Family Affair

Yes siree Spinebloggers, "the ability to promote from within is culturally invaluable."  Yet, it depends on ones interpretation of what type of culture one would like to promulgate.  When one thinks of something quick and agile, TSB suspects that the proverbial 800 pound gorilla is not what comes to mind unless one wants unquestionable power. Yet, after years of chewing up and spitting out employees and convincing sales reps and distributors to drink the purple kook-aid, the Bear is at a proverbial public relations cross roads.  Will he survive or will he walk the proverbial gang plank?  As one great sage once said, "all things must pass."  One can use only so many metaphors until it begins to fall on def ears. Yet, between the Cheetah being an endangered species,  how does a 14 year old company still considers calling itself a start-up?  What's it starting up?  Is that what Nuvasive pays its New York based public relations firm for?

Let's face it, NuVasive is no longer the Cheetah that it was seven years ago, it resembles the elephant that it detested in its old mentor and training ground Medtronic Sofamor Danek.  It has become top heavy and resembles a sever layer cake, fat with bureaucrats and administrators who like to tell one another and the lackey analysts  how great they are. How does a company build a unique culture when it recruits from DePuy? US Surgical? or Medtronic? Are you really building something unique? Is it a "new" culture or is it really just building the mirror image of what it has told the street and its investors    it wasn't going to be? It was only yesterday, a day in the lives of some of Nuvasive's bureaucrats, that they wanted to be something different, they took pride in being different than their former employer.  In many respect  Nuvasive has become everything it said it would not.

Mr. French can only coddle Jodie and Buffy so long before he no longer sings as the tenor.  TSB is sure that Mssrs. Link, Powers, and Durall are probably good citizens whom have now been tasked with attempting to make right what has gone wrong. Yet, if Mr. French is now going to be quoted as saying that he is "pleased to be engaged with his sales executives," does that mean that up until this point he wasn't?  Our readers have to love those corporate buzz words, "making progress on multiple initiatives, sales force penetration deeper into accounts (TSB bets that sends a tingle down the ladies spine), efforts that are not expected to hinder the company's profitability."  Who knows with a press release like that cigarette sales will be up across the board.  So as Sly Stone once sang,

"Newly wed a year ago, but there still checkin' each other out, Nobody wants to blow, Nobody wants to be left out, You can't leave cause your heart is there, but you can't stay because you've been somewhere else.................It's a family affair, It's a family affair.

Black Friday

The last couple of weeks have been an eye opener of sorts as TSB is traveling the U.S. talking to many of your peers to get a pulse on the industry.  It has become evident that management in most  companies still don't get it.  Since the market crashed and nearly burned in late '07 thru most of '08, the oracles of the industry are still stuck in that proverbial time warp.  20% growth use to be the norm, but as Don McLean once sang, "bye, bye Miss American Pie." The insanity of the industry is closely tied to those CEO's that are still attempting to manipulate their stock portfolio's and promise the Street that they are will be the next billion dollar baby. How can anyone run a company that has so much tied into the current and future valuation of their own stock? Are they making prudent decisions based on potential technologies?  Let's face facts, this isn't a new phenomenon, the NY Times (that socialist publication) has had numerous articles on this topic dating back to 1996.

What is it about our society and American business people in general.  That's right we're talking about the golden oracle theory, I said it, therefore, it must be true.  Just look at today's talk shows and hear them debate the economy.  "Sales aren't what we expected."  "Stores opened on Thursday night, and sales were still not up to expectation." Just because you opened Kmart, JC Penny's, Target, or Walmart 12 hours earlier doesn't mean that people that shop at those stores are going to spend more, all they are going to do is look for a better deal.  And this brings us to the gist of today's blog.  The spine industry is no different than the insanity that prevails on a daily if not monthly basis in this country.  The golden oracle theory holds true.  Don't believe it, listen to the insanity.  

