Subject: Compound Q; DDI; Pentamidine/Ganciclovir; Obtaining Treatments Date: May 5 1989 (802 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 #78, May 5, 1989 CONTENTS: [***** appears here at each new item] Compound Q Warning, and Update DDI Information Published Aerosol Pentamidine, Ganciclovir Recommended for Approval Obtaining Treatments from Abroad San Francisco: Community Research Alliance Receives AmFAR Grant San Francisco: Quan Yin Herbal Program Deadline June 1 Boston, Los Angeles: Peptide T Trials Recruiting The Drug-Trials Debacle, Part II: What to Do from Here ***** COMPOUND Q WARNING, AND UPDATE Compound Q, an experimental AIDS treatment extracted from the root tuber of a Chinese cucumber, has received wide publicity in the last month. On May 5 we heard the first report of a severe adverse reaction to a bogus "compound Q", apparently homemade from the root which was obtained from a health-food store, and injected. According to Martin Delaney of Project Inform, who is now warning buyers' clubs, the person almost died as a result, and was in intensive care for three days. This case occurred in Kansas City. We have also heard that some health-food stores are exploit- ing the situation and promoting a dried root or extract by sug- gesting that it contains compound Q. People should know (1) that the root also contains lectins, which are poisonous when injected because they cause blood cells to clump together, which can cause heart attacks or strokes, and (2) that compound Q (which is a protein called trichosanthin) is almost certainly destroyed by drying, so the dried root used as an herbal medicine for other purposes does not contain the active ingredient. It is generally believed that a good-quality equivalent of compound Q does exist in China, and has been used there for other purposes for several years (see AIDS TREATMENT NEWS #77, pages 1-2 and page 5). However, this drug is tightly controlled and very difficult to obtain. We have heard from knowledgeable per- sons (but have not yet been able to confirm independently) that only half a million doses a year are manufactured, all by one factory in or near Shanghai, and that some of it did reach a few persons with AIDS in the U. S. While extracting the active ingredient (trichosanthin) from the Chinese cucumber root is not too difficult for a protein chemist, there are practical prob- lems, especially the need to obtain large quantities of the fresh or frozen root, as well as the usual difficulties of setting up effective manufacturing and quality control for pharmaceuticals. Any credible, good-quality data which may develop from use of the Chinese compound-Q equivalent would be very important in speeding the authorized clinical trials. At this time, the only clinical trial planned anywhere in the world is a "phase I" study to take place at San Francisco General Hospital. This trial may be slowed by the current budget crisis of the City and County of San Francisco, since hospitalization is required for the study but there is not enough funding to staff the nursing support for the hospital beds. The San Francisco trial will also be slow because it is designed primarily to test for toxicity and determine the maximum tolerated dose, not to determine whether the drug can help patients. A tiny dose which no one believes could be effective will be tried first, followed by a wait to look for side effects. This process will be repeated several times, with a wait each time. This dose-escalation study could take as little as three to six months, or as long as a year. By contrast, "underground" users of the Chinese drug will test reasonable doses right away -- the same which have already been used in China -- so they can get results far ahead of the official trials. If such use should happen to produce credible evidence that the drug is useful in treating AIDS, then far more pressure would develop to speed the research and regulatory system and make compound Q available through authorized channels. If you have any information about anti-HIV use of the Chinese "crystalized" grade of trichosanthin, please send it to AIDS TREATMENT NEWS at the address above, or call us at 415/255-0588. We have heard that a phase II trial is now being designed, and could be started before phase I is finished. We will continue to report on compound Q as we learn more about it. ***** DDI INFORMATION PUBLISHED At a recent Washington, DC meeting of the American Federa- tion for Clinical Research, Dr. Robert Yarchoan summarized results so far of the longest-running clinical trial of DDI (dideoxyinosine), being conducted by himself and others at the National Cancer Institute. DDI is a relative of AZT, but it may be considerably less toxic. No written paper accompanied the talk, and the researchers are not giving interviews until their presentation at the V International Conference on AIDS in Montreal in early June. But the Los Angeles Times covered the Washington meeting in a page- one story published May 1; other newspapers reprinted parts of the Los Angeles Times report. That article may have the latest news available on DDI until June. (For background information, see AIDS TREATMENT NEWS #72, January 13, 1989, page 3, and the references cited there.) The National Cancer Institute study, conducted in