Subject: AIDS Treatment News #136 Date: Oct 11 1991 (849 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 #136, October 11, 1991 phone 800/TREAT-12, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] Expedited Access: The "Campbell Bill" Controversy Foscarnet Approved MAC: New Azithromycin Access Lymphoma: New Agent Under Study National Commission on AIDS Major Report Announcements: San Francisco: Immune-Based Therapies Panel, October 23 Clinical Care Conference December 9 and 10, San Francisco In Memoriam: Marty Blecman In Memoriam: Elenore Pred In Memoriam: Belinda Mason ***** Expedited Access: The "Campbell Bill" Controversy by John S. James On July 11, Representative Tom Campbell, a liberal Republican who represents the high-tech "Silicon Valley" area of California and strongly favors measures to improve U. S. technological and industrial competitiveness, introduced H. R. 2872, a bill to direct the U. S. Food and Drug Administration (FDA) "to provide for the expedited approval of drugs or biologics for individuals in need of treatment for a life- threatening disease or seriously debilitating illness." Although almost everyone agrees with the bill's ultimate goal, H. R. 2872, commonly known as "the Campbell bill" in the AIDS community, has generated confusing and sometimes bitter controversy among treatment activists. The main issue is one of strategy: is it better to go to Congress to seek reform of the drug-approval process, or to seek reform internally within the FDA? We believe that the controversy over this bill illustrates the need for a forum or institution where national policy on treatment issues in AIDS and other diseases can be discussed and formulated. (One proposal for such a structure was presented last week at the AIDS Treatment Activist Conference in Washington, D. C.) If a national policy-making body could find consensus on leading issues, then initiatives based on that consensus could start with widespread support and progress smoothly and rapidly toward implementation. What the Bill Provides H. R. 2872, officially titled the "Access to Life-Saving Therapies Act," begins by stating several findings of Congress: "(1) For many Americans with life-threatening or seriously debilitating diseases, new pharmaceutical products may offer the best, and sometimes the only hope of treatment; (2) Patients with life-threatening or seriously debilitating diseases are often denied the most advanced therapies because the drug approval process lacks flexibility; (3) Patients with life-threatening or seriously debilitating diseases are often willing to accept greater risks with respect to the safety and efficacy of drugs than our current drug approval system allows; (4) The current mechanisms for expanded access to experimental therapies through Parallel Track, Group C Designation, and treatment INDs do not adequately meet the needs of patients with life-threatening or seriously debilitating diseases and may create disincentives for the development of drugs for patients with life-threatening or seriously debilitating diseases; (5) Health insurers now unfairly discriminate against experimental therapies, even when there is no alternative therapy; (6) There is no more efficient way to expand access to a new drug than to permit it to be marketed; and (7) The drug approval laws should be amended to permit the marketing of drugs for any life-threatening or seriously debilitating disease using similar criteria used to permit drugs for HIV infection to be distributed under Parallel Track." The bill then directs the FDA to approve "a drug or biologic needed to treat or prevent a life-threatening disease or seriously debilitating illness (including AIDS, cancer, Alzheimer's disease, cardiovascular diseases, and Parkinson's disease)" if nine conditions are met. These require reasonable safety and promising evidence of efficacy, no satisfactory alternative treatment, and ongoing research by the drug's sponsor, including one or more clinical trials to test for efficacy, and in addition, special monitoring for adverse effects in patients who purchase the drug. H. R. 2872 also requires that drugs approved under its provisions be available only by prescription. In other provisions, H. R. 2872: * Gives the FDA 120 days to review an application for expedited approval; if the FDA does not act within 120 days from submission of the completed application, it is automatically approved; * Forbids public and private health-insurance plans from distinguishing between these drugs and other FDA-approved drugs for reimbursement purposes; * Requires withdrawal of approval if two or more post- approval studies fail to confirm the safety and efficacy information on which the approval was based; and * Requires written informed consent of the patient or patient's representative. History of H. R. 2872 H. R. 2872 was first drafted by Jim Driscoll, an AIDS activist who is president of the PATH Foundation and a member of ACT UP/Golden Gate. Driscoll worked with the staff of Representative Campbell's office to improve the draft and express it in the legal language and format appropriate for a new bill. Driscoll and others have continued to build support for the bill. At this time 35 members of Congress have signed on as cosponsors -- and most of them are Democrats, despite the fact that the bill was introduced by a Republican. The cosponsors cover the entire ideological spectrum, from the most liberal to the most conservative. With this level of