Omission: The AZT Scandal
Spin Nov. 1989
On a cold
January day in 1987, inside one of the brightly-lit meeting rooms
of the monstrous FDA building, a panel of 11 top Aids doctors
pondered a very difficult decision. They had been asked by the
FDA to consider giving lightning-quick approval to a highly toxic
drug about which there was very little information. Clinically
called Zidovudine, but nicknamed AZT after its components, the
drug was said to have shown a dramatic effect on the survival
of Aids patients. The study that had brought the panel together
had set the medical community abuzz. It was the first flicker
of hope - people were dying much faster on the placebo than on
But there were
tremendous concerns about the new drug. It had actually been developed
a quarter of a century earlier as a cancer chemotherapy, but was
shelved and forgotten because it was so toxic, very expensive to
produce, and totally ineffective against cancer. Powerful, but unspecific,
the drug was not selective in its cell destruction.
around the world were sifting through hundreds of compounds in the
race to find a cure, or at least a treatment, for Aids. Burroughs
Wellcome, a subsidiary of Wellcome, a British drug company, emerged
as the winner. By chance, they sent the failed cancer drug, then
known as Compound S, to the National Cancer Institute along with
many others to see if it could slay the Aids dragon, HIV. In the
test tube at least, it did.
At the meeting,
there was a lot of uncertainty and discomfort with AZT. The doctors
who had been consulted knew that the study was flawed and that the
long-range effects were completely unknown. But the public was almost
literally baying at the door. Understandably, there was immense
pressure on the FDA to approve AZT even more quickly than they had
approved thalidomide in the mid-60s, which ended up causing drastic
worried about this one. To approve it, said Ellen Cooper, an FDA
director, would represent a "significant and potentially dangerous
departure from our normal toxicology requirements."
approving the drug, one doctor on the panel, Calvin Kunin, summed
up their dilemma. "On the one hand," he said, "to
deny a drug which decreases mortality in a population such as this
would be inappropriate. On the other hand, to use this drug widely,
for areas where efficacy has not been demonstrated, with a potentially
toxic agent, might be disastrous."
not know what will happen a year from now," said panel chairman
Dr. Itzhak Brook. "The data is just too premature, and the
statistics are not really well done. The drug could actually be
detrimental." A little later, he said he was also "struck
by the facts that AZT does not stop deaths. Even those who were
switched to AZT still kept dying."
with you," answered another panel member, "There are so
many unknowns. Once a drug is approved there is no telling how it
could be abused. There's no going back."
reassured the panel that they would provide detailed two-year follow-up
data, and that they would not let the drug get out of its intended
parameters: as a stopgap measure for very sick patients.
Dr. Brook was
not won over by the promise. "If we approve it today, there
will not be much data. There will be a promise of data," he
predicted, "but then the production of data will be hampered."
Brook's vote was the only one cast against approval.
not enough data, not enough follow-up," Brook recalls. "Many
of the questions we asked the company were answered by, 'We have
not analyzed the data yet,' or 'We do not know.' I felt that there
was some promising data, but I was very worried about the price
being paid for it. The side effects were so very severe. It was
chemotherapy. Patients were going to need blood transfusions. That's
was tending to agree with me," says Brook, "that we should
wait a little bit, be more cautious. But once the FDA realized we
were intending to reject it, they applied political pressure. At
about 4 p.m., the head of the FDA's Center for Drugs and Biologics
asked permission to speak, which is extremely unusual. Usually they
leave us alone. But he said to us, 'Look, if you approve the drug,
we can assure you that we will work together with Burroughs Wellcome
and make sure the drug is given to the right people.' It was like
saying 'please do it.'"
FDA press officer, was at that meeting. He says he doesn't recall
that particular speech, but that there is nothing 'unusual"
about FDA officials making such speeches at advisory meetings. "The
people in that meeting approved the drug because the data the company
had produced proved it was prolonging life. Sure it was toxic, but
they concluded that the benefits clearly outweighed the risks."
ended. AZT, which several members of the panel still felt uncomfortable
with and feared could be a time bomb, was approved.
