Subject: AIDS Treatment News #90 Date: Nov 14 1989 (611 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 number 90, November 3, 1989 CONTENTS: [items are separated by "*****" for this display] U. S. Videotape Explains Cooking and Food Preparation for Persons with AIDS Hypericin Study Needs Help to Finish AZT Now Available Free for Children Information on HIV in Pregnancy and Pediatrics Germanium Danger: British Government Warns Physicians Aerosol Pentamidine Newsletter Publishes Treatment Price Comparison Call for Information: Your Experience Applying for ddI Access San Francisco: ddI Public Forum November 15; New Issue of BETA San Francisco: Quan Yin Recruiting for New Herbal Study Nurse Needed for San Francisco AIDS Research AIDS TREATMENT NEWS 1990 Publication Schedule Proposal: An Ombuds Office for Promising Treatments and Public Policies ***** U. S. VIDEOTAPE EXPLAINS COOKING, FOOD PREPARATION FOR PERSONS WITH AIDS Persons with immune deficiencies are in serious danger of food- borne diseases. Proper selection, cooking, and handling of food can greatly reduce the risk. Now two Federal agencies -- the Food and Drug Administration, and the Centers for Disease Control -- have produced the first videotape to alert people to this danger, and explain how they can protect themselves. The 15-minute videotape includes information on foods to avoid, proper cooking, avoiding contamination in the kitchen, eating in restaurants, and travel abroad. Individuals and organizations can obtain the tape without charge from the CDC's National AIDS Information Clearinghouse (NAIC). To order a copy, call NAIC at 800/458-5231; or send a written request to NAIC, P. O. Box 6003, Rockville, MD 20850. ***** HYPERICIN STUDY NEEDS HELP TO FINISH by John S. James The hypericin monitoring study by San Francisco's Community Research Alliance has enrolled 33 patients, and is collecting some of the best data anywhere on anti-HIV use of hypericin, which may be one of the most promising antivirals. (For background see AIDS TREATMENT NEWS #63, #74, and later issues.) Now we need the community's help to finish the study, and to start other rapid, low-cost trials of promising treatments. The Community Research Alliance (of which this writer is a co- founder) is not the only group researching hypericin, but it was able to begin its study early. The leading academic team studying the drug is now planning animal toxicity tests required for FDA approval before its human trials can begin. But the Community Research Alliance could start its study last June, because people with HIV were already trying hypericin, found in herbal extracts which have been in human use for years for other medicinal purposes. Because the organization does not give anybody a drug, but is only doing blood work and other data collection on patients who obtain their own treatment from buyers' clubs or health-food stores, the study could proceed immediately. Data is being collected as in university clinical trials, under a protocol designed in advance and approved by the organization's scientific advisory committee and institutional review board. It took only two weeks to recruit enough study volunteers, partly because the Community Research Alliance was created by the PWA Coalition and other grassroots AIDS organizations in San Francisco, and partly because this study does not ask patients to give up any other treatment or otherwise change what they would be doing anyway. The Community Research Alliance helped pioneer this kind of prospective monitoring study. While this study will not obtain the more definitive data of a randomized controlled trial, it has the advantage of taking weeks instead of years to get into operation. And because all patients have blood work and other tests under a protocol designed in advance to answer important questions -- and all are tested at the same intervals and by the same lab, to obtain comparable results -- this trial can produce far better information about an available treatment (in this case, hypericin-containing herbal extracts) than anecdotal reports, or any data collected from patients who were not following a uniform protocol. In short, this low-cost, rapid, and flexible kind of trial, which does not ask patients to make any sacrifices in their treatment, can produce the best data available for years -- and if it shows promising trends, it could stimulate interest in more formal trials, so that they would be organized sooner than if the observational study had not been done. In New York, the Community Research Initiative plans a similar study of hypericin. It will be larger and better funded, but it has not started yet. The importance of the San Francisco study is that it started in June and its data collection will be finished next month. What We Need Now The hypericin study needs your help. The Community Research Alliance needs $10,000 to finish it -- for laboratory costs, data entry and analysis, and to pay the principal investigator and a staff assistant. Few foundations have ever funded any AIDS project -- and of those who have, almost none will touch research. (The one major exception, the American Foundation for AIDS Research -- AmFAR -- has already given $30,000. to the Community Research Alliance.) In the future, the Community Research Alliance hopes to conduct similar studies of treatment possibilities which may be important, but will not otherwise be researched promptly. For example, when a potentially important antiviral might be obtained from an edible plant (such as the sulfolipids in blue- green algae -- see AIDS TREATMENT NEWS #87, September 8, 1989) academic and commercial researchers spend the time to prepare the pure chemical, with associated laboratory and animal tests, before any human trial can start. Only pure chemicals, not plant products, have academic and commercial value in the United States. But in appropriate cases, a prospective monitoring trial of a natural product could begin very quickly, avoiding years of delay. The Community Research Alliance has already done one such study, and is well positioned to do others. The government will not pay for this kind of research, foundations will not pay for it, the pharmaceutical industry will not. Unless the community supports this work, it will not happen. In the future, we hope to find one or more sponsors for each study -- a community-minded individual or business who could contribute the relatively small amount, usually under $20,000, required for this kind of trial. People are more willing to contribute when they know exactly what their money will pay for, what they will make possible that would not happen otherwise. If you might be able to help in any way, call the Community Research Alliance at 415/626-2145; the best times are 10 AM to 6 PM on weekdays. If you can send a contribution, mail it to Community Research Alliance, 273 Church St., San Francisco, CA 94114. The Community Research Alliance has shown that it can organize studies very quickly. But at least for now it gets little support from established research institutions, which have their own ways of doing business, ways which cannot respond quickly to the AIDS emergency. The work of this organization, and of other community-based AIDS research, depends on you. ***** AZT NOW AVAILABLE FREE FOR CHILDREN Until recently, it has been very difficult for physicians to give AZT to children, for two reasons. First, the drug was not approved for children, as the early dosage, safety, and efficacy trials only recruited adults. Physicians could legally prescribe AZT for children, but without official guidance, most were reluctant to do so, and if they did, insurers were unlikely to pay. Also, the drug only came in capsules designed for adults; these had to be opened and their contents divided to obtain the right dose for a child. On October 4, Burroughs Wellcome announced that AZT would be available in syrup form in a few weeks -- allowing dose adjustment for children, and also making the drug more accessible to adults who cannot swallow capsules. On October 26, the Department of Health and Human Services announced that the FDA had approved a "treatment IND" application from Burroughs Wellcome, allowing the company to distribute the drug free for children who meet certain medical requirements. AZT had already been given to at least 200 children in clinical trials; it seemed to be no more or less toxic to them than to adults, and it seemed clearly beneficial in some cases, especially in treating dementia. For more information about the treatment IND, physicians can call Burroughs- Wellcome at 800/829-PEDS. While the drug is free, we do not know how associated costs will be paid -- especially the cost of blood tests to detect toxicity, and of any treatment required for side effects. Many children with AIDS come from poverty backgrounds and are unlikely to have insurance. State Medicaid programs ought to cover these costs, but we do not know if they will do so. ***** INFORMATION ON HIV IN PREGNANCY AND PEDIATRICS The standards of medicine applied to children, infants and pregnant women are often different and more complex than those for other populations. Some treatments which are ordinarily safe can be dangerous during pregnancy, and drugs approved by the Food and Drug Administration are assigned a rating according to the Pregnancy Risk Category. Drug doses for newborns and pediatric patients are not arrived at by simply lowering the recommended adult dosage, because the mechanisms through which childrens' bodies absorb, metabolize and excrete drugs are qualitatively different. Consequently, when questions of treatment for HIV and AIDS have been addressed for non- pregnant adults, they have remained largely unanswered for children and women in pregnancy. The October issue of Focus, published by the AIDS Health Project in San Francisco, contained two good overviews of these questions: "Pregnancy and HIV", by Laurie B. Hauer, R. N. who is the Coordinator of the Bay Area Perinatal AIDS Center at San Francisco General Hospital, and "Caring for Children with HIV Infection", by Ellen R. Cooper, M. D., Medical Director of the Pediatric AIDS Program at Boston City Hospital. To obtain a copy of this issue, (volume 4, number 11, October 1989), write to Focus , UCSF AIDS Health Project, Box 0884, San Francisco, CA 94143. Single