Date: 03 Sep 94 09:44 PDT From: "John S. James" Lines: 882 AIDS TREATMENT NEWS Issue #206, September 2, 1994 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: AIDS Pathogenesis -- New Understanding Why AIDS Drug Development Has Failed Accelerated Approval: Statement to FDA Announcements HIV Infection in Women Conference, February 22-24, 1995 Paris Global Summit on AIDS -- Action Alert, More U.S. Effort Needed Yokohama Overview: List of Topics Available San Francisco: Personal Survival Strategies, September 28 Cryptosporidiosis: Los Angeles Trial of Garlic Extract SEARCH Alliance Seeks Medical Director AIDS Medicine & Miracles -- Boulder, Colorado, September 29 - October 2 California AIDS Legislation -- Action Alerts ***** AIDS Pathogenesis -- New Understanding by John S. James While there was new information at the Tenth International Conference on AIDS, August 7-12 in Yokohama, that meeting mainly served to summarize the current state of scientific knowledge about many aspects of HIV disease -- areas of evolving consensus, and also continuing disagreement among experts. In pathogenesis -- the study of the mechanisms by which disease develops -- there are still vast unknowns, gaps in knowledge filled only by guesses. For example, it is known that relatively few T-helper cells are killed directly by HIV -- and no one knows what is causing the disappearance of most of the cells, although there are several theories. Despite the unknowns, there is more clarity today about HIV pathogenesis than is commonly realized. The developing knowledge will be useful for understanding the limitations of current treatments, and the requirements for better ones. This article looks at part of the evolving picture of HIV disease, focusing on aspects highlighted at the conference. ** Latent Infection Surprisingly Large In a major plenary address, Dr. Ashley T. Haase of the University of Minnesota reported finding an "extraordinarily large" number of cells in lymph nodes and some other tissues infected by HIV early in the disease process. For example, 25 percent or more of CD4 cells in the lymph nodes were found to be infected; but only about one percent of those were actively producing virus at any one time. The others were latently infected; HIV had entered the cell and become part of its genetic inheritance, but because the cell was not activated, the HIV was not reproducing or creating abnormal proteins. These latently infected cells are undetectable by the immune system, since the HIV genetic information remains quietly inside the nucleus of the cell and does not affect the cell surface; for the same reason, this latent infection is undetectable by most laboratory methods. Dr. Haase's team used a special technique called in situ PCR; this causes PCR (polymerase chain reaction, which detects a particular DNA sequence by causing it to successively duplicate itself) to occur within each cell, allowing latently infected cells to be distinguished from uninfected ones in the laboratory. This latent infection, a "Trojan horse," may not cause damage while it remains latent; but at any time some of the cells will become activated. Then more virus is produced, spreading the infection and/or killing the cell. The latently infected cells form a reservoir of virus which is not affected by the immune system, or by AZT or similar drugs; this reservoir enables the virus to persist, and may also be involved in transmission of HIV from person to person. This view of HIV infection was not new at Yokohama, but grew out of several years of work at the Department of Microbiology of the University of Minnesota Medical School in Minneapolis; a major paper was published in 1993. (1) [Comment: This information does suggest approaches to treatment, even though there are no known drugs which can selectively attack the latently infected cells, or the HIV genetic material within them. AZT, etc., and also the protease inhibitors, or other drugs which target various enzymes in the HIV life cycle, can help to prevent the infection from spreading into new cells; protease inhibitors might be better than AZT-type drugs for doing this, because they cause the newly-produced virus to be defective and non- infectious, while AZT, etc., only help block infection of new cells after it is already underway. These antivirals can be combined with other treatment approaches which may reduce the amount of activation. Aggressive diagnosis and treatment of opportunistic or other infections can help, since infections increase the activation of immune cells. Activation could also be reduced by various kinds of drugs. One example is immune suppressive therapies, which can be dangerous, but might be used in some cases, for example in early treatment, before serious immune deficiency has developed; or treatments might be used to reduce particular immune responses which are overactive. Various drugs are being tried to reduce abnormally high levels of TNF (tumor necrosis factor), which increase activation of HIV. Still another approach is to screen for drugs which inhibit the LTR (long terminal repeat) of HIV; it is now believed that certain CD8 cells inhibit HIV quite effectively by producing a substance (so far unidentified) which inhibits the