Subject: AIDS Treatment News #137 Date: Oct 18 1991 (710 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Copyright 1991 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #137, October 18, 1991 phone 800/TREAT-12, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] ddI (VIDEX) Approved Clarithromycin: Accessible or Not? Hemophilia, HIV, AZT: Proof of Effectiveness Published Oregon Health-Rationing Plan: AIDS Impact Feared Announcements Eighth International Conference on AIDS: Dates, Deadlines Antiviral Conference, San Francisco, November 14-16 HIV and People of Color: West Coast Conference in November Project Inform PI Perspective October Issue DATA: New Organization Announces Hypericin Fund, Seeks Research Reform ***** ddI (VIDEX) Approved by John S. James On October 9, the U. S. Food and Drug Administration approved ddI (also called didanosine; its brand name is VIDEX) for treating HIV in adults and children over six months old who cannot effectively use AZT. ddI, developed by Bristol-Myers Squibb Company, is the second anti-HIV drug approved in the United States, following AZT, which was approved over four years ago, in March 1987. ddI (VIDEX) is or soon will be available from pharmacies in tablet form with a new buffering chemical (the buffer used in the expanded-access distribution program for ddI was widely blamed for causing diarrhea). It is also available in the same packets of powder used in the expanded-access program, and in a separately formulated powder to be mixed by the pharmacist as a liquid form for pediatric use. The tablets will be in four strengths (25, 50, 100, and 150 mg); recommended doses vary according to the patient's weight. The most common dose of 200 mg twice daily should cost about $2,000 per year retail -- less than the the current price of AZT -- but for persons weighing 75 kg (165 lb) or more, the recommended dose will cost about $3,000 annually, while for those under 50 kg (110 lb) the cost will be about $1250 annually. Persons on the current expanded-access program will continue to receive free drug for at least six weeks from the approval date; and Bristol-Myers has set up a telephone assistance service to help patients obtain reimbursement, or, if all else fails, to provide free drug to those who need it and have no other option for obtaining it. Who should use ddI? The large, controlled clinical trials which showed benefit from AZT have not yet been completed for ddI; therefore most physicians will probably follow the current recommendation and use AZT as their first choice. ddI is important as an alternative, as an antiviral for persons who cannot tolerate AZT or do not seem to be benefiting from it. What about combination treatment with ddI and AZT? Trials are now testing this combination. Early data from one trial was presented last June in Florence, at the Seventh International Conference on AIDS. The data suggested some benefit, but was much less dramatic than the results of ACTG 106, which tested a different combination -- ddC and AZT. (For results of the ddC+AZT combination, see AIDS TREATMENT NEWS #115, November 23, 1990). Some patients and physicians might want to combine ddI and AZT, and they are legally able to do so, but it is too early to know how useful such treatment might be. [Note: the FDA "labeling" accompanying the current ddI approval recommends the drug for patients who cannot tolerate AZT or have done poorly while using it. This labeling would probably exclude most combination use. Physicians can legally prescribe drugs for "unlabeled" uses (and sometimes it is standard medical practice to do so), but insurers often refuse to pay in these cases.] ddI can have serious side effects; they are different from those of AZT. ddI does not cause bone-marrow suppression, as AZT sometimes does. The most serious toxicities of ddI are pancreatitis, which can be life-threatening, and peripheral neuropathy. Various precautions are necessary to control these and other potential problems; hopefully physicians will receive adequate warnings, and inform their patients. Besides providing a therapeutic alternative, the ddI approval is also important in showing the FDA's new willingness to move more rapidly than before to approve critically important new treatments for life-threatening conditions. Under past procedures, approval would probably have been delayed for at least a year and a half while current studies were completed and analyzed -- mainly because of the need to collect data which statistically proved a survival benefit of the new drug, a requirement which imposed long delays for any drug, no matter how good, used to treat a slowly developing disease like AIDS or cancer. With ddI, the FDA showed that it could accept credible evidence of benefit to approve a drug with great public-health importance, while further studies continue -- especially since there was much safety information, because thousands of people had received ddI under the expanded-access program. This example removes hopeless delays which stood in the path of the new generations of AIDS drugs now being developed. It should speed not only the regulatory steps to approval, but the whole development process, as pharmaceutical companies realize that they now have a feasible path to market for potentially life- saving new drugs -- where they did not before. How to Pay for ddI The fact that the FDA approves a drug should mean that public and private health