issues are $3. The Children's Hospital AIDS Program (CHAP) of Children's Hospital of New Jersey published a useful guide for families with HIV+ children called The Child with AIDS. The guide discusses blood tests, opportunistic infections, medications, nutrition, and emotional dilemmas for parents, siblings and legal guardians. CHAP also houses the National Pediatric HIV Resource Center. The Center provides telephone consultations to health professionals regarding drug trials, home care, school issues and child welfare agencies. Both CHAP and the Pediatric HIV Resource Center can be reached at 201/268-8251. We will report on more resources for parents and children with HIV in an upcoming issue. ***** GERMANIUM DANGER: BRITISH GOVERNMENT WARNS PHYSICIANS by John S. James In an unusual letter dated October 10, the British government warned all doctors in England of health risks from use of germanium compounds, which have been widely sold in health- food stores. The warning followed an article on germanium toxicity by well-known investigative reporter Duncan Campbell, published September 8 in New Statesman & Society, London. The official letter to physicians begins as follows: "The purpose of this letter is to alert you to a potential health hazard caused by germanium, found in certain dietary supplements which can cause nephropathy, leading in some cases to renal failure and death. Other complications include cardiomyopathy and peripheral myopathy. (The letter references T. Matsusaka and others, "Germanium-induced nephropathy: report of two cases and review of the literature," Clinical Nephrology (West Germany), December 1988, volume 30 number 6, pages 341- 345.) In a review of 10 cases, pathological changes occurred following ingestion of germanium, 50 to 200 mg per day, for periods of four to 18 months. Death occurred in two cases." The letter went on to express concern that persons with AIDS and chronic fatigue were especially likely to use germanium. It said that the Department of Health had no evidence that the substance had any nutritional value or health benefit, and urged physicians to have their patients stop using it. Except for occasional mentions in lists of treatments, we have not previously covered germanium in AIDS TREATMENT NEWS. Another View We spoke with Parris Kidd, Ph.D., founder of the Germanium Institute of North America (which he has since closed). Dr. Kidd told us that there are no published cases of toxicity from the germanium compound which is supposed to be in the capsules, namely germanium sesquioxide, also called Ge-132. He believes that the toxicity is due either to another compound, germanium dioxide, or to an unknown contaminant. (This information is consistent with what we have seen in the published literature; however, we know of no proof that even the pure product would be safe.) Dr. Kidd explained that it is difficult and expensive to test for potentially dangerous contaminants -- and that because of lack of uniform testing, no one can be confident of the safety of germanium compounds. He also told us that while there were no controlled human trials, he has heard many anecdotal reports suggesting that germanium sesquioxide might be helpful in treating various conditions, including chronic viral infections. He also told us that germanium is not known to be a nutrient, as no deficiency condition has been established. There has been a little research published in medical journals on possible medical uses of germanium sesquioxide; we have not seen any related to AIDS. (A different compound, spirogermanium, has been widely tested as a potential cancer treatment.) Our conclusion, based on the evidence we have seen so far, is that germanium compounds available today may be dangerous, and that no benefit has been proven. ***** AEROSOL PENTAMIDINE NEWSLETTER PUBLISHES TREATMENT PRICE COMPARISON A newsletter published by PANT (Patient Advocates for Necessary Treatment) gives prices for monthly aerosol pentamidine treatment at 18 different hospitals, clinics, and physicians offices in San Francisco. The prices, which range from $175 (University of California San Francisco Medical Center) to $280 (tie between St. Mary's Hospital, and Pacific Presbyterian Medical Center) can also help to establish reasonable price ranges elsewhere. For a copy of the newsletter (vol. 1, no. 2), send a self- addressed stamped envelope to: Morgan Fine, PANT, 4302 19th Street, San Francisco, CA 94114. ***** CALL FOR INFORMATION: YOUR EXPERIENCE APPLYING FOR DDI ACCESS Lambda Legal Defense and Education Fund is collecting information about the process of applying for access to ddI. It especially wants to hear from anyone who has had difficulty or been rejected. If you have information, phone David Barr, a staff attorney who is working on AIDS issues, at Lambda Legal, 212/995-8585. ***** SAN FRANCISCO: DDI PUBLIC FORUM NOVEMBER 15; NEW ISSUE OF BETA On Wednesday, November 15, speakers from the National Cancer Institute, Bristol-Myers Squibb and San Francisco General Hospital will discuss recent developments concerning the drug ddI at a public forum sponsored by the San Francisco AIDS Foundation, the County