support, H. B. 2872 may be crossing the threshold from an "idea" bill to serious legislation. Issues Behind the Controversy Few persons or organizations have yet taken positions on H. R. 2872, and many of the arguments on both sides have not been expressed in writing. For this reason -- and also to focus on the issues involved, instead of the personalities -- we chose to write our best understanding of the case on each side, based on conversations we have had with advocates of each. The arguments below do not always represent our own position; for our view, see the Comment section. (We hope that anyone quoting from the "for" or "against" sections of this article, below, will make it clear that we are summarizing the arguments on both sides, not taking our own position on the bill.) The two central disputes seem to be: * If an experimental drug (for example, ddI or ddC) is urgently needed, and already has enough evidence for safety and efficacy to justify distribution to thousands of people (but not enough to justify full approval under today's system), should the FDA approve that drug for marketing through regular channels, or only for free distribution under expanded-access arrangements like those for ddI or ddC? (The central purpose of the Campbell bill is to allow such marketing.) * Is it tactically wise to seek drug-approval reform through Congress at this time, or would it be better to wait for FDA Commissioner David Kessler to implement such reforms administratively? The Case For the Bill The U. S. drug-approval system is the most severe in the world, requiring years of development and well over $100,000,000 per new drug approved. Because of the delays, many patients with life-threatening conditions are denied treatments which are clearly their best or only hope. To relieve this intolerable situation, the FDA has devised a series of programs, with names like "compassionate use," "treatment IND," and "parallel track," to allow early access to critically needed drugs which are not ready for general marketing approval. The reason there are so many different programs is that none of them met the need very well; as each one fails, a new one is devised to replace it. The problem with all of these expanded-access programs is that the company which owns the drug has little or no incentive to agree to provide it -- and does have reasons not to, since these programs can be quite expensive to administer. With AIDS drugs at least, the pattern we have seen again and again is that companies first flatly refuse to provide the drug. Under great public pressure they may relent, but then they use unnecessary medical requirements and burdensome paperwork to limit participation; many physicians refuse to enroll their patients because of this burden, and public clinics almost never provide these drugs, because their hurried physicians do not have time for the paperwork. Another barrier to participation is that patients may have to pay for special laboratory tests out of their own pockets; insurance programs usually refuse to pay on the ground that the treatment is "experimental." These restrictions, imposed by the pharmaceutical companies largely to save themselves money, make "expanded access" distribution even less equitable than standard marketing of drugs, even more restricted to those with private physicians and their own financial resources to pay for care. After activists have generated the public pressure to gain initial access to a drug, they have to generate another pressure campaign to get the restrictions relieved to the point that the program is usable. But some drugs, for example peptide T, are being developed by small companies which could not possibly afford a large expanded-access program, so these drugs will never be available through expanded access. And now we are beginning to see another problem -- less visible than the ones above, but worse. It appears that companies are beginning to conceal important advances, even to the point of not doing the research which could lead to demands for a large expanded-access program, often considered a costly corporate nightmare. Worse yet, expanded access may poison the process by which critically important new medicines are developed, by creating a disincentive for developing life-saving therapeutic advances, thus shifting pharmaceutical research efforts toward producing copycat drugs -- projects which are safe, can be profitable, and will never lead to a demand for expanded access. This disincentive extends all the way back to preclinical development and even to basic research, changing the climate in which innumerable internal corporate battles are won or lost. No one will ever know what critical treatments never came into being, and who died needlessly as a result. The Campbell bill corrects these problems by turning the demand for early access to life-saving drugs from a corporate nightmare into a positive incentive. Instead of punishing companies that develop important advances, it rewards them by making it easier to get to market with a major advance which is important to human beings than with a safe, copycat drug. And yet it does this with no compromise to human health and safety, since it only applies only to drugs which are safe and promising enough to be distributed to thousands of people under current standards, even without H. R. 2872. Today we are in the middle of a revolution in biotechnology, a revolution representing one of the most important scientific advances