&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Copyright 1992 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #148, April 3, 1992 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] Passive Hyperimmune Therapy (Passive Immunotherapy): New Data Released, California Approval Possible International AIDS Conference: Satellite Meetings Anti-Drug Politics Impede Medical Use of Marijuana Announcements: Alternative Treatments: San Francisco Forum, April 18 Meet Your Local CongresspersonsQHelp Fund AIDS Research and Care Help Wanted: AIDS TREATMENT NEWS Needs Marketing/Outreach Coordinator ***** Passive Hyperimmune Therapy (Passive Immunotherapy): New Data Released, California Approval PossiblE by John S. James At a press conference on March 23, HemaCare Corporation, a small blood-products company in Southern California, released preliminary six-month results from its one-year clinical trial of passive hyperimmune therapy (also called passive immunotherapy) in persons with AIDS. Because the company had to be conservative in its interpretation, and because it did not release supporting details at this time, the importance of the report has not been widely understood. The HemaCare results, which are consistent with those of other studies, confirm once again that this treatment is highly beneficial for some patients, and almost certainly should be available as a treatment option. This article examines the new report in the context of previous published studies of passive hyperimmune therapy, and also examines related treatments to see where this therapeutic approach may lead in the future. Background: What Is Passive Hyperimmune Therapy In passive hyperimmune therapy (PHT, also called passive immunotherapy, or PATH), blood plasma is taken from donors who are HIV-positive but unusually healthy, and whose plasma has been found to have high levels of neutralizing antibodies (those which prevent the growth of HIV in laboratory tests). The plasma is usually pooled from several such donors, so that it is likely to contain antibodies effective against many strains of the virus. The pooled plasma is sterilized chemically to kill HIV and any other disease-causing organisms. The treated plasma is then infused into persons with AIDS who have lost their own ability to produce protective antibodies. In the recipient, these antibodies can last for several weeks; the current HemaCare study gives the infusion treatment once per month. Donating the plasma is not believed to cause any harm, as the effective antibodies are quickly replaced; donation, in fact, often appears to be beneficial, as the body is stimulated to produce more antibodies and the levels rise to be higher than they were originally. Only blood plasma is donated; the blood cells are separated by a process called plasmapheresis and returned immediately to the donor, allowing the plasma collection to be done more frequently than regular blood donations. The most challenging steps in passive hyperimmune therapy are: (1) Identifying the best plasma donors. This step is partly an art as well as a science, since at this time there are still many unknowns about which antibodies are most important in controlling HIV infection. (2) Sterilizing the plasma. It is important to be sure that HIV in the donor's plasma is killed, to avoid re-infection with a different strain of the virus. But this must be done in a way that does not destroy the useful antibodies. As a safety check, every lot should be cultured to confirm that the virus has been killed; and the plasma should be processed in facilities meeting the standards of good manufacturing practices for pharmaceuticals. (3) Setting up and administering the process. Regulations require that dedicated equipment and facilities be used to process HIV-positive blood, to avoid any chance of accidental contamination of other blood. If the treatment comes into wider use, community support will be needed to help find donors. And the treatment is inherently expensive, because it is labor- intensive and requires skilled medical specialists. Background: Other Related Therapies * This treatment is called passive hyperimmune therapy in contrast to vaccines, which stimulate the body to actively develop its own immunity. In PHT, the antibodies are provided; the body does not need to make its own. * Passive immunization with antibodies derived from human blood is widely used in medicine to prevent or treat infections other than HIV. Usually the whole plasma is not given; instead, the antibodies are extracted, and given as a product called intravenous immune globulin (IVIG). Several brands of IVIG are approved in the United States for prescription use; they may be useful in some cases to help persons with AIDS, especially children, resist various infections. IVIG