To our only weapon against AIDS, Margaret Fischl owes everything:
Her fame and her infamy
1990 Dr. Margaret Fischl was 32, one year out of residency - an
obscure assistant professor at an obscure medical school in Miami.
She was a hard-working, serious young woman without any particular
spark or brillance. She had been a good student at the University
of Miami, and looked to be on course for an average career in
academic medicine. Her research was hardly on the frontiers of
medical science. The one study she had published was entitled:
"An index predicting relapse and possible need for hospitalization
in patients with acute bronchial asthma."
Then came the
young men whose bodies disintegrated before her eyes, refusing to
respond to the most aggressive treatment medicine could devise.
It was then
that Dr. Fischl did something out of the ordinary, something that
would mark her for the rest of her life: She paid attention.
years later, Margaret Fischl flew to San Francisco to reap the benefits
of her foresight. She had been invited to appear before the 12,000
delegates to the Sixth International Conference on AIDS to give
a major address before some of the greatest medical scientists in
the world. On the speaking platform with this young woman, a general
practitioner, were highly specialized virologists and immunologists
from three continents and at least 10 years her senior. She stood
among them as an equal, one of the most powerful members of the
AIDS research establishment in the United States. It should have
been a moment of honor and glory.
But it was
more than that: Fischl was escorted onto the stage by a bodyguard
of burly men. Outside the convention center she was being tried
in absentia by the very people she had presumably dedicated her
life to saving. The charge: "Crimes against people with AIDS."
guilty," the crowd of AIDS activists from across the nation
cheered after the open-air mock court accused her of putting careerism
before compassion, self-interest before science.
and irony, of the moment says a lot about the life and work of Margaret
Fischl, and about the agony of the national effort to stem a tide
As she strides
purposefully across the campus of Jackson Memorial Hospital, Margaret
Fischl turns few heads. The tall, serious woman radiates none of
the power and authority she has earned. She slumps at the shoulders
as she walks, as if to disguise her height. Her demeanor is self-contained,
almost timid; she eschews calling attention to herself.
In the early
'80s, when the first young men began showing up at Jackson with
weird cancers, exotic pneumonias and baffling brain infections,
Fischl, still a resident in general medicine at the University of
Miami, enlisted in the struggle against AIDS. The disease still
had no name. She had no way of knowing that it would not kill the
doctor, along with the patient.
a one-woman crusade in her hospital, her university, and the state
Legislature for funds to educate the public to prevent what has
since become an epidemic and to build a treatment program to cope
with it. She was the first person in Florida to try to awaken both
physicians and politicians to the looming threat. She was one of
the first researchers in the nation to warn about heterosexual transmission
of the virus.
have made her an American heroine. But the fight against AIDS is
not like the race for a polio vaccine, or the Manhattan Project.
It is a politicized battleground in which the disease's primary
victims are suspicious of and increasingly hostile toward the very
people who are charged with saving them.
was inevitable from the moment that AIDS became known as a "homosexual
disease." While it has become virtually taboo to express prejudice
against any other minority group in American society, in many quarters
homosexuals are still openly scorned.
As some fundamentalist
ministers preached that AIDS was "God's judgment against homosexuality,"
the president of the United States refused to so much as mention
the word for the first six years of the epidemic. There were serious
proposals in state legislatures to quarantine known AIDS carriers,
or even brand them. The disease spread unchecked for five years
before the federal government began a coordinated research effort
aimed at stopping it.
So even when
the effort began in earnest after years of neglect, thanks to people
like Margaret Fischl, many AIDS activists remained skeptical. They
had an attitude: They were not prepared to accept just any crumb
thrown in their direction as manna from heaven.
And the biggest
crumb of all was AZT.
Line Is Death
AIDS is more
than a disease: It's a multibillion dollar growth industry.
bureaucrats compete to make sure their agencies get a share of the
$3 billion the federal government is doling out annually for AIDS
education, treatment and research. Private scientific laboratories
line up at the government trough for some of the millions the administration
handing out. Scientists race for a cure that they know will carry
the Nobel gold. Pharmaceutical companies scramble to strike their
own mother lode in the form of chemical compounds that prove deadly
to the AIDS virus, and not to the AIDS patient.
