Subject: Hypericin; Megace; Drug-Trials Debacle Date: Apr 21 1989 (1318 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1989 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue # 77, April 21, 1989 CONTENTS: [***** appears here at each new item] About This Issue Compound Q (GLQ223) Hypericin Update Megace Caution The Drug-Trials Debacle -- and What to Do About It (Part I) Announcements: AIDS TREATMENT NEWS Institutional Subscription Rate San Francisco: Healing Alternatives Foundation Moving May 2 Denver: Community Research Initiative Being Organized Terry Sutton: 1955 - 1989 ***** About This Issue AIDS TREATMENT NEWS skipped its scheduled April 7 publica- tion; the last published issue was #76, dated March 24. All sub- scriptions will be extended one issue to compensate. We never cancel an issue because of lack of news to report. At this time there is more news than ever, more than we can keep up with. We skipped the last issue because of the unusual diffi- culty of integrating and making sense of what is going on at the present time. Today we have the best news ever on treatment developments. But the human and organizational failures in both the medical- research establishment and the AIDS community itself are so pro- found that it is hard to see how the potential advances now in view will get to the persons who need them, except through grassroots or underground movements. These human and organizational failures are not new; they have been pervasive since the beginning of the epidemic. But today's improved prospects for treatment development are greatly increasing the cost in human life of squandered opportunities and institutional bankruptcy. In "The Drug-Trials Debacle" (below) we provide a simple mathematical model supporting a conservative estimate of fifty thousand unnecessary deaths over the next several years -- bar- ring policy changes or lucky developments, such as a much better treatment becoming available underground. We show that behind the flimsiest fig leaf, provided as a service for those who prefer denial, the research establishment has written off people with AIDS. Besides the remarkable lack of urgency, we propose that the crux of the problem is a scientific and medical issue, in which the research establishment is correct in its own terms, but wrong in its choice of terms. We show that the refusal to accept the fact that patients and physicians must and do make decisions under uncertainty -- and the narrow insistence that all drug-treatment research be geared to developing statistical proof of safety and efficacy -- has inadvertently turned the commend- able effort to develop a more proven, scientifically-based medi- cine into a gruesome public disservice. We will suggest practical ways, through coalition building and through community-based research, for bringing the real issues of AIDS research into the light of day where they can be discussed and decided on their merits. The interview with friends of Terry Sutton, a San Francisco treatment activist who died this month, brings a human and spiri- tual perspective to the issues of drug access and clinical tri- als, and of the AIDS community's slowness to face these issues and insist that deficiencies be corrected. ***** Compound Q (GLQ223) In the last few weeks a potential AIDS treatment, so far tested only in the laboratory, has generated enormous public and scientific interest. We have followed compound Q (also called GLQ223) and do agree that it is important (we listed it as one of eight treatments to watch in 1989, in our January 13 issue). But we are not yet ready with an in-depth report. Instead, this note will refer readers to authoritative, accessible published infor- mation -- and also include cautions about use of a similar drug from China, should it become available. The reason for the interest is that laboratory studies sug- gest that compound Q might kill infected macrophages, and elim- inate this major reservoir of HIV from the body. No other treat- ment has been found to do so. Two good, readily-available articles summarizing information on compound Q were published in The New York Times, April 18, 1989, Medical Sciences section, and Business Week, April 24, 1989, page 29. For technical background, see the article by Michael S. McGrath and others, "GLQ223: An Inhibitor of Human Immunodefi- ciency Virus Replication in Acutely and Chronically Infected Cells of Lymphocyte and Mononuclear Phagocyte Lineage," Proceed- ings of the National Academy of Sciences, USA, April 15, 1989. Also see the United States Patent, number 4,795,739, date of patent January 3, 1989. The active ingredient in compound Q is a protein called trichosanthin, which is extracted from the root of a Chinese cucumber, Trichosanthes kirilowii. It must be given by injec- tion. This protein is also used in China to induce abortions, and to treat ectopic pregnancy, hydatidiform moles, and one particular kind of cancer, choriocarcinoma. (For an overview of the Chinese medicinal use of trichosanthin, see Yu Wang and oth- ers, "Scientific Evaluation of Tian Hua Fen (THF) -- History, Chemistry, and Application," Pure and Applied Chemistry, volume 58, number 5, pages 789-798, 1986. "Tian Hua Fen" is the name of the herbal preparation from which trichosanthin, the active ingredient, can be extracted.) Injecting impure preparations of the protein could cause fatal side effects. In China there are three different different grades of trichosanthin prepared for injection: crude extract, purified extract, and crystalized, which is the highest purity. Only the crystalized form can be used safely; the others cause severe side effects. (Animal tests cited by Wang and others, reference above, showed a lethal dose to be only three times higher than the effective dose for the least pure grade, only six times for the intermediate, so-called "pure" grade, but over 75 times higher than the effective dose for the purest, crystalized grade.) Fortunately it is fairly easy to test for impurities, using a standard chemical technique called gel chromatography, so it should be straightforward to test that a drug claimed to be the "crystalized" grade really is. We have heard that side effects (of the Chinese "crystal- ized" grade) can include fever, muscle weakness, and possible electrolyte imbalance, lasting 12 to 18 hours. These problems may not start for about 12 hours. Because of the possibility of electrolyte imbalance, the patient must be monitored by a physi- cian, so that treatment can be given if necessary. Wang and oth- ers (reference above) mention 1,042 cases of human use of the crystalized grade, by intra-amniotic or intramuscular injection, in their paper published in 1986. They said there were no signi- ficant side effects; a low fever of 37.5 degrees occurred in 79 percent of the cases. (Since there are no side effects of com- pound Q in animals unless the dose is extremely high, the side effects of the Chinese crystalized version may result from some remaining impurities, or from the intended killing of target cells, which presumably would not occur in animal toxicity tests.) There may be additional precautions. For example, repeated use could conceivably cause anaphylaxis, although no such problem has been seen in animal tests. We do not know if there is any Chinese experience with repeated use. This drug may be dangerous, and must not be used without knowledgeable professional supervision. A story widely reported in the press claims that six people in Florida used a Chinese version of compound Q, and had to be hospitalized due to side effects. We have heard serious doubts about the