Document:Banality of Evil

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New York Native
19 March 1990

Last weekend I travelled to Washington, DC to attend a "State of the Art Conference on AZT Therapy for Early HIV Infection", sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), held in the National Institutes of Health (NIH) headquarters in Bethesda, Maryland on 3 March 1990. The purpose of the conference was described as follows in a NIAID press release:

The conference goal is the development of specific recommendations for the use of AZT (zidovudine) by physicians who care for patients with early HIV infection. A panel of AIDS researchers, community physicians, statisticians, and other experts will review data from clinical trials and other relevant studies of AZT. During the last hour of the meeting, opportunities will be provided for questions and comments from the audience.

The timing of the conference coincided fortuitously with a decision of the Food and Drug Administration the day before (2 March 1990) to approve the use of AZT for healthy people having antibodies to the tendentiously named human immunodeficiency virus (HIV), also known as the "AIDS virus". With the new recommendation, physicians will be encouraged to have their "high risk" patients (like gay men) tested for HIV antibodies, and then to prescribe AZT for those patients who test positive and whose T4-cells drop below a count of 500 cells per cubic milliliter of blood (a count which is slightly below normal).

A testimonial to the drug was given by no less a public official than Health and Human Services Secretary Louis Sullivan, who said:

The studies and the change in labeling mean that better treatment can now be offered to thousands of people at earlier stages of infection with the AIDS virus before their health deteriorates critically. (1)

The FDA decision to recommend AZT for long-term use by healthy people goes together with another recent FDA decision to halve the recommended daily dose of AZT to 600 milligrams per day. Prior to the dose reduction, AZT's acute toxicities were so great that few if any patients could take the drug for more than a few months without requiring transfusions, discontinuance of the drug, or both. AZT is now the most toxic drug ever prescribed for long-term use.

The conference consisted mainly of slide talks, accompanied by sometimes desultory discussion. NIAID has promised to furnish a written document on the conference, which I'll review if and when I receive it. In this article, I'll describe the general nature of the conference, followed by highlights of individual presentations.

Manipulating Group Consensus

The conclusions of the conference were obviously determined well in advance. The panel of experts, after reviewing data from slide talks, were supposed to bolster the FDA decision of the previous day by recommending to physicians that they should give AZT to HIV positive members of high risk groups with T4-cell counts below 500.

The panel was stacked, inasmuch as it contained no critics, but many advocates of AZT. The panel members fell into two main segments. The first segment, comprising the majority of panelists, were independents, who were willing to be persuaded one way or another. The other segment consisted of hard-core AZT partisans, players on the Burroughs-Wellcome team (and presumably payroll). The struggle was unequal – as Lenin forcefully demonstrated, both in theory and in practice, a disciplined and surreptitious minority can powerfully prevail against a fragmented and unorganized majority. The independents were concerned with the truth, as well as the welfare of the human beings to whom AZT might be prescribed, and so they were properly hesitant or cautious at times. The AZT partisans had no such inhibitions: they acted in concert, and in line with a clear and pre-determined goal.

My presence was regarded as a threat by the organizers of the conference, and with good reason. I have no written more on AZT than any other writer in the world, and I am one of the very few writers (including Joseph Sonnabend, Peter Duesberg, Celia Farber, Ian Young, Brian Deer, Katie Leishman, and Gary Null) who have dared to expose the lies supporting this deadly nostrum.

For several days before the conference, I had carried on discussions with the organizers over whether I could gain admittance to the main conference room, or be relegated to an "overflow room" from which I could "observe the proceedings by closed circuit telecast". They intransigently insisted on the latter. When I arrived at the conference, several tensely officious females were ready and waiting. One of them informed me that an "overflow situation" existed, and that if I even attempted to take a look inside the main room, guards would be called. Another wrote my name on a waiting list. Admitting temporary defeat, I went into the "overflow room", and watched the first three presentations on the television screen. The visual quality was so poor that it was impossible to read the numbers that appeared on the slide tables. Having a view of the door, I could see person after person being admitted into the main room, even two hours after the conference had begun. Then, during the mid-morning break, one of my colleagues, who had simply walked into the main room, informed me that, far from an "overflow situation", there were at least three dozen empty seats. With a rush of adrenalin, I gathered up my gear and walked into the main room. No one attempted to stop me, and for the rest of the day I was able to observe live human beings presenting legible (if sometimes dubious) information.

