&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Copyright 1992 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #151, May 15, 1992 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] Immune Restoration Conference: Interview with Martin Delaney of Project Inform Epidemiology Study May Be Ended, Redirected to Vaccine Federal Research: Hidden Fund Shift Exposed Treatment Activism Update: Letterwriting Campaigns Announcements: Survey Asks Needs of People with AIDS Accelerated Approval: Public Comment Period Ends June 15 California: Prisoner Demonstration Rescheduled Berkeley: Primary Care Conference June 3 ***** Immune Restoration Conference: Interview with Martin Delaney of Project Inform by John S. James On April 25th and 26th in Washington, D. C., Project Inform convened an invitational conference of about 35 leading immunologists and other AIDS researchers, to focus on restoring the immune system, especially for persons with T- helper counts under 50. The scientists included Jean-Claude Chermann, Anthony Fauci, Robert Gallo, Alan Goldstein, Daniel Hoth, Tom Merrigan, Robert Redfield, Jonas Salk, Robert Schooley, Robert Yarchoan, Daniel Zagury, and others less known to the public. Some came from as far as France and Australia. Project Inform paid airfare and other expenses with assistance from pharmaceutical companies and other sources -- about $50,000 in all -- and provided the organizational support. Jesse Dobson of Project Inform organized the conference, and helped design the technical program. So that participants could discuss freely, it was agreed not to quote what people said, or to publish their specific data, without their permission. But most of those who are interested in this meeting and its results do not need the specific numbers, but rather an overview of what is most important, and in what directions the leading research is moving. To make this information available quickly, we interviewed Martin Delaney, co-founder of Project Inform, who attended the conference as a facilitator. We asked Mr. Delaney to start with a history of how this meeting developed. [Note: The interview includes some technical terms and concepts. These are explained in the glossary section, below. Also, note that our own explanatory comments within the interview are enclosed in brackets.] History, Goals, Organization Martin Delaney: "About two years ago Project Inform made an internal decision to direct its research efforts on late- stage disease and restoration of immunity...not out of any disbelief in the virus, but because everybody else was working on that, and there wasn't enough attention given to the immune-restoration area. Our ongoing goal is to facilitate research in this area. Over time almost everybody with the disease must confront the problem of the damage done to the immune system. "I first raised this issue in a talk at the community programs of the 1990 International Conference on AIDS [in San Francisco]. I challenged Fauci to help create a conference on this subject by year's end. We urged the Institute of Medicine program of the National Academy of Sciences, their Round Table on AIDS [on which Mr. Delaney serves] to host the first conference on immune restoration, a state-of-the-art review. We got that done in December of 1990. Then we held a second program, with some of the same people, in mid-1991 on disease pathogenesis. It became clear from both of these meetings that people in this field weren't talking to each other; just having them in the room at the same time led to a lot of learning and creative thought among them. So after that second conference we committed to somehow continue this process; the Institute of Medicine was addressing other topics at that time. But by that time we knew who the key players were, in the U. S. and around the world. "Later, when Jesse Dobson started Project Immune Restoration [of Project Inform], creating a third immune restoration conference was a natural task for him. "Also, I had attended a think tank sponsored by the Pediatric AIDS Foundation. They had been holding these meetings for some time, originally to guide them on how to spend their money. It was an informal setting, usually at a wealthy person's home or a private screening studio. There would be presentations, but mostly informal discussion among the people, with an experienced facilitator guiding it. At the end of that, they would try to decide collectively what the Pediatric AIDS Foundation would fund next. That process was different from what we had been doing at the Institute of Medicine." JJ: So different from the ordinary way that grants are awarded. MD: "I think it's a brilliant way to do granting; I wish we could do that with other foundation money, or with government money. There's so much less bureaucracy, and a much clearer sense of your goals. "Our recent conference combined elements of what we saw at the Pediatric AIDS Foundation with the Institute of Medicine programs. We sent out the invitations, and to our surprise almost everyone came. It's one thing when the Institute of Medicine of the National Academy of Sciences invites you to give a presentation; it's something else when a rebellious community group invites you. We had to turn people away. "We wanted people to be able to think freely, to be able to make mistakes, to try out new ideas (they're not allowed to do that, usually), and to sound off. So one of the commitments we made is no direct quotations, no press, and none of the specific data would be released. "Some of the information, because it's on the leading edge of the technology, is proprietary. There was a mix of people from industry and government; they had to all agree to come together with their pants