insurance programs will pay for it; however, this is not always the case. With AZT, for example, the public does not realize how much work Burroughs-Wellcome did, with little publicity, to assure that the drug would be reimbursed. With ddI, indications are that companies will pay. The San Francisco Examiner, in a page-one story published October 14, called major health-insurance companies and associations nationally and in Northern California, including the Health Care Association of America, the Blue Cross-Blue Shield Association, Kaiser Permanente, Bay Pacific, and Heals/Qual-Med; all said they intended to pay for ddI as for other approved drugs. Bristol-Myers, following what is becoming a common practice when companies introduce a costly new pharmaceutical, has set up a program to help patients obtain payment from third parties. According to the company, physicians or patients can call the VIDEX HelpLine to work with trained specialists, who have a database of almost 300 possible reimbursement sources and are familiar with payers' policies and procedures. Reimbursement sources are identified based on information such as state and county of residence, total annual income, monthly expenses, and total liquid financial assets; information from the prescribing physician is also required. Two weeks later, the HelpLine will follow up with the physician to make sure that reimbursement is available, or to plan other courses of action; in some cases its specialists can serve as advocates in appealing denials. If all other options are exhausted, the HelpLine will provide the physician with an application for the VIDEX Temporary Assistance Program, which will provide the drug without charge to patients meeting the company's medical and financial criteria, for up to three months; after three months, a new application will be required. Patients or physicians can call the HelpLine, 800/788-0123, from 8:00 a.m. to 8:00 p.m. Eastern Time on business days. Spanish-speaking specialists are available. Package-Insert Information The "package insert" for ddI, four pages of very fine print written for physicians, provides certain basic information about proper use the drug. But it does not address all of the issues which physicians have encountered during the expanded-access program. Besides reading and understanding the package insert, physicians need to have good communication with each other, so that those who are prescribing the drug for the first time will hear from those who are experienced with it. Here is some basic information which patients should know. Of the three different formulations of ddI which will now be available (tablets, buffered powder for oral solution, and pediatric powder for oral solution), most adults will use the tablets; the buffered powder used in the expanded-access program remains available as a backup. The recommended dose depends on body weight. For adults weighing 35 to 49 kg (77-108 lb), the starting dose is 125 mg twice daily; 50 to 74 kg (110-163 lb), 200 mg twice daily; and 75 kg (165 lb) or more, 300 mg twice daily. These starting doses may be adjusted by the physician because of side effects, or for other reasons. A chemical buffer is necessary to reduce stomach acidity; without it, the ddI would be destroyed by the acid environment of the stomach. To get the correct buffering, two tablets always need to be taken together (except for infants from six months to one year of age, for whom one tablet is enough). Therefore, if the dose needs to be reduced, different tablets need to be used; it would not work to just take part of the two-tablet dose, since the buffering would not be sufficient. The two tablets "should be thoroughly chewed, manually crushed, or dispersed in at least 1 ounce of water prior to consumption. To disperse tablets, add 2 tablets to at least 1 ounce of drinking water. Stir until a uniform dispersion forms, and drink the entire dispersion immediately." Doses should be taken every 12 hours, on an empty stomach, since food can reduce the absorption by as much as half. Because the ddI formulations affect stomach acidity, drugs which require an acid stomach, such as ketoconazole or dapsone, should be taken at least two hours before ddI. Because of the buffering used, the tablets and the pediatric power -- "should not be administered with a prescription antibiotic containing any form of tetracycline." Also, quinolone antibiotics (e.g. ciprofloxacin) "should not be taken within 2 hours of taking VIDEX tablets or pediatric powder, since the buffering used with those formulations can decrease the absorption of some quinolones." Because of the danger of pancreatitis, it can be dangerous to combine ddI with other drugs which can cause toxicity to the pancreas, such as intravenous pentamidine. Alcohol use can also increase the risk of pancreatitis. We do not know whether moderate drinking could be a problem, or only alcohol abuse. The package insert notes that ddI doses may need to be adjusted for patients with kidney or liver impairment. Perhaps the most important single warning is to watch for signs of pancreatitis and peripheral neuropathy, so that medical attention can be sought quickly and the drug stopped or reduced, at least temporarily, if either occurs. "Patients should be informed that the major toxicities of VIDEX are pancreatitis, which has been fatal in some patients, and peripheral neuropathy. Symptoms of pancreatitis include