Japan’s Health Ministry is set to file criminal charges against the local office of Swiss pharmaceutical firm Novartis for its alleged manipulation of data to market their blood pressure drug, Diovan. Health Minister Norihisa Tamura described the scandal involving an employee of Novartis Pharma KK who failed to disclose his affiliation with the company during a medical study of the effects of the drug as “extremely regrettable”.
Studies held in various universities indicated that Diovan had some prophylactic effect on strokes and angina but the basis of the studies were supposedly manipulated with incomplete clinical data to market the drug with the additional benefits. The Health Ministry is now seeking punishment for the company and individuals involved for a violation of Japan’s pharmaceutical law of exaggerated advertising and can be sentenced with up to two years’ prison time, or a fine of up to 2 million yen (about US$19,400) if proven guilty. Novartis insists that it is not aware of such an incident, and Novartis Pharmaceuticals chief David Epstein promised the company’s full cooperation in the investigation and has since apologized for the incident, but did not acknowledge the company’s role in the charges.
Tokyo’s Jikei University School of Medicine already withdrew research published in the medical journal The Lancet six years ago due to false data, and Kyoto Prefectural University of Medicine also admitted that their studies on the drug used incomplete data. Chiba University maintains that it did not find any false data on the studies, but did not mention that they have been receiving scholarship grants from Novartis from 2007 to 2009.
[via Channel News Asia]
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