VIRUSMYTH HOMEPAGE
AZT ON TRIAL
By Celia Farber
Spin July '96
The treatment for AIDS stands accused of being deadlier than the
disease itself.
Kananack, Murgatroyd, Baum & Hedlund is one of the nation's leading
"mass disaster" law firms, generally handling plane crashes,
train wrecks, and other types of accident litigation. It also handles product
liability: The firm has instigated several lawsuits alleging damage caused
by such drugs as Prozac, Ritalin, and the experimental hepatitis drug FIAU,
which resulted in the death of five people in a government drug trial.
Now it's taking on AZT.
The firm represents several people who are convinced that they or their
loved ones have been injured or killed by AZT, a drug whose effectiveness
and toxicity have been hotly debated since its release onto the market
in 1987.
AZT is a chemotherapeutic agent, and as such it massively and unselectively
destroys cells, causing "side effects" ranging from bone-marrow
toxicity to muscle wasting, anemia, neuropathy, and more. The drug was
approved by the Food and Drug Administration after a quick and flawed study
indicated that those who took the drug lived longer, and was rushed onto
the market following demands by AIDS activists who were accusing the government
of foot-dragging. According to defenders of the drug, it served a vital
function--despite its limitations--at a time when there was nothing at
all doctors could prescribe for AIDS. But to detractors, AZT represents
the most cynical medical scandal of modern times.
"What it really comes down to here," says Paul Hedlund, the
lead attorney on the AZT cases, "is that AZT was sold to us as a bill
of goods. The drug not only turned out not to be good, it turned out to
be bad. We believe that the manufacturer has known this all along and has
tried to deceive everyone, and we think that's really wrong." Ramona
Jones, a spokeswoman for Glaxo Wellcome, told SPIN that the company had
not yet been notified of the possible litigation and so could not comment
directly on it. "I can tell you," said Jones, "that the
drug went through clinical trials and was renewed by the FDA. It had an
acceptable clinical safety profile."
A pivotal legal point will be that the manufacturer's own data promoted
the initial misconception that AZT would prolong life in people who were
HIV-positive but had no symptoms of AIDS. Following this research, Anthony
Fauci, the director of the National Institute of Allergy and Infectious
Diseases, officially recommended in 1989 that people who are HIV-positive,
even if healthy, start taking AZT as soon as their T cells fall below the
mark of 500. This was an expansion of the original patient group that AZT
was approved for: those who were far along in their illness.
The drug has fallen from grace somewhat in the past few years, largely
due to negative publicity from the 1993 European "Concorde" trial,
which demonstrated that many of the claims made for AZT were false. But
doctors are still widely prescribing the drug. Though most AIDS doctors
no longer believe AZT prolongs life, they do not, by and large, believe
that it shortens life either. That is what will now be hammered out in
court. Recent studies have indicated that those who take AZT die up to
a year faster than those who do not take it, and Hedlund claims that the
Concorde team has yet-to-be-released toxicity data confirming that AZT
can, in certain cases, shorten life. His team is eagerly awaiting the release
of this data.
As long as doctors can find any medical rationale for AZT, damage litigation
will be exceedingly difficult, particularly since AIDS is broadly defined
to include up to 27 different symptoms and diseases. And AZT itself has
up to 50 side effects listed, several of which overlap with AIDS symptoms,
as AZT causes immune deficiency like that seen in AIDS.
But Hedlund stands firm that if even the slightest acceleration of death
can be proven, Glaxo Wellcome is in trouble, a stance that radically departs
from the cynical assumption that people with HIV are "going to die
anyway." "Anything that shortens a person's life is actionable,"
says Hedlund.
AZT litigation is already underway in Britain, and at least two cases
have been filed there by lawyer Graham Ross. Ross's primary case is that
of the widow of a hemophiliac who was relatively healthy, but weakened
and died shortly after beginning AZT therapy.
Hedlund plans to file a number of cases against Glaxo Wellcome, and
possibly against involved physicians and hospitals as well. One case is
that of Jak McDonnell, who, says Hedlund, was HIV-positive but asymptomatic
when he started AZT, and who then died much sooner than expected. McDonnell's
surviving partner, Chris Michaels, says, "Jak took a nosedive when
he started on AZT. That was the beginning of the end." Hedlund says
point-blank that McDonnell's death was a "tragic death caused by AZT."