August 17, 1989. Newspapers across America banner-headlined that
AZT had been "proven to be effective in HIV antibody-positive,
asymptomatic and early ARC patients," even through one of the
panel's main concerns was that the drug should only be used in a
last-case scenario for critically-ill AIDS patients, due to the
drug's extreme toxicity. Dr. Anthony Fauci, head of the National
Institutes of Health (NIH), was now pushing to expand prescription.
The FDA's traditional
concern had been thrown to the wind. Already the drug had spread
to 60 countries and an estimated 20.000 people. Not only had no
new evidence allayed the initial concerns of the panel, but the
follow-up data, as Dr. Brook predicted, had fallen by the waysite.
The beneficial effects of the drug had been proven to be temporary.
The toxicity, however stayed the same.
of those in the AIDS afflicted and medical communities held the
drug up as the first breakthrough on AIDS. For better or worse,
AZT had been approved faster than any drug in FDA history, and activists
considered it a victory. The price paid for the victory, however,
was that almost all government drug trials, from then on, focused
on AZT - while over 100 other promising drugs were left uninvestigated.
stock went through the roof when the announcement was made. At a
price of $8,000 per patient per year (not including blood work and
transfusions), AZT is the most expensive drug ever marketed. Burroughs
Wellcome's gross profits for next year are estimated at $230 million.
Stock market analysts predict that Burroughs Wellcome may be selling
as much as $2 billion worth of AZT, under the brand name Retrovir,
each year by the mid-1990s - matching Burroughs Wellcome's total
sales for all its products last year.
AZT is the
only antiretroviral drug that has received FDA approval for treatment
of AIDS since the epidemic began 10 years ago, and the decision
to approve it was based on a single study that has long been declared
The study was
intended to be a "double-blind placebo-controlled study,"
the only kind of study that can effectively prove whether or not
a drug works. In such a study, neither patient nor doctor is supposed
to know if the patient is getting the drug or a placebo. In the
case of AZT, the study became unblinded on all sides, after just
a few weeks.
of the contributed to the unblinding. It became obvious to doctors
who was getting what because AZT causes such severe side effects
that AIDS per se does not. Furthermore, a routine blood count known
as CMV, which clearly shows who is on the drug and who is not, wasn't
whited out in the reports. Both of these facts were accepted and
confirmed by both the FDA and Burroughs Wellcome, who conducted
Many of the
patients who were in the trial admitted that they had analyzed their
capsules to find out whether they were getting the drug. If they
weren't, some bought the drug on the underground market. Also, the
pills were supposed to be indistinguishable by taste, but they were
not. Although this was corrected early on, the damage was already
done. There were also reports that patients were pooling pills out
solidarity to each other. The study was so severely flawed that
its conclusions must be considered, by the most basic scientific
The most serious
problem with the original study, however, is that it was never completed.
Seventeen weeks in the study, when more patients had died in the
placebo group, the study was stopped short, and all subjects were
put on AZT, no scientific study can ever be conducted to prove unequivocally
whether AZT does prolong life.
who voted against approval, warned at the time that AZT, being the
only drug available for doctors to prescribe to AIDS patients, would
probably have a runaway effect. Approving it prematurely, he said,
would be like "letting the genie out of the bottle."
out that since the drug is a form of chemotherapy, it should only
be prescribed by doctors who have experience with chemotherapeutic
drugs. Because of the most severe toxic effects of AZT - cell depletion
of the bone marrow - patients would need frequent blood transfusions.
As it happened, AZT was rampantly prescribed as soon as it was released,
way beyond its purported parameters. The worst-case scenario had
come true: Doctors interviewed by the New York Times later in 1987
revealed that they were already giving AZT to healthy people who
had tested positive for antibodies to HIV.
The FDA's function
is to weigh a drug's efficacy against its potential hazards. The
equation is simple and obvious: A drug must unquestionably repair
more than it damages, otherwise the drug itself may cause more harm
than the disease it is supposed to fight. Exactly what many doctors
and scientists fear is happening with AZT.
