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, 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.
The intensity, 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 of death.
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.
Fischl became 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.
That should 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.
The conflict 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.
The Bottom Line Is Death
AIDS is more than a disease: It's a multibillion dollar growth industry.
Government 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
Congress are 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.
But before 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 research.
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
Few corporate 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 AIDS treatment.
The effect 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.
The company's 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.
Despite the 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.
Meanwhile, 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: AZT.
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
Clinical Trials 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.
"As AIDS 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."
An extreme 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 pill form."
Callen has 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.
But that's 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.
Still, Callen 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 cancer.
AZT's supporters 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.
"Whatever 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 AIDS studies.
"If used 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."
The problem 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.
The AZT Elevator
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
That Fischl, a relative newcomer, would get the lead billing on such
a crucial study was extraordinary. How did it happen?
"You have to ask Burroughs Wellcome that," is Fischl's response.
It's almost 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."
Margaret Fischl had published no anti-viral work.
Says Richman, the famous virologist, "The initial group was chosen
by Burroughs Wellcome. Someone at Burroughs Wellcome must have figured
out she was good."
Whatever the 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 research effort.
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.
In January 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 project."
The research establishment exploded.
"The proposed 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 new regulations.
Fischl herself 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."
Fischl makes $120,000 a year, paid out of UM's share of the grants she
Dr. Bernard 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
Many would 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.
"Money 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."
Fischl thinks 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."
Daniel Hoth, 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."
Dr. Joseph 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
Just Say 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 experiment down.
Margaret Fischl, 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?
Members of 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 their decision.
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 produce something.
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
Cooper opened 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.
Cooper worried 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."
Committee Chairman 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."
Brook concluded: "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 not know."
Nonetheless, 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 patients died?
"I was 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."
Sonnabend reviewed the data and tried to figure out what had happened.
His conclusion: The research was not good enough.
Sonnabend speaks 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
International 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.
He published 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 AZT?
That should 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.
Except, FDA 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.
Didn't need 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"
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.
"That's an accusation of fraud, not bad scientific design,"
he told Nussbaum. "There was no fraud in the study."
Sonnabend says 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.
Sonnabend: "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.
"What 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."
In October 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 serious infections.
"I'm pessimistic about AZT," he told The Miami News.
Fischl took 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.
"We absolutely recommend continued therapy despite falls in T-cells
and infections," she told The News.
The Pressure Cooker
Margaret Fischl 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 of Miami.
Physicians in the community want advice, reporters want comment on every
new development, and her researcher colleagues from around the country
want to talk.
Meanwhile, 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 Memorial Hospital.
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.
"She started 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
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 her experience."
Her grants 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.
"She is 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."
Robert Rubin: "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."
"That 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."
"If she 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.
"Somewhere about five or six years ago," Rubin says, "everyone
was driving her crazy. Something snapped in her psyche."
She responded, he says, by retreating behind a wall of privacy. Whatever
the intended effect, it only served to deepen the suspicions and inflame
Getting 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.
Information 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 said.
Members of the public relations staffs of both the University of Miami
and the Public Health Trust openly admit that Fischl is a PR "nightmare."
A spokeswoman 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.
"The less 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.
"Eventually 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.
But Fischl 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
Despite their 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
Fischl told 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.
Ian Weller, 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.
Meanwhile members 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?
VA researchers 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
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.
Most researchers 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
Many physicians 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 therapies objectively?
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 isn't producing.
The federal government, the commission cautioned, needs to respond to
the perception of possible conflict of interest between federally funded
scientists and private pharmaceutical companies.
The Mystery of Margaret Fischl
Is Margaret Fischl a heroine, or a dupe? Is she making a selfless sacrifice
in the name of medicine, or simply grabbing for personal glory?
Whenever there 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.
For Fischl, 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.
A Thursday 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
"Dr. Fischl, 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, Dr. Fischl," he tries again when she re-emerges
and moves toward the nurses' station. The patients again await her response.
It never comes.
Months later. 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. *