&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Copyright 1993 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #169, February 19, 1993 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] Immune Restoration Conference Plans Late-Stage Treatment Research Clinton: Setting New Directions on AIDS, Part II Political Phone Cards: AIDS TREATMENT NEWS San Francisco Edition Announcements PBS Documentary "Healing and the Mind" Starts February 22 Movie, "Lorenzo's Oil" HIV-Related Speech, Hearing, and Vision Loss Conference, San Francisco Feb. 26 Off-Label Reimbursement Denial: Major Survey Begins ***** Immune Restoration Conference Plans Late-Stage Treatment Research by John S. James On the weekend of January 23, over 25 leading AIDS scientists from government, industry, and academia, and from as far as France, Swedend Australia, attended the second meeting of the "Immune Restoration Think Tank," held in Rutherford, California and sponsored by San Francisco-based Project Inform. (See AIDS TREATMENT NEWS #151, May 15, 1992, for information on the first immune restoration conference, held last April in Washington, D. C.) Funding was provided by Project Inform, with the help of corporate and individual donations. This event differed from most scientific AIDS conferences in several ways: * The invitation list included over 25 top scientists, all but two of whom showed up. Names most likely to be known to our readers include: Daniel Zagury, M. D., Robert Schooley, M. D., Robert Redfield, M. D., Thomas Merigan, M. D., Clifford Lane, M. D., Robert Gallo, M. D., John Dwyer, M. D., (see AIDS TREATMENT NEWS #164), and Nobel prize winner David Baltimore, Ph.D. Anthony Fauci, M. D., was expected but had to cancel due to events in Washington. * Participants were asked to focus especially on developing treatments for late-stage AIDS -- for example for persons with T-helper counts under 50, who have often been ignored in research and excluded from most clinical trials. * The scientists were divided into four teams; two were asked to create plans for developing the best treatments in 12 months, and the other two teams were given a 36-month time frame. On the first day, they were asked to create ideal research strategies as if there were no resource limitations; on the second day, to plan for the real world. * Project Inform is coordinating ongoing followup to (1) document the research strategies which came out of the conference, giving all participants a chance to make corrections and sign off on the finished product, and (2) "market" the recommendations to pharmaceutical companies, government agencies, and others, to gain the cooperation necessary so that the research can actually occur. * The conference took place on the Northern California estate of movie maker Francis Ford Coppola, who led the group in theater exercises before the meeting to create an atmosphere for teamwork, unlike the individualistic, competitive atmosphere of most scientific meetings. (Coppola is developing a movie about AIDS research; however, no filming was done at this conference.) The details of the research directions proposed and the consensus reached are currently being drafted for submission to the participants for corrections. In general, the 12-month plan focuses on progress in treatments already in clinical trials; the 36-month plan also considers improvements in critical technologies which provide a basis for better diagnosis and therapy. [Note: some parts of this article, below, include technical terms which are not defined here. Readers do not need to know these words in order to understand the rest of the article. We included them so that scientists and physicians will know what was discussed at the immune restoration conference. We expect to explain these terms and concepts in future issues of AIDS TREATMENT NEWS.] The 12-month plan will likely include development of: * Antiviral strategies, especially laboratory and phase I studies to determine the best three-drug combinations, then six-month trials of these, measuring CD4 counts, viral levels with PCR and other techniques, opportunistic infections, and other indicators of efficacy; * CD8 and CD4 cell expansion and transfer; * Exploring antiviral activity of supernatant from CD8 cells of asymptomatic seropositives; * Adoptive cell transfer between identical twins; * HLA-matched transfers; * Passive immunity studies with IVIG, and with CMV antibodies; * Maximum opportunistic infection prophylaxis; * Restoring cytokine balance (e.g., the current pentoxifylline trials); * Measuring effects of GM-CSF and M-CSF (macrophage colony stimulating factor) on antigen presenting cell function in patients; * Monitoring results of thymosin-alpha with IL-2; * Possible use of growth factors and gene therapy. We intend to cover the 12-month plan in more detail, and to look at the 36-month plan, when more information is available. Interview with Jesse Dobson and Martin Delaney The followup to the conference is being coordinated through Project Immune Restoration of Project Inform, by Jesse Dobson, Brenda Lein, and Martin Delaney. In early February AIDS TREATMENT NEWS interviewed two of the coordinators about what can be done to see that the research recommended by consensus of the scientists actually gets carried out. ATN: What came out of the conference, and where will it go from here? JD: We developed two plans, one for what we could do in 12 months, and another for 36 months, to find the best ways of reconstituting the immune system of persons at a late stage of HIV disease. The scientists divided into four teams -- two for each time period -- and there was an amazing amount of overlap between the groups, and agreement within each groups. All the scientists pretty much wanted to do the same things. Unfortunately it's not what is now being done. We created steering committees to flesh these plans out: what needs to be done, where it needs to be done, who it needs to be done by, who it needs to be done to, and what lab tests are required, to optimize our base of knowledge when it comes