down for this to work." Research Directions "Some of the researchers there said this was the first time in their ten years of working with AIDS that anybody had asked them to focus on the very late stage of the disease. They also admitted that the scientists and the government people had always been operating under the assumption that these people are written off. We've always suspected that; this is the first time I have heard them own up to it. "But having said that, they then said, 'That's an interesting challenge. Why is it all that different, say, from bringing somebody back after a bone-marrow transplant with cancer? It's not something that inherently dictates abandoning the patient.' It was a new thinking process for them, to begin looking at it in that way. "Another general consensus that evolved among them, comparing data from the seven different fields we looked at, was that when people had gone down to the 50 or 100 T-helper cell levels, there was far more resilience in the immune system than any of them would have anticipated just a couple of years ago." [Note: the seven fields referred to above are: cell line expansion (including cryopreservation); gene therapy; passive immunotherapy; soluble factors; stem-cell research; transplants; and vaccines.] JJ: Did they fail to find this resilience even lower, around zero T-helper count, or had they just not looked? MD: "They hadn't looked. They did not go that far with their data. "For example, one vaccine group had expected that the therapeutic vaccines would only show benefit in the over 500 T- cell group. As they extended it lower and lower, they began seeing response and reaction as low as 200 T-helper cells, and now they are going down to the 50 to 100 range. They're far below the level where they thought they would see a reaction." JJ: ACTG 106 [the earliest trial of ddC+AZT combination treatment] surprised us. MD: "Good example. The patients had a median T-cell level of about 70 when they began the treatment, and those people really moved up. "And there was also a strong sentiment among the researchers that response doesn't just mean more T-cells. Redfield (of the Walter Reed Army Institute of Research) was strong on the skin test as a test of functional immunity. This isn't the usual test with the same several antigens each time. They've improved it with a variety of randomly selected antigens. Otherwise, you might just be sensitizing people to a few particular ones [when the test is used repeatedly], rather than improving a general response." JJ: Could people obtain this test? MD: "I think it would be a great diagnostic tool, if physicians could have access to it. It gives you a functional measure of whether your therapy is helping a patient or not. Especially now, with the choice of three different antivirals, or no antivirals, how do you know which ones are helping? I think this test is done with a combination of commercially-available antigens. Redfield was eloquent about why it is valuable, instead of just looking at T-cells [to tell whether a treatment is working]. "One of the great issues in AIDS is how to measure a response to a drug. The government has finally agreed to T-cells as a surrogate marker, but everybody knows there are many exceptions to that -- for example, people with zero T-cells who are healthy. Collaboration "Another major outcome was the opening of new research collaborations among the group. It had never dawned on me that as a result of this meeting, they would right on the spot make some new agreements, but they did. "For example, one group at the National Cancer Institute agreed to work with the people doing the CD8 expansion with Kaposi's sarcoma (KS) -- which is a natural. "Before the conference, a representative from one company confided to us that he was nervous. He said they had been beat up or ignored for four years, because nobody would believe that CD8 cells were important, or that you could expand those cells once they were lost. But the next day he was one of the highlights of the show." JJ: It's hard to think that people are starting now to talk to each other after more than ten years of the epidemic. MD: "Why is it only now that these things are happening? Why is it that these people didn't even come together before? Project Inform is not the only foundation in town. It has taken us six, seven years to get in a position where we had the money and credibility to create something like this. Why hasn't this been going on every six months since 1985? Why isn't the government itself routinely doing it? "Dan Hoth (director of the Division of AIDS of the National Institute of Allergy and Infectious Diseases) met me for lunch the week before, said he'd heard about the conference, and that it was the kind of thing they should be doing. He asked, what would it take to get him into the conference? Of course he was welcome; but on a lark, I said you could start by giving us some financial help. To my surprise, they were able to pay several peoples' travel expenses; he did it in a day and a half. They can do things in a hurry if they want to. "Another collaboration: an Australian group is doing cryopreservation of cell lines; that has immediate importance. One of them is now talking with the CD8 expansion people, as he has demonstrated that freezing the cells is viable, and when they're thawed, they're functional. So by connecting his work to that of expanding the CD8 cells, you give people the opportunity to create their own cell bank, for use at a later stage of the disease." JJ: This fits with the work that just came out of Italy on superantigens and selective cell deficits (of CD4, i.e. T- helper, cells). MD: "Another collaboration is that a leading