According to latest official information, 30 people died due to complications during drug trials in the month of January this year.
Data provided by the Drug Controller General of India (DCGI) under the Right to Information (RTI) act, reveal that in 2012, January alone witnessed 30 deaths due to SAEs. The data, in possession of The Hindu, was obtained by Indore-based medical rights activist Anand Rai.
Earlier, the DCGI had furnished details regarding deaths caused during drug trials over the last five years. From 2007 to 2011, Serious Adverse Events (SAEs) during drug trials caused a total of 2193 deaths.
The year-wise break-up of the deaths are: 132 (2007), 288 (2008), 637 (2009), 688 (2010), 438 (2011) and 30 (January, 2012).
As the figures show, the number of deaths due to SAEs during the drug trials kept rising substantially from 2007 through 2009, peaked to 688 in 2010 and then declined to 438 in 2011.
However, compensation was paid in only 22 cases and that too only in 2010, the DCG (I) data show. No compensation was paid during 2008 and 2009.
The reason for such a small number of cases receiving compensation is simple: Pharma companies conducting clinical trials pay compensation only in cases where it is established that the death was caused as a result of the trials and not merely during the trial.
Keywords: Drug Controller General of India, RTI query, drug trials, death
There are many reasons for deaths to occur in clinical trials and they dont always have to be due to the drug being insvestigated. Deaths could be due to progression of the disease(say Cancer), use of prohitied medication, not following the instructions or totally non related event such as a fall at home or car accident. SAE is defined as an event requiring hospitalization, results in dealth or congenital anomaly and it is not always a result of the investigational drug.
The reason for such deaths must be studied before claiming that they were as a result of clinical trials. It is not responsible on the part of the person to report such news without looking at all the facts. And not just in India, but in any country in the world, subjects who died will not receive compensation unless the death was as a result of the investigational drug.
So, please donot try to create any negative opinion on Pharma companies in people without first getting all the facts right.
This is highly unfair. People chosen for the trial should make sure in written that they are paid before and after (if required) the trial. Why would anyone risk his/ser life for nothing.
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