COMPASSION IN RESEARCH?

Last week, at the international AIDS conference in Paris, an associate professor at the Harvard Medical School presented results of a study of ribavirin. This study gave it to 15 persons with AIDS or ARC, and reported good results and no toxicity from the drug after eight weeks. But when the treatment was stopped, the virus returned.

This is the same ribavirin which people have been taking for months on their own, if they can keep making trips to Mexico to bring back the permitted one-month personal supply (to find out more about doing so, contact Project Inform). (If someone is too ill to travel, it is illegal for anyone else to bring in their supply for them.) It is the same ribavirin which has been
approved as an antiviral in dozens of countries around the world.

Then why, in the middle of an epidemic, isn't it allowed here? The main reason seems to be that if the government made an exception to the lengthy approval process, due to the AIDS emergency, then other companies would complain that their products didn't get an exception, too.

If it has taken until now for officially-sanctioned researchers to publish a trial with fifteen patients, imagine how long it takes for the complete approval process -- even for a medicine already known to be beneficial.

Another problem is that the manufacturer, which has a legal monopoly on ribavirin, recently imposed a major price increase even though the drug was already expensive and a serious financial burden to its users. Insurance will not pay for ribavirin because it is not officially approved.

Federal new-drug approvals, intended to protect the public from unsafe or ineffective drugs, have in fact become chips in a corporate bartering process. They impact stock prices, determine the fate of investments, and set the ground rules for an institutional game of inside tracks and old-boy
networks. The patients are not represented.

Why are you and your doctor not allowed to consider ribavirin, which is quite safe, well known, well tested, and in use in dozens of other countries? Not for your good, but rather because the manufacturer has not yet earned the right to market it in the U.S. Therefore no one can sell or provide it here, aside from limited and restricted experimental trials, even when
persons with AIDS or ARC could clearly benefit by having the option.

Why are you and your doctor not allowed to weigh the risks and benefits of azidothymidine, which is more dangerous than ribavirin but also more effective? Why not AL 721, almost certainly completely safe, although we do not know how effective because trials were delayed for months and began just recently, on only eleven patients, and in secrecy? Why are persons with
AIDS or ARC told to wait a year or more, for definitive results on treatments already known with fair-to-high confidence to offer important benefit?

A special legal status called "compassionate use" approval is supposed to provide an emergency exception to such roadblocks. But a drug company must apply for compassionate use, and the U.S. Food and Drug Administration must grant approval. The process includes lots of red tape, and considerable expense to the company. We are hearing that there is less interest in
compassionate use for AIDS or ARC than for other diseases which affect far fewer people. Once again we see that the institutions of this country are refusing to respond to AIDS as an emergency.

Repeated appeals to change these hideous policies have had little success. Perhaps we need to let more people know exactly what is happening, how business decisions and government regulations are delaying the most promising research, and prohibiting doctors from using what is here now to save lives. Perhaps we will need lawsuits by the friends and families of
those denied access to the best treatments available. Certainly we need to develop our own understanding of the situation, and our own channels for getting things done.