The addition of valsartan to optimized therapy in a cohort of Japanese patients with coronary heart disease and hypertension provides. Description: RETRACTION: The editors of the European Heart Journal have retracted the article reporting data/results of the Jikei Heart Study. The Lancet has formally retracted the Jikei Heart Study paper, originally published in The retraction had been widely anticipated for more.
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Given this finding, we now wish to retract the Jikei Heart Study on the grounds that we no longer have confidence in the published results. When the Jikei Heart Study was first published, Staessen and Richart 2 congratulated the investigators on their report. But we soon became aware that there was concern in Japan about the trial.
In October,we received correspondence expressing concern about the similarity of the standard deviations of the mean blood pressure measurements in the two studies, and we invited the authors to comment. Although we were initially satisfied with their response, in we published a letter from Dr Yui reporting further concerns.
An investigating committee headed uikei Professor Hashimoto from Jikei University was established. We became aware of this development on April 29,and on May 2 we wrote to Jikei University asking for details of the investigation and requesting that we be kept informed. We wrote again on June stuey and June 19 asking when the investigation might be completed. We wrote again on July 31 after we were made aware that a press conference had been held.
Lancet retracts Jikei Heart Study of valsartan following investigation – Retraction Watch
The report identifies concern over the reliability of the blood pressure data: The report also comments on the affiliation of the person entrusted with the statistical analysis, Nobuo Shirahashi. Our attempts to obtain a response from Mr Shirahashi were hindered by his recent retirement from Novartis, but the Global Head of Medical Affairs, Dr Usman Azam, did share with The Lancet that Mr Shirahashi had been employed by Novartis throughout the period of the trial and its publication.
Dr Azam also told us: He held the position until Taken together, 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.
Valsartan in a Japanese population with hypertension and other cardiovascular disease Jikei Heart Study: Sum and substance in the Jikei Heart Study.
Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: Eur Heart J ; Concerns about the Jikei Heart Study.
Lancet retracts Jikei Heart Study of valsartan following investigation
Larry Husten, at Cardiobrief, has been following the story in detail, and notes that the saga began with questions about papers by Hiroaki Matsubarawho now has eight retractions. Matsubara is not an author on the Jikei study.
Another outrageous and potentiall quite dangerous violoation of medical, scientific, and human ethics by Big Pharma trying to sell their products. There should be some accountability here by executuves at Novartis. If the CNS journals did the right thing, we would have seen several more retractions recently McGill etc.
Of course, The Lancet has been burned before Wakefield… and this is a clinical trial not basic science — hence jikwi has prevailed. The Lancet deserves a tip of our hat for such a detailed note. I hope many more journals will take the same detailed approach.
Accumulated sales of Diovan in Japan reaches 12 billion dollars US!
This is outragenous given all those incomes come from healthinsurance and copay form patients. The government is now investigating how to recover monies from Novaritis, a company obtaines so much moneny based on false and fabrictated data.
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