By John Lauritsen
New York Native
19 October 1987
I argued in
a previous article (Native #215) that the theory behind AZT
(now known by its trade name of Retrovir) was false, inasmuch as
the hypothesis that HIV causes AIDS has been refuted by Prof. Peter
H. Duesberg, a world-renowned molecular biologist at Berkeley; that
AZT's alleged benefits were not backed up by reliable evidence;
that its toxicities were firmly established and severe; and that
therefore the drug should not be prescribed, recommended, or used.
In his interview
with me (Native #220), Prof. Duesberg referred to AZT as
"a poison" and as "cytotoxic" (lethal to body
cells). Duesberg said that the theories behind AZT were false, that
there was "no rationale for treating with AZT", that prescribing
AZT was "highly irresponsible", and that AZT was "guaranteed"
to be harmful:
AZT hits all
DNA that is made. It is hell for the bone marrow, which is where
the T and B cells and all those things are made. It's hell for that.
It has a slight preference for viral DNA polymerase compared to
cellular DNA polymerase, and that's based on in vitro studies
only, but that's certainly not absolute. It kills normal cells quite,
At the time
these articles were published, the only reports on the Food and
Drug Administration (FDA) trial that was the basis for granting
government approval to market AZT, were in the popular media or
a promotional film produced by AZT's manufacturer, Burroughs-Wellcome.
Doctors who prescribed AZT did so on the basis on very limited information,
along with the assurances of the Public Health Service that AZT
represented the "best hope".
to have changed. The 23 July 1987 issue of the New England Journal
of Medicine (NEJM) contains a two-part report on the
FDA's "Double-Blind, Placebo-Controlled Trial"-"The
Efficacy of Azidothymidine (AZT) in the Treatment of Patients with
AIDS and AIDS -Related Complex" and "The Toxicity of Azidothymidine
(AZT) in the Treatment of Patients with AIDS and AIDS-Related Complex".
Margaret A. Fischl, M.D. is identified as the primary author of
the first article, and Douglas D. Richman, M.D., of the second.
became clear to me that there were serious problems with the reports.
The description of methodology was incomplete and incoherent. Not
a single table was acceptable according to statistical standards-indeed,
not a single table made sense. In particular, the first report,
on "efficacy", was marred by contradictions, ill-logic,
and special pleading.
In the meantime,
I received about 500 pages of material which Project Inform in San
Francisco had obtained from the FDA under the Freedom of Information
Act. This material showed the dark underside of the double-blind,
placebo-controlled trial-falsification of data, sloppiness, confusion,
lack of control, departure from accepted procedures-things not even
hinted at in the NEJM reports. Martin Delaney of Project
Inform gives a fair summary of what emerges from the FDA material:
clinical trials of AZT are perhaps the sloppiest and most poorly
controlled trials ever to serve as the basis for an FDA drug licensing
approval. Conclusions of efficacy were based on an endpoint (mortality)
not initially planned or formally followed in the study after the
drug failed to demonstrate efficacy on all the originally intended
endpoints. Because mortality was not an intended endpoint, causes
of death were never verified. Despite this, and a frightening record
of toxicity, the FDA approved AZT in record time, granting a treatment
IND in less than five days and full pharmaceutical licensing in
less than 6 months.
through the FDA material several times, I called Drs. Fischl and
Richman, and spoke with each of them for about half an hour. The
conversations were not very enjoyable for any of us. Neither one
of them could explain the tables in the reports that they themselves
had supposedly written. They both repeatedly said that I should
call Burroughs-Wellcome to find out how the tables were developed
or to obtain answers on other questions. Dr. Richman became quite
truculent at one point, saying that I was "fixated" on
the tables; that I should "forget about the tables"; that
the report would be "just as good without them". Their
ignorance regarding these tables is really amazing. As a market
research analyst, I am accustomed to working with tables, and I
can say that I have never written a report containing even a single
table I could not explain and interpret.
reports of the horrible physical consequences of taking AZT, several
of the New York City physicians most prominent in treating AIDS
and ARC patients are not only prescribing AZT, but actively proselytizing
for it. I think that history will judge these doctors harshly. This
article will argue that no credence should be placed in the NEJM
reports, that the "benefits" attributed to AZT remain
an update on the central question: What causes AIDS?
HIV is not
is officially defined as a drug for "symptomatic HIV infection".
