In last 4 yrs, 1,725 persons have died in clinical trials; weak law compounds risks
Tribune News Service
New Delhi, August 7
For the first time since 2010 when six tribal girls from Gujarat and Andhra Pradesh involved in the clinical trials of anti-cervical cancer HPV vaccine died, the government has admitted that 1,725 persons have lost their lives to drug trials in the last four years.
The number of deaths has risen from 132 in 2007 and 288 in 2008 to 637 in 2009 and 668 last year, indicating the complete ineffectiveness of regulatory controls over the $400 million sector. Last year, the government gave compensation in just 22 cases out of the 668 that resulted in deaths due to “serious adverse events” during drug trials, Health Minister Ghulam Nabi Azad told Parliament this week.
Currently, 1,868 clinical trials are going on as per the Clinical Trial Registry of India maintained by the office of the Drug Controller General of India (DCGI). Many of the drugs being tested are not even of specific relevance to the country and could have been tested anywhere. Equally shocking is the fact that the rules, under the Drugs and Cosmetics Act, entirely trust the trial investigator with the reason attributed for the death of a subject. This is resulting in gross under-reporting of actual deaths during clinical trials.
Dr Chandra Gulhati, a leading medical practitioner, who led several clinical trials in the UK, says the number of deaths would be much more than we will ever know. “We have no system of independent auditors to investigate the cause of death of subjects involved in clinical trials. Whatever the investigator says is believed even if he attributes the death to a prior disease. Such investigators are always hired by the firm conducting the trial. How can we expect them to be objective all the time?”, he asks.