• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » EXCLUSIVE: Carragee responds to call for his ouster at Spine Journal

EXCLUSIVE: Carragee responds to call for his ouster at Spine Journal

July 1, 2013 By Brad Perriello

Medtronic's Infuse: Orthopedics This Week calls for Carragee's ouster as Spine Journal editor

The fallout from Medtronic‘s (NYSE:MDT) controversial Infuse bone putty spread to a pair of orthopedics publications when the publisher of Orthopedics This Week called for the resignation of Dr. Eugene Carragee as editor of The Spine Journal.

Last month a long-awaited Yale review found that Medtronic’s Infuse product, which uses recombinant human bone morphogenetic protein-2 or BMP-2, was equivalent to the gold standard of iliac crest bone grafts in some spinal fusion procedures. A flurry of editorials ensued, including from OTW and Carragee.

OTW and its founder and publisher, Robin Young, later called for the North American Spine Society to review Carragee’s role in the Infuse controversy.

"I’m not concerned about Carragee’s role as a critic, as someone who has reviewed old studies and found them to be wanting. In that role he’s done just fine," Young told MassDevice.com. "But he is editor-in-chief of The Spine Journal and he’s taken on the role of advocate and of being a partisan. … The core issue is bias. Bias in the original [Spine Journal] study and bias in the way the information was presented.

Young cited "a number of really troubling flaws including exclusion of data" in Carragee’s June 2011 review of a slew of original study publications on Infuse.

"For example, Carragee makes the point that in the 13 original studies, none mention adverse events, and he makes the point in this study, he said the word ‘zero.’ Zero means zero – nothing," he told us. "But then I went back and I found that 1 of the studies had a table that listed adverse events. I brought that up to Carragee.

"He didn’t do a thing, he ignored it," Young said.

In an exclusive interview with MassDevice.com, Carragee denied Young’s accusations and termed the call for his ouster "amazing."

"That’s a fabrication," Carragee said of Young’s version of events subsequent to The Spine Journal‘s June 2011 expose on Infuse. "That has not been disputed anywhere except by [Young]."

Asked if he’s used Infuse in his own spine surgery practice, Carragee said, "Sure."

"I’ve published results of using [Infuse] in 100s of patients," he told us. "Simply on the facts, [Young’s] incorrect that I have a reckless bias against the product or its availability, as I’m the only one who’s said it should be on the market. … My problem is not with the product. It’s with the representation of its efficacy and risks."

As for charges of bias, Carragee said it’s the job of the editors of peer-reviewed publications to be prejudiced in favor of patient safety.

"We’re obliged to have a partisan advocacy for patient safety. An editor who’s not doing that is not taking the job seriously," he said.

Carragee also said that Young has a conflict of interest of his own to contend with, namely Medtronic’s past sponsorship of OTW and Young’s side business as an orthopedics consultant. Young has avoided writing a letter to the editor at The Spine Journal detailing his concerns, as Carragee claims to have suggested, because he wants to avoid disclosing his financial ties to the orthopedics industry, Carragee contended.

Medtronic paid $2.5 million to Yale and provided all of the data in its possession on Infuse for the Yale studies, carried out by teams at England’s York University and the Oregon Health & Science University, after the controversial June 2011 issue of the Spine Journal claimed that the risk of adverse events with Infuse could be as high as 50%.

Carragee, writing in response to the Yale project results, highlighted the bias found in early publications on Infuse.

"In some cases, an extraordinary merry-go-round of comprehensively conflicted faces are found at each check and balance: In one instance, it seems the principal investigator with strong financial ties to Medtronic helped design a trial, and then the same person acted as the surgeon and, for consistency, monitored complications, then went on to author the paper, whose drafts were written in whole or in part with the company, and then submitted the manuscript for review to…well…himself as editor in chief or section editor of the journal!" Carragee wrote. "In some cases the editor in chief of the journal reviewing his own paper was also, in fact, both the developer and the royalty holder on one or more products being investigated. It would be hard to envision a situation less likely to produce an unbiased journal publication. And now the [Yale Open Data Access Project] group – echoing The Spine Journal’s critical review from 2 years ago – tells us that important concerns about BMP-2 complications were ‘underreported’ or just missing. As YODA project director Harlan Krumholz, MD, SM, delicately puts it, ‘Evidence suggests that some data are not missing at random.’ Annals editors are more blunt: ‘Early journal publications misrepresented the effectiveness and harms through selective reporting, duplicate publication, and underreporting.’ Ouch."

