Tough luck, St. Jude: No retraction for you

If St. Jude Medical ($STJ) had hoped that HeartRhythm would retract a controversial study it published regarding the company's recalled Riata defibrillator wires, the journal's editor-in-chief dashed that hope Tuesday afternoon.

Douglas Zipes told Bloomberg that the journal would not be changing anything. "At least at the present time, the only thing that has been peer-reviewed has been [Dr. Robert] Hauser's manuscript and that will stay in place," Bloomberg quotes HeartRhythm's editor-in-chief as saying. However, he told the news service the journal is trying to be "as fair as possible, knowing that there are several people with a dog in the fight."

St. Jude last week demanded that the journal retract a study by Hauser finding that the company's Riata defibrillator lead caused more deaths than Medtronic's ($MDT) Quattro Secure leads. That bold statement led to a bit of a schoolyard brawl earlier this week, with Medtronic saying it stood by Hauser's study. The St. Jude rival added that its own analysis of the FDA MAUDE database Hauser used produced the same results.

Zipes, a cardiology professor at the Indiana University School of Medicine, explained that two independent researchers reviewed the paper by Hauser, a cardiologist at the Minneapolis Heart Institute Foundation, before the journal accepted it. But he also proposed that St. Jude write a letter to the journal presenting its own data, after which Hauser could respond. (As of Tuesday night, the company hadn't sent anything in yet.)

St. Jude hasn't sold the Riata leads since December 2010, after safety concerns with the leads surfaced over a high rate of insulation failures. A voluntary medical device advisory letter followed late last year, and the FDA has now determined the alert to be a Class I recall, which is considered to be the most serious. In other bad publicity, the company also announced last week that it stopped marketing its QuickSite and QuickFlex left ventricular leads for cardiac resynchronization therapy devices due to multiple cases of worn insulation.

And the bad publicity continues to hurt. As Reuters reports, the company's shares dropped 12% within the last week, dipping another 1.2% to close at $38.43 late Tuesday afternoon.

- here's the Bloomberg story
- check out Reuters' take

Related Articles:
UPDATED: Medtronic backs Hauser's findings on Riata leads
St. Jude demands retraction of Riata lead study

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