appears to be underused in AIDS treatment, primarily because it is expensive. IVIG contains no antibodies against HIV, since for safety purposes the blood used to prepare it is carefully selected to be HIV-negative; therefore IVIG may help to fight opportunistic infections, but not HIV itself. Sometimes the supplier of IVIG can select from a lot which happens to have a higher than average activity against a certain infection, such as CMV, which the physician wants to treat. * A form of IVIG especially made to have high anti-CMV antibodies, called CMV-IVIG, was approved by the FDA on April 17, 1990 for certain kidney transplant patients. This drug was developed as an orphan product by the state of Massachusetts, and distributed by the American Red Cross, Northeast Region. Because of supply problems, the drug was restricted to the patients considered most likely to benefitQ those without CMV who received kidneys from CMV-positive donors. As of two years ago, the supply problems were expected to last about nine months. We have not heard of this treatment being tried for persons with AIDS- related CMV. * An IVIG preparation specifically made with anti-HIV antibodies, called HIVIG, may be tested as an HIV treatment, at least in infants, or tested to see if it can prevent mother- infant transmission of HIV during pregnancy. This treatment appears to be essentially equivalent to passive hyperimmune therapy. HIVIG is only made by Abbott Laboratories, however, and that company seems less than enthusiastic about developing it. * The ultimate future direction of passive immunotherapy for HIV and other diseases is likely to be in monoclonal antibodies. These are not extracted from human blood, but are produced by cells which are created in the laboratory by genetic engineering and other techniques. An anti-CMV monoclonal antibody is currently in clinical trials. The development of anti-HIV monoclonal antibodies may be more difficult because of uncertainty about which antibodies are beneficial and clinically important. In the laboratory the wrong antibodies can actually increase viral infection; this has not been a problem in passive hyperimmune therapy trials, however. There is intense research interest in learning which antibodies are effective, since this information is important not only for developing antibodies for treatment, but also for developing vaccines, and for preventing HIV transmission during pregnancy. The AIDS community must pay more attention to developments in monoclonal antibodies around the world, to make sure that research and development move forward as fast as technically feasible. Passive Hyperimmune Therapy: The HemaCare Study HemaCare Corporation had not previously run clinical trials, but it did have experience well suited for a study of passive hyperimmune therapy. The company specializes in therapeutic hemapheresis, a process of "separating the blood into its components, removing unwanted substances, and returning the other components to the patient." This therapy is used in at least 30 different diseases; HemaCare provides mobile units which travel to hospitals and administer the treatment at the patient's bedside. The company also sells platelet concentrates and other blood products from healthy donorsQas well as plasma which contains rare antibodies. It had this experience before becoming involved in AIDS. The current placebo-controlled study has 219 volunteers with ARC or AIDS. They are randomized to three groups: full-dose (500 cc of plasma once a month), half dose, and placebo. Although six-month interim data was reported, the trial is still continuing. The most important result so far is that there were only a third of the deaths in the full-dose group as in the placebo group. However, there have not been enough deaths in the study for this result to reach the level of statistical proof; it only reached the statistical significance level of p=0.1276 (meaning that if the treatment were useless, the odds would be one in eight that a result this good or better could have occurred by chance alone). In most medical research, the statistical significance must be p<.05 (meaning that the odds are less than one in 20 that the result could occur by chance alone) for a finding to be taken seriously. As a result, the company could not emphasize this survival difference, and its significance has been underreported and underrated. What is widely overlooked is that the value of p<.05 is an arbitrary level which has become customary, not a gold standard of truth. A result which fails to reach that level because there were too few volunteers (or too few deaths) in a trial should not be ignored as if it did not exist. Instead, it should be considered together with other information which is available from the same or other trials. And