Date: Fri, 02 Jun 1995 19:12:12 -0700 (PDT) Reply-To: Conference "aidstreatment" From: Tadd Tobias Subject: AIDS Treatment News Issue #224, June 2, 1995 AIDS TREATMENT NEWS Issue #224, JUNE 2, 1995 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: Diarrhea, and the Experimental Treatment Saccharomyces boulardii When Treatments Go Untried Gallo Starts Major AIDS Research Institute in Baltimore Lymphoma: New TAG Report Chinese Medicine: Where Does It Work Best in HIV/AIDS? ***** Diarrhea, and the Experimental Treatment Saccharomyces boulardii by John S. James Saccharomyces boulardii is a live yeast widely used in Europe and elsewhere to treat diarrhea; millions of doses are sold each year. Recently, with increasing interest in using it for HIV-related diarrhea, this potential treatment has become one of the top sellers at some AIDS buyers' clubs, including Healing Alternatives in San Francisco, and the PWA Health Group in New York. A number of published clinical trials (almost all in HIV- negative persons) have reported apparent usefulness in preventing or treating diarrhea resulting from various causes. No one knows how S. boulardii may work, however. It does NOT seem to kill diarrhea-causing organisms directly; instead, it may reduce inflammation in the gut, or increase certain immune responses in the blood. (The latter theory might explain how one study found S. boulardii may have been modestly useful for treating acne, even though the yeast did not leave the intestinal tract.) HIV-Related Research Little research has been done with S. boulardii in persons with HIV. In 1990, French researchers reported on 30 patients who had four to eight liters of watery stools per day for at least three months. When they were given three grams per day of S. boulardii, "fecal output decreased to less than one liter per day after 48 hours of treatment, and eight days after the onset of the drug, stools were fully formed."(1) The following year, the same research team reported on improvement in 17 patients with HIV and diarrhea; in 12 of them, the cause of the diarrhea could not be diagnosed. The average number of stools decreased from 9 to 2.1 per day in 15 days, and there was an average weight gain of 8 kg (17.7 lbs).(2) Neither of these reports were from controlled trials, however. In 1992 French researchers reported the results of a placebo- controlled trial of S. boulardii, in 36 patients with AIDS- related diarrhea which -- importantly -- was not responsive to any attempt to treat any known cause of the diarrhea.(3) On entry into the trial, their average age was 34.8 years, and their average weight was 58.7 kg (130 lbs). Thirty five of the 36 patients completed the study. At the end of the trial, 10 of 18 patients who received S. boulardii were diarrhea free, vs. only 1 of 17 who received the placebo -- a difference which is highly statistically significant. Also, the treatment group gained 2.0 kg (4.2 lbs), while the placebo group lost 3.1 kg (6.85 lbs); this difference is also statistically significant. The length of the trial was not stated in the abstract. As far as we know, this is the only completed controlled trial of S. boulardii in persons with HIV. The latest medical article anywhere on S. boulardii in HIV- related diarrhea was published in 1993; it is a case report of a successful treatment.(4) (Unfortunately, one major computer database mis-translated the German title into English as "Saccharomyces boulardii Therapy of HIV Associated Failures," instead of "Saccharomyces boulardii Therapy of HIV Associated Diarrhea," giving a completely wrong impression of the article. But the MEDLINE database generally used in the U.S. does have the correct translation of the title.) Until recently, 26 persons with HIV were being studied in controlled clinical trials in Seattle. During the first two weeks, some were randomly assigned to receive a placebo. Then everyone received the drug in decreasing doses, to help define the safest and most effective maintenance dose. Unfortunately, this trial was recently stopped -- for business reasons, not because of any problem with the treatment. (The sponsor decided to focus on another trial, testing S. boulardii with antibiotics to prevent recurring Clostridium difficile diarrhea; all the persons in that trial must be HIV negative. That study may be finished by the end of 1995; with luck, S. boulardii could be approved for preventing C. difficile recurrences in about two years.) S. boulardii appears to be quite safe; no serious adverse effects have been found in any clinical trial. But one theoretical danger is that this yeast could take advantage of an immune deficiency and cause a systemic infection. Only two cases of this have been reported, out of perhaps more than a million people who have used the treatment since it was first used for diarrhea in the 1950s. Both were probably HIV- negative (neither had been tested, but neither was being treated for anything HIV related); both previously had serious intestinal problems which may have allowed the yeast to leave the intestine and enter the bloodstream. Both cases were successfully treated with amphotericin B, a powerful antifungal. Clinical Trials for Other Diseases McFarland and Bernasconi(5) reviewed controlled trials studying S. boulardii for treatment or prevention of diarrhea due to various causes not related to HIV. All the results reported below -- from studies they reviewed, and also from more recent reports -- are from controlled trials, and are statistically significant. Three large trials studied S. boulardii for prevention of antibiotic-associated diarrhea.