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
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
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
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
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.*