when the available information on passive hyperimmune therapy is considered togetherQnot broken up into pieces which are each thrown away because no piece by itself is conclusiveQit provides considerable confidence that this treatment can provide substantial benefit to persons with AIDS, including survival benefit. The six-month data did show statistically significant changes in T-helper counts, and in levels of beta-2 microglobulin, in those receiving full dose compared to placebo. There were also fewer opportunistic infections with full dose than with placebo, although this change was not statistically significant at this time. The treatment may have worked best in patients who started with T-helper counts over 50. The trial is continuing, so more results should be available in about six months. Side effects were minor. Over 1300 infusions have been given (counting treatment and placebo groups together); and none of the more than 200 volunteers has had to discontinue treatment due to toxicity. There was also a large drop in p24 antigen in the full-dose group. But this measurement may be hard to interpret in studies of passive hyperimmune therapy, since the infused antibodies may simply combine with the p24 antigen, directly affecting what is being measured without necessarily helping the patient. Other Studies * The most recently published study of passive hyperimmune therapy was conducted by researchers at the Hospital Necker in Paris; it was reported in French in May 1991 (1) and in English in February 1992 (2). This study randomized 18 patients to either an experimental group, to receive plasma with high levels of antibodies against HIV, or to a control group given plasma from HIV-negative donors, which would not have any antibodies against HIV; the treatment was given every two weeks. Both groups also received AZT, and conventional opportunistic infection (OI) prophylaxis. The experimental group had a greatly reduced number of opportunistic infections compared to the control groupQtwo vs eight OIs, a difference which is statistically significant. But when the treatment was stopped at the end of the study, the p24 antigen, which had become undetectable, rose to higher than its original value, and was correlated with severe clinical deterioration. This rebound effect suggested that it may be dangerous for persons with severe immune deficiency to stop passive hyperimmune therapy unless a similarly effective treatment can be substituted, "as virologic relapse may be explosive and poorly tolerated." * The most important work on passive hyperimmune therapy has been published by the group headed by Abraham Karpas, M. D., of Cambridge University, who is generally credited with developing this technique as an AIDS therapy. Karpas and others published a series of papers starting in December 1988 (3-8). * Another group of researchers, including G. Jackson, M. D., at The London Medical College, and colleagues at the University of Illinois College of Medicine and at Abbott Laboratories, published early studies of this treatment in several patients (9-11). * A larger trial has been conducted at the Bronx Veterans Administration Hospital in New York. Results have not been published, however. Passive Hyperimmune Therapy: A Brief History PHT for AIDS is not new. It was first tested in patients over five years ago. Three years ago there was a large, active, and enthusiastic patient-activist movement, especially in San Francisco, to support testing and availability of this treatment. AIDS TREATMENT NEWS listed PHT as one of the most important new AIDS treatments to watch during 1989 (issue #72, January 13, 1989). A brief chronology of early public interest: * January 23, 1987: THE TIMES (London) reported that Karpas' method was being tested on four patients, who had been treated for just over a month. This trial followed published research by Karpas which showed that antibodies were effective against HIV in laboratory tests. The idea of administering antibodies this way as a treatment was not new, having long been used successfully with other diseases. * August 21, 1987: THE WALL STREET JOURNAL reported that Medicorp, a Montreal company which now holds patent rights to passive hyperimmune therapy and licensed the method to HemaCare for its current study, was planning to begin a trial at two hospitals in London, and at a Veterans Administration hospital in New York. A spokesperson for the U. S. National Institutes of Health expressed the usual skepticism, saying that the treatment had "not much rationality for AIDS, because we don't know the function of antibodies, especially since many infected people with antibodies in their blood often go on to develop the disease anyway." * June 15, 1988: Dr. Jackson's group reported evidence of clinical improvement