truth of this rumor, and have not been able to confirm it. We plan to publish further reports on compound Q in future issues. ***** Hypericin Update AIDS TREATMENT NEWS reported about hypericin, a chemical in the St. John's wort plant which has shown antiretroviral activity in laboratory and animal tests, in issues number 75, 74, and 63. In the last two months, a number of people have started using commercially-available St. John's wort extracts which have been tested and found to contain significant amounts of hypericin. It is too early to be confident that the treatment is valuable, but the results continue to look good: * Of the handful of people who were P24 antigen positive before starting hypericin, and had another P24 test after using it and reported the results to us, every one either became P24 negative, or had a greatly reduced antigen level. Some were using AZT in addition to hypericin, others were not using AZT. (Note: as we went to press we heard of two cases in which P24 antigen failed to improve after use of hypericin. We do not know how long it was used, or what dose.) P24 antigen, a measure of HIV activity, only occasionally becomes negative without treatment. AZT is known to reduce its level. * Almost everybody whose results have been reported to us has had at least one dramatic, unexpected improvement in symptoms (except of course for those who were asymptomatic, who had noth- ing to improve). However, many have also had other symptoms which failed to improve. Our current impression from the few cases reported so far is that improvements might be most likely to be seen in increased energy level and reduced fatigue, neuropathy, certain cases of diarrhea but not other cases, weight loss, and (as already dis- cussed) P24 antigen levels. T-cell counts seem to improve, very slowly if they start from very low values, more rapidly oth- erwise. Dr. David Payne in Mesa, Arizona, who has the most experi- ence with hypericin with 70 patients now using it, believes that improvements are least like in symptoms which may be autoim- mune, such as low platelet levels or certain skin rashes. We have also heard of other symptoms failing to improve (for exam- ple, one case of KS, and one case of diarrhea), but there are too few reports so far for a pattern to have developed. * We have not heard of any case of a person believed to have been harmed by St. John's wort extracts. We have received one report of slightly increased sensitivity to sunlight, and several of drowsiness, especially with large doses. AIDS TREATMENT NEWS #75 reported one case of a patient taken off of hypericin extracts by his physician because his liver enzymes were found to be too high. Since then we have heard of another case of elevated liver enzymes; this patient was using many drugs, in addition to hypericin. There is no way to be sure whether or not the hypericin (St. John's wort extract) was responsible. However, Dr. Payne has found no evidence of any such problem in his 70 patients using hypericin, even though he has been looking for it. As a precaution, we continue to urge that anyone using hypericin be monitored by a physician, with the monitoring including a blood-chemistry panel. Doses There is still much uncertainty about the best dose and schedule for using hypericin. Dr. Payne has increased his dose slightly, from 120 drops a day of the Hyperforat tincture to 160. (Some of his patients are using a different brand, Yerba Prima St. John's wort tablets, which is less expensive and easier to obtain in the United States.) Because animal studies suggest that less frequent or inter- mittent doses might work better, some of Dr. Payne's patients are trying an intermittent schedule. They are taking two of the tablets every four hours on Monday and Tuesday only, and no hypericin during the rest of the week. (The four-hour schedule does not include the middle of the night, so the total dose comes to ten tablets each day, 20 total for the week. Hypericin is believed to be eliminated slowly from the body, so some will remain for several days or weeks.) As more information about hypericin becomes available, we will report it. ***** Megace Caution Issue #76 of AIDS TREATMENT NEWS announced recruitment for a study of Megace (megestrol acetate) through the San Francisco County Community Consortium. The goal of the trial is to deter- mine whether Megace, a prescription drug used to treat breast cancer, also has the potential to enhance appetite and weight gain in people with ARC who are experiencing cachexia, or wasting syndrome. James Kahn, M. D., the principal investigator of this study was notified earlier this month by the manufacturer, Bristol- Myers, that one participant in another Megace study had developed a severe rash covering most of his body after eight days of Megace, 1200 mg each day. The rash was later diagnosed as Stevens-Johnson Syndrome. It was treated with benadryl and steroids and resolved slowly. Because the participant had a diagnosis of AIDS and had been receiving other medications, there is not a conclusive link between the rash and Megace. Neverthe- less, Dr. Kahn felt that we should caution people on Megace to be aware of any allergic reactions (which must be seen immediately by a physician). Dr. Kahn can be reached at 415/821-5531. The Consortium trial is still open, and as before, all participants will be closely monitored by nutritionists, nurses and physicians. Those interested can call Helen Mudie at 415/821-5495 or Ann Conroy at 565-6649. ***** The Drug-Trials Debacle -- and What to Do About It (Part I) by John S. James Today the news is better than ever on AIDS treatment developments. But even the good news cannot dispel a widespread despair that no matter what comes out of the labora- tory, the treatments will not be tested rapidly, and will not become available to physicians and patients in time to prevent massive, unnecessary deaths. One long-term survivor and treatment expert noted recently that almost nothing was being done to save lives. And a leading AIDS physician commented off the record that the research com- munity had convinced itself it would take ten years to cure this disease, and that "they want to milk the grants and appropriations." AIDS TREATMENT NEWS has long criticized the treatment- research establishment for having written off those now ill with AIDS or HIV, and for the remarkable lack of urgency about saving lives. Recently we have had more contact than previously with this establishment, and we have found the situation even worse than we had realized. So entrenched and near-universal is the commitment to unworkable viewpoints, approaches, and programs, that in meetings and conversations we must temporarily suspend our own view of what is happening, and operate from the prevail- ing mindset in order to allow any communication to take place. The real issues of how to save lives in this epidemic are so far removed from the conventional wisdom of the research and regula- tory professionals, that if these issues are put forward in meet- ings, no dialog is possible. Many professionals as individuals would want to challenge the prevailing ideas; but they have lacked a conceptual infrastructure that is developed enough to hold its own against the conventional views -- views which started with the inevitable deaths of those now ill, accepted a priori without looking at facts or doing any analysis. Here we will outline the real issues as we see them, and suggest analytical tools for bringing these issues out of their current limbo and into the light of day, where they can be con- sidered openly and decided on their