Slide talks are, by their very nature, a form of propaganda. It is almost impossible to comprehend, evaluate, and retain the data that are flashed on the screen. One cannot, as when reading a detailed written report, dig in, go back and forth over methodology, tables, graphs, etc. Instead, information washes over one, the critical faculties are dulled, and one ends up accepting the generalities and conclusions that are offered by the presenter.

In spite of the one-sided planning of the conference, the desired consensus was not reached, and a couple of bombshells went off. Before going into highlights of the presentations, I'd like to give credit to Charles C. J. Carpenter, Professor of Medicine at Brown University, who did a good job of chairing the conference. Carpenter was fair and impartial, and did his best to maintain standards of civility among the panelists.

Margaret Fischl

Margaret Fischl is one of the stars on the Burroughs-Wellcome team. She coordinated the fraud-ridden Phase II AZT trials, which I analyzed two and a half years ago (2). When I spoke to Fischl on a previous occasion, she was unable to answer some very simple questions about a report which she herself had allegedly written, and she referred me to Burroughs-Wellcome for answers. It is scandalous that someone of her caliber should have been allowed to supervise clinical trials in the first place, let alone to continue to do so.

Fischl's first slide talk was on "NIAID AIDS Clinical Trials Group Protocol 016: The Safety and Efficacy of AZT in the Treatment of Patients with Early ARC". In this study, patients with "early ARC" were treated with AZT, and allegedly remained in better health than did patients who received a placebo. When I commented on this study last August, I wrote:

The study design was rotten at its core through sheer subjectivity. The "exciting" results were based entirely on perceived progressions from milder to more serious symptoms – on progressions from gray to gray. If no one at NIAID even knew what the qualifying symptoms were, one can only imagine the cognitive chaos that must have prevailed in the field, when physicians had to decide if a particular configuration of symptoms qualified as mild ARC, serious ARC, AIDS, or none of these. (3)

Nothing in Fischl's presentation shed light on this central problem. Interestingly, much of the claimed efficacy of AZT in this study was based on results from the now-discredited p24-antigen test, about which more later.

Fischl blithely dismissed AZT's toxicities by claiming the drug was "remarkably well tolerated". Although fatigue, malaise, nausea, and hematologic abnormalities were found more frequently in the AZT than in the placebo group, almost all patients taking a low dose were able to tolerate the drug – according to Fischl.

Margaret Fischl later gave a second slide talk, entitled "NIAID AIDS Clinical Trials Group Protocol 002: The Safety and Efficacy of AZT in the Treatment of Patients with Post First Episode PCP." Fischl said this was a brand new study: "I almost feel like the birth of a baby!" (No, I am not kidding. She really did say that.) The point of this study was to compare the efficacy of a low dose (600 mg/day) with that of a high dose (1,200 mg/day) of AZT in patients who had had one episode of pneumocystis carinii pneumonia (PCP). Apparently the low dose was just as effective as the high dose, and with less hematologic toxicity.

One the whole, AZT did not do a very good job of "extending the lives" of the patients in Protocol 002. After two years of treatment, 66 to 72 percent of them were dead.

No report has been written or published on either of these studies. I refuse to comment on them further until I can look at a proper report in a peer-reviewed journal. From a complete written report an analyst can analyze methodology, study design, or data – but he cannot analyze the generalities and snippets of information that are tossed out in a slide talk. Based on Fischl's past record, no research in which she has taken part should be accepted without considerable skepticism.

Paul Volberding

Paul Volberding from San Francisco was another of the Burroughs-Wellcome stars. His talk, dually presented with Stephen Lagakos of the Harvard School of Public Health, was entitled, "NIAID AIDS Clinical Trials Group Protocol 019: The Safety and Efficacy of AZT for Asymptomatic HIV Infected Individuals". This, of course, was the theme of the conference. The alleged results from Protocol 019 had previously been promulgated in a skimpy and incoherent NIAID press release on 17 August 1989. At the time I characterized this practice as "The great AZT scam: results without data" (4).

