How good is "good enough"? The case for varying standards of evidence according to need for new interventions in HIV prevention.
In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it.
University of Sydney, Sydney, Australia. bridget.haire@sydney.edu.au
Bridget
B
Haire
John
J
Kaldor
Christopher F C
CF
Jordens
D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000282:Administration, Intravaginal; D000284:Administration, Oral; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004338:Drug Combinations; D000068679:Emtricitabine; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D026689:Ethical Analysis; D028663:Ethical Theory; D032984:Ethics, Research; D019317:Evidence-Based Medicine; D005260:Female; D005782:Gels; D017408:Guidelines as Topic; D015658:HIV Infections / Q000517:prevention & control*; D006297:Health Services Accessibility / Q000941:ethics*; D006301:Health Services Needs and Demand; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D063065:Organophosphonates / Q000008:administration & dosage; D009943:Organophosphorus Compounds / Q000008:administration & dosage; D011322:Primary Prevention / Q000941:ethics* / Q000379:methods / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000941:ethics; D035842:Research Subjects; D011477:Sex Work; D000068698:Tenofovir; D057212:Therapeutic Equipoise; D014481:United States; D014486:United States Food and Drug Administration
D019380:Anti-HIV Agents; D004338:Drug Combinations; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D005782:Gels; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine