Drug trials, at whose cost?

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Five women hospitalised in Guntur district of Andhra Pradesh, after "volunteering" for a drug trial. Now that's a story that we know will make headlines over a weekend. But each time a story such as this comes about, it brings to my mind that unending debate of ethics in such clinical trials. No, I'm not going into the technicalities of the greater good, the need of medicine etc. instead this is just to finally confront a few nagging thoughts that come up each time I cover a story on illegal clinical trials.

The first time I came across a death due to a clinical trial was in Dec 2008, when a young 24-year-old lad died under suspicious circumstances. Investigations revealed, he had volunteered for several drug studies, all at the same time, thus leading to an untimely death. While the several Pharma companies were quick to distance themselves from this tragedy and their responsibility to do a background check on the volunteer, what was even more surprising was that even the family was unaware of how the young man was earning them one square meal a day.

Amidst those family tears then and the voices of the recently hospitalised women now, the story remains much the same. Poor villagers, living under tarpaulin tents and hoping to get some labour work each day to live for another, comprise the victims' list. Vulnerable and eager to earn a few hundred rupees, these villagers are lured by middlemen to act as volunteers for drug trials. Hired by a few Pharma companies, these middlemen are paid to identify such volunteers, who are then brought to clinics in bigger cities like Hyderabad and Vishakapatnam. The "volunteers" are then tested for basic medical parameters to ascertain their suitability. Once deemed fit, they are then administered the dosage of the under-study medicine. A few districts like Guntur and Warangal are considered hot recruitment spots for such "volunteers."

But where are the checkpoints? Who checks for the legality of this process? While some small clinics claim, they do have permission to conduct such trials, the question then is, what happens to the ethics of this practice, when most often than not, the villagers aren't even explained what could be the possible side effects of a drug trial?

The state health ministry admits it is an aberration in the system. But the admission, clearly, is not enough! Who will plug this hole? The state machinery palms off the responsibility to the Drug Control Authority of India and if pressurized further, eventually an investigation is ordered. A few local clinics raided and seized. While the trials continue unhindered in several other by-lanes of the metro.

As I speak with villagers and see visuals of the women hospitalised, I am flustered by the ignorance in these slums. A healthy able body traded for a few hundred rupees? Even if poverty is their excuse, is this really a good deal? Maybe they are aware but chose to ignore the dangers?

The truth is, I have the luxury to question their actions, the luxury to analyser the consequences. they don't! They need the money and they will do whatever it takes to survive. The Pharma companies need them and they will do whatever it takes to keep them coming, despite all this being illegal and unethical for a reason.

And one can only count on the government authorities to act tough and break this "poor villager-opportunistic middleman- profit hungry Pharma Company" nexus. Officials have time and again told me, stringent laws do exist but the problem is ensuring these are implemented.

As I move on to another day and another story, I know these questions will haunt me again, soon. it's a tragedy waiting to happen!