Simple one: - AZT

At the original dosage of 1250mg everyone died.

AZT IS DEATH
AIDS; Words from the Front

By Celia Farber

Spin Aug. 1993

AZT is death. Celia Farber picks up the pieces of a shattered medical
establishment at the Ninth International Conference on AIDS in Berlin.

I emerged from the organized madness known as the Ninth International
Conference on AIDS feeling strangely muted, a logjam of emotions caught in
my throat: Despondency and rage among them, but also something bordering
on joy, the joy of truth long held captive and finally released. The
famous Concorde study has driven a stake through the heart of the
seemingly endless AZT mythology that has enveloped and governed the AIDS
treatment debate for six years now. It's baffling to see how truth can be
suspended for long periods - endlessly subdued, rerouted, rejected. But
like an airplane in a holding pattern, eventually it has to land.

In the past I have described my feeling that AIDS research is driven by
ideological undercurrents - that it tends to mold all observations in such
a way as to confirm, rather than challenge, its central believe system. A
veteran attendee of these gigantic conferences, I have finally realized
that simply to report the bits and pieces of data one has absorbed misses
the point; it is not so much the data that changes from year to year, it's
the AIDS establishment's response to and interpretation of the data. What
reporters are really reporting on year is the zeitgeist of the
establishment - which data they reject, endorse, ignore or trumpet. That
is what shapes the forthcoming reality.

"Confusion," "reassessment," and "open-mindedness" were the buzzwords of
this year's conference and normally arrogant AIDS figureheads gathered in
roundtable discussions and spoke in hushed tones about the need to
reexamine their old convictions about treatment, pathogenesis, and
epidemiology. The reason for this remarkable soul-searching was that
1992-93 was a period that saw several cornerstones of AIDS ideology
crumble.

Among them:

*    That "early intervention" with AZT is in any way beneficial to people
with HIV antibodies but no symptoms.
*    That HIV causes the immune system to collapse by a direct cell-killing
mechanism. (Instead, "indirect" mechanisms and cofactors were explored.)
*    That CD4 cell counts are a good marker for immune status, health, or
drug efficacy. Instead, it was revealed that large segments of the
"healthy"-HIV-negative population have the same low CD4 counts typically
associated with AIDS.
*    That everybody with HIV will eventually succumb to AIDS and die. An
estimated 5 percent of the HIV-infected population are now expected never
to develop AIDS.

Last year, in Amsterdam, the great conference revelation was that an
"AIDS-like illness" had occurred in people who showed no sign of infection
with HIV. Health officials scrambled for plausible responses to the
startling "mystery," which, in fact, had been documented in the medical
literature since 1986. This year, in Berlin, the headline in the "news"
that AZT, the pinnacle drug of AIDS treatment and research since 1987, is
a failure.

To anybody who has followed the literature on AZT throughout, this is not
news at all, but merely "official" confirmation of what has been known for
years. If one had launched a full-scale truth-finding expedition - groping
through the fallen rubble of AZT propaganda to find the kernel of truth
underneath it all - the Anglo-French Concorde study would not have seemed
revelatory at all.

Concorde went on for three years, examining 1,749 HIV-positive but healthy
people at 38 health centers in the U.K., Ireland, and France. Because the
research lasted the longest of all AZT studies to fate, and its pedigree
was unassailable (it was conducted by the highly reputable British Medical
Research Council and its French equivalent), Concorde could not be
dismissed. The team concluded that AZT - a highly toxic and carcinogenic
drug - neither prolongs life nor staves off symptoms of AIDS in people who
are HIV-antibody positive but still healthy.

The blueprint for the Concorde "disappointment" has been in the literature
for many years. As we reported in November 1989, the first objective study
was completed in France in 1988 and was published with very little fanfare
in the Lancet, a British medical journal. The study found that AZT was too
toxic for most people to tolerate, had no lasting effect on HIV blood
levels, and left the patients with fewer CD4 cells than they had started
with.

If Concorde appeared surprising, it was because we in the U.S. have been
captivated by self-induced AZT mythology for so many years. It was our FDA
that approved AZT for use in 1987 based on very flimsy data and with a
little arm-twisting, and it was our National institutes of Health (NIH)
that expanded the parameters for AZT to be given to all healthy,
HIV-positive people. In 1989, the NIH cited a study, known as Protocol
019, that it said had "clearly shown" that early administration of AZT
would keep AIDS at bay in that population. Dr. Anthony Fauci, director of
the National Institutes of Allergy and Infectious Diseases (NIAID),
recommended that anyone with HIV antibodies and less than 500 CD4 cells
should start taking AZT at once. At that time, that meant 650,000 people
in the U.S.

I had heard that the Concorde team had been under tremendous pressure from
AZT's manufacturer. Burroughs Wellcome, to soften its results. After one
of the sessions in which the results were discussed, I walked up to Dr.
Ian Weller, a chief investigator of Concorde, and congratulated him. I
asked whether there had indeed been pressure from Wellcome. He nodded. A
woman standing next to him, also on the Concorde team, nodded emphatically
and finally burst out: "Yes, there has been pressure, and it has been
placed at the very highest level."

Doesn't that, I asked, frustrate and infuriate you? She nodded, furiously,
and said, "The most frustrating thing is that I can't tell you about it."
Much of that raw Concorde data, particularly on toxicity, remains to be
revealed.

Weller cleared his throat.

"We've carried out this study against incredible adversity, but we are not
going to cave in to any pressure," he said. "We'll win the battle in the
end. We show the science, that's all that matters."

I asked him how he felt about the fact that doctors in the U.S. still
prescribe AZT to asymptomatics (people who have HIV antibodies but no
symptoms of AIDS). "I think Concorde is going to take time to sink in," he
said. "How you take on board the results very much depends on what you
believe in before you saw them." As an afterthought he added, "I think
it's very hard, if you've been giving AZT to large numbers of patients, to
swallow this result." *

AZT: AN AIDS-DEFINING DRUG

By Martin Walker

Continuum June/July 1997

AZT both reflected and reinforced the basic paradigm
within which almost all AIDS research was to take place.
-- Nussbaum (1990)

Introduction

In April 1984, Robert Gallo told America that he had found the ‘probable’
cause of AIDS in ‘a virus’ later called the Human Immunodeficiency Virus
(HIV). Since that time, those who have dissented from orthodoxy have been
trying to understand how within two years the general consensual
acceptance of Gallo’s hypothesis -- which came to be that an HIV was the
sole cause of a number of AIDS-defining illnesses -- was transformed into
a universal scientific tenet . Gallo’s idea, which has never been
scientifically proven, even survived the opinions of Luc Montagnier, one
of France’s most eminent virologists who is now credited with having
discovered HIV in 1983 and who in l991 stated that HIV alone was
insufficient to cause AIDS.

Because Gallo and his disciples are virologists, much of the debate about
consensus and hegemony in AIDS science has focused on scientists and
scientific institutions (Bernstein, Duesberg, Eleopulos, Hodgkinson,
Lauritsen, Schiff). Some gay writers have looked tentatively at the role
which gay men themselves and gay culture in general has played in
reinforcing the HIV=AIDS=DEATH construct. Few commentators however, have
focused on the crucial role which the production and marketing of AZT, the
first drug licensed as anti-retroviral, played in reinforcing Gallo’s
idea.

AZT specifically, and ongoing work by scientists on attempts at anti-viral
therapies generally, confirmed in both the public and scientific mind,
that a HIV was the sole cause of AIDS. AZT was marketed as the cure for a
viral condition and, lay thinking went, scientists would not have invented
an anti-viral cure if the illness was not caused by a virus. AZT may well
have been the first drug in history which defined the illness it was meant
to treat, rather than the other way around.

AZT has proved a remarkably persistent poison in the pantheon of orthodox
medicine. Between 1987 and 1992, crucial years in the development of
research into the causes of what many have accepted as AIDS, AZT was the
sole drug licensed for the treatment of a HIV in people who had AIDS
diagnoses. In 1992, ddl and ddC were trialled against AZT controls and
were later prescribed only in conjunction with it. In 1993, the delayed
publication of the Concorde trial results showed conclusively that
asymptomatic antibody-positive individuals who took AZT, died more quickly
and in greater number than those simply affected by AIDS-defining
illnesses. Following these results, the drug went out of fashion as a
mono-therapy. Wellcome, its scientists, and public relations staff
however, worked hard to rehabilitate the drug and in large part succeeded
in burying the implications of the Concorde Trial results.

Today, ten years after licensing, AZT is still used as a gold standard by
scientists and doctors who believe an HIV is the sole cause of the
AIDS-defining complex of illnesses. As the progenitor of other apparently
anti-viral drugs and circular proof that ‘HIV causes AIDS’, AZT has had
immense tantric, but no clinical value. This article looks back at the
part which AZT played in transforming Gallo’s theoretical assertion --
that an HIV was the sole cause of AIDS -- into an apparently indisputable
scientific and material reality.

The production and marketing of commodities creates certain realities and
‘truths’ which are often far more persistent than the scientific
assumptions upon which the commodities themselves are based.

In the process of producing and marketing AZT, the Wellcome Foundation set
in chain a powerfully persuasive machine which created information,
culture and social relations with one purpose, to sell the drug. This
network had a life force which would have continued to drive it forward,
even if it had occurred that the drug quickly killed everyone who took it.

Trading Places

The production and marketing of AZT can best be viewed within the context
of the global pharmaceutical industry in general and the Wellcome
Foundation in particular*. The world pharmaceutical industry is worth £130
billion. Over the last ten years the industry has been characterised by
high growth and high profits.

Throughout the eighties and nineties, the pharmaceutical industry has been
in a state of transition. Mergers, takeovers, the buying up of smaller
companies and the divestment of unprofitable productive sections, has left
a few large companies jostling for position.