Bethesda, Maryland, should not be confused with a separate phase I trial conducted at New York University and the University of Rochester by the National Institute of Allergy and Infectious Diseases and Bristol-Meyers, which obtained an exclusive license to DDI from the National Institutes of Health. According to the Los Angeles Times, Dr. Yarchoan reported that most of the patients improved, with "minimal toxicity" -- at least for the six months observed so far, even for those who can- not tolerate AZT. Two patients had seizures, which might or might not have been caused by the drug; two had low white counts; and some reported minor side effects such as headaches or insomnia. These problems, which can occur without drug treatment in persons with HIV, were fewer than would be expected in such a study. DDI can be taken by mouth, if used with antacid, and it does cross the blood-brain barrier. DDI has not been released for compassionate use, even for those who cannot tolerate AZT. We have heard that the phase I trials have been delayed by failure to find toxicity, since rules require that such trials continue until a maximum tolerated dose is found -- meaning that the safer the drug is, the longer the trial will take. Caution is understandable, as other drugs of the same class (AZT and DDC) have had serious toxicities which did not show up immediately. But the risk of some hypothetical side effect which appears only after months must be balanced against the risk of untreated AIDS for persons who cannot tolerate AZT and have no alternative. Persons with AIDS and their physicians should have some role in making this decision. Today they are shut out. On March 30 of this year, the news service Reuters reported that the Japanese company Ajinomoto had set up mass production facilities to produce DDI from uridine, under contract with Bristol-Meyers for use as an AIDS treatment. ***** AEROSOL PENTAMIDINE, GANCICLOVIR RECOMMENDED FOR APPROVAL On May 1 an advisory committee of outside experts set up by the Food and Drug Administration recommended full new-drug appro- val for aerosol pentamidine, used for prevention of pneumocystis. The next day, the committee recommended similar approval for gan- ciclovir (DHPG) for treating CMV retinitis. Official approvals are expected within several weeks or months. What will be the practical effect of these approvals of drugs which have already been available under a variety of arrangements? For aerosol pentamidine, full approval will help with insurance reimbursement. Until now, some insurance companies and government agencies have refused to pay for the treatment, claim- ing that it was "experimental". Others have paid, since the cost of preventing pneumocystis with aerosol pentamidine is far less than the cost of treating it in a hospital. It is widely suspected that companies which refused to pay have calculated that they could save money in the long run by having their clients die. For ganciclovir, approval will allow the manufacturer to charge for the drug, currently provided free under a treatment IND. We do not know what the price will be. Insurance presum- ably will pay since the drug will be approved, but many do not have insurance, or do not have policies which cover prescription drugs. One advantage of the approval is that physicians will be allowed to use ganciclovir to treat CMV infection in the intes- tines or elsewhere besides the retina, even though the FDA appro- val will not specifically cover such use. Physicians may be reluctant to prescribe for such "unlabeled" uses, however, and insurance companies may refuse to pay. Another advantage of the approval of ganciclovir is that it will now become possible to conduct a trial to compare this drug directly with foscarnet for treating CMV retinitis, a trial specifically recommended by the advisory committee. Until now such a trial has been blocked by the prohibition against using more than one "experimental" drug in the same study. ***** OBTAINING TREATMENTS FROM ABROAD Buyers' clubs in New York and San Francisco recently began helping people import drugs with promise for AIDS/HIV and oppor- tunistic infections, from countries where these drugs are approved. This is possible because a physician can legally prescribe any drug for her or his patient if it is approved for human use in the country of origin; the FDA recently said it would not obstruct shipments ordered only for personal use, at least for drugs that the agency deems safe. The PWA Health Group in New York is able to obtain flucona- zole, roxithromycin (see AIDS TREATMENT NEWS #75, March 10, 1989), dextran sulfate, isoprinosine, ribavirin, and hypericin herbal extracts (which are also available in the U. S.). It will consider requests for other drugs if approved for prescription use in other countries. The PWA Health Group can be reached at 212/532-0280. A long tape message will answer first with a comprehensive explanation of available products and prices, so have a pen and paper on hand. The Healing Alternatives Foundation in San Francisco can order dextran sulfate, fluconazole, hypericin herbal extracts, and possibly roxithromycin. Healing Alternatives may be able to ship orders to customers. Their number is 415/626-2316. This development is a vital step in the direction of people gaining