LTR. Drugs to reduce activation are not likely to provide the whole answer, since some activation of immune-system cells is necessary for normal functioning; but reducing activation can be one of a number of approaches toward helping the immune system maintain or re-establish control of the HIV infection.] ** Major Lymph-Node Study Examines AZT, ddI Effects DATRI-003 (run by the Division of AIDS Treatment Research Initiative, of the U.S. National Institute of Allergy and Infectious Diseases), is the largest study to date using lymph-node biopsies; 32 patients had two biopsies, eight weeks apart, and some of them started or changed treatment after the first biopsy. This study is important because HIV infection is especially active in lymph nodes. But some of the preliminary results are confusing or hard to interpret; we will know more when a full report is available. All 32 patients had T-helper counts above 250, often much higher. They were divided into four groups. In group 1, patients had not had any antiretroviral therapy, and AZT was started. In group 2, there was no prior therapy, and none was started. In group 3, patients were already on AZT, and it was continued. In group 4, they were already on AZT, and ddI was added. There was essentially no change in the percentage of infected cells in the lymph nodes of the different groups. (This result would be expected, as there is no reason to think that AZT or ddI could eradicate infection in cells where it was already established.) Viral replication did decrease in the six patients who added ddI to their treatment (group 4); this was seen by measuring HIV RNA in both the lymph nodes and in the blood, although the decrease in the lymph nodes, which was seen in four of the six, was not statistically significant. Surprisingly, however, no effect was seen on viral replication in the lymph nodes in the group which started AZT -- although their T- helper count did rise. One possible explanation of this difference is that those who started AZT began with a high T-helper count (mean 654), while those who added ddI begin with a mean of 394; the authors suggested that the antiviral effect of these drugs may be less in early disease. However, we would like to see the full report (which is currently being prepared for publication), since viral levels can be hard to measure in early HIV infection, even with the new tests. Is it clear that AZT did not reduce viral replication, or could a reduction have been missed because there is less to measure at that early disease stage, and there were only a few patients in this study arm? It would be a surprise if AZT does not affect viral replication in the lymph nodes in early HIV disease; therefore, we want to see more information before reaching that conclusion. There has also been some confusion about this study due to the current lack of standardization of terminology. In the Yokohama conference abstract, the authors used the term "HIV burden" to mean the proportion of infected cells. The authors plan to avoid this terminology in the future, because "viral burden" is sometimes used to mean the number of copies of viral RNA in blood plasma; "viral load", "viral activity," "viral reproduction" have also been used, more or less interchangeably, for the latter meaning. No one knows how this usage will standardize in the future; our guess is that "proportion of infected cells" will refer to the former meaning, while either "viral activity" (or perhaps "viral load" or "viral burden") will be used for the latter. The two meanings are quite different, since the proportion of infected cells apparently becomes established early in HIV disease and then tends changes only slowly, while the number of copies of viral RNA in blood plasma can change greatly within days, due to changes in drug treatment or for other reasons. Because of this rapid response, and because the proportion of infected cells is difficult to determine, while tests to measure plasma HIV RNA have now become routinely available (see AIDS Treatment News #204, August 5, 1994), and because HIV RNA level indicates the number of viral particles and correlates with the ability to grow the virus in culture, the plasma RNA level is becoming the measurement of interest for testing new drugs, and for individualizing therapy with existing drugs. [Note: There was much more information on pathogenesis at the Yokohama conference. We will continue our coverage in future articles.] References 1. Embretson J, Zupancic M, Ribas JL, Burke A, Racz P, Tenner-Racz K, and Haase AT. Massive covert infection of helper T lymphocytes and macrophages by HIV during the incubation period of AIDS. Nature. March 25, 1993; volume 362, number 6418, pages 359-362; comment on pages 292-293. 