Note to reader: the studies by Drs. Coovadia and Vermund described in this press release were later altered so that they were never actually conducted with the designs described here.



JULY 1, 1998

HEALTH GROUP ATTACKS SECOND GENERATION
OF UNETHICAL PERINATAL TRIALS IN AFRICA

Researchers to Deny HIV-positive Pregnant Women Effective,
Less Expensive Drug Regimens

GENEVA, Switzerland -- HIV-positive pregnant African women involved in HIV experiments continue to be denied effective treatment, resulting in the needless infection of dozens of babies, says Public Citizen?s Health Research Group.

Despite the U.S. Centers for Disease Control and Prevention (CDC)?s identification of a less-expensive regimen of AZT capable of reducing HIV transmission from mother to infant by 51%, several studies now being designed still do not plan to provide this potentially life-saving intervention, says the group.

This and further unethical aspects of past and present perinatal HIV trials in developing countries will be explored by Peter Lurie, MD, MPH of Public Citizen?s Health Research Group in an oral presentation at 15:00 on Wednesday, July 1, 1998 in Hall I at the 12th World AIDS Conference in Geneva, Switzerland. In a highly unusual scheduling decision by the organizers, Dr. Hoosen Coovadia of the University of Natal in South Africa, who has conducted some of the unethical research, is to provide a "Reply" immediately after Dr. Lurie?s presentation.

In April 1997, Public Citizen?s Health Research Group criticized 15 studies, most funded by the U.S. government, in which thousands of HIV-positive pregnant women were denied access to AZT, a drug shown in a study in the U.S. and France to dramatically reduce perinatal HIV transmission. The studies were designed to identify more affordable versions of the successful U.S./French regimen that could be utilized in developing countries where the vast majority of the 500,000 annual perinatal HIV transmission occur. Public Citizen criticized the failure to provide AZT to some of the women in these studies; in some studies women received placebos instead of the known effective medication.

In September 1997, Public Citizen renewed its attack in the New England Journal of Medicine; the Journal?s Executive Editor, Marcia Angell, supported Public Citizen?s criticism. Despite this, most of the studies continued. In February 1998 a CDC-sponsored placebo-controlled study in Thailand confirmed what Public Citizen had predicted all along: short courses of AZT reduced the rate of HIV transmission from mother to infant, by 51%.

In his presentation, Dr. Lurie will focus on three studies now being designed that do not provide even the less expensive regimen proved effective in the Thailand/CDC study to all study participants. For example, in a study Dr. Coovadia is now planning for potential funding from the Wellcome Trust, HIV-positive pregnant women would simply be observed to determine the rate and predictors of HIV transmission to infants, even though two provinces in South Africa are currently developing plans to provide AZT for such women.

"It is simply unbelievable that any researcher would design a study in which no intervention whatsoever is offered to the women, particularly after the Thai/CDC results," said Dr. Lurie. "What was the purpose of the previous round of studies if not to identify drug regimens that could actually be offered to HIV-positive pregnant women?"

Dr. Lurie will also discuss two U.S. government-funded studies: HIVNET 012 (Principal Investigator: Brooks Jackson, Johns Hopkins University) in which the HIV-positive pregnant women will not receive any AZT prior to delivery (this was an important part of the Thai/CDC regimen) and another HIVNET study involving chlorhexidine vaginal washings (Principal Investigator: Sten Vermund, University of Alabama) in which no women receive any AZT.

Dr. Lurie will also examine the ethical implications of the failure to provide treatment for the women once they have delivered their infants; risks include the development of resistant HIV strains due to stopping and starting drug regimens.

"It seems that these researchers have learned little from the initial debate over the ethics of the perinatal studies," said Dr. Lurie. "Rather than embarking upon a second generation of unethical trials, the researchers should immediately redesign these studies to ensure that all women have access to life-saving antiretroviral medications."