[Distributed by GENA/aegis as a public service. 714.248.2836 * 8N1/Full Duplex * v.34] AIDS TREATMENT NEWS Issue #210, November 4, 1994 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: Searle Abandons Its Protease Inhibitor Protease Inhibitors -- Task Force Proposed HIV RNA -- Time to Wake Up and Save Lives New AIDS Treatment Information Service, 800/HIV-0440 Human Growth Hormone -- Canadian Number Disconnected for U.S. Callers AIDS Patents Now Available Free through Internet Drugs for Infants and Children: Call for Reform California: AIDS Drug Assistance Program, New Drugs Proposed; Title II Public Input Sought Title II National Organization Formed Global AIDS Summit, Paris, December 1 ***** Searle Abandons Its Protease Inhibitor In a November 4 conference call, Searle announced that it was stopping development of its protease inhibitor SC-52151, saying that despite promising results in laboratory tests, two clinical trials have shown no indication of antiviral activity in people. The company issued the following statement: "Based on the results from two studies, Searle has decided to halt development of its candidate HIV protease inhibitor SC- 52151. The highly promising results seen in earlier IN VITRO studies were not confirmed in either Searle #005, a clinical study of the use of the compound as monotherapy in people with advanced HIV infection, or ACTG #282, a formulation and dosage study. While well-absorbed into the bloodstream and achieving the desired blood levels, SC-52151 produced no measurable effect on any standard surrogate marker of anti- HIV activity -- CD4, p24 antigen, and PCR RNA -- in patients." The problem with SC-52151 appears to be unique to the Searle drug, and not to affect other protease inhibitors such as the Merck compound. Searle researchers believe that the drug binds to a protein (AAG) in the blood, and is then removed by the liver. Laboratory tests have shown that adding this protein causes the drug to lose antiviral activity. A similar experiment with the Merck compound did not show loss of activity. More importantly, other protease inhibitors have shown a striking though temporary drop of viral load in people; the Searle drug produced no such effect. This means that we already know the other drugs will not fail in the same way as SC-52151 did. ***** Protease Inhibitors -- Task Force Proposed A proposal for a high-level task force on protease inhibitors received strong support from FDA Commissioner David A. Kessler, M.D., and from Philip R. Lee, M.D., Assistant Secretary for Health, U.S. Department of Health and Human Services, at the October 27-28 meeting of the National Task Force on AIDS Drug Development. After the proposal was presented, Dr. Kessler suggested a special meeting of the National Task Force in early 1995 devoted solely to protease inhibitors. The protease task force was suggested by Jules Levin, an AIDS activist from Brooklyn, New York. We were not at the meeting; the following summary is from documentation he provided to us: "We are at a crucial juncture for all of us. We are in the early stages of the development of the protease inhibitors. We need a proper plan for their orderly and effective development. "I propose we form the Protease Task Force to plan for and guide the development of this new class of drugs. It would be a collaborative and coordinated effort to address all of the attendant issues. Some of these are: * How best to design the overall approach for all trials, both pre-marketing and post-marketing; * What combinations ought to be examined in which trials; * Which controls to use; * What markers for efficacy and safety will be utilized; * Potential drug interactions between the protease inhibitors and other medications used by people with AIDS; * The need for expanded access for those with more advanced HIV disease; and * Other questions we want answered, and how best to address them. "The participants on the Protease Task Force would represent the following groups: * Physicians who treat large numbers of HIV patients; * Representatives from the HIV-affected and activist community; * Government representation from the Food and Drug Administration, and the National Institutes of Health; and * All of the pharmaceutical companies developing protease inhibitors. "We urgently need discussion of access for those with more advanced HIV disease. This group includes persons with T- helper counts under 50, as well as others with higher counts who have exhausted approved treatment alternatives. [Note: persons with T-helper counts under 50 have been excluded from most if not all current trials of protease inhibitors.] These people have been subjected most harshly to the mistakes of the past; and they have volunteered for the trials of nucleoside analogs and other drugs. We cannot abandon them now." Mr. Levin told the National Task Force that "the issue burning up the wires between people with HIV is, 'When are we getting access to protease inhibitors?'" After the presentation, Dr. Kessler said the development of protease inhibitors is the most important work the National Task Force can do now, that the time is right. Jules Levin urged the AIDS community to rally and offer support, so that the FDA and Secretary Lee do not lose focus on this issue. If you can help, call Jules at 718/624-8541. ***** HIV RNA -- Time to Wake Up