U. S. researcher wants to work with an Italian group which has been working with thymosin, a thymic hormone. The Italians have completed a three-arm study with AZT, vs. AZT and interferon, vs. AZT and interferon and thymosin, and that study appeared to show a rather dramatic benefit for the arm which included thymosin. This might tie in to work with IL-2. "Perhaps it is time to combine several such factors. No one of these thymic hormones or cytokines is going to replace everything that's lost. But some combination may be more effective than any individual one. "Another possible collaboration would be to combine vaccines with thymic hormones or other soluble factors. The researchers said yes, it made perfect sense. We pressed them, why not now? One of the vaccine experts invited us to meet to discuss a protocol for doing this; another was open to trying it later, but not for his existing studies. A third pointed out that he is already doing something similar, combining an antibody against interferon with a vaccine. The purpose is to give a turn-off signal to the immune response, so that overactivation doesn't continue. "On cell preservation (cryopreservation), discussions are underway to create a nonprofit foundation which would develop practical applications of the insights gained by Australian researchers and the CD-8 expansion people. [Then people could save blood or bone-marrow cells early in the disease. Later, those cells could be used to grow many more (outside the body, using special equipment). The descendents of the person's own cells would then be injected to replace cells which had been lost.] "These things were not going to happen before that weekend. You get something just by bringing these people together. "There are other conversations going on, but we don't know their outcome yet. These include the area of gene therapy. We pointed out that all of these efforts so far seemed to be devoted to the same thing, producing an internal antiviral response (inside the cell). We asked why not also use gene therapy to stimulate cell-line growth? The answer was, "Yes, we could do that." One researcher asked us to contact somebody else who may already be working on it. So they may connect, to see if the two approaches can be combined into a single gene-therapy approach. "There seemed to be a general agreement to focus on the under-50 T-cell group. This was new to all of them; they agreed that it could be done and should be done. We saw the redirection of gene therapy to at least begin addressing cell-line restoration. We had a heated discussion on whether so much effort should be given to creating a better antiviral response, if we are not sure that the disease pathology is caused directly by the virus. Initially there was a reaction, We said no, we agree that HIV is the trigger. But the question is, what is the bullet? "No one had a proven theory on how disease pathology proceeds. The group concurred that we don't know. Many argued that no disease has been conquered without first conquering the triggering agent. But meanwhile are there other things that should be done. Gallo said he thought it was very important to shut down TNF production. That led in to the cytokines and other approaches that could be addressed directly, with or without addressing HIV. The antiviral response we get today with AZT, etc. is significant and measurable. Therefore, why don't we see a better result in people? "We also had an intense discussion between two leading scientists over methodology. One asked what are the concepts, what are you trying to achieve, where are you trying to go? He was very strong on big-picture thinking -- 'And don't trouble me with the details.' Whereas the other will eat you alive on the details, but may be blinded on the big picture, where he's going. This led to intelligent discussions of the need for the different kinds of methodologies, and what the payoff is -- along with some admission about how neither side had been listening to each other for a long time, and it was important that they do so. "The meeting agreed to the continuation of the group as a standing think tank on restoration of immunity in AIDS, with regular meetings every six months. They agreed to work on the transcripts of the conference, and to attempt to publish a report on it in Science or Nature. "We also talked about how these communication difficulties seemed to be affecting science seriously. Should one of the functions of the think tank -- in addition to the scientific issues -- be to serve as a training vehicle for process, for scientists to work with each other in ways they are unaccustomed to doing? That's on the table; they have left it up to us to decide who the core of the group will be. We'll probably keep the big thinkers in, with some people coming to the meetings depending on the subject matter. "They made a pretty convincing argument that the immune activation research does not contraindicate using a vaccine -- as Montagnier and some others have suggested, fearing that therapeutic vaccines might make things worse in the long term. But the top vaccine experts at this meeting said there is no evidence of that They have had people on vaccines for three years or more, and there is no evidence of disease acceleration. The opposite was being shown, that there is evidence of long-term stabilization. Vaccines seem to be functioning as antiviral agents, but safe, nontoxic ones. "The roundup on the vaccine area was the commitment to consider therapeutic vaccines for persons with lower T-cells, and to combine the vaccines with soluble factors or antiviral medications. We will meet with the U. S. experts to try to develop protocols. In Europe, the problem is funding, as