own merits. In particular, this article will: * Show that, barring a miracle, fifty thousand unnecessary deaths over the next several years is a conservative estimate of the cost of continuing with current policies and directions. * Provide a simple mathematical model which anyone can use to calculate the number of unnecessary deaths caused by any given treatment research and access delays. We will also show how to use this model to analyze proposals for regulatory reform, how to do the arithmetic to determine whether or not a given proposal could possibly help to prevent these deaths, even if it worked perfectly. * Show that even if an AIDS "penicillin" is developed -- a dramatically successful new treatment -- all bureaucratic incen- tives would be not to release it, but rather to conceal it for as long as possible. We will show that such concealment of dramatic breakthroughs may have happened already. * Explain the crucial scientific dispute which underlies these problems. We will show that the research establishment is right, of course, in its own terms -- but wrong in its choice of these terms, and in its uses of them. We will show that the fun- damental dispute is not a scientific but a human one -- rooted in the failure of academic researchers to acknowledge that at least for now and for some time to come, patients and physicians must and do make decisions under uncertainty -- and that trials designed to statistically prove isolated drugs safe and effective after several years may serve the interests of drug companies, the regulatory system, and research professionals, but that there are much better research strategies for supporting the actual decisions which must be made now in the course of medical prac- tice. * Suggest examples of the kinds of research which need to be done. We will show that much of it is legally possible in the United States today, and can be done very economically, without the financial support of the research establishment, with money raised directly from the community. We will also show that some of the research needed cannot be done in the United States under the current regulatory climate -- and that the AIDS community must let the world know that other nations cannot rely on the United States to do anything in these areas, but must do their own work independently. * Show where to start in building a coalition to bring the real issues in AIDS research into the open, to force an open choice: a research effort oriented to saving lives vs. writing people off a priori. Estimating Unnecessary Deaths: A Mathematical Model How many deaths are caused by each month or year that red tape, malice, or unworkable policies or systems delay AIDS treat- ment development? A simple mathematical model provides rational estimates. We propose this model as an intellectual tool to help in analyzing the costs and benefits of public policies (or lack of policies). AIDS deaths have increased approximately at a geometric progression -- meaning that they tend to double, and then dou- ble again, and so on, during the same fixed amount of time. (Fortunately the doubling time for AIDS deaths had increased somewhat over time, meaning that the death rate is not exactly a geometric progression; this variation does not greatly affect our model, however.) We have not looked up the latest epidemiologi- cal figures, but an estimate of national (or world) AIDS deaths doubling every 18 months is close enough for the purpose of illustrating this model. In any geometric progression (or any other sequence which doubles repeatedly), it turns out that the last doubling accounts for at least half of the cumulative total -- no matter how long the sequence has gone. To illustrate with simple arithmetic, if we take the geometric progression 1, 2, 4, 8, 16, 32, 64, 128, 256, the last value, 256, is very close to half of the total of all the numbers, which is 511. No matter where we stop the sequence, the last doubling will account for half of the grand total of all the numbers. How does this model apply to AIDS deaths? Someday there will be a cure or effective treatment. What the model shows is that no matter when the cure is found, the last doubling before that time (about 18 months) will account for half of the cumula- tive total of AIDS deaths throughout the entire epidemic. Therefore, a delay of 18 months anywhere in the treatment research and development process will account for half of the total deaths of the epidemic. An unnecessary delay of 18 months, anywhere in the political mobilization, funding, coordination of research, conducting of the trials themselves, analysis of the data, or regulatory approval, means that half of the total deaths which will ever be due to AIDS will be unnecessary. A delay as long as 36 months (3 years) in treatment development will cause three quarters of all the deaths of the epidemic -- deaths which would otherwise not have occurred. If there is no single cure, but instead a gradual, incremen- tal improvement of treatments which brings the deaths to an end, then the calculations become more difficult, but the bottom-line result of the model does not change. There have been fifty thousand AIDS deaths in the United States so far. No major drugs are likely to come out of the regulatory pipeline for at least another 18 months -- during which time an additional fifty thousand deaths will occur. Therefore, the cost of any unnecessary 18-month delay, in research or in patient access to whatever treatment turns out to be effective, can be estimated at fifty thousand lives. But what delays are unnecessary? The research establishment tells the public that there are none -- that we are going as fast as we can, that the only issue is whether to compromise the stan- dards of Good Science, due to public impatience, and replace it with Bad Science. Researchers who break with this party line will jeopardize their future projects and future careers, so few will speak out. Journalists, politicians, and others involved with public education and public policy naturally tend to follow the consensus of recognized scientists on scientific questions -- especially since one could otherwise be accused of wanting to weaken the standards of science. Good Science, like God, patrio- tism, and the flag, are rhetorical devices designed to be impos- sible to argue against -- devices often used in the absence of a good case on the merits. Later in this article we will show how the most important drugs in the pipeline could be tested and made available in weeks or months, not the years which will be required under present procedures. First, however, we must provide some additional background necessary for the defense of this statement, which understandably may seem preposterous to the reader. How, one might ask, could drugs be tested properly in weeks, when the scientific establishment has said that such testing takes years? What Will Happen When a Cure Is Found? Researchers have told us that if an AIDS "penicillin" is discovered -- a drug which works dramatically well -- it will be made available to patients very quickly. However, it is hard for us to understand how all existing procedures will suddenly be suspended, in favor of a new set of procedures which so far as we know have never been written down or even thought through, let alone implemented as public policy. Governments, corporations, and professional bodies seldom work that way. In fact, all bureaucratic incentives would be not to release such a drug, but rather to conceal it. To release it would mean that some person or institution would have to take responsibility for a momentous