Its label states it is for the "management of certain patients
with serious manifestations in infections caused by the human immunodeficiency
virus (HIV)." Therefore it is crucial to know whether or not
HIV really is the cause of AIDS, or whether HIV infection is even
harmful. According to Duesberg, HIV is a benign passenger virus,
and HIV "infection" is nonpathogenic. If so, prescribing
a poisonous drug to attack a harmless virus would be utter madness.
in the sciences have told me that we should now consider it highly
probable that HIV is not and could not possibly be the cause of
AIDS. I agree. Not only are the arguments compelling that are put
forward by Drs. Peter H. Duesberg, Joseph A. Sonnabend, Nathaniel
S. Lehrman, and others-but no attempt to rebut these arguments has
been made by any of the leading HIV champions, including Drs. Robert
Gallo, William Haseltine, Myron Essex, or their faithful colleagues
in the Public Health Service.
The HIV edifice
appears to have collapsed, and the "AIDS virus" crowd
have resorted to stonewalling. A British television team recently
attempted to interview Gallo. They were informed by National Cancer
Institute (NCI) officials that it would first be necessary to submit
in writing a list of all questions he would be asked, and that under
no circumstance would the world's premier "AIDS researcher"
discuss etiology, or whether or not HIV was the cause of AIDS.
and censorship versus science
is supposed to be a public activity, where scientists verify each
other's work in a mutual endeavor to establish the truth. Scientists
are expected to describe their experiments precisely, and to make
their data available, so that other scientists working independently
could replicate their experiments and verify their findings. Likewise,
scientists are expected to enter into scientific dialogue, to respond
to the criticisms and arguments of other scientists. It is therefore
disgraceful that the NCI scientists refuse to respond to Prof. Duesberg's
is also incompatible with the ideals of science.
agencies, like the FDA, ought to be willing to make their materials
public, so that their work can be verified independently. Although
the FDA did release material under the Freedom of Information Act,
it was heavily censored. As many as a dozen pages at a time were
missing. Individual pages had words, lines, or paragraphs whited
out. And most of the pages were entirely or almost entirely illegible-they
looked as though the copy machines had been badly out of focus.
There is no excuse for this. We live in the age of the copy machine,
and the FDA could have produced legible copies. The lives of thousands
of people are affected by the AZT trials, and it is wrong to treat
information about these trials as though it were classified military
placebo-controlled" trial of AZT was conducted by the FDA at
twelve medical centers throughout the United States. Although the
patients did not enter the study all at one time, each patient was
intended to undergo a full 24 weeks of "treatment"-either
with AZT or with a placebo.
the study it was observed that only one patient on AZT had died,
whereas more than a dozen on placebo had. According to the received
version, it was then decided it would be unethical to continue
the study, since AZT was so spectacularly (if unexpectedly) prolonging
the lives of those who took it. The study was terminated; all patients
were told whether they had been taking AZT or a placebo, and all
were given the opportunity to take AZT. As I'll argue later, there
are good reasons for being skeptical of the mortality data, as well
as the motives for prematurely terminating the study.
Owing to the
early termination, only 15 patients (5% of the total) completed
the full 24 weeks of treatment. Twenty-three patients were treated
for less than four weeks. On the average, patients had received
treatment for about 17 weeks at the time the study was aborted.
(See Table 1.)
As might be
imagined, the premature termination invalidated the original study
design and caused chaos from an analytical standpoint. Tables which
would have been entirely straightforward if all patients had finished
their 24 weeks of treatment had to rely upon controversial statistical
projections. For example, instead of showing the percentages
of patients in each group who experienced opportunistic infections
during the 24 weeks, it became necessary to develop a projected
probability of their experiencing opportunistic infections within
24 weeks. This is analogous to estimating the probability of developing
arthritis by the age of 70, using a sample in which only a few people
had reached this age, and in which some were still teenagers. The
method used (Kaplan-Meier Product-Limit Method) is a statistical
attempt to estimate what results would have been if the study
had not been terminated. Like mopping up milk, it may be
the best thing to do-but it would be better not to spill the milk.
restraint, an FDA mathematical statistician registered his misgivings
over the early termination:
There are a
number of disquieting aspects concerning this NDA. It contains only
one controlled clinical trial, and thus there is no independent
confirmatory evidence for that study's results. It contains a relatively
small number of patients (<200) who have been treated with AZT.
