Vol , Issue Date of Publication: April 01, 2004
DOI: https://doi.org/10.20529/IJME.2004.036

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DOI: https://doi.org/10.20529/IJME.2004.036


The author defends

With regard to reference to Shantha Biotechnics, I wrote the following:

‘How many people know that eight patients in Hyderabad who were administered recombinant streptokinase to test its efficacy and safety have died? According to the Genetic Engineering Approval Committee (GEAC), the trial was being conducted by the drug’s manufacturer Shantha Biotechnics without taking clearance. Not surprisingly, the Company denies the allegation claiming that it had taken permission from the DCGI. In this game of passing the buck, no one is shedding any tears on the lives lost or compensating the families of those whose loved ones have died. Without any independent enquiry, the death of ‘trial subjects’, as they are impersonally called, has been attributed to ’causes other than the use’ of the drug!’ In his rejoinder, Mr Prasad has not disputed any point except the number of reported deaths. I made the following points. (1) The GEAC claimed that the trial was done without its permission. I also added that Shantha Biotechnics denies the allegation and claims that it had the DCGI’s permission. Mr Prasad agrees with this statement by saying ‘a tussle between two government agencies has dragged us into the controversy’. (2) Families of dead subjects have not been adequately compensated. Mr Prasad has not disputed this point. (3) There was no independent enquiry into the cause of deaths. Mr Prasad has not disputed this point either.

The only point of dispute is the number of deaths. He himself agrees that a ‘Bangalore-based NGO inflated the number of deaths from two to eight.’ However in the next paragraph he contradicts himself by saying that total deaths were in fact six. His company’s product-related deaths were three while those related to the comparative drug was another three. Nowhere did I say that all the eight deaths (six admitted by Mr Prasad) were due to Shantha Biotechnics’ brand. The deaths took place in a clinical trial sponsored by Shantha Biotechnics. In any case, the issue is not whether eight, six or two people died. Even one death is too many. Mr Prasad has himself raised many other points, not mentioned in the article and attempted to answer them as well.

Chandra M Gulhati, Editor, Monthly Index of Medical Specialities.

About the Authors
Chandra M Gulhati
Editor
Monthly Index of Medical Specialities
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