Biologics Redux

Based on the overwhelming response from our readers, TSB felt that it would be beneficial to revisit our discussion about grafting material in light of the fact that on February 16th, 2009 Robin Young will be holding his fifth annual Stem Cell Symposium at the South Street Seaport in New York City, New York.

Whenever TSB hears Robin utter the words "Stem Cells," a flashback to the movie Gladiator enters one's psyche where Commodus, the son of Marcus Aurelius (aka Caesar), speaks to Maximus about the Senate "pouring honey potion in your ear and one day you'll wake up and all you'll say is, Stem Cells, Stem Cells." Because these are the new buzz words in biologics. TSB does not dispute the science, yet, there is much more that needs to be identified and validated before we adore Stem Cells with the biologic crown. Whenever one sings the praises of a NuVasive, Orthofix, Wright Medical, or Osiris, one has to wonder if this is nothing more than another Joel Osteen moment, an evangelical preacher leading his flock to the promised land.

For some reason, many years ago it seems that the industry was sold on the fact that autograft was no longer a viable option. The rationale was it was too expensive to harvest iliac crest bone graft, it increased the patient's morbidity rate, it increased the cost of the procedure, it increased the operative time, it increased the length of stay for the patient, the patient experienced post-op pain for months on end, and most of all, it questioned the surgeons skills at harvesting bone graft. You get the point. It does take patience and good surgical technique to harvest iliac crest bone. These were all legitimate concerns.

Yet, most of us would agree that surgeons would use whatever is being sold by their favorite rep without substantiating the rationale for its use. It probably comes down to convenience much more so than science. To claim that BMP-2 produces equivalent results to iliac crest bone graft is a bit of sophistry considering that our industry has never fully disclosed the many issues and challenges that surgeons had with the initial dosing of InFuse as far back as 2002. TSB would be curious to know how much of an inconvenience, and how much of a cost did the industry incur to take care of those patients? Today, using it in the cervical spine is off-limits based on the most recent MDR's.

Our readers are correct when they report that no other bone graft substitute has been thoroughly studied as BMP-2 has by the surgeons within our industry. Boden himself became the poster child for InFuse. Considering that this is really a pharmaceutical rather than a biologic, BMP-2 has set the bar for exorbitant pricing, and with that pricing will come the same pricing for products that dub themselves "Stem Cells."

But wait a minute, the hospital industry is much more savvy than we ever thought. Today, they have scrutinized the cost of biologics, especially, BMP-2 whereas they are mandating alternative options for surgeons use. They are no longer willing to pay $5,000 a level for BMP let alone $3,000 per level for synthetics in major markets or purchasing groups. Yes, there are those that have the ability to sell product for $3,000 per 10cc's, but the market is slowly but surely shrinking.

So as you sit there and listen next week, ask yourself some questions, is this old technology with a new spin, or is this new technology with an old spin. TSB wants to know what our readers think?