A Regional Manager that works for a highly esteemed and beloved favorite of the Street recently stated, "I received a 30% increase in quota, our ASP is going south, my sales team has increased the number of cases from 2011 and I am still short of quota year to date.  Even if I finish at 98.6% my CEO and VP of Sales are not going to be happy."  Or, "my CEO and VP of Sales called with two days left until the close of the month and asked if we could call Dr. Famous and ask him to book a few cases."  That has to be one of TSB's all time favorites.  What is it about things dick heads that makes them believe that just because you have a surgeon that is a loyal customer, that they are just going to pull a couple of patients out of their ass and get you those numbers? These aren't isolated situations.  There seems to be an epidemic in the industry. Do any of those oracles understand how much the landscape has changed  since they were out in the field?  Whatever happened to the oracles that made grandiose promises of increasing the business 300 or 400% at some of the smaller companies within the industry? As Ray Davies once sang, "everybody's a hero, everybody's a star," until reality sets in. Some of these oracles are walking the concrete down on 125th St, or in Southern Cal licking their wounds. What has happened to the companies that have burned through $20-$25 million of investment capital and are struggling because the person at the helm of the ship has no experience. What has happened to all that foreign capital that some were waiting for? Nada. Bupkus. Even the Captain of the Costa Concordia knew when to jump ship with the bella donna. What happened to some of those companies whose CEO claimed that they were offered $18 million only to exclaim, "if someone is offering me $18, then my company must be worth at least $45 million."  Today, they are scratching and scraping a mere existence.  How do some of those investors really feel? Were they taken for a ride?

Happy Days no longer exist. Richie and the Fonz have been replaced by Reality Television, deep down everyone wants to be like the Spine Executives of Orange County or Montgomery County. Hey maybe TSB should trademark those names and bring that concept to the cable networks? Borscht and  Hariyali Kebab will be on the menu, it would be pretty funny. Some people wonder why there hasn't been more written about spine, but the question must be asked, what is so new and innovative that it warrants the attention of TSB? Zimmer is going to train regulators in China? Regulation? How about some quality control lessons for our Asian brethren? How about teaching them about ethical business practices? If there ever was a Xerox culture, welcome to China. Medtronic buys 80% of China's tier one hospitals? Has anything really changed. Nuvasive's most innovative technology this year was the Houdini Rod Bending System, the now you see it, now your don't system, increasing the price of their implants? Innovation in procedural tools doesn't necessarily warrant an increase in pricing or  necessarily will increase your sales volume. It may even make the case go ten minutes faster, but as an accountant what's the difference if hospital operating rooms are run on fixed costs. Could it be that the spine industry is hanging on to the last vestiges of its stellar past?  Could the rise and fall of spine be equated to Pompeii? 

Maybe "the secret" is understanding current market conditions and having the innate ability to adjust rather than continue doing the same things over and over.  Maybe fewer MBA's and more worker bee's would suffice, especially on the corporate level?  Maybe fewer bullshit artists running these companies would better serve the BOD and stockholders? TSB has beaten the drum on POD's, POC's, and Consultancies to the point of ad nauseam.  Today, we hear the biggest and baddest CEO preempt a quarterly earnings report by informing the same analysts whom placed him on a pedestal that his companies revenue is in sequential decline due to factors out of their control. What world was this person living in? We hear of other CEO's laying off employees due to the Affordable Care Act, which is nothing more than political theater, considering that the real owners are left wing sympathizers.  Talk about responsibility?  Maybe some of our highly esteemed oracles should learn that the same way the Street nearly sucked the life out of our economy, they will eventually suck the life out of this industry.

This isn't what is known in media circles as "blow job" journalism, if you want that, go to OTW or OrthoWorld, it's up to the people that run the very companies that make up the spine world to adapt or perish.  Maybe being realistic is too simple.  Maybe aligning your quotas and expectations in addition to respecting your employees knowledge, dedication and hard work is too simple a formula, but then they don't teach that to MBA's because its all about the numbers. Maybe the commitment that you show your employees has more to do with the success of your organization, than pandering to the shareholders who live in a world of short term results but expect long term viability.  So in closing,

When Black Friday comes, I'll stand down by the door
And catch the CEO's when they dive from the fourteenth floor
When Black Friday comes, I'll collect everything I'm owned
And before my friends find out, I'll be on the road
When Black Friday falls you know its got to be
Don't let it fall on me.

