Subject: AIDS Treatment News #93 Date: Dec 21 1989 (826 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1989 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue # 93, December 15, 1989 Contents: [items are separated by "*****" for this display] 1989/1990: Where Are We Now? The Wrong Nightmare: The Worst Delay of Clinical Trials NAC: "No Miracles" San Francisco: Oral Thrush Study San Francisco: Chinese Herbal Program Deadline January 5 New BETA (Bulletin of Experimental Treatments for AIDS ) Lymphoma Treatments Reviewed Chronic Fatigue Organizations Seek Coalition with AIDS Efforts Community Research Alliance Hypericin Funding Caution: Malicious "AIDS" Computer Disk Sulfadiazine Temporary Supply Problem Reminder: AZT Questionnaires Next Issue January 5 ***** 1989/1990: WHERE ARE WE NOW? by John S. James 1990 begins at a time of confusion about research and new- treatment issues. Much is happening, and the year ahead could develop in any of a number of different ways. Here is one area we believe will be important next year. From Access to Oversight? Last January we predicted that access would be the major treatment issue of 1989. At that time it was already clear that no major treatment advance would be approved in 1989; one could know that by looking at the drugs in the clinical-trials pipeline. Therefore, the issue would be whether people could use promising treatments while they were still experimental -- treatments like ddI which probably work but will take years to acquire statistical proof that they do. Great progress on access was made last year, thanks largely to two key events: Fauci's proposal for a parallel track, and the ddI program developed by Bristol-Myers in cooperation with the FDA, AIDS activists, front-line physicians, and others. Major problems remain, and questions, issues, and conflicts around access will be very much with us in 1990. But we think that another issue may become central next year -- the need for better definition, design and management of the clinical trials, so that they can respond better to the needs of the public- health emergency. We see resources as the most important single issue of 1990 -- money for prevention, research, treatment, and other care. Since we are not experienced in financing issues, we will follow the lead of service organizations and others. We are familiar with research, however, and here we believe that effective scientific and administrative oversight of the trials will become a critical issue. It has been the most important issue all along, but until now little has been said about it. Pressures are building to end the silence: * No major approvals in 1990. It is already clear that no important HIV treatment will be approved in 1990 under current procedures. ddI and ddC are now farthest ahead, but approval for each must wait for (among other things) trials which will probably take two years. And neither of these clocks has started yet, because each only starts when the last patient called for by the respective protocol has been recruited and entered into the study. As we will show below, this problem does not arise from any law of nature, but from unexamined assumptions in an overlooked meeting place between scientific study design and public policy. Critical options have been ignored because policy makers lack the scientific background to develop them, scientists lack the authority, and institutions lack the incentive. The growing AIDS case load and continually worsening emergency are increasing the pressures to bring the light of public examination and debate into some previously dark corners. * Parallel track limitations. A pivotal event of 1989 was the proposal by Anthony Fauci, M. D., Director of the National Institute of Allergy and Infectious Diseases (NIAID), for "parallel track" access to promising treatments while they are still being tested in clinical trials. Until Fauci's proposal, the dominant idea had been that no early or compassionate access should be allowed for AIDS treatments, because otherwise people would not volunteer for clinical trials. Much of this thinking had been based on a misreading of the case of the drug ganciclovir, made available for compassionate use to thousands of people over a several-year period to prevent blindness from AIDS-related cytomegalovirus (CMV). The pharmaceutical industry wrongly assumed that ganciclovir's developer, Syntex Corporation of Palo Alto, CA, was being punished by the FDA for making an AIDS drug available through compassionate use. Since an analysis of the new drugs in the pipeline showed that no important HIV treatment would be fully approved for several years, this prevailing mindset was a death sentence for tens of thousands of people. Fauci's parallel track proposal broke this mental logjam and opened a door for new thinking throughout government and industry. The head of the world's largest AIDS trials program had proposed that some early access could be allowed without damaging the trials. The new openness allowed the development of the system for early access to ddI -- a development unprecedented both in its speed, and in its bringing together of many different interests, getting some of the people involved talking to each other for the first time, to produce results. Parallel track is