and Save Lives by John S. James Accurate tests for the level of HIV RNA in blood plasma -- which shows the number of HIV virions present in the blood -- are now commercially available to physicians, and have been available for research use for some time. The greatest need now is to use these tests in many small, rapid trials, to learn how to better use the drugs we already have, and others which could readily be made available. We need to try many strategies to reduce the viral load as much as possible, and keep it down. We need to individualize these strategies for individual patients, because it is clear that existing, available drugs and combinations of drugs can work very well for some people but not at all for others. We need to quickly learn who is benefiting, and test other options for those who are not. Many researchers agree with this kind of strategy. But the mainstream is not yet ready to move. Instead, it wants to first do other trials to prove beyond a doubt that HIV RNA testing is useful for testing drugs. These trials will take years -- if they can be conducted at all. Yet it is already clear that HIV RNA is a much better measure of the virus in the bloodstream than any other test we have. It is also becoming clear that this viral load in the blood reflects viral reproduction in the lymph nodes and elsewhere. Reducing the level of virus in the blood does NOT mean that it has been removed from the lymph nodes or other tissues; but usually it does mean that the virus throughout the body has become, at least temporarily, less active. We need to learn how to use combinations of drugs and other treatments to keep HIV inactive indefinitely. It will probably be hard to do this. But we now have tests that open doors to creativity by researchers, physicians, and patients, because they can tell rapidly and reliably whether a treatment is working for a patient to reduce the virus -- and how long it is working. When it stops working, new approaches can be tried. As experience develops and knowledge is exchanged -- in research settings, and also in physicians' offices -- we will learn what strategies are most likely to work, and how to deliver better care to patients in all stages of HIV disease. Examples: Approved Antiretrovirals What drugs should be tested in this way? One good place to start is with the drugs already approved by the FDA as antiretrovirals -- AZT, d4T, ddI, ddC -- and combinations of those drugs. First, establish a baseline value of HIV RNA for an individual patient, while the patient is on a stable treatment regimen. If that value is low, and the patient is otherwise doing well, the decision might be to leave well enough alone -- but to watch the test in the future. If the value is high, then switch to (or add) other regimens which make sense for that patient; within about two weeks the test will show whether the new regimen is working to reduce the virus. If it is not, other options can be tried. What is "low" and what is "high"? This is still being learned, but a rule of thumb is that anything under 10,000 copies of RNA per milliliter of plasma is fairly low, and anything over 100,000 copies is fairly high. [Note that some testing companies report the number of copies for other than one milliliter of plasma; in this case the number on the lab report needs to be multiplied by 20, or by some other factor, to get the number per milliliter.] Some researchers believe that it may be good enough to keep the HIV RNA under some threshold amount, probably somewhere between 10,000 and 100,000; others suspect that it may be important to keep the value as low as possible. At this time no one knows for sure. Example: Acyclovir Besides the four approved antiretrovirals, many other treatments can be tested this way. For example, two major trials and one epidemiological study have unexpectedly suggested that acyclovir may substantially improve survival of persons with advanced HIV disease. But none of these studies was planned in advance to test that possibility, and none has given definitive answers, so this issue remains controversial. There are at least four unpublished studies with additional information; but it is clear that at least three of the four, and perhaps all of them, will not give definitive answers either. Acyclovir does NOT inhibit HIV directly; but it might help indirectly by inhibiting certain herpes viruses, which are believed to make HIV more active. If so, this indirect benefit might be indicated by a decrease in HIV RNA. If such a decrease is seen -- and a small, rapid trial would be enough to find out -- then physicians might be more confident about using acyclovir for improving survival of people with AIDS, and targeting the treatment to those most likely to benefit. Small trials measuring viral load could help to answer questions which are unlikely to be answered in any other way. (1) Is AZT necessary to get this possible benefit from the acyclovir? No one knows, since the previous trials which suggested this benefit all used AZT in addition. (2) If acyclovir is found to (indirectly) lower HIV in late-stage disease, would it also help in earlier stage HIV infection? None of the previous studies have shown such a benefit. But they would probably not have found it even if it was there, because people with early infection either were not included in the