Allegedly, HIV positive individuals on either a low or a high dose of AZT were less likely to develop AIDS than were those on placebo. Unfortunately, Volberding and Lagakos did not present sufficient data to support this conclusion.

However, a number of interesting statements were made during their presentations. One of the patients was murdered during the course of the study. Volberding admitted to a "strong suspicion" that most of the patients knew whether they were getting AZT or placebo. The "suspicion" was strengthened by the fact that patients on placebo were far more likely to drop out of the study. In other words, the study was not really blind, as it was designed to be! The study was therefore invalid on this basis alone.

Stephen Lagakos gave an excruciatingly inept performance. The numbers he presented were illegible on the television screen I was watching at the time. However, he showed a line chart depicting CD4 counts over time by treatment group. A glance was enough to show that there was no clear pattern, and the differences were trivial. This is what he should have said. But instead he talked endlessly about a meaningless chart.

During a break, Volberding told me that a report on Protocol 019 was "in the process of being reviewed", and that he hoped it would be published soon. Fine. When I see the report I'll comment on this research further (5).

Since Volberding and Lagakos, as well as Fischl, frequently made reference to results on the p24-antigen test, as a measure of AZT's efficacy, a brief discussion on this topic is in order.

The Discredited p24-antigen Test: A Digression

As readers of the Native are aware, the p24-antigen test is unvalidated – it is not known exactly what the test measures, or how accurately it measures it. Over two years ago, Harvey Bialy, Research Editor of Bio/Technology, wrote an editorial in which he assailed the uncritical use of the test, the shoddy peer-review standards of medical journals, and the gullibility of the press (6). Bialy demonstrated that the claimed results from the p24-antigen test, as reported in recent medical journals, could not possibly be true.

A year later the eminent molecular biologist Peter Duesberg, in his magisterial refutation of the hypothesis that HIV is the cause of "AIDS", demonstrated the worthlessness of the p24-antigen test, pointing out that, among other things:

All studies on p24 report AIDS cases that occur without p24 antigenemia, indicating that p24 is not necessary for AIDS. They also report antigenemia without AIDS, indicating that p24 is not sufficient for AIDS. (7)

In the 14 December 1989 issue of the New England Journal of Medicine, two articles and an editorial appeared, which attempted to show that, contrary to the arguments of Duesberg, HIV really is biochemically active, and therefore might still be either a cause or the cause of "AIDS". Both articles demonstrated that results from the p24-antigen test were meaningless (8). In an editorial, David Baltimore wrote:

If this new approach [to drug testing] is to succeed, accurate early markers of drug efficacy will be of great value. None of the currently available "surrogate" markers are completely satisfactory in this regard. Detectable quantities of p24 antigen are found in only a fraction of infected persons and, as shown by Ho and Coombs and their coworkers, correlate poorly with the presence or amount of replicating HIV. (9)

My point, then, is that much of the AZT research for the past three years has relied upon results from the p24-antigen test – a test which is now admitted, even by advocates of the HIV hypothesis, to be worthless.

A digression within a digression: The New England Journal of Medicine has agreed to run a letter from Peter Duesberg replying to the articles by Ho, Coombs, Baltimore, and Feinberg. In scientific, as opposed to propagandistic terms, the HIV hypothesis has not yet risen from the grave.

John D. Hamilton

The major bombshell of the conference was detonated by John D. Hamilton, a soft-spoken gentleman who is Professor of Medicine at Duke University. His talk was entitled, "Veterans Administration Study #298: AZT Treatment of AIDS and ARC, Part I: Treatment of Patients with ARC". This was a large case-control study evaluating AZT treatment (1,500 mg/day) of patients whose T4-counts were between 200 and 500. The principal endpoints were AIDS, death, or both.

Although Hamilton was not able to release specific data, owing to a rule which some medical journals have (if data from a study have been made public, the article is automatically rejected), he did give the major conclusions. Whether looking at survival, clinical benefits, quality of life, or any other measure, there was no evidence that AZT had benefits of any kind.

