Proposal seeks wider access to AIDS drugs.

Proposal seeks wider access to AIDS drugs

An influential federal health official has proposed easing restrictions on certain experimental AIDS drugs, a move that would allow many AIDS patients access to the latest therapies. Groups representing AIDS patients hail the proposal, but some scientists worry that patients will no longer willingly participate in clinical research trials if they can easily obtain a new drug through their own physician.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, outlined his proposal last week at the HIV Treatment Awareness Week meeting in San Francisco. The plan has been well received by Food and Drug Administration officials.

Under the current system, AIDS patients can receive experimental drugs by enrolling in clinical trials designed to test the drugs' safety and efficacy. Many AIDS advocacy groups contend this system takes years and excludes many patients who can't meet a strict study protocol.

Fauci's plan would not supplant FDA's evaluations of experimental drugs but would create a separate program under which doctors could give AIDS patients certain experimental treatments approved by FDA on a case-by-case basis. Drugs in the program would have to pass FDA's Phase I toxicity evaluation but would be available for general dispersal while FDA continued to test the experimental drug's efficacy in a Phase II clinical trial.

Fauci's spokesman says many details of the plan have to be worked out, including safeguards to protect patients from hastily approved drugs that later prove unsafe.

Drug researchers worry that such a plan might mean a dearth of clinical trial participants. Fauci says he believes some AIDS patients will continue to participate in clinical trials in the hope that rigorous monitoring will translate into better health care and a better prognosis.

FDA this week put Fauci's plan in action by allowing wider distribution to AIDS patients of r-erythropoietin, an experimental drug undergoing tests as a treatment for the severe anemia suffered by some AIDS patients who are taking zidovudine, commonly known as AZT.

Also this week, the General Accounting Office (GAO) released a report contending that methods used to gauge the U.S. AIDS epidemic greatly underestimate the number of people who will develop the disease. Although statistics vary widely, the Centers for Disease Control in Atlanta projects that cumulative AIDS cases will total 185,000 to 320,000 by the year 1991. GAO's research suggests the number will be closer to 480,000.