Dr Douglas Zipes explains his rare Riata editorial

Steve Stiles and Shelley Wood

May 07, 2012

St Paul, MN - A number of letters to the editor over a controversial article[1] detailing "high-voltage failures" with Riata and Riata ST implantable defibrillator leads—including a letter from St Jude Medical—will be published online Tuesday, heartwire has learned, just as rhythm experts are descending on Boston for the Heart Rhythm Society 2012 Scientific Sessions . Hauser et al's article, reported by heartwire , caused a second wave of headlines when St Jude took the unusual step of demanding Heart Rhythm retract the article[2] (something editors there declined to do) as well as conducting its own review of the Manufacturer and User Facility Device Experience (MAUDE) database, which was the data source for Hauser et al's publication. Last week, in another twist, editor in chief Dr Douglas Zipes (Indiana University School of Medicine, Indianapolis) published a rare editorial saying he was "compelled to speak out" in defense of the peer-review process that led to his decision to stand by the publication of Hauser et al's paper[3].

Last week, heartwire spoke with Zipes about his editorial and the decision making behind the Hauser et al publication.

Douglas Zipes: An interview

heartwire : How common is it for a company to make a public announcement that they want something retracted? A press release is an unconventional route; did you get the feeling that maybe you weren't only the intended recipient of the request?

Zipes: I have been a journal editor 23 and a half years, and this is the first time this has happened to me. . . . I don't know. I don't want to put myself in St Jude's head. All I know is, in my experience this has never happened before in the 15 years I edited the Journal of Cardiovascular Electrophysiology and the almost nine years I have edited Heart Rhythm.

H: They said something rather unusual; they said St Jude 'wasn't consulted' before the report came out.

Z: There would be no reason for an author necessarily to consult [with the company]. They may want input from industry—that's up to the individual author, but there is no reason that they have to. They've written a letter to the editor that [will soon be] posted online.

H:Was there anything inappropriate about their issuing that press release?

Z: They did what they thought they had to do. Hauser reported what he felt was an honest evaluation of the MAUDE database and the outcomes, and I serve as the judge, essentially. Hauser's article went through the appropriate adjudication process and was published, St Jude has now written a letter to the editor, which [will] also [be] published, and that's the way it is.

H: Did St Jude contact you in person after they wrote the original press release?

Z: Yes, I've spoken on multiple occasions with Dr Mark Carlson, their senior medical physician [in cardiac rhythm management], and he could not be more gentlemanly, more cooperative, more insightful. I have nothing but accolades about my interactions with him.

H: It sounds like the message of your editorial hit home with St Jude. Your editorial was really support for the process.

Z: Absolutely. I'm taking hits now from Taser, for my publication last week[4], and I don't know if anyone is contacting [editor Dr Joseph] Loscalzo at Circulation, but his response, I'm certain, would be as mine is: the paper was written, it went through peer review, and it ended up getting published. It's no different from a court decision, and if you disagree with it, there are well-defined processes for showing your disagreement.

H: Would there be any exceptions to that particular process?

Z: There are, on occasion, exceptions, when fraudulent data is discovered—reviewers and editors are not infallible.

H: The peer-review process at Heart Rhythm—is there anything unusual about it?

Z: No. It's exactly as you would find in any of the major journals. It is vigorous, I interact with all phases of it, our overall acceptance rate is 18%. It is a vigorous peer review.

H: How many reviewers were there for this article?

Z: Two. I ask for more when there is dissension between the two or if I disagree with the reviewers, but there were two; the reviews were appropriate, and I agreed with them. Hauser made his revisions, they went back to the reviewers, they approved, I approved, and it was published.

H: Is there a policy at Heart Rhythm regarding conflicts of interest (COI) and disclosures for the reviewers?

Z: Sure, so any reviewer who might have a COI is expected to state that and recuse him- or herself. If I personally have a COI, I do the same thing and get a guest editor, and I do that with any manuscripts from my medical center, and I did that with Medtronic manuscripts when I was consulting for them. That's ended, so that is not a problem anymore.

I'm the frequent guest editor for all the Circulation journals when a manuscript is submitted by a Boston author and Loscalzo or one of the other editors feels there might be a conflict.

H: So the process was followed to the letter; the reviewers would presumably not have had any COI.

Z: Precisely.

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