Takeovers and mergers represent one response to a crisis of profitability
in the industry, a crisis which has been brought about by cut backs in
public health spending in Europe and America and spiralling research and
development budgets. This integration into larger global corporations has
occurred also because many pharmaceutical companies have been extending
their reach into different levels of health care, into hospital
management, corporate employee health schemes and cradle to grave health
care planning.

The development of a single medicine from initial conception to the market
place is said to entail an average investment of between £200 million and
£500 million. Other major costs include contribution to the administration
costs of licensing and the cost of mistakes, dropped development and
recalled drugs.

In the mid nineteen eighties, the Wellcome Foundation was outside the top
ten ranking world pharmaceutical companies. These rankings are, however,
based upon turnover and more generally, money spent on research and
development. In other respects the Wellcome Foundation was a hugely
powerful organisation.

Outwardly its success was due to a few market leading drugs. Zovirax the
anti-herpes virus drug, had been Wellcome’s top seller for a decade. The
company also held the patents on a number of antibiotics and anti-
bacterials, especially Septrin, and had, in the past produced whooping
cough vaccine. Wellcome’s major problem throughout the seventies and early
eighties, was that its ethos was too academic and its production tended to
be unfocused. The company produced animal health products as well as
organo-phosphate pesticide.

In the early eighties, Wellcome started to rationalise, cutting back on
staff, shedding some of its unfocused production and developing a more
professional, less academic approach to marketing. By the mid-eighties the
company had moved into all the contemporary buzz-word areas -- cell
biology research, life science and genetic engineering -- and it was eager
to find another ‘modern’ market-leading drug.

In his 1935 will, Sir Henry Wellcome left clear instructions that the
profits from the Wellcome Foundation were to be invested in the
non-profit-making philanthropic Wellcome Trust. By the mid 1980s this
Trust was one of Europe's biggest medical research funders.

The Trust was linked with the other major European Medical Research Trusts
and consequently, Wellcome-connected scientists staffed many of the
university departments and regulatory bodies across the world.

Because the Wellcome Foundation was founded by a Briton and an American,
William Burroughs, it joined that small coterie of very powerful
government and non-governmental organisations which could call themselves
Anglo-American. From the early part of the century a special relationship
has existed between Britain and America which has meant that various
organisations of the American state, together with the country’s largest
philanthropic trusts and foundations, its transnational corporations, and
its scientific and medical professional bodies, have all been interlocked
with their British counterparts.

The Rockefeller Foundation, America's largest Trust, which pioneered
scientific medicine at the turn of the century, often had British
representatives on its board, as did the Carnegie Foundation. The
Rockefeller Foundation and the Rockefeller Institute financed British
hospitals, British universities and British scientific and social
research. Rockefeller Institute work with the Wellcome Foundation and
later the Wellcome Trust had gone on since the early days of a British and
American presence in Africa, China and South East Asia. Following the
second ‘world war’, the Wellcome Trust which was almost bankrupt relied
upon American financial support to get back on its feet. By the end of the
1950s, Rockefeller interests and those of Wellcome covered many
overlapping areas.

The power and influence of the Rockefeller Foundation in the years between
the ‘world wars’ and up until the late 1960s was considerable. Not only
did the empire influence and manipulate many of America’s biggest
corporations but it also had influence within the CIA, the FBI and all the
most powerful institutions of the US government, from the State Department
to the NIH.

The Rockefeller empire set up numerous organisations in America, Europe
and Britain, to engineer the social and political direction of these
countries. They also set up international organisations which would work
towards balancing the world foreign policy and political economy; the
first of these, the American Round Table, published the Foreign Affairs
Journal and was related to the British Institute of International Affairs.
This transatlantic policy organisation was added to, in the fifties, with
the Bilderberg Group, and in 1974 the Trilateral Commission (Britain,
America and Japan).

The senior executives of multinational corporations that attended
Bilderberg and Trilateral Commission meetings, could rub shoulders with
officials from the State Department, British Ministers of Defence,
Japanese Government officials and heads of the most powerful financial
institutions in the world. Three out of the last four presidents of the
United States have been Rhodes Scholars and Trilateral members.

The reality of the influence held and exercised by the Trilateral
Commission, has been obscured by smoke screens thrown across their
activities by participants. Despite this, a number of generalisations can
be made; first the Trilateral Commission has discussed every important
world economic and political crisis, whether concerning oil or population
growth, usually years before they occurred. Secondly this group provided
the world’s most powerful people with a ready-made network of world
political strategy and industrial influence. The Trilateral Commission was
throughout the nineteen seventies and eighties the policy think tank of
the developed world.

Throughout the nineteen eighties, the Wellcome Foundation and the Wellcome
Trust both participated in the Trilateral Commission. At this time, the
Wellcome Foundation had forty main subsidiaries worldwide. Their largest
subsidiary and major profit earning company was the US-based Burroughs
Wellcome. Wellcome was sending medical support and aid to the dissenting
parties in the eastern bloc countries and breaching the Japanese market
with an expanding new plant.

AIDS HOPES DASHED BY TERRIBLE TRUTH ON AZT

By Tim Rayment & Neville Hodgkinson

The Sunday Times (London) 10 April 1994

It was the drug that held out hope to people carrying the world's most
feared virus. It had the power to move share prices by millions. What it
could not do was help people facing AIDS.

This weekend the truth about AZT is in the open: a comprehensive trial, so
big it equals all the other research put together, shows that the drug
which dominates AIDS treatment has no effect in delaying the onset of the
disease. After all the promise and the profits, AZT has nothing to offer
people with HIV.

The findings came in the final report on the Anglo-French Concorde trial,
published yesterday in The Lancet. Some 1,749 patients with HIV, but who
showed no symptoms, were given either the drug or a placebo. There was no
statistical difference in the progress of the two groups: after three
years 18% had AIDS or were dead.

The results leave a terrible void for the 12m people worldwide said to be
infected with the virus, and crush any remaining hopes that AZT might
delay the onset of symptoms. They also raise questions as to how those
hopes were fuelled in the first place.

Doubts about AZT were first revealed by The Sunday Times five years ago. A
painstaking investigation showed that AZT had been rushed to market on the
back of a flawed study that was supposed to demonstrate its
effectiveness.

The American Food and Drug Administration (FDA), responsible for
protecting the public from risk, had been aware of flaws in the trial, but
gave AZT approval. Documents obtained under the American Freedom of
Information Act showed that records compiled during the trial had been
altered, giving the drug a more favourable record; "multiple deviations"
from the terms of the study had occurred; and FDA investigators had argued
for data from one centre to be dropped entirely from the results. A senior
FDA official believed AZT should not be granted a licence, but was
overruled.

The doubts did nothing to inhibit Wellcome, AZT's maker, from promoting
its drug. Patients with HIV, but without AIDS symptoms, were the new
target. They are worth more money because there are more of them and
because they have longer to live.

To show the drug's usefulness to this lucrative group, Wellcome trumpeted
a big American trial called Protocol 019. The trial was halted in August
1989, after less than two years, on the grounds that it had already shown
such benefit to HIV-positive people it would be unethical not to give the
drug to all who wanted it.

Such "benefit" was judged only by time free from disease. A new analysis
of the trial data, however, reaches a similar conclusion to Concorde: that
AZT is essentially useless.

The original results were announced with a fanfare by the National
Institute of Allergy and Infectious Diseases, which sponsored it with
Wellcome's support. In London, The Independent newspaper gave its front
page to the findings, under the headline "AIDS drug offers lease of
life".

The very different picture painted by last month's analysis, in the New
England Journal of Medicine, comes after investigators paid more attention
to the drug's side-effects. These can include anaemia, liver damage,
fatigue, nausea, headaches and sometimes a collapse in white blood cells,
making patients more prone to disease.

The researchers looked at the average time patients experienced neither a
progression of disease nor an adverse effect. Those treated with low doses
of AZT were found to suffer a reduction in quality of life "due to severe
side-effects of therapy" that approximately equalled any benefit from
slowing down the disease; people on higher doses suffered even greater
side-effects, outweighing the supposed benefit.

Dr Peter Duesberg, the American virus expert who has claimed for years
that AZT is not a rational therapy, says it is clear that the original
claims were completely ill-founded. "The opposite interpretations of the
same data lead me to conclude that those responsible are not acting as
scientists; they are acting as politicians.

"When the time is ripe to say that AZT is detrimental, that it actually
hurts, the interpretation will change again."

For patients with AIDS-related symptoms, AZT will continue to be
prescribed: the consensus remains that it gives a temporary benefit.

For those without symptoms, hope centres on combinations of drugs, or on
other approaches such as gene therapy. However, Professor Ian Weller, of
the Middlesex hospital in London, who was the principal British
investigator in the Concorde trial, is alarmed by the drive to give AIDS
patients an AZT drug cocktail as if it were already an established
therapy.

"There's a suspicion of more toxicity if you combine it with other
treatment, and we are a long way from showing an important clinical
benefit, or that it is safer than AZT on its own," he said. "There are
physicians who are jumping the gun."

As late as Thursday, Wellcome was insisting that AZT "remains the best
weapon we have to slow the progress of the disease". Dr Trevor Jones, its
research director, said: "The question is where in the course of the
disease you begin." *

THE CURE THAT FAILED

By Neville Hodgkinson

The Sunday Times (London) 4 April 1993

Jody Wells has been HIV-positive since 1984. He was diagnosed as having
AIDS in 1986. Today, seven years on, he says he feels fine with energy
levels that belie his 52 years. He does not take the anti-HIV drug AZT.

Wells, unlike thousands of doctors and patients around the world, was
neither surprised nor disappointed last week when the Medical Research
Council announced that early treatment with AZT, sold under the brand name
Retrovir, is useless. In fact, he welcomed the announcement. Not because
he could tell his doctors "I told you so" he has consistently refused
entreaties to take the drug but because he believes it is a poison that
harms more than it helps, and can even kill, producing symptoms which
doctors misinterpret as AIDS.

