Friday, October 1, 2010

Weekend Op-Ed Piece

Since the inception of TSB, on numerous occasions fellow bloggers have questioned and opined as to the decaying state that has become a standard within our industry.  To many of our readers' surprise, this standard is a by product of something much larger that has infected our society.  Our country has evolved from an agrarian society, into the industrial revolution, to Silicon Valley, and today, we live in a predatory environment.  If man behaves rationally, and markets can be contested, information  sufficient, corporations or man's conduct would be honorable.    The industry like the world is ruled by a monied elite.   Retrospectively, history has, and will prove that regulated capitalism yielded prosperity for everyone.  Today, the signature of our industry is not competition but predation.  Essentially, we work in an industry where one organism captures and feeds on another, the equivalent of a zero-sum market.  Those companies that are willing to bend  the rules by featuring consultancies, setting up physician owned distributorships, or being outright unethical, are complicit in contributing to a decaying industry.  These are the defining features of the spine industry, if not the leading force.  The aforementioned features are what we deliver to our customers.

In a predatory environment, nothing is done to benefit the public or the patient.  In a predatory environment, the rules of economics and law do not apply.  There is no discipline.  Predators compete by not following the rules but by breaking them at every opportunity that presents itself.  If it's okay for the Street to be predatory, why can't we behave that way?    Rules are not designed to guide our behavior, they exist to define the limits of unpunished conduct.  A good example would be fake consultancies.  It becomes easy to step over the line, once you get near it.  We foster and reward bad behavior.  So who is responsible for this type of behavior?  It is the CEO's and executive management teams at every company, whether you are  a legacy or a start-up company.  Yet, there is a consequence for this type of behavior, invariably, you fail.  Predators suck the life out of any business.  So in closing, how do we re-establish some normalcy in spine?  How do we establish some checks and balances, that lead us back to some purpose beyond cutting the deal, and making millions of dollars.  As we approach NASS, maybe it would behoove the governing body to sit down and perform some due diligence on the current state of spine, before it's too late.  TSB wants to know what our readers think?

44 comments:

  1. The problem is that US and state governments do not enforce the laws. The law should be black and white, but in this industry everything is gray because the government rarely prosecutes surgeons or dirty companies that pay off the surgeons one way or the other. The reality is that surgeon consultants are essential to product development and innovation. But, how many surgeons do companies reasonably need? Do the companies such as Alphatec, and yes lately even NuVasive, really use the services that their consultants provide? The surgeons probably do the work, but it goes into a black hole ever to be seen again. Clearly this is dirty and unethical, yet is may be legal.

    Surgeon owned distributorships are CLEARLY unethical. Whenever surgeons use a product for any reason other than price, performance, and service then it is less than ethical. Good surgeons can make anything work, but does that make it right to use inferior products? Most importantly, if surgeons profit from their prescribing, then it is unethical.

    Until the DOJ and state AGs begin doing their jobs and enforcing the law, then unfortunately our industry will continue to have less than ethical surgeons tied to unethical companies who fill their pockets. He who cheats the worst sometimes wins. Examples include MSD, Stryker, Zimmer, Blackstone in the past and currently Verticor, Spine 360, Alphatec, Sea Spine, etc. presently.

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  2. TSB, Start a topic on who’s the best and worst VC in Spine and you will hear silence. Why? Hardly anyone is familiar who these VCs are and because they are the true Puppet Masters running the show. It’s a wannabe dotcom bubble all over again (but soon will burst). How often do you hear private CEO’s be replaced because of poor performance? Hardly, but you frequently read in the WSJ that public CEO’s are often being replaced. Why? Too much is at stake and Sarbanes/stakeholders are breathing down their necks. Can you imagine how much more f’ed up the medical field would be if these VC’s went public on penny stock? I guess Sarbanes does have its perks. The majority of these Puppet Masters don’t have the experience to be in this industry. Sure they can crunch numbers and craft a nice term sheet, but they lack the impeccable integrity to survive in this industry. I look at it like this, the sitcom stars hardly go into blockbusters and vice versa. But more often a blockbuster star may go into sitcoms. Why? They can’t handle prime time anymore and still like to flock their feathers. Although capitalism is good; the Commanding Heights keeps it under control. SS

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  3. “So, if this show teach you anything, it should teach you how to respek everyone: animals, children, bitches, spazmos, mingers, lezzers, fatty boombahs, and even gaylords. So, to all you lot watching this, but mainly to the normal people, respek. West side.”

