Friday, April 13, 2012

St. Jude Medical's Riata Lead Data Gets Peer Reviewed

When articles are submitted for publication in a scientific journal, they undergo a process called peer review.  In that process, highly respected scientists with experience in the subject matter of the submitted manuscript review the new work and decide if it is worthy for publication.  During the process of peer review, the reviewers determine if the hypothesis of the work is supported by the available data and if the work is sufficiently valuable to the scientific community.  Usually there are at least two reviewers who independently reach their conclusion regarding the manuscript and who report their decisions to the journal's editor.  The editor ultimately determines the manuscript's fate.  During this process, the authors are notified of the publication decision and feedback is provided to the authors by way of a written critique. That way, if a paper is rejected, authors can still benefit from the process in the hopes future submissions are improved.

This morning, St. Jude Medical undergoes a similar process, but in a more public way.  Because the company chose to seek retraction of a scientific peer-reviewed manuscript by Dr. Robert G. Hauser from the Heart Rhythm Journal, an independent customer-reviwer, Edward J. Schloss, MD, Director of Cardiac Electrophysiology at The Christ Hospital in Cincinnati, OH, decided to subject St. Jude Medical's request to scientific review. (I'll call it a "customer review")  Dr. Schloss hypothesized that differences in search methodology of the MAUDE database used by the company could explain the discrepancy in numbers of deaths found by Hauser et al’s Heart Rhythm Journal manuscript and the company's own numbers.  His crystal clear analysis appears this morning at Cardiobrief and brings into sharp focus the severe shortcomings of St. Jude’s claims.

By way of background, readers of his work should know that Dr. Schloss attempted to offer this analysis at the Heart Rhythm Journal before publishing his analysis in its current format, but recieved a one-sentence reply from the Heart Rhythm Journal's editorial staff, stating the work would not be worthy of publication there. We can only speculate why his request was rejected.

So he published his analysis on Cardiobrief instead.

Dr. Schloss should receive our appreciation for his dogged determination to get to the truth.  With his matter-of-fact and scientific analysis, he provides an invaluable service to his colleagues and our patients.   Like all of us, he wanted to understand the truth behind the Riata/Riata ST defibrillator lead safety statistics. 

But the value of this work extends further.  Just like the scientific peer review process that rejects a manuscript on its first pass, we can only hope that St. Jude Medical learns a powerful lesson about their customers and the ever-watchful and increasingly influential medical blog-o-sphere.


Addendum: For another excellent take on this fiasco, please see the comments and analysis by Dr. John Mandrola.


Anonymous said...

I don't understand how Ed could do in a couple days, by himself, what St. Jude said they were unable to do after over 300 hours of analysis attempts.

Jay said...


If you simply analyze and report, without an agenda, this speeds things up quite a bit.

(call me) Jay

Anonymous said...

Jay, you're saying "without an agenda"? While i enjoy reading your cogent analysis of the ongoing riata problems, i have to ask some questions. I believe you to be a true patient advocate, and thus that being your primary motivation. Could you please disclose your pre-riata recall vendor implant mix? Or at the very least, were you a regular implanter of St. Jude icd leads? This would give some added perspective.

Anonymous said...

I would like to hear that as well. Seems like bias is at work on both sides. One EP I'm a colleague of was paid to attend Hauser's "Riata Summit" by . . . Medtronic. Said he wasn't alone.

Anonymous said...

What is Wes's implant mix? He and Jay have not disclosed that?

DrWes said...

Anony 07:37-

I'll be happy to disclose my implant mix when you disclose your identity.

Now, since neither your identity nor my implant ratio will be easily verifiable by the casual reader, can we stick to the data presented by Dr. Schloss vs. St. Jude rather than wandering off topic?