&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on AIDS &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Copyright 1992 by John James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #155, July 17, 1992 phone 800/TREAT-1-2, OR 415/255-0588 CONTENTS: [items are separated by "*****" for display] Note: This special issue includes the first AIDS TREATMENT NEWS INTERNATIONAL EDITION ***** Intrernational Edition Contents: Bitter Melon: Traditional Treatment Tried for AIDS Combination Antivirals: ddC Plus AZT Approved Three-Drug Combination Trial: ddC Plus AZT Plus Interferon Hypericin: Antiviral from St. John's Wort Gamma Globulin: Inexpensive Treatment May Help Prevent Infections New Medical Journal Available by Computer International Treatment Communication: About This Issue ***** Issue # 155 Contents: About This Issue International Conference: Advance Overview AIDS Action Council Hires Derek Hodel As Treatment Advocate; Expands Political Assistance San Francisco: Combination Trial of Compound Q Plus AZT Books: The Medical Management of AIDS, Third Edition Against the Odds: The Story of AIDS Drug Development, Politics, and Profits ***** Bitter Melon: Traditional Treatment Tried for AIDS As many as 100 persons with AIDS or HIV in Los Angeles, California, may be using bitter melon (Momordica charantia) - - a traditional herbal treatment, and also a food, in Philippine, Chinese, and certain other cultures -- in the hope that it might be helpful as an AIDS treatment. No scientific trials have yet been run; and use of bitter melon as a possible AIDS treatment seems to be mostly limited to the Los Angeles area at this time. If bitter melon is found to be helpful, it would be important throughout the world, because this treatment costs very little, so people everywhere could afford it. Interest in bitter melon for HIV began in two different ways: First, academic researchers found two proteins in bitter melon which inhibit HIV in laboratory tests: MAP 30, and momorcharin. But no one knows for sure what active ingredient or ingredients (if any) might have clinical usefulness. Second, the public interest in bitter melon developed because of the work of one patient, who tried the treatment after learning that it was being tested in the Philippines for treating leukemia. He has used it for three years and reports very good results. He happens to live in Los Angeles, and has spoken at many AIDS meetings there. That is why the AIDS/HIV use of bitter melon is currently centered in that city. So far there seems to have been little risk from this treatment; however, pregnant women must be warned that bitter melon extracts can induce abortion. Not everybody finds that this treatment works; some have reported that it did not seem to help. And if it does work, it may take four to six months for clear benefit to be seen. Bitter melon is traditionally prepared for medicinal use as a tea for drinking. But most of the people trying it for AIDS are using it by retention enema, because of concern that some ingredients might be destroyed in the stomach. A report about bitter melon, including instructions for obtaining and using it, is being prepared by an AIDS support organization. To obtain a copy, send a self-addressed envelope to: AIDS Intervention Team of APLG, 300 West Sunset Blvd., Los Angeles, California 90012. (Note: Persons outside North America should include two international postal reply coupons, if possible, with their request for this report.) ***** Combination Antivirals: ddC Plus AZT Approved The U. S. Food and Drug Administration has approved the drug ddC for treating people with advanced HIV infection, including AIDS -- but only for use in combination with AZT. This approval, effective June 19, 1992, was based on two small, preliminary studies which showed much greater improvement in T-helper counts with the combination treatment than would be expected with AZT alone. (But a large study comparing ddC alone with AZT alone was stopped early, because the AZT worked much better; those treated with AZT had a lower chance of dying of AIDS than those treated only with ddC. That is why ddC was approved for use in combination with AZT, but not for use by itself.) "ddC" is an abbreviation for the chemical name 2,3'- dideoxycytidine; it is also called zalcitabine (generic drug name) or HIVID (brand name). The drug, developed as an AIDS treatment by Hoffmann-La Roche, was first approved in Austria, on April 7, 1992; Roche has also applied for approval in over 20 countries in Europe. ddC is inexpensive to manufacture, probably pennies a day. The reason is that very low doses are used; one kilogram is enough to treat 1,000 people for more than a year. But unfortunately, ddC may not be practical as a low-cost treatment which could be available anywhere in the world, since AZT is also required. AZT costs more to manufacture, and it also costs more to use, since blood tests are required to use it safely. The main side effect of ddC is peripheral neuropathy, which causes numbness, tingling, burning, or pain in the hands or feet. If moderate discomfort occurs, it is important to stop the drug immediately. Sometimes half-dose treatment can resume later. For more