urgent access to potentially life-saving drugs -- drugs like fluconazole which could languish out of reach for years if we have to wait for FDA approval or NIH or drug-company funding. If other buyers' clubs are able to follow suit, we would like to hear from them, especially regarding treatments not mentioned above. Call Denny at AIDS TREATMENT NEWS, 415/255-0588. ***** AMFAR FUNDS COMMUNITY-BASED RESEARCH IN 15 CITIES On April 27, the American Foundation for AIDS Research awarded $1.4 million in development grants for community-based research -- efforts to organize community physicians and patients to test treatments under the supervision of research profession- als, but outside the major medical centers where such trials would usually be run. Organizations receiving the awards are located in Atlanta, GA, Austin, TX, Boston, MA, Brooklyn, NY, Dallas, TX, Houston, TX, Los Angeles, CA, New Haven, CT, New York, NY, Portland, OR, Redwood City, CA, San Francisco, CA, Santa Fe, NM, Springfield, VA, and Westwood, NJ. In San Francisco, the Community Research Alliance (see AIDS Treatment News #70, December 1, 1988) received $30,000 under this program for organization development. The County Community Con- sortium received two grants, one for development and another for its AZT and HIV alternative-treatment databases. ***** SAN FRANCISCO: QUAN YIN HERBAL PROGRAM DEADLINE JUNE 1 Quan Yin Healing Arts Center is starting its next herbal research and treatment program on June 14; the deadline for applications is June 1. For more information or to apply, call Amanda at 415/861-4963. For background on Quan Yin and this program, see AIDS Treat- ment News #68, November 4, 1988, and #74, February 24, 1989. Note: Quan Yin is facing a severe financial crisis, due to unexpected construction expenses required for its recent move, more clients paying near the bottom instead of the middle of its sliding scale, and insurance companies initially denying more claims. It is vitally important that this well-managed research and treatment organization be able to continue. If you can help, contributions can be sent to Quan Yin, 1748 Market Street, San Francisco, CA 94102. If your contribution needs to be tax deduc- tible, make the check to Quan Yin Healing Arts Center at the same address. For more information, call Katharine Woodruff at 415/861-4964. ***** BOSTON, LOS ANGELES: PEPTIDE T TRIALS RECRUITING Phase I trials of Peptide T, a safe but much discussed and controversial anti-HIV treatment possibility, are now seeking recruits at the University of Southern California Medical Center in Los Angeles and the Fenway Community Health Center in Boston. For information about inclusion or exclusion criteria, the Fenway's number is 617/267-7573; for the USC study call 213/226- 4643. ***** THE DRUG-TRIALS DEBACLE, PART II: WHAT TO DO NOW by John S. James "If you ask researchers the question, as I have several of them, 'If you did not need to deal with the FDA regulations, if you did not need to face all the questions of marketing and licensing, etc., and just get an answer, could you determine within six months whether a drug is going to be useful in the fight against AIDS?' If you just ask the question in that simple way, all of them I've asked say, 'Well, of course we could.' "That being the case, let's get some of this baggage out of the way, and get these answers more quickly, and act like this really is the emergency that everyone says it is." -- Martin Delaney, co-founder and director of Project Inform, on KQED public radio "Forum" program, May 3, 1989. Part I of this article (AIDS TREATMENT NEWS #77, April 21, 1989), presented a simple mathematical model which anyone can use to calculate the loss of human life caused by delays in AIDS research and treatment access. We showed that because of the geometric progression of the epidemic, a delay of 18 months to three years** would cause half of the total of all the deaths due to AIDS -- deaths of people whose lives can be saved if the delay can be avoided. This model brings home the cost of the widespread unspoken attitude that everyone infected with HIV is going to die anyway, and therefore we can write them off and ignore research and access delays, in favor of other things such as services for the dying short of saving their lives, or grief support. If we assume that the epidemic will someday be con- trolled, then it is certain that we can save many thousands of lives by eliminating some of the unnecessary delays now built into the research and treatment access and delivery systems. In Part I, we also showed that if a cure were found, there would be no mechanism to release it to people quickly -- that in fact the bureaucratic incentives are to avoid risks and therefore to conceal treatment advances rather than release them. We pointed out that delays in the new-drug research and regulatory "pipeline", delays long enough to cause tens of thousands of deaths, serve the interests of major corporations by rationaliz- ing and protecting their drug-development investments -- and that perhaps as a result, the "reforms" allowed to take effect have been only those which could not change the outcome, even if they worked perfectly as intended. Part I showed what is wrong. Here we suggest what we believe can and should be done