Subject: AIDS Treatment News #99 Date: Mar 21 1990 (1073 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1990 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue # 99, March 16, 1990 CONTENTS: [items are separated by "*****" for this display] ddI Risks: Perspective and Precautions Compound Q: New Project Inform Community Research Alliance Study KS News and Confusion People of Color Confront HIV, Health System Grassroots Lobbying and Organizing Opportunities Announcements: New San Francisco trials directory; Cryptococcal meningitis study; Cryptosporidiosis studies; Research associate help wanted News Notes: Incubation period now 11 years; Blue-green algae production; MEK test; World Program on AIDS; California Office of AIDS ***** DDI RISKS: PERSPECTIVE AND PRECAUTIONS by John S. James Recently there has been much publicity about the risks of using the experimental AIDS treatment ddI. Some of the reporting has been misleading and unnecessarily frightening. But some risks are real, and experts recommend simple precautions that anyone using ddI should begin immediately. Background ddI is an antiviral in the same general class as AZT. It may be about equally effective, although no one knows for sure until trials are completed. There is much interest in ddI, not because it is believed to be better than AZT, but because the toxicities of the drugs are different, and also because ddI may work even after AZT has become less effective, as it does for some patients after a year or two of use. ddI is important because it provides another therapeutic option, with its own profile of risks and benefits. Three major clinical trials (named ACTG 116, ACTG 117, and ACTG 118) are now testing ddI. In addition to these formal trials, Bristol-Myers, the company developing the drug, has made it available without charge through an expanded access programs to patients who cannot enter the formal trials and cannot use AZT -- persons with no other treatment options. At this time, about 700 people are in the formal trials, and about 8,000 additional people are receiving the drug through the expanded access program. On March 4-7, hundreds of AIDS researchers from around the country met near Washington, DC, at a conference of the AIDS Clinical Trials Group (ACTG). This quarterly meeting is closed to the press and the public, but important news gets out. At this meeting, physicians heard the latest safety reports on the ddI trials and expanded access program, and exchanged information about their own experience with the drug. They learned that at least one patient in the formal trials and six in the expanded access program have died of pancreatitis, believed to have been caused by ddI. This death rate is about one in a thousand for both programs. (Over 30 non-fatal cases of pancreatitis have also been reported.) The total deaths from all causes (including the pancreatitis) is 2 of the 700 in the formal trials, and 290 of the 8,000 in the expanded-access program. While the data has just begun to be analyzed, this difference in death rates between the formal trials and the expanded-access program is almost certainly caused by the fact that many of the patients receiving the drug through expanded access were more seriously ill. Patients selected for trials are usually well enough to be expected to survive the trial, whereas many enter the expanded- access program as a last resort. There is no evidence that ddI contributed to these deaths (other than those caused by pancreatitis), and no reason to believe that receiving the drug was any more risky in the expanded-access program than in the trials. The safety monitoring is similar in both programs. Researchers suspect that ddI did contribute to the pancreatitis deaths, because the very severe and rapidly developing pancreatitis had not previously been expected with AIDS. Other drugs or diseases may also have contributed; intravenous pentamidine, for example, can also cause pancreatitis. All data from these cases will be analyzed to determine (1) if there is a dose-response relationship, with those receiving more drug per body weight at greater risk, and (2) if any cofactors, such as other drugs, were present more often in those patients who did get pancreatitis than in those who did not. If the answer to either question is yes, then ddI could be used more safely by adjusting the dose, or by stopping or not using the drug if any dangerous cofactor is present. The much larger number of deaths from other causes will also be investigated, especially to see whether ddI may have contributed to any of them. Precautions The FDA has asked Bristol-Myers to write to all physicians who are using ddI, to inform them of recommended precautions. Meanwhile, the Los Angeles Times quoted Robert Yarchoan, of the U. S. National Cancer Institute, on precautions patients should take now. Dr. Yarchoan has run the longest clinical trial of ddI, at the National Cancer Institute, and is probably the world expert on use of the drug. "Patients receiving ddI who develop abdominal pain [which can be the first symptom of pancreatitis] should probably stop the drug immediately and consult their physicians as soon as possible. They should also not drink alcohol, and their physicians should try to avoid prescribing medications that might cause pancreatitis." (Dr. Yarchoan, quoted in the Los Angeles Times, March 10, 1990.) Other experts have noted that anyone on ddI who develops pneumocystis and must be treated with intravenous pentamidine should stop using ddI while on the pentamidine. A major problem in treating the pancreatitis believed to be caused by ddI is that it can progress so rapidly that it is difficult to diagnose in time. Other researchers have recently made progress in diagnosing serious pancreatitis, for example by testing for trypsinogen activated peptide in the urine. We do not know if this test is yet available, or if it would be useful in the ddI trials or expanded-access program. Perspective Before the above information about the risk of ddI was available, AIDS TREATMENT NEWS had heard both good and bad reports about the drug, but