of poor
Khadija Magardie
Prominent South African researchers and medical ethics specialists are alarmed that proposed amendments to research protocols could open the door for researchers to use patients in poor countries as human guinea pigs in global medical research.
In a series of open letters challenging the values of the medical fraternity, the group cautions that proposed amendments to universal medical research protocols could lead to unprecedented exploitation of the developing world in the service of science.
This comes as the World Medical Association (WMA) considers significant revisions to the Helsinki declaration – the internationally recognised benchmark for ethical practice in research.
The proposed revisions want to establish the principle that investigators and researchers should not be held responsible for providing better health care than is generally available in a particular country.
In addition, the revisions also propose various conditions under which requirements, such as informed consent in experimental procedures, may be waived.
According to a renowned academic and ethicist, Professor Solly Benatar of the University of Cape Town’s (UCT) department of health, such proposals “will make it easier to do research in developing countries, opening avenues for exploitation”.
One of the possible implications could be that risky procedures could be tried out or tested with impunity in the world’s poorer countries – procedures and treatments that would lead to billion-dollar lawsuits if unsuccessful in the developed world.
Professor Leslie London, of UCT’s department of public health, who has been at the forefront of the bioethics debate, questioned whether “the globalisation of medical ethics would set some rules for poor countries, and others for rich ones”.
London, who has co-authored several journal articles on the subject, wrote a letter to the South African Medical Journal last year sounding the alarm on the proposed revisions. He wrote that such revisions could “roll back the very important human rights considerations that underpin the [Helsinki] declaration”.
In his letter London cautioned that abandoning an existing universally applicable standard of treatment would be “an abrogation of researchers’ responsibilities”. He added that it would “hasten increasing inequity, and establish a two-tier system of appraising ethical requirements for research”.
London acknowledged that each individual situation needed to be judged on its own merits, but added that researcher accountability was paramount.
South Africa is a favourite for drug trials, ranking fourth in the world behind the United States, Europe and Japan.
This is, morbidly, due to the wide prevalence of disease, exacerbated by the spread of HIV/Aids, coupled with a reasonably efficient infrastructure.
It is for this reason, London urges, that South African doctors and the South African Medical Association should “take the lead in opposing changes that will make it easier for unethical research to be conducted on people in vulnerable positions”.
The WMA has temporarily shelved the proposed amendments and is calling for further consultation.
n Meanwhile, Minister of Health Manto Tshabalala-Msimang announced on Tuesday that 4,2-million people, or one South African in every 10, are estimated to be HIV-positive and more than half of these are between the ages of 20 and 30. The Ministry of Health says the infection rate of pregnant women has declined slightly, from 22,8% to 22,45%, but the minister says this could be attributed to factors like higher mortality rates and fewer HIV- positive women falling pregnant.