VIRUSMYTH HOMEPAGE


TALK ON AZT

By John Lauritsen

Alternative AIDS Symposium, Amsterdam, May 1992


I'm going to talk mostly about AZT, and the main point of what I will say is that the research which is used to claim benefits for it is no good. But first I would like to let you know where I'm coming from. My academic background is in the social sciences; my professional background for two decades has been survey research, also known as market research. This is the main area of my expertise. However, for the last six years I have been in a second career, that of a journalist, writing as an AIDS dissident. I have written a book which is called 'Poison by Prescription: The AZT Story'.

With regard to etiology, I think that at this point we don't know what AIDS is or what causes it, though we must find out before we can have a rational approach to treatment. The official paradigm is that AIDS is a single disease entity with a single cause, which is believed to be one or more retroviruses. I strongly disagree with this paradigm. I don't believe that AIDS is just one single thing. I subscribe to the 'Risk-AIDS' hypothesis, which says that different groups of people or different individuals are getting sick in different ways and for different reasons. We need to find out what risks affect their health, in ways that might cause them to develop one or more of the 25 old illnesses which qualify as 'AIDS'. In a sense I'm not sure that 'AIDS' exists, although undoubtedly people are sick. But from the very beginning, 'AIDS' was essentially a construct -- I would say a phony construct. For example, very early, way back in 1982, there were ten Haitians who were diagnosed as having diseases which were common in Haiti, including pneumocystis carinii pneumonia, toxoplasmosis, cryptococcus, candidiasis and tuberculosis. These are all reasonably common in Haiti, but uncommon in the US. But members of the US Public Health Services chose to believe that this was something rare, a disease that the world had never seen before, simply they were not familiar with the diseases.

Or, let us take the very first five gay male cases of AIDS. (It was not called AIDS then, but GRID, which stood for 'Gay-Related Immune Deficiency'.) One of the orthodox truths is that gay men who got AIDS were incredibly promiscuous. And indeed, a lot of them were. But in order to understand something like promiscuity, in terms of numbers, statistically, you have to see the whole distribution. You don't want to see merely the mean, which is only one way of expressing the average. You want to see, regardless of the average, whether there were some people who had little sex or none at all.

I will have to say this again and again: members of the US Public Health Service frequently attempt to do survey research (my field), which they call 'epidemiology'. They don't know how to do it. And in fact the only way you really can learn survey research is to go through the apprenticeship of being in the profession itself. Survey research is a rather small field. The entire membership of the American Marketing Association is only about 30.000 people, and only a small proportion of these actually do survey research. People in academia, in government, in industry, and in the Public Health Service are always trying to do survey research, and their efforts are pathetic. They know absolutely nothing about it.

Of the first five gay-male cases, only two were really promiscuous. The other three weren't. But all five of them were heavy users of poppers. And yet, in the early years of the epidemic, the Public Health Service did its best to minimize the role of drugs and other health risks, and they focussed entirely on what was hoped to be and eventually claimed to be a new and exotic microbe. From the standpoint of survey research, the very first priority ought to have been to find out the characteristics of people with AIDS. This was never done-competently. The CDC did attempt to do this in 1982, and their blotched attempt at survey research was reported in August 1983 in the Annals of Internal Medicine. (Of course all of the CDC people have PhD degrees, which in America does not guarantee that they can write grammatical English, or know anything at all.) The CDC 'epidemiologists' concluded that promiscuity was the only health risk, and for quite a long time the only advice the CDC gave gay men was to reduce the number of sexual partners, which is truly idiotic advice. The questions that need to be asked are: why are people in different risk groups getting sick, why are different individuals getting sick? I have some hypotheses of my own, but I think at this point we should be very open-min- ded. We should be willing to entertain all reasonable hypotheses as to what AIDS is and what causes it.

In the case of the intravenous drug users, the answer is probably quite simple. Intravenous drug users are getting sick now in the same way they were getting sick 30 or 40 years ago. Which is to say, they have lung disease (one of the various forms of pneumonia or tuberculosis) and they are wasting away. This is the clinical profile of an intravenous drug user many decades ago. In New York City, Dr. Polly Thomas, a member of the New York City health department, has said, that if you had an intravenous drug user with tuberculosis and wasting, to know if this was an AIDS case, you would have to give the HIV antibody test. If the individual had HIV antibodies he would be counted as an AIDS case, and the assumption would be that HIV had done it, that HIV had made him sick. However, if an intravenous drug user had the identical clinical profile, and they could not find HIV antibodies, they would say, 'this is just one more junkie wasting away with pneumonia.' Obviously this is irrational.

