Subject: CMV Retinitis, Pigeonshit, Wasting Syndrome Date: Dec 16 1988 (812 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 #71, December 16, 1988. CONTENTS: [***** appears here at each new item] CMV Retinitis -- Ganciclovir, Foscarnet, and Other Treatments: Background, History, and Emerging Controversy CMV Retinitis -- Organizing Committee Contact Drug Trial Snafu: The Mandate for Ignorance San Francisco: Chinese Medicine Resources New York: Passive Immunotherapy Needs Donors Passive Immunotherapy Organizing Group: New Phone Number Tulsa, Oklahoma Buyers Club: New Phone Number Typhoid Shots: Project Inform Urges Caution Pigeon Health Hazard -- And Effective Repellent Next Issue January 13; Price Increase Coming on Back Issues Wasting Syndrome: Good Results with Prescription Drug ***** CMV Retinitis -- Ganciclovir, Foscarnet, and Other Treatments: Background, History, and Emerging Controversy by John S. James In the last two weeks we heard from two persons with CMV retinitis in immediate danger of going permanently blind because they have fallen between cracks in the red tape surrounding drug development and treatment access. Both had failed using ganci- clovir (also called DHPG), one of the two experimental but recog- nized treatments for CMV retinitis. But because they had used that drug, they are ineligible at this time for trials of the other recognized treatment, foscarnet. They were excluded not because of medical incompatibility, but because the researchers want clean data, unaffected by prior use of a different drug. (A "salvage" trial of foscarnet, for persons who cannot use ganci- clovir, will hopefully start by March, 1989.) For other serious diseases such as cancer, a system called compassionate has filled such gaps. But for reasons discussed below, a Federal consensus has recently developed that compas- sionate use of non-approved drugs should not be allowed except as part of scientific studies to determine whether or not the drugs work. While plausible in theory, this policy may cause severe problems in practice, problems which threaten not only the lives and health of patients, but continued progress in scientific drug research as well. We have heard that the manufacturer of foscarnet is getting five to six calls a day from physicians and patients seeking that drug because for medical reasons they cannot use the only other available treatment, ganciclovir. Because of the recent movement against compassionate use, these patients can seldom get foscar- net, either -- but for bureaucratic reasons, not medical. As a result, many of these people are now going blind. Behind this situation is a bizarre and complex history -- and it includes good news as well as bad. This history touches on some of the most central issues in U. S. drug development -- not only on what is wrong, but also on steps now being taken to improve the process. Exclusion from treatment for CMV retinitis could become a major, bitter, and confusing dispute. The people affected need to know what their options are. And they may need political sup- port; therefore the larger community must be informed. CMV Retinitis CMV retinitis is an infection of the retina of the eye by cytomegalovirus (CMV). The opportunistic infection causes blind- ness if left untreated. Because damage can occur very rapidly, persons with AIDS should see a physician immediately if they notice blind spots, blurred vision, or loss of peripheral vision. Sometimes there are no symptoms, and the disease is discovered during a routine eye examination. While it has not yet been documented, experts strongly suspect that the risk is much greater for persons with fewer than 50 T-helper cells. Since 15 to 45 percent of persons with AIDS will eventually develop CMV retinitis (according to a press release from Syntex Corporation, which has the most experience in treating this condition), such persons would probably benefit from a screening for the disease, or from routine eye check-ups from a private physician. Apparently CMV retinitis is becoming a larger problem because persons with AIDS are living longer. CMV can also affect other organs besides the retina of the eye, such as the intestines or the lungs. It may also be a cofactor causing HIV itself to progress further. One study of autopsy reports found that half of the persons with AIDS who died had active CMV infections unsuspected while they were alive (see AIDS Treatment News #65, September 23, 1988). The same treatments used for retinitis may also be effective for treating CMV infections elsewhere. A program for distribu- tion of the drug ganciclovir (see below) intends to allow anyone with life-threatening CMV to obtain the drug, even if they do not have retinitis. For more information, call the ganciclovir study center (phone number below). Ganciclovir (DHPG) During the past three years, over three thousand persons with CMV retinitis have been treated with ganciclovir, which stops the progression of the disease and usually saves the person's remaining eyesight. Unfortunately ganciclovir has side effects, especially bone-marrow toxicity; therefore it usually cannot be combined with AZT, which has similar toxicity. Patients have often had to give up AZT in order to use ganciclo- vir to save their sight. Also, ganciclovir must be given intravenously. Ganciclovir has