September 5th, 2013

Lancet Formally Retracts Jikei Heart Study of Valsartan

The Lancet has formally retracted the Jikei Heart Study paper, originally published in 2007. The retraction had been widely anticipated for more than a month, after a series of news reports in Japan made it clear that the long-simmering controversy over scientific misconduct involving the Novartis blood pressure lowering drug valsartan (Diovan) had come to a full boil. (See our earlier story here.)

As reported previously, the current scandal first began to unfold in late 2011 when a Japanese blogger pointed to a number of apparent errors in publications authored by Hiroaki Matsubara. This ultimately led to a series of retractions of Matsubara’s papers and the retraction of the main paper of the Kyoto Heart Study itself by the European Heart Journal.

In the notice of retraction, the Lancet editors outline the chronology of the case, stating that shortly after publication of the Jikei Heart Study in the Lancet they first became aware of concerns in Japan about both the Jikei and the Kyoto Heart studies, both of which studied valsartan and had shared several authors. However, despite the publication of a letter questioning the statistics of the Jikei Heart Study, no further actions were taken until earlier this year.

Following the retraction of the Kyoto Heart Study in February 2013, Jikei University initiated its own investigation. After some delay, and after some prodding from the Lancet after the announcements in the Japanese press, Jikei informed the Lancet editors that blood pressure data in the study had been intentionally altered during the statistical analysis. The person responsible for the data manipulation was Nobuo Shirahashi, whose listed affiliation was “Clinical epidemiology, Osaka City University Graduate School”. Sharahashi, however, was actually an employee of Novartis, and the Osaka City University did not provide statistical analysis for the Jikei Heart Study. A Novartis official told the Lancet that Shirahashi had “obtained an unpaid position in about 2001 with the Osaka City University Graduate School’s Medical Research Faculty as a part­-time lecturer in the Department of Medicine. He held the position until 2011.” Shirahashi has now retired from Novartis and has not cooperated with the investigation.

“Taken together,”write the editors, “these findings indicate that there is now sufficient doubt as to the integrity of the Jikei Heart Study and the obfuscation over affiliation of the study statistician for The Lancet formally to retract the paper from the scientific record.”



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