AZT was singled
out among hundreds of compounds when Dr. Sam Broder, the head of
the National Cancer Institutes (NCI), found that it "inhibited
HIV viral replication in vitro." AIDS is considered a condition
of immune suppression caused by the HIV virus replicating and eating
its way into T-4 cells, which are essential to the immune system.
HIV is a retrovirus which contains an enzyme called reverse transcriptase
that converts viral RNA to DNA. AZT was thought to work by interrupting
this DNA synthesis, thus stopping further replication of the virus.
While it was
always known that the drug was exceedingly toxic, the first study
concluded that 'the risk/benefits ratio was in favour of the patient."
In the study
that won FDA approval for AZT, the one fact that swayed the panel
of judges was that the AZT group outlived the placebo group by what
appeared to be a landslide. The ace card of the study, the one that
cancelled out the issue of the drug's enormous toxicity, was that
19 persons had died in the placebo group and only one in the AZT
group. The AZT recipients were also showing a lower incidence of
While the data
staggered the panel that approved the drug, other scientists insisted
that it meant nothing - because it was so shabbily gathered, and
because of the unblinding. Shortly after the study was stopped,
the death rate accelerated in the AZT group. "There was no
great difference after a while," says Dr. Brook, "between
the treated and the untreated group."
study was so sloppily done that it really didn't mean much,"
says Dr. Joseph Sonnabend, a leading New York City AIDS doctor.
Bialy, scientific editor of the journal Biotechnology, is stunned
by the low quality of science surrounding AIDS research. When asked
if he had seen any evidence of the claims made for AZT, that it
"prolongs life" in AIDS patients, Bialy said, "No.
I have not seen a published study that is rigorously done, analyzed
and objectively reported."
is also a molecular biologist, is horrified by the widespread use
of AZT, not just because it is toxic, but because, he insists, the
claims its widespread use are based upon are false. "I can't
see how this drug could be doing anything other than making people
very sick," he says.
facts about AZT and AIDS are indeed astonishing. Most ironically,
the drug has been found to accelerate the very process it was said
to prevent: the loss of T-4 cells.
AZT kills T-4 cells [white blood cells vital to the immune system]"
says Bialy. "No one can argue with that. AZT is a chain-terminating
nucleotide, which means that it stops DNA replication. It seeks
out any cell that is engaged in DNA replication and kills it. The
place where most of this replication is taking place is the bone
marrow. That's why the most common and severe side effect of the
drug is bone marrow toxicity. That is why they [patients] need blood
AZT has been
aggressively and repeatedly marketed as a drug that prolongs survival
in AIDS patients because it stops the HIV virus from replicating
and spreading to healthy cells. But, says Bialy: "There is
no good evidence that HIV actively replicates in a person with AIDS,
and if there's isn't much HIV replication in a person with AIDS,
and if there isn't much HIV replication to stop, it's mostly killing
of California at Berkeley scientist Dr. Peter Duesberg drew the
same conclusion in a paper published in the Proceedings, the journal
of the National Academy of Sciences. Duesberg, whose paper addressed
his contention that HIV is not a sufficient cause for AIDS, wrote:
"Even if HIV were to cause AIDS, it would hardly be legitimate
target for AZT therapy, because in 70 to 100 percent of antibody
positive persons, proviral DNA is not detectable... and its biosynthesis
has never been observed."
As a chemotherapeutic
drug, explained Duesberg, explained Duesberg, AZT "kills dividing
blood cells and other cells," and is thus "directly immunosuppressive."
is almost a million-fold bigger target than the virus, so the cell
will be much, much more sensitive," says Duesberg. "Only
very few cells, about one in 10,000 are actively making the virus
containing DNA, so you must kill incredibly large numbers of cells
to inhibit the virus. This kind of treatment could only theoretically
help if you have a massive infection, which is not the case with
AIDS. Meanwhile, they're giving this drug that ends up killing millions
of lymphocytes [white blood cells]. It's beyond me how that could
possibly be beneficial."
