” one health official said.

Thus far, its most serious side effect appears to be anemia.

Plays Trick on Virus

Azidothymidine, which has been considered the most encouraging of six drugs being tested in this country, works by playing a chemical trick on the virus that causes AIDS. Scientists believe it stops the growth of the virus by disrupting the chemical chain it needs to replicate itself inside the body of an AIDS patient.

Researchers are also enthusiastic about AZT because it appears to be one of the few drugs capable of crossing the “blood-brain barrier,” a complex body mechanism involving the blood vessels and brain lining that prevents most chemicals from reaching the brain. Because the AIDS virus has been found in the brain--and has resulted in severe neurological problems for many AIDS sufferers--it must also be attacked there.

Early studies on the drug indicate it may also result in some restoration of the body’s immune function.

The AIDS virus is transmitted by the exchange of bodily fluids such as semen and blood. It kills part of the body’s immune system, thus leaving victims fatally vulnerable to a wide variety of diseases.

As of Monday, there had been a total 24,859 AIDS cases in this country and 13,689 deaths.

The centers in California participating in the study include UCLA, USC, UC San Diego, and UC San Francisco.