From: "John S. James" Date: 02 Oct 94 21:16 PDT Subject: AIDS TREATMENT NEWS #208 AIDS TREATMENT NEWS Issue #208, October 7, 1994 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: AIDS Drug Interactions Guide Available Patents and Biotechnology: Federal Hearings October 17 in San Diego, Comments Invited AIDS and Nutrition: Clarification, Additional Resources KS: DOX-SL Submitted for Approval Yokohama Conference: Behind U.S. Media Coverage FDA Proposes Financial Disclosure for Clinical Researchers Grassroots Organizing: Communication Groups California (and Beyond): Proposition 187 and Public Health ***** AIDS Drug Interactions Guide Available Project Inform has compiled an 11-page fact sheet on interactions of drugs commonly used by people with HIV disease, including experimental drugs. Everyone using multiple drugs for HIV-related treatments should obtain a copy. The September 28 version includes interaction between other drugs (and some foods) and: acyclovir (Zovirax); amphotericin B (Fungizone); antineoplastics; atovaquone (Mepron); azithromycin (Zithromax); AZT (Retrovir); ciprofloxacin (Cipro); clarithromycin (Biaxin); clindamycin (Cleocin); clofazimine (Lamprene); cycloserine (Seromycin); dapsone; ddC (Hivid); ddI (Videx); delavirdine; d4T (Zerit); ethionamide (Trecator); fluconazole (Diflucan); flucytosine (Ancobon); foscarnet (Foscavir); ganciclovir (Cytovene); interferon alpha (Intron A; Rofereon); isoniazid (INH); itraconazole (Sporanox); ketoconazole (Nizoral); nevirapine; pentamidine (Pentam); protease inhibitors; pyrimethamine (Daraprim; contained in Fansidar); rifabutin (Mycobutin); rifampin (Rifadin); sulfadiazine; TMP/SMX (Bactrim, Septra); trimetrexate (Neutrexin). Also included are suggestions for working with your health-care provider so that drug interactions receive proper attention. A short glossary defines medical terms used in the fact sheet. For a free draft copy of the Project Inform Drug Interaction Fact Sheet, call the Project Inform hotline, 800/822-7422 or 415/558-9051, Monday through Saturday 10 a.m. to 4 p.m. Pacific time. ***** Patents and Biotechnology: Federal Hearings October 17 in San Diego, Comments Invited by John S. James Public hearings on biotechnology patents will be held October 17, 1994, at 9:00 a.m., in the Cooper Room of the San Diego Concourse, 202 C St., San Diego. Persons interested in speaking or in sending written testimony should contact the Commissioner of Patents and Trademarks (see information below). Background -- Why It's Important The AIDS community has largely ignored patent issues until now -- not because it does not matter, but because there has been no activist to investigate this area and explain its importance. Patent issues are important because it can take four years or more between the time an AIDS, cancer, or other biotechnology patent is applied for, and the time it is granted. During this time, the patent application usually stays secret. Delays, therefore, not only hold up the development of one treatment (since investors are unlikely to finance clinical trials until the patent is granted), but can also delay other research and development by keeping cutting-edge medical information secret. (One example is compound Q, the well-known experimental AIDS treatment, which seems to have been delayed for about two years while the patent was pending. If this drug had turned out to be the home run that many who were close to it expected, the delay would have caused many thousands of deaths. And if current directions continue, the drug or drugs which finally do lead to major advances in HIV treatment could very well suffer similar delays.) Biotechnology patents used to take much longer than the average of all patents to be granted, with industry and the PTO essentially blaming each other. In July 1990, the U.S. General Accounting Office reported that it took an average of four years to get a patent in genetic engineering, and three years in other areas of biotechnology, vs. an average of 18 months for all patents. Major improvements have been made since then, but we do not have current figures. Recently a patent attorney for industry told us that patents for AIDS and cancer treatments take much longer than patents for other diseases, due to the way the PTO interpreted the "utility" requirement -- the requirement that an invention be useful. But another expert told us that there were no figures to prove this -- and that companies often deliberately delayed their own applications, for reasons explained below. The "Utility" Controversy The patent law requires that a patentable invention not only be new, and more than a non-obvious advance that would have inevitably been discovered in routine progress of the field, but also that it be useful (have "utility"). This means that somebody trying to patent a new medical treatment may be asked for in vitro (animal or human, not just test tube) data to convince the PTO that it works. The FDA, of course, will ultimately make this determination, when granting marketing approval for the drug (or medical device); but unless the patent is granted at a much earlier stage, the trials leading to FDA approval are unlikely to ever occur. The reason AIDS and cancer patents take longer than patents for other diseases, according to this industry view, is that it is harder to prove that AIDS and cancer drugs work; to solve this problem, the PTO should ease up on the utility requirement. The second expert quoted above had a different view. He said that with medical patents, it is often