Unethical clinical trials conducted without obtaining informed consent of the participants have struck India again, killing 254 women from the most marginalised sections of society. The deaths, or rather murders, have taken place in the course of a 15-year long United States funded clinical trial for a cervical cancer screening method. The women who perished were part of a control group kept without screening. This, according to information available through various media reports, was done to study death rates in unscreened populations.
The trials flouted the basic ethical norms of medical research. Approximately 140,000 women were kept uninformed that cervical cancer screening reduces the incidence of cancer, thereby duping them into being part of the control group. That the unethical trials were conducted intentionally is further betrayed from the fact that the participants for the control group were chosen from the slums of Mumbai and villages in Osmanabad and Dindigul, as against the 224,929 women better-off backgrounds who received different types of cervical screening. The the women were not provided adequate information for informed consent was later confirmed by the United States Office for Human Research Protections (OHRP).
Unfortunately, this is not the first time big pharmaceutical companies have turned the lowest strata of Indian citizenry into guinea pigs and gotten away with it. This time it has happened under the watchful eyes of the Supreme Court of India as it is hearing a writ petition (WRIT PETITION (CIVIL) NO(s). 33 OF 2012) filed by the Swasthya Adhikar Manch, Indore and others against the Union of India over the issue.
On 22 October 2013, the Supreme Court had stopped 157 clinical trials over serious problems in adherence to both the Helsinki guidelines on medical research, which state that “the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention” and the guidelines of the Indian Council of Medical Research, which specify that a placebo can be used only if the disease is self-limiting or when no proven preventive, diagnostic, or therapeutic method exists. (More details in an earlier AHRC statement here). Cervical cancer screening methods exist and often prove to be life saving for many potential victims.
How did this trial continue with impunity? How did the trials escape the new three tier regulatory system put in place by the Supreme Court that consists of New Drug Advisory Committees (NDACs), technical committees, and the apex committee? Finally, what was the Supreme Court doing to ensure that its orders were honoured and enforced by an executive that was primarily responsible for enforcing them on its own, without the intervention of the judiciary? The answers to these questions expose a rotten system, a so-called democracy that does not bother with the death of its lesser citizens.
Clinical trials have ended in serious adverse effects, including the death for more than 4,000 people in 2012 and 2013, of which the government admits to only 506 in the ongoing writ petition. In an earlier response, the government has stated that compensation was paid to only in 22 cases of deaths out of the 89 deaths it conceded. The absurdity of both the response and the data was lost on neither the Court nor the petitioners.
The Court recently asked the government why compensation was paid only in cases of death, and not for the participants that had been seriously affected? The absurdity of the government figures is betrayed by the figures submitted by Ministry of Health and Family Welfare, which has accepted 2,868 deaths of participants of clinical trials in India during the 2005-2012 period, qualifying a mere 89 of them as trial-related.
On 10 March 2014, the Supreme Court directed the Union government to provide details on the number of deaths and severe adverse effects caused to people subjected to clinical trials. It has also asked the government about the continuing discrimination in compensating only deaths and not the people suffering lifelong adverse effects due to the experimental medicines.
It is in this context that the stakeholders cannot absolve themselves from criminal culpability in these murders. The Indian government is the biggest culprit for firstly failing to institute a foolproof regulatory system, and, subsequently, for protecting those responsible for such murders, from the doctors conducting trials without obtaining informed consent, to the contract research middlemen, to the pharmaceutical companies themselves. Perhaps such behaviour can be seen as consistent for a government that persists in denying starvation deaths in the country by blaming them on diseases ranging from diarrhoea to tuberculosis even while accepting widespread prevalence of malnutrition.
Almost all of the participants for the trials in question, be it in the HPV vaccine trials in Andhra Pradesh, where 14000 tribal girls in the 10-14 age group were made to participate on the basis of consent form signed by their wardens, or the current one, are marginalised and come from poor backgrounds. Many participants are known to be enticed into these trials for ‘wages’ often as low as Rs. 100 ($ USD 1.6). What can one say for a government that pushes its citizens into becoming guinea pigs, a government whose citizens choose possible death by experimental medicines over death by starvation?
The Supreme Court of India appears culpable in this case – being aware of the facts and yet taking no actions against the guilty. Between the Court and the government, why has no one responsible for the illegal trials halted by the Court ever been prosecuted, so as to serve as a deterred to others indulging in similar crimes?
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