Condemning Many to an Early Grave : AIDS: Unconscionable flaws in drug trials deny the poor access, while allowing many firms to reap benefits at no cost.

The estimated 1.5 million Americans infected with the AIDS virus are in a desperate race against time. Without treatment, most people with the virus progress to serious, often fatal illness within seven years. Most of those afflicted now were infected about seven years ago.

For this reason, there has been no more urgent agenda in the communities affected by AIDS than the creation of swift access to any promising therapy.

This is a complex issue that involves striking a delicate and admittedly risky balance between ensuring that any drug made available to the public is safe and preserving the integrity of the time-honored clinical-trial process and saving hundreds of thousands of lives.

A great deal of progress has recently been made. There has been much fanfare over the planned early release of some new AIDS therapies, most notably the drug DDI, before full approval by the Food and Drug Administration.

But there is a key element that has been missing from discussion of the issue. To date, early-release programs have been available only to those who can afford them. Excluding the poor--and by extension, the exclusion of the minority groups disproportionately affected by AIDS--is a basic flaw in the early-release process. That flaw may condemn thousands to an early death if not addressed now.

Poor people are excluded from early drug-release programs because of two crucial and easily correctable flaws in the design of these programs.

First, patients enrolled in early drug- release programs are required to submit volumes of laboratory data documenting how well the drug is working, as well as the extent of any adverse reactions. Drug companies participating in the programs provide the drug free (they cannot legally market it before approval), but they do not pay for any of this required lab work or for the doctor visits that must accompany it.

Certainly the collection of this data is in the interest of both the public and the patient. But it is also in the economic interest of the drug company, which will use the data to build a case for the drug’s eventual licensing and marketing.

Because the manufacturer directly benefits from the collection of data, the firm should pay for it as part of the cost of drug development. Failure to do this has cut thousands of people out of the early DDI trials, in which the cost of the lab work alone is about $600 per month per case.

Second, these programs require an ongoing relationship with a doctor. For the millions of medically indigent people in California who rely on county and community-based clinics, this is neither an economic nor a cultural reality.

In the case of DDI, the access problem has been exacerbated by restriction of the drug to a very narrow range of the most desperately ill patients. HIV is a relentlessly progressive infection. For thousands of people at many different stages of the illness, the one approved drug, AZT, no longer works. If we restrict DDI to a handful of people in the last stages of AIDS, we condemn tens of thousands of others to the same fate.

Federal officials, with substantial community input, are working on a new kind of early-release program called parallel track. Under this plan, once a drug has passed safety trials and shows reasonable signs of efficacy, the drug would proceed on two tracks: more research and early release to those who do not qualify for, or have access to, the research trials.

But the parallel tracks must be different in specific ways to really benefit everyone in need. Parallel-track drugs should be made available not only for private patients but through community clinics and county hospitals.

Consortiums of physicians in poor communities should be permitted to certify patients for eligibility. Paper work should be condensed and streamlined. Drug companies, which will profit the most, should be required to pay for the lab work. And people at any stage of HIV who have no other alternative should be allowed to participate.

If these steps are not incorporated into the parallel track program, it will be one more early-release program that benefits a limited number of predominantly white people. AIDS activists--united as never before--will not stand for that. We have come too far, and seen too dreadful a loss, to settle for a program that helps only a few. More than a million lives are at risk. All of them, regardless of race and income, deserve a chance to be saved.