Friday, April 15, 2011

Open Letter to NASS

Dear NASS:

TSB wanted to write an open letter to your organization commending it for the wonderful job that you continue to do as a medical society.  Your organization is dedicated to promulgating the  professions highest standard of evidence based and quality spine care.  Unfortunately, the past few weeks have cast an image on your profession that leaves many believing that the foxes are guarding the hen house.  Those of you that are members of NASS' executive committee must feel slightly embarrassed by last week's and this week's Wall Street Journal expose on Dr. Makker.  Maintaining and preserving your professions integrity with America's public must be your top priority.  It must be concerning to  each of you that the actions of a few, is casting a black eye on the many spine surgeons that really do care.  Words like honor and trust in your disclosure policy have no meaning if one does not live up to those standards.  

The general public doesn't truly understand the importance of having collaboration with physicians in developing new modalities of treatment, assessing the potential of an idea, or simply providing their clinical expertise, all which result in enhancing the patient's quality of life.  This synergy is vital for our mutual existence.  What is concerning is that there a fundamental breakdown between doctor and patient when the patient is viewed as a profit center.  And it should be a concern.  Recently, TSB reviewed the program for the 2011 AANS meeting, granted another organization whose many members perform spine surgery.  There were over twelve pages dedicated to disclosure along with five pages of surgeons that are not affiliated with any company.  Many of those surgeons were from foreign countries.  If a spine surgeon is working with five or eight companies on projects, how could this individual really focus on the task at hand? Undoubtably, we live in America and no one has the right to tell another person how he or she can pursue one's livelihood, yet, when outside financial interests and bias influence a surgeons decision making process, this behavior is damaging not only to the profession, but also to the patient.

With all the negative press that the Wall Street Journal and New York Times have published regarding the Dr. Makker's, Kuklo's, Polly's and Wang's, just to name a few, is there no concern that only one surgeon had the nerve to stand up, identify himself, and be heard in a public forum?  What does this say about our industry and your profession?   Contrary to what NASS believes, there are many surgeons that still fail to disclose the many side deals that they have initiated for their own financial gains.  If disclosure is important to your organization then you need to expand the scope of the types of financial relationships that your members partake in.   Unfortunately, past members of NASS have set a poor example of how to conduct oneself both professionally and financially by creating an atmosphere of gaming the system, and for those tenured in this business, we know who they are.   How many of your members are investors in companies and have failed to disclose?  How many are actively involved in POD's that have failed to disclose?  How many are owners of Physician Owned Hospitals, and have failed to disclose?  

The bylaws that you espouse can be interpreted as nothing more than lame duck principles in a futile attempt to create an image that you are a governing body for an organization that has no legal authority to police or monitor its own members.  Hopefully, this will be a wake up call.


  1. If NASS hopes to maintain credibility in many different areas, it will have to create a policy concerning PODs and surgeon consulting agreements. PODs are clearly unethical if not illegal. However, NASS also makes coding recommendations. The surgeons from NASS that make these coding recommendations are often have a financial relationship with companies. It seems that many of the coding decisions are gamed to benefit a particular company or companies. Surgeons who have a financial relationship with a company should recuse themselves from participation in NASS decisions that impact industry. NASS should also take a stand on unethical PODs.

  2. Nice job MM - see below regarding the NASS disclosure policy. If they truly believe in their own policy, then enforce it!!!

    In addition, I think they they are also part of the problem - $1000 and upwards for admission to the upcoming show in Chicago - C'MON MAN!

  3. Speaking of full disclosure, I think TSB and the first poster should fully disclose their personal financial interest in NOT having PODs in their communities. Conflict of interest runs in both directions, gentlemen.

  4. @ 6:30

    It's nice to know that some scumbag doctor's are reading this blog. Are you one the TBI surgeon's who just announced that they are creating their own POD and bringing all implants in house?

  5. I think in general organizations like NASS exist to get vendors and customers together. All the rest, like statements of ethics are window dressing. IMHO.

    The really dirty little secret of spine, that no one wants to talk about, is that a lot of this stuff ends up leaving the patient worse off than before. There's an awful lot of surgery out there that is unnecessary (black discs? So what?). And a lot of necessary surgery (pediatric scoliosis) is barbaric.

    I know that in 50 or a 100 years they're going to look back at what we did to human beings and hang their heads in shame.

  6. 6:30

    You are an idiot.

  7. "NASS, AANS, AAOS and AdvaMed are lame duck organization. Rarely if ever has the industry disciplined one of its own."

    - TSB April 14th, 2011 "Thursday Op-Ed Piece"

    You we're right on the 14th. Today's post is like watching someone complain to their city council about how the highway noise keeps them up at night.