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  4. 10:26: Were you stoned when you wrote that? The bubble burst already.

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  5. Custom Suit Wear'en, Private Jet Fly'en, Kiss Steal'en Wooo! The dirtiest player in the game. Call me Nature Boy! Wooo!

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  6. The demise of any territory is a physician owned facility. Shortly after these less than stellar businessmen open the doors to their shiny new center for advanced spine technology to advance patient care (spits coffee out nose onto screen and falls out of chair) ,the mission statement in the entry way stating the aforementioned starts to mold and tarnish.
    Its only a matter of time after the doors open on the shiny facility that these amateur businessmen start assessing every product from every vendor they use and try to figure out a way to cut out the vendor and profit.
    Its honestly sickening to me personally. I take pride in the fact that I have been in the industry for over a decade and have played fair and square. To see the things that are going on in todays market is very disheartening. Like TSB, I think ultimately those involved in these activities that are contributing to the current state of the industry will fail in the end, I only hope the failure is heavy handed and swift.

    end rant....

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  7. @ 9:52PM you wrote "He who cheats the worst sometimes wins. Examples include MSD, Stryker, Zimmer, Blackstone in the past and currently Verticor, Spine 360, Alphatec, Sea Spine, etc. presently."

    Have you checked the NASS site to see how many pockets Depuy is in?
    Was that an oversight on your part? and the NASS site only lists those who are willing to particpate in NASS and disclose. The real $$$ is in the relationships with customers who opt out of public disclosure. Consultancies are alive and well across the board. Chris Christie did not change anything. He just pushed companies to hire smarter lawyers and get paperwork in order. The quid pro quo is still there. There is no end in sight. POD's are next to become a standard. No one will stop that end run either. Once that door opened it was already to late. You can bet on that. With this knuclehead in the white house- he's to busy trying to redistribute the wealth. POD's work in his favor. If surgeons make an extra 400-500K a year from implants, they will be less passionate about lobbying aginst reform.

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  8. POD's baby!!!!!!!!!!!!!!!!!

    suck it bitchass

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  9. Its funny that the guys who have put together sham deals, gifts and perks for their docs for years are the ones who complain loudest about PODs. They are upset about being left out of the loop, pure and simple.

    If it hits you in the wallet, you have every right to be upset. Just don't spout BS about being holier then thou.

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  10. One contributing factor is that there hasn’t been anything new in spine for years. The result is an industry that has been commoditized and in many cases corrupted because it’s almost impossible to compete on features and benefits. In order to create significant new technologies takes investment and risk. Is it new, is it true and does it make a difference? Remember that? In my opinion, the VC community made some reasonable bets that haven't paid off (e.g. nucleus replacement and annual repair). That’s unfortunate but its part of the game. The travesty is that even more money was invested in fads that really did not hold much promise of advancing care (post Charite discs, dynamic stabilization, high priced vertebroplasty devices). Combine that with poor management and excessive burn rates and we have a giant waste of money.


    The poor returns on these past investments, coupled with increased regulatory risk, reimbursement pressures, and healthcare reform have made it extremely difficult to fund potentially game changing technologies. The writing is on the wall. Are we reading it? Increased scrutiny on reimbursement and healthcare reform tell us new products need to reduce the cost and offer a clinical benefit (no more $4,000 balloons or expensive artificial discs). The increased regulatory risk means that our products need to have clinical data demonstrating their utility. Is that so bad, really? Opportunity being the mother of invention, there is a clear opportunity to improve upon the care of spine patients and reduce cost at the same time.

    I'll step out on a limb and say that these technologies are likely going to be targeted to the spine interventionalists rather than the spine surgeons. Sorry NASS. It has happened before. Consider the shift in business from cardiovascular surgeons to interventional radiologists. These types of technologies will enable us to get back to a market that competes on the merits of our products rather than leveraging 'relationships.'

