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A landmark ethical clearance

August 25, 2014 12:33 am | Updated November 16, 2021 05:41 pm IST

On August 11, for the first time a 12-member World Health Organization panel unanimously agreed that the use of “unproven interventions” in humans as potential treatment or prevention options for the Ebola virus disease is ethical in the West African countries of Liberia, Guinea, Sierra Leone and Nigeria. The interventions would also be evaluated for safety and efficacy in the best possible clinical trial settings. But the tricky ethical issue of ensuring “fair distribution” among the affected populations and countries will be looked into later. The green signal is specific to the circumstance of this outbreak, and subject to certain conditions like “transparency about all aspects of care, and informed consent” being met. The factors that played a vital role in the WHO’s decision were the continued spread of the disease, about 55 per cent mortality rate and the lack of vaccines/drugs to prevent infection or treat the disease. As on August 22, the number of people infected with the virus was 2,615 (1,528 confirmed) and the mortality figure, 11,427. But it was the controversy over the use of an untested drug, ZMapp, on two Americans who came down with the disease that forced the WHO to look into the ethics of using it in the four countries.

Prior to the WHO clearance, there were three main reasons cited for not supplying the untested drug to dying Africans. First, the level of medical care that is necessary to monitor for any serious adverse effects that might arise after drug administration is currently not available in the four countries. The second reason was the inability of the U.S. to decide who the recipients of a limited supply of drugs should be. The third was the backlash the drug company and the U.S. would face if the experimental drug first used on Africans were to cause serious adverse effects. But the use of the experimental drug on two Americans and then on a Spanish priest brought back to his country has further eroded the goodwill that the U.S. enjoyed in the four countries. It has also heightened the affected population’s level of suspicion against national and international doctors and health workers. Even the supply of drugs to Liberia to treat two doctors just prior to the WHO debating the ethical issue may not turn out to be an effective balm to reduce the ill-will; by default or design, the WHO’s ethical clearance has preceded the use of the drugs on the two Liberians. If many unethical human clinical trials, like the one carried out in 1996 in Nigeria by an American drug company during a meningitis outbreak, seriously affected the prospects of conducting trials in Africa, instances such as this only complicate it. So it remains to be seen how successful other Ebola drug treatment trials would be.

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