really kill them," Burroughs Wellcome scientists Sandra Lehrman
argues. "You don't necessarily have to destroy the cell, you
can just change the function of it. Furthermore, while the early
data said that the only very few cells were infected, new data says
that there may be more cells infected. We have more sensitive detection
their function? From what - functioning to not functioning? Another
example of mediocre science," says Bialy. "The 'sensitive
detection technique' to which Dr. Lehrman refers, PCR, is a notoriously
unreliable one upon which to base quantitative conclusions."
questions about the alleged mechanisms of AZT are asked, the answers
are long, contradictory, and riddled with unknowns. Every scientific
point raised about the drug is eventually answered with the blanket
response, "The drug is not perfect, but it's all we have right
now." About the depletion of T-4 cells and other white cells,
Lehrman says, "We don't know why T-4 cells go up at first,
and then go down. That is one of the drug mechanisms that we are
trying to understand."
of AZT are pressed on key scientific points, whether at the NIH,
FDA, Burroughs Wellcome or an AIDS organization, they often become
angry. The idea that the drug is "doing something," even
though this is invariably followed with irritable admissions that
there are "mechanisms about the drug and disease we don't understand,"
is desperately clung to. It is as if, in the eye of the AIDS storm,
the official, government-agency sanctioned position is immunized
against critique. Skepticism and challenge, so essential to scientific
endeavour, is not welcome in the AZT debate, where it is arguably
needed more than anywhere else.
The toxic effects
of AZT, particularly bone marrow suppression and anemia, are so
severe that up to 50 percent of all AIDS and ARC patients cannot
tolerate it and have to be taken off it. In the approval letter
that Burroughs Wellcome sent to the FDA, all of 50 additional side
effects of AZT, aside from the most common ones, were listed. These
included: loss of mental acuity, muscle spasms, rectal bleeding
of AZT's common side effects, is the depletion of red blood cells,
and according to Duesberg, "Red blood cells are the one thing
you cannot do without. Without red cells, you cannot pick up oxygen."
Fred, a person
with AIDS, was put on AZT and suffered such severe anemia from the
drug he had to be taken off it. In an interview in the AIDS handbook
Surviving and Thriving With AIDS, he described what anemia feels
like to the editor Michael Callen: "I live in a studio and
my bathroom is a mere five-step walk from my be. I would just lie
there for two hours; I couldn't get up to take those five steps.
When I was taken to the hospital, I had to have someone come over
to dress me. It's that kind of severe fatigue... The quality of
my life was pitiful... I've never felt so bad... I stopped the AZT
and the mental confusion, the headaches, the pains in the neck,
the nausea, all disappeared within a 24-hour period."
very good at this point," Fred went on. "I feel like the
quality of my life was a disaster two weeks ago. And it really was
causing a great amount of fear in me, to the point where I was taking
sleeping pills to calm down. I was so worried. I would totally lose
track of what I was saying in the middle of a sentence. I would
lose my directions on the street."
AIDS patients are anemic even before they receive the drug."
Says Burroughs Wellcome's Dr. Lehrman, "because HIV itself
can infect the bone marrow and cause anemia."
betrays a bizarre reasoning. If AIDS patients are already burdened
with the problems such as immune suppression, bone marrow toxicity
and anemia, is compounding these problems an improvement?
is a form of chemotherapy." Says the man who invented the compound
a quarter-century ago, Jerome Horowitz. "It is cytotoxic, and
as such, it causes bone marrow toxicity and anemia. There are problems
with the drug. It's not perfect. But I don't think anybody would
agree that AZT is of no use. People can holler from now until doomsday
that it is toxic, but you have to go with the results."
finally and ironically, are what damns AZT. Several studies on the
clinical effects of AZT - including the one that Burroughs Wellcome's
approval was based on - have drawn the same conclusion: that AZT
is effective for a few months, but that its effect drops of sharply
after that. Even the original AZT study showed that T-4 cells went
up for a while and then plummeted. HIV levels went down, and then
came back up. This fact was well-known when the advisory panel voted
for approval. As panel member Dr. Stanley Lemon said in the meeting,
"I am left with the nagging thought after seeing several of
these slides, that after 16 to 24 weeks - 12 to 16 weeks, I guess
- the effect seems to be declining."