    I'm not confident that many 'predatory' VCs will recognize these opportunities, or that they will have the money or conviction in today's climate to make these investments. I hope they do but it’s just so easy to say ‘no,’ and yes, I’ve heard ‘no’ my share of times. These investments are out there and wealth will be created if smart bets are made (high chance of clinical success and efficient use of capital). The attention of the 'spine industry' will move towards the interventional folks. I expect a change in the landscape in the coming years.

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  11. 10:26 - Yes, DePuy was an oversight. They should have been included. Yours Truly, 9:52PM

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  12. innovation is haulted by consulting agreements, i can't sell my awesome product to guys that are on board with other companies... that's why we are screwed

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  13. Consulting agreements don't help but if they are preventing you from selling your awesome product, then how awesome is it really?

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  14. I think there are still great opportunities in spine. We have just forgotten how to initiate them. Let's stop relying on relationships to sell. There over-rated man. How many times does this happen - Hey doc...what do you think of this? Oh you don't like that, I've got another just like it. These relationships have made us all lazy and with it comes short-cuts. Don't be a spine hack! Remember when we used to ask good questions? You know open probes, expanders, etc.

    Why should a customer buy a product from a rep that doesn't believe in it, or is not passionate about what he is selling? Stop reacting to the empty or full buckets that you have or do not have in your portfolio. Solve a problem that your customer has, both seen or unseen, and you will become more valuable, different, and less jaded. Pedicle screws are bad, whether they are put in open, mini-open, or percutaneously, yet they are still used on most cases. Why is a 1990's technology still driving our market in 2010? Its because the big 4 want it that way... That technology sucks and we can do better!

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  15. I disagree David 2:13. There have been many new and interesting technologies recently - stand-alone ALIF, XLIF, AxialiF. These are new approaches to spine offering an alternative to having your back fillet for open for a TLIF or PLIF.

    These approaches are new and better than the commodity crap that most reps focus on. We like the zombies in "Dawn of the Dead..."

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  16. Unfortunately the bell has been rung and you cannot unring the bell. This problem eminates directly from the surgeons. Our society has held them up to be Gods, something that they are not. They are men with the same issues that everyone else has...pride, greed, ego, etc. Because they held the key to our incomes for so long we came to them looking for something that only they could give...and over time they succumbed to the temptations that were laid before them, especially when their incomes began to shrink over the last 10 years in our current healthcare environment.

    Three possibilties:
    1. The surgeons will have to police this themselves. They will have to stand up and enforce any kind of morality that they deem correct in accepting gratuity for any part of their business. Frankly, I don't think they will as the state of their culture is such that they will continue in their quest for supplementing their incomes.
    2. Obamacare forces the surgeon to become employees of the hospitals and the hospitals regulate the surgeon via contract to the extent that they can no longer cut "side deals". However, knowing the state of the inner man, I believe that they will find a way to get around this as the companies will find a way to get around this.
    3. As prices continue to fall, and the final commoditization of our industry is complete, the profits may not be there to support graft and greed.

    But my prediction: "the cheaters, they will always be with you"
    ...SpineSeller

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  17. AxiaLIF is better than the commodity crap? Ha ha ha ha ha ha ha ha ha ha ha ha ha hee hee hee ha ha ha ha ha ha ha ha ho ho ho ha ha hee hee hee ha ha!!! Ha ha ha ha ha ho ho ho ha ha ha ha ha ha ha ha ha ha ha ha ha ha ha ha ha ha hee hee hee ha ha ha ha ha ha ha ha ha ha ha ha!!!

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  18. supply and demand. This is economics 101 with an oversupply. The next price floor will be the pricing that surgeons can acquire product that is currently fueling the POD, and thus, eliminate that component of the supply chain. I Don't think anyone will fix this (i.e. the Gov). The free market will - its just going to be painful. New technology will then bring this market "back".

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  19. Necessity will drive innovation... Greed will not. Surgeons won't think more if they are paid consulting agreements or own PODs. What new wrinkle have they brought? Entrepreneurs solve problems and create technology, not surgeons. Granted, surgeons help in the process, but rarely is it their brainchild. Afterall, they are clinicians, not entrepreneurs. I mean no offense to Dr. Michelson. You are the exception. Kudos to you for figuring this bs out.

