👀Huh? Tell that to the hundreds - and thousands
maimed or killed with the rushed- thru AZT. Actual
trials and scientific research? Nope. Just using
living human beings as lab rats.
AIDS and the AZT Scandal: SPIN’s 1989 Feature, ‘Sins
of Omission’
The story of AZT, one of the most toxic, expensive,
and controversial drugs in the history of medicine
Written By Celia Farber October 5 2015, 3:47 PM ET
At the end of 1989, two years after we had started the
highly controversial AIDS column in SPIN, we published
an article by Celia Farber called “Sins of Omission”
about the truly bad and corrupt science surrounding
promoting AZT as a treatment for the syndrome of
diseases.
Celia was the editor and frequent writer of the column
and unearthed hard evidence of the cold-bloodedness of
the AIDS establishment pushing a drug that was worse
than the disease, and killed faster than the natural
progression of AIDS left untreated. AZT had been an
abandoned cancer drug, discarded because of it’s fatal
toxicity, resurrected in the cynical belief that AIDS
patients were going to die anyway, so trying it out
was sort of like playing with the house’s money.
Because the drug didn’t require the usual massively
expensive research and trial processes, having gone
through that years earlier, it was insanely profitable
for its maker, Burroughs Wellcome. It was a tragically
perfect storm of windfall profits, something to pacify
AIDS activists and the media, and a convenient boom to
the patent holders for HIV testing.
Celia — who should get the Congressional Medal of
Honor for her brave and relentless reporting, here and
throughout the ten years we ran the column — exposed
the worthlessness of the drug, the shady studies and
deals to suppress the negative findings, and its awful
and final consequences. This piece very literally
changed the media’s view of AIDS and sharpened their
discerning and skeptical eye. And soon after, AZT was
once again shelved, hopefully this time forever.
Many times over the years since, people have come up
to me and said that reading this article saved their
lives, that they either stopped taking the drug and
their health improved vastly, or they never took it
because of what we reported. Nothing ever made me
prouder.
— Bob Guccione Jr., founder of SPIN, October 3, 2015
[This story was originally published in the November
1989 issue of SPIN. In honor of SPIN’s 30th
anniversary, we’ve republished this piece as part of
our ongoing “30 Years, 30 Stories” series.]
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 cell destruction.
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, considering the climate of
fear and anger all around.*
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 fact
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 approval.
“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 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 serious.”
“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. “There was
no political pressure,” he says. “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.
CREDIT: Getty Images
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 though 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 wayside. The beneficial effects of the
drug had 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 uninvestigated.
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.
“Does AZT do anything? Yes, it does. But the
evidence that it does something against HIV is really
not there.”
AZT is the only antiretroviral drug that has
received FDA approval for treatment of AIDS since the
epidemic began ten 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 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 a
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 of
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 into the study, when more patients had died in
the placebo group, the study was stopped, five months
prematurely, for “ethical” reasons: It was considered
unethical to keep giving people a placebo when the
drug might keep them alive longer. Because 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.
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 effect 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.
“I personally do not prescribe AZT. I have continued
to experience that people live longer who are not on
it.”
AZT was singled out among hundreds of compounds when
Dr. Sam Broder, the head of the National Cancer
Institute (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/benefit ratio was in favor 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 canceled 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 this 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
objectively reported.”
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.
CREDIT: Getty Images
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 in 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 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 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 a 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, 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
scientist 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 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 quantitative
conclusions.”
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 understand.”
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 progress and so prevalent in
every other area of scientific endeavor, is not
welcome in the AZT debate, where it is arguably needed
more than anywhere else.
The results, finally and ironically, are what damns
AZT.
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, and
tremors.
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 ???gen.”
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 editor Michael Callen: “I live in a studio and
my bathroom is a mere five-step walk from my bed. 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 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
Horwitz. “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.”
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 off 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 that 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 weeks 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
recalls, “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 no
persistent improvement in 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-
Welcome emphasized how the drug had “lowered” the p24
levels; at the follow-up meeting they didn’t even
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?”
They didn’t.
“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 better.”
Dr. Lange suggested that the drug may be
effective in 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?”
A physician with extensive experience with AIDS
patients who asked to remain anonymous told SPIN,
point blank: “I personally do not prescribe AZT. I
have continued to experience that people live longer
who are not on 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’s
effective. It’s slowing down the progression of the
disease.”
“Sometimes I fee like I’m 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
this 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 s–t
kicked out of 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.”
“I’m convinced that if you gave AZT to a perfectly
healthy athlete he would be dead in five years.”
The last surviving patient from the original AZT
trial, according 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 for 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 at Stony Brook, who is completing a study on AZT.
“There are not very many long-term 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 Pentamadine [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.”
“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 City’s first and
most reputable AIDS doctors, 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 Pentamadine for AIDS. A
recent Memorial Sloan Kettering study concluded the
following: By 15 months, 80 percent of people on AZT
not receiving Pentamadine had a recurrent episode of
pneumocystis. Only 5 percent of those people who did
get Pentamadine 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 any
autopsies for that study. What kind of faith can one
have in these people?”
“If there’s one 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 this 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 this kind of shoddy
science,” says Bialy. “In all 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 than
AIDS he answered: “It’s more than possible.”
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 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-page 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 ARC and asymptomatic
patients were divided 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
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 now. 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
risk.”
“I’m convinced that if you gave AZT to a perfectly
healthy athlete,” says Fedorko, “he would be dead in
five years.”
“This is such shoddy science it’s hard to believe
nobody is protesting.”
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 things 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.”
“Thus the benefits of AZT are limited to a few months
for ARC and AIDS patients,” the French 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 people
asking for AZT. I’m terrified. I don’t know what to do
as a responsible physician. The first study was
ridiculous. Margaret Fischl, 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 T-4 cells are below 500,
start taking AZT,'” says the AIDS 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 to protect your grant, 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 driving this.”
When Duesberg heard the latest announcement, he
was partially 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 to AZT. “These
people are running into the gas chambers,” says
Duesberg. “Himmler would have been so happy if only
the Jews were this cooperative.”
* = This sentence was changed to correct an error in
the original version of this article, which wrongly
stated that the FDA had approved Thalidomide.
TAGS: AIDS, spin 30
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