mostly good. ddI seems to have made a dramatic difference for many people; we suspect that many who are now alive would not be without it. We had also heard of a number of cases where people had to stop using this drug because of side effects. Dr. Yarchoan told The Wall Street Journal (issue of March 12) that it was "absolutely necessary to go forward with phase 2, or effectiveness studies," the formal clinical trials mentioned above. "Only then can you put the toxicity in the context of benefits and go on." Drug-development experts consider this finding of toxicity with ddI not at all unusual, except for the fact that this drug trial is being conducted in a fishbowl of public attention. Initial studies gave the drug to only a few dozen people. Problems which rarely occur would not be likely to show up until later trials, when more patients are receiving the drug. News of the deaths in the ddI program was published in the Los Angeles Times on March 10, and in The New York Times, The Wall Street Journal, and the Washington Post on March 12. These four newspapers are especially important, because most of the press follows their lead in selecting and framing the news. The coverage in The New York Times was more negative and alarming than that in the other three, and it has been widely criticized. Later articles, in The Wall Street Journal on March 13, and The New York Times on March 19 put the risks in better perspective. Despite the new information about the risks of ddI, we still consider ddI to be one of the most important new treatment possibilities. It would be tragic to lose this drug -- or to lose the concept of parallel track or early access to treatment -- due to hasty decisions not based on careful assessment of all the facts. Note: the related drug ddC has not been found to cause pancreatitis. ***** COMPOUND Q: NEW PROJECT INFORM COMMUNITY RESEARCH ALLIANCE STUDY By John S. James On March 8 the U. S. Food and Drug Administration approved a re-treatment study of compound Q (also called GLQ223, or trichosanthin), to be administered by the Project Inform Community Research Alliance and conducted by physicians in four cities: San Francisco, Los Angeles, Miami, and New York. This trial is for patients who have been treated with the drug previously. One hundred volunteers will be randomized into two groups, one to receive compound Q every three weeks, the other every six weeks, for up to six months. The dose will be 16 mcg/kg per administration. Unlike most clinical trials today, this one will allow patients to continue using other medications considered important for their health -- both for ethical reasons, and to obtain information about use of the drug under realistic conditions, not in a highly restricted test environment. This study, for example, will be the first to obtain practical knowledge about the combined use of compound Q and AZT. A third group of patients, who meet the identical entry criteria (including previous use of compound Q) but do not choose to continue treatment at this time, can volunteer for a self- selected no-treatment group, which will also be followed under the protocol. (Note: as we go to press, the Institutional Review Board is still reviewing the study; there could be changes in the above design.) The study director is Larry Waites, M. D., M. P. H., of San Francisco; the four principal investigators are Lysette Cardona, M. D., M. P. H., Los Angeles; Barbara Starrett, M. D., New York; Paula Sparti, M. D., Miami; and Alan S. Levin, M. D., San Francisco. Others, including Vera Byers, M. D., Ph.D., an expert in protein drugs, also contributed to the study design. The trial is financed in part by a grant of $250,000 from Sandoz, U. S. A.; some community fundraising will also be necessary, as Project Inform and the local sites will have to absorb part of the cost. The drug is being contributed by Genelabs Inc., the biotechnology company in Redwood City, California, which developed the U. S. version of compound Q. Comment This study will not by itself be enough to lead to FDA approval of compound Q; other studies are now being run or designed by other researchers. The Project Inform Community Research Alliance study does, however, serve the following purposes: * Many patients who have already used compound Q want to continue their treatment, and would do so with or without this program. The formal study provides the treatment without charge. At the same time, it collects systematic data which otherwise would be lost. * Scientists usually want data from "randomized" trials -- that is, those which assign patients at random to two or more different treatment groups, which are later compared. Without randomization, it is impossible to be sure that all biases due to self-selection are accounted for, or even known. But randomization raises ethical concerns, as patients and their physicians often have good reason to choose one treatment or another, based on specifics of the individual case which are often not accounted for in the study design. This trial provides a compromise. Volunteers who want to continue using the drug will be randomized between receiving treatment every three weeks or every six weeks. But the study designers could not have asked these volunteers, who had used compound Q before and had a very good idea of whether or not they wanted to continue, to be randomized between treatment and no treatment. Having a self-selected no-treatment group is better than having none at all. Not only will it allow an admittedly imperfect comparison with the treatment groups, it will also provide systematic monitoring of long-term results of the compound Q which these volunteers had taken previously. And it will keep faith with those who volunteered for the original Project Inform compound Q study, by providing extensive monitoring free to them even if they do not want to continue the treatment. * This study will not by itself lead to FDA approval, because it does not address the question of whether treatment or no treatment is best for patients who have never taken the drug before. But it will provide information