The controlled clinical study is relatively short (i.e., 24 weeks)
and WAS TERMINATED EARLY ON THE BASIS OF UNANTICIPATED FAVORABLE
RESULTS IN A MANNER THAT HAS NEVER BEEN ADEQUATELY DEFINED IN TERMS
OF ITS IMPACT ON THE SUBSEQUENT STATISTICAL ANALYSES. [Emphasis
The study was
planned as a "double-blind" trial, which means that the
drug was supposed to be labelled and the study conducted in such
a way that neither doctors nor patients knew whether AZT or a placebo
was being administered.
the AZT trial became unblinded rather quickly.
An FDA medical
officer writes: "the fact that the treatment groups unblinded
themselves early could have resulted in bias in the workup of patients".
The study became
unblinded among the patients as a result of differences in taste
between AZT and the placebo:
placebo capsules, which were indistinguishable from the AZT capsules
in appearance, were distinguishable in taste. This difference was
corrected and the placebo capsules replaced with new ones after
early reports were received of patients breaking the capsules and
tasting the medication.
has spent time with PWAs is aware of the keen interest with which
they compare treatments. And anyone who has observed the gay grapevine
is in awe of the speed with which information can travel around
the world. I can well believe that from the time the first two patients
compared notes on how their capsules tasted, it was only a matter
of days until many or most of the patients knew whether they were
getting AZT or a placebo.
discovered what medication they were receiving by taking their capsules
to chemists for analysis.
In some instances
patients pooled and shared their medication, thus ensuring that
all of them could receive at least some AZT. Other patients, who
found out their medication was only a placebo, took Ribavirin that
had been smuggled in from Mexico.
From the standpoint
of the doctors, the study unblinded itself through the strikingly
different blood profiles of the two treatment groups. (See "Toxicity"
below.) No attempt was made to blind the blood results from any
of the doctors in the medical centers at which the trials were held.
According to an FDA analyst:
groups may have unblinded themselves to a large extent during the
first two months due to drug-induced erythrocyte macrocytosis.
There are very
good reasons why blind studies are required for the approval
of a new drug. The potential biases are so great, for both patient
and doctor, that a drug-identified trial would be scientifically
entered the trial out of desperation, believing that death was immanent
without the intervention of a new "wonder drug". For these
patients, the psychological consequences of finding out that they
were receiving only a placebo must have been devastating. A sense
of despair and hopelessness may well have contributed to the high
mortality in the placebo group.
scientists in general, are often extremely gullible people. In their
book, Betrayers of the Truth: Fraud and Deceit in the Halls of
Science, William Broad and Nicholas Wade devote an entire chapter
to "Self-Deception and Gullibility". Scientists unconsciously
see what they want to see. Even the most absurdly crude hoaxes,
like the Piltdown man, were believed for many years by eminent scientists.
With high expectations engendered for AZT, it is not unreasonable
to assume that unconscious biases affected not only how data were
interpreted and recorded, but also how patients were treated. The
shockingly high death rate among the placebo patients suggests that
these patients may not have been managed well by their attending
When I spoke
to Drs. Fischl and Richman, they both vehemently denied that the
trial had become unblinded before it was terminated. This suggests
that they had little control over, or knowledge of, what was happening-or,
that they were not telling the truth. As FDA analyst Cooper stated,
it was fact that the study became unblinded early on. And
since the AZT trial was not blinded, the entire study was invalid
and worthless. On this basis alone, FDA approval of the drug was
neither proper nor legal.
improprieties, false data
The AZT trial
was characterized throughout by sloppiness and lack of control.
Recording forms were poorly designed, leading to confusion when
doctors were asked to make judgments. For example, doctors were
asked to record 10 subjective symptoms "often associated with
HIV infection", and to decide whether they were symptoms of
AIDS or adverse reactions to the drug treatment. Understandably
it was hard to differentiate among "malaise, fatigue, and lethargy",
let alone to decide whether these were caused by drug or by disease.
Midway through the trial the "sponsor" (Burroughs-Wellcome)
substituted a 33-item "AIDS-related signs and symptoms"
sheet, at which point confusion became utter chaos. Most of the
medical centers were unable to relate one form to the other, or
even to comprehend the 33-item form, and so in the end the incomplete
data on the 10-item form served as the patients' only baseline data.
When FDA analysts
reviewed the Case Report Forms, numerous improprieties were observed:
previously checked off on the 10-item sheet were crossed out or
otherwise changed, usually without the principal investigator's
initials, and sometimes with a date of change much later than the
date the form was originally filled out, without explanation as
to why changes were made.
of data from 10-item symptom form to the 33-item form was performed,
sometimes without date of initials of who did the transcribing.
