Subject: Affordable Treatment Options, Suramin Disaster Date: Jul 15 1988 (505 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1988 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS issue #60, July 15, 1988. CONTENTS: [***** appears here at each new item] Affordable Treatment Options: You Can Help PCR Test Now Available Suramin Disaster: The Story Is Told Dallas AIDS Group Sues County Hospital On AIDS Care San Francisco: Volunteers Needed Washington DC: Weekly Wellness Series AIDS Treatment Research Policy: What Must Be Done To Save Lives? ***** Affordable Treatment Options: You Can Help The Stockholm AIDS conference will continue to be a major theme for the next several issues of this column. But due to reader requests we are also starting a theme of affordable treat- ment options -- whether they were discussed in Stockholm or not. The list below shows some of the treatments we plan to investigate; we don't yet know about safety, rationality, or availability/affordability of some of them. You could help by bringing others to our attention, especially any which have worked well for you or persons you know. Call Denny Smith at AIDS Treatment News, (415) 255-0588; if the phone is busy during the day you can call any time at night and leave a message. Or write to: AIDS Treatment News, attn: Options, P. O. Box 411256, San Francisco, CA 94141. We have no exact cut-off for affordability, but are aiming for treatments costing less than a dollar a day; some cost only pennies a day. Because of this cost criterion, many treatments which patients should consider, such as AZT, acyclovir, and dex- tran sulfate, do not appear on this list. The big question, of course, is what role the substances listed should have in AIDS/HIV treatment, if any. The list so far, in alphabetical order: * acidophilus * aloe vera * antabuse (as DTC substitute) * aspirin (or indocin, as prostaglandin inhibitor) * BHT * Chinese herbs * chlorophyll (including wheat grass, algae, chlorella, etc) * coenzyme Q * dapsone * DHEA * DMG, TMG (dimethylglycine, trimethylglycine) * DNCB * DTC (imuthiol) * fatty acids * ganoderma * garlic * germanium * homeopathy * hydrogen peroxide * lecithin * linaza seeds (used in Central America for nausea) * lysine * macrobiotics * monolaurin * naltrexone * propolis * selenium * septra * shiitake * vitamins: C, B12, others * zinc We may also look at attitudinal approaches, lifestyle changes, and self care. What distinguishes the "affordable" list from more main- stream lists of experimental treatments, such as found in the AIDS/HIV Experimental Treatment Directory compiled and published by AmFAR (American Foundation for AIDS Research), is not that the "affordable" ones are necessarily inferior, but that less is known about them. Neither industry nor government has had any serious interest in treatment possibilities which do not have commercial potential. Yet the treatments which develop a grassroots following without promotion, like most of those above, would be excellent candidates for small, well-managed, scien- tific clinical trials. For one thing, the grassroots treatment possibilities are generally safer than the high-tech options which generate commercial, government, and professional interest. And they are available now, not after several years of bureau- cratic delay and frequently ill-designed, unethical, and unwork- able trials. The U. S. needs public policy which recognizes that people must and will make treatment decisions, and then supports them in that process. We at AIDS Treatment News are becoming increasingly unhappy about reporting on treatments which have only fragmentary, anec- dotal, or theoretical evidence of effectiveness -- such as many of those listed above. At this stage in the epidemic, there should be direct scientific evidence that treatments actually benefit certain groups of patients. But until we have a public commitment to do the research needed to help people stay alive, we see no choice but to continue to report what evidence there is. ***** PCR Test Now Available A new HIV test far more sensitive than any other is now available commercially to physicians. The new test, called PCR (polymerase chain reaction), often detects HIV infection months before the antibody test; in one case reported at the AIDS conference in Stockholm, it detected HIV three and a half years before seroconversion. Some persons who are negative on the antibody test, P24 antigen, viral cul- ture, and all other tests have been found to be positive on the PCR. PCR will prove especially useful for testing infants, because only about 40 percent of the infants who test antibody positive for HIV are really infected; the others are only carry- ing their mother's antibodies temporarily, and the usual antibody tests cannot tell the difference. No one knows how many people will be found to be positive on the PCR even though they are negative on the antibody and all other tests. And no one knows whether everyone who is PCR posi- tive will become antibody positive eventually, or whether some people who are positive only on the PCR might have controlled the virus successfully. The PCR detects very small amounts of a particular sequence of DNA, which contains the hereditary information of cells. For HIV diagnosis, the PCR test is used