information about using ddC, see the "package insert" for the drug, which is written for physicians. A package insert is available in the United States, or in other countries where the drug has been approved. ***** 3-Drug Combination Trial: ddC+AZT+Interferon Burroughs-Wellcome Corporation, which markets AZT, has found that a three-drug combination (AZT plus ddC plus alpha interferon) worked very well against HIV in laboratory tests -- much better than the two-drug combination of ddC and AZT (which was recently approved by the FDA in the United States). The company has recently started a large clinical trial in the United States to see if this combination also works well in people. The trial, which started treating its first volunteers in late June, is comparing standard doses of AZT and ddC against the same doses of those drugs plus a dose of 3 MU of interferon injected once per day. The form of interferon being used in this trial is Wellferon, a "natural" alpha interferon which contains at least 16 variants of the interferon molecule. Wellferon is approved in some European countries, where it is used for treating hepatitis B. Other brands of alpha interferon might be equivalent, but no one knows for sure. For more information about the three-drug combination, see "Three-Drug Study Begins: AZT Plus ddC Plus Alpha Interferon, Eight U. S. Cities," AIDS TREATMENT NEWS Issue #154, July 3, 1992. Note: The controversial AIDS treatment Kemron is a form of alpha interferon similar to Wellferon. But Kemron treatment is very different from standard interferon treatment, such as that used in the Burroughs-Wellcome trial, for two reasons. First, Kemron contains doses of interferon which are thousands of times lower than those generally used. Second, Kemron is placed under the tongue, instead of being given by injection like conventional interferon treatment. ***** Hypericin: Antiviral from St. John's Wort St. John's wort, a common plant which grows throughout the world, contains a chemical called hypericin, which may have broad-spectrum antiviral activity -- against HIV, cytomegalovirus, human papillomavirus, influenza, hepatitis B, and perhaps other viruses. St. John's wort has long been used in herbal medicine; however, the plant contains very little hypericin, and attempts to use crude extracts of it as an HIV treatment have had little success. It is relatively easy to chemically extract pure hypericin from the herb; but, because of commercial motivations and government regulations, this has seldom been done. There are reports that some people have had unusually good results with concentrated chemical extracts obtained through the AIDS treatment underground, but we have been unable to confirm these reports. Instead, the commercial effort to develop hypericin has used a chemically synthesized version of the drug, not a plant extract; several years have been lost in testing this potential treatment, because of the time required to develop an efficient synthesis procedure, and for other reasons. Clinical trials are now being done at New York University, in New York City. In order to get good scientific data, these trials have given hypericin by intravenous injection -- even though everyone expects that this drug will be used orally. Recently the dose had to be reduced, because a side effect was found; some people receiving the injections reported discomfort in their hands and face, probably due to phototoxicity (abnormal sensitivity to sunlight or other strong light), which has been seen in animal tests of hypericin. The trial is now proceeding with the reduced dose. As of early July, no data is yet available about the possible effectiveness of the drug as an HIV treatment. (Note: oral use may cause less toxicity than intravenous use. Also, there are reasons to believe that the purified plant extract may work better than the synthetic now being tested.) What is most needed now is for research groups to extract concentrated hypericin from St. John's wort, and try it orally as a treatment for AIDS or for the other viral diseases listed above, outside of the constraints which inhibit such research in the United States. A chemist, perhaps at a university, working together with a physician, could be the core of such a group. For More Information At least 30 articles have been published in scientific and medical journals about hypericin's anti-HIV activity, and its success in treating retroviral diseases in animals. (The first of these articles appeared in Proceedings of the National Academy of Sciences, USA, July 1988.) We do not have space for a full bibliography here. AIDS TREATMENT NEWS published reports on hypericin, including recent bibliographies, in issue #125, April 19, 1991, and issue #146, March 6, 1992; we will send these reports on request. ***** Gamma Globulin: Inexpensive Treatment May Help Prevent Infections Intramuscular gamma globulin, often used by travelers to prevent hepatitis and other infections, might help to protect against AIDS-related opportunistic infections. However, it cannot protect against HIV itself. This potential treatment was brought to our attention by Joseph A. Hertell, M. D., an internist who treats AIDS patients near