Clinical trial deaths and compensation in India

By Ed Silverman // May 5th, 2011

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. (How can they be so sure that the medication did not weaken the individual)

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.

These companies are so filthy rich yet seem so wretchedly POOR because they cannot even bring themselves to part with a miniscule percentage of profit they make thanks to  millions of such guineapigs.

 



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