AIDS TREATMENT NEWS Issue #183, September 17, 1993 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: Vaccine Controversy: The Army gp160 Trial Cosalane: New Approach to HIV Drug MEGACE Now Approved for AIDS: New Formulation Recent Journal Articles: AZT: European-Australian Study Shows Benefit, Especially in Early Treatment Ateviridine: Upjohn "BHAP" Drug May Be Useful After AZT Resistance TMP-SMX: High Treatment Dose Can Cause Hyperkalemia Lymphoma: EBV Test May Help in Diagnosis Resources: September Scientific American: Special Issue on the Immune System AIDS Treatment in Prison: Booklet Useful for Non- Prisoners, Too Announcements: AZT Muscle Problems: L-Carnitine Study Recruiting HIV-Related Nerve or Muscle Problems -- IVIG Study Recruiting New York: Community-Based Aspirin Study Recruiting California: Breast Cancer Research, Needle Exchange, Insurance Reform -- Calls, Letters Needed Before October 10 ***** Vaccine Controversy: The Army gp160 Trial by John S. James Three East Coast AIDS organizations are seeking professional and community input on what should be done concerning a bitterly controversial trial of an AIDS treatment vaccine. Decisions must be made quickly; otherwise, the trial will go ahead as currently planned and test only a single vaccine. Neither this outcome, nor stopping the trial without an alternative, is satisfactory. A Federal panel of leading vaccine experts has recommended that another trial, to compare several vaccines, be conducted instead. This article can only outline the basics of a situation described in the July 17 New Scientist as "bizarre events... descending into political farce." The controversy started when Congress appropriated $20 million for the Department of Defense (DoD; the Army is the lead organization within DoD to conduct this research) to test a vaccine made from the gp160 protein of HIV, to treat persons already infected with the virus. Only one company, MicroGeneSys, Inc., of Meriden, Connecticut, had a gp160 product (named VaxSyn, produced by genetically engineered insect cells) with enough safety data to enter a large trial with thousands of people; most of the other vaccines which have enough data are based on gp120 instead. Leading scientists and health officials have been very concerned that Congress specified a particular product in legislation, instead of letting decisions about which drugs to test be determined by scientific review. (MicroGeneSys got the appropriation by an effective lobbying campaign, including hiring ex-Senator Russell Long of Louisiana to lobby Congress.) The law allowed the trial to be scuttled if the National Institutes of Health, the Food and Drug Administration, and the Department of Defense agreed (within six months) that the trial as specified was not scientifically justified -- in which case the money would be used for other AIDS research instead. So NIH convened a panel of vaccine experts to decide what to do. But instead of making a formal determination against the one-vaccine trial, as the law clearly allowed, the panel instead recommended a trial comparing several different vaccines (including VaxSyn). Many of the experts believed that some of the other available treatment vaccines are more promising -- that VaxSyn should be included, but not as the only agent being tested. The Army, whose experience in AIDS vaccines is largely limited to VaxSyn, agreed to turn the money over to NIH to conduct the comparative trial. (Other possible candidates include vaccines from Genentech; from Biocine, a partnership of Chiron and Ciba-Geigy; from Immuno AG of Vienna, Austria; and from Immune Response Corporation.) But then MicroGeneSys refused to donate its vaccine, and asked NIH to pay $10 million for it -- half of the total appropriation. Other companies agreed to donate their vaccines. NIH is unwilling to pay for the drugs which it is testing, at public expense, to the great benefit of the companies developing them -- and it was unwilling to allow this case to set a precedent which could hurt all government clinical trials in the future. (If pharmaceutical companies start charging the government for drugs its scientists want to use in trials, less could be done with the increasingly scarce Federal resources). Because the legislation specified gp160, it was not possible to drop MicroGeneSys and proceed without any gp160 vaccine; no other gp160 vaccine was ready for such a trial, although one might be ready early next year. Because of this impasse, the money was never transferred from DoD to NIH, as both parties had agreed in principle to do. The Army proceeded with its original plan for testing the MicroGeneSys product alone. The Army also insisted that the company donate the vaccine, and MicroGeneSys then agreed to do so. Meanwhile, the VaxSyn data used in lobbying for