on use of compound Q in real-world conditions -- unlike academic studies, which test drugs under conditions which seldom correspond to how patients are actually treated. For example, this study will allow volunteers to also use AZT, other antivirals, immune modulators, or other treatments which they and their physicians believe they should use. Therefore, it will provide information on the use of compound Q in combination with AZT. For more information about this study, call the Project Inform hotline at 415/558-9051 (or toll-free at 800/334-7422 from within California, or 800/822-7422 from other states). Note: The re-treatment study described in this article is only open to patients who have already been treated with compound Q. A separate study of the drug is taking place at other locations in California. For more information about that study, call the clinical trials referral hotline operated by the U. S. National Institute of Allergy and Infectious Diseases, toll-free at 800/TRIALS-A. ***** KS NEWS AND CONFUSION By John S. James Several different news reports on Kaposi's sarcoma (KS) may have much long-term importance. Unfortunately they have little immediate relevance to treatment -- and they have caused some confusion. New Treatment in Japan? On February 22 Robert Gallo, M. D., of the U. S. National Cancer Institute, presented an overview on AIDS to an academic meeting at Fordham University. A short section of the talk implied that a much better potential treatment for KS has been developed in Japan -- but did not say whether there had been any human test: "We have compounds from a company in Japan that wipe out the Kaposi's sarcoma in a way I have never seen before. That is, no toxicity, and the tumor's gone, and never reappears. "So now comes the politics of forming the collaboration, getting the compound, and all these things that are the most confusing things about recent science, I would say." Such a statement might normally have been ignored by the academic audience. But the New York Native published a transcript of the talk in its March 12 issue, with part of the above quote on page one. A number of people have called the National Cancer Institute, but little additional information has been released. In response to an inquiry of Congressman Sidney R. Yates (D- Chicago), the National Cancer Institute released the following statement: "The compounds to which Dr. Gallo referred are under preclinical development. Any activity seen to date is based on laboratory observations and should not be construed as implying that these compounds are cures for Kaposi's sarcoma. Further testing will be required before it may be determined whether these compounds would be effective or safe for use in patients. Dr. Gallo has indicated that his laboratory will pursue establishing collaboration with this company to further investigate these compounds." Even a successful animal test would be important, however, because there is a good "mouse model" for KS. In the same talk, Dr. Gallo summarized some of the most important animal work, which has been published. When certain cells which cause human KS are injected into immune-deficient mice, they caused a KS lesion to form within 10 days. But the cells in the lesion turned out to be mouse KS cells. Apparently certain abnormal cells cause KS by secreting a chemical, apparently a kind of growth factor, which causes abnormal growth of blood vessels, resulting in KS lesions. The fact that the same chemical causes human KS in humans and mouse KS in mice suggests that the mice with KS could be used to screen various substances (some of which might already be available in familiar drugs or even in foods) to find ways to destroy the unwanted growth factor or block or reduce its effects. Dr. Gallo's remark quoted above suggests that a good candidate has already been found. (For background on the KS tests in mice, see Nakamara and others, 1988, and Salahuddin and others, 1988.) We do not have any more information at this time. We are checking a rumor of a successful human test in Japan, but have not been able to substantiate it. One AIDS research physician guessed that the compound might possibly be beta-cyclodextrin tetradecasulfate or a chemical relative, used in combination with certain steroids. This anti- angiogenic substance (one which prevents unwanted growth of blood vessels) is being tested as a possible cancer treatment, because solid tumors must stimulate growth of blood vessels in order nourish themselves if they grow beyond a certain size. For more information on this chemical, which U. S. researchers obtain from Japan, see Folkman and others, 1989, and Folkman, 1989. The latter, an editorial in The New England Journal of Medicine, is especially important because it mentions a number of approaches to control of abnormal blood-vessel growth, approaches which may not yet have been investigated for KS. (However, the unprecedented single case of successful treatment of pulmonary-capillary hemangiomatosis, described by White and others and discussed in Folkman's editorial, used alpha interferon, which is already used for KS. We do not know of any human use of beta-cyclodextrins.) Scientists often discuss the appropriate time to release their findings, and they usually conclude that the right time is after the work is "finished," i.e. well-packaged for publication or presentation to a scientific meeting. Sometimes this approach works badly. U. S. institutional leadership has been slow to mobilize to treat AIDS seriously as an emergency, and therefore the pace of progress is unduly influenced by "the politics of forming the collaboration, getting the compound, and all these things." The public cannot trust that major opportunities will automatically be followed up vigorously. But when even a member of Congress gets the brush-off (the reply to Congressman Yates above could loosely be translated as "get lost," as it leaves no role for his further involvement), the public and its representatives are denied the opportunity to bring attention and resources to bear to overcome the mindless delays which usually