time to write these protocols. Also we will coordinate with the FDA and others -- there were FDA people at our meeting -- so that they can prepare, so that when we come to them for approval they will already know what is being done and why. There is also the funding issue. Once we have these plans on paper, with these names attached to them, we have a product we can sell -- to the Clinton administration, to Congress, to industry, to academia, to the NIH. Hopefully, we can sell the idea of them working together on this. We have to persuade the necessary parties to get the money to do this, and the permissions from the FDA and others. MD: The other challenge is that doing this work requires integrated research, instead of segregated research. So much of existing research is not about curing a patient or ending a disease, it's about licensing a drug for sale, or a process. If that happens to benefit a patient, great, but the research is organized for commercial goals. But here, the object is an overall biological outcome in the patient. And to make that happen will, in many cases, require coordination with multiple pharmaceutical products, multiple blood products or technologies, and probably more than a single institution to bring these pieces together. I don't know where that coordination should be happening, whether the government should be capable of doing it, but clearly it is not happening. So for the moment, we're just going to do it. ATN: What will be the administrative structure to bring this about? Are these 12-month and 36-month plans for particular clinical trials? JD: Particular integrated approaches. Not just clinical trials; for example, for CD8 expansion, there are several techniques to optimize the growing of cells with the best function. This kind of research can be done in a coordinated way around the world: some people look at IL-2 and PHA, some at adding IL-4, some could use anti-CD3 instead of PHA. These are approaches the scientists thought needed to be investigated, but many would be left uninvestigated if there is no overall plan, since often there is no commercial motive. ATN: For the ongoing initiative to make these things happen, will Project Inform take this and keep running with it? MD: The collective weight of this group will be used to make it happen. If the policies and programs get blessed by this list of over 25 people, including a Nobel prize winner and the rest of them, it gives it an authority none of us have alone. JD: We're just going to do the administration, keeping it together, having steering committees which include some of these scientists and others as well. For example, if a steering committee concludes that a particular technology needs to be done, and we need a particular substance to do it, and the company that makes that substance is not particularly interested, but their director of research used to go to school with one of the scientists in this project, then that scientist will call. We're going to play every angle we can to move it forward. MD: That angle is already being played on the continuing development of PEG-IL-2, because that has essentially been blocked by Chiron's disinterest in the drug. But now we have members of the committee weighing in on that process. ATN: How did you set the tone for the weekend? JD: The whole weekend was to first promote camaraderie, to make the scientists feel like part of the group instead of rivals, and also to promote creativity, as opposed to having to promote their own particular approach. In everything we did, those were our themes. Now we go to followup, let's go forward together. On both the creativity and the camaraderie, Coppola's participation was unique, something we couldn't have provided without somebody like him. MD: He had some theater exercises; I think it was very important for the atmosphere of the group. ATN: How can people support this process now, in the followup stage? JD: I need help in monitoring what's going on, to do the administrative followup, the faxes, the conference calls, the flights to companies around the world to talk to them about making their drugs or technologies available. The more assets we have, the more we can do of whatever it takes. MD: Not all the steps of this plan need to be done in the same place, or even as part of a single plan. There are some elements that, just by being publicized, may trigger the experiments happening in other locales. And that's OK. JD: As long as we know about them and learn from them. Hopefully people will contact us to say that they've seen our plan, and they're doing parts of it anyway, and to ask whom they should contact to see that their information is coordinated. And we need community volunteers for tasks such as transcribing tapes of meetings, helping make phone calls, faxing documents. And we need support from people with scientific expertise. I've been looking for that for a long time. And we need political support. People with late-stage disease have long been left out, and we're trying to get put into the overall agenda. So we need your help in writing your Congressperson, or the Clinton administration, or a pharmaceutical company, whatever. MD: One example of a need is getting the word out to people with AIDS who have an identical twin. Work has already been done with a treatment called adoptive lymphocyte transfer, with considerable success. Now it's also being done at the National Institutes of Health. But in the past, people have only heard about the bone-marrow transplants, which have pretty much been disastrous as a treatment for HIV. But this new approach, which is much less invasive and appears to be much more successful, can readily be done now for people with an identical twin. Recently I spoke on this at a meeting of a church group, and there happened to be someone in the audience who had a twin and was in desperate need of just this. So we have already referred him to where he can get the work done. JD: Another important message to get out concerns saving your own blood cells. In 36 months, people with 300 