In the name of science: Ethical violations in the ECHO randomised trial

Abstract

It was in the 1990s, that the possibility of increased transmission of HIV with the use of injectable contraceptive Depo-Provera®, was first flagged in medical literature. This has posed a challenge for its use in countries, particularly in the African region, where the prevalence and transmission rate of HIV is high. In 2015, a randomised 'clinical' trial, the Evidence for Contraceptive Options and HIV Outcomes (ECHO) was launched in four African countries to resolve the question whether the increased risk was causal. Contrary to expectations, the ECHO trial successfully recruited and randomised the specified number of girls/women participants. This paper argues that this was made possible by exercising undue influence, by using incentives, coercive language, and by concealing the real nature of the clinical trial during recruitment. The ECHO trial is unique in subjecting a group of healthy girls/women knowingly to a contraceptive drug with an intention not of finding out whether it is efficacious as a contraceptive, but to find out how risky or life-threatening its use could be. Thus, the ECHO trial has violated one of the central tenets of the Helsinki Declaration by privileging pursuit of knowledge over the interests of the girl/women trial participants from Africa.

HIV, progestins, genital epithelial barrier function, and the burden of objectivity†

“…Providing answers to these and other unresolved questions with prospective clinical studies is vital but time consuming and resource intensive. Such studies must also overcome ethical hurdles, residual confounding created by varying sexual behavior among individuals using DMPA or a long-acting reversible contraceptive vs. no contraception, and the frequency with which women discontinue or change contraceptives [ 7 , 39 ]. These challenges highlight the need to utilize experimental models with the ability to acquire data unobtainable in clinical investigation, explore plausible links between HIV susceptibility and a specific contraceptive agent, and define the contraceptive choices least likely to enhance HIV transmission.…”

Randomized Control Trials in the Field of Development

“…Blustein (2005) discusses the reasons. 47 See, for example, Sathyamala (2019) on an RCT used to study the health risks of a contraceptive drug in Africa.…”

Depot contraception and HIV: an exercise in obfuscation

“…Basing their recommendations on the ECHO trial’s conclusions suggests a lapse in scientific rigour by WHO’s guideline development group 12. Not taking account of ethical concerns about this trial is another opportunity lost 13…”