Is it a Pharmaceutical or Device?

With the rash of recent newspaper articles by the Wall Street Journal and the NY Times, it's time Medtronic and Stryker stop at the pharmacy and buy some calamine lotion (zinc oxide and ferric oxide help inflammatory conditions). Why has the media placed the spotlight on the efficacy and cost of bone morphogenic proteins? In order to fully appreciate this publicity, the reader has to understand the history of the product. INFUSE was original discovered, developed and manufactured by Wyeth (a major pharma company) with a licensing agreement executed between both parties in 1995. Medtronic originally received FDA approval for INFUSE to be used in conjunction with the LT-Cage, a titanium lumbar cage rarely used in today's spinal fusions. With the advent of PEEK (Poly-Ether-Ether-Keytone) a biomaterial with better modulus of elasticity, the LT-Cage went the way of the Rogazinski Spinal System. (Bye-Bye!) So why all the publicity? OFF LABEL USE!

The cost attributed to the intra-operative use of INFUSE, retrospective data and clinical results when the product is used "off-label" in the cervical spine has led to a maelstrom in the media. It has been reported that on average the cost of INFUSE is $5,000 per level. This means that in capitated markets the minimum implant charge ( lumbar hardware and BMP) for a one-level fusion is anywhere from $10,000-$12,000. In markets where the hospital does not capitate implant cost, the estimates are as high as $15,000. So, why the big fuss?

As recent as last year, July 2, 2008, the FDA was made aware of 38 adverse events following anterior cervical discectomies. There had been reports of swelling, and patients having to be intubated 2-14 days post-op as a result of breathing difficulties. With the Brigham and Women's study, some light is now being shed on the complications of using INFUSE "off-label" in cervical discectomy procedures. But is this only a concern that we should have if the product is used in the cervical spine? For all the good things that have been reported about INFUSE, it is interesting to note that not much has ever been reported about some of the issues related to using INFUSE in the lumbar spine. How many of us have heard stories of bony in-growth into the canal during its early years? The major challenge with any pharmaceutical product is dosing. Yes, readers INFUSE is a pharmaceutical product regardless of how Medtronic got this product past the FDA. Since dosing is important, how does a surgeon determine intra-operative concentration levels needed to effect fusion without excessive bone growth? Retrospective data? Company dosing recommendations? What happens if the surgeon uses more than is needed? We know how some surgeons minds work, if "x cc's" is good, add a little more and you have a better cocktail. What happens if INFUSE is not contained in its delivery system, i.e. a PEEK Cage or Collagen Sponge?

It is interesting to note that the Medtronic spokesperson (she is learning how to perform a great soft-shoe) stated that the company is close to completing a trial to show how to manage use of the product to minimize complications. I guess it's always better to find out the handling characteristics and side effects after the fact. Just what the patient wants to hear, minimizing complications! Maybe the FDA really needs to take a closer look at this product along with its cousin, OP-1 (originally developed by Creative Biomolecules). For as good as these product may be for certain patients with associated medical problems, its not for everyone. Unfortunately, we all know the joke in our industry, "give a doctor a hammer and everything becomes a nail." If I had my druthers I would opt for some of the synthetics that have been offered by other companies in the market place. They are as efficacious and cost a lot cheaper.

In closing, in all the years that I have had the opportunity to be in the operating room with a Medtronic or Stryker rep, I have never heard them state that the product was not approved for "off label" use. The Spine Blogger wants to know what you think?

PS: Maybe it's time the industry stop its practice of teaching surgeons how to use a new product and start educating them on how not to use a product.