Over the last few years, TSB has questioned the legitimacy regarding many of the practices and business models that have been established in the spine industry. Some have attacked us, claiming socialistic values and making various claims. Accusations aside, TSB thought it would be interesting to get our readers take on the title of today's post, "Is There Anything That Money Can't Buy in Spine?" Wouldn't a moral debate about the the limits or no limits of the spine market enable us to decide where our market serves the public good, and where it truly doesn't belong?
Has the spine industry become an extension of a greater problem that our country and society have become, whereby we have drifted from a free market into a society where everything is for sale? How do we value the goods and services that we provide and offer on a daily basis? These questions are not merely economic interrogatories, they are moral and political questions. Have we, and are we commoditizing our personal and business relationships, the same way that we have commoditized the industry? Not only have the products become commodities, so have the surgeons, the reps, and the companies.
Today, we are no longer a unified industry. We have become factions and camps resulting in an almost like underground economy where everyone attempts to stay two steps ahead of rules and regulations. Ever make a sales call where the surgeon seated across from you states that if you provide his program with an endowment or grant you can do business at his facility? Of course, the check must be written to him personally, and he will redistribute the monies. Ever make a sales call and the surgeon asks if your company is looking for a consultant to work on "some" project? Have you ever been asked by a distributor whether you were looking to make more money as a surgeon? Or how about our favorite, "if you buy me a home on the gulf, I'll promise you $3 million in business every year." The parlous state of our industry should be a concern to everyone regardless whether you are Medtronic or Brand X. Advancing technology should not be the only innovative solution the industry should focus on. As more and more people rationalize their behavior and beliefs, the question must be asked, are we heading in the right direction, or does the industry truly need a correction? Obviously, the gnomes at AdvaMed, or NASS, or AANS will tell you otherwise. Someone has to make a stand, eventually.
Markets don't pass judgement on results, all markets want to know is how much is something worth and is it for sale, each participant must decide on the value of the exchanged. So what price are you paying for working in an industry where everything is up for sale? TSB wants to know. Is there hope, or are we heading to that grifter industry that we really would like to be?
The problem is that it is very difficult to collect real data on spine surgeries. People want to please their surgeon, or want pain meds, or want to not work any more--there is just too much bs out there to really know what works and what doesn't. Is it any wonder we attract more than our share of grifters?
ReplyDeleteWhen spine instrumentation reaches the efficacy of hips and knees the grifters will start to disappear. But not before.
This isn't a sales problem. It's an imagination problem on the part of the people who own and run spine companies.
TSB for once I totally agree with you on this posting!!!! I feel the pain in your 3rd paragraph. In my territory is a very large Spine Teaching Medical Center (lets just say its in the UC system and is up North), and have been told year after year "well if you just sponsor our fellowship program..." One can read between the lines here. They have clearly placed a value upon what we give them, rather than what or how our products serve or treat their patients.
ReplyDeleteLets face it, surgeons have been treated like rock stars for years and so they act like it, selling or pimping themselves out to whomever will listen. We took them to exotic places, sometimes too exotic, if you know what I mean. We feed them the most expensive food and cracked open the most expensive wines, for what...to be their friends? Hell, for their business. So we shouldn't be so surprised, we asked for it, now we have to deal with it. We (being the reps and manufactures) created this monster now we are trying to tame the beast...I wish us all the luck in the world. One can only hope that the new crop of residents will bring in a fresh look, attitude and face to the business. I welcome your feedback...
Peace!
Depuy, Medtronic, and Stryker have spent years building good will with these entertaining trips, and lavish dinners. Generations of surgeons now have been raised to use these companies. There is no way for the government to level the playing field, the barn door opened a long long time ago. The surgeons who do not like to be strong armed by the hospitals into using the big 3 have sought out other options.. hence... PODs and other supply chains . The medtronic rep in my area tried to maintain complete control over his doc and went too far and it backfired,, Doc went POD
DeleteYes, is the answer to your questions.
ReplyDeleteSounds like someone else is also reading
ReplyDeletehttp://www.amazon.com/What-Money-Cant-Buy-Markets/dp/0374203032
I disagree that surgeons and reps have become commoditized. The ones we read and hear about all sound the same because they are the ones wrecking the industry and its (our) reputation. I have been fortunate that the surgeons in my area that I deal with have NEVER asked for a piece of the supply side pie. There are a few around who play fast and loose with the rules, but none like the Makkars, Steinmanns and Hochshulers of the industry. I also have some very good competition in my area with some very good reps that have all been around a long time. Maybe the usual suspects on both sides are becoming commodities among their peers. How many more creative ways can you induce a surgeon? Why do they all seem to find each other, yet many of us (I hope) are like me and have never been approached for a deal.
