AZT - CAUSE FOR CONCERN
Tonight, Dispatches challenges
the claims made for the main anti-AIDS drug, AZT. In America later this
evening, the results of a new study of life expectancy for those on the
drug will be published. Those results will throw new doubts on the effectiveness
of AZT. Tonight's Dispatch is the third on the subject of AIDS.
As before, the programme's advice is clear; no-one should alter medication
without consulting a doctor - still less, on the basis of a television
programme. But the role of tonight's Dispatch is to examine the
evidence. It will argue that in this country, the Wellcome Foundation,
the manufacturers, are making false and misleading claims about the drug
and could be in breach of the law. That's AZT - CAUSE FOR CONCERN.
In May, 1990, the American
AIDS activist group ACT UP organised a demonstration outside the National
Institutes of Health in Maryland. They were protesting about AZT or zidovudine,
the only approved drug for AIDS. This was a remarkable about turn because
three years earlier other ACT UP demonstrations had clamoured for more
AZT to made available at a cheaper price. What had changes?
For several years the
rock magazine Spin has run an AIDS column. In it journalist Celia Farber
has kept a close and critical watch on AZT.
CELIA FARBER: "Attitudes
about AZT have changed dramatically over the last couple of years and especially
in the last year. The leaders of the gay community in the major cities
here were on AZT, many of them in the beginning. And then when it stopped
working for them they turned around and they said "It isn't working".
Whereas initially they had defended it so adamantly."
GENE FEDORKO: "A lot
of people who were involved with ACT UP, and who were on nucleoside analogues
like AZT, had bad experiences with the drug eventually. And then there
was a panic, and then there was this realisation, this horrible disillusionment
that indeed the drug they were begging the government to get into their
bodies were in fact very ineffective if not toxic."
If they were aware that
the drug had unfortunate side effects, why were people so anxious to take
CHRIS BABICK: "Because
there didn't seem to be any alternative. The propaganda was that AIDS is
a hundred percent fatal which it isn't. There is a 15% survival rate today,
and of course people are living longer, and people were desperate at that
time, and didn't know much. AIDS is basically political. It's been politicised,
moralised in this country and there's a lot of misinformation about the
Through public protests
and demonstrations AIDS activists were giving voice to serious misgivings
about toxicity and the expectations for AZT amongst leading doctors and
DR. MICHAEL LANGE (Head of
AIDS Programme St. Lukes Hospital, New York): "I think the central
fact is that despite five years of AZT and trials, and four on the open
market, people keep dying in large numbers, and hence it is clearly not
as wonderful a drug or life saver as it is made out."
DR. JOHN HAMILTON (co-chair
Veteran's Administration AZT Study, Durham, North Carolina): "First
of all I think it's self evident that our study does not provide the kind
of benefit that everyone wished for. It can't be a secret that patients
wanted something that would help them live longer. Unfortunately it has
not demonstrated that and therefore this has to be unwelcome news."
DR. ROBERT HOFFMAN (Professor
Cancer Biology, University of California, San Diego): "Well the effect
of AZT on body cells as a whole is very deleterious because it prevents
cells from replicating. There's a second point in that cells that may survive
AZT may themselves become cancerous so there is a double danger for AZT
the way I see it."
When AZT was licensed
in the United States in 1987 hopes were running high. Tucked away in a
corner of the massive Jackson Memorial Hospital complex, is Miami University's
AIDS research unit. Here Dr. Margaret Fischl was one of the leading figures
in the trials that led to the licensing of the drug.
DR. MARGARET FISCHL: "I
think in the very beginning when the studies were actually being designed,
our greatest expectation or hope would be that it would delay progression
of the disease, it would improve quality of life, decrease the severity
of the disease. Although we designed survival benefits into this study
we actually did not expect to see them."
At San Francisco General,
Dr. Paul Volberding another leading AZT researcher supports AZT's early
DR. PAUL VOLBERDING: "The
drug was approved in 1987, for use in what we would now call advanced HIV
disease, patients who had substantial deterioration, on the basis of a
clinical trial that was really quite short. But a trial that showed, compared
to the placebo, a rather striking difference in the mortality rate in patients
with AIDS. So we stared experience with the sense that this was a very
active drug clinically, but with still questions to be answered about the
appropriate use of the drug, the appropriate dose of the drug."
