Subject: Community Research Alliance; Interferon; Plasma Date: Dec 2 1988 (765 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1988 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS issue # 70, December 2, 1988 CONTENTS: [***** appears here at each new item] In this issue: * Community Research Alliance (CRA) -- San Francisco People With AIDS Coalition starts research group to run community- based trials. * Interferon/FDA -- Mathilde Krim, Ph.D., best known as founding chairperson of the American Foundation for AIDS Research (AmFAR) but also a leading interferon expert, explains why the alpha interferon doses recently approved by the FDA may be much too high. * Plasma -- Behind the headlines on passive immunotherapy (plasma infusions), widely reported in the news last week. * Placebos -- Two recent clinical trials show more humane use of placebos, by study designs which end the trial early when patients do poorly, rather than waiting for serious disease or death. * AIDS Treatment News receives award from San Francisco physicians' group. * Community-based research -- new NIAID (NIH) program receives favorable comments. ***** Community Research Alliance: New San Francisco Effort for Community-Based Trials by John S. James For over two months this writer has been a founding board member of the Community Research Alliance (CRA), a San Francisco organization modeled after the Community Research Initiative in New York. AIDS Treatment News has not reported on the CRA, because the board asked its members not to publicize the organi- zation until it had better defined its identity. Earlier this week the board ended the request to avoid publicity. This arti- cle is the first published description of the CRA. Like New York's CRI, San Francisco's CRA began under the fiscal sponsorship of the PWA Coalition. Initial funding came from pledges of $1000. from each of five organizations: AIDS Treatment News, The Healing Alternatives Foundation, Project Inform, PWA Coalition, and the San Francisco AIDS Foundation. Other donations, including office space, use of computers, and especially the work of a volunteer administrator, allowed the CRA to begin swiftly, without waiting for major funding. Background on Community-Based Trials Community-based trials is a concept pioneered in different ways by two organizations: the County Community Consortium in San Francisco, and the Community Research Initiative in New York. Within the last year this concept has won widespread recognition and support, from groups including the Presidential Commission on the HIV Epidemic which commended New York's CRI, from Congress which appropriated over $5,000,000 for community-based trials, and from the National Institute of Allergy and Infectious Diseases (NIAID), which is administering these Congressional funds. (See "NIH Announces Program for Community-Based Trials", page 10 in this issue.) What are community-based trials? Traditionally, clinical trials of experimental drugs or other treatments were done in major medical centers, usually con- nected with leading universities. Everyone agrees that some tri- als must be carried out in such specialized institutions -- for example, tests of dangerous treatments, or of chemicals never before taken by humans. But other trials do not need such spe- cial facilities. Anything that happens in major medical centers is expensive and time-consuming. So in New York the Community Research Ini- tiative, started as a project of New York's PWA Coalition with $5,000 from that organization, set up all the arrangements legally required to conduct human trials with patient volunteers in the practices of private physicians. The CRI, which is now running five trials, is believed to be the first organization in history set up by patients to conduct fully sanctioned, profes- sional scientific research for testing new treatments. (The current CRI trials are aerosol pentamidine, egg lecithin lipids, antabuse monitoring study, erythropoietin, and bovine milk immune globulin. Four more trials are in advanced planning: DHEA, len- tinan, dextran sulfate, and pyrimethamine prophylaxis for toxo- plasmosis. The aerosol pentamidine trial, originally financed by LyphoMed for one year, was recently extended for six months. The trials of lipids and of DHEA are financed by fundraising events organized by People Taking Action Against AIDS, a Long Island group which raises money for AIDS work.) For more background on community-based trials and the CRI, see The New York Times, March 15, 1988. Also see our articles about the CRI in AIDS Treatment News #38 (August 14, 1987) and #45 (November 20, 1987). Two Models of Community-Based Trials The phrase "community-based trials" means scientific tests of experimental drugs or other treatments conducted through the practices of private