File date: August 19, 1990
©1998 The Estate of Michael Callen
This afternoon I will be speaking as just one more lowly person with AIDS who wakes every morning to face the real possibility of his own imminent death. I have resigned as President of the Board of the Community Research Initiative of New York. I want to emphasize that the remarks that follow are my own idiosyncratic perspectives and not those of CRI.
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The topic we’re here to discuss is how to resolve the conflicts which unfortunately exist between conducting scientifically credible treatment research and providing compassionate, wider access to promising experimental therapies. I’m willing to put in my two cents, but I feel compelled to observe that the question has largely become moot.
In this country, at this time, anyone white enough, rich enough and clever enough can have access to just about any drug he (and rarely, she) wants–all with the tacit approval of the government. And if you’re rich and famous and know the First Lady or highly placed individuals within the pharmaceutical industry, you may even be able to gain access to experimental drugs which are in development.
For example, while we debate how ddI will be distributed through parallel track, any person with a thousand dollars a month can easily obtain pharmaceutical quality ddI on the underground. What we should really be discussing here is how to provide more equitable access to experimental drugs since, obviously, not everyone has a thousand dollars a month to buy the latest hot drug.
In the early days of the epidemic, being clever meant resorting to drug smuggling. Now, much of the excitement has been taken out of the game by the FDA policy which permits the importation of a three-month supply of drugs which are not approved in this country. Parallel track will further widen access to experimental drugs whose efficacy is unknown.
Don’t get me wrong. Given the abysmal failure of the federal AIDS effort to deliver, such pressure release values are absolutely necessary. But we mustn’t lose sight of the fact that they are stopgap measures which wouldn’t be necessary if properly conducted treatment research on a variety of promising therapies had been expeditiously and competently conducted from the start. And we wouldn’t need to be discussing the conflict between research and access to treatments if properly conducted research had resulted in treatments in which we could have confidence.
As anyone with half a brain can see, the current system of drug testing in this country doesn’t work. Thanks to government indifference and ineptitude, only one drug–AZT–has been approved by the FDA for the treatment of AIDS; and serious questions exist about the wisdom of this approval.
But even if we assume–though I do not–that AZT does extend life for those who can tolerate it, this still leaves the half of all people with AIDS who can’t tolerate AZT at all with no proven therapies to choose from after nearly a decade and the expenditure of close to a billion dollars.
The FDA drug importation policy and the recent advent of community-based clinical trials have probably staved off open rebellion and as such have had the inadvertent and paradoxical effect of deflecting scrutiny concerning just how utterly federal AIDS treatment research efforts have failed. By the time ACT-UP stormed the Bastille in Bethesda, the big, bad FDA had already become an impotent, desiccated hull.
That there is a need for such an importation policy and for parallel tracks is the government’s own blatant admission of how utterly the American system of drug testing has failed. If the government AIDS establishment had done its job, we wouldn’t need to import drugs like fluconazole from civilized countries or resort to underground, illegal trials of potentially toxic therapies.
One quantitative measure of the magnitude of the failure of the current system of AIDS drug testing is that fact that in two years of operation, the PWA Health Group in New York City, one of many buyers clubs, reported gross sales of over 2 million dollars. That’s 2 million dollars worth of desperation and frustration.
The second pressure release valve has been the recent emergence of a community-based treatment research movement. Just like the words “all natural” stamped on a box of Cracker Jacks or a bag of potato chips, the descriptor ”community-based” is designed to make everyone feel warm and gooey inside. In fact, community-based means many different things to many different people and can be used to cover up a multitude of sins, as the recent description of the renegade Compound Q trial as being community-based so amply demonstrated.
But my personal opinion of the Q trial is irrelevant now. The real importance of Q is that it represents the start of a new era of the total deregulation of drug testing.