T-helper counts now may be those with 50 T-helper counts then. There are technologies being developed right now for cryogenic preservation (freezing) of bone marrow and cells. It wibe much easier to do cell transplantation with the patient's own cells than with any others. ATN: If somebody reads this and says, "I want this done," where do they go? MD: We had plans to get this going after our last meeting. They fell through when the company involved pulled out. Now we're trying to work with other companies to set this up. The scientists were just about unanimous in the value of that technology if we could make it available. JD: If this is to be made widely available, it will have to be through a private organization, either a nonprofit or a business. Government research programs could only do it for a few. ATN: Could this be done by existing blood banks? MD: We want to see if the people who have parts of the technology on hand could invest in the parts they don't have. JD: The big problem is that most of the groups sophisticated enough to do this process don't work with HIV- positive blood, and you need to have separate facilities for that (to avoid the possibility of an administrative mistake in which someone is accidentally given HIV-positive blood). Also, there is the expense of obtaining a programmable freezer. And you have to demonstrate the ability to properly store and track the samples. MD: A task for us is to have an early meeting with the FDA to talk through what the requirements will be. ATN: We have to work together to get this on the public agenda. MD: Yes. ATN: If it's potentially within reach, then it's easier to get it on the agenda than if it's just an issue that people may want to work on but there's no possibility that they could get it done for themselves. It's too much to expect that people go to Australia (where the only clinical trial is now under way) to get this done. If we can find a way to do it even on a small scale in this country, that would help a lot. ATN: Before the meeting Dr. Dwyer (who is conducting the cell preservation trial in Australia, and came to California to attend the immune restoration conference) told us that he wanted to talk with Dr. Redfield about combining his work with the work on vaccines, so that you could educate the cells before freezing them. Did anything come out about this coordinated effort? MD: That's part of the plan. JD: But if I were a potential donor now, I wouldn't wait to harvest cells, but would want to go ahead now. ATN: How enthusiastic were people at the meeting to actually begin cryogenic preservation of one's own cells on a larger scale? JD: They are enthusiastic, but nevertheless realistic. They're counting on us to come up with this product (the plans with the scientists' backing) to sell, to push back some of the barriers that they find when they try to work together this way. The institutions, the patent rights, etc. lead to a system of secrecy and rivalry that makes it hard to move forward. They are counting on our leadership with their support for making the system more flexible, to allow them to do this type of coordinated research. It will be important for the AIDS community to support us in this effort. ATN: You mentioned the Merck drug L661, an antiviral. How did that come into this meeting on immune-based therapies? JD: People thought that when we tested some of the immune therapies in people, we would also want the best antiviral possible. They recommended some laboratory and human testing of combination antivirals. They expressed regret that L661 was not available for the testing they wanted now. MD: There is a human study going forward with the three- drug combination of AZT, ddI, and nevirapine, the Boehringer Ingelheim drug; the Harvard group reported at Amsterdam that a similar combination with L661 (pyridinone) produced a dysfunctional mutation (abstract # P. A 2450). But this study, which has started or will soon begin, is only for people with T- helper counts above 150. What we need is to also recruit a cohort with lower T-helper counts, so we will also learn how well the combination works in that group. The group seemed to feel that the L661 would have been the better drug in this combination trial (since it had been used in the laboratory test), but it wasn't available because Merck wasn't interested in playing ball in this study. We have to work on Merck for that. [Note: Merck is doing other testing of L- 661.] JD: The tat drug is another obvious one that we would like to see in combination. ATN: What did the scientists think of thymus cell transplants? JD: That's one of the 36-month plans. We need to know more about how the thymus, and stem cells, and therapies for those, have a role in immune restoration. The steps include doing a workshop in bone marrow, studying autopsies of the thymus at various stages of diseases which we don't have right now, learning how to evaluate the state of the thymus without taking it out -- things like that haven't been done. Also, looking at the bone marrow at different stages to find what we can do. The issues they identify are: how do cells reject these kinds of grafts, how does the age of the donor affect the ability of the cells to still be useful, using thymus cells from other people and possibly from animals, and what kinds of T-cells do they generate? We also need to characterize the function of the cells, how the growing process could optimize this -- and how the cells could be grown to last longer when put into the patient. Comments from Scientists On the last day of the conference, five of the scientists -- David Baltimore, John Dwyer, Robert Gallo, Thomas Merigan, and Robert Schooley -- answered questions at a press conference organized by Project Inform. The following is from our recording of that press conference: Dwyer: I'd like to congratulate Project Inform for very constructive activism here. Those of us who care for people with HIV know how important it is to come up with strategies to help people who have fairly advanced disease...There has to be