in a company's interest to deliberately delay its own application. The reason is that with a non-medical invention, as soon as you get the patent (or even before), you can start selling the product; but with medical treatments, you cannot sell the drug until it is approved by the FDA. Since the patent runs for a fixed term of years, a company may not want to get its patent too long before FDA approval, lest it decrease the value of the patent by reducing the number of years of exclusive sales. (This situation is common enough that patent examiners have a phrase for it: the "submarine patent." For additional background on the submarine patent, and other problems it can cause, see article by Paul Karon in the Los Angeles Times, June 1, 1994, business section, page 9.) One possible reform would be to not require proof of usefulness for medical treatments. Since the FDA will eventually make this determination anyway, and since without the FDA's finding of efficacy the treatment will be commercially worthless and the patent would not matter much anyway, why should the PTO slow down the process by insisting on making its own separate, lesser determination of whether or not a drug works? This kind of reform might be considered, although it might take an act of Congress; but any big change must be made carefully, since the "utility" requirement -- part of the U.S. patent system for over 200 years -- is there for a reason. Without it, someone could tie up a new area early, without doing the work required to produce a useful invention. Then others who were ready to do the work could be locked out. Also, the PTO is concerned about the credibility of patent information to investors, who often do not understand the technology involved, and instead rely on the fact that a patent has been issued. There is a fear that if the "utility" requirement were weakened or eliminated in some cases, the public could be misled to invest unwisely. Issues at the San Diego Hearings The October 17 hearings in San Diego will address certain specific issues, including: * The "utility" controversy, partially outlined above. (Other "utility" issues involve patenting human genetic sequences when their function is not known.) * The "operability" requirement (that the invention must be fully described so that an independent expert in the field can make it work). * Technical issues around determining "non-obviousness" of biotechnology patents, in a rapidly changing field. * Implications of patent-reform proposals which have been introduced in Congress. One would provide a patent term of 20 years from the date of filing of the patent application (eliminating the incentive of industry to delay the processing of medical patent applications). Another would automatically publish patent applications 18 months after filing (as the European patent office now does), to prevent important information from being withheld from the public for years in many cases. * The current rules allowing research use of patented drugs or other materials without the permission of the patent holder. (Loss of this defense to patent-infringement suits would be disastrous to medical research, especially because of the difficulty of getting pharmaceutical companies to cooperate with each other.) * U.S. plant patents, which currently restrict only the sexual reproduction of plants, or use of the plants so produced. This allows plants to be grown outside the U.S., and the harvested products to be imported to the U.S. without payment to the patent holder. (Changes here could conceivably affect access to improved herbal treatments.) And a major concern which is not on the program for San Diego is delays caused by the high turnover of patent examiners with experience in both the science and the law of biotechnology. After two or three years experience in the PTO, these people can find more money and a less bureaucratic work environment in industry. (See "The Looming Biotech Vacuum," The Recorder [a legal newspaper in San Francisco], March 28, 1994, page 1.) For More Information Anyone planning written or oral comments should obtain "Notice of Public Hearings and Request for Comments on Patent Protection for Biotechnological Inventions," Federal Register, September 1, 1994 (volume 59, number 169), pages 45267-45271. Those wishing to speak must submit a request to do so by October 12; written comments, however, may be sent by mail, fax, or email either before or after the hearings, until November 23. Comment It is vitally important that at least a few AIDS activists seriously follow patent issues, and how they affect the development of new treatments for AIDS and other serious illnesses. We hope that this short article will help to introduce this complex but critical area. ***** AIDS and Nutrition: Clarification, Additional Resources by Tadd Tobias AIDS Treatment News recently published a two-part interview on nutrition and AIDS (issues #204 and #205, August 5 and 19, 1994). A dietitian suggested that we further clarify the difference between the terms "nutritionist" and "registered dietitian," and include some additional resources for nutritional information. Many states have enacted legislation which regulates licensing and practice of this profession. These regulations vary widely among states, however, and the only truly national standard ("Registered Dietitian") is voluntary. Practically anyone can call themselves a nutritionist, and this person may or may not have the educational background and training to dispense accurate nutrition information. Many