It may come as a surprise to some of you to learn that we no longer have drug regulation in this country. I’m embarrassed to say that it took me a while to catch on. But drug regulation in this country effectively died when the FDA refused to stop the illegal Q trial. Indeed, rumors are rife that individuals at the FDA were deeply involved in the trial; the fact that the FDA spent four hours examining the data and has apparently given its blessing to allowing those who participated in the trial to continue receiving Q certainly lends credence to these rumors.
The stage is thus set for anybody to test any drug, regardless of toxicity, based on any fucocta theory. We no longer have regulatory grounds to object to any renegade, non-IRB approved clinical trial. Should the FDA ever rouse itself from its pathetic, impotent slumber, all the zealous advocate of an underground Compound R trial will have to do is point to the precedent of Q.
And so it’s clear to me that we no longer have a system of drug regulation in this country and maybe, after all, it’s for the best, given the abject failure of the current system. The order of the day is anarchy. The AIDS activist movement has joined with the drug deregulation movement to score a knock-out victory. And so when we discuss the question of the conflict between treatment and research, we have to do so within the context of the new era of drug deregulation that we’ve entered.
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Before proceeding to consider in detail the conflict between treatment and research, it’s instructive to pause and ask ourselves how and why we have arrived at this state of anarchy. Why did this illegal trial occur? Why have federally designed protocols languished for lack of enrollment? Why have ATEU/ACTG studies been sabotaged by lying, cheating and stealing? Why have those who used to argue that we could work with the system suddenly abandoned it so dramatically? Why will underground, unregulated trials become commonplace and why will the government do nothing to stop them?
The renegade Q trial will be looked back upon as a watershed because it represents the precise moment when a majority of the AIDS-affected community realized there isn’t a rat’s chance in hell that the massive federal AIDS research bureaucracy is going to save our lives. As those of us who founded the community-based AIDS treatment movement realized some time ago, we will have to do the research ourselves.
We’re in this alone. The federal effort is hopeless. It’s truly every man for himself–and I use the masculine pronoun intentionally, since women have largely been excluded from the mad scramble for cures.
The FDA has long since rolled over and is playing dead. And the NIH, for all its bluster, is pathetic and intellectually and morally bankrupt. Like a mosquito, more annoying than dangerous, the NIH can do little more than make mischief. The NIH’s final gasp is the recent attempt to coopt community-based research and turn it into a pale version of its failed ATEU/ACTG system. By employing the ancient but effective tactic of pitting marginalized groups against one another, the NIH has already created deep divisions within the fragile community research network. But I am confident that because our lives depend on making this system work, we will find a way to take their money and run.
All the truly creative suggestions about ways to solve the immense difficulties posed by conducting AIDS treatment research have come from the activist community itself. And it has been galling to see history rewritten for reasons of political expedience. The most glaring example is the frequent attribution of credit for the concept of parallel track to Dr. Anthony Fauci. Everyone familiar with the facts knows that parallel track was conceived by the ACT-UP New York Treatment and Data brain trust (Mark Harrington in particular), with West Coast input from Project Inform and John James.
Another example concerns DHPG. And after fucking up the approval of DHPG, Dr. Fauci and Dr. Young of the FDA are now considered heroes for reversing their earlier opposition.
That we have to stand by and watch the fruits of our intellectual labor be used to prop up the image of the very federal system which has failed us is too nauseating to endure.
The major issue which remains to be decided doesn’t involve the federal government. The affected communities are going to have to decide which particular brand of community-based research is going to win out–regulated, qualified, IRB-approved research or underground, unregulated research. As the civil war over Q demonstrated, this will no doubt be a bloody battle.
The point I’m making is that while I’m willing to discuss the conflict between research and access to experimental treatments, what really matters is how community-based research resolves these questions. Federally designed AIDS research has become irrelevant. Given the track record of the ATEU/ACTG system, and the inherently adversarial relationship which exists between people fighting for their lives and an establishment which has squandered precious time and lives with nothing to show for it, there is little chance that the conflict will ever be usefully resolved at the federal level. Just give us the drugs and give us some of our tax money back, and, one way or another, we’ll do our own research, thank you.