The results of the early
AZT trial on people with full blown AIDS appeared to be so convincing that
the drug was given a new fast track approval by the United States Food
and Drug Administration - before any long term toxicity trials in animals
had been completed.
COMMISSIONER FRANK YOUNG:
"These new regulations specifically will have special criteria that
would apply to immediately life threatening conditions recognising that
such patients are willing to accept the greater risk than that which normally
would be the case."
The Wellcome Foundation,
UK manufacturer of AZT saw its shares spiral upwards. AZT was to be the
new wonder drug. Then in 1989 after further trials were terminated early
in the United States because results looked promising, it was announced
that AZT could be used not only in people with AIDS diseases but in a much
larger group with HIV and low immune cell count but no other symptoms.
Wellcome's shares soared to new heights adding 1.4 billion pound to the
company's UK stock market value in one day. Today annual sales of AZT are
worth around 170 million pound.
Opening up the drug's
use to so-called "asymptomatics" means a substantial increase
in the number of people who could be prescribed AZT indefinitely. In the
UK the estimated number of HIV positive people is 50,000. In the United
States it's around one million. This 1990 US poster campaign - Living with
HIV - was co-sponsored by Burroughs Wellcome. People were encouraged to
get tested for HIV. The posters said: 'Early medical intervention could
put time on your side.' As AZT was the only approved drug for AIDS at the
time this was a way of increasing Wellcome's market for the drug.
DR. MICHAEL LANGE: "I
think it's a disgrace. It lures people into the belief that if they're
HIV positive they should go and get themselves tested and that there's
an answer that will keep them alive and that's far from the truth."
More and more people with
no symptoms of AIDS but who have HIV and a low immune cell or T-cell count
are being drawn into AZT studies. The Concorde trial based here at the
Middlesex Hospital and at the Brompton Hospital in London involves some
3,000 British and French participants with HIV but no AIDS symptoms. In
October last year, a progress meeting was held at the Terrence Higgins
Trust. We were barred but an amateur recording has been handed to us. Professor
Ian Weller, chairman of the Concorde trial working party, argued the case
for continuing the trial.
DR. IAN WELLER: "It
seems to me that the Data and Safety Monitoring Committee feel very comfortable
in allowing this study to proceed into what I think is new territory. And
my feeling is that it's that territory that most patients and physicians
are interested in. that is if there is benefit, is it maintained, or will
it wear off? In which case we may cause more harm than good."
Professor Weller said
that the monitoring committee found no clear evidence on which to base
new recommendations for clinical practice and that the trial into AZT or
zidovudine would continue for a further seven months. He also said:
DR. IAN WELLER: "My
feeling is that this is the only chance, that anyone will have of sorting
out the uncertainty that I think is at the basis of some of the frustration.
That is whether it is better in the mid to long term - rather than short
term - to give zidovudine early or rather leave it to a later stage of
infection. Early intervention does make biological sense. The question,
the pragmatic question, the practical question is, do we have the right
AZT was first developed
in 1964 as a cancer chemotherapy drug. It was designed to destroy proliferating
cells. Later at the US National Cancer Institute in Maryland it was tested
as an AIDS drug. Normally cancer chemotherapy drugs are used for limited
periods but AZT is given for open ended use. It's effect on the body can
be very serious. Some people simply can't tolerate it and suffer vomiting,
muscle pain and unendurable headaches. Lower doses produce less side effects
but on high doses bone marrow cells are affected with up to 30% of recipients
needing blood transfusions.
