Why AIDS Treatment Delay?

(ACT UP Los Angeles newsletter (213-668-2357) asked us for this article. It is appearing simultaneously in ACT UP Los Angeles, and in AIDS Treatment News.)

Today we know that hundreds of thousands of people will die of AIDS in the United States alone over the next several
years--unless effective treatments become available. Yet government, business, the general public, and the AIDS community alike have failed to mobilize to assure that solid treatment leads get prompt attention and research, and become accessible to patients when they should be. Far more attention has gone to supporting the dying process than to making it unnecessary.
Dozens of serious, promising treatment possibilities exist. For almost all of them, virtually nothing effective is
being done. We won't be any closer next year than now to knowing if and when they work.
A look at the promising treatments of two years ago--such as ribavirin, isoprinosine, AL 721, DNCB, foscarnet, HPA-23, lentinan, gamma globulin, plasmapheresis, AZT--shows that in two years nothing decisive has happened, except for AZT. The rest are still in the same limbo they were then, still on the same promising-treatment list two years later, still neither in nor out. Some have suffered vituperation or neglect in the shifting political winds, but none has been rejected (or accepted either) on rational grounds based on evidence. The research just was not done.
And it isn't being done today. The much-touted spectacular progress in "AIDS research" concerns high-tech, basic science which could not possibly produce practical treatments for years.
Treatment research can be done right. For example, some European physicians noticed spectacular improvement in one AIDS patient treated with an antibiotic, fusidic acid. Small trials with ten to twenty patients each were quickly started in Denmark and England; apparently they showed that the drug is ineffective. Although the drug failed, the research which tested it succeeded excellently. It showed how practical trials can be done.
Similar immediate, no-nonsense trials could test not only single drugs, but drug combinations, in fact any reasonable
therapeutic plan or protocol. Recently the head of San Francisco's Department of Public Health offered to start trials immediately in City facilities; he called the current clinical trials "leaden-footed".
Virtually never has quick but workable testing of any other AIDS treatment possibility (besides fusidic acid) been
carried out. In the United States, the rules of the Food and Drug Administration (FDA) would not allow it. These rules
often require, for example, "phase I" dosage and toxicity tests even for drugs in common use for years and well known to be safe. Even such well-known drugs can take a year or more of negotiations and paperwork just to crank up a phase I trial even after financing has become available--as it almost never does unless the drug happens to fit into the commercial plans or scientific preconceptions of the day. "Phase II"--efficacy testing--takes years longer.
AIDS experts have agreed for years that drug combinations will probably be necessary for treatment. But the FDA refuses to allow human testing of combinations of two or more unapproved drugs. Except for combinations with AZT--which is approved, but unsuitable for many patients--this rule alone adds several years delay before testing can even begin on any promising AIDS therapy.
U.S. rules and procedures also delay drug trials abroad in Europe and elsewhere, even if privately financed by foreign companies with no U.S. support. How can the U.S. government affect AIDS research conducted elsewhere without U.S. funding? The answer is that the U.S. AIDS market so dwarfs all others that pharmaceutical companies fear doing anything anywhere in the world, until the FDA has given its blessing to their research plans.
We have heard that a handful of people at the FDA--one report said only two, both young physicians recently out of
training--constitute the bottleneck which all proposed AIDS drugs must go through. Almost every AIDS drug trial anywhere in the world waits in line for permission at this door.
U.S. medical planners can confidently predict hundreds of thousands of deaths, because there is no way an effective drug could get through this system in time. The FDA's much touted "new rules"--supposed to allow faster access to treatments for serious or life-threatening diseases--apply only late in phase II, have no constituency within the FDA, and have had practically no effect on AIDS treatment availability in almost a year of their existence.
The official U.S. drug-research system may find a cure in five to ten years, but meanwhile it has nothing to offer but
death.
An alternative-treatment movement is growing explosively and doing some of the most useful AIDS-treatment research--the only AIDS research in the United States at least designed to get quick results. Now it faces increasing attacks through government, corporate, and even international sabotage-- actions taken solely to deny treatment access to persons with AIDS, or to harass research efforts by private physicians. For example, at least fifteen companies in Japan sell dextran sulfate--available there as a non-prescription drug for 20 years, and now one of the most promising experimental AIDS treatments--but within the last two months every one of these companies started refusing to sell it to Americans. And when the old Salk killed-virus polio vaccine showed good results as an AIDS/ARC treatment, the only company in the world which manufactures it refused to sell it to physicians for that purpose. We don't yet know where the pressures came from, or why. But no one involved has even pretended that concern for patients' safety or welfare led to these decisions.
For the first six years of the epidemic, practically every AIDS organization slept on treatment and research issues,
refusing to inform itself or have anything to do with the matter. This utter lack of treatment advocacy allowed horrors
like those outlined above to come into being. Now the community is awakening. The faster it awakens, the more lives
will be saved.