physicians. But two different approaches to such trials have developed. Much confusion and sometimes debate stem from the failure to understand the differences. The two approaches are illustrated by the two different organizations, the Community Research Initiative described above, and the County Community Consortium. In San Francisco, the County Community Consortium (CCC), organized primarily by researchers at the University of Califor- nia San Francisco Medical Center, conducted the first community- based trials anywhere. At this time, the CCC is conducting seven trials; its meetings are attended by almost every physician with an AIDS practice in San Francisco. This organization works closely with the AIDS Clinical Trials Group sponsored by the U. S. National Institutes of Health and located in San Francisco General Hospital, which has developed an efficient system of run- ning clinical trials. (The seven trials currently open are two with aerosol pentamidine for pneumocystis prophylaxis, two moni- toring studies (an AZT database, and an alternative treatments database), clofazimine for MAI prophylaxis, AZT with vitamin B12, and megace. None of these trials is sponsored by pharmaceutical companies.) Both the Consortium in San Francisco and the Community Research Initiative in New York conduct trials through the prac- tices of front-line AIDS physicians. Both run trials designed by leading researchers, approved for scientific merit by a Scien- tific Advisory Committee, and approved for ethical treatment of patients by an Institutional Review Board (IRB). The difference is in the degree of PWA participation in the organization of the research. In both cases, the scientific and medical issues are decided by qualified professionals. But the Community Research Initia- tive, operating under New York's PWA Coalition, includes much participation by PWAs in policy decisions concerning the research. In San Francisco, community-based trials developed dif- ferently. The County Community Consortium was started so that university researchers could inform community physicians about the latest AIDS medical information, and improve coordination between private-practice physicians and San Francisco General Hospital, which is closely affiliated with the University of Cal- ifornia San Francisco Medical Center. Later, some of the physi- cians wanted to participate in trials of experimental drugs; as a result, community-based trials began. But patients had nothing to do with the development of the trials; their involvement began when they signed up for a study. Until a year ago, most persons with AIDS in San Francisco probably did not know that the Consor- tium existed. Recently, however, the Consortium has set up a Com- munity Advisory Board, to improve communication and allow input from persons with AIDS/HIV and treatment advocates. (For more background on the Consortium, see "Conversations with Donald Abrams, M. D. ", AIDS Treatment News issue #54, April 8, 1988, continued in #56, May 6, 1988.) New York's Community Research Initiative, started by a PWA Coalition, has much patient involvement in research policy. The PWA community has funded at least two trials through fundraising events, has set its own policies on placebo use, and has insisted that trials under its sponsorship be effectively open to women and minorities, not only to gay men. Such prior community involvement in policy issues around the selection and conduct of trials makes recruitment easier and increases patient- experimenter cooperation, for example by greatly reducing any need to "cheat" in the study by taking other drugs without tel- ling the researchers. Why the CRA? Why should there now be a second organization (the CRA) to conduct community-based trials in San Francisco, when the Consor- tium is already doing so? The CRA has not officially answered this question, but the answers we suggest below seem representa- tive of views found in the organization. (1) The Consortium can only conduct a handful of trials at one time. More needs to be done. The CRA will not duplicate work of the Consortium. Instead it will do additional studies which otherwise would not have been conducted. (2) PWAs want to be involved in the policy making, organiza- tion and administration of the research. Otherwise, the PWA com- munity would remain only a passive recipient of research efforts conducted in its behalf by others. (3) The Consortium does not have its own Institutional Review Board (IRB); the CRA plans to establish one. There is concern that existing IRBs may be too conservative to respond appropriately to the AIDS emergency. PWAs fear -- rightly or wrongly -- that many physicians will not be able to get approval for formal scientific tests of well-supported treatment options which they may in fact already be using in their