toward correcting the problems. We will show what kinds of studies could quickly and inexpen- sively produce information that would assist the treatment deci- sions physicians and patients must make now -- and why the research establishment largely rejects such studies. We will show that the mainstream research tradition in the United States has become skewed toward producing the kinds of information which corporations and regulators need to make their decisions -- not the information which patients and physicians need to make theirs. We will show that much of the needed research could be done legally in the United States today, using community funding to bypass the financial control and ineffectual bureaucracy of the research establishment -- and that some of the studies which could not be conducted in the United States could be done else- where. Politically, we will suggest that a key, doable first step is to develop clearer statements of consensus within the coali- tion of individuals and groups already committed to saving lives, then use this consensus to get our friends on board. The Mainstream View Of Research One school of thought has come to dominate government fund- ing and permissions, and therefore research careers, in the United States. This establishment approach is not, of course, all bad. The problem is that it has achieved such dominance that it can insist on applying its own ways of doing things to all situations, no matter how inappropriate the result. Mainstream treatment research is based on the following mindset: * The first goal of clinical research is to prove, to a sta- tistically stated degree of confidence, that a drug does work better than nothing, or better than some existing treatment. * There must be a control group, as otherwise there would be no way to justify the statement that the drug to be tested is better than something else. * Above all, clinical trials must guard against the danger that a drug which is useless and perhaps harmful could become accepted and generally used in medicine, as has hap- pened many times in the past. * Since most drugs being tested will show only a small bene- fit, trials must be designed to distinguish a small benefit from none at all. * If patients use other treatments during a trial, their effects could interfere with the results. Therefore sub- jects must refrain from other treatments -- even if the drug being tested will in fact be used with other treatments after it is approved. * The fact that a trial imposes an unrealistic environment which may never occur in practical use of the new drug does not matter. What is important is to learn about a drug in isolation, not a therapy in practical use. * If for whatever reason (such as lack of national political will) it is impossible to arrange a trial which meets these and all other standards of pure research, then it is better to do nothing until such future time as trials may be done, instead of doing any other kind of a study, which could lead to error. * There is no need to design trials in such a way that it is feasible for any particular patients to volunteer, or for physicians to recommend their patients. If the trial fails to recruit subjects, that is not the fault of the researcher, whose job concerns pure science, not practical medicine. * It is ethical to deny access to treatments until the tri- als are complete or at least well along -- either to force patients into trials, or to maintain a stockpile of untreated patients available for future studies which may occur when someone gets around to paying for them. * If the necessary trials do not get done, no one is respon- sible, since no one has the job of expediting trials, or untangling the snafus which block them. * No one is responsible for the tens of thousands of unnecessary deaths which will result from this approach. All involved can make the case that they have done their jobs. The final outcome is no one's responsibility. This system developed to serve the needs of the powerful players: drug companies and Federal agencies. The companies want above all to get their "NDA" (new drug approval), allowing them to market a drug which they have exclusive rights to and have chosen to push. The Food and Drug Administration, supported by consumer protectionists in Congress and elsewhere, wants above all to protect the public from unsafe or unproven drugs. The National Institutes of Health wants to pursue studies which are scientifically interesting. No one has the mission of making sure that trials which are critically important for saving lives get done quickly, or making sure that patients have access to treatments which are clearly beneficial but which for any of a multitude of reasons have not gone through all the steps neces- sary for full marketing approval. Prospective Monitoring Studies: Another Kind of Trial The main problem with controlled, randomized trials, the kind the U. S. research establishment has insisted on, is that they are very difficult to get going. They are difficult because the procedures which take place in these trials are so different from those in the normal practice of medicine. There are major ethical and practical difficulties in giving patients a placebo -- or in asking them to submit to any randomized study, in which they do not