Surgeon calls out Zoll Medical for withholding failed primary endpoint on booth at EHRA 2018
On March 10th, Zoll Medical announced the results from the “Vest Prevention of Early Sudden Death Trial (VEST)" as a Late-Breaking Clinical Trial at the American College of Cardiology’s 67th Annual Scientific Session in Orlando, Florida.
At first glance, the results seem extremely favorable as the study demonstrated that use of the LifeVest® wearable cardioverter defibrillator (WCD) reduced total mortality by 36 percent in the first 90 days following a heart attack for patients with a reduced heart function.
However, in their first randomized trial, the Zoll LifeVest failed to meet the primary endpoint as it did not reduce sudden cardiac death or death due to ventricular arrhythmias, although total mortality was lower.
“The VEST Trial demonstrated that the WCD was associated with a reduced total mortality in the 90 days following a heart attack,” said Jeffrey E. Olgin, MD, FACC, Co-Principal Investigator, Professor and Chief of Cardiology at the University of California San Francisco Heart and Vascular Center. Dr. Olgin added, “While the VEST Trial did not meet the endpoint of sudden death mortality, the ability to determine the cause of death as sudden when unwitnessed is difficult and could result in misclassification. These meaningful total mortality results add large randomized controlled trial data to an already large body of clinical evidence in support of the 2017 AHA/ACC/HRS Guideline recommendations for WCD use in patients at risk of sudden cardiac death (SCD).”
Fast forward to the European Society of Cardiology meeting (EHRA) going on in Barcelona where Zoll Medical is a sponsor and has a booth.
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Electrophysiologist, Suneet Mittal, from Ridgewood, NJ, stopped by the Zoll Medical booth at the meeting and noticed their booth didn't show data of the failed primary endpoint.
The positive data was highlighted, but why not data from the primary endpoint?
So what did Dr. Mittal do? Like anyone in 2018, he took a picture and posted it to Twitter, taking Zoll Medical to task for failing to print the full results in their marketing material.
The Zoll LifeVest booth at #EHRA2018. No mention that trial missed its primary endpoint (not even in the fine print). I guess you can market anything you want, how you want! @escardio @drjohnm pic.twitter.com/eJta82iCfx— Suneet Mittal (@drsuneet) March 20, 2018
The tweet set off a thread of responses from other physicians taking Zoll Medical to task, asking society leadership to stand up to the company, even if they are a sponsor of the meeting.
Hey @HRSonline and @escardio @ACCinTouch @AHAScience — We need some leadership here. How about opposing Zoll’s brazen attempts to hide a trial’s primary endpoint?— John Mandrola, MD (@drjohnm) March 20, 2018
Prove the #COI believers wrong. Stand up to a sponsor.
In the past, companies could get away with not sharing the full results of studies and tailor the messages in their marketing material to fit their sales narrative. Not anymore.
Social media has changed this. Surgeons now have the ability to share their opinions on a world wide scale with the click of a button. They're connected to colleagues all over the world and aren't afraid to share their thoughts.
And the consequences could be significant, especially for sales reps calling on physicians who hear the actual results from their colleagues and not the company. It makes Zoll Medical look like they're hiding something. In actuality, they are.
Good for the surgeons.
Too often, medical device product managers and PR firms don't consider how messaging can impact the sales organization. The disconnect between marketing and sales has always been a point of contention in medical device organizations and this is a perfect example of what can go wrong when both teams are not on the same page.
For marketing, they don't have to meet with customers on a daily basis and do not take this into account when crafting their messaging. Sales reps are out in the field meeting with customers everyday. The last thing a sales rep wants is to get blindsided by a customer accusing their company of being unethical.
Simple solution --- dont use / prescribe their technology! Dont talk to the sales team!— andrew murphy, md (@PAallergy) March 20, 2018
Medical device sales reps already have a hard enough job.
Just like each sales rep is supposed to be a reflection of the company they work for, Zoll Medical needs to understand that they have a commitment to be everything they expect out of their reps.
Let this be a lesson for Zoll Medical. Here's to hoping they rework their marketing material with messaging that doesn't just address their revenue goals but also provides an honest representation of what their products can do and what their company stands for.
As a medical device sales rep, I would expect more from my company. Marketing and sales need to get on the same page and apologize. In all honesty, they need to thank Dr. Mittall for pointing out this "oversight."
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