‘Guinea pig’ fear after trial cloud on three hospitals – Institutes accused of violating guidelines

G. S. Mudur | The Telegraph | 26 November 2012

Three hospitals in India violated clinical guidelines while testing a drug on patients with heart disease in a trial that a medical expert said also illustrates how India’s lax regulatory watchdogs allow foreign drug companies to use Indian patients as “guinea pigs”.

A review by the US Food and Drug Administration has observed that Janssen Pharmaceuticals, the US-based sponsor, had detected violations at hospitals in Bangalore, Hyderabad and Mangalore — three of more than 40 sites across India that joined the trial.

The trial, managed by Bayer Pharmaceuticals in India, was aimed at evaluating the efficacy of a blood-thinning agent called rivaroxaban in preventing cardiovascular events (heart attacks or strokes triggered by blood clots) among patients who already had a history of heart disease.

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