Tuesday, May 21, 2013

RTI brings to light drug trial on humans.

Times of India: Jaipur: Tuesday, May 21, 2013.
A doctor conducted drug trial on heart patients but seven of them died during trial of the drug. Moreover, another doctor conducted drug trials of different companies and 10 of his cancer patients died during the trials.
An RTI filed by a government-run Indore hospital Dr Anand Rai exposed deaths leading to drug trials in entire country. Answering to the RTI, office of drug controller general, ministry of family health and welfare, gave a list of deaths to the appellant that happened during clinical trials. Exposing that 40 patients died from 2008 to 2011 during clinical trials in Rajasthan, drug controller office report shows that only eight hospitals were majorly involved in clinical trials, where deaths were reported and two of them were government hospitals.
The report shows that 27 deaths during clinical trials were reported in private hospitals, which shows that the private hospitals took a lot of interest in clinical trials. Besides, 13 deaths during drug trails were reported in two government hospital of the state.
Most of the patients died during clinical trials, who were suffering from cancer, heart ailments and gastro related problems. At least 21 patients suffering from cancer died during clinical trials from 2008 to 2011 in the state, while 12 heart patients and five gastro patients died during clinical trials in the same period.
Rajasthan has emerged as one of the hubs for clinical trials in country and it has brought along its side effect too. At least 40 people died in the state from 2008 to 2011 during clinical trials especially to check the efficacy of drugs for cancer, heart and gastro treatment.
The state government too accepted in the counter affidavit filed before the Supreme Court in relation to a PIL, that there were 326 clinical trials conducted in the state. But, the figures could be much more as information from various principal investigators are still to come. I Rajasthan there are at least 139 principal investigators, who are conduction clinical trials.
In the affidavit, the state government mentioned that at least 139 principal investigators are present in Rajasthan as posted on the website of the Clinical Trials Registry- India (CTRI). But, the state government, expressing concern over deaths during clinical trials, mentioned in the affidavit that the state government must also be involved with regard to registration of sites, hospitals, institutes for conduct of trials, the nature of trials which are going to be conducted, the criteria for selection of patients who would be administered during trials.
The state government mentioned in the affidavit that from 2005 to 2012, at least 95 persons died. Moreover, in four death cases, the decision to pay compensation has been taken. But payments in two cases have been made and compensation proceedings are in process for two cases.