the Congressional appropriation, presented by Robert Redfield, M.D., of the Walter Reed Army Institute of Research, at the Amsterdam AIDS conference in 1992, has been seriously questioned. The presentation showed stabilized or reduced viral levels in patients, with statistical significance compared to natural-history controls. But not all patients had been included, for reasons that are in dispute. A later analysis, with all patients, failed to find a statistically significant difference. A spokesperson for Redfield was quoted, in an article in the September 1993 Lear's, as saying, "If the conclusion that people believe they heard in Amsterdam was that this gp160 was efficacious, or that we stabilize disease, or that we're curing patients, all of those things are incorrect." The chief statistician working on the project, Bill McCarthy, threatened to remove his name from one of the papers; recently he resigned (from the Henry M. Jackson Foundation, a nonprofit organization which does medical research for the Army); see "Key Statistician Ousted As Waxman Enters gp160 Fray," Nature, July 29, 1993. Fortunately the Army has already obligated the $20 million to the Jackson Foundation, so the money will not be lost to AIDS research at the end of the current fiscal year (end of September) if the plan for the VaxSyn-only trial is changed. It is not hard to see why MicroGeneSys has an incentive for testing only its vaccine. The first AIDS therapeutic vaccine to get FDA approval could be worth a billion dollars or more. If only one vaccine starts phase III testing, no other will have enough data to be a candidate for approval at the time the Army test ends; the FDA will have to approve VaxSyn or nothing. But if the other vaccines were tested, one or more of them might prove significantly better, and then VaxSyn might not be approved at all. The public loss from this result is equally clear. First, thousands of people with HIV will receive a vaccine which many experts believe is less promising than other available candidates, in a trial which a panel of leading vaccine experts concluded should not be run as currently planned. And the way MicroGeneSys could benefit from having its vaccine tested alone would be through the loss or delay of other vaccines which are as good or better, which is likely to adversely affect hundreds of thousands of people. What You Can Do This article only sketches some of the elements of the gp160 treatment-vaccine controversy. Much more information has been published in Science, Nature, New Scientist, and major newspapers. Three AIDS organizations (Treatment Action Group [TAG], ACT UP/New York Treatment + Data Committee, and the AIDS Action Council) are now investigating both administrative and legislative alternatives to letting the VaxSyn-only trial go forward as now planned. But time is very short, and they need to know what people think should be done. They have distributed the following survey, asking people which of the following options are acceptable, and in which order, as well as which are unacceptable: 1. Allow the Army to proceed with a comparison of gp160 vs. placebo in a phase III trial with clinical endpoints. 2. Implement the NIH/FDA panel's recommended multi-product, placebo-controlled large trial with clinical endpoints, mandating that sponsors provide vaccine free. 2a. If MicroGeneSys remains unwilling to guarantee free drug for the full duration of the trial, instruct trial organizers to consider Immuno AG's mammalian-cell based gp160, safety data on which will be in by January. 3. Allow the Army to redirect the $20 million to other AIDS research programs: 3a. Mandate ad hoc external peer review for the disbursement of AIDS awards by the Army with this $20 million, as will be done with the Army's $210 million breast cancer appropriation. 3b. Specify that the money be spent on therapeutic research. 3c. Specify that it be spent on vaccine research. 3d. Specify that it be spent on basic research. 4. Other (please specify). Fax your answers (or any other comments) to TAG at 212/260- 8561. Or leave them a phone message at 212/260-0300. ***** Cosalane: New Approach to HIV Drug Cosalane, developed by researchers at Purdue University and the U.S. National Cancer Institute, is not yet ready for human testing, but is interesting because it represents a new class of drugs and new ideas for developing an HIV treatment. The work is supported by the U.S. National Cancer Institute. Cosalane was developed from a chemical known as ATA (aurintricarboxylic acid), which has long been known to have anti-HIV activity. ATA has not been developed as a drug because it is difficult to work with. It is not a single chemical, but a mixture of many different polymers -- and every batch tends to be different. This creates problems for quality