Given the more
than eight million people worldwide infected with a communicable
killer disease with no cure, such a drug would have seismic implications
for the bottom line. Even the prospect has pharmaceutical stock
prices as jumpy as a Mexican hat dancer.
the cash can flow, a drug has to be anointed by a tiny group of
scientists totaling no more than two dozen, who by controlling the
AIDS Clinical Trials Group have unprecedented power to set priorities,
hand out the federal funds, and evaluate the progress of AIDS drug
A drug company
could theoretically strike out on its own, without the support of
these scientists. But the expense, and the odds against success,
would be so high that the possibility is likely to remain theoretical.
As a practical
matter, without this group's blessing, there will be no stock surges,
no windfall profits, no big headlines in The Wall Street Journal.
executives are holding their breath. After four years, and a billion
tax dollars, the national effort is monopolized by one drug-and
one drug company. In 1985, a giant British pharmaceutical firm called
Burroughs Wellcome pulled an old compound out of its stockroom.
It was an extract from-of all things-herring sperm. Originally developed
in 1964 as a possible cancer treatment, it had been discarded as
too toxic. But 20 years later, the same scientists who would become
the gatekeepers of the national research effort declared AZT a promising
was galvanic-both on the thousands dying horribly in and out of
AIDS wards, and on the corporate fortunes of Burroughs Wellcome,
which has exclusive rights to produce AZT for 17 years. The company's
profits-which were already considerable from the sale of drugs like
Sudafed, Empirin and Actifed-doubled in two years to almost $200
million. Then in 1989, the federal government announced that AZT,
then the most expensive prescription drug ever manufactured, might
also be effective in delaying the onset of AIDS symptoms in apparently
healthy people infected with the AIDS virus.
stock surged by 33 percent in a single week. The Wall Street Journal
estimated that by 1992, Burroughs Wellcome will have annual AZT
sales of $1.2 billion-half of that pure profit.
windfall, the same scientists who gave AZT credibility voted to
allocate millions more tax dollars to fund the drug's continued
testing-a program that has made it potentially even more profitable.
most of AZT's potential competitors languish on the shelves untested.
Virtually all the federal research money is already taken: AZT research.
Even if a big drug company was willing to pay for testing a new
drug on its own, virtually all the labs and the scientists are busy:
Such are the
fruits of gaining a stranglehold on the biggest government medical
research project in history. For its good fortune, Burroughs Wellcome
can thank the elite group of scientists in the Aids
Group, and most especially, it can thank Margaret Fischl.
And for the
same reasons, a growing number of scientists, physicians, AIDS patients
and their families damn her.
villains go, Margaret Fischl is pretty low on my list," says
Michael Callen. "She's a middle-level, third-string scientist
who the big boys shoved out front. But I think that my people have
paid a hellish price for AZT. To the extent that Margaret is part
of that, despite her best of intentions, she is complicit in the
deaths of thousands."
view from an ironic source. Michael Callen was diagnosed with AIDS
in 1982. "Six to 18 months," the doctors in New York gave
him. Of the thousands of people who have been handed that death
sentence, nobody else has lived as long. And Callen has survived
with no help from AZT. In fact, he is convinced his refusal to take
AZT is the main reason he is still alive.
In his forthcoming
book about long-term survivors of AIDS, Callen writes: "If
I saw a friend about to drink a glass of Drano, I would without
hesitation knock it from his hand. I consider AZT to be Drano in
been worried about AZT ever since the patients in the first major
study of the drug-many of them friends of his-began turning up with
anemia. Transfusions became part of their weekly schedules. Then
his friends started suffering from nausea and insomnia. Their muscles
began to ache, and then disintegrate until there was literally nothing
but skin and bone. Callen was used to seeing his friends get sick,
but this was different. The medicine seemed more like poison.
not what researchers-led by Margaret Fischl-reported. AZT Prolongs
Life of AIDS Patients the headlines declared. During the study period,
the findings showed, subjects taking placebos were 19 times more
likely to die than those taking AZT.
remained suspicious. Then in late 1988, he saw the report of a team
of French researchers in the British medical journal Lancet. These
scientists had studied AZT, too, but they described its benefits
as "disappointing": The drug so damages the blood cells
that the average patient could expect only six months' benefit before
the therapy began to backfire. The American researchers had had
no way of knowing that: They ended their study abruptly before any
of the subjects had taken the drug for that long.