studies, or would not have had time to get sick during the period that the studies were run. (3) Which patients benefit? Only those who have been infected with herpes (which includes much of the general U.S. population, including a large majority of gay men)? Only (or mainly) those who have active herpes outbreaks? Or could those who have never been infected also benefit, perhaps because the acyclovir suppressed unknown viruses which might activate HIV? Definitive answers to these questions would require trials with hundreds of people, lasting for years. Obviously such trials will never be run. But it would be easy to find out if the amount of virus in the blood goes down after the treatment is started. And this information -- which would strongly suggest that the treatment is beneficial, although it would not prove that -- would be useful for physicians and patients making treatment decisions. Example: "Alternative" Treatments Dozens of herbs, nutritional supplements, and other treatments without commercial or government sponsors have come into substantial use by persons with HIV. Some -- for example, certain herbs used in traditional medicine as anti- infectives -- have shown anti-HIV activity in laboratory tests. But conventional drug development, which costs an average of over $100,000,000 per new drug approved, will never be done for them. It is quite possible that some "alternative" treatments do in fact reduce viral load in people. They could then be tested in combination trials with approved antivirals, protease inhibitors, or other treatments, to help design better antiviral regimens. But others, which are being taken in the hope of an antiviral effect, will be found to have none. Persons who are using those treatments clearly need to know this information. Recently a small underground trial tested the combination of Ro 24-7429 (the abandoned Hoffmann-La Roche tat inhibitor) plus pentoxifylline, a prescription drug, using blood tests to detect changes in viral load. Laboratory experiments had suggested that the two drugs might work very well together. But in people, the combination was found to be completely ineffective as an antiviral. Viral load went up, sometimes greatly, in four of the five patients; in the fifth, the viral load was down at four weeks, but the decrease was so small that it was well within the error of the test. This result has not previously been published; AIDS TREATMENT NEWS is seeking more information and preparing a more complete report. There is no evidence of any benefit from Ro 24-7429; this small trial answered the one remaining question, of whether the combination with pentoxifylline would have antiviral activity. If modern viral testing had been available when Ro 24-7429 was first tried in people, several years of wasted effort could have been avoided. The Obstacles Today Testing for HIV RNA is now being incorporated in most new trials of antiretrovirals -- not to prove that the drugs work, but to help in understanding their action. We agree this is appropriate. What, then, is the issue? The central issue is not about technology, but about professional, commercial, and political will. The small, exploratory trials of available drugs are not being done today for the same reasons they have not been done in the past. These reasons include lack of commercial incentive, excessive influence of industry over professional and governmental agendas, and pervasive neglect of treatment and research by the leadership of AIDS organizations. This is why the trials we need are not being done -- despite the new technology which would make them faster, cheaper, and more reliable then ever before. Perhaps the basic problem in AIDS research is that the interest we share in saving lives does not translate into the institutional arrangements necessary for doing so. ***** New AIDS Treatment Information Service, 800/HIV-0440 by John S. James The AIDS Treatment Information Service (ATIS), sponsored by a group of several U.S. Public Health Service agencies, is providing information about AIDS treatments, based on guidelines published by the Federal government. This service, which is free and confidential, is open Monday through Friday from 9 a.m. to 7 p.m. Eastern time, and can be reached at 800/HIV-0440 (800/448-0440); you can also send questions by fax (301/738-6616) or by mail (ATIS, P.O. Box 6303, Rockville, MD 20849-6303). ATIS can answer questions in English or Spanish. ATIS began operation on October 31. It joins a number of other AIDS information sources provided by Federal agencies, of which some of the most important are: * The National AIDS Hotline -- 800/342-AIDS, 24 hours; 800/344-SIDA (Spanish speakers), 8 a.m. to 2 a.m. Eastern time; 800/AIDS-TTY (TTY access for the deaf), 10 a.m. to 10 p.m. This hotline answers general questions about AIDS, and can refer callers to service organizations in their area. * The AIDS Clinical Trials Information Service (ACTIS) -- 800/TRIALS-A (800/874-2572), Monday through Friday 9 a.m. to 7 p.m. Eastern time, which can provide information about clinical trials in your area -- what drugs are being tested, entry criteria, etc., and whom to call locally for further information. ATIS staff are working with these and other information services to build a treatment information referral network, which will be used to link callers to