Emerging controversy in spine surgery research

Imaging this scenario:  You’ve been suffering from chronic back pain for many months and you’ve tried multiple therapies, injections, medications, etc to no avail.  The next step is to go and consult with the neurosurgeon who recommends a fusion of the vertebral segments that they determine are the source of your pain.  They outline all the risks, chances of improvements, and potential time of rehabilitation.   After much deliberation, you decide to have the fusion surgery.  Back in the day when you had a spinal fusion, the bone used to fuse the vertebrae together was actually harvested from the patients own iliac crest (hip bones). 

Now, this is where the fun begins. Medtronics, the words largest manufacturer of medial devices, developed a bone morphogenetic protein, BMP-2, that has since become the standard of care.  Back in August of 2010,  John Fauber, of the  Milwaukee Journal reported that  “in 2002 the FDA approved a product that many thought would revolutionize spinal surgery — recombinant human bone morphogenetic protein-2, or BMP-2, which could almost magically create bone where none existed”.  This eliminated the need for harvesting bone from the patients own iliac crest, thereby reducing complications and expediting recovery.  Great, winners all the way around….not quite so fast…

When Medtronics produced RCT (random controlled trials) demonstrating the superiority of their product over the old way of harvesting bone, there were many problems that were over looked at the time:

  • 9 of the physicians that were involved in the research studies had financial stakes in the company, creating an obvious conflict of interest.
  • The company sponsored research exaggerated the negative effects of the previously used methods of harvesting bone from the patients iliac crest while at the same time downplayed and under reported the complications from their product, BMP-2.

Many surgeons, not aware of the flawed research procedures, began using MMP-2 on a regular basis, to the tune of 500,000 fusion procedures alone in the US.  The result is that many tens of thousands of patients may have suffered adverse effects from surgeons unknowingly using BMP-2. According the the Back Letter, Vol 26, No.8, August 2011,  “Complications can include back and leg pain, disc space collapse, infections, and retrograde ejaculations and associated infertility-as well as implant displacement, catastrophic airway problems, cancer, and perhaps even death”.

So where does the field of spine research go from here to prevent something like this from happening again?  The US Senate has launched an investigation in to how research is conducted and are patients given the full picture before they consent to a procedure. 

The bottom line is that a system needs to be adopted to produce unbiased, scientific research that can safely help the millions of people with chronic back pain.  

Ed Deboo, Physical Therapist,  Bellingham, Washington

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