About the same
time that Fischl was delivering her paper in San Francisco this
summer encouraging the use of AZT for 650,000 Americans infected
with the AIDS virus but not yet sick, the National Cancer Institute
announced that almost half the people who have taken AZT for three
years can expect to develop an aggressive form of lymphoma, a deadly
rushed to the defense of the drug.
AZT does not
cause lymphoma, Fischl insisted in San Francisco. "I cannot
fathom why AZT would be causing lymphoma. It's just that people
are living longer," and therefore increasing their chances
of contracting lymphoma unrelated to AZT.
is going on, it's certainly not as simple as: AZT causes lymphomas,"
said Paul Volberding, head of the AIDS program at San Francisco
General Hospital and one of Fischl's closest colleagues on the various
correctly, AZT is an extremely good drug," says Dr. William
Reiter, a Ft. Lauderdale physician who specializes in AIDS treatment.
"You can't rule out the possibility it is causing lymphoma,
but I don't believe it."
is that no one is sure: No one has compared the lymphoma rates of
AIDS patients who have refused to take AZT with those who have not.
No one has studied differences between the patients who reacted
badly to AZT and those who didn't. No one knows what effects long-term
use of AZT will have.
In 1987, Margaret
Fischl's name appeared on a credit line in the New England Journal
of Medicine as principal author of the single most important AIDS
treatment study to date: the publication of the first research on
AZT. Her major co-author, Douglas Richman, was a world-famous virologist.
While Margaret Fischl was still in medical school, he was already
producing trail-blazing work on immune responses to viral infection
and on anti-viral vaccine development.
a relative newcomer, would get the lead billing on such a crucial
study was extraordinary. How did it happen?
to ask Burroughs Wellcome that," is Fischl's response.
impossible to get much closer to the truth. A spokeswoman for Burroughs
Wellcome said: "Most of the sites were picked based on (the
local researchers') reputations with anti-viral work."
had published no anti-viral work.
the famous virologist, "The initial group was chosen by Burroughs
Wellcome. Someone at Burroughs Wellcome must have figured out she
reasons, the drug company plucked Fischl from obscurity and put
her career on rockets. Since then, Fischl has been either the lead
or second author on virtually every important study of AZT. She
is one of only 10 members of the executive committee of the AIDS
Clinical Trials Group, which directs the $100 million-a-year government
She is the
sole U.S. representative to the International AIDS Society, which
coordinates the global effort against the disease. At the University
of Miami, she is a franchise player: Fischl's research brings in
more than $10 million a year in federal and private grant money,
half of which goes directly into the university general fund.
All of which
raises an uncomfortable question. If Margaret Fischl owes her dazzling
rise to prominence to the same corporation whose drug she is testing,
can she possibly be objective about her findings?
Some take that
even further: Many American AIDS activists assume Margaret Fischl
is on the take. She makes advertorials for AZT-television spots
explaining the virtues of AZT, bought and paid for by Burroughs
Wellcome. Her face is prominently displayed in literature advertising
the drug in glossy magazines distributed to physicians. She must
be taking money-honoraria or consulting fees-from Burroughs Wellcome,
her critics conclude. After all, last December Dr. Martin Hirsch,
the former chairman of the same elite group of scientists that includes
Margaret Fischl, acknowledged at a federal hearing that almost all
the federally funded AIDS researchers were receiving money from
the pharmaceutical companies whose products they were testing.
1989, the National Institutes of Health-attempting to pre-empt conflict
of interest legislation brewing in Congress-decided to take a straightforward
approach to the problem: It announced it would prohibit federally
funded researchers from having a financial stake in any company
"that would be affected by the outcome of the research or that
produces a product or equipment being evaluated in the research
guidelines are inoperable, are an affront to the personal integrity
of the vast majority of scientists, are an invasion into the private
lives of multitudes of individuals," a prominent cancer researcher
wrote in a typically indignant letter to the federal agency. Of
the 700 letters NIH received, more than 600 were hostile. U.S. Secretary
of Health and Human Services Louis Sullivan quietly canceled the
did not oppose the prohibition. "This is not relevant to me,"
she explains. "We are not salaried through pharmaceutical companies.
