Subject: Ethics, Seropositive Clinic Date: Jan 1 1988 (547 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1987 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS #47, January 1, 1988 Also published in SAN FRANCISCO SENTINEL, same date. CONTENTS: [items are separated by "*****" for this display] Treatment Optimism and Research Ethics Seropositive Clinic Opens in San Francisco Correction: Paying for AZT ***** Treatment Optimism and Research Ethics: Interview With Nathaniel Pier, M.D. Nathaniel Pier, M.D. has about 300 AIDS/ARC patients in his private practice in New York. He also works with New York's Com- munity Research Initiative (CRI), a project of the PWA Coalition. The CRI has obtained State and Federal approval to design and conduct clinical drug trials, providing unique opportunities for persons with AIDS to have input into clinical drug research. We have spoken with Dr. Pier several times in the last two months, about the growing optimism on AIDS treatments, and about problems in research policy. We recorded and transcribed parts of these conversations and interviews. We have learned that physicians in private practice are more free to speak openly if they want to, than scientists who usually need permission to make public statements, and who dare not offend the institutions which control research funding. Growing Optimism On AIDS Treatments "The point we've reached in late 1987 is really quite an optimistic one. A year ago when we were just starting out with AZT we could say that whether or not AZT works there's a profound change here, which is that we do have a tool which is a first step in treating people. And it forced the government and Otis Bowen at the meetings in June (the III International Conference on AIDS, in Washington, D.C.) to admit that people who are already affected by AIDS should not be thrown on the dunghill of humanity, that it was worth trying to save them, that in fact medications could be developed or should be developed that would treat them. And that's led to a profound change in the way peo- ple approach AIDS. "Part of the optimism here is that we're beginning to bias the process in favor of good news. We're beginning to have more than one option. It's not just AZT now, it's AZT plus a number other drugs that are in phase II testing that may work. "This perspective must be brought out. Patients must hear that although they have a serious problem that may result in them getting very ill or even dying, it's equally reasonable for them to hear that scientific progress has advanced significantly to the point where we can now introduce variables into the course of their disease that may mean they will not die. That, coupled with the fact that it is clear that there are long-term sur- vivors, and that this is not a universally fatal, 100-percent- everybody-dies disease, makes it from a medical person's point of view a much more manageable disease. If you look at the 30-35 year old age group who have Kaposi's, one in three is living more than five years. This is better statistics than many cancers. And somebody who presents in that fashion should not be told that they have a universally fatal illness. "We must appeal to other physicians to stop the gloom and doom stuff. I know people are dying of AIDS, but when you're talking to an individual patient who is perhaps being diagnosed for the first time ... they shouldn't necessarily feel that they're obligated to get sick and die to prove the CDC correct, or the New York Times for that matter. "As far as practical things, if you ask the doctors in New York City about mortality rates, most of them, in fact everyone I talk to will tell you that the mortality rates have gone down considerably, partly because of AZT, some believe, partly because we're getting better at treating diseases that occur in AIDS, partly because of pneumocystis prophylaxis. But it is clear that AIDS is not the profoundly, "Oh, shit, the patient's got six months to live" kind of thing that it was a year or two ago. And it's clear that physicians who are very skilled at dealing with AIDS do not lose patients in the kind of numbers that the same physicians did two years ago, or that other physicians who are not very skilled at dealing with AIDS are losing their patients." The Wrong Way to Treat AIDS "Recently some Harvard-trained physicians visited me to look at my practice and see how I deal with AIDS, because I've had so few deaths. They were astonished. What I do they do not do. They never heard of resources like AIDS Treatment News or Project Inform. And as a consequence their patients don't get the full spectrum of counselling, their opportunities for choosing their therapies are limited, and they don't do as well. "It should be clear to the medical community that if you make a concerted effort with each individual to discuss therapeu- tic options that may be appropriate for them, such as participat- ing in a trial of an experimental drug, or trying alternative therapies, they may do better, and survive longer and in better shape with a better quality of life. That's the message that's being lost. If you ask the infectious disease specialist, who may be the typical doctor that is asked to consult