Clinical Trial Deaths And Compensation In India
3 CommentsBy Ed Silverman // May 5th, 2011 // 7:27 am
An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes.
And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials.
A Novartis spokesperson tells the paper that its clinical trial investigator insisted any deaths were not caused by a medication, but instead due to the progression of underlying diseases. And compensation is not required in such cases. Other drugmakers offered a similar argument. Ministry officials also say that most deaths, which were attributed to cancer or cardiovascular and cerebrovascular disorders, seemed to have occurred due to the advanced stage of illness among volunteers.
However, there were 26 deaths that went unexplained. These occurred during trials run for or by Lilly, Amgen, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Sanofi and Pfizer. Quintiles, the contract research organization, was also on the list. And some members of the Committee on Government Assurances, which conducted the probe, are not satisfied with the explanations provided.
“Of the 671 deaths they (ministry) have mentioned, 26 are directly related to the administration of the experimental medicine. But they are not sure about the other cases as they use terms like ‘could be’ and ‘may be’, instead of outright rejection. They need to be more specific,” Maneka Gandhi, a member of Parliament from the Bharatiya Janata Party, tells the paper.
The committee began its probe because the ministry did not have records on the number of deaths and the socioeconomic status of the clinical trial subjects who died. According to Gandhi, the growing number of clinical trial deaths - 137 deaths registered in 2007, 288 in 2008 and 637 in 2009 - prompted the review.
grave pic thx to tammra mccauley on flickr
industry insider
It’s a sign of a desperate shortage of US clinical trial subjects where a drug company would conduct studies in countries where it is legally mandated that families of study subjects who died during the study would receive compensation. Only happens stateside through the judicial system, and even then when there is product liability involved.
Maybe those countries should set up an insurance fund, let the subjects pay the premiums, and let the survivors cash in if they die during the study. Works like life insurance, which is really death insurance by any other name. Seems fair to me.
nisha
Most likely, those dying are in same dire conditions as the people who have been forced to sell their organs. Shame on India for forcing its poor citizens to be clinical guinea pigs (some countries are trying to protect even the guinea pigs.
shruti
Who is responsible for the compensation which is given to the subject in case of death or injury?Is ethics committe play any role in this or not.