Dr. Douglas Zipes told the New York Times that the piece by Dr. Robert Hauser, which went online last month and is slated for print publication later in April, was peer-reviewed before it appeared on the journal’s website. And although Hauser has agreed to minor edits to adjust "inflection" ahead of print publication, "the bulk of the manuscript stays as is," Zipes told the newspaper.
Late last week, St. Paul-based St. Jude called for the retraction of the study, a review of medical device adverse event reports in the FDA’s MAUDE database. St. Jude continued the offensive over the weekend, with CEO Daniel Starks accusing its peers of smearing its name to gain an edge in the slumping cardiac rhythm management arena, a charge arch-rival Medtronic (NYSE:MDT) vehemently denied yesterday.
Hauser’s manuscript reviewed data on the Riata line of defibrillator leads from the MAUDE database, culling 133 lead-related deaths. Of those, the study attributed 22 to failures in the Riata or Riata ST leads, compared to 5 for Medtronic’s Quattro Secure leads. According to St. Jude, however, 2 of the 22 deaths in the study were duplicates, 9 were the result of abrasions and another 9 can’t be assigned to specific failures because the failed leads were not returned to the company, leaving 2 that were definitively the result of electrical shorts. And the company claimed it found 377 deaths related to Medtronic’s Quattro lead, compared with Hauser’s 62, and 74 deaths related to the Riata leads, compared to Hauser’s 71.
Zipes told the Times that he’s offered to have the St. Jude data peer-reviewed, but that Hauser’s piece will stand.
"I understand industry’s pain, but I will not abrogate the rules and regulations that have served us so well," he said, according to the Old Gray Lady.