Filed Under: News Well Tagged With: Orthopedics This Week, Resorbable bone materials, Spine Journal, Yale Open Data Access project

In case you missed it

  • 16 surgical robotics companies you need to know
  • Report: Elon Musk looks to invest in brain-computer interface competitor Synchron
  • AI-powered imaging startup AIRS Medical raises $20M Series B
  • Analysts ask: Can Medtronic leaders execute?
  • Medtronic announces cash dividend for Q2 2023
  • EchoNous partners with Samsung on AI-guided ultrasound
  • RefleXion expands footprint through multi-system contract with Select Healthcare
  • Report: 3M faces losses of $100B in earplug lawsuits
  • Caregility, Eko partner to bring smart stethoscope to telehealth platform
  • Henry Schein makes $400M increase to share repurchase plan
  • Tandem Diabetes Care delivers 1 million insulin boluses using t:connect mobile app
  • CathVision closes $7.2M financing round for electrophysiology recording tech
  • Verily’s Onduo, Sword Health collaborate on virtual care
  • FDA clears expanded labeling for Preceptis Medical’s ear tube system
  • KeyCare raises $24M for virtual care platform
  • FDA says 44 more deaths have been reported in Philips ventilator recall
  • Paragonix reaches milestone of 2,000 organs preserved, transported for transplantation

RSS From Medical Design & Outsourcing

  • MIT engineers fabricate chip-free, wireless e-skin
    MIT engineers have developed a new wireless, wearable sensor without semiconductors or batteries in what they say is a first step toward chip-free wireless sensors. This electronic skin — or e-skin — is a flexible, semiconducting film that MIT describes as a sort of electronic Scotch tape. The device has an ultrathin gallium nitride film… […]
  • Owens & Minor and Allina Health partner on supply chain resiliency
    Owens & Minor (NYSE: OMI) and Minneapolis-based Allina Health are partnering on what they call a “unique integrated service model for supply chain resiliency.” An Owens & Minor distribution center that has been in operation for more than 25 years in Moundsview, Minnesota will serve as the integrated service center powering the model, the companies… […]
  • Chronic pain researchers say sound and electrical stimulation has treatment potential
    University of Minnesota researchers are using sound and electrical stimulation to treat chronic pain and other sensory disorders without pharmaceutical drugs. The combination of sound and stimulation activates the brain’s somatosensory cortex, according to a study on guinea pigs published in the Journal of Neural Engineering. Also known as the tactile cortex, the somatosensory cortex is… […]
  • What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic
    Dr. Laura Mauri faced a monumental moment with former Medtronic CEO Omar Ishrak shortly after she joined the company as VP of global clinical research and analytics. It was late 2018, and Mauri — who’s now an SVP and the chief scientific, medical and regulatory officer at Medtronic (NYSE: MDT) — was in a meeting… […]
  • Senators seek post-market FDA study of pulse oximeters and skin color
    Democratic U.S. senators are prodding the FDA to launch a post-market study of pulse oximeters due to unreliable performance for patients with dark skin. Pulse oximeters estimate blood oxygen levels (SpO2) and pulse rates in patients using infrared light — usually on a fingertip — at home or in clinical settings. Blood oxygenation is one… […]
  • TE Connectivity opens global medical device prototyping center in Ireland
    TE Connectivity (NYSE:TEL) today announced it opened its global Propelus Prototype Center for medical devices in Galway, Ireland. The $5 million rapid prototyping center was built into its existing manufacturing site in Galway and directly connects TE engineers with customers to reduce development time and increase speed to market for lifesaving and life-improving medical devices. Propelus… […]
  • Contract manufacturer Minnetronix Medical launches its first in-house product, MindsEye
    Minnetronix Medical has launched MindsEye, making it the first medical device that the contract developer and manufacturer has conceived and commercialized. St. Paul-based Minnetronix Medical’s MindsEye is the first expandable brain access port on the market. The FDA cleared the device under the 510(k) pathway in August 2020. The minimally invasive device gives neurosurgeons deep… […]
  • What’s next for Jennifer Fried after leaving Explorer Surgical?
    Explorer Surgical co-founder Jennifer Fried has resigned from the company after selling it to Global Healthcare Exchange in October. Fried announced her departure last week on LinkedIn, saying she’s preparing for her next professional chapter. “It’s bittersweet — I’m so proud of everything our team has built and accomplished,” Fried wrote. “The time has flown… […]
  • The 24 best medical device innovations of 2022
    The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.… […]
  • FDA issues new COVID-19 testing guidance to avoid false negatives
    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
  • Confluent Medical expands Costa Rica manufacturing footprint for nitinol, complex catheter production
    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

DeviceTalks Weekly

August 19, 2022
DTW - What’s the state of the Medtech job market? We go to the pros to hear things you need to know
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy