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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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. The follow-up period will be three years. Valsartan in a Japanese population with hypertension and other cardiovascular disease Jikei Heart Study: The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker, in addition to conventional treatment, will improve the prognosis of Japanese patients with cardiovascular diseases hypertension, ischemic heart disease, congestive heart failure.
Matsubara is not an author jieki the Jikei study. Concerns about the Jikei Heart Study.
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. But we soon became aware that there was concern in Japan about the trial.
Learn how your comment data is processed. He held the position until Of course, The Lancet has been burned before Wakefield… and this is a clinical trial not basic science — hence sanity has prevailed. In Heatt,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.
Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: This site uses Akismet to reduce spam.
Sorry, your blog cannot share posts by email. The Lancet deserves a tip of our hat for such a detailed note. Although we were initially satisfied with their response, in we published a letter from Dr Yui reporting further concerns.
Dr Azam also told us: It is therefore important to verify that the results of these jiksi are also valid for Japanese patients.
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. I hope many more journals will take the same detailed approach. Secondary endpoints will include death from any cause, changes in left ventricular size and function, renal function, changes in neuro-hormonal levels and quality-of-life assessments. Papers on potential cancer drugs retracted for image manipulation.
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. We wrote again on June 4 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. Asian patients including Japanese were under-represented in these trials, however, and no large-scale clinical trials of ARBs have yet been performed in Japan.
This is outragenous given all those incomes come from healthinsurance and copay form patients. Eur Heart J ; The government is now investigating how to recover monies from Novaritis, a company obtaines so much moneny based on false and fabrictated data.
Lancet retracts Jikei Heart Study of valsartan following investigation – Retraction Watch
When the Jikei Heart Study was first published, Staessen and Richart 2 congratulated the investigators on their report. The primary endpoint will be the onset of any cardiovascular event.
Accumulated sales of Diovan in Japan reaches 12 billion dollars US! Several recent clinical trials have demonstrated that angiotensin II receptor blockers ARBs have cardiovascular as well as renal protective effects. Heqrt and substance in the Jikei Heart Study. There should be some accountability here by executuves at Novartis.
Lancet retracts Jikei Heart Study of valsartan following investigation
Another outrageous and potentiall quite dangerous violoation of medical, scientific, and human ethics by Big Pharma trying to sell their products. Follow Follow this blog Get every new post delivered right to your inbox. Improved prognosis would confirm the role of angiotensin II receptor blockers in the treatment of the cardiovascular disease in Japanese patients. Leave a Reply Cancel reply Your email address will not be published.
The report identifies concern over the reliability of the blood pressure data: An investigating committee headed by Professor Hashimoto from Jikei University was established.
Too much skin in the game, as duplications force retraction of psoriasis paper. Sub-studies will explore the effect in patients jeart diabetes mellitus, hyperlipidemia and the effects of combination of drugs. Your email address will not be published. If the CNS journals did the right thing, we would have seen several more retractions recently McGill etc.