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Excuse for Depo: Wait for (unethical) research

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The ECHO trial (Evidence for Contraceptive Options and HIV Outcomes)

Another excuse to delay phasing out Depo in Africa is to ask people to wait for results from new (and unethical) research. As the scientific consensus finally accepted that Depo increased women’s risk for HIV, Depo promoters – including Gates Foundation and USAID – funded new research, delaying action on available evidence.

This new research enrolled and randomly assign more than 7,000 HIV-negative women in Africa to use one of three birth control technologies: Depo injections; an implant (levonorgestrel, with a progestin unlike Depo), and an IUD (inter-uterine device).[1,2] The study follows and retests women for HIV during 2015-18. The object of the research is to see how many women with Depo vs. implants vs. IUDs get HIV.

The ECHO trial vs. the Declaration of Helsinki

This research conflicts with the Declaration of Helsinki’s guidance for medical research on human subjects. Two points:

1. The Declaration states: “It is the duty of the physician to promote and safeguard the health, well-being and rights of…those who are involved in medical research.” Because research to date shows Depo use increases women’s risk to get HIV, it is unethical (and also scientifically unnecessary!) to give women Depo to watch them get HIV.

2. The Declaration states: “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s)..” Among all birth control technologies, what are the best options? According to a lot of research, birth control pills do not increase women’s risk for HIV.[4] Hence, pills should be one of the arms, so what is tested can be compared to a “best proven intervention.” Other arms could assign women to other birth control options for which there is so far no good evidence or reason to suspect it increases women’s risk to get HIV. This may include IUDs and levonogestrel. But Depo should not be one of the options!

The principle here is “equipoise”: research can be justified in situations where so far we don’t know the answer, but if we already know the answer (Depo increases women’s risk for HIV), then it is not only unethical but also unscientific to “research” something that is already known. That’s like research asking women to cross streets with their eyes closed to see if they are more likely to get hit by cars vs women who keep their eyes open. Don’t we know the answer?

Ethics committees from Family Health International and WHO approved the trial. That doesn’t mean the research is ethical — over the years, similar committees have approved a lot of unethical research. Recognizing the reality of weak ethical oversight, the US government routinely posts a disclaimer on its ClinicalTrials web pages describing each research project, including this one: “The safety and scientific validity of this study is the responsibility of the study sponsor and investigators…”

References

1. Hofmeyr GJ, Morrison CS, Baeten J, et al. Rational and design of a multi-center, open-label, randomised clinical trial comparing HIV incidence and contraceptive in women using three commonly-used contraceptive methods (the ECHO study). Gates Open Res 2017; 1: doi: 10.12688/gatesopenres.12775.1. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5771152/ (accessed 2 April 2018).

2. ClinicalTrials.gov. The evidence for contraceptive options and HIV outcomes trial. Available at: https://clinicaltrials.gov/ct2/show/NCT02550067 (accessed 2 April 2018).

3. WMA [World Medical Association] Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 2013. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (accessed 2 April 2018).

4. Polis CB, Curtis KM, Hannaford PC, et al. An updated systematic review on hormonal contraception and HIV acquisition in women. AIDS 2016; 30: 2665-2683. Available at:  http://aura.abdn.ac.uk/bitstream/handle/2164/7653/An_updated_systematic_review_of_epidemiological.13.pdf?sequence=1&isAllowed=y (accessed 2 April 2018).

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