set the real pace of research, in AIDS and other diseases as well. Among many ways to seek one's place in the world, public service usually works better than possession and control of secrets. But too often, career structures encourage the latter. ***** KS Is Not Cancer; Is It Also Not AIDS? While KS is often called a cancer in the general press (and sometimes even in technical papers), experts have long realized that it is not really a cancer (as first suggested by Costa and Rabson, 1983). Biologically, the cells in KS lesions do not behave as cancer cells. Clinically, there are many differences also; San Francisco physician Marcus Conant summarized some of them in a recent public meetings on AIDS. It is generally believed that KS is caused by one or more growth factors. If so, it should potentially be easier than cancer to treat. Is KS really AIDS? Researchers have long noted that it has a very unusual epidemiology, very different from AIDS itself. For example, it is about 20 times as common in gay or bisexual men with AIDS as in hemophiliac men with AIDS. Women infected with AIDS through heterosexual contact are more likely to have KS if their partners are bisexual than if they are IV drug users. KS is 300 times more common in people with AIDS than in people with other immune deficiencies; by contrast, the incidence of non- hodgkins lymphoma is about the same. Children are unlikely to have KS -- but all 12 children younger than 5 years who have KS are from Florida, and 11 of the 12 have Haitian mothers. This epidemiology has led researchers to suggest that KS may be caused by a yet-unknown infectious disease, usually transmitted sexually (Beral and others, 1990). Many minor epidemics are always occurring, in the modern, cosmopolitan world at least, and usually they pass without being noticed. Some experts believe that KS might have been another hardly-noticed disease, except that many people also had immune deficiencies due to HIV, and as a result the KS was much worse than it otherwise would have been. This theory suggests that some persons who were HIV negative would also have been likely to get KS, although probably a mild form. Such cases have now been found (Friedman-Kien and others, 1990). Unfortunately, only a small percentage of persons with KS were HIV negative; the researchers had to test 349 people with KS to find the six. These six had a very mild disease, with complete or almost complete recovery, after a median time of five years since diagnosis. Since KS has by definition been classified as AIDS, due to decisions made early in the history of the epidemic when much less was known, many people diagnosed with KS never took the HIV antibody test; they were assumed to be positive since they had AIDS by definition. Now it appears that a few patients with KS may be HIV negative and not really have AIDS at all (except by the old definition, which is still in force). These people may be able to live for a normal lifespan, with little or no treatment. Researchers would like to get in touch with anyone who is HIV negative but has or has had KS. References Beral V and others. Kaposi's sarcoma among persons with AIDS: a sexually transmitted infection? The Lancet, volume 335, page 123-128, January 20, 1990. Costa J and Rabson AS. Generalized Kaposi's sarcoma is not a neoplasm. The Lancet, page 58, January 1/8, 1983. Folkman J. Successful treatment of an angiogenic disease. The New England Journal of Medicine, volume 320 number 18, pages 1211-1212, May 4, 1989. Folkman J and others. Control of angiogenesis with synthetic heparin substitutes. Science, volume 243, pages 1490-1493, March 17, 1989. Friedman-Kien AE and others. Kaposi's sarcoma in HIV-negative homosexual men. The Lancet, volume 335, pages 168-169, January 20, 1990. Nakamura S and others. Kaposi's sarcoma cells: Long-term culture with growth factor from retrovirus-infected CD4+ T cells. Science, volume 242, pages 426-430, October 21, 1988. Salahuddin SZ and others. Angiogenic properties of Kaposi's sarcoma-derived cells after long-term culture in vitro. Science, volume 242, pages 430-433, October 22, 1988. White CW and others. Treatment of pulmonary hemangiomatosis with recombinant interferon alfa-2a. The New England Journal of Medicine, vol. 320 number 18, pages 1197- 1200, May 4, 1989. ***** PEOPLE OF COLOR CONFRONT HIV, HEALTH SYSTEM by Denny Smith In less than ten years the AIDS epidemic has highlighted many failings of health care and social programs in the U. S. These include gaps in education and earnings which guarantee lives of poverty and poor health for disproportionate numbers of Blacks, Latinos, Asians and Native Americans; the inconsistent and often nonexistent health care allotted to working-class people in general and women in particular; academic research geared to favor the needs of business at the expense of taxpayers and consumers; and an ongoing barrage of discriminatory legislation aimed against gay people, immigrants, and anyone suspected of being either. These failings and the prospects for correcting them were among the issues addressed at the Third Annual National Black Gay and Lesbian Leadership Conference and Health Institute in Atlanta, February 16-19. AIDS TREATMENT NEWS attended the conference with a particular interest in discussions of HIV treatment access for HIV positive people of color. The U. S. government and medical complex was neglectfully slow to respond to the AIDS crisis when the epidemic was considered, incorrectly of course, to be a threat mostly for white gay men and intravenous drug users. To compensate for the lack of concern and urgency, activists of all colors in the lesbian and gay community mobilized their political skill, called on the help of affluent friends of the community, and mounted a strong, compassionate response to AIDS both locally and nationally. Explicit information generated from a community perspective produced a sharp decline in the rate of HIV transmission, and campaigns urging early treatment intervention are now extending health and survival. The information from the AIDS service community, as well as from