Atlanta, Georgia. Dr. Hertell was involved in developing this medication in the early 1950s, when he was medical director of the American National Red Cross. Dr. Hertell is now using the Gammar brand, which costs about $30 for a multiple-use vial; he gives 2 cc of gamma globulin per week. He believes that his patients are getting fewer infections than they would otherwise, and that some are able to resume work and other activities as a result. For more information on this use of gamma globulin, see "Gamma Globulin to Prevent Infections?" AIDS TREATMENT NEWS #152, June 5, 1992. ***** New Medical Journal Available by Computer Starting July 1, 1992, The Online Journal of CURRENT CLINICAL TRIALS has been published by computer. This fully peer- reviewed journal is published by the American Association for the Advancement of Science, in Washington, D. C. -- the same organization which publishes the journal Science. This computer journal avoids all printing and mailing delays (as well as the wait for space in an issue) to get important medical information as rapidly as possible to doctors, scientists, and others. The articles are provided in typeset quality, complete with charts and other graphics, if your local computer equipment provides that kind of display. If not, you can read the text of the articles by computer, and then order typeset copies delivered by fax or mail if you want. One advantage of this computerized journal, especially if you do not have easy access to a large medical library, is that when articles in CURRENT CLINICAL TRIALS reference articles in other journals, the abstracts from those other journals are usually included in the computer, too, so you can see them immediately. For international use, CURRENT CLINICAL TRIALS is available through the Internet -- but for text-only access at this time. To receive typeset-quality graphics, you currently need a computer running Windows 3.0 software, with a 9600-bps modem. Text-only access is available from any computer running software which emulates a VT100 terminal, with at least a 2400-bps modem. The full graphics interface is now being developed for Internet, and for Apple Macintosh computers. A subscription costs about $100 per year plus telecommunication charges. For information about subscribing, call CURRENT CLINICAL TRIALS, 202/326-6446, or send a fax to 202/842-2868. ***** International Treatment Communication: About This Issue AIDS TREATMENT NEWS has published more than 150 issues in San Francisco -- twice each month for over five years. It is well known in the United States (see "Underground Press Leads Way on AIDS Advice," by Katherine Bishop, The New York Times, December 16, 1991), and has subscribers in many countries. Recently we also decided to publish the AIDS TREATMENT NEWS International Edition, designed for free distribution to AIDS organizations everywhere, and through them to their clients. This first issue of the International Edition is being distributed at the VIII International Conference on AIDS/III STD World Congress, July 19-24, 1992, in Amsterdam. International Medical Communication We have found that the biggest obstacle to international sharing of AIDS treatment information is not the language barrier. Instead, it is the great variety of medical traditions, the differences in economic circumstances, and the differences in AIDS itself, in different parts of the world. In order to be understood by persons in many cultures and medical traditions, we chose a journalistic style modeled in part on the television network CNN. Each treatment article will be short. It will tell what people are doing, why they are doing it (whether their rationale or authority is scientific, traditional, empirical, or other), and how you, the reader, can get more information about that treatment if you want to. In this way the International Edition will try to report complex medical issues in a context that can be understood by both professionals and lay persons. Because this newsletter is short and published only four times a year, translation, printing, and shipping will cost relatively little. We hope to raise money to provide free copies to AIDS organizations that want them, anywhere in the world. All costs, including shipping, should be funded, so that lack of money or of foreign exchange will not be an obstacle for anyone. This newsletter must speak to two audiences -- those who seek treatments regardless of cost, and those with little or no money who want to learn about treatments which they can obtain. The expensive treatments are not always better; sometimes big money creates its own dynamics far removed from practical experience. But usually the expensive treatments are studied scientifically, and the low-cost ones are not. AIDS TREATMENT NEWS International Edition will report about both. When data from scientific trials is not available, we will do the best we can through investigative journalism -- while strongly supporting the scientific study of noncommercial treatments by agencies such as the World Health Organization. But before there is data, we should remember that until very recently, there were no scientific trials for any treatment; all drug development in history was based