research on how to help those people. The excitement of being with colleagues who all have something to contribute I find most stimulating, and I think good things are going to come out of this approach to science. Schooley: What's most striking to me is the sense of what's possible in the next 36 months -- if we can put the resources together in an organized way, we could see major changes in the next 36 months, if this is done right...In a meeting like this, all the possibilities are thought of in a neutral way, and in a way that in the long run people can integrate. Baltimore: This meeting is the kind of thing that should have been happening all along for the last decade. Maybe it presages an attempt to evaluate the programs that have been going on over the last decade, to put them in the perspective of the disease as it affects immunity, and develop a more strategically oriented research program for the Federal government. Merigan: I think this is a product of a maturation of the relationship between activists and investigators, rather than necessarily government oversight. It's involving government, industry, the people doing the studies, and the people who will be studied. It's coming out of private, nonprofit support, and that is exciting. Dwyer: Yesterday we were invited not to be inhibited, to put forward ideas that might turn out not to be practical. Today we were asked to be more realistic. As we refined the opportunities it became clear that the sort of collaborative effort that is going on this weekend among scientists, that if we don't get the same sort of enthusiasms for moving forward together from regulatory bodies, from high-tech companies, from drug companies that are working on a new drug, if they are not prepared to enter into this same sort of collaborative spirit to really accelerate practical research, then much of what we were talking about today won't come to fruition. I would like to think that our enthusiasm for this whole process will be translated back to Washington, back to a number of the companies that are involved in working on one small piece of the jigsaw puzzle so we can put the pattern together that much faster. Schooley: It is striking that yesterday we tried to develop these 12 and 36 months plans without any constraints philosophically on what we were doing; today was a supposedly more targeted and practical discussion. But the actual plans we came up with are not that different, which argues very strongly that when we're thinking philosophically, when we're thinking practically, we have the tools; it's just a matter of turning ourselves loose to use them. If we can do that, we should have major progress both in our approach to this disease, and also in thinking about how we should approach other diseases. Gallo: In the end, sometimes in the laboratory you're doing work on pathogenesis and come up with an idea for something you think is useful therapeutically, but we at NIH are limited by the chance that the industry will be interested, or what is their position on that approach, or is there a company that will drive something forward and produce a product. (Press): Do you have a wish list for President Clinton? Merigan: The opportunity in biomedical research is unprecedented now. And to have us constricting, and perhaps lose our leadership as a country, is a real loss. The Clinton administration will get a return in keeping alive one of America's strengths if we do the right thing with this problem. Dwyer: The socioeconomic costs to the country of not coming up with solutions to this problem, as people require more and more care, and it's expensive care, and in the most productive phase of their life can't contribute in the way we would have liked, those costs are staggering. Any money spent that reverses those trends is a very cost-effective way to go. Schooley: We are moving from an era in which all the drugs have been basically of one class to an era with drugs of multiple classes coming along, giving us an opportunity to combine these drugs. Major new theories suggest ways of inactivating the virus by using a sequence or combination of drugs in a specific way...In 1985 and 1986, the average life expectancy of someone who presented with pneumocystis was five or six months; we're now five or six fold better than that, with the very limited tools we have had in the last five or six years, one very limited class of drugs, and focus primarily on one specific opportunistic infection. With the tools being developed now, we might make the same five or six fold improvement in survival. This is a time for optimism. When you have these tools available and want to apply them, to see the resources constricting is enough to drive one crazy. This is the time to use all these tools and be innovative...The focus of this conference was removing the barriers that have slowed us down in the past. (Press): What are your barriers? Part of it is the culture in which we all work. At this meeting we had people from government, people from academia, from industry -- usually we don't talk together very well. We tend to think about isolated projects, with individuals working on specific areas, but we don't think about how to integrate that into the overall picture, how to have resources flow in a rapid way as we should, as new leads are developed, and how to integrate the advances in one area rapidly in another. (Press): Could the FDA help in problems with pharmaceutical companies? Gallo: I don't know if the FDA could affect that. It's one of the real obstacles that there's not a clear solution to. You can form collaborative research agreements very easily with companies. But suppose our research indicates that a compound is very important to go forward. Very often they're very enthusiastic and it fits right in, and it's wonderful, and you go forward. But if they' not enthusiastic, or don't have enough capital at the time, or don't have the patent priority, that's the problem. Also, we have more administrative blocks now than when I came to the National Cancer Institute in 1965. It