to detect genetic information inserted into the DNA of human cells by HIV. Unfortunately the current version of the PCR only tells whether or not the DNA created by HIV was detected -- it does not give any indication of how much. Therefore the test now avail- able cannot be used to monitor how well patients are responding to treatment -- or as an indicator of how well experimental drugs are working -- because once a person is positive on the PCR, he or she will presumably remain positive, short of being completely cured. Later improvements in PCR technology may enable the test to give quantitative results, so that it could be used to monitor therapy and drug trials. How It Works The PCR (polymerase chain reaction) is a major scientific advance which will be an important tool for many kinds of basic research, and for diagnosis of other diseases as well as AIDS. The PCR test works by taking advantage of the fact that DNA can make a copy of itself, as it does during normal cell divi- sion. The sample being tested is treated in such a way that each piece of the DNA being tested for will double into two pieces. The treatment is repeated, and the two pieces become four, then eight, then 16, etc. After 20 or more repetitions, the DNA (if any) will have multiplied more than a million times, and then it can be detected by ordinary biochemical tests. The PCR can detect HIV infection even if it is completely latent, in the DNA of macrophages or other cells, not causing the replication of virus or the production of antibodies. Persons who are antibody positive would presumably always test positive with the PCR. Those who are antibody negative despite high risk of exposure to HIV could use the PCR for reas- surance if they are negative, or to start early infection con- trol, periodic blood work, or early treatment if they test posi- tive. For more background on the PCR, see "Multiplying Genes by Leaps and Bounds", Science, June 10, 1988. Where To Get the PCR The PCR is now available with a physician's prescription everywhere except New York State, which requires special licens- ing the companies have not yet obtained. The cost for the test itself is $145., and it takes about five days to get the results. Cetus Corporation, a biotechnology company in Emeryville, CA, developed the PCR. Last week Cetus licensed two companies to provide the test commercially. Physicians who want to order the test should call customer service at either (1) Pathology Insti- tute, Berkeley, CA, (800) 438-8674 or (415) 540-1638, or (2) Specialty Laboratories, Inc., Santa Monica, CA, (800) 882-1345 from within California, (800) 421-7110 from other states, or (213) 828-6543. The PCR might also be available through whatever laboratory the physician uses already, by subcontract with the one of these two companies. ***** Suramin Disaster: The Story Is Told An article in the July/August issue of San Francisco: The Magazine traces the history of the suramin drug trial in 1985 -- the first multicenter test of an antiviral AIDS drug in the United States. This disastrous trial killed some of the partici- pants and became a major setback for AIDS research, delaying the progress of clinical trials for perhaps as much as two years or more. It has provided the foundation for justifying the slow pace of trials, restrictions on access to experimental treat- ments, the movement to accept and romanticize death in the gay community, and the corresponding attitude in government, busi- ness, medicine, and the media to write off those already ill or infected, and not bother with the practical clinical research or other public policy commitments designed to save their lives. Yet for the last several years word of mouth reports circu- lating among those in the AIDS community close to the suramin trials said that major mistakes in the conduct of the trials had contributed to a disaster that was at least in part avoidable. The current article in San Francisco, by San Francisco Sentinel reporter Charles Linebarger, brings some of this history into public view for the first time. We learn, for example, that the National Institutes of Health didn't tell the investigators running the trial that adre- nal damage was a possible side effect of suramin because "any doctor can make a clinical diagnosis of adrenal insufficiency". But the symptoms of that condition can mimic AIDS symptoms, so they were not recognized until too late. If the physicians run- ning the trials had been warned, they would have included a sim- ple test for adrenal damage. The San Francisco article may help to shake the fatalism which resulted in part from the Suramin trials -- a fatalism which has allowed U. S. public policy to accept projections of hundreds of thousands of AIDS deaths with remarkably little effort to avert them. ***** Dallas AIDS Group Sues County Hospital On AIDS Care A major lawsuit over substandard care of persons with AIDS in Dallas may establish national precedents on whether indigent patients have a right to health care. Parkland Memorial Hospital, the large county hospital com- parable to San Francisco General here, treats over 1,000 patients with AIDS, ARC, or who are HIV positive. Only one full time and one half time physician have to handle this patient load, with 700 patient visits per month. Typical AIDS patients are persons who lost their jobs as the disease progressed, and exhausted their savings, thus becoming indigent. The lawsuit, brought by the Dallas Gay Alliance and the American Civil Liberties Union AIDS Project, seeks to end these practices: * A waiting list for AZT. The cost of the drug is not the issue, because the AZT is provided by a State program with Federal funds. But the hospital does not assign enough physi- cians to monitor patients using the drug. The lawsuit also names the University of Texas Southwestern Medical Center, which provides medical personnel -- students, residents, fellows, and professors -- to the hospital. This medi- cal school rotates its personnel through all 132 of the clinics at Parkland Memorial, except for one -- the AIDS clinic. This discrimination exacerbates the shortage of physicians in the AIDS clinic. The hospital admitted that in the one-month period from April 7 to May 6, 1988, seven people on the AZT waiting list died. These were patients for whom AZT was medically prescribed but not available due to the hospital policy. * Arbitrary denial of aerosol pentamidine prophylaxis and treatment. The hospital's full-time AIDS physician, after his recent resignation, pointed out that pentamidine costs the hospi- tal about $100. per month per patient, while each hospitaliza- tion for pneumocystis costs the hospital $10,000 for the average stay of seven days. * Rationing of AIDS beds. Persons with AIDS have been forced to wait for a rationed AIDS bed until another patient is discharged or dies, even though other beds are empty. Patients ill enough to need hospitalization have had to wait 12 hours or more for a bed. Legal Results So Far The lawsuit was first filed in a state court. Judges in Dallas are assigned at random, and a conservative judge was assigned to the case. But even he ruled against the hospital, forcing it to end the AZT waiting list, deliver aerosol pentami- dine, and end the AIDS bed control. He gave the hospital 30 days to comply. Then the hospital moved the case to the Federal court sys- tem. This time a moderate-liberal judge, with a reputation for being very thorough and fair, has been assigned. Recently the Dallas Gay Alliance has asked the court for permission to change their pleading to a class-action lawsuit, which would include 28,000 people and have a wider impact. The ruling on this motion is pending. This article cannot do justice to the excellent organizing and action around the Parkland hospital case by the Dallas Gay Alliance and other organizations. This work is a model for organizations elsewhere and may set important legal precedents concerning health care for AIDS and other conditions as well. For more information, call William Waybourn, president of the Dallas Gay Alliance, (214) 748-2222. ***** San Francisco: Volunteers Needed The Healing Alternatives Foundation (formerly Healing Alter- natives Buyers Club) needs volunteers for several projects: * Improving its AIDS library; * Implementing a "doctor report card" and "treatment case history" file; * Facilitating small treatment study groups; * Helping out in selling nutritional products such as egg lecithin lipids. Volunteers can work evenings or weekends, as well as week- days, on many projects. For more information call Terry Beswick, director of The Healing Alternatives Foundation, at (415) 626-4053, or stop by Tuesday through Saturday 1-5 PM at 273 Church St. The Healing Alternatives Foundation is a nonprofit organiza- tion based on the philosophy that AIDS is a treatable disease. ***** Washington DC: Wellness Workshop Series The Whitman-Walker AIDS Program in Washington, DC will offer a "Wellness Workshop Series" of nine weekly meetings Thursday evenings starting July 28. Topics include AZT, experimental drugs in clinical trials, acupuncture, Chinese and American herbs, nutrition, guided imagery, and spiritual issues. For more information call Rusty Lynn at (202) 797-3541 or Michael Evanson at (202) 797-3557. ***** AIDS Treatment Research Policy: What Must Be Done To Save Lives? (Statement distributed at the Lesbian and Gay Health Conference and AIDS Forum, Boston, July 1988) For over two years we have published biweekly articles on experimental and "alternative" AIDS treatments and research, in the San Francisco Sentinel and as AIDS Treatment News. We could not come to Boston this July, so we prepared this statement to contact health organizers about what is needed in AIDS research policy, how we can help, and how you can help. Barring a miracle, hundreds of thousands of people in the United States alone are expected to die of AIDS over the next several years -- and the Federally controlled research establish- ment as it is currently operating will have little impact on this catastrophe. No one disputes the projections of what will happen without better treatments. And just last week FDA Commissioner Dr. Frank F. Young told Senator Kennedy's Senate Committee on Labor and Human Resources that he expected little to come out of the official drug development process in the next three years. In other words, hundreds of thousands of deaths are virtually inevitable under current policies. Everyone agrees that these predictions are horrifying. The question is, are they inevitable? Few now