St. Jude in spat over Heart Rhythm paper

April 17, 2012 – 12:32 PM | By Rob Kimball | No comments yet

After the tussle, perhaps?

“Take it back!”

“No, I won’t take it back, you stop bothering me!”

“I said . . . take it back!”

No, I didn’t hear this exchange at the playground in my neighborhood. Nor did this occur at the customer service counter of my local department store. But rather, this is the tone of a med-tech spat taking place in the “virtual” sandbox that has been taking place this week; one which has caught the attention of industry observers.

St. Jude Medical (St. Paul, Minnesota) is miffed about a recent paper published in the journal Heart Rhythm written by Robert Hauser, MD, and colleagues out of Minneapolis heart institute. The matter at hand involves study results from an analysis that assessed the number of death reports associated with St. Jude Medical Riata and Riata ST defibrillation leads compared with Medtronic (Minneapolis) Quattro Secure leads. This assessment was based on a search of the FDA Manufacturers and User Facility Device Experience (MAUDE) database.

On April 6, St. Jude issued a press release alleging numerous mistakes and oversights in the article, titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads” published online in Heart Rhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. The company publicly asked the journal, which is published by the Heart Rhythm Society, to retract the article.

St. Jude went on the offensive and continued its assault on the Hauser article by posting a link to findings from the MAUDE database. The company contended that Hauser had grossly undercounted the number of deaths tied to Medtronic’s Quattro Secure lead, thereby making its own Riata leads appear far worse by comparison.

Medtronic, for its part, is saying its own review of an FDA database supports the controversial findings of the study tying St. Jude’s recalled Riata defibrillator leads with deaths from internal short circuits.

In the latest twist to the story, Douglas Zipes, the editor of Heart Rhythm, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude’s embattled Riata leads.

Zipes defended the publication’s process of expert review. “I understand industry’s pain, but I will not abrogate the rules and regulations that have served us so well,” Zipes said in the New York Times, referring to the peer review process. He said that Hauser had agreed to make some changes to his article before its print publication involving what he called “inflection” but added that “the bulk of the manuscript stays as is.”

No doubt this is concerning for St. Jude, given that these leads were once widely sold. The company removed the leads from market in late 2010 due to wires within the cables working their way through the insulation surrounding them. This would cause electrical problems, including shocks at inappropriate times. Then, a year later, the FDA issued a Class I recall on the leads, which caused some in the investment community to express concern on potential market share in 2012. St. Jude has since issued newer upgraded versions of the leads, which it claims are not affected by the same problem.

So . . . which side of the fence (or corner of the sandbox) do you fall on? St. Jude isn’t denying the deaths took place, it claims that the methodology was wrong and somewhat biased by Hauser. Speaking of whom, Hauser gave Medical Device Daily a “no comment” when reached Monday, and has only released a brief statement on claiming the authors “stand by the conclusion of our study.”

It’s not been a good April for St. Jude. Just last week, the company said it was having problems with its QuickSite and QuickFlex left ventricular leads used to connect cardiac resynchronization therapy (CRT) devices to the heart. The company reported that it has sent an advisory letter to doctors about visual observations of externalized conductors on the silicone end of the QuickSite and QuickFlex leads, however there have been no reports of patient injury or loss of therapy due to externalized conductors in these leads, the company noted.

As of Thursday night, April 12, there were no new developments in the saga, But, as always, we will keep readers updated as this drama continues and in and out of the sandbox.



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