By John Lauritsen
Alternative AIDS Symposium, Amsterdam, May 1992
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'.
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.
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.
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.
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
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
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.
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.*