not been approved by the FDA. But its developer, Syntex Corporation of Palo Alto, CA., has made the drug available for several years through compassionate use at no charge to the patient, at a cost to the company of over 25 mil- lion dollars, mostly in research and development expenses. Unfortunately the widespread availability to ganciclovir by compassionate use led to a bureaucratic nightmare involving the manufacturer and the FDA. Everybody knew that the drug worked, but the only way to "prove" under the regulations that it did work would involve a trial in which patients were deliberately allowed to go blind, which everyone agreed was unethical. FDA rules insist that a drug must be shown to work through formal scientific trials. But Syntex could not ethically run such a study It would be bad enough if a drug could not be approved in spite of the fact that it was known to work. But this situation was even worse. Ganciclovir could not be tested and approved because it was known to work. This knowledge itself meant that complying with the regulations necessary for approval would be universally recognized as unethical. In an attempt to end this impasse, Syntex presented pub- lished articles and reports of thousands of cases to the FDA, asking for an exception in this case because it was so obvious that the drug was effective. But over a year ago, on October 26, 1987, an FDA advisory committee shocked the medical community by recommending against approval (see "DHPG Blindness Drug Threatened", AIDS Treatment News #44, November 6, 1987). Despite fears that the company might then abandon the drug, it continued to make it available for compassionate use, while working with the FDA and the National Institutes of Health (NIH) on what to do next. But meanwhile, all other compassionate access to AIDS drugs became much more difficult, if not impossi- ble. Companies were determined that what happened to Syntex would not happen to them. It is clear that many deaths have resulted from this side effect of the ganciclovir rejection; but it is difficult to address this fact politically because it would be difficult to prove which ones. Physicians seldom ask for access to a drug if they know they not get it. So in most cases no record of the rejection, and no audit trail of the public pol- icy behind it, is ever made. It is clear that the FDA feared that approving the drug without the scientific trials normally required would set a pre- cedent of allowing companies to do an end run around the regular process of drug approval, by means of widespread compassionate use and the resulting political pressure. The FDA was determined that Syntex would not get away with this, would not receive approval without doing a trial. (The thousands of cases recorded under compassionate use did not constitute a formal trial, because these cases occurred as physicians treated patients, not according to a randomized protocol designed in advance by scien- tists to exclude potential errors such as biases in patient selection, or poor record keeping.) So the impasse remained. In jurisprudence there is a saying that hard cases make bad law. In the case of ganciclovir, a public-policy stampede against compassionate use was triggered by an unusual situation. Scientifically designed trials are not only the right way to prove drug efficacy, they are usually the cheapest way too, because uncontrolled use requires far more patients to get con- vincing information. There should be no need to abolish compas- sionate use in order to force companies to do proper trials, because they have an economic incentive to proceed that way any- way. But when ganciclovir was first discovered, Syntex and Burroughs-Wellcome were engaged in litigation over rights to the drug; Syntex eventually won. It appears that the companies were unwilling to invest in trials because they did not know whether or not they would have the rights to the drug. But Syntex made ganciclovir available by compassionate use, to a few patients at first. Once it was clear that the drug did work, the company was stuck. The FDA refused to accept the drug without scientific clinical trials, and the company was ethically barred from conducting the trials required. Oral Ganciclovir Ganciclovir is always given by intravenous infusion, usually requiring daily visits to a medical center. An oral form has been created, however, and a successful but very preliminary human test was published over a year ago (Jacobson MA and others, Human pharmacokinetics and tolerance of oral ganciclovir, Antimi- crobial Agents and Chemotherapy, volume 31 number 8, pages 1251- 1254, August 1987.) As far as we know, no further testing has been done. Syntex has applied to the FDA for an IND for permission to test oral ganciclovir. That IND is pending. Syntex will not make public when it first applied, but many months ago we had heard that a proposed trial of oral ganciclovir could not get an IND and therefore would not take place. An aerosol form of ganciclovir has also been tested, and found effective against CMV lung infection in an experiment in animals. (Debs RJ, Montgomery AB, and others. Aerosol adminis- tration of antiviral agents to treat lung infection due to murine cytomegalovirus, The Journal of Infectious Diseases, volume 157 number 2, pages 327-331, February 1988). The