urgently necessary. But it will not solve all the problems: (1) Parallel track requires the good will of the company which has the exclusive rights to each new drug. The company must spend money to save lives, with no certainty of reward. Many will be unwilling to do so. (2) Individuals receive the drug without charge but pay for required physician time and laboratory tests. Third-party payers will probably learn to identify these expenses and refuse them as "experimental," meaning that parallel track may be even more limited by social class than standard medical care. It will be difficult to define standards of care if crucial parts of care come to be delivered on an optional, "experimental" basis. (3) The most important question is what drugs to use and how to use them. Clinical trials are supposed to help answer these questions. t there are no trs designed to address the needs of parallel track. Parallel track lives only on the crumbs of knowledge which happen to fall out of trials designed for something else. (This isn't as bad as it sounds, however; clinical- trial design has so lost its way that standard medical practice lives largely on such crumbs, also.) Despite these reservations, we totally support the parallel track. It is a life and death issue and there is no alternative ready to go. Sometimes a second-best solution is infinitely better than no solution at all. Parallel track is an emergency stop-gap until the entire system of clinical trials can be rethought and redesigned. * The clinical-trials logjam. Those who run the major Federal system of AIDS clinical trials, the AIDS Clinical Trials Group (ACTG) system in NIAID, are quick to admit that the system is overloaded and cannot keep up with the important new drugs coming out of the laboratory. People are tired from overwork due to inadequate staff; tasks which everyone agrees are important are postponed or eliminated. The problems only look worse in the future as there will be more people with AIDS, more new drugs to try, but no more and maybe even less support from Congress. Behind this problem is the fact that new-drug approval in the United States has become so elaborate and inefficient that it costs an average of $120 million for each new drug approved. The ACTG system, started from scratch to provide grants for testing AIDS drugs, cannot be expected to test dozens of new drugs under these rules with the limited resources available. * Serious administrative problems. At a closed ACTG meeting on November 6-8, 1989, it was announced that no major new trials could start for six to nine months -- an estimate which may be optimistic. The reason is that the statistical and data- processing center for the ACTG system was being moved from Triangle Research Institute to Harvard University, and the new center would not be ready until then. This delay most seriously impacts trials for opportunistic infections, since other trials were not ready to go anyway. In any system adequate to meet the needs of the emergency, no such delay would be tolerated. * Questions about lack of results. A December 12 memo from ACT UP/New York to Federal agencies and others begins with the sentence, "After three years supported by hundreds of millions of public funds, the AIDS Clinical Trials Group (ACTG) has yet to develop data leading to a single new treatment for any HIV related condition." We are not close enough to the ACTG to evaluate its performance independently. But ACT UP's Treatment and Data Committee is very well informed about the ACTG system and its problems. Needed: Effective Oversight It seems clear that some capable and independent oversight body needs to examine and analyze the record, point out problems or improvements needed, and see that the changes are made. The National Commission on AIDS will not do this job. It is working in other areas and has no interest in oversight of research. The well-regarded Institute of Medicine of the National Academy of Sciences has a committee to investigate the ACTG system. It remains to be seen whether this group will be effective. The entire area of clinical research needs a thorough examination by top scientists and top administrators, with the staff, resources, authority, and independence to do the job. ***** THE WRONG NIGHTMARE: THE WORST DELAY OF CLINICAL TRIALS by John S. James The clinical trials of ddI and ddC both illustrate what we believe is the worst bottleneck delaying AIDS treatment research. The problem, which affects any HIV treatment but is usually less severe with other diseases, is largely responsible for the fact that hundreds of millions of dollars have gone into AIDS trials and produced few useful results. This lack of productivity is not due to any law of nature, but to a widespread misjudgment. Physicians, scientists, and regulators have marched into a morass because they have chosen the wrong nightmare. The clinical trials of ddI need hundreds of volunteers and will probably have to run for two years after the last subject is recruited. The same delay applies to all HIV treatments, and therefore becomes a death sentence for tens of thousands of people -- although some of them will be saved by the parallel track. (The public does not realize that the faster approval of AZT cannot be repeated, because today it