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The current chaos makes no sense unless one understands that AIDS is our holocaust. As we enter the second decade, the AIDS-affected communities are fighting back with a fury heretofore unseen. Any and all weapons may be used. Rather than sit passively while we’re murdered by federal indifference and incompetence, we’ve decided to fight with everything we’ve got.
Why should we follow your rules? Where has it gotten us? How much precious time has been lost while we have waited patiently for treatments to come from people who have demonstrated callous disregard for our well-being?
I won’t mince words. The federal AIDS treatment research policy has been one of passive genocide. I recognize that these are strong words, but I believe I can justify their use.
As many of you know, in 1977–four years before the first case of AIDS–a placebo-double blind study by Dr. Walter Hughes and colleagues proved that two double-strength bactrim tablets a day can essentially prevent PCP. Without spending a cent, the federal government could have saved countless lives if only it had urged physicians to consider PCP prophylaxis. At the very least, prophylaxis should have been the standard of patient care for someone with AIDS who had survived one bout of PCP.
I asked a CDC statistician how many AIDS-related PCP deaths had occurred since the beginning of the epidemic. How many Americans have needlessly suffered and died from PCP because of the lack of federal leadership on the issue of PCP prophylaxis?
According to the CDC, as of February 20th, 1989, 30,534 Americans had died of AIDS-associated PCP.(1)
I repeat: 30,534 United States citizens have died from a disease which at least since 1977 has been essentially preventable.
The extent of drug importation and the massive outpouring of support for the underground trial movement only makes sense if one acknowledges how it feels to have endured 30,534 unnecessary deaths due to the fact that finding drugs which prevent opportunistic infections has not been a federal research priority. As a result, federal AIDS treatment research efforts have produced virtually nothing of value for those of us with AIDS.
The two major treatment advances which have occurred in the management of AIDS have been the result of non-governmental research. I refer to aerosol pentamidine for the prevention of PCP and to better diagnosis and treatment of opportunistic complications. In other words, hard-won advances in patient management.
Aerosol pentamidine was approved by the FDA on the basis of data generated entirely by community-based research. Improvements in patient management have occurred without federal guidance. Physicians on the front lines of this epidemic have had to learn, through trial and error and at the cost of much needless suffering and thousands of unnecessary deaths, how to recognize and treat the opportunistic infections which, after all, are what kill those of us with AIDS. The federal effort has concentrated exclusively, and with no success, on an anti-retroviral approach.
Years from now, I believe that the sordid saga of federal AIDS treatment research will be considered a scandal of the magnitude of HUD. Nearly a billion dollars in AIDS-specific treatment research has been spent and we have next to nothing to show for it. There has simply been no accountability and as a result, thousands have died, and thousands more will die–needlessly.
* * *
Now, if after my brutal, bitter assessment of the situation you’re still interested in my opinions about the conflict between research and access to experimental treatments, I’m willing to proceed.
The central problem derives from confusion about the difference between treatment and research. They may at times be related, but they are not the same and it has been enormously frustrating to hear the terms used interchangeably. Confusing research with access to treatment usually results in insuring that neither occur.
“Treatments” generally contains a sense of “proven” and “research” generally contains a sense of “unproven.” “Access to experimental treatments” linguistically blurs these important distinctions, often for the purposes of political expediency.
Someone who is ill has the expectation that treatments will make him or her better. Research, in contrast, makes no such promise of benefit. Someone who enters a research protocol expecting–or demanding–to benefit from participation will usually be sorely disappointed.
Research is supposed to be designed to answer treatment questions and any of four outcomes are possible: (1) answers are inconclusive because the question was poorly framed and/or the study was poorly executed; (2) the subject benefits from the experimental treatment; (3) the subject doesn’t benefit but isn’t harmed by the experimental treatment; or, (4) as has often been the case with federally designed AIDS treatment research, the subject is actually harmed by the experimental treatment, for example, Suramin and interferon.