appropriate resources. Surgeon General Joycelyn Elders, M.D., urged "community-based organizations and AIDS service organizations all over American (to) help get the word out about ATIS." The sponsoring agencies are: Agency for Health Care Policy and Research, Centers for Disease Control and Prevention, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and the Substance Abuse and Mental Health Services Administration. Comment The organizers of ATIS asked this writer and others for input and advice while designing this system. We believe that ATIS can be important, but users need to understand its limitations. First, like any treatment information service, it can provide information, but not treatment advice. The people answering the phone are information specialists, not physicians; and even physicians could not provide advice by phone without examining the patient or getting a medical history. A more serious limitation is that ATIS can only provide Federally-published information; otherwise there would be endless uncertainty about what could and what could not be included. But Federal AIDS information is extensive -- including, for example, the treatment guidelines of the Agency for Health Care Policy and Research (AHCPR), articles in the MMWR SERIES (MORBIDITY AND MORTALITY WEEKLY REPORT, published by the U.S. Centers for Disease Control and Prevention), and U.S. National Institutes of Health consensus statements. ATIS will also refer callers to non-Federal agencies when appropriate, as the National AIDS Hotline commonly does. ***** Human Growth Hormone -- Canadian Number Disconnected for U.S. Calls In our last issue, AIDS TREATMENT NEWS published a phone number in Canada for obtaining human growth hormone for HIV- related wasting syndrome, a major cause of death for persons with AIDS. As this issue went to press, we learned that this number for physicians (800/935-8853, for the Serono Canada Information Line for Human Growth Hormone in HIV-Associated Wasting) has been disconnected for U.S. callers; it still works for callers from Canada. According to a leading treatment activist working on this issue, U.S. access to the program was cut off after Serono's lawyers received a letter from the FDA saying that the FDA did not approve Serono to import human growth hormone for compassionate use at this time. Comment These intended shipments of human growth hormone, to persons in the U.S. for treatment of AIDS-related wasting, would appear to be within the FDA policy allowing personal use of drugs approved abroad. The potential for abuse by athletes is a complication, but must not be allowed to prevent access for essential medical use. Two other companies (Genentech Inc., and Eli Lilly and Company) already sell human growth hormone in the U.S., where it has been approved and available for years to treat growth hormone deficiency in children. While an approved drug can normally be prescribed "off label" for other medical uses, the distribution of growth hormone is tightly controlled by a unique system set up by the companies and the FDA to prevent abuse. So far, we do not know of anyone who has been able to obtain growth hormone from U.S. sources for AIDS-related use. Another way to provide the drug would be through a "treatment IND" program, which Serono has applied to the FDA for permission to start. For several years there has been interest in human growth hormone as a possible treatment for AIDS wasting syndrome. But the first results from a large-scale trial, sponsored by Serono Laboratories, were released only recently, in August 1994, at the International Conference on AIDS in Yokohama. Clearly government and/or corporate attention is needed so that U.S. citizens with this life-threatening condition can receive the drug. ***** AIDS Patents Now Available Free through Internet by John S. James On October 26, the U.S. Department of Commerce announced that the text of more than 1500 AIDS-related patents is now online on the Internet. The patents can be searched by any word in the text, or in other ways; and the full patent (or only parts of it) can be printed out immediately. AIDS TREATMENT NEWS tried out this database shortly after it was available; we believe it will be valuable to researchers seeking in-depth information about certain treatments. The system is very easy to use, once one is set up to use the Internet. First, we had no trouble finding the patent database, without being told where it was located; we looked under U.S. government, then under Department of Commerce, then under the PTO (Patent and Trademark Office), then under AIDS. Once we got there, using the database was self- explanatory; instructions are available, but we did not need them for simple searches. As a test, we used the system to look for patents relevant to "compound Q," long a controversial potential treatment for HIV. The technical name for compound Q is trichosanthin, so we searched for that. We found 10 patents, and looked at the "front page" for each. This page has the patent number, the date the application was filed and the date the patent was issued, the inventors, the assignee (the company assigned the rights), an abstract of the patent, and other brief information. We also searched under "RIP" (ribosome- inactivating protein, which is the class of agents to which Compound Q belongs), and found 18 