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PHL283 Mar 10 2011

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University of Toronto Mississauga
Jonathan Peterson

PHL283 th March 10 Is it ethical for researchers in developed countries to carry out research on subjects in developing countries? AZT Trials - background is the world AIDS pandemic - HIV is a significant problem in parts of the developing world in particular - if someone with HIV becomes pregnant, the disease can be transferred through pregnancy and breastfeeding o finding ways to try to reduce the risk that HIV will be transmitted from mother to child - in 1994, research in France to find an effective intervention to reduce such a risk o found out that zidovudine could significantly reduce the risk of transmission - AZT: regimen that involves zidovudine o 076 regimen - what do you do? o you need to have large quantities of the drug and in complicated schedules o must be taken for a minimum of 12 weeks to be effective – begins in second trimester o take it 5 times a day orally o during labour, have to receive it intravenously o for 6 weeks after delivery, infant takes it orally 4 times a day o reduced the risk by 2/3 o if you look at the transmission rate from the controlled group (which was receiving a placebo) – 25% - and the active group – 8% o such a big breakthrough that they stopped the trial early and started to administer it to everyone in the study (including the controlled group) - in 1994, the US public health service said that AZT become the standard treatment o becomes the standard of care - 076 regimen is fairly expensive – the cost for the drug is $800-$1000 o issue of the complexity of the regimen - in developing countries, $10 per person is spent on healthcare per year – how is this drug feasible? - other practical problems o many people don’t seek medical attention for pregnancies that early o also, how many clinics will you find in developing countries that will administer AZT intravenously during labour o many births don’t even take place in hospitals or clinics o not enough resources o in a culture where breastfeeding is norm, not doing it becomes a stigma  the infant has to be fed formula - not going to be practically possible to give this to people that need it the most - clinical trials – to come up with something shorter, simpler, and less expensive that will also be effective in reducing transmission rates o randomized placebo controlled trials - what was done? o 16 trials in 11 countries o Burkina Faso o Ethiopia o Dominican Republic o Ivory Coast o Kenya o Thailand o Malawi o Uganda o South Africa o Zimbabwe o Tanzania - some involved comparing 076 to a different kind of treatment altogether that didn’t involve AZT - but a number of them involved placebo controlled trials - looking for something that is less effective than 076 but that is better than nothing - did the women even know they had HIV? - what is problematic about this? Angels - this is about as problematic as you can get when it comes to clinical research - comparable to Syphilis - believes we have enough information for the historical studies o placebo controlled trials are unethical 1. Double Standard - 076 is regarded as the standard of care in the developing world - a placebo trial would be unethical in any place with a standard of care o an active controlled trial has to be done instead - doing something that would not be ethically permissible in Canada/US/etc. o if its not ethical in the developed world, why is it ethical in the developing world? - but if 076 is practically impossible, we need to find a
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