Japanese Research Scandal Involving Novartis Blood Pressure Drug Widens

The Japanese scandal over research using the Novartis blockbuster hypertension drug Diovan (valsartan) continues to widen. The first major figure brought down in the scandal was Hiroaki Matsubara, a prominent cardiologist and researcher at Kyoto Prefectural University in Japan, who  resigned from his position after numerous retractions and investigations. Then last year accusations surfaced about another prominent researcher, Issei Komuro, a professor…

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Saying Sorry May Not Be Good Enough For Novartis

Novartis has issued a formal apology over misconduct relating to valsartan (Diovan) research in Japan, but that apology does not appear likely to satisfy the Japanese Health, Labor and Welfare Ministry, which plans to fully investigate the company’s role in the scandal. If necessary, ministry officials are prepared to raid the company’s offices in Japan. A Novartis…

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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.)…

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More Bad News For Novartis Blood Pressure Drug

In the last few days more bad news about valsartan (Diovan, Novartis) has emerged in Japan. Another major study conducted in Japan– the Jikei Heart Study– will be retracted and Japanese health authorities said they were investigating severe skin reactions associated with use of the drug. The new events are only the latest problems for the…

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Diovan Data Was Fabricated, Say Japanese Health Minister And University Officials

Following a long series of accusations, retractions, and the resignation of a prominent professor, it now is clear that data from a large Japanese study of valsartan (Diovan, Novartis) was fabricated. On Thursday officials at Kyoto Prefectural University of Medicine said that “had patient records been used in their entirety,” the Kyoto Heart Study “would have…

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Novartis Acknowledges Employees Participated In ‘Independent’ Trials

Novartis has acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company. The company said that a broader “comprehensive investigation with independent third party experts is ongoing” but that it has “provided an update” to Japanese medical societies and to the principal investigators of the five…

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Japanese Research Scandal Expands To A Second Trial And A Novartis Employee

A Japanese research scandal, which has so far centered on actions taken by the once-prominent cardiologist Hiroaki Matsubara, has now expanded. As has been previously reported, several papers authored by Matsubara have been retracted, including, most notably, the main publication of the Kyoto Heart Study in the European Heart Journal. Now, however, questions have been…

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Two Retractions For Embattled Chief Investigator Of Kyoto Heart Study

The editor of Circulation Journal, the official journal of the Japanese Circulation Society (and not to be confused with the American Heart Association’s better known Circulation) has announced the retraction of two substudies from the Kyoto Heart Study. The papers, according to the editor, “contain a number of serious errors in data analysis.” Read my entire…

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Another One Bites the Dust: Diovan Patent Expires But Generic Valsartan Is MIA

Although the patent on valsartan (Diovan, Novartis) expired last Friday, a generic version of the popular antihypertensive drug has yet to make it to market. By contrast, a generic version of Diovan HCT, the combination of valsartan and hydrochlorothiazide, was recently launched by generic drugmaker Mylan. As reported on Pharmalot, Ranbaxy, the embattled generic drugmaker, holds…

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