AIDS TREATMENT NEWS Issue # 22, January 16, 1987
John S. James

Unfortunately much confusion grew from the ribavirin announcement. The extensive media reports have not told what is going on.

The announcement, by ICN Pharmaceuticals of Costa Mesa, CA, at a Washington, DC press conference, essentially consisted of six numbers. Of 56 patients who received a placebo, ten developed AIDS in the 24-week trial. Of 55 who received 600 mg per day of ribavirin, six developed AIDS. Of 52 who received 800 mg, none developed AIDS.

These results raised two questions. First, few physicians believe that the difference between 600 and 800 mg could be as significant as these results suggest; therefore we should not assume that 800 mg dose was completely effective, because it is more likely that the fact nobody at all to AIDS was partly due to lucky chance. Also, the total number who developed AIDS in the first two groups was much higher than would be expected, and no one knows why.

While the scientists' work continues, people must make life and death decisions. There is little doubt that these results taken as a whole add powerful support to the already powerful case that ribavirin can be an important treatment for some patients. Still, you have to get it in Mexico, and physicians are reluctant to advise you to do so.

Behind the Scenes

Here is some background information we have not seen reported.

* Last-minute change. The January 9 press conference had been planned to announce not only the results above, but also Federal approval of an extended IND (investigational new drug) application. ICN already has an IND for ribavirin, which gave it permission to use the drug in the trials mentioned above. The new IND would have allowed much larger trials, probably with thousands of patients, under a detailed protocol somewhat like the one used for AZT. In fact, the FDA (U.S. Food and Drug Administration) agreed to handle ribavirin like AZT, in order to treat the two manufacturers equally.

But unexpected events days before the press conference prevented final completion and approval of the plan. ICN and the FDA quickly agreed, one day before the press conference, that the company would go ahead with the announcement but release only the principal result at this time.

Unfortunately, the ensuing confusion in the first day's media reports made everyone look bad. ICN appeared to be raising false hopes in order to promote itself, by getting front-page publicity for partial results which left important questions unanswered. And the widely circulated report in early editions of the January 10 New York Times implied that both ICN and the FDA were passing the buck; it quoted ICN as saying it had no plans to make ribavirin available until the FDA approved, and quoted the FDA as saying that ICN had not submitted a formal request for approval. Technically both statements are true, but our well-placed source reports that the agency and the company are in fact working well together, that together they have produced a plan for large-scale distribution which came within a hair's breadth of release on January 9, and that the plan is now under review and likely to be released, possibly in as little as two weeks.

* The ARC study. The results given January 9 concerned only persons with lymphadenopathy. A separate part of the same study tested whether ribavirin could prevent development of AIDS in persons more seriously ill with ARC. These results are expected shortly--along with the release of the plan mentioned above. We have heard that 24 of the ARC patients developed AIDS, but we don't know the breakdown of the 24 into the three treatment groups (placebo, 600 mg, and 800 mg).

* Dosage. Some people believe that 1000 or even 1200 mg would be better than 800, for those persons who can tolerate that much. Apparently almost everyone can tolerate 800; we heard that no one had to be taken off the ICN study due to side effects, and no one needed a transfusion.

Ethical Issues

The gay community and others involved with AIDS must address and clarify certain ethical issues concerning experimental treatments.

* False hope or false hopelessness? Is it raising false hope to spread good news about promising but as yet unproven treatments? Or is it false hopelessness to teach people to ignore new developments and prepare for death?

The conventional approach is to leave treatments to the experts until they are proven safe and effective and released for marketing. But we should remember that final proof and approval take years even after a drug has proven itself well enough to get many scientists, physicians, and investors behind it.

The other way is to run with every reasonable treatment lead until we know whether or not it works. The risks are often very small, and in any event they must be balanced against the risks of doing nothing. AIDS has killed perhaps a thousand times more people as all the experimental treatments put together. And any published results help doctors and scientists develop better treatments in the future. Why give up on all new treatments just because several have been disappointing?

* Publicity and secrecy. Researchers have been criticized when they report results to the press and public, rather than through medical journals or meetings. But it takes months to get published in a medical journal, and during this time most journals insist that the results be kept secret from the press and public, and therefore also from most scientists and physicians. This secrecy enables journals to make a splash in the news when their issues come out, but it has seriously slowed AIDS and other research. This research depends on public interaction among scientists who may be in different lines of work and unable to communicate privately since they do not personally know about many others who are doing work relevant to them.

In recent years the public has shown an unprecedented interest in and demand for detailed medical knowledge. Books like the Physician's Desk Reference have become bestsellers. This trend is part of the growing movement for persons to take more responsibility for their health, instead of leaving it to the experts.

Persons with AIDS and ARC and their physicians must make treatment decisions, including decisions about unapproved treatment options. It is wrong to withhold the information they need.

* Availability. Ribavirin has been sold for human use for 12 years. It is now approved in about 40 countries, including many in Western Europe and elsewhere which have sophisticated drug-testing requirements. For over two years, growing evidence has suggested that this broad-spectrum antiviral might be useful for AIDS.

Now ribavirin has shown good results in a major double- blind placebo trial. Still, U.S. physicians cannot prescribe it, and patients must get it in Mexico. This is inexcusable.

The U.S. drug-approval system reflects the interests and needs of giant pharmaceutical companies far more than the interests and needs of persons with AIDS. Government drug approvals have in fact become corporate assets, like patents, licenses, stocks, and other forms of wealth. This web of vested interests, not concern for patients' welfare, has controlled the regulatory response to the AIDS emergency. Corporations which played by the rules, and earned their drug marketing approvals at the cost of tens of millions of dollars each, would object to the government now giving quick and free summary approvals to their rivals. Consider, for example, the current Federal decision to treat ribavirin and AZT equally, although one has been in routine human use for 12 years while the other is brand new and known to have serious risks. Corporate interests, not patients' interests, came first.

This system will continue to deny medically sound treatments to persons who are seriously ill until medical associations, patients' organizations, and other public- interest groups start advocating far more forcefully for patients' rights to treatment, telling Congress, the media, and others that the current system which purports to protect the welfare of patients is in fact undermining it.

We can start by remembering the third of the Four Moral Appeals of the ARC/AIDS Vigil:

"We appeal to the FDA to immediately allow American physicians to prescribe medicines and treatments for ARC and AIDS that are available to their colleagues in other countries."

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