(6,7,8) This condition can occur as a side effect of certain antibiotics, which can kill beneficial organisms in the gut and thus allow an overgrowth of disease-causing organisms which are normally kept under control. In all three of the trials, S. boulardii reduced the incidence of diarrhea by at least 50 percent. Two other controlled studies showed that S. boulardii treatment caused about a two-fold or three-fold reduction in diarrhea caused by feeding with a nasogastric tube.(9,10) S. boulardii, used with certain antibiotics, has also been studied for treating C. difficile, a serious intestinal infection. After several positive case reports and uncontrolled studies, a major placebo-controlled trial found that S. boulardii plus antibiotics prevented recurrences of C. difficile better than the antibiotics alone,(11) but this could only be established for patients with a history of recurrences; for those with their initial C. difficile infection, the difference between the treatment and placebo groups was not statistically significant. (This failure to reach statistical significance does not mean that S. boulardii failed to help in these cases, however; "because of the small numbers of patients with initial CDD who failed, there was only a 10% power of detecting a significant difference; therefore, the result could be a type II error."(11)) A study in a few patients with Crohn's disease also found statistically significant benefit of S. boulardii in reducing diarrhea.(12) Researchers in Austria tested S. boulardii in 3,000 healthy volunteers for prevention of travelers diarrhea. They gave a small dose (250 mg per day), a moderate dose (1 gram per day) or a placebo to persons about to travel to distant regions. Those who received the treatment, especially the higher dose, were significantly less likely to get diarrhea.(13) Studies of S. boulardii for treating ordinary diarrhea in children(14,15) have shown significant benefit. And in a trial in adults,(16) the treated group did not have a significant reduction in the number of stools, but it did have a lower proportion of watery stools. S. boulardii does not remain in the intestine after use is stopped, but is eliminated from the body within several days.(5) Research findings differ on whether the yeast needs to be alive when taken. Even dead yeast may cause some of the effects which have been observed. Note: A number of laboratory studies, animal studies, and uncontrolled human trials, NOT involving HIV in any way, have suggested that S. boulardii might be helpful in treating specific kinds of diarrhea or other illnesses. In this article, we have not reviewed or referenced those studies. Instead, we have focused on all HIV studies, and on placebo- controlled human trials for any condition. Availability Today At least two different S. boulardii products are available in AIDS buyers' clubs today. Laboratoires Biocodex, the French company now running clinical trials of S. boulardii, markets a lyophilized (freeze-dried) form of the yeast in Europe, South America, and Africa, but not in the U.S. It is sold under different brand names (Ultra-Levure(tm), Thiemann(tm), Perenterol(tm), Floratil(tm)) in different countries. This product is available from the PWA Health Group, the largest AIDS buyers' club in New York (212/255-0520). The three-gram per day dose used in trials for AIDS-related diarrhea is moderately expensive; at the PWA Health Group, a four-day supply costs $36. Biocodex has been selling S. boulardii since 1962. A competing product sold by Jarrow Formulas is less expensive; but whether the two products are equivalent is controversial. The PWA Health Group only carries the Biocodex version; while Healing Alternatives, the major AIDS buyers' club in San Francisco, carries only the Jarrow brand; both can ship the product anywhere within the U.S. Some health- food stores also sell the Jarrow brand. With the Biocodex product, each 250-mg capsule is formulated to contain one billion live yeasts, when tested six months or more after manufacture. According to Biocodex, their in-house testing, which has not previously been published, has shown that there can be as much as a two log (99 percent) drop in the number of live yeasts in the month after manufacture. According to Jarrow Rogovin, president of Jarrow Formulas, this does not happen if the capsules are refrigerated. With the Jarrow product, each 310-mg capsule is formulated to contain at least 500 million live yeasts when manufactured; it may contain more. We believe that what is most important is to find out whether or not S. boulardii may be helpful for you -- and that the best way to do this is to try a test with the more established Biocodex product, starting with three grams a day (twelve 250-mg capsules) for at least a week, and preferably for two weeks. (You might want to order additional supply, to avoid running out if it does seem to work.) After this test, if you decide to continue