Amartya Sen has observed that “among the most important freedoms we can have is freedom from avoidable ill health and from escapable mortality”. In other words, public health is inextricably linked to human rights. Unfortunately, we in India have a long way to go before we can accept this relationship.
This was evident on January 23 when Supreme Court’s dismissed a public interest litigation on unethical research on cervical cancer screening for poor women by Tata Memorial Hospital, the country’s top cancer institute, and other institutions.
Three trials were conducted on some 3,75,000 poor women in Mumbai slums and villages in Osmanabad district of Maharashtra and Dindigul in Tamil Nadu – regions with high prevalence of cervical cancer. The Mumbai trial was funded by the Unites States’ National Institutes of Health and the other two trials were funded by the Bill and Melinda Gates Foundation. The trials evaluated whether trained “non-doctors” –health workers, auxiliary midwives and nurses – could use “visual inspection with acetic acid” to detect cervical cancer early.
The objective to help poor women with little access to healthcare is laudable. The standard screening test for cervical cancer is the pap smear, which is expensive and must be conducted by a trained doctor. An affordable test for early detection and treatment of cervical cancer would give women freedom from avoidable ill health and from avoidable death from this disease.
The problem was that these trials contained a “no screening” control arm where about 1,41,000 women were deliberately not offered any test for cervical cancer in order to compare the differences in outcomes between screened and unscreened women – that is, how many in each group would fall ill and die from cervical cancer. A total of 548 women enrolled in the trial eventually died of cervical cancer, of which 254 were from the group that had not been screened. These 254 women were not given the option of having their cancers detected early and treated.
International covenants to which India is a signatory, such as the Declaration of Helsinki of the World Medical Association, and national guidelines of the Indian Council of Medical Research have severe restrictions on the use of placebo or no-treatment groups in clinical trials. Placebo or no-treatment is permitted only when absolutely necessary, when there is no alternative effective intervention and when it will not cause severe or irreversible harm.
Presumably on these grounds the institutional review board of Tata Memorial Hospital declared in 2009 the “no screening” arm of the trial unethical and ordered it to be stopped. But the trial continued with no change in protocol.
In 2012, the US Office for Human Research Protection, which has authority over US government-funded research, examined the informed consent form used in the Tata Memorial Hospital trial and found it to be inadequate and grossly misleading. The office accepted a “correction” – that women in the control arm be offered screening. But an application under the Right to Information Act in 2014 revealed that the hospital did not know how many women in the control arm of the Mumbai trial received screening – if any.
Even this incontrovertible evidence of violations was apparently not sufficient reason to admit the PIL.
Clinical trial risks and harm
There appears to be some misconceptions on the way risk and harm in the course of the medical trial have been perceived. Both the researchers involved in the trial and jurists contended that the women were not harmed because they were not given drugs. Even though no drug was used in the trial, more than 1,40,000 women were not given a potentially life-saving test and some of these women suffered irreversible harm as a result. An act of omission can cause equal harm. The majority of women in the control arm diagnosed with cervical cancer came in only when the symptoms disturbed them in stages three and four of their cancers when they are largely untreatable. The women’s lives could have been saved if they had been screened and treated earlier.
The jurists also seemed to agree with the researchers that poor women in villages would not have otherwise received cancer screening; at least this way some women were offered this inexpensive and effective test. The researchers also made the case that this research has enabled the introduction of the cervical cancer test into the national programme. However, even though women in rural areas are not regularly screened for cervical cancer, when they are enrolled in a trial, researchers conducting the trial have a duty to screen all of them and not just 50% of them.
Human rights are founded on principles of moral philosophy, which lay the foundations for ethics including the code of professional ethics. Researchers have a higher ethical obligation to trial participants than doctors have towards their patients. They must look after the best interests of all participants, even those who would not otherwise have access to regularcare. No participant may be subjected to avoidable harm.
Knowledge and consent
Another grounds on which the public interest litigation was dismissed was that these women gave their voluntary informed consent to participate in the trial, this despite the fact that the US Office for Human Research Protection report that the consent forms were inadequate and misleading.. No one with complete knowledge and autonomy would willingly enter a trial if she knew that, as part of the very structure of the trial, she would not be offered an available and potentially life-saving health intervention.
This case seems to show that both researchers and jurists misunderstand the concepts that ethical violations can also result from the absence of action, that researchers have special responsibilities and that consent must be truly informed and voluntary. The undisputed association between poverty and poor health should be the prism through which such research is viewed. But that will have to wait another day.
Veena Johari is a human rights lawyer based in Mumbai and was involved in filing the RTI and drafting the PIL.
Note: The first petitioner in this PIL is Sandhya Srinivasan, who is associated with Scroll.in as consulting editor. The second petitioner was Mahila Sarvangeen Utkarsh Mandal (MASUM), a Pune-based organization working in women’s health and rights.