Even Indian Council of Medical Research (ICMR) guidelines stipulate that a placebo can be used only if the disease is self-limiting or when no proven preventive, diagnostic or therapeutic method exists. "Clearly these trials violated both international and national guidelines," said Sandhya Srinivasan of the Indian Journal of Medical Ethics (IJME), who in her editorial on the subject in April last year pointed out that "these studies would not have been permitted in the country of the funding organizations (US National Cancer Institute and the Bill and Melinda Gates Foundation (BMGF)." An article in the latest issue of the IJME by Dr Eric Suba, a San Francisco-based pathologist, who had filed a complaint in the US in May 2011 against the trial, has demanded compensation for the families of the women who died and immediate screening and treatment, where necessary, of the women in the unscreened group. The three-cluster randomized controlled trials looked for a cheap screening treatment for cervical cancer for introduction into the public health programme. The screening treatments being examined were Visual Inspection with Acetic Acid (VIA) screening, Pap smear — which is the standard of care in the west — and HPV screening.
In the IJME article, Dr Suba asked what purpose was to be served by keeping 140,000 women without screening when the effectiveness of cervical screening is well accepted. "...people should not be used to demonstrate exactly how much death results from lack of medical care," stated Dr Suba.