with S. boulardii, you might be able to reduce the cost by reducing the dose, and/or switching to the Jarrow product, to see if a less expensive regimen works as well for you. How S. boulardii Is Used Because of the lack of scientific studies of S. boulardii for persons with HIV, information on how to use this treatment is highly anecdotal and imprecise, and sometimes contradictory. According to at least one of the buyers' clubs, most people using S. boulardii for HIV-related diarrhea start with 3 grams a day, and then work down to 1 gram a day if that is sufficient to keep the diarrhea controlled. Most people divide the dose into two or three portions, and take the capsules with a glass of water after eating. (One recommendation we have seen says two hours after meals; another just says after eating.) Some people take a gram a day or less "for gut regulation or stomach aches," even without diarrhea. According to the PWA Health Group, there are no known drug incompatibilities, although it has been suggested that if fluconazole maintenance is being used, the two treatments should not be taken at the same time, so that the fluconazole will be less likely to kill the yeast. How many people have used S. boulardii for HIV-related diarrhea? No one knows; the PWA Health Group estimates that maybe a few hundred people have tried it; and they have received only one report of a suspected side effect, a rash. Healing Alternatives was selling about 90 bottles a month before a recent article in a gay newspaper in San Francisco increased demand. It has only heard one anecdotal report that the treatment did not work; all the other reports have been positive, even with severe diarrhea. (Readers should keep in mind, however, that negative results are usually the least likely to be reported; the treatment is probably not working as well as the existence of so few negative reports might suggest.) Perhaps the most serious safety concern with S. boulardii is that appropriate medical care could be delayed, if people treat themselves for diarrhea without first getting medical attention so that the underlying cause of the problem can be diagnosed and treated, when possible. People should remember that the HIV-related medical studies cited above were done with patients whose diarrhea either could not be diagnosed, or could not be treated by standard means. In many cases, standard medical care cannot help; this is why new treatments are needed. But failure to use available therapy for a treatable condition, such as CMV infection, could lead to serious harm. The Future So far there has been very little study of use of S. boulardii for treating AIDS-related diarrheas. We have heard that a trial is being conducted in Germany; as far as we know, this is the only study anywhere of S. boulardii in persons with HIV. Biocodex may study it again for HIV diarrhea sometime in the future, but probably not until the development for C. difficile is complete. It would be very difficult for anyone to conduct a legal, U.S. study of S. boulardii independently of Biocodex, either using its product, or any other; collaboration might be possible, however. Sally Cooper, executive director of the PWA Health Group in New York, informally outlined some research directions she would like to see, in a private communication to AIDS TREATMENT NEWS on May 30, 1995: "Things I'd like to see followed up: use in kids with HIV -- what a great thing to have a safe intervention for kids, who have wicked diarrhea all the time, and there have been at least two studies in non-HIV kids; amoebas (also a small number of promising abstracts, much gentler than Flagyl and even tinidazole, again safe for kids); various stomach ailments; thrush and preventing the spread of thrush (as per animal studies). 80% of the lymph is in the gut, so things that work specifically in the gut, like S. boulardii and ketotifen, seem especially interesting. Both are theorized (and shown in people with ketotifen, but only in animals with S. boulardii) to improve and maintain mucosal membrane health in the gut. And people gain weight -- seems like more than just stopping up the system. I suspect it might be an excellent maintenance therapy for PWAs with low CD4 counts, or anyone starting a major course of antibiotics, especially clindamycin." [Note: tinidazole and ketotifen are drugs which are approved in some countries but not in the U.S., and are used by people with AIDS.] The bad news is that none of this research is likely to start for years; who would pay for it? But the good news is that a great many people have used S. boulardii, and some people have used it for AIDS-related diarrhea over the last several years; from all we know at this time, the treatment appears to be exceptionally safe. The other good news is that if S. boulardii is going to work, it works quickly, usually greatly reducing diarrhea within a week or two. A short test should be enough to see if it is going to work for you. If not, little has been lost. And if the treatment does work, then the financial cost, and the small, largely theoretical risk of serious side effects, may be worth accepting. References 1. Saint-Marc T, Sellem C, Rosello L, and Touraine JL. Treatment of chronic diarrhea with Saccharomyces boulardii. Sixth International Conference on AIDS, San Francisco, June 20-24, 1990 [abstract #Th.B.363]. 