dispute that U. S. public policy has written off almost everyone who is now ill or HIV positive. National policy has consigned these people to death with remarkable equanimity, with no serious debate, and no serious effort to develop alterna- tive strategies for a different outcome. In over two years of researching these matters and publish- ing over 60 articles on AIDS treatments, we have never found any compelling scientific or medical support for believing these deaths are inevitable. Instead we have found that commercial and political reasons account for the continuation of policies which will allow hundreds of thousands of deaths. For example, no HIV treatment has been approved since AZT, and no new approvals are now in sight. But meanwhile, dozens of unapproved, "underground" AIDS treatments have acquired a grassroots following, most with little or no commercial promo- tion. Solid evidence that these treatments work is admittedly scanty. But the evidence that they don't work is far scantier, often nonexistent. The research establishment simply assumed these treatments do not work, without evidence, because the ideas did not come from the mainstream of corporations, agencies, and professionals -- a network which does not pursue leads unless they have commercial potential, or relevance to elegant, commer- cially desirable science such as biotechnology. Besides the basic research in fields such as virology, which is already being done well, we need a mechanism to test dozens or even hundreds of attractive treatment leads which are available now, in small, fast (but well designed and well managed) scien- tific clinical trials. Any treatment known to be safe, and which acquires either a significant grassroots or scientific following, should be tested. We may not find a cure this way. But we probably will find therapies to restore health and slow the disease process, perhaps indefinitely, for most people. Then when basic research does find a cure, perhaps in five or ten years, these people will be alive to benefit from it. And billions of dollars in medical costs for hospitalization and care of the dying might well be avoided. Money isn't the problem; the cost of what amounts to an assembly line for mass production of small clinical trials would be modest. Most of the potential treatments themselves cost lit- tle. The problem, rather, is that the kinds of trials needed to save lives in this emergency do not fit into the conventional way U. S. drug development is done. The small trials suggested above, for example, might not count toward FDA drug approval -- especially if there is no sponsor to pay the $80 million to $120 million generally recognized as the cost to develop each new drug through final U. S. approval. (These trials could contribute indirectly, however, by focusing attention on anything found to work dramatically well.) And releasing drugs without full appro- val would threaten the investors who have put millions of dollars into the conventional drug development and approval process, threaten regulators who have built their careers on it, and even threaten consumer protection advocates who have made a religion of keeping drugs off the market and away from people before full proof of efficacy -- though everyone knows that even when the drugs do work such proof takes years, and is so cumbersome that it may never happen at all. These are the commercial and politi- cal obstacles which delay research for years when it could other- wise take weeks or months. Instead of perfect proof of efficacy, we need practical tri- als which support patients and physicians in the treatment deci- sions that they are already making anyway. Such trials have already begun on a very small scale through organizations like the Community Research Initiative in New York and the County Community Consortium in San Francisco, and through the practical experiences of individual physicians. Therefore we do not need to lobby for something totally new, but rather we need to expand a process already taking place, and to focus some of the central energies of this nation on it. The first and most important step your organization can take to contribute to this effort is to develop in-house expertise in some aspect of AIDS treatment research policy, somewhere within your organization. Without such knowledge, you will be forced to accept at face value views and analysis by experts dependent on the existing system, analysis loaded with the institutional interests of the most powerful players in the $550 billion dollar per year medical industry. No serious advocacy can operate without its own centers of expertise. The AIDS service community ignored treatment advocacy for the first six years of the epi- demic. Fortunately the tide has begun to turn. We need not overthrow the system, only make room at the negotiating table for one more party. The fortunes, the empires, the turf wars, the games, the maneuvers, the coups, all will con- tinue. But the lives of hundreds of thousands of people must also count when the real decisions are made. To discuss how we can work together to promote national treatment strategies for saving lives instead of writing people off, call us at AIDS Treatment News. ***** [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display