registered dietitians call themselves "nutritionists," especially when they work in the community or outpatient settings. This seems to be a more "user friendly" term. As stated in the previous article, a registered dietitian with experience in the field is the first place to look for appropriate nutrition information regarding HIV disease. Be aware that "let the buyer beware" applies to this situation as well as any other. Remember that someone who calls themselves a nutritionist may or may not be a registered dietitian; be sure to check their credentials. Also, it is important to understand that, if they inexperienced in caring for persons with AIDS, a registered dietitian may not be the best source for information. According to the Commission on Dietetic Registration, which is the credentialing agency for The American Dietetic Association, a Registered Dietitian is defined as an individual who: * Has completed the minimum of a baccalaureate degree granted by a U.S. regionally accredited college or university; * Has met current academic requirements (Didactic Program in Dietetics) as approved by the American Dietetic Association; * Has completed 900 hours preprofessional experience accredited/approved by The American Dietetic Association; * Has successfully completed the Registration Examination for Dietitians; and * Has accrued 75 hours of approved continuing education every five years. Individuals may ask the Commission on Dietetic Registration to check authenticity of a practitioner's credentials. A general information packet, which outlines the pathway to registration, is also available for persons interested in becoming a registered dietitian. Contact: Commission on Dietetic Registration, 216 W. Jackson Blvd., 8th Floor, Chicago, IL 60606-6995, 312/899-4859, fax 312/899-1772. Additional Resources * "Dietitians in HIV Practice" was started in 1993 as a networking vehicle for registered dietitians working with people with HIV/AIDS in the San Francisco Bay area. The group meets about six times a year at various sites to discuss current practices and research, and to develop community resources and educational materials. They are now seeking financial support to help publish a guide to nutritional services for people with HIV/AIDS. For more information contact Lisa McMillan at 415/252-1941. * Project Open Hand provides comprehensive nutrition services, free of charge to persons with symptomatic HIV disease. For persons living in the San Francisco Bay area they support a food bank, a home-delivered meal program, and individualized nutritional counseling. Additionally they publish a newsletter, Positive Nutrition, three times a year. Contributors often are leading HIV nutrition experts, and the culturally sensitive editorial content includes useful information such as dietary suggestions, recipes, consumer tips, and research news. Subscriptions are free and available for anyone. Contact: Positive Nutrition, c/o Project Open Hand, 2720 17th St., San Francisco, CA 94110, 415/558-0600. * The newly-formed National HIV-Nutrition Team (N-HINT) provides nutrition referrals for counseling, conducts workshops, and produces a quarterly newsletter for both the lay and professional audience. Information is available in English and Spanish. Contact: Gustavo Wong, R.D., N-HINT, P.O. Box 5874, Berkeley, CA 94705-0874, 510/655-3702, toll- free 800/434-4468, fax 510/547-8548. * Persons or organizations interested in developing educational materials or specialized care clinics focusing on nutrition and AIDS may contact Kristin Weaver, R.N., M.S.N., C.N.S.N., 1601 Ocean Ave., Suite 212, San Francisco, CA 94112-1717. ***** KS: DOX-SL Submitted for Approval by John S. James Liposomal doxorubicin (trade name DOX-SL*) is a form of the chemotherapy drug doxorubicin which has been enclosed in specially designed liposomes (microscopic spheres of fat). Studies have found that the liposomal form of the drug is better targeted to KS lesions (and also to certain cancer tumors) than the free drug, which has long been used in KS treatment. Better targeting allows more effective doses to be given, usually with less side effects. DOX-SL has been submitted to the FDA for possible marketing approval, according to a September 7 announcement by Liposome Technology, Inc. (LTI), of Menlo Park, California. According to treatment activists who have closely followed this drug, it is likely to be considered by an FDA advisory committee either in December, or at a special meeting, probably in February. A recent trial at several U.S. medical centers studied 42 patients with KS who had failed conventional chemotherapy, either because of toxicity, or because it did not work for them. With DOX-SL there were no complete responses, 66.7% partial responses, 31% stable disease, and 2.3% progressive disease.(1) Another recent trial, reported at Yokohama, treated 247 patients with moderate or severe KS, but who had not necessarily failed other chemotherapy. With these patients, who were probably less seriously ill than those in the trial above, the best response reported for each person was 6.3% complete response, 74.4% partial response, 18.4% stable disease, and 0.8% progression.