New Treatment IND and Clinical Trial Recently a new attempt to resolve the problem was announced by the National Institute of Allergy and Infectious Diseases (NIAID, a branch of the NIH), the FDA, and Syntex Corporation. Under the plan, which will replace the compassionate use system in effect until now, everybody who has already been using ganciclovir will be allowed to continue receiving it. New patients will be examined by an ophthalmologist to determine whether the CMV lesions are near the center of the field of vision and therefore immediately sight threatening. Those with immediately sight-threatening disease will be allowed to receive ganciclovir under a system called the "treatment IND", new rules for earlier access to experimental drugs approved in mid-1987 but seldom put into effect since then ("IND" stands for "investiga- tional new drug"). Those with CMV retinitis which is not sight threatening will instead be directed to a controlled clinical trial. No placebo will be used, but patients will be randomly assigned either to receive immediate treatment, or to receive later treatment if there are signs of deterioration (allowing them to remain on AZT longer if appropriate). Among persons with AIDS and physicians we have heard from, this plan has been greeted with mixed feelings. On the negative side, it reduces treatment options for those with less serious disease. We have also heard medical questioning of specifics of the study design. The overall plan (the treatment IND combined with the clini- cal trial) may be a brilliant and partly successful effort to find a medical reason for a study really being done for regulatory-political purposes. The ostensible question is whether it is better to start ganciclovir immediately or wait in cases of non-sight-threatening disease; but what the study is really trying to prove is that Syntex and other manufacturers cannot get away with substituting compassionate use for clinical trials. Yet despite these negatives, we see the new ganciclovir plan as possibly a watershed advance, moving toward a new compromise and consensus on how to reconcile the scientific requirements of good studies with the needs of patients and their physicians. (1) In the past, clinical trials usually required eligible patients to stop other treatments and then risk getting a pla- cebo. And persons who did not meet the scientific entry criteria for the study were simply abandoned. By contrast, this plan for ganciclovir serves everyone who needs the drug -- and takes patients' needs into account. (2) In the past, trials of AIDS treatments typically used death, pneumocystis, or other severe deterioration as "endpoints" of the study. Patients have often been subjected to bad medical management -- such as being required to stop aerosol pentamidine -- in order to make these endpoints more likely for the placebo arm, increasing the power of the trial to tell whether the drug worked better than no drug. But here, the patients not given ganciclovir will receive "very close monitoring for clinical deterioration", according to an FDA press release announcing the new ganciclovir treatment IND and clinical trial -- presumably to take them out of the study and give them the drug before serious damage is done. (3) The ganciclovir plan sheds light on what we believe is a hidden but awesomely important impediment to the overall success of clinical trials, as well as to compassionate treatment access by patients. We call this problem the "mandate for ignorance" which follows from certain ethical requirements on placebo- controlled or other randomized trials, as they are now designed. (See "Drug Trials: A Mandate for Ignorance", below.) For More Information on Ganciclovir For information about entering the ganciclovir program, phy- sicians and patients can call the Ganciclovir Study Center, 301/497-9888. There is no charge to patients, as costs are paid by Syntex Corporation. Foscarnet Foscarnet, often used in Europe as a first choice for treat- ing CMV retinitis because it does not require that the patient stop using AZT, may also have some effectiveness against HIV. Its manufacturer, the Swedish company Astra, had intended to test the drug as an AIDS treatment in the U. S. But according to an edi- torial in The Wall Street Journal (April 21, 1987), Astra left those trials due to frustration with bureaucratic obstacles to AIDS research in the U. S. Foscarnet, like ganciclovir, must be given intravenously. It does not cause bone-marrow toxicity like ganciclovir. But it can cause kidney toxicity, which may be reduced by giving the patients enough water, sometimes by intravenous infusion. Published reports of European experience in using foscarnet for CMV retinitis are mixed. It seems clear that the drug does stop the disease during a high-dose "induction" phase of the treatment. But patients are then put on a lower "maintenance" dose, and relapses during this maintenance phase have often been reported. According to information from the National Eye Insti- tute, a branch of NIH, a 70-85 percent rate of favorable response has been reported. NIH is now running two different studies of foscarnet. One, by the National Eye Institute, was reported in AIDS Treatment News November 4, 1988. This study requires trips to Bethesda, MD, near Washington, DC, but all expenses