Sometimes the original form was not submitted.
* Adverse experiences
were sometimes crossed out months after initially recorded, even
though "possibly related to test agent" had been checked
off originally by the investigator or his designee.
The last set
of improprieties is especially serious, as it appears to be tendentious,
favoring AZT by reducing the cases of adverse reactions to the drug.
If done deliberately this would constitute cheating and fraud, things
that people controlling and directing studies must constantly be
vigilant against. If there can be cheating in little things, there
can be cheating in big things as well.
these various improprieties, the FDA analyst insouciantly dismissed
the whole mess with a sentence that caught me completely off guard:
"real" data may be, clearly patients in this study, both
on AZT and placebo, reported many disease symptom/possible adverse
the 'real' data may be..."! I can't get over this phrase.
Is this an expression of bureaucratic cynicism, a sardonic form
of humor, simply indifference, or what? Do FDA analysts even care
whether their data is "real" or not?
were uncovered at one of the 12 medical centers. According to an
The FDA inspector
found multiple deviations from standard protocol procedure, and
SHE RECOMMENDED THAT DATA FROM THIS CENTER BE EXCLUDED FROM THE
ANALYSIS OF THE MULTICENTER TRIAL. [Emphasis added.]
The FDA inspector's
report did not reach an appropriate department until late December
1986, three months after the trial had been terminated. The decision
was then made...
inspection of all twelve centers which participated in this trial,
due to the importance of this drug, its high public visibility,
and because one of the early inspections had revealed "significant
deviations" from FDA regulations regarding the proper conduct
of clinical investigations.
At this point
inspecting all 12 centers was like locking the barn after the horse
was stolen. Of grave concern is the fact that one of the problems
noted in the delinquent center had to do with "drug accountability",
perhaps the most serious impropriety that could be imagined. If
there is even the slightest reason to doubt that all "AZT patients"
really were getting AZT, and all "placebo patients" really
were getting placebos, then the study has fallen apart at its very
there were numerous cases of "protocol violations". When
the study was designed, various conditions were defined as constituting
"protocol violations", as a result of which a patient's
data would be excluded from the data base. Most of the protocol
violations concerned the unauthorized use of other drugs in addition
to the treatments administered in the study. These restrictions
were necessary in order to avoid drug interactions, confounding
results, and so on. At an FDA in-house meeting convened to decide
what to do about the patients in whom protocol violations were noted,
one FDA officer commented that "if exclusion of all patients
with protocol violations were strictly applied, quite a few patients
would probably be deleted from the database."
After a certain
amount of agonizing over the "highly visible, potentially inflammatory
issue" of whether to exclude data from the delinquent center
or from patients with protocol violations, it was decided to exclude
nothing. False data were retained. Garbage was thrown in with the
good stuff. These appalling decisions were made with the following
mortality analyses were so strongly in favor on the drug, any slight
biases that may have been introduced when minor 'protocol' violations
occurred were highly unlikely to influence the outcome."
This is egregiously
beside the point. It is irrelevant whether or not throwing in bad
data with good data will "influence the outcome". The
point is that you don't do it on principle. It is an absolute and
iron-clad principle of research that you don't use bad data. No
principled analyst would ever proceed to interpret data that he
knew were contaminated.
One may note
that not a hint of these problems appears in the NEJM reports
by Drs. Fischl and Richman.
data that so dazzled the FDA that they terminated the AZT trial
prematurely and accepted bad data are shown in Table 2.
Only 1% of
the 145 AZT patients, compared to 14% of the 137 placebo patients
died during the course of the trial. Statistically, this is highly
significant-the probabilities are better than 99 out of 100 that
the difference (1% vs. 14%) is real, as opposed to being
a product of chance.
One must caution,
however, that these mortality data reflect a very short time period-only
17 weeks, on the average. It would be fallacious to assume that
the death rate would have continued to be higher in the placebo
group if the time period were 30 weeks, or a year, or two years.
there are good reasons to be skeptical of the mortality data. For
one thing, the death rate in the placebo group is shockingly high.
According to doctors in New York with extensive experience in treating
AIDS patients, with good patient management, nowhere near this many
patients ought to have died in such a short time.
the death rate in the AZT group is suspiciously low when compared
with other trials of AZT. After the "double-blind, placebo-controlled"
study was terminated, all patients were informed which treatment
they had been receiving, and were offered the option of receiving
AZT. (See Table 3)
A total of
227 patients accepted the offer, and continued or began to receive
AZT (127 who were originally treated with AZT and 100 who were originally
treated with placebo). AZT no longer prevented patients from dying.