DR. ROBERT HOFFMAN: "I
believe that the drug AZT can have at least two important areas of toxicity
and that is the inhibition of production of critical white cells and also
the production of malignant cells such as lymphoma cells. The two courses
can be monitored but they can also reach the point of no return where nothing
can be done about it. So even with monitoring, these toxicities can be
Although the effects of
AZT also called by its generic name zidovudine are listed in Wellcome's
US and UK information sheets for doctors, their promotional leaflet for
doctors and the public in the UK makes some startling claims about AZT's
safety and efficacy. For example, it states here that doctors can manage
the serious blood problems and 'there are no life threatening toxicities
associated with zidovudine.' These and other claims have encouraged some
doctors and patients to embark upon high dose therapies, sometimes over
long periods of time. There is evidence that some of these claims are false
and others seriously misleading. There are worrying differences and omissions
between the US and UK doctor's information sheets.
Before a drug is licensed
for use it normally has to undergo animal toxicity studies and clinical
trials in humans. No long-term animal studies were completed when AZT was
licensed. The clinical studies in humans - called phase-II - which led
to the licensing of AZT were financed by Wellcome. They were presented
as complying with the only reliable scientific test for a drug - double
blind studies - and published in the New England Journal of Medicine in
July 1987. In this type of trial one group is given the drug and the other
a placebo or a dummy tablet. Neither the volunteers nor their doctors should
know who is getting what, in order to eliminate any bias in expectation
of what a particular treatment, or no treatment, may do. This is called
blinding. In this document Wellcome claims that: 'Non of the volunteers
or the clinicians involved knew who had received placebo and who had received
the active drug.'
We have the following
evidence that the trials became unblinded early on. This internal document
from the Food and Drug Administration, the US authority that licensed the
drug, was obtained through the freedom of information procedure. Dr. Ellen
Cooper in reviewing the AZT data writes: 'The fact that the treatment groups
unblinded themselves early could have resulted in bias in the work up of
patients.' If the FDA knew this then Wellcome would have been incompetent
not to know.
Through the pages of the
New York Native, a gay weekly newspaper, journalist John Lauritsen, author
of the book AZT; Poison by Prescription, and deputy editor Neenya Ostrum
have kept up constant pressure about inconsistencies in the events that
led up to the licensing of AZT.
JOHN LAURITSEN: "There
were so many contradictions. But the real horror of this study only became
apparent after going through documents which were obtained under the Freedom
of Information Act. And it indicated that there had been not only sloppiness
of every conceivable sort but that there had been actual cheating in a
number of areas. It indicated that the study had become unblinded very
quickly in the first few weeks although it was planned as a double-blind
placebo-controlled study. In fact, it was nothing of the kind. Both patients
and doctors knew who was getting AZT and who was getting placebo."
As far as we can ascertain
everyone in the phase-II trial has died. Chris Babick of People with AIDS
Coalition used to advise trial participants on a telephone helpline where
they could get their pills analysed.
CHRIS BABICK: "During
the phase-II trials we received many phone calls in our office from individuals
who wanted to determine whether or not they were using the placebo or actually
receiving AZT. There were three laboratories in New York which would analyse
the medication. We would refer individuals there. If in fact they were
on placebo they would make arrangements to acquire the drug AZT. Often
times they would share it with individuals who were in the trials and thus
really rendering the phase-II trial, unblinding the phase-II trial."
Dr. Michael Lange helped
run one of the trial centres.
DR. MICHAEL LANGE: "I
don't think they were really blinded because when you take AZT your red
blood cells increase in size and this happens after two to three weeks
and you can notice that on an ordinary blood count, and since blood counts
were monitored and the information fed back to patients, this information
was available to the investigators."
DR. PAUL VOLBERDING: "Well,
I don't think it's completely true that the trial was unblinded. There
- in retrospect - are ways that we could have known who was taking the
drug. The drug causes the red blood cells - for example - to enlarge in
size. But that wasn't really known at the time. And so I think that trial
was in fact quite well blinded."
Did you knew that the
phase-II trials became unblinded earlier on in the study?
DR. MARGARET FISCHL: "Oh,
I don't think it became unblinded. I think that's fanfare and does incredible
misjustice to that trial. Did we know that, or suspect that some of the
patients were on AZT? Of course. You know when you say unblinding you assume
that the whole study is unblinded. That both the patients and physicians
know exactly what they're on and that typically does not happen in most
clinical trials. Are patients suspicious sometimes of what they're on?