on clinical experience. With today's modern communication and information processing, plus laboratory science at academic institutions throughout the world, treatment development through practical clinical experience can be more powerful and more useful than it ever has been before. Treatment Information Politics When AIDS TREATMENT NEWS began in 1986, there was little interest in AIDS treatments, because almost everyone believed that everybody with AIDS would die. There was never scientific evidence to support this social myth of universal death; in fact, there has long been evidence to the contrary. But people were already "written off" as lost, so there was little organized effort to save their lives. Instead, AIDS organizations tried only to prevent the spread of the infection, or to provide comfort and services for the dying. What changed this fatalism was the development of a vigorous AIDS treatment activist movement, energized by people trying to personally survive the epidemic, and to help others do so. Today, non-government organizations like ACT UP and Project Inform negotiate with scientists and officials, with pharmaceutical companies and government agencies, to make sure that research is properly funded, and that clinical trials are designed so that they can be conducted effectively in the real world. Nonprofit groups called buyers' clubs help people obtain rational therapies at the lowest possible prices -- whether or not those treatments are officially approved. Newsletters, including AIDS TREATMENT NEWS, describe promising experimental treatments and summarize what is known, months or years before the information appears in medical journals -- and critique government and corporate policies which are often negligent and sometimes politically malicious. But in most of the world there is no treatment activist movement, and no organized effort to save the lives of people who already have AIDS or HIV. Government programs only try to prevent new infections. In one sense this policy may be understandable, since resources are limited and prevention costs much less than treatment; the same money spent on prevention can save many more lives than if spent on treatment. But treatment activism is also needed, because it can mobilize the energy of people who want to save themselves and their friends, greatly benefiting the entire fight against AIDS, prevention as well as treatment. In much of the world, AIDS treatment is either nonexistent, or limited to what people can find among local healers and traditional medicines. Some of these traditional treatments may have great value, and be important for the world. We need more communication about treatments among the practitioners of different medical traditions, and among organizations in different countries. We need to develop ongoing working relationships, so that the international treatment community can know itself better, and can judge who is credible and who is not. We hope that the AIDS TREATMENT NEWS International Edition will contribute to this development. Funding AIDS TREATMENT NEWS has been supported entirely by subscriptions and unsolicited gifts; we do not seek or receive government, foundation, or corporate grants. We paid for this first issue of the International Edition with our own funds. But future issues must be funded to allow translation and printing in Spanish, French, and other languages, and free distribution to agencies throughout the world. To preserve editorial independence, AIDS TREATMENT NEWS prefers not to receive this funding directly. Instead, we want to work with other organizations which can act as fiscal sponsors, and manage the translation, printing, and distribution of the newsletter. Funding could come from corporations, foundations, government agencies, or individuals. Note: (1) You may reproduce this International Edition, either by photocopying, or by republishing these articles either in English or in translation. We ask that our address and fax number be included. No permission is necessary, but we suggest that you contact us in case more recent information is available. Also, we can mail master copies (originals from a laser printer) so that your copies will have the best possible print quality. (2) When the International Edition refers to articles in the original AIDS TREATMENT NEWS, we will fax or mail those articles upon request, without charge. (3) To contact us for any reason -- to be on our mailing list for future copies of the International Edition, to tell us about treatments we should cover, or to discuss the content of this newsletter, write or fax to: AIDS TREATMENT NEWS International Edition, Post Office Box 411256, San Francisco, California 94141. Our fax number is 415/255-4659. ******************** ISSUE # 155 ******************** About This Issue The four-page centerfold of this issue is the first AIDS TREATMENT NEWS International Edition -- designed to provide practical information about experimental and traditional treatments to people from many different cultural backgrounds and medical traditions. We are taking 3,000 copies to the AIDS conference in Amsterdam next week. In the future, we hope to publish the International Edition four