(2) Several other trials of liposomal doxorubicin have also been published. In the U.S., DOX-SL is available in an open-label trial for patients who cannot be treated with conventional chemotherapy. This trial, called protocol 30-12, requires the treatment to be given at one of the trial sites, so that the required data can be collected. LTI hopes to replace this trial with an open-label safety study, which will collect much less data, and therefore could allow patients not near a study site to receive the drug through their regular physician. For more information about protocol 30-12 (or the new safety trial, if and when it begins), call LTI, 415/323- 9011, and ask for the medical department. Comment We are continuing to hear good reports about DOX-SL from physicians and patients who have used it. For background about KS and its treatments, see The KS Project Report: Current Issues in Research and Treatment of Kaposi's Sarcoma, an 85-page report by Michael Marco and Marty Majchrowicz, published in July 1994 by the Treatment Action Group (TAG). Copies are available from TAG, 147 2nd Ave., Suite 601, New York, NY 10003, 212/260-0300. A $10 donation is requested, but no one will be denied the report due to lack of funds. References 1. Thommes J, Northfelt D, Rios A, and others. Open-label trial of Stealth liposomal doxorubicin in the treatment of moderate to severe AIDS-related Kaposi's sarcoma. Proceedings of the Annual Meeting of the American Society for Clinical Oncology. 1994; volume 13, abstract 24. 2. S Stewart (for the International DOX-SL Study Group). Efficacy and safety of Stealth liposomal doxorubicin in AIDS- related Kaposi's Sarcoma. Tenth International Conference on AIDS, Yokohama, August 7-12, 1994 [abstract #PB 0123; data above from poster at the meeting]. ***** Yokohama Conference: Behind U.S. Media Coverage by John S. James Because of the continuing effects of the generally gloomy news coverage of the Tenth International Conference on AIDS, in Yokohama, Japan, August 7-12, 1994, readers should have some background into the mechanics of how the press coverage came about. First, the tone and content of most U.S. media coverage of this conference was largely determined by one newspaper, The New York Times. This is because the Times has, for years, been extremely successful in selling its stories to other newspapers. And since the vast majority of U.S. media outlets that ran Yokohama stories did not send anyone there, they generally re-ran portions of the Times coverage. (Other nationally-circulated newspapers, including the Washington Post, the Los Angeles Times, and the Wall Street Journal, also covered the AIDS conference. But The New York Times is reprinted more widely.) The New York Times did not send its usual AIDS or medical writers to Yokohama. Instead it sent a reporter who usually covers Japan and Korea -- writing about computers, automobiles, nuclear and other technologies, corporate finance and other business news, and current political issues. His articles from Yokohama are what one would expect from a competent general reporter; the problem is that this large and complex a conference is very difficult to cover in depth. A reporter not familiar with the subject basically seeks out authority or other figures, and finds something to talk with them about -- which could be done any time by telephone, no conference needed. The thousands of other presentations at the meeting might as well not have happened, as far as most of the U.S. public is concerned, since this one reporter largely wrote what the U.S. read. We don't know why The New York Times did not send one of its usual AIDS reporters, who could have included more depth and different perspectives. The savings in airfare and lodging costs (since the person they did send already works in the region) is one possibility. ***** FDA Proposes Financial Disclosure for Clinical Researchers by John S. James The U.S. Food and Drug Administration has asked for public comment on a proposed rule that would require researchers running human trials of drugs or medical devices to disclose certain personal financial interests in the outcome of the trial, if and when the data is submitted to the FDA to support marketing of the drug or device. Written public comments are due by December 21. The proposed rule would not affect: * Employees of the pharmaceutical companies sponsoring the trial; * Investigators running pre-clinical or laboratory studies; * Investigators running human trials if they are not submitted to the FDA in support of marketing approval for a drug. Also, the rule would not ban would not ban specified arrangements for compensating investigators, only require their disclosure. (This is important because many small companies are underfinanced, and could not run trials unless they could pay the investigator with part ownership in the company.) The rule would apply to independent investigators (such as university researchers) who run clinical trials for pharmaceutical companies that are trying to get their drug approved for marketing. When these companies submit their application to the FDA, they will have to identify the investigators involved, and submit one of two forms. One is a simple certification by the company that "(name of company) has not entered into any financial arrangement with any clinical investigator, whereby the value of compensation to the investigator to conduct the study could be affected by the outcome of the study. I also certify that each clinical investigator was required to disclose to (name of company) whether the investigator had a proprietary interest in this product, or a significant equity interest in (name of company), and that no such interests were disclosed. I also certify that the investigator was not the recipient of significant payments of other kinds as defined in 21 CFR 54.2(f)." The proposed rule rule