well as scientific rivalries. "On passive immunization [also called passive immunotherapy, or passive hyperimmune therapy], we contacted the Veterans Administration in New York, which has conducted a small trial of infusion of plasma which is rich in anti-HIV antibodies. They came to the meeting, but chose to talk about monoclonal antibodies instead, feeling that that was more hopeful than the plasma-transfusion approach. They are developing a number of monoclonal antibodies. Jesse Dobson convincingly argued that this approach should be accompanied by some kind of a diagnostic test, where the patient's virus could be exposed to different antibodies, to see which ones are most effective against it, since people have so many strains of virus. They agreed to that, at least to try to build a test around their antibodies. "In the stem-cell research area there seems to have been a shift in goals. There is now talk about commercializing stem- cell technology as a delivery vehicle for gene therapy. Everybody doing gene-therapy work needs a vehicle to deliver it. They need some kind of a cell, and the more primitive the cell, the better. "Our concern was where does that leave the original purpose, which was to begin rebuilding the immune system with these stem cells? That led to a debate about whether this approach could work, whether you also needed a functional thymus gland or not; immunologists are divided on that. "The Australians said they would be interested in combining stem-cell work with their thymic transplants -- given a break in the U. S. discouragement of fetal-tissue research, however. They will at least talk about this. "The stem-cell people also implied that regulatory and public-policy obstacles are being encountered against their research, and that the impact of these obstacles might be a delay in the planned human testing. That was hoped to begin this year, first in a breast-cancer patient this spring. If that went well, last year their plans were to try it in an AIDS patient by the end of 1992. They seemed to imply that that's not going to happen now, and that these obstacles are the cause of the delay. We said that if they would put the cards on the table, we might be able to help fight those obstacles. "The stem-cell technology was created for the project to develop the SCID-hu mice. Several years ago the goal was to set up facilities to test hundreds of antiviral drugs a month using these mice. But what we hear is that the company then became more proprietary, less willing to share. Nobody ever developed the large-scale use that was anticipated, and most of them said it was because of the price (of the mice). "Now you wonder if the same thing may be happening. The stem- cell work evolved from that technology for the mice. Researchers isolated human stem cells, and took bits of fetal human thymic tissue, and fetal human liver tissue, and implanted them in nude mice. The consequence of that was the generation of a human immune system in a mouse. "Initially the goal was to produce the mice for testing HIV treatments. But soon it became obvious that this work could also be the key to rebuilding an immune system in an AIDS patient; it only took a few human stem cells to generate the whole system in the mouse. The commercial efforts had seemed to be focusing on doing that, but now there is more interest in commercializing the stem cell as a delivery vehicle for gene therapy. Maybe now, after a major recent investment in this technology by Sandoz, it may be possible to do both. "In gene therapy, we were struck by how far along it is -- farther than most people believe. Some of the groups at the meeting claimed to have something virtually ready for human testing; but they are very nervous about the regulatory and policy obstacles. One group has a two-part gene therapy that they think can shut off most viral replication in the cells. They hope to get permission to move rapidly to human testing, building upon the success of prior gene therapy experiments -- that gene therapy can be developed like other treatments, and no longer needs to be treated as something exotic. We will get behind them on this, and see if some regulatory pressure could be released, so they could start testing. "Another U. S. researcher was urging the opposite approach -- to go slow, for fear of a backlash if something went wrong from a premature experiment. Researchers tinker in the laboratory, and don't always feel the pressure to take their work into human testing. We talked about the willingness to take risks in the research process, and go forward. Some of them agreed, and even thought it was important that they be reminded of that regularly. "The cell-line expansion got nothing but respect from the group. Others wanted to collaborate. There was some discussion about whether to expand all the CD8 cells, vs. expanding only the CD8 cells which make the antiviral factor which Jay Levy talks about, the cytotoxic killer cells which will kill HIV-infected cells. At least the activists in the room thought there might be a problem with the selective approach, because it banks everything on combating HIV -- whereas the principal benefit seen from CD8 expansion so far was an anti-KS effect, which probably was not mediated through HIV. So wouldn't you want to expand all the CD8 cells? There might also be cells specific to other diseases. The evidence was that there was no harm from expanding all the cells. "The Australians reported that their thymic transplant work had partly been put aside, because of a consensus reached at the first immune research conference in 1990, that you wouldn't accomplish much by doing thymic transplants without stem cells, and at that time the stem cells