meeting, two years after the original Burroughs Wellcome study,
was scheduled to discuss the long range effects of AZT, and the
survival statistics. As one doctor present at that meeting in May
1988 recall, "They hadn't followed up the study. Anything that
looked beneficial was gone within half a year. All they had were
some survival statistics averaging 44 weeks. The p24 didn't pan
out and there was no persistent improvement in the T-4 cells."
in the blood are measured by an antigen called p24. Burroughs Wellcome
made the claim that AZT lowered this level, that is, lowered the
amount of HIV in the blood. At the first FDA meeting, Burroughs
Wellcome emphasized how the drug had "lowered" the p24
levels; at the follow-up meeting, they didn't mention it.
As that meeting
was winding down, Dr. Michael Lange, head of the AIDS program at
St. Luke's-Roosevelt Hospital in New York, spoke up about this.
"The claim of AZT is made on the fact that it is supposed to
have an antiviral effect," he said to Burroughs Wellcome, "and
on this we have seen no data at all... Since there is a report in
the Lancet [a leading British medical journal] that after 20 weeks
or so, in many patients p24 came back, do you have any data on that?"
counts is the bottom line," one of the scientists representing
Burroughs Wellcome summed up, "the survival, the neurologic
function, the absence of progression and the quality of life, all
of which are better. Whether you call it better because of some
antiviral effect, or some other antibacterial effect, they are still
Dr. Lange suggested
that the drug may be effective the same way a simple anti-inflammatory,
such as aspirin, is effective. An inexpensive, nontoxic drug called
Indomecithin, he pointed out, might serve the same function, without
the devastating side effects.
AIDS researcher, who was part of the FDA approval process, says
today: "Does AZT do anything? Yes, it does. But the evidence
that it does something against HIV is really not there."
have always been drugs that we use without knowing exactly how they
work," says Nobel Prize winner Walter Gilbert. "The really
important thing to look at is the clinical effect. Is the drug helping
or isn't it?"
proof that AZT works," says one person with ARC on AZT. "I've
been on it for two years now, and I'm certainly healthier than I
was two years ago. It's not a cure-all, it's not a perfect drug,
but it is effective. It's slowing down the progression of the disease."
I feel like swallowing Drano," says another. "I mean,
sometimes I have problems swallowing. I just don't like the idea
of taking something that foreign to my body. But every six hours,
I've got to swallow it. Until something better comes along, this
is what is available to me."
absolutely convinced that people enjoy a better quality of life
and survive longer who do not take AZT," says Gene Fedorko,
President of Health Education AIDS Liaison (HEAL). "I think
it's horrible the way people are bullied by their doctors to take
the drug. We get people coming to us shaking and crying because
their doctors said they'll die if they don't take AZT. That is an
absolute lie." Fedorko has drawn his conclusion from years
of listening to the stories of people struggling to survive AIDS
at HEAL's weekly support group.
take AZT if you paid me," says Michael Callen, cofounder of
New York City's PWA coalition, Community Research Initiative, and
editor of several AIDS journals. Callen has survived AIDS for over
seven years without the help of AZT. "I've gotten the shit
kicked out me for saying this, but I think using AZT is like aiming
a thermonuclear warhead at a mosquito. The overwhelming majority
of long-term survivors I've known have chosen not to take AZT."
The last surviving
patient from the original AZT trial, according to Burroughs Wellcome,
died recently. When he died, he had been on AZT for three and one-half
years. He was the longest surviving AZT recipient. The longest surviving
AIDS patient overall, not on AZT, has lived for eight and one-half
study of long-term survivors of AIDS followed 24 long-term survivors,
all of whom had survived AIDS more than six years. Only one of them
had recently begun taking AZT.
In the early
days, AZT was said to extend lives. In actual fact, there is simply
no solid evidence that AZT prolongs life.
