Document:AZT Front 1

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On the AZT Front

Part One

by John Lauritsen

New York Native
2 January 1989

It's now more than a year since the New York Native published my analysis of the Phase II AZT trials, which were the basis of the drug's hasty approval by the Food and Drug Administration (FDA). In that article ("AZT on Trial"), I demonstrated that the FDA-conducted trials of AZT were not merely sloppy, but fraudulent. In the meantime, a lot of water has gone under the bridge. On the one hand, Burroughs-Wellcome, the manufacturer of AZT (now known as Retrovir) has launched a world-wide propaganda juggernaut, with great success: the majority of physicians treating AIDS patients now prescribe and even proselytize for AZT, and thousands of gay men (including those with ADS, with ARC, and merely with antibodies to HIV) are being dosed with the drug. On the other hand, there is now a groundswell of opposition to AZT, based on shared experience concerning the drug's side effects. This column will review some recent developments.

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Surviving and Thriving With AIDS

The People with AIDS Coalition has just published Surviving and Thriving With AIDS: Collected Wisdom, Volume Two (1). This large book, written entirely by PWAs and their friends and family, is worth more than dozens of the "medically correct" AIDS books that have flooded the market. As did the first volume, it contains a wealth of practical information. Many photographs and personal accounts vividly document the experience of being a PWA.

A variety of viewpoints and approaches are expressed on treatments, though on the whole most contributors favor non-toxic therapies. In an article, "Surviving and Thriving with AIDS", Michael Callen, who conducted a study of long-term survivors (who "had survived full-blown CDC-defined AIDS for three or more years"), observes:

Despite intense pressure among physicians to take AZT – the only federally approved treatment for AIDS – only one of the gay long-term survivors was on AZT at the time of these interviews. [The single exception subsequently discontinued taking AZT.]

This is to be expected. The AZT philosophy, based on the assumption that "AIDS is a terminal disease", can offer no more than the forlorn hope of "extending life" for a few months (and there is no factual basis for even this modest claim). Long-term survivors, on the other hand, are convinced that they can and will get better. They are endeavoring to strengthen their bodies through a healthy lifestyle: exercise, good nutrition, rest and stress reduction, and avoidance of harmful substances (including cigarettes, alcohol, poppers, and all other "recreational drugs"). Toxic chemotherapy – like AZT – is incompatible with recovery.

Barry Gingell, a PWA who is also an MD, writes:

The magic drug Retrovir [AZT] which has been foisted on the public as a triumph against AIDS is actually turning out to be a cumulative poison. While it may prolong life in the short term [not true – JL] AZT creates its own set of serious hematologic problems, which may in fact contribute to the disease rather than moderate it.

One of the book's highlights is "The Pros and Cons of Taking AZT: A Round Table Discussion: June 21, 1988", in which a group of PWAs discuss their experiences with AZT. Some of the main points emerging from the discussion are the tremendous pressure from doctors and peers to take AZT; the hopes, delusions, and subsequent disappointments involving the drug; and the very real and horrible side effects. I cannot imagine that any PWA who reads this 18-page article thoughtfully would have the slightest inclination ever to try AZT.

A common theme is that the discussion participants feel much better, and sleep better, after they cease taking AZT. For example:

SCOTT: I'm feeling better than I've felt in a long time. And a lot of it I attribute to being off the AZT. It was only within the last week that I've actually started sleeping a five hour period. On AZT, I'd wake up after half an hour and then I couldn't go back to sleep. Then I'd fall asleep for an hour and then I'd be up again for another couple of hours.... That might have been the cause of a lot of the fatigue during the day. I can't pinpoint the cause of the sleep problems exactly, but I do attribute them to AZT.

Another PWA comments:

JEREMY: Since I stopped taking AZT, my stomach hasn't felt bloated; my appetite has been much better and that is good for my general feeling of wellness. Recently, I've been sleeping more than usual, which may be because my body needs it and I'm just catching up.... When I was taking AZT around the clock, I wasn't getting as much sleep. Or when I did sleep, they were lots of little naps instead of one uninterrupted daily sleep. (2)

Another participant, Frederick Glenn, states that in general his health has been good since his diagnosis of PCP:

FRED: The only hospitalizations which I have actually incurred were due to the AZT. Twice I ended up in emergency rooms in a state of severe confusion, temperatures, nausea, headaches, which after extensive testing they had to attribute to the AZT. I was transfused three times.