Yes. Do they necessarily change their behaviour because of that? No. do
physicians or nurses that care for patients in blinded studies sometimes
suspect what the patient is on? Yes. Does that necessarily change their
behaviour in the conduct of a trial? No. they typically will proceed with
the conduct of the trial as it is outlined."
JOHN LAURITSEN: "Well
one could argue over how much of an effect it would have for a study to
become unblinded. Certainly all kinds of biases are possible. It could
be everything from the psychological effect on the patient to the way that
the doctor managed it. But certainly the gold standard of drug testing
is a double-blind placebo-controlled study. And most importantly, if the
study was not blinded it is dishonest to describe it as being a blind study.
And to this very day the advocates of AZT continue to say that this was
a double-blind study when it was certainly nothing of the sort."
We would like to have
put some questions to the Burroughs Wellcome Company based here in Raleigh
North Carolina. Wellcome financed the phase-II trials that led to the fast
track approval of AZT. They declined our invitation to be interviewed.
In the same UK promotional
leaflet Wellcome claims that AZT is an antiviral drug. The leaflet gives
the impression that AZT can target the HIV virus without killing cells.
Professor of Molecular Biology at Berkeley, California, Peter Duesberg,
is known for his view that HIV is not the cause of AIDS. His concern about
the use of AZT stems not simply from this view but from a criticism of
AZT's molecular activity. He objects to Wellcome claim that AZT is an antiviral
DR. PETER DUESBERG: "That's
is a euphemism. It's not wrong, but it kills or inhibits all DNA synthesis,
everything that's going. It inhibits the cell first, and with it the virus."
Peter Duesberg and some
other leading scientists claim that HIV has never been shown in humans
to present a meaningful target for AZT. In order to understand these assertions
we need to examine the way in which a retrovirus - like HIV - works.
The blueprint for all
living cells is the double stranded DNA - deoxyribonucleic acid. But a
retrovirus id different, it's made of a single stranded RNA - ribonucleic
acid - which in order to replicate needs to insert itself into a cell's
nuclear DNA. So, a retrovirus - like HIV - doesn't destroy it host cell.
It penetrates the cell wall and with the help of an enzyme called reverse
transcriptase converts its own single strand of RNA into a double strand
of DNA. It can then insert itself into the nucleus of the cell. The fundamental
life-giving process of cell re-generation depends on DNA. Which is made
up of four building blocks which slot together. One of these is called
thymidine. AZT is a copy or analogue of thymidine, which, when it attaches
itself to the viral DNA chain, stops it because nothing else can attach
itself. Some scientists claim that, whether a cell is infected with HIV
or not, AZT terminates the DNA chain stopping more DNA from being formed.
DR. ROBERT HOFFMAN: "It
inhibits the replication or duplication of DNA and thereby prevents the
cell itself from duplicating."
Wellcome claims that AZT
can target HIV and delay symptoms of AIDS in people who are HIV positive
by inhibiting HIV when reverse transcription takes place.
DR. MARGARET FISCHL: "Once
it enters that cell the drug has to undergo a transformation so it becomes
active and then it actually prevents the virus from getting into the genetic
make up of the cell and infecting that cell."
But Duesberg maintains
that AZT can't prevent the virus from infecting that cell without killing
it and others as well.
DR. PETER DUESBERG: "In
people who are given AZT, healthy or sick, only one in five hundred cells
is ever infected by HIV. That is to say in order to kill that one infected
cell, we have to kill five hundred normal cells, god cells that people
with AIDS desperately need to survive, and healthy people need them too.
It is like trying to kill a terrorist in a city of Berkeley of 200,000
by poisoning the water. You may get the terrorist, but you will get most
of the other people as well."
But does AZT have a viral
target at all?
Peter Duesberg maintains
that once a person has developed antibodies to HIV, HIV becomes inactive
and there's essentially no more reverse transcription going on for AZT
DR. PETER DUESBERG: "There's
no evidence for it. It's not detectable, and the numbers of infected cells
remain the same. It remains very low, and remains constant, which is direct
proof that further infection is not taking place. Further infection depends
on reverse transcription."