includes payments to the spouse and dependent children of the investigator, but not to their business partners. If there are payments as defined above, then instead of the certification, a disclosure statement must be included. If one of the required forms is not submitted, the FDA will not file the application for approval of the drug. For more information For an in-depth discussion of the rationale for this proposal, and instructions on how to submit comments, see "Financial Disclosure by Clinical Investigators," Federal Register, September 22, 1994, volume 59, number 183, beginning page 48708. ***** Grassroots Organizing: Communication Groups by John S. James The AIDS community has been at a continuing disadvantage in organizing grassroots support in the form of letters and phone calls to Congressional representatives, and to other national, regional, and local officials. The right wing has been very good at this. We believe that the key to mobilizing grassroots response is effective integration of political activity with personal and social life. We propose organizing "communication groups" -- small, personal groups of friend who meet regularly for social activities organized around writing and calling public officials (and, for those who are inclined, calling talk shows, and writing letters to the editors of newspapers). Each group can work with many different AIDS organizations, helping them to generate public response on their issues. Because these are also social groups, organizers are responsible for making sure that they work for people -- not just for a cause. We have developed this proposal into a five-page article, but it is too long to include in this newsletter. For a copy, send a self-addressed stamped envelope to: AIDS Treatment News, attn: Grassroots, P.O. Box 411256, San Francisco, CA 94141. [Note: The full article is included here, although it did not fit in the printed newsletter.] "Communication Groups" for Mass-Movement Grassroots Organizing by John S. James, 415/861-2432, 10/2/94 SUMMARY Why do people go to church? Usually not for the theology, but for the people. A successful church provides institutional structure and support to help make a group work well. Churches are popular in the U.S. because the dominant business-professional structure, through which we make our living, does not provide a complete framework for human life. Churches help to fill the void. Successful MASS MOVEMENT grassroots organizing must address the same need. It requires an institutional structure which will take responsibility for making human groups work -- responsibility, for example, for maintaining a warm and inviting atmosphere, and for successfully matching people to groups which are suitable for them. But AIDS, gay, and progressive organizations have failed to do this. Until they do, their grassroots organizing will appeal mainly to specialists; it will never be a mass movement. And without a mass movement, we cannot protect our basic rights in the modern world. We have proposed one possible way of structuring such a movement. This particular model is based on small, autonomous groups, so that it can be tested and improved quickly, without waiting for national organizations to move. The Problem Right-wing and hate groups have been very effective in organizing their members to call and write to public officials, call talk shows, etc. Sometimes they can generate ten to a hundred times the calls of anybody else, even on issues where public opinion is against them. This imbalance has caused a painful loss of public civility and quality of life, a national distraction from the most important issues (AIDS, economic insecurity, others), and a potential threat to our future. How can liberal, libertarian, left, or other views, which should be providing a balance, become more effective in being heard? We believe that the key is to integrate political action with social life -- geared toward meeting compatible people, and/or toward building an ongoing extended family and support network, like many churches do. Almost all political organizations outside the right have done very poorly in getting their members to call and write public officials. And no wonder -- since their model, basically, is getting each person to go home alone and write or call, with little or no social support. A few people work well this way, but most do not. As a result, the many "action alerts" mailed or otherwise transmitted -- almost all based on this do-it-all-alone model -- usually lay unused on desks until thrown away. A Model: Communication Groups To illustrate a different model, we will picture one small group. If this approach can work well for people, there could be many. The core will usually be a small invited membership of persons who are comfortable with each other -- perhaps five to 15 people, who may plan to stay together for years. They might meet once a week at a member's home, a coffeehouse or restaurant, etc. Any member can bring visitors. (The core group itself would grow like an affinity group -- starting with two or three people, then inviting new members who are compatible with those already there.) At any time, one member will be the convener, who does the groundwork so that the meetings happen: making sure that the next meeting is scheduled and everyone knows the time, place, and agenda; making sure that supplies (including writing materials, envelopes, stamps) will be there; and making sure that several issues will be brought to the meeting for action. Any member can bring an