are paid. The other NIH study is a multi-centered trial taking place in San Francisco, New York, and Los Angeles. In San Francisco (and probably the other locations also), these studies are recruiting patients now who have not been treated with ganciclo- vir or foscarnet before. The main advantage of foscarnet over ganciclovir is that patients can continue using AZT; foscarnet is also believed to have some anti-HIV activity. Patients in the San Francisco area interested in enrolling in this study can call the protocol coordinator at 821-5139. Both these trials are excluding patients who have previously used ganciclovir. NIH does plan to start a multi-center "sal- vage" protocol for such patients, hopefully early next year. Meanwhile, for patients who have failed ganciclovir the only access to foscarnet at this time is in Houston, TX; patients must pay their own travel, lodging, and hospitalization expenses, unless their insurance will cover part of the cost. One other group of patients may also be left out -- those who are using ganciclovir successfully, but should be on foscar- net instead so that they could use AZT. We brought this potential problem to the attention of the group designing the protocol. For those who fall between the cracks, compassionate use of foscarnet should be available. But the FDA recently led the charge against such access. NIAID is trying to devise plans which can include everyone. When all goes well, these plans may do their job. But when things go wrong and studies are delayed, the current policy against compassionate use makes the patients pay. It seems clear that foscarnet is not a miracle drug, although it will probably have an important role in treatment. European physicians are using it to treat CMV retinitis, often as first choice over ganciclovir. When nothing else works, U. S. patients and physicians should have the option of using it. Other Treatment Possibilities Besides ganciclovir and foscarnet, other possible treatments have been suggested. We have not been able to research these fully by press time. Acyclovir. This drug may have some effect. NIH plans to study a combination of acyclovir and AZT to treat CMV retinitis. Anti-CMV antibodies. Passive immunotherapy using donors with high CMV antibody levels was described as producing con- flicting results for CMV disease (Reed, H. C. and Meyers, J. D., Treatment of Cytomegalovirus Infection, Clin. Lab. Med. (USA), volume 7 number 4, pages 831-852, 1987). But several European articles describe the use of 'Cytotect' from Biotest Pharma, a product containing CMV-specific hyperimmune globulin, for preven- tion or treatment of CMV. The option of using this treatment should be available to U. S. physicians. (S)-HPMPA or (S)-HPMPC. These new drugs are highly active against CMV in the test tube. We do not know of any human use. For background, see De Clercq E and others, A novel selective broad-spectrum anti-DNA virus agent, Nature, volume 323 number 2, pages 464-469, October 1986. Or see De Clercq E and others, Antiviral activity of phosphonylmethoxyalkyl derivatives of purine and pyrimidines, Antiviral Research number 8, pages 261- 272, 1987. BHT. Over two years ago, AIDS Treatment News reported interest in BHT as a possible anti-AIDS treatment (issue number 10, August 15, 1986). BHT, used in small amounts as a food preservative, has been an underground herpes treatment used by hundreds of people during the last several years; one clinical trial found some effectiveness in treating herpes in humans. One laboratory report found that BHT was highly effective against CMV in the laboratory (Kim KS and others, Inactivation of cytomegalo- virus and semliki forest virus by butylated hydroxytoluene, The Journal of Infectious Diseases, volume 138 number 1, page 91-94, July 1978). BHT must be used carefully, because large doses are toxic. Even lower doses involve some risk. Letters in medical journals have reported several cases of toxicity, especially gastrointes- tinal problems, from doses commonly used to treat herpes. We have not systematically researched BHT since writing the August 1986 article. But recently we talked to a person with AIDS in San Francisco, who has used BHT as his only treatment for CMV retinitis, and is convinced that it did slow although not stop the progression of the disease. This patient started using BHT in 1986 or early 1987. In January 1988 he stopped temporarily, for about six weeks, follow- ing a doctor's advice; during this period without BHT he developed CMV retinitis, which "started galloping"; he saw new blind spots daily. He went back on BHT, using a very large dose for about six weeks, four grams per day dissolved in oil and taken rectally; he reported an instant "high" from the mental effect of this dose. After six weeks, he went back to smaller doses, about two grams per day used orally (still a large dose). In the eight months since, there has been slow deterioration of vision; he can still read, but with difficulty. While this per- son is convinced that BHT has worked partially for him, and would not dare discontinue it again, he also emphasizes that there is no proof that it has helped. AIDS Treatment News is preparing an information packet on BHT. For a copy, send a self-addressed stamped envelope to: AIDS Treatment News, P. O. Box 411256, San