Dr. Harvey Bialy supports
this view. He is research editor of Bio/Technology, sister to the science
journal Nature. In this interview he is expressing his personal views.
DR. HARVEY BIALY: "The
majority of time the person is infected with HIV there is essentially no
reverse transcriptase activity that can be detected. So, it is really beyond
me how a drug that is claimed to inhibit reverse transcription of the virus,
inhibit virus replication, can be a suitable agent for treating AIDS, or
even for that matter for treating HIV infection since the immune system
does a very good job of keeping a virus replication at undetectable levels."
On the west and east coasts
of the United Sates, the agony of AZT combined with the uncertainties about
AZT, have led to the growth of support groups like HEAL, run by Michael
Ellner, whose members seek alternative approaches to the treatment of AIDS.
HEAL helps people who are suffering side effects come off AZT.
GENE FEDORKO: "They're
scared. They know that they don't like the way that they feel and we show
them other people who come to HEAL and there's always a good 20 to 30 people
who are on cold turkey from AZT. They just stopped taking it."
Cliff Goodman has been
HIV positive for four years. We asked him if he would take AZT.
CLIFF GOODMAN: "No way.
I wouldn't give it to my cats. I would think it was murder. I've seen people
go on AZT and I've seen them waste and their hair fall out, and their muscles
shrivel below their knee. And I've seen many males become impotent. So,
there's no way I'm gonna take something like that, you know. I think it's
almost like a punishment."
ALLAN ROUNDTREE: "At
first I gained weight and I said 'Boy, this stuff must be working.' And
then about another two weeks later it did start working. The headaches
came. The dizziness, the nauseousness and the whole time. And I had fingernails
that were so black it looked like I had nail polish on, you know. And an
upset stomach, nothing tastes right, food or anything. And the main thing,
it would affect you so where you couldn't listen to people cause you don't
wanna hear them because you're hurting so bad. And it left me impotent.
It destroyed my hopes for living, you know."
Wellcome's AZT promotional
leaflet in the UK states: 'Zidovudine... improves both the quality and
length of life.'
We asked Dr. Lange if
there is any data to support AZT prolonging life?
DR. MICHAEL LANGE: "I
don't think that we have, that the data has been made available. The major
problem is that all published AZT studies were prematurely concluded. And
what happened to these people after the study was concluded is not very
well known, nor is it published anywhere."
Do you believe that AZT
DR. MARGARET FISCHL: "In
patients that have advanced disease? Yes. That has been shown in numerous
studies. When used early, when patients are still asymptomatic, have no
symptoms or they have minimal symptoms and their immune system is not severely
damaged? There we know that AZT prevents or delays the occurrence of AIDS,
which we felt in the United States was the most important thing to look
JOHN LAURITSEN: "The
claim is made that AZT extends life - and yet most of the belief that it
does - are based on the phase-II trials which - as I just said - were seriously
flawed, utterly worthless. Other studies used to claim benefits for AZT
range all the way from tiny little studies of uncontrolled patients. You
know five or six here or there, which are really nothing better than anecdotes."
Dr. John Hamilton, at
the Veteran's Administration Medical Centre in North Carolina, is co-chair
of one of the longest completed AZT studies published in a leading American
medical journal this week. The drug was given to 338 patients. One group
early in the disease, and another when their immune cell count fell below
200. He believes that AZT should be given to people in the later stages
of the disease, but is less certain about giving AZT to people early in
DR. JOHN HAMILTON: "The
results of the trial demonstrated that patients on early therapy had a
delay in the progression to AIDS. However, there was no difference in survival,
comparing one group with the other. That is, the same number of individuals
died in each group and the time at which they died was the same."