Wednesday Op-Ed Piece

Good Morning spine bloggers, now that America gets to take the proverbial mornin' after pill, and nurse an election hangover, as the pundits backtrack and attempt to rationalize their poor prognostications, there is a need to express a few words to our readers.  The 2012 election was a referendum by "We the People." Those words signify the very essence of what has made, and will continue to make these United States of America unique and special. This country was built by the blood, sweat, and tears of immigrant people long gone but not forgotten.  Yet, America is no longer a mirror image of our European ancestors. The landscape has dramatically changed. Ironically, a Republican politico declared that for the first time in this country's history, the election was decided by minorities.  He needs to be corrected, "it's the first time that minorities have become the majority in the U.S. electoral process, affecting the final outcome. Americans need to learn and accept the foundation on which this country was built upon. "We the People," symbolizes everyman and woman regardless whether they are, Republican, Democrat, Independent, Libertarian, Tea Party member, Young, the Elderly, Blacks, Whites, Latinos, Homosexuals, Catholics, Presbyterians, Jews, Bible Thumpers, Agnostics, or Aetheists' to name a few. It includes the rich, the middle class, and the poor. The gateway to this country has a credo that says, "give us your tired, your poor and your hungry." This is what made this country great. Yet, until we learn to respect ourselves, respect one another's opinions, respect our differences as people, we will never be a United States, we will be a divided country. Yes fellow bloggers, this election was a referendum, that  the People have the Power in a Democracy.  No amount of money, not even the Supreme Court could influence the out come of a Presidential Election. We can learn to adapt or we can perish. Life isn't a 30 second sound bite spewing some ridiculous commentary about either candidate. This isn't Egypt, or Iran, Russia, Syria, China, or India for that matter. That's what makes this the greatest country in the world.  Don't believe it?  Why do the Indians, the Chinese, or Middle Easterners send their children to our schools? Why do they want to be like us?  Why do they desire a pedigree education? Why do people want iPhones or iPads? Why do people love blue jeans, rock n'roll, the blues, gospel, or jazz? Why do they like the Almighty Dollar?  Because contrary to  some of our beliefs, they believe that this is a better place, that maybe the streets are lined with gold.  

Maybe this is the start of something new?  Is that wishful thinking? Is that being idealistic?  TSB leaves that up to your own illusions. The spine industry and business in general needs to stop behaving like the spoiled children that they are. The sky is not falling, you will still be able to earn a living in America contrary to what you hear, even if Obama is the POTUS.  It's not you the people that need to change, it is the people that run this country. The CEO's  in our industry need to tighten their own belts and stop blaming the ordinary workers that have built their companies for the state of the healthcare union. It's time to tell the Street and your shareholders that you need to take a little less to achieve some long-term results, if any of you have the balls to do it? Your short-term mentality, and lack of planning has brought you to this crossroad. Don't believe it? I recommend that you listen to Alex Lukianov's last conference call with the analysts. "Sequential decline?" How can we not laugh our asses off.  It's called immediate gratification. It's called greed. It's called manipulating the information to increase the valuation of your stock portfolio. If the oracles of the industry spent as much time on developing their people and their products, you wouldn't need to rationalize your failures or make excuses. Leadership means leading by example, not chewing up and spiting out your employees. For once, stop spouting off the irrational and ridiculous commentary that you have been making for the last four years. How absurd and treasonous is it to hear someone say that a 2 plus% medical device tax is going to cost people their jobs. Really?  Haven't we heard that for the last twenty years?  "Remember the good old days?"  "Remember when we made serious money?" Individually each and everyone of you has that opportunity, it comes down to hard work and a lot of luck. So what will be the outcome of this election and how will it effect your success or failures?  That's up to you.  Do you want to lead or do you want to be sheep? Obama is not going to affect you earnings, your companies product portfolio, your companies ability to adapt, and your desire to succeed will be the ultimate factor. Do you want to do it the right way or do you want to take more short cuts?  The companies in our industry and other industries tout that they will look to expand in foreign markets?  Really? Go sell your products in Europe or in China, and then tell us what your margins are.  How absurd is it to hear a CEO of a shitty pizza company say that he is going to have to raise the price of his pizza 15 cents in order to provide his employees healthcare?  Really? How absurd is it to have to listen to another physicians complain about ObamaCare when it hasn't even been implemented?  Maybe if we spent as much energy on rolling up our sleeves and coming up with innovation and solutions, working hard and working smart, we would stop worrying about the other guy. Stop worrying about the shareholders, and start worrying about your people, your most valuable resource.