Much has been made about the hemophiliac AIDS cases. Why are they sick ? The answer here may be quite different. Hemophiliacs were born sick. Hemophilia is a type of sickliness, which goes far beyond the inability of the blood to clot. On top of this there is Factor VIII concentrate, which has greatly extended the lives of hemophiliacs, but which also has consequences for the health. Factor VIII concentrate represents a pooling of all the microbes and all the toxins from the blood of many donors. It is not good stuff to take. So, it may very well be that 'AIDS' in hemophiliacs is nothing more than congenital sickliness aggravated by Factor VIII concentrate.

The interesting and difficult question is: Why are gay men getting sick? Well, first of all, gay men as a whole are not at risk for AIDS. This is simply not true. It is only a small and very particular subset of gay men that are at risk. And I believe, if we did the research which ought to be done and did it competently, we would find in virtually all cases that recreational drugs were the villain. But there are certainly many things which could have made these particular gay men sick. The way that they lived, beginning in the 1970's, was extremely unhealthful. Gay bathhouses and clubs became drug dispensaries. Some of the gay discotheques had designer drugs manufactured especially for them. There were rituals where thousands of men in a gay discotheque would take a half a dozen different 'recreational' drugs in the course of an evening. At one time everyone would take 'Special K', then later in the evening they would all take MDA or Ecstasy, and so on. All night long some of them would snort poppers, which they didn't even consider to be a drug. We have no way of knowing the long-term consequences of any one of these drugs, nor what they did in interaction with each other.

Drugs that were part of the gay scene would include the nitrite inhalants or 'poppers'. And I'm proud to say that, together with Hank Wilson, I can take- much of the credit for the fact that poppers are now illegal in the US-al- though they are still sold legally here in Amsterdam as well in the United Kingdom. Poppers are definitely not a safe drug: among other things, they cause severe anemia, they damage the chromosomes, and they form carcinogenic compounds in the body. Other popular drugs included of course alcohol, MDA, and Eve, Ecstasy and Special-K, which are designer drugs, cocaine and heroine, quaaludes, barbiturates, ethyl chloride, amphetamines, and many others.

Another risk factor for the gay men who developed AIDS was promiscuity. Most of them had had dozens of cases of venereal disease in the decade before they developed AIDS. Each time they were treated with stronger and stronger doses of antibiotics, which can have a devastating effect on the immune system. On top of the chemical assaults on their bodies, these gay men experienced a great deal of stress and depression; we should not ignore these psychological factors. In addition, and I say this as a musician ... (I think Michael Callen should have mentioned music as something which is beneficial, since he is a musician. I think music does have healing powers.) ... Because I'm a musician I hate disco. I would almost say that this is a corollary: he who loves music hates disco; he who loves disco hates music. But aside from the merits of disco, which are non-existent musically, it is extremely loud. At a typical gay disco the sound would be right at the pain threshold, all night long. As a consequence, many of the young men who were in the gay disco scene in the 1970's had to wear hearing aids in the 1980's. Prolonged exposure to pain-thres- hold noise is extremely bad for the health in general and the immune system in particular. I'm not saying that any one of these risk factors made gay-men sick in ways that are called 'AIDS', but I would say that none of them were good for the health. We should certainly find out what the contributions were, individually and collectively, of these risk factors: drug abuse, venereal diseases, antibiotics, prolonged exposure to pain-threshold noise, and stress and depression.

I would suggest a radical shift in paradigm. Instead of looking for a microbial enemy and trying to find a drug that will kill it, we should instead have a concept of health-which is anathema to the medical profession. My outlook has been influenced by Robert Mendelsohn's book, 'Confessions of a Medical Heretic'. In it he states that modern medicine is a religion, the doctors are priests, and the god of the religion is Death. The concept of health is alien to most of the doctors treating AIDS patients in New York City. I have known quite a few people with AIDS who still smoked 2 to 3 packages of cigarettes a day. Most of them are dead now. I'm not saying that cigarettes are the cause of AIDS, but I do say this: someone who has had an attack of pneumocystis carinii pneumonia should not be smoking three packages of unfiltered Lucky Strikes per day. Nor should people with AIDS be attempting to survive on Coca Cola and candy bars rather than on good food. My point is that their doctors never told them to give up either cigarettes or sugar. I remember visiting a friend in a Roman Catholic hospital. He was chain smoking cigarettes from his hospital bed. There was a small mountain of cigarette butts in the ashtray next to his Teddy bear. The nurses, the nuns, the doctors-none of them told him to stop smoking. I was the first to do so.