Hamilton's conclusion, understated but authoritative, was this:

In conclusion: We hope this panel will acknowledge the uncertanties discussed today, and that the message to patients and practitioners will reflect the lack of information in many areas.

This was the last thing the Burroughs-Wellcome Mob wanted to hear. Why should a physician prescribe a toxic drug for long-term use if the drug has no benefits at all? Several times as Hamilton was speaking, Margaret Fischl, whether from nervousness or boorishness, went into episodes of snickering. This may be her mode of refutation. Over two years ago, when I asked her if she had read Peter Duesberg's article in Cancer Research refuting the HIV hypothesis, she responded by snickering.

Under sharp questioning from the AZT advocates, Hamilton expressed confidence in his study, which was carefully designed and had large samples. He considered it most unlikely that the results would change appreciably over time.

Mitchell Gail

The most ludicrous presentation of the conference was given by Mitchell Gail, a "Medical Statistical Investigator" with the National Cancer Institute (NCI): "Recent Deficits in the Incidence of AIDS". He tried to make the utterly preposterous case that AZT therapy should be given credit for the fact that the incidence of AIDS is going down.

Well now, I have been arguing for three years that the CDC projections of AIDS incidence were far too high (10). I demonstrated a year and a half ago that the incidence of AIDS was dropping (11). Until just recently, public health service officials simply denied all this – they said that the estimates were accurate and the incidence was not dropping. However, it is now clear that the CDC projections for 1988 and 1989 were far too high, and everyone wants an explanation (as though it were not in the nature of epidemics to peak at some point).

Whatever the explanation may be, it cannot be AZT, which has only recently been given to small numbers of "asymptomatic" people.

AZT and Cancer

Kenneth Ayers, Senior Toxicologist at Burroughs-Wellcome, spoke on "AZT Carcinogenicity". He discussed the recent rodent carcinogenicity studies, in which AZT caused vaginal tumors in mice and rats. Ayers did a competent job of presenting the findings, although, being on the payroll of Burroughs-Wellcome, he tended to downplay their significance.

Some of his information went beyond that which was available last December, when I reported on these findings (12). For example, back in December apologists for AZT, such as James Mason of the Public Health Service or Mathilde Krim of AmFAR, claimed that the AZT doses given the rodents were far higher than the equivalent human doses. I argued at the time that this could not be true, since at such high doses the rodents would all have perished from anemia. Now it turns out that the information given in the press had been quite incomplete. In both rodent studies, the doses of AZT had to be sharply reduced "in the interest of long-term survival". In the study on rats, the doses were reduced sharply after 90 days, and had to be reduced even further after 279 days.

Ayers explored the question of how AZT causes vaginal cancer in rodents, and inclined to the hypothesis that cancer results from local contact of vaginal tissue with urine with high AZT concentration. Interestingly, rodents absorb much less AZT than do human beings. Whereas rodents excrete 90% of the AZT they are given, humans excrete only 20%. Therefore, the systemic, as opposed to localized, toxicities of AZT may be much worse in humans than in rodents.

Ayers correctly stated that the significance of the rodent carcinogenicity studies was: an indication of general carcinogenic risk in humans. He then went on to characterize AZT as a weak rather than a general carcinogen, and to claim that "there are other drugs that cause cancer in animals, but are still in common use at the discretion of the physician and the patient". He failed to mention what those drugs might be, and whether they are prescribed for long-term use in healthy people.

Amazingly, Ayers did not even mention the results of the Cell Transformation Assay, which was performed over three years ago. In this standard in vitro test utilizing human cells, AZT proved to be highly positive, indicating, in the words of the FDA toxicology analyst, that AZT should be "presumed to be a potential carcinogen". Burroughs-Wellcome is well aware of this finding, as it is alluded to (if cryptically) in the AZT (Retrovir) entry in the Physician's Desk Reference. In a conference devoted to evaluating the merits of long-term AZT therapy, in a presentation devoted to "AZT Carcinogenicity", the failure to discuss or even mention the Cell Transformation Assay is deplorable, and can only be regarded as a deliberate intent to deceive on the part of Burroughs-Wellcome.