2. Saint-Marc T, Rossello-Prats L, and Touraine JL. Efficacite de Saccharomyces boulardii dans le traitement des diarrhees du SIDA. ANNALES DE MEDECINE INTERNE. 1991; volume 142, number 1, pages 64-65. 3. Blehaut H, Saint-Marc T, and Touraine JL. Double blind trial of Saccharomyces boulardii in AIDS related diarrhea. Submitted to the Eighth International Conference on AIDS, Amsterdam, 1992, but not published in the conference abstracts. 4. Born P, Lersch C, Zimmerhackl B, and Classen M. Saccharomyces-boulardii therapie HIV-assoziierter durchfalle. DTSCH. MED. WOCHENSCHR. 1993; volume 118, number 20, page 765. 5. McFarland LV and Bernasconi P. Saccharomyces boulardii: A Review of an Innovative Biotherapeutic Agent. MICROBIAL ECOLOGY IN HEALTH AND DISEASE. 1993; volume 6, pages 157-171. 6. Adam J, Barret A, Barret-Bellet C, and others. Essais cliniques controles en double insu de l'ultra-levure lyophilisee. Etude multicentrique par 25 medecins de 388 cas. GAZETTE MEDICALE DE FRANCE. 1977; volume 84, pages 2072-2078. 7. Surawicz CM, Elmer GW, Speelman P, McFarland LV, Chinn J, and Van Belle G. Prevention of antibiotic-associated diarrhea by Saccharomyces boulardii: a prospective study. GASTROENTEROLOGY. 1989; volume 96, pages 981-988. 8. McFarland LV, Surawicz CM, Greenberg RN, and others. Prevention of beta-lactam-associated diarrhea by Saccharomyces boulardii compared with placebo. THE AMERICAN JOURNAL OF GASTROENTEROLOGY. 1995; volume 90, number 3, pages 439-448. 9. Tempe JD, Steidel AL, Blehaut H, Hasselmann M, Lutun PH, and Maurier F. Prevention par Saccharomyces boulardii des diarrhees de l'alimentation enterale a debit continu. LA SEMAINE DES HOPITAUX DE PARIS. 1983; volume 59, pages 1409- 1412. 10. Schlotterer M, Bernasconi P, Lebreton F, and Wassermann D. Interet de Saccharomyces boulardii dans la tolerance digestive de la nutrition enteral a debit continu chez le brule. NUTRITION CLINIQUE ET METABOLISME. 1987; volume 1, pages 31-34. 11. McFarland LV, Surawicz CM, Greenberg RN, and others. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. JAMA. 1994; volume 271, number 24, pages 1913-1918. 12. Plein K, and Holtz J. Therapeutic effects of Saccharomyces boulardii on mild residual symptoms in a stable phase of Crohn's disease with special respect to chronic diarrhea -- a pilot study. Z. GASTROENTEROL. (Germany). 1993; volume 31, number 2, pages 129-134. 13. Kollaritsch H, Holst H, Grobara P, and Wiedermann G. Prevention of traveler's diarrhea with Saccharomyces boulardii. Results of a placebo controlled double-blind study. [English translation of the title.] FORTSCHR MED. 1993; volume 111, number 9, pages 152-156. 14. Chapoy P. Traitement des diarrhees aigues infantiles: essai controle de Saccharomyces boulardii. ANNALES DE PEDIATRIE 1985; volume 32, pages 561-563. 15. Cetina-Sauri G and Basto GS. Evaluacion terapeutica de Saccharomyces boulardii en ninos con diarrea aguda. TRIBUNA MEDICA. 1989; volume 56, pages 111-115. 16. Hochter W, Chase D, and Hagenhoff G. Saccharomyces boulardii bei akuter erwachsenendiarrhoe. MUNCHENER MEDIZINISCHE WOCHENSCHRIFT. 1990; volume 132, pages 188-192. ***** When Treatments Go Untried by Denny Smith The HIV pandemic is fourteen years along, affecting at least that many millions of lives, with no certain end in sight. New treatments are winding their way through laboratory studies and clinical trials, but not at a pace that reassures people who now have AIDS. For many, it is a situation defined by anxiety. Yet long-time observers have seen some true progress in HIV research and clinical care. Four antiretrovirals are available in developed countries. Though certainly inadequate in the long run, they can at the least delay HIV progression for many people, especially when used in combinations. And almost every opportunistic illness can be controlled to some degree with one or more treatments. Moreover, significant progress has been made in the treatment of wasting, and dementia is finally receiving the sort of attention that could make a difference in outcome. But we are concerned that potential treatments often lie idle on pharmacy shelves, that useful treatment strategies are languishing on the printed page, and that for many people the hard-won progress in research and care generally is being squandered. This impression grows out of years of conversations with readers of AIDS TREATMENT NEWS, with activists and physician friends, and with people who care for someone with HIV. Why do potentially valuable treatments go untried? Lack of availability is the simple answer for millions of people, especially in developing countries. Where availability is not the problem, however, lack of motivation often is. Following are the most common problems, in our view, and some potential remedies. Some of the problems are nearly solved simply by being acknowledged. * Insufficient information An enormous percentage of treatment decisions seem to be made with only a limited number of options on the table. For example, one reader told us that his doctor had no treatment for a KS lesion on his eyelid that had grown so much that his vision was impaired. Other lesions had responded well to radiation, but his doctor said that radiation