So in closing, its another day in the Crystal City and TSB is healthy, happy and  I have a job in the greatest country in the world.  America, you gotta love it, or go try building a casino and skyscraper in Somalia.  Peace!

Edition X Subtraction = Bad Press

Since the U.S. financial market nearly crashed and burned in 2008, resulting in an economy running on quaaludes with high unemployment rates, and major bailouts for criminal banksters, with the little guy being everyone's scapegoat, we have learned that as long as we capitalize on our behavior we can rationalize success without any consequence.  But can We? Yesterdays WSJ and NYT's reported that the U.S. Senate Committee on Finance reported that Medtronic edited studies by outside researchers pertaining to INFUSE (C'est Moi). This finding stems from reports alleging that physicians authors who had financial ties to Medtronic failed to report dangerous side effects associated with INFUSE. A minor omission, all for the love of the Almighty Dollar, but more on that at the end of this blog. But rather than get caught up in the Pomp and Circumstance that is always played out on Capitol Hill, let's be equitable and analyze this from a realistic perspective. There are two parties culpable in aiding and abetting these findings. Medtronic and the individual Spine Surgeons involved in the original studies.  NASS your members do have a wonderful reputation. Here are the findings;

Medtronic

• Drafted, edited and shaped the content of the studies
• Paid $ 210 million to physicians involved in the studies
• and its employees recommended against publishing adverse effects
• prepared Hal (rust never sleeps) Matthews remarks to the FDA
• attempted to adopt weaker safety rules

As we all know INFUSE was originally approved for an ALIF surgical approach, yet the statistical analysis goes on to expose that the original issues concerning the FDA regarding INFUSE came to roost.  The fact is that 85% of all lumbar surgery was off-label use in 2009, in 2008 75% of all reported adverse events were for off-label use for cervical spine, leading up to the FDA's refusal to approve Amplify in 2011. Dosing has always been an issue, as has off-label use.  For the many good results that INFUSE has produced, by hiding the adverse events, and skewing the data, INFUSE'S long-term viability has been assaulted all for short-term gains.  But isn't this the exact business philosophy that has driven the United States economy into a grifter society?

As a by product of this report, there are many questions that need to answered if spine is to cleanse it reputation, once and for all.

• What happens when a physician has financial ties to a company's success?
• Does this affect their ability to make legitimate rational decisions?
• How does this affect the market and "free-market" enterprise?
• What happens when employees start to collaborate with physicians on the substance and content of a clinical study?
• Does this drive up the cost of delivering healthcare?

If we believe in the "Peer Review Process," how can any company defend and accept the contributions of their employees to a clinical study?  Have any of these employees contributed first-hand surgical data to these studies? If adverse events are consciously omitted, and the physician authors agreed to this tactic, what does it say about the physicians involved?  TSB is not OTW, calling out the adversary for questioning the substance and content of these studies, but then TSB is not some wannabe financial advisor that kisses the ass of the industry all for the love of our own motives. Their is something fundamentally perverse when we game the system, extract hundreds of millions, if not billions of dollars from the healthcare system, and then we complain about the iron clad hand of government cracking down on healthcare delivery.  As TSB's mentors use to say, "there's a right way and a wrong way of doing things." How many of you recollect the many horror stories we heard in the 2002 or 2003 from some of the surgeons involved in trialing INFUSE?  

