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Read Original Story

Bone-Growth Proteins Show Risk in New Study

Rating

4 Star

Bone-Growth Proteins Show Risk in New Study

Our Review Summary

This story provides a clear alert to the potential hazards of using bioengineered proteins to promote bone growth in spinal fusion procedures to treat pain in the upper spine.

However, the story is thin on context about approaches to treating neck pain. It does not mention alternatives to surgery nor the indications for, or typical outcomes of, spinal fusion. Although the journal article about the study included background on neck and back pain, treatment approaches, and hospital charges for spinal fusion; little of this information was included in the story.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

While this story reported that one manufacturer of bone-growth proteins had an estimated $760 million dollars worth of sales of the products in 2008, it did not include the higher hospital charges highlighted in the study published in the Journal of the American Medical Association. According to the study authors, 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.

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

Not Satisfactory

The story briefly mentions that the bioengineered proteins can promote bone growth; however it does not go into any detail about why the proteins are used in certain spinal fusion procedures nor does it provide any information about treatment outcomes. The average reader is left pondering why there was a dramatic increase in the use of the product. 

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

Satisfactory

The harms associated with the use of bone-growth proteins in fusions to treat upper spine pain are the headline of the story – and the study it is based on. The story specifically notes that patients have reported life-threatening complications, including difficulty breathing and swelling of the neck.

The story would have been better if it had included some explanation of the number needed to treat in order to see an additional case of harm.

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

Satisfactory

The story notes that the study used a database with information from 20 percent of the nation’s hospitals to compare in-hospital complication rates for spinal fusion procedures with or without bone-growth proteins. It also noted that this study was prompted by earlier case reports of complications, and it compared the results of this analysis to some of those earlier clinical reports.

The story also noted that a manufacturer of bone-growth proteins is doing a clinical trial on their use in fusion procedures in the upper spine in order to learn more about how to manage complications.

The story does state that the study appeared in the current Journal of the American Medical Association.

Does the story commit disease-mongering?

Satisfactory

This story does not directly address the prevalence of back pain nor the indications for treatment; but by highlighting complications seen in surgical treatments of upper spine pain, this story’s overall tone is cautionary. On the other hand, the story did not mention non-surgical approaches to dealing with back pain.

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

Satisfactory

The story includes comments from two independent experts, as well as a study author and a spokeswoman for a manufacturer.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The treatment of back and neck pain is hotly debated, but this story does not mention any of the non-surgical approaches nor does it provide any context about the outcomes of spinal fusion procedures.

 

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

Satisfactory

The story notes that bone-growth protein infusion received FDA approval in 2002 for use in spinal fusions to treat lower back pain. It reports that by 2006 the proteins were used in about one-quarter of all spinal fusion procedures in the hospitals included in the study, including procedures in other regions of the spine 

The story also states that the use of these proteins in upper spine fusion procedures has dropped following reports of complications.

Does the story establish the true novelty of the approach?

Satisfactory

The story notes that bone-growth proteins have been used in spinal fusion procedures in the U.S. since 2002.

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

Satisfactory

The story includes quotes three experts that appear to be from interviews.

Total Score: 7 of 10 Satisfactory

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