    I think you're / we're gonna have to dig a little deeper here my friend.

    Sunshine's the best disinfectant.

  8. 7:13, Please refrain from calling names. It lessens the impact of this forum, and places you down on the same level as the surgeons who have chosen to depart from implanting devices based solely upon clinical requirements, to choosing to implant only devices that they can obtain for resale themselves.

  9. 6:30
    I disclose that my sole interest in our profession, is that of treating patients with devices and treatments that are selected with the only bias being that of clinical efficacy combined with demand matching, not financial interest.
    The fact that you feel PODs are troublesome to our community for purely financial reasons is telling...

  10. Are PODs illegal? Yes
    Are they unethical? Yes
    Have they hurt my business? Yes
    If they hadn't personally hurt my business, would I still be upset they exist? Nope
    Do I think patients will mind? Nope

  11. 10:01 AM - Do you actually believe that the patients that Dr. Makker operated on multiple times mind the fact that his decision to operate on them was obviously impacted by his personal financial motive associated with his unethical affiliation with a POD? Additionally, many surgeons are strongly opposed to PODs due solely to ethical concerns. PODs are clearly unethical and likely unlawful.

  12. As a PhD researcher in orthopaedics, I find this entire situation laughable. For decades sales reps have pushed surgeons to use their products and they are rewarded for convincing surgeons to perform additional procedures. Their goal was always to increase product usage and the patient was just a vehicle to achieve this. Now that surgeons have removed the sales reps, there is an outcry for the wellbeing of the patient coming from the reps.

    As a researcher with no financial incentives to promote device usage, it is blatantly clear that the patient has never come first. Nothing has changed with PODs. Someone else is just making the money now.

    I agree that the system needs to change, but people need to stop playing the victim card. Unfortunately, the patient has always been the victim in this field.

    Go ahead and respond that you always sold products based on clinical evidence and the patient always came first. I could use a few good laughs this afternoon.

  13. 10:19 - Definitely agree. How many reps have complained to their manager their concern over their bread-and-butter doc who was performing "too many surgeries?!"

    Funny how the ethics are muted when you're making money, and
    shouted when you're not.

    The only person here who should have a prominent voice and doesn't is the patient. Unfortunately, ignorance isn't bliss - It's a 3rd time lumbar fusion revision.

    Round and round we go.

    -Former rep, not a doc (thank God)

  14. 10:19

    It appears that you are confused about the time honored tradition of pushy selling tempered by prudent buying.

    I will ever join a POD due to the blatant ethical conflict. The position that since it is "already a conflict of interest to prescribe treatment and then treat", somehow justifies a further financial conflict of interest, is specious at best.

    Although reps may Sell in the OR, with the traditional method the lack of direct remuneration back to the surgeon for the implants chosen, provided no appearance of temptation. The judgement to prudently have the hospital only purchase what was best for the patient is upheld, without further potential for conflict.

    Once a surgeon joins a POD, and the Prescriber becomes the Seller, the hospital is forced to pay for whatever that surgeon sells that day, or risk losing the referrals.

    No thanks, sounds like a temporary opportunity laced with ethical impropriety. We should stick to addressing the absurdly low rates of reimbursement.

  15. better side to be on...orthofix or nuvasive?

  16. hahaha globus is still private!! ha ha ha ha

  17. 12:23

    There is no confusion here. In fact, you obviously missed my point.

    In your own words, the reps practiced "pushy selling" for decades with little regard for patient outcomes. Now the reps are the ones crying foul on the PODs based on the potential financial conflicts.

    PODs are clearly unethical. "Pushy selling" is clearly unethical. That is exactly my point. I just find it humorous that reps are now playing the "ethics" game.

    Surgeons have always had financial incentive to perform more surgeries. That hasn't changed with PODs.

    I am in no way supporting PODs, I just wanted to point out that the financial/ethical conflicts have always been there. It was just in the rep's favor before so you didn't speak up.

    Whether it's "pushy selling", consulting agreements, or PODs - the patient clearly loses in all situations. This is what concerns me.

  18. Hey 10:19, sorry, but you're giving the rep, and the industry way too much credit. I have NEVER known a rep who would even try to argue that a surgeon should or should not operate on a particular patient. So forget about pinning any unnecessary surgeries on the industry. That's entirely the domain of the surgeons.

    Quite frankly, it's even rare that a rep will attenpt to convince a surgeon to use an implant where they weren't planning to. "Yes doc, you should go ahead and plate that single level ACDF, all of my other customers do that." is not something you're ever likely to hear. When and in whom to use our products remains entirely at the discretion of the surgeon, not the industry. That noted, we work hard to ensure that when an implant is needed, that it's ours that's chosen.