The same concerns that the FDA initially had came to fruition, off-label use.  But then, the FDA should accept some blame in this game, INFUSE is a pharmaceutical and not a biologic product in the truest sense.  The FDA should have held this product to a different standard.  As healthcare comes under assault, the potential for profiteering has escalated whereby we no longer created new technology but new ways of gaming the system.  The days of signing Dr. Famous to a consulting agreement in exchange for their business has evolved into multi-layered business models.  Today, doctors don't want to be doctors, they want to be everything but being a doctor. But who's to fault for this behavior? The company's and CEO's that have built this industry? They have advocated and encouraged this aberration, we call spine.  Today, the same people that poached other companies sales people or surgeon consultants cry foul when they have to compete against POD's and POC's. They orate that they have had "a sequential decline in revenue" due to market forces out of their control. Excuses, excuses, excuses. Can't handle the heat? Get out of the kitchen. Payback can be a bitch. If companies learned how to treat their employees respectfully, set realistic revenue expectations, and stopped kissing the ass of the milquetoast analysts, maybe spine would be an honorable industry. But then again, that would be wishful thinking, so party on.  Another bottle of Petrus please.  

Thomas P. Rainey - RIP

Yes, fellow bloggers TSB is alive and well.  Unfortunately, its been tough getting excited about NASS where the self-proclaimed oracles of the industry fellate one another in a spinal bacchanalia.  Alex is licking his wounds, while David rode in on his elephant with his sidekick Tatoo pulling on the reins, the VBrothers believe that they invented spine, of course, that's Robin Young their personal shill putting that spin on their recent success. Who really cares whether LDR is up for sale? What death teaches us is that life is nothing more than an illusion. The things that many of you place tremendous value on can be snuffed out or taken away in a single gasp of one's breath. Does any of this make sense?  Are any of you really that important?  Maybe in your own mind, to assuage your insecurities.  

This week delivered a cold dose of reality to those of us that ever had the opportunity to know Tom Rainey. Unexpectedly, he succumbed to multiple myeloma. If any of you knew Rainey, he was one of the good guys. You won't read about him in OTW because he wasn't kissing anyone's ass, or blowing anyone's horn, or telling everyone how great he was. He did his job. He left self-promotion up to the nitwits in this industry. And God only knows that there are many nitwits in this industry, just take the blinders off as you walk down the aisle at NASS this week. You might even be working or representing product for one.  

So as many wonder what happened to TSB, at times reality rears its ugly head and bites you in the ass. Look around and come to grips with your own mortality, death has a rude way of reminding you of how insignificant this really is. NASS?  Who cares.  Remember what Jackson Browne sang:

Keep a fire burning in your eye, Pay attention to the open sky

You never know what will be coming down, 

I don't remember losing track of you

You were always dancing in and out of view

I must have thought you'd always be around, Always keeping it real by playing the clown

Now you're nowhere to be found

I don't know what happens when people die, can't seen to grasp it as hard as I try

It's like a song I can hear playing in my right ear

That I can't sing, I can't help listening

And I can't help feeling stupid standing around, crying as they ease you down

'cause I know that you'd rather we were dancing. dancing our sorrow away

No matter what fate chooses to play

Just do the steps that you've been shown

By everyone you've ever know

Until the dance becomes your very own

No matter how close to yours

Another's steps have grown

In the end there is one dance you'll do alone

So in closing, go to The Lodge tonight and have a drink and remember we will all do this dance alone.  Rest peacefully my friend you will be missed.

TSB

Sunday Op-Ed Piece

In April of 2011, the Wall Street Journal wrote an article about one V. James Makker, formerly a practicing neurosurgeon in Oregon.  The article identified that the former doctor had performed multiple  spine fusions on patients, 10 times the national average, at that time Makker was being investigated by the FBI and the Medical Board for the state.  At a meeting on September 24th, 2012, the Board and Makker have agreed that it was time for the former neurosurgeon to leave the medical profession.  What is fascinating with the pomp and circumstance of stripping away his right to practice medicine is that the deal includes Mr. Makker denying he has done anything wrong.  So why didn't he fight the Board's demands?

In 2006, the laissez-faire Oregon Medical Board had investigated Makker and accused him of inappropriate and unnecessary billing, unnecessary surgeries, misleading statements, and "gross or repeated negligence." His punishment?  New training and an audit of his billing to settle the case.  In retrospect, the patients that have been harmed should probably consider suing the Oregon Medical Board that handed down this decision for negligence.  If the foxes are protecting the hen house, how is John Q. Public protected?  Makker has agreed to provisions in the settlement that he can never reapply for the privilege to practice medicine in Oregon, and that this finding will be reported to every state in the union making it unlikely that he will ever practice medicine legally in the United States.