2. Cohen OJ, Pantaleo G, Graziosi C, Niu M, and Fauci AS. Effect of antiretroviral therapy on HIV burden and replication in lymphoid tissue. Tenth International Conference on AIDS, Yokohama, August 7-12, 1994 [abstract #001B). ***** Why AIDS Drug Development Has Failed by John S. James [Note: The following is from our statement to the San Francisco AIDS Foundation public policy forum on research issues, 8/23/94.] The Problem The recent Yokohama conference was badly reported in the press. Behind the gloom and doom on AIDS treatments, much valuable science was overlooked. AIDS Research is improving, and good work is finally being done; but drug development, a very different process by different people, is still a disaster. Why? If you ask scientists, most will say that the lack of treatment progress results from the biological difficulty of the problem, of controlling the HIV virus. This is true -- but not the whole story. The lack of progress also results from systematic human mistakes. Yes, if the biology of stopping HIV were easy, even the crippled effort we have today would have already been successful. A hard problem means that we have to do better to succeed. But there are political reasons why it has been difficult or impossible to successfully raise the alarm. And the same political obstacles are stopping progress today. Medical Research Progress -- Where It Comes From Almost all medical advance in the past, and still today, comes not from rational calculation or design, but from the unexpected, the unpredictable, the unknown. And the unknown first comes into view without a major corporate, professional, or political constituency behind it. But today, the process of mainstream drug development creates such high barriers and obstacles -- regulatory, financial, legal, and other -- that only the largest companies, with a major corporate commitment, can progress over them. This means that the new ideas and information that come to doctors, scientists, and others through accident and chance observation -- the very ideas and information that feed medical progress -- usually cannot go anywhere. No matter what their intrinsic merit, they cannot move at all to build the credibility required to crank up the very expensive processes required today before the first human test. There is no path which leads over the barriers. So they are stuck forever. Hundreds of entirely reputable ideas wait like this, frozen on display in peer-reviewed journals, or out of public sight in a scientist's or doctor's mind or in unpublished work. Eventually, a tiny handful may be picked up by a well- financed corporate development project. But because of the great role of the unexpected in medical research, there is no reason to think that these lucky few are the cream of the crop. Instead, they are essentially selected at random, based more on patents, contracts, deals, and personalities than on perceived merit (however unreliable even the latter is). As a result, the world has appallingly few shots at a significant treatment improvement. What is needed is a rational development path for the hundreds of other good ideas and proposals, so that they can begin the process of establishing their credibility, if they merit it. Many different possibilities would then have a chance at development. Eventually, the best of them could move into formal clinical trials. AIDS Politics: The Unholy Alliance It's no accident that this reform was not accomplished long ago. Start with a big picture, beyond AIDS, beyond medicine. In any public-policy arena where regulation is involved, there is usually an ongoing battle between two superpowers, big business and consumer protection. And public policy is determined by where the battle line between them ends up. This battle is the normal and usual process by which we as a society balance different risks and different benefits against each other. In drug development, for AIDS or for other diseases, this battle proceeds, as elsewhere. But unfortunately, there is one key place in drug development where the battle does not work as it should, and instead produces pathological results. And this key place is the unexpected, the creative, the chance observations, the new ideas -- which proceed from the unknown, and form the river which feeds most of the potential for advances in treatment development, as discussed above. In this one key area (which is unimportant for the present, but centrally important for the future) big business and consumer protection are not in conflict, but instead work together -- an unholy alliance against new ideas. For very different reasons, both of these superpowers want the barriers and obstacles, which any forward movement must cross, to be set as high as possible. Consumer protectionists want high barriers to protect the public against dangerous products and unscrupulous companies; big business wants high barriers to protect itself against competition by small business. Big business can pay almost any price; and later, with a monopoly of an essential drug, raise prices as high as necessary to get the money back and more. Whether a potential advance is a major corporate development project with tens of millions of dollars behind it, or an accidental observation with no constituency yet, doesn't matter -- both are treated equally. But the multimillion dollar corporate effort can (with sufficient merit) overcome the barriers and prevail, while the new idea which has had no chance yet to build a constituency or financial support is stopped cold, usually forever. This problem has not been solved because both consumer protection and big business have such a pervasive influence throughout the AIDS research and service communities. Almost everybody