practice. (Phy- sicians do not need IRB approval to use non-approved "treatments" for their patients; they do need approval, however, if the same treatments are called "research". This system, intended to pro- tect patients against exploitation and unconscionable risks at the hands of scientists or pharmaceutical companies using them to get data, has also had the unfortunate side effect of creating a physician underground, forcing legitimate, legal treatments out of the public arena, preventing proper research and open communi- cation of results. An IRB created by PWA organizations would allow physicians to submit these treatments they are using without fear of automatic rejection.) Research Policy Issues: The Need for Patient Involvement There is a common assumption that since everyone is on the same side, doing their best to find treatments for AIDS, we can leave the whole matter to professionals, since the only decisions are scientific and medical ones which must be made by special- ists, not policy decisions in which affected citizens need a voice. Some simple examples will show how this assumption is wrong: (A) Drugs approved under the current system will be expen- sive, because pharmaceutical companies are only likely to support products which will provide them with the highest return. And because trials are expensive, scientists and physicians can only conduct research that someone will pay for. It is no coincidence that AZT, one of the most expensive drugs in history, has become most intensively studied -- while readily available treatments are hardly studied at all. Persons with AIDS or HIV, by contrast, want affordable treatments. U. S. insurance companies, hospitals, employers, and public agencies are increasingly dumping patients who cannot pay the extreme costs of U. S. medicine. Patients want studies of treatments which could be made available to all, not only those with money or insurance. (B) A number of antibiotics which may be essential for sav- ing lives of persons with AIDS are in common use in Europe but not available in the U. S., because their manufacturers do not want to spend the years and tens of millions of dollars required for U. S. approval. Here again the interests of patients and professionals differ. Patients want the drugs tested, and want their physi- cians to have the option of recommending them. If red tape gets in the way, they are willing to rock the boat. But for scientists, the professional incentives are to stay away from drugs without commercial sponsorship in the U. S. Here again, the interests of patients and professionals differ. (C) When preliminary studies of a new treatment show very good results, research professionals not surprisingly want to do more studies, which will take years. No one objects to the stu- dies; the issue is access by patients who need the treatment now. There is no institutional incentive to provide this access until double-blind studies have been designed, cranked up, run, analyzed, and published, and then delayed several more years for FDA approval. The interests of the research community, the pharmaceutical industry, and regulators have all been well represented. None of these have put the patients' needs first. And unless the PWA community is involved in the many diffi- cult details of organizing actual trials, it will not have the depth of knowledge needed to effectively articulate and realize its interests. The PWA community must have organizations which understand the administration of AIDS research as well as any university, corporation, or government agency. The Community Research Alliance is committed to always hav- ing effective PWA representation on all decision-making bodies: the Institutional Review Board (IRB), the Scientific Advisory Committee, and the board of directors. As far as we know, it is one of only two clinical-research organizations in the country to do so; the other is New York's Community Research Initiative. The CRA Today At this time the CRA board of directors includes people listed below. The board is seeking new members to broaden its base in all parts of the AIDS community. Because it is hard for a large group to conduct routine business, a smaller executive committee makes recommendations to the full board, which makes the final decisions. To date (December 1) the Scientific Advisory Committee has not met. But 16 physicians and scientists have so far expressed interest in working with this group. And 19 physicians with private practices in the Bay Area have expressed interest in par- ticipating in the trials. (Nine are on both groups). Several physicians have already proposed research studies. The Institutional Review Board has not yet been formed. The CRA has an office and a full-time administrator, Tom Wilcox, who recently moved to San Francisco from New