    One can argue that research sponsored by the industry and presented at society meetings or published in journals has made compelling arguments when and why products should be used. But this research is conducted by surgeons and for surgeons, and it is the surgeon who chooses to adopt this information into their practice, and with a few eggregious exceptions notwithstanding, it's not under the influence of a company or rep.

  19. @ 12:23 Beautifully said!

    @ 12:44 Is it the pushy mortgage guy's fault that you bought a house you can't afford?

    Salespeople can inform a doctor about the features advantages and benefits of a product. They are not informed enough or qualified to make a decision as to whether or not it is right for a particular patient, or whether or not the patient even needs surgery. The surgeon also taken an oath to keep factors like how much it will financially benefit them out of the equation. In short, sure a rep is incentivized to sell more implants, but like 12:23 said, they can't make the decision to buy them too.

  20. Read OTW, LOL has this website ever taken a position on issues that play out in the industry? Smoking gun or just smoke, depends on what you boys and girls are smoking at OTW. Wake up and stop walking around with your heads in the clouds.

  21. Look who is attacking the WSJ the bastion of the orthopedic and spine world OTW, I'll second that LOL

  22. 12:44

    I believe it is a significant ethical error to lump Pushy Selling, Consulting Agreement, and PODs into the same category.

    All surgeons have pushy reps. They do not determine the choice of implants, I do. It is not their place, nor do I give them the choice.

    I have never chosen an implant based upon a sales rep "pushing" me into it. I have not chosen to use a manufacturer based upon remuneration for speaking engagements.

    Neither provides enough incentive to cloud my judgement enough to cause me to switch my implant choice, nor has any patient been harmed as a result of a pushy rep. The physician is the Pilot In Command and ultimately has the responsibility for the outcome. I have never met a rep in the OR that could not be put in his place by a simple stare and shake of the head. (OK maybe twice and a point to the door) Any surgeon that feels compelled to implant a device that is against his decision, but will satisfy the pushy rep, should stay out of the operating room.

    PODs on the other hand, clearly have a direct and immediate effect on the choice of implants which a surgeon "investor" chooses. Are you aware of any surgeons who "buy in" to a POD, and then continue to use the implants they felt were best for the patient before their investment?

    I understand your point was that reps only chose to cry foul ethics when their livelihood was threatened. I feel it is an ill-informed comment to state that reps push the surgeons decision making abilities to the extent that they harm patients, and place the effects a pushy rep might have on the surgeon responsible for the outcomes, in the same category as a Physician Owned Distributorship.


    Wow... What kind of impact would this have on the industry?

  24. OTW is a POS and is as conflicted as the Industry it covers.

  25. OTW?? Off the wall? Too many acronyms.

  26. 2:05

    no noticeable affect other than the sacrificing of price for hollow returns on mandated volume

  27. You called it right, TSB! Ryan Young is incapabable of offering any criticism of our industry (just or not). He scolds the WSJ for failing to provide evidence that Omega is a POD. Nowhere does he show any outrage about Omega sales letter that the WSJ posted online. More importantly, nowhere does he show any outrage about or sympathy for Dr. Makker's butchered patients. Way to go WSJ!! I'm keeping my WSJ subscription and dumping ortho this week.

  28. Ryan Young or Rotten Young

  29. Dear OTW

    Stop pandering to your friends in the industry. A spreadsheet with check numbers plus $547 thousand is only part of the equation. I'll bet you that this story opens up an investigation by the OIG if not the State of California's Attorney General's office into workman's comp alliances between attorneys, physicians and distributors. For a company that reports on the spine industry you sure are a milquetoast publication. You know the saying where there's smoke there's fire.

  30. Its interesting reading the physician/physician advocates posts here.
    The majority of the people on here are industry sales folks, how NOT surprised can you be that they would want to stand in your yard with pitchforks and torches and out you when something you are doing threatens their incomes?

    WE (reps) did not make the STARK laws, and are not in charge of enforcing them. You can be damn sure that anyone worth their salt is not going down without a fight when it comes to losing their income, so stop acting surprised or saying we are pulling the ethics card when we are simply trying to protect our livelihoods. I will throw a POD under the bus as quickly as I can if I think it will protect my interests when it comes to finances. I would do the same thing to a competitive sales rep in my territory to protect my income, find their weakness and exploit it to my advantage. This is sales ladies, we fight for every scrap! Some fight fair, some do not... it will all come out in the wash.

