11_ethics_of_trials_02

11_ethics_of_trials_02 - 10. Bio46 October17,2002 status...

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10. Ethics of drug testing in other countries Bio 46 October 17, 2002 Mother of all HIV challenges What was the response of Rachel’s husband when she learned her HIV+ status? What treatment(s) reduce the mother to child transmission of HIV? What societal factors make reduction of mother to child transmission in Africa difficult? What is a placebo and what is its role in a clinical trial? What was the 076 study? What is nevirapine and how effective is it compared to AZT? Why did the researches abruptly end the nevirapine trial? Why do many women avoid testing or substituting formula even though it increases the  chances of having a healthy baby? 1 10/6/09
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Ethical complexities of conducting research in developing countries When the 076 data was released there was uniform agreement to adopt it as the  standard of care for HIV+ pregnant women in the industrialized world.   There was also a  unified global demand for a therapy as effective but easier to implement for HIV+  women in the developing world.  The contested issue was what research design should be  used to test new therapies and what the results should be compared to. WHO special meeting: 076 used as control in all developed countries But not feasible for developing countries Suggested clinical trials with placebos These funded by CDC/NIH Signif document, Belmont report Dept health education welfare Response to  Tuskegee disclosure Laid out principles for use of human subjects in medical research Suggests sometimes no clear cut answer
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