The All India Institute of Medical Sciences (AIIMS) last week launched an inquiry into the deaths of 49 children under 12 years of age who have died in drug trials at the New Delhi institution since January 2006. But questions are being raised over whether the inquiry is necessary on scientific grounds.
The death rate in the 42 separate clinical trials was just over 1%. The trials involved a total of 4,142 young patients, 2,728 of whom were under a year old. Among the drugs being tested were the cancer drug rituximab, as well as olmesartan and valsartan, which lower blood pressure.
"The deaths were due to sickness only. All drugs used were of proven safety," Shakti Kumar Gupta, the head of hospital administration at AIIMS, told Nature. The overall mortality rate at the institute, which treats seriously ill patients from all over India, is 3.6%.
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Inquiry launched into Indian drug trials. Nature 454, 1041 (2008). https://doi.org/10.1038/4541041d
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DOI: https://doi.org/10.1038/4541041d