who is professionally involved worships at one or both of these altars. Big business funds thousands of projects by scientists, doctors, and service organizations -- as it should (and small business, incidentally, funds almost nothing in comparison). Meanwhile, consumer protectionists dominate policy almost everywhere in AIDS, from our friends in Congress, to the FDA of course, to AIDS Action Council and the large service organizations -- which, despite ongoing pressure from their major donors, have usually refused to become seriously involved with treatment development. To do so could jeopardize important relationships that they must maintain in order to accomplish their service missions. The end result is that treatment progress is seldom allowed to happen outside of big-business control. And big business had no interest in AIDS until AZT made money, and is losing interest now as ddI, ddC, and d4T are unlikely to ever repay their development costs. The result? Near-guaranteed stagnation, which is what we have today, and have had since the beginning of the epidemic. This is why there has been so little progress in finding better treatments for HIV, and why so little relief is in sight. HIV RNA: New Viral Tests and Their Importance New viral blood tests, much more accurate than the ones used before, have recently become available to physicians. These may provide a partial escape from the bleak drug-development and political landscapes above. [For background on these tests, see "HIV RNA: New Blood Test for Individualized Therapy and Faster Trials," AIDS Treatment News #204, August 5, 1994.] These tests are important because they can indicate quickly (within a month, and possibly within days) whether a particular antiviral treatment is working for a particular patient. It doesn't matter if the treatment is mainstream, such as ddI, or "alternative," such as Chinese herbs; if the virus in the blood is reduced, the tests will show that. This means that certain new treatments -- those in actual use by people with HIV, or which can be prescribed by physicians or otherwise obtained -- now will have a path to begin to build credibility. Probably the great majority of "alternative" treatments will be found not to work, and be largely discarded. But if one patient benefits dramatically from a treatment (as seen by reduction of virus in the blood), and then a second, third, and fourth also show a dramatic reduction, then there will probably be enough interest to get that treatment into a formal trial, either through a community-based research organization, or by finding a corporate sponsor. The potential new treatment will then be on a development path, instead of left waiting forever. This almost never happened before the new tests were available, since it has been necessary to crank up an expensive and cumbersome trial before there was any credible data suggesting measurable benefit in people. Now, the credible data can start with one person's decision to use an unproven treatment, not for research but for their own medical care. If the early data is negative -- the usual case -- the patient can drop the treatment quickly, and perhaps try another. And if the data is promising enough, formal research can follow. ***** Accelerated Approval: Statement to FDA by John S. James [The U.S. Food and Drug Administration has requested public comment for the September 12-13 meeting of its Antiviral Advisory Committee, which will examine accelerated approval -- the regulations now in effect which allow critically needed drugs to be approved based on blood tests which show virological or immunological improvement, with further research to be done later. (The alternative to accelerated approval is to require statistical proof that the new drug improves survival or reduces serious illness before it is approved, and such studies commonly involve thousands of people and take several years to complete.) Drug-approval policy requires a weighing of risks and benefits, and the FDA has heard proposals that it retreat from its accelerated- approval system to make sure that companies get better data before drugs are approved. [The meeting will be at the Holiday Inn Plaza Ballroom, 8777 Georgia Ave., Silver Spring, Maryland, starting at 8:30 a.m. on September 12 and September 13; all parts of this meeting are open to the public, and there might be times to make a brief statement to the Committee even without prior arrangement. Also, written statements can be submitted after the meeting. Address them to Antiviral Advisory Committee, c/o Lee Zwanziger, Ph.D., Advisors and Consultants Staff (HFD-9), Parklawn Building, Room 8B45, 5600 Fishers Lane, Rockville, MD 20857; or fax them to 301/443-0699. For more information, call Dr. Zwanziger at 301/443-5455.] The following is an outline of our talk to the Committee: * While everybody agrees that better data is needed, what AIDS Treatment News is hearing from people with HIV disease is the strong, widespread feeling that access remains most important to them, and must not be sacrificed. This is true whether or not people are highly educated about treatments. When conventional treatments are failing, no special education is needed to know that other possibilities have shown