PHARMA & HEALTHCARE
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2/02/2013 @ 11:57AM |5,133 views
Important Study Of High Blood Pressure Medicine Retracted
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(Updated February 3 & February 5)–The editors of the European Heart Journal have retracted the 2009 paper reporting the main results of the Kyoto Heart Study, a randomized, open-labeled study testing the add-on effect of valsartan to conventional therapy in high-risk hypertension. The retraction notice gave no details about the problems that led to the retraction. Here is the full text of the retraction notice:
“This article has been retracted by the journal. Critical problems existed with some of the data reported in the above paper. The editors of the European Heart Journal hereby retract this paper and discourage citations of it.”
For the past year the chief investigator of the Kyoto Heart Study, Hiroaki Matsubara, who had been a prominent cardiologist and researcher at Kyoto Prefectural University in Japan until the recent scandal, has been under fire. Last March, following accusations by independent bloggers in Japan and Germany, the American Heart Association (AHA) issued an Expression of Concern about five papers published in AHA journals co-authored by Matsubara. Then, last month, 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) 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.”
It is worth noting that the Kyoto Heart Study was considered to be an important study with significant clinical implications at the time of its publication. The title of the press release issued by the European Society of Cardiology when the study was originally released was: “Valsartan reduces morbidity and mortality in Japanese patients with high risk hypertension.” My own news story about the study asked, in the headline, “have ARBs finally come of age.” Valsartan is now available as a generic drug. When still on patent, under the brand name Diovan, it was one of the best-selling drugs in the world for Novartis.
At the time of the initial publication of the Kyoto Heart Study well-known hypertension researchers Franz Messerli, Sripal Bangalore and Frank Ruschitzka wrote an editorial that raised some questions about the study. Responding to today’s news of the retraction of the main study, Messerli said:
”…in our editorial we use terms like ‘somewhat surprisingly’, ‘due to chance’ and ‘somewhat difficult to believe’ to describe the findings of the Kyoto Heart Study. This clearly shows that we had difficulties in reconciling the data with existing evidence from other studies. I am therefore not surprised that the veracity of main results also turned out to be questionable.
February 3 Update: Here’s a question for readers out there: how many randomized controlled trials with human subjects have been retracted? (I don’t know the answer, but I doubt there have been many large trials that have been retracted.)
February 5 Update: Hiroaki Matsubara has issued a statement in Japanese about the retraction [PDF]. I am informed that Matsubara remains a professor at the Kyoto Prefectural University and he is still listed as a board member of the Japanese Society of Hypertension.
