Trials and tribulations (clinical outsourcing??)

India has a large pool of patients suffering from cancer, diabetes and other maladies which has attracted many international drug companies who wish to outsource clinical trials to India in an effort to save money. And in an attempt to make hay while the sunshines, the policy makers have jumped onto the band wagon, making it easier for drug companies to set up trials here. Does anybody sense a disaster in the making?


At the heart of any clinical trial lies a large body of human subjects. Let's make that informed and consenting subjects. The very reason that numbers of volunteers in the Western world are shrinking is an understanding of the risks involved in testing drugs which are under development. Here, government policies protect the consumer or in this case, the patient, whereas in our topsy-turvy country, money is worshipped while man is not.


Recently, there have been reports of unethical drug trials conducted in India WITHOUT THE KNOWLEDGE OF the volunteers. With no laws in place to safeguard the interest of the volunteers, these trials are a travesty of human rights.

I for one, am also concerned about the statistical reliability of such data. Whether blind trials will actually be blind, whether volunteers will abide by rules which forbid them from introducing confounding variables, are all big concerns when conducting a drug trial. Also, protocol should be in place to force the trial conductors to intervene when trials go bad. The fist AZT trial illustrates this point. First of all, the volunteers were denied any other form of medication while on the trial. Spare a thought for the ones that unfortunately belonged to the blind placebo category, who were kept away from their regular medication and on top of that recieved a tasteless, odorless, USELESS carbohydrate as the only remedy. To cut a long story short, when it was noticed that 19 patients out of 137 on placebo died and 1 patient out of 145 on AZT died, they had to stop the trials since they were no longer fair... Can you imagine what would have happened if this was conducted in India where regard for life is already low?

All in all, trials are tricky business and drug companies find loopholes inspite of having measures in place. But in India, they will have a field day.