would be dangerous focused directly toward the eye. However, we had heard that a small lead shield could be placed between the eye and the lid during radiotherapy. He brought that information to his doctor and was successfully treated within a few weeks. Only coincidence and timing brought that information from an unrelated treatment setting to AIDS TREATMENT NEWS and through the patient back to his doctor. How could the process be more dependable? When faced with an apparent treatment dead-end, the physician and the patient should consider whether all options have been uncovered. The first resort could be a literature search which calls up all relevant journal abstracts for the last several years. Next, community news sources should be surveyed, because a lot of potential treatments are tried in the community before they attract well-funded research backing. At some point, a specialist with HIV experience should be consulted. Our friend's doctor had effectively treated KS before, but only a radiation oncologist would be likely to know about seldom-used techniques like the lead shield. * Acceptance of the "terminal" prognosis Many people, including some who should know better, continue to regard HIV infection as a terminal condition, rather than a chronic, life-threatening disease. The distinction is important for shaping public policy. But there are also scientific reasons for dumping the word "terminal." (1) According to data from the San Francisco Clinic Study, which has tracked long-term HIV infection in hundreds of gay men, among people who have been infected for ten to 16 years, 6.9% continue to have CD4 counts above 500; another 8.7% have counts below 500 but above 200. No one can dismiss the possibility that many of them will fulfill their natural life expectancy. (2) For people with declining CD4 counts, the antiretroviral drugs now on the market can delay the progression to opportunistic illnesses for months or years. (3) New treatments for opportunistic illnesses can extend lives well beyond the first symptoms of AIDS. Beyond inaccuracy, the "terminal" label can itself be life- threatening, since a choice of words implies a choice of action. The word "terminal" fosters a sense of resignation for both the patient and provider, such that when a health crisis presents itself, neither party is motivated to pursue more than the minimal, most conservative diagnostic work-up and treatment. It is an approach that certainly simplifies life but, almost as certainly, shortens it. One does not get more than what one settles for. * Disinterested health care providers Too many people with HIV are finding themselves under the care of physicians who are simply unenthused about HIV medicine. Sometimes there is little choice in the matter for the patient; for reasons of geography, or health-care coverage, they cannot easily switch doctors. Nor is it a choice of every physician to assume the responsibility of managing an unpredictable, complex disease for which treatment recommendations are constantly changing. Yet that is the situation faced half-willingly by physicians and patients who meet each other in one of two contexts: health-maintenance organizations (HMOs) and teaching institutions. HMO subscribers are limited to seeing only physicians who participate in that health plan. Within this limit, fortunately, it is often possible to find a good, collaborative "match." But people who do not have private insurance in the U.S. often get their care in teaching institutions, where they are followed by young interns who rotate through various clinical situations as part of an extended residency program. Such teaching programs are an important vehicle for taking medical students from school into the real world of patients. But they are also a great money-saver for large institutions, which would otherwise have to pay enormous salaries to more experienced physicians. The interns can be caring and attentive and are sometimes more willing than older, established physicians to try innovative treatment approaches. But they are just as often exhausted and hurried and prone to inappropriate assessments. It is a system that can only guarantee minimal HIV training to a new doctor and minimal health care to their patients. Moreover, many people who get their care in teaching institutions come from trying or troubled social settings, and they tend to delay health care until the need is acute. And so, in many instances, individuals with the most urgent personal concern are tracked into a health-care setting with the least eager professional concern. One solution would be to exempt interns and residents from patient care that they truly are unprepared for. Another, parallel, solution is the HIV-focused clinic, where the care is largely provided by experienced physicians, with some uncomplicated patients managed by residents genuinely interested in HIV medicine. HIV infection should not, in our opinion, be considered just another responsibility of general internal medicine. It presents too many complexities that cross over many medical disciplines, including immunology, hematology, dermatology, infectious disease, gastroenterology, oncology, psychiatry and neurology. HIV medicine warrants a distinct setting of expertise, where each patient receives individualized care. * Hyper-cautious providers There are other health care providers who are both informed about HIV and interested in treating it, but who adhere to an oppressively conservative clinical approach. What may be a well-worn strategy in some disease models can be ill-applied to HIV. Diabetes, hypertension, heart disease or liver disease usually have well-understood causes and prognoses. They may best be managed with behavioral changes and cautious observation. But other health crises, like cancer and HIV disease, are fundamentally different. Caution and behavioral counseling may prevent them but will not treat them. Exam room philosophies like "watchful waiting," "if it ain't broke...," and "do no harm" can have a legitimate place, but miss the mark in contexts where progress has been achieved with innovative, aggressive intervention. One example of excessive caution is the unwillingness to prescribe drugs off-label. Off-label refers to the use of an FDA-approved drug for a purpose that was not part of the original treatment indication, or "labeling." All physicians have the professional discretion to prescribe any drug off- label, and many drugs have been found to be invaluable for new uses, such as mexiletine for neuropathy. To adhere arbitrarily to the original labeling can deprive patients of the treatment they need. This is an ethical, not a regulatory, problem. Another example of misplaced caution is the avoidance of anecdotal or empirical evidence of treatments. A number of indispensable HIV therapies started out as anecdotal reports from physicians and patients who pioneered new treatment approaches out of necessity. In many HIV-related situations, there is no established treatment or the established treatment just does not work for everyone. Today's anecdotal report may be tomorrow's treatment. * The artificial polarity between "conventional" and "alternative" treatments The U.S. has a large and vital alternative health culture. Depending on how the word 'alternative' is defined, this culture may encompass holistic or naturopathic medicine, Chinese medicine and acupuncture, nutritional supplementation, homeopathy, herbal medicine, chiropractic, and other forms of treatment. Unfortunately, alternative therapies are not taken very seriously by many traditional physicians; and allopathic, or conventional, "Western" medicine is often posed in the community as the "other," a mercenary devil, the problem for which alternatives exist. There is on both sides a propensity toward unreasonable exclusion of the other. The most productive approach would probably integrate everything that works, with an eye toward dropping the distinctions of alternative vs. conventional. If a treatment works when nothing else has, what about it is "alternative"? This idea was well presented in the following excerpt from a manifesto by the New York activist Jon Greenberg, who died of AIDS in 1993. "The AIDS community tends to fall into two separate camps regarding alternative therapies. Some dismiss all alternative treatments, regardless of evidence demonstrating efficacy, and others defend all alternative treatments, regardless of evidence demonstrating toxicity or lack of efficacy. The reality of most alternative therapies probably lies somewhere between these two extremes . . . The goal of alternative treatment activists is to advocate for controlled clinical trials of alternative treatments, so that approval and acceptance can be gained for those treatments which are found to be effective. Our goal is to make the term 'alternative' obsolete." * Over-eager concerns about expense We have met physicians who hesitate to use a potentially valuable treatment if they think it is very expensive or will not be reimbursed by the insurer. This is partly a symptom of the inefficient, commerce-driven system of healthcare in the United States. Doctors are forced to spend inordinate amounts of time worrying about money instead of medicine. At least some of the concern, however, may be inflated. We know of instances in which a treatment was avoided by physicians who assumed the cost could not be covered by the insurance company, when in fact the same treatment had been covered by that insurer when prescribed with convincing documentation by other physicians. Furthermore, many pharmaceutical companies have assistance programs for patients who are underinsured. No treatment should be automatically considered out of reach. * The culture of rumor consumers Many people will not take the approved antiretrovirals-AZT, ddI, ddC, and d4T-because they heard the drugs do not work, or even that they are "poison." The truth, less dramatic but widely accepted, is that these drugs can inhibit HIV progression to some limited degree, and also can cause some side effects. But ever since it became clear the drugs were not the final answer, and that not everyone has the same experience with each drug, a subculture of misinformation has been simmering. This subculture is characterized by inconsistency. Some people who absolutely refuse to try AZT are inexplicably open to the other nucleosides (some of which have potentially more serious toxicities). Others will not use any nucleoside analog whatsoever but are famous for tying up community hotlines each time