were not available. In the interim, the group has done the cryopreservation project, freezing CD8 and CD4 cells for later expansion and use. They've only done it with a few people, but apparently it has been universally successful; the cells are viable after freezing, and they can be stored indefinitely as far as is known. "Some researchers asked why not expand the CD4 population (as well as the CD8)? In the past, the stock answer to this question had been that some of the cells were infected. But that's only a small ratio of them. If you grow the cells, the worst you could do would leave the ratio of infected to uninfected cells the same, which would not hurt -- and you might be able to do better than that by treating the growing culture with antivirals. The immunology people agreed that this should be done; although nobody decided who would do it. That's on our to-do list. "There was also a review of the bone-marrow transplant data. That was a history of disappointment. For a while the treatment seemed to show benefit; but then the growing cell counts would hit a wall and collapse, usually within a year. The researchers' explanation was that this must be happening because virus is still there. We suggested that the problem might be due to other factors suppressing cell growth, factors we haven't identified yet. They said maybe, and moved on. "On the soluble factors, we had presentations from Italy on the thymosin study, from France on THF, and on IL-2. The IL-2 is probably the most thoroughly developed data, most intensively studied; it showed no evidence of boosting viral levels. [It had been feared that this drug might do so, since it stimulates the growth of T-helper cells, some of which are infected.] The drug produces a "sawtooth" effect, with T-cell counts rising rapidly after infusion of IL-2, then dropping again with time after the infusion. But over time, the trend remained above baseline. So it wasn't just moving cells back and forth, between the tissues and the blood, as some were suggesting; the data seems to show that there is some expansion of the population. IL-2 alone is not the answer, but it may be a part of it. "On thymic humoral factor (THF), a new study is being unblinded this May, so we did not see that data; all we saw was a summary of early phase I experience, which suggested that further testing was warranted. The researcher is also seeing elimination of live virus in the peripheral blood, using different culture methods to test -- even at very low doses of THF. "What is interesting about the soluble factors is that they're all showing some activity. Then why not try them together? None alone is enough by itself." Simplified Glossary CD4 cells. Often used loosely as a synonym for T-helper cells. Some other cells also have the CD4 receptor, which is a protein on the surface of the cell. CD8 cells. Another kind of immune-system cell. It is widely believed that these cells produce an unknown soluble factor which inhibits HIV. CD8 cells also appear to inhibit KS. CD8 expansion. Growing the patient's CD8 cells outside the body, in order to inject them back into the patient as a therapy. This treatment has been tested on only a few people so far. Cryopreservation. Freezing cells (especially CD8 cells) for use by the same patient later in the disease, in case the cells in the patient have been destroyed or damaged. Gene therapy. Adding new genes to certain cells (such as T- helper cells) to make them immune to infection by HIV, or for other purposes. IL-2. A protein produced by the body which stimulates the growth of T-cells. A genetically engineered form has just been approved by the FDA for use in treating certain cancers. SCID-hu mice. Mice born with severe combined immune deficiency (SCID), which have been given a human immune system by transplants of various cells. Stem cell. A cell in the bone marrow which can grow into many different kinds of immune-system blood cells. Soluble factors. Certain proteins and other substances (e.g. IL-2, TNF, alpha interferon) found in the blood. They may have either helpful or harmful effects on disease progression. Therapeutic vaccines. Vaccines used to treat a disease after someone is already infected or ill (as opposed to prophylactic vaccines, which only work as a preventive and must be given before infection). Thymic humoral factor (THF). A hormone produced by the thymus. Recently there has been considerable interest, especially in Los Angeles, in its possible use as an AIDS/HIV treatment. Thymosin. Another of the many hormones produced by the thymus. Tumor necrosis factor (TNF). A substance produced by the body, but which is often harmful because it is found in excessive amounts due to certain disease conditions. ***** Epidemiology Study May Be Ended, Redirected to Vaccine by John S. James Federal funding cuts at the National Institutes of Health will end or greatly reduce a major AIDS cohort study which has tracked the epidemic since 1984, researchers have learned. The issue now is whether this project will be dropped entirely, or continued in a greatly reduced form. There are also scientific and ethical questions about the particular vaccine work proposed to replace the study. But these questions have received little public attention so far. The Mens' Health Study The San Francisco Mens' Health Study (SFMHS), which may now be terminated, is not the only AIDS cohort. (It should not be confused with the San Francisco Clinic Study, which is funded by the Centers for Disease Control, not the National Institutes of Health.) But unlike other cohorts, the Mens' Health Study is population based; volunteers were recruited when researchers knocked on every door in one census tract in San