Mr. Makker's response on his LinkedIn page was even more troubling, to paraphrase, "my success generated jealousy, I was slandered, etc., etc.  So here is TSB's suggestion to the Board of Directors at NASS, rather than toast yourselves at this years meeting, patting one another on the back, telling each other how great you are, or about the next big deal you signed with some POD or some desperate company, a moment of silence and reflection may be needed on why you really entered the art of medicine. You are "entitled" to be compensated commensurate for your skill sets, but at the same time, somewhere back in time you took an oath to practice medicine ethically and honestly, who knows, it might do some of you some good. But then, it may not. You should be thankful that you have a career that other people envy, but at the same time, as a member of that exclusive club, it doesn't give you the right to do whatever you can within the confines of the law to potentially make someone worse at the expense of padding your personal wallet.  

In closing, maybe Mr. Makker will take the time to come to grips with his own realities. He had the world and the health of his patients in the palm of his hands, only to have it taken away by the type of behavior that gives a great profession a very bad name. Does a man or an industry have the ability to change its innate nature? Rather than be critical of the current environment and the debate that surrounds all Americans regarding healthcare, we should be asking ourselves questions, whether the actions of the few permeate and delude our perceptions of what is right and what is wrong? Do we justify our behaviors by income rationalization?  TSB wants to know what our readers think?

Nuvasive - Where's Vanilla Ice When You Need Him?

The last two days have been terrible for the biggest and baddest cheetah in the jungle.  The hunter has become the hunted. The predator has become the victim.  Even the performance that Vanilla Ice had last night has not provided NuVa with a respite.  Who knows maybe he can save the company by coming in a leveraging more money against NuVa's balance sheet, take out his management fees, and then sell off the company?  Maybe David Paul may be interested, he has been dubbed the new king of the jungle, hasn't he?  Looks like NuVasive is going down faster than Marilyn Chambers ever did. Alex's sphincter must be pretty tight considering that he is starting to run out of excuses.  POD's affecting his top line?  Come on, that's another excuse, big boy.  Maybe he can blame Obama for the current environment that we are all learning to adapt to.  You know what Axl Rose use to say;

Welcome to the Jungle we've got fun and games, we've got everything you want Alex we know all the names, We are the people that can find whatever you may need , If you got the money honey we got your disease. Can anyone spell SHORT?

Orthofix: The Beat Goes On!

Bad Karma is well, Bad Karma.  Ever since Orthofix acquired Blackstone Medical, the stars have not been aligned, nor have the Gods been conciliatory, casting pestilence and disease over Lewisville, Texas. No news is good news. Orthofix just cannot stay out of the news.  On September 28th, 2012, the U.S. Attorney charged one Brian Racey, a resident of the Commonwealth of Pennsylvania, and an employee of Orthofix, with one count of Healthcare Fraud.  The charge was levied against the accused in the United States District Court for the Eastern District of Pennsylvania for allegedly scheming to submit $250,000 in fraudulent claims that did not meet Medicare guidelines for bone growth stimulators. Is it a wonder why sales have been robust at O'fix?  With all the hoopla surrounding Obamacare and the governments insistence on controlling the cost of healthcare, is it any wonder why the government is policing this industry? Haven't we learned anything? Hasn't this company learned anything? Who knows where all the dead bodies lie?  Haven't the employees at O'fix learned anything? Many will insist that there isn't anything wrong with the system, but as allegations and convictions continue to mount in the O'fix Hall of Shame, the time has come to accept the fact that corruption runs rampant, and until some O'fix executives and physicians are prosecuted and jailed it will be business as usual until the next time.  It's time for the government to stop accepting the old Rudy Giuliani, aka the Sergeant Schultz defense, "I know nothin'!"

