Friday, April 06, 2012

David vs. Goliath: St. Jude Medical Seeks Retraction of Heart Rhythm Journal Manuscript

St. Jude Medical, a widely-used manufacturer of implantable cardiac devices, finds they have a bit of a problem with a form of insulation that surrounds wires contained in several lines of their pacing and defibrillator leads.  They decide to pull these products from the market after substantial evidence that their leads' reliability falls below their standards. 

A credible doctor, Robert G. Hauser, MD, known for his work in reviewing medical device safety issues, published a perspective piece critical of the post-market surveillance of the Riata leads in the New England Journal of Medicine.  St. Jude Medical takes issue with Dr. Hauser, and publishes a rebuttal in the same issue of New England Journal of Medicine.

Dr. Hauser then submits a paper to the scientific peer-reviewed Heart Rhythm Journal for publication.  The paper reveals deaths that might be caused by St. Jude Medical's faulty leads.  The reviewers feel it is an important paper to share with their readership.  The paper is published

Today we find that St. Jude Medical is REALLY not happy with Dr. Hauser and demands that his paper be retracted from the Heart Rhythm Journal on the basis of their competitor's lead data reliability that they feel was misreported.  The same letter fails to mention their own quality issues.

They then issue a press release to assure viral media spread in an attempt to discredit the physician's findings far and wide before facts can be verified.  They say in their press release that they are justified in their action because Dr. Hauser failed to come to them before publishing his article:

St. Jude Medical was not consulted prior to the publication, nor asked to validate any of the data against its returns analyses. Since the manuscript was published, the company has spent more than 300 hours attempting to reach the same conclusions as Dr. Hauser, but can find no way of analyzing the MAUDE database that reproduces the same numbers reported in the manuscript. The company has identified duplicate reports, inconsistent categorizations and failures to include all available reports.
Ladies and gentlemen, this is an electronic SMACKDOWN!

Interestingly, word on the street is that a not-so-pleasant article about St. Jude's lead issue and the problems therein is about to be published in a major newspaper. (Addendum 4/6/2012 @ 11:07pm: Here's the New York Times article now in print)

As Shakespeare famously said: "The lady doth protest too much, methinks."



Anonymous said...

This smackdown will affect how reliability issues, communication issues, and lots of other issues evolve in the device field. I'm all for David. What's the option? The Goliath press release didn't even MENTION ICD users. Since I have a Durata lead, I can only wish that Goliath had spent 300 hours on developing an algorithm that will warn me if my lead is bad, rather than searching for Medtronic-related deaths. Thank you for covering this.

Anonymous said...

St Jude focusing on the exact number of deaths is a sign of weakness. St Jude shows anger, denial, and negotiation. These are self-centered reactions that show no empathy for the patients who suffered and sometimes died because of design flaws in their device. St Jude is behaving as if they were just told they have a terminal disease (i.e., anger, denial, negotiation...). Thus they have fated themselves to be handled as very sick.