control, and makes it almost impossible to get FDA approval for marketing. The first attempt to overcome this problem was to separate out the smaller molecules (lower molecular weight) in the mixture, to look for a single molecule which could be made uniformly. But, unfortunately, the low molecular weight molecules have the least anti-HIV activity. Chemists then took one of these low molecular weight components of ATA, and attached it to a steroid molecule (in addition to making other chemical changes). The purpose was to target the substance more effectively to the surface of viruses and of cells. The result, cosalane, has a relatively low molecular weight but works as well as any of the ATA fractions. Cosalane is believed to inhibit binding of HIV to the cell, and also to inhibit viral entry (the fusion of the virus and the cell, after binding). In laboratory tests, it is active in concentrations of about 3 micromolar (not especially good compared to other drugs), and it must be present continuously to protect the cells. But it has been effective against all strains of HIV-1 and HIV-2 tested, including virus which is resistant to AZT or to the non-nucleoside RT-inhibitor drugs. And plasma concentrations higher than the effective anti-HIV concentration have been achieved in animal studies. The obstacle now to cosalane's development is making enough for further tests. Only small quantities have been synthesized in laboratories -- not enough to finish animal tests, let alone run a clinical trial. Efforts are now underway to scale up the fairly complex manufacturing process. Little has been published about cosalane so far, although several papers have appeared about the work with ATA which led up to it. Mark S. Cushman, Ph.D., presented the first technical information at a meeting of the American Chemical Society, August 22-27, 1993. A non-technical article about cosalane appeared in AIDS Weekly, September 6. ***** MEGACE Now Approved for AIDS: New Formulation MEGACE (megestrol acetate), a drug long approved as a palliative treatment for certain cancers, was approved by the FDA on September 10 for treatment of unexplained significant weight loss, or loss of appetite, in persons with AIDS. Because of the large doses used with AIDS (which are inconvenient to take with the MEGACE tablets previously approved), a new oral suspension form was also approved on September 10. It should be in pharmacies within the next few weeks. In controlled studies, weight increased by an average of 7.8 to 11.2 pounds in high-dose groups, and 4.2 pounds with a lower dose, compared to a weight loss of about two pounds with placebo. Also improved were appetite, caloric intake, and sense of well being. The weight gain was shown to include lean body weight and muscle mass, not just water. However, a followup study a year later found no difference in survival between the treatment and placebo groups. And impotence occurred in as many as 12 percent of the patients at the highest dose; it appears to be reversible when the drug is discontinued. A suggested starting dose for most patients is 800 mg per day, reduced to 400 mg after one month. In practice, according to Jamie Von Roenn, M.D., lead investigator of a MEGACE trial, patients are likely to start with the high dose until they gain weight, then reduce the dose to maintain the weight. According to Bristol-Myers Squibb, the price to wholesalers will be $4.15 per day or less; we do not know what dose was used for this computation. For patients who need the drug but cannot pay, physicians can call 800/788-0123 to apply for free drug when no third-party options are available. ***** Recent Journal Articles Note: This section is new in AIDS Treatment News. Usually we do not focus on articles published elsewhere, but prefer in- depth reports which may come out months before the journal articles (or months after, giving us a chance to hear professional reaction). We have left reporting of recent articles to others. However, the most comprehensive sources on recent journals are either very expensive (AIDS WEEKLY) or often very technical (ATIN: AIDS TARGETED INFORMATION). Our coverage will not be comprehensive. For every article included below, we examined about ten other recent AIDS treatment articles which we chose not to include -- mostly because we thought they would not be relevant to our readers. Some of those we omitted are important for physicians, but concern specialized areas which we could not cover adequately. Note that we cannot do the same in-depth investigation for these reports as we do for major articles. The main focus here is the fact that the article appeared. But sometimes we will include background to help readers understand the context. We plan to focus on information which is practical now, and also on information which helps