York, where he was manager of the PWA Health Group, and worked closely with the Community Research Initiative. We list the current CRA board members below. Note that some of the organizations with which these people are affiliated have not taken any position on the CRA; therefore this listing does not imply organizational endorsement. Ron Baker Editor and co-author, Bulletin of Experimental Treatment for AIDS, San Francisco AIDS Foundation. Keith Barton, M. D., C. A. Private practice in Berkeley, CA. Terry Beswick Director, The Healing Alternatives Foundation, San Francisco. Misha Cohen, O. M. D. Founder and Clinical Director, Quan Yin Acupuncture and Herb Center, San Francisco. Martin Delaney Co-director, Project Inform. Rick Graham PWA Coalition (alternate for Hank Wilson). John James Editor and publisher, AIDS Treatment News. Tom O'Connor Author of Living with AIDS: Reaching Out. Jim Palazzolo Co-author, Bulletin of Experimental Treatments for AIDS, San Francisco AIDS Foundation (alternate for Ron Baker). Curtis Ponzi Attorney. Pat Sanders, M. S. N., C. A. Unit Manager, NIH HIV Research, Kaiser Permanente, San Francisco; and licenced acupuncturist in private practice, San Francisco (alternate for Tom O'Connor). Hank Wilson PWA Coalition, San Francisco. Tim Wilson National Task Force on AIDS Prevention, of the National Association of Black and White Men Together. Funding Because of donations of office facilities, and of the time of volunteer administrator Mike Lipson who was invaluable in starting the organization, little money has been spent. With pledges and a matching grant totaling $8,000 so far, about $4,000 additional will carry the organization through the next three months, which should be enough to complete the development of the Scientific Advisory Committee and IRB, and start evaluating research proposals from physicians and scientists. Later, the organization will need major funding for the tri- als themselves. Trials can cost $2,000 or more per patient, mostly for laboratory tests, which are usually paid for by the study. There may also be additional physical examinations. Usu- ally the drugs are donated by the manufacturer, so they would not be an expense for the CRA. In New York, most of the studies now being conducted by the Community Research Initiative are financed by pharmaceutical com- panies, which were eager to participate because of their frustra- tions in getting their drugs tested through other channels. The CRA may also do such studies. But it hopes to raise money from foundations, corporations, individuals, and other contributors, so that it can focus research attention on what may be the fastest, most cost-effective way to get results -- including the study of medically promising treatment possibilities which have been overlooked so far because for various of reasons they are not commercially attractive. CRA does not yet have this funding and will need community help in getting it. How You Can Help CRA is building a skills list of friends who can help this project in any way -- fundraising, organizational skills, helping us contact people we should be working with, technical skills such as computers, graphics, or printing, medical and scientific experience of course, etc. If you want to help, call Tom Wilcox at 415/626-2145, and let us know what you can do. Or write to Community Research Alliance, 273 Church Street, San Francisco, CA 94114. The CRA greatly needs volunteers. It plans to follow the CRI model of having one person be volunteer coordinator, with most of the work done by volunteers. This approach not only con- trols expenses; it also allows for participation by PWAs who are on disability and not permitted to earn money without risking their benefits. Contributions to CRA are tax deductible. Make checks pay- able to "PWA Coalition", and send them to the CRA at the address above. The organization would like to form a "Friends of the CRA" auxiliary, to be a social organization which would also raise money, find volunteers, develop contacts and community coali- tions, and otherwise promote the work of the CRA. ***** Alpha Interferon Approved for KS; Official Dose Too High? On November 21 the Food and Drug Administration (FDA) approved use of alpha interferon to treat KS. The drug, already available by prescription since June 1986 and previously approved to treat hairy cell leukemia and genital warts, is being marketed under two brand names, Intron-A (Scher- ing Corp.) and Roferon (Hoffman-La Roche). The two versions have slightly different molecular structures. After the FDA approval, AIDS Treatment News talked with Mathilde Krim, Ph.D., founding chairperson of the American Foun- dation for AIDS Research (AmFAR). While best known for her work with AmFAR, Dr. Krim is also a leading expert on interferon. In 1975 she became co-director