the mainstream media, has frequently been designed to target the white, gay male population. The epidemic is expanding rapidly outside of this arbitrary limit, and outside of its network of information and practical resources. People who acquired HIV through heterosexual contact, or contaminated needles or blood products, generally haven't benefitted from the organized community support which helped gays and their families endure the past decade. A new awareness of these factors is evident in the growing network of organizations and information forums for minority HIV concerns. This network shares much overlap with the older AIDS establishment, particularly for gay and bisexual people of color. Important and unique issues for these communities have frequently been overlooked by the larger gay and minority organizations, but their multiple perspectives are critical to planning for the future. The largest program offering HIV prevention information to gay and bisexual men of color is the National Task Force on AIDS Prevention, a project of the National Association of Black and White Men Together (NABWMT). This task force is based in San Francisco but operates HIV/safer sex workshops around the nation. Other examples of San Francisco's well-organized multicultural gay and lesbian communities include the Community HIV Project of the Gay Asian Pacific Alliance (GAPA), and workshops for men who have sex with men conducted by the American Indian AIDS Institute. (Supporting early HIV treatment and intervention, the San Francisco Department of Public Health recently awarded $115,000 to the Gay Men of Color Consortium, and $35,000 to the Mission Neighborhood Health Center.) A particularly urgent situation is now facing African American and Hispanic communities, where longstanding deficits in community health are now compounded by the new crisis. Current assumptions regarding the epidemic's future could be deceptive unless planners factor into their projections the specific variables in given populations. Some examples: * Public health information on HIV transmission and treatment often does not take account of differences in language and culture, or for lack of a community's access to printed media. If a community relies on television and radio for news, it will probably receive information that is missing large portions of reality, like the importance of condoms, realistic discussions of sex and drugs, and the optimism around early treatment for HIV. * Access to quality healthcare in the U. S. is hit and miss to begin with, and low-income or underemployed people are essentially thrown scraps by Federal programs, and patchy supplements from particular states and cities. Scraps do not encourage regular check-ups and aggressive, preventive health care. If medical help is sought only when symptoms appear, treatment for many illnesses, including HIV infection, is more difficult. * The health of someone using intravenous drugs is often compromised by poor nutrition and infrequent health exams. If HIV is factored into the situation, the prospects of monitoring one's health and obtaining early diagnosis or treatment are hindered from the outset. * Some occupations which are filled predominantly by minorities, such as migrant farm work, may pose increased exposure to sources of opportunistic infections. Toxoplasmosis, valley fever and MAI are all caused by microbes commonly found in soil. Even aside from occupational exposure, Filipino, Native American and Black people are already at higher risk for Valley Fever, or Coccidioidomycosis (Bronnimann and Galgiani, 1989). These situations help explain why Blacks represent 27.7% of all people diagnosed with AIDS, though only 11.5% of the U. S. population, and Latinos account for 15.6% of AIDS diagnoses, but only 6.4% of the general population. In addition, 75% of all children with AIDS and 71% of all women are Black or Latina. Behind these statistics hides a larger impending disaster, given the delay between the initial infection and the appearance of symptoms, and additional delays in antibody testing or early treatment intervention. Information on HIV prevention may decrease new infections among people who know their antibody status, yet miss people who are already infected and have not been tested. While they remain asymptomatic, these people may not feel the need to observe safer sex or needle precautions, and can unwittingly transmit HIV to their partners and possibly to future children. Unfortunately, sexually transmitted diseases run highest in the age group least receptive to health cautions -- teenagers from 12 to 15 years of age. An HIV infection occurring in adolescence may not cause obvious symptoms until the mid-twenties, well into child-bearing years. The future success of efforts to stop HIV transmission may depend heavily on parallel efforts to offer testing and treatment. And successful treatment for over a million Americans with HIV will absolutely require a more rational, equitable system of delivering health care. An on-going source of news addressing the HIV concerns of minorities are the Multi-Cultural NOTES on AIDS Education and Service of the National AIDS Network (NAN). Specific back issues are available to anyone, although a regular subscription requires membership in NAN. For information, interested persons can call 202/293-2437. NABWMT's National Task Force on AIDS Prevention can be reached at 415/255-8378. References Bronnimann, D A and Galgiani, J N. Coccicioidomycosis. European Journal of Clinical Microbiology and Infectious Diseases, volume 8, number 5, pages 466-473, May 1989. ***** GRASSROOTS LOBBYING AND ORGANIZING OPPORTUNITIES by John S. James Last month, AIDS TREATMENT NEWS examined the arguments now being heard to reduce Federal AIDS research ("New Threats to AIDS Research Funding," issue #97, February 16). This article briefly describes some options by which you can make your voice heard in Congress. There is a widespread myth that an "AIDS lobby" is already highly effective. The fact is that while AIDS organizations have been effective in other ways, much less has been