readers understand developments which may be important for the future. But there are thousands of different medical journals, and we can only scan a few. We will inevitably miss important articles, and hope that readers will bring them to our attention. ** AZT: European-Australian Study Shows Benefit, Especially in Early Treatment The third large trial of AZT, by the European-Australian Collaborative Group, was published in the July 29 New England Journal of Medicine. The results are not new, having been presented in conferences and known to physicians for some time, but the fully peer reviewed publication provides an opportunity for a closer look. And no matter how you look at the data, AZT showed some benefit on the average, with disease progression in the AZT group about half (or a little more than half) that in the placebo group. This trial included 993 volunteers, who were randomly assigned to take AZT or placebo for three years. All were HIV positive and asymptomatic, with T-helper counts above 400, when they started. Why is this result different from that of the Concorde study (the second major AZT trial, and the one which accounted for much of the pessimism coming out of the recent International Conference on AIDS in Berlin), which found only a small and temporary benefit from AZT? No one knows for sure, but a major difference is that the patients entering the European- Australian study started at an earlier stage in disease progression (median T-helper count was about 650). Also, there were a number of other differences between the trials, such as the exact definition of what was counted as disease progression. When the negative results of the Concorde AZT study came out, most physicians did not change their prescribing practices greatly; instead they chose to wait for more information. Some of the press reports exaggerated the pessimism, however, probably leading some patients to be too quick to drop antiretroviral treatment. It is clear that AZT, ddI, ddC, and probably d4T are poor anti-HIV drugs. But for many patients, they seem to be clearly better than nothing. And the European-Australian study suggests that early treatment is better than late. "The implication is that most patients with HIV infection should be treated, but the benefit may be greatest if therapy is begun when CD4 cell counts are over 300 to 400 per cubic millimeter," according to an accompanying editorial. [Cooper DA, Gatell JM, Kroon S, and others. Zidovudine in persons with asymptomatic HIV infection and CD4+ cell counts greater than 400 per cubic millimeter. THE NEW ENGLAND JOURNAL OF MEDICINE. July 29, 1993; volume 329, number 5, pages 297-303. Also see editorial on pages 351-352 of the same issue.] ** Ateviridine: Upjohn "BHAP" Drug May Be Useful After AZT Resistance Ateviridine (U-87301E) is an experimental drug being developed by Upjohn Laboratories. It is one of the "BHAP" (bisheteroarylpiperzine) chemicals synthesized by that company and tested for anti-HIV activity. Two BHAP drugs, U- 87301E and U-90152, are now in clinical trials. (U-90152, sometimes called "super BHAP," is active in lower concentrations. Due to the time required to analyze results and get them published in journals, only U-87301E is reported in the current article.) The BHAP compounds are part of a class of drugs called non- nucleoside reverse transcriptase (RT) inhibitors. Unfortunately, a major problem with all the known drugs which work this way is that HIV can quickly become resistant to them. But different kinds of resistance (different mutations on the virus) develop with different non-nucleoside drugs; the different drugs of this class are not interchangeable. This suggests that useful combination treatments including these drugs may be possible. (Also, low-level drug resistance can sometimes be overcome by increasing the dose.) The recent Ateviridine article reported that: * Ateviridine was found to be effective against a number of clinical isolates (HIV taken from patients), regardless of whether or not the virus strains are AZT resistant or ddI resistant. No virus tested was resistant to both ateviridine and AZT, or to both ateviridine and ddI. The authors suggested that such cross resistance might not occur. (However, only a few different strains were tested and reported in this paper.) * Laboratory tests showed that the combination of ateviridine and AZT might be useful against AZT-resistant viruses. This combination was synergistic against AZT-resistant viruses (meaning that the combination worked better than would be expected by adding how well the drugs worked separately). But against AZT-susceptible virus, the combination was only additive. With ddI the result was different; the combination was additive whether or not the virus was resistant to ddI. The authors conclude that