We’re in the mess we’re in regarding research because we missed the boat in the crucial early years of the epidemic. Now, most people with AIDS aren’t willing to enter trials unless they believe the drug being tested offers them more hope than drugs widely available, but of unproven efficacy.
A major reason why it’s virtually impossible for the federal government to fill its clinical trials is because there is now a cruel hoax afoot, begun and promoted, I fear, by my own community, that AIDS has somehow suddenly become a chronic, manageable disease. I wish somebody would tell me what treatments, aside from AZT, are supposed to produce this remarkable result. Where is the data to support this claim? Yes, thanks to a plethora of treatment newsletters and the relentless PR of groups such as Project Inform urging what is referred to as “early intervention,” there are many drugs which desperate PWAs are injecting, ingesting and imbibing. Some of these drugs may actually be slowing the progression of AIDS. But because we haven’t done the research to prove it, we may never know and the chaos will continue.
The saga of egg lipids is instructive. A letter which appeared in a prestigious medical journal written by the government’s premier scientist, Dr. Robert Gallo, suggested that AL721 stopped replication of HIV in the test tube. When asked to explain why the NIH was not investigating lipids, Dr. Fauci denied that there was any good evidence that egg lipids were worth testing. When reminded that Dr. Gallo claimed to have demonstrated that lipids stop HIV replication in the test tube, Dr. Fauci scoffed and said that test tube data was virtually useless. “If I put enough oregano in a test tube with HIV it would probably stop HIV replication. Does that mean I should do a clinical trial of oregano?” I responded that if one believes HIV is the cause of AIDS, and if it could be shown that oregano stopped HIV replication, oregano would indeed be a perfect candidate for a clinical trial because, unlike other antiretrovirals, it presumably has no toxicity! Despite the fact that Dr. Fauci doesn’t put much credence in test tube results, many activists do. This in part is why the drug-of-the-month phenomenon is so out of hand. Every time an article comes out suggesting that some drug is antiretroviral in the test tube, a whole movement springs up to begin testing it.
To repeat, there is simply no substitute for properly conducted research. That is the only way that we’ll ever truly have treatments for AIDS and only then will the tension between treatment and research evaporate.
Early on, people with AIDS were willing to enter placebo-controlled trials in part because they altruistically realized that this is the fastest, cleanest way to find treatments which work and to discard ones which don’t. I knew many of the first wave of PWAs and they were keenly aware of the greater good of the greater number and were willing to be guinea pigs because (a) they might inadvertently save their own lives and (b) even if they didn’t, they might help save the lives of others. But those days are long gone and now it’s every man for himself.
Another problem is the fact that for many people who are uninsured, entering a research protocol is their only chance of receiving primary care.
Desperate people, fighting for their lives, perceive clinical trials as a means of widening their treatment options. (I say “widening” because the experimental drug is often merely added to an already long list of unproven substances being touted by treatment newsletters. Of course, one never admits the use of concurrent medication because it would mean being bounced from the trial.)
I recently spoke with an individual with ARC who was in a placebo-controlled clinical trial of a popular experimental medication. He had his pills analyzed at a lab recommended for such purposes by the PWA Coalition. He determined he was getting drug, not placebo. He is stockpiling the drug by only taking half of the dose which the principal investigator believes he is taking. As a result of cutting his dose in half, his blood work has actually improved and, unlike others, he’s not suffering side effects. He wants to tell the truth, but realizes that if he does, he’ll be punished by being bounced from the trial.
He understands that as a result of his selfishness a potentially useful drug may be erroneously discredited or that the toxicity pronouncements made will be erroneous. But he has seen drugs rumored to be effective get jammed in the pipeline and he wants his own little nest egg. Like most, he has chosen to save his own life and damn the study. Still, his conscience bothers him and he told me that, when the study ends, he will confess what he has done. But he doubts that the PI will exclude him from the data analysis because the PI actually suspects that many more are doing the same thing and the trial will be unevaluable if the extent of the cheating is acknowledged.
