The Japanese Ministry of Health, Labour and Welfare today asked prosecutors to investigate a possible violation criminal laws on the marketing of the drug by the Japanese subsidiary of the Swiss pharmaceutical giant Novartis. The department says the company may have exaggerated the benefits of its hypertension drug valsartan.
Last July, Novartis Pharma has admitted that a former employee has created a conflict of interest in participating in clinical studies of valsartan, sold under the trade name Diovan led by five Japanese medical schools while concealing his affiliation with the company. Several studies have been retracted after investigations by the medical schools and the Ministry of Health turned to the manipulation of data which skewed the results. Novartis Pharma ads emphasized studies showing that the use of Diovan reduces risk of heart attack and stroke in patients better than hypertension replacement drugs. According to Japanese media reports, the potential fines could be just $ 20,000, but there is a small chance executives could face prison sentences.
Also today, Novartis Japan issued a statement in Japanese on its website acknowledging the investigation and apology "to patients, their families, health workers and citizens to have caused great anxiety and trouble. " As in previous statements, Novartis has pledged to cooperate fully with the authorities but did not acknowledge any wrongdoing.
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