promise, and to want to try them. * Parallel track and other pre-approval access programs cannot replace accelerated approval, as companies are increasingly refusing or unable to pay for them. * The concerns around accelerated approval of ddC and other AIDS drugs reflect the inadequacy of the drugs, not fundamental flaws in the approval process. * Within the research and medical communities, there is a rapidly growing consensus that plasma RNA is a much better indicator of antiviral effect than the measurements we have had in the past. This new marker will almost certainly improve future decisions about antivirals. Accelerated- approval decisions will not be based on any one marker, however, but will reflect a judgment involving all information available. We should avoid premature decisions or doctrines which would limit flexibility and prevent timely and effective use of new technologies as professional consensus develops. For example, it may be tempting to impose the doctrine that whenever accelerated approval is given, it must be in the context of a development plan that will eventually use clinical endpoints to prove or disprove the drug's superiority to standard treatment. In some cases, this approach may make sense; in other cases, different ways of organizing post-marketing studies may be more effective in obtaining the information physicians need to optimize use of the drug. And the human costs of clinical-endpoint trials (which tend to keep people on protocols that don't work for them so that body counts can be obtained) are often underestimated. These costs are highest for marginal drugs, where the resulting information is of least value. * A major problem in drug development is that most credible treatment possibilities do not even begin clinical research, because the cost barriers to eventual approval are too high. This is especially tragic in view of the historical experience that important medical advances are seldom predictable -- meaning that the few drugs which do get big- corporate backing are not the cream of the crop, but closer to a random selection. Critical treatment advances may be quietly lost, if they do not look good ahead of time and therefore never get the chance to begin developing credibility. Accelerated approval can reduce cost barriers by deferring major expenses until after there is an income stream, encouraging early testing by making the ultimate development path more feasible. * In addition, the movement toward individualized therapy will make accelerated approval more important than it has been in the past, as physicians and patients rely less on averages and more on viral and other measurements for rapid indications of which treatments are working for which people. ***** Announcements: ** HIV Infection in Women Conference, February 22-24, 1995 The first national scientific meeting on HIV infection in adult and adolescent women will take place February 22-24, at the Sheraton Washington Hotel in Washington, D.C. This conference is sponsored by the National Institutes of Health, the Centers for Disease Control, the Food and Drug Administration, the Public Health Service Office on Women's Health, and other Federal agencies. Due to delays in getting final approval, the conference was not announced publicly until recently. To receive the Announcement and Call for Abstracts, or for exhibitor information, contact: HIV Infection in Women Conference, Conference Secretariat, Suite 300, 655 15th St. NW, Washington, DC 20005, phone 202/639-4111, fax 202/347- 6109. ** Paris Global Summit on AIDS, December 1 -- Action Alert, More U.S. Effort Needed The French government has invited heads of state of 42 countries to attend a Global Summit on AIDS, in Paris on December 1. Five working groups (on safety of the blood supply, vaccine and treatment research, care and social support, prevention of transmission, and protecting vulnerable populations) will hold preliminary meetings in September and October. Mervyn Silverman, M.D., president of the American Foundation for AIDS Research (AmFAR), has said that "several results are clearly attainable, especially in guaranteeing the safety of the world's blood supply and significantly improving the effectiveness of prevention and care efforts in the developing world." The U.S. has said that it will send Health and Human Services Secretary Donna E. Shalala (instead of President Clinton); meanwhile, U.S. officials have shown little interest in the preparatory meetings. It is urgent that President Clinton and other officials hear from citizens that the Paris AIDS Summit demands their attention. A background article by AIDS activist Eric Sawyer will be published in Spanish in SIDAhora, a newsletter of the PWA Coalition in New York; we could not confirm English publication by press time. For more information about the Summit, contact the Global AIDS Action Network (GAAN), 415/488-1453, or by fax at 415/488-1942. ** Yokohama Overview: List of Topics Available A short overview listing important topics covered at the Tenth International Conference on AIDS is available from Project Inform. Call the hotline, 800/822-7422 (or 415/558- 9051 from San Francisco), and ask for a copy of the overheads from the August 31 Project