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| Article - Abstract. To view full article click on the article title. | |
eMJA: McNeill, Should research ethics change at the border? Should research ethics change at the border? The use of placebos in HIV drug trials has raised concerns about research ethics in developing countries MJA 1998; 169: 509-510 Research on mothers with HIV in poor countries has attracted vehement criticism. The researchers (largely funded from the West) are accused of changing their ethics "at the customs desk."1 In defence of their own position researchers (and their sponsoring bodies) claim that ethical standards are unrealistic and that local conditions require studies "that might not be found ethically acceptable in developed countries."2 They argue for achievable standards that depend on local circumstances.2-4 The controversy concerns the use of placebos in zidovudine drug trials on mothers with HIV in Thailand, Africa and the Caribbean. The trials aimed to test the effectiveness of a short course of low-dose zidovudine in preventing transmission of HIV from mothers to infants by comparing transmission rates of mothers given zidovudine with those offered only a placebo. The short course is an alternative to a more expensive regimen of treatment with zidovudine for both mother and infant previously demonstrated to be effective in the trial known as ACTG 076.5 Although the ACTG 076 regimen has been effective in reducing transmission rates by almost 70%, it is not available in resource-poor countries because of the cost and lack of necessary facilities and support.3 Placebo trials in Thailand have recently shown that a simplified regimen of zidovudine was effective in reducing the transmission of HIV between infected mothers and their infants by 51%. This finding is from studies with women who did not breastfeed and who were given zidovudine orally for three to four weeks before birth. No zidovudine was given to their infants.6 This result now makes it clear that placebo comparisons are no longer ethical in mother-to-child HIV transmission studies, even in poorer countries. Full Article: http://www.mja.com.au/public/issues/nov16/mcneill/mcneill.html |
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2006 Ethics-Governance.com |
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