the words 'AIDS' and 'treatment' appear in a television newscast. No one should be faulted for having legitimate qualms about drug toxicities, or a legitimate interest in new research developments. But mainstream news sources rarely get a story straight, and someone who will not consider a reasoned treatment approach from their doctor is ill-prepared to interpret a patchwork story from an evening newsmagazine. The community-generated news media, where the stakes are more personal than mercantile, can be a more dependable source of HIV news, but can also display more subjectivity than objectivity. Some community news sources have allowed very irresponsible opinions to be set forth as newsworthy. These include the discredited idea that HIV is harmless, the claims that AZT is a prohibitively toxic drug with no redeeming benefit, and the advice that everyone can or should manage AIDS exclusively through non-medical therapies. There is a disingenuous approach to medical news throughout the larger culture that is fueled by a contemporary anti- science trend in America and that has unfortunately found some friends in HIV treatment circles. Mostly this trend just obstructs a presentation of the news in its entirety. But at its worst, anti-science thrives on promotions which tug selectively at people's cynicism: HIV is the product of a government plot and pharmaceutical drugs are an extension of this plot, or AIDS is simply an imbalance of oxygen or energy in the body, or the U.S. research establishment can't be trusted but a clinic in Switzerland or Kenya or Mexico has a cure. Promotions, or evasions, like these are not always mistruths so much as manipulated bits of the larger truth. Anti-science often shares company with the superstitions of right-wing ideology, including creationism, anti- environmentalism, and the demonization of homosexuals. All anti-science ideology endangers the fight against AIDS in one way or another. Not the least of these are the paranoias keeping some people from medical therapies that could extend the length and quality of their lives. * * * Running through all of these problems is the lack of a widely-accepted, coherent treatment strategy for HIV. Piece- meal management by conflicting agendas does not serve the AIDS community well. The problems above should be solved with long-term strategies that anticipate and not merely react to crises, strategies that are generated together by people with HIV and the health professions. ***** Gallo Starts Major AIDS Research Institute in Baltimore by John S. James Leading AIDS scientist Robert Gallo, M.D. is leaving government service after 30 years at the U.S. National Cancer Institute, to start the Institute of Human Virology, which will be part of the University of Maryland system. The new Institute will focus on AIDS, but will also do research in other human viral diseases, and in cancer. The Institute is being started with over $16 million in funding from the state of Maryland, the University of Maryland, the city of Baltimore, and other sources. It will begin operations this fall with a staff of 50; Dr. Gallo hopes it will eventually grow to have a staff of about 250 and an annual budget of $30 million. Dr. Gallo told AIDS TREATMENT NEWS that the Institute will focus on basic research, primarily to develop better therapies. Specific areas include gene therapy, antisense, looking for treatments which target cellular factors which do not mutate as rapidly as the virus (e.g. hydroxyurea), and hormonal control (e.g. HCG, the hormone found at high levels in pregnant women which may help to control Kaposi's sarcoma). Other research will involve manipulation of cytokines to treat HIV. An immediate goal is to "hit the ground running" with a focus on KS. Dr. Gallo noted the calls for virology research centers near rain forests, to watch for emerging viruses. He said we also need centers elsewhere which are immediately ready to study viruses which break through, as AIDS did. Dr. Gallo will be program director for basic research. He will share leadership with two other program directors, William Blattner, M.D., in epidemiology, and Robert Redfield, M.D. in clinical research. Dr. Gallo believes this is the first AIDS research institute to combine basic research, clinical research, and epidemiology -- which will allow, for example, the development of a cohort of well-studied patients who can volunteer for trials of new therapies which are particularly appropriate for them. Gallo also hopes to start a biotechnology company, to be called Virex, which will allow new discoveries to move immediately into drug development, without waiting until business executives elsewhere get interested. The Institute is also beginning collaborations with leading private and government research centers in the U.S., in Europe, and in Asia. It is setting up an ultra-modern telecommunications system, with the help of one of the founders of CSPAN. Dr. Gallo praised Parris N. Glendening, Governor of Maryland, whose brother died of AIDS last year. Governor Glendening, who formerly taught at the University of Maryland, has been personally involved in negotiations for the Institute for the last six months. Comment Dr. Gallo has been one of the most productive AIDS scientists. At the National Cancer