Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
Reuters NewMedia, Inc. - Thursday October 23 8:56 PM EDT
Maggie Fox, Health and Science Correspondent
The trials were designed to see whether drug treatments could stop pregnant women from passing on the virus that causes AIDS to their babies. More than 830,000 children around the world are infected with human immunodeficiency virus and most got it from their mothers.
The trials have been criticized because some of the women get placebos instead of drugs. Placebo arms are important to scientific trials because they provide a baseline measurement.
Groups like Public Citizen, founded by consumer advocate Ralph Nader, criticized the trials saying it was unfair to withhold potentially life-saving therapy from anybody.
Last month Marcia Angell, editor of the prestigious New England Journal of Medicine, weighed in with her own attack.
She likened the researchers to those who carried out now-infamous experiments in which black men with syphilis in Tuskeegee, Alabama, were deliberately not treated for 40 years.
The Journal also published Public Citizen's criticisms.
AIDS researchers have defended the trials as completely ethical, saying that hardly anyone in Africa would get such drugs were it not for the trials.
A spokesman for Johns Hopkins University confirmed that the placebo arm of one trial in Ethiopia had been dropped, but denied the controversy had anything to do with it.
"The change had to do with science," he said. He said a separate trial in Thailand, being conducted in part by Harvard University researchers, had provided evidence that it would not affect results if all the women were treated.
Public Citizen had said in a letter to Health and Human Services Secretary Donna Shalala that it had obtained information that the placebo arm was being dropped in the Ethiopia study, which is being funded by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).
They also said they had unpublished data that showed even a very short course of drugs before delivery would help prevent the transmission of HIV from mother to baby.
"On the basis of the new information, we demand that you immediately order the researchers to stop any arm of their studies in which women are designed access to antiretroviral drugs and to provide at least short-term AZT for all women now getting a placebo or other unproven treatments," the letter read.
Standard treatment for HIV-infected women in the United States is now to give them AIDS drugs such as AZT while they are pregnant, in an intravenous infusion while they are in labor, and then to give the drugs to babies after delivery.
Scientists say this greatly reduced mother-to-child transmission.
But in developing countries like those in Africa where AIDS is most rampant, drugs like these are far beyond the means of patients and health authorities. Researchers are trying to see if there is a cheaper way to stop babies from getting infected.
NIH researchers involved in the study were not immediately available for comment. Johns Hopkins said it would issue a statement Friday.
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