Douglas Richman

Douglas Richman from San Diego is also on the Burroughs-Wellcome team, having been a principal investigator in the Phase II trials. However, his presentation, "AZT Resistance", was not very encouraging for the AZT advocates. In brief, he reported that HIV does develop resistance to AZT over time, and there are many unanswered questions in this area. Obviously, for those who believe that HIV is the cause of "AIDS", such resistance would not bode well for long-term therapy.

Discussion Among the Panel

Most of the afternoon was devoted to discussion on various topics among the panel. Jay Sanford, President and Dean of the Uniformed Services University of the Health Sciences, made a key point: If the progression rate (from HIV infection with low T4-counts to AIDS) is so low anyway (4% or less), is it really justified to give AZT on a mass scale? None of the AZT advocates attempted to answer him.

Neil Schram, a gay physician from Palos Verdes, California, emphasized that hasty decisions (like taking AZT) should not be made on a single CD4 count, as such readings normally go up and down in the course of a day, and transient infections like flu can greatly lower the CD4 count. He added that many patients look upon their CD4 counts in absolute terms, and are unaware of the expected day-to-day and hour-to-hour variance in their readings.

On the topic, "Monitoring of Patient Immune Status", the p24-antigen test was described as having no practical value by three of the panel members. No one defended the test.

In the discussion, "Initiation of AZT Therapy", Neil Schram dissented from the encroaching consensus that AZT should be given to all HIV positive individuals with T4-counts below 500. He said he didn't know – that the Veteran's Administration study had changed his mind, and he was no longer willing to say that AZT should be given to those with T4-counts between 200 and 500. Schram's caution was impermissible, and immediately he came under attack from Fischl and Volberding. Fischl characterized Schram's hesitation as "dangerous", and said that "We must rely on the data before us" (meaning presumably the unpublished data from Volberding and herself). Anthony Fauci then entered the fray, siding with Fischl and Volberding against Schram. According to Fauci, those who start AZT earlier (when their counts are higher) do better than those who start AZT later.

This was rather an ugly episode, and I think that homophobia played a role in the contempt with which three straights (Fischl, Volberding, and Fauci) addressed a gay man. Fortunately, other panel members came to Schram's defense – Robert Couch, Professor and Chairman of the Department of Microbiology and Immunology at the Baylor College of Medicine, pointedly told the AZT gang that Neil Schram was not the only one with misgivings over the blanket recommendation. Jay Sanford and Gerald Friedland, Professor or Medicine and Epidemiology and Social Medicine at the Albert Einstein College of Medicine, also supported the caution of Schram and Couch. Fischl responded by pleading with the panel to "Give the positive message" (presumably meaning to recommend AZT).

The discussion, "The Management of HIV Infected Individuals on AZT Therapy", was largely concerned with what to do about the toxic side effects of AZT: anemia, neutropenia, myopathy (a muscular disorder), etc. Here the discussion became very unreal: whether to reduce doses, or to discontinue therapy; whether to resume therapy, and at what doses, and so on. To pose such a question is to answer it: What should be done if the administration of a toxic drug has caused a patient to become anemic, or his muscles to ache violently and shrivel up? How much common sense does it take to make a decision?

Public Discussion

As time was running short, only a half hour was available for public discussion. I put my name in early, and ought to have been the thrid person in line. However, a woman deposited more slips of paper on the Chairman's podium, and then Anthony Fauci went up and rearranged the slips. With about five minutes to go, it didn't look as though I would be allowed to speak, so I went up to the podium and explained to Charles Carpenter that I thought I was next. I found the slip with my name on it on the bottom of the pile and handed it to him. He then called on me, and I introduced myself and said something like the following:

I'd like to express my concern in two areas. First, caution is needed regarding the chronic toxicities of AZT. We do not know what the long-term side effects of this drug are in human beings. We should not minimize the potential of AZT to cause cancer. I was shocked that the toxicologist from Burroughs-Wellcome did not even mention the results of the Cell Transformation Assay, which was performed well over three years ago. In that standard in vitro test of carcinogenicity, involving human cells, AZT was found to be highly positive. The results mean, in the words of an FDA toxicologist, that "AZT should be presumed to be a potential carcinogen". Burroughs-Wellcome is well aware of these results, as a reference to them appears in the Retrovir entry in the Physicians Desk Reference.