ateviridine might be useful in combination with AZT -- especially in the common case where patients have already been using AZT alone for some time, and are likely to have developed strains of AZT-resistant virus. [Campbell TB, Young RK, Eron JJ, D'Aquila RT, Tarpley WG, and Kuritzkes DR. Inhibition of human immunodeficiency virus type 1 replication in vitro by the bisheteroarylpiperzine ateviridine (U-87201E) in combination with zidovudine or didanosine. JOURNAL OF INFECTIOUS DISEASES. August 1993; volume 168, pages 318-326.] ** TMP-SMX: High Treatment Dose Can Cause Hyperkalemia A study by physicians at the Brookdale Hospital Medical Center in Brooklyn, New York, measured serum potassium levels in 25 patients who were given high-dose TMP-SMX for treatment of pneumocystis, compared with 26 patients not given that drug. They concluded that high-dose TMP-SMX could result in life-threatening hyperkalemia, particularly 7 to 10 days after the start of treatment, and that serum potassium levels should be monitored closely. (Note: this study looked at the high doses used to treat pneumocystis -- not the much lower doses used for prophylaxis.) [Greenberg S, Reiser IW, Chou SY, and Porush JG. Trimethoprim-sulfamethoxazole induces reversible hyperkalemia. ANNALS OF INTERNAL MEDICINE. August 15, 1993; volume 119, number 4, pages 291-295. The following article starting on page 296, by different authors, looks at a possible cause, involving effects of the drug on the kidney.] ** Lymphoma: EBV Test May Help in Diagnosis A research test (not now available commercially) found Epstein-Barr virus DNA in the cerebrospinal fluid from 17 of 17 patients who were diagnosed at autopsy with primary CNS lymphoma -- but in only 1 of 68 HIV-positive patients without detectable lymphoma at autopsy. The authors concluded that the test was 100 percent sensitive and 98.5 percent specific for AIDS-associated primary CNS lymphoma. [Cinque P, Brytting M, Vago L, Castagna A, Parravicini C, and Zanchetta N. Epstein-Barr virus DNA in cerebrospinal fluid from patients with AIDS-related primary lymphoma of the central nervous system. THE LANCET. August 14, 1993; volume 342, pages 398-401.] ***** Resources ** September SCIENTIFIC AMERICAN: Special Issue on the Immune System A special issue of SCIENTIFIC AMERICAN, "Life, Death, and the Immune System," now on the newsstands, provides an excellent tutorial and background on how the immune system works. It is especially helpful for giving the background information needed to understand technical discussions of AIDS -- including the technical terms, such as "T cells," "B cells," "stem cells," "MHC molecules," "cytokines," etc. Besides several general chapters on the immune system and its development, there are chapters on AIDS, autoimmune diseases, and allergies. The AIDS chapter has little treatment information, but much background on theories of what happens in the body during HIV infection. The reading level is more advanced than that of AIDS Treatment News, and readers will need some familiarity with the material to understand the articles without assistance. For those without such background, the issue could be a useful "textbook" for a short course on AIDS and the immune system, led by an instructor. Organizations could provide a service by setting up such a course for their clients. ** AIDS Treatment in Prison: Booklet Useful for Non- Prisoners, Too The Treatment Education Program of AIDS Project Los Angeles has published a 46-page booklet, BE GOOD TO YOURSELF: A SELF- CARE MANUAL FOR INMATES LIVING WITH HIV. It focuses on what can be done with treatments which are likely to be accessible to prisoners. These approaches are therefore accessible to most people without difficulty. Chapters include acupressure, stress reduction, exercise, massage, nutritional supplements (which some prisons allow), AIDS prevention information, and a resource list for prisoners. This book does not include Western medicine in prison, or the related issues of access and standards of care. "Many of these treatments originated in Oriental medicine or other forms of traditional therapy. They were not specifically designed for HIV infection, but to strengthen natural defenses. Most of them have not been formally tested as a treatment for HIV disease, mainly because traditional medicine is largely neglected by scientists and physicians in charge of AIDS research in Western countries. For this reason, no warranty or endorsement is made as to the success of any of these treatments. This information should be considered as source material only." (From the Introduction.) For a copy, write to: Treatment Education Program, AIDS Project Los Angeles, 6721 Romaine Street, Los Angeles, CA 90038. ***** Announcements ** AZT Muscle Problems: L-Carnitine Study Recruiting The Neuromuscular