Going into AZT, tomorrow there will be shown a documentary made by Meditel, 'AZT Cause for Concern'. I think this is a fine documentary, which will explain many of the theoretical objections to the use of AZT, so I won't try to repeat all those arguments. Suffice it to say that AZT therapy is based on the false HIV-AIDS hypothesis and on the false premise that HIV is actively replicating. Not only is the theory behind AZT wrong, but it is a terrible drug, by virtue of its essential biochemical properties. It is a drug whose basic action is to terminate DNA synthesis, all of it. It is a random terminator of DNA synthesis, which is nothing less than the life process itself. Such a drug cannot possibly be beneficial. And so it is not surprising that AZT has many terrible toxicities-it causes the muscles to waste away, it causes excruciating muscular pain, it attacks the nervous system, it especially attacks the blood, it causes life-threatening anemia, violent headaches. And all of these are merely the short-term toxicities.

A lot of lies have been told by Wellcome, the manufacturer of AZT. You will find them published in the New England Journal of Medicine, in press releases, and in package inserts. One of the lies, which they are now claiming, is that AZT has few toxicities. Always they look only at what are called the 'acute toxicities', meaning short term. But any toxicologist will tell you that there are also 'chronic toxicities' or long-term. And one of the truisms of toxicology is that you can't predict chronic toxicity from acute toxicity. Some of the classic carcinogens have no acute toxicities at all, but in the long term they cause cancer. AZT is now being given to people who are objectively healthy. There is nothing wrong with them, aside from the fact that they have HIV antibodies. And so it is obviously of concern whether AZT will cause cancer.

AZT is a known carcinogen. We can say this from four different, mutually supporting lines of reasoning. Number one: by its very nature biochemically, AZT will cause cancer: the fact that it is a terminator of DNA synthesis; the fact that when AZT is taken into a cell there are only two things which can happen-either the cell dies, or if the cell is lucky it mutates and you get cancer. (That is lucky for the cell, but not lucky for you.) The second reason is that, according to a standard in vitro test to screen for carcinogenicity, the Cell Transformation Assay, AZT was highly active. The FDA toxicologist who reviewed the results said that, on the basis of this test, we should assume that AZT will cause cancer. The third line of reasoning is that AZT causes cancer in rodents, and based on a century of animal testing for carcinogenicity, any time a substance causes cancer in animals, the assumption should be that it will also cause cancer in human beings. (A lot of disinformation has been put out by Wellcome, the tobacco industry, and others, where they say, 'well, just because it causes cancer in mice doesn't mean it will in people'. This is not true. Although a few toxins are species-specific, the assumption should nevertheless always be that a substance which causes cancer in animals will do so in humans.) And the fourth line of reasoning is that we now see a strong correlation between long-term AZT therapy and various forms of cancer, especially cancer of the lymph system.

Now I want to talk about AZT research. I will say that basically it is no good, and one thing that I will repeat several times is that the Phase II trials of AZT were fraudulent. Some people are afraid of what they perceive to be extreme viewpoints. They like to believe that the truth always lies in the middle. It often does, but then sometimes one extreme viewpoint is correct and the other consists of lies. I maintain that any word short of 'fraud' is not adequate to describe these studies. And what this means is that AZT was approved by the Food and Drug Administration of the US on the basis of fraudulent research. This means that the approval was illegal. It means that most of the public health services in the world have simply followed the lead of the US Public Health Service in basing approval on fraudulent research. It means in a way that AZT has been sold illegally and fraudulently all over the world.

