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About Just out. (Portland, OR) 1983-2013 | View Entire Issue (Feb. 1, 1988)
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AZT: Genie or viral treachery?
In the year since FDA approval of AZT, a cure hysteria has
emerged. AZT does not cure AIDS. Nevertheless , HIV-positive
individuals flock to physicians for a prescription.
R I S
W I S H E R
strongly recommend that we initiate AZT
therapy, fully informing him or her of the risks
zidothymidine (AZT), manufactured by
and benefits, the toxicity we have to watch for.”
Burroughs Wellcome Co. under the
brand name Retrovir, is the only approved drug Loveless said he is uncomfortable prescrib
on the market to combat acquired immune defi ing AZT to an individual whose T cells hover
between 400 and 200 because nobody knows if
To look at it. there is nothing conspicuous or the risks will outweigh the benefits. (Normal
T cell count is 600 to 800 or greater.)
unusual about a 100 mg. capsule — a white,
“ If the patient is asymptomatic and the Tcell
opaque cap printed with “ Wellcome. ’ * and a
unicorn Iogo.“ Y9C” and“ 100” printed on the counts are stable for two to three months. I say
wait and see what happens. If an individual’s
body with a dark blue band.
T cell counts are dropping and they're still
There is more to this innocent capsule than
asymptomatic. I have to be concerned that the
meets the eye.
trend is going in the wrong direction. I would be
AZT spells controversy on several fronts.
much more likely to propose to the patient to
The Federal Drug Administration established
consider AZT therapy in spite of the risks
indications as to who qualifies for AZT. yet
involved. The key is to stop the destruction of
doctors have prescribed it to patients outside
T-4 cells, which are the best markers for
this group. AZT is cost-prohibitive to patients
with or without medical insurance coverage.
Unproved AIDS drugs can be procured without
To complicate matters further, in the wake of
prescription on the street. AZT carries
the FDA’s March 1987 approval of AZT. a cure
dangerous, toxic side effects; patient refusal is hysteria has emerged. AZT does not cure
AIDS. Nevertheless. HIV-positive individuals
According to the drug-package insert. AZT
flock to physicians for a prescription. Sampson
indications are based solely on the results of a
said people will take any risk.
random, double-blind, placebo-controlled
“ You see many patients making their deci
study conducted at 12 medical centers in the
sion to take AZT based on erroneous informa
United States. 59 people took AZT, 62 took a
tion. It’s a classic scene just as when a patient
placebo. The study stopped when 19 people in
comes in with a sore throat and demands an
the placebo group died due to opportunistic
antibiotic. You know antibiotics don’t even
infections. AZT shot through the FDA approval touch viruses. Yet the patient pushes and
process in an unprecedented four months.
pressures the doctor to prescribe it or he'll go
Cancer drugs, in contrast, take a decade to wade elsewhere until he gets it,” he said.
through this process.
The usual dose in AZT therapy is two 10 mg.
The drug-package insert indicates AZT for
capsules every four hours. The average cost of
AIDS patients who have had a recent bout of
AZT is $20 to $25 per day. $6,000 to $8,000 per
pneumonia, specifically pneumocystis carinii,
year — an expensive endeavor regardless of
patients who show no signs of opportunistic
infection such as Kaposi’s sarcoma, and AIDS-
Sampson sees an economic benefit for the
Related Complex (ARC) patients. Outside of
patient. A year’s supply of AZT plus one to four
these indications, it’s anybody’s guess whether transfusions “ is still less than one hospitaliza
the benefits of taking AZT outweigh the risks.
tion with lab work and doctor visits. Taking this
Is it ethical to prescribe AZT to patients out medication means decreased hospital costs to
side these indications?
the patient,” he said.
“ Professionals make decisions to prescribe
Nevertheless, funding issues of far-reaching
medication or not based on risk involved in
implications emerge due to the high price of
taking that medication.” said Dr. Jim Sampson AZT. Loveless sees economics playing a
of Good Samaritan Primary Care Clinic. Fie
major role in the future of AZT therapy.
contends that doctors can go outside the FDA’s
“ Physicians are caught in a bind between
indications on any medication, but the real issue what we feel reasonable to do based on current
is that AZT is toxic to some individuals.
data, and there is justification for being more
“ It is important to establish risk management.
liberal with AZT than the FDA. On the other
I prescribe AZT on a case-by-case basis and
hand, third-party providers such as insurance
consider factors such as medical history, social companies and welfare agencies are paying for
history and patient desire to risk taking the
the drug. often only when criteria on the product
medication.” Sampson said.
insert are met. There are patients who are put in
Dr. Mark Loveless, an infectious disease
a bind where we know their immune systems
clinician at the Oregon Health Sciences Uni
are not doing well. We know that AZT is the
versity. also steps outside the FDA indications
only treatment, yet they don’t meet the arbitrary
w hen prescribing AZT. He believes current and
criteria of the third-party provider. Therefore,
previous studies show a benefit for starting AZT the third-party provider won’t pay for AZT.” he
treatment early in the disease.
“ When individuals come in who are showing
Meanwhile, instances of patients splitting
me signs that their immune system has very
their doses with HIV-positive friends, who are
little reserve left, I have made a decision, ethi
shut out by arbitrary criteria, become common
cally. to step outside the absolute boundaries as place.
defined in the product insert,” he said.
Loveless surmises that a number of people
Loveless’s personal strategy is this: ” 1 look
take AZT without prescription. “ There are
for clinical signs that the immune system is not desperate things being done by people feeling
functioning such as evidence of yeast in the
desperate about their disease.” he said.
mouth, evidence of persistent viral infections,
Funding remains a key issue. "Ethics become
evidence of poorly healing infections like
not so directed at the physician but more at the
herpes, signs of persistent fungal infections in
health-financing organizations, be it the state or
the toes and groin, signs of venereal warts or
private insurance companies or Medicare. The
other warts, persistent diarrhea and things that
issue could become. ‘Yes. we know AZT is
don ’t particularly fit into the category of AIDS
effective, but we’re going to wait until the later
that we could classify as ARC. If I see these
stages of the disease before we fund it,’ ” said
clinical indicators, then I’ll test an individual
for T cells. If T cells are lower than 200.1
Seemingly, the person holding the purse