issue to a meeting; no permission is required. Whoever brings the issue is responsible for bringing an adequate description (either oral and/or written), important points to be made when communicating with public officials, etc., and the names, phone numbers, and addresses of officials to communicate with. (Often the issue will be prepared the easy way -- by copying an action alert from a friendly organization which is trying to mobilize public support. Or sometimes an outside organizer or expert will speak.) Another way to develop issues is directly from the news. Every day there are many outrages which are prominent enough to get media coverage. For a single individual, it is seldom feasible to do the research required to find out what the real story is, and what response, if any, is appropriate; as a result, almost always there is no response, and our values as human beings have no effect on public life. A group, however, can share the research work; also, its response can be more powerful than an individual's. This makes it much more feasible for the group to act on a story in the news. Not everyone will agree with every issue, or be comfortable writing or calling about it. That is one reason why several issues should be available at each meeting; persons not comfortable with one can work on others. The meeting proceeds largely as a "discussion group with stationery." Letters to officials can be written right there, since short, handwritten letters are usually best. Phone calls, and more involved letters such as to newspapers, might be outlined at the meeting, with the benefit of feedback and social support, and sent later. (Note: the "stationery" is plain paper; the group does not need any letterhead, since people write as individuals.) If there are five issues at a meeting, and each has an average of four relevant officials to write or call -- a reasonable scenario -- then each person can send up to 20 communications from that single meeting. If there are five or ten participants, and they meet weekly, then clearly a single group can have an effect; on some local issues, one group might register more public opinion than all the rest of the public combined. And if this form of organization can fit well into different peoples' lifestyles and aspirations, then there could be thousands of such groups operating all the time on behalf of humane causes. Advantages Coalition. Since each group will require a continuing supply of issues to address, it will need to reach out to related causes, to different ethnic communities, etc. And it will have something valuable to offer them. This will build working relationships between people who should be talking more often to each other. Independence. Each group can independent if necessary, not an arm of a national organization; therefore it can work simultaneously with many "cause" organizations, not just one. (And it must work with many groups, or it would run out of action alerts to respond to.) Competition. These communication groups will create healthy competition among national organizations. Those that stay in touch with the public will get support on their action alerts; those which become distant from people will see how and why others are succeeding, and how they might improve. Attention. Usually organizations have to push their action alerts out onto a seemingly uncaring world. For a group to come to them and ask for alerts to work on is unusual. This change should get their attention -- and therefore help this kind of grassroots organizing catch on. Report-back. Each meeting should include time for persons to tell what calls, letters, etc. they have sent since the group was last together; this provides recognition for them, and communication models for others. There might also be awards; for example, the one who sends the most communications each month might be taken out to dinner by the others. Evaluation. It is important to keep good records of the communications sent -- in order to evaluate group performance, and also to inform outside organizations, which will want to know what letters and calls have been made on their issues. When organizations ask separate individuals to write to Congress, etc., it is difficult to find out how many actually did so. But when a group works on the project together, information and evaluation can be a standard part of the process. Social benefits. So widespread is the need to find ways of meeting people that small industries have grown up to provide occasions. But many people are not comfortable going to bars or other venues to meet strangers; they would rather start with others with whom they have something in common -- for example, a readiness to defend their community, or a sense of history and willingness to act on it. Existing political organizations can serve for meeting new people and developing circles of friends. But usually they operate in a business mode, often cold and competitive; they are seldom designed or intended for social purposes, and using them that way may be resented. Also, newcomers usually must start by sitting through many boring meetings, which drive most people away. Communication groups, on the other hand, are set up for socializing; but at the same time, new people start doing useful work immediately. This is especially important for reaching those who are busy in their careers or otherwise. Many would like to find a compatible social group which is also defending their community. AIDS, gay, and progressive organizations have failed to offer this option. * Talk