times a year in partnership with other organizations, in English, Spanish, French, and other languages, and to find funding to provide free copies to AIDS organizations that want them, anywhere in the world. Most treatments reported in the International Edition will have already been covered in more detail in the regular AIDS TREATMENT NEWS. An exception is the article on bitter melon, enclosed; our longer article is not finished yet. Please send any comments on the International Edition to John S. James at AIDS TREATMENT NEWS. ***** International Conference: Advance Overview by John S. James The VIII International Conference on AIDS, the largest AIDS conference of 1992, will take place in Amsterdam, July 19-24, 1992. The great amount of information presented at each year's conference is overwhelming and sometimes confusing. An advance overview can help in understanding news reports during the meeting itself, and in understanding the summaries which will appear later in AIDS TREATMENT NEWS and elsewhere. We have not yet seen the abstracts to be published at the conference, nor the authors and titles of poster sessions. (We urge future conferences to make this information available in advance, so that attenders can prepare ahead to make better use of the six busy days of the meeting.) We do have a press backgrounder on what the conference organizers think is some of the most important information to be presented. In addition, we have our list of treatments and other topics to look for. The press backgrounder from the conference lists 13 topics, of which three are most directly important to the readers of AIDS TREATMENT NEWS: "Vaccine Development and Vaccine Therapy: Currently fifteen HIV vaccines are in clinical trials. These include both preventive and therapeutic vaccines. Studies of particular interest in this area include the work of Robert Redfield (Walter Reed Hospital, USA) and of Fred Valentine (New York University Medical Center, USA). Both studies concern the introduction of a vaccine based on rgp 160 into volunteers with early HIV infection and high CD4 cell counts. In the area of vaccine development, important new work will be presented by Abdelizsiz Benjouad and others (Institute Pasteur, France) and Tun-Hou Lee (Harvard School of Public Health, USA). Both studies involve removal of sugar from the HIV molecule, a process crucial to effective vaccine therapy. Gene Therapy: One of the most promising and exciting areas of HIV/AIDS research is gene therapy, an approach in which attempts are made to use other genes to interfere with the replication of HIV-1 and its ability to cause AIDS. Progress will be reported in efforts by Matsuda and Essex (Harvard School of Public Health, USA) to reduce the infectivity of HIV through introduction of virus-specific interfering molecules, and in efforts by Caruso and Klatzman (Hopital de la Pitie- Salpetriere, France) to develop selective killing of HIV- infected cells by booby-trapping them with toxic molecules. Early AZT and Combination Antiretroviral Therapy: In recent months, there have been conflicting reports on the risks and benefits of early treatment with AZT. A series of presentations will help clarify study results on this issue. The latest evidence will also be presented for the efficacy of combining antiretrovirals rather than treating with only one such drug. In addition, novel approaches for rationally using combinations to prevent the emergence of resistant viruses will be discussed." The other ten topics highlighted in the press backgrounder are: Animal models; Evidence of differing transmission efficiency by genotype; The definition of AIDS; HIV transmission in health care settings; Genetic variations and the epidemiology of HIV; Human rights and HIV; Women and HIV; HIV/AIDS in the developing world; Traditional and alternative therapies; and Global meetings. Other Questions Four people from AIDS TREATMENT NEWS will be at this conference in Amsterdam. The following list (which did not come from the conference organizers) includes some of the questions we are using to organize our own approach to information gathering at the meeting: ddI: Information from an Italian study may support ddI over AZT as initial therapy. AZT, ddI, ddC: For the approved antivirals, the most important question is what medical consensus is developing on when and how to use them. Other nucleoside analogs: We have heard generally good (but sketchy) reports on d4T and 3TC, which are now in clinical trials. We have heard little about FLT and other fluorinated nucleoside analogs. PMEA: This drug, active against both HIV and a number of other viruses, might be important, but has received little public attention in the U. S. Development appears to have languished for business reasons; we have heard that a clinical trial may start in the fall. Tat inhibitors, protease inhibitors: We will be looking for any information on these. Protease inhibitors, the target of major research by pharmaceutical companies, have performed very well in laboratory tests, but apparently are proving difficult to turn into useful drugs. Hypericin, NAC: We do not know whether information will be presented at the conference. Bitter melon: We