know which of two or more medicines they will receive. Only large, well-financed institutions can manage such trials, and the red tape involved usually creates months or years of delay. It may seem that these trials, however cumbersome, are the only way to get credible information. After all, researchers can show with statistics that using fewer patients, or deviating from their rules for running trials, may cause wrong answers to be found. It is well known that many inadvertent biases in the design or conduct of clinical trials can cause a drug to appear appear effective when really it is not, or vice versa. But these arguments assume that the goal of the trial is to prove (or fail to prove) that a drug is effective. This is the information which drug companies and regulators need for their decisions, and of course this information is useful to patients and physicians too. However, there are other kinds of studies which do not even try to prove whether or not a drug is effec- tive, which can produce information useful to patients and physi- cians (but much less useful to corporations and regulators). One of the problems we face today is that if the large, cumbersome trials have not been done, then the only alternative has been anecdotal information, which is notoriously unreliable, and often under the control of self-interested parties -- true believers or promoters with a product to sell. The obvious prob- lems of such reports have discredited any information not con- firmed by big-money, big-bureaucracy trials. If you are considering a new treatment now, you have several alternatives, all of them unsatisfactory: * Wait several years or more until official trials have been done and the drug is approved. * Try to get into a trial -- but it may not start for a year, the nearest site may be hundreds of miles away, you may not qualify, you may have to stop other drugs (or have never used them), and then you may get a placebo. * Ask around. Maybe a friend knows two people who used the treatment and whose T-cells went up. Maybe they forgot to say that the before and after tests were at different labs, that they began other treatments at the same time, and that other blood values deteriorated. * Read articles about the treatment. Unfortunately, the writers may have an interest in promoting it. And even if not, they will usually have had to base their articles on anecdotal reports, since good information is not available. There is another alternative, however -- very well managed collection, handling, and presentation of data about a particular treatment, in the environment and context in which that treatment is actually used. Community-based research organizations can take treatment information out of the hands of the true believers and promoters, and have it controlled instead by professionally guided research teams which serve no interests except those of the patient community. Besides waiting for years for randomized trials, or using anecdotal reports to make treatment decisions, there should be another choice. Prospective monitoring studies could provide another source of treatment information. Here is how they can work: When persons with AIDS or HIV start using a new treatment (for example, hypericin), a research organization could offer to monitor perhaps 20 to 50 persons, paying for blood work and phy- sical examinations. The study would be designed in advance (that is why it is called "prospective") and approved by a scientific advisory committee, so all the important data would be collected for every patient, in a uniform way; for example, all blood work would be done by the same lab, to avoid inter-lab variations. All physical exams and medical histories would be conducted uni- formly. Identical patient diaries can be used. All patients would be accounted for. Data handling would be audited and would meet the same standards as in any other clinical trial. A purely monitoring study cannot ask patients to change what they were doing for the sake of the research. Therefore patients can use whatever other treatments they want during the study, as long as they tell the researchers what they are doing. As the study proceeds, data is statistically summarized and given to one or more leading HIV physicians for their interpreta- tion. Is anything happening which is dramatically different, either better or worse, from what would have been expected without the treatment being tested? Or is it unclear whether or not the treatment has helped -- meaning that the benefits, if any, are less than dramatic? These evaluations by the physi- cians, along with the statistical summaries, would be published as the report of the study. Because there is no control group and no randomization, this study is not designed to "prove" the drug safe or effective. The treatment group is in effect being compared with the expectations of the expert physicians chosen to evaluate the data obtained -- a method not as statistically pre- cise as using a placebo control, but certainly able to pick out a decisively effective treatment, which is what these studies will be looking for. Instead of asking for statistical proof, the important ques- tion for judging a monitoring study is whether it provides infor- mation useful for making treatment decisions. Primary-care phy- sicians