done to reach Congress than most people realize. The great majority of members of Congress are uninformed on AIDS, and have no staff member following it, because they have never heard from voters or opinion leaders in their districts that AIDS matters to them. Only a few members of Congress are carrying all the weight on AIDS -- and they need to be supported. Do not think that Congressional funding for AIDS research proves that lobbying is already being taken care of. Most members of Congress basically want to avoid AIDS. By voting for research money, they can tell themselves that they have done their duty and then forget about AIDS; they can hope that if they propitiate the monster, maybe it will go away. The political organizations we do have deserve much credit for what progress has been made, but there is only so much they can do unless they get more support from the public. It would be a great mistake to complacently assume that our own efforts have been powerful, when in fact the glaring reality is how little Congress has heard from the public, compared to the importance of AIDS. The essence of lobbying today consists of mobilizing public support, letting members of Congress know that voters, opinion leaders, and campaign contributors in their state or Congressional district care enough about an issue to visit their offices, write, call, send Mailgrams, etc. Usually it is not necessary for an organization to address everybody in Congress at once, because a few strategically-placed or swing votes will be crucial at a particular time. But an organization working on AIDS needs to have an ongoing presence among the voters of as many districts as possible, because today power in Congress is decentralized, meaning that a group may need the active support of dozens of Senators or Representatives to get something done. It is no longer enough to convince just two or three chairpersons of key committees, as was often the case 20 years ago. And as battles in Congress develop, organizations may need to mobilize audible public support within days or sometimes hours as new districts suddenly become strategic. But today, unfortunately, many of even the most important members of Congress have nobody in their districts working with their offices on AIDS. The next few months will be especially important in developing next year's budget, aid to areas heavily impacted by AIDS, funding for early treatment, passage of the Americans with Disabilities Act, and perhaps removing travel restrictions for persons with HIV entering the United States. If you have only a little time or money to contribute toward Congressional lobbying, then you can work with organizations that will help you be heard by your Congressman or Senators at the most important times. If you can contribute more effort, then you can help by organizing others in your area. In either case it is important to find one or more organizations that you are comfortable working with, as it would be very difficult to follow the details of what is happening in Washington on one's own. Here are some groups which have, or are developing, programs for involving individuals who want to work directly with their representatives in Congress on AIDS issues. Our list, which is in alphabetical order, is not complete; these are the ones we reached before press time. We would like to hear about others. (Note that this list does not include some very important organizations, such as the American Civil Liberties Union AIDS and Civil Liberties Project, which work directly with Congress or with other aspects of AIDS lobbying and public policy, but do not focus on organized programs directed to the general public to help individuals communicate with their representatives in Congress about AIDS. Also, we did not include those directed to state or local governments, such as the California AIDS Life Lobby in Sacramento.) * AIDS Action Council. This group, whose mission is to lobby for sound Federal AIDS legislation, works primarily with community-based organizations across the United States. Any individual or organization which would like information about lobbying can contact the Council at 2033 M St. NW, Suite 801, Washington, DC 20036, phone 202/293-2886. Note: AIDS Action Council also convenes the National Organizations Responding to AIDS (NORA), a group of 140 national organizations which meet regularly in Washington. * American Foundation for AIDS Research (AmFAR). AmFAR is beginning to develop a lobbying program targeted to a specific purpose -- supporting funding for community-based clinical trials organizations. About 40 such research groups already exist; only a few have Federal funding, and there is no guarantee that this component of Federal research will be continued. The lobbying program aims to help these groups let their Congressional representatives know that they exist, what they are doing, and why community-based research is important. AmFAR has prepared an information packet on lobbying. For more information, contact Bill Flanagan at AmFAR, 212/719-0033. * Gay and Lesbian Political Action Committee (GALAPAC). This group includes a number of elected officials in Congress and local offices; it is a supporting member of five major AIDS or gay political organizations (National Organizations Responding to AIDS, AIDS Action Council, and National Gay and Lesbian Task Force in Washington, D. C. ; California Life AIDS Lobby in Sacramento; and the International Lesbian and Gay Association in Stockholm, Sweden.) Its program includes encouraging citizen lobbying for AIDS action, including a national telephone campaign to increase AIDS funding. Now through the end of April, it is especially important to lobby six Representatives, who are swing votes for AIDS funding in the House. They are Leon Panetta (D-CA), Frank Guarini (D- NJ), Anthony Beilenson (D-CA), Bernard Dwyer (D-NJ), Willis Gradison (R-OH), and William Thomas (R-CA). If you live in their districts or know anyone who does, have them contact GALAPAC. For more information, contact GALAPAC at P. O. Box 46577, West Hollywood, CA 90046, or call 213/931-6195. * Human