abdominal pain, and nausea and vomiting. Symptoms of peripheral neuropathy include tingling, burning, pain or numbness in the hands or feet. Patients should be advised that these symptoms should be reported to their physicians. They should be counseled that these toxicities occur with greatest frequency in patients with a history of these events, and that dose modification and/or discontinuation of VIDEX may be required if toxicity develops. They should be cautioned about the use of other medications that may exacerbate the VIDEX toxicity, including alcohol." According to the package insert, pancreatitis occurred in nine percent of patients in phase I trials who received the currently recommended dose or less, and five percent of those in the expanded-access program; and it was fatal in 0.35 percent of patients treated with the drug, 27 cases out of 7,806 who received ddI. Many physicians use an amylase test -- a test for certain enzymes in the blood -- as an early warning of possible pancreas toxicity. The ddI package insert does not include a recommendation to use the amylase test. For this and other reasons, we believe it is important that physicians closely follow the evolving medical consensus among those most experienced with the drug, and not rely only on the package insert. This article is not complete, but can only only point to some of the most important information about using ddI. The package insert, for example, mentions a number of other, less frequent, side effects which may be caused by the drug. We believe it would be helpful if patients received, along with their prescription for this and other drugs, written explanations and practical instructions prepared by medical organizations and reflecting the prevailing expert consensus. ***** Clarithromycin: Accessible or Not? by Denny Smith Clarithromycin is a macrolide antibiotic now under study in the U. S. to treat several infections. Like its chemical cousin, azithromycin, it is hoped that it will be useful for treating toxoplasmosis, cryptosporidiosis and Mycobacterium avium complex (MAC, formerly known as MAI -- for background information, see AIDS TREATMENT NEWS #113). Clarithromycin is already approved in some European countries and can be obtained through AIDS community buyers' clubs in Los Angeles, New York and San Francisco. The drug's developer, Abbott Laboratories, has established an open-label trial intended to create "expanded access" for physicians treating patients with MAC. But that program has come under the scrutiny of physicians and activists recently for extraordinarily stringent entry criteria and monitoring requirements. Last August 20, the Community Consortium, an association of San Francisco Bay Area HIV physicians, sent a letter to Abbott asserting that troublesome entry criteria and laboratory processing for the clarithromycin protocol are not translating into truly "expanded" access. Among the complaints leveled against the protocol is that its stipulations resemble those of a full-fledged controlled clinical trial, but that it is not funded as such by the developer; a protocol which would not be considered burdensome within the context of a multi-center controlled study with adequate support services is instead falling on the shoulders of busy, individual doctors. The implication emerged that Abbott is collecting the benefits of large-scale trials while avoiding the expense. Another problem is the requirement that potential participants, even as their blood cultures prove they have MAC, must discontinue other MAC drugs for one month before receiving clarithromycin. The Consortium letter called this "clinically unjustifiable." In the end, those patients needing a new option the most may become the least eligible under Abbot's protocol. Other problems, which may have been partly addressed by Abbott since the letter was sent, include the requirement of multiple processing of lab specimens and proof of disseminated MAC. On September 10, Abbott responded to the Consortium with a brief letter, saying essentially that the protocol's design was warranted and would not be changed. Abbott acknowledged that some of the requirements "are more cumbersome than that of other compassionate programs," and that "there is presently a substantial use of clarithromycin obtained through illegal sources and that patients are taking as little as 250 mg twice a day, which may be an insufficient dose and result in the development of resistant organisms and leave patients with no alternative treatment ..." (Comment: If Abbott is referring to the importation of clarithromycin from abroad, then the choice of the phrase "illegal sources" is inaccurate. Americans are not transgressing FDA limits when they acquire, for personal use, drugs approved in other countries. If Abbott is genuinely concerned about collecting sufficient data to establish safe and efficacious doses for clarithromycin, then what is warranted is a protocol that streamlines the responsibilities of the physician petitioning for the drug, thus optimizing the number of participating patients, and eliminating their need to pursue other avenues of access). Abbott has been pursuing FDA approval for clarithromycin to treat certain non-life-threatening skin and respiratory infections. Theoretically, the company might save enormous amounts of money by skipping the studies needed to prove to the FDA that the drug is also effective against MAC, toxoplasmosis