In the 21 weeks of the "open-label" trial, 10% of the
patients died. Curiously, not only deaths but also opportunistic
infections increased in the original AZT group as soon as the first
study was terminated. There is no good explanation why this should
of AZT occurred prior to the "double-blind, placebo-controlled"
trial. (See Table 4) This was a "Phase I" trial, intended
to give a preliminary estimate of the drug's toxicities. In the
Phase I trial, 12% died during a time period of only 6 weeks. The
four patients who died were replaced, and all 33 patients continued
to take AZT in an "extended trial", during which an additional
21% died. It is unclear from the FDA material exactly how long the
extended trial lasted-but at any rate a cumulative total of one-third
(33%) of the patients died, either in the phase I or in the extended
provided data to the FDA on deaths which occurred among patients
who began taking AZT following release of the drug. The information
was in incredibly garbled form, but I was able to ascertain at least
the deaths that occurred during the first 8 weeks of treatment.
During this short time period 6% of the patients died. Table 5 shows
a comparison of these four studies of AIDS or advanced ARC patients
who were treated with AZT.
It can readily
be seen that the death rate in the "double-blind, placebo-controlled"
trial (the first column) is significantly lower than in any of the
other studies, especially considering that the trials in columns
three and four represented much shorter time periods. In other words,
the mortality data from the "double-blind, placebo-controlled"
trial are almost certainly wrong, based on comparisons with mortality
data from other AZT trials.
and I regret having to say this, skepticism is warranted by virtue
of the stakes involved-hundreds of millions of dollars-and the participants:
big business and the FDA. The materials released by the FDA show
that Burroughs-Wellcome was quite willing to bend rules or stretch
interpretations if doing so would facilitate approval for their
The FDA did
not come to the AZT trials with clean hands. In fact, the FDA has
a long history of collusion with industry. A number of examples
can be found in the book, How to Get Rid of the Poisons in Your
Body, by Gary Null and Steven Null.
where the FDA catered to the needs of big business can be found
in a crude propaganda piece, "Evaluation of Health Aspects
of Sugars Contained in Carbohydrate Sweeteners", recently circulated
by the sugar industry, and prepared by the Division of Nutrition
and Toxicology, Center for Food Safety and Applied Nutrition, Food
and Drug Administration. This report, which strives to exonerate
sugar from any connection with obesity, diabetes, hypertension,
tooth decay, etc., uses pseudo-scientific language and tables, but
is conspicuously short on references. It is not hard to imagine
that the authors of the sugar report were motivated by something
other than scientific ideals.
One more example
of the FDA's tainted past: For more than a decade, the FDA has been
asked to recognize the fact that poppers are drugs, and to regulate
them as such. The FDA has repeatedly refused to do so, claiming
that poppers are "room odorizers", since they are labelled
as such. This is preposterous, for the FDA has traditionally been
concerned with truth in labelling. They would certainly take action
if snake oil were labelled as an "AIDS remedy", or if
cocaine were labelled as a "nasal decongestant". Why should
they accept at face value the cynically ridiculous claim that poppers
are used as "room odorizers"?
I am also distrustful
of the mortality data because of the fact that problems with "drug
accountability" were among those found at the delinquent medical
center. Suppose that some of the placebo deaths were really AZT
patients who had been posthumously reassigned? There are a number
of ways that this could have been done. As a check it would be desirable
to have some way of verifying that the placebo patients who died
really had been placebo patients. Unfortunately, the causes of death
were listed in perfunctory and even incorrect ways ("AIDS",
"pneumonia [unspecified]", "suspected TB or CMV"
or "suspected MAI or CMV"). Since death was not an endpoint
of the study, many of the causes of death were not verified. No
autopsies were performed. These might have yielded useful information,
and would have verified whether or not there were traces of AZT
or other drugs in the bodies of the "placebo" patients.
requested copies of the medical records of the patients who died.
It would have been possible to determine from these, with considerable
accuracy, whether or not the patient had been treated with AZT.
