Sunday, March 21, 2010

Sunday Op Ed Piece - The Big Lebowski

This is the story of "the Dude" and Walter (most of our readers know who they are) collaborating to sell an artificial disc in 2003 only this time to pull the old switcheroo on DePuy. Rather than "the Dude" and Walter having to figure out that there wasn't a million dollars in the briefcase, it was DePuy that was left holding the bag. While "the Dude" and Walter rode off to the bowling alley, DePuy was scurrying to beat every other competitor to the marketplace with Charite. Yes fellow readers, based on the latest news reports, it seems that the Charite has been put to rest, and that a new and improved version has replaced it. The new device as many of you know is called the In Motion, preferably it should have been called Slo- Motion. You have to love our industry, it does come up with some banal names.

Based on many retrospective studies that have been published, it seems that artificial discs seem to show fair to good results. Yet, like any spine surgery, there are always reports of complications associated with subsidence, wear, adjacent disc degeneration, migration and facet joint degeneration. Posterior fusion has been the gold standard for many years and with the advent of the artificial disc spine surgeons and Wall Street started seeking the new new thing. Much of the hype back then was that "in theory" the procedure was to have advantages over fusion, minimizing the potential for ADD since fusion eliminates motion and causes overloading on the adjacent discs. Yet, some estimated that ADD would occur 10 years down the road. Some investigators even found no evidence that long-term disc results were any better than fusion.

Back then the race was on. Bring on the marketing studies and financial forecasts! Should we be the first? Would it be better to be second? Many strategies abounded. TSB remembers hearing some oracles of the industry claim that 65-75% of fusion patients will be candidates for an artificial disc. Back in 2003 or 2004 one of the major investment banks even put out an analysis on the potential payback. In retrospect, $5,000 per level was an entertaining forecast. But who are we to laugh at Wall Street? They always get it right, don't they? Artificial Disc replacement was going to create a major paradigm shift. Once DePuy acquired Charite, " V-III" sold ProDisc to Synthes, Stryker in its haste acquired Tom Errico's SpineCore device, while Medtronic feverishly labored on Marverick. The industry didn't even have a two year retrospective follow-up in the US market and companies were touting their devices as first gen, second gen, third gen without any rhyme or reason. At that time, the industry hadn't answered the question whether a device should be constrained, semi-constrained or unconstrained. Should it be metal on poly? Poly on Poly? Metal-on Metal? PEEK?

If the Charite is to be remembered as having attained legendary status because it opened the door to motion preservation, it was quite an expensive door opening. If the device was approved by the FDA in 2004, and to date there have been 5,000 implantations, (assuming this is US data) on average DePuy and its surgeons are averaging an estimated 833 procedures per year. Would our readers consider this to be a windfall? Considering that statistically people over 60 have more back problems than younger people, what were we expecting when CMS issued non-coverage decisions for all lumbar disc devices for patients over 60?

So this week "the Dude" and Walter stood over the cliffs of LaJolla and eulogized the old boy, opening the coffee can with the remnants of Charite and throwing it into the wind. May it RIP. TSB wants to know what our readers think?


15 comments:

  1. The V brothers at the time predicted the discs would put Infuse out of business. Right.......

    The Charité, as one may remember, was developed in communist East-Berlin before the wall came down, and should be applauded for breaking new ground. Also applauded should be the 'titanium-polymer sandwich' disc that Steffee implanted as early as the late 80's. Steffee's concept was more difficult to make, but more physiological in its mechanical behavior than Bütner-Janz's design.

    With the exception of the AxioMed disc, which is a refinement of the Steffee concept and has little clinical data as yet, all the lumbar discs touted as 2nd, 3rd, and 4th generation are not any generation, but attempts to one-up the competition in the patent office. All one can say is that they are slightly more sophisticated than the door-hinge tested and patented by John Kostuik, but imho still too crude to subject humans too.

    Today, about 5 years after the first wave of implantations, during which some surgeons one-upped one another by showing how many levels they dared to do in one setting (yes, especially in Germany!) it becomes less and less rare to find patients shopping around to have their failed discs removed. However, few surgeons are willing to perform this risky surgery, including the surgeons who put them in in the first place.....