This is a recipe for research disaster, as we’ve seen. As is widely known but rarely admitted, federal studies have been sabotaged by cheating of all sorts and by the frequent inability to fill poorly designed, often unethical ATEU/ACTG studies. I understand that the NIH organized an emergency telephone conference call among the principal investigators of the original AZT multicenter trial when they became aware of just how pervasive cheating was during this trial. Not surprisingly, they decided to downplay the extent of the cheating. Now the original AZT trial is held up as the gold-standard for the proper conduct of a trial–a standard against which all future trials must be measured. If so, community-based research is home free since it is not likely that we’ll ever conduct a moreinept trial.
Clinging to some arbitrary, ivory tower standard of placebo, double-blind trials this late in the game is delusional, especially since alternative study designs exist. Data generated by trials perceived as punitive must be viewed as inherently suspect. If the government had made the prevention of the half dozen major OIs a top priority long ago, we might now have proven therapies to prevent most of the major killers of people with AIDS. And if government studies didn’t forbid the use of prophylaxis, as the original ATEU/ACTG studies often did, people with AIDS might now be willing to enter placebo-controlled trials of agents aimed at treating the underlying immune deficiency because they would know that they weren’t likely to die of preventable diseases during the course of a trial!
I know I keep repeating it, but I feel compelled to emphasize the point since arrogant researchers are acting as if it is we who have failed to act in good faith. If in the early days the federal government had done good research, we might now have treatments to offer. Whatever interim solutions are tried to make experimental drugs more widely available–for example, parallel track–there will never be a substitute for doing research right in the first place, so that one can have confidence in the answers generated. Prove through good research that treatments work and there won’t be any confusion between treatment and research.
I want to confess something. It’s damned difficult to run a good clinical trial, as we’ve found out the hard way at CRI. But for all the problems we’ve faced at CRI, I am still convinced that properly designed, properly regulated, IRB-approved clinical trials are the best hope we have of finding treatments that work. I believe that most people with AIDS will be more likely to cooperate honestly and altruistically with community-based research in which they’ve had a say than they have been with federal research. I’m not suggesting that we’ll be free of enrollment problems, difficulties recruiting ethnic minorities and women, the use of concurrent medications and other forms of cheating, and all the other obstacles, but I believe we have the trust of the community because we include them in study design deliberations and because we are exploring creative solutions and because community-based clinical trials are informed with a sense of urgency and fairness which have been consistently lacking in federal trials.
* * *
The community-based AIDS treatment research movement will have to grapple with the following momentous questions, and how we answer them will profoundly affect how–or whether–we will be able to conduct research which will lead to treatments in which we can have confidence: Does every individual have the absolute right to make and act upon treatment decisions? Or is there such a thing as expertise? Do some people know better than others how to access the risk/benefit ratio of taking a particular drug? And if we conclude that experts should be permitted to limit the right of individuals to have access to whatever drugs they might like, which experts should make the decisions: an individual’s physician or a neutral, qualified government agency?
There is a vocal, even violent contingent of the AIDS community whose rallying cry is drugs into bodies, which usually turns out to mean any drug into any body. And woe to anyone who dares to suggest that sometimes people who take no toxic drugs or who receive placebo do better than those subjected to a highly toxic experimental drug.
Though some San Franciscans might not believe it, I’m basically a pro-choice kind of guy. My instinct is to say that people do have a basic right to risk killing themselves in the belief that a particular experimental drug may save their lives. Particularly in a situation where someone is clearly in the terminal stages of a disease for which there is no proven treatment, it’s hard to justify prohibiting them from one last crap shoot.
But for those who aren’t all that sick, I’m not entirely comfortable saying that everybody should have the right to try any drug, since I am well aware that drugs can harm as well as help.
