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Exhibition Floor at NASS / Source: RRY Publications, LLC

Medtronic Shrugged

Robin Young • Fri, November 1st, 2013

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Is the North American Spine Society (NASS) turning into a dystopian community where surgeons and companies are no longer welcome to engage in open and fair scientific discussion and debate?

To Medtronic, Inc. (and, indeed, a growing group of senior surgeons and company executives), the answer appears to be “yes.”

For the first time in the history of either NASS or Medtronic, there was no Medtronic Spine booth at the NASS Annual Meeting. No Booth. No product. No sales people.

The only Medtronic presence in NASS’s exhibit hall was a square open space filled, not with implants, or instruments or biologics, but chairs, tables and sofas.

The only Medtronic personnel in the space were the firm’s medical affairs group and they were there to talk. Not sell. Talk.

Doug King, president of Medtronic Spine explained the company’s decision this way; “We believe that the recent editorials and publications, including those supported by the North American Spine Society as well as the potentially unbalanced panel presentations at this year’s NASS Annual Meeting could add to surgeon confusion on this topic (rhBMP2). Therefore, Medtronic is repurposing our exhibit space at this year’s NASS Annual Meeting. Our entire space will be devoted to our Office of Medical Affairs (OMA) personnel, who are trained and authorized to answer questions related to the scientific and clinical evidence supporting our Spinal products.”

The financial impact of Medtronic’s decision on NASS and, indeed, New Orleans, was significant. Millions of dollars in hotel rooms, airfares, restaurants, temporary worker and NASS fees were slashed.

What happened?

NASS’s open support for Dr. Eugene Carragee’s campaign against surgeons, BMP-2 and Medtronic, specifically, was a factor, no doubt. But the tipping point was likely NASS’s decision to stack the educational programs with anti-Medtronic members.

Not an Overnight Decision

Two and half years ago the editor-in-chief of The Spine Journal, Dr. Eugene Carragee, decided to devote an entire issue of the Journal to a retrospective critique of 13 early studies of BMP-2 (InFuse). Dr. Carragee was lead author of the study. He asked Dr. Chris Bono to sit in for him as the editor of The Spine Journal for that single issue and Dr. Bono bears partial responsibility for what ultimately emerged.

Dr. Carragee’s critique omitted key data from two studies (Dimar and Boden) which would have argued against his conclusions. He also employed data from The Wall Street Journal in a manner which misled readers and damaged the reputations of a long list of prominent spine surgeons.

Carragee’s 2011 retrospective critique was, in fact, deeply flawed and methodologically suspect.

In order to both set the record straight and to elevate the discussion to a more scientifically and methodologically sound level, Medtronic sponsored a $2million comprehensive retrospective review of all BMP-2 studies at Yale University, later also the University of Washington.

While the Yale study was progressing, the problems with the original 2011 The Spine Journal study were being widely discussed and disclosed in this publication and from the podiums at various spine surgeon meetings—most notably at the Cedars Sinai meeting where Dr. Paul Anderson presented the damning critique directly to Carragee who was also on the podium.

Many times NASS was asked to investigate the problems with Carragee’s 2011 study. Many times NASS was asked to stop actively promoting via its press office the Carragee campaign against Medtronic and BMP-2.

But nothing seemed to register. No committees were formed to check allegations of methodological error. No adult stepped in tone down NASS’s support for Carragee’s partisan campaign against Medtronic or BMP-2.

No one made sure that NASS stayed, at least, neutral.

Here, for example, are comments the NASS PR department issued on Carragee’s behalf earlier in 2013:

  • “The YODA (Yale University Open Data Access Project) report published today in the Annals of Internal Medicine is the latest shock in a series of re-examinations of Medtronic’s ill-fated biologics product.”
  • “Ten years after BMP-2’s introduction, we cannot identify a single well-proven area of benefit, but we know it can kill you in the cervical spine and probably can promote cancer, which can then kill you.”
  • “The hyperbolic fever of BMP-2 promotion before its current fall from grace turned spinal conferences into Elmer Gantry-styled revival meetings.”
  • “Many of us feel like 10-year-olds after the Black Sox series: “Say it ain’t so, Joe.”
  • “BMP-2’s fifteen minutes of fame had ticked by. The cost: maybe 15 billion dollars, maybe cancer, maybe worse.”
  • “In the end, less than one percent of the 250 participants voted for the old dream…people seemed kind of bored. Older guys thought of the Black Sox, groaned as they got up. Young guys glanced at the time (how confident the reps had seemed). But their attentions had moved away from the carnival hoopla of yesteryear. In the end, people yawned and some chuckled to themselves and…finally…left the room.”

What is NASS’s Role?

Medtronic and the other corporations who exhibit and support NASS through their advertising and sponsorships would like the society to foster open and fair scientific discussion. They would also like NASS to stop taking sides against them.

Yes, companies are commercial entities. Yes, companies are partisan for themselves. But…it is also in their self-interest to support authentic, vigorous and scientifically valid discourse. Despite the negative stereotypes promulgated by Dr. Carragee and The Spine Journal, companies and their executives are honest, have integrity and try to earn the trust of their surgeon customers with good science and a commitment to better patient outcomes.

Are there company executives who behave badly? Absolutely. Are there journal editors who behave badly? Yes. The fact that one such editor heads up NASS’s own journal is creating an increasingly polarized North American Spine Society.

NASS’s role is at its annual meeting is to foster open, fair and scientifically solid programs where alternative points of view are respected and heard.

Didn’t happen in 2013. So Medtronic sent a powerful message.

Who knows, maybe this is a trend. Maybe corporate support is no longer a ‘given’ at NASS.

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One Response to “Medtronic Shrugged”

  1. Patrice Montminy says:

    I think Medtronic is right. Dogmatic attitude is not reasonable in spine surgery.

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