Standard of Care







"Ethical Imperialism."

In the course of the debate, critics of the placebo-controlled trials were sometimes accused of "ethical imperialism"--that is, of seeking to impose their ethical standards on countries that had made their own judgments on the merits of the trials, based on their particular needs. Many of those who made this charge were health officials and clinicians from developing countries. The host countries in sub-Saharan Africa had played an active role in designing the trials, they said, and were not merely the pawns of sponsoring nations.

In a letter to Satcher and Varmus, which they quoted in their New England Journal of Medicine article, Edward Mbidde, chairman of the AIDS Research Committee of the Uganda Cancer Institute, wrote: "These are Ugandan studies conducted by Ugandan investigators on Ugandans. Due to lack of resources we have been sponsored by organizations like yours. . . . It is not NIH conducting the studies in Uganda but Ugandans conducting their study on their people for the good of their people." Furthermore, these critics maintained, the clinical trials had been carefully examined by ethical review committees in the sponsoring and host countries; they conformed to international standards, yet were tailored to suit the realities of medical care in their communities.

Many of the researchers and health officials from sub-Saharan Africa who responded to the criticism of Lurie et al. questioned the depth their understanding of conditions in their countries, sometimes in harsh terms. Writing in the New York Times on September 28, 1997, Danstan Bagenda and Philippa Musake-Mudido, a biostatistician and a pediatrician, respectively, from Uganda, asserted:

Those who can speak with credibility for AIDS patients in Africa are those who live among and know the people here or have some basic cross-cultural sensitivity. We are suspicious of those who claim to speak for our people, yet have never worked with them. Callous accusations may help sell newspapers and journals, but they demean the people here and the horrible tragedy that we live daily.

Critics of the trials in sub-Saharan Africa dismissed both the charges of ethical imperialism and the defense of the ethical review process that preceded the studies. Regarding the latter, they questioned the disinterestedness of the review, both at home and abroad, particularly in view of the substantial research money at stake.

Moreover, some argued, the researchers and health officials who levied charges of ethical imperialism were not necessarily advocates for the poor citizens of their nations. The term, "ethical imperialism," Angell points out, was not a new one, but rather "an old argument in new clothes." Ten years earlier, she had written an editorial on the issue in The New England Journal of Medicine, when questions arose about the appropriateness of seeking informed consent from women in some developing nations, where their husbands or village chiefs normally spoke for them. Then, as now, she and others argued that the charge of ethical imperialism obscured a more insidious danger to developing countries: ethical relativism, which opened the door to exploitation of the vulnerable peoples of the Third World.   



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