decision, with little preparation or lead time -- something bureaucracies seldom do. It would be very difficult to develop a consensus to abandon all existing procedures and move into uncharted territory. But another consensus would be easy to reach. Almost by definition, the research and political establishments agree that underground, unauthorized use of a treatment is undesir- able. And unless the treatment could be tightly controlled, a large grassroots use of it would be inevitable if the public knew that the drug clearly worked. There would also be extensive pol- itical activity, which would be troublesome to the establish- ment. This means that the incentives built into the system would be to conceal an effective drug from the public, not to release it. Large-scale clinical trials cannot be hidden, because too many patients are involved. Successful concealment is only pos- sible at the early stages of a treatment's development, before anyone knows for sure that it works. Phase I trials could either be postponed, or drawn out. We are not suggesting that anyone would do this deliberately to have people killed. But institu- tional pressures lead inexorably toward this kind of institu- tional denial, motivated by the normal bureaucratic fear of mak- ing major decisions and being forced unprepared into uncharted territory. Long-term concealment of major advances in AIDS treatment may have happened already. One example is Compound Q. On April 18 The New York Times reported that "The researchers were so afraid of raising false hopes in people with AIDS that they did not disclose their findings for two years, until they were ready to test the drug in people." One of the researchers explained, "If I told you that we had found a drug that selectively kills HIV-infected cells in a single dose but then told you that it won't be available for two years, you'd go nuts." However, a version of the drug was already available and in routine use in China; it could easily have been tested in people two years ago, as soon as it was found to work in the test tube. But in fact, the secrecy around the Compound Q research largely ended on the day the patent for it was issued -- suggesting that the wait for patent approval may have been what really held up not only release of the laboratory results, but also the testing in people with HIV (which could not have been kept secret) for as long as two years. (FDA rules would have accounted for some portion of this time even if the patent were not an issue.) Companies normally keep their work secret until they receive a patent. Otherwise, rivals could learn what they were doing and file their own patent application. While the original party would normally be protected because it filed first, its applica- tion might be found to be defective and thrown out, losing its priority and perhaps losing the patent to the rival. The time taken to receive a patent is variable, because there may be negotiation with the patent office over specific claims. During the approximately two years of quiet development of compound Q, laboratory and animal research did proceed. But in view of the prior human experience in China, where the same active ingredient is given by injection in comparable doses, laboratory work has little practical relevance to the safety and usefulness of the drug as an AIDS treatment. Only tests in patients can show how well it can work. Such tests will start now, with tiny, useless doses of the proprietary drug, much as they could have been done two years ago with active doses of the Chinese version. If Compound Q does work as well as some people think that it might, this delay in its development could by itself account for half of the total deaths to date (see the mathematical model above). We should not blame the developers, who seldom have con- trol over the key decisions. The fault is with the lack of national will to treat the epidemic as an emergency and make the system work. And if, as expected, it takes yet another two years go get compound Q through clinical trials before it becomes widely available, then we can add another 50,000 unnecessary deaths, from this second delay alone. For if the drug does have dramatic effects, it would take only weeks at most to discover that fact. And long-term toxicity is little danger in a drug already widely used in humans elsewhere without any such problems. Certainly it is less of a danger than untreated AIDS. Of course, compound Q may turn out not to work at all. But eventually, whatever drug finally does work will face the same kinds of delays. The public policies in effect today make the massive unnecessary deaths which we have predicted inevitable, regardless of whether compound Q or some other substance turns out to be the particular occasion where the delays cause the deaths. Another example of a major advance in AIDS treatment con- cealed from the public and from many physicians is fluconazole (an antifungal for opportunistic infections, not a treatment for HIV or AIDS itself). When AIDS TREATMENT NEWS first reported about fluconazole over 18 months ago (September 25, 1987), it was so little known in the United States that few physicians had heard of it. Yet even at that time two thousand persons in Europe had used the drug. Today fluconazole is approved in Eng- land; yet in the United States many physicians have never heard of it, and few know how to get it for their patients if they need it. A third example of deadly concealment of treatment informa- tion is pneumocystis prophylaxis. This treatment, using aerosol pentamidine, bactrim, or other drugs, is now becoming the stan- dard of care for persons with AIDS. But what few people realize is that pneumocystis prophylaxis (with bactrim) was already the required standard of care for persons at risk for pneumocystis for any reason except AIDS -- ever since the 1970s, before AIDS was known. A few physicians have used this treatment all through the epidemic, and their patients are among the long-term AIDS survivors today. Most patients, however, were never told about this option. The point of these examples is that major AIDS treatment advances can be and are concealed from the public, and sometimes from the medical and scientific communities, at major cost in loss of human lives. Many people believe that the commercial pressures of capi- talism are driving drug research and development as fast as it can safely go. In fact, even today the AIDS market is considered too small to be very profitable. Companies are better off wait- ing for this market to expand. They know that nothing will beat them to the market, because they can see for months or years ahead what is coming (or not coming) through the clinical-trials pipeline. This long pipeline delay, required by FDA rules, rationalizes and protects the investments of the entire pharma- ceutical industry. This is why the clinical-trials pipeline is not being seriously shortened, although empty "reforms" (those which in practice could not save lives in the foreseeable future, even if everything went right and the reforms worked exactly as they were designed to) may be provided as public-relations diversions. AZT, the only AIDS drug ever allowed to move rapidly through the clinical-trials pipeline, was unique in that there was no competitive product ahead of it to be threatened. However, there will never be such a slot again. (Note: Part II of this article will appear later.) ***** Announcements: AIDS TREATMENT NEWS Institutional Subscription Rate AIDS TREATMENT NEWS is starting a separate subscription rate for businesses and organizations. This rate