Diseases Section of the U.S. National Institute of Neurological Disorders and Stroke (NINDS) is now recruiting for a study of high-dose L-carnitine as a possible treatment or preventive for AZT-related muscle problems. Patients may be eligible if they are using AZT and experiencing either fatigue, decreased endurance, or weakness; these can be symptoms of AZT-induced muscle toxicity. [Note: persons with HIV and nerve or muscle disorders, whether or not they are taking AZT, may be eligible for a separate NINDS study of a different treatment; for more information, see the announcement below.] This six-month study is being conducted at the National Institutes of Health campus in Bethesda, Maryland, near Washington D.C. All expenses are paid, except for the cost of travel for the first trip to Bethesda to see if you qualify for the study. (Lodging is paid for this first trip, and all expenses are paid for later trips.) No insurance company will be billed, and all information will be kept confidential. There are no T-helper count requirements for this study. All test results (including physical examination, laboratory tests, EKG, echocardiogram, and muscle biopsy) will be forwarded for the patient's clinical care. This is a placebo-controlled study. At the end of the study, if the treatment is determined to be effective, it will be provided. Background L-carnitine is an essential nutrient, which is found especially in muscle tissue. Deficiencies can cause muscle and heart problems. A study published last year found low levels in 72 percent of AIDS patients who were using AZT.1 Another study2 gave a high dose of L-carnitine for two weeks to AIDS patients treated with AZT, and found improved results of certain blood tests. The goal of the NINDS study is to see if correcting an L-carnitine deficiency (if there is one) could relieve AZT-related muscle problems. Carnitine is sold in health-food stores and buyers' clubs. But be sure to use only L-carnitine (not DL-carnitine, which at one time was the only kind available there). DL carnitine consists of a mixture of equal parts of L-carnitine and D- carnitine. Only L-carnitine is active; and some people suspect that D-carnitine might be harmful. Better yet, if you can get your physician to prescribe L- carnitine, you can be assured of getting the highest quality. Some physicians will be reluctant, because this use (for AZT- related muscle problems) is experimental and unproven at this time. References 1. De Simone C, Tzantzoglou S, Jirillo E, Marzo A, Vullo V, and Martinelli EA. L-carnitine deficiency in AIDS patients. AIDS. February 1992; volume 6, number 2, pages 203-205. 2. De Simone C, Tzantzoglou S, Famularo G, and others. High dose L-carnitine improves immunologic and metabolic parameters in AIDS patients. IMMUNOPHARMACOLOGY AND IMMUNOTOXICOLOGY. January 1993; volume 15, number 1, pages 1- 12. For More Information For more information, call Edward J. Cupler, M.D., at NINDS, 301/496-9979. ** HIV-Related Nerve or Muscle Problems -- IVIG Study Recruiting A separate study of HIV-related muscle and nerve problems is also being conducted at the Neuromuscular Diseases Section of NINDS. This study is for patients with "inflammatory myopathy and HIV-associated demyelinating neuropathy... We will evaluate patients with neuropathic symptoms of numbness, distorted sensation, or weakness starting distally and progressing proximally." This study is testing high-dose IVIG (intravenous immune globulin) to treat these conditions. There are no T-helper count requirements. It does not matter whether the patient is taking AZT or other antivirals. For More Information For more information, call Edward J. Cupler, M.D., at NINDS, 301/496-9979. ** New York: Community-Based Aspirin Study Recruiting A study of aspirin as a potential treatment for AIDS, conducted by the Community Research Initiative on AIDS (CRIA) in New York City, is now recruiting. The hope is that reducing HIV-related inflammation might result in lower viral burden. The principal investigator is Donald Kotler, M.D., Director of Gastrointestinal Immunology at New York's St. Luke's Roosevelt Hospital Center. The study will administer high-dose aspirin (4 grams, equivalent to about 12 ordinary [325 mg] aspirin tablets per day), plus 3 grams of Sucralfate as a buffer to help prevent stomach irritation, for eight weeks. Volunteers will be randomly assigned either to receive the aspirin, or to receive acetaminophen as a control. Volunteers must be asymptomatic, with no history of opportunistic infections, and with T-helper counts of 50 to 350. They will be tested, and need to have a detectable level of HIV plasma viremia (so that the study can detect improvement by telling whether the viremia is reduced). They must have a platelet count over 150,000, cannot have a