He feels so strongly about the issue that he works up to 18 hours a day
establishing a fledgling charity called Continuum, "an organisation for
long-term survivors of HIV and AIDS and people who want to be". Founded
late last year, the group already has 600 members.

Continuum emphasises nutritional and lifestyle approaches to combating
AIDS, arguing that these factors have been grossly neglected in the 10
years since Dr Robert Gallo declared HIV to be the cause of AIDS.

To most within the "AIDS" community, the MRC's announcement came as an
unpleasant shock. It meant that a decade of the most intensive research
ever mounted by the medical and scientific community against a single
virus, costing $1.5billion a year in the United States alone, had left
them empty-handed in therapeutic terms.

AZT, some doctors had declared, was the "gold standard" of AIDS treatment.
They believed in it so strongly that many patients have come under heavy
pressure to take it, and to join trials liberally funded by Wellcome, the
drug's manufacturer. At the last count, more than 50 hospitals across
Britain were involved in such studies. It is even being given to
HIV-positive children.

Yet as The Sunday Times first reported in 1989, some scientists have
argued against the huge concentration of resources on AZT, and the wisdom
of giving patients a drug originally developed for cancer patients but
considered too toxic to administer.

They have also questioned the rationale of an exclusively anti-viral
approach to AIDS, pointing out that science has not yet been able to
locate a mechanism through which HIV alone could account for the collapse
of the immune system seen in AIDS.

"It is an Alice in Wonderland world," says Wells. "There are so many
uncertainties, and yet this extremely toxic drug has been given to
thousands of people, many of whom are completely well apart from having
antibodies in their blood to HIV. It is outrageous that they should have
been put at risk in this way."

Last week Wellcome was trying to limit the damage to AZT's credibility,
arguing the trial results were not all they seemed, that several other
trials have shown benefit, and anyway, AZT's future lies in being used in
combination with other drugs. But the latest trial, called Concorde, is
far and away the most scientific mounted. Although it was directed at
finding out whether AZT would help symptom-free HIV-positive patients
rather than those with full-blown AIDS, it adds to the concerns of
scientists who doubt whether the drug has any place in AIDS treatment.

AZT is big business. It earned Wellcome more than £ 200m last year and £
131m in the six months to February this year. How could a "useless" drug
earn the reputation of being the "gold standard" in AIDS and achieve such
heights of success?

In an age when so much has been achieved by science, both professionals
and the public often subscribe to the Spock-like image of the scientist as
a cool, calm, dispassionate seeker after truth. This is a myth. Scientists
are as prone as any other human beings to having their judgement distorted
by their emotions, whether from compassion or greed. Normally, the
scientific method seeks to overcome this subjectivity by requiring careful
analysis of claims.

In the mid-1980s, American researchers were under huge pressure from a
panic-stricken homosexual community to fast-track anti-AIDS drugs on to
the market. AIDS conferences became as much political as scientific
events, with angry demonstrators chanting "Give us the drugs NOW!".

It was in such a climate that AZT, first designed in the 1960s for the
treatment of leukaemia, came on the scene. The drug terminates DNA
synthesis, the process underlying cell division, and scientists originally
hoped it would prevent cancerous, rapidly multiplying blood cells from
replicating. It was abandoned because of its toxicity and ineffectiveness
in animals.

After HIV was declared the cause of AIDS by Gallo, Dr Samuel Broder, a
colleague at the US National Institutes of Health (NIH) in Bethesda,
Washington, instigated laboratory tests showing AZT helped block the
virus's replication. He steered the drug through regulatory procedures
from test-tube to patients in a record 19 months.

Working at the time as associate director of the National Cancer
Institute's clinical oncology programme, Broder spoke in 1986 of the
tension he felt as his every move was scrutinised and criticised by AIDS
lobbyists. "I've had to recognise that we cannot approach this problem in
the usual scholarly way," he said.

Later he spoke for much of the scientific community in declaring: "I view
AZT as the battle of El Alamein. It is symbolic that we can do something
against the virus that causes AIDS; that we can make progress; that those
who preached that it was inherently untreatable were wrong."

AZT was granted its licence by America's Food and Drug Administration
(FDA), with licensing authorities around the world soon following suit, on
the basis of a single, multi-centre study. It took place in 1986, and
involved 281 AIDS patients. They were supposed to be tested for 24 weeks,
but the trial was called off prematurely, when only 15 patients had run
the full course, because there seemed to be a dramatic improvement in
survival in the AZT-treated group. Only one had died, compared with 19
patients receiving a dummy pill.

Later, it became evident that investigators and patients had not been
"blind" to who was receiving which pill; there were numerous breaches of
protocol designed to ensure comparability between the treated and
placebo-only patients, and sicker patients may have been placed in the
placebo group; there was an acceleration of deaths in the treated group
after the study ended (many had been kept alive by repeated transfusions);
many adverse reactions were not reported; and that for 19 patients to die
within weeks was a phenomenally high death rate never seen again in any
other comparable group, suggesting they were not properly treated.

According to John Lauritsen, a gay movement activist and author of Poison
by Prescription: the AZT Story, FDA documents obtained under the Freedom
of Information Act show a meeting was convened to decide what to do about
the "protocol violations and bad data".

"The decision was made to keep everything," he says. "The researchers
excused these inexcusable decisions on two grounds: one, if they didn't
use the false data, there would be hardly any patients left in the study.
Two, using the false data didn't really change the results very much." The
FDA's stamp of approval on AZT set in motion a bandwagon which seemed
unstoppable.

A flood of reports started appearing claiming various benefits for AZT.
Many of these were "anecdotal" that is, based on individual clinicians'
observations of patients, rather than arising from scientifically sound
trials. Lauritsen has a scathing description of such reports in his book,
published in 1990.

"These doctors," he writes, "many of them rather gullible individuals,
have been told that AZT represents the 'best hope'. With this expectation,
they begin dosing their patients with AZT, and sooner or later some of
them believe that they have 'seen good results'.

"Perhaps a patient, having undergone multiple transfusions and suffered
agonising side-effects, dies after 11 months; the doctor can then
rationalise that he would have died sooner if it hadn't been for the AZT."

As millions poured into Wellcome's coffers from AZT, the company sponsored
an ever-growing number of research projects, as well as AIDS "educational"
materials and PR campaigns.

In August 1989, Wellcome achieved a breakthrough that appeared to make the
sky the limit as far as its future earnings were concerned. It won
"scientific" backing for the idea that all HIV-positive patients, not just
those progressing towards AIDS, could benefit from AZT. A trial it had
sponsored with the National Institute of Allergy and Infectious Diseases
in the US also part of the National Institutes of Health was stopped
early, just like the original one, on grounds that the drug had been shown
to halve the rate at which a group of HIV-positive patients became ill.

Wellcome's shares rose by 164p, adding £ 1.4 billion to the company's
stock-market value. And there were calls for a rethink over a
multi-million-pound Anglo-French study, known as the Concorde trial, which
was tackling the same question that the American study seemed to have
answered: of whether AZT could delay the onset of illness in all
HIV-positive people. Surely, with AZT now of proven benefit, it was
unethical to continue Concorde and deny some of its participants the
benefits of AZT?

"Drug offers lease of life", ran the headline across the front page of The
Independent on August 19, 1989, with the sub-heading "AZT could be made
widely available in Britain after US research shows it can delay onset of
the disease". Similar optimism was expressed elsewhere.

Such reports gave scientists involved with Concorde a tough decision to
make. They decided to compromise and keep the trial going, but change the
protocol so participants would no longer be left in the dark on whether or
not they were taking an active drug, but could, if they wished, be
switched to AZT.

There were still unanswered questions. It was possible AZT gave a
short-term boost to immunity, but failed to give benefit in the longer
term. The Americans' habit of stopping trials early could disguise such a
phenomenon.

There was also evidence that the American trial, just like the original
one with AZT, had failed at least initially to conceal from doctors or
patients who was on the active drug and who was not, allowing bias to
enter.

Last week, first results from the four-year Concorde trial were published
in The Lancet. They show no clinical benefit from AZT in symptom-free
HIV-infected individuals, either in terms of living longer or in delaying
progression towards disease. Armed with this exposure of the weakness of
previous claims, the licensing authorities must surely now review whether
AZT is fit to be prescribed to patients with AIDS as well.

They should do so as a matter of urgency. Last year a four-year trial
among 340 HIV-positive patients with preliminary signs of AIDS found that
rather than saving lives, AZT resulted in slightly more deaths.

The Concorde trial appears to offer one crumb of comfort for Wellcome.
Although more than 100 of the 1750 patients in the trial had to drop out
because of severe side-effects, that is considered to be a relatively low
frequency, and no unexpected toxicity was seen.

Jody Wells, however, believes the real picture is worse than it appears.
The reason, he says, is that most patients know from the changes in their
body when they are on AZT, even if supposedly "blinded" to the fact when
in a trial. He claims to know several who, not wanting to rock the boat,
have quietly taken unilateral action. They have thrown their tablets down
the toilet.

AIDS is not the first illness that doctors, en masse, have taken up as a
crusade, at the expense of science. Similar problems arose when the
profession, again egged on by drug companies, decided heart disease was
caused by raised blood pressure or raised cholesterol and tried to
persuade millions to change their eating habits or go on lifelong
medication. Numerous studies now show not only a lack of benefit from this
approach, but actual harm.

Sometimes crusades do bring benefit, but perhaps the worst feature of the
medical and scientific professions' behaviour on AIDS has been the
enormous dominance of a single focus HIV for research, prevention, and
therapeutic efforts, to the exclusion of other approaches.

Last week The Lancet published a letter from Dr Gordon Stewart, professor
emeritus of public health at Glasgow University and a former World Health
Organisation adviser on AIDS, pointing out that previous AIDS projections
for 1992 were up to 10 times higher than the actual figure, largely
because of false assumptions about heterosexual spread.