Individual people differ
greatly in the way they react to drugs, and there's no way of knowing who
will suffer severe side effects or tolerate the drug well. Jim Pruitt lives
in Miami. He suffered AIDS symptoms since 1986, and took high doses of
AZT for a year. He then broke off treatment because of muscle and liver
problems, and has been on intermittent much lower doses since then. Although
Jim's T-cell count hasn't improved overall since he started on AZT, he
says it has improved his quality of life.
JIM PRUITT: "I began
to feel better. I started gaining weight, the fevers went away, clinically
I was doing better. My energy returned. This was not a response that I
think everyone experienced with this drug, but my response was very good."
Gordon living in Central
London has had no problems with AZT. Because he had developed mouth lesions
and had a low blood clotting cells - or patelets - he was prescribed 1000
milligrams of AZT for 18 months. He's now reduced his dose by half.
GORDON: "I do accept
that I'm one of the lucky ones. I do of course accept the evidence that
it is not a good drug, and that it does have toxicities, which can be quite
severe. My attitude would be: find out all you can about it. Ideally talk
to someone who has a good experience of the drug, and someone who had a
experience of the drug. And then you just have to follow your own instincts."
Cass Mann is a volunteer
counsellor for Positively Healthy, the London based self-help group. It
provides members with free information about AIDS and different treatments.
Does he think AZT improves quality of life?
CASS MANN: "No. That
is not true. I have never seen it improve the quality of life. Certainly
when people begin the drug, they begin with the best possible motive and
expectation, but after a period of time there are of course people who
claim it does. But I've known no one who's been on it for an extended period
who would claim that."
DR. JOHN HAMILTON: "There
has been no formal demonstration of improvement in quality of life. It
was assumed that the delay in progression to AIDS would translate into
an improved quality of life because it seemed logical and made sense. In
fact, the only study that has been done on this point and published to
my knowledge has failed to demonstrate an improvement in quality of life."
In the UK and US doctors
reference books there are marked differences in the entries about AZT under
its brand name Retrovir. For example in the US entry there is a section
called 'Information for Patients'. There is no such helpful section in
the UK Data Sheet Compendium. In this US section it states that patients
should be informed that: 'the drug had been studied for limited periods
of time and that long-term safety and efficacy are not know.' Nowhere does
this appear in the UK document. There are other omissions and anomalies.
Human Rights Lawyer Larry Gostin, director of the American Society of Law
and Medicine in Boston, believes AZT can benefit people with AIDS, but
that the difference in information is concerned that the difference in
information discriminates against people in Britain.
LARRY GOSTIN: "In effect
that treats patients in Britain less favourably, and with less respect
than patients in the United States. And that is wrong. The drug companies
ought to disclose to physicians, and physicians should disclose to patients,
all relevant risks, whatever the country maybe, whatever the legal system
In West London, Stuart
Marshall is also concerned about the different standards of information.
He's a trustee of Positively Healthy. He knows he's been HIV positive for
eight and half years, and has always resisted pressure to take AZT. His
immune cell or T-cell count has quadrupled over the last four years and
is now between five and six hundred.
STUART MARSHALL: "When
I was first offered AZT I was told nothing at all about the side effects.
I knew a lot about the side effects because of having a lot of information
from America about it. It's really my opinion, based on a of personal experiences
that people are still not being told about the side effects properly, and
therefore I don't think they're able to make a proper informed decision
about whether they should take the drug or not."
Currently in the USA,
much speculation and concern surrounds possible links between AZT and the
emergence of a type of lymphoma or cancer of the blood in the late stages
of AIDS. This FDA internal document, describing mutating human cells in
an AZT laboratory experiment, says: 'This behaviour is characteristic of
tumor cells and suggests that AZT may be a potential carcinogen'. However,
Dr. Paul Volberding believes that the lymphomas appearing late in AIDS
patients are not associated with AZT.
DR. PAUL VOLBERDING: "The
appearance of lymphomas in patients receiving anti-retroviral therapy is
a reflection of the longer duration of survival, and the ability to remain
alive, and therefore unfortunately, at risk for some of these other complications
of HIV disease. So, we see the lymphomas as an unfortunate reflection of
our success at this point, rather than a reason for real caution."