expect some information to be presented, and want to see how it is received. Compound Q: Data from at least one ongoing study will be presented. CD8 expansion: Trials are starting now, so it may be too early to expect much information. Hyperimmune milk, similar antibody treatments: For some years there have been positive reports about this potential therapy for cryptosporidiosis. Last week a related article (although not mentioning AIDS) appeared in the "Patents" column of The New York Times (July 11); it concerned hyperimmune milk and eggs, from cows and chickens which have been specially vaccinated. Apparently such "nutriceuticals" are already being sold in Asia. We do not know if there will be any information at the conference. Other treatments we will look for include passive immunization, BI-RG, human growth hormone, itraconazole and other new antibiotics (and new uses of old antibiotics), HPMPC, and anti-angiogenesis drugs for KS and cancer. We are also interested in advances in diagnostic tests and markers of disease progression, and in international treatment organizations and communication. Pathogenesis -- understanding the development of HIV disease and AIDS -- will be a major focus of attention at the conference. A potentially important paper was published in June 1992 in the Journal of Infectious Diseases (M. Cerici and others, "Cell-Mediated Immune Response to Human Immunodeficiency Virus (HIV) Type 1 in Seronegative Homosexual Men with Recent Sexual Exposure to HIV-1"); it reported that a few HIV-negative men had clear immunological evidence of having been exposed to HIV, but may have either fought off the virus, or been infected and recovered. We want to see what new information or consensus about this report may develop at the conference. ***** AIDS Action Council Hires Derek Hodel As Treatment Advocate; Expands Political Assistance by John S. James The AIDS Action Council, "the only national organization dedicated solely to shaping federal AIDS policy," has hired Derek Hodel, formerly executive director of New York's PWA Health Group, the largest and most influential buyers' club in the nation, as a full-time, Washington-based treatment advocate, starting July 13. Hodel will "lobby, advocate, and organize on issues associated with HIV-related research and HIV-related drug development and access within all relevant branches and agencies of the federal government, within the private sector, and within the AIDS and health-advocacy communities." His first assignment will be to represent the AAC at the International Conference on AIDS in Amsterdam. AAC Assistance for Community-Based Organizations For the last year, the AAC has run the AIDS Action Network, currently consisting of 720 CBOs from 144 states -- including 170 minority organizations. These member organizations receive a short newsletter (usually five or six pages) every two weeks, providing background on policy issues. Recent newsletters have included healthcare reform, the Presidential campaign work of United for AIDS Action (see AIDS TREATMENT NEWS #153, June 19, 1992), and tuberculosis. Sometimes they include "federal funding alerts" on deadlines to apply for funds; these can be faxed if urgent. Recently the AAC started a Community Organizing and Education department, run by Belinda Rochelle (who is well known as a treatment advocate, especially with the AIDS Clinical Trials Group of the U. S. National Institute of Allergy and Infectious Diseases). This project will help local organizations to lobby effectively -- for example, by letting them know what political work can legally be done by publicly-funded service groups, who, like others, have a right and responsibility to stay in touch with their Congressional representatives. It will work with the whole spectrum of AIDS organizations in a target city, when invited by them, to help them solve federal, state, or local problems -- concerning lobbying for state funding, for example, or talking effectively with federal agencies. Initial cities to receive this help are Cleveland, San Diego, and Richmond. The new department is also assisting in visits to eight other cities -- Houston, Austin, San Antonio, Cleveland, Portland (Oregon), Chicago, Des Moines, and Little Rock -- to work with local groups to organize visits to key members of the appropriations committees in the Senate and House, to urge maximum funding for all AIDS programs. If your community-based organization wants to join the AIDS Action Network, call Belinda Rochelle at AIDS Action Council, 202/986-1300, ext. 20. AAC Background The AIDS Action Council is a membership organization supported by the over 500 community-based organizations which are its members. (Do not confuse these organizations with the 720 member organizations of the AIDS Action Network; no fee is required to belong to the latter.) It has been active on many issues, for example: Congressional funding for prevention, care, and research; fighting the federal freeze on funds for housing for disabled persons with AIDS; fighting political restrictions on effective campaigns against AIDS transmission; bringing together physicians and other experts to develop policies on the tuberculosis epidemic; and