{"id":28210,"date":"2012-04-10T16:23:53","date_gmt":"2012-04-10T20:23:53","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=28210"},"modified":"2012-04-10T16:23:53","modified_gmt":"2012-04-10T20:23:53","slug":"round-two-heart-rhythm-editor-rejects-st-jude-request-to-retract-riata-paper","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/04\/10\/round-two-heart-rhythm-editor-rejects-st-jude-request-to-retract-riata-paper\/","title":{"rendered":"Round Two: Heart Rhythm Editor Rejects St. Jude Request to Retract Riata Paper"},"content":{"rendered":"<p>Douglas Zipes, the editor of\u00a0<em>Heart Rhythm<\/em>, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude&#8217;s embattled Riata leads.<\/p>\n<p>On Friday, <a title=\"David vs. Goliath: St. Jude Medical Seeks Retraction of Heart Rhythm Journal Manuscript\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/voices\/david-vs-goliath-st-jude-medical-seeks-retraction-of-heart-rhythm-journal-manuscript\/\">as electrophysiologist Wes Fisher told CardioExchange<\/a>,\u00a0St. Jude issued\u00a0<a href=\"http:\/\/investors.sjm.com\/phoenix.zhtml?c=73836&amp;p=irol-newsArticle&amp;ID=1680886\">a press release<\/a>\u00a0alleging numerous mistakes and oversights in\u00a0<a href=\"http:\/\/www.heartrhythmjournal.com\/article\/S1547-5271(12)00291-3\/abstract\">an article by Robert Hauser published online in\u00a0<\/a><em><a href=\"http:\/\/www.heartrhythmjournal.com\/article\/S1547-5271(12)00291-3\/abstract\">Heart Rhythm<\/a>\u00a0<\/em>linking the company\u2019s Riata and Riata ST leads to 20 or more deaths. The company publicly asked the journal, which is published by the Heart Rhythm Society, to retract the article.<\/p>\n<p>On Tuesday,\u00a0<a href=\"http:\/\/www.nytimes.com\/2012\/04\/11\/business\/st-jude-medical-rebuffed-over-device-report.html?_r=3\">the\u00a0<em>New York Times\u00a0<\/em>reported<\/a>\u00a0that Zipes stood by the journal&#8217;s peer review process and would not retract the article. Zipes said there will be &#8220;some changes&#8221; to the article &#8220;involving what he called &#8216;inflection'&#8221; but that &#8220;&#8216;the bulk of the manuscript stays as it is.&#8221;<\/p>\n<p>Earlier Tuesday, St. Jude continued its assault on the Hauser article by issuing\u00a0<a href=\"http:\/\/investors.sjm.com\/phoenix.zhtml?c=73836&amp;p=irol-newsArticle&amp;ID=1681527\">a press release<\/a>\u00a0and posting\u00a0<a href=\"http:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.riatacommunication.com%2F&amp;esheet=50233546&amp;lan=en-US&amp;anchor=Riatacommunication.com&amp;index=2&amp;md5=e90ecbae1a1eec5bf8c148b8b86a69a3\">a link<\/a>\u00a0to findings from the MAUDE database. The company contended that Hauser had grossly undercounted the number of deaths tied to Medtronic&#8217;s Quattro Secure lead, thereby making its own Riata leads appear far worse by comparison.<\/p>\n<p>Hauser and Zipes have not responded in detail to the St. Jude accusations, but\u00a0<a href=\"http:\/\/cardiobrief.org\/2012\/04\/06\/st-jude-seeks-retraction-of-hauser-article-on-riata-leads\/\">Hauser told CardioBrief on Friday<\/a>\u00a0that the authors &#8220;stand by the conclusion of our study.&#8221; In\u00a0<a href=\"https:\/\/twitter.com\/#!\/ejsmd\">a series of tweets<\/a>, electrophysiologist Edward J Schloss (who has <a href=\"http:\/\/cardiobrief.org\/?s=schloss\">blogged extensively about Riata<\/a>), noted that Hauser and St. Jude had applied different methodologies in their search of the MAUDE database, and that St. Jude may have failed to exclude Quattro deaths with no known lead problems.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Douglas Zipes, the editor of\u00a0Heart Rhythm, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude&#8217;s embattled Riata leads. On Friday, as electrophysiologist Wes Fisher told CardioExchange,\u00a0St. Jude issued\u00a0a press release\u00a0alleging numerous mistakes and oversights in\u00a0an article by Robert Hauser published online in\u00a0Heart Rhythm\u00a0linking the company\u2019s Riata [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[1217,975,1209],"class_list":["post-28210","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","tag-medtronic","tag-riata","tag-st-jude-medical"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28210","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=28210"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28210\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=28210"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=28210"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=28210"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}