In addition to incapacitating anxiety, Frederick Glenn suffered anemia so severe that he was incapable of dressing himself. Finally one doctor realized that Glenn was having a toxic reaction to AZT, which was causing the anxiety attacks, and recommended he discontinue the drug. The result of going off AZT was an immediate and dramatic improvement:

FRED: I stopped the AZT. And the mental confusion, the headaches, the pains in the neck, the nausea, all disappeared within a 24-hour period. Now, there has to be some correlation there. There has to be. And the minute those symptoms disappeared, my anxiety disappeared with them.

At one point Michael Callen asked the others if they knew anyone who had been on AZT for a year or more, who was doing well, and who experienced no side effects. All of them shook their heads "no". This is significant, because among themselves the discussion participants probably knew thousands of PWAs, including many hundreds who were on AZT.

An exchange between Mike Callen and Kenny Taub offers real insight into the psychology of patients who continue to have faith in AZT, despite the very real suffering they have to undergo, and despite the lack of tangible benefits from the drug:

MIKE: Can you tell us about what opportunistic infections you had during the two and one-half years that you've been on AZT?

KENNY: OK. I've had PCP four times and tuberculosis once. And that's all.

MIKE: What makes you think AZT is doing you any good if you've had pneumocystis four times and tuberculosis while you were on AZT and while you've also had to have 25 transfusions because of AZT-induced anemia? When you say that you think it's doing you good, what do you mean by that?

KENNY: I don't believe that the AZT could stop any opportunistic infection from occurring... All I can say is, it has been my choice to go on AZT and to stick with it. I've spoken to many researchers nationwide who were pro-AZT in the sense of increasing longevity. And so I made the choice to stick with it and go through the transfusions, even though, yes, they are a pain int he ass.

MIKE: I still don't understand. You have continued to take AZT for a long time because you think it's doing something. What is it that you think it's doing if you've continued to have opportunistic infections and to have serious side effects from AZT? Were you losing a lot of weight, or having fevers, and have those subsided? Has your mental state improved because of AZT or is there some blood test that you feel you've shown a marked improvement on that you attribute to AZT? Something has made you stick with AZT through a lot of transfusions and a lot of opportunistic infections. What is that something?

KENNY: That's a good question. Probably the only answer I can give is that I'm psychologically addicted. There's also an ego thing about it. I want to make the Guinness Book of World Records as the longest AZT freak, or something. [Laughs]] And I just...I don't know.

Kenny Taub died on 15 December 1988. He had suffered still more attacks of PCP and tuberculosis, as well as collapsed lungs.

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A Panel on AZT at Columbia University

On 19 November 1988, a conference was held at Columbia University, "AIDS: Improving the Odds — 1988". On the whole it was a flop. Attendance was far below what was anticipated. The auditorium was barbarously overheated. Little was said that was either new or useful, and much was said that was untrue. Open discussion was not permitted. The many slides that were shown by various speakers were projected on the back wall of the stage in such a way that they could not be seen – the bottom half of each slide was blocked by the table and panel participants on stage. (Curiously, nobody complained, and perhaps it is just as well.)

The least uninteresting panel was on "Azidothymidine – safety, efficacy, and use in asymptomatic HIV infection [sic]", moderated by Laura Pinsky, one of the organizers of the conference. The first speaker was Craig Metroka, MD, PhD, who gave a presentation that was almost inhuman in its glibness. Metroka rattled off "complications" associated with AZT, as though these were nothing more than the little words on a bottle of over-the-counter pain killer. The "complications", Metroka assured us, were "completely reversible once AZT is stopped". [I'm not so sure that AZT-induced death is "completely reversible", but then why quibble?] Metroka described the "benefits" of AZT, using as his source the notorious Fischl article, which disingenuously reported on the fraudulent, FDA-conducted Phase II trials of AZT (3).

The second speaker was Martin Delaney, Co-Director of Project Inform. His talk represetned a sharp about-face. A year and a half ago, Delaney was in the Ribavirin camp, and was an important opponent of AZT. It was Project Inform, together with ACT UP, that obtained the FDA documents, under the Freedom of Information Act, which were the basis of my exposé of the AZT trials, as well as the basis of exposés by NBC News and by Joseph Sonnabend , MD. A year ago this summer, Delaney described the AZT trials in scathingly critical terms.

Delaney has changed his tune, and is now on the Burroughs-Wellcome team. His talk was a hard-sell pitch for AZT. "AZT is not the enemy" pleaded Delaney, "let's not get into a shouting match [?]". He urged the audience not to "argue all day about flaws [only flaws?] in the [AZT trials] study", since it was "necessary to look at all studies of AZT".