Francisco, CA 94141; be sure to mention BHT. Toward a Way Out Recently a top FDA official suggested an idea for reconcil- ing the need for scientific, rigorous studies with the need of patients for access to treatments. The approach is to have a small, tightly controlled scien- tific trials with rigorous entry criteria. But in addition, as a condition for approval to conduct a study, the company would also make the drug available on a compassionate basis or "treatment IND" to other patients who needed it -- with careful monitoring and reporting, both to enhance patients' safety and also to col- lect more information about the drug. What we like about this proposal, which is similar to what is already being started with ganciclovir, is that everyone receives treatment, no one is abandoned. (Placebo studies are now becoming less common, with controlled trials usually compar- ing one treatment option against another, not against no treat- ment. It is true that controlled studies reduce the patient's power to choose, since for scientific reasons patients must be assigned at random to the different treatment groups. If there are not enough volunteers, a lottery might be necessary to decide who goes into the controlled trial, and who receives treatment through the compassionate-access, monitoring study.) This approach will not solve all the problems. But it may allow researchers to conduct tightly controlled studies without sacrificing vital interests of any patients, whether in the study or not. It would certainly improve on the present system, in which treatment is denied in order to force patients into ill- designed trials, with those who don't qualify being abandoned. ***** CMV Retinitis: Organizing Committee Contact Anyone interested in a political action and patient support group to make treatment for CMV retinitis more available can call Terry Sutton in San Francisco, 415/621-7996, before 10 PM Pacific time. ***** Drug Trial Snafu: The Mandate for Ignorance We use the term "mandate for ignorance" to refer to a hidden but, we believe, enormously important problem in the effective management of clinical trials. It is widely agreed that a placebo trial (or any other drug trial in which patients are assigned at random to two or more treatment possibilities) is unethical unless the researchers can state an honest "null hypothesis" -- that is, unless they really do not know which of the treatment arms is better. For example, a placebo trial is unethical if the researchers know that the drug works better than no treatment. But if they do not know, then the study is OK, and they are free to proceed with it. This ethical standard is obviously intended to safeguard the welfare of patients who become subjects in experimental trials. The idea is that subjects should not have to risk a placebo unless nobody knows whether the drug or placebo is better. But the ganciclovir history shows that this well-meaning ethical standard also has monstrous consequences, because it puts a prem- ium on ignorance. Why have drug companies become so adamant about refusing compassionate access to AIDS treatments, access commonly avail- able for cancer or other diseases? One reason is to force patients into placebo trials -- trials often so poorly designed and poorly publicized that few would enter them voluntarily. But another reason is that drug companies must remain ignorant of how well their own products work, lest that knowledge ethically bar them from conducting the very trials which the FDA requires for approval! This catch-22 is exactly what happened to Syntex with ganci- clovir. And it has terrified other companies into denying com- passionate use, and thereby refusing to learn how to use new their drugs effectively except as the result of cumbersome, years-long formal trials. What should Syntex have done with ganciclovir? Everyone seems to agree that the company should have run placebo trials early -- in what is being called "the window of opportunity" to conduct clinical trials -- before the public or even the researchers know whether the drug works or not. In other words, the trial must be run before compassionate use -- lest the knowledge that the drug does work make it impossible to run the trials. But in practice, trials have usually taken years to set up and conduct. Therefore, compassionate use must be denied for those years. This mandate for ignorance not only denies compassionate access to patients; it also saps the vitality of the entire clinical-research enterprise. It requires that companies not know that their drug works until after they run formal trials -- not before. But companies have little motivation to invest money in trials unless they believe that the drug does work -- the same belief that would make those trials unethical. So nothing hap- pens. One consequence is that drug companies refuse to cooperate when physicians want to test new uses for products in develop- ment. Besides other problems such as fear of liability if things go wrong, the company could lose its window of opportunity if things go right. Therefore the mandate for ignorance not only destroys the commercial incentive to run trials, it also forbids the normal exploratory phase of science -- which here would be physicians trying experimental drugs in compassionate, well-supported attempts to treat