Inform Town Meeting on the Yokohama conference. There are 27 overheads, reduced to fit onto three sheets of paper. (Hotline hours are Monday through Saturday 10 a.m. to 4 p.m. Pacific time.) Note: These overheads were used as the basis for a two and a half hour Yokohama update, by the four Project Inform speakers who attended the conference. The overheads are not always self explanatory, but do provide a list of the major topics addressed in Yokohama. ** San Francisco: Personal Survival Strategies, September 28 "Living with HIV: Personal Strategies for Long-Term Survival" will be addressed by a panel of speakers on Wednesday, September 28, 7:30 p.m. at the Metropolitan Community Church, 150 Eureka St. (between 18th and 19th streets) in San Francisco. Admission is free, donation requested. The speakers are Will Carter, Sandy Davis, Jeff Getty, Darcy Ike, Joel Thomas, and Hank Wilson. For more information, call the Project Inform hotline, 415/558-9051. ** Cryptosporidiosis: Los Angeles Trial of Garlic Extract SEARCH Alliance, a community-based research organization in Los Angeles, is conducting a small, uncontrolled trial of allicin, an oil derived from garlic, as a treatment for cryptosporidiosis. The trial will enroll 25 patients and last for three weeks, with five outpatient visits. Five patients have already been enrolled. According to the concept sheet from SEARCH Alliance, "the primary objectives are to determine the safety of oral and rectal administration of allicin, while monitoring the change in symptomatology and character of stool specimens in individuals with cryptosporidiosis." Allicin has shown activity against many disease-causing organisms; this exploratory trial was organized after anecdotal reports of good results in two patients. Entry criteria include symptomatic diarrhea, a positive stool smear for cryptosporidia, and negative stool cultures for salmonella, shigella, campylobacter, giardia, and ameba. For more information, contact Mark Lazarin or Charles Chesson, Ph.D., 213/930-8820. ** SEARCH Alliance Seeks Medical Director SEARCH Alliance in Los Angeles, a non-profit community-based research organization which has the independence to pursue early testing of new treatment ideas, is seeking a Director of Clinical Research to replace its current Medical Director, Natalie Sanders, M.D. Candidates must have a current M.D. license, a strong background in HIV/AIDS, experience in clinical protocol development and trials research, and supervisory ability. Fax or mail a cover letter with salary history to: SEARCH Alliance, 7461 Beverly Blvd., #304, Los Angeles, CA 90036, fax 213/934-3919. ** AIDS Medicine & Miracles -- Seventh Annual Conference, Boulder, Colorado, September 29 - October 2 AIDS Medicine & Miracles, a conference which "focuses on creating a supportive, healing, retreat environment for PWAs, their loved ones and caregivers," will meet September 29 - October 2 at the Clarion Harvest House Hotel in Boulder, Colorado. Speakers include Joan Borysenko, Ph.D., Martin Delaney, Lark Lands, Ph.D., and Torkin Wakefield. For more information, call 800/875-8770, or 303/447-8777. Or write to AIDS, Medicine and Miracles, P.O. Box 9130, Maxwell Building, Boulder, CO 80301-9130. ***** California AIDS Legislation -- Action Alerts ** Medical Marijuana Legislation to California Governor; Federal Issues Both houses of the California legislature have passed a bill to allow physicians to prescribe marijuana for medical purposes. Governor Wilson has until September 18 to decide whether or not to veto the legislation. Letters to support this bill, S.B. 1364, Providing for the Medical Use of Marijuana, should be addressed to: Governor Pete Wilson, State Capitol, Sacramento, CA 95814. Also send a copy to the office of the sponsor, State Senator Milton Marks, 711 Van Ness St., Suite 310, San Francisco, CA 94102. Senator Marks is especially interested in hearing from persons who are suffering from effects of AIDS, cancer chemotherapy, glaucoma, or other serious conditions which marijuana might help. This legislation, which would change marijuana from a "Schedule I" drug (no medical use) to "Schedule II" (drugs like morphine, considered to have serious abuse potential but with legitimate medical use) will not by itself allow physicians to prescribe marijuana, because it will still be Schedule I under Federal law. But it will send the strongest message to the Federal government to change its policy to allow medical use. The bill has been endorsed by the California Medical Association, the California Nurses Association, the California Senior Legislature, and others. Comment Medical access to marijuana, which many patients with serious illness have said is the only effective relief for their condition, is supported by huge majorities throughout the country. But it is often hard to get politicians to respond. Both President Bush and President Clinton have been particularly intransigent; Bush ended a Federal compassionate-access program which had previously been in place, and Clinton decided to continue the ban, saying that more research is needed. The "more research" argument is a smokescreen; anyone who knows patients knows that marijuana works best for some, while Marinol (a legal oral