and then director of an interferon laboratory at Memorial Sloan-Kettering Cancer Center in New York, a position she held until 1985 when she left to do AIDS work. Dr. Krim is concerned that the doses on which the FDA based its approval may be much too high. Two weeks ago, at an interna- tional meeting on interferon research in Japan, Dr. Ernest Borden showed that as long as the dose was enough to produce the desired effect, a higher dose made little difference; this result was based on human as well as test-tube work. Other researchers, including Dr. Clifford Lane and colleagues, who used high dose interferon and published an article in The Lancet (November 26, 1988), showed that those who responded well usually started with over 150 T-helper cells, while those who did not respond had fewer. The important factor seemed to be the state of the immune system, not the dose. Also, clinical studies with the high doses, 20 million units a day or more, caused such unpleasant flu-like side effects that in order to keep the patients in the study, physicians had to reduce the dose to half or a quarter. Yet the beneficial effects continued. Dr. Krim also noted that much smaller doses have been found effective in treating hairy cell leukemia, in some cases as lit- tle as one and a half million units given twice a week. But the early studies of alpha interferon for KS had used large doses, because the dominant thinking, derived from chemoth- erapy, was that the dose should be as high as the patient could tolerate. The FDA had to use the data available, much of it from early studies, as the basis for the approval. This may give patients and physicians the impression that they need high doses. But these doses cause unpleasant side effects, and also are very expensive, conceivably costing as much as $50,000 in a year. Dr. Krim believes that alpha interferon would probably be effective at much lower doses, and would be well worth trying. ***** Passive Immunotherapy: Major New Article -- And Patient Support Group in San Francisco In October, AIDS Treatment News (issue #67) reported on pas- sive immunotherapy, a treatment which consists of taking plasma from healthy HIV-positive donors who have high levels of antibo- dies against the core proteins of the AIDS virus, and infusing the plasma into persons who have lost the ability to produce those protective antibodies. That work, by researchers at the London Hospital Medical College, the University of Illinois Col- lege of Medicine, and Abbott Laboratories, had been presented at the Stockholm AIDS conference in June, 1988, and also published in The Lancet, September 17, 1988. Now other researchers at Cambridge University in England have published a report of their study of ten patients with AIDS or ARC who received monthly passive immunotherapy treatments in the December issue of Proceedings of the National Academy of Sci- ences (U. S.). We have not seen this article before going to press. But news reports quoted the researchers as saying that the virus disappeared from the blood of all ten, nine of whom are still alive and reasonably healthy nine months later. A principal developer of the treatment, Dr. Abraham Karpas, assistant director for research for the Department of Hematologi- cal Medicine at Cambridge University in England, described pas- sive immunotherapy as completely nontoxic, and said that while more studies are needed, he saw no reason it could not be made available now. A year ago August, Dr. Karpas noted that in a small test with four patients, "there was considerable subjective improve- ment in the patients noted by both the medical and nursing staff". The October/November issue of Positive Directions News, a publication of Positive Directions, an association of HIV-posi- tive persons in Boston, MA., interviewed AIDS researcher Dr. Clyde Crumpacker of Harvard Medical School about the Stockholm AIDS conference (June 1988). Most of the published interview concerned passive immunotherapy, which Dr. Crumpacker called one of the most interesting findings presented at that conference. (Positive Directions News can be reached at 617/787-8770.) Since our earlier article, we have heard the following from physicians: (1) Precautions must be taken to minimize any risk of transmitting different strains of HIV, or any other viruses, to the recipient. Viral cultures may be used to make sure the donor's HIV has been killed by the heat treatment of the plasma. (2) The plasmapheresis step might be avoided, simply by cen- trifuging tubes of blood to obtain the plasma, and not returning cells to the donor. Avoiding plasmapheresis, which requires com- plex equipment, could make the treatment less expensive and easier to administer. (The drawback is that the donor could not donate as often.) (3) There is concern that red tape could