Unconscionable act

Barely a day after Karnataka health minister Ramdas announced a temporary ban on the conduct of clinical trials in hospitals and medical colleges in the state, chief minister B S Yeddyurappa has shot it down. Yeddyurappa’s backtracking is shocking since his health minister had made some valid points in announcing the ban last week. He drew attention to the way subjects in clinical trials were being treated as guinea pigs and rightly pointed out that this exploitation was possible because of the absence of clear regulations.

Therefore, Ramdas said, he would set up a committee to frame rules to regulate clinical trials and pending this, a ban on trials was put in place. What was so objectionable in Ramdas’ announcement that the chief minister had to reverse the decision within a day?
India is a particularly attractive site for clinical trials as it has a huge patient base, a large ‘drug-naïve population’ (untreated patients) and its people have myriad diseases, ranging from tropical infections to degenerative disorders.

Besides, it has a large population that is poor and illiterate, making them vulnerable to pressure and ill-equipped to give informed consent. To pharma companies, India represents a gold mine as it enables them to test cheaply. This has contributed to Bangalore’s emergence as the world’s clinical trials capital. This is an industry that is worth billions of dollars and businesses in Karnataka have gained immensely from it.

However, there is a flip side to this sunshine sector, which Yeddyurappa is ignoring and that is the terrible exploitation of subjects of clinical trials. Most of them are not aware they are being tested upon, about the impact the drugs could have on them or of their rights, if any. Thousands are said to have died in the course of drug trials and many times they have developed serious complications. But rarely has compensation or medical treatment been extended to the victims.

Pharma companies wash their hands, claiming that the drugs do not have fatal consequences, that the patients had not followed instructions and so on. It is to protect these patients that Ramdas has called for tighter regulation of the industry. Yeddyurappa should act to protect the interests of the vulnerable, not cave in to pressure from the rich and powerful. A demand for greater accountability from pharma companies is essential.