with this treatment, in a talk at the IV International Conference on AIDS in Stockholm. * August 1988: The AIDS / HIV EXPERIMENTAL TREATMENT DIRECTORY of the American Foundation for AIDS Research (AmFAR) published a section on passive immunotherapy, briefly reviewing the results to that time. * December 1988: THE NEW YORK TIMES reported encouraging indications from studies by Jackson's group (10) and by Karpas' group(8). * February 6, 1989: An article by Tim Campbell in the Minneapolis, Minnesota GLC VOICE reported that the U. S. Food and Drug Administration (FDA) had approved HIVIG for human trials, on January 27 of that year. The article discussed the history of the development of this drug, and suggested that it might eclipse AZT as the treatment of choice. * February 1989: The first issue of PATH PROJECT NEWS, a newsletter of the Passive Immunotherapy Foundation (often called the PATH Foundation), reported that California physicians hoped to obtain approval to begin a study of passive hyperimmune therapy "within two to four weeks, and to begin screening donors soon afterward." * March 10,1989: AmFAR and the Pharmaceutical Manufacturers Association sponsored a discussion by invited experts on passive hyperimmune therapy; a report appeared in the AIDS / HIV EXPERIMENTAL TREATMENT DIRECTORY. The meeting focused on producing a more standard product for future research and possible use, and it suggested designs for future studies. * December 1989: The fourth issue of PATH PROJECT NEWS reported that HemaCare was recruiting both donors and recipients for what was then expected to be a 100-patient study. In the last two years there has been little public interest in passive hyperimmune therapy. The reason is simply that there is no way people could get the treatment. The plasma cannot be obtained by buyers' clubs or guerilla clinics; preparation of the plasma is too complex and exacting to be done safely in the average physician's office. Regulatory and commercial obstacles continually impeded the development of this therapy. Little if anything would have happened in the United States, except for the fact that California can approve its own clinical trials without the approval of the FDA, provided that the drug being tested is manufactured entirely within California. Since the plasma used in the HemaCare trial is collected and processed without ever crossing state lines, the California Food and Drug Branch (FDB) was able to approve this trial. As a result, passive hyperimmune therapy may be approved only in California. (Since the treatment is given only once a month, others could presumably come to California for it.) HemaCare plans to apply to the FDB for a "treatment IND" to allow it to provide passive hyperimmune therapy to up to one thousand additional patientsQbefore full approval, which would presumably come at the completion of the trial. The company could not provide this treatment without charging enough to at least cover its costs. It does not yet know what its costs will be when the plasma is collected and processed on a larger scale. The treatment IND will also require community support to help in recruiting HIV-positive donors. Only a minority of persons with HIV have the best antibodies and could qualify as donors. Therefore several potential volunteers will need to be tested for each donor who is accepted. What will be most needed over the next several months is community vigilance to see that this project stays on track, and that the detours of the past are not repeated. References 1. Lefrere JJ, Vittecoq D, Mattlinger B and others. Passive immunotherapy in AIDS: transfusion of plasma rich in anti-p24 antibody (phase I trial). [English translation of title.] REV. FR. TRANSFUS. HEMOBIOL. May 1991: volume 34, number 3, pages 199-211. 2. Vittecoq D, Mattlinger B, Barre-Sinoussi F, and others. Passive immunotherapy in AIDS: A randomized trial of serial human immunodeficiency virus-positive transfusions of plasma rich in p24 antibodies versus transfusions of seronegative plasma. JOURNAL OF INFECTIOUS DISEASES February 1992: volume 165, number 2, pages 364-368. 3. Karpas A, Gray J, Byron N, and others. Passive immunization in ARC and AIDS. BIOTHERAPY 1990: volume 2, number 2, pages 159-172. 4. Karpas A, Hill F, Youle M, Gray J, and Gazzard B. Long-term follow-up on the effects of passive immunization in patients with ARC and AIDS. Sixth International Conference on AIDS, San Francisco, June 20-23, 1990 [abstract S. B. 499]. 5. Hewlett IK, Epstein JS, Lee SF, and Karpas A. Evaluation by PCR of HIV-1 status of AIDS patients receiving passive immunotherapy. Sixth International Conference on AIDS, San Francisco, June 20-23, 1990 [abstract #S. B. 498]. 