Why raise questions on the “ethics” of the Gadchiroli trial?

I congratulate your team on publishing the article: “Was the Gadchiroli trial ethical? Response from the principal investigator”. Abhay Bang raised some practical questions for discussion with the international community (1). The following are my views in response to this article:

I wonder how researchers from these reputed institutions can raise questions on the ethics of a study which has clearly provided a ray of hope not only for the poor and vulnerable children in India but also for children in other developing countries. Such debates make me feel that the international community fails to understand the importance of this trial to the lives of innocent children; they do not realise the realities of socioeconomic conditions and the health system in remote areas of India. How much could one expect from a man, with limited resources, who really wanted to help deprived children and give life to theoretical concepts like “the right to life”? Even if he had provided “state-of-the-art” health services in the control area of the study, what difference would it have made in the remaining villages across India? I could also not understand the rationale for calling the standard of care provided in Gadchiroli “unethical”.

In fact, following the Gadchiroli trials, various studies were conducted in other south-east Asian countries, and all these studies adopted more or less the same model of “home-based neonatal care” that was adopted by the Gadchiroli trials. Further, none of them provided “standard care” as per the norms of the US or western Europe. Baqui et al, from Sylhet, Bangladesh, reported a 34% reduction in neonatal mortality by training female health workers to provide home-based newborn care as per WHO’s integrated management of childhood illness guidelines (2). Manandhar et al achieved a 30% reduction in the neonatal mortality rate in rural Nepal by introducing community-based newborn care through women’s groups (3). Bhutta et al in Pakistan engaged and trained an existing cadre of women health workers for community-based newborn care. In addition, trained birth attendants or “dais”; were also trained for newborn care. They eventually reduced the neonatal mortality rate by around 19% in four intervention villages (4). If the standard of care in the Gadchiroli trial is described as unethical, then I must say that the standard of care provided in all of the above mentioned trials is also unethical.

However, now we know that the interventions of the Gadchiroli trial have shown the effective way to reduce infant mortality substantially; instead of debating the ethics of the Gadchiroli trials, researchers should come forward and try to mobilise policy makers to adopt home-based neonatal care. I agree with Abhay Bang’s challenge to those who call this trial unethical: “Should one wait until the best standards, and the resources needed for using them in the control area, are made available, and allow children to die until such time?”