or cryptosporidiosis. Early approval of clarithromycin for any indication would automatically make it available for physicians treating AIDS-associated infections. But unfortunately, health insurers, public and private alike, are eager to deny payment for any treatment unless specifically indicated in the product labeling. In other words, clarithromycin could remain virtually out of reach for most people, whether or not it wins FDA approval. On the positive side, some of the other charges leveled against Abbott's program may have been answered. The original protocol called for proof that the MAC infection was disseminated. On October 17 Gordon Nary of the Physicians Association for AIDS Care (PAAC) in Chicago told us that after some negotiating, Abbott has agreed to accept a positive culture that has tentatively ruled out tuberculosis -- allowing for a presumption of the dissemination. A procedural detail regarding Institutional Review Boards was also loosened. The original protocol also disallowed anyone who had tried the drug already, meaning, of course, the many people who have spent considerable money buying imported clarithromycin from Europe. Under pressure from ACT UP and Project Inform, Abbott has created an additional protocol which will admit those who have had prior experience with the drug. Michael Wright of Project Inform met personally with Abbott representatives, and told us that about 500 patients had been enrolled under the first protocol, and about 100 are enrolled in the new one. He said that even if Abbott's drug is approved for lesser infections, he expects the company to continue studies toward AIDS-related indications. Michael is willing to field calls from people who are still having a difficult time with Abbott's clarithromycin protocols. Messages can be left for him at the Project Inform hotline (for hours and phone numbers, see the Project Inform announcement, below, on page 8 of this newsletter). Meanwhile, Abbott is expected to begin trials of the drug as a prophylaxis against MAC by January 1. The question remaining is when clarithromycin will be tested in combination with other MAC drugs to treat active MAC infections. Most researchers and clinicians we've spoken to think that this infection will not optimally respond to single-drug treatment. The number at Abbott to call for clarithromycin information is 800/688-9118, 9 a.m.to 9 p.m. Eastern time. ***** Hemophilia, HIV, AZT: Proof of Effectiveness Published by Denny Smith Positive results of a clinical trial testing AZT in adult hemophiliacs with asymptomatic HIV infection were published in the August edition of Blood. Protocol 036 of the AIDS Clinical Trials Group (ACTG) was begun in early 1988 as a placebo- controlled trial. The placebo arm was halted two years ago, after another AZT study, the famous ACTG 019 protocol, revealed that the drug was helpful for asymptomatic non-hemophiliacs who had less than 500 helper cells (see AIDS TREATMENT NEWS #86, August 25, 1989). The current report only analyzes the data gathered before the placebo arm was switched to AZT. One of the most important outcomes of the study was the discovery that AZT did not adversely affect liver functions, which tend to be chronically abnormal in people with hemophilia because of repeated transfusions of pooled blood products. A large majority of people with hemophilia continue to be infected with hepatitis C through infusions of clotting factors. In the past, elevated liver enzymes have frequently been used to exclude potential participants from AIDS clinical trials. So hemophiliacs were routinely denied access to important investigational drugs, even though their underlying liver problems were essentially stable. We asked Brad Lewis, M. D., of the Adult Hemophilia Program at Alta Bates Hospital in Berkeley, California, about the significance of protocol 036. He said that the results were of course welcome, but not a surprise, and that physicians treating this patient population had been giving AZT when appropriate anyway. However, Dr. Lewis feels real progress was made by completing a clinical trial which enabled patients to be enrolled outside of ACTG centers. The clinicians at ACTG sites are not usually familiar with the medical aspects of hemophilia. This trial instead enrolled patients through local hemophilia treatment centers, where people with hemophilia are already monitored by their primary physician. Dr. Lewis is now following some of his patients on ddI and ddC, and he has not seen any problems that are not already noted in the non-hemophiliac population. On the other hand, he feels that the question of exactly when to begin intervention in asymptomatic infection still has not been answered, whether or not hemophilia is an additional factor. ***** Oregon Health-Rationing Plan: AIDS Impact Feared by John S. James The state of Oregon is now asking the Federal Government's HCFA (Health Care Financing Administration) for permission (in the form of waivers of existing Federal laws) to replace its Medicaid plan with the "Oregon Medicaid Demonstration Project" for explicit rationing of health care. The goal of the plan is to list medical services in order of priority, using public input from hearings and phone surveys as well as input from ethicists and medical professionals. Then the legislature will use what funds it wants to spend to pay for the highest priority services, working down the list until