will make this determination, when they decide what stu- dies are credible. Our own expectation, after reporting on AIDS treatments for three years, is that for many unapproved thera- pies, a single such study, scientifically designed and profes- sionally managed by an unbiased research organization and col- lecting complete data from several dozen patients, could produce better information on the use of the treatment for HIV than all of the world's anecdotes and rumors put together, even for sub- stances which had already been widely used for months or years. Perhaps most importantly, such monitoring studies could be used as a quick screening for the most promising treatments now entering human trials (such as compound Q, DDI, or D4T). The goal would be to look for very dramatic benefits, in order to bypass years of ineffectual bureaucracy for any treatment found to work so well that there could be no dispute about its value. Monitoring studies have several advantages of flexibility and ease of use: * No FDA permission is required, because the study does not give any drug to people -- it only collects data. Major delays are therefore avoided. * The cost is low. Less than a thousand dollars per patient will pay for physical examinations and for six to eight months of blood work more complete than that of many offi- cial "phase II" studies. Therefore this research can be supported directly by contributions from the public, bypass- ing government agencies which often take more than a year to award money -- a year after completion of the ponderous applications, which can run to hundreds of pages. Since there is no major overhead cost, monitoring studies can start with whatever funding is available and add more patients later as additional money comes in, or let patients pay for their own blood work until funding can be found. * Reports can be compiled and published at any time, not just after the study is done, as is usually the case with randomized trials. Mainstream medical journals may reject these papers because there is no control group. But the results can be distributed immediately by community organi- zations to patients and physicians, without being restricted for months by pre-publication secrecy. * The fact that patients can use other treatments during the study will make the results more difficult for the physician(s) engaged for that purpose to interpret. But in return there are two advantages of not restricting other therapies. First, the treatment is studied in the actual context of its use, not in an artificial context of a single drug tested in isolation. And second, in the traditional trials which kick people out for using additional treatments not in the protocol, patients whose lives are at stake often use other drugs anyway, and conceal what they are doing. The difference is not whether other drugs are used, but whether the researchers know about it. * Since these studies do not require any medical sacrifice of the patient -- they simply offer free blood work -- recruitment can be much easier. Randomized trials are often delayed for months and sometimes cancelled entirely because they cannot recruit patients. * Since no big institution is needed to run monitoring stu- dies, this research can be more responsive to community needs than the official, randomized drug trials. * Monitoring studies can legally be done in the United States, provided that patients can obtain and use the drug without the help of the researchers. If patients cannot obtain a drug here, the study might be conducted abroad. Monitoring studies are already occurring -- for example, an antabuse project of the Community Research Initiative in New York, and monitoring of AZT, and of alternative therapies in gen- eral, by the County Community Consortium in San Francisco. Although the idea of community-based research is to conduct tri- als through physicians' offices, monitoring studies might work better if the blood tests, physicals, and patient interviews were handled at central locations when possible, so that staff can be trained to do these consistently. The research organization must coordinate with primary-care physicians, of course, and give them copies of laboratory reports and other information. But most primary-care physicians are too busy to go out of their way to collect data in a specified, uniform manner. This job can be done by medical staff trained by the project and following writ- ten guidelines. Treatment Politics: Challenging the Death Consensus The fast, inexpensive kind of study suggested above is only one example of how AIDS treatment research could be improved. The political task is more basic: how to overcome the widespread fatalism which makes even friends of the AIDS community unwilling to deal with treatment issues, as they have already given up on saving the lives of persons now ill or infected, and written them off as dead. How to we respond to the widespread, often silent assumption in professional and institutional circles that saving the lives of those now infected or ill is either impossible or not worth doing? Congress, for example, is today largely a wasteland on the issues addressed here. The usual attitude toward those who bring the subject up has been described by one treatment advocate as, "You are the doomed