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 infectious diseases: see communicable diseases. , outlined his proposal last week at the HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. Treatment Awareness Week meeting in San Francisco San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden . 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 Main article: HIV and AIDS misconceptions Patient Zero theory
Some advocates hold that the disease was introduced by a flight attendant named Gaetan Dugas, referred to as "Patient Zero". Other advocates argue that there were cases of AIDS much earlier than initially known. 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 FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. 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 Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II .
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 zidovudine /zi·do·vu·dine/ (zi-do´vu-den) a synthetic nucleoside (thymidine) analogue that inhibits replication of some retroviruses, including the human immunodeficiency virus; used in the treatment of HIV infection and AIDS. , commonly known as AZT AZT or zidovudine (zīdō`vydēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called .
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.