history of peptic ulcer or bleeding disorder, and must meet certain other inclusion criteria. They may be using AZT, ddI, and/or ddC, but these are not required. They cannot be taking NSAIDS (non-steroidal anti- inflammatory drugs), and cannot have used more than 0.5 grams of aspirin per day for any period longer than a few months. There are also certain other fairly standard entry criteria -- for example, liver enzymes not greater than five times normal. A total of 46 volunteers will be enrolled. Several different viral tests will be used: plasma viremia, quantitative HIV microculture, acid-dissociated HIV p24 antigen levels, quantitative HIV RNA in plasma, and quantitative DNA and RNA PCR on lymphocytes. (The plasma HIV RNA levels will be measured by David Ho, M.D., director of the Aaron Diamond AIDS Research Center, who is donating his services to this study.) A total of 46 volunteers will be randomly assigned to the treatment or control arms. Persons interested in enrolling in this study can call Bette Smith at CRIA, 212/924-3934. Note: AIDS Treatment News first reported aspirin as a possible HIV treatment in issue #109, August 17, 1990. As far as we know, the CRIA study is the first formal trial. Caution: Dr. Kotler noted, "Due to the possible risks of serious gastrointestinal problems and severe bleeding associated with aspirin use, particularly in people with low blood platelet counts, patients are strongly recommended to consult with a physician before beginning any sort of long- term aspirin treatment." ** California: Breast Cancer Research, Needle Exchange, Insurance Reform -- Calls, Letters Needed Before October 10 AB 478, an important bill to support breast cancer medical research and education with a cigarette tax of 2 cents a pack, is now on Governor Wilson's desk. Unfortunately, Wilson may veto it if he does not hear from the public. Wilson is concerned that any tax increase will offend conservatives -- and he is also under pressure from the tobacco companies. Why is breast-cancer research important to people with AIDS? * AIDS, cancer, rheumatoid arthritis, diabetes, and other diseases involving the immune system, are more closely linked than people realize. Any solid progress against one will almost certainly help research on the others. That's why the LIFE Lobby in Sacramento, which addresses AIDS and gay issues, supports AB 478. * This bill brings new money into medical research, from a cigarette tax. It does not shift money around to pit one disease against another. * Coalitions between AIDS, cancer, and other organizations are extremely important. * Arguments that funding should be determined by experts, not legislation, are understandable, but they do not apply here. First, this bill is good on its merits. Second, the public should be involved in mobilizing the political will to get medical research funded -- not excluded from the process. The experts cannot create the needed political will alone. To support AB 478, call or write to: The Honorable Pete Wilson, Governor, State of California, State Capitol, Sacramento, CA 95814, 916/445-2864, or 415/703-2218 (San Francisco office), or 916/445-4633 fax. (Better yet, get your friends to call, call talk shows, or write to newspapers.) Other AIDS Legislation Other AIDS-related bills supported by the LIFE Lobby at this time are: * AB 260: Allows needle exchange in San Francisco. * AB 1100 and SB 590: Insurance reform to stop "post claims underwriting" -- insurance companies canceling policies of people with AIDS or other chronic diseases after they start to file claims. * SB 670: Protect confidentiality of T-helper count test results (sometimes used to discriminate when HIV-test results cannot be used in California). * AB 623: Set up licensure requirements of residential care facilities for the chronically ill. October 10 is the deadline for Governor Wilson to sign or veto all these bills. He usually leaves the controversial ones until the deadline is near. Note Grassroots organizing on medical research funding is urgently needed. For example, no one told AIDS Treatment News that the cancer bill was on the governor's desk; fortunately, we happened upon it in a newspaper. This should be all over the talk shows, all over the newspapers and newsletters, and all over the phone lines to the governor. What is needed is (1) organizations to put out timely, credible, user-friendly action alerts, probably by fax broadcast, to (2) local organizers who will call their own phone lists and phone trees, of (3) people ready and willing to respond. More people must get involved in making this happen. ***** 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 and Business: David Keith Thom Fontaine 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 1993 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.