"I have been trying to put this across for nearly four years," Stewart
said. "I have tried numerous journals. The response has either been
rejection, or silence."

Stewart's efforts have included letters to several government bodies
arguing that the medical establishment had "jumped the gun" in using AZT
so widely. "I received no comment whatever in response," he said. "They
were all persuaded HIV was the sole cause of AIDS, that an anti-viral drug
would destroy viral replication, and thereby delay the onset of AIDS. They
wouldn't consider any alternative reasoning."

Perhaps Concorde, like its namesake, will also now break a sound barrier:
the misguided consensus on AIDS that has kept people like Stewart from
being heard for so long. *

HIV VOODOO FROM BURROUGHS-WELLCOME


By John Lauritsen

New York Native 7 Jan. 1991 [revised 16 Jan. 1991]

Those who have eyes to see are witnessing genocide-the genocide of gay
men. Millions of dollars are now being spent on an international
advertising campaign, "Living With HIV", in which gay men and other
members of "risk groups" are being told:

Get tested for antibodies to HIV [the alleged "AIDS virus"] -- if you
"test positive" you need "medical intervention" which could "put time on
your side". The "medical intervention" is AZT (also known as Retrovir and
zidovudine), and the campaign is paid for, directly and indirectly, by
Burroughs-Wellcome, the manufacturer of AZT.

The campaign consists of a phoney diagnosis followed by a lethal
treatment. Already tens of thousands of objectively healthy gay men have
been scared and bullied and bamboozled into taking AZT, allegedly in order
to "slow the progression to AIDS". Optimism regarding their prognosis
would be foolish. Except for the lucky few who stop "treatment" in time,
they will die. Death is the expected biochemical consequence of taking
AZT, for the fundamental action of the drug is to terminate DNA synthesis,
the very life process itself. As Joseph Sonnabend has stated, "AZT is
incompatible with life". Without a single benefit demonstrated by honest
and competent research, AZT can do nothing but kill.(1)

It is odd, the power of words to cloud reality or discredit a line of
reasoning. A British journalist once told me that no one would ever
believe what I wrote if I persisted in using words like "genocide". My
response is that, while I want my arguments to be convincing, I write what
I consider to be true, not necessarily what people will find believable.
Genocide has occurred at other times and in other places, and it is
happening here and now, whether or not anyone wishes to believe it.

Craig Schoonmaker, the founder of Homosexuals Intransigent, has suggested
the word "autogenocide", to emphasize the role of low self-esteem and
self-hatred in motivating gay men to acquiesce in their own destruction.
Casper Schmidt, a New York City psychiatrist, has proposed
"pharmacogenocide"-genocide through drugs. The late Robert S. Mendelsohn
put forward the word "iatrogenocide" in his best seller, Confessions of a
Medical Heretic: A new word was recently coined by Dr. Quentin Young to
describe one activity of Modern Medicine: iatrogenocide. Iatrogenocide
(iatros in the greek for doctors) is the systematic destruction of a large
group of people by doctors.(2)

This new form of genocide, directed against gay men, rests on two pillars:
Homophobia and Profit. The ancient taboo from the Holiness Code of
Leviticus, which prescribed the death penalty for males who had sex with
each other, is now being carried out, profitably, by the pharmaceutical
industry: "If a man lie with mankind as with a woman, both of them have
committed an abomination: they shall surely be put to death; their blood
shall be upon them." (Leviticus 20:13)

Jewish priests 2500 years ago ordained death by stoning for the
"abomination" of sex between males. Modern priests, the doctors, prescribe
AZT, and they do so with the extraordinarily hypocritical dogma that by
giving a life-terminating drug they are really "extending life".
Considering the agonizing side effects of AZT "treatment", it might be
argued that death by stoning were preferable.

Deadly Diagnosis + Lethal Treatment = Genocide

The weaknesses of the HIV-AIDS hypothesis have been discussed
elsewhere.(3) Behind the scenes a growing number of important scientists
are now convinced that HIV is not the cause of "AIDS". The two
"discoverers" of HIV, Luc Montagnier of the Pasteur Institute and Robert
Gallo on the National Cancer Institute, have both reneged on promises to
defend the HIV-AIDS hypothesis against the criticisms of Peter Duesberg,
and have therefore lost the debate by default.

What does it mean to be diagnosed as "HIV positive"? Objectively it means
nothing, other than having antibodies to a harmless passenger virus. In
the absence of "medical treatment" or other specific health risks, there
is no reason why someone who is "HIV positive" should not live to a ripe
old age.

The "HIV positive" diagnosis itself, however, can be deadly. It has led to
suicides, has destroyed marriages and careers, and is used to justify AZT
treatment. An East Berlin writer recently summed it up with the phrase,
"Nicht das Virus, sondern die Diagnose totet". ("The virus doesn't kill,
the diagnosis does.")(4)

The toxicities of AZT have also been described elsewhere.(5) The
short-term (acute) toxicities of AZT are serious, and many patients die of
them. These toxicities include severe anemia, muscle disease, and damage
to the kidneys, liver, and nerves. However, it is the long-term (chronic)
toxicities that are of most concern when AZT is being prescribed for
healthy people to take for the rest of their lives. The cumulative,
long-term effects of AZT are unknown, since no one has lived for more than
three years on AZT treatment. However, the evidence we have-including
biochemical analyses, test tube studies, rodent studies, and correlations
between cancer of the lymph system and AZT therapy-strongly indicates that
AZT will cause cancer in the long run.

So then, perfectly healthy members of a group, which is hated for
theological reasons, are persuaded through lies to take a drug that will
kill them. If there's a better word than "genocide" to describe this, I'd
like to know what it is.

The Marketing of Genocide

Burroughs-Wellcome's full-page "Living With HIV" advertisements have
appeared in The New York Times and in lesser publications all over the
world. In a typical ad, a man is shown in silhouette by a grand piano, his
head bowed in dejection, and above his head the statement, "I learned I
was HIV positive 5 years ago. I felt angry, deserted, and victimized." At
the bottom of the ad is an insert photograph of the same man, now smiling
and confident: "Today I'm back in control." The theme of "control" is
echoed in the ad slogan, "The sooner you take control the better." In all
of the "Living With HIV" ads, the body copy is the same: Every day, more
and more people are learning to live with HIV. People are finding ways to
stay healthier, strengthen their immune systems, develop positive
attitudes. They've found that proper diet, moderate exercise, even stress
management can help. And now, early medical intervention could put time on
your side.

Today, HIV positive doesn't mean you have to give up. So, the sooner you
take control, the better.

For more information on living with HIV, we urge you to call the number
below ...anonymously, if you wish.

Such phrases as "stay healthier" and "put time on your side" are
insidious, as they suggest that someone with HIV antibodies is already
sick and doomed. The references to diet, exercise, and so on are merely
window dressing. Any HIV positive who calls the number will find out soon
enough that "taking control" means "early medical intervention" means AZT.

In their nauseating hypocrisy, the Burroughs-Wellcome ads are reminiscent
of a series of ads which in 1983 were run in gay publications for Great
Lakes Products, the world's largest manufacturer of poppers (nitrite
inhalants). Entitled "Blueprint for Health", the Great Lakes ads gave
advice to gay men on how to stay healthy through exercise, nutrition,
stress reduction, and so on. And this "message of good health and
wellness" was sponsored by the manufacturer of poppers, a drug which,
among other things, damages chromosomes; causes anemia, immune
suppression, and cardio-vascular collapse; and forms carcinogenic
compounds in the body.(6)

Concomitant with the Burroughs-Wellcome ads, The New York City Department
of Health put up posters with the theme, "Living Longer, Staying Strong",
conveying essentially the same message, that "people with HIV" are sick
and doomed, but might "stay healthy longer" with the help of "early health
care and new medicines".

Genocide doesn't take holidays. On Christmas day I was listening to WINS
radio, and heard a "Message on HIV" from the Centers for Disease Control
(CDC). It was a virtual clone of the "Living with HIV" series. I called
the number, and the woman who answered gave me the now-familiar pitch
about the importance of getting tested, early medical intervention, and
the rest of it.

The Gay Press Promotes Autogenocide

Gay publications all over the world, from local bar rags to those with
international circulations, are now carrying the "Living with HIV" ads.
The New York Native and the west coast magazine Outlook are the only
exceptions I know of. According to an article by Chris Bull in The
Advocate, Burroughs-Wellcome marketing representative Joe DiSabato found
"little opposition to the ads from the gay press." DiSabato richly
deserves the 1990 gay Pollyanna prize for his statement, "In a way
Burroughs Wellcome is giving money back to the community through the
campaign. Economically, this will be great for the gay press."

The German magazine Magnus received 20,000 DM to run a Burroughs-Wellcome
ad, and a prominent gay activist with "AIDS" was recruited to assist in
the campaign. A Burroughs-Wellcome ad appeared in the latest issue of
Babilonia, from Milan.

In Houston, the Body Positive group received $85,000 plus donations of
computers and other equipment from Burroughs-Wellcome. In return, Body
Positive ran under its own name a series of television, radio, billboard,
and press advertisements with the theme, "We can't get results until you
do." For those who would test positive, the ads offered the bleak hope,
"There's a chance for a longer and healthier life with early medical
intervention." Houston's mayor, Kathy Whitmire, proclaimed September the
"Get Tested Now" month, stating that, "prompt medical and psychological
intervention can slow down the progress of the [HIV] disease and
ameliorate some of its effects."

Some of the ads in the gay press were sponsored by branches of the Public
Health Service, paid for with our tax money. One such ad, which ran in Au
Courant (Philadelphia), contained the following copy: Today, people with
HIV are doing something most of us didn't think possible. Living longer.
Today, a person who is infected with HIV and receives prompt treatment can
live longer. If you are at risk [read: if you are gay], now's the time to
seek counseling and testing. If you are infected with HIV, work with a
doctor to understand medical options that may prolong your life.