But who gets to decide how sick is very sick, especially since many AIDS activists are increasingly promoting a conveyor-belt theory of AIDS which dooms all those who are HIV-infected? Who decides when someone is truly terminal? How can the risk of potential toxicity be balanced against the potential for benefit? Unless the AIDS activist community can make a convincing case for the need to factor in some concept of the good of the greater number, we may never be able to conduct the kind of research necessary to prove convincingly that any drugs, alone or in combination, actually slow the progression of AIDS.
In any event, it’s difficult to articulate any rational, consistent, workable limitation on an absolute principle of self-determination.
To illustrate the problem, I like to examine a scenario which is not entirely far-fetched. Suppose that a person discovers that he’s HIV antibody positive with 500 T-cells. He is immediately put on AZT, but experiences AZT psychosis and other serious side effects which resolve when his doctor reluctantly takes him off AZT. But all is not lost. A Chlorox salesman shows him convincing data that proves that Chlorox is viricidal. He decides that he wants to inject Chlorox into his veins. Chlorox is a chemical which is easily available. According to a prestigious medical journal, when Chlorox is put in a test-tube with HIV-infected blood, it kills the cells. Unfortunately, like AZT, it doesn’t differentiate between healthy and infected cells. But so what, he argues. “I know that some say Chlorox is poison,” he says, “but I intend to inject it in tiny, homeopathic doses that I don’t believe will kill me. Besides, it’s been tried in humans before; my cousin drank some when she was a kid and it didn’t kill her!”
“It’s my absolute right to try this,” he stridently asserts. “In fact, I intend to organize an underground, renegade trial and see what effects low-dose Chlorox has on AIDS.”
I, for one, would not be comfortable allowing someone to inject Chlorox into their veins based on the theory that it’s viricidal. I would try to stop this person and if I couldn’t I might be tempted to call the authorities. But I’d do so with a guilty conscience, since the authorities have such a terrible track record.
It seems clear to me that there needs to be some expert oversight of drug testing. True, federal experts have failed us so far, but I believe that there are individuals with a good track record who truly care about science and finding the right answers. But how do we convince others that Dr. A is an expert and Dr. B is a fraud? I’m tempted to suggest common sense and track record, but these too are subjective.
Many individuals associated with the renegade Q trial have asserted the absolute, unlimited right of persons with AIDS to make their own treatment decisions. One prominent early intervention spokesperson has reportedly begun to assert that death itself is part of the PWA self-empowerment movement in an attempt to downplay the tragedy of the deaths of individuals who, in pursuit of an absolute right to determine their treatment choices, take a toxic drug and die as a result.
Nevertheless, some continue to assert that while drug decision-making should be made in consultation with a physician, ultimately, it should be the individual who decides.
I was therefore surprised to read newspaper accounts of the New York arm of the Compound Q trial which seemed to suggest that one particular patient’s request for treatment had been overruled by a medical expert.
Scott Schaffer is the New Yorker who died during the Compound Q trial. Although we will probably never know for certain whether his death was caused by Q since no autopsy was performed, let us assume for the sake of discussion that prior to receiving his first infusion with Q, Scott was already in the terminal stages of AIDS. Let us further assume that he was lucid, rational and able to make an informed choice when he made the decision to participate in the Q trial. Much is made of the fact that Scott was videotaped during the whole process.
Although I am apparently one of the few people who has not seen what I’m sure is a heart-rending videotape, there is no disagreement that Scott went into a coma following his first infusion. And yet, Scott apparently wanted to stay in the trial. He returned to the study site, was videotaped describing in graphic detail his adverse reaction for the benefit of other trial participants. Nevertheless, he demanded to get his second infusion. His doctor refused to administer another infusion and bounced Scott from the study.
