FLUCONAZOLE: IMPORTANT ANTIFUNGAL APPROVED

On January 29, the U. S. Food and Drug Administration (FDA) approved fluconazole (brand name Diflucan), a major broad- spectrum antifungal especially important for treating cryptococcal meningitis. Fluconazole, which has long been approved in England, is about equally effective as amphotericin B, but has much less toxicity. Also, fluconazole can be taken by mouth, while amphotericin requires intravenous infusions, often every day in a hospital.

Fluconazole should be available to pharmacies by late February. If local pharmacies cannot get it quickly, patients or physicians could check availability with a mail-order pharmacy such as American Preferred Plan, 800/227-1195 (in New York State the number is 800/445-4519). Until the drug is actually delivered, the PWA Health Group in New York will continue importing it from England, which takes about a week.

We do not know the price, but fluconazole will be very expensive. If price is an obstacle, people should know that another drug itraconazole (brand name Sporanox) may be almost as good as fluconazole and is available in Mexico at a fraction of the fluconazole price (see AIDS TREATMENT NEWS #80, June 2, 1989).

History and Comment

Physicians familiar with fluconazole agree that it should have been approved long ago, probably well over a year ago. No one seems to know why it took so long for this drug to become widely available in the United States.

AIDS TREATMENT NEWS published an in-depth article on flu-conazole over two years ago ("Fluconazole: A Major Advance for Cryptococcal Meningitis and Other Systemic Fungal Infections? " issue #41, September 25, 1987). At that time the drug was already in widespread use in Europe, where over a thousand people had taken it, mostly for relatively minor infections. In addition, about 150 persons with AIDS had been treated with fluconazole for serious or life-threatening fungal infections. But few U. S. physicians knew about the drug at that time; one leading AIDS specialist told us he had heard about fluconazole but could not follow up because he did not know how to get more information about it. (AIDS TREATMENT NEWS had also given up on an earlier attempt to cover fluconazole, because we could not find information.)

The fluconazole history illustrates once again how much U. S. medicine could improve if it could take advantage of important treatment successes in common use elsewhere in the world. In this age of rapid globalization of business and communication, why is medicine such a major exception to the trend? The answer is that the corporate/regulatory dynamic creates business, regulatory, professional, political, and media empires which are threatened by the free flow of medical practice into the United States from other countries. Medicine will be the last refuge of protectionism, to the great detriment of the health of the American people. Progress in solving this problem could make solid contributions to better quality, less costly health care.

While fluconazole was unapproved in the United States, it was made available through studies and/or compassionate use in life-threatening emergencies for people who could not tolerate amphotericin and had no other alternative. We do not know how many fell through the cracks of this system. For example, although the drug was free, did grotesquely underfunded public clinics have the physician time to do the paperwork required? What happened when their clients needed the drug to save their lives?

Of all drugs in history, fluconazole may be the most precisely targeted to matter least to those who in the United States matter most -- HIV negative white men. For aside from AIDS, the drug will be especially important to Blacks and members of some other races for treatment of valley fever (coccidioidomycosis), a disease much more serious for them than for whites. (Valley fever is endemic in certain geographical areas, including parts of the Southwestern United States, and the San Joaquin Valley in California.) And in Europe, fluconazole has been used primarily for treating women with vaginal candidiasis. We do not know whether this demographic profile of the drug allowed it to remain unavailable for so long.

AIDS TREATMENT NEWS did not investigate these particular questions about fluconazole because of repeated rumors that approval was imminent. And after mailing our 1987 article to thousands of people, we thought that followup could be left to others. In retrospect, we made a mistake in not pursuing this drug aggressively.

The shallow press coverage of this shameful chapter in U. S. medicine shows that history laundering is well advanced.