Francisco. Because it followed all volunteers who met age and other qualifications in an area with a high incidence of HIV -- not just those who came to a clinic or otherwise were selected in some way -- it can answer certain questions about HIV spread which the others cannot -- questions such as how the proposed CDC redefinition of AIDS would affect the AIDS caseload, or (after the data is analyzed) how dangerous is unprotected oral sex. The frozen blood samples saved in this study will answer future questions which we cannot yet anticipate. The project had applied for and received its third four-year grant. Over one thousand men, gay and straight, HIV-positive and HIV-negative, were entered into this study. John Caldwell, a volunteer in the trial, learned about the termination because he has been active in a community advisory board which he and other volunteers set up so that they could have a voice in the conduct and direction of this study. (Caldwell has also been a volunteer with Project Inform for over five years.) Caldwell told us that in February the researchers were informed that their four-year funding would not be provided, and the project would be ended. But researchers could keep their support if they could reconstitute the project to use it for building an infrastructure for testing a prophylactic (preventive) vaccine. The scientists proposed that a small part of the epidemiological investigation might be allowed to continue, to phase down the study in an orderly way; whether this will be funded has not yet been decided. Vaccine Proposal and Questions This vaccine work would only be for testing a preventive vaccine for HIV-negative persons -- not a treatment for those already ill. Some experts believe that San Francisco may be the only place in the U. S. where a very large preventive vaccine trial would be feasible, since it has enough HIV infection in a large population of individuals who have been cooperative with research studies in the past. Several sites in other countries have also been proposed for vaccine studies. The San Francisco trial would likely require thousands of people and last for several years -- especially if the vaccine turns out to be only partly effective. This is because few people will become HIV-infected; therefore it will be difficult to get the numbers needed for statistical proof that the vaccine is better than the placebo. (There are smaller "phase I" tests of prophylactic vaccines, but these are looking for indicators of efficacy, such as higher antibody levels, rather than seeking direct proof that the vaccine prevents HIV infection.) No candidate vaccine is ready yet for the possible San Francisco trial. The purpose for redirecting the Mens' Health Study is to prepare the infrastructure (e.g. by obtaining data about the population) so that a trial can be started quickly if and when an appropriate vaccine does become available. One of the concerns locally about this study is that, since HIV vaccine technology is now developing very rapidly, any early vaccine put into a years-long trial will likely be obsolete long before the trial finishes. The great expense of running such a study might not lead to any useful result. Therefore it might be better not to rush into such a trial with the first possible candidate. The issue then becomes whether it is premature to prepare San Francisco for major vaccine trials before the first possible candidate has come into view -- especially at the cost of compromising a proven, productive study (the SFMHS). Caldwell also mentioned ethical concerns. For example, would a major research focus on preventive vaccines be in the best interest of the community participating in this trial (gay men in San Francisco), when so many are already infected and interested in treatments instead? Also, is it ethical to end the Mens' Health Study for financial reasons, after volunteers have participated for several years with the understanding that their doing so was important? For More Information For more information about either the termination of the San Francisco Mens' Health Study or the proposed vaccine project in San Francisco, contact John Caldwell, 415/206-1000. ***** Federal Research: Hidden Fund Shift Exposed by John S. James A memo leaked to the Human Rights Campaign Fund, a gay and AIDS lobbying organization in Washington, D. C., showed that almost a million dollars was quietly "reprogrammed" away from AIDS research and AIDS service programs to pay for administration at the National AIDS Program Office (NAPO). This recent fund shift was apparently unauthorized, since Congress was not notified as required. According to Terry Beswick of HRCF, Congress had deliberately cut funding to NAPO by $1.3 million in fiscal 1992, because the office was doing a poor job of coordinating Public Health Service AIDS programs. Beswick said that the fault was not with NAPO itself; rather "NAPO has not been granted the authority or responsibility to develop a comprehensive HIV plan...This is chiefly due to the fact that they have no decision-making power or authority. Conservatives in the Administration, including the Secretary [Sullivan], have prevented NAPO from asserting any leadership." Most of the cut that Congress had made was restored, without its consent, by the reprogramming, at the expense of AIDS research, prevention, and treatment. Beswick stressed that HRCF strongly supports the effective coordination of Federal AIDS programs, as proposed by the National Commission on AIDS. For more information on this and other Federal-funding issues, contact Terry Beswick at Human Rights Campaign Fund, 202/628-4160. [Note: The Human Rights Campaign Fund is the largest lesbian and gay political organization