shows. These present special opportunities for those who are into calling them. For example, the reason there are so few liberal talk shows (leading to the right-wing imbalance) is not because of a conspiracy, but because liberal hosts don't get enough callers to survive. This means that you can be almost sure of getting on the air with sympathetic hosts, even on some of the biggest radio stations, and reaching many thousands of people. Hostile hosts are easier to find, but obviously harder to work with; they are very experienced, often deliberately unfair to callers, and they control the switch. Groups may want to get professional advice and run training sessions to teach members how to accomplish their purpose (reaching the audience, not beating the host) in this difficult setting. * Newspapers. Letters to the editors can reach thousands of people; and it is easier to get published than generally realized. The group can provide support, brainstorming, ideas, etc. -- allowing everyone, whether or not they have writing skills, to participate in developing the message; the writers can finish and mail their letters later. Since they will be writing as individuals, there is no need to come back to the group for approval; this allows rapid response to public issues, and also avoids intra-group "process." * No external funding needed. The expenses -- postage, phone calls (mostly local), and occasional photocopying -- are less than people ordinarily spend on social activities. Funding, therefore, is not an issue. Anyone can move ahead to develop this model without waiting for others to get on board. Next Steps We see the following next steps in developing this project: 1. Suggestions and discussion to improve this outline. 2. Several "prototype" communication groups to test the idea, refine it, and produce a kit to help people who want to start new groups. (As an early test, I would like to start a group to support existing AIDS organizations by responding to their action alerts on local, regional, and national issues.) 3. Outreach. Since these groups are set up for communicating, they can handle outreach (for this grassroots organizing model) by doing what they do anyway: helping existing organizations, writing to community newspapers, and otherwise encouraging the formation of new communication groups. The permanent goal is to develop ways to live that build the kind world we want to live in. ***** California (and Beyond): Proposition 187 and Public Health by Tadd Tobias and John S. James Proposition 187, on the November 8 ballot in California, would prohibit publicly funded hospitals and clinics from providing any but emergency public medical care to undocumented immigrants. Doctors would be required to report suspected illegal immigrants to Federal authorities. Most media attention so far has been focused on other parts of Proposition 187, such as barring children from schools; our concern is that the medical consequences have not been well communicated to the public. While this particular proposal would apply only to California, it has major implications for national policy. Despite antibiotics, the modern world is inherently susceptible to epidemics because of its unprecedentedly large population and massive, rapid travel. Besides known dangers like AIDS, tuberculosis, and plague, there are many thousands of unknown viruses, some of which have caused deadly local epidemics of new diseases with no known treatment -- leading to fear among experts that a pandemic could potentially get out of control and quickly spread throughout the world. The public health system is our main protection against epidemics. But this system works quietly, through disease surveillance and prevention measures, and can easily be ignored until something goes wrong. In the U.S., the public health system has been seriously weakened in recent years by defunding and neglect. Because it is low profile, it is politically vulnerable; the public can take foolish risks without realizing that anything is being lost. One concern about Proposition 187 is that it will make people afraid to seek help when they should. In one recent case, an 87-year-old Korean woman died in Pinole, California after being burned in a bathtub accident, when relatives did not call emergency help because of fear that some family members could be deported; the local police chief said she would not have died otherwise. ("Immigrants' Fear of Seeking Help Proves Deadly; Woman Dies After Family with Illegals Hesitates to Get Medical Assistance," San Francisco Examiner, September 6, 1994, page A4). Health experts fear that such cases will become more common if Proposition 187 passes. In this case there was no danger to "the general public"; but if health workers cannot diagnose and treat contagious diseases, everyone's risk is increased. Last week AIDS Treatment News asked Bob Prentice, Ph.D., Deputy Director for Community and Public Health Programs, San Francisco Department of Health, about the potential impact of Proposition 187 on his organization's work. He made the following points: * "It would be a tremendous setback to public health efforts because it would mean losing access to people who may be either vulnerable to exposure or in fact have some communicable disease and putting others at risk. Communicable diseases don't know anything about insurance or immigration status. There are aspects of this legislation which would handcuff our efforts to reduce communicable diseases." * "(Having to check immigration status and report