dna edit: Error in clinical trials

Friday, 27 December 2013 - 9:16am IST | Agency: DNA
For too long, a weak regulatory regime incentivised foreign pharma companies to conduct clinical trials by exploiting poor participants and violating safety norms.

The power of public interest litigation to rectify a patently unjust system has been proven once again by the Supreme Court’s decisive intervention in clinical trials since late 2012. Earlier this year, the health ministry informed the Rajya Sabha that 2,868 deaths occurred during clinical trials between 2005 and 2012, but only 89 deaths had been attributed directly to the trials. Of these only 45 were compensated, the House was told. Activists allege that the confirmed deaths have been grossly under-reported and that research companies exploited  participants’ poverty and illiteracy, thus undermining the concept of informed consent.

As a result of Supreme Court orders since January, a new three-tier regulatory regime comprising a New Drug Advisory Committee (NDAC), a technical committee and an apex committee — was set up to clear clinical trials. The three committees have cleared only five clinical trials this year compared to the whopping 157 trials approved in 2011 and 2012. In October, the Supreme Court suspended these 157 trials that were approved by the Drug Controller General of India (DCGI) until they were scrutinised by the three-tier committees.

In August, the parliamentary standing committee on health tabled its 72nd report in the Rajya Sabha on alleged irregularities in human papilloma virus vaccine trials conducted by an American agency, Programme for Appropriate Technology in Health (PATH). The trials on adolescent tribal girls in Andhra Pradesh and Gujarat lead to many deaths. The report is a damning indictment of regulatory agencies like the Indian Council of Medical Research and the DCGI. The DCGI was slammed for responding to the vaccine deaths in a “casual, bureaucratic” manner to the violations without taking any “concrete actions” to safeguard citizens’ lives.

The standing committee even found the fundamental requirement of informed consent thrown to the wind. A large number of consent forms had thumb impressions indicating the respondents were illiterate; witness signatures attesting to the communication of the contents to such participants was missing. In many cases, school principals and hostel wardens signed the forms for the participating girls without consulting them or their parents. The report recommended an investigation of PATH’s activities and probing the conspiracy angle with government officials.

This week, health minister Ghulam Nabi Azad voiced the predilection of our policymakers caught between the twin imperatives of GDP growth and public safety. He approved of the Supreme Court’s actions, acknowledged that the ruling was in national interest, but in the same breath bemoaned that clinical trials have witnessed a 50 per cent drop. While clinical trials are important for the development of new drugs and treatments and boosting foreign investment, the right to life is the most sacred covenant our republic promised its citizens.

The new regulations — videographing of consent and the reporting of clinical trials within 24 hours — could help end the impunity with which many research firms operated. Worried about the SC’s activism scaring away the clinical trial industry, the government has walked a tight-rope and tabled the Ranjit Roy Choudhury committee report balancing higher compensation for clinical trial patients with time-bound approval of trials to prevent delays. Corporations complaining about suffering business have shot themselves in the foot by exploiting the poor and uneducated under a weak regulatory regime.

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