was significantly easier then than now for experimental testing, and just getting clinical specimens. We've had new administrative regulations and rules in the last three to four years; to get a (blood sample) for any studies requires going through one or two committees. To analyze a sample that comes from abroad is even worse. We've lost wisdom, balance, logic, for the sake of the rule. The analogy I give is the sign that says don't step on the grass, and a man is dying of a heart attack on the grass. I'd like to see a committee to protect the scientists, that says you won't get in trouble for using clinical specimens, because somebody else will watch that. Baltimore: The NIH is a remarkable organization for the funding of basic research. It brings out the best that America has to offer, it evaluates it very clearly, and it funds with a reasonable sense of priority and expense. That's fine for setting the base of understanding. It's not necessarily fine for developing a focused program. In a focused program there are real needs, and those needs may or may not be met by the existing pluralism of the scientific community. There should be somebody who can say that there's a hole in this puzzle that needs filling, and go out and encourage the filling of that hole, trying to find the very best people. That's an authority that, as far as I can tell, nobody has in the Federal government; certainly if they have it they don't use it. The solution certainly involves having a strong figure at the head of the research program, a leader who has the authority of oversight over the whole research program. I think Dr. Fauci has made a major contribution to the AIDS program and to American research, but he is limited by not having authority over the whole program; the programs are divided among various institutes at the National Institutes of Health and they should be coordinated together. There's a very great need for coordination of industrial, university, and government activities, and we should look at what it takes to do that. The notion of a czar is just a word, the notion of a Manhattan project is a convenient word, for saying that we ought to be looking at this in a different way. Merigan: But we have to maintain diversity, because this isn't a problem that any one human being can structure completely. Baltimore: Look at the Manhattan project; it was the best brains in physics getting together to solve a problem. It was a pluralistic program from the beginning. Since they didn't know exactly how things were going to end up working out, they started down many different lines. You don't give up the diversity in a focused research program, but you do have some sense of where you're going and what it takes to get there. Dwyer: The attractiveness of what we're doing this weekend in a mini way, if it were expanded, is that you're likely to get infinitely more return on the dollars you spend. You're going to need more dollars, because what we're talking about is going to require considerable resources. But you get more return on your money by bringing together people who can cross-fertilize and stimulate each other, and come up with the major holes in our story that need to be plugged before we can go forward. Merigan: A broad consensus of investigators and activists coming together, and going in the same pack, can really move the process when there is a barrier on the company side. Schooley: When we are running a clinical trial we are asked to test if this drug works. We as scientists want to know if the drug works as well, but we also want to be asking about the disease process at the same time. So whether the drug works or doesn't work, we've learned something else about the disease, allowing us to come up with more innovative and useful approaches. But if the trial is sponsored only by a drug company, and if within the company the interest is only to market their drug, you don't have the resources to ask the kinds of questions that will let you make the next leap. More and more drug companies are seeing this, and realizing that their progress will be enhanced by being able to ask these deeper questions. This is not going to be a disease cured with one drug, but with multiple approaches. As companies realize that they work together; that's one of the healthiest things I've seen in the last several years. Note: If you can help in any way -- with contacts, scientific or other expertise, volunteer office help, money, or otherwise -- call Jesse Dobson or Brenda Lein at the Project Inform office, 415/558-8669 on weekdays. ***** Clinton: Setting New Directions on AIDS, Part II by Keith Griffith Note: Part I of this article, published in AIDS TREATMENT NEWS #168 (February 5, 1993), examined two areas the new administration pledged to address in the campaign: appointment of an "AIDS czar," and funding levels. A Manhattan Project No single campaign pledge will more directly impact the search for AIDS treatments than the call for a "Manhattan Project" -- recalling the massive government research and development effort in World War II to develop the atomic bomb. David Baltimore, Ph.D., a Nobel-prize winning scientist at Rockefeller University in Manhattan, applauds Clinton for including in his campaign the call for accelerated research: "I would say that more focused research -- that integrated the various aspects of government programs, that dovetailed closely with private industry and that particularly had the committed involvement of the best brains in the external scientific community, external to National Institutes of Health (NIH) -- is something we desperately need." Exactly what will develop to fulfill this pledge is currently a focus of attention and debate among many activists, researchers, and government officials. Just how important could an accelerated research program be to keeping people with HIV alive? Martin Delaney of Project Inform told us that he "believes the pieces are out there that can be used to fairly dramatically change the outcome of this disease. But there are currently enormous obstacles