Use of Placebos in
Debate in
By HOWARD W. FRENCH
BIDJAN,
HIV-infected mother and patient in an
American-financed AIDS treatment experiment
here,
doesn't yet know if the disease has spared her year-old
son.
Like scores of other women who have taken
part in the
same tests, she has no idea whether she received
medicine or a dummy pill. And she may never be told.
It is now more than a year since she took
pills
prescribed to her in the program meant to determine the
effectiveness of a short course of the anti-AIDS drug
AZT in preventing pregnant mothers from
passing the HIV
virus on their chidren.
A longer treatment with AZT is known to
significantly
reduce the rate of transmission of the virus from
mother to baby, but the cost and complexity make it
prohibitive in the
determine the effectiveness of various lower levels of
the drug have been conducted here, the Dominican
Republic and
tests, however, has set off a furor among medical
ethicists in the West.
Ms. Guede, however,
still doesn't quite grasp -- even
after repeated questioning -- what exactly a placebo is
or why she might have been given one instead of a real
medicine.
"They gave me a bunch of pills to take,
and told me how
to take them" said the woman, who is illiterate.
"Some
were for malaria, some were for fevers, and some were
supposed to be for the virus. I knew that there were
different kinds, but I figured that if one of them
didn't work against AIDS, then one of the other ones
would."
For Ms. Guede, the
reason to enroll in the placebo
trial last year was clear: it offered her and her
infant free health care, and a hope to shield her baby
from an infection that she understands is deadly.
Unmarried and unemployed, this new mother,
like many
others, said that the prospect of help as she brought
her baby into the world made taking part in the
experiment all but irresistible.
Still, the question of whether she and other
pregnant
women really knew the implications of consenting to a
placebo test hangs over the project, financed by the
National Institutes of Health and the Centers
for
Disease Control and
Prevention. It has set off a
raging
debate over medical ethics in the
barely raised a ripple in this poor West African
country of 11 million people.
In the
with AZT, known as the 076 regimen, and comparing the
drug's effects with those of placebos ended in 1994
once it was shown that the drug sharply reduced
transmission of the virus from mothers to their babies.
It would be virtually impossible, doctors
say, to
receive approval for tests in the
AIDS-infected mothers using placebos now that
the 076
regimen has been proved effective.
But other medical ethicists argue
differently: There is
no question of 076 being adopted in
its high cost, they say, and that is precisely why a
low-cost method is needed. Some people say the best way
to do that is to compare different low-cost methods,
with no placebo group, but others say this would take
longer and be less reliable than a placebo test.
"We cannot afford the 076 regimen,"
said Dr. Rene
Anatole Ehounou Ekpini,
one of a team of local
health-care workers employed in the program. The
treatment is not only costly; it requires early
intervention in a woman's pregnancy, long courses of
the expensive drug, and intravenous treatments during
childbirth. And none of this seems practical here.
"We already know what the alternative is
to what we are
doing," said Ekpini, who
spoke in the simple state-run
maternal and infant-care clinic in
working-class district of Koumassi, where
the trials
are being conducted. "The alternative is giving
everyone here the placebo treatment, because if you
step outside, that is what pregnant women with the
disease are getting here: nothing."
One American doctor involved in the research,
who spoke
on the condition of anonymity, echoed that argument.
"The regimen that is proven in the
$1,000 per woman, which this country and
others like it
cannot afford."
The American scientists involved in the
experiments
here were told by the U.S. Embassy not to speak on the
record about their work.
In the
said that the women who take part are willing
volunteers who knowingly accept the risks.
But extended interviews with a handful of the
women,
made available to a reporter by the researchers, made
it clear that despite repeated explanations by project
case workers, the understanding of these mostly poor
and scantily educated subjects does not match the
complexity of the ethical and scientific issues
involved.
Social workers and nurses employed in the
experiment do
brief potential subjects about the nature of the
testing program. But a session in which one
HIV-positive woman was invited to take part
showed just
how quickly the details of the testing are disposed
with.
Minutes after she was informed for the first
time that
she carried the AIDS virus, one pregnant woman, Siata
Ouattara, still visibly shaken by the news, was quickly
walked through the details of the tests, as well as
general advice about maintaining her health and
protecting others from acquiring the disease.
In less than five minutes, in which the
previously
unknown concept of a placebo was briefly mentioned, the
session was over, and Ms. Ouattara,
unemployed and
illiterate, had agreed to take part in the tests. Asked
what had persuaded her to do so, she responded, "the
medical care that they are promising me."
The gap in understanding of the issues
involved
corresponds to that between the means of industrialized
countries, like the
conducting such tests, and developing countries, like
One of the most highly educated of the women
who spoke
to a reporter, a 31-year-old single mother with a
degree in law who gave her name only as Nicole, said
that she had never been made to understand that the
medicine being tested, AZT, was already known to stop
transmission of the virus during pregnancy.
"I am not sure that I understood all of
this so well,"
Nicole said. "But there were some
medicines that they
said might protect the mother and the child, and they
wanted to follow the evolution of my pregnancy and the
effectiveness of the treatment."
Asked if the treatment had helped her, Nicole
responded
"I am sure, because I gave birth to a
little girl who
is doing very well and I feel fine myself."
Pressed further, Nicole, like the other
mothers, said
that she had not been told the results of blood tests
on her 1-year old.
Then asked what how she would feel if she
learned
tomorrow that she had received a placebo when a proven
treatment existed, Nicole's tone changed abruptly. "I
would say quite simply that that is an injustice." she
said.
Then, regathering
her composure, Nicole posed the
problem another way. "At the time they explained this
to me I asked myself the simple question of whether I
had any choice," she said. "As long as there
was a
possibility to save my daughter, I had to try."
For other mothers who took part in the test,
the
confusion was far more profound. Some acknowledged that
they understood little of the tests but hoped to save
their children or get health care that they could not
otherwise afford.
Several Ivorian doctors objected to the
ethical
questions being raised over AZT testing, saying that
outsiders consider Africans incapable of weighing their
own interests.
"One has the impression that foreigners
think that once
white people arrive here they can impose what they want
and we just accept it in ignorance," said Dr. Toussaint
Sibailly, one of the doctors employed in the project.
"If that was once the case, those days
are long past."
Still, even though the testing here was
reviewed and
approved by an
senior health official seemed surprised when told that
a test like the one underway in
likely take place in the
"If the country that is paying for the
study cannot
accept conducting it, then we can't be expected to
accept it either," said Dr. Issa
Malick Coulibaly, the
senior health ministry official with oversight over the
AZT research.
An American scientist with the project said
later that
the
research could be performed in the
that the experiment was designed according to the
strictest American and international standards for
medical research.
The women taking part in the study seemed to
have a
sense of obligation when they were told that the trials
are meant to find an affordable drug regimen that can
save tens of thousands of lives down the road.
"If the scientists say that it has to be
this way, then
I can only agree with them," said a
mother named
Salimata, who spoke as she clutched her tiny
4-month-old daughter. "People are trying to help us,
and if a bunch of people have to die first, I am ready
to risk my life too, so that other women and their
babies can survive.
"If I got the placebo,
that will hurt, for sure. But
there is no evil involved."
Copyright 1997 The
New York Times Company