I do not own stock in pharmaceutical companies... I have never gotten
a 'kickback' from Burroughs Wellcome, if that is the terminology."
$120,000 a year, paid out of UM's share of the grants she brings
Fogel, dean of the UM medical school: "Margaret Fischl gets
a single check from the University of Miami. Every other dollar
she receives-from a drug company, patient or grant -- comes to the
University of Miami."
argue that that does not guarantee that Fischl-or any other researcher
in her position-is not influenced by the pharmaceutical industry.
U.S. Rep. Ted
Weiss, D-N.Y., is the driving force behind the disclosure movement
in Congress. "It's not that we think that scientists are greedy
bastards," says Diana Zuckerman, Weiss' spokeswoman. "It's
that we have to ask if close working relationships with scientists
and officials at drug companies, if becoming friendly with folks
there, does not bias what a scientist decides to study or thinks,
whether he knows it or not.
is only one way that people are influenced. There is the pressure
to publish that is facilitated when a drug company gives you a grant;
the tremendous desire to say something new works; the prestige that
bringing in grants and consultancy fees earns you within your university."
that's nonsense: research cannot be influenced that easily. "It's
not just the pharmaceutical company, you're also working with the
FDA. They are involved with designing the study from the beginning."
the federal official who runs the AIDS drugs research effort: "We
all have bias, but there are checks and balances. I wouldn't tolerate
for a second anything that looked like bias."
Sonnabend, a New York physician who has probably treated more AIDS
patients than anyone else in the world, isn't impressed: "These
people fly you around the country to speak at conferences. They
promote you and your research. You get a bit of fame and glory.
Maybe being on the emotional take is ultimately more insidious than
being on the dollar take."
Yes To Drugs
From the beginning,
there were signs that AZT was trouble. Two months into the first
major trial that began in February 1986, dozens of the 145 patients
on AZT were developing anemia. Researchers started panicking, says
Robert Yarchoan, a researcher at the National Cancer Institute.
The new drug was killing healthy bone marrow cells at an alarming
rate. One possible result: aplastic anemia, an often fatal ailment.
Physicians who had supplied patients for the tests were threatening
to pull them out. The pressure was mounting to simply close the
the principal investigator, turned it around. Despite the pressure
to stop the study, she resisted-and prevailed. "She was convinced
AZT was working," Yarchoan says. "She was convinced it
was worth the risk. She kept the ball rolling."
The study continued.
None of the subjects died of anemia. But by the middle of September,
19 of the placebo patients had died of AIDS-related causes. Only
one patient taking AZT had died. Researchers had intended to keep
the trial running through December, a total of 11 months. Instead,
they shut it down after seven months. How could they allow patients
to keep taking placebos when the benefits of AZT seemed so apparent?
the media were called and told that a "promising" drug
had been discovered. On Jan. 16, 1987, the Anti-Infective Drugs
Advisory Committee of the Food and Drug Administration met to make
a decision that would affect almost every AIDS patient in the country.
Burroughs Wellcome sent a team of nine; billions were at stake.
Fischl was there. She had just turned 37 a few days before. This
was her study, her reputation, her future. Dr. Itzhak Brook, the
committee chairman, and his colleagues were given one day to make
No one was
under any illusions about the bind the committee was in: AIDS activists
and politicians were screaming for the federal research effort to
But some of
the committee staff objected to the hurry-up atmosphere. "We're
all under tremendous pressure and there's no question that politics
is a much greater part of AIDS drug development than approval and
availability of drugs in less publicly visible diseases," said
Ellen Cooper, the FDA medical investigator who had analyzed the
AZT drug study.
the meeting. She didn't like what she had seen in the research data.
She worried about approving a drug on the basis of a single trial
that was stopped before its completion. She worried about approving
a drug on the basis of a trial with fewer than 300 people, most
of whom had taken AZT for fewer than six months. She worried about
approving a drug without knowing anything about its long-term effects.
especially about judging the effectiveness of the drug when so many
of the subjects were being treated with a host of other drugs. That
kind of contamination would have certainly discredited almost any
other drug trial. Approval, she said, would be a "significant
and potentially dangerous departure from our normal toxicology requirements."
When the reviewers
sorted through the data, they bumped up against one puzzle after
another. When the study was terminated in September, patients on
placebos were switched to AZT. Even so, in the following three months,
13 more people from the original placebo group died, and there were
seven deaths among those who had been on AZT from the beginning.