patients. As a result, clinical trials must be designed in a vacuum -- based on whatever theories are fashion- able, rather than on exploratory experience of what actually does work in practice. The result is irrelevant, indecisive, and ultimately ineffectual clinical trials, when they happen at all. In a recent editorial in the Journal of the American Medical Association, a former head of the FDA urged a re-examination of "all of the assumptions on which the scientific requirements of the present system (of drug approvals) are based" (November 25, 1988; see also The New York Times, Medical Science section, December 6, 1988.) We hope that this mandate for ignorance will be among the issues addressed. ***** San Francisco: Chinese Medicine Resources In AIDS Treatment News #68 (November 4, 1988), we described work at the Quan Yin Acupuncture and Herb Center, and the San Francisco AIDS Alternative Healing Project. Another important San Francisco resource on Chinese medicine is the American Foun- dation of Traditional Chinese Medicine (AFTCM), a non-profit foundation. AFTCM founder Barbara Bernie, C. A., has worked with Chinese medicine since 1972. She contributed to the successful effort to pass California legislation which since 1975 has allowed acupunc- turists to be licensed and practice openly in the state. She has made many trips to Asia and Europe to meet experts in the field of traditional Chinese medicine. AIDS Projects Herb study with San Francisco General Hospital. AFTCM introduced a highly experienced Chinese physician, Dr. George Zhao, to Donald Abrams, M. D., Assistant Director of the AIDS Division at San Francisco General Hospital, to design a scien- tific study of Chinese herbal medicine for persons with moderately severe AIDS. 40 patients will be enrolled, 20 using herbs and 20 being controls, with evaluation and crossover at 12 weeks. Unfortunately this study will cost over $200,000 and only $30,000 has been raised so far. If you can help with fundrais- ing, contact Barbara Bernie at the phone number below. Qi Gong classes starting in January. Qi Gong is an ancient system of breathing exercises -- over one thousand exercises in all. It is the root of tai chi, and of many martial arts. AFTCM will teach classes in medical Qi Gong starting in January; morn- ing and evening sessions will be available. For information, call AFTCM at the number below. Other services. AFTCM publishes a newsletter, distributed on a donation basis. It is translating Chinese medical books not previously available in English; two have been translated and published already. It sponsors lectures and other public pro- grams, announced through its mailing list. AFTCM is bringing together traditional Chinese physicians practicing in the United States with experience in treating AIDS. It plans to offer an AIDS treatment program, and also advanced classes for practitioners, but these are not ready yet. AFTCM maintains extensive contacts with experts in China, Taiwan, Korea, Japan, and other countries. It hopes to become an international center for medical practitioners, and for persons interested in improving health care around the world. For more information, call Barbara Bernie at 415/956-3030. Or write to the American Foundation of Traditional Chinese Medi- cine, 2390-A Powell St., San Francisco, CA 94133. ***** New York: Passive Immunotherapy Needs Donors Nathaniel Pier, M. D., a New York physician who has been interviewed in AIDS Treatment News, called to tell us about a study of passive immunotherapy in New York. This important study needs to collect 2,000 liters of plasma -- enough to treat 100 persons for a year -- and will use the plasma for treatment. Volunteers must be HIV positive, but should be generally healthy. They will be screened by a health questionnaire and by blood tests. Plasma donors will not be paid, but will have high priority to receive the treatment, if they should later need it. Also, it is widely believed that the process of donating plasma is itself beneficial to some persons with HIV. If you are a potential donor in the New York area and want to help with this study, call Medicorp at 212/674-4680. ***** Passive Immunotherapy Organizing Group: New Phone Number The San Francisco area patient support group which is organ- izing for access to immunotherapy (see AIDS Treatment News issues #67 and #70, October 21 and December 1, 1988) can now be reached by leaving a message for Gary, at 415/549-9137. ***** Tulsa, Oklahoma Buyers Club: New Phone Number The 800 number for Nutrico, published in AIDS Treatment News #69, November 18, 1988, is being disconnected -- and there is no referral. The group's original number, 918/749-9777, remains valid. ***** Typhoid Shots: Project Inform Urges Caution The use of typhoid injections as an AIDS treatment is being aggressively promoted in the media. Many physicians are con- cerned that general immune stimulation might also stimulate the growth of HIV and cause AIDS to progress faster; but many of the typhoid-shot advocates believe that AIDS is really syphilis and HIV doesn't matter. Most of the information available about the typhoid treat- ment has come from its advocates. Many people are using or con- sidering using the treatment; they should be able to hear from different perspectives, not only from the advocates. Recently Project