Drug trials - the dark side.

This troubling documentary looks at how poor and illiterate patients in India are being hoodwinked into participating in clinical trials aimed at getting drugs licensed in the West. It is estimated that by 2010 there will be two million Indian citizens involved in clinical trials - Paul Kenyon investigates how the pharmaceutical companies recruit so quickly and extensively. We meet Vijay Kumar of Neeman Medical International who looks for recruits for drug trials for drug company Novatis. He explains that the large population of poverty-stricken Indians provides ripe picking for large pharmaceutical companies, and that the populations drug illiteracy is a bonus as they are often clear of any other medications making the trials easier to conduct. Kenyon meets cancer patients outside a hospital who have signed consent forms worded in English with a thumb print as they are illiterate. They seem to have little knowledge that their treatment involves them being guinea pigs for new medicines. B.N. Bhattathiri, a radiologist working at the Regional Cancer Center (which attracts key medical figures involved in Southern Indian drug trials) became concerned when new drug M4N was being tested on cancerous tumours. We hear from the family of one of the patients involved in this trial who now have no illusions that his current extremely poor health is at least in part due to his involvement in the trial. Ashwini Kumar, Drugs Controller General for India, admits that the protocols for obtaining informed consent are not very clear. Shashank Joshi from private hospital Lilayali in Mumbai refuses to participate in drug trials as he believes there is too much patient exploitation. He feels that patients are often so poor that to be offered 'free' medication seems enough of a benefit to outweigh any thought of risk. Arvind Chopra of Glaxo Smith-Kline says it is hard to get patients to acknowledge that a treatment is only a trial. In London, Vikram Patel investigated a drug being trialed in India on patients with bipolar disorder. He was shocked to discover that as part of the trial patients were taken off their normal medication and only some of them given the new drug, others a placebo, meaning that some extremely ill patients were receiving no medical help whatsoever. We meet two men with bipolar disorder affected by this trial. Vivek Kusumaker of Johnson & Johnson defends the trial. Throughout the programme patients repeatedly affirm their absolute faith in doctors - this is clearly also a factor open to exploitation by those conducting clinical trials in India.