the funds run out. Lower priority services will not be covered. If Oregon is allowed to adopt this health-care rationing plan, other states are "waiting in line" and may essentially copy it for their own use. This Oregon plan could also become a national model, perhaps adopted as a Republican approach to health-care reform. Because AIDS and other organizations may have only until mid November to bring their concerns to HCFA, we are publishing this short article now, even though we received the following information shortly before deadline and could not do an in-depth analysis. The main argument in favor of the Oregon plan is that health-care rationing decisions are being made in any case, in that those who cannot afford health care and do not have insurance are denied access. Oregon wants to replace this haphazard health rationing with a rational system drawn up by health-care experts, ethicists, and the public. "Excluded, for example, are medical treatment for infertility, medical treatment for a viral sore throat, routine screening (e.g., colon cancer) for adults not otherwise at risk, and aggressive treatment for the end-stages of AIDS and cancers and for newborns weighing less than 500 grams and having less than 23 weeks gestation" (quoted from Oregon's application to HCFA for waivers to allow the state to implement the plan). Advocates say that the plan will cover all the poor, and provide them with basic benefits through managed care at reasonable rates. Here are some of the concerns we have heard from opponents of the plan: * While early treatment of HIV infection is given a fairly high priority, as is treatment of opportunistic infections when the treatment is not "experimental," "end stage" HIV disease (which is never defined) is rated very low and will not be funded, except for "comfort care" such as pain management. "Diagnosis -- End Stage HIV Disease; treatment -- Medical Therapy...represents those cases where there is very little likelihood that the patient's quality of life will be at all improved by any known aggressive treatment for HIV disease. In these cases, comfort care will be offered as a replacement for ineffective or experimental treatments which hold little promise of stopping the disease (quoted from an explanatory attachment to the Oregon plan, emphasis in original). Oregon patient advocates have been unable to get State officials to give definitions of "end-stage HIV disease," "end- stage AIDS," or "end-stages of AIDS," all used interchangeably throughout the Oregon Medicaid Demonstration Project. This vagueness could be reserving the right to defund most AIDS care, especially since many treatments for opportunistic infections are "experimental." Advocates are worried because of the history of the plan; early drafts did attempt to defund AIDS by providing only "comfort care" unless there was judged to be a 10 percent chance of survival in five years. * Another concern is that well-organized groups such as the elderly can lobby for better treatment, whereas other groups such as infants cannot. Senator Albert Gore (Democrat, Tennessee), a leading opponent of the Oregon plan, commented on a TV documentary, "The Health Quarterly with Roger Mudd: The Oregon Experiment," that "They've picked out only poor women and poor children, and they say: 'You've got to bear the full brunt of this entire rationing scheme.'" The Children's Defense Fund, in a September 10, 1991 memorandum, concluded that "rather than adding women and children to the Medicaid program and improving its performance in the areas of maternal and child health, the waivers, if granted {by HCFA}, would not only diminish coverage for the women and children now enrolled in Medicaid but could result in the denial or termination of any benefits whatsoever for thousands of children and women currently eligible for assistance (emphasis in original). * Mike Isbel of Lambda Legal Defense is concerned with long- term implications: "The overall purpose of the plan has been to put resources into early care, and not pay for end-stage care, which is often expensive. But it has always been understood that a few who are very sick consume most of the health-care resources. The Oregon plan -- likely to be copied by other states and perhaps proposed nationally -- is an attempt to peel off the bad risks. "Such attempts are based on the myth that the United States does not have the money to pay for health care for everyone. But we pay a much larger percentage of our gross national product for health care than other industrialized nations, which have health plans covering everyone. The problem is inefficiency and how resources are allocated, not lack of resources. For example, administrative costs consume twice as large a share of healthcare expenditures in the United States as they do in Canada, because of the hodgepodge of U. S. providers, each with its own rules designed to shift the cost burden to someone else. To reduce benefits instead of correcting such inefficiencies is completely disingenuous. "The Oregon plan is frightening because it could become a national pattern for conservative health-care 'reform'. We as a nation cannot live with a health-care system which takes care of the healthy and abandons those who become seriously ill." For more information For more information on the concerns about the Oregon Medicaid Demonstration Project, and how your organization can become involved, contact: * Lambda