Clarithromycin: Abbott Seeks Compassionate Access for MAC

Abbott Laboratories has contacted the U. S. Food and Drug Administration (FDA) and proposed a draft protocol for compassionate use of clarithromycin for persons with AIDS who have mycobacterium avium complex (MAC, also called MAI).

Clarithromycin, a new broad-spectrum antibiotic approved in 20 countries but not yet in the United States, has quickly become a major concern of treatment activists. MAC is one of the most widespread opportunistic infections, and conventional treatment (usually a "cocktail" of four or five antibiotics) is often unsatisfactory. Early research results and practical experience both suggest that clarithromycin is much more promising than any of the standard treatments. Persons with MAC have imported the drug, but it is expensive, and often financially burdensome or unavailable, since unapproved drugs are seldom covered by insurance. It is hoped that some form of compassionate treatment access can fill the gap until the drug can be financed in the same way as other medical care. We do not know how long it will take for Abbott's preliminary proposal for compassionate use to be completed and implemented.

Clarithromycin was first developed for uses not related to AIDS. For these purposes the drug is less critical, because other satisfactory treatments are available. Clarithromycin has the advantage of broad-spectrum activity; according to Abbott's April 1 news release, it "has been shown to be active against all significant respiratory pathogens as well as against the full range of community-acquired skin and gastrointestinal infections."

For more information on clarithromycin, see AIDS TREATMENT NEWS #109 (August 17, 1990) and #113 (October 19, 1990). Also see the interview with Larry Bruni, M. D., in this issue. For information about obtaining the drug now, call the PWA Health Group, 212/532-0280, or LABC/Staying Alive, 213/748-1295.