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Novartis charged in Japan over data falsification

Prosecutors claim pharma company employees manipulated Diovan data
Novartis building

Japanese prosecutors have laid formal charges against Novartis in the clinical data manipulation scandal that has already claimed the jobs of several senior executives.

Novartis' local subsidiary and former employee Nobuo Shirahashi have been named in the prosecution's case, which alleges that data in a study of blood pressure drug Diovan (valsartan) was tampered with to make it look superior to competing drugs in the market.

A report in the Wall Street Journal notes that the Japanese authorities have also place Shirahashi under arrest for the second time in the last few weeks as they investigate manipulation of data in a sub-analysis of the Kyoto Heart Study that they suggest violated Japan's Pharmaceutical Affairs Law.

The trial suggested Diovan was more effective than rival drugs in warding off angina and stroke, but it was subsequently discovered that some patient histories had been falsified to indicate they had suffered a prior stroke when in reality that was not the case.

Various published papers based on the results of the study were withdrawn from medical journals after questions were raised over the validity of their findings, which led to the resignation of Hiroaki Matsubara, a professor in Kyoto University's department of cardiovascular and internal medicine, last year.

Novartis said in a statement that it has not yet received official notification from the authorities but acknowledged that the Tokyo District Prosecutor's Office (TPO) has publicly disclosed its intention to file charges.

The company said its local subsidiary Novartis Pharmaceuticals KK (NPKK) has been drawn into the prosecution because under Japanese law it is responsible for "failing to oversee an employee". The charge carries a maximum fine of 2m yen (around $20,000), it added.

A separate investigation is looking at data from clinical trials involving Novartis' leukaemia drug Tasigna (nilotinib). While in this case falsification is not suspected, the authorities are unhappy about procedural anomalies, such as the involvement of sales reps in data collection and reporting.

The Diovan case centres on investigator-initiated trials (IITs), according to the company, which said it has introduced "several measures designed to identify and correct all issues with IITs in Japan, including the replacement of the … senior management team".

Novartis has always maintained that the data manipulation did not relate to registration trials for Diovan or information appearing on patient information, although it has been suggested it may have had an impact on sales or treatment guidelines in Japan.

"Novartis and NPKK have already undertaken decisive action to address problems with the company's IIT research programmes in Japan," said David Epstein, global division head of Novartis Pharmaceuticals.

"We are committed to changing the culture at NPKK and demonstrating ethical leadership among pharmaceutical companies in Japan," he added.

Article by
Phil Taylor

2nd July 2014

From: Research, Sales, Regulatory

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