to integrating those pieces." Delaney adds, "I think we could make much more of what we already have, even with no new AIDS treatments, by better using what is already known." Senate Bill 1 The first significant opportunity for structural reform of government AIDS research is already underway. Senate Bill 1, the NIH Revitalization Act, would consolidate planning, budgeting, and oversight of all NIH AIDS research into one office, the Office of AIDS Research (OAR). Under this plan, research would continue in the various institutes at NIH; there would be no separate AIDS institute. However, the OAR director would be given considerable powers to coordinate research across institute lines. Some proponents of the bill believe this will allow NIH to take the lead in developing a greatly accelerated and well- organized "Manhattan Project." Opposition to the bill is mounting. Sources who did not wish to be identified told AIDS TREATMENT NEWS that persons within NIH have orchestrated a campaign to weaken key aspects of the bill, in spite of the support of their new boss, Health and Human Services (HHS) Secretary Donna Shalala. This campaign is evident in articles that have begun surfacing in the press. In a story in Science (Volume 259, January 29, 1993, page 587), headlined "NIH Panics Over AIDS Manhattan Project," Richard Stone writes that "officials from the NIH are concerned about how Congress intends to organize the power shift, with activists obtaining more influence...and NIH management becoming less powerful." New York Times (February 7, 1993, page 3) and Los Angeles Times (February 9, 1993, page A6) articles have also reported that the NIH is opposed to reform. In spite of these attempts by some within NIH, public support has been growing. Among those who have written or spoken out in support of the bill are some of the nations leading AIDS scientists: David Ho, M. D., Thomas Merigan, M. D., Ellen Cooper, M. D., Donald Abrams, M. D., and numerous others. Mark Harrington of Treatment Action Group, which along with the AIDS Action Council, spearheaded the fight for passage of the bill, told us he is very concerned that compromises made to appease NIH may ultimately distort the intent of the bill. "We are asking NIH to institute major changes with this bill and there is resistance. However, I would remind these government officials of the president's call for all Americans to adapt to new ways so that government works better for the people it represents." Harrington is particularly concerned about budget authority in the bill. "Without considerable budgetary authority, the real power we had hoped to see vested in OAR will not come about. We will continue with a mere figurehead and no one in charge at NIH. " Harrington suggests that opponents of the bill with a vested interest in NIH may wish to seriously reconsider their strategy of seeking to undercut reforms currently up for a vote in Congress. "They don't seem to recognize that far more radical reforms are circulating out there and will no doubt surface should this package be shot down or made meaningless." Other Proposals Larry Kramer, who many consider the father of AIDS street activism, urged that, "The research arm, where we go from here, must definitely be taken out of the control of NIH...It has got to be placed in a separate entity and given emergency powers...There is no way we will ever get a cure if it (AIDS research) stays under the aegis of NIH. " Kramer contends that "there has never been a cure for any major illness" from NIH. ACT UP/New York has proposed creating a research program "jurisdictionally separate from the NIH," establishing one central location for a special AIDS institute. While NIH would continue conducting AIDS research, it would have to compete with a separate agency that would be granted extraordinary powers to carry out the explicit mission of curing AIDS. Advocates for this position seek to borrow heavily from the original Manhattan Project. But almost no one we spoke with for this article supported modeling AIDS research directly on the World War II example; some noted that the situation we face today with AIDS is very different from building an atomic bomb. Lenore Herzenberg, Ph.D., a researcher at Stanford University, reminded us that scientists converged on Los Alamos with "many of the key questions already answered. Einstein wrote a letter to the president saying we could do this. Who is going to write that letter right now?" Because there are many proposals of how to accelerate research, Martin Delaney suggests that a good starting point would be to convene a "blue-ribbon assessment and recommendations panel" whose goal would be to determine "key next steps in AIDS research, as well as proposing the specific model for some form of more directed research." Delaney is aware that many will bristle at the idea of one more commission, but he is prepared with a counter-argument: "Yes, we have had commissions and panels, but none of them have addressed these sorts of fundamental research questions. This failure is why the effort continues to go in circles year after year." He adds that any panel should be required to complete its work in as little as 3 months. Are We Ready For Clinton? The new president is moving rapidly to fulfill some of his campaign promises regarding AIDS. As we go to print, his HHS Secretary has signed an order that will remove restrictions on immigrants with HIV, though as we go to press the order has yet to be issued. He recently announced that a strategy to fully fund the Ryan White Care Act (which supports direct services in heavily impacted cities and states) has been authorized. As reported above, his administration has thrown its support behind the NIH reform package. All of these moves are also bringing the president under fire from opponents of reform. But so far the AIDS community, and the organizations at represent its interests in Washington, have not beeable to counteract our opponents with any sizable grassroots support on any of the AIDS issues the White House is moving