[PAA-Discuss] Fwd: Pharmalot - Clinical Trial Deaths And Compensation In India

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From: Vince Boehm <vince_19805 at yahoo.com>
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Sent: Thu, May 5, 2011 3:53 pm
Subject: Pharmalot - Clinical Trial Deaths And Compensation In India


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Clinical Trial Deaths And Compensation In India
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By 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.
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