Now, following the 1990 Meditel documentary, Wellcome sent out a letter to doctors in which they claimed that there were 4.000 published studies which showed benefits for AZT. Well, I ask all of you how credible this particular statement is. If you were merely to glance at each of these studies for ten minutes, which is not very long, and if you worked for 35 hours a week reading them, which is a normal work week, it would be almost the end of this year before you could finish reading all of the 4.000 alleged studies. And by this time there would probably be another 4.000 studies, perhaps 8.000. The statement is ridiculous. I myself have examined, not 4.000 studies, but at least the major ones. I once confronted Anthony Fauci, America's premier AIDS bureaucrat, and said, 'Look, could you cite three or four studies that qualify as good research and show benefits for AZT ?' At least he answered the question. He said the Phase II trials, the Pizzo study, and the Creagh-Kirk survival study. I will get to these. I also asked the same question of David Barry - a truly evil man, the vice president in charge of research at Burroughs Wellcome; he also cited the Pizzo study, the survival study and the Phase II trials.

All of the studies I have looked at that claimed benefits for AZT have been no good in one way or another. Sometimes they were simply sloppy and incompetent; sometimes they were manifestly fraudulent. Many studies were just little bits of nothing: a few patients in a totally uncontrolled study, which is not even on the level of a good anecdotal report. Let me use an analogy. Assume you had a barrel of apples. (I suppose if it held 4000 apples it would have to be a very large barrel, or very small apples.) If you reached into it, picked out an apple, and found it was rotten, and you picked out another apple and it was also rotten, and a third and it was even more rotten then the other two-af- ter you had gone through two dozen rotten apples, you might justifiably assume that the whole barrel was filled with rotten apples. This is a legitimate inference. Other people might say: 'How can you say that, you only looked at two dozen apples out of 4.000. Maybe somewhere in the middle of the barrel or the bottom of the barrel there are good, fresh apples'. I personally don't wish to think this, and in fact there are forms of statistics (sequential analysis) which deal with this particular problem; at a certain point you decide that the apples are all rotten.

I'll get to the Phase II study in a moment, because I want to go into my allegations of fraud. I'm not expressing my personal opinion when I say they were fraudulent, It is my professional opinion, meaning that not a single one of my colleagues who had the information I have, which includes FDA documents released under the Freedom of Information Act, would disagree with me. The Phase II study was done in 1986, and on the basis of it AZT was approved in 1987.

First, let's consider the survival study, whose principal investigator was Terri Creagh-Kirk, an employee of Burroughs Wellcome. (Terri Creagh-Kirk et al., 'Survival Experience Among Patients With AIDS Receiving Zidovudine [AZT]', Journal of the American Medical Association, 25 November 1988. The fifth chapter of my book deals with this study in some detail.) I attempted to speak to Terri Creagh-Kirk, who made it clear that she was not allowed to speak to me, and instead I spoke to a Burroughs Wellcome public relations woman. In this study, in which the investigators were attempting to track the survival of about 4.000 patients, they managed to lose 1,120 patients, more than a quarter of the sample. They had not the slightest idea if these 1,120 patients were still taking AZT, if they were alive or dead, or anything whatever about them. This is absolutely flabbergasting incompetence, almost beyond the pale of imagination. Yet when they wrote their report, Creagh-Kirk et al. covered up the fact that they had lost these people. They quietly admitted it in the middle of their report, but not in the abstract at the beginning or the conclusion at the end. In the abstract and the conclusion sections they presented a guess ('statistical estimate') of theirs as though it were a real percent. This is a type of fraud, a form of lying. If you make an estimate, you call it an estimate; if you present a percent, that means it is a hard figure based on real data, not just a guess.

I would comment here that medical reporters and AIDS activists often cite scientific studies, and yet most of the things published in medical journals are not good research. Most of these people simply look at the abstract at the beginning of the report or the 'discussion' at the end, and then parrot the generalizations they find there. Very few people understand what it means to design, to execute and to analyze a study, and so they can only read research reports uncritically.

Another study, which according to both Fauci and Barry demonstrated benefits for AZT, is a total joke. (Philip Pizzo et al., 'Effect of Continuous Intravenous Infusion of Zidovudine (AZT) in Children with Symptomatic HIV Infection', New England Journal of Medicine, 6 October 1988.) Philip Pizzo studied 21 children given AZT. He claimed that giving them AZT boosted their IQ's by 15 points, which would be one standard deviation. Despite the fact that five of the children died, in a very short time, Pizzo concluded, on the basis of 'neuro-developmental' improvements (meaning IQ scores allegedly went up), that even newborn babies should be given AZT. I'm not making this up. Believe me I'm not. How could you satirize anything so foolish? Anyone who has the slightest grasp of the theory and practice of IQ testing knows that in no way could giving a drug to people make their IQs go up by 15 points.