    The Charité was no windfall for DePuy. No disc should be a windfall for any company until good long term studies are complete. New hip technologies need at least two year data to get on the market, and then surgeons still ask for the 10 year survival data before committing, which admittedly creates a vicious circle. Spine surgeons appear to be comfortable with just 10MM cycles on the Instron, and the reassurance of the company engineers the disc works. Yet it are the patients who pay the price, in more ways than one.

    This reader wants better (pre-) clinical science and less irresponsible decisions driven by competitive arguments and greed.

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  2. Doesn't this story represent in a small way the Slo-Motion demise of this Industry on one side, and the continuing Company responses to re-define themselves as Holier than Thou....? Now in stores, the Right Answer to motion preservation- In Motion. PLEASE!! TSB keep up your efforts to bring the Best-in-Show of Orthopedics, Neuro and Spine to the forefront.

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  3. as for charite the instruments always were terrible and the concept of dragging teeth through the endplates has always beem barbaric.

    as for other discs theres no reimbursement for it. period.

    it is no more difficult to implant than stand alone interbody no profile fusion devices and that is >$100 mm market growing 40% annually.

    its the reimbursement. reimbursement takes years and no one is trying to change things.

    lastly find me pma quality fusion data besudes the controls of disc studies. 99% of what is implanted nowadays in the fusion market has no data so people talking about years of data needed are absolutely clueless.

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  4. Home: clueless or not, without real data the day of reckoning is coming nearer.

    Fact: Rate of fusion surgery in the US is 2.5 times higher than anywhere else in the developed world. Are our backs worse? No. The simple explanation is a a combination of too much supply (ever counted the number of spine surgeons in the LA area alone?) and the fusion procedures being so much more lucrative than any alternative.

    Fact: Spinal fusion patients are found disproportionally among the lower socio-economic classes. Why? Because they do more 'back breaking' work? Maybe, but equally important seems to be that they are covered by worker's comp at nice rates and that they are less likely to understand what is being proposed and ask for second opinions. (how many of the spine professionals reading this blog have had a (lumbar) fusion procedure, or a disc for that matter?)

    Fact: outside direct re-exploration there still is no sufficiently reliable method to assess fusion, except in the most extreme cases at both end of the spectrum. CTs, the least unreliable method, still overestimate success rates. This in part explains all these 99.7% fusion rates presented.

    Fact: the clinical outcomes of patients undergoing fusion surgery still has remarkable little to do with whether the construct is considered fused or not. A simple explanation is that a lot of fusion surgeries are done in patients who do not have a clear anatomical abnormality for which it has been proven that a fusion surgery is the right treatment.

    Imagine that the above facts were true for hip and knee replacements...

    With the government and the insurance companies having access to reams of data as well as getting smarter, the world inevitably is going to change. I would interpret the non-reimbursement of discs as a piece of evidence of where these changes may lead.

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  5. As for discs its very important 2 things.

    1) Charite is a truly 1st generation device. in fact with its instrumentation it was behind the curve of orthopedics in general. What saved it in peoples minds was that the implant was fully unconstrained. Since it allowed the most motion some people thought it was the most evolved instead of the least.

    2) Charite lived off of the fact it would be first to market. To me it is very sad that the 1st device in a product category can hurt the rest to such a degree. Regulatory has separation of device in their minds but also are highly influenced by previous devices within the same category. Reimbursement actually thinks of a devices in the same category as the exact same. And doctors seem to be inbetween. This thought process kills innovation.

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  6. Interesting posts, and the merits of individual discs, their attributes, and the science behind them can certainly be debated. But let's all recognize one thing.