in the U. S. ; it employs five lobbyists, has sent 400,000 constituent mailgrams to Congress in the last three years, and will give a million dollars to political campaigns this year. It is best known for its "Speak Out" program, in which members authorize HRCF to send mailgrams to Congress at critical times on lesbian and gay rights, AIDS, womens' health, and reproductive choice. It also coordinates letterwriting campaigns, telephone trees, constituent visits to Congress, and volunteer help for political campaigns. At this time it is working on AIDS budget issues. To join any of these programs -- or to find out about paid canvassing work by signing up people at public events -- call the Human Rights Campaign Fund Speak Out program, 800/777- HRCF.] ***** Treatment Activism Update: Letterwriting Campaigns by John S. James In our March 20 article on AIDS treatment activism, we asked to be informed about other projects our readers could work with -- especially those suitable for persons who would like to begin doing this work. The following have come to our attention. This list is not complete; it would be impossible to make a comprehensive list. Instead, we will publish updates from time to time. If your organization or project should be listed, let us know. ** Citizens Network: Largest Letterwriting Campaign The largest AIDS-related letterwriting campaign in the country, with ten thousand members, is the Citizens Network, sponsored by AIDS Project Los Angeles, a major service organization. Citizens Network sends out a monthly Action Alert which briefs members on a critical current AIDS issue, provides a sample letter, and gives the address of a targeted elected official. Citizens Network tackles prevention, education, funding, and treatment issues at the Federal, California, and local (Los Angeles area) levels. Membership in Citizens Network is free and the mailing list is confidential. Recent Action Alert topics have included the Federal AIDS research budget, the California AIDS budget, and a California bill to allow needle exchange pilot programs. To join Citizens Network, or for more information, call Christopher Kush, 213/962-1600 x507. ** Treatment Action Network: Project Inform's Letterwriting Campaign The Treatment Action Network of Project Inform has started a letterwriting campaign specific to treatment issues. It is now focusing on the Federal budget, working together with Citizens Network, and with other AIDS service organizations. It also works on faster approval for drugs for serious or life-threatening conditions. Treatment Action Network has sent out extensive background information on major cuts now being made in AIDS research spending, and on the well-promoted myth of "too much spending on AIDS. " They have also sent sample letters, and suggestions on communicating effectively with the media, and with members of Congress. To join Treatment Action Network, or for more information, call Project Inform, 800/822-7422 (toll-free U. S. except California), 800/334-7422 (toll-free California only), or 415/558-9051, from 10 a.m. to 4 p. m. Pacific time, Monday through Saturday. ** Mobilization Against AIDS Lobby Team Mobilization Against AIDS is best known for its International Candlelight Memorial and Mobilization, which takes place in over 40 nations throughout the world each May. It also lobbies and organizes constituents of public officials throughout the year on funding and other issues important to people with AIDS. Its Lobby Team consists of persons who write letters, send postcards, and make personal visits focusing on the district offices of members of Congress, mainly the House of Representatives. MAA focuses on the Budget and Appropriations committees, trying less to support specific projects than to increase the whole pie, for a wide range of programs including education targeting people of color through the U. S. Centers for Disease Control, the Ryan White Care Bill funding, and funding for the National Institutes of Health and the Food and Drug Administration for more rapid development and approval of new treatments. Last year MAA generated several thousand letters and about 50,000 postcards in its campaigns. There is no fee to join the program. MAA does request a $10 donation for materials (background information packets on critical issues, and how to respond to them), but this is waived if people do not want to pay. MAA does insist that people tell them if they are writing letters; if they are not writing, they are dropped from the program. To join the Lobby Team, or for more information, call Mobilization Against AIDS, 415/863-4676, or write them at: 1540 Market Street, #160, San Francisco, CA 94102. ***** Announcements ** Survey Asks Needs of People with AIDS The National Association of People With AIDS is distributing 35,000 copies of a "Survey of Needs" to map out the major problems facing people with AIDS. Fifteen questions take up issues such as type and quality of health care, insurance coverage, financial security, emotional support and discrimination. Other questions deal with respondents' demographic characteristics. According to Paul Sathrum of NAPWA, "Until now, no one has documented what people with AIDS think their greatest needs are. This survey is kind of a run-through that will give us an idea of what to target in follow-up questionnaires." Survey results will establish priorities for public policy lobbying efforts. Community based AIDS organizations throughout the country are giving out the questionnaire, which should be sent back by June 1. If copies of the "Survey of Needs" are not available to you, they may be obtained by calling NAPWA at (202) 898- 0414. **Accelerated Approval: Public Comment Period Ends