forward. One source we spoke with categorized our ability to generate grassroots support as "abysmal." One of the few people we spoke with who was willing to go on record with his concerns is Tom Sheridan, who once worked for AIDS Action Council, but is now a lobbyist in his own firm. "I fear we have gotten off to the wrong start with the Clinton White House. A friendly White House requires as much, if not more, advocacy efforts to get the president's agenda through Congress." When this reporter contacted AIDS organizations in Washington the morning after Clinton announced a strategy for full funding of the Care Act, it appeared to us that everyone was scrambling to find out what the plan was, rather than having actually had input with the administration. Sheridan admitted he was also in that position and added, "Big decisions are being made now in the White House, and the president is with us, but I would like to have some friends in there right now." Getting AIDS leaders inside the administration appears to have been one area where AIDS agencies failed. We contacted several national and two community agencies (AIDS Action Council, NAPWA, AmFAR, Treatment Action Group, Human Rights Campaign Fund, Gay Men's Health Crisis, San Francisco AIDS Foundation) to ask specifically if they were aware if names had been submitted for possible appointments either in coalition with others or independently. Only one agency we spoke with, the San Francisco AIDS Foundation, told us they put together a list of names. Many others offered that it had been done unofficially, but many we spoke with felt it would have been politically impossible for AIDS organizations to agree on a set of names to put forward. Comment Examples of this lack of leadership may become increasingly apparent now that the AIDS agenda has the support of the president. If organizations and their constituency continue to fail to generate significant support for the president's agenda, how long will it be before he decides it is no longer politically worthwhile? The AIDS community must learn the importance of writing letters, sending postcards, telegrams, faxes, e-mail, and making phone calls to the White House and Congress. Local groups should arrange delegations to meet their representatives on a regular basis to make it clear how important the AIDS agenda is to their constituency. [See "Political Phone Cards," below.] Whether or not this community and its organizations are ready, the need to mobilize is urgent. Senator Jesse Helms (Republican, North Carolina) was expected to attach an amendment to Senate Bill 1 this week that would legislate the exclusion of immigrants with HIV, the same ploy he succeeded with in 1987. If such an amendment emerges from both houses of Congress, the president may very well feel compelled to veto the entire bill, dashing hopes to reform AIDS research at NIH. Rene Durazzo, Public Policy Director of the San Francisco AIDS Foundation, feared that we could lose the immigration vote on the Senate floor "because we are not prepared to back up our president on any of these issues." Until the AIDS community and its national and local organizations can generate grassroots campaigns to support the necessary policy reforms, no amount of leadership and new direction from President Clinton will succeed in reversing this nation's failures on AIDS. ***** Political Phone Cards: AIDS TREATMENT NEWS San Francisco Edition AIDS TREATMENT NEWS is publishing a business card with the most important phone numbers to call to support the AIDS community on federal, state (California), and local (San Francisco) issues. ACT UP/Golden Gate in San Francisco is publishing a similar card, and we expect other organizations to do so for their localities. People can carry these cards with them and call their elected representatives and other relevant officials whenever AIDS issues arise. Organizers can give out the cards with explanations of what issues are current and why it is important to call -- or set up a phone line and answering machine updated with taped messages explaining current issues and telling people how they can help. (For background, see "Political Action Proposal: Cultural Change for Electronic Grassroots Democracy," AIDS TREATMENT NEWS #168, February 5, 1993; also see "Clinton: Setting New Directions on AIDS, Part II," in this issue.) To get several of the AIDS TREATMENT NEWS card (with phone numbers for San Francisco residents) send a self-addressed stamped envelope to: AIDS TREATMENT NEWS P. O. Box 411256 San Francisco, CA 94141 Or you can copy the information, which is reproduced below. What if you have already called your representatives about an important issue, and want to do more? One way is to get your friends to call; start your own informal telephone tree. It is especially important for people in places like San Francisco to get friends and family elsewhere to call or write their representatives. In most of the country, politicians almost never hear from their constituents about AIDS, so they do not think it is important to the people they are being paid to represent. (Or they hear only from the forces of organized hate. For example, even in San Francisco, with over ten thousand AIDS deaths, politicians get calls and letters opposing AIDS research on the grounds that the disease is God's punishment for homosexuals.) When representatives have heard little or nothing from their constituents, even a few letters or calls supporting sensible policies can be very important. They know that every one who takes the time to contact them represents many more who also care about the situation. Federal issues: (area code 415 if omitted) White House comment line, 202/456-1111 Senator Barbara Boxer, 403-0100, 202/224-3553 Senator Diane Feinstein, 249-4777, 202/224-3841 Rep. Nancy Pelosi (SF) 556-4862, 202/225-4965 Rep. Tom Lantos (Southwest SF, & San Mateo) 342-0300, 202/225-3531 Or call 202/224-3121 (any member of Congress) Legislative Status Office, 202/225-1772 California issues: (area code 415 if omitted) Governor Pete Wilson, 