Memo to The War Conference, February 26-28 1988 AIDS Treatment Research and Care Issues: The Need for Advocacy

During the last two years I have published 50 articles on experimental AIDS treatments and the public policy issues
around AIDS research. This work has illuminated critical gaps in advocacy for medical, research, and treatment-access concerns of persons with AIDS, ARC, or asymptomatic HIV.
Many "AIDS deaths" are in fact unnecessary. For example, even in San Francisco many people known to be at risk for pneumocystis die of it without having had any preventive treatment--despite an editorial in the New England Journal of Medicine (October 15, 1987) that persons at risk should receive such treatment. And an article in the same issue of the New England Journal showed that a "salvage" therapy with two experimental drugs (trimetrexate and leucovorin) saved the lives of over two thirds of the patients for whom the standard drugs had failed. This new treatment has almost no side effects. Yet how many persons with pneumocystis have access to it if needed?
Apparently two thirds or more of the deaths from pneumocystis could now be prevented if safe, effective (though
officially experimental) treatments were used when appropriate. The basic problem is the lack of uniform standards of care. And there has been almost no advocacy from gay political organizations (or from AIDS service groups or even gay physicians' organizations) on such matters. We have relied almost solely on the pharmaceutical companies to do our advocacy for us--and their interests get pushed, not ours. Horror stories like the example of pneumocystis above are common because necessary treatments remain "experimental" for years after they are known to work, and physicians are discouraged from considering them no matter what the facts of the cases in their care.
The gay movement has understandably deferred such issues to the physicians. So has the national media. The physicians have deferred to the scientists. And the scientists have deferred to the White House--to the tone and undercurrents of national policy which scientists do not flout if they want their careers to prosper. And Reagan's White House has proved highly agreeable to forces with mixed feelings to say the least about saving the lives of those now ill or infected with AIDS.
The United States government controls much of the money for AIDS research--not only in the U.S. itself, but around the world. (Few of the large pharmaceutical companies even have an antiviral research program, let alone and AIDS program.) And in the U.S. itself, Federal agencies also control an immense network of interlocking permissions necessary if any project, even in the private sector, is going to move. No wonder scientists are notoriously afraid to speak to the press on the record--unless they are acting as official spokespersons for their institutions. Pharmaceutical corporations are even more afraid to speak out, because their lifeblood is FDA approvals which can be denied at any time with no reason given.
The result is that practically every public statement from a "credible" source about AIDS research is loaded with
institutional self interest. It may not represent the speaker's (or anyone else's) real beliefs about what is wrong in AIDS treatment research and what should be done about it.
And we cannot rely on the media to challenge medical and scientific experts, as they challenge other public and private officials. The media simply defers to scientific expertise, and refuses to question what government experts say. The media has come to feel that in order to avoid raising false hope, in order to avoid being used in unethical promotions of false remedies, it will not report medical information except from official sources. That's understandable--but results in coverage which is little more than rewrites of official press releases.
With the exception of AZT, almost all of the money in AIDS research has gone into basic-science projects which couldn't possibly come into widespread use for several years or more. Scientists have a bias toward elegant research based on attractive theories, the kind of work that wins Nobel prizes. They don't like to do what the AIDS treatment underground is doing--searching the world for safe treatment options which seem to have something going for them (under any theory--or perhaps none at all because no one knows how they may work) and trying them out. We are not arguing against careful, theory- based basic research--just that there should be empirical research too.
Look at the example of dextran sulfate, an antiviral now being studied at San Francisco General Hospital. It took a
year to get this study going, as the FDA was concerned about safety. (The drug has been used in Japan for 20 years and is safe enough to be available there without a prescription. Antiviral effects were described in published papers as far back as 1964 (sic).) And this study--the only official clinical trial in the world of dextran sulfate for AIDS or ARC-
-is only a "phase I" dosage and toxicity trial. When it is finished, there will be more years for "phase II" (efficacy) and "phase III" (comparison with other drugs). (The "new rules" of the FDA, supposed to liberalize access to experimental drugs, only come into effect well into phase II, and then only if the Commissioner of the FDA wants them to; no standards for how a drug can qualify have ever been released. And no person has yet received any treatment for AIDS or ARC
under these rules.)
Meanwhile hundreds of people have obtained dextran sulfate underground and used it, usually under their doctor's
supervision. We have been told that the medical records of over 300 people are now being entered into a computer in an underground research project. Everyone agrees that it is too early to be sure--several more months of experience will be needed--but most of the doctors who are using (whoops, monitoring patients who are using) dextran sulfate in
combination with other antivirals are saying that they have never seen so much early promise, from AZT or anything else. And this drug has the advantage over AZT of having little toxicity.
In short, the practical work (for saving lives) of several years' of official treatment research is being condensed into a
few months--and with no funding at all. The key to the great effectiveness of this kind of research is that it works
together with people's efforts to save their own lives. Yet the official research establishment has little use for this kind of directly practical research. It prefers to test individual drugs for years before testing treatment combinations which have been suggested by the best judgment of experienced practicing physicians. This academic research approach reflects the interests of scientists in producing elegant work, based in state-of-the-art theory, impervious to criticism--and the interests of pharmaceutical companies, which want their new drug approved--but not the interests of patients, who need straightforward, competent testing of treatments potentially ready now.
Official research has often displayed an arrogance which considers only its own ideas, initiatives, and procedures;
which refuses to cooperate with patients' attempts to save their lives; and which belittles and ignores the practical knowledge and experience developed by thousands of peoples' long-term, committed, and often highly informed and intelligent efforts to find and use treatments for themselves.

