SINS OF OMISSION
The AZT Scandal
By Celia Farber
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 the drug.
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
Drug companies 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 birth defects.
Everybody was 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."
Just before 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."
"We do 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."
"I agree 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."
Burroughs Wellcome 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
'There was 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 very
"The committee 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.'"
Brad Stone, 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."
The meeting ended. AZT, which several members of the panel still felt
uncomfortable with and feared could be a time bomb, was approved.
Flash forward: 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.
The majority 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
Burroughs Wellcome 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 invalid.
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.
Both sides 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 the study.
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 standards, unproven.
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
Dr. Brook, 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."
Brook pointed 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 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 opportunistic infections.
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."
"That study was so sloppily done that it really didn't mean much," says Dr. Joseph
Sonnabend, a leading New York City AIDS doctor.
Dr. Harvey 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
Bialy, who 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.
The scientific 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.
"Undeniably, 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 transfusions."
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 healthy cells."
University 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."
"The cell 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."
"It doesn't 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 techniques now."
"Changes 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
When specific 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
When promoters 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
Anemia one 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."
"I feel 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."
"Many 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."
This argument 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?
"Yes AZT 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
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."
A follow-up 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."
HIV levels 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
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?"
"What 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.
One leading 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."
"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?"
"I'm living 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."
"Sometimes 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."
"I am 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.
"I wouldn't 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 years.
An informal 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.
"I think 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."
"AZT does 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."
"Many 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
"Whether 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.
Several studies 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 these people?"
"If there's 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."
"If AIDS 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
August 17, 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.
The leading 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.
However, the 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 two.
"It's 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 terribly significant."
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.
Burroughs Wellcome 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
"I'm convinced that if you gave AZT to a perfectly healthy athlete," says Fedorko,
"he would be dead in five years."
In December 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
"Thus 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."
"It's 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."
"It's 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."
"I'm ashamed 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."
When Duesberg 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." *