or advocates for the doomed, and the doomed always want more drugs." End of conversation -- and of any effort or interest in dealing with the issue. To change this attitude, which today forms a consensus even among many friends of persons with AIDS in Congress, we need to start in our own community. Recently a leading gay rights lobbyist, describing his com- mitment to AIDS work, was quoted in a major newspaper as saying, "I feel compelled to use my professional skills to make it easier for those who will die, and to prevent others from getting sick." Too many organizations have written off much of their consti- tuency as dead and left out any involvement in saving the lives of the tens of thousands who will die unnecessarily as a result of current policies. No wonder Congress and the research commun- ity have failed to examine their own fatalism, their unwilling- ness to lift a finger to change policies which make thousands of unnecessary deaths inevitable, since even the AIDS community's organizations and advocates have not done so. How can we expect others to speak for us when we will not speak for ourselves? Why have most AIDS organizations been so reluctant to work on treatment issues? There seem to be many reasons. One is that they fear differing with their political allies, usually liberals, who for years have been fighting for consumer protec- tion. Consumer protectionists want to see the strongest possible FDA, strong regulations, and the most exhaustive testing of new drugs before they are released. They are afraid that AIDS will allow the pharmaceutical industry to weaken the regulatory system they have worked so hard to build, and that flexibility in treat- ment access will facilitate quackery and unscrupulous exploita- tion of persons who are desperate. (We too support consumer pro- tection -- but not at the cost of human lives. AIDS must be treated as an emergency, as it would have been if it had not first been perceived as a gay disease. It is not enough to sim- ply apply old battle lines in utter disregard of the existence of this emergency, and of the effects of its eight years of its malign neglect under the Reagan White House.) A second reason is that AIDS service organizations are usu- ally publicly funded, sometimes with Federal funds, so they may be fearful of questioning Federal agencies. A third reason is the emotional issue of HIV testing. Of hundreds of AIDS organizations in the country, only a handful, mostly in San Francisco, are now willing to recommend that per- sons at risk of AIDS seek voluntary, anonymous testing. The oth- ers may be deterred from becoming involved in treatment issues, because if they did, they would face the contradiction that peo- ple cannot obtain early treatment (such as aerosol pentamidine before a first attack of pneumocystis) unless they seek testing to find out whether they need it. Organizations must re-evaluate strongly held positions in light of the fact that early, volun- tary testing has now become a medical issue, as there are many patients who clearly should receive preventive treatment even though they feel fine and have no outward sign of illness. The AIDS community needs to tell its advocates what kind of representation it wants. Are we satisfied to accept projections of tens or hundreds of thousands of deaths, without making any effort to change a system which keeps new treatments in the drug development and regulatory "pipeline" for years longer than necessary? Are we willing to accept a consensus which keeps designing trials which are so unworkable and inhumane that it is widely believed that patients must be denied access to treatments outside of trials, or else nobody would volunteer and the trials could not be conducted? The death consensus is so entrenched that it is hard to know where to begin to change it. One Washington, DC-based PWA organ- izer made what seems to be an excellent suggestion. The way to start, he suggested, is to develop a coalition of those who already agree, then use that coalition to force other friends of the AIDS community to face the issue. He only saw three groups already mobilized for saving the lives of those now infected or ill: persons with AIDS or HIV, "treatment physicians", and some AIDS activists. While today the picture is bleak, there are great pressures for change. Treatment will inevitably become a central issue in AIDS, as more and more people see that it affects them. Mean- while, the first steps are clear. We need to develop explicit consensus among those already committed to saving the lives of persons with AIDS or HIV, and then talk with those among our friends who have so far refused to become involved. Footnote: ** The 18-month figure for the doubling time of the AIDS death rate, used in part I of this article, is approximately consistent with the projection of the U. S. Public Health Service of 179,000 deaths at the end of 1991. In San Francisco, however, the pro- jections fortunately indicate a longer doubling time, between two to three years. There are many possible reasons for this differ- ence, among them different statistical methods used, the later stage of the epidemic in San Francisco, and much earlier safer- sex education in San Francisco than nationally. 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