would be unethical to give research subjects only a placebo when an approved treatment is available, and it is much harder to get definitive results when comparing a new treatment to an active control than to a placebo.) In the design of the ddI trials, statisticians computed the numbers of subjects needed, assuming a two-year study. The fact that the numbers came from mathematical computations gave them an aura of infallibility, unchallengeable by ordinary mortals. But we can and must examine what these trials are trying to do, and why. The trial design -- including the two years, the hundreds of subjects, and the consequent need for time-consuming and expensive coordination of many widely distant medical centers -- was created to produce a single bit of information, one yes-or- no answer. The question to be answered is whether, if the drug really does nothing at all, the chance of the trial falsely concluding that the drug does work (just by chance alone) is less than a given probability (usually five percent). Is this the question that most needs answering? Should this question be allowed to add two years or more delay to every new HIV drug? Should this question serve as a gatekeeper which prevents other research from starting until it is answered? Should it be allowed to make research so costly in money, facilities, and (most importantly) qualified personnel, that it limits the trials to a handful of new drugs, when there will soon be dozens that clearly deserve followup? The real issue with ddI is not whether it works. A growing working consensus holds that it probably does. And drugs do not begin multimillion dollar clinical trials unless pharmaceutical companies, which are in the business of evaluating drugs, believe in them. The most important questions now are long-term toxicity, and when and how to use ddI most effectively in various groups of patients. Some of this information will come out of the ddI trials -- but only by accident. Because the trials will take so much time, long-term toxicity data will be produced. And restrictive entry criteria will assure us much information about using ddI in certain groups of patients, and none about using it in other groups. The whole structure of the trials is built around the need to get that one statistical bit of information, to be able to walk away with that single yes-or-no answer -- not to answer the questions which are most important now to patients and physicians. Trials which studied long-term toxicity by design instead of by accident could be started much sooner, probably as a continuation of phase I, and could use many fewer patients. The time and money saved could be used to test several other drugs which otherwise will be neglected. The medical world today is obsessed with one nightmare -- that a worthless drug will come into widespread use. This danger is real, as such cases have occurred many times in the past. The problems come from using this nightmare as the sole gatekeeper which controls everything else, regardless of all other elements in the real-world situation. A Better Way A rational program for clinical testing and early use of new drugs would probably involve an expanding circle of research and treatment, starting with dose and toxicity studies and, depending on results obtained, moving continuously into wider use in appropriate groups of patients. The research aspect would be most intensive at first; then gradually the treatment aspect would predominate. This expanding circle of use, with research most intensive at first, is what already occurs with conventional phase I, II, III, and IV studies. But today's process is not rational or planned as a whole. It is full of arbitrary discontinuities, prohibitively burdensome requirements derived from theories, and deliberate,ied blindness to th actual questions, issues, knowledge base, and opportunities of the specific drug, in its social and public-health context. Note that we are not suggesting dropping the legal requirement that drugs show efficacy before they are marketed. That is a different issue. We are saying instead that narrow efficacy testing should not completely dominate clinical trials, should not be applied blindly and rigidly in ways that straightjacket and paralyze the entire research enterprise. A coherent, rational design for an integrated research and treatment process, using to advantage the specifics of each situation and addressing the actual questions at issue, could get the most important answers far faster than the present system, and at a fraction of the cost. It could bring many more drugs into trials than the present system, which is seriously overloaded with unnecessarily costly trials. It could bring us years closer to better treatments for AIDS, thereby saving most of the lives which otherwise would be lost. This is one of the central research issues we intend to address in 1990. ***** NAC: "NO MIRACLES" In our issues of December 1 and October 6, AIDS TREATMENT NEWS reported on indications that NAC (N-acetylcysteine), a drug widely used in Europe to treat bronchitis, might be useful in treating AIDS or HIV infection. Since publishing those articles we have talked with Barbara Starrett, M. D., who sees many AIDS patients in New York. About ten of her patients have used the