On Friday (as reported here) St. Jude issued a press release alleging numerous mistakes and oversights in an article by Robert Hauser published online in Heart Rhythm linking the company’s 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.
On Tuesday, the New York Times reported that Zipes stood by the journal’s peer review process and would not retract the article. Zipes said there will be “some changes” to the article “involving what he called ‘inflection’” but that “‘the bulk of the manuscript stays as it is.”
Earlier Tuesday, St. Jude continued its assault on the Hauser article by issuing a press release and posting a link to findings from the MAUDE database. The company contended that Hauser had grossly undercounted the number of deaths tied to Medtronic’s Quattro Secure lead, thereby making its own Riata leads appear far worse by comparison.
Hauser and Zipes have not responded in detail to the St. Jude accusations, but Hauser told CardioBrief on Friday that the authors “stand by the conclusion of our study.” In a series of tweets, electrophysiologist Edward J Schloss (who has published guest posts about Riata on CardioBrief), 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.