    As far as reps and ethics go, its like physicians. There are some good and some bad, there is policing on both sides of the fence. Bad/unethical reps will sell products looking for an indication and base their merits on reimbursement advantages, these reps obviously exist. Bad doctors make patient care decisions based on personal gain. The fact of the matter is we both have rules/laws to follow and someone is always going to try to bend the rules on both sides, some will get caught and some will not. My strength is relationships, but even that is not strong enough to overcome the mighty dollar when it comes to your best physician friend owning his/her own facility etc... I have experienced all of this.

    Physicians and sales reps know the rules when they take the job. If I have to follow stupid rules about not paying for a doctors wife while at dinner or not paying for a golf fee then you should have to follow some rules too when it comes to making pure decisions in your patients best interest.

    Again, we didn't make the rules..... but will help enforce them if our livelihoods are in jeapordy

    In the famous words of Antoine Dodson....
    "Run and tell that HOMEBOY"

  31. We lookin' for you homeboys, especially in Huntsville, Alabama. We comin' to get you.
    Antoine Dodson

  32. I find that the shady reps and shady surgeons find each other and vise versa. This is no different than two religious people, two drug dealers, or two sports fans becoming friends.
    The problem is that the shady surgeons operate on 5 out of 10 patients instead of 1 out of 10.
    "Be careful of the company you keep"

  33. Nice catch 4:52

    So true but so sad.

  34. After many years in the business, it is a shame to the decay of the domestic spine market. What or who is to blame? As with any analysis of a what went wrong it is a variety of factors that span back almost two decades. First no one listened to Neil Kahanovitz MD s call to arms when he was president of NASS. The professional. Societies did nothing to protect reimbursement and show positive outcomes. Also around the same time, a group of very unethical US Surgical Managers entered into to upper management of several spine companies. Their lack of ethics spread like a metastatic tumor through the industry. We are now left with the dregs and results of both factors. Innovation is now happening outside the US plus all the other factors in the news and posted on this blog.

  35. It all begins and ends with money, and who can get the most. If a surgeon gets 100 dollars for sending a patient to the physical therapist, and 5000 for doing an IDET, what do you think he's gonna do? (I know IDET is no longer there, but it is a nice clear example of many of the unproven worthless surgical interventions). At least 50% of spine surgeries in this country are unnecessary and inappropriate, and leave the patient no better or worse off than before. NASS has never done anything to curb this, as a club it is protecting the interests of its members, not promoting clinical science or excellence. The article below makes for an eye-opening read.

    Long-term outcomes of lumbar fusion among workers' compensation subjects: a historical cohort study Spine 2011; 36(4), 320-331.

  36. Bottom line is that the inmates ARE running the asylum and there seems to be no warden in sight to corral the corruption.

    It is not up to NASS, AANS, or any of the societies to police what is going on as much of it stems from those who in power in these organizations.

    The only way for much of this to come to an end is if the DOJ, FBI or some other legal entity actually shows the stones to get involved. Until then, it will continue to go on,,

    As they say, "The more things change, the more they stay the same."

    And there doesn't seem to be any true end in site. In fact, with the emergence of PODs, things seeem to only be getting worse in this industry.

  37. One of the best comments I have ever read on this site:

    QUOTE: 8:13am
    "The really dirty little secret of spine, that no one wants to talk about, is that a lot of this stuff ends up leaving the patient worse off than before. There's an awful lot of surgery out there that is unnecessary (black discs? So what?). And a lot of necessary surgery (pediatric scoliosis) is barbaric.

    I know that in 50 or a 100 years they're going to look back at what we did to human beings and hang their heads in shame."

    How many of you would ever have a fusion? I've asked many a spine surgeon if they have recently had an MRI of their spine - most of them have and two things always happen at that point in the conversation. 1. they say why the MRI isn't 'pretty' 2. they say that they are 'holding off' on a fusion.

    Now I know docs treat patients, not pictures, but I have yet to meet a spine surgeon with a fusion. I know they're out there, but if someone told me that I need to have L5-S1 fused as a rite of passage to sell these products - damn, I'd be selling cell phones at the mall....or capital equipment.

  38. There is a spine surgeon who volunteered to be a patient in an FDA study for an artificial disc. He was randomized to the disc, operated by the P.I., and operated again by one of his partners within days to remove a bone fragment from the canal/cord. He now no longer operates and after his law suit was awarded about 600k.

  39. One just needs to look in eastern Tennessee to see one of the biggest POD creators in the US, Choice Spine. Word has it that good ol' Rick and Marty fly out almost every week to consult with surgeons on how to do this legally, lol. The DOJ and OIG definitely need to look into their operation sooner than later.

