NEW DELHI: The death of 254 Indian women from modest backgrounds in the course of a 15-year US-funded clinical trial has triggered a raging debate about its ethicality. The trial was for a cervical cancer screening method and the women who died were part of a control group kept without screening to study death rates in unscreened populations.It is a well established fact that any kind of cervical screening reduces the incidence of the cancer. Yet, almost 140,000 women in the control arm of the trial were not screened. After a complaint made to it, the United States Office for Human Research Protections (OHRP) determined that the women were not given adequate information to give informed consent.Those arguing that the trial was unethical also say it violated the international ethical guidelines on medical research, the Helsinki Declaration ’s guidelines, which clearly state that “the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention”.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.The trials were conducted among Indian women of the lowest socioeconomic status in Mumbai slums, villages in Osmanabad in Maharashtra and in Dindigul in Tamil Nadu. These studies compared the cervical cancer death rate among 224,929 women who were offered the different types of cervical screening to that among 138,624 women who were offered no screening at all.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.Trial researchers claimed that having unscreened control groups is ethically justified in India because no-screening is considered “standard care”. So all that the unscreened women got were health education information on cervical cancer, the importance of screening and where it was available.Since at the time of the trial there were no doubts about the benefits of cervical screening, the creation and maintenance of unscreened control groups in the US-funded studies in India required inadequate informed consent, pointed out Dr Suba’s article, something that the OHRP also had determined.If, at any time during the past 15 years, the women in the unscreened control groups had been told the simple truth that cervical screening would lower their risk of death from cancer, they would have left the control groups and sought screening on their own, thereby nullifying a scientifically defective experimental design, Dr Suba argued. The OHRP determined that it was thus difficult to presume that the BMGF-funded studies are not compromised by the inadequate informed consent, wrote Dr Suba.