Ethical concerns with cervical cancer screening trials in India

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Anita Chary

Anita Chary

Anita Chary, MD PhD, is an anthropologist and resident physician at the Harvard Affiliated Emergency Medicine Residency. She is Research Director of the non-governmental organization Maya Health Alliance | Wuqu' Kawoq, which provides health care and development services in rural indigenous communities of Guatemala.

Recently, the Indian Journal of Medical Ethics published an article by Dr. Eric Suba regarding ethical and scientific controversies about large-scale longitudinal randomized trials of various cervical cancer screening methods (Pap smears, visual inspection with acetic acid, and HPV DNA testing) in India.  Trials funded by the US National Cancer Institute (NCI) and the Gates Foundation compared cervical cancer death rates among women offered one of these forms of screening to those offered no screening.

Notably, this trial followed women through multiple rounds of screening over more than a decade.  However, when groups receiving novel screening exams showed lower cervical cancer incidence and mortality than control groups, the interventions were not offered to the unscreened control groups.

So far, over 250 Indian women in the unscreened control groups have died of cervical cancer.  Furthermore, the US Office for Human Research Protections (OHRP) launched an investigation of the ethics oversight of the trial and concluded that study participants did not provide informed consent.

This article raises some important questions for global health practitioners:  How can we ensure that clinical trials are conducted with the highest ethical standards in the Global South?  When is it ethical to employ control groups?  Should we be considering more stepped wedge trials?  Is it ethical to measure death rates in a control group even after an intervention is found to be successful–or as one critic puts it, is it acceptable to “let people die to show something you already know”?

Read more here:

US-funded measurements of cervical cancer death rates in India: scientific and ethical concerns – by Eric Suba, Indian Journal of Medical Ethics.