AZT-
Cause For Concern
Transcript
UK Channel 4 Dispatches Documentary
Meditel
Productions,
London 1992
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 it?
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 disease."
Through public
protests and demonstrations AIDS activists were giving voice to
serious misgivings about toxicity and the expectations for AZT amongst
leading doctors and scientists.
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 track record.
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 tool?"
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 life
threatening."
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 drug.
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 to target.
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 prolongs life?
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 for."
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 the disease.
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 may be."
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 public debate.
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 effects.
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 therapy."
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. *
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