This is an example of expert intervention. Scott’s doctor overruled Scott’s absolute right to determine what risk he was willing to take even though they had determined he was terminal. I knew Scott, although not well. (I fixed him up with his last lover.) Although no one will ever know for sure, I happen to believe Scott would be alive today if he hadn’t tried Q. And so I believe the doctor made the right decision in refusing to give him another infusion; but I probably wouldn’t be able to successfully defend that belief against those in our community who argue that the right of self-determination for people with AIDS should know no limitation.
With only a slight twist on the actual facts of Scott’s case, we can examine another aspect of the question of the appropriateness of expert intervention. What if Scott’s doctor, in the mistaken belief that Scott’s coma following his first injection has immunized him to Q’s effects, had gone ahead and administered a second infusion at Scott’s insistence? And what if, then, Scott had fallen into another coma and died as a result? Wouldn’t this have been an argument in favor of the need for neutral expert oversight of all drug testing? Can we not argue that when highly complex issues are involved there is a legitimate role for expert intervention and even a limitation on the right of self-determination?
It’s necessary at this point to discuss expertism. These days, the word “expert” is usually preceded in the gay press by the modifier “so-called.” I have reluctantly concluded that I must bear some responsibility for contributing to the prevailing attitude of rabid-anti-expertism.
But as I’ve thought about it more, the problem isn’t expertism, but rather the poor track record of those who are considered AIDS experts. I fear we’ve thrown the baby out with the bathwater and dismissed the notion that there is such a thing as qualified experts because we’ve been so abused by those in positions of authority who have asked us to trust in their expertise.
But this leads to circular reasoning. I will call experts those people I happen to agree with and others will certify as experts those they agree with. In fields as highly complex as chemistry, toxicology, trial design and biomedical ethics, it’s difficult to articulate objective standards by which experts can be judged. And that is part of the reason why we’re in the mess we’re in.
The caustic philosopher of science Paul Feyerabend has addressed precisely this problem in his book Science in a Free Society. He suggests that one solution is to include laypeople along with experts in the process of making such momentous decisions. He proposes a scientific version of no taxation without representation. If people with AIDS, he would argue, are to bear the risks of trying a particular experimental drug, then we ought to participate in the design and execution of the studies along with qualified, neutral experts.
The idea that laypeople should participate in making fundamental decisions is precisely the organizing principle of the community-based research movement. At CRI-New York, people with AIDS and community physicians are involved at every level, including the Institutional Review Board, the Scientific Advisory Committee, the Board of Directors, on staff and as volunteers.
In my criticisms of the renegade Q trial, I have emphasized the need for qualified, neutral IRB oversight of trials involving human subjects. Supporters of the trial have repeatedly and correctly pointed out that the current system of drug testing in this country–including IRB oversight–has failed utterly.
We cannot risk totally abandoning the concept of qualified, neutral oversight simply because the current system doesn’t work. Just because IRBs in the past have approved murderous, unethical protocols which forbade the concurrent use of PCP prophylaxis doesn’t mean to me than the concept of IRBs is flawed; merely the execution. My experience as a member of CRI’s IRB has proven to me that the IRB system can work and that, in fact, making it work is in the best interests of the affected communities.
While I understand why many have concluded that anarchy and total drug deregulation are the only viable responses to the intellectual and ethical bankruptcy of the federal system of drug testing, I am perhaps naive enough to believe that community research, properly conducted, can inform drug testing with an appropriate sense of urgency, find creative and human alternative study designs and retain what is good about IRB oversight of human subjects research.
Many of us have worked hard to ensure that CRI will be around to test Compound R and Compound T and Compound X. I regret the acrimony which has resulted from the Q trial.
In conclusion, resolving the problem of conducting scientifically credible research in an environment in which access to experimental treatments is virtually unlimited is the daunting task facing responsible community research groups. Solving this dilemma will require that the community pull together and settle our differences. I truly hope that will occur since I believe our lives depend on it.