is $150. per year (vs. $100. previously). The regular individual rate, and the reduced rate for per- sons with AIDS or ARC, are unchanged. We have never raised the reduced rate in over two years of publication. We will continue to give a free subscription to each PWA Coalition. San Francisco: Healing Alternatives Foundation Moving May 2 The Healing Alternatives Foundation, a San Francisco buyer's club and AIDS treatment library, will move from its Church Street office to a new location, 1748 Market Street (at Valencia), and be open for business there on May 2. The phone number will remain the same, 415/626-4053. The new office is wheelchair accessible, and near the Van Ness Metro station, and several major bus lines. It adjoins the new location of Quan Yin Acupuncture and Herb Center. Healing Alternatives will also fill orders by mail; an 800 number will be installed. A grand opening is set for Saturday, May 6, from 6-8 PM at the address above. Denver: Community Research Initiative Being Organized The Colorado Health Action Project (CHAP) is organizing a community research initiative to assist in development and coordination of clinical trials in the Denver area. Medical professionals and community members who are interested in participating can contact CHAP at 303/894-8650, or at P. O. Box 18247-148, Denver, CO 80218. ***** Terry Sutton, 1955 - 1989 Terry Sutton, 33, who died of AIDS on April 11, 1989, had quickly become one of the most important AIDS treatment activists, helping to make foscarnet and other treatments more available in San Francisco. He is also the one who suggested blocking the Golden Gate Bridge, which took place in the early morning of January 31. We spoke with two of Terry's close friends, Marty Blecman and Michelle Roland, asking them to speak about whatever came to mind. The following is part of that 90-minute interview: Marty: Terry took on the fight of drug access, and went up against what many seem to feel are overwhelming odds, an overwhelming bureaucracy. Terry saw it clearly, cleanly, and simply: Unless I get drug access, the treatments I need, my life will be shorter and I won't be here for the cure. People need to understand that there isn't an army of activists fighting for this access, and that people can be power- ful as individuals. Terry Sutton was not Gandhi, he was just an average guy who used to teach school, who came down with HIV and got his power -- and spiritually wouldn't let a government that did not care about him, wouldn't let even a community that did not seem to care about him, stop him from going after what he wanted for himself, and ultimately for everyone. Foscarnet could treat CMV, and allow him to go back to AZT, which could keep him alive longer. Terry was determined to stay alive until there was a cure. But he was realistic, that prob- ably he didn't have enough time to do that. Finally he went into the hospital. CMV was on the ravage, and he was told that he would lose sight in his right eye. So they went to full-dose DHPG -- what he had to do to save his sight. The result of DHPG was that his white blood cells kept drop- ping. They went so low that he eventually became septic, had an infection throughout his system. The day came when the doctor said, this is it, the antibiotics aren't working. Terry died a fighter. He was not giving into death and being metaphysical about it and letting go. He was comatose throughout most of this, but the last day he came back to cons- ciousness, and he was having seizures, and was alert enough to know what was going on in the room, and he was definitely terri- fied and panicked. He was biting his tongue and grinding his teeth in seizures, and it was horrible; he died a horrible, frightening death. The irony is that he didn't have a lot of choices. When Terry wanted foscarnet, he couldn't get it. This has to change. We're in the middle of an epidemic. People don't have seven years (the usual time for new-drug appro- val -- ed.), some don't have two years, some don't have two months. The system has to recognize this and turn it around -- not take five years to turn it around, but do so now. Unfortunately it's human nature not to feel the urgency to turn it around. Those who really feel the urgency for drug access are those who are going blind, or looking at death's door, and knowing that the only thing that's going to keep them from dying is this drug. Denial plays into it, thinking it's never going to be my issue. To fight for drug access while you're healthy is saying to yourself that you might end up in a terminal position. This holds many people back from fighting. Michelle: Terry turned around on the treatment access issue when he was diagnosed with CMV. He knew he could not survive on DHPG -- he would ultimately fail that drug. He would either go blind and die of some other opportunistic infection, or die because DHPG wiped out his white blood cells, which is what hap- pened. When he was diagnosed with CMV, treatment issues were his reality. When the foscarnet issue came along, he said, "Maybe this will work. Maybe I can treat the HIV (with AZT, which can be combined with foscarnet but not with DHPG), and keep the CMV in check. I know that I can't do it with the DHPG, so why not try the foscarnet?" Marty: Terry studied the Black Plague of Europe. In mass hysteria, people were bludgeoning themselves with clubs, to ward off or deal with the epidemic. In our time that doesn't make much sense. But maybe when history looks back on the epi- demic, they'll say, "Everybody was caregivers." Terry said that he could do without the support of organiza- tions like PAWS, or Open Hand. "Take away everything, and just give me people who will fight for my life, and fight for drug treatments, to give me a drug to help me live longer. I'll take care of the rest of the support." What's wrong now is that we're eight years into the epi- demic, and the caregivers can't seem to take on the fight. Not only are they getting burned out, but they haven't got it through their heads that after they've watched so many people die, when will they say, "Enough is enough," and stand up and do something? Terry Sutton stood up, and motivated people by his anger and desperation to get a drug, and brought a whole treatment-access issue into the forefront. He had discussions with Dr. Anthony Fauci (Director of the National Institute of Allergy and Infec- tious Diseases) which moved this man to go back to Washington and speak compassionately, saying he had met with people in San Francisco, and we must change the system. That foscarnet now has "salvage protocols" in San Francisco is directly related to Terry Sutton bringing the fight forward. People have got to start telling the truth about what's going to stop the epidemic, and not what's going to support it. Michelle: I saw Terry in Washington at the Quilt. I was very uncomfortable, watching the volunteers in the clean, white clothes running around shoving Kleenex at everybody who let a little tear run down the side of their face. I wondered how many of the people willing to volunteer for this quilt, and for Shanti, Open Hand, and other support organizations, were going to show up at the FDA that Monday? Terry wouldn't walk on the Quilt. I looked at him and said, "Are you feeling it too?" We sat down and just raged on the side of the Quilt. We saw that we as a community have made this epi- demic OK. We take care of ourselves -- not only physically, we've even learned how to take care of our grief. But we're not doing anything to stop the epidemic. It's so infuriating that every- body is patting themselves on the back about