What Can Be Done?

On these kinds of issues--illustrated by the examples of pneumocystis or of dextran sulfate--we have to advocate to save our lives; the system will not do it for us. How far would the environmental movement have come if it had no independent expertise and could not evaluate ecological or conservation issues on their merits, but had to rely solely
on government and corporate experts for its definition of reality? It would be limited to replanting trees, caring for injured animals, etc., and could almost never go to the courts, the legislatures, or to the media and public opinion, as an equal player at least as well informed on its issues as are the representatives of the corporations or government agencies.
And that is where the gay movement is today on the life-and-death issues surrounding AIDS treatment research,
development, access to treatments, and standards of medical care for persons with AIDS. We can only support people through the dying process, and have not touched the very addressable issues that determine life or death.
How many medical or scientific experts do all of the organizations represented at The War Conference together have
on their staffs? Full-time, paid, that is, so they don't have to depend on grants or salaries from anyone else, and can
formulate independent views.
We have assumed that on something so serious as AIDS treatments and research, everyone is working together, and therefore we can accept the official experts' views as delivered, we don't need independent analysis or advocacy.
Nothing could be further from the truth. We obviously need advocacy on civil liberties issues surrounding AIDS. We need it just as truly on the medical and scientific issues reflecting research and patient care.

Notes:

(1) A few AIDS organizations like AmFAR already have access to scientific and medical experts. AmFAR does excellent work, but it funds laboratory science, seldom or never clinical studies. And AmFAR is unlikely to advocate, lobby and litigate for changes in medical or regulatory practices, such as improved standards of care for persons at risk for pneumocystis, or immediate trials of promising combination therapies without years of preliminaries with single drugs.
(2) Today the FDA approved trimetrexate/leucovorin therapy discussed above for pneumocystis, under the new rules for "treatment IND" (Investigational New Drug), in cases where standard drugs could not be used. This is the first approval of any AIDS drug under these rules, which were intended to speed access to new drugs for serious or life-threatening diseases--over six months after the rules were published.
We could interpret this approval as proof that the FDA is doing its job and we don't need to be involved. Or we could
ask about the dozens of other drugs (such as fluconazole for cryptococcal meningitis) which clearly should be more
available. We could ask why trimetrexate wasn't made available last October when data clearly supporting it was published (reference above); was the announcement timed to correspond with an AMA-sponsored conference on access to new drugs, and the Presidential Commission's hearings on AIDS drugs, which both occurred in the same week as the announcement?
We could ask if trimetrexate can finally be tried for cryptosporidiosis, where it would very likely be effective.
And above all we could monitor how many persons with pneumocystis who need trimetrexate and have no other option but death actually have access to it in the future.

Three Recommendations

(1) Improve liaison and communication between gay political organizations and treatment-oriented organizations
such as AmFAR, Community Research Initiative, Project Inform, and gay physicians' organizations. The War Conference should set up a task force to facilitate such communication.
(2) Create an advisory board of scientists and physicians as a resource on scientific and medical issues for gay
political organizations. Choose members able and willing to break with established views when appropriate.
(3) When funding permits, the gay political community needs a research and advocacy organization which includes
scientists and physicians on its staff.