Institute he was hampered by lack of a clinical partner, problems with technology transfer, government rules which are becoming increasingly burdensome despite activists' work, and repeated investigations resulting from years'-long demonization by the CHICAGO TRIBUNE and by the office of Congressman John Dingell (Democrat, Michigan). The new Institute should allow more effective focus on the task at hand of finding better treatments for AIDS. ***** Lymphoma: New TAG Report The Treatment Action Group (TAG) has published a 64-page booklet on the current status of AIDS-related lymphoma. THE LYMPHOMA PROJECT REPORT: CURRENT ISSUES IN RESEARCH AND TREATMENT OF AIDS-ASSOCIATED LYMPHOMA, by Michael Marco, with an introduction by Lawrence D. Kaplan, M.D., is based on interviews with dozens of experts. Lymphoma, of which there are several kinds, is a cancer of the lymphatic system which occurs in HIV-negative as well as HIV-positive persons; it is much more common in persons with immune deficiency (whether caused by HIV, by drugs to prevent rejection of organ transplants, or by other causes) than in the general population. Lymphoma occurs in about five to ten percent of persons with HIV, often after AIDS has been diagnosed (although it is the first AIDS-defining illness in about three percent of persons with AIDS). While it can occur at any CD4 (T-helper) count, the risk is greater when the count is low. However, the length of time one is HIV infected may be a more important risk factor than the degree of immune suppression; for this reason, the number of cases of lymphoma is increasing since people with HIV are now living longer than before. Unlike Kaposi's sarcoma, which occurs mainly in gay men, lymphoma occurs about equally in all HIV risk groups; for unknown reasons, white men are at a slightly higher risk than others. Sometimes lymphoma is found in a single rapidly-swelling lymph node; in other cases there is no specific sign, and the disease is difficult to diagnose. Lymphoma can be cured in many cases, with chemotherapy, radiation, or other treatments. But it still remains a major life-threatening condition, with many people living less than a year after diagnosis. The TAG booklet, first released May 1995 at the 31st Annual Meeting of the American Society of Clinical Oncology, looks at all aspects of AIDS-related lymphoma, including conventional and experimental treatments. It includes 23 recommendations, mainly for improving future research. The writing is fairly technical, about at a medical-student reading level. THE LYMPHOMA PROJECT REPORT is available for $10 from Treatment Action Group, 200 East 10th Street #601, New York, NY 10003. It is available free of charge to people living with HIV disease who cannot afford to pay: call TAG at 212/873-9044. ***** Chinese Medicine: Where Does It Work Best in HIV/AIDS? In San Francisco, where Chinese medical treatment has been funded for three years by the Ryan White CARE Act, the American College of Traditional Chinese Medicine has treated over 300 symptomatic HIV-positive patients in long-term care. A study of the medical records of these patients, and of quarterly health surveys, has identified seven HIV-related conditions which appear to be most responsive to Chinese medicine. These seven conditions are: weight loss; diarrhea/loose stools; abdominal pain; nausea; headaches; enlarged lymph nodes; and neuropathy. Note: The American College of Traditional and Chinese Medicine can be reached at 415/282-9603. Reimbursement Issues After many years of refusing to pay for "alternative" care such as traditional Chinese medicine, the trend today is toward coverage by insurers and other third-party payers. The reason is that alternative care usually costs much less than Western medicine, and companies can save money by paying for it. In San Francisco, acupuncture was covered under the health plan for city employees for several years, but was discontinued last year due to a budget shortage. It has now been restored effective July 1. But the San Francisco plan has only covered acupuncture; other parts of traditional Chinese medicine, such as herbal treatment, have had to be paid by the individual. There is now a movement to expand coverage for San Francisco employees, and for others; San Francisco supervisor Angela Alioto has been very supportive. The state of California has licensed acupuncturists for many years. (The law also allows medical doctors to practice acupuncture, regardless of whether they have been licensed or trained to do so.) California law requires health insurance companies which have their home office in California, and which are not HMOs or PPOs, to cover acupuncture treatment. Many of these companies, however, have ignored the law and refused to do so. For information on how you can help to expand health-care coverage for traditional Chinese medicine in San Francisco and in California, call George Wedemeyer at 415/661-2080. ***** 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 fax: 415/255-4659 Internet: aidsnews@igc.apc.org Editor and Publisher: John S. James Reader Services and Business: Richard Copeland Thom Fontaine Tadd Tobias 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 1995 by John S. James. 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