Community Consortium, and the San Francisco Medical Society. The forum begins at 8 p.m. at the San Francisco Medical Society Auditorium, 250 Masonic, near Turk St. Physicians are invited to an earlier meeting, 5:30 at the same address, to discuss monitoring their patients on ddI and the administrative requirements of ddI access. The latest (fourth) issue of BETA (the Bulletin of Experimental Treatments for AIDS) will soon be released by the San Francisco AIDS Foundation. It should be available at the ddI forum. ***** SAN FRANCISCO: QUAN YIN RECRUITING FOR NEW HERBAL STUDY The Chinese Herbal Treatment Program of San Francisco's Quan Yin Healing Arts Center is again open to enrollment for a twelve week HIV research and treatment protocol. The cost is $190. and includes required lab work. The program is structured for all seropositive persons, with or without symptoms. Participants must already have a primary physician, and other treatments and medications can be continued. The deadline for enrollment is Friday, November 24, and the program begins the following Thursday, November 30. For information, call David at 415/861- 4963. Another, more intensive program sponsored by the Healing Arts Center is the San Francisco AIDS Alternative Healing Project, and begins December 4. This program also runs for twelve weeks and will include acupuncture, psychotherapy, chiropractic, hypnosis, massage and nutritional counseling as well as herbal treatments. For more information call Amanda at 415/861-4964. Both the Quan Yin Herbal Program and the AIDS Alternative Healing Project approach HIV as a manageable chronic viral syndrome. ***** NURSE NEEDED FOR SAN FRANCISCO AIDS RESEARCH A registered nurse is needed for community-based AIDS research in San Francisco. Duties include providing research support and monitoring clinical trials conducted in physicians' offices and in clinics in the Bay Area. HIV experience is strongly preferred, but prior research experience is not required. For more information, call Carroll Child, County Community Consortium, 415/821-3144. ***** ERRATA Two errors appeared in our last issue, #89: (1) In the article about the upcoming hemophilia conference and the difficulty of participants entering the United States, we gave the wrong state of Senator Jesse Helms. The correct state is North Carolina. (2) The editorial contrasting the response to the earthquake and the response to AIDS suggested that there have been over 2,000 AIDS-related deaths in San Francisco. In fact there have been over 4,700 deaths in San Francisco -- hundreds of times the toll of the earthquake. ***** AIDS TREATMENT NEWS 1990 PUBLICATION SCHEDULE On January 1, AIDS TREATMENT NEWS will start publishing twice a month, on the first and third Fridays, instead of publishing every two weeks. Therefore a one-year subscription will be 24 issues, instead of 26 as currently. The individual and reduced-rate subscription prices will stay the same. However, as there will be fewer issues, the cost per issue will be about 8 percent higher. Any new subscription or renewal which we receive through the first week in January will be credited at the rate of 26 issues per year. Subscriptions received later will be counted as 24 issues per year. The subscription price for organizations will change, from the current $150.00 per year, to $100.00 for nonprofits and $200.00 for businesses and institutions. The cost for back issues will be greatly reduced, as issues 1-75 are being published (by Celestial Arts, Berkeley, CA) with an extensive, updated index, and a resource list with current addresses and phone numbers. We will announce the book when it is available, probably by the end of this year. If you want to order back issues now, see "How to Subscribe to AIDS TREATMENT NEWS," below. There will be no issue on December 29 of this year. All subscriptions will be extended one issue to compensate. Our regular and reduced-rate subscription prices have had no important changes in our three years of publication, although the average length of each issue has almost doubled. Our goal is to keep prices unchanged at least through 1990. ***** PROPOSAL: AN OMBUDS OFFICE FOR PROMISING TREATMENTS AND PUBLIC POLICIES by John S. James Note: We submitted this suggestion to the Mayor's HIV Task Force, San Francisco, which requested our comments on clinical trials and the parallel track. One of the other invited speakers challenged our characterization of ddI as a relative success in drug development. He pointed out that the anti-HIV activity of ddI was discovered at almost the same time as that of AZT, and that if ddI had been developed promptly the clinical trials could have been finished, and ddI approved two years ago. (We should note that Bristol-Myers Squibb and others now working with ddI were not involved at that time.) We left the statement below as we submitted it, but the point is a good one. The Problem The mainstream, national response to the earthquake shows what can and should be done in responding to a disaster. But AIDS has killed hundreds of times as many people, both in San Francisco and nationally, without calling forth even a shadow of the response to