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Medtronic’s Infuse a hit in growth of spine fusion


3 Star

Medtronic’s Infuse a hit in growth of spine fusion

Our Review Summary

This story comes from the newspaper in the town where one of the product manufacturers is headquartered.  Perhaps not surprisingly, it included more of the company’s perspectives than other stories we reviewed.  Examples:

  • The story’s headline in print read: “Medtronic’s Infuse a hit in growth of spine fusion."  You’d never know there were problems if you didn’t read further.
  • The statement, “JAMA’s findings loom large for Medtronic…” doesn’t make it clear whether that was looming large in a good way for this so-called “blockbuster device” or whether it was looming large in a bad way because of the study that the New York Times covered with the headline, “Bone-Growth Proteins Show Risk in New Study.” 
  • The story let Medtronic criticize the new study, but didn’t interview the authors themselves to defend their analysis. 

Meantime, one noteworthy local angle was missed by the Minneapolis paper.  The Wall Street Journal noted – but the Star Tribune didn’t – that:

 “…an article in 2002 by former Army surgeon David W. Polly Jr., now of the University of Minnesota, and colleagues said, "Preliminary results suggest that from a payer perspective, the upfront price of bone morphogenetic protein is likely to be entirely offset by reductions in the use of other medical resources. That is, bone morphogenetic protein appears to be cost neutral."

Dr. Polly, who last year received substantial consulting and speaking fees from Medtronic, didn’t immediately respond to requests for comment."

The story failed to give the reader any information on what benefits – if any – have been shown with the use of the product.  So it left readers empty on the question of why there’s been such a “meteoric rise” in the use of these products. 

The real story – which perhaps the Star Tribune will pursue as a followup – is that this is a costly procedure associated with more complications for which there isn’t much data supporting any additional benefit. Maybe health care reform can look to places like this to find out where to save costs to cover more Americans with health insurance.


Does the story adequately discuss the costs of the intervention?


This story provides cost estimates for the product, as well as for spinal fusion surgery. 

Even though the study in JAMA compared hospital charges associated with BMP use in spinal surgery with non-BMP spinal surgeries, these figures were not provided in this news story. (The median hospital charges for spinal fusion procedures using the bone-growth proteins was $46,112, about 40 percent higher than the $31,179 median charge for procedures that did not include the proteins.) We think that was an important piece of information.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

This story mentions that BMP was associated with increased complication rates for cervical fusion, but not with thoracic or lumbar fusion; however, the story gave no data to show how big (or small) the product’s potential benefit may be.   The study also found that the use of BMP is associated with additional cost, but the story does not address any benefits that may come with this higher pricetag.  The average reader is left wondering why there is such "meteoric rise" in the use of these products.   

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story didn’t explain how big were the potential harms.  According to the results of the study, the use of BMP in anterior cervical fusion is associated with a 51.4% higher complication rate compared to patients who did not receive BMP (7.09% vs. 4.68%, respectively).  However, these data were not presented in the story.

Does the story seem to grasp the quality of the evidence?


The story does an adequate job of describing the study that appears in the Journal of the American Medical Association.  However, it commits a common error in journalism when it says, "A prominent medical journal said…."  It also says, "JAMA’s findings loom large for Medtronic…"  The semantics are important here.  They’re not "JAMA’s findings." The prominent journal didn’t say anything.  "A study published in the journal…" would have been accurate. Journals "say" something when their editors write an editorial or commentary, which is not the case here.

Does the story commit disease-mongering?

Not Satisfactory

This story fails to provide any information regarding the evidence or indications for spinal fusion surgery and BMP. Specifically it states, "The popularity of spine fusion surgery comes as no surprise — back pain is a leading cause of disability…" Well it does come as a surprise when you consider that there is remarkably little data that it helps patients. The story doesn’t provide any information to place this procedure in context. A reader may think this is the only treatment for back pain. In fact, it is only for certain types of back pain, and in its most common use, for chronic degenerative low back pain, it appears to be no better than intensive rehabilitation. The story never mentions its role for those with chronic pain. 

Does the story use independent sources and identify conflicts of interest?


The story includes an interview with a Medtronic spokesperson, as well as a physician from the Center for Restorative Spine Surgery. 

The Medtronic spokesperson states that BMP use is associated with reduced complications and costs in the long-term; however, in the study the authors present the argument that delayed complications from BMP can occur in the outpatient setting and may lead to readmission.  These contradicting views were not addressed in the story. 

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story briefly mentions autogenous bone grafting; however the focus is largely on the pain associated with harvesting the bone.  Additionally, there is no mention of allograft bone grafting or non-surgical options.    Given all of the problems with spinal fusion and with this product, we think the story could have at least nodded in the direction of nonsurgical alternatives – even in one line. 

Does the story establish the availability of the treatment/test/product/procedure?


This story clearly states that bone morphogenetic proteins (BMP) have been approved by the FDA.  

Does the story establish the true novelty of the approach?


The story clearly cites usage data from the study and indicates that the FDA approved its use for lumbar spinal fusion in 2002.  Information on the prevalence of off-label use of the product would have been useful. 

Does the story appear to rely solely or largely on a news release?


Because multiple sources were used, it doesn’t appear that the story relied on a news release.

Total Score: 6 of 10 Satisfactory


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