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. 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 questioned 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 morbidity results from the 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. 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. This case study depicts that unless exemplary action is taken against those who bent the rules, illegal trials will go on and the poor will continue to be used as guinea pigs.

Sangeeta Natarajan

Final Year B.Pharm

Tags: MET Institute of Pharmacy