Suddenly, the mortality differential between the two groups didn't
look quite so dramatic-not 19 to 1, but less than 2 to 1.
The FDA committee
members were concerned. Dr. Stanley Lemon of the University of North
Carolina Medical School: "After 16 to 24 weeks -- 12 to 16
weeks, I guess-the effect seems to be declining."
Brook told the packed meeting room, "I was struck by the fact
that AZT does not stop deaths. Even those who were switched to AZT
still kept dying."
"There are so many unknowns that it is hard to exactly know
the truth. We do not really know what will happen a year from the
beginning. The data is just too premature and the statistics are
not really well done. The drug may actually be detrimental. We do
the FDA committee members kept harkening back to the 19 to 1 fatality
differential in the early part of the study. The final vote was
10 to 1 in favor of approval. Brook was the only dissenter.
When Dr. Joseph
Sonnabend first read the AZT study report, he had lots of questions,
but the first one had nothing to do with AZT: Why had so many placebo
suspicious of the study from the beginning because the mortality
rate was simply unacceptable," Sonnabend says. "My patients
were simply not dying in those sort of numbers that rapidly."
the data and tried to figure out what had happened.
The research was not good enough.
with some authority. A medical researcher trained in infectious
diseases at the University of Witwatersrand in Johannesburg and
the Royal College of Physicians of Edinburgh, Sonnabend did research
on anti-viral treatments and the immune system at the prestigious
Institute for Medical Research in London in the 1960s, before the
field had even entered the scientific mainstream.
He wound up
in New York in the 1970s and put his expertise in sexually transmitted
diseases to work in the gay community. The shy, soft-spoken South
African was among the first physicians to notice that something
new-something terrifying-was menacing his patients.
the first article demonstrating that something was destroying the
immune systems of gay patients. Without any government assistance,
he conducted much of the first research on the new phenomenon.
When he began
investigating Fischl's research, Sonnabend was frustrated because
there was no detailed information about what had actually killed
the placebo patients: (No autopsies had been performed). AIDS, after
all, does not kill; it simply allows other infections to do so.
Sonnabend had an added difficulty: The causes of death provided
to the FDA did not quite match those in the article on the research
Fischl had written for the New England Journal of Medicine. "Sloppy
research," Sonnabend said. He pressed on.
As he puzzled
through the death reports, Sonnabend began to worry that the patients
on placebos might have died because they were neglected. Was it
that the physicians caring for them had had insufficient experience
warding off and treating these infections, he asked, or were they
unwittingly treating placebo patients differently from those on
be impossible, he knew. Carefully controlled scientific experiments
are almost always double-blinded: Neither the physician nor the
participant knows which patients are on the drug being tested and
which are on a placebo. And Fischl's New England Journal article
was specific: This had been a double-blinded study.
scientists openly acknowledged it was not.
The side effects
of high doses of AZT are so extreme that researchers knew who was
on AZT simply by how frequently the participants needed blood transfusions.
(Another thing that bothered Sonnabend: Could the short-term benefits
attributed to AZT actually have been the result of so many transfusions
of fresh blood?) And beyond the transfusions, the standard lab tests-in
which the action of AZT on the blood was clearly visible-would have
told researchers instantly who was on the drug and who was taking
a placebo. In other drug tests, such information is simply whited
out by lab workers to keep clinicians from seeing it. In the testing
of AZT, it was not.
to be, says Fischl. The lab-profile of AZT users, and their need
for transfusions, was something discovered during the study. The
double-blind wasn't compromised, she argues, because researchers
didn't know about the reactions in advance-though she admits some
might have "surmised" the connection.
In Good Intentions,
a new book on AIDS by Bruce Nussbaum due out at the end of October,
Dr. Samuel Broder, director of the National Cancer Institute, defended
the integrity of the study in a slightly different way. The whiting-out
was not necessary, he said, because researchers can be trusted not
to be biased. In fact, Broder takes heated exception to Sonnabend's
entire line of reasoning.
an accusation of fraud, not bad scientific design," he told
Nussbaum. "There was no fraud in the study."
he is not accusing Fischl of fraud: He is asking why, if unblinding
presented no significant problem, Fischl, as author of the study,
claimed to have overseen a double-blinded study.
