Unauthorised HIV trial questions ethics processes

Were patients told of their right to informed consent? Copyright: WHO/Eric Miller

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[ZOMBA, MALAWI] The trial of a hospital technician accused of conducting unauthorised drug trials has highlighted a host of ethical issues surrounding research on patients, say commentators.

Thadeo Mac’osano, who coordinated the Palliative Care Unit at St Luke’s hospital in southern Malawi, is accused of running chemotherapy drug trials independently, without oversight or permission, until September 2008 (see Medic charged with unauthorised drug trials in Malawi). Six patients on the trials died, though it is not clear if their deaths were caused by the drugs.

Ethicists say the case demonstrates the need for more comprehensive regulatory oversight of clinical trials.

Mac’osano was arrested in October after providing the hospital with the preliminary results of his experiments, conducted on people suffering from HIV and the related cancer, Kaposi’s sarcoma.

St Luke’s hospital administrator Anthony Chilembwe testified in court this month (8 January) that as soon as Mac’osano submitted the report, Chilembwe investigated, discovered he had no approval and suspended him.

Questions should be asked about how Mac’osano had access to chemotherapy drugs and whether the hospital had failed to educate patients about their rights to informed consent, said Jillian Gardner of the Steve Biko Centre for Bioethics at the University of the Witwatersrand, South Africa.

Mac’osano faces four counts, including conducting clinical trials without permission from Malawi’s Pharmacy Medicine and Poison Board (PMPB) or the National Health Sciences Research Committee (NHSRC); administering medication without the correct licenses; and conducting drug tests on patients without their informed consent. He has pleaded not guilty to all charges.

Mac’osano claimed to have submitted applications to conduct drug tests to the College of Medicine Research and Ethical Committee and the HIV unit at the Ministry of Health, according to a preliminary investigation by the PMPB.

But PMPB lawyer Ishmael Wadi told SciDev.Net, that what Mac’osano claims to be the application is a letter seeking financial assistance to start the trials.

Gardner said South African regulatory bodies are obliged to inform all applicants of whether their application had been approved or rejected, whereas Mac’osano’s application was apparently ignored.

The trial also shows the need to ensure funding for ethics committees to do their job properly and ”highlighted the importance of having systems and procedures in place”, Gardner told SciDev.Net. 

She said it was ”bizarre” that Mac’osano thought he could conduct a drug test without permission but noted that the fact that he applied to the regulatory bodies meant he had an understanding of basic research responsibilities.

Evidence from all nine witnesses was completed yesterday (28 January) and the defence and prosecution lawyers now have 21 days to present their submissions to the magistrate. A ruling of whether Mac’osano has a case to answer is expected on 7 April.