The psychology of genocide

In formulating hypotheses on what might be the real causes of "AIDS",
multifactorialists who reject the HIV-AIDS hypothesis have concentrated on
such probable etiological factors as "recreational" drug use, known and
yet-to-be-identified infectious agents, and excessive medical treatment
with antibiotics and other drugs. We have, regrettably, tended to slight
psychological factors. This is unfortunate, as the concept of
psychosomatic illness is well established. There can be no doubt that
extreme and chronic fear, depression, stress, and grief are capable of
causing illness and death.

In 1983 the Journal of Psychohistory published a paper by Casper Schmidt,
which was perhaps the first to challenge the "AIDS virus" hypothesis.(7)
Entitled "The Group-Fantasy Origins of AIDS", this brilliantly original
essay advances the thesis that epidemic AIDS has a psychosocial
origin-that AIDS is psychologically contagious, being spread through
suggestion rather than through microbes. In Schmidt's view, we are
witnessing a mass sacrificial ritual, with sadistic persecutors on one
side and willing (masochistic) sacrificial victims on the other. The
extraordinary irrationality that characterizes the AIDS epidemic can be
explained through the concept of group fantasy-people are collectively in
a trance.

Schmidt is somewhat more tentative in trying to explain why gay men and
other members of "risk groups" are getting sick in ways that qualify for a
diagnosis of "AIDS". He proposes that chronic and inescapable fear can
elicit a biochemical reaction in the body, which in time causes
"psychogenically-reduced cell-mediated immunity". He maintains that this
hypothesis has fulfilled the animal model for "AIDS", inasmuch as
laboratory animals subjected to inescapable threats have developed immune
deficiency. While I withhold judgment on this aspect of Schmidt's thesis,
I wholeheartedly agree that a sacrificial ritual is taking place.
Especially noteworthy, in my opinion, is the role of the
facilitators-those gay men (and lesbians) who are leading the victims to
the sacrificial altar, without necessarily allowing themselves to be
sacrificed.

In this second wave of sacrifices, in which perfectly healthy people are
being targeted for genocide, a crucial role is played by psychological
suggestion. Highly sophisticated psychological techniques are being used
to make gay men perceive themselves as sick, and become sick, in order to
qualify as consumers of AZT. The "Living With HIV" campaign is, quite
literally, a form of voodoo.

Michael Ellner, the president of the Health Education AIDS Liaison (HEAL),
recently posed the question of whether un-recognized hypnosis might not be
a risk factor in the development of "AIDS". A certified master
hypnotherapist himself, Ellner believes that classic elements of hypnosis
are present in the "Living With HIV" campaign, in innumerable
pronouncements from AIDS groups and public health agencies, and in a
recent video from Burroughs-Wellcome (about which more below). Ellner
cited the elements of hypnotism as being, in no particular order:
perceived authority, fixation, suggestion, repetition, confusion,
relaxation, imagination, and post-hypnotic suggestion.

In a recent paper by Michael Ellner and Andrew Cort, "Programmed to Die:
Cultural Hypnosis and AIDS", the following points are made: Bone pointing,
or voodoo death, is a well-documented hypnotic phenomenon that clearly
demonstrates the awesome power of belief. There are people in Africa,
Haiti and Australia with the belief that the shaman (or witch doctor) has
power over life and death. For them, being the target of a bone pointed by
such an authority can be fatal. The hex is harmless to a non-believer; but
to a believer it is deadly. After having a bone pointed at them, healthy
people go home and obediently die.(8)

A Burroughs-Wellcome video: Brainwashing the doctors

A few months ago, doctors who treat AIDS patients received a video
cassette from Burroughs-Wellcome, "The Psychology of Treating Patients
With HIV Disease". The basic premises of the video are the same as those
of the "Living With HIV" campaign, that "HIV infection" and "AIDS" are
more or less equivalent, and that early medical intervention (with
AZT/Retrovir) is called for. Beyond this, doctors are told to "ally with
the treatment", by knocking down any hesitation or objections their
"HIV-infected" patients might have to going and staying on AZT therapy.

The video is narrated by Leon McKusick, Ph.D., a gay psychologist in San
Francisco. In the beginning his voice is heard saying: HIV disease is
coming to be seen as a chronic infection. And for many individuals this is
the first intimate realization of death and disease, particularly among
those who are relatively young.

After McKusick introduces himself, he quickly gets to the point: The
decisions surrounding the initiation of Retrovir therapy force you, the
physician, to evaluate the patient's support network.... This video will
share with you the psychological reactions we've seen from patients who
are diagnosed positive for the HIV antibodies, and then alert you to the
emotions that follow as they encounter the progression of the disease and
then are motivated towards treatment with Retrovir.

McKusick describes "HIV-related depression", emphasizing that the symptoms
mimic those of HIV infection itself, as well as "some of the early side
effects of AZT". In other words, if a patient on AZT should experience
sleep disturbance, eating problems, fatigue, or weight loss, these might
be merely short-term "HIV-related depression", rather than side effects of
AZT.

For physicians to "assist individuals going through emotional depression
reacting to HIV or going on treatment", McKusick offers the following
guidelines: enlightened reassurance, cognitive reframing, social support,
reinforce structure, plan of action. In commenting on the video, Michael
Ellner has expressed the opinion that "cognitive reframing" means
hypnotizing or brainwashing the patient.

The video features a panel discussion, with two doctors and a number of
people with AIDS (PWAs). Like McKusick, the other two authority figures
are gay and are identified with title: Marcus Conant, M. D., and Ron
Grossman, M. D., whereas the PWAs are identified simply as "Bob", "Steve",
"Tom", and "Bill". Drs. McKusick, Conant and Grossman are understanding
facilitators. Bob, Steve, Tom, and Bill are willing victims.

Grossman argues that "AIDS" ought to renamed as "HIV spectrum". His words
are regarded by his colleagues as profound and original.

McKusick says, "Sometimes it's best to combat feelings of stigmatization
with a sense of humor." He smiles. The camera shifts to Conant, who tries
to smile-but his face is heavy and his eyes are dead tired. And then Bob
tells an anecdote. It seems he was in a play writing workshop when the
timer of his AZT pill box went off: Twenty pairs of eyes zeroed in on me.
The only thing I could do, I took out the pill box and turned it off-and
they were still looking-so obviously I had to respond to it-so I made a
joke out of it. I said, "It's a phenomenon of the latter part of the 20th
century in the United States. Every four hours, gay men start to beep."

Bob stops speaking. It becomes apparent that the point of his joke has
been made, and that people are expected to laugh. They begin laughing. The
camera goes from one person to another to show them laughing. They applaud
Bob's performance.

Clearly Bob is intended to be a role model. He states, "As soon as I
started taking action, I started feeling better.... Action is the key to
salvation."

The prickly topic of AZT's side effects is raised. McKusick asserts that
the physicians role ought to be "helping the patient realize that their
fears were unfounded." Robert makes a joke about "horror stories" of side
effects. Everyone laughs.

McKusick then declares that anxiety symptoms are very much like both HIV
symptoms and early symptoms of AZT side effects. He artfully sows
confusion by stating:

Sometimes a person could benefit medically from the drug, but could reject
the drug for psychological reasons. Some patients, who have just begun
AZT, have complained about side effects which, once they've talked about
it with their counsellors, were determined to be more related to their
anxiety about being on the drug, than to the drug itself.... Sometimes a
person could benefit medically from the treatment, but rejects the drug
for psychological reasons, after being on it for just a brief period.
Therefore, it's important to recognize that some of your patients' early
reactions may be psychological.

Bob makes his contribution: "I have to say-Thank God! -- that I have had
no side effects whatsoever." Bob clearly is not well. His skin is
stretched taut over a death's head, and his facial expressiveness is
limited to rolling his eyes. He mentions a few symptoms, which he
attributes to HIV, and says, "I can handle that". He laughs bravely.

McKusick commends Bob on the way he "handles attribution". It's very
important", says McKusick, "to ally with the drug against the disease."
The single most stomach-turning episode in the video is provided by the
New York physician, Ron Grossman, who smiles as he delivers the following
little speech:

That pill should be an absolute symbol of life, and not a symbol of "Oh,
I've got this...." (Marcus Conant nods in agreement) The whole issue of
empowerment here, of people taking charge of their own lives, is involved
with this decision making, to take this drug.

To summarize: The whole thrust of the video is to downplay AZT's side
effects. Doctors are to dismiss their patients' objections to AZT therapy
as "psychological", as short-term depression or anxiety. The loyalty of
the doctor should be to Retrovir ("the treatment") rather than to the
patient ("the disease"). The hidden message to doctors is that they should
not hesitate to kill their patients.

The hidden message to gay men is this: "You are doomed. Be brave, willing
sacrificial victims. People will applaud you, and laugh at your jokes. Do
not listen to the messages of your body."

Who is responsible?

Unscrupulous pharmaceutical companies, corrupt government officials, venal
physicians, stupid and cowardly media people, incompetent and dishonest
researchers-none of these things are new. They are business as usual.
Where, then, does the buck stop? Who is responsible for pharmacogenocide?

My thinking on this question was altered recently when I read Confessions
of a Medical Heretic by Robert Mendelsohn, who uncompromisingly places the
blame on the members of his own profession: Despite the obvious corruption
of the drug company/doctor marketing connection, I don't blame the drug
companies, the detail men, the government agencies which are supposed to
police these activities, or the patients who badger their doctors for
drugs. Doctors have enough facts in their possession to know what's going
on. Even where the drug is fully tested and the side effects and
limitations of the drug are well known, most of the harm is done by
doctors indiscriminately prescribing the drug. Doctors, after all, are the
ones who claim the sacred power and the ethical superiority that goes with
it. The drug companies are in business to make money, and they do that by
selling as much of their product as they can at as high a price as they
can. And although the drug companies subvert the scientific process
through which drugs are tested, certified, and made available to doctors,
once the drugs are available, they do let doctors know-albeit subtly-just
what these drugs can and cannot do.