how good they are, taking care of each other, and just creating this whole system where it's OK to watch people die and die and die. People had a hard time hearing that. And I told Terry, "If I ever make a panel for you, it's going to say, "Terry Sutton hated this fuck- ing Quilt." That's when he started thinking of San Francisco as not a model community -- it's a myth. First, we don't really take care of everybody in the community, as we say we do. And second, taking care of people is not stopping this epidemic; in fact, by itself, it's enabling the epidemic to continue. And nobody from the outside has to deal with it, because we're taking care of it and making it OK. Marty: I could swallow the Quilt more easily if at least they acknowledged that in the face of genocide, we must have a Quilt, to enlighten people. And in the face of genocide, we have Shanti. And in the face of genocide, we have PAWS, and in the face of genocide, we have the AIDS Emergency Fund, because society has looked at us and said, "It's not our problem," because society thinks we're faggots and drug users and blacks and Hispanics, and it's not our problem -- that we're not going to get infected because we're good, straight, clean people. When society takes a segment of the population and turns its back on them, it's genocide. Many gay men don't want to acknowledge that they're hated, despised enough to be let go by the wayside -- because that goes to the root of their coming out, and acknowledging that they're OK. The layers of denial around the epidemic -- people must start telling the truth. If Terry stood for anything, it's the truth. He told the truth about himself most of the time, the good and the bad. He told the truth about his doctors, and the treatments, and the issues, and the straight society and the gay society. He kept telling the truth, and he shut a lot of people down. But he moved a lot of people, moved them into action. He moved me into action. Everybody he touched he moved. Because he told the truth. And they didn't want to hear it, and then they went home and cried because they knew it was right. Michelle: The sad thing is that when he was screaming and shouting, "Help save my life, now, do it now, I need the fos- carnet and I can't do it by myself, you guys have to help me," it didn't happen. I'm glad that now people are mobilized around Terry's death, but it's sad that it had to take Terry's death to mobilize people to make the sense of urgency real. Terry made the salvage protocol happen, but that salvage protocol didn't work for Terry Sutton, and it isn't working for the vast majority of people who want to try foscarnet. They have to get sick enough that the drug probably cannot be effec- tive anyway. Terry knew he had to fail DHPG in order to get access to foscarnet. I watched him day after day in the hospital trace the fall of his white cells, until he said to me, "I'm eli- gible for foscarnet now." Marty: "But I'm almost dead." Michelle: When he told me his doctor was going to get him foscarnet, I wanted to support him, to say that's great, but what happened inside, I felt that if that doctor walks in with that drug I'm going to strangle him -- "How dare you offer him foscarnet now when he has 700 white cells, when he's been saying for six months that he wanted a chance to try this drug." Marty: Terry heard through one of his Deep Throats that foscarnet wasn't working for people. And the assumption was that they were so sick when they got on the foscarnet that it wasn't working. Michelle: The other issue was that you have to pay for your hospitalization to administer the drug, about a thousand dol- lars a day. You have to be in the hospital for the first 14 days of foscarnet. Marty: We need an information network among physicians. I spoke to an ophthalmologist in Los Angeles. He has a patient failing DHPG, going blind; he's trying to get DHPG to use for direct injection into the eye. The drug company said, "No, you can't have the drug." The doctor didn't know there were salvage protocols going on in Houston or San Francisco. And he's an ophthalmologist in Los Angeles. What this comes down to is that if there are five thousand caregivers in San Francisco, there's probably at most five hun- dred who would actually go to a demonstration, and maybe only 100 people who are politically activated, who are really fighting the epidemic in San Francisco. The proportion who are fighting to stop the epidemic, it's screwed up. People have got to get it, or this thing is going to go on and on. Michelle: One of the things Terry was able to do was to fight it from many perspectives. He really moved doctors; when he first met them they were willing to do placebo trials with CMV patients. And after Terry had known them for a while, they were willing to fight for ethical protocols. He motivated me to be able to move from being a caregiver 100 percent, to being able to decide to spend part of my time caretaking and part doing political work, and find more time to do it. He moved many people. There were friends in his life for years who had never done anything political, who were on the roof of Burroughs Wellcome getting arrested, who were at the FDA get- ting arrested, who were on the Golden Gate Bridge getting arrested. Marty: Terry said to his mother, "If you're not willing to fight for my life now, while I'm alive, don't you dare come to my death scene." We talked a lot about what's going on in the community. To be able to fight, you have to have a will to live. I think some- where deep down, people have lost touch with their will to live. They question what do they have to live for, and do they deserve to live. People have to look at these issues to get in touch with their power. If a government is denying you access, and a protocol is denying you access, and a doctor is denying you access, and they're killing you because you're being denied access, how can you go to healing circles, how can you go to sup- port groups, and how can you learn to live powerfully with AIDS, and live this metaphysically OK life, and go to your grave without fighting? The natural human spirit would be to fight back, to fight the death squads. If people were marching through the streets and gunning us down, we would still need support groups to deal with the grief and the anger around the death squads, but the support groups would be telling the truth about the death squads, and mobilizing people to fight them. Something has gone wrong -- a mass psychological hysteria... something is wrong with the picture. I don't know how to straighten it out, or who's going to straighten it out. What people do catch onto are squeaky wheels. Fortunately, squeaky wheels get oiled. It's that simple; if people get diag- nosed with HIV and they lay down with it, and they don't stand up for their rights, and they don't stand up for their spirit, and they don't stand up for the right to live, because they deserve it as a human being and a citizen of the United States and as a citizen of the planet, if they don't stand up for their rights, then they will get walked over. People just have to squeak, and I don't know what's holding them back -- fear, being overwhelmed. Michelle: Terry ran himself ragged. There were many break- fasts he just didn't have time to eat because he was off to a meeting, trying to straighten this mess out. And it wasn't just for him. He was very much aware of try- ing to save his own life. But when some brave soul in the medi- cal community was going to pull strings, and pull illegal strings, to get Terry fos carnet, and he wouldn't do it. If not for everyone, then