delay the availa- bility of this treatment. A patient support group on plasmapheresis, focused espe- cially on making it available, is being started in San Francisco. The first meeting will be Monday December 12 at 7: 30 PM. For location or other information call Richard, 824-2016. ***** How to Obtain Medical Articles AIDS Treatment News often cites articles in medical jour- nals. How can you get copies of these articles if you do not have access to a medical library? A number of commercial document-retrieval services can take orders by telephone and copy and mail the articles within a few days, usually for less than $10. They can obtain hard-to-find published articles on any subject. The service we are using is Dynamic Information Corporation in Redwood City, CA, 415/591-5900. Prices for most articles are $4.80 plus 20 cents a page plus copyright (usually $1. to $1.50) plus shipping; copies can usually be mailed within two days if the article is available on the library shelf. Articles not found at major university libraries cost somewhat more. Rush service, overnight delivery, fax, etc., are available. Credit card or prepayment is required on orders from individuals. ***** Antabuse/DTC: Controlling Gastrointestinal Side Effects Many people using antabuse (or using DTC, also called imu- thiol) as an immune modulator experience cramps and diarrhea the day after taking the medication. Bernard Bihari, M. D. asked a nutritionist about possible diet supplements to control these effects. The method suggested completely controlled the problem in seven of eight persons using antabuse who have tried it so far; the eighth was much improved. (It has also worked for two people who obtained imuthiol from Paris.) The diet is simply: (1) Include a bowl of high-fiber cereal (4 to 5 grams per serving) with breakfast every day; and (2) On the days the antabuse or DTC is used, take two table- spoons of olive oil an hour before lunch; then take the medicine with lunch. The recommended dose of antabuse, which is a prescription drug, is 500 mg twice per week. Precautions are to avoid alcohol, of course, and also to watch out for cough syrups and other liquid medicines, which may contain alcohol. Alcohol-free formulas are available. ***** San Francisco: Free Medical Care in Two Studies: Erythropoietin (EPO) for Anemia; AZT in Early ARC (for Veterans) Administrators of two clinical trials in San Francisco told AIDS Treatment News about their need for volunteers. While both these studies do use placebos, they were designed with more con- cern for the patients' welfare than most placebo studies in the past. Both monitor blood work, and take patients off the study if they show disease progression, and offer open-label treatment (without placebo) instead. (1) Positive Action HealthCare is doing a trial of EPO, a substance which causes the body to produce more red blood cells, and therefore can substitute for transfusion in cases of anemia. All expenses are paid; you do not need to be a patient of Posi- tive Action. Patients must have anemia (hematocrit under 30), and cannot have taken AZT or certain other drugs during the last 30 days. The placebo study will run 12 weeks, then all patients will be eligible for EPO for six months. But patients will be moni- tored monthly, and if they show signs of disease progression, they will receive free outpatient treatment (including EPO if needed). Positive Action has also negotiated to cover free out- patient care for a year for participants, including transfer fac- tor and dextran sulfate as appropriate; however, the clinic can- not cover the cost of AZT. For more information, call Fred Ponder at Positive Action HealthCare at 415/788-7545. (2) The second study, AZT for early ARC, is for veterans, and is being conducted at the Veterans Administration Medical Center at 4150 Clement St., San Francisco. Patients must have 200-500 T-helper cells, and be mostly well, but with one ARC symptom. Patients for this study cannot have AIDS, nor presently be taking AZT; certain other antivirals such as ribavirin or isoprinosine are also exclusions. AL 721 is OK. A placebo is used, but if patients go under 200 T-helper cells they are taken off the study and given open-label AZT. This trial is being conducted by the Cooperative Studies Project (CSP), the same group that did the study with doctors taking aspirin to see if it prevented heart attacks. This AZT study is identified as CSP #298. For information on volunteering, call the San Francisco V. A. Medical Center, 415/221-4810, ext. 3224. ***** Scientists: Jobs Available in AIDS Research Scientists (Ph.D., M. S., B. S., bench or administrative experience) interested in AIDS work can contact Kalvert Personnel Services, Deer Park, Long Island, New York, 516/567-2444. They represent several biotechnology companies