In a country of 120 crore people, where lakhs are born and almost the same number die every day, life comes pretty cheap — as shown by the unabashed continual of human drug trials sans conformation to ethical norms.
The recent expose by Lancet on unethical human trials that took place in a Madhya Pradesh government hospital shows the extent to which pharma companies have been able to sabotage the very system that should ensure good practices.
For pharma companies who want to conduct human trials, India offers several advantages such as low operational costs, large number of high-end private hospitals, English-speaking doctors and technicians and most importantly — a massive supply of diverse, impoverished people who can be used as human guinea pigs.
Getting information on medical records itself is difficult and involves a maze of rules, procedures and not the least, miles of red tape. Well… there is more bad news. Only a small segment of the human trials take place in government hospitals, the rest take place in private clinics — which are not obliged to provide any information under the Right to Information Act.
Figures provided by the Lancet speak for themselves — up from about 50 human trials cleared in 2003, there have been 1,852 projects registered with the Clinical Trial Registry India (CTRI) in mid-2011. Ironically, this registry was set up only in 2007.
An even more shocking aspect is that the Madhya Pradesh government had banned all human drug trials in the State as recently as 2010 and the ban is still in force.
The aberration that has been exposed in Madhya Pradesh is just the tip of the iceberg. Drug companies of repute, both national and international, use clinical research organisations (CROs) to do the dirty work for them. The CROs, in turn, use services of dubious characters as agents to recruit the subjects (read victims).
Informed consent, which is mandatory, remains a farce as the subjects are usually illiterate or barely-literate and cannot read the elaborate forms (usually in English) that they sign. They are also equally unaware of the nature of the drug that is going to be tested on them and the possible side effects.
And even when the side effects surface at a later point of time, these people rarely have the means to get treatment or a collective mechanism to seek compensation. The most preferred human guinea pigs are tribals, most of whom are neither organised nor literate.
“The CRO industry generated $485 million in revenue in 2010—11 and has been growing about 12 per each year. The number of CROs grew from a handful before 2005 to more than 150 today. However, there is no government registry for CROs in India,” points out another reference in the Lancet report.
The worst part about the whole human drug trial episode is that the doctors, who have sworn to protect life and uphold medical ethics, are the facilitators for these unethical practices.It has been only been seven decades since the notorious human experiments of Nazi doctors on inmates of concentration camps. We might be a democracy, but with laxity on regulations, we swing dangerously close.
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My interests lie in current affairs, social issues and political analysis. A strong believer of independent thinking and healthy scepticism.