We’ll need to better understand the drug-of-the-month phenomenon–what factors influence PWA public opinion. We can’t risk setting up community trials only to have subjects abandon a trial before it’s completed simply because a newsletter or The New York Times or a respected community activist anoints Drug X as this month’s most promising potion.
Although I am taking a hiatus from the fray, I’d like to propose to my fellow AIDS activists that in the interest of promoting dialogue among us, we agree at least temporarily to remove two words from our vocabulary: promising and murder. Think about it.
Finding treatments for AIDS will require a certain altruism on the part of people with AIDS. There is a greater good for the greater number, and our task is to achieve it while exposing individuals to the least possible risk. I believe this is an achievable goal and, despite my bitterness, believe I will live to see a cure for AIDS.
ADDITIONAL DUMPED MATERIAL:
As many of you know, NIAID recently declined to fund the Community Research Initiative of New York despite the fact that we are one of only two such groups in the country which have produced clinical trial data which has led to the approval of AIDS therapies: aerosol pentamidine and erythropoietin. And the fact that 25% of those enrolled in our most recent trials are people of color, and the fact that we have enrolled many women in our clinical trials gives lie to the rumor that we were turned down for funding because the peer review panel doubted the seriousness of our commitment to ethnic minority outreach.
No, the real story is that refusing to fund New York’s CRI is the last gasp of an intellectually and morally bankrupt federal AIDS research establishment. To ask the government to fund an organization whose track record is better than its own is to ignore the way power really works in this country. I’m embarrassed to admit that I actually thought they wouldn’t be able to get away with so egregious an insult to the wave of the future, but they have. But it’s too late to stop the community-based research movement[, despite the loss of $7 million]. If a cure is to be found–if prophylaxis against the major opportunistic infections which kill us are to be worked out–it is going to have to be at the level of community-based AIDS treatment research. Everyone know it, but it’s not polite to say it out loud.
But I have a reputation for being impolite. (As one NIH official suggested to someone friendly to CRI-NY who called to inquire why CRI hadn’t been funded, “What goes around comes around.”)
By manipulating projections and claiming that 100% of people who are HIV infected will eventually die from AIDS, certain well-meaning AIDS activists have contributed to a frenzied atmosphere in which perfectly healthy people are willing to take tremendously toxic, even carcinogenic drugs at high doses presumably for the rest of their lives because they are desperate to do something. I am not only referring to AZT, although it is the most glaring example.
By suggesting, as some have, that those of us who have urged caution regarding the promiscuous use of AZT are murderers–that we are responsible for the deaths of anyone who didn’t subject themselves to AZT–is part of an insidious campaign to urge everyone to abandon their critical faculties at precisely the moment they need them most. It is difficult to imagine just what informed consent means in an atmosphere where already legitimate fear is fanned irresponsibly. Peer pressure says that anyone with HIV who isn’t taking some combination of toxic chemicals is acting irresponsibly and suicidally, which is nonsense.
I guess encouraging PWAs to cultivate an attitude of informed skepticism is simply too bitter a pill to swallow; better to suppress dissent along with your bone marrow by popping AZT and calling those of us who doubt its efficacy murderers. At least one can take AZT with the comfort of having the full support of both AIDS establishments — activist as well as government. The placebo effect enhanced by such unanimity of opinion is not to be underestimated, and I’m frankly tired of trashing AZT only to hear some PWA whimper “You’re probably right that it’s not good for me, but what choice do I have?”
We’re simply too far down the road of HIV/AZT orthodoxy for my heretical views to be accessible to those to whom it might matter. Besides, I really have nothing more to say on the issue of HIV and AZT, and my views are readily available in print to anyone who cares to consider them. So it’s time to move on.
1. See AIDS Weekly Surveillance Report-United States, published by the AIDS Program, Center for Infectious Diseases, Centers for Disease Control, February 20, 1989 and September 5, 1988. Thanks to Mary Ann Pesa of the CDC for reading me these figures.