Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
U.S. ready to allow AZT treatment for children
San Francisco Chronicle - Thursday October 26, 1989
David Perlman, Chronicle Science Editor
After more than a year of political and medical pressure, the U.S. Food and Drug Administration is about to allow the use of the anti-viral drug AZT to treat AIDS in infants and children under the age of 13, government sources disclosed yesterday. The announcement is expected to be made today by Dr. Louis W. Sullivan, director of the Health and Human Services Department. The drug's manufacturer has indicated it will provide the compound free under the FDA's "compassionate use" program, which allows doctors to prescribe drugs even when they are still in clinical trial and have not been licensed. It was not entirely clear whether the FDA will approve AZT only for those children who already have full-blown symptoms of AIDS, or whether the action also will extend to those who are known to be infected with HIV, the AIDS virus, but who do not yet show any symptoms. Although no drug can yet cure the acquired immune deficiency syndrome, AZT has been shown to extend the life of adult AIDS patients significantly -- often in combination with other drugs. It also wards off the onset of symptoms in healthy people infected with the virus. AZT was approved by the FDA for teenagers and adults in March 1987. Researchers have been trying to determine whether children with the same stage of infection also would benefit from the highly toxic drug. According to the national Centers for Disease Control, more than 1,860 children have been diagnosed with AIDS since 1981, and about 1,000 of them have died. Most of the young patients have been less than 5 years old, and an increasing number have been infants born to mothers who have used intravenous drugs. In San Francisco, 22 children are known to be AIDS patients, and two recent surveys have estimated that 80 to 100 more have been infected with HIV, according to Dr. George Lemp of the health department's AIDS office. Dr. Diane W. Wara, a pediatric AIDS specialist at the University of California in San Francisco, said the long-awaited federal decision will mean that physicians will be free to prescribe AZT for their young patients and that health insurance companies will pay for the treatment once the drug is approved for marketing. In adults, regular full doses of AZT cost about $6,500 a year; children may be able to use smaller doses. Wara noted that most of the state's young AIDS patients are indigent and without any health insurance, but she said the California Chlldren's Service branch of the state health department has been "extremely progressive" in supporting AIDS treatment for children. The agency already has drawn up guidelines that will allow state funds to cover the costs of AZT for all children who cannot afford it, she said. Until now there has been no standard therapy for the hundreds of children with AIDS. More than a year ago, Philip A. Pizzo, a pediatric AIDS specialist at the National Cancer Institute, reported that limited trials in children showed evidence that AZT is safe and that it appears to work as well in the infants and youngsters as it does in adults. The National Institute of Allergy and Infectious Diseases is studying the drug's broad-scale effectiveness in 280 children under the age of 13, and that trial will continue. Another trial, in progress at UCSF and other medical centers, is aimed at studying the effectiveness of gamma globulin, an immune system booster, in a small group of infants who also are being given AZT. That trial is proceeding well, Wara said yesterday.
Keywords: AIDS; CHILDREN; DRUGS; MEDICINE; RULING; US; DEPARTMENTS; U.S. FOOD AND DRUG ADMINISTRATION; AZT (DRUG)
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