European form of the drug, some starting as early as December 1988. Dr. Starrett is confident that the drug has not hurt anybody, and thinks that it may work as a stabilizer or mild immune modulator. Her patients have remained stable. But she has seen no great improvements, and has no definitive proof that the drug helped. Most of her patients had chosen to stop taking the drug, because it did not seem worth the expense. (Prices vary greatly, and her patients had been using one of the most expensive brands, from Switzerland.) Dr. Starrett is concerned that people may have expectations which are too high. But she says there is no question that the drug should be available. NAC Survey In New York, the PWA Health Group, in association with ACT UP's Treatment and Data Committee, will conduct a survey of people using NAC, to ask about short-term subjective benefits and risks. They hope "to gain some practical information about trials yield results." Registration forms and baseline questionnaires will be available at the PWA Health Group; followup surveys will be mailed for at least three months. Buyers clubs in other cities might also join this study. ***** SAN FRANCISCO: ORAL THRUSH STUDY Persons with oral thrush are needed to help test a new antifungal at San Francisco General Hospital. The study, conducted by Merle Sande, M. D., and others at the Department of Medicine, lasts only 10 days. The drug, from Schering Corp., is known as SCH 39304. Patients will randomly be assigned to one of three groups: ketoconazole 200 mg daily, SCH 39304 25 mg daily, or SCH 39304 50 mg daily. Blood samples will be drawn on days 1, 3, 7, and 10, requiring a visit to the clinic on those days. Although the drug does not yet have a name, this is a phase III study; SCH 39304 has already been given to dozens of people, and only occasional minor side effects have occurred. To volunteer or to learn more about this study, call Dr. Belle Lee, Pharm. D., at 415/821-8450. ***** SAN FRANCISCO: CHINESE HERBAL PROGRAM DEADLINE JANUARY 5 The Quan Yin Healing Arts Center in San Francisco continues to sponsor HIV treatment and research studies for seropositive people, whether symptomatic or not, through its Chinese Herbal Treatment Program. The next deadline for enrollment is January 5, for a 12-week program beginning January 10. Participants can continue with any other treatments or medications, and should already be under the care of a primary physician. The cost of the program is $190 for the 12 weeks. Interested people can call 415/861-4964. Results of Earlier Programs We asked Quan Yin about results of their earlier programs. A summary appears in "The Role of Chinese Herbal Medicine in the Defeat of the AIDS Epidemic," by Subhuti Dharmananda, Ph.D., published by his Institute for Traditional Medicine and Preventive Health Care, Portland, Oregon. Two groups of patients were reported. In the first, with 93 participants completing the study, "40 felt more healthy at the end of the program, 47 felt about the same, and only 6 reported feeling less healthy. White blood cell counts increased by an average of 2.85 percent and hematocrit increased by an average of 1.08 percent. T-cells were measured in 26 participants. Fifteen showed an increase, 10 showed a decrease, and one had no change. Individuals who were categorized as HIV+ indicated better response overall, and by blood tests, than those with ARC or AIDS...Of the 93, six changed diagnosis from HIV to ARC and two from ARC to AIDS. Besides the 93 who completed that study, 54 dropped out (including two who died); a total of 147 had started. Many were listed as dropping out only because they failed to provide the last report at the end of the three months. In the next group, 164 participants began the protocol and 127 completed it. "Fifty nine of the individuals completing the study reported feeling more healthy and 58 reported feeling about the same, while only 10 individuals considered themselves to be less healthy at the end of the three-month period. White blood cell counts increased by an average of 5.8 percent and hematocrit increased by an average of 2.1 percent. T-cell counts were available for 12 participants; of these, six showed an increase, one stayed about the same, and five experienced a decrease...Four individuals changed diagnosis from HIV+ to ARC and one from HIV+ to AIDS during the course of the study." Another group began in September, 1989, but results are not yet available. ***** New BULLETIN OF EXPERIMENTAL TREATMENTS FOR AIDS The San Francisco AIDS Foundation has published the Fall, 1989 issue of BETA (Bulletin of Experimental Treatments for AIDS), a useful publication available free to San Francisco residents and by subscription to others. The current issue (dated November, 1989) includes articles on ddI, compound Q, parallel track and treatment IND, different options for prevention of PCP, blood tests for HIV progression, and an update on AZT. There is also a complete copy of the directory of open HIV trials in the San Francisco area, published by the County Community Consortium. To subscribe to BETA, call 800/327-9893, or 415/549-4300. For non-residents, the cost is $25.00 per year for individuals, $50.00 per year for organizations. ***** LYMPHOMA: A CURRENT LOOK AT THERAPIES by Denny