Rights Campaign Fund (HRCF). This gay rights political organization, the largest in the country, runs a very effective program called "Speak Out," which sends pre-authorized messages from constituents to their representatives in Congress at critical times. About 70 percent of the issues they select concern AIDS. About 20,000 people throughout the United States have participated. Persons in the program also receive a newsletter, Capitol Hill Update, several times a year. Congress is very much aware of the difference between orchestrated and unorchestrated mail. Letters written spontaneously by constituents are better indicators of public opinion than mail generated by organized campaigns. But orchestrated mail does show how well organized a constituency is in a state or Congressional district. In the past, the HRCF would sometimes find that the majority of the public was on its side of an issue, but there was no mail on its side and an avalanche on the other, orchestrated by conservatives and fundamentalists. The Speak Out program helps redress that imbalance. Persons can also earn money by signing up new members for this program -- sometimes $15 to $25 an hour, especially while working at public events and demonstrations. Besides the messages to Congress, the HRCF also encourages people to visit their representatives at their local offices, and organizes parties in peoples' homes to discuss how to assure a better Federal response to AIDS. When elected officials visit Washington, HRCF gets them in touch with the important people on Capitol Hill. And anyone visiting Washington can call HRCF to make arrangements for meeting with their representatives -- and to be briefed on what is happening on the Hill with AIDS. For more information, write to Steve Endean, Human Rights Campaign Fund, P. O. Box 1723, Washington, DC 20013, or call 202/628-4160. * Mobilization Against AIDS (MAA). MAA, best known for organizing the international candlelight memorials and for its work on Federal-budget and on treatment issues, is starting a new lobbying effort which so far is fully active only in California. People who join this program agree to write at least four personal letters a year to their Congressional representatives. Meanwhile, MAA follows all the (California) representatives and the AIDS issues in Congress, and lets people know when it is most important for them to write. Persons in other states can join the program, but they will be contacted infrequently because MAA does not have the resources at this time to keep track of all Congressional districts in the country. Mobilization Against AIDS can be contacted at 1540 Market St., Suite 60, San Francisco, CA 94102, phone 415/863-4676. * National Gay and Lesbian Task Force (NGLTF). This organization, a leader in the gay rights field but not primarily focused on AIDS, is planning an AIDS and gay rights lobbying month in June. For more information, call 202/332-6483. For More Information For background on how organizations can influence Congress in today's environment, see: * How to Win in Washington, by Ernest and Elisabeth Wittenberg, Basil Blackwell, Cambridge, MA 1989. This is a short (about 150 pages) and very practical book by two Washington, D. C. public-relations professionals. It describes many examples of successful lobbying campaigns, and points out that they all follow similar patterns. This book may be hard to find in stores outside of the Washington area, but it is worth ordering if necessary. It can be ordered through bookstores, or from the distributor at 800/445-6638. * The Power Game: How Washington Works, by Hedrick Smith, Ballentine Books, Random House, New York, 1988. The author, former Washington bureau chief of The New York Times, wrote a much longer (almost 800 page) book on how Congress works -- and doesn't work. Neither book has any information about AIDS. ***** ANNOUNCEMENTS New Directory of Clinical Research in the Bay Area The Spring 1990 listing of AIDS/HIV clinical trials now recruiting patients in the San Francisco Bay Area is available from the Community Consortium (formerly called the County Community Consortium) in San Francisco. To obtain a free copy, send your name and address to: Community Consortium, SFGH Building 80 Ward 84, San Francisco General Hospital, 995 Potrero Avenue, San Francisco, CA 94110. San Francisco: Cryptococcal Meningitis Study, SCH 39304 Persons who have had cryptococcal meningitis are needed to help test a new oral antifungal at San Francisco General Hospital. The study, conducted by Merle Sande, M. D. and Belle Lee, Pharm. D., and others in the Department of Medicine, lasts 12 months. The drug, SCH 39304 from Schering Corporation, is now in phase III, and has been given to dozens of people, with only occasional minor side effects. Patients will be given 600 mg once a week for 12 months for suppression of cryptococcal meningitis. There are a total of 14 visits during the 12 months for blood drawing, and there will also be lumbar punctures on the second and 12th months. To volunteer or to learn more about this study, call Dr. Belle Lee, at 415/821-8450. NOTE: On December 15, AIDS TREATMENT NEWS carried a notice for a thrush study using SCH 39304, comparing 25 mg and 50 mg daily doses of the drug against 200 mg of ketoconazole, in a trial lasting only 10 days. The thrush study is still open. New York: Cryptosporidiosis Studies of Diclazuril, Milk Globulin Two trials of possible therapies for Cryptosporidium infections are now open to new participants at St. Luke's/Roosevelt Hospital Center in New York City. The treatments under investigation are diclazuril and bovine milk globulin, which were discussed with several other potential treatments for cryptosporidiosis in AIDS TREATMENT NEWS #95, January 19, 1990. Anyone interested in participating in one of these protocols should call Anita Tierney at 212/523-3671. Help Wanted: Clinical Research Associate The Project Inform Community Research Alliance is hiring a clinical research associate to initiate and monitor clinical studies for its AIDS/HIV treatment research program. The work includes