people) is such a philosophical contradiction to everything that all of the staff that work in our programs are committed to. They are working to protect the public health. The physicians in our community health centers have gone on record unanimously opposing Proposition 187 because that's not why they are doctors... I think it is going to cause a tremendous burden on them if they try to decide how they are going to handle something that is completely inconsistent with the basis of their training, the basis of their current practice." We asked Dr. Prentice if Proposition 187 would save California money by reducing the demand for services. * "The basic principle of public health is that prevention is the best and least costly approach. For example, if we are precluded from carrying out the relatively simple and inexpensive screening for tuberculosis, and treating people early if there is some indications they are developing active disease, then all the interventions appropriate for that earlier stage will be missed. As a result, people could develop active disease and expose others. "Another example is if a woman is pregnant and does not get regular prenatal care. It certainly increases the risk during the pregnancy and the risk of having a complicated birth. Those become tremendous expenses. Those are things we could monitor during prenatal care, to anticipate that there may be a high-risk pregnancy, and manage it successfully so it doesn't become costly." Other Medical Officials * Sandra Hernandez, M.D. Director of Health, San Francisco Department of Public Health: "Passage of Proposition 187 will: 1) increase the risk of contagious diseases; 2) increase the administrative burden on our employees, while diverting precious resources away from direct care services; 3) seriously threaten federal funding; and 4) contradict our state mandate to provide medical services to the poor and indigent... Clearly, the health and public safety of all residents will suffer with the passage of this initiative. Finally, the combination of these austere requirements challenges the ethical and legal obligations of our county public health system." * Findings of fact from San Francisco Health Commission resolution urging the Board of Supervisors and the Mayor to oppose Proposition 187: - "Proposition 187's requirement that publicly-funded health care facilities verify the immigration status of person suspected to be undocumented will increase the likelihood that immigrants will delay seeking timely medical attention for fear of harassment or deportation. - "This situation may result in a significant increase in the number of persons treated in San Francisco General Hospital's emergency room whose conditions might have been treated less expensively in an outpatient facility. - "Studies have consistently shown that prenatal care services, for which undocumented women are eligible under current law, significantly improve a woman's ability to deliver a healthy baby and minimizes utilization of costly neonatal care. -"Denying undocumented children access to immunization through publicly-funded facilities would reduce the already low percentage (49%) of San Francisco two-year olds who are fully immunized, and increase the risk of contagious disease outbreaks among children. - "California led the nation in AIDS deaths in 1992 and had the second highest number of deaths from tuberculosis, and failure to provide undocumented persons preventative and treatment services for these and other contagious diseases would hinder efforts to control the spread of these diseases among the population as a whole. - "Proposition 187 proposes to deny undocumented persons incarcerated in the San Francisco County Jail and other correctional facilities in California access to non-emergency health care services and, thus, exacerbate the difficulty of controlling the spread of contagious diseases among inmates, employees and the population at large upon their release." * Dr. Thomas Peters, Chairman, Association of Bay Area Health Officials: "The initiative would have us turn patients away from clinics treating tuberculosis, HIV/AIDS, sexually-transmitted diseases and other communicable diseases. Such a protocol does not make the diseases disappear -- it leaves them undiagnosed, untreated and unfettered. In one fell swoop, the carefully crafted disease-control system in California would be destroyed. Disease prevention cannot be done selectively..." "It is not just someone else's health that would be threatened, it is yours." Comment This is just the beginning of a look at the medical and public health consequences of Proposition 187; other areas include childhood immunization, HIV confidentiality, and even street-outreach disease prevention programs. So far the media has failed to adequately inform the public about the medical consequences of Proposition 187. If it passes, these problems cannot be fixed by the legislature; a new state-wide vote would be required. And even if some of the provisions are permanently or temporarily blocked by court decisions, much of the damage will be done anyway, because many people will not know the technicalities, and will avoid medical care due to fear. It is the duty of the press and electronic media to let the public know the consequences of its actions -- before, not after, they are irrevocable. Reporters need only call medical professionals involved in public health, and ask how their work, and how the public, would be affected. ***** 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.