April 9th, 2012

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

CardioExchange welcomes this guest post from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem in Evanston, Illinois, and a Clinical Associate Professor of Medicine at University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes.

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 the 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 learn 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 that they feel their competitor’s lead data reliability 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 was that a not-so-pleasant article about St. Jude’s lead issue and the problems therein was about to be published in a major newspaper, and it has – here’s the New York Times article.

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

3 Responses to “David vs. Goliath: St. Jude Medical Seeks Retraction of Heart Rhythm Journal Manuscript”

  1. Steven Greer, MD says:

    The Heart Rhythm Society is funded by the medical device industry. Just as the stent makers complained and had the ACC’s I2 summit changed over to CRF control, St Jude will try to get their way here as well. If the HRS allows this, they will be in admission that they are not a real peer review independent society, but rather a marketing arm of the ICD makers.

  2. Thank you for raising this. I am sure that such actions will become more commonplace unfortunately.

    I look after 15 or so patients with Riata leads, implanted by a colleague who has now retired. I am contemplating screening them all to get a handle on the real rates. Does anyone have a view on whether screening is sensible and ethical?

  3. Judith Andersen, AB, MD says:

    Can’t comment on the veracity of any of the claims, but worry that their potential fiscal impact will distort the ensuing dialogue about all of the available AICDs. Who can be regarded as “clean” in this discussion, since virtually all clinical investigators of these devices have conflicts of interest? Would vote on the side of patient safety — the FDA is not a nimble institution in situations like this, and because most investigators have allegiances to many device manufacturers, would advocate a consensus committee of those investigators– perhaps chosen by the AHA– to render an opinion on the relative safety of the available AICD — with full declaration of their research and advisory affiliations.