Thursday, September 8, 2011


Imprudent policies on clinical trials call for urgent attention

A few issues back, I wrote on how foreign companies use poor illiterate Indians as guinea pigs and test drugs on them that lead to permanent physical and mental disabilities in these patients. Leave aside forming policies on increasing accessibility of medicine and treatment to the underprivileged, our government is doing less than nothing to deter such pharma companies and save hundreds of lives. The reluctance of government over this matter is primarily owing to the fact that most of the time the aggrieved party is a poor Indian belonging to lower strata of our society. And the irony is that these researches help the so-called affluent families to have access to better and upgraded medicines at the cost of lives of hundreds of poor people.

The Drugs Controller General of India recently announced death of 671 people during various clinical trials in 2010, out of which merely 22 families were compensated. The pharma companies cheat them on the pretext of false reports and transfer the onus of death to already existing diseases (among the patients) and go scott-free. For the uninitiated, our Drugs and Cosmetics Act 1940 has gone under merely one amendment in 2005 and has seen no major changes that could safeguard the rights of ill-affected patients. Thanks to such corroded laws, India today has become the most sought-after destination for clinical trials. More because, unlike other nations, the costs of trials are cheaper, laws are weak and above all, the patients rarely are conversant with the rights and legal formalities. Patients are asked to sign on consent forms (written in English) to avoid legal intricacies! Going by newspaper reports, several survivals of Bhopal gas tragedy (who luckily survived), receiving treatments in the government hospitals, are used as guinea pigs without their consent! Mostly, poor patients are lured in these trials on pretext of free treatments and compensations. Even family doctors and private doctors push their patients for such experiments in return for money and fringe benefits from pharma companies.

Globally, registered Contract Research Organisations (CROs) are authorised for hunting patients and asking them for voluntarily taking part in such trials. But then, this is done after explaining the patients all possible pros and cons of such trials and compensation are clarified along with ensuring that pharma companies follow all laid down measures and protocols so that the lives of these patients are not at risk! Clinical trial by concept is voluntary. But what we see here is that the patients rarely get to know that he is being used for the same.

No doubt that we need stringent regulations in place but then what we need more urgently is transparency in the entire process. In order to reduce the abuse and allow healthy practice of clinical trial, the government should come out with a centralised online portal. This portal would be one-stop point for people who would like to volunteer for such experiment and even for companies seeking such volunteers. The portal would additionally maintain health records about these patients and inform the patients/volunteers about his rights and compensation policy. This, of course, would not eliminate the abuse completely, but would make it transparent and lower down the incidence of death. And above all, such practice is meant for healthy nations where people have enough immunity to tolerate such trials and not for nation like ours where people die out of curable diseases!


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