Inform, a San Francisco organization which for several years has provided information about non-approved treatments, wrote to Spin, a music magazine which had carried a highly favorable article about the typhoid-shot treatment. Pro- ject Inform's three-page letter included detailed criticisms of the AIDS-is-syphilis theories and of the claims for the typhoid injections. The letter also noted that Project Inform had heard from many patients treated with typhoid shots, and that most of them had reported negatively, saying that their bloodwork continued to decline. You can obtain a copy of the letter from Project Inform, 415/558-9051, or 800/334-7422 from California, 800/822-7422 from other states. A stronger negative comment about typhoid-vaccine shots recommended by researchers who think that syphilis not HIV causes AIDS -- "I think (they're) quacks -- and don't know the first thing about AIDS" -- came from Barry Gingell, M. D., a physician who has AIDS and who edits Treatment Issues, an AIDS treatment newsletter distributed without charge by the Gay Men's Health Crisis (GMHC) in New York. Dr. Gingell was quoted in an article published in 7 Days, November 23, 1988. For the case for the typhoid-injection treatment, send a self-addressed stamped envelope to: Michael Smith, 279 Colling- wood, San Francisco, CA 94114. We believe that the best way to resolve the issue is to find out how people are doing who started the typhoid injections a year or more ago. There was a flurry of interest at that time, especially on Long Island. A telephone survey could find out how these people are doing -- how many are still alive, whether they have continued the treatment, and what they think about it a year after starting. Such a study could determine long-term results quickly, with little expense. ***** Pigeon Health Hazard -- and an Effective Repellent Bird droppings, a breeding ground for disease-causing fungi and other organisms, can be a health hazard especially to persons with immune deficiencies. In San Francisco, pigeon droppings have become a growing public concern. Many people do not know that there is a simple, effective repellent to keep pigeons from lighting on window sills, etc. The Healing Alternatives Foundation in San Francisco had a problem with pigeon droppings, and learned from a contractor about a product called "Bird Tanglefoot", a sticky substance which birds avoid. For the Healing Alternatives building it has been close to 100 percent effective. The product costs a few dollars in hardware stores, and an application should last for about a year. If you cannot find this bird repellent locally, you could call The Tanglefoot Co., in Grand Rapids, MI. ***** Next Issue January 13; Price Increase Coming on Back Issues AIDS Treatment News will not publish a December 30 issue; the next issue will appear January 13. All subscriptions will be extended so that subscribers will receive the expected number of copies. We need time off for year-end catch-up. Also, we will raise the prices of complete back issues by 50 percent, effective January 15, to $18.00 for persons with AIDS or ARC, and $75.00 professional; you can still order now at the old price. The current prices were set for 50 back issues, and we are now approaching 75. The PWA/ARC rate was computed to cover the incremental printing and mailing cost of sending 50 issues, with nothing left over for research or overhead, and we have lost considerable money filling these orders. We plan to lower costs later by selling a Highlights edi- tion, which most people would want instead of the complete back issues. But this edition will not be ready for several months, and we could not maintain the back-issue prices for so long. The rate for subscriptions to AIDS Treatment News will remain the same. ***** Wasting Syndrome: Good Results with Prescription Drug Megace (megestrol acetate), a readily available drug usually used to treat advanced breast cancer in women, showed good results in treating wasting syndrome (cachexia) in every one of 14 persons with HIV (13 of whom had AIDS) reported in an article published last month. (Von Roenn JH and others, Megestrol ace- tate for treatment of cachexia associated with human immunodefi- ciency virus (HIV) infection, Annals of Internal Medicine, pages 840-841, November 15, 1988.) The patients selected for the study were all HIV positive, and had all lost at least 10 percent of their body weight and were losing weight when they began the treatment. All patients gained weight on the treatment, at an average rate of .5 kg per week. All reported improved appetite, and seven also reported a marked improvement in sense of well-being. No side effects were noted. However, four patients have died from recurrent oppor- tunistic infections. In San Francisco, the County Community Consortium plans to begin a trial of megace in January. Any physician in the San Francisco area can participate in this trial. Physicians can of course also prescribe the drug on their own. For more information about the Consortium trial, physicians can call principal investigator Jim Kahn, M. D., or clinical tri- als coordinator Carroll Child, R. N. Both can be reached through the AIDS Activities office of San Francisco General Hospital, 415/821-5531. ***** [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display