it's not right. People have got to start telling the truth. And then the answer to the epidemic is clear, it's give us treatments and keep us alive. The fundraisers that go on are great -- but God forbid that anyone would do a fundraiser and give a million dollars to ACT UP. It's unthinkable. They all want to do the same thing, direct service. It's natural to want to help the people who are sick. People should. But they must realize that they'll be helping the people who are sick from now till eternity unless they start helping to find a cure, or treatments. I'd gladly take pills the rest of my life; if I could play my life out to a basically normal old ripe age, and get all the grey hair I deserve, I'll take drugs for the rest of my life. But I won't sit here and live powerfully with AIDS, and go off to healing circles and enrich my life and smell the roses and go to my death without screaming about it. Michelle: It's such a complex situation. Where do you fight? We fought the drug companies, and we went to the FDA and fought there, and we meet with Congresswoman Pelosi about drawing up legislation. Terry took the time, and spent the emotional and mental energy, to try to figure out where the appropriate targets were. He had file cabinets full of files, and phone numbers of contacts in every file. He spent hours and weeks and months, sorting that out and educating people. I feel scared about what's going to happen without Terry. We are trying to pick up where Terry left, and not let this work fizzle out, but it's a full-time job. Terry had the ability to mobilize people, as very few have. People would meet him, and you either fell in love with Terry or you didn't. If you didn't, fine, but if you did, you listened and you were moved. Who's going to be able to do that -- be able to move the doctors, the officials like Fauci, and all the people who came into his life? Who will take up the fight? It doesn't take very many peo- ple. People say, "They'll take care of it, there's ACT UP, they'll fight for me, there's Terry Sutton and he'll fight for me, there's Mobilization Against AIDS and they'll fight for me." People go on with their lives because it's hard enough just getting through the day, let alone taking on the FDA, or taking on a drug company, or taking on a major issue. But one of Terry's favorite quotes was, "If not now, when? And if not me, who?" There aren't a lot of people out there doing it. The philosophy of Terry hopefully will live on, and the peo- ple he inspired will continue to inspire other people, and the fifty thousand people who have gone before Terry will not be for- gotten. Terry didn't have a lot of patience for PWAs who weren't fighting. He would get angry with them. "How can you sit there and get infused every day, and throw up your guts on the floor, and not be willing to come to San Francisco General and sit down on the floor and get arrested? What have you got to lose?" What do people have to lose -- except their denial, maybe, and their fears? And what they have to gain is everything. You gain victories, you gain power, and you gain personal insight and knowledge, you gain control over your life, you gain hope, you gain all kinds of things from action. Plus you gain just getting yourself out of bed to do something. How many people died of pneumocystis while aerosol pentami- dine was hanging out there for two years? Michelle: He was forced into wanting that diagnosis. He didn't really have the option of going to work, but as we know, people with ARC are not acknowledged as disabled most of the time. There's no way Terry could have worked 40 hours a week. Marty: He was wasting away. Work was going to start in September, and he was freaked out. He was also freaked out when he got his diagnosis, but there was also a sigh of relief, "Now I can fight, and get paid for it" -- barely. Michelle: Then he had to ask how he could live on $600. a month. Marty: When I asked him to be my roommate, he cried. Michelle: Terry was involved in the formation of AIDS Action Pledge, and Burroughs Wellcome was a kick-off. Marty: Terry was one of the first Shanti volunteers, back around 1982 or 1983, before he knew he had HIV. He was one of the first volunteers at Kaiser who supported the AIDS ward. Michelle: He did the Kaiser work up through his diagnosis. And he would come home after going to Kaiser, and he had to talk about what he had just seen and experienced. One of the problems that Terry had, and one of the problems in the AIDS activist movement, is that he couldn't talk about his emotional experience with activists. AIDS activists are very separate from the actual experience of living with AIDS. Terry was one of the rare people who could do both of those things, but had a hard time finding people who could support him and listen to the terror and the anger and the fear and the sadness that came in that work, help- ing people die. Marty: He did a workshop by Sally Fisher called the AIDS Mastery. A friend said that after the mastery, he got in touch with his power. Before the mastery he was very shy, and quiet. The mastery lit his fire. When the "Midnight Caller" episode came up, Terry was the first one to light everybody's fire; he found out about the script, and plugged everybody into it, and became a negotiator. After "Midnight Caller," he took on foscarnet, which led to the sit-in at San Francisco General -- which of course brings up the (blockade of the Golden Gate) Bridge. Michelle: I remember Terry saying that we had to do some- thing, something really radical to shake people up; that we have to increase the militancy in the AIDS activist movement, we can't just sit in front of empty buildings or even full buildings, that's not doing it. Terry's phrase around the Bridge was, "Bridge the treatment gap." Because there were many people from different organizations represented in the Bridge, people wanted it to include more issues, so it became "AIDS equals genocide." On the day of the Bridge itself Terry was really sick. He went out there and sat in the fog, and got arrested. And after the Bridge, when everybody was celebrating and feeling really good about ourselves, Terry came home and went to bed. In my mind, the Bridge was Terry Sutton. That there were people in the community who hadn't been involved in AIDS activism before, who were willing to take the risk of shutting down the Golden Gate Bridge, infused him with a lot more hope, more belief in the possibility that people would come around and start doing this work. And partly the Bridge came off out of respect for Terry. People knew how important it was to Terry. Marty: The Bridge was a tremendous success. The media hoo- pla that swelled around it was pretty much expected. It was expected that many in our community would snub their noses at it at first, and say that these stupid people were going to turn everybody off. And it was also expected that they would turn around and get it, after they had thought about it for a while. It's like, "What have we got to lose -- and if not now, when?" And as for those poor commuters who were inconvenienced for an hour and a half, well, excuse me, my life's been put on hold. Michelle: The power that it had in the AIDS community was more important than in the general community. It shook people up in the service community, and in the Democratic clubs, and even in the AIDS activist community. It's a challenge. It said that we have to do things that are more militant, and we have to be more committed. Marty: More people have died of AIDS in this country than died in the Vietnam War, but with Vietnam it was easier to con- nect, to