AZT does prolong life in most people," says Dr. Bruce Montgomery
of the State University of New York City at Stony Brook, who is
completing a study on AZT. "There are not very many long-tern
survivors, and we really don't know why they survive. It could be
luck. But most people are not so lucky."
seem to help many patients," says Dr. Bernard Bahari, a New
York City AIDS physician and researcher, "but it's very hard
to determine whether it actually prolongs life."
of the patients I see choose not to take AZT," says Dr. Don
Abrams of San Francisco General Hospital. "I've been impressed
that survival and lifespan are increasing for all people with AIDS.
I think it has a lot to do with aerosolized Pentamidine [a drug
that treats pneumocystis carinii pneumonia]. There's also the so-called
plague effect, the fact that people get stronger and stronger when
a disease hits a population. The patients I see today are not as
fragile as the early patients were."
you live or die with AIDS is a function of how well your doctor
treats you, not of AZT," says Dr. Joseph Sonnabend, one of
New York's City's first and most reputable AIDS doctor, whose patients
include many long-term survivors, although he has never prescribed
AZT. Sonnabend was one of the first to make the simple observation
that AIDS patients should be treated for their diseases, not just
for their HIV infection.
have concluded that AZT has no effect on the two most common opportunistic
AIDS infections, Pneumocystic Carinii Pneumonia (PCP) and Kaposi's
Sarcoma (KS). The overwhelming majority of AIDS patients die of
PCP, for which there has been an effective treatment for decades.
This year, the FDA finally approved aerosolized Pentamidine for
AIDS. A recent Memorial Sloan Kettering study concluded the following:
By 15 months, 80% of people on AZT not receiving Pentamidine had
a recurring episode. "All those deaths in the AZT study were
treatable," Sonnabend says. "They weren't deaths from
AIDS, they were deaths from treatable conditions. They didn't even
do autopsies for that study. What kind of faith can one have in
any resistance to AZT in the general public at all, it's within
the gay community of New York," says the doctor close to the
FDA approval, who asked to remain anonymous. "The rest of the
country has been brainwashed into thinking this drug really does
that much. The data has all been manipulated by people who have
a lot vested in AZT."
were not the popular disease that it is - the money-making and career-making
machine - these people could not get away with that kind of shoddy
science," says Bialy. "In all of my years in science I
have never seen anything this atrocious." When asked if he
thought it was at all possible that people have been killed as a
result of AZT poisoning rather then AIDS he answered: "It's
more than possible."
1989: The government has announced that 1.4 million healthy, HIV
antibody-positive Americans could "benefit" from taking
AZT, even though they show no symptoms of disease. New studies have
"proven" that AZT is effective in stopping the progression
of AIDS in asymptomatic and early ARC cases. Dr. Fauci, the head
of NIH, proudly announced that a trial that has been going on for
"two years" had "clearly shown" that early intervention
will keep AIDS at bay. Anyone who has antibodies to HIV and less
than 500 T-4 cells should start taking AZT at once, he said. That
is approximately 650,000 people. 1.4 million Americans are assumed
HIV antibody-positive, and eventually all of them may need to take
AZT so they don't get sick, Fauci contended.
newspapers didn't seem to think it unusual that there was no existing
copy of the study, but rather a breezy two-pages press release from
the NIH. When SPIN called the NIH asking for a copy of the study,
we were told that it was "still being written." We asked
a few questions about the numbers. According to the press release,
3,200 early AARC and asymptomatic patients were devided into two
groups, one AZT and one placebo, and followed for two years. The
two groups were distinguished by T-4 cell counts; one group had
less than 500, the other more than 500. These two were then divided
into three groups each: high-dose AZT, low-dose AZT, and placebo.
