Diovan Data-Manipulation Scandal Touches Novartis in Japan

Shelley Wood

July 19, 2013

KYOTO, JAPAN — The past week has seen a number of new twists in the tale of a prominent Japanese cardiologist accused of fabricating and manipulating data and images for cardiology research later published in a range of cardiology journals.

Last year, the American Heart Association (AHA) issued a notice of concern about five papers appearing in three AHA-published journals--Circulation, Circulation Research, and Hypertension--between 2001 and 2004, as reported by heartwire .

Concerns about Dr Hiroaki Matsubara ultimately spread to the Kyoto Heart Study , the >3000 patient, postmarketing study Matsubara presented to some fanfare at the European Society of Cardiology 2009 Congress and subsequently published in the European Heart Journal ( EHJ). The EHJ later retracted that article, a move the AHA opted to follow this May after concluding its review of the studies published in a number of the association's journals. Matsubara resigned from his post at Kyoto Prefectural University earlier this year.

Last Friday, Japan's minister of health, Norihisa Tamura, as well as university officials at Kyoto Prefectural University announced that the Kyoto Heart Study data were "very likely" fabricated, according to AFP. "Incomplete" patient data were used in the study, which concluded the blood-pressure drug could also reduce other cardiovascular end points via mechanisms unrelated to blood-pressure lowering. Had "complete patient records" been used, the study would have reached "a different conclusion," the university concluded.

Finally, it has also emerged that two Novartis employees were involved in the conduct and analysis of the Kyoto Heart Study and a second investigator-initiated trial, the Jikei Heart study , although their participation was not acknowledged in publications and presentations of the data. Those employees are no longer with Novartis.

Novartis has issued a statement saying that it had launched a third-party investigation into allegations of conflict of interest (COI) relating to the two Novartis employees back in April.

"At the time these Japanese valsartan [investigator-initiated trials] IITs started between 2001 and 2004, there were no specific guidelines for COI in IITs," the statement reads. "The former employees and their managers misunderstood the appropriate level of involvement in IITs of employees of a pharmaceutical company. However, there are now COI guidelines for in place across the industry, which are followed by all Novartis Pharma Japan employees."

In June, after its investigation concluded, the company implemented "preventive and corrective measures . . . to address the causes identified in the third-party investigation, demonstrating our social and ethical accountability," the statement notes.

According to AFP, Novartis has also stressed that the university "was not able to conclude that there was intentional wrongdoing" and that it remains possible that the "inconsistencies" may have been unintentional.

The retractions, Matsubara's resignation, the Novartis announcement, and other details have been followed in detail on blog sites Retraction Watch and Cardiobrief , as well as on PharmaTimes .

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