ReplyDelete4:57,
ReplyDeleteIf you want to be approached for a deal, try doing business in Miami/Palm Beach. You can't swing a dead midget without hitting a brilliant 'design surgeon'. Pioneer, Penile USA, Amendia & Globus are working overtime. Kind of hard to make a living by just providing good stuff and service.
These pricks can't even change their own oil. The fact that they think they can design a mechanical device is astounding. Their designs are laughable.
DeleteLook at the screws they use. LOL!
Other than the M6 and the NeoDisk everything else is junk.
SO as everyone is aware The VP of Xspineless is getting phased out! Will the company be more profitable with the tools that are left to run the show? Will Dr K have to go back to performing surgeries since according to him is the father of modern spine surgery. Will the brothers that run the show figure out that with out Plastic Joe sales go away?
ReplyDeleteI AM A SPINE SURGEON AND AM NOT INVOLVED IN ANY OF THIS BS. HOWEVER, NOTHING WILL CHANGE UNTIL SOME OF THESE SPINOMANIACS ARE PUT IN JAIL AND LOSE THEIR LICENSES. SINCE THE OIG CAN'T SEEM TO DECIDE WHAT'S LEGAL OR NOT, AND SINCE THE STEINMANNS OF THE WORLD WILL CONTINUE TO INFECT DOCS, THERE WILL BE NO REASON TO CHANGE THEIR GREEDY BEHAVIOR. GOD HELP US ALL.
ReplyDeleteplease read my reply below to you and thank you for understanding what we patient suffer at the hands of corrupt medical device industry.
DeleteHey Doc,
ReplyDeleteThat was the best, well placed 911 call of all time :)
Peace!
The question I would like answered is how many Depuy Consultants are there? It seems that the distributors did a great job of getting consultancy agreements in place for the work horse customers. Depuy really seems to have figured out how to keep up the engagement of customers as good as if not better than before the deferred prosecution agreement. I am certain it's all done correctly through the J&J legal powerhouse; but it still translates to influence of surgeons in the real world. Now that the sales force is transitioning to a direct force how will they pick consultants for new endeavors? Well there are still a few distributors left and they probably will have first pick of who is signed up.
ReplyDeleteTo Spine Surgeon: your post was music to my ears. My cervical spine is seriously damaged due to a metal on metal trial implant with nickel. The protocol required the sponsor to disclose all metals, as well as prescreen for allergies. The sponsor did neither, and as it turned out I am extremely allergic to nickel. Here is a picture of a myelogram taken two years post implant, with me complaining of excruciating night pain and waking up paralyzed or without any feeling what so ever in my arms and hands - http://CerviCoreSpine.com ( turns out it was never a fully approved IDE - had a conditional approval and sponsor
ReplyDeletenever complied with the conditions)
I recently had X rays taken and there is a huge black lesion posterior C5 and the device has subsided on one side (left) approximately 6 CMs. Since this is a questionable trial device, independent surgeons are reluctant to diagnose or treat me. The FDA requires surgeons to report clinical failures of medical devices and surgeons are not willing to get involved since insurance will not cover investigational surgeries or revisions. The sponsor refused to remove the device when I filed a claim 3 years ago, because it would have drawn attention to just how out of compliance the entire study was. Today I live in excruciating pain from the metallosis due to my nickel allergy and so far I am told there isn't much I can do about it if the sponsor refuses to pay for removing the device. Even though the consent form clearly promised to pay for medical expenses if I were injured. What I did not know at the time of the implant surgery was that the study was remanded to FDA black box for trial of device never approved for any use in 2007 - and I was recruited in 2008, long after it was stopped by FDA.
It is refreshing to see an honest spine surgeon out here in the wilderness. Patients who are permanently injured because of criminal negligence committed by sponsor in a trial that turned out to have been never fully approved leaves a very bitter taste in the mouths of the injured person. More so since the sponsor attempted to pay me off with an offer of $10,000.00 if I signed a release form stating that my injury was not caused by the device - and the sponsor still had not disclosed to me that there was nickel in the CerviCore disc. I had to buy a medical book that was touting these new trial devices to learn what the real protocol was supposed to be for this device - and the fact that timing of MacMillan's ouster and Stryker sending letters to the subjectsmabruptly halting the study is very curious, as it happened the same week in February, 2012.
I have been contacted by 9 other volunteers who all have the same story to tell and the FDA is in lock lip mode. We have no idea what we are supposed to do aboutmour injuries as the sponsor is still not disclosing to us that there is nickel in their device and we were supposed to have been prescreened for all of the metals in the device - for this very reason, to disqualify us if we had a hyper sensitivity to any ofmthe metals.
Please don't ever sell out your integrity doc - you are our only hope.
I used to work with powdered metal. It was a mix of nickel and chromium. Both are known carcinogens. There are so many better materials.
DeleteMedtronics bribed 100 doctors to lie about Infuse during clinical trials. J&J Depuy knew that their hip implant was dangerous junk before it went into clinical trial.
These things are not screw ups. Nobody is that stupid. They make money, rip off investors, kill and maim, pay a fine, rinse and repeat.
Snipers? Think about it. If SEAL team 6 dumped a few of these gangsters with the warning that if the don't clean up their act more will follow they will clean up their act.
To the honest spine surgeon: You are what is known as the exception that proves the rule. Most spine surgeon I know really need their teeth knocked out and their fingers broken.
Make sure to go on Rate MD, Heath Grades ect.. and trash these butchers. If you are at the point where your life is is not worth living make your life count for something and take out some of these crooks. It would not be wrong.
The medical industry has no problem with being called the medical industry and that is a problem. That is the problem.
ReplyDeleteThe spine industry is just as sleazy as the rest of the medical industry.
My Godfather was a doctor. When he was a doctor he was part of a profession that was guided by compassion and the Oath.
Greed sucks.
Snipers?
Fat Bastard,
ReplyDeleteIn a just world, your approach is justified. We do not even live in a sane world where common sense makes sense. We live in a plutocracy. Snipers work for the Plutocracy - and do not do favors for innocent victims of white coat sociopaths. Only in the movies... My way is to expose them - if they have a problem with reading the truth - then sue me! Otherwise, I fear that we victims may be the ones who should watch our backs and look up to check out roof tops for a sniper in position. Since we Stryker CerviCore victims are starting to surface in numbers, Stryker may have to 'cull the herd in an attempt to slow down the domino effect'.
I am not the Spine Doctor. I am the victim of an illegal spinal implant at C5 C6 that was manufactured by Stryker Spine in their plant in Cestas, France. The device is called: CerviCore Disc. It lives in an FDA database called: trial device NOT approved or cleared by the US FDA. It was listed as a. " delayed posting" which means that it was never FULLY approved for any use. It briefly had a " conditional approval " which gives the corporation 45 days to meet FDA criteria for a full IDE approval. If the conditionsaree not met within 45 days, the IDE becomes invalid. That would have been sometime in April of 2006 - give or take some grace time. The first MAUDE Adverse Event was reported in June 2006, stating that the device subsided within 24 hours of implantation. This is a device malfunction and the FDA will halt a study if the actual Device malfunctions - and it appears that it was halted, except that Stryker did not want to tell their stockholders that their $126,000, 000.00 million dollar acquisition of SpineCore to launch two new devices was a total bust. So Stryker continued the pretense that the study was legit and paid the surgeons to continue to recruit - now there are approximately 200 innocent people walking around with this disc who first off, were never told about the nickel or the toxicity of the combination of metals. I now have beebread tested as having a severe metal allergic reaction to the device, a condition called metallosis. The consent form I signed stated that if I were injured by the device, Stryker would pay medical expenses to remove it, etc. They turned my claim down, said that I was a-ok and would " I please sign am release of all liability" in exchange for a check for $10,000.00! ps, Sponsor are prohibited from coercing clinical trial subjects from waiving any right or inducing them with money to waive a right . But since this was NOT legit, they just do whatever they want knowing that it is next to impossible for an injured clinical trial subject to get a law firm to sue Stryker because of the implied FDA exemption that is protected by trade secret confidentiality. This means if Stryker illegally implanted these discs in our cervical spines and injured us, nothing can be done until the FDA says the trial was halted and ordered to the FDA black box. In other words, Stryker can Kill us and the government may or may not protect us, depending on how complicit the government was in allowing Stryker to illegally implant toxic devices into our cervical spines. Did I mention that I have met approximately 11 other victims whose lives have been destroyed by this corporation and their surgeons who are covering up the severity of the adverse events? What will be, will be Fat Bastard! I will leave it to karma - covert karma works in strange and mysterious ways. Goddess Kali
Click HERE Stryker Howmedica Cervicore Crimes
ReplyDelete