All of us who know the truth about AZT will have to do what we can.
Friends who are on AZT must be told directly and forcefully that they must
get off the drug if they want to live. Public health officials,
representatives of AIDS organizations, and various and sundry other "AIDS
experts" must be confronted with their lies. Above all, doctors must be
told that they have no right to prescribe a drug that can only lead to the
deaths of their patients. The buck stops with the AZT-pushing doctors.
They are responsible. *

References

1. John Lauritsen, Poison By Prescription: The AZT Story, New York 1990.

2. Robert S. Mendelsohn, Confessions of a Medical Heretic, Chicago 1979.

3. The most cogent and comprehensive arguments against the HIV-AIDS
hypothesis are found in Peter H. Duesberg, "Human Immunodeficiency Virus
And Acquired Immunodeficiency Syndrome:

Correlation But Not Causation", Proceedings of the National Academy of
Sciences, Vol. 86 (February 1989) pp. 755-764.

Peter H. Duesberg and Bryan J. Ellison, "Is the AIDS Virus a Science
Fiction?", Policy Review, Summer 1990, pp. 40-51.

4. Erhard Neubert, "Kunstprodukt 'AIDS' in Schwierigkeiten" ("The Phony
AIDS Construct in Trouble"), Raum & Zeit (Space & Time), Special 4,
Sauerlach, Germany, October 1990, pages 98-102. (The entire 115-page
special issue of Raum & Zeit is devoted to German, Swiss, and American
AIDS dissidents, who attack the AIDS orthodoxies with much intelligence
and militancy. My favorite phrase, "Nur tote Fische schwimmen mit dem
Strom!" ["Only dead fish swim with the stream!"])

5. Poison By Prescription.

6. The toxicities of poppers and the shady dealings of the poppers
industry are described in Death Rush: Poppers & AIDS, by John Lauritsen
and Hank Wilson, New York 1986.

7. Casper G. Schmidt, "The Group-Fantasy Origins of AIDS", The Journal of
Psychohistory, Summer 1983.

8. Michael Ellner and Andrew Cort, "Programmed to Die: Cultural Hypnosis
and AIDS", manuscript 1990.

FDA DOCUMENTS SHOW FRAUD IN AZT TRIALS

By John Lauritsen

New York Native 30 March 1992

After an arduous three-month battle with the Food and Drug Administration
(FDA), I have finally obtained documents which describe in detail many
acts of fraud committed in the conduct of the Phase II AZT Trials. It was
on the basis of the Phase II Trials that AZT was approved for marketing by
the FDA in 1987.

Anyone who requests government documents under the Freedom of Information
Act should be aware that he's in for a hard time. If the requested
documents are completely innocuous, then the government will probably lose
them through incompetence. If the documents are not innocuous, then
dilatory tactics of every kind will be employed, on top of the usual
incompetence. If the documents should eventually be found and released,
they will be heavily censored.

On 12 December 1991 I filed my request with the FDA's Freedom of
Information Staff, asking for various documents pertaining to the
multi-center Phase II AZT trials conducted in 1986. My requests comprised
the "Establishment Inspection Report" on the Boston center, written by FDA
investigator Pat Spitzig, and two sets of minutes, written by Jackie
Knight and Mary Gross. Three weeks after filing my request I got an
acknowledgment. When I called the woman who sent it to me, she said that
all three of my requests had been found, and I would get them soon. A few
days later a form letter arrived from another woman, stating that none of
my requests could be found, and my search had been completed. I began
calling around until finally I got a Freedom of Information specialist
within the FDA, Liz Barbakos, who went to bat for me. With her help, the
people in Boston were able to re-find the Establishment Inspection Report
by Pat Spitzig, and the people in Maryland (the FDA's headquarters) were
able to re-find the Jackie Knight minutes, though not those by Mary Gross.
Barbakos said I should receive them in a few days.

Weeks went by, and nothing arrived. I called Barbakos again, and she
investigated. She called back to explain that the Jackie Knight minutes
would be sent immediately, and that Barbara Recupero in Boston had had the
Spitzig report on her desk for two weeks, and was waiting for her
supervisor to give the OK before sending it. The next morning I got a
conference call, with Liz Barbakos and Barbara Recupero on the other end.
Barbakos said she wanted me to hear what Recupero had to say. Recupero
said that she had no idea what document I was referring to. I then called
Pat Spitzig, the author of the Boston Inspection Report, who called Liz
Barbakos and told her exactly what the document was. This put an end to
the stonewalling, and I received the 76-page report. Almost every page was
heavily censored. Obviously my difficulty in obtaining the document had
nothing to do with problems in finding it-they knew where it was all the
time. Rather, the difficulty derived from the FDA's unwillingness to let
the document see the light of day, and the various censorship decisions
that needed to be made once they realized that further stonewalling would
be counterproductive.

The Mary Gross minutes are another story. On the first four times I called
her, she was always "away from her desk", and my calls were not returned.
On the fifth try I finally got her, and expressed my disbelief that she
should be unable to find her own minutes of a very important meeting. The
next day she called to say that something I said had triggered her memory,
and she had found the minutes. She then faxed them to me, and I found that
they consisted of a half page of nothing. For reasons I'll explain later
in this article, I do not for one minute believe the minutes she sent me
are genuine. Indeed, I regard the phony minutes I received as one more
form of censorship, one more way the FDA has of circumventing the spirit
and the letter of the Freedom of Information Act.

Background: The Fraudulent Phase II Trials

A bit of background is in order. In the approval process for a new drug,
the most important tests are the Phase II trials, which are supposed to
determine whether or not the new drug is safe and effective. (The Phase I
trials are concerned solely with toxicity-whether or not it is possible to
administer the drug to human beings, and if so, to estimate what a proper
dose might be.) The Phase II AZT trials were conducted in 1986, in 12
centers around the country. They were designed as a "double-blind,
placebo-controlled" study, though in practice they were nothing of the
kind.

The Phase II AZT trials were prematurely terminated in the fall of 1986,
owing to what appeared to be a spectacular difference in death rates
between the AZT and the placebo group. Allegedly only one person in the
AZT group died, as compared to 19 in the placebo group. The trials were
terminated "for ethical reasons", so that everyone in the study would have
the opportunity to take the "life-extending" wonder drug. As I have argued
repeatedly since 1987, these mortality data cannot possibly be correct;
not only are they in conflict with mortality data from other AZT studies,
but from the standpoint of common sense, one cannot expect dramatic health
benefits from a drug that is only injurious to health.

On the basis of hundreds of pages of FDA documents that were released
under the Freedom of Information Act, I wrote an analysis of the Phase II
trials in 1987, concluding that the study was not only appallingly sloppy,
but manifestly fraudulent.(1) For my accusation of fraud (which I, as the
son of a lawyer, do not make lightly), I relied on the fact that the
investigators had deliberately used bad data, and that they had covered up
the premature unblinding of the study. The Phase II trials are still
relevant today, even though they took place six years ago. Since these
fraudulent trials were the basis for the FDA's approval of AZT for
marketing, the approval itself was improper and illegal. Consequently, AZT
is being marketed illegally at this very moment.

A document written by Ellen Cooper, the FDA Medical Officer who reviewed
the New Drug Application for AZT, indicated that many serious violations
of the "protocols" of the study had occurred in all of the centers.(2)
(Since protocols represent the rules of the game, so to speak, to violate
them constitutes cheating.) The Boston center, whose principal
investigator was Robert Schooley, was especially bad. It was so bad that
an FDA investigator recommended that all data from the Boston center "be
excluded from the analysis of the multicenter trial."(3)

A series of FDA meetings were held in order to decide what to do about the
numerous violations of protocol, and in particular, about the delinquent
Boston center. The decision was made to exclude nothing, to throw in all
of the garbage along with the good data. The rationale for this appalling
decision was two-fold: one, if all of the patients with protocol
violations were excluded, there would be almost nobody left in the study;
and two, including the bad data didn't really change the results very
much. Needless to say, these are the excuses of crooks and idiots. No
ethical scientist would ever knowingly use bad data. Period.

This, then, is the background for my keen interest in obtaining the
Establishment Inspection Report on the Boston center. After nine years of
research and writing on "AIDS", from a dissident standpoint, I'm not
easily shocked anymore. But this report succeeded in making my mind reel,
from time to time, as it described innumerable, brazen acts of fraud
committed by the investigators in the conduct of the trial. Even more
shocking is the fact that the FDA, at the very highest level, chose to
excuse and cover up these acts of fraud. For the rest of this article I'll
describe the crimes and blunders that were committed in Boston in 1986.

The Delinquent Boston Center

In October and November 1986 FDA Inspector Patricia Spitzig made a "For
Cause Inspection" of the Massachusetts General Hospital clinical center,
which was used in the Phase II multi-center AZT trials. Her findings are
contained in her 76-page "Establishment Inspection Report" (EIR). The
principal investigator at this center was Robert Schooley, MD, who was
assisted by co-investigator Martin Hirsch, MD; Dr. (no first name cited)
Ho, and Teri Flynn, Research Nurse. The "Monitor"- the man who appeared to
be calling the shots-was Ron Beitman, an employee of Burroughs Wellcome,
the manufacturer of AZT. (Although the censors attempted to prevent me
from knowing Beitman's name, they slipped up a couple of times.)