In the group with more than 500 T-4 cells, AZT had no effect. In
the other group, it was concluded that low-dose AZT was the most
effective, followed by high-dose. All in all, 36 out of 900 developed
AIDS in the two AZT groups combined, and 38 out of 450 in the placebo
group. "HIV-positive patients are twice as likely to get AIDS
if they don't take AZT," the press declared.
figures are vastly misleading. When we asked how many patients were
actually enrolled for a full two years, the NIH said they did not
know, but that the average time of participation was one year, not
terribly dishonest the way they portrayed those numbers," says
Dr. Sonnabend. "If there were 60 people in the trial those
numbers would mean something, but if you calculate what the percentage
is out of 3,200, the difference becomes minute between the two groups.
It's nothing. It's hit or miss, and they make it look like it's
The study boasted
that AZT is much more effective and less toxic at one-third the
dosage than has been used for three years. That's the good news.
The bad news is that thousands have already been walloped with 1,500
milligrams of AZT and possibly even died of toxic poisoning - and
now we're hearing that one third of the dose would have done?
With all that
remains so uncertain about the effects of AZT, it seems criminal
to advocate expanding its usage to healthy people, particularly
since only a minuscule percentage of the HIV-infected population
have actually developed ARC or AIDS.
has already launched testing of AZT in asymptomatic hospital workers,
pregnant women, and in children, who are getting liquid AZT. The
liquid is left over from an aborted trial, and given to the children
because they can mix it with water - children don't like to swallow
pills. It has also been proposed that AZT be given to people who
do not yet even test positive for HIV antibodies, but are "at
that if you gave AZT to a perfectly healthy athlete," says
Fedorko, "he would be dead in five years."
1988, the Lancet published a study that Burroughs Wellcome and the
NIH do not include in their press kits. It was more expansive than
the original AZT study and followed patients longer. It was not
conducted in the United States, but in France, at the Claude Bernard
Hospital in Paris, and concluded the same thing about AZT that Burroughs
Wellcome's study did, except Burroughs Wellcome called their results
"overwhelmingly positive," and the French doctors called
theirs "disappointing." The French study found, once again,
that AZT was too toxic for most to tolerate, had no lasting effect
on HIV blood levels, and left the patients with fewer T-4 cells
than they started with. Although they noticed a clinical improvement
at first, they concluded that "by six months, these values
had returned to their pretreatment levels and several opportunistic
infections, malignancies and deaths occurred."
the benefits of AZT are limited to a few months for ARC and AIDS
patients," the Fench team concluded. After a few months, the
study found, AZT was completely ineffective.
The news that
AZT will soon be prescribed to asymptomatic people has left many
leading AIDS doctors dumbfounded and furious. Every doctor and scientist
I asked felt that it was highly unprofessional and reckless to announce
a study with no data to look at, making recommendations with such
drastic public health implications. "This simply does not happen,"
says Bialy. "The government is reporting scientific facts before
they've been reviewed? It's unheard of."
beyond belief," says Dr. Sonnabend in a voice tinged with desperation.
"I don't know what to do. I have to go in and face an office
full of patients asking for AZT. I'm terrified. I don't know what
to do as a responsible physician. The first study was ridiculous.
Margaret Fishl, who has done both of these studies, obviously doesn't
know the first thing about clinical trials. I don't trust her. Or
the others. They're simply not good enough. We're being held hostage
by second-rate scientists. We let them get away with the first disaster;
now they're doing it again."
a momentous decision to say to people, 'if you're HIV-positive and
your T4-cells are below 500 start taking AZT,'" says the doctor
who wished to remain anonymous. "I know dozens of people that
I've seen personally every few months for several years now who
have been in that state for more than five years, and have not progressed
to any disease."
of my colleagues," Sonnabend laments. "I'm embarrassed.
This is such shoddy science it's hard to believe nobody is protesting.
Damned cowards. The name of the game is protect your grants, don't
open your mouth. It's all about money... it's grounds for just following
the party line and not being critical, when there are obviously
financial and political forces that are driving this."
heard the latest announcement, he was particularly stunned over
the reaction of Gay Men's Health Crisis President Richard Dunne,
who said that GMHC now urged "everybody to get tested,"
and of course those who test positive to go on AZT. "These
people are running into the gas chambers," says Duesberg. "Himmler
would have been so happy if only the Jews were this cooperative."