the earthquake. The Federal failure to support San Francisco's model AIDS programs illustrates the lack of national mobilization, the fact that the United States has backed into the epidemic and still does not have a coherent, rational AIDS program. How can San Francisco increase its impact on national policy? Lost Opportunities: An Example Our three and a half years of publication has documented a catalog of lost opportunities -- both particular treatments, and broader public policies -- largely neglected when they clearly deserved feasible, cost-effective research or other followup. The example of ddI shows that while Federal policies have significantly improved, they are still unable to respond effectively to the epidemic: * ddI has been handled with unprecedented speed and unprecedented communication between AIDS advocates, industry, and the FDA -- all very much for the good. * But this rapid mobilization applies only when the public's imagination is engaged. For example, the related antiviral DDC appears to be about as good as ddI, but cost hundreds of times less to manufacture. It could be developed as a treatment available to all, anywhere in the world, regardless of ability to pay. But our initial inquiries indicate that no one anywhere is developing this treatment option -- a critical lack when many people have no treatment available at all, and little prospect of treatment in the future, since only the expensive treatment possibilities are being developed. * The current clinical trials of ddI will probably take over two years to complete -- obviously not acceptable for the purposes of public health. Clinical trials are still being designed under business as usual, without mobilization of top scientific and statistical talent to re-examine the underlying assumptions of trial design in view of the current emergency. Questions about the two-year delay are usually dismissed with the comment that those who need the drug in the meantime can get it through parallel access. But -- * The parallel-access system now developing for ddI will work only for those who have aggressive primary-care physicians, and who can afford the extensive paperwork and laboratory tests required. Insurance will probably refuse to pay for these costs, meaning that we will have parallel access only for those with money. Yet ddI is the success story. Hundreds of promising treatment and policy options have been overlooked for lack of attention and advocacy. One systematic problem is that the interests and views of impacted jurisdictions like San Francisco, which are called on to provide medical care of last resort when others institutions have walked away, are not represented when decisions are made. What Can San Francisco Do? Inadequate national response to the AIDS/HIV epidemic is creating intolerable burdens in impacted areas. The recent earthquake will make the financial strain even worse. How can San Francisco affect national policy through programs which cost little or no money? One way would be to apply the concept of an ombuds office -- which usually serves individuals -- to serving PROPOSED POLICIES instead. The traditional ombudsman hears problems from individuals, and helps get these problems addressed as well as possible by existing agencies or other institutions. The ombuds office may advise the individual on how to proceed, or may call officials and others to help clear up snafus; but it does not substitute for the agencies, or do their work itself. Therefore a small effort can have a great impact, by overcoming just those problems which the experienced ombuds office can easily deal with, and getting the existing system to work as well as it can. Later, statistics generated by the ombuds program can be used to guide legislation or other institutional improvements. San Francisco could develop a highly leveraged impact on national policy by creating an ombuds function which receives PROMISING PUBLIC POLICIES instead of individuals -- and helps shepherd them through existing systems, as the traditional ombudsman helps individuals. The proposed ombuds office would receive complaints or suggestions from anyone, then investigate and prioritize the problems and decide which ones it might handle most effectively. It could help to resolve simple snafus through telephone calls to Federal, state, local, or other government officials, to corporate officials, to the media, etc. It could make recommendations to City departments, but would have no power except persuasion. And of course it could refer persons who brought problems, complaints, or suggestions to anyone else they should be talking to. A key to the success of such an ombuds office is that it could address any problem that impacts on San Francisco's ability to respond to the epidemic -- medical research, standards of care, insurance reimbursement (private, Federal, or state), funding for services, organizational snafus. Some problems can be resolved quickly by bringing the right people into communication. Problems which cannot be resolved easily can be articulated with cogent analysis and well-justified recommendations. ***** 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