Hedlund's star client, however, is five-year-old Lindsey Nagel. Lindsey
was born in the Romanian coal-mining town of Petrosani, deep in the Transylvanian
Alps, to an impoverished mother of three who gave her up at birth. She
was adopted as an infant by Steve and Cheryl Nagel, who, after weeks of
wrangling over the adoption process in Romania, took her home to Minneapolis.
Once home, Lindsey was taken in for a routine check-up and was found to
be HIV-antibody-positive, presumably, like so many Romanian children, from
a blood transfusion. Noting that she was a "very bright, smiling,
happy girl," Lindsey's doctor nonetheless prescribed Septra, a powerful
anti-pneumonia drug, and told the Nagels that their child would probably
not live to be two years old.
At about three months of age, Lindsey was put on AZT, in the form of
fruit-flavored syrup, four times a day. A month later, she started to decline,
losing her appetite and falling behind her proper growth rate. Because
AZT kills all dividing cells in the body, Lindsey soon stopped growing
altogether. Her parents grew anxious, but Lindsey's doctors were adamant
about the necessity for AZT treatment and, in fact, praised her "progress"
at each visit. By Lindsey's second birthday, she was waking up at night,
clutching her legs, and screaming in pain. This continued each night for
a month. The Nagels knew that this was due to muscle wasting, a known side
effect of AZT. "While she was on AZT, Lindsey looked exactly like
an AIDS patient," says Cheryl. "She was so sick. She was emaciated.
She cried all the time. She never smiled. And all the time her doctors
were telling us that these were the symptoms of her 'AIDS'."
By chance, the couple stumbled upon an article featuring molecular biologist
Peter Duesberg, who contests the idea that HIV is a deadly virus and calls
AZT "AIDS by prescription," arguing that the treatment produces
the same symptoms as the disease it is intended to combat. "I called
Duesberg," Cheryl recalls, "and he said, 'Take her off that drug.'
He sent us documentation of everything he said. We researched AZT, found
out how unsubstantiated all the claims for it were, and took her off it."
Lindsey's health improved immediately. According to Cheryl, her daughter
became a new child almost overnight. She stopped screaming; she gained
weight; her appetite came back. "She's a perfectly healthy little
girl now. I'm sure he has his flaws, but Peter Duesberg saved my daughter's
life," says Cheryl. Lindsay, now almost six, is still in perfect health.
Oddly enough, at this point it is not clear whether Lindsey is in fact
infected with HIV. Examining her daughter's medical records after discharging
the physicians, Cheryl found that although Lindsey had indeed been antibody-positive
to HIV, her viral-culture test--the test that measures the actual virus--was
negative. "It said Negative in big bold letters across the page,"
says Cheryl. "I was so shocked." Why had the Nagels been told
that this particular test was positive? "We don't know," she
says. "There are a lot of questions we still have to sort out."
Lindsey's story encapsulizes the absurdity of current HIV and AIDS medical
practice. Many of the complications stem from the faulty HIV-antibody test,
which, because of cross-reactions with several other microbes and underlying
blood conditions, has a high false-positive rate. All too frequently, a
barrage of toxic drugs are prescribed at the first hint of a positive result,
soon making the distinction between toxic effects and AIDS symptoms impossible
to determine.
Dr. Michael Lange, associate chief of infectious diseases at St. Luke's-Roosevelt
Hospital in New York and one of the doctors the FDA consulted when evaluating
AZT in 1987, says even he sometimes has trouble differentiating between
AZT's toxic effects and AIDS itself: "There are a number of things
where it is difficult to sort out whether it's HIV- or AZT-related. When
you know that it could be AZT-related, the first thing usually is to stop
the AZT, to see if the problems persist."
Lange, who has a large AIDS-treatment practice and has been treating
the disease since its inception, is cautious about using AZT. "This
is not a particularly good drug. I have never said that AZT is the worst
poison and that it should never be used. But knowing how little it did,
I've always felt it should be very judiciously used. The side effects that
can happen are potentially quite serious. If you're on death's doorstep,
you might be willing to take that kind of risk, just like you may be willing
to take chemo when you've got bad cancer."
Hedlund points out that Lindsey, far from being "on death's doorstep,"
was perfectly healthy until she took AZT. "What we are going to sue
for is the extreme pain and suffering that this small child had to go through.
Not just her but her whole family.
"I think that the overwhelming information is that AZT is deadly
and it just hurts people," Hedlund continues. "We have to at
least alert people so they can make an informed choice." *
VIRUSMYTH HOMEPAGE