Delaney downplayed the toxicity of AZT by claiming that toxicity data "in the most part were coming from very sick patients". A lot of the problems with AZT, he argued, came from giving it to "the wrong people at the wrong time"; the side effects were "far less significant when used in healthier people".

Toxicity out of the way, Delaney began to wax enthusiastic. There were hundreds of patients, he contended, who had been using AZT successfully for one year, two years, and longer. The value of AZT lay in administering it in "early stage of infection" in order to "halt the progression of HIV". Delaney then related an anecdotal case, and advocated using AZT in half doses and in combination with such drugs as dextran sulfate and acyclovir.

Ending on a maudlin note, Delaney lamented, "A lot of people are being discouraged from ever trying AZT." "Give them a chance to use it", he pleaded, "Let's not close the door on this drug until we find something to replace it with!"

The next speaker was Joseph Sonnabend, MD, M.R.C.P., who has privately published his own critique of the AZT trials (4). Sonnabend began by saying that the toxicities of AZT should not lightly be dismissed. The harmful effects of the drug are real, and they are serious. Technically, AZT is a poison; it is cytotoxic [i.e. it kills cells]. The drug cannot distinguish between infected and healthy cells; it kills both. Never before has a drug as toxic as AZT been prescribed for long-term use. The long-term effects of AZT, the cumulative toxicities, are unknown. Sonnabend emphasized the ethical responsibilities of the physician, to be sure that there was a sound scientific basis for the benefits of the drug, considering that its toxicities were firmly established.

Sonnabend then described some of the shortcomings of the AZT trials, in particular the fact that the study became unblinded early on [i.e., both doctors and patients knew whether AZT or a placebo was being administered]. The basic design of the study was thus violated. Not only did the unblinding have a powerful psychological effect on the patients, but it may have led to unequal and biased patient management fromt he attending physicians.

After Sonnabend finished his presentation, he was attacked by Martin Delaney, who maintained that he had seen a lot of patients go back to work, that not all studies of AZT were meaningless, and that at least a dozen other studies had produced similar results.

Michael Lange, MD, spoke next, concentrating on a single point: whether an antiviral effect against HIV has been demonstrated scientifically for AZT. Lange acknowledged that some scientists were convinced that HIV is not the cause of AIDS. Nevertheless, it is claimed that AZT works by preventing HIV from replicating, and this claim ought to be examined. Lange then proceeded to review all of the data, both published and unpublished, that bore on the question. He concluded that evidence for an antiviral effect of AZT on HIV was completely lacking. Two years ago, in early 1986, claims were being made that AZT inhibited HIV, on the basis of the p24 antigen test. However, at the FDA hearings held in early 1988, there was no talk of the p24 antigen test; it had not panned out. Lange criticized the way AZT had been promoted by the "Medical Industrial Complex", stressing that we do not know what the long-term effects of the drug are.

The next speaker was Ron Grossman, MD, who immediately launched into a personal attack on Joseph Sonnabend: "With all due respect, Joe, no drug is not poison – you know that well – there are far more poisonous drugs than AZT!" [Grossman's statement is pure demagoguery. What other drugs are as toxic as AZT? And have they been prescribed for long-term use by healthy people?]

Doing his best to pooh-pooh the toxicites of AZT, Grossman asserted that every other drug in medicine also had toxic effects. He went so far as to claim, "We know more about the toxic effects of this drug than about any other drugs studied." [This is a blatent falsehood. Since no more than a handful of people have taken AZT for more than two and a half years, the cumulative toxicities of the drug are totally unknown.] Grossman went on to describe the AZT trials in glowing terms, arguing that the speedy approval of AZT showed, "There aren't just bad guys in Washington." Grossman ridiculed the notion that co-factors (like poppers or other drugs) played a role in causing AIDS: "The only co-factor is time. We know that." He concluded by saying that AZT slowed progressiion of HIV, the drug bought "quality time", and "AZT offers hope".

Next, Michael Callen, of the PWA Coalition, described the "overwhelming peer pressure to take AZT". In response to Grossman's claim that AZT "offers hope", Callen suggested it would be better to offer hope through substances that didn't have the serious toxicity of AZT. "It is not rational", said Callen, to say that everyone with AIDS ought to try AZT. The arguments against AZT are very well developed, and very rational, and what we ought to do is make certain that everyone has access to the arguments on both sides of the issue." "There are those of us who made a rational choice not to try AZT", he stated, "and we need to support those who have decided not to take AZT, just as we have supported those who are taking AZT."

