AIDS Treatment Research Policy: What Must Be Done To Save Lives?

(Statement distributed at the Lesbian and Gay Health Conference and AIDS Forum, Boston, July 1988)

For over two years we have published biweekly articles on experimental and "alternative" AIDS treatments and research, in the San Francisco Sentinel and as AIDS Treatment News. We could not come to Boston this July, so we prepared this statement to contact health organizers about what is needed in AIDS research policy, how we can help, and how you can help.

Barring a miracle, hundreds of thousands of people in the United States alone are expected to die of AIDS over the next several years--and the Federally controlled research establishment as it is currently operating will have little
impact on this catastrophe. No one disputes the projections of what will happen without better treatments. And just last week FDA Commissioner Dr. Frank F. Young told Senator Kennedy's Senate Committee on Labor and Human Resources that he expected little to come out of the official drug development process in the next three years. In other words, hundreds of thousands of deaths are virtually inevitable under current policies.

Everyone agrees that these predictions are horrifying. The question is, are they inevitable?

Few now dispute that U.S. public policy has written off almost everyone who is now ill or HIV positive. National
policy has consigned these people to death with remarkable equanimity, with no serious debate, and no serious effort to develop alternative strategies for a different outcome.

In over two years of researching these matters and publishing over 60 articles on AIDS treatments, we have never
found any compelling scientific or medical support for believing these deaths are inevitable. Instead we have found that commercial and political reasons account for the continuation of policies which will allow hundreds of thousands of deaths.

For example, no HIV treatment has been approved since AZT, and no new approvals are now in sight. But meanwhile, dozens of unapproved, "underground" AIDS treatments have acquired a grassroots following, most with little or no commercial promotion. Solid evidence that these treatments work is admittedly scanty. But the evidence that they don't work is far scantier, often nonexistent. The research establishment simply assumed these treatments do not work, without evidence, because the ideas did not come from the mainstream of corporations, agencies, and professionals--a network which does not pursue leads unless they have commercial potential, or relevance to elegant, commercially desirable science such as biotechnology.

Besides the basic research in fields such as virology, which is already being done well, we need a mechanism to test dozens or even hundreds of attractive treatment leads which are available now, in small, fast (but well designed and well
managed) scientific clinical trials. Any treatment known to be safe, and which acquires either a significant grassroots or scientific following, should be tested.

We may not find a cure this way. But we probably will find therapies to restore health and slow the disease process, perhaps indefinitely, for most people. Then when basic research does find a cure, perhaps in five or ten years, these people will be alive to benefit from it. And billions of dollars in medical costs for hospitalization and care of the dying might well be avoided.

Money isn't the problem; the cost of what amounts to an assembly line for mass production of small clinical trials would be modest. Most of the potential treatments themselves cost little. The problem, rather, is that the kinds of trials
needed to save lives in this emergency do not fit into the conventional way U.S. drug development is done. The small trials suggested above, for example, might not count toward FDA drug approval--especially if there is no sponsor to pay the $80 million to $120 million generally recognized as the cost to develop each new drug through final U.S. approval. (These trials could contribute indirectly, however, by focusing attention on anything found to work dramatically well.) And
releasing drugs without full approval would threaten the investors who have put millions of dollars into the conventional drug development and approval process, threaten regulators who have built their careers on it, and even threaten consumer protection advocates who have made a religion of keeping drugs off the market and away from people efore
full proof of efficacy--though everyone knows that even when the drugs do work such proof takes years, and is so cumbersome that it may never happen at all. These are the commercial and political obstacles which delay research for years when it could otherwise take weeks or months.

Instead of perfect proof of efficacy, we need practical trials which support patients and physicians in the treatment
decisions that they are already making anyway.

Such trials have already begun on a very small scale through organizations like the Community Research Initiative in
New York and the County Community Consortium in San Francisco, and through the practical experiences of individual physicians. Therefore we do not need to lobby for something totally new, but rather we need to expand a process already taking place, and to focus some of the central energies of this nation on it.

The first and most important step your organization can take to contribute to this effort is to develop in-house expertise in some aspect of AIDS treatment research policy, somewhere within your organization. Without such knowledge, you will be forced to accept at face value views and analysis by experts dependent on the existing system, analysis loaded with the institutional interests of the most powerful players in the $550 billion dollar per year medical industry. No serious advocacy can operate without its own centers of expertise. The AIDS service community ignored treatment advocacy for the first six years of the epidemic. Fortunately the tide has begun to turn.

We need not overthrow the system, only make room at the negotiating table for one more party. The fortunes, the
empires, the turf wars, the games, the maneuvers, the coups, all will continue. But the lives of hundreds of thousands of
people must also count when the real decisions are made.

To discuss how we can work together to promote national treatment strategies for saving lives instead of writing people off, call us at AIDS Treatment News.