patents, including many of the trichosanthin ones. We printed out one complete patent, and saved another in our computer, so we could use a word processor to locate all instances of certain words within the text. Computer and Internet Information The patent database is available through World Wide Web, a "hypertext" system for navigating the Internet. With World Wide Web, you see a document, with certain words or phrases underlined (or otherwise highlighted or noted). You simply "click" on any highlighted word or phrase to get more information on that topic. That information may be in a different computer, even on a different continent; you as the user do not need to know where it physically resides. This makes World Wide Web so easy to use that even computer novices can be effective in minutes -- provided that an expert sets up the software for them. The only drawback is that, for beginners, getting set up to use the Internet can be difficult. We have heard there are new products, such as "Internet in a Box," which make it much easier to get started, but we have not seen these products ourselves. Some Internet services also allow use of World Wide Web with an ordinary terminal program, without the graphical interface provided by Web browsers like Mosaic or MacWeb. And those without access to World Wide Web can use the patent database through an electronic mail gateway; for more information, send a message containing the single word HELP to ezgate@cnidr.org. In case the system you are using needs a URL (Universal Resource Locator) to find the U.S. Patent and Trademark database, you can use http://www.uspto.gov; From there it should be straightforward to find the AIDS patent database. (We did not publish the URL for the AIDS patent database itself, since this may change soon when the database is moved to a larger computer.) Additional Information Patents are useful for researchers seeking in-depth information, but seldom for guiding treatment decisions. It usually takes years before patents are granted; until then the applications are confidential. This means that medical practice will usually be far ahead of the patent. But the patent will often have the most detailed technical information available -- more detailed than articles in technical journals -- because the patent system is set up to force inventors to fully disclose their technology in order to assert their claim of exclusive right to it. This makes the Patent and Trademark Office a huge database of useful information, open to the public; even while the patent is in force and the technology is proprietary, others can use this information (with or without the patent owner's permission) to make other inventions, or for other purposes. The information placed in the AIDS patent database this month is not new; anyone could buy printed copies of the same patents, and various systems for computer searching are available, although usually they are expensive. The advantage of the new system is that it makes AIDS-related patents easily and immediately available, 24 hours a day, in a computer-searchable form, to researchers throughout the world. There is no charge for the service, nor any need to get permission or make advance arrangements to use it. This patent database software was designed for the U.S. Patent and Trademark Office by CNIDR (Clearinghouse for Networked Information Discovery and Retrieval), an organization created by MCNC, of Research Triangle Park, North Carolina. MCNC [formerly called Microelectronics Center of North Carolina, but now known by its initials] is a private, nonprofit corporation, established in 1992 with the support of the National Science Foundation. AT&T is also contributing to this project by providing computer services, as the demand is expected to overload the computers at MCNC. ***** Drugs for Infants and Children: Call for Reform Infants and children with life-threatening diseases face a shocking lack of drugs tested for safety in children -- and tested for the stability of the improvised formulations doctors are often forced to use. At the same time, unnecessary efficacy testing in children -- for example, testing in children of biologically inappropriate ages -- delays treatment availability, and creates obstacles to the testing which is necessary. Arthur J. Ammann, M.D., Research Director of the Pediatric AIDS Foundation, and a member of the National Task Force on AIDS Drug Development, analyzed these problems in a presentation to the Task Force on October 28. He made 14 recommendations for improvement, directed toward the approval of drugs for life-threatening conditions simultaneously for both children and adults. We cannot summarize the 10-page testimony of Dr. Ammann -- an expert in drug development who was formerly a leading researcher at Genentech, Inc. The bottom line is that this problem is far more serious than generally realized -- and far more correctable. The kinds of re-thinking proposed would improve drug development generally, for adults as well as for children. For more information, contact Dr. Ammann at the Pediatric AIDS Foundation, 81 Digital Drive, Novato, CA 94949, 415/883- 1796. ***** California: AIDS Drug Assistance Program, New Drugs Proposed; Title II Public Input Sought by John S. James California's AIDS Drug Assistance Program (ADAP) pays for certain drugs required by