6. Karpas A, Hill F, Youle M, Gray J, Oates JK, and Gazzard B. Effects of passive immunization in patients with ARC and AIDS. J. CHEMOTHER. INFECT. DIS. MALIGNANCIES (Supplement 1) 1989 [meeting abstract A295]. 7. Karpas A, Hill F, Youle M, Gray J, Oates JK, and Gazzard B. Effect of passive immunization in patients with ARC and AIDS. Fifth International Conference on AIDS, Montreal, June 4-9, 1989 [abstract #W. B. P. 314]. 8. Karpas A, Hill F, Youle M, Cullen V, Gray J, Byron N, and others. Effects of passive immunization in patients with the acquired immunodeficiency syndrome-related complex and acquired immunodeficiency syndrome. PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, USA, December 1988: volume 85, number 23, pages 9234-9237. 9. Hague R, Yap P, Mok JY, Jackson GG, Hargreaves FD, and Coutts NA. Infusion of anti p24 antibody rich plasma in two children with persistent HIV antigenaemia -- a pilot study. Fifth International Conference on AIDS, Montreal, June 4-9, 1989 [abstract # T. B. P. 246]. 10. Jackson GG, Perkins JT, Rubens M, and others. Passive immunoneutralization of human immunodeficiency virus in patients with advanced AIDS. LANCET, September 17, 1988: pages 647-652. 11. Jackson GG, Perkins JT, Paul DA, and others. Passive immunoneutralization of HIV p24 antigenemia in patients with advanced AIDS by infusion of human plasma. Fourth International Conference on AIDS, Stockholm, June 12-16, 1988 [abstract #3064]. ***** International AIDS Conference: Satellite Meetings The major AIDS conference of 1992, the VIII International Conference on AIDS/III STD World Congress, will take place in Amsterdam, July 19-24. As in previous years, many satellite meetings sponsored by nonprofit groups and by pharmaceutical corporations are scheduled to occur during the Conference, or a few days before or after. Persons making travel arrangements may need to know about these meetings early; also, persons who are not going to Amsterdam may want to know about the organizations sponsoring them, so that they can contact groups with whom they share common interests. [Note: some low-cost air tickets will allow the return date (but not the starting date) to be changed, with payment of a moderate fee; others will not allow either date to be changed.] Below we list the non-profit and commercial satellite meetings officially recognized by the International Conference as of March 31, when this issue went to press. There will probably be other relevant meetings in Amsterdam which are not officially recognized by the Conference; we would like to list those too, but there is no systematic way to find out about them. If you know of any such meetings, please let us know. The AIDS conference this year is combined with the III STD World Congress, on sexually-transmitted diseases. We decided to include the whole list, but to give only the contact person, affiliation, phone, and fax, even if addresses were available. We have found that fax is usually the best means for communicating with distant areas, because of its speed and reliability, low cost for short messages, convenient use across time zones, and the ability to route messages correctly despite language differences and to communicate even when persons who speak the same language are not in the offices at the same time. Nonprofit Satellite Meetings Women with HIV/AIDS -- Workshop, July 14-17. Anita Bolderhey, Dutch HIV Association (HIV VN), 31-20-66-44-076, fax 31-20-66- 46-689. Women's Meeting (for researchers, program workers, and seropositive women), July 19, 12:30-15:00. Anita Bolderhey (see above). AIDS Documentation/Information Systems -- Workshop, July 17. Mary Hommes, National Committee on AIDS Control (NCAB), 31-20-69-39- 444, fax 31-20-69-27-989. AIDS and Drugs -- Peer Pressure for Risk Reduction, July 20, 20:00-22:00. Wouter de Jong/Sam Friedman, NCAB (see above). Work Stress and Burnout in Health Care Professionals Related to HIV/AIDS, July 22, 19:45-22:00. Emma van Dongen/Wiebe van der Woude, NCAB (see above). European Lesbian and Gay Psychologists, July 17. Jan Schippers, Schorer Foundation, 31-20-66-24-206, fax 31-20-66-46-069. Network of Sexwork-Related HIV/AIDS Projects, July 18, 10:00- 18:00. Jan Visser, Mr. de Graaf Foundation, 31-20-624-7149, fax 31-20-624-6529. Asian Solidarity Against AIDS -- Workshop, July 19, morning. I-S. Gilada, Indian Health Organization, Bombay, 91-22-851-9020, fax 91-22-851-9020. NARESA Meeting, July 20, evening. Francesta Farmer, Nairobi, 254-2-581-080 or 254-2-224-154. ICASO Latin America Meeting, July 20, evening. Juan Jacobo Hernandez Chavez, Mexico D. F. 52-5-605-8299, fax 52-5-658-3534. ICASO Africa Meeting, July 20, evening. As Sy Elhadj, Dakar, 221-21-9695, fax 221-22-2695. ICASO Asia/Pacific Meeting, July 20, evening. Hisham Hussein, Kuala Lumpur, 60-3-282-1200 ext. 349, fax 60-3-230-1640. ICASO Euro Meeting, July 20, evening. Arne