  40. Hey 8:01,

    Sorry, but your train of logic (if it can be called that) never made it out of the station. A. I personally know several spine surgeons that have had fusions, both cervical and lumbar. B. The incidence of disease meriting spine fusion surgery is very small. (1 in 600 people per year in the US.) It's ridiculous to assume that among a population of less than 10,000 spine surgeons there would be more than a few prominent ones (or ones that you may know in your area) that would need one, have one, and you would know about it. They're out there, and they get them. C. Spine surgeons are well aware of the conditions that lead to fusion, and how to prevent it. They are also very well aware of the success that good non-operative management can afford, something that patients often don't have the patience to appreciate or pursue. Surgeons are also well aware of the adverse consequences that some will experience, and don't underestimate them as some patients do in their zeal for a simple fix. And finally, when you call the pediatric deformity correction surgeries "barbaric", and seem to lump them in with other fusion surgery, you really do seem ignorant. I believe the "deformity" contingent of the field may be doing truly the most miraculous and rewarding spine surgical work, and I'll bet their patient satisfaction scores reflect it. Go ask their patients, and I'm sure you'll find most will say "barbaric" would be leaving them to their life without the surgery.

  41. 1:30pm; I agree as well, I have seen several of my spine docs that have had fusions done, lumbar and cervical, so the 8:01 comments are way off base.

  42. 1:30 - good post and you raise a few good points.

    Deformity procedures are a tough call and while barbaric you are correct in saying that their patient satisfaction scores may be the highest.

    It's tough that America always likes the quick fix - and the general population picks up the tab. "They are also very well aware of the success that good non-operative management can afford, something that patients often don't have the patience to appreciate or pursue."

  43. 1:30 - to contest that deformity surgery is not barbaric is laughable. Please review the indications for treatment of AIS, and tell me how many people undergo massive fusions and will not progress, per the natural history of the disease. Patient satisfaction scores are "ok", we are lacking 10yr+ f/u on pedicle screw constructs, need to see those before you venture any guesses. The approach is the WORST approach in all of orthopedics, paraspinal musculature gets destroyed.
    Seriously, read Weinstein, Lonstein etc in JBJS and Weinstein JAMA.

  44. Interesting dialogue overall. The WSJ article brings to light the dark side of POD's and the logical consequence: overutilization. That is squarely what the government created Stark to mitigate. Check our the Hogan and Hartson brief attachment showing the revision rates after surgeon ownership.

    One interesting tidbit from the Omega letter in WSJ is the companies participating. The one glaring company, publicly traded, is Alphatec. I would think that Ted Bird and Stephen Lubisher et al would be running for the hills after the example made at Stryker Bio receiving criminal charges. I would think that the shareholders of Alphatec would be up in arms about the POD's implication and threat to upend any revenue gain. I would love to see them short sold to oblivion.

    As i post this, the government is active and has plants all over the country to bust POD's. As sad as it may be some surgeons who were talked into this may be legally implicated. I am sympathetic to my surgeon friends and wish that they had the ability to collectively bargain for better fee schedules. That is where they should have financial gains.

  45. Where were Stryker's Goodman Bros when Dr. Makker was doing his 7th surgery on that poor guy. Probably at the bar celebrating.

  46. Late to the party here...some observations:
    'Birds of a feather flock together'...many of the former US Surg peeps ended up with ONE company and all cashed out either millionaires or close to it before heading out to start, manage, or angel-invest in other companies...however, the metastisis was already under way as junior management observed the show...and also took the model elsewhere--how else did we end up with over 200 companies to date? It takes end-users to create revenue...but, in some ways it reminds me of the mob going legit...
    The whole POD deal just proves that we are all coin-operated...I don't condone, but realize surgeons today are under compression with lower reimbursements and crazy mal-practice/overhead. Many have witnessed their reps or distributors build multi-million dollar homes--or pull up in a Benz, Lexus, whatever...and are pissed. I am NOT involved, nor am I a millionaire. That said, I happen to know a couple of surgeons involved in a POD. The ones I know are still legit and ethical enough to put themselves at risk by over-indicating surgery, (maybe a minority) regardless of their involvement. Those stupid or short-sided enough to maintain this type of attitude will over time experience karma...
    I wish I had an answer for the deformity scenario--as a 20+yr professional, it does seem barbaric to take a kid and fuse them stem to stern. Yet I don't see the fda clearing a modular, expandable, flexible, modular system any time soon.
    I appreciate TSB for this forum...

  47. RE my last post at 2:17, I meant to say, NOT put themselves at risk by inviting more scrutiny in a very gray area...I'd like to add that I also know many physician owned hospitals, surgery centers, etc where they directly profit from efficient management of the facility and business. It can be done.