June 15 The U. S. Food and Drug Administration has formalized and published in the Federal Register a proposal for accelerated approval of drugs for serious or life-threatening illnesses. Written comments can be submitted through June 15. These comments will be considered in drafting the final rule. The published document combines elements of several proposals which have been made during the last two years -- by the Lasagna Committee, by FDA Commissioner David Kessler, M. D., and by the Council on Competitiveness. The procedures it formalizes are essentially those already used in the approval of ddI, and in the recent recommendation for the approval of ddC plus AZT combination therapy. The document also includes a separate provision allowing for approval of certain dangerous drugs only under restrictions specified by the FDA; examples of such restrictions include distribution only to specialized facilities or to physicians with specialized training or experience, or requiring that certain medical tests be used to monitor for dangerous reactions. The proposal specifies that "Drugs or biological products approved under this proposal will have met the requisite standards for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act...and thus will have full approval for marketing." The purpose of this statement appears to be to put the FDA on record as opposing discrimination by public or private health-insurance systems against reimbursing drugs approved under this provision. There are also provisions which affect pharmaceutical companies: for requiring postmarketing studies; for FDA monitoring of promotional materials used with accelerated- approval drugs; and for streamlined withdrawal procedures in case later research does not confirm drug efficacy. Comment We strongly support accelerated approval for drugs for serious and life-threatening illnesses. This proposal has enough momentum that it will probably be accepted without major weakening. There is some danger, however, since the pharmaceutical industry is likely to object to some of the provisions, especially for streamlined withdrawal of drugs for other than safety reasons. This could lead to industry pressures which would make the rule less usable, as happened with the "treatment IND" proposal of several years ago. Or some provisions might be considered so onerous that companies might not to seek accelerated approval even when they could obtain it. We do not know whether such problems were effectively worked out in advance. For More Information The accelerated-approval proposal was published in the Federal Register April 15, 1992, pages 13234-13242. Written comments should be sent to the Dockets Management Branch (HFA- 305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, Maryland 20857. For more information, contact Marilyn L. Watson, Center for Drug Evaluation and Research, FDA, 301/295-8038. ** California: Prisoner Demonstration Rescheduled The Sacramento demonstration by ACT UP/CHAIN (California HIV Activist & Inmate Network), originally scheduled for May 4 and announced in AIDS TREATMENT NEWS issue #149, has been rescheduled for June 1. The rally begins at 11 a.m. at the State Capitol, 10th St. and Capitol Mall. For more information, contact your local ACT UP chapter, or ACT UP/Los Angeles (213/669-7301; P. O. Box 26601, Los Angeles, CA 90026), ACT UP/San Francisco (415/563-0724; P. O. box 14844, San Francisco, CA 94114), or ACT UP/Santa Barbara (805/569-3299; P. O. Box 4899, Santa Barbara, CA 93140). Comment The date was changed because organizers felt the issue might be lost among the events and media coverage stemming from the verdict in the Rodney King police-brutality case. Also, many activists were arrested at a May 1 protest in San Francisco and jailed for much of the weekend preceding the Monday planned for the prison demonstration. On May 1 and again on May 8, hundreds of people were arrested in San Francisco when they attended peaceful, legal rallies (against the Rodney King verdict) and obeyed all police orders. Although the May 1 and May 8 events were not AIDS related, the new tactic of police traps and mass arrests against legal demonstrators who did not intend to be arrested threatens AIDS protests as well, and raises concern about other AIDS services in San Francisco. The arrests stem from the election of a new mayor, who took office in January 1992, and his recent appointment of a new police chief. It is widely believed that the purpose of the arrests was to please the mayor's conservative supporters, who are hostile to protests in general and seldom supportive on AIDS. ** Berkeley: Primary Care Conference June 3 "AIDS Update for Primary Care: Maximizing Quality and Length of Life," a one-day conference for physicians, nurses, emergency personnel and others involved in primary care of HIV positive patients, will by held Wednesday, June 3, 12: 30 p.m. to 8: 30 p. m., at Alta Bates Medical Center, 2450 Ashby Avenue, in Berkeley, California. The fee is $120 for physicians, $70 for nurses and residents. For more information, call Mary Grim, Medical Education Program Manager, 510/204-1420. ***** 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 415/255-4659 fax Editor and Publisher: John S. James Medical Reporters: John S. James Michelle Roland Denny Smith Reader Services, Business, and Marketing: Thom Fontaine Jason Heyman Laura Thomas 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 1992 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. &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display AIDS Treatment News [ATN] (RO): Select r/q/c/i/d/e/h/p/g (or ?): -- ------------------------------------ Jack Hamilton jfh@netcom.com P. O. Box 281107 SF, CA 94128-1107