Smith Lymphoma is a diagnosis facing at least 5% of people with AIDS. The term lymphoma refers to a number of malignancies in which various cells of the body's lymph system have proliferated out of control; those most commonly seen in the presence of HIV are of B-cell origin, and are classified as high and intermediate grade, large cell immunoblastic or small non- cleaved Non- Hodgkin's lymphomas (NHL). They may develop in lymph nodes, but are more commonly found at extra-nodal sites such as the central nervous system (CNS), bone marrow, the bowel, liver, or lungs. The other major malignancy identified with AIDS is Kaposi's sarcoma (KS -- see AIDS TREATMENT NEWS #73, 75, & 87), which has probably gathered more attention than lymphoma from the treatment establishment. Fortunately the rate of new KS diagnoses has slowed since early epidemic years; however, the incidence of lymphoma appears to be on the rise. Like KS, lymphoma occurring as a consequence of HIV infection is considered an opportunistic neoplasm, or cancer, rather than an infection caused by organisms. In spite of that distinction, however, the development of some lymphomas has been linked to infections of a herpes-family virus, Epstein-Barr (EBV). This virus can cause infectious nucleosis, and implicated in the development of lymphomas in people who must take immunosuppressing transplant medications. For similar reasons, an HIV-impaired immune response may allow a latent EBV infection to reactivate, and theoretically provoke lymphoproliferations. EBV is already known to be implicated in hairy leukoplakia, and has been much discussed as a possible cofactor in HIV immune deterioration -- each virus has been observed in vitro to activate the other. However, EBV is not always present in people with HIV, nor uniformly evident in AIDS-associated lymphoma tissue. In data collected at San Francisco General Hospital, EBV was identified in only about a third of lymphoma biopsies, suggesting that EBV could be a passenger virus which coincides with but is not the cause of AIDS lymphoma. Diagnosing lymphoma can involve several complications. The symptoms of CNS lymphoma in adults might resemble other, more common AIDS-related neurological problems such as toxoplasmic encephalitis. By contrast, CNS lesions in children with AIDS will much more likely prove to be lymphoma than otherwise. The non-invasive tests for diagnostic purposes, CT or MRI scans, are not usually dependable for distinguishing infections from lymphoma in the brain. A conclusive diagnosis can be made by biopsy, but antibiotic therapy may be tried first in adults to rule out infections, and if the symptoms fail to respond then presumptive treatment can begin for lymphoma. For children that approach could represent a dangerous delay in appropriate treatment, given the probability of finding lymphoma behind these symptoms. Symptoms of lymphoma in the rest of the body may resemble lymphadenopathy but are easily verified with a biopsy. Obtaining a sample of tissue through a fine-needle aspiration is less invasive than a surgical biopsy, although needle aspirations produce a somewhat higher rate of false-negative results. Standard treatments for lymphoma have involved radiation or chemotherapy, or both. These and a few experimental therapies are briefly discussed below. The occurrence of AIDS-related lymphoma, like any consequence of HIV, warrants the start or continuation of an anti-HIV agent such as AZT to address the underlying problem. A review of patients treated for CNS lymphoma at three Los Angeles medical centers pointed to concurrent opportunistic infections as a factor diminishing the rate of survival following otherwise successful lymphoma treatments. The report suggests that an HIV therapy would affect positively a course of treating lymphoma. Ironically, the underlying problem can be exacerbated by treatments for secondary infections. Radiation and chemotherapy, for example, each suppress bone marrow production of blood cells (myelosuppression) independently of HIV or AZT. We spoke to several AIDS- experienced physicians about refinements in lymphoma therapy which, like new approaches to KS, attempt to minimize this danger. CNS lymphoma usually develops as small, individual lesions on the brain, and can be treated with a series of localized, low- volume doses of radiation over a period of 5 to 7 weeks. If the lymphoma is disseminated, present at multiple sites within the central nervous system, radiation treatment alone is not advised and is augmented with a chemotherapy agent, such as methotrexate, administered intrathecally (injected into the cerebrospinal fluid) since many drugs given intravenously fail to penetrate the blood-brain barrier. William Wara, M. D., of the Department of Radiation Oncology at the University of California in San Francisco, described his modification of the treatment for AIDS- related CNS lymphoma. By irradiating lesions with larger dose volumes and shortening the duration of the total therapy to 3 weeks, Dr. Wara obtains an optimum tumor response while minimizing the trauma of a longer course of therapy. He found this more intensive regimen improved on previous practice without increasing immunosuppression, because the field of radiation remains very small and specific. Treatments