on an AIDS patient, what to do, it's AZT or nothing. That's a disaster. They don't take a look at what options the patients have, they don't counsel the patients as to what other alternatives there are, and if the patient doesn't do well on AZT they don't offer them anything else. "If you look at medical literature you see statistics like 80 to 90 percent of AIDS patients develop dementia. These reports come from a skewed population. These papers are written by neurologists who see end-stage AIDS patients in tertiary care centers. They don't see what I see or what the usual clinical doctor sees. I have 300 patients with AIDS or ARC in my prac- tice, and maybe one of them has dementia. And why? Because I see the healthy group of AIDS patients. The people who write papers in tertiary care centers see a biased population. They see the disasters, they see the ones who haven't done well. And so naturally they publish these horrendous statistics of how poorly AIDS patients do. But if they come and they see my prac- tice and they see what I see week after week, of basically healthy people who are out there in society, who are working, who are not demented, who don't have severe peripheral neuropathies, who very occasionally have problems that are AIDS related but are basically doing OK, they would write very different papers. There's a serious bias in the medical literature also as to what is being reported, and it's giving people a distorted picture of what is going on with AIDS. They're not seeing the people who are doing well, the people who are surviving long, the people who have good quality of life, because those people don't go to those centers and therefore they don't get papers written about them. "The bottom line is that if a physician takes the time to look at each individual and talk about what their options are,in terms of taking standard orthodox therapy, in terms of enrolling in an experimental treatment program, or in terms of looking at alternative therapies that may in fact have some value, like AL 721 or naltrexone, you can not only treat a patient and get them into a state where they can have some hope and some idea that there's something to do besides wait for the bomb to drop, that in fact if one of these therapies works,you've done an enormous good." Research Policy and Ethics: Pneumocystis, DHPG, Ampligen, Len- tinan "The people who are affected by the research, by the disease, are demanding to know what the timetable is, and they want explanations. "AIDS has forced the American medical scene to look at aspects it's never looked at. Like the bio ethics of drug test- ing. Is scientific data proprietary? Should the private drug companies, which the FDA constantly points to as being in partnership with the government, should they have proprietary interest over scientific data, like do their drugs work, or should the people who are actually paying for the government have the right to demand that these companies make their scientific data public? What about the degree of time it takes to get scientific data published? "A good example of that is pneumocystis prophylaxis. In New York we've been using pneumocystis prophylaxis for a year, some have been using it for 18 months or longer. And in June when we spoke with Dr. Anthony Fauci (of NIH) about pneumocystis prophy- laxis, people from ACT-UP and the PWA Coalition, he told them that they were fools, that there was no study that showed that pneumocystis prophylaxis was of any value and that we might be putting people in danger by doing it. In fact, five months later the New England Journal of Medicine published an editorial which essentially states that prophylaxis for pneumocystis should be standard therapy for people with AIDS. If we were wrong it would have done little harm. But we were right and therefore many people's lives were saved. "If a therapy is generally deemed safe and we employ it,if we're wrong we haven't lost much, but if we're right we've done a great good. In drug therapies where there is a track record in human beings of safety, we needn't wait for efficacy to be proved before we give the individual the opportunity to choose to use or not use such a therapy. This doesn't mean that good rigorous studies couldn't or shouldn't be done; it's just that the number of people affected is so large and the time so precious that we need to construct a system whereby both the needs of the indivi- dual to choose therapies is acknowledged and accepted as well as the need for researchers to do rigorous science. "If DHPG has clearly been demonstrated to help people with CMV retinitis, it seems completely illogical not to approve it for use, even though the studies haven't been done. And to pun- ish people, to punish the patients by letting them go blind or die, in order to make the companies do the tests right, is just not logical or humane, and it should call into question why this decision is made and who is making it. "I know of a patient in a small town who went blind in one eye and was told by an ophthalmologist who diagnosed him as hav- ing CMV retinitis that there was nothing to do about it. In fact within a few hours of his getting me on the phone he was in an appropriate hospital