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GEN News Highlights : Feb 20, 2014

Japan Raid Raises Pressure on Novartis

  • Alex Philippidis

Novartis restated its promise to cooperate fully with Japanese public prosecutors after confirming the authorities’ raid yesterday of the Tokyo offices of its Japanese subsidiary—part of an inquiry into the pharma giant’s marketing practices for the blood pressure drug Diovan (valsartan).

The raid comes more than a month after Japan’s Ministry of Health, Labour and Welfare filed criminal charges against Novartis Pharma K.K., accusing the pharma giant of violating the nation’s pharmaceutical affairs law by including studies with false data in its advertising for Diovan. Back then, Novartis said it had implemented measures designed to prevent a recurrence of the problem, and pledged full cooperation with authorities.

“Novartis does not comment on pending legal matters. We will cooperate fully with the Prosecutor’s investigation,” the company stated, in a terse comment furnished this morning to GEN.

The pharmaceutical affairs law bans exaggerated advertising of drugs, and sets penalties of up to two years in prison, and/or a fine of ¥2 million ($19,100).

The ministry contends that Novartis ads for Diovan cited clinical study reports by two Japanese universities containing false data and claiming that the drug was more effective than others in reducing the risk of cerebral stroke and angina.

The first doubts about that claim surfaced in 2012, when a Kyoto University doctor questioned the credibility of findings in studies by Tokyo’s Jikei University School of Medicine, published 2007 in The Lancet, and by Kyoto Prefectural University of Medicine published two years later in the European Heart Journal. Both studies were retracted last year, with the Kyoto retraction leading to Jikei’s investigation and eventual retraction.

Yoshiki Yui, M.D., stated on the website of The Lancet that data on average blood pressure data in different groups of patients cited in Diovan’s reports was too similar, thus meriting additional scrutiny. Novartis rebutted Dr. Yui’s contentions in the July 2012 edition of Pharma Medica, a Japanese medical publication.

Last July, Usman Azam, M.D., Novartis’ global head of medical affairs, acknowledged to The Lancet that a former employee, Nobuo Shirahashi, participated in clinical studies of the blood pressure drug conducted by five Japanese medical schools while furnishing to the journal an affiliation of “clinical epidemiology, Osaka City University Graduate School.” The grad school has no such department and Shirahashi had not disclosed he was an employee of the company, creating a potential conflict of interest.

Last month, after Japan’s health ministry filed charges against Novartis, the company issued a statement saying it had taken unspecified measures aimed at “ensuring that a repeat of the valsartan IIT issue cannot occur and ensuring adherence of Novartis Japan associates to the highest standards of ethics and compliance.”

“Japan is, and will continue to be, a key place for Novartis to invest and grow,” the company stated at the time.

Diovan sales slipped last year to $3.5 billion from $4.4 billion in 2012, with Novartis citing the launch of generic competition following the end of patent protection for the drug in most markets, and the impact of the clinical trials issue. But in the U.S., Novartis has benefited to date from FDA’s hamstringing Ranbaxy from launching its generic version of the blood pressure treatment by barring the Indian company from importing ingredients from four manufacturing plants where the agency has raised issues about product quality.

Sales of Diovan in Japan have surpassed ¥100 billion ($954 million) annually, according to numerous published reports.