Clinical Trials- Trial by Hire

- Rakesh Kalshian

IN EARLY 2012, a promising experimental antidepressant failed to make any impression on American patients in last-stage trials, forcing its developer, a small US drug company called Targacept, to call off further research on the drug. The fiasco came as an unexpected shock especially as the drug, labelled TC-5214, had earlier passed with flying colours in trials on Indian patients.

As Targacept and AstraZeneca, the Anglo-Swedish pharma giant that had agreed to pay as much as US $1.24 billion for exclusive rights to the drug, cursed their luck and licked their wounds, the episode raised fresh stink about the murkiness surrounding clinical trials. In an angry article for thestreet.com, Adam Feuerstein, a much-respected enfant terrible of the drug industry, put the entire blame for the Targacept disaster on offshore trials: “Never trust clinical data from India. Clinical trials conducted in Russia aren’t any more credible, so don’t trust data from there either.”

He might have added to the rogue gallery more countries from Asia and Eastern Europe, like China, Bangladesh, Poland, and Ukraine, which have become hotbeds of clinical trials for Western drug companies in the past two decades. Reliable data on offshore trials are notoriously hard to get because drug companies are not required to report them, but just to give you some idea about the offshore clinical trial mushroom, according to the US Department of Health and Human Services, the number of trials for drugs meant for the American market rose from a modest 271 in 1990 to a staggering 6,485 in 2008, a spike of over 2,000 per cent! And early in September, an investigation by an online health paper called statnews.com revealed that 90 per cent of new US drugs approved this year were tested at least in part outside the US and Canada.