restoring funds cut from programs targeting AIDS prevention in minority communities. AAC also convenes the National Organizations Responding to AIDS (NORA), "a 150-member coalition of national health care, civil liberties, women's, minority, and gay groups involved in the fight against AIDS. " Comment AIDS Action Council's work "to forge the bonds between community-based service providers and national decision- makers," is especially important because many members of Congress have said that they are not hearing about AIDS from their constituents. If more people would let their representatives (and other officials) know that AIDS is important to them, that we need effective prevention programs, treatment research and development, access to care, and compassionate treatment of persons with AIDS or HIV, then the battles in Washington would no longer be an uphill fight. The AIDS Action Council believes that grassroots pressure will keep AIDS a priority in government, and in people's minds. Educating those who care about AIDS on the mechanics of being heard in local, state, and federal governments, and on the background of the policy issues involved, will make that pressure more effective. Today the usual answer on AIDS, from members of Congress and other federal officials, is that there is no money. AIDS Action Council answered, "However bad the year, where there is political will, increases can be found. We saw that with Desert Storm." (We could add that Congress is willing to spend billions of dollars for weapons systems the Pentagon doesn't even want, just to make jobs in members' districts. AIDS funding would create more jobs, while saving lives instead of accumulating useless hardware.) But not all the problems are financial. The research and development of new treatments, on which so many people's lives directly depend -- and which, when successful, will make many other problems far more manageable -- has been characterized by unbelievable wasting of opportunities even when money is not the issue, due to lack of leadership and lack of political will. Until recently there has been a dangerous advocacy vacuum concerning federal issues of science, management, and drug development; the Washington organizations have had to focus elsewhere (on funding, prevention, and services), while the treatment organizations have not had the resources or the federal experience to give these issues the attention they deserve. This is why we are encouraged that two major organizations which know the federal system -- the AIDS Action Council, and the Human Rights Campaign Fund -- have started treatment-advocacy projects. San Francisco: Combination Trial of Compound Q Plus AZT A trial at San Francisco General Hospital is now comparing GLQ 223 (trichosanthin, also called compound Q) in combination with AZT, vs. AZT alone or GLQ 223 alone. Standard doses of AZT will be used; the compound Q will be given every week for the first four weeks, and then every three weeks, in escalating doses. The study will last 45 weeks. To be eligible, volunteers must have AIDS or symptomatic HIV infection (but not have an active AIDS-defining opportunistic infection when they enter the study). They must have a T- helper count between 200 and 500, have been on AZT for at least nine months before the study, and never have used compound Q. There are additional entry criteria, but these are the ones most likely to rule out potential volunteers. For more information, call Carol Arri, 415/476-9296 ext. 84094. ***** Books: Medical; History ** THE MEDICAL MANAGEMENT OF AIDS, THIRD EDITION. Edited by Merle A. Sande, M. D., and Paul A. Volberding, M. D. W. B. Saunders, Philadelphia, 1992. This book, written by over 40 AIDS physicians and other treatment experts from around the world, and edited by leading physicians at San Francisco General Hospital, is the most authoritative textbook on mainstream AIDS treatment. The information is up to date; the third edition, published in six months from when the chapters were ready (very rapid turnaround for A medical textbook), is reaching bookstores now. The material is well organized, with 26 chapters covering such areas as dermatologic care, oral complications, gastrointestinal manifestations, neurological complications, hematologic manifestations, and specific infections including pneumocystis, cryptococcal infections, toxoplasmosis, bacterial infections, syphilis, TB and MAI, and malignancies. A "Special Aspects of AIDS" section includes chapters on pediatric AIDS, therapeutic issues in women, AIDS litigation, and supporting health care workers in treatment of HIV- infected patients. Not everyone with HIV will want to read so technical a book about it. But The Medical Management of AIDS should be readily available, perhaps in libraries of support organizations. Patients may want to see how their specific diagnosis fits into a larger picture, or how their treatments look from the viewpoint of mainstream consensus. ** AGAINST THE ODDS: THE STORY OF AIDS DRUG DEVELOPMENT, POLITICS, AND PROFITS. By Peter S. Arno, Ph.D., and Karyn L. Feiden. HarperCollins Publishers, New York, 1992. This is the second book to tell the history of AIDS treatment research and