Another study, which has been used recently to claim benefits for AZT, was conducted by Paul Volberding. (Paul Volberding et al., 'Zidovudine in Asymptomatic Human Immunodeficiency Virus Infection', New England Journal of Medicine, 5 April 1990.) In this study AZT was given to people who were asymptomatic. The alleged findings were used by the FDA to justify prescribing AZT for healthy people who are HIV positive. This is wretched, wretched research, and I'm grateful to Robert Laarhoven for giving me the preliminary report on it, which indicates even more fully the ignorance of these people. Paul Volberding has admitted publicly that the Protocol 019 study became unblinded. Therefore it was invalid. It was designed and supposed to be a double-blind, placebo-controlled study, and in a completely cavalier way Paul Volberding admitted it was not.

When you write a report, and I have written I suppose a couple of hundred research reports, you want to be very clear. You want to write your report so clearly that even a businessman could understand it. Even the chief executive officer. Because if they don't, if it goes to the chief executive officer and he can't understand it, he will be angry and go to the market research department and say, 'What does this mean?' And if they can't explain it they will come to me and say, 'How dare you write something that our chief executive officer could not understand!'. Well, I read Volberding's report several times, and it made no sense at all to me, or to anyone else I know who read it.

People like Volberding are incredibly ignorant. The 'preliminary report' showed their attempts to make questionnaires. This is one of the ways that those of us who are research professionals recognize another professionals-the ability to make a good questionnaire. Now, there isn't only one way to do it. We have many different styles. But we can certainly recognize someone who has no idea whatever how to go about designing a recording form or questionnaire. Their attempts were pathetic.

Another way that we recognize other research professionals are through tables. Statistical tables. In study after study, and certainly in the Volberding study, the tables make absolutely no sense. But a good table must make sense. It must have everything there that you need to understand it. In 1987 I talked to Margaret Fischl, that silly woman who is now regarded as an expert on AIDS. I had to tell her what the word 'replicate' meant in English, which is something that anyone who has studied about science ought to know-that you try to design a study and describe it so well, that someone else could come along later, replicate the study, and get similar results. Fischl could not explain the tables that appeared in her own study with her own name on it. This is insane. In every study that I have ever written, I could explain the tables because I made them myself. But Fischl couldn't. All she could do was whine that I should call Burroughs Wellcome, and maybe they could tell me what the tables meant.

Another thing which become quite clear is that the 'AIDS experts' do not understand statistics. In the beginning of Volberding's 'preliminary report' is a faulty formulation of the study design hypothesis. Among other things, Volberding and his accomplices believed that it is correct to use a one-tailed t-test in evaluating the efficacy of drug vs. placebo. Truly mind-boggling ignorance! A study where you test a drug against a placebo is a classic textbook case where you must use a two-tailed t-test. The reason is quite simple. In refuting the null-hypothesis, there is not only the possibility that the drug may not be better than the placebo, but also the possibility that the placebo may be better than the drug.

And finally, in a good report, even if it is very brief, a methodology section should clearly explain what was done. Their methodology sections make no sense whatever. These people obviously have no idea what a good report should be. They will ramble on, paragraph after paragraph-words ... numbers ... words ... numbers ... blah, blah, blah. In contrast, a professional, in one simple little table, would make absolutely clear everything that these people, who are equally inept with words and numbers, are trying in vain to explain.

A recent study, which was more of a media scam than a study, involved Acyclovir. Especially in England, front page stories trumpeted the message that AZT plus Acyclovir doubled the survival of people with AIDS. Underneath the media hype it turned out that the study was simply a test of the efficacy of Acyclovir against cytomegalo virus. When it became clear that Acyclovir was completely ineffective, the study was terminated. But then a cunning person looked at the data and came up with the mad notion that somehow the combination of AZT and Acyclovir was efficacious. Wellcome ran to the media with the story, and suddenly people thought there was a new miracle combination. Even Magic Johnson thought that this was the thing that would help him survive-notwithstanding the fact that he is suffering from nothing more than the presence of HIV antibodies, and ought to remain in excellent health if he can stay away from harmful drugs like AZT.