703-2218 (SF office) State Senator Milton Marks, 3rd District, 474-0308 State Senator Quentin Kopp, 8th (far West SF) 952-5666 Assemblyman Willie Brown Jr, 17th District, 557-0784 Assemblyman John Burton, 16th (West SF) 557-2253 San Francisco issues: Mayor Frank Jordan, 554-7111 Board of Supervisors, 554-5184 -- especially Angela Alioto (President), Carol Migden (Budget), Kevin Shelley (Health), Barbara Kaufman Health Commission, 554-2666 ***** Announcements ** PBS Documentary "Healing and the Mind" Starts Feb. 22 Public television stations around the country will soon begin broadcasting the five-part series "Healing and the Mind," by journalist Bill Moyers. Part I, "The Mystery of Chi," looks at traditional Chinese medicine. In Part II, "The Mind Body Connection," Moyers talks with Candace Pert, Ph.D. (who developed peptide T, now being researched as an AIDS treatment) about how the mind and the immune system communicate. Part III, "Healing from Within," examines preventive medicine, meditation, support groups, and lifestyle in patients with serious illnesses, including AIDS. "The Art of Healing," the fourth segment of the documentary, looks at the doctor/patient relationship and the role of education in healing. The last part, "Wounded Healers," explores the difference between being cured and being healed at a visit to the Commonweal Cancer Self Help Program in Bolinas, California. The first broadcast is scheduled nationally from February 22 through 24 between 9:00 and 11:00 p. m.; the series will be repeated at later dates. Check local schedules for rebroadcast dates and times. ** Movie, "Lorenzo's Oil" Lorenzo's Oil, now in theaters throughout the U. S., is based on the true story of Michaela and Augusto Odone, parents without scientific training who did their own medical research and found an effective treatment for an inherited disease afflicting their son -- adrenoleukodystrophy (ALD), which before the treatment was invariably fatal. While the film is not about AIDS (which is mentioned only briefly), parallels with AIDS activism are obvious. The often-difficult relationships between medical-scientific experts and activists are well portrayed. ** HIV-Related Speech, Hearing, and Vision Loss Conference, S. F. Feb. 26 A one-day conference "for healthcare providers, caregivers, and people with HIV" will take place February 26, 8:30 a.m. to 3:30 p. m., at the Laurel Heights Auditorium, 3333 California St., University of California San Francisco. The conference is sponsored by The Community Consortium, The Hearing Society for the Bay Area, Lighthouse for the Blind and Visually Impaired, San Francisco AIDS Foundation, and UCSF Center on Deafness. The program includes "Speech and HIV/AIDS," "HIV-Related Hearing Loss," and "An Integrated Approach to Vision Loss and HIV. " There are panel discussions with questions from the audience. A catered lunch will be provided. The conference fee, which includes lunch, ranges from $40 for physicians to $15 for persons with HIV, families, etc., with no one turned away for lack of funds. For more information, call Kathy Abrahamson, 415/431-1481. For TTD/TTY calls, call Karen Rachels, 415/863-2550. ** Off-Label Reimbursement Denial: Major Survey Begins A survey of physicians' practices in treating HIV, and the impact of reimbursement denials on obtaining optimum care, is now being mailed to physicians. The study, called ComPACT 2 (Community Partnership in AIDS/HIV Clinical Trials), is being conducted by San Francisco's Community Consortium, an association of over 200 healthcare providers in the San Francisco area; it is funded by the American Association for AIDS Research (AmFAR). "The aim of ComPACT2 is to determine the extent to which there are reimbursement denials when drugs to treat the medical complications of HIV disease are used for 'off-label' indications (clinical indications other than that for which the drug received approal from the U. S. Food and Drug Administration). We are primarily interein the extent to which insurers deny reimbursement for off-label drug use and the extent to which providers alter the way they treat HIV- related conditions because of difficulties in obtaining adequate reimbursement for off-label drugs use." (From explanation sent with the survey.) Because of the need to poll a representative sample of physicians who care for patients with HIV, physicians have been selected at random to receive the questionnaire, and others cannot volunteer to participate. For the same reason, it is important that as many as possible of those who do receive the form fill it out and return it -- estimated to take half an hour. The survey, which consists mostly of extensive checklists, asks details of patient characteristics, current medications (over 120 are listed), and HIV-related conditions, for the last three HIV patients the physician saw before completing the questionnaire. It also asks for first-line and second- line treatments for HIV and for a number of opportunistic infections. Other sections look at access barriers to optimal treatment, extent of reimbursement problems, and drugs used off label in the last 12 months. Physicians' responses will be kept confidential. Results will be analyzed and provided to all participants. In addition, there are plans to convene a public policy panel with experts from government agencies, AIDS service organizations, and insurance companies to review the results and make reimbursement recommendations to the U. S. Public Health Service. For more information about this important study, call Tom Mitchell at The Community Consortium, 415/476-9554. ***** 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: Jason Heyman John S. James Nancy Solomon Reader Services and Business: David Keith 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 1993 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 - - - - - - - - - - - - from AIDS Info BBS, 415-626-1246 (free) 8-N-1 From: Ben Gardiner Return address: ben@maggadu.Queernet.ORG -- ben@maggadu.QueerNet.ORG AIDS Info BBS 415)_626-1246 free since July 25, 1985