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AIDS TEST PLACEBOS TOUCH OFF FUROR; THIRD WORLD EXPERIMENTS RAISE ETHICS, CONSENT ISSUES IN WEST.

Byline: Howard W. French The New York Times

Cecile Guede, a 23-year-old 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 human immunodeficiency virus to their children.

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 Third World. That is why tests to determine the effectiveness of various lower levels of the drug have been conducted in the Ivory Coast, the Dominican Republic and Thailand.

The use of placebos in these tests, however, has set off a furor among medical ethicists in the West. And Guede 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 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 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 United States but has barely raised a ripple in this poor West African country of 11 million people.

Tests of an intensive course of treatment with AZT, known as the 076 regimen, were interrupted in the United States in 1994 once it was shown that the regimen dramatically reduced the number of babies who contracted the virus from their mothers. It would be virtually impossible, doctors say, to receive approval for further tests in the United States on AIDS-infected mothers using placebos for any other drug regimen.

But other medical ethicists argue differently: There is no question of 076 being adopted in Africa because of its high cost, they say, and that is precisely why a low-cost method is needed. Some 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 that seems practical in the Ivory Coast.

``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 Abidjan's 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.''

The American scientists involved in the Ivory Coast experiment were told by the U.S. Embassy not to speak on the record about their work.

In the United States, proponents of the AZT trials have said 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 caseworkers, 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 carries 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 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.''
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Publication:Daily News (Los Angeles, CA)
Date:Oct 9, 1997
Words:920
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