    7:48 can laugh all he wants, but the reality is that Trans1 is a novel alternative to pedicle screw fixation, not that I would ever want either. Still, if I could avoid the 30% incidence of ASD due to facet impingement I would do it. PSF is bad medicine. Who wants a 30% chance of another fusion w/in two yrs. No me man! Keep your commodity.

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  20. At what is 7:48 laughing? Xialif is just another product in the line wacky technologies invented for the purposes of selling a company. Xialif is dead (ref: stand-alone Ray Cage days)

    I also agree with the eco 101 theory...we are now experiencing "spine inflation"...too many companies chasing too few surgeons. However, when it comes to a clean transaction I insist that it is in the hands of the surgeon customer.
    ...SpineSeller

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  21. 7:15. In my opinion, BMP-2 is the most significant 'new' advancement in spine. It eliminates the harvest site so that's good but the price can be a bit 'hard to swallow' (forgive the cervical pun). XLIF may offer advantages- and its doing well right now. In its day, stand-alone ALIF reduced OR time and cost. Jury is out on Trans1. I don't think its a standalone product and its too limited.

    A buddy of mine and I have been talking about the AAOS workgroup recent position statement saying that vertebroplasty is not supported by data. A big literature review with many papers- all pretty much disregarded in favor of the recent RCTs by Kallmes and Buchbinder. I think that baby is being thrown out with the bathwater on that one. How do a couple questionably designed RCT's trump all the collective experience? Unfortunately, this premature position statement makes it more difficult to do follow on RCTs on the subject. The medical community is all about Evidence Based Medicine. While I support that concept, we need to be careful not to distill that down to just one RCT and remember the principle that data must be repeatable by multiple investigators.

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  22. That is the point. We have been trying to get rid of pedicle screw fixation (PSF) since the mid-90s when TFCs were introduced. Unfortunately, BAK & Ray were the false solution, however they succeeded in doubling the size of the market. You have to give credit to companies like Trans1 and NUVA for ingenuity in thinking how to solve a problem differently, i.e. - how to get a fusion w/o PSF. That is why stand-alone ALIF (zero-profile), XLIF, and Axialif are interesting.

    In an effort to tie these devices together with the discussion topic, they are all successful with some exceptions. Axialif is declining because of pressure from big player influence, i.e CPT coding recommendations from NASS coding committee. This was also attempted with XLIF, but NASS members backed this up as an ALIF, otherwise NUVA stock would have continued to plummet. This is now happening to zero-profile stand-alone devices because the majors are protecting the PSF market. Lets keep the market locked into 1991 technology. As long as this happens the market will be driven by commoditization, greed, sloth, and corruption.

    There are still many problems to fix in spine. How do we get fusion without causing more harm than good? For many patients, this challenge is still unmet. Until then, either imitate or innovate. If you imitate, then you are part of the problem and not offering a solution.

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  23. I was surprised to see SeaSpine listed by 9:52 as an unethical company...MM gave them big kudos just one year ago as a strong company under $50M with great leadership.
    Maybe 9:52 has an issue with a distributor in his/her territory?
    From my experience, they're a great company to work with, and I know that they have some really solid designs in their pipeline right now.
    Am I missing something?

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  24. From what I hear, SeaSpine was largely built out of surgeon investment, raising potential concerns for conflict of interest. It seems like a decent bunch of guys running the show, but they do have that skeleton in the closet. The companies who are based upon that model will be hearing louder rattling from those skeletons moving forward.

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  25. How many spinal device companies are there? Yet, I usually only hear about a hand full doing questionable practices. Relationships protect the distributor/rep from management decisions to replace them. No manager should ever have a stronger relationship than the local rep or they are f**ked. There is no spine company that deserves any loyalty

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  26. It's all about the Benjamins....All the consulting agreements and the pathetic whining bastards on here going on and on about lack of loyalty...blah blah blah. Make your money while you can and move on. Soldier of Fortune could be our industry magazine. Get over yourselves.

