Get It to the Right People Faster

New Federal Drug Administration dosage recommendations for AZT will facilitate the treatment of those with AIDS, a welcome development. But continued FDA delays on another crucial use of the same anti-viral drug are blocking life-extending treatment for thousands of others infected with the human immunodeficiency virus (HIV) that causes AIDS. That needs an urgent response.

The new dosage for those with AIDS and AIDS-Related Complex (ARC) is half that previously recommended. The change is based on further research that demonstrated the efficacy of the reduced dose. This, in turn, opens the treatment to those who had to give up the drug because of bad side effects from full dosage. With the dosage reduction, cost also is cut in half, a development that is helpful at a time of cutbacks in public health spending and the increased demand implicit in findings that the drug also is useful in treating persons infected with HIV but not yet showing symptoms of AIDS or ARC.

Unfortunately, implementation of early intervention treatments with AZT of asymptomatic persons has been delayed by an absence of FDA recommendations on dosage. The delays, according to Dr. Anthony S. Fauci, director of the National Institute for Allergies and Infectious Diseases, are due to “an accumulation of multiple bureaucratic and trivial reasons.” The institute itself has yet to convene a promised conference on the new procedures. And progress has also been slowed by delays in publishing the research findings in the scientific journals that guide physicians. Excuses aside, the situation was best summarized by Dr. Neil Schram, a leading AIDS expert in Los Angeles, when he said “It is an outrage.”

Peer review is essential before research is reported in medical journals. But there are shortcuts in sharing this vital information that the FDA could facilitate so that there will be no further delay in using AZT in this new way, a way that will buy longer lives for those infected with HIV.