of peripheral lymphomas, those diagnosed at sites outside the CNS, are relieved of the challenge of crossing the blood-brain barrier; therefore the diseases can be addressed with a wider spectrum of treatments. The first line of options consists of various chemotherapy combinations, both with and without radiation. A list of chemotherapeutic agents tried against lymphoma, in addition to methotrexate already mentioned, includes bleomycin, cyclophosphamide, daunorubicin, dexamethasone, doxorubicin, etoposide, ifosfomide, prednisone, procarbazine, and vincristine. Apparently no consensus regarding the choice of agents or degree of treatment aggressiveness has been established. Physicians at San Francisco General Hospital noted shortened survival rates among patients who were treated with high-dose cyclophosphamide, and they suggest that lymphoma regimens be designed to control toxicity or to include agents for reducing bone marrow and immune suppression. Another report at the Montreal Conference described a decision by clinicians at the Los Angeles Oncologic Institute and Baylor University Medical Center in Dallas to decrease the aggressiveness of lymphoma chemotherapy. They then obtained excellent results in five patients with cautious use of bleomycin, vincristine, and prednisone combined with acyclovir and low-dose AZT (abstract B. 588). The investigational agent called granulocyte macrophage- colony stimulating factor (GM-CSF) may prove useful for protecting the bone marrow from damage associated with chemotherapy, and permit the addition of other valuable but potentially suppressive therapies, such as AZT and interferon. esearchers at thentro di Riferimento Oncologico in Aviano, Italy, presented a report at the International Conference on AIDS last June finding GM-CSF effective for reversing myelosuppression due to chemotherapy and AZT in some people with KS or lymphoma (abstract M. C. P. 103). GM-CSF is available in the U. S. only through clinical trials. Refractory lymphomas, those which resist other treatment attempts, have been affected by mitoxantrone with cytarabine. Researchers at the Johns-Hopkins University describe a man successfully treated for AIDS-associated NHL with a bone marrow transplant from his sister (Montreal abstract W. B. P. 319). Anti-idiotype antibody therapy and chlorodeoxyadenosine (CDA) are both currently pursued in clinical trials in the U. S. We spoke to Lawrence Kaplan, M. D., an oncologist at San Francisco General Hospital and principle investigator for five trials there involving some of the potential treatments mentioned above. These trials are all still in progress, and we hope to report any conclusive results in the future. Dr. Kaplan was willing to share some early positive impressions: CDA, a novel drug used with success in treating another diagnosis, has been helpful for some patients with NHL which was unresponsive to previous treatments. Anti-idiotype antibody therapy, also for relapsed lymphoma, is a strategy which borrows functions ordinarily employed by natural immune defenses. This treatment appears useful in about 25 percent of certain lymphomas. In a randomized study, GM-CSF is being administered to two of every three participants, all of whom receive chemotherapy for NHL. Dr. Kaplan is optimistic for the potential of GM-CSF to reduce the neutropenia following chemotherapy, and shorten associated hospitalizations. For this trial and two others at San Francisco General Hospital which include chemotherapy, the particular agents used are cyclophosphamide, doxorubicin, vincristine, and prednisone. These trials are open for recruitment, and persons interested in participating in any of them should call 415/821-5531. REFERENCES Epstein, L G and others,"Primary Lymphoma of the Central Nervous System in Children With Acquired Immunodeficiency Syndrome," Pediatrics volume 82, number 3, September, 1989. Formenti, S C and others, "Primary Central Nervous System Lymphoma in AIDS-Results of Radiation Therapy," Cancer, volume 63, number 6, pages 1101-1107, March 15, 1989. Ho, A D and others, "Mitoxantrone and High-Dose Cytarabine as Salvage Therapy for Refractory Non-Hodgkin's Lymphoma," Cancer, volume 64, number 7, pages 1388-1392, October 1, 1989. Kaplan, L D and others, "AIDS-Associated Non-Hodgkin's Lymphoma in San Francisco," Journal of the American Medical Association, volume 261, number 5, pages 719-724, February 3, 1989. Lang, D J and others, "Seroepidemiologic Studies of Cytomegalovirus and Epstein-Barr Virus Infection in Relation to Human Immunodeficiency Virus Type 1 Infection in Selected Recipient Populations," Journal of Acquired Immune Deficiency Syndromes, volume 2, number 6, pages 540-549, 1989. Rahman, M A and others, "Enhanced Antibody Responses to Epstein- Barr Virus in HIV-Infected Homosexual Men," The Journal of Infectious Diseases, volume 159, number 3, pages 472-479, March 1989. ***** CHRONIC FATIGUE ORGANIZATIONS SEEK COALITION WITH AIDS EFFORTS A major advocacy group for persons with Chronic Fatigue Immune Dysfunction Syndrome (CFIDS) wants to contact AIDS activists and organizations to discuss coordination of our efforts to advance prevention, research, and patient care. CFIDS, like AIDS, is an infectious disease that causes serious immune-system malfunction. In 