looking for persons with expertise in one of the following areas: Immunoassay development, or molecular biology, or protein chemistry, or virology, or clinical microbiology. Jobs are on both the East and West coasts. All fees are paid by the employer. ***** AL 721 (R) -- Trademark Confusion Ethigen Corporation of Los Angeles, CA called to remind us that the name "AL 721" is their registered trademark, and should not be used to refer generically to egg lecithin products. We had used it that way in recent articles. In the future we will use "egg lecithin lipids" to refer generically to egg lecithin products (including AL 721) in which the 7: 2: 1 ratio of NL, PC, and PE is present or intended, and "AL 721" to refer to the Ethigen product. There is more confusion. Ethigen Corp. will also introduce the same product under a new trademark name, "Altrigen", for over-the-counter sales in the U. S. It will continue to be called "AL 721" in clinical trials, and in Europe, where it is now available by prescription in England, although it cannot be pro- moted there until trials are complete. The "Altrigen" name apparently resulted from a compromise with the FDA, which objects to products being sold as food sup- plements if they are also in clinical trials for approval as a drug. Ethigen will be allowed to sell its remaining stocks which are already labeled as "AL 721". Until recently, Ethigen was unable to speak publicly about this situation, due to its nego- tiations with the FDA. You can order AL 721 (which will soon be called Altrigen) from Ethigen by calling 800/752-5721. You can obtain generic products through buyers' clubs (see list in AIDS Treatment News #69), or from some health-food stores. EDITORIAL NOTE: The current situation with egg lecithin lipids is complex, ambiguous, and controversial. There is much speculation (but no compelling proof from scientific human tri- als) about whether this treatment works at all, or whether any particular version works best. Our impression from talking with persons using this treat- ment, plus what little scientific clinical information is avail- able, is that egg lecithin lipids are a significant help to some people. But we have also heard several reports of growing skep- ticism among physicians and others in New York, where more people are using the lipids than anywhere else. We will provide more information as it becomes available. ***** AIDS Treatment News, Project Inform Receive BAPHR Public-Service Awards The Bay Area Physicians for Human Rights (BAPHR), an organi- zation of gay physicians in the San Francisco Bay Area, presented community service awards to organizations, to both AIDS Treatment News and Project Inform, at its annual awards meeting on November 18. Other award recipients included Donald Abrams, M. D., organ- izer of the County Community Consortium. AIDS Treatment News thanks BAPHR for this recognition. To us it marks the theme -- reinforced by observances of World AIDS Day on December 1 -- of an end to an era of isolation which began for AIDS Treatment News in our early days, when very few AIDS organizations would touch treatment issues. Today there is a growing interest in consensus building, cooperation, and involve- ment by AIDS organizations in treatment issues. ***** NIH Announces Program for Community-Based Trials On November 22, the National Institute of Allergy and Infec- tious Diseases (NIAID), a branch of the National Institutes of Health (NIH), announced a new program to involve community physi- cians in AIDS research. Contracts for this research "are tar- geted to individual or group providers, public and private clin- ics, community organizations, or hospitals that may have no prior experience in conducting clinical trials". The program is coordi- nated by Lawrence Deyton, M. S. P. H., M. D., who will serve as NIAID Assistant Director for Community Research, advising NIAID Director Anthony S. Fauci, M. D. Dr. Deyton and staff will assist organizations and individuals in preparing contract bids. NOTE: On the week of this announcement, NIAID invited representatives from a number of AIDS organizations to Washington to discuss this program. We talked with Martin Delaney of Pro- ject Inform, who attended the Washington meeting and thought that the program was beginning well. He was impressed by the openness of NIAID officials to communication with AIDS organizations and physicians. Everyone acknowledged that clinical trials cannot by themselves meet the need for access to health care; this problem must be dealt with directly. And many specific problems remain, for example in the ganciclovir and foscarnet trials for CMV retinitis. But the improvement in communication between NIH and community groups is an important step forward. ***** [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display