The firestorm unleashed by patient safety champion Dr. Robert Hauser’s Riata study, which associated only 5 lead-related deaths with Medtronic’s (NYSE:MDT) Quattro Secure leads, is unique in Schloss’s nearly 2-decade career, he told MassDevice.com today.
"I can’t recall seeing a more contentious and open dispute between medical device companies in my 19 years working in this field," Schloss, director of cardiac electrophysiology at the Christ Hospital in Cincinnati, told us.
Hauser’s study in the Heart Rhythm Society’s journal dropped online last month, to a swift and vociferous response from St. Jude disputing his findings. The furor escalated last week, when the company asked the journal to retract the online story and cancel plans to put it in print in its next issue (the journal has said it will not alter its plans to publish the Hauser analysis). Over the weekend, St. Jude CEO Daniel Starks raised the stakes by accusing his Twin Cities arch-rival of fostering a "whisper campaign" to gain an edge in the struggling cardiac rhythm management market. Medtronic then jumped into the fray, corroborating Hauser’s Quattro numbers, prompting St. Jude to publish the 377 deaths it attributes to the MDT leads today.
The study analyzed 62 lead-related deaths for Quattro and 71 for Riata after weeding out deaths that were determined not to be lead-related. Those reports were then narrowed down further to deaths attributed to lead failures, leading to Hauser’s result of 22 Riata-related deaths and 5 Quattro-related deaths.
St. Jude’s tally, however, links 377 deaths with Medtronic’s leads. That’s proof that Hauser’s study was fundamentally flawed, at least according to St. Jude.
"The company has identified duplicate reports, inconsistent categorizations and failures to include all available reports," according to a press release.
Schloss, who has been closely following the Riata controversy, raised concerns about St. Jude’s methodology in collecting the 377 incidents.
"On first pass, the difference may be due to Hauser exclusion of deaths with no known lead problems," he wrote on his Twitter account earlier today, before noting "a high proportion [of] ‘not lead related’ deaths" in the 377 Quattro reports, adding that Hauser’s methodology excluded reports where "there was no known lead problem or allegation of lead malfunction."
St. Jude excluded duplicates entries from its MAUDE database request, but did not cut out deaths that were deemed unrelated to lead failure, providing a possible explanation for the vastly different conclusions reached by Hauser and the device maker.
It’s not the 1st time that Schloss has taken to Twitter to comment on the Riata recall. In February, he made headlines for live-Tweeting from a closed-doors Riata summit admitting only a handful of industry personnel and 55 physicians with a wealth of experience with the recalled device. Schloss revealed poll results from that summit suggesting that more than half of the attendees surveyed at the end of the day said that the "Riata problem is worse than Fidelis."
"This has become a topic of competitive marketing," St. Jude CEO Daniel Starks told the New York Times over the weekend. "We have competitors going to physicians and informing them, either incompletely or mistakenly, of a competitively hostile view of the facts."
Starks and other executives also accused Medtronic of spreading rumors and breeding doubt about St. Jude’s newer Durata leads, which use a different coating material than the Riata line and have not been associated with the same insulation issues.
"This is not a new accusation. From the very beginning of this Riata issue, St. Jude has been making claims that this is nothing more than a marketing campaign by Medtronic," Medtronic spokesman Chris Garland told MassDevice.com. "Medtronic has reviewed the MAUDE filings, applying the search criteria that Dr. Hauser used in his paper. Our results are roughly in line with Dr. Hauser’s results."