In the discussion period, both Sonnabend and Lange commented that poor quality science had been used on behalf of AZT, and asked Martin Delaney to state specifically what studies he had in mind. At this point Delaney became truculent: "I don't have a list of studies in my briefcase, but there were page after page in the [Stockholm] abstracts supporting positive results from studies of AZT. And if necessary, I'll meet with you privately [?!] to show you some of these studies." Delaney's diatribe continued: "Let's not pretend that there's even a significant minority opinion out there that suggests that AZT is not an antiviral. I can't find anyone outside this table to suggest that that's the case.... That AZT argument is becoming a magnet for anti-establishment feelings. That's not OK when lives are at stake."

Sonnabend, maintaining his dignity, replied that he had looked at the Stockholm abstracts, and that the quality of evidence was soft. The abstracts involved uncontrolled observations of small numbers of patients; for scientific debate, they were little better than anecdotal evidence. Grossman then snapped at Sonnabend, "That's poppycock! Everyone at the table except you knows that's rubbish!"

Laura Pinsky, who as moderator ought to have attempted to keep Delaney and Grossman to some measure of civility, instead joined the pack and told the audience that Sonnabend and Lange were "very much a minority". Her comment was gratuitous and unfair, and caused one gentleman in the audience to proclaim, "That doesn't mean they're wrong!" At this point I raised my hand and attempted to speak; Pinsky screamed that there would be "no discussion from the floor". The panel was over.

I then went up on stage, and asked Pinsky when there would be an open discussion, as I wanted to correct a number of untrue things that had been said during the panel. Pinsky told me, not very courteously, that there would be no open discussion, and that if I had a question I should write it on a piece of paper like everyone else. I then approached Grossman, and asked him if he had read my article on the AZT trials. Grossman's response was to snarl something inarticulately and to turn his back on me. When I returned to my seat, a security guard approached me, and said he had been asked to "escort" me from the building. I and the people with me were amazed, to say the least, but it was time for the lunch break, so I let myself be escorted out.

Later in the day, during an afternoon panel, I left the auditorium to go to the men's room, and was intercepted by the same guard, who said he had been asked to see that I didn't enter the auditorium. I told him that everything was all right, and not to worry, and went back in, half expecting him to follow. He didn't.

After the conference was over, I asked Pinsky why a guard had tried to keep me out of the auditorium. She denied knowing anything about it, and said I should point out the guard to her. Perhaps Pinsky was telling the truth, but she is no friend of free speech. Last summer Pinsky, and her colleague Paul Douglas, went around Fire Island, as official representatives of Gay Men's Health Crisis (GMHC), telling gay men that they should get themselves tested for HIV antibodies, and if "positive", should consider going on AZT. At one of these talks, a Fire Island resident took issue with some of Pinsky's and Douglas's statements concerning the causal role of HIV and the benefits of AZT. Pinsky's response was to ask the audience to agree with her that he should not be allowed to speak. On this occasion she played the wrong card, for on Fire Island it was she was the outsider, and the audience emphatically indicated they wanted to hear what their friend had to say. Pinsky and Douglas did not attempt to answer his arguments.

The Columbia conference was an uncomfortable experience for me. I don't like having security guards called on me because someone is afraid of my presence: that I might say something out of place or write an article for the New York Native. I don't like showcase conferences devoted to creating delusions so fragile that they would be shattered by free and open discussion. This is totalitarianism.

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References and footnotes

↑ Michael Callen, ed., Surviving and Thriving With AIDS: Collected Wisdom, Volume Two, $20 plus $1.75 postage from: People with AIDS Coalition, 31 West 26th Street, New York, NY, 10010.
↑ Jeremy was subsequently persuaded by his doctor to go on a quarter dose of AZT. He died several months later.
↑ Margaret A. Fischl; "The Efficacy of Azidothymidine (AZT) in the Treatment of Patients with AIDS and AIDS-Related Complex", and Douglas D. Richman; "The Toxicity of Azidothymidine (AZT) in the Treatment of Patients with AIDS and AIDS-Related Complex"; New England Journal of Medicine, 23 June 1987.
↑ Joseph A. Sonnabend, "Review of AZT Multicenter Trial Data Obtained Under the Freedom of Information Act by Project Inform and ACT UP", AIDS Forum, January 1988.