in Miami receiving DHPG therapy. It's dis- turbing to me that the medical establishment feels it has no responsibility to offer to people with no other options therapies that have at least shown some efficacy. One can't exactly say that this ophthalmologist was committing malpractice, but cer- tainly in the name of humanity, in the name of this man's vision, he should have known that in fact there was something to do besides letting him go blind. "The FDA continues to say that the DHPG rejection was an advisory committee decision that has nothing to do with whether the FDA will or will not approve it. What the FDA hasn't done is put down a set of guidelines or rules that will allow persons who are interested to determine whether or not a drug will be approved. Exactly how many trials need to be done,what kind of trials, how many patients, etc? In a meeting with FDA Commis- sioner Frank Young that a number of concerned people had a couple of weeks ago, what he said is that it was completely up to his judgment, that there were no hard and fast rules; all you could say is that if a company wanted the drug to be approved, it would just have to apply and the FDA would use its judgment. But he refused or was unable to give out any guidelines. Of course if he did that it would allow people with AIDS to determine whether and how the FDA was influencing research policy. "A good example is that the Ampligen study that's being done now in New York City at St. Luke's/Roosevelt Hospital apparently forbids any pneumocystis prophylaxis. This is a major ethical point; if you have a therapy that is of accepted benefit, is it ethical to deny this therapy to people at risk, because it might interfere with your endpoint for drug tests? This is an major question, and I asked the fellow who spoke about the Ampligen study who designed this protocol, and was there any input into this protocol by persons with the disease, did they voluntarily say yes, we will agree not to take this life-preserving therapy in order to advance science? "It is clear that if the FDA has decided that, say, the end- point for the efficacy of a drug that is designed to prevent peo- ple from going on to develop full-blown AIDS is whether or not they develop PCP, and therefore pneumocystis prophylaxis cannot be given, this is an major ethical question. I don't think that most people who are in genuine risk of developing PCP would in fact agree that this is an acceptable endpoint. And since Ampli- gen is one of the most hopeful drugs that we have, the exclusion of the ability to prevent PCP and the exclusiveness of Ampligen, the lack of number of slots in the trial, is coercive, is basi- cally saying to a patient, "You do what we say, or die". "I would still like to know why lentinan hasn't been tried. I would still like to find out what goes on in the AIDS drug selection committee, why they meet so infrequently, why the minutes of their meetings aren't published, and why people aren't watch dogging them from Congress or other public agencies, and why they don't allow proprietary data that's submitted to them by private companies to be examined if it's relevant to the health and well being of people. Like the studies of lentinan, why Bristol Labs does not allow them to be published, it's completely unethical. And I think that people with AIDS should rise up en masse, and say that you can't do this to us anymore. "These questions of ethics in human research are profound,and it's a service to humanity that the community of people with AIDS is performing by calling them into question and forcing the medical establishment to examine them. And we can be proud of the fact, and look forward to the resolution of some of these issues in favor of the people who are suffering. This would include not only AIDS, but also other grave illnesses like cancer and multiple sclerosis. It's always the case that in war like this, episodes of heroism and rapid progress occur even in the face of disasters. In this war the people who are suffering most are also offering the most and making the profound changes that will benefit everybody. "This is not just a call for expressing anger, but a call to organize behind dramatic change in the way that medical research is done, and organize behind a further dethroning of the cult of medicine. The medical authorities must also be asked to be responsible to the public that benefits from their efforts and also pays for their work. We're asking that these people ack- nowledge the fact that the consuming public does have the right to do this, even though they might not have the knowledge to make medical judgement. We don't want to condemn the sincerity of any individual's efforts to combat AIDS. What we're asking for is a two-way street. ***** Seropositive Clinic Opens in San Francisco by John S. James On January 1 Alan S. Levin, M.D., an immunologist in private practice in San Francisco, will open Positive Action Healthcare, one of the first outpatient clinics focused on treating healthy seropositive persons to attempt to prevent progression to AIDS or ARC. Typical patients will be HIV-positive persons usually with some T-cell or other immunological deficiency, but either asymp- tomatic or