AIDS/HIV patients, for those with annual gross income under $50,000. For those with under 400 percent of the Federal poverty level, the drugs are provided free; for those with incomes over that amount, but under $50,000, a copayment may be required. To qualify, you must also have a prescription signed by a physician licensed in California, and not have the drugs covered by your health insurance program. (If your health insurance requires a copayment which creates a financial hardship, the program may help with the copayment.) For more information about qualifying for the program, California residents can contact their county's health department. Also, a brochure published by California lists the following hotline numbers: Northern California, 800/367- 2432; Southern California, 800-922-2437; Spanish hotline (Southern California only), 800/400-7432. However, the people who answer the phone are sometimes not informed about the program. The drugs currently covered are: acyclovir, amphotericin B, atovaquone, azithromycin, AZT, clarithromycin, clindamycin, clofazimine, clotrimazole, dapsone, ddC, ddI, ethambutol, fluconazole, flucytosine, foscarnet, ganciclovir, ketoconazole, nystatin, paromomycin, pentamidine (aerosol), pentamidine (intravenous), pyrimethamine, rifabutin, sulfadiazine, and trimethoprim-sulfamethoxazole. In addition, the physician advisors to the program have recommended adding the following drugs: d4T, trimethoprim, all chemotherapies, megace, itraconazole, G-CSF (Neupogen), EPO Procrit), alpha interferon, marinol, trimetrexate. Their highest priority recommendation is d4T. Whether these drugs are added will depend on their estimated cost to the program, and whether the money is available. This year there has been an unexpected decrease in ADAP expenditures, due to a fall-off in demand for AZT. Exact figures are not available, apparently due to lack of statistical staff at the California State Office of AIDS. If the figures are not provided by December 6 and 7, $1,000,000 held in reserve for ADAP is likely to be transferred to home and community-based care for persons with AIDS or HIV. [As of today, the preliminary recommendations for the different programs are: $15,158,881 for health care and support services administered through local HIV CARE consortia -- the 50 percent, required by law; $7,449,105 for ADAP; $1,500,000 for CARE/Health Insurance Premium Payment Program; $2,178,000 for Home and Community-Based Care to expand statewide; $1,515,888 for planning and evaluation, $1,515,888 for administration, and $1,000,000 in reserve for ADAP.] These programs are Federally funded by Title II of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act of 1990. (Title II pays for state AIDS programs; Title I funds heavily-impacted cities.) This act authorized funding for five years, and will expire after 1995 unless it is reauthorized by Congress. Reauthorization of Ryan White is perhaps the highest Federal priority of AIDS service organizations today. [Note: AUTHORIZATION does not by itself make the money available. Congress must also APPROPRIATE the funding each year, in competition with other priorities; in fact, the Ryan White Care Act has never been fully funded (up to its authorized level). Without reauthorization of Ryan White, Congress could still authorize and appropriate money annually for the same purpose, but there would be an additional fight for AIDS funding every year, and probably less money would be available.] Title II Funding Distribution -- Public Comments Sought by November 15, and on December 6 and 7 Recommendations for distributing Title II money will be finalized by the HIV Comprehensive Care Working Group, at its meeting at the Waterfront Hilton Beach Resort, 21100 Pacific Coast Highway, Huntington Beach, California, on December 6 and 7. A public comment period is scheduled for 9 a.m. on December 6. In addition, public comment will be taken on November 15, from 4 to 6:30 p.m., at hearings in six cities: Fresno, Long Beach, Oakland, Redding, San Diego, and Ukiah -- or can be mailed to the CARE Section of the Office of AIDS until November ll. These comments, unfortunately, will not be transcribed until after the decisions have been made; instead they may be summarized for the working group. Public comment may be more influential at the meeting of the Working Group itself. The major decision on the table is how to allocate the money among three programs: ADAP, AIDS Case Management Program (CMP), also referred to as Home and Community-Based Care (HCBC), and CARE/Health Insurance Premium Payment Program (CARE/HIPP). All of these programs serve people with AIDS or HIV, and all three are important. The Working Group needs to hear from those with personal experience with these programs. For more information about how to have input into the Title II process, including ADAP funding, contact David Lewis, Project Inform, 415/558-8669, ext. 225; he is in the office on Monday, Wednesday, and Friday. Or contact the California Office of AIDS, 916/327-6804, and ask for time and place of the Title II hearings on November 15, in one of the six cities listed above. Note: Project Inform, ACT UP, and other activists have spent hundreds of hours improving the California AIDS Drug Assistance Program. They secured funding increases, and demanded the establishment of a medical advisory