"Double-blinding exists for a very clear reasons: to ensure
that no unconscious bias can creep into the way we treat patients.
If there were not a need for it, it would not exist.
I am saying is that the study doesn't tell us what we need to know.
It was technically substandard. For all we know from that study
AZT may even be better than they claimed. But it may be worse."
1987, a year after Fischl's study ended, Dr. Gordon Dickinson, Fischl's
research collaborator at the University of Miami, presented the
results of his own study of patients receiving long-term AZT treatment.
During their first six months on the drug, patients gained weight
and produced a larger number of "T-cells"-the blood cells
that give our natural immune systems the power to fight infections.
But after that, they began losing both weight and T-cells and developing
about AZT," he told The Miami News.
sharp exception to his analysis, although she did not dispute the
findings. She reminded reporters that she, not Dickinson, was the
chief AIDS researcher at the University of Miami.
recommend continued therapy despite falls in T-cells and infections,"
she told The News.
has been under siege for almost a decade. "The phone in her
office rings off the hook with patients begging for appointments
and patients' families screaming 'murderer' into the receiver,"
says Fischl's boss, Dr. Robert Rubin, vice provost at the University
in the community want advice, reporters want comment on every new
development, and her researcher colleagues from around the country
want to talk.
she moves swiftly between the Old Elliott Building where her clinical
trials are conducted; the Special Immunology Clinic, where she oversees
care and treatment of 5,000 AIDS patients; and the wards of Jackson
Of the 600,000
physicians licensed to practice medicine in the United States, only
2,000 list themselves as willing to accept AIDS referrals.
In the early
days physicians snored during Fischl's Continuing Medical Education
presentations on AIDS. Callers snarled wrath of God speeches at
her. Members of the Legislature refused to take her seriously. Even
the head of her medical school, Dr. Bernard Fogel, admits that he
did not want to believe her predictions that Jackson was going to
need special units and specially trained personnel. "When a
young faculty member comes up and says, 'We're going to have an
epidemic of X proportions,' it is easy for people to think she is
being an alarmist," he says.
In those days,
Margaret Fischl was easy to dismiss. She was, Fogel says, fragile,
even a little scared. And for good reason: Suddenly she found herself
at the center of a maelstrom.
as a pretty naive serious young woman who just got overwhelmed with
the tragedy of the disease," says Rubin. But it was more than
tragedy that overwhelmed her. Fischl was confronting for the first
time the ritualized promiscuity of the gay community, the anything-goes
sexuality. "She was shocked-and had to be trained both formally
and informally-by the whole issue of the life style of her patients,
her gay patients."
Then, of course,
there was the politics: The politics of getting federal grants;
the politics of prying resources out of a hesitant university; the
politics of dealing with colleagues jealous of the sudden prominence
of a young upstart.
And along with
the jealousy of her peers came the competition from her seniors.
"A lot of famous people-much more famous than her-got into
the act," Rubin says. These were international experts in virology,
in vaccine development, in immunology and genetics. "Margaret
was thrown right into the center. She is not a basic scientist.
She is not going to win a Nobel in virology. She is a clinical scientist.
Suddenly she was competing with people twice her age and ten times
began getting turned down because she had no experience in gene
cloning or retrovirology, he says. "So added to the burden
of the press, patients and parents, there was the intellectual stress
of being told, 'You're not a real scientist.'"
At the same
time, there were people telling her she wasn't a good doctor either.
Many doctors who treat AIDS patients are lionized. But Fischl's
adoration became mixed with invective. She was accused by some of
being unfeeling, secretive and uncooperative. Others defended her.
a private person," says Sally Dodds, another of Miami's pioneers
in the war against AIDS who has worked closely with Fischl for almost
a decade. "Margaret catches an awful lot of heat because she
symbolizes medicine, and there are a lot of patients who want everyone
who has an MD after her name to make it better."
"The part that never comes out is seeing her break down and
cry when she is attacked by the families of the people she's trying
to help. She's taken on this burden, and families call up and say
she is killing their son or their brother, calling her the worst
pornographic names in the world. This is harder than the ego-deflation
of academia. Sometimes she sits down and cries. If the public could
see that, they would be less critical."
woman doesn't cry for anyone but herself," says Albert Julbe,
founder of Share Your Gift, an AIDS buddy program. "Don't ask
us to believe something that could not be true."
was crying, it must be because she had a gnat in her eye, or her
dog died," says Doris Feinburg, founder of the AIDS resource
center Body Positive in Miami.