only mildly ill. While Dr. Levin is willing to treat persons more seriously ill with AIDS or ARC, he believes that other physicians are better equipped to do so and will refer such patients to them. Dr. Levin is best known for his work with "transfer factor" -- a substance prepared from human white blood cells of healthy donors and used to confer certain immunities to patients. But he emphasizes that Positive Action Health care will not be a transfer-factor clinic. Dr. Levin has developed a protocol for seropositive persons, including transfer factor, AZT, acyclovir, and intravenous gamma globulin. But he is willing to modify the protocol in coopera- tion with the patient, including using experimental treatments as they become available. For example, four patients are already using dextran sulfate. The clinic will also publish a monthly newsletter for patients and others. And it will offer evening support groups, run by mental-health professionals. And Positive Action Healthcare has hired an attorney who is also a physician, to go after insurance companies which try to evade reimbursing patients. This service will be available at no cost to the patient. Comments This writer cannot evaluate the medical merits of the treat- ment protocol planned for Positive Action Healthcare; readers may want to discuss it with a physician they trust. But we believe that this clinic can contribute toward a national model for care of seropositive persons, in several ways: * Willingness to treat healthy seropositive persons with both conventional and experimental treatments -- and to be public about it. Official FDA guidelines do not recommend any treatment for seropositive but healthy persons. Yet current information indi- cates that without treatment, over 70 percent of these people will eventually become ill with AIDS or ARC. And many physicians strongly suspect that treatments given early are both safer and more effective than if they are delayed until after serious ill- ness develops. But there is no proof that any specific treatment will help prevent progression to AIDS or ARC. The disease progresses so slowly that it will take years to run the trials to get such proof. And the medical profession has developed a cautious approach -- which usually served well before AIDS -- of strongly preferring in theory at least to use only procedures which have been tested and proven to work. Physicians are reluctant to recommend treatments based only on the best possible inferences from available information, when there has never been an actual test to show that the treatment works in fact, not only in theory. And here the tests will take years, time the patients don't have. The result of this situation is that many leading physicians provide very different treatment to their own patients than they are willing to recommend publicly. (For an overview of some of the issues involved, see the page-one story in the New York Times, "Doctors Stretching Rules on AIDS Drug", December 21 1987.) The big problem we see with this situation, one not dis- cussed in the Times article, is the lack of development of a pro- fessional consensus because leading physicians are reluctant or unwilling to give their colleagues in public the benefit of the same best judgment they give their patients in private. As a result, most patients end up getting treatment by the book which is in fact second-rate care. By being open and high-profile about what it is doing, even to the point of working with a public relations firm and planning a press conference later in January, Positive Action Healthcare may help to bring the huge but largely silent issue of treatment for seropositive persons to the much-needed forefront of national attention. * Willingness of leading non-gay physicians to get involved in AIDS. A tiny minority of physicians now treat most of the patients with AIDS or ARC. Unwillingness of many physicians to treat per- sons with AIDS threatens to become a serious problem. Dr. Levin already has an allergy practice of about a thousand patients; he could easily have chosen to stay away from AIDS. But he has excellent qualifications to get involved. Dr. Levin has been an M.D. for over 20 years and is board certified in both immunology and pathology. He has published dozens of articles in major medical and scientific journals. In addition to private practice he has academic experience, and is currently Adjunct Associate Professor of Immunology at the University of California San Francisco Medical Center. Dr. Levin has little experience in treating AIDS or ARC; that is why he refers the more seriously ill patients elsewhere. But no one has much experience in treating healthy seropositive persons to prevent progression of the illness -- especially since it is too early to see much of the results of such treatment -- and here Dr. Levin's academic and research background stands out. Incidentally Dr. Levin's wife, Vera Byers, M.D., an immunol- ogist who also has a Ph.D., has also published dozens of medical and scientific articles on immunology. Dr. Levin's resume also includes a paragraph-long listing of military honors, awarded during his service as a flight surgeon in Vietnam. In recent years he has been a