India initiates probe against drug trials

Illegal drug trials had led to the death of six children in 2010 in two states.

Bijoy Basant Patro/OneWorld South Asia

The Union Health Ministry has announced action against medical professionals who had allegedly been conducting illegal drug trials on tribal children in two states of India. These illegal drug trials had led to the death of six children in 2010 in these states. The Health Ministry is set to initiate punitive action against medical professionals for violations in conducting the clinical trial of the human papilloma virus vaccines (HPV vaccines). The trials were carried out in the states of Andhra Pradesh and Gujarat, wherein the controversial vaccines were administered to tribal children as part of a clinical trial in early 2010. Six children had died. Senior officials in the ministry are presently examining the files, sources said, adding that action was imminent. The trials were suspended under a government order on April 7, 2010, following the deaths of children. In all, 13,791 girls were vaccinated in Khammam in Andhra Pradesh and 9,637 in Vadodara, Gujarat. The ministry had then appointed a three-member committee of experts to investigate issues of ethics. The matter has mostly remained under wraps. Controversially, though, the committee of experts ruled out direct linkage between the deaths and the trials when they put in their final report saying that “the cause of death in all cases could not be established with certainty”. But the affair has been a subject of debate in the health community ever since. The report also voiced concern over the supply of vaccines. MSD Pharmaceuticals` vaccine Gardasil and GSK Pharmaceuticals’ Cervarix were provided for free. The Indian media has of late provided coverage to the subject because the expert report brought to the fore serious lapses in the conduct of the trials, its planning and its implementation. The project failed to consider the adverse consequences from administering the vaccine. Nor was an independent monitoring agency appointed because of which there were unacceptable delays in the reporting of deaths. Globally, some 40 per cent of all clinical trials now take place in the developing world and the present case offers an explanation for the choice of the target. Sources point to a lack of regulation and accountability, especially because of the low cost of operation and wide availability of target participants. For these reasons, multinational drug companies, researchers and institutions are attracted to conduct their clinical trials in India. In the 2010 trials, glaring discrepancies have been observed in the consent forms of the vaccinated girls. Sixty-nine forms did not have a signature, for instance. The inquiry report has also indicted the Indian Council for Medical Research (ICMR) for its role, especially for toeing a corporate line that the project was an observational study. ICMR is an autonomous body under the Union Health Ministry and it provides technical support for the development of protocols and advising on ethical issues. Earlier in 2006, the Netherlands-based WEMOS Foundation, also a partner of the World Health Organisation, listed 22 examples of unethical clinical trials. Eight of these, WEMOS said, were operating in India. These involved Sun Pharmaceuticals and Novartis’s Letrozole for inducing ovulation (this, incidentally, was approved only for breast cancer), Novo Nordisk’s for diabetes treatment, Solvay Pharmaceuticals’ for treating diarrhoea, Johnson and Johnson’s for treating acute malaria, Pfizer’s for cardiac events, Otsuka’s for arterial disease and the John Hopkins University’s trials for treating oral cancer. Two Indian companies, namely Shantha Biotechnics and Biocon, were also listed for the trial of their drugs for diabetes. (The views expressed in the article are of the writer.)