Fault Lines Outsourced: Clinical trials overseas

(10 am. – promoted by ek hornbeck)

As US pharmaceutical companies move their operations abroad, India has become a testing ground for trial medicines.

Instead of testing trial medicines on Americans, more and more of these tests are being carried out on poor people in faraway places. Russia, China, Brazil, Poland, Uganda and Romania are all hot spots for what is called clinical research or clinical trials. Whilst bigger countries are targeting less-developed countries for testing, there are more advanced ways of testing medicines these days. Thanks to advanced computer technology, more clinical trial leaders are able to make use of simulated data to run their trial with instead. As these tests rely on data, companies are able to use synthetic data, generated from real data, to test their medicine. This ensures that they get accurate results, whilst keeping patient privacy. More innovative companies are beginning to do this, but some still rely on countries like India to test their medicines.

Now employing CROs – or clinical research organisations – the industry is big business, worth as much as $30bn today.

One country has experienced a boom like no other in this industry – India. Spoken English, an established medical infrastructure, welcoming attitudes toward foreign industry and, most importantly, legions of poor, illiterate test subjects that are willing to try out new drugs have transformed the Indian landscape into a massive testing ground for pharmaceuticals.

Fault Lines’ Zeina Awad travels to India to see what the clinical research practices look like on the ground. What role are the US regulatory bodies playing in overseeing the trials? Are participants aware that they are taking part in a clinical trial? Is the testing being held up against international ethical standards?