Tuesday, December 16, 2008
Clinical study death
Surendar, a 25-year-old who enrolled in a clinical study to establish the similarity between two versions of widely used blood pressure drug felodipine, died last week after complaining of chest pains.
Surendar was given his first dose of felodipine on 26 November, but he died on 5 December before a second dose could be given, says Hyderabad-based GVK Bioscience, which conducted the study. GVK observes that Surendar used to participate in medical studies by other companies, implying that he might have had doses of other drugs between 26 November and 5 December. Generally, a gap of three months between clinical studies is desirable to avoid harmful drug interactions.
But since there is no system to monitor this, there is no way of knowing if a volunteer, who is paid to participate, has enrolled in more than one study simultaneously or within three months. A biometric fingerprinting system could help track these volunteers who offer themselves for drug experiments to make a quick buck.
Businessworld
Gauri Kamath
Surendar was given his first dose of felodipine on 26 November, but he died on 5 December before a second dose could be given, says Hyderabad-based GVK Bioscience, which conducted the study. GVK observes that Surendar used to participate in medical studies by other companies, implying that he might have had doses of other drugs between 26 November and 5 December. Generally, a gap of three months between clinical studies is desirable to avoid harmful drug interactions.
But since there is no system to monitor this, there is no way of knowing if a volunteer, who is paid to participate, has enrolled in more than one study simultaneously or within three months. A biometric fingerprinting system could help track these volunteers who offer themselves for drug experiments to make a quick buck.
Businessworld
Gauri Kamath
