Slinging Mud Over Recalls and Advisories: What About the Patient?

Salesmen in medicine are charged with moving product.  Competition in certain areas such as the Pacemaker and Defibrillator space can be fierce, particularly in a flat or declining market.  Unfortunately, companies often rely on “mud-slinging” and “competitor bashing” rather than on hard data in order to gain market share.  A particularly poignant example is that of the recent battles between Medtronic and St Jude Medical over lead recalls.  Both companies have been dealing with significant recall issues that have negatively impacted thousands of defibrillator patients in the last several years.  In the interest of full disclosure, let me begin by saying that I have no financial stake in either company.  I have been a consultant for both of these organizations over the last 10 years but own no stock.

As I mentioned, both companies have had their share of recalls and advisories.  Some are very significant and can pose a serious danger to patients.  Medtronic has the Fidelis lead and St Jude Medical is dealing with the Riata lead both of which have failed at alarmingly high rates.  Although both companies have a significant lead recall issue, Medtronic’s problems occurred first.  Because of the timing nature of the recall events, more recent press has been devoted to the St Jude Medical lead issues.  In order to gain a competitive advantage, many Medtronic sales representatives in my area have approached doctors with information on the “terrors” of the competitor’s lead rather than focusing on their own product in an attempt to gain market share.  Relying primarily on anecdotal and non documented evidence, the Medtronic push has been to connect known and documented failures in the Riata lead with those of a next generation lead known as Durata.

Recently data was presented at the Heart Rhythm Society scientific sessions in Denver Colorado concerning the failure rate of the controversial Durata leads manufactured by St Jude Medical.  The registry review was scientifically rigorous and was conducted independent of industry sponsorship.  The authors/presenters of the analysis compared their work to clinical trial work as opposed to the current “anecdotal evidence” that has been the basis for numerous articles in the New York Times and Wall Street Journal.  No one argues that the Riata lead from St Jude Medical is a real problem with negative impacts on patients.  However, the assumption that the same issues would occur with newer generation leads appears to be unfounded.  The independent research presented this week indicates that the failure rate of the Durata appears to be less than 1% at 5 years (consistent with some of the best leads in the market today)

Chart below from a Post published by Heart.Org this morning summarizing registry findings on Durata presented at HRS this week 

End point

Failure rate (%)

Freedom from failure at 5 y (%)

All-cause mechanical failure

0.35

99.4

Conductor fracture

0.22

99.6

Insulation abrasion

0.07

99.9

Externalized conductor

0

100

These data were derived from more than 10,000 leads from 3 separate registries.  Althougth we cannot be sure that issues will not arise further into the life of the lead, it does appear that there is a significant misconception about failure rates of the Durata lead in the market today.  The true impact of the Durata lead will not be known for several more years.  Objective study and vigilance is the best course of action moving forward.

To be fair, it is not just an issue with Medtronic and St Jude Medical.  On the last day of the Heart Rhythm Meetings, I received an email sponsored by Boston Scientific displaying a graph that showed the failure rates of Medtronic leads.  It is my assumption that the advertisement email was intended to boost sales of Boston Scientific leads–but instead of touting the performance of their own leads, they focused the reader on the high failure rates of the Medtronic Fidelis lead.  It is important to note, however, that Boston Scientific had a record number of device recalls several years ago–some of which resulted in patient deaths.  For many company executives and PR personnel it must be “out of sight, out of mind”.  I find this type of behavior appalling.

Putting all of this aside, however, the biggest issue with the lead recalls and advisory is the way in which industry handles the fallout.  Some leaders take an offensive approach and rigorously defend the product.  Others push the microscope away from their recalled product and focus on the shortcomings of the competition.  Both approaches, in my opinion, are flawed.  The real issue with lead recalls is the PATIENT.  Both industry and physicians should focus more on the best way to protect patients from adverse events.  Sales and market share must become secondary when it comes to saving lives and reducing morbidity.  (I realize this is not realistic in the business world, but it feels good to say it anyway).  Capitalizing on the failures of competitors and marketing product with a negative sales pitch is dishonorable.  Even though the medical industry is all about making a profit and keeping shareholders happy, I believe that those in the medical space must rise to a higher calling–keeping the safety and well being of the patient at the top of the spreadsheet.  By turning attention to the mission of preserving life and treating those will devastating illness, all of us will ultimately succeed–no matter whose company ID you wear on your jacket.

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