Medical journal rejects St. Jude retraction request

  • Article by: JAMES WALSH , Star Tribune
  • Updated: April 10, 2012 - 8:43 PM

The med-tech firm claimed deaths tied to a competitor's heart-device wires were undercounted in an article.

Heart Rhythm Journal will not retract an article by Minneapolis cardiologist Dr. Robert Hauser, despite St. Jude Medical's insistence that it is biased and inaccurate.

Dr. Douglas Zipes, managing editor of the online journal and a professor at the Indiana University School of Medicine, said Tuesday that Hauser's work analyzing deaths attributed to St. Jude's Riata and Medtronic Inc.'s Quattro Secure leads had been extensively peer-reviewed before it was accepted for publication. A lead is a wire that connects an implantable defibrillator to the heart.

"It's not going to happen," Zipes said of a retraction.

Little Canada-based St. Jude Medical Inc. on Friday demanded a retraction, saying that Hauser under-counted the number of deaths associated with the Medtronic device in his comparison with Riata leads. Hauser, a consulting cardiologist at Abbott Northwestern Hospital's Minneapolis Heart Institute, used data in the U.S. Food and Drug Administration's Manufacturers and User Facility Device Experience (MAUDE) database to analyze deaths attributed to the devices.

In an article posted March 26, Hauser said his research found at least 20 deaths caused by high voltage failures in the Riata leads. Hauser reported five deaths associated with the Quattro Secure lead. Using the same data, St. Jude said it found 377 deaths connected to that lead.

In December 2010, St. Jude took Riata leads off the market after wires were found to have protruded through the leads' outer insulation. The device has since been recalled. Fridley-based Medtronic continues to sell Quattro Secure leads.

Hauser said Friday that he stands by his conclusions. On Tuesday, Medtronic spokesman Christopher Garland said the company also has looked at the data and that Hauser's numbers about Quattro leads appear to be accurate.

Zipes said Dr. Mark Carlson, chief medical officer for St. Jude, has been offered an opportunity to write a letter to the editor, to which Hauser would be given an opportunity to respond.

Reacting to the journal's decision, St. Jude spokeswoman Amy Jo Meyer said the company's only interest is that patients and physicians have correct information about the Riata lead.

"Our intent in correcting the manuscript and in calling for a retraction is simply that our research indicates that the data in the published manuscript is in error," she said. "We will continue to work through the proper channels with the Heart Rhythm Journal and the Heart Rhythm Society to ensure there is an appropriate presentation of validated, accurate information."

James Walsh • 612-673-7428

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