The FDA refused to release the medical records, claiming that they
were "confidential". It is hard to see why the records
would have been "confidential" if the FDA had whited out
the names of the patients. And the FDA knows well enough how to
white out things. What exactly is the FDA afraid of?
descriptions of causes of death, the lack of verification of death
causes, the lack of autopsies, the refusal to release medical records-these
things are even more suspicious in light of the stringent procedures
that the FDA laid down for trials of other drugs. In a recent trial
of Ribavirin, autopsies were obligatory, and a Death Report form
of more than 30 items had to be filled out for each patient who
data are even more suspect in light of the fact that the "double-blind,
placebo-controlled" trial failed to demonstrate that AZT had
any benefits, relative to the placebo group. Slight increases in
the T-4 cell counts in the AZT group did not persist over time.
There is no known mechanism by which AZT could produce benefits
sufficient to account for the dramatic differences in mortality.
AZT was found
to have "no significant antiviral activity against a variety
of other human and animal viruses, including herpes simplex virus
type 1, cytomegalovirus, adenovirus type 5, measles virus, rhinovirus
13, bovine rotavirus, and yellow fever virus. It has been shown
to inhibit the replication of Epstein Barr virus (EBV)...though
the clinical significance of this finding is unknown."
(Retrovir) is officially defined as a drug for "symptomatic
HIV infection", it was no more effective against HIV than the
placebo was. Several measures of viral activity were used, and "no
statistically significant changes in the percent of positive cultures
or time to detection of virus in culture were observed." After
reviewing the failure of AZT to prove efficacious in any known way,
an FDA analyst concluded that AZT treatment is likely to be worse
than the disease in the long run:
concern is the possibility that the hematologic toxicity of the
drug when administered over a prolonged period of time may eventually
debilitate patients to such an extent that they may become less
able to resist opportunistic infections and other complications
of HIV-disease [sic] than if they had been left untreated.
adverse reactions to the drug, the FDA medical officer states, "The
majority of patients who were randomized to receive AZT in this
trial experienced significant toxicity." This is, if anything,
an understatement, especially considering that many AZT patients
were treated with the drug for only a few weeks. If all AZT patients
had been treated for 24 weeks, as originally planned, the percentages
experiencing various toxicities would undoubtedly have been even
suffered from many adverse reactions to the drug, the most severe
involving blood toxicities. These are summarized in Table 6. In
less than 18 weeks of treatment, on the average, almost one-third
(31%) of the AZT patients required at least one transfusion; one-fifth
(21%) of them required multiple transfusions.
was experienced by 45% of the AZT patients, but only 12% of the
placebo patients. Macrocytosis (enlarged red blood cells, associated
with pernicious anemia) occurred in 69% of the AZT patients, but
in none of the placebo patients. This measure, which clearly distinguished
AZT from placebo patients in over two-thirds of the cases, played
a major role in the unblinding of the study among the doctors.
to the "double-blind, placebo-controlled" trial, many
experiments were performed, which further demonstrated the high
toxicity of the drug. The results of the Cell Transformation Assay
AZT may be
a potential carcinogen. It appears to be at least as active as the
positive control material, methylcholanthrene.
The FDA analyst
who reviewed the pharmacology data, Harvey I. Chernov, succinctly
summarized the effect of AZT on the blood:
the dose varied, anemia was noted in all species (including man)
in which the drug has been tested.
his review of the pharmacology data by recommending that AZT should
not be approved:
the full preclinical toxicological profile if far from complete
with 6-month data available, but not yet submitted, one-year studies
to begin shortly, etc. The available data are insufficient to support
There is no
doubt that AZT is a highly toxic drug, that it will be harmful to
patients, many of whom are already severely debilitated. On the
other hand, there is no scientifically credible evidence that AZT
has any benefits whatsoever. The "double-blind, placebo-controlled"
trial of AZT is unworthy of credence. Assurances from representatives
of the pharmaceutical industry or the Public Health Service, that
AZT represents the "best hope", are also unworthy of credence.
I submit that
it is malpractice for physicians to prescribe AZT, a poison which
can only harm the patient.