1984-1985, a major ourbreak among residents at Incline Village, Nevada, affected 300 people; since then the disease has become a widespread epidemic, with thousands of cases. While few people die from CFIDS, about a third become seriously disabled, often for months or years. CFIDS, like AIDS, can also cause neurological symptoms, or lead to lymphomas. CFIDS is more contagious than AIDS, although most people exposed do not become ill. The illness appears not to be sexually transmitted. It affects women two to three times as often as men. Treatments, including acyclovir, ketoconazole, and gamma globulin, may be helpful in some cases. As with AIDS (although for different reasons) government agencies and medical professionals have been slow to respond to CFIDS. Recently, however, important progress has been made. Milestones include publication by the U. S. Centers for Disease Control of official criteria for diagnosis, and a major scientific conference in San Francisco in April 1989. The best single information source on CFIDS (also called CFS, for Chronic Fatigue Syndrome) is The CFIDS Chronicle, published by Community Health Services, P. O. Box 220398, Charlotte, NC 28222-0398, phone 704/362-CFID. Contact for AIDS Organizers Persons interested in developing working relationships between CFIDS and AIDS organizations should contact Jan Montgomery, at the Chronic Fatigue Immune Dysfunction Syndrome Foundation, 3543 Eighteenth St. #20, San Francisco, CA 94110, 415/525-6415. ***** COMMUNITY RESEARCH ALLIANCE HYPERICIN FUNDING Our issue number 90 (November 3, 1989) included an appeal to help San Francisco's Community Research Alliance finish its hypericin observational study. Readers contributed $3049.00 in response to this appeal. In addition, the Community Research Alliance received two other contributions of $5,000.00 each. The total is more than enough to complete the study. Data collection is being finished this week, and there is also a budget for a statistical consultant to help in interpreting the results. While the hypericin study is proceeding well, we do not have funds to continue the operation of the organization itself beyond the end of January. The Community Research Alliance was started primarily by persons with AIDS. It represents the patient's perspective and interests, but has always been weak on fundraising. Anyone who could help in developing an ongoing fundraising program could contact John James at AIDS TREATMENT NEWS, or call the Community Research Alliance at 415/626-2145. ***** CAUTION: MALICIOUS "AIDS" COMPUTER DISK Widespread news reports have warned that an "AIDS Information Diskette" mailed to thousands of computer users actually contains a malicious program to destroy other data in the computer. The disk is for IBM PC-compatible personal computers. The disk was mailed from "PC Cyborg Corp.," a company which may not exist. A Panama City address included with the program was fictitious. The malicious program is not technically a computer virus, because it does not spread from computer to computer. The program appears to involve no great technical sophistication. What is unusual about this case is that someone appears to have spent over a hundred thousand dollars to package and promote a destructive program, with no apparent motive. The disk was sent primarily to mailing lists of computer users, and to health professionals. Anyone who receives a copy of the disk should destroy it, so that it is not accidentally installed in any computer. ***** SULFADIAZINE TEMPORARY SUPPLY PROBLEM A temporary interruption in the supply of sulfadiazine, one of the most common drugs used to treat toxoplasmosis, occurred last week when Eli Lilly Co. discontinued manufacturing it. Physicians learned about the supply problem only after patients could not get their prescriptions filled. At least two other companies are now manufacturing sulfadiazine. Pharmacies should be able to get the drug through their regular wholesalers. Wholesalers can buy sulfadiazine from either Consolidated Midland, in Brewster, NY, or from Lannett, in Philadelphia. Pharmacies can also order directly from Lannett. ***** REMINDER: AZT QUESTIONNAIRES If you have used AZT for at least a year, you could help others by returning the one-page questionnaire attached to our last issue. We are interested in what treatments people are using to supplement or replace AZT after long-term use, ann how successful these treatments have been. The deadline for returning the questionnaires is January 15. ***** NEXT ISSUE JANUARY 5 As announced in our Nov. 3 issue, AIDS TREATMENT NEWS will now publish on the first and third Friday of each month, instead of every other Friday -- a total of 24 issues per year instead of 26. Our next issue will be dated January 5. ***** STATEMENT OF PURPOSE AIDS TREATMENT NEWS reports on experimental and complementary treatments, especially those available now. It collects information from medical journals, and from interviews with scientists, physicians, and other health practitioners, and persons with AIDS or ARC. 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. We also examine the ethical and public-policy issues around AIDS treatment research and treatment access. [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display