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  27. Who said anything about whining. The fact is, there are no ethics, integrity, and loyalty in this industry, let alone this country. Yeah, yeah, yeah, you're going to pontificate in your next comment about being a free-marketeer, unless it doesn't effect your 401k. The reality is that you've probably never been a soldier, and, you probably don't have a fortune, meaning that you have to go to work like the rest of us. If you haven't noticed, this industry just experienced a major downturn, does Inion, Pegasus, Vertebron, Applied Spine, Archus, and U.S. Spine ring a bell? Who's next? Loyalty, integrity, and ethical business practices are what built this country. If you don't believe that, why are there so many people bouncing around from job to job? Why is everything short-term? Why is there no stability or continuity in this industry. Why do people carry three different pedicle screws, two different cervical plates, biologics etc.....? Because there's loyalty? Right. Like any rational person, there has to be some balance in business just like in your life. It's a law of personal nature. Regardless what Puff Daddy sang, it's not all about the Benjamin's, if you truly believe that you're in for a rude awakening when that POD's eliminate the need for your job. PS: You're probably one of those people who never assumes responsibility for anything you do, because it's everyone else's fault except your own. It's call accountability, not entitlement.

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  28. Musculoskeletal man- you wrote at 4:45 am
    "Regardless what Puff Daddy sang, it's not all about the Benjamin's, if you truly believe that you're in for a rude awakening when that POD's eliminate the need for your job."

    wouldn't POD's be an argument that it is all about the money? If you are saying it's not, what other factor will make POD's eliminate traditional spine distribution? thanks in advance for the clarification

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  29. 6:57AM: It was a crunk night.
    5:37PM: The complete list of spine startups and no sign of slowing.

    http://orthostreams.com/?page_id=497

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  30. The POD trend will not be stopped until the OIG makes an example. The OIG will not move until this thing hits critical mass. I think it is clear that there is a great deal of momentum for POD's. I just dont think it is big enough for the them to get involved. Plus isnt is causing significant price erosion in the marketplace...dont you think the feds like that?

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  31. The spine related DRG's have had a meteoric rise between 2000 and 2010. For a basic lumbar fusion with no complications the national average in 2000 was $7,770. For the same procedure in 2010, the national average is $20,972.

    A couple things have factored into this rise - CMS averages the reported costs three years prior to come up with the next years payment. With the proliferation of Infuse, IBF's, and the advancement of technology that allowed for severe curvature of the spine to be corrected.

    Medicare has, of late, hit a critical mass whereby rates have actually decreased over the last year and are projected to decrease further over the next few years with the Whipsaw provision going into effect that will reduce rates by over 7% (in aggregate).

    With Obamacare hitting the doors and payors moving in lock step with CMS, there just isn't the room for higher costs, carte blanche, surgeons. When administrators look at the cost of a spine service, it is rather easy to tweek the vendor mix, save six figures, and come up with a spine service that makes - not loses - money.

    Then again, it would really be telling is to see a DOJ lawsuit akin to what happened in the Recon industry several years back!!!

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  32. Just catching up:

    @8:59 - your excusing Michelson from your rant demonstrates your ignorance. It's commonly believed that he didn't have the innovation, just the best patent attorney and a zealousness to run out and patent every idea he came across, his, or anyone elses. He sure revolutionized the level of greed and expectations among surgeons, though. Not sure that's a good thing. There are countless spine surgeons who actually innovated without any regard to personal enrichment, perhaps hoping only for professional recognition in the process, that much more deserved your excusing.

    And as for the future, only the option 3 that SpineSeller proposes (prices fall and available money for excess or unnecessary services and consulting agreements dries up) will lead to long term stability in the marketplace. 10/2 7:52 may hate the POD for ruining his revenues, and I dislike them for the ethical challenges they pose as well, but one has to recognize that the doctors sudden interest in the value of the products they purchase, is in the general public interest.

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  33. I'm sorry to enter this discussion a little late and change the subject here but............
    How many "spine professionals" know that according to our FDA that if you utilize an alternative to PEEK Optima like MediPEEK you may not have to submit your existing device for a new round of 510(k). As of today the FDA has no regulations that mandate that an OEM must go through this when simply changing material suppliers. Now that being said, they the FDA, openly admits to not having a "complete understanding" according to one of the on staff Dr.'s Are there proper and things that must be done. Absolutely. Come see us at NASS booth 1875 and we'll be more than happy to help you navigate this.