I submit that
it was unethical for AZT to be approved on the basis of research
which was, to put it as generously as possible, invalid.
blood supply belongs to all of us. If AZT continues to be administered
to thousands of patients-apparently there are almost 10,000 patients
on AZT, at last count -- this will mean an intolerable drain on
the blood supply, with many AZT patients requiring transfusions
as often as every other week. It is one thing when someone becomes
seriously ill or has an accident or major operation. Such a person
is entitled to receive blood. But AZT is now creating entirely another
category of patient-those whose bone marrow becomes irreversibly
damaged. A category of iatrogenic vampires. And this is gratuitous,
the result of a drug that should never have been administered in
the first place. In this sense AZT harms all of us, not just the
patients who are being poisoned by it. *
9 March 1988
After I wrote
the above article, I learned of a California lawsuit that charged
collusion between federal agencies and Burroughs-Wellcome, the manufacturer
of AZT. If such collusion did indeed take place as early as February
of 1985 (a year before the AZT trials began), then of course it
is likely that there was collusion in the trials as well.
the lawsuit are found in an article in the Bay Area Reporter (5
November 1987) by Ray O'Loughlin, under the headlines, "Lawsuit
Charges Collusion Between Feds, AZT Maker:
$55,000 for Research; Special Status Granted for Marketing Drug".
Following are some excerpts:
The two federal
agencies which approve and regulate AIDS treatments are accused
of colluding with drug manufacturers. The National Institutes of
Health (NIH) and the Food and Drug Administration (FDA) are accused
of expediting the approval of AZT in exchange for a $55,000 donation
by the AZT manufacturer, Burroughs Wellcome. In July 1985, Burroughs
received exclusive rights to market AZT for seven years.
is part of a class action lawsuit filed in June by San Francisco-based
Gay Rights Advocates. The suit accuses the NIH of failing to spend
$47 million appropriated by Congress for experimental drug treatments.
In response to the government's motion to dismiss the suit, NGRA
released a series of letters indicating that certain medications
are put on a "fast track for approval." They charge that
there are unethical conflicts of interest in the agencies' operations.
judge allows this case to go forward, we will prove that government
officials have been engaged in unethical and illegal conduct resulting
in serious delays of promising new AIDS medications," said
NGRA's legal director, Leonard Graff.
documents filed in U.S. District Court in Washington, D.C., Dr.
Samuel Broder of the National Cancer Institute, part of NIH, encouraged
Burroughs Wellcome to fund three research positions in his laboratory.
that Burroughs applied to the FDA for "orphan drug" status
for AZT. Two weeks later Broder's office received the check for
$55,000 from Burroughs. That same day FDA granted the company exclusive
rights to market AZT. Originally developed as a cancer treatment,
AZT has been in existence for over 20 years.
alleging a special cooperative relationship between sister agencies
that put certain drugs on a fast track for approval," said
Graff.... Broder's action, he said, "violates conflict of interest
as set out in an executive order" issued by Pres. Lyndon B.
Johnson in 1965. At the very least, it "indicates a cozy relationship,"
he said, between the agencies and the drug firm.
of whether or not there was collusion, the AZT trials were invalid,
worthless, and fraudulent. "Fraudulent" is by no means
too strong a word to use in describing a study in which false data
were knowingly retained, and in which improprieties and violations
of protocol were knowingly ignored. It is fraudulent to describe
an unblinded study, which the AZT trials most certainly were, as
being a "double-blind" study, as Margaret Fischl and Douglas
Richman did in their NEJM reports. Either Fischl and Richman were
unaware that the study had become hopelessly unblinded, in which
case they are guilty of incompetence, or they did know and covered
it up, in which case they are guilty of fraud.
On 27 January
1988, Perri Peltz of NBC news did an expose on AZT, which closely
followed some of the points of my article (without giving me credit).
NBC investigators independently found that:
- The test
became unblinded early on. Everyone knew who was getting what.
- A chemist
admitted analyzing medications for patients in the trials.
in the trials shared medications.
- There was
mass tampering with the rules of the test-Patients took other medications.
Such violations of the rules of the test took place from coast to
- A government
memo recommended that Boston be dropped from the study because of
gross improprieties. Nevertheless, the bad data from this center
were retained. The memo observed that if all patients with protocol
violations were dropped, there wouldn't be enough left in the study.
of the NIH and the FDA resorted to stonewalling. According to Perri
preparing this report we repeatedly tried to interview Dr. Anthony
Fauci at the National Institutes of Health. Both Dr. Fauci and Food
and Drug Administration Commissioner Frank Young declined our request
PATIENTS FINISHED THE FULL 24-WEEK PROTOCOL
- PATIENTS / AZT / PLACEBO
Who Began Trial - (282) / (145) / (137)
(24 Weeks) - 5% / 6% / 4%
Did Not Finish
Trial - 95% / 94% / 96%
Participating" (But Finished Less Than 24 Weeks Of Treatment)
- 73% / 79% / 67%
Of Study - 22% / 15% / 29%
Weeks Of Treatment
(Mean) - (17.3) / (17.6) / (16.9)
TABLES IN THIS ARTICLE ARE MY OWN; THEY ARE NOT TAKEN FROM THE NEJM
AZT / PLACEBO
Who Began Trial - (145) / (137)
Deaths During Trial - 1% / 14%#
Weeks Of Treatment
(Mean) - (17.6) / (16.9)
higher than AZT at the 99% confidence level.