leading witness in the lawsuit by Vietnam veterans seeking government assistance and compensation for injuries suffered from exposure to agent orange, a chemical defoliant used by the U.S. military during the Vietnam War. * A collaborative relationship with patients. Dr. Levin is willing to work with patients to devise an individual program which they want to pursue, which may include experimental treat- ments. We talked to one patient on another matter and found that he is very happy with Dr. Levin. John Athey of San Francisco,a long-time survivor who was diagnosed in January 1984 and who is active in helping other persons with AIDS, has been a patient of Dr. Levin since September 1984. He liked their assurance that if one treatment didn't work it wasn't the end, there were others to try. "Dr. Levin said, 'Don't worry, John, we'll keep you alive until they find a cure. And by we I mean you and I working together.' "If you go in and you have questions, he'll take time,he'll answer them, he'll write all over the table, he'll get books out and pile books up on the examining table, he's just incredible. I'll ask a question and he'll say, and he hands me articles and I give him articles. "He really cares, he listens, he gets excited, and he fights." * Openness to community input and cooperation. One of the partners in Positive Action Healthcare is Fred Ponder, a patient of Dr. Levin, who works professionally doing business development projects. Mr. Ponder has been active for years in the National Gay Rights Advocates, and is currently chairman of the board. Recently he also joined the board of Project Inform. The third partner in Positive Action Healthcare is Richard White, the chief operations officer. He is the one whom persons are most likely to talk to first when they call the clinic for information. Incidentally, fees are comparable to those of other physi- cians. For example, the initial visit includes a two-hour physi- cal and costs $225.; the routine monthly follow up is $60. Transfer factor is expensive, costing $170. every two weeks for an injection. AZT will of course be the major cost when it is used. The good news on costs is that Positive Action Health care plans to go to great lengths to help patients obtain reimburse- ment for their treatment from their insurance. * Prompt reporting of usable results. Dr. Levin is now treating 20 HIV-positive patients. He plans to publish fre- quently, and also report informally in the clinic's newsletter to patients. He made available to this writer T-cell statistics of the ten patients treated long enough for data to be obtained. These results so far, of five patients who started treatment in 1987 and five who started in earlier years, are interesting but not spectacular. Overall, helper T-cells increased in three of these ten, and decreased in seven. Seven of the ten are using transfer factor and had before and after T-helper values; of these seven, the counts increased after transfer factor in four and declined in three. None of the 20 patients has progressed to AIDS or ARC. These early tabulations do not prove anything. But we are impressed that Dr. Levin is willing to put them on the table,letting outsiders see raw data immediately, both good results and otherwise. Unfortunately most physicians to not col- lect or report data suitable for research; and most research pro- jects take years from conception through proposal, funding, run- ning the trial, analysis, and final publication of edited results. By contrast, Positive Action Healthcare plans monthly or even biweekly reporting of raw data, organized in a way which makes outside analysis possible. No one knows for sure what treatments may slow or prevent progression from seropositive status to AIDS or ARC. What interests us about Positive Action Heath care is not any specific treatments -- physicians must evaluate those -- but the contribu- tion toward an open, community-based model of treatment and research which may greatly speed the process of finding out what works. For More Information For more information about Positive Action Healthcare,call Richard White at the new number for the clinic, (415) 922-8501. ***** Correction: Paying for AZT A note in our last issue on a Federal program to help per- sons pay for AZT erroneously stated that the only medical qualif- ication required was a valid prescription from one's doctor. The correct information is that persons will have to meet the FDA guidelines for use of AZT, which generally means either having had pneumocystis, or having T-helper cells under 200 and having ARC symptoms. The person who brought the story to our attention had heard the wrong information from a California state office; he was the first of several to inform us of the correction. We have heard that the confusion resulted from the fact that the Federal law itself does not require the FDA guidelines. But states have the right to insist on them, and they will do so in order to protect themselves from possible lawsuits. For an overview on the different medical practices on the use of AZT, see "Doctors Stretching Rules on AIDS Drug", New York Times December 21 1987, p. 1. ***** [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display