(In recent scandals involving the FDA's acceptance of fraudulent data on
silicone breast implants and the drugs Halcion and Versed, it was
disclosed that the FDA basically works on the Honor System.(4) Drug
manufacturers do their tests, all by themselves, and then present their
"data" to the FDA, who assumes that everything was done honestly and
competently. The FDA has no subpoena power, so even if it found something
fishy, it would be unable to investigate any further. And even if acts of
fraud should be clearly documented, as they were in the Boston case, it is
still likely that the FDA would cover them up.)

The record-keeping at the Boston center was incredibly sloppy. Often there
no indications of when, by whom, or why entries had been made, erased or
changed. The "monitor", Ron Beitman, appears to have taken the lead in
most of the misdeeds that were committed, though this by no means absolves
Schooley, Hirsch, Ho, and Flynn from culpability. Certainly Schooley, as
principal investigator, ought to have known what was happening. And
co-investigator Martin Hirsch had previously gotten in trouble over a drug
trial:

Dr. Schooley has not been inspected previously; Dr. Hirsch has, in 1979,
covering an Interferon Study. That EIR revealed errors in the Protocol; no
notification of the IRB re Protocol changes or other Study medications
used; subjects were given each other's drugs; and some of the label color
was visible, thereby breaking the code.(5)

Among others, Spitzig found the following forms of improprieties in the
Boston center:

The current EI revealed numerous deviations, many of them similar to those
cited above in the 1979 EI. The observations listed on the FD- 483
included: Deaths (two, so far) and adverse reactions have not been
reported to the IRB; undocumented Protocol deviations including:
concomitant meds, subjects not meeting entrance criteria admitted (two);
tests not performed as frequently as required by the Protocol; adverse
reactions not reported as such on Case Report Forms ("CRF's"). There were
changes made on photocopied CRF's usually with no explanation, date, or
initials; significant observations were not addressed on CRF's by clinical
investigator; some raw records could not be located and were explained to
have been discarded. Accountability of the Study medication is inadequate;
87 bottles/containers shipped cannot be accounted for; Pharmacy kept the
inventory and it does not correlate with shipping records;

Study medication returned by subjects was not counted, stored properly, or
signed off by the clinical investigator.(6)

In addition, Spitzig found that Schooley and his accomplices frequently
indicated on Case Report Forms that patients were in the study much longer
than they really were. Amazingly, Spitzig missed the single most serious
act of fraud, apparently because she was unaware that AZT is the
abbreviation for the full chemical name of the drug, "azidothymidine":
Patient #1009, who was already taking AZT, was illegally entered in the
study as a placebo patient. After being in the study for only four weeks,
he dropped out. When he died two months later, he was counted as a death
in the placebo group! More about this later.

It should be explained that the Case Report Forms (CRFs) were the official
recording forms for the study. What was written on the CRFs became "data"
for the study. However, medical information on patients was also contained
in medical records kept by private physicians, hospitals, and the clinical
center at Massachusetts General Hospital, as well as in patients' diaries.
For virtually every patient in the Boston center, FDA Investigator Spitzig
found serious discrepancies between the medical records and what was
entered on the CRFs.

A note about censorship: Virtually every page of the report I received was
covered with black splotches. The censors attempted to prevent me from
even knowing what the name of the study was, or that it concerned AIDS and
ARC patients, or that it was testing the drug AZT. There can be no legal
justification for this kind of censorship, and it is clearly in violation
of the principles of the Freedom of Information Act. I have sent a letter
of protest to the FDA, demanding to be given the complete and uncensored
report.

I shall now describe, by category, the major violations that were
uncovered by Spitzig in her investigation of the Boston center.

Lies about length of time in study

Comparing the CRFs with medical records, FDA investigator Spitzig found
that the CRFs often falsely indicated that patients had been in the study
longer than they really were:

Another general issue applying to a number of subjects in the Study is
that a cursory review of their Case Report Forms would indicate that they
had been on the Study longer than actually happened. Generally this is due
to the fact that Study records continued to be generated even when the
subject had been dropped from the Study for a period of two weeks to a
month. Examples include: number 1053, [CENSORED] dropped out of the Study
for two weeks from June 19th to July 3rd, and he was off the Study again
on August 11 for a final time due to decreased white blood cell count. CRF
were generated as though he were on the study through 9-8-86. Number 1057,
[CENSORED] was on the Study for 13 to 14 weeks but the Monitor's
Accountability Sheet indicates that he was on the Study for 16 weeks. The
Case Report Forms showed that he last came to the Clinic during Week 14
and nothing was returned thereafter. Subject Number 1008, [CENSORED] was
off the Study for a month even though the Accountability Record indicates
that he never left it. He was off the Study during the Week 6 visit. It is
unclear if the Week 8th's medication was dispensed. In fact during Week 4
the Case Report Form states that he had pneumonia beginning July 7th and
ending August 7th. And during the week four visit he was not dispensed any
medication. In fact it appears that he was hospitalized then or soon after
although the Case Report Forms do not state that he wa hospitalized. So he
was off the Study medication for at least a month, but to view the Record
of Dispensing of Medication to him, as an example, D-2 it appears that he
was on the Study pretty regularly for 12 weeks.(7)

This sort of thing is not merely a form of sloppiness. It is cheating, and
it is serious. For one thing, survival rates were an important issue in
the study. Falsely extending the length of time that a patient was in the
study would affect the statistical projections that were made regarding
survival rates.

In addition, falsely extending the length of time patients were in the
study made the final results look more plausible than they really were.
The Phase II trials were designed so that each patient would be treated
for 24 weeks. In practice, when the study was prematurely terminated, some
patients had been treated for only three or four weeks, and arcane
statistical projection techniques were used to compensate for this
violation of the study design. The official "data" on the Phase II trials,
deriving from the CRFs, indicated that patients were treated for an
average of only 17 weeks. However, if the same kind of cheating took place
in the other 11 centers, as did in Boston, the average may well have been
much less than 17 weeks.

Finally, Schooley and his accomplices profited by lying about the length
of time patients were in the study. It is stated in Spitzig's report, "The
Investigator [Schooley] would be paid [CENSORED] per patient.... For
patients who drop out of the Study the cost would be 'pro-rated based on
the amount of time the patient was in the Study.'"(8) That is to say, the
longer a patient was in the study, the more money Schooley got. While this
may not amount to grand larceny, it is nevertheless a form of theft.

Concealment of adverse reactions

The rules of the study indicated clearly that all adverse reactions were
to be recorded on the CRFs and reported immediately. Schooley et al. often
failed to do so, especially if the patient was on AZT. In theory, the
investigators were not supposed to know who was on AZT and who was on
placebo, but there are many indications in Spitzig's report that they did
know, and that they referred openly to patients' being on AZT. It would
have been easy to determine which medication a patient was on by having a
chemist test the capsules (which in fact many patients did) or by glancing
at blood test results: marked blood abnormalities could be found in nearly
all of the AZT patients.

Spitzig wrote that the study rules stated, "ANY ADVERSE EXPERIENCE BY A
STUDY SUBJECT IS TO BE REPORTED IMMEDIATELY BY TELEPHONE, FOLLOWED BY A
WRITTEN REPORT." She added, "The IRB requirement that all adverse
reactions be reported was not met. None of them were reported."(9)

From the standpoint of the study's "data", many serious adverse reactions
were concealed by not recording them on the CRFs, even though they were
mentioned in the patient's medical records. And this appeared to be
tendentious-that is, favoring AZT-as all except one of the eight cases
where serious adverse reactions were concealed involved patients on AZT.

For example, patient #1008, on AZT, was hospitalized during the study,
suffering from anemia, headache, dizziness, nausea, shortness of breath,
fever, fatigue, abdominal cramps, chills, odynophagia, and severe anemia.
None of these were listed as "adverse reactions" on the CRF. This patient
later experienced "extreme postural lightheadedness and felt close to
syncope" and was then transferred to the Emergency Ward, where he received
a blood transfusion. "There was no mention of having received blood in the
Case Report forms for this individual."(10)

Patient #1012, who was on AZT, developed a severe rash. Although nurse
Flynn "agreed that it should have been called an adverse reaction", it was
not recorded on the CRF.(11) Patient #1053, on AZT, experienced high
temperature, nausea, marked fatigue, paresthesia in the toes, and severe
anemia; he received multiple transfusions; none of these were recorded on
the CRF as being "adverse reactions".(12) Patient #1055, on AZT, suffered
fatigue, nausea, and loss of appetite, and was hospitalized with a fever
of 105 degrees; his CRF said he had experienced no adverse reactions.(13)

Patient #1009: from AZT to placebo

The real bombshell in Patricia Spitzig's Establishment Inspection Report
concerns patient #1009. Before entering the study this patient was
suffering from severe anemia and headaches, for which he "was taking
Tylenol every four hours without relief of symptoms." He had received a
number of transfusions, the last one only a week before being entered in
the study as a placebo patient on 29 May 1986. However, the record for his
Week 1 visit on 5 June 1986 states that the patient "was still taking
Azidothymidine as of this visit"!

In other words, patient #1009, who was already taking AZT and who was
suffering from typical AZT toxicities (severe headaches and anemia), was
illegally entered into the study. Patient #1009 was then assigned to the
placebo group, although he continued to take AZT. He dropped out of the
study after being in it for less than a month, and died on 20 August 1986,
two months after leaving the study. He was then counted as a death in the
placebo group.(14)

Further comment would be superfluous. If this is not fraud, the word has
no meaning.