TRIAL FOLLOWING TERMINATION OF DOUBLE-BLIND, PLACEBO-CONTROLLED
TRIAL (18 September 1986 - 13 February 1987)
IN EXTENDED, OPEN-LABEL TRIAL ORIGINALLY TREATED WITH...
TOTAL / AZT
Participating - (227) / (127) / (100)
Deaths During Open-Label Trial (21 Weeks Of Treatment) - 10% / 8%
TRIAL OF AZT (No Placebo Control)
Receiving AZT - (33)
6-Week Trial - 12%
Extended Trial - 21%
Deaths - 33%
Of AIDS/ARC Patients Treated With AZT)
Placebo Controlled Trial / Extended Open-Label Trial / Phase-I trial
/ Following Release of Drug
(Mean: 17 Weeks)
/ (21 Weeks) / (6 Weeks) / (8 Weeks)
In Each Trial
(145) / (227) / (33) / (2552)
Trial 1% 10%# 12%## 6%*
higher than the Double-Blind, Placebo-Controlled Study at the 99%
Confidence Level or more.
higher than the Double-Blind, Placebo-Controlled Study at the 95%
(Double-Blind, Placebo-Controlled Study)
AZT / PLACEBO
Who Began Study (145) / (137)
<7.5) - 25%# / 4%
<3.5) - 13%# / 2%
decreases >2g. - 38%# / 2%
Had at least
one transfusion - 31%# / 10%
transfusions - 21%# / 4%
Grade 3 marrow
neutrophile <750, or white cells <1500) - 45%# / 12%
(ASSOCIATED WITH PERNICIOUS ANEMIA)
volume <100 cubic angstroms - 69%# / -
volume <110 cubic angstroms - 41%# / -
(white blood count <1500) - 27%# - 7%
(neutrophile counts <750) - 16%# / 2%
Weeks Of Treatment
(Mean) - (17.6) / (16.9)
higher than Placebo at the 99% Confidence Level or more.
1. Peter H.
Duesberg, Ph.D.; "Retroviruses as Carcinogens and Pathogens:
Expectations and Reality"; Cancer Research, 1 March 1987.
"Saying No to HIV: An Interview With Prof. Peter Duesberg,
Who Says, 'I Would Not Worry About Being Antibody Positive'";
New York Native; Issue #220.
op. cit.; Lauritsen & Duesberg, op. cit.
3. J.A. Sonnabend,
MRCP and Serge Saadoun, M.D., M.S.; "The Acquired Immunodeficiency
Syndrome: A Discussion of Etiologic Hypotheses"; AIDS Research;
volume 1, number 1, 1984.
Joseph A. Sonnabend,
MD; "Looking at AIDS in Totality"; New York Native, Issue
S. Lehrman, M.D.; "Is AIDS Non-Infectious? The Possibility
and its CBW Implications"; Covert Action, Number 28.
Lehrman, M.D.; "A 'Natural' Epidemic?"; New York Native,
Issue # ?.
Hauptman, Ph.D.; "Statistical Review and Evaluation";
Class 1A, Burroughs-Wellcome Company, AZT Capsules; p. 17.
6. Ellen C.
Cooper, M.D., M.P.H.; "Medical Officer Review of NDA 19-655";
7. Ibid. p.6.
8. Ibid. p.
9. Ibid. pp.
10. Ibid. p.
11. Ellen C.
Cooper, M.D.; "Addendum #1 to Medical Officer Review of NDA
19,655"; p. 1.
12. Ibid. p.
13. Ibid. p.
14. Ibid. p.
15. John Lauritsen
and Hank Wilson, "DEATH RUSH: Poppers & AIDS", Pagan
"Medical Officer Review...", p. 128.
17. Ibid. p.
18. Ibid. p.
19. Ibid. p.
I. Chernov, Ph.D.; "Review & Evaluation of Pharmacology
& Toxicology Data", p. 4.
21. Ibid. p.
22. Ibid. p.