of all time. In the near future it will become possible to develop new drugs and other treatments in vastly faster and more efficient ways than could be done in the past. Yet today's drug-approval system was designed 30 years ago, in the early 1960s; and the natural accretions of bureaucracy have left it more cumbersome now than it was then. The Campbell bill will be critically important even if it never becomes law. For it sheds new light on what is shaping up to be one of the major debates of our time. On one side are the forces opposed to change because they benefit from the current system. These include big companies that want to protect their markets by keeping small companies out, investors and financial analysts who appreciate the predictability of being able to see new drugs in the pipeline years before they reach the market, and consumer protectionists understandably fearful of losing ground in their ongoing war against corporate abuse. Also, the current price estimated at $100,000,000 to $200,000,000 or more for each new drug approved is all paid to someone -- mostly to professionals and associated businesses, who therefore have much incentive to maintain the current system. Until recently it was very difficult to organize a constituency for reform, because almost everyone close enough to the drug-approval system to understand it also made money from it. But now, on the side of change, a new "triple alliance" is coming into view: * First, the AIDS, cancer, Alzheimer's, and other grassroots activists have a common interest in access to (and better and faster development of) life-saving treatments. The future of AIDS activism is with this alliance, since many people believe that AIDS does not concern them, but everyone knows that they could get cancer or another deadly disease, and their life may depend on access to new treatments. So the alliance includes not only all the disease groups, but everyone. * Second, there is great interest today in reducing the cost of medical care. The best way to reduce cost without reducing quality is to improve technology. The Campbell bill would reduce the cost of developing the most important new drugs, thereby reducing pressure on prices. In addition, by allowing more drugs to be developed, it would further reduce prices through increased competition. And perhaps most importantly, it would reduce costs by speeding the process of supplanting poor medical technologies with better ones. * Third, this alliance can further expand to include those concerned U. S. industrial efficiency and competitiveness. Biotechnology has the potential to become the most important area of U. S. scientific and industrial leadership. By imposing the 1960s system of drug approval -- a system found nowhere else in the world -- on the technology of the 1990s and beyond, we will seriously damage a vital national resource and harm this country's future. The AIDS treatment movement can and should help to build this alliance for reform. The Case Against H. R. 2872 The issue is not whether reform is needed, but whether this legislation now is the best way to get it. FDA Commissioner Kessler very much wants to speed critical drug approvals, and is already preparing a plan to do so -- a plan based on new regulations (or on a policy statement) under existing law, not new legislation from Congress. Most experts believe that the FDA already has the power to do what the Campbell bill would ask it to do. Why, then, is new legislation necessary? Most of the arguments in favor of the bill, above, could just as well be used in favor of Kessler's proposal. And if legislation is unnecessary, there are many reasons not to seek it: * Legislation takes time. The FDA can act -- and is ready to act -- much more quickly on its own. * Even introducing legislation can impede FDA reform, as opponents can argue that the FDA should wait to see what Congress does before taking its own action. Furthermore, if the Campbell bill is defeated -- and the great majority of bills introduced in Congress never become law -- then the FDA may be unable to implement its own reforms, since Congress will be seen as having rejected the concept of "weakening" the efficacy standard to allow faster access to life-threatening therapies. [The bill's advocates answer that congressional opponents of FDA reform could kill regulations more easily than they could kill a bill, which would not get to them until other members of Congress had already given their support.] * The way this bill was introduced was, in several ways, not politically astute. It was introduced by a Republican, when the Democrats control Congress; the bill should have been bipartisan. (This argument was made before the bill had a majority of Democrats as sponsors, as it does today.) Democrats are likely to consider it a Republican deregulation scheme -- not popular these days. Few members of Congress will study the bill on its merits; most will follow their leadership and vote against it. And it doesn't help that the bill was drafted by an AIDS activist, Jim Driscoll, who twice attacked the leading Democrat on health issues -- Representative Henry Waxman of Los Angeles -- in two op ed pieces in the Wall Street Journal (March 6, 1991, and June 20, 1991). Waxman is exceedingly important to the AIDS community in restraining the senior Republican on health issues in the House of Representatives -- Representative William Dannemeyer of Orange County, California, who is obsessed with