The temperature is rising again in the ICD lead affair. By issuing a press release, St Jude Medical, Inc. has announced very publicly that it is seeking a retraction of the manuscript accepted for publication in the Heart Rhythm Journal by Dr. Robert Hauser, et al., entitled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.”
Just over a week ago we reported (here) the online release of the paper and the initial response from St Jude’s Chief Medical Officer, Dr Mark Carlson. The company has now sought a full retraction of the article citing what it calls inaccurate facts and biased analysis.
Cardiologist and principal activist in the ICD lead controversy, Dr Robert Hauser has been among the more vocal physicians at the sharp end of what is looking like an increasingly intractable situation. His new paper compares St Jude’s Riata® and Riata ST leads with Medtronic’s Quattro Secure leads, using FDA’s own Manufacturers and User Facility Device Experience (MAUDE) database as source material.
St Jude is arguing that after it’s own analysis of the data there is a significant disagreement about the interpretation, not least that Dr Hauser’s research substantially undercounted total deaths in the Quattro Secure group, which consequently skewed any comparisons with its own leads.
And there’s more
St Jude complains that Dr Hauser singled out only one Quattro Secure lead model, when deaths are reported with others.
The company claims it’s transparency on data reporting contrasts with Medtronic’s reporting of the “least amount of detail”, which in turn builds in bias in favour of the Medtronic product. St Jude believes a comparison of “lead-related” and “indeterminate” deaths would therefore level this playing field as the resulting number would only exclude deaths that were clearly not lead related.
Finally, the company questions the entire premise of the comparison of a recalled silicone-only insulated lead versus Quattro Secure, which is a product insulated with a polyurethane outer insulation. It implies that this shortcoming could have been avoided if the data comparison had been based on like-for-like product comparisons of Riata and Riata ST with Medtronic’s Sprint Fidelis.
What happens next?
St. Jude Medical complains that it 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 says it has spent more than 300 hours attempting to reach the same conclusions as Dr. Hauser, but can find no way of analysing the MAUDE database that reproduces the same numbers reported in the manuscript.
It even goes so far as to say that FDA’s home page states that “MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”
So can we expect a riposte from either Heart Rhythm or Dr Hauser, or both? We think that’s a safe bet.
Source: St Jude Medical Inc, Business Wire