All the pressure
took a toll.
about five or six years ago," Rubin says, "everyone was
driving her crazy. Something snapped in her psyche."
he says, by retreating behind a wall of privacy. Whatever the intended
effect, it only served to deepen the suspicions and inflame the
most rudimentary information about Margaret Fischl is like trying
to break a secret Pentagon code. Her office refuses to hand out
her complete resume. Even county officials who run the hospital
where she works could not get one when they tried.
on the programs Fischl directs for the tax-funded Public Health
Trust is public. But when The Herald requested that information,
it did not appear: There was a confusion in processing, agency officials
said. A request for documents evaluating her personal performance
as a physician during her internship and residency at Jackson Memorial
Hospital was initially denied: Margaret Fischl was never employed
by Jackson, its personnel director insisted. Two weeks later, when
another official admitted that she had been, the records request
was waylaid by University of Miami lawyers. Releasing such information
could damage the quality of health care in the city, the lawyers
the public relations staffs of both the University of Miami and
the Public Health Trust openly admit that Fischl is a PR "nightmare."
for Jackson Memorial Hospital, where Fischl directs all AIDS programs
through the University of Miami, does not even know where Fischl
is from. Joyce Goldberg, the hospital spokeswoman, tried to find
that information for an article she was preparing for the hospital
magazine. She asked Fischl directly. Fischl refused to answer.
It took elaborate
investigative reporting techniques to determine: that she is from
New Jersey; that her father is a baker. In dozens of interviews
with people who might have some knowledge of Fischl, only two other
personal facts surfaced: Fischl herself is a fine baker. And she
plays the harpsichord.
Even her marital
status is a matter of debate among people who work with her. Some
say she is married to Dr. Karl Magleby, a University of Miami physiologist
who shares a home with her. Some say she is not. Neither Fischl
nor Magleby will address the question.
people know about her the better," Magleby says. "Then
she can get some work done."
On Aug. 17,
1989, newspapers around the world announced a dramatic new finding:
Early treatment with AZT can hold off AIDS.
At that moment
1.4 million Americans were assumed to be infected with the AIDS
virus, known as HIV.
all of them may need to take AZT so they don't get sick," said
Dr. Anthony Fauci, head of the federal agency that sponsored the
two studies on which the conclusion was based. The major study,
on which Fischl was a second author, was supposedly based on 3,200
Americans infected with the virus who had not yet progressed to
full-blown AIDS. Over a two-year period half had been given AZT
and half a placebo. The authors' conclusion: "HIV-positive
patients are twice as likely to get AIDS if they don't take AZT."
Once the data
became available, the advance seemed less dramatic. The research,
it turned out, was based not on 3,200 subjects, but on less than
half that many -- 1,338; the remainder either dropped out of the
study or had been enrolled too late to be counted. The average subject
was followed for one year. While only 25 of the 910 participants
on AZT progressed to AIDS, only 33 of the 428 placebo-takers joined
them -- 7.6 percent got sick while taking a placebo, 3.6 percent
got sick on AZT.
Some say there's
a problem: considering the small numbers in each group who got sick,
the statistical difference between them is not great.
does not accept that argument. "A two- to three-fold difference,"
she insists, "is not attributable to chance."
The good news
everyone accepted was that an AZT dose one-third the strength of
that used in Fischl's 1986 study was shown to be as effective in
hobbling the AIDS virus as the earlier one, vastly reducing the
toxic side-effects of the drug. Nonetheless, patients on low-dose
AZT were still five times more likely to suffer anemia than others,
and 15 times more likely to suffer severe nausea.
enthusiasm, the researchers on the federally funded study concluded:
"... the data provide no information about the possible long-term
benefit or safety of (AZT). Thus it is possible that the eventual
risks of disease progression in the three treatment groups could
become similar after a longer time period... it is possible that
even if (AZT) persistently delays the onset of AIDS, it may not
have an ultimate effect on survival."
journalists these findings were "a quantum leap" in the
treatment of AIDS.