homosexuality (he has authored a book about it -- Shadow in the Land: Homosexuality in America, published in 1989) and has impeded constructive national response to AIDS. Dannemeyer, ironically, might be supportive on treatment-access issues; but the chance of an alliance between him and the AIDS community is zero. * Another political problem with this particular bill is that it was created by a single activist who then found a member of Congress to introduce it. Few AIDS activists knew about the bill before it was introduced, so they had no chance for input or to have their concerns considered. * Despite the good intent behind H. R. 2872, the fact remains that the drug-approval law of the United States affects the flow of billions of dollars. Every word of the current law has been litigated; almost three decades of legal precedents have been established. Any change in the current law will make some of these precedents uncertain, unleashing new litigation which itself could harm drug development; change could also upset boundaries and relationships which have developed over the years between major companies and other powerful interests and institutions. The pharmaceutical industry, the insurance industry, and others will certainly come forward while the bill is going through Congress -- if only to defend their technical interests, which the public, the AIDS community, and even the drafters of H. R. 2872 do not understand. No one knows what will come out of this process, how the bill may be changed before becoming law. Why invoke the legislative process when it is unnecessary, and before we have examined the realities involved or even worked out consensus among ourselves about what we want? * It has been argued that we need legislation because we cannot trust the FDA; administrative reform can easily be overturned by later officials. But administrative flexibility is necessary so that rules can change as situations change. When Congress plays doctor it does a terrible job of it, as we have recently seen; should Congress now play scientist also? The right way to achieve reform is to change the professional and public consensus about what is right, and what is wanted, in drug development. A new consensus will guard against arbitrary changes by bureaucrats, giving us the permanence we want -- but no more. * Another problem is that the bill could create an incentive for sham research. Companies would win approval based on early data, provided they agreed to continue studies. But if two studies fail to support the early approval, the approval would be withdrawn; therefore, it may well be in companies' interest to never finish their studies, or to delay them as long as possible. In addition, there could be a special incentive to price gouge for dubious drugs, since they would have only a short market life until their drawbacks became known. * The insurance provision in H. R. 2872 -- that companies cannot distinguish drugs approved under its provisions from other FDA-approved drugs -- is likely to be thrown out by the courts, leaving the individual to pay the whole cost burden. (The bill's proponents might answer the last two objections by saying that a reform to speed access to life-saving new treatments should not be expected to simultaneously solve the underlying problems of the U. S. medical system, such as price gouging and insurance flight. The way to stop price gouging is hardly to keep new drugs from being approved. The FDA, and the medical community -- both inherently skeptical -- will serve as barriers against scams. And if there are problems in the current draft H. R. 2872, it can easily be changed as the bill moves through the legislative process.) Comment While both sides of the controversy have persuasive points, we feel that the dispute itself is unfortunate. This bill could help to build coalitions between AIDS groups, other disease groups, and the public as a whole. The lack of consensus in the AIDS community has impeded this progress. The bill's supporters have gone to Congressional offices never before approached about AIDS, let alone about treatment issues, and have found a very encouraging response; for example, some of the 35 current House cosponsors were not approached by anybody, but heard about the bill on their own, read it, and signed on. This good reception in Congress for H. R. 2872 shows the great potential for broadening the AIDS appeal beyond its customary focus on the rights and needs of those with HIV, to also address issues which speak to everybody. Drug-approval reform could save anybody's life; if properly explained, it is an issue anyone can understand. And anyone can understand that what the AIDS community has learned on this matter could someday translate into a critical benefit for them. Drug-approval reform therefore provides an unprecedented issue where the work of AIDS activists could save the lives of those who choose to think that AIDS is not their problem. In one stroke it rescues AIDS from being seen as special pleading, and instead begins building a new mainstream around the central, universal concerns of life and death, the widespread distrust of bureaucracy, and the fear of abandonment in adversity if the medicine you need is not available. The current controversy is unnecessary because the universal message, from all sides, is that we need regulatory reform to speed access to critically important new drugs. This basic demand for change does not specify a "legislative" or an "administrative" solution. It is far easier to organize public support around legislation in Congress than around an internal FDA proposal not even released to the public yet; this is why attention now focuses on the Campbell bill, as it should. But ultimately, policy experts may decide that administrative reform offers a faster, cleaner, and more flexible route to the goal. That is legitimate, too. Whether or not the Campbell bill ever becomes law (and whether or not it ever should) it will make an enormous contribution if it helps to show a way out from the current national political paralysis on AIDS. ***** Foscarnet Approved On September 27, the U. S. Food and Drug Administration (FDA) approved foscarnet (brand name Foscavir) for treatment of CMV retinitis. In the U. S., foscarnet has been available since August 1990 for treating CMV retinitis which does not respond to ganciclovir. In Europe, the drug has been routinely used for years, often as a first-line treatment for CMV. FDA Commissioner David Kessler, M. D., said that "the availability of an alternative treatment for this disease adds a new dimension in the fight against AIDS, as it gives patients and physicians more options in combating this disease. FDA is determined to help broaden the array of drugs to treat AIDS and related conditions." The approval does not include the other important uses for foscarnet -- treatment of CMV in organs other than the retina, and treatment of acyclovir-resistant herpes. Physicians will be free to prescribe the drug for these purposes, but insurance companies are likely to use the FDA "labeling" as an excuse not to pay. And the drug will be expensive; we have heard the figure of $58 per day wholesale. The company, Astra Pharmaceutical Products, is setting up a program to help persons unable to pay for the drug. Foscarnet has considerable toxicity, and a number of precautions are necessary for using it safely. In future issues we hope to report both on unlabeled uses and on cautions required with this drug. ***** MAC: New Azithromycin Access by Denny Smith People who have been unable to tolerate standard treatments for Mycobacterium avium complex (MAI or MAC) may be eligible for an new expanded-access protocol of azithromycin. This drug and a related antibiotic, clarithromycin, have been suspected for over a year to be very useful for treating a wide spectrum of infections, including toxoplasmosis and possibly cryptosporidiosis as well as MAC (see AIDS TREATMENT NEWS issues #113 and #129). Azithromycin's developer, Pfizer Inc., also has a compassionate-use protocol making the drug available to people who are failing the established therapies for toxoplasmosis. And a Pfizer physician told us that a similar program is planned for the very near future to treat cryptosporidiosis. Physicians interested in the current azithromycin for MAC protocol should call Pfizer at 203/441-5941. (The number for the toxoplasmosis protocol is 203/441-5701). ***** Lymphoma: New Agent Under Study by Denny Smith Anti-B4 blocked ricin, or Oncolysin B, is a new drug now entering phase I and II trials to treat HIV-associated lymphoma. Lymphoma is usually treated with conventional chemotherapy drugs and radiation; experimental approaches have produced mostly disappointing results (see AIDS TREATMENT NEWS issues #93 and #110). Oncolysin B was developed by ImmunoGen, Inc., of Cambridge, Massachusetts, which already has the drug under investigation for the treatment of certain leukemias and non-AIDS-related lymphoma. In those trials, Oncolysin B has been found not to decrease white cell counts, which is one of the serious drawbacks of more established therapies. ImmunoGen told us that the current trials are expected to fill quickly, but that the drug is also expected to pass safety questions quickly. When that happens, larger efficacy trials will open to recruitment. Meanwhile, an additional protocol designed to combine Oncolysin B with a standard chemotherapy regimen is planned for the near future. For any of these trials, the number for interested physicians to call is 800/446-9633 or 617/661-9312, between 8 a.m. and 6 p.m. Eastern time. ***** National Commission on AIDS Major Report by John S. James The National Commission on AIDS sharply criticized the U. S. government and social response to the epidemic in a 165-page report, America Living with AIDS, issued September 25, 1991. From the executive summary: "The people of the United States have arrived at a crossroads in the history of the HIV epidemic. In the months to come they must either engage seriously the issues and needs posed by this deadly disease or face relentless, expanding tragedy in the decades ahead... "Workers on the front lines are struggling heroically to cope with illness and death, but their tools have been too few, their resources too constrained, and their logistics too crippled by the sabotage of disbelief, prejudice, ignorance, and fear... "Worst of all, the country has responded with indifference. It is as if the HIV crisis were a televised portrayal of someone else's troubles. It has even appeared relatively painless; many of the torments are hidden because so many people do their suffering and grieving in secret, out of fear of stigma, discrimination, or rejection. But the epidemic will not remain painless much longer even for the most indifferent observer; soon everyone will know someone who has died of AIDS. If we are to honor our fundamental social contract with our fellow