N. Husdal, Oslo, 47- 2-114-900, fax 47-2-360-269. Indigenous Solidarity Against AIDS Meeting, July 21, 19:45- 22:00. Ron Rowell, National Native American AIDS Prevention Center, Oakland, California, 510/444-2051, fax 510/444-1593. ICASO General Meeting, July 21, evening. Richard Burzynski, Ottawa, 613/230-3580, fax 613/563-4998. ICASO North America Meeting, July 20, evening. Richard Burzynski (see above). International AIDS Society Gay and Lesbian Caucus, date to be announced. Greg Herek, International AIDS Society, Dept. of Psychology, University of California, Davis, CA 95616. Culture, Sexual Behavior, and AIDS Prevention, July 24-26. Han ten Brummelhuis, AIDS and Anthropology Group, Department of Anthropology, University of Amsterdam, 31-20-525-2504, fax 31- 20-525-3010. HIV and Homosexuality -- Workshops: 1. A Gay and Lesbian Preview of the VIII Conference on AIDS/III STD World Congress, July 20, 20:30-22:00. 2. Towards an International Gay and Lesbian AIDS Policy, July 22, 20:30-22:00. 3. HIV Policy, Prevention, Care, and Research: A Gay Perspective, July 23, 20:30-22:00. 4. HIV Policy, Prevention, Care, and Research: A Lesbian Perspective, July 23, 20:30-22:00. Mart Simonse, Dutch Association for the Integration of Homosexuality -- COC, 31-20-62-34-596, fax 31-20-62-67-795. AIDS and Primary Health Care: Implications for General Practice and Family Medicine, July 19, morning. Mr. Ludwig Benecke, Benecke Consultants, Amsterdam, 31-20-69-66-349, fax 31-20-69- 18-446. Red Cross/Red Crescent AIDS Seminar, July 18 10:00-18:00, July 19 10:00-15:00, July 20, 18:30-21:00, and July 24(?), 13:30-17:30. International Federation of Red Cross and Red Crescent Societies, Geneva, 44-21-734-5580, fax 41-22-733-0395. Symposium on Clinical Topics and Nutrition, July 25, 8:00-17:00. Gordon Nary, Physicians Association for AIDS Care (PAAC), 312/222-1326, fax 312/222-0329. Neurological and Neuropsychological Complications of HIV Infection, July 14-17. Dr. Peter Portegies, Academic Medical Center (AMC), Clinical AIDS Department, Amsterdam Zuidoost, 31- 20-56-69-111, fax 31-20-55-64-440. HIV Infection: The Quality of Life and Its Biopsychosocial Aspects, July 16-17. Dr. S. Christopher W. Mead, Dr. Frits, S. A. M., Netherlands Cancer Institute/WHO Quality of Life Center, 31-20-51-22-482, fax 31-20-61-72-625. EEC-AIDS Task Force Program in Developing Countries, July 19, 12:00-16:00. Dr. Lieve Fransen, EEC Task Force, Brussels, 32- 2-231-1495, fax 32-2-230-5574. HIV Nursing: Caring for the Future, July 19, 10:00-15:00. James P. Halloran, Association of Nurses in AIDS Care, Yardley, Pennsylvania, 215/321-2371, fax 215/321-2370. General Meeting on Street Children, July 21, 20:00-22:00. Ana Filgueiras, SOS Crianca, Rio de Janeiro, 55-21-227-4029 (phone and fax). Working Group: Street Children, July 22, 20:00-22:00. Ana Filgueiras (see above). AIDS as a Development Program, July 19, 12:00-14:00. Walter Deville, Health Care and Disease Control, Royal Tropic Institute, Amsterdam, 31-20-568-8711, fax 31-20-568-8444. Drugs and AIDS (in the Netherlands): Policy and Practice, July 21, 19:45-22:00. Ger Rolsma, Project AIDS and the Use of Drugs, Dutch Institute for Alcohol and Drugs (NIAD), Utrecht, 31-30-24- 1200, fax 31-30-31-6362. Models of AIDS Prevention by Drug Users for Drug Users, July 22, 19:45-22:00. Ger Rolsma (see above). Talking About Risk (Strategies and techniques to help drug users), Ger Rolsma (see above). Empowering People with HIV/AIDS for Self-Advocacy in Developing Countries, July 22, 20:00-22:00. Prof. Dr. I. Wolffers, Department of Social Medicine, Free University, Amsterdam, 31- 20-548-3366, fax 31-20-646-2228. The Nature of Buddy-Support as Voluntary Work, July 19, 10:00- 15:00. Bouko Bakker, Buddy Project, Schorer Foundation, Amsterdam, 31-20-662-4206, fax 31-20-664-6069. "Safe Not Sorry" and "Safe Sex and How to Get It" -- Premier of two videos on assertion in preventing HIV infection in sexually active women, July 22, 19:45-22:00. Delys Sargeant, Social Biology Resources Center, Melbourne, 61-3-347-8700, fax 61-3- 347-5892. HIV Drug Resistance -- Workshop, July 17-18. The Conference Secretariat, International Clinical Forum Consultants, Wicker House, West Sussex, United Kingdom, 44-903-205-213, fax 44-903- 210-296. STD Diagnostics Initiative -- Annual Meeting, July 16 and 17, Secretariat, STD Diagnostics Initiative, PATH, Seattle, Washington, 206/285-3500, fax 206/285-6619. Ethical Aspects of HIV/AIDS -- Workshop, July 27. Rob Tielman/Jean Davies, International Humanist and Ethical Union (IHEU), Utrecht, 31-39-31-21-55, fax 31-30-36-71-04. Euthanasia, Medical, Ethical and Legal Issues -- Workshop, July 29. Rob Tielman/Jean Davies (see above) Endpoints in HIV Clinical Trials, July 18, 14:00-18:00. Dr. J. A. M. Lange, National AIDS Therapy Evaluation