We asked Dr. Michael Lange
if he was convinced by the explanation that lymphoma is a natural consequence
of living longer with AIDS.
DR. MICHAEL LANGE: "No
I'm not. The major reason for that is that most, almost all the lymphoma
that I have seen was a first AIDS event, and occurred not at the late stages
of the disease, but was the diagnosis that was made, that made that patient
an AIDS patient. And prior to AZT coming along I never saw lymphoma in
people who had had several opportunistic infections as a late stage event."
In October last year,
a new anti-AIDS drug called ddI with similar mechanism to AZT was licensed
in the United States under the fast track system. in the USA AZT is now
being tested on pregnant women. And London's Great Ormond Street Hospital
for sick children will soon be part of a European AZT study involving several
hundred children and babies. All of this is occurring without any real
Of course no one should
ever change medication whatever the drug without proper medical advice.
Many AIDS doctors and carers are convinced that particularly in the later
stages of the disease AZT is invaluable. But some of its greatest exponents
are only too aware of its limitations.
DR. MARGARET FISCHL: "Does
AZT prevent death? No. Does AZT cure AIDS? No. No one ever said it did.
It only works by preventing cells from becoming infected. So, therefore
it will have limitations and we recognise that and that's why drug development
has still surged ahead."
As we've already demonstrated
it's arguable whether AZT can actually 'prevent' cells from becoming infected
without killing them as well. So, what are we left with? At best its supporters
argue that AZT can delay progression to full blown AIDS. Albeit with side
DR. PAUL VOLBERDING: "I
think the question is one of starting the drug before the patient becomes
so advanced that the side effects become intolerable. But in terms of long-term
administration, I think when the contrast is taking a drug that has some
possibility of toxicity, versus the certainty of disease progression without
the drug, I think most people make the understandable decision to try drug
But critics of AZT argue
that the benefit is not proven.
DR. MICHAEL LANGE: "I
would say in most cases, or in a number of cases, you do see a small increase
in T4-cells during the first three to four months. Usually by six to nine
months, if you are lucky by twelve months, you're back to where you started
from. And from there on there's in most cases a general decline so that
you end up with T4-cells less than beforehand."
Resistance to calls for
more open debate about AZT has come from the US FDA, the medical profession,
and the pharmaceutical industry. The FDA and Burroughs Wellcome in the
United States, two doctors running the current UK Concorde trial, and the
Wellcome Foundation in the UK, have all refused to take part in this programme.
Wellcome UK said this was because they didn't believe we would be sufficiently
balanced and objective in our approach to the subject of AZT to make a
reasonable programme about it. Last week Wellcome made another announcement
encouraging the wider use of AZT. This letter issued to doctors in the
UK describes favourable results from a trial in ten countries involving
nearly 1000 HIV positives without very low immune cell counts. But the
doctors have been approached before details of the trial have been published
in a scientific journal.
In the UK there has been
negligible coverage of the issues surrounding AZT. In the USA however more
voices have been raised. Florida's Miami Herald has kept up a spirited
attack on the AZT establishment through journalist Elinor Burkett.
ELINOR BURKETT: "The
reaction almost universally in the research community and the patient community
was hysteria. There was tremendous sense that I think has happened to journalists
all over the world, that by writing such an article, I was being socially
irresponsible because I was going to make a group of very sick people stop
taking their medication. The fundamental truth of the American research
establishment is that the scientific community feels that it shouldn't
have to answer to the rest of us. So, the notion that a non-scientist would
go in and question the research that they used, the accuracy of their data,
and the truth of their interpretation, provoked a tremendous controversy
throughout the research establishment."
CELIA FARBER: "I think
there's a terrific arrogance. I think there's always been an arrogance
on the part of the medical establishment. They believe themselves to know
everything, and once they've made up their minds about something they're
very unwilling to change it."
Dispatches has been advised
by leading counsel that the false and misleading claims about AZT described
in this programme could amount to a breach of the Medicines Act, which
if successfully prosecuted would constitute a criminal offence. Dispatches
is sending a dossier of relevant information to the Medicines Control Agency
at the Department of Health.