citizens, with ourselves, and with our children, we must somehow develop a sense of urgency..." (As if to illustrate the nation's problem in engaging seriously with the epidemic, the next day The Washington Post, under the headline "Lack of Leadership on AIDS Cited," covered the report's release by running a wire-service dispatch. On the same day, in the Style section, the Post published a 1900-word original article titled, "Kimberly Bergalis's Ride of Rage: The AIDS Victim, Frail but Resolute, Comes to Congress to Plead for Mandatory Testing.") The Commission's report includes 30 recommendations, in the areas of prevention and education, caring for people with HIV, health-care financing, clinical trials and treatment-related research, and government responsibilities. Each chapter includes quotes for persons who have testified in hearings of the Commission, as well as a selected bibliography. The National Commission on AIDS was formed two years ago to advise Congress and the President. Its 15 members include five appointed by the Senate, five by the House, two by President Bush, and the secretaries of Health and Human Services, Defense, and Veterans Affairs. For a complimentary copy of the report, call the National Commission on AIDS, 202/254-5125. To purchase multiple copies, call the National AIDS Clearinghouse, 800/458-5231. The report is also available from the U. S. Government Printing Office. ***** Announcements ** San Francisco: Immune-Based Therapies Panel, October 23 Project Inform and the AIDS Health Project will sponsor an expert panel on "Immune-Based Therapies for HIV: Theory and Application," on Wednesday evening, October 23. Speakers are Jay Levy, M. D., from the University of California San Francisco Medical Center, Dobri Kiprov, M. D., California Pacific Medical Center, and Leonard Herzenberg, Ph.D., Stanford University Medical Center. Topics include the role of CD8 cells; antibodies; and antioxidants such as NAC in the treatment of HIV disease. There will be time for audience questions. The meeting will be October 23, 7-9 p.m., at 1855 Folsom Street (near 15th; free parking available). There is no admission charge. For more information, call the Project Inform hotline, 800/334-7422 (from California), 800/822-7422 (other states), or 415/558-9051; the hotline hours are Monday through Friday 10 a.m. to 4 p.m. Pacific time, Saturday 10 a.m. to 1 p.m. ** Clinical Care Conference December 9 and 10 in San Francisco The University of California San Francisco is sponsoring a two-day conference to address the current state of clinical AIDS care. The program will be presented by physicians from San Francisco General Hospital, and is slated to cover the spectrum of issues faced by clinicians, including diagnostic tests, natural history of HIV, and therapies for major and minor opportunistic infections and malignancies. The conference will be held at the San Francisco Marriott Hotel December 9 and 10. For registration information, call 415/476-5808; for program information, call 415/476-5208. Continuing education credits are available. ***** In Memoriam: Marty Blecman Marty Blecman, President of Megatone Records and an AIDS activist, died at his home in San Francisco on September 20, 1991. Marty's introduction to the AIDS activist movement came to him through Terry Sutton, a person with AIDS and CMV retinitis who fought until his own death in April 1989 for access to the anti-CMV drug foscarnet. After Terry's death, Marty continued to answer the endless phone calls that came in for Terry from people with CMV and to advocate for their access to foscarnet. Ironically, Marty suffered with CMV colitis himself for the last 14 months of his life; while finally able to obtain foscarnet, the side effects were very unpleasant and it was clear that his CMV disease did not respond to the treatment. Marty was a close personal friend of AIDS TREATMENT NEWS writer Michelle Roland. After Terry's death, Marty and Michelle were interviewed about the inspiration that Terry had been to both of them in their struggle against AIDS; AIDS TREATMENT NEWS published the interview in issue #77. Marty became the inspiration for Michelle's articles "Managing Your Doctor" (issue 111) and "Gastrointestinal Manifestations of HIV," (issue 133), as well as for her continuing activist and medical work. Marty was a writer himself; here are some of his thoughts: Summer 1989: "101 T-Cells and Counting: Over 100,000 AIDS diagnoses, over 65,000 Americans dead, and still no war on AIDS has been declared by President Bush or our government...In view of the truth, one of the most logical things going on is the growing AIDS activist movement. These people have hit the streets, hit the papers, hit the negotiations, and won major battles for thousands who sit in judgment or apathy or are too sick to fight...When history looks back at the World War II holocaust there were Jews, Gypsies, and Homosexuals who dared to ACT-UP and were constantly criticized by the majority for fear of 'making things worse.' Perhaps the majority never heard 'Silence = Death, Action = Life'... "This infection of the immune system is not a 'chronically managed illness.' If it were, people wouldn't be dropping like flies...Spiritually, I can face death, but not by neglect or apathy or homophobia. I will go out fighting for my rights as a citizen of the planet and then die at least an honorable death... "The controversy and energy spent criticizing AIDS activists never ceases to amaze me. One