Center (NATEC), Academic Medical Center, University of Amsterdam, 31-20-566-43- 80/44-79, fax 31-20-691-88-21. Slide Seminar in Oral Pathology, July 24-25. Mrs. D. Chevalking, Congress Secretariat Oral Pathology, Free University Hospital, Department of Oral Pathology, Amsterdam, 31-29-548-2306, fax 31- 20-548-5226. Corporate Satellite Meetings HIV Treatment Strategies for the 1990s, July 19, 10:30, in Grote Zaal, RAI Center. The Wellcome Foundation Limited, contact Caroline Gay, Kent, England, 081-658-2211, fax 081-650-9862. Gastrointestinal Disorders in HIV-Infected Patients, July 20, 19:30 in Forum Zaal, RAI Center. Sandoz Pharmaceuticals Corporation, contact Tammy Altmark, Audio Visual Marketing, Inc., New York, 212/614-1370, fax 212/979-1214. Management Strategies for Cytomegalovirus and Other Herpesvirus Infections, July 20, 19:30 in Grote Zaal, RAI Center. Astra Pharmaceutical Products Inc., contact: Deborah Rachlin, Triclinica Communications, Inc. New York, 212/698-4084, fax 212/698-4003. Polymerase Chain Reaction: Diagnostic Kits for HIV, Mycobacteria and the Implications for Diagnosis of Opportunistic Infections, July 21, 19:30 in Midden Zaal, RAI Center. Roche Molecular Systems, contact: Thomas H. Callaway, M. D., Director of Scientific Affairs, Sommerville, New Hampshire, 919/361-7735, fax 919/361-7797. Therapeutic Treatment of HIV Patients: Clinical and Laboratory Tools, July 22, 19:30 in Grote Zaal, RAI Center. Bristol-Myers Squibb Company, contact Leif Anderson, Health Science Communications, New York 212/727-1337, fax 212/727-2463. The Evolution of Community Care, July 21, 19:30 in Grote Zaal, RAI Center. Caremark, contact: Dr. Patrick Rafferty, Berkshire, United Kingdom, 44-635-200-020, fax 44-635-578-800. ***** Anti-Drug Politics Impede Medical Use of Marijuana by Denny Smith Two government bureaucracies have recently decided to uphold regressive positions on the therapeutic use of marijuana (Cannabis sativa), and the effect of the decisions was given an added sting by the death last week of Barbra Jenks, a Florida woman with AIDS who was once arrested for growing marijuana for her personal medical use. On March 18, The U. S. Drug Enforcement Administration (DEA) decided to uphold its barricade against medical access to marijuana. (For background information, see AIDS TREATMENT NEWS issues #131 and #139.) The decision comes almost one year after a Court of Appeals ordered the DEA to reconsider that position, and one week after the U. S. Public Health Service revealed that it would not expand its compassionate-use marijuana program (beyond the twelve patients now receiving government-grown drug). An estimated 300 people had applications pending for compassionate access to marijuana. The decisions have been widely and sharply criticized. While the oral drug Marinol (a pharmaceutical version of marijuana's component THC) is available by prescription, many people with severe nausea and vomiting prefer marijuana. The Public Health Service argument that smoking marijuana could cause lung infections is generally regarded as specious, since the dried plant can easily be sterilized. The American public appears to support medical access to marijuana: 35 states have acknowledged its therapeutic value, and last November the city of San Francisco voted four to one to add it to California's list of approved medicines. Reaction to the decisions was particularly critical from four organizations which have been working to reverse the criminalization of medical marijuana: the Alliance for Cannabis Therapeutics (ACT), the Marijuana AIDS Research Service (MARS), and the Drug Policy Foundation, all based in Washington, D. C., and the American Medical Marijuana Movement (AMMM), based in San Francisco. Spokespersons for ACT and the Drug Policy Foundation told us that lawmakers are timidly deferring to the Bush administration's indiscriminate war on drugs, and that they need to hear from the public to chart a more rational course. ACT is encouraging people who disagree with the government's position on medical marijuana to register their opinion with their senators and congressional representatives, and with the following legislative committees: * Labor and Human Resources, Room SD-428, U. S. Senate, Washington, D. C., 20010, telephone 202/224-5375. * Subcommittee on Health, 2415 RHOB, U. S. Congress, Washington, D. C., 20015, telephone 202/225-4952. For more discussion of the role of marijuana in HIV therapy, we recommend the book "Marijuana & AIDS: Pot, Politics & PWAs in America," written by Robert Randall, President of ACT, and published by Galen Press. The book includes a chapter comparing marijuana and Marinol, as well as testimony given at a DEA hearing by Ivan Silverberg, M. D., a San Francisco oncologist who has treated many people