But not everyone
was buying it. In November, a group of European AZT researchers
published an article in Science magazine challenging the Americans.
The article's authors suggested that the study data had been withheld
from them, complaining that it had taken three months of begging
before the study results arrived. And when they did, the Europeans
concluded, they did not prove what the Americans said they proved.
a British researcher, concluded that AZT had been recommended for
wider use for political-not scientific-reasons. Their article received
virtually no press attention on this side of the Atlantic.
of the Veterans Administration AIDS research team were also examining
the new data carefully. They were two years into their own three-year
study of the effects of AZT on patients infected with the AIDS virus
but not yet sick. If Fischl's study had already proven that AZT
delayed the onset of AIDS, how could the VA ethically continue a
study in which half the patients were given placebos instead?
took an early look at their data. They met with representatives
from the National Institutes of Health and the Food and Drug Administration.
There was something wrong: Their results were not tracking Fischl's
study. The VA scientists were finding no statistical difference
in progression to AIDS between AZT patients and placebo patients.
So the Veterans
Administration decided to continue. The study will end in January.
One of the
members of the VA research team was Gordon Dickinson-Fischl's former
colleague at UM. Despite his concerns about AZT, he believes the
drug has value. "AZT has unequivocally been shown to have a
beneficial effect, although a limited one," he says. His primary
concern is this: If you're spending your time working with AZT,
you're not working with other drugs that may prove to be of lasting
benefit to AIDS patients.
Almost 80 percent
of all patients enrolled in federally sponsored AIDS drug trials
are in studies related to AZT. As of August 1989, the government
was supporting twice as many drug trials-and spending four times
as much money-on AZT than on all other potential AIDS treatments
put together. Of the six new anti-HIV studies announced for 1990,
four involve the use of AZT in combination with other drugs.
believe that more than 100 other theoretically promising compounds
have been left by the wayside as limited funds have been channeled
into deciphering precisely how toxic AZT really is-or isn't-and
precisely how effective and dangerous its cousin compounds might
prove to be.
Some of the
most promising drugs are owned by small corporations that do not
have the money to prime the research pump-wine and dine federal
officials, fly scientists around the country, provide 30 million
capsules of their drug free-all of which Burroughs Wellcome did
when AZT testing began.
critical of the AIDS research effort are beginning to ask questions.
They note that many promising drugs are derived from food products
and thus not easily patentable, and wonder if any drug company will
sponsor research on a substance from which it can derive no profit.
Can a research program dependent on the initiative of pharmaceutical
companies-and researchers working closely with them-pursue all possible
Now their concerns
are shared at the highest levels of government. In August, the National
Commission on AIDS, a blue-ribbon presidential panel, issued a report
to President Bush concluding that the AIDS research effort simply
government, the commission cautioned, needs to respond to the perception
of possible conflict of interest between federally funded scientists
and private pharmaceutical companies.
of Margaret Fischl
Fischl a heroine, or a dupe? Is she making a selfless sacrifice
in the name of medicine, or simply grabbing for personal glory?
is as much to lose, and gain, as there is in America's response
to the AIDS crisis, the motives of the prime movers in that response
will always be questioned.
those questions are complicated by her self-enforced silence, her
insistence that who she is, and what she thinks beyond the specifics
of her research, are nobody's business. However the debate over
AZT plays out, the woman behind the drug will remain enigmatic.
afternoon, Special Immunology Clinic at Jackson Memorial Hospital.
An emaciated young man sits uncomfortably in his wheelchair waiting
to see Fischl. His body is covered with scabby purple lesions: Kaposi's
sarcoma. Extra oxygen enters his lungs from a tank on the floor
next to him.
Dr. Fischl," he moans weakly as his physician walks past on
her way to a treatment room. Two dozen patients turn their heads
awaiting her response. She does not turn her head in his direction.
Dr. Fischl," he tries again when she re-emerges and moves toward
the nurses' station. The patients again await her response. It never
Early evening, Three North, Jackson Memorial Hospital. A young man
lies dying in his hospital bed on the AIDS ward. Fischl examines
him and then sits on the side of his bed, holding his hand and speaking
gently to him.
When she leaves
the room, tears are streaming down her face. She looks around, regains
composure and moves on to the next patient. *