helping develop protocols and case-report forms, and monitoring a multi-center study to ensure adherence to protocol, drug accountability, accurate data collection, and compliance with regulations. Minimum two years experience in pharmaceutical industry or biomedical research; graduate degree in science desirable. Send resume and salary requirements to: PICRA, 347 Dolores St., Suite 202, San Francisco, CA 94110. ***** Next Issue in Three Weeks Because AIDS TREATMENT NEWS is now published on the first and third Friday of every month, the next issue (#100) will be published in three weeks, on April 6. ***** NEWS NOTES Median AIDS Incubation Period Now Eleven Years The San Francisco Department of Public Health, which maintains the oldest and probably the most accurate data on AIDS epidemiology, has published a study of HIV positive gay and bisexual men showing that the median incubation period from seroconversion to AIDS is eleven years. Dr. George Lemp is the principal author of the report, "Projections of AIDS Morbidity and Mortality in San Francisco," published March 16 in the Journal of the American Medical Association. The results were collected in collaboration with the San Francisco City Clinic Cohort Study and the University of California at San Francisco and Berkeley. Dr. George Lemp, Chief of Surveillance for the AIDS Office, said that "We anticipate the incubation period will become even longer as a result of earlier intervention with new treatment modalities." He also said that projections of the future of the AIDS epidemic -- essential for accurate planning for early intervention and other services -- have been hampered by lack of information on the distribution of HIV in the population. ***** Blue-Green Algae Production Contract from NCI On February 28 Martek Corporation of Columbia, Maryland, a specialist in commercial production of algae under controlled, closed-culture conditions, announced that it has been awarded a contract by the U. S. National Cancer Institute (NCI) to scale up production of two strains of algae which produce sulfolipids, a class of chemicals found to have anti-HIV activity in the test tube. (For background information, see "Antiviral Found in Blue-Green Algae," AIDS TREATMENT NEWS # 87, September 8, 1989.) Martek will initially provide four kilograms of algae to the NCI, and it can provide much larger quantities if needed. The two species of blue-green algae are Lingbya lagerhemii and Phormidium tenue. NOTE: In our September article, we suggested library (and possibly some laboratory) research to quickly determine whether it might be possible to obtain a significant dose of sulfolipids through blue-green algae or other plants which are already in use as food. Someone with a scientific background and no relationship to companies selling algae is needed. We have been unable to take on this project ourselves, and hope that someone can do so. ***** New York: Community Research Initiative Will Test MEK The Community Research Initiative (CRI) has received funding of at least $300,000 from TNI Pharmaceuticals, Inc. to test immune modulator methionine enkephalin (also known as MET-ENK, or MEK). The trial is expected to start in April. The funding was announced on March 16 by Dr. Nicholas P. Plotnikoff, chairman and founder of TNI, which holds patents on the use of MEK as a possible treatment in AIDS and cancer. ***** Jonathan Mann Forced Out at W. H. O. Jonathan Mann, M. D., who built the Global Program on AIDS in the World Health Organization (W. H. O.) of the United Nations, resigned effective in June, citing policy differences with Hiroshi Nakajima, M. D., who has been director-general of W. H. O. since 1988. A March 17 New York Times report quoted officials as saying that Dr. Nakajima wants to de-emphasize AIDS to focus more on other diseases, and had vetoed Dr. Mann's staff appointments, transferred staff out of the AIDS program, delayed critical decisions for months, and prevented Dr. Mann from attending an AIDS conference he had organized in Eastern Europe. The Global Program on AIDS, with a staff of 220, raises most of its $109. million annual budget itself, instead of taking the money from W. H. O. This fundraising had given it more autonomy than other programs within the health agency. Dr. Mann has concluded agreements to establish AIDS programs in 155 of the 166 countries in W. H. O. Dr. June Osborn, chair of the National Commission on AIDS, called the resignation "a world tragedy": "From July 1986, when he didn't even have an office, to more than 150 useable, constructive agreements on such a sensitive issue is the most brilliant job of international creative work that I know of." (Dr. Osborn, quoted in The New York Times. March 17.) ***** California AIDS Office Leaves Money Unspent? According to a March 10 story in the San Francisco Examiner, California's Office of AIDS has spent only $8 million out of $50 million available, in the first three quarters of its budget year. The article quotes experts and officials in other agencies as saying that excessive bureaucracy and other administrative problems have kept the office, with a staff of 143, from responding effectively to the epidemic. For example, a study by two associations of health officials found that a typical contract can be 60 pages long and take six to eight months for paperwork. The office says that it has approved contracts worth $35 million, but that much less has been spent so far because requests for payment often come in months later. ***** STATEMENT OF PURPOSE AIDS TREATMENT NEWS reports on experimental and complementary treatments, especially those available now. It collects information from medical journals, and from interviews with scientists, physicians, and other health practitioners, and persons with AIDS or ARC. Long-term survivors have usually tried many different treatments, and found combinations which work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. We also examine the ethical and public-policy issues around AIDS treatment research and treatment access. [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display