The horror of Africa's placebo babies


BOSTON -- Imagine if it were happening here. Imagine if our government were sponsoring research in the poorest pockets of our country where masses of pregnant women are infected with HIV.

The researchers know that AZT could save many of their babies from being born infected. Without AZT one in four babies is infected by the mother, with it only one in 10.

But AZT is expensive, $1,000 a mother as it is prescribed now, and the need for a cheaper regimen is critical. So with the best of motives, they set up a study to see if lower, less costly doses are as good as higher doses.

Some mothers are given the current AZT protocol, some are given smaller doses.

But half -- this is the crucial fact -- are given placebos, those doses of nothing pills.

After all, the researchers reason, how else can they find out if something is better than nothing?

Imagine now what happens when the placebo children are born, when it is discovered that in the name of science the researchers withheld a known treatment. When it becomes known how the government justified this research saying that these few babies were sacrificed today for the good of more babies tomorrow. And that their mothers would never have had any medical care anyway.

It is, of course, unimaginable. Yet it is happening in Uganda, Malawi, Zimbabwe, Ethiopia and other countries where AIDS has spread like, well, AIDS.

And happening with the best of American intentions and funding.

In some African countries, up to 40 percent of pregnant women are infected. On average, the annual health care budget in Africa hovers around $11 a person a year. The likelihood that these women will get AZT as it is given in our country is virtually nil.

The urgency of the problem and the poverty of the people are used to explain research that would never pass ethical muster here. Does a double medical standard justify a double ethical standard?

Here, giving a placebo when a known effective treatment exists violates all the canons for research on human subjects.

But in the seven AZT studies funded by our government abroad, the women being given dummy pills will give birth to more than a thousand infected babies.

Sidney Wolfe and Peter Lurie of the Public Citizen's Health Research Group, who helped raise the furor, insist the studies not only violate our guidelines for conducting research in developing countries, they violate guidelines that say "ethical standards should be no less exacting" in poor countries than in our own.

Marcia Angell, executive editor of the New England Journal of Medicine, compared these studies on African mothers to the infamous Tuskegee studies on African-American men.

In Alabama, researchers silently charted the course of syphilis in their subjects long after a cure for the disease was discovered.

But many respected AIDS researchers heatedly disagree, arguing that in the real world of African AIDS, where women have little prenatal care and nothing is the norm, these placebo studies offer the best, fastest hope.

Are we then imposing our standards of ethics? Or extending them? Can one size fit all?

The argument about universal human rights in a diverse world underlies a host of issues from child labor to women's equality to free speech.

It is often said that poor countries cannot afford universal human rights.

But if AZT is too expensive for Africa, do we deal with a low economic standard by lowering an ethical standard? If so, developing countries could become convenient offshore research factories, for ethically cheap science.

After the infamous Nazi medical experiments, the world adopted a single code for research on humans. It says that we can't subordinate the interest of the subjects to the study. When women come into the AIDS study, researchers become responsible for their well-being -- and for their babies'.

As Marcia Angell says, "People can't be used as a means to a noble end."

Ellen Goodman is a syndicated columnist.

Pub Date: 9/25/97

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