find the enemy. In the AIDS fight, there might be a problem because the peo- ple who feel the epidemic the most are in a constant state of mourning. They're depressed, and may be shutting down. If you lose a friend in February, and lose one the next month, and again the next week, and you can't even get through the grief and the mourning process of the last friend, emotionally you start to shut down. Maybe that's what's going on. Michelle: The other difference is that it's easier to fight for other people. When the Vietnamese are the victims, we can get out and say that our government is wrong. But when we're the victim, saying that our government is wrong is acknowledging that our government doesn't give a shit about us. People can't do that. People are so totally invested in believing that the government and the research community are doing everything that they possibly can to end this epidemic, and you guys just have to be patient, and it's a virus and we don't know that much about viruses, and on and on. It makes perfect sense why we're so invested in that. It's terribly painful to think, "My country, my government, and my society are willing to watch me die." Terry pushed us to confront AIDS as genocide. Even some activists felt, "Intellectually I can get it, but emotionally it's so horrifying, that I want to figure out all the rationali- zations why it's not true." Terry's the one who said, "You've got to tell the truth, this is what it's about." Marty: People shut down. I can talk about how Terry died, how gruesome it was, and people still keep open and listening. And I can talk about emotional things, and people still listen. But when I talk about politics, and about genocide, and about maybe getting up off their ass and doing something to stop the epidemic and facing the reality that maybe we're disliked, then they shut down. I see them drifting off into space, and looking the other way, and feeling uncomfortable, and wanting to get out and away from me. That's when I lose it. What scares me more than having HIV is watching people shut down to the truth. (We asked about the scattering of Terry's ashes at sea.) Michelle: We had balloons with "Silence Equals Death" writ- ten on them, and we let them go symbolically, to let go of Terry a little bit, of the grief. From the time we pulled out of the dock and headed toward the bridge, it was the first time since he started dying that it felt really real. I guess that's why we do these services and go through these rituals, because we need ways to accept what's hap- pening, and to deal with the reality of it. I was very upset and I cried almost the whole way to the bridge. And then when they shut off the motor under the bridge, to be underneath the Golden Gate Bridge to say good-bye to Terry was such a powerful and sad and exciting experience. I felt it from everyone; the grief on that boat, and the pride, to be underneath the Bridge doing this for Terry. Marty: We did an "Act Up, Fight Back, Fight AIDS" chant under the bridge, and another chant for Terry. Marty: Terry was a teacher and emotional support person, and he urged people continuously to get their powers of attorney signed, and their wills taken care of. And because Terry con- stantly joked about having just a mild case of AIDS and not hav- ing to get this together yet, he never did get together his power of attorney or his will. The havoc that caused throughout his hospital stay when he went unconscious was horrible -- practi- cal and emotional. It was very hard on his friends and care- givers, and on his family, and on his doctors, trying to make decisions and not knowing exactly what he wanted. Don't stay in denial about getting your powers of attorney and wills done, because "If not now, when?" Michelle: Terry asked three of his friends to do the power of attorney. And I believed and he believed that he would get out of the hospital and we'd do that. Guess what, less than one week later he was unconscious, and it didn't happen. Thank God we'd had the conversations, he had them with the three of us, so we knew what he wanted. We were able to work with the doctors and the family. Marty: The obit we wrote, it was not, "Terry died peace- fully in the arms of his friends and his lovers and went peace- fully to the light beyond." It was basically, "He died a gruel- ling, uncomfortable, drawn-out, horrible death." Michelle: That truth has to be told, too. We all live in this illusion that there's this peaceful passing. There was nothing peaceful, nothing OK or reassuring, about Terry's death. Marty: If more people were scared -- it's like, "Don't make me not scared of death, please. Don't make me not afraid to get sick, and to watch my body fall apart. Don't make me not scared to not be supported, and to be financially broke." We're putting bandaids over these natural reactions to the holocaust. Maybe we've put too many bandaids on people. I'm plugged into the AIDS Mastery, and I've seen hundreds of PWAs come through and learn to live powerfully, and get their lives back, and get out of that state. But to get beyond that, and to fight, is a different story. And that's the only way we see out of the epidemic. Unless a miracle happens. Michelle: And even with a miracle, it will take seven years to get that miracle out. Marty: And if compound Q is the answer, God forbid you are on DHPG or foscarnet or whatever. Who are they going to exclude from the protocol right off the bat, and when will they make it acceptable and accessible to everybody? When do the HIV babies get it? We're talking about people shutting down and not wanting to stand up and fight for foscarnet, when too many gay men in this town won't even get tested. How are they ever going to stand up and fight? How do you move these people from not knowing what their status is, to fighting to save their lives? People are not telling the truth, all the time, all the truth. They're putting it in candy wrappers. And when you know the truth, and you don't get the support of people around you, you start to think you're crazy. And Terry Sutton would listen to people say, "You're crazy," and then look at it and say, "No, no I'm not. This is the truth." If people want to make donations in Terry's name, they should donate to ACT UP. That's probably the closest thing to him. Marty: His experience in teaching emotionally disturbed children got him his power. All of us to some degree are emo- tionally disturbed around AIDS. He got us to understand. To get an emotionally disturbed child to calm down and listen to some- thing -- he got me calm enough to accept the fact of genocide, he affected people as a teacher. Michelle: And he could play, and he could be crazy, and silly, and have fun, and really act out. That helped us emotion- ally, too, because there was all this heavy shit going on, and then we could just crack up, with Terry. Marty: He was happy, actually. He was a pretty happy guy. Michelle: He had a lot of friends. Statement of Purpose AIDS Treatment News reports on experimental and complemen- tary treatments, especially those available now. It collects information from medical journals, and from interviews with scientists physicians, and other health practitioners, and per- sons with AIDS or ARC. Long-term survivors have usually tried many different treat- ments, and found combinations which work for them. AIDS Treat- ment News does not recommend particular therapies, but seeks to increase the options available. We also examine the ethical and public-policy issues around AIDS treatment research. ***** [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display