Ethicists challenge foreign AIDS experiments

WASHINGTON (AP) — The United States is paying for experiments in poor countries that could allow 1,000 babies to die of AIDS unnecessarily by withholding a protective drug from HIV-infected pregnant women, the patient advocacy group Public Citizen charged Tuesday.
The government says the studies are ethical because they are the only way to find new HIV protections that poor countries can afford. Pregnant women in developing countries today do not get the AZT therapy that American AIDS patients use to protect their unborn children.
But in a letter signed by prominent bioethicists and Dr. Wilbert Jordan, head of the Black Los Angeles AIDS Consortium, Public Citizen compared the U.S.-funded foreign research to the infamous “Tuskegee experiment” in Alabama in which the government withheld syphilis treatment from poor black patients.
Also, federal law says U.S. doctors cannot do experiments abroad that would not be tolerated here, the letter added in requesting a federal investigation.
“We are confident that you would not wish the reputation of your department to be stained with the blood of foreign infants,” said the letter to Health and Human Services Secretary Donna Shalala.
Shalala did not immediately respond, but the National Institutes of Health and Centers for Disease Control and Prevention vigorously defended the studies.
“In the absence of identifying some regimen that is affordable, hundreds of thousands of kids are going to die,” said the CDC’s Dr. Phillip Nieburg.
Studies in 1994 studies on American women indicated that taking the drug AZT during pregnancy and labor — and giving it to infants for six weeks after birth — cuts by two-thirds babies’ chances of catching HIV from mothers.
But that treatment costs about $800 per person, too expensive for developing countries, so doctors are studying potential alternatives such as shorter courses of AZT or giving malnourished pregnant women vitamin A.
But nine of these U.S.-funded studies in Africa, Thailand and the Dominican Republic compare the possible new therapies with dummy pills, instead of giving the comparison women the U.S.-style AZT treatment.
The government insists a placebo comparison is the only way to prove potential new therapies are better than no treatment.
But Public Citizen’s Dr. Peter Lurie accuses the researchers of a double standard by “conducting abroad experiments we would not condone here.”
He estimated that 416 babies unnecessarily caught HIV in two just-completed foreign studies that gave their mothers placebos. An additional 600 babies are at risk in the continuing experiments, he said.
But ethics rules “also say you don’t study a treatment that can’t be used in the country where the study is being undertaken,” countered NIH’s Dr. Jack Killen, who noted each country agreed to these studies. “They look at it as a chance to deal effectively with the thousands of infants a day who are not in a study,” by identifying affordable treatments.
The United Nations, South Africa and Europe are funding similar placebo-controlled studies in developing countries.
“We’re doing this for their benefit,” said Dr. Joseph Saba, head of the United Nation’s AIDS study.
“We are informing the women that they have a … risk of not getting any treatment,” added Saba, who said the World Health Organization in 1995 declared placebo-controlled studies the best way to quickly find AZT alternatives.
But Jordan, who ships his California patients’ leftover AZT to Africa, argues that researchers knowingly pass up a chance to save some infants in the studies.
“We are doing something overseas that we wouldn’t be doing here,” he said. “We’ve just continued to infect everyone.”
Lurie noted that yet another study in Thailand, funded by Harvard University and the NIH, did compare “short-course” AZT to U.S.-style longer AZT therapy, proving experiments without dummy pills are feasible.