    Lack of reimbursement has so far crippled the lumbar artificial disc market. And it did it in the "try it out" stage. We all know that most surgeons rely on one primary factor above all in their treatment decision making, and that is their personal experience. And when the Charite was released with its FDA approval, there was clearly sufficient scientific and regulatory justification for the surgeons to "try it out" in several appropriate patients. In fact, surgeons attended the training courses in droves, and lined up their initial patients. But the operations too frequently never followed, with reimbursement requests denied at the outset. Presuming the surgeons' personal results would have mimicked those in studies, unquestionably the technology would have been further embraced and found a place. But with obtaining reimbursement being nearly impossible at the outset, and not relenting much subsequently, the surgeons subsequently gave up or joined those who in the absence of personal experience question the merits of the technology.

    Whether and to what extent low back pain patients should receive surgery can be debated, but clearly a significant amount of fusion surgery is still currently going on for that indication. Having shown comparable results in those patients, and being a marketable, and motion preserving new technology, there's no question that the number of lumbar discs being implanted would be multiples higher if the reimbursement blockade, especially at the outset, hadn't been so significant and steadfast.

    Good reimbursement isn't an accepted reason to do a procedure, but no reimbursement is an acceptable reason not to.

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  7. More “fodder” for the conversation there is another implant device that has only limited reimbursement - dental implants.

    A complete "roundhouse" of the upper or lower dentition can run more than $20k for the implants alone, the actual teeth or prosthetic device(s) add as much or more.

    Last I checked with those folks they have fully adapted this into treatment options for patients.

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  8. Good "fodder", but isn't the distinction there that folks don't consider dental implants a covered benefit of their insurance? (Falls along the same lines as orthontics, etc.) And there isn't a substitute procedure that has comparable outcomes, as there is in this example.

    If you were a patient that believed, along with their doctor, that surgery for their low back pain was indicated, and the choice was a fully reimbursed fusion procedure, or an artificial disc plus $30-50k out of pocket, presuming you could even afford the latter, would you choose it?

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  9. Will be of interest to see if the more natural bio-mechanically replicating design of the Spinal Kinetics M6-Lumbar disc has superior outcomes over ball/socket or sliding core devices over time. Good long term results are not predicated on MOTION alone, but the way that motion matches the native bio-mechanics in any type of arthroplasty procedure.

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  10. Was that a Spinal Kinetics sales guy that just walked past?

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  11. Sounds like it. The M6 is cervical, where the demands are a lot simpler. The design is elegant, but looks like a bear to mass produce. The number and size of the keels is worrysome, though. In my mind the AxioMed lumbar disc comes closest to mechanically doing what the natural disc does. Bases on experience with its predecessor, the Steffee lumbar disc, one has to wonder how long it will survive in patients. So far AxioMed is to tight lipped to have any idea. (which goes to show that I am not an AxioMed sales person....)

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  12. Notice how nobody selling discs ever talks about resistance to extension? Devices without it have failed, the variations in tailfins and spikes haven't really been improved upon yet---time will tell, but right now the flaws in design are the primary instability in extension---all the new terms disguise this one important need.

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  13. Reimbursement is often blamed, but whose fault is it really?

    As far back as the late 1990's, the smarter VC's were pushing their start-ups to include reimbursement in their initial strategy.

    The fact is that J&J ran a study that proved that the Charite was the same as a fusion - and this is important - at 2 years. Any other supposed benefits from longer-term comparisons were not observed or included in the PMA.

    Then, J&J tried to charge $10,000 for a level, which is more than most insurance companies were willing to spend on 1-level fusion hardware.

    Why?

    Who in their right mind would agree to pay that much for something based on the theoretical long-term benefits that weren't studied?

    J&J should have done more to study the other benefits that they thought would add value but they didn't, and that is their fault.

    It hurt everyone, but who didn't predict this? After all, look what they did when they were the only ones on the market with a stent?

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  14. Why is no one talking about Steve Kurtz and van Ooij? Hired by Medtronic, they put out paper after paper of old Charite cases of poorly sterilized cores, showing no connection between cause for retrieval and device breakdown. van Ooij actually stood up at Eurospine and demanded that everyone stop implanting discs until we understand them, yet he had never implanted a disc in life! They nailed a perception in everyone's mind and shot the disc industry a severe wound. Medtronic waged war on polyethylene and nearly killed themselves at the same time. (Synthes' lawyers finished Maverick off)

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