Editorial: Clinical trials in the dock

Published in The Hindu on February 10, 2012

With the Supreme Court issuing notice to the Central government on the matter of illegal drug trials, the sordid state of human clinical trials is all set to be exposed. For multinational companies eager to cut corners, India offers an attractive package of weak laws, lax and almost non-existent oversight of trials, a huge illiterate, vulnerable population that can be easily exploited, very little volunteer protection and a sizeable number of unscrupulous doctors willing to compromise on ethics for gain. Recent reports of 42 mentally ill patients in Madhya Pradesh being enrolled in a trial held between 2008 and 2010 for testing the efficacy of dapoxetine in curing premature ejaculation highlights the scant regard for ethics. Mentally ill patients can be enrolled only in trials involving drugs that would directly benefit them or reduce the harm they cause to society. In fact, around 230 such patients were enrolled in several trials that do not benefit them. Cases of patients becoming a part of a study without knowing it, and of children being enrolled without obtaining informed consent from parents, have also been reported from the State. It will not be wrong to assume that in other trials the poor, unlettered parents who had signed the informed consent form — the most sacrosanct document of a trial — were ignorant or misled and misinformed of the contents. Individuals subjected to multiple trials, and principal investigators being involved in many studies have also been reported from Madhya Pradesh. The situation may be the same in other States as well. The 2010 expose of human papilloma virus (HPV) vaccine trials conducted without proper consent on nearly 23,500 girls in the 10-14 age group in Vadodara, Gujarat and Khammam district of Andhra Pradesh is a case in hand.

It is essential that the Central and State governments put a quick end to this sordid state of affairs. Ensuring the safety of patients is paramount as more than 1,700 persons have died in clinical trials across the country between 2007 and 2010. Doctors go scot-free despite failing to follow up serious adverse events, including deaths. Having amended the patent laws in 2005 to make India an even more attractive destination for trials, the government is duty-bound to put in place a proper regulatory and monitoring mechanism that would prevent unethical trials from being initiated and flagrant violations from taking place. Doctors and companies earning handsome profits by throwing ethics and procedures to the winds and turning vulnerable people into guinea pigs will then, hopefully, become a thing of the past.