panel, making possible the addition of 13 of the drugs listed above, as of April 1994. They also decentralized the program, in San Francisco at least, and insisted that its existence be advertised to potential clients. ***** Title II National Organization Formed by John S. James A national organization of Title II recipient agencies and others concerned is now being formed. Every state and territory has Title II Federal funding, which supports thousands of community-based agencies and AIDS programs. (The process of distributing Title II funds is different in every state; California is not typical.) Nationwide, grassroots, organizing around Title II issues is now imperative. For more information, contact the Title II National AIDS Coalition (T. II N.A.C.), P.O. Box 1387, Kingston, NY 12401, phone 914/331-7909, fax 914/331-3538. The organizers want to hear from anyone who (1) will consider joining later when forms and letters are ready, or (2) can pitch in during the next two to three months in the organizing process. A national organizing conference has been set for Washington D.C., February 10-13, with Congressional lobbying on the 13th. ***** Global AIDS Summit, Paris, December 1 Leaders of about 40 nations will gather in Paris on World AIDS Day, December 1, for the first-ever international summit meeting on AIDS. According to the organizers -- the French government, and the World Health Organization -- this is the first time in world history that heads of government will be considering a health problem. The meeting will seek: * Funding for international research programs to develop vaccines and better treatment; * Agreements to reduce discrimination against people with AIDS, including travel bans like those of the United States and many Arab countries; * Access to health care -- including prevention, education, and treatment for vulnerable population groups; * "A more effective global response to the AIDS pandemic based upon the basic principles of respect for individual rights and moral ethics." The preparatory meetings have found that developing countries are interested, but the developed countries, who would have to supply much of the funding, are often reluctant. U.S. Press Coverage -- No News AIDS TREATMENT NEWS did computer searches of the full text of all stories in several dozen leading U.S. newspapers, and found only six that even mentioned the Paris summit once. None mentioned it more than once. Only Reuters, the international news service, cover the summit effectively. Of the five U.S. newspapers that mentioned the summit, two devoted two short paragraphs each. One had two sentences; the other two, one sentence each. This may be the total U.S. press coverage so far. What is more alarming are reports of responsible U.S. officials, and leading AIDS experts in private organizations, not even knowing about preparatory meetings, after the preparations were well under way. The U.S. delegation to the Paris summit will be headed by Health and Human Services Secretary Donna E. Shalala; it had been hoped that at least Vice President Gore would attend this summit, planned as a meeting of heads of state. Also, it appears that Japan is willing to make a serious financial commitment to stopping the global epidemic, but the U.S. is offering little new money. The commitment of many countries will be influenced by what the U.S. does. A commitment comparable to that at the recent Cairo meeting (the United Nations International Conference on Population and Development, where the U.S. delegation was led by Vice President Gore), would support the French effort to build momentum for an effective international AIDS response. Note that the Cairo conference attracted enormous U.S. government and media attention, even though population is not seen as a bread-and-butter issue that directly affects most people in the U.S. AIDS affects individuals much more severely, yet a comparable international meeting on AIDS has received almost no attention. Perhaps we can study this example to learn how to better mobilize interest, attention, and support in the future. ***** AIDS TREATMENT NEWS Published twice monthly Subscription and Editorial Office: P.O. Box 411256 San Francisco, CA 94141 800/TREAT-1-2 toll-free U.S. and Canada 415/255-0588 regular office number fax: 415/255-4659 Internet: aidsnews.igc.apc.org Editor and Publisher: John S. James Reader Services and Business: Thom Fontaine Tadd Tobias Rae Trewartha Statement of Purpose: AIDS TREATMENT NEWS reports on experimental and standard treatments, especially those available now. We interview physicians, scientists, other health professionals, and persons with AIDS or HIV; we also collect information from meetings and conferences, medical journals, and computer databases. Long-term survivors have usually tried many different treatments, and found combinations which work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. Subscription Information: Call 800/TREAT-1-2 Businesses, Institutions, Professionals: $230/year. Nonprofit organizations: $115/year. Individuals: $100/year, or $60 for six months. Special discount for persons with financial difficulties: $45/year, or $24 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U.S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207 Copyright 1994 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.