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[ 250 ] We read with interest the recent editorial (1) in the IJME on the ethics of standard care in screening trials for cervical cancer in India. The author takes exception to the fact that three cervical cancer screening studies in India used no screening as the control arm, in spite of evidence that the Pap smear is an effective screening tool. The author argues that the Pap smear should have been the standard arm in these trials, and that it was unethical to “withhold” this screening method from participants in the control arm of the trial. At the outset, we wish to declare a conflict of interest in our response by virtue of being investigators of one of the aforesaid trials, but feel it necessary to clarify certain facts that have been overlooked. First, during the consent process, all women in the Mumbai trial (control and intervention arms) were counseled on Pap smear testing, given information on the centres nearby that offered the Pap smear and assured that they were free to get themselves screened if they so wished. Second, the author’s assertion that visual inspection with acetic acid (VIA) had already been proven to be effective on the basis of crosssectional studies, and that there was no need to perform randomised trials to prove that it was effective, lacks scientific credibility. The hierarchy of medical evidence places the randomised trial at level 1, or providing the highest level of evidence, whereas that yielded by cross-sectional studies is considered to be level 4 evidence, ie evidence that is unreliable. Major national public health policy decisions are always made on the basis of randomised level 1 evidence. Prior to our study, there had been no randomised evidence that VIA performed by trained primary health workers (who are the only healthcare providers available for the vast majority of the poor in rural and urban areas) leads to cervical cancer mortality reduction. In fact, an earlier study had shown that neither the Pap smear nor VIA had led to a decrease in mortality due to cervical cancer in India (2). Should we not obtain robust level 1 evidence before making a major public health decision to offer VIA as a routine screening method to all women in India?

Ethics of “standard care” in randomised trials of screening for cervical cancer should not ignore scientific evidence and ground realities