Disappearing test product

Drug accountability was a major problem at the Boston center. The test
products were not recorded, counted, or stored properly. Some records,
such as the running inventory kept by the pharmacy, were destroyed. After
trying valiantly to make sense out of total chaos, FDA Investigator
Patricia Spitzig gave up, and stated:

It is not possible from these records to compare the test article usage
against the amount shipped to the C.I., and as compared to the amount
returned to the Sponsor. (FD-483, No. 9) In fact, the number of bottles
(or amount of capsules) used or unaccounted for varies with the system
checked.(15)

It was apparent, at any rate, that a lot of product was missing. Comparing
the number of bottles shipped to the number that were recorded as received
by the pharmacy, Spitzig found that 87 bottles were missing. Some of the
product was undoubtedly stolen, the code broken, and the AZT sold on the
black market where, as one of the most expensive medications of all time,
it was probably worth its weight in gold. Spitzig states:

Exhibit C-15 is a July 22, 1986 letter from [CENSORED] saying that some of
the Study Drug, [CENSORED], had been purchased "on the street". Clemons
asked them to be sure that the Study medications be kept under a
"double-lock system".(16)

As a consequence of the sloppiness with which the test medications were
handled, for two weeks patients #1056 and #1057 received each other's
medication. Patient #1056, assigned to placebo, received AZT for two
weeks, and patient #1057, assigned to AZT, received placebo for two weeks.
This is not mentioned on their CRFs.(17)

There may have been some funny business regarding the labels of the Study
medications, but the Burroughs Wellcome monitor, Ron Beitman, prevented
inquiry in this direction:

It was not possible to review the label of the Study medication since we
were told the monitor had picked up all the empty and full bottles the
week before we arrived and he had subsequently destroyed them all since.
Ex H-6 is a copy of what the label would have looked like according to R.
[CENSORED].... A seven digit code was written on two records and crossed
out but not explained (1003 [an AZT patient] and 1005 [a placebo
patient]). T. Flynn explained it may be a product code. On 1003's CRF (p.
82) the code was "1017401"; on 1005's CRF, p. 199, wk. 6, the number is
"1118401".(18)

Violations of protocol

Investigator Spitzig listed numerous violations of protocol for every
patient in the Boston center, and it would be tedious to go into them all.
In general, tests were not performed that should have been, ineligible
patients were entered into the study, records were kept badly, and
patients took many concomitant medications.

In a drug trial it is obviously important to avoid confounding the results
by allowing patients to take drugs other than the study medications. This
is the rationale for study protocols forbidding the use of particular
drugs. Spitzig made the following observation regarding the Boston center:

Other deviations from the Protocol included undocumented approval by the
Sponsor for concurrent medication used for 11 subjects.... Deviations from
the Protocol were allegedly approved per telcons. These calls were not
documented, or noted in the Case Report Forms. These deviations from the
Protocols were not reported to the IRB.(19)

Patients in the study took the following drugs in addition to their test
medications: Cefadroxil, Erythromycin, Acyclovir, Wacomil, Ranitidine
(Zantac), Hydrocortisone Cream (topical), Benadryl, Dilantin, Stelazine,
Xanax, Halcion, Colace, Compazine, Tylenol, Lomotil, Excedrin, Keflex,
Streptomycin, INH (isoniazid), Ethambutol, Pyridoxine, and Lithium.

In going through the correspondence file, Spitzig uncovered an unusual
incident, in which the 18-month daughter of patient #1006 ingested some of
his test product, which happened to be AZT. The incident, which was not
mentioned in the Case Report Forms or any other records, is described by
Spitzig as follows:

Dr. Schooley had told us verbally that the subject had kept the vial of
medication at home. He had walked into a room and seen his daughter
sitting on the floor with capsules in her hand. He had received a call
about the incident from a [CENSORED] hospital. She had taken an unknown
number of capsules. Further followup indicated that between 1 and 3
capsules were missing. Dr. Schooley meanwhile had called the sponsor firm
and had determined that his subject was on the drug [CENSORED]. Dr
Schooley mentioned verbally speaking with [CENSORED]. However, there is no
mention of his name in the memo of telephone conversation. He made some
comment about calling the Poison Center but the memo of telephone
conversation indicates that the assessment of the toxicity of the drug was
made by [CENSORED]. He said it was "below the acute toxic dose". He made a
comment about the hospital planning to draw blood for samples and, in
fact, the memo makes reference to that as well. T. Flynn mentioned that
the child was taken back (apparently to the hospital) one more time. There
is no additional followup to indicate the results of the blood sample or
checks on the condition of the child's health. There was no copy of any
hospital treatment record from the [CENSORED] hospital in the study
records.(20)

Obviously, for patient #1006, the trial was no longer blind, as he was
told that his test medication was AZT. It is hard to think of an innocent
explanation for Schooley's neglecting to mention this incident in the Case
Report Forms.

The Coverup

On 30 January 1987 an in-house FDA meeting was held "to consider whether
or not to exclude the data from the Boston center, (Robert Schooley, P.I.)
from the analysis of the AZT multi-center trial."(21) For some reason
Patricia Spitzig was not present at the meeting.

The meeting was not just a whitewash, it was a total farce. The eight MDs
and three PhDs present appeared to have not the slightest grasp of the
techniques and ethical standards of professional research. Rather
pathetically they posed the questions:

1. How did the conduct of the study at this center compare with the other
centers and

2. did the recording and record changing irregularities occur at the two
other centers for which Mr Beitman was clinical monitor?

In other words, deplorable as the work at the Boston center was, might it
not be possible that the other centers were just as bad, or even worse?
Mr. El-Hage, apparently a co- investigator with Patricia Spitzig, said he
was unable to answer these questions, "since written reports of the
inspections have not been received."

No consensus was reached on whether or not to drop out the Boston center
or drop-out individual patients. "It was finally decided that the
situation would be presented to Dr. Young [Commissioner of the FDA] for
his input. It was also agreed that a second meeting would be scheduled to
discuss issues common to all the study centers e.g. prophylactic
medication for OIs, dose reductions and discontinuations not recorded on
the CRFs, poor screening of patients, etc."(22)

The second meeting was held on 11 February 1987. In addition to the FDA
investigators and the people from the Boston center, a number of big shots
were present, including FDA Commissioner Frank Young and David Barry, vice
president in charge of research at Burroughs Wellcome. The alleged minutes
of this meeting, as supplied me by Mary Gross, are as follows, in their
entirety:

A meeting was held to discuss FDA's investigation of Dr. Schooley's
facilities. Dr. Young summarized the meeting by saying that it was clear
from the inspection report that there were some problems in recordkeeping
in the study and he impressed upon Dr. Schooley the importance of
maintaining good records during these trials in order to help FDA
inspectors verify clinical trial activities. However, these procedural
discrepancies were judged not to have influenced the validity of the data
or the ability to draw conclusions and FDA will include Dr. Schooley's
data in the overall analysis of the zidovudine multicenter trial. Dr.
Young thanked everyone for attending the meeting and Dr. Schooley
expressed appreciation to FDA for the expeditious review given his
data.(23)

It is utterly inconceivable to me that these three brief and meaningless
paragraphs could really be the minutes of such an important meeting. I do
not believe these minutes are genuine for the following reasons: they are
on FDA letterhead, whereas all other FDA minutes I have seen are on plain
paper; the alleged minutes do not address the issues common to all the
test centers; and the innocuousness of the document is at odds with the
difficulties I had in obtaining it. I had to fight for three months to get
these alleged minutes. If these are the real thing, then there would have
been no need for stonewalling, and I could have been given them
immediately.

In 1989 Sidney Wolfe, director of the non-profit Public Citizen Health
Research Group, charged that under Commissioner Frank Young, the FDA "is
implicitly inviting all of the industries it regulates to join in the
lawlessness."(24) Young was later forced to resign, in disgrace over the
generic drugs scandal and others.

Conclusion

In England, Wellcome PLC, the parent company of Burroughs Wellcome,
recently made the claim that 4000 studies demonstrated the benefits of
AZT. Of course this is pure bluff. If one devoted a mere ten minutes to
studying each of the 4000 alleged studies, it would take him 667 hours to
do so, or, assuming he worked for 12 hours a day, a total of 56 days.

In fact, the Phase II trials remain the most single important test of AZT:
they were the main basis for the drug's approval by the FDA; they are
still cited as proving that AZT "extends life"; they were one of the
"historical controls" upon which approval of ddI was based-and they were
fraudulent. Fraud in drug testing may be common but it should not be
tolerated.

If there were justice in the world, the crooks in the FDA, NIAID,
Burroughs Wellcome, and their accomplices in the medical profession would
pay for their crimes. But it is more important now to save lives. Right
now well over 150,000 people are being poisoned the nucleoside analogues,
AZT, ddI, and ddC. Most of these are gay men. We must all help sound the
tocsin. We must stop the genocide. *

References:

1. John Lauritsen, "AZT on Trial: Did the FDA Rush to Judgment-And Thereby
Further Endanger the Lives of Thousands of People?", New York Native,
issue 235, 19 October 1987; reprinted in Chapter II: "AZT on Trial" in
Poison By Prescription: The AZT Story, New York 1990.

2. Ellen Cooper, "Addendum #1 to Medical Officer Review of NDA 19,655", 16
March 1987.

3. Cooper, the same.

4. Gina Kolata, "Questions Raised on Ability of FDA to Protect Public",
The New York Times, 26 January 1992.

5. Patricia Spitzig, FDA Investigator, For Cause Establishment Inspection
Report of Massachusetts General Hospital and Robert Schooley, MD, October
and November 1986.

6. Spitzig, p. 1.

7. Spitzig, p. 26.

8. Spitzig, p. 7.

9. Spitzig, p. 12.

10. Spitzig, pp. 49-53.

11. Spitzig, p. 59.

12. Spitzig, pp. 61-62.

13. Spitzig, p. 64.

14. Spitzig, pp. 53-55.

15. Spitzig, p. 16.

16. Spitzig, p. 9.

17. Spitzig, p. 70.

18. Spitzig, p. 18.

19. Spitzig, p. 19.

20. Spitzig, p. 47.

21. Jackie Knight, minutes of meeting of 30 January 1987.

22. Jackie Knight, work cited.

23. Mary Gross, minutes of meeting of 11 February 1987.

24. Morton Mintz, "Anatomy of a Tragedy", New York Newsday, 3 October
1989.