A recent study which people are talking about is called 'The effects of early intervention in immunodeficiency virus infection', published in The New England Journal of Medicine, 16 April 1992. Again the claim is made that AZT makes people live longer. Now on the level of common sense, one might ask: if AZT makes people live longer, why are they all dying? But when people are in the midst of a delusional system, like now, they don't observe what is happening around them. This study itself is meaningless. The tables are meaningless. As a whole it is meaningless. If someone asked me to analyze this study, I would have to say: 'There is nothing here. No data. The methodology section says nothing. This is not a study. There is nothing I can say about it. Go away! Don't waste my time with such nonsense!' But this is not what the media did. Media people looked at the abstract at the beginning, they glanced at the generalizations at the end, and then they wrote stories saying that AZT makes HIV-infected people live longer.

Now let's talk about fraud. Let's talk about lies. I should have made a list of all the lies that have been told about AZT. But only last night I discovered still a new one in the package insert. The manufacturer claimed that in the Phase II trials, patients were treated anywhere from 12 weeks up to 26 weeks. This is absolutely not true. The study was designed so each patient was supposed to be treated for 24 weeks, but it was prematurely terminated for specious reasons. It is quite clear, from FDA documents released under the Freedom of Information Act, that 23 patients in the study were treated for less than four weeks. Therefore, the statement that all patients were treated from 12 to 26 weeks is an out-and-out lie. And there are many such lies.

I have stated in print since 1987 that the Phase II AZT trials were fraudulent. And this is still the most important study of AZT, because it was the basis of the drug's approval. People will say, 'Why you do always harp on this one study when there are 3999 other studies?' And I would have to say, 'This is the main one, this is where the drug was approved'. Now fraud in drug testing is an old, old story. It was a major achievement in the US to achieve regulation of patent medicines. In the 19th century there was a situation of total anarchy. Anything could be sold, including deadly poisons, and many people died from the patent medicines of that time. But as soon as there were any government regulatory agencies, immediately they were taken over by the industries they were intended to regulate. This is true of the Environmental Protection Agency and the manufacturers of pesticides; it is true of the Food and Drug Administration and the pharmaceutical companies. Some classic exposes have been done on this topic, one by Morton Mintz in 1960, called 'The Therapeutic Nightmare', one by a Ralph Nader group and Jim Turner in 1970, called 'The Chemical Feast'. Both books document many cases where extremely dangerous drugs were approved on the basis of fraudulent research and illegal collusion between members of the FDA and the drug companies.

I won't go into all of the things I found wrong with the Phase II study-they are described in my book-except to say that I call it fraudulent because the investigators deliberately used data that they knew were false. This is it. No honest and reputable researcher would ever knowingly use bad data. From the FDA documents released under the Freedom of Information Act I also learned that the rules of the game, the so-called protocols, were violated right and left. It doesn't matter if you are playing football or gin rummy, or if you are conducting a drug trial: If there are rules, you follow them. If you don't follow the rules, you are cheating.

In the Phase II study, one of the twelve centers, Boston, was particularly bad. The chief investigator there was Robert Schooley. I have been fighting now for five months to get the report of the 'for cause' investigation of the Boston Center. A couple of months ago I got a very heavily censored version, and I am now fighting to get the uncensored version of it along with other materials. My relationships with the Freedom of Information people are not as friendly as they were. Only two days ago an FDA man said to me, 'Look here; this is not a candy store; you cannot just come in here and ask for anything you want.' I was furious. I have lost a very large amount of money, by working outside my field for the past six years. And there are perhaps 150.000 people currently being poisoned by nucleoside analogues. Surely my asking for these documents is something more than a child going into a store and demanding a lollypop. This report is absolute dynamite. I have a copy of it here, if people wish to look at it later.