Legal Defense, attn: Mike Isbel, 666 Broadway, 12th Floor, New York, NY 10012, 212/995-8585. * AIDS Action Council, attn: Laura Fogt, 2033 M Street NW, #802, Washington, DC 20036, 202/293-2886 ext. 21. * Vanguard, P. O. Box 231261, Portland, Oregon 97223, 503/245-6799. ***** Announcements ** Eighth International AIDS Conference: Dates, Deadlines The Eighth International Conference on AIDS / Third STD World Congress, originally scheduled for Boston but moved due to U. S. travel restrictions on persons with HIV, will be held in Amsterdam on July 19-24, 1992. This conference will be jointly sponsored by Harvard University and the Dutch Foundation AIDS Conference 1992, and co-sponsored by the International AIDS Society and the World Health Organization. A new Call for Abstracts and Registration Brochure will be issued in December. The deadline for abstract submission and early registration is March 2, 1992. For information on registering or on submitting abstracts, write to the address nearest you: Harvard AIDS Institute 8 Story Street Cambridge, MA 02138 or VIII International Conference on AIDS/III STD World Congress CLB Plesmaniaan 125 Postbus 9190 1006 AD Amsterdam Netherlands ** Antiviral Conference, San Francisco, November 14-16 The third annual "New Directions in Antiviral Chemotherapy," a conference sponsored by the Department of Medicine of the University of California San Francisco and by San Francisco General Hospital, will be held at the Sheraton Palace Hotel in San Francisco, Thursday November 14 through Saturday November 16. The program will include drugs in clinical trials and preclinical development for HIV and for other viruses, including herpes simplex, cytomegalovirus, and hepatitis. The program chairmen are John Mills, M. D., San Francisco General Hospital, and Lawrence Corey, M. D., University of Washington, Seattle. The registration fee is $200, and continuing education credit is available. For more information, contact Postgraduate Programs, 521 Parnassus Avenue, C-405, San Francisco, CA 94143-0656, 415/476- 5208. ** HIV and People of Color: West Coast Conference in November A multicultural conference addressing issues of HIV and AIDS in communities of color will be held in Seattle, Washington, November 14, 15 and 16, at the Westin Hotel. "Taking Charge: People of Color in Solidarity Against the HIV/AIDS Epidemic" is sponsored by the U. S. Public Health Service, and is intended to be a forum for African American, Asian/Pacific Islander, Latino/Chicano, and Native American/Alaska Native communities from Alaska, California, Hawaii, Idaho and Oregon. The registration deadline for the conference is October 28, and space is limited. For more information, call 206/728-8911. ** Project Inform PI PERSPECTIVE October Issue The October issue of PI Perspective, a newsletter published three times a year by Project Inform, includes major articles on: expedited drug approval; how ddI was approved and what the process means for the future; immune-based therapies; aggressive early intervention; and total parenteral nutrition. There is also a guide to opportunistic infections, a "clinical update" with brief descriptions of a number of experimental drugs now being developed, and several shorter notes and articles. PI Perspectives is available without charge, but a donation is appreciated. To obtain a copy, call the Project Inform hotline, 800/822-7422 (U. S. except California), 800/334-7422 (California only), or 415/558-9051. Hours are 10 a.m. to 4 p.m. Monday through Friday and 10 a.m. to 1 p.m. Saturday, Pacific time. [sysop note: for a quick glance, look at the display here of this latest issue of PI Perspective #11] ** DATA: New Organization Announces Hypericin Fund, Seeks Research Reform DATA (Direct Action for Treatment Access), a new treatment activist organization including AIDS and other major diseases, recently began as a project of the nonprofit PATH Foundation, an organization which has worked for two years to promote research into passive immunotherapy for AIDS. DATA is seeking donations for a "Special Trials for Alternative Treatments Fund"; donations may be directed for use in research or research advocacy for hypericin, an experimental HIV treatment, or for passive immunotherapy; or donors may leave their funds unrestricted for use as the board believes best. Other treatment research projects may be added in the future. DATA has also started a treatment newsletter, Access, which is available through the address below. At this time the board of DATA consists of Steven Wm. Fowkes, editor of Forefront, a health newsletter; James P. Driscoll, Ph.D., best known for his work on the "Campbell bill" for faster access to drugs for life-threatening conditions (for background on the Campbell bill, see AIDS TREATMENT NEWS #136); and Dale Gieringer, Ph.D., author of papers on regulatory reform, some of them published by the Cato Institute, a public-policy foundation dedicated to limited government and free-market ideas. Steven Fowkes provided major assistance to AIDS TREATMENT NEWS on one of our earliest major articles, on BHT as a potential HIV or herpes treatment (issue #10, August 15, 1986). Membership in DATA is $20 per year. The organization is also seeking volunteers. For more information, send a self- addressed stamped envelope to: DATA, P. O. Box 60391, Palo Alto, CA 94306, or phone 415/323-6051. [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display