{"id":38657,"date":"2013-09-05T18:30:15","date_gmt":"2013-09-05T22:30:15","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=38657"},"modified":"2013-09-05T19:15:34","modified_gmt":"2013-09-05T23:15:34","slug":"lancet-formally-retracts-jikei-heart-study-with-valsartan","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/09\/05\/lancet-formally-retracts-jikei-heart-study-with-valsartan\/","title":{"rendered":"Lancet Formally Retracts Jikei Heart Study of Valsartan"},"content":{"rendered":"

The\u00a0Lancet<\/em> has formally\u00a0retracted the Jikei Heart Study<\/a>\u00a0paper, 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\u00a0here<\/a>.)<\/p>\n

As reported previously<\/a>, 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\u00a0Matsubara. This ultimately led to\u00a0a series of retractions of Matsubara’s papers\u00a0<\/a>and\u00a0the retraction of the main paper of the Kyoto Heart Study itself<\/a>\u00a0by the European Heart Journal<\/em>.<\/p>\n

In the notice of retraction<\/a>, the\u00a0Lancet<\/em> editors outline the chronology of the case, stating that shortly after publication of the Jikei Heart Study in the Lancet<\/em> 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<\/a> questioning the statistics of the Jikei Heart Study, no further actions were taken until earlier this year.<\/p>\n

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 <\/em>after\u00a0the announcements in the Japanese press, Jikei informed the Lancet<\/em> editors that blood pressure data in the study had been intentionally altered during the statistical analysis. The person responsible for the data manipulation was\u00a0Nobuo Shirahashi, whose listed affiliation was \u201cClinical epidemiology, Osaka City University Graduate School\u201d. Sharahashi, however, was actually an employee of Novartis, and the Osaka City University did not provide statistical analysis for the Jikei Heart Study.\u00a0A Novartis official told the\u00a0Lancet<\/em> that Shirahashi had “obtained an unpaid position in about 2001 with the Osaka City University Graduate School\u2019s Medical Research Faculty as a part\u00ad-time lecturer in the Department of Medicine. He held the position until 2011.\u201d Shirahashi has now retired from Novartis and has not cooperated with the investigation.<\/p>\n

“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<\/em> formally to retract the paper from the scientific record.”<\/p>\n

 <\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

The\u00a0Lancet has formally\u00a0retracted the Jikei Heart Study\u00a0paper, 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. […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[1905,1617,969,1963,1478],"class_list":["post-38657","post","type-post","status-publish","format-standard","hentry","category-general","tag-jikei-heart-study","tag-kyoto-heart-study","tag-scientific-misconduct","tag-the-lancet","tag-valsartan"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/38657","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=38657"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/38657\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=38657"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=38657"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=38657"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}