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  34. @ 11:51, the only thing you didn't apologize for is posting a blatant advertisement, which you should have. Imagine if everyone did the same for their company. I, for one, don't want to wade through such crap. How about we jump right back to our regularly scheduled programming?

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  35. 11:51 isn't telling the whole truth there...if MediPeek material is equivalent material from a Masterfile standpoint and truly is no different PEEK, and there has been a device already cleared against it, you could do as he says...(same case if you had Ti64AlV vendor switching)..you would still have to note it in your system's quality manual and your annuals for FDA in the event of an audit....make sure they can provide the clearance letter though!!

    regarding the POD model, something to think about is how the dental implant market, the breast implant market and any other non insurance based medical implant market works....the surgeon is the user AND the buyer... what about sports medicine? Go to any surgeon owned ASC and the user is also the buyer....surprisingly, in all of those scenarios, costs have remained relatively stable over the past 5-7 years...

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  36. @ 6:41- dental and cosmetic surgery are mostly elective , (cosmetic implants). not driving healthcare and workers comp and medicare etc. through the roof
    explaining to a patient they need 3 or 4 dental implants, or a womans breast implants is different than a patient comprehending a 1 level vs a 2 level fusion.

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  37. What is unethical about a POD? If the surgeons is using a FDA cleared product that is clincally as good as what he used in the past, saves the hospital money but makes a little money himself, what is wrong with that? It is unethical if you are not in on it and are hurt by it. How is a POD any more unethical than a manufacturer charging a 1000-1500% for an implant. I tell you what 10/1 9:52 cut your commission pass the savings on to the hospital. I bet a pig will fly out of my ass before you are willing to do the moral and ethical thing for the better good of society.

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  38. 10:17 you are an idiot.

    it's unethical bc its a conflict of interest. the surgeon is incentivized to do more surgeries, cut more levels, and can control more income.

    he can drive the price down so hospitals won't bark too much. and that is not a good thing for the reps in the field. f k2m!!!!!!!!

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  39. 12:35 can you not engage in a civilized conversation, you only show your true colors.

    You assume, and you know what thatmakes you, that all surgeons will over utilize to make more money and that is not the case. There is no conflict of interest if the surgeon is using good clinical products, still performs the same good surgery and saves the hospital money. The only one that is left out is you!

    Maybe your high salary for simply standing in surgery and filling out paperwork is the unethical conflict that this industry is having the problem with.

    Sounds like you have been stung by this, so I can see why you have the childish anger.

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  40. So we can all agree that 4:08 is most definitely a surgeon, and makes some good points. If a surgeon simply sees a rep as "someone who stands in a room and fills out paperwork," who can blame them for the overall jaded outlook on what a rep does? When innovation is lacking and procedures are routine, it can easily appear this way.

    I agree that, when the products are all similar, the natural dictation of the market if for price reduction and consolidation. If you're simply closing your eyes and ignoring this reality, then I'm sorry. We should not be shocked at this.

    Great reps will adapt and find ways to LEGALLY add value. Some good reps will likely have to leave. Bad reps will find ways to add value unethically.

    It is what it is folks.

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  41. I believe PODS are illegal and unethical because they place a physician in a position of being both the decision maker in the spending of government money (Medicare $), and the supplier bidding for that purchase (a vendor). We don't allow it for defense contractors, and we won't allow it for docs.

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  42. I asked my wife, the most ethical and moral person I have ever met, about the POD thing. Her first comment, which I found to be striking, was that the perscription glasses she had just purchased were from the store adjacent to the optometrist who owns the store and had just written the perscription. Interesting take!

    By the way, when do you think the office supply companies will be signing up surgeons for post-it note and writing pen consulting agreements now that pharma is not giving them away!
    ...SpineSeller

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  43. It would be rather difficult to sell a patient an unnecessary pair of prescription glasses. If your vision problem is coming from some other non-optical condition, you will not be convinced that the glasses will help.
    Back pain on the other hand is an entirely different story. The patient only knows that their back hurts, and does not understand the multiple and variable causes, nor their appropriate and and initially conservative treatments. A patient should not be railroaded into surgery by the person that has charge of their well being. I'm not saying all, or even very many, are bad players, but monetary incentive is sure to pull more to the dark side.

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