Belinda Beresford
A LEADING UNITED STATES UNIVERSITY HAS BEEN USING HUMAN GUINEA PIGS IN UGANDA TO TEST THE RATE AT WHICH HIV CAN BE TRANSFERRED FROM INFECTED TO UNINFECTED PARTNERS – WITHOUT APPRAISING THE UNINFECTED PARTNERS OF THE RISKS INVOLVED.
The trial, which was conducted by researchers from Johns Hopkins University, has triggered a furore in medical circles because it used different standards to those that would be applied in the developed world. The trial resulted in 90 potentially preventable new cases of HIV among the participants.
The study, published in the latest edition of the New England Journal of Medicine (NEJM), has heightened the debate on whether human subjects in developing countries should be treated in the same way as subjects of trials in developed countries.
The researchers tracked 415 heterosexual couples where one partner was infected with HIV and the other not. Although the HIV- positive individuals were advised to tell their partners, the researchers did not ensure this was done. Free condoms were supplied but were often not used.
In an editorial in the NEJM Marcia Angell said: “It is important to be clear about what this study meant for the participants. It meant that for up to 30 months several hundred people with HIV infection were observed but not treated.
“In addition many people who were found to have other sexually transmitted diseases were left to seek their own treatment. Such a study could not have been performed in the United States where it would be expected that patients with HIV and other sexually transmitted diseases would be treated. In addition, in most states it would be expected that caregivers would see that seronegative partners were informed of their special risk.
“The ethical standards, then, were indeed different from those that would govern research in developed countries.”
The study had been passed by five ethics boards, including the Aids Research subcommittee of the Uganda National Council for Science and Technology.
A rationale for applying different treatment standards is that researchers only need to provide care comparable to that generally available in the community from which the human guinea pigs are drawn.
There is also an argument that different standards can be applied if the research is of special relevance to the region being studied.
The opposing side of the debate is that ethical standards should be the same regardless of the place or socio-economic conditions of the human subjects. There is also an argument that researchers assume responsibility for the health of their subjects, which should lead to medical treatment for other illnesses which are not research- related. There are doubts about the level of understanding of the human trialists, who may regard doctors as healers rather than as researchers.
While calling for an honest and reasoned debate on the subject, Angell said that in her opinion political and economic conditions should not justify lower standards of care. “In practical terms any other position could lead to the exploitation of people in developing countries in order to conduct research that could not be performed in sponsoring countries.”
The controversial study showed that the higher the level of HIV in a person’s blood, the greater the chance of transmission. This suggests that the use of drugs which lower the amount of the virus in humans could also help slow the spread of the disease by reducing the likelihood of transmission.