Testing Therapies Less Effective than the Best Current Standard: Ethical Beliefs in an International Sample of Researchers

• Published in: American journal of bioethics 2003-05, Vol.3 (2), p.28-33
• Main Authors: Kent, David M., Mwamburi, Mkaya, Cash, Richard A., Rabin, Tracy L., Bennish, Michael L
• Format: Article
• Language: English
• ISSN: 1526-5161; 1536-0075
• DOI: 10.1162/152651603322874898

Objectives : To test the range of beliefs regarding the ethics of testing, in resource poor settings, new therapies that are less efficacious but more affordable and feasible than the best current therapeutic standard. Design : Using a web-based survey, we presented a hypothetical scenario proposing to test a therapy for HIV disease ("therapeutic inoculation") known to be less efficacious than highly active antiretroviral therapy (HAART). Respondents evaluated various trial designs as ethical or unethical. Participants : 604 subscribers to two listservs for individuals interested in international health research ethics. Main outcome measures : Proportion of respondents endorsing trials testing this "substandard" therapy, and proportion endorsing placebo-controlled trials. Results : There were 215 respondents from 47 countries. Forty-five percent of respondents were from low or middle income countries; 96% devoted at least some time to research activities; and 75% had "some" or "considerable" research experience in developing countries. Of respondents, 97% (95% CI 94.7 to 99.4) endorsed testing therapeutic inoculation, without HAART, in patients with HIV disease; 86% (95% CI 81.4% to 90.7%) endorsed testing against placebo. Sixty-eight percent explicitly endorsed principles where the standard of care for subjects in clinical trials is determined by local, not universal, standards. There were no differences in responses based on respondent education-level or the income-level of their country of citizenship. Conclusion : There was broad agreement that a therapy of potential local benefit may be tested, even when that therapy is known to be inferior to the standard of care in wealthy countries. Most agreed that a placebo control may be used in some circumstances.