with AIDS. Barbra Jenks, who died on March 28, was in the eye of the national media when she and her husband Kenny went on trial for marijuana cultivation. The Florida Supreme Court eventually cleared the couple of the charges by reason of medical necessity, and Kenny Jenks continues to survive with AIDS. In 1990, in her affidavit for the trial, Ms. Jenks told the court: "In every sense of the word, marijuana made a critical difference in my medical care. We were not throwing up. We were eating well and our weight was coming back. Kenny, despite his low T-cell count, continued working and bringing home a paycheck. Our mood was good. "Because we were eating well, we were able to continue taking AZT, the only drug known to help retard the HIV virus. Many patients, unable to tolerate the intense nausea and vomiting of AIDS and AZT therapy, are forced to quit AZT. Unable to tolerate treatment, their disease becomes progressive and they rapidly fall prey to opportunistic infections. Marijuana helped us avoid this dangerous trap. "Things went on like this for a year. Our health was stable, our spirits good. We stayed out of the hospital and with each other. Odd as this may seem, we were generally happy. I thank God for each day I am alive and try to make the best of each day." Comment The eloquence of Barbra Jenks, a 25-year old woman with AIDS, won a victory in Florida for all people who may one day need to use marijuana. She spent her limited time and energy fighting what many consider a foolish and heartless national policy. Meanwhile, the federal government remains intransigent on the issue. Dennis Peron of AMMM told us that California alone spends $17 million annually trying (unsuccessfully) to eradicate marijuana cultivation, and that the U. S. government's total expenditures for its controversial drug war is $17 billion a year. Such a sum invites us to question why funding for medical research and health care is always a struggle at budget time. Perhaps these grossly tilted priorities will yet become an election-year issue. ***** Announcements ** Alternative Treatments: San Francisco Forum, April 18 A free public forum, "Alternative Approaches to the Treatment of HIV," will be held April 18th from 1:00 to 4:00 p.m. at Davies Medical Center Auditorium, Castro and Duboce Streets, in San Francisco. Panelists will include persons with HIV, and practitioners of acupuncture, Chinese herbal medicine, Ayurvedic medicine, and massage therapy. This event is sponsored by ACT UP/San Francisco, AIDS Treament News, PHREDA Project, the San Francisco AIDS Foundation, and Women's AIDS Network. For more information, call 415/255-0824. ** Meet Your Local Congresspersons Help Fund AIDS Research and Care Mobilization Against AIDS has called a national AIDS lobby day on May 18Qthe day after the international AIDS candlelight memorial, which occurs in over 100 U. S. cities. Most members of Congress have never met a person with AIDS or HIV from their home district; that is why they do not sense the seriousness of the epidemic. On May 18, people with AIDS or HIV or their supporters anywhere in the U. S. will meet their Congresspersons or assistants in their local district offices (you do not need to travel to Washington) to ask for adequate funding for AIDS research, education, and treatment. Mobilization Against AIDS will provide information and help you prepare for this meeting. For more information, call them toll-free at 800/24-LOBBY. ** Help Wanted: AIDS TREATMENT NEWS Needs Marketing/Outreach Coordinator AIDS TREATMENT NEWS needs someone with marketing experience and achievement, who is familiar with HIV treatments and organizations, to work half to full time to market the newsletter and to develop other forms in which our information can be used. We cannot pay market rates for the expertise we need, so we are looking for someone who believes in what we are doing and would like to work with us. We do offer full health coverage (Kaiser). When we began, AIDS TREATMENT NEWS did no advertising, marketing, or community outreach, but relied only on word of mouth. More recently we have used conference exhibits, direct mail, and display advertising. We want to continue these efforts when appropriate; but we expect to focus on building relationships with community and service organizations, corporations, the media, and others, through special projects which are useful to them. If you are interested, send a resume before May 1 to: AIDS TREATMENT NEWS, P. O. Box 411256, San Francisco, CA 94141. ***** 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: John S. James Michelle Roland Denny Smith Reader Services, Business, and Marketing: Thom Fontaine Jason Heyman 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. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&