Second, skepticism is needed regarding unpublished data purporting to show benefits of AZT. For one thing, there are studies that show no long-term benefits of AZT therapy. A case-control study conducted in France by Dournon and colleagues found that the very, very slight "benefits" of AZT vanished and were utterly nonexistent after six months (13). And today we have heard that a Veteran's Administration study found no benefits at all from AZT therapy.

In addition, we need to be skeptical because many of the studies allegedly demonstrating AZT's benefits were very bad research. I've done an analysis of the Phase II trials, which were the basis for AZT's approval, using documents the FDA was foced to release under the Freedom of Information Act. In that study, sloppiness and cheating of all kinds was tolerated. Among the many sins that were committed against the ethics of science, the investigators deliberately used data that they knew were false. Only one word is adequate to describe such "research". That word is FRAUD.

Conclusions

The AZT conference enhanced my appreciation of Hannah Arendt's phrase, the "banality of evil". Most of the participants in the conference were not intrinsically evil. Some of them were weak, conformist, susceptible to peer pressure or bribery. But the majority were good people doing their best to make fair and rational decisions based on the information available to them.

Nevertheless, the panel members were leading players in a monumentally evil program – the terrorizing and poisoning of gay men and other members of "risk groups". Many thousands of people may die because of the actions of the panel, coupled with the FDA decision of the previous day to recommend AZT for healthy people.

Evil people do exist, and some of them were present at the conference – people whose unchecked egocentrism has made them indifferent or even hostile to the welfare of their fellow human beings. But for the most part, the triumph of evil follows when good people remain silent.

References and footnotes

1. ↑ "AIDS Drug", Associated Press, 3 March 1990.
2. ↑ Native, Issue 235. Another highly critical review of the Phase II trials was written by 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.
3. ↑ Native, Issue 331.
4. ↑ Native, Issue 340.
5. ↑ The article was published just as this book [Poison by Prescription] is going to press. Paul A. Volberding, Stephen W. Lagakos, et al., "Zidovudine in Asymptomatic Human Immunodeficiency Virus Infection: A Controlled Trial in Persons with Fewer than 500 CD4-Positive Cells per Cubic Milliliter", New England Journal of Medicine, 5 April 1990.
   In brief, the research is unacceptable. The authors' ignorance of elementary statistics is beyond belief. None of the tables show bases or make sense. Willy-nilly they compare percentages with raw numbers.
   Much of the article consists of crude special pleading. As support for the "benefits" of AZT, the authors cite the fraudulent Phase II Trials and the shoddy AZT survival study, along with the ridiculous Pizzo study. However, they don't even mention the far superior Dournon study (see reference 13).
   In no way does this article demonstrate benefits of AZT treatment for asymptomatic, HIV-infected persons.
6. ↑ Harvey Bialy, "Commentary: Where is the Virus? And Where is the Press?", Bio/Technology, February 1988.
7. ↑ Peter H. Duesberg, "Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome: Correlation But Not Causation", Proceedings of the National Academy of Sciences, February 1989.
8. ↑ David D. Ho et al., "Quantitation of Human Immunodeficiency Virus Type 1 in the Blood of Infected Persons", New England Journal of Medicine, 14 December 1989.
   Robert W. Coombs et al., "Plasma Viremia in Human Immunodeficiency Virus Infection", Ibid.
9. ↑ David Baltimore and Mark B. Feinberg, "HIV Revealed: Toward a Natural History of the Infection", Ibid.
10. ↑ Native, Issue 203.
11. ↑ Native, Issue 286.
12. ↑ Native, Issue 348.
13. ↑ E. Dournon et al., "Effects of Zidovudine [AZT] in 365 Consecutive Patients With AIDS or AIDS-Related Complex", Lancet, 3 December 1988.

© 1990 by John Lauritsen
Originally published in The New York Native
Reprinted in Poison by Prescription