drug which contains the main active ingredient of marijuana), works better for others. Optimum medical care requires that both be available; proof that one or the other works better "on the average" would not be very useful. And when a desired drug effect is inherently subjective, such as pain relief or appetite stimulation, both scientific sense and simple humanity suggest trusting the patient's choice of what works for him or her. The real reason for Clinton's opposition is that the marijuana issue was used against him in the presidential campaign (when he admitted having smoked marijuana but said he didn't inhale), and he wants to focus attention elsewhere. Meanwhile, according to a recent article in the Atlantic Monthly, there may be more people in prison now for marijuana violations than ever before; and people who use the drug for medical purposes can go to prison, in part because seizure laws allow money, cars, and other assets to be taken and used by law-enforcement agencies. Thousands of letters asking Federal officials for medical access to marijuana sit in boxes, while government refuses to respond. It may be necessary to develop tactics to continually embarrass the Clinton administration and other government bodies over the ban on medical marijuana. Politicians often refuse to do the right thing until other actions turn out to cost them more. ** Domestic Partner Legislation on Governor's Desk, Needs Support Limited domestic partner legislation has passed both houses of the California legislature, and is awaiting action by Governor Wilson. He has until late September to decide whether or not to veto the bill. This bill, AB 2810, is the first domestic partnership legislation passed by any state legislature in the U.S. According to the LIFE AIDS Lobby (a gay and AIDS lobby in Sacramento), "The bill, by Assemblyman Richard Katz (D-Los Angeles), will enable all committed couples in California to register as 'domestic partners' and assume certain responsibilities and limited benefits. To qualify, couples must maintain a common residence, share basic living expenses, and meet other simple requirements. Under the bill, domestic partners will be recognized for family visitation rights at healthcare facilities, legal preference to administer each other's affairs should one partner become incapacitated, and the ability to use a standard legal form to will each other property." Note this bill does not help couples obtain health insurance. This bill passed because it was supported by a coalition including gay and senior-citizen organizations. It is important for older people, many of whom cannot officially remarry without losing important pension and other benefits. Currently they are officially regarded as strangers when illness or emergency strikes. The bill is opposed by anti-gay legislators and organizations. Letters in support of AB 2810 should be addressed to Governor Pete Wilson at the address below. ** Other AIDS Legislation The LIFE AIDS Lobby has asked for support for two other bills, and opposition to one. Support: AB 3102 (by Martinez) designates the State Office of AIDS as the lead state agency for HIV and AIDS policies, as recommended by a University of California evaluation of the Office of AIDS. Support: AB 2610 (by Bronshvag), would allow local jurisdictions to create pilot programs for a one-to-one clean needle exchange. Oppose: SB 1239 (by Russell), would allow non-consensual testing for HIV in certain cases when a doctor or healthcare worker has experienced a "significant exposure" to a patient's blood. The bill has weak confidentiality provisions, requiring only "good faith efforts" to keep the patient's HIV status private. This bill is sponsored by the California Medical Association, opposed by the California Nurses Association and others. Address letters on any of these bills to: Governor Pete Wilson, State Capitol, Sacramento, CA 95814. Note: Do not address more than one bill in a single letter; always send a separate letter for each bill. Or you can call Governor Wilson's office at 916/445-2864, or 916/445-2841. (There may also be local office in your area; for example, in San Francisco the number is 415/703-2218, in Los Angeles it is 213/897-0322, in San Diego it is 619/525- 4641, and there are also offices in other cities.) When you call, it's best to know the bill number that you support or oppose. ** California Voter Registration Toll-Free Number A convenient way to register to vote in California is to call a toll-free hotline run by the California Secretary of State. You leave your name and address, and receive a postage-paid form which takes about two minutes to fill out. The last day to register for the important November 8 election is October 11. You must re-register if you move, change your name, or wish to change political parties. The voter hotline number is 800/345-VOTE. A Spanish-language hotline is also available, at 800/232-VOTA. The Secretary of State's office encourages organizations to publish these numbers for their members. ***** 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: Thom Fontaine Tadd Tobias Rae Trewartha 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 1994 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.