Good researchers attach great importance to the integrity of the data. For example, if you have a questionnaire, it is filled out by the interviewer. At the end of the questionnaire, the interviewer will sign a statement saying that she conducted the interview according to the rules. This has the standing of a legal document, like a contract or a cheque. Nothing is ever, ever to be changed on the questionnaire that the interviewer has done. The same ought to be true with regard to the recording forms that are used in clinical trials. In market research, the interviewer almost always uses black. Some places prefer ballpoint pen, others a pencil, but it is black. It is always clear exactly what the interviewer wrote. Then other things need to be done. The questionnaire will be edited for consistency, for logic. The editor will use a blue pencil. Later certain questions need to be coded. The coders will use red. People will review each of these steps. There will always be a record of who did what. This is something that everybody in market research knows, but apparently clinical researchers do not. In the case of the Boston Center, records were changed again and again, months after they were recorded. Things were erased, but there were no indications of who made the changes. Even worse, these changes were tendentious: they favored AZT. Anybody with research experience immediately recognizes the likelihood of cheating. Someone without research experience might say, 'Why be so fussy; people change a few things, you know, it is just a matter of being sloppy.' It is not just sloppiness. It is cheating.

It appears that in drug testing, the foxes are guarding the chicken coup. The drug manufacturers are totally in charge, and nobody checks up on them. A man who was called the 'monitor' of the study was an employee of Wellcome, and he was responsible for many of the acts of fraud that were committed.

Among other things, investigators in Boston lied about the length of time patients were in the study. Somebody might be in the study for a few weeks, drop out for several more weeks, come back for a week, drop out, and so on. The case report forms, which recorded the official data for the study, indicated that these people never left the study and that they had been in much longer than they were. Somebody in the study for 14 weeks might be reported as having been in the study for 19 weeks. This is lying. One reason for the lying is that the investigators were paid according to how long people were in the study. Therefore, since payment was prorated on length of time in study, this was simply a form of theft. By way of analogy, if someone worked five hours for a company, and altered his time sheets to say he had worked for ten hours rather than five, and was then paid for ten hours, everyone would say that he was engaging in a form of theft. This also was theft. In addition, the length of time in the study was used to calculate survival rates. So, this was also a way of lying about the efficiency of the drug AZT.

Another form of fraud which took place was the concealment of adverse reactions to the drug. On the medical records, on the hospital records, on the patients' diaries, terrible forms of toxicity would be recorded, but this information was not recorded on the case report forms, where it belonged. Therefore, even though the final results did in fact indicate very terrible toxicities for AZT, they were nevertheless much lower than they should have been. It becomes absolutely clear from these documents that the doctors all knew who was getting what. The 'double-blind' study was completely unblinded in practice. The investigators made no attempt even to pretend it was blinded. And then, there were the violations of protocols, which I mentioned; the rules of the study were violated again and again. The most outrageous violation involved patient 1009. The description of this patient before he entered the study indicated that he was in very, very bad shape. He had had several transfusions before being accepted into the study. He was taken into the study, and assigned to a placebo group. However, an entry on his medical record for the first week he was in the study states: 'At this point the patient was still taking azidothymidine', which is another name for AZT. This means that the patient should never have been allowed in the study in the first place. Since he was already taking AZT, it was illegal for him to be entered in the study. Secondly, his being assigned to a placebo group, when in fact he was taking AZT, is blatantly wrong. Patient 1009 was in the study only for one month, and then he dropped out for two months, at which point he died. He was counted as a death in a placebo group. There is nothing more I can say. If this is not fraud, nothing in the world has ever been fraud. So much for AZT.

Another nucleoside analogue, DDI, was recently approved on the basis of evidence that was virtually non-existent. DDI's approval was based partly on fraudulent AZT data and partly on bogus 'surrogate markers'-such things as T-cells going up briefly, which is meaningless. The DDI approval was based partly on a 'peak' at on-going research being conducted by-guess who? Robert Schooley, the principal investigator of the fraud-ridden Boston center. That is how DDI was approved.

At this point the situation is very grave. There are 150.000 people, more or less, who are on nucleoside analogues, and we may expect that they will all die. There is no way they could survive under the assault their bodies are going through with these drugs. What is to be done? I'm not really sure. I'm not very clever politically. I only know that we must stop the genocide. We must stop our friends from being poisoned. And I would say that, ethically and legally, there is nothing one could not do to prevent a friend from being poisoned with AZT. Nothing whatever. A venerable principle of common law holds that one has the right and the duty to do whatever is necessary to prevent injury to another person.

Finally, I do not adhere to the decadent notion that turning the other cheek is a virtue. I believe in the old philosophy that justice is good and malefactors should be punished. I hope that at some time in the future we can see the AIDS criminals bought to justice.*


VIRUSMYTH HOMEPAGE