would think the controversy and intellectual discussion would swell around why more people aren't angry enough to get out and fight for our lives... "I'll probably die of AIDS but not without a fight, to at least honor all of my friends who have gone on before me and to perhaps save a few who are yet to follow. It would be nice if I saved my own ass in the process... "The epidemic seems out of control to me and I always thought by now much more would be done to stop the dying. I go out in the world and things seem business as usual with an occasional AIDS report on television. When things become familiar, do they lose their impact on us? Did I really shut down? Got me. I just hope my obituary doesn't say I crossed peacefully into some wonderful familiar light." For information about a Celebration of Life Party for Marty on October 26, call Michelle at 916/753-0292. ***** In Memoriam: Elenore Pred Elenore Pred, founder of Breast Cancer Action and a leader of the movement to build coalitions between AIDS and cancer activists, died October 3 in San Francisco from complications of cancer chemotherapy. Breast cancer kills 44,000 women each year in the U. S. One in nine women will get the disease, and of these, one in three will die. The incidence of breast cancer is rapidly increasing, and no one knows why. "After 50 years of no progress toward preventing or curing the epidemic that is currently killing record numbers of women, we who have the disease, along with families, friends, and concerned citizens, are angry. This is not only a personal tragedy -- it is a political and economic tragedy played our upon community, national and world stages. "We are responding to an inadequate channeling of funds for breast cancer research. Billions of dollars are spent on treatment -- surgery, radiation, and drugs which puts profits into the hands of a medical-pharmaceutical establishment who have not brought the mortality statistics down in 50 years. A major focus of our organization is to influence the availability and prioritization of funds for medical research toward the prevention and cure of breast cancer." [letter from board of directors, Breast Cancer Action] "We've got to stay in their faces," Pred told The Washington Post (June 11, 1991, "Quest for Breast Cancer Cure"). That's why ACT UP was so successful. They had somebody constantly making the politicians know that there were people behind the statistics." U. S. News and World Report selected Elenore Pred as one of eight "National Heros of 1991" and published a two-page article on her life and work (August 26/September 2, 1991). Breast Cancer Action can be reached at P. O. Box 460185, San Francisco, CA 94146, 415/922-8279. ***** In Memoriam: Belinda Mason Reporter, playwright, and AIDS activist Belinda Mason died on September 9, 1991. Ms. Mason was appointed to the National Commission on AIDS in July of 1989; she also served as president of the National Association of People With AIDS, and a founder of the Kentucky PWA Coalition. Two of us from AIDS TREATMENT NEWS met Belinda in January, 1990 at the Rocky Mountain Regional AIDS Conference in Denver. Following are excerpts of the remarks she delivered to the Conference. "There are lots of very exciting developments in AIDS, and things are moving very quickly. I'm sure for some of you, as for me, there's a sense of gratification, the feeling that we've broken through some kind of wall, we have a momentum now ...there's lots of money now that we don't have to worry about killing Russians with. Maybe some of that money will come to AIDS ...Many, many people with AIDS still do not have access to any kind of medical care, any kind of decent medical care or quality medical care. I can tell you truthfully that the reason I have become so prominent in this work ...is that I'm a person of privilege by birth. I was born a white woman in the upper South, and my family had the kind of connections to get the drugs for me, the information for me that I needed to get. Most people with AIDS are not like me. They are not so lucky. We all have to remember that when we start to advocate for causes ...We need access to experimental therapies, there needs to be easier ways -- you shouldn't have to be a Belinda Mason to be able to get a treatment. There should be a more broad and a more equitable distribution of the resources as they exist. And we have to make sure that as we're working as advocates for people with AIDS that we continue to help them use the channels that exist, and even circumvent the channels or invent new channels to experimental therapies ...People have lived and are living very well with AIDS. It's not a pipe dream. And it's at least as reasonable, I think, to teach people to believe in the possibility of life as it is to teach them to be ready for their own death." On August 1, 1991, Belinda Mason wrote to President George Bush, who had appointed her to the National Commission on AIDS, asking for his leadership in supporting a more constructive national approach to the epidemic: "After more than ten years of the AIDS crisis, it is disheartening to realize that some people are still pointing fingers and looking for a place to lay blame. Only our effort as a united people has any hope of slowing the epidemic and avoiding the further human tragedy that statistics tell us we will all surely face one day. "Mr. President, those who come after me are counting on you." [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display