Inquiry looks into Indian cancer deaths

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An inquiry is being set up to investigate allegations that medical treatment was deliberately withheld from 1,107 Indian women with uterine cervical dysplasias, even though it was known that some of the lesions could become cancerous. The seven-member inquiry committee will be headed by a retired judge.

The women, who were attending gynaecology wards in six hospitals, were part of a study on cervical cancer, but had not given written consent to take part in the experiment. Rather than being treated, they were registered for a long-term follow-up, during which 69 women ‘progressed to malignancy’ and had to undergo cancer treatment or have the uterus removed. Two women died during radiation treatment. Investigators do not know what happened to ten others with advanced dysplasias who failed to report for the follow-up.

The study, conducted between 1976 and 1988 by the Indian Council of Medical Research (ICMR), was intended to identify risk factors in the transformation of dysplasias into cervical cancer, the biggest killer among cancers in Indian women.

Usha Luthra, ICMR's then deputy chief and the project's principal investigator, maintains that the women were “verbally” informed, as written consent was not mandatory at the time. “Ethical guidelines keep changing. If I had to go back to the 1970s I would repeat the study exactly the same way,” she says. She says the study helped India to evolve screening guidelines for a national cancer control programme.

But some doctors and women's groups are questioning the ethics of the study in the absence of documented proof that the women — mostly poor and illiterate — were made aware that their lesions could develop into cancer without treatment. Saheli, a prominent women's group, has appealed to the National Human Rights Organization for “stringent actions against those responsible for the barbaric tests”.

Vulimuri Ramalingaswami, who headed ICMR between 1978 and 1985, argues that the study should be viewed in the context of the ethical standards of the time (the ICMR had no guidelines until 1980). “When it was found that moderate and severe dysplasias more often turned into cancer, such women were taken off the study and put on treatment,” he says.

But N. P. Gupta, formerly deputy director general of ICMR, describes the study as inhuman. “I did not know that such a study was going on. We are all criminals.” G. V. Satyavati, the immediate past head of ICMR, ordered a probe by an independent committee before she retired in August.

Although the controversial study was closed nine years ago, it is being highlighted now to ensure that ICMR's guidelines — which are being revised by a committee headed by the former chief justice of the supreme Court — are made tougher than those issued in 1980.

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Jayaraman, K. Inquiry looks into Indian cancer deaths. Nature 390, 653 (1997). https://doi.org/10.1038/37710

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