development in a way nonspecialists can understand. (The first was Good Intentions: How Big Business and the Medical Establishment are Corrupting the Fight Against AIDS, by Bruce Nussbaum, published in 1990.) Against the Odds may have more influence; it is being reprinted as the first printing quickly sold out. Like Good Intentions, it is based on interviews with some of the key people involved, as well as on documentary evidence. Health economist Arno and health writer Feiden, who are both well known in their fields, focus on the time between the approval of AZT in March 1987, and of ddI in October 1991. Their health expertise allows them to speak authoritatively on many issues: for example, to place the modern history in the context of the other horrors that happened before the development of modern ethical standards for research (the infamous "Tuskegee experiment" was the most notorious case, but far frOm the only one); and to show that much of the treatment access AIDS activists are still fighting for has long been routine with cancer. The most important part of the book is its catalog of dramatic, disastrous mistakes, mostly by government agencies, which delayed the development of AIDS-related drugs -- pentamidine and other pneumocystis prophylaxis, ganciclovir, fluconazole, trimetrexate, and others. (Pharmaceutical companies may have made fewer notable mistakes because most of them chose not to help in AIDS at all.) Here also are the partial successes, such as the rapid approval (but not the pricing) of the first anti-AIDS drug, AZT. The book is also a short history of "the activist and patient communities who have informed themselves about this epidemic more fully than any community ever has and have now altered the course of government policy toward AIDS and other diseases." One of the most important points was quoted from Martin Delaney of Project Inform: "There is no bureaucracy in this nation whose goal is to advocate on behalf of the needs of people with this disease. FDA's task is to keep unsafe or ineffective drugs out; NIH's task is to conduct the research. Whose task is to make sure that people get what they need? Nobody's." We could add that AIDS activism has developed to fill this gap as best it can. The book ends inconclusively. "For now, the story of AIDS drug development remains a struggle between those who have all the time in the world and those for whom time is running out. But it also remains a story of hope -- a hope that holds steadfast against the odds." Comment Where are we now? Our own view is consistent with the picture supported by Arno and Feiden. We believe that the end of the drug-development pipeline -- FDA approval of urgently needed drugs -- has been repaired as well as we can expect given political realities. The new accelerated-approval procedure has delivered ddI and ddC. We must be vigilant against forces seeking backsliding. But the main problem now shifts from a constipated pipeline to an empty one. For repairs have only started on the beginning of the pipeline (getting promising agents through preclinical testing and into humans for the first time) and the middle (larger human trials, by the often-disorganized AIDS Clinical Trials Group, and the often-uncommitted pharmaceutical industry). This development is no happenstance. For activists have had to step in where national leadership (both government and private institutions) has failed. And some parts of the leadership vacuum are more difficult than others for grassroots activists to fill. For example, it is easy to organize around FDA delays late in drug development, because by then data exists, and the drugs are ready to go. But -- as Arno and Feiden quoted from AIDS TREATMENT NEWS -- "It is harder to organize people around deaths caused by drugs which do not exist and perhaps never will, but should." ***** AIDS TREATMENT NEWS Published twice monthly Subscription and Editorial Office: P. O. Box 411256 San Francisco, CA 94141 800/TREAT-1-2 toll-free U. S. and Canada 415/255-0588 regular office number 415/255-4659 fax Editor and Publisher: John S. James Medical Reporters: Jason Heyman John S. James Nancy Solomon Reader Services, Business, and Marketing: David Keith Thom Fontaine Jason Heyman Nancy Solomon Laura Thomas Tadd Tobias Rae Trewartha Statement of Purpose: AIDS TREATMENT NEWS reports on experimental and standard treatments, especially those available now. We interview physicians, scientists, other health professionals, and persons with AIDS or HIV; we also collect information from meetings and conferences, medical journals, and computer databases. Long-term survivors have usually tried many different treatments, and found combinations which work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. Subscription Information: Call 800/TREAT-1-2 Businesses, Institutions, Professionals: $230/year. Nonprofit organizations: $115/year. Individuals: $100/year, or $60 for six months. Special discount for persons with financial difficulties: $45/year, or $24 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U. S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207 Copyright 1992 by John S. James. 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