A health ministry panel started investigating Novartis Pharma's use of clinical research data in promoting the sale of its blood pressure-lowering drug Diovan, saying it "could constitute misleading advertisement" following the revelation that some of the data was manipulated.
This is the latest punishment for Novartis' scandal-plagued unit in Japan. The Swiss drugmaker has weathered a chain of scandals over retracted Diovan clinical trials, data-tampering allegations, false advertising charges, and internal investigations. Novartis cleaned house, replacing its top management in the country and adding remedial training for employees.
Another major scandal erupted in April last year when Novartis failed to report the side effects of leukemia drugs Tasigna and Gleevec. Ten serious cases of side effects, which surfaced as the company collected data on 3,000 patients under leukemia treatments, were not reported as required by law. This side-effects scandal came soon after Novartis staff members and sales reps faced allegations of serious misconduct in a trial of its leukemia drug Tasigna. Employees were accused of breaking trial protocols in data collection and patient privacy, and attempting to cover up their missteps by shredding and deleting documents. In July, the government ordered Novartis to improve business practices and clean up its act in.
The company was already facing charges of exaggerated advertising for the blood-pressure remedy Diovan, by citing data from questionable and possibly fabricated data in promoting the drug. Academic researchers had already retracted at least two Diovan trials after evidence of potential data-tampering surfaced.
Source: Drugs.com
Japan Times
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