Probe finds Indian medical trials unethical

A committee tasked to investigate allegations of misconduct in clinical trials of a vaccine for the human papilloma virus (HPV) found gross ethical violations, according to India's Hindu newspaper.

Indian volunteers take a nap inside the Subjects Housing room at the a Bangalore facility of a contract research outsourcing (CRO) firm. (DIBYANGSHU SARKAR – AFP/Getty Images).

The trial, which was suspended in March 2010, came under scrutiny after seven children died after being administered the vaccine. Although the cause of the deaths was found to be unrelated to vaccination, the incident revealed a total failure of the mechanism to monitor the ‘volunteers' for both serious and non-serious adverse events following vaccination, the paper said. 

The test was carried out by the Program for Appropriate Technology and Health (PATH), an NGO, in collaboration with the Andhra Pradesh and Gujarat governments and the Indian Council of Medical Research, the paper said. It was conducted on nearly 23,500 girls in the 10-14 years age group in Khammam district (Andhra Pradesh) and Vadodra (Gujarat), though the Times of India reports that the central government maintains it was a study and not a clinical trial.

Do the semantics matter?  Maybe. 

TOI points out that the pharmaceutical industry's efforts to cut R&D costs has led to a $20-billion market for so-called "contract research outsourcing" of clinical trials, with the market slated to reach $35 billion by 2015. CROs are said to complete clinical trials about 30 per cent faster than trials conducted inhouse by pharma companies, TOI said. But there's increasing concern from medical ethics watchdogs that part of the reason may be that CROs in developing countries are cutting corners to rope in poor, unlettered test subjects — and with its massive, mostly never medicated population, India is set to become the testing ground of choice in the future, although it accounts for only around $500 million of the business today.

What can go wrong?

In their final report on the manner in which the clinical testing was conducted, the committee condemned the "casual approach" taken with respect to informed consent documents–which are meant to guarantee that the test subjects, or in this case, their parents, understand the risks of participation, other treatment options available, and their right to refuse to participate. The committee found that these forms were filled in "very carelessly," with "incomplete and probably inaccurate" information, according to the paper. Moreover, in the state of Andhra Pradesh, nearly 2,800 consent forms were improperly signed by a dorm warden or school principal because the pupils' parents were not easily reachable. 

In the cases of the seven children who died after the trials, there was a five-month delay in reporting a death, while two deaths in Khammam district went unreported altogether, the paper said, even though measuring and reporting the adverse events after vaccination were the “primary end points of the study."