The "Physio-Stim," the smoking gun, is only covered by Medicare if a patient has an established non-union of a long bone fracture. Between 2004 and 2011, the government alleges that numerous physicians prescribed bone growth stimulators for patients that did not meet this criteria. During this period  Medicare paid out $250,000 for at least 100 claims submitted by Racey. Mr. Racey is accused of allegedly forging physician chart notes and prescriptions to create the appearance that the orders met Medicare guidelines.  Where does the insanity stop?  On average Racey made a whopping $500 commission per a Medicare paid claim of $3,020.  Based on these numbers, Racey made an estimated $41,000 in commissions.  Mr. Racey violated Title 18, of the United States Code, Section 1347.  Was it worth it?  Can one say treble damages?  Maybe its time that the judicial system in this country stop pandering to white collar criminals and literally throw the book at these people.  Imagine that someone can get 10 years for robbing a gas station for $50 dollars, eighty percent of ten years is an eight year term that must be served if convicted, maybe its time for Mr. Racey to cut a deal?  Someone needs to take down the ship.  What do our readers think? 

Former CEO of Hospital for Special Surgery Charged

Yes, fellow bloggers, TSB is alive and well.  It's been an entertaining yet pathetic week and a half on this blog in lieu of the drums that some of our readers insist on beating.  TSB intends to censor as much as possible.  For the three plus years that we have been reporting about the medical device industry, we have never been as fixated on crucifying the industry for its short-comings as have a few of our readers. In spite of those that believe that TSB only writes about the negative, we believe that there are many people in this industry that deliver exceptional medicine and care to their patients.  That there are many sales people that get up everyday and do the best they can.  That there are a few executives that really would like to do the right thing.  As usual its, the 20% that ruin it for the rest of us.  We do not need to be reminded that there are many things wrong, but there are many things that are done with the best of intent. It's called checks and balances. Yet, the last few weeks have been educational to say the least.  Today's breaking news continues to validate the many things that need to be eradicated from within the healthcare industry. The delivery of healthcare has become such a big business with so many nefarious players, is it a wonder that today's story about a former CEO of "The" Hospital for Special Surgery, the mecca for Orthopedics, cast dispersions and a black cloud over the creme de la creme of hospitals?

On Wednesday, September 26th, 2012, John Reynolds a former CEO of New York Hospital for Special Surgery was arrested at his home in Cataumet, Massachusetts and charged in federal court with racketeering and making false statements.  These charges are punishable by 25 years, which would mean that if Mssr. Reynolds is convicted of all of the charges he will have to serve at least 20 years in the big house.  Mssr. Reynolds served as the Chief Financial Officer from 1986 through 1997, and was CEO from 1997 through 2006. 

Prosecutors allege that Mssr. Reynolds was engaged in a decade long kick back scheme that solicited money from vendors, a hospital employee, and a UK based healthcare organization. Obviously Mssr. Reynolds attorney was quoted as saying that these allegations are baseless and that Reynolds looks forward to his day in court.  But isn't this the typical tactic by all attorneys? Everything is baseless until discovery proves that there may be sufficient evidence for conviction. And then what does it say about how business has been done in the past, the present, and potentially the future at a facility like Special Surgery.  Have we stooped so low that some surgeons actually demand a payment from a rep to make a sales pitch on his product?  Do we now have to deal with hospital administrators shaking down company reps for an opportunity to sell their products in a free market?  TSB can't wait for all those free-marketeers to defend these actions.  But let's be honest, if the federalis didn't have evidence that they believed that they could win a conviction, would they even bother with Mssr. Reynolds?

TSB's money is with the feds. Mssr. Reynold's is entitled to his day in court, but if TSB is gambling with my money, my bet is plea deal after all is said and done.  What do our readers think?  

Amedica: To Be or Not To Be, That Is The Question?

If ever there was a company in the spine industry that has resembled a roller coaster, Amedica may be the poster child for the ups and downs of the world of spine.  After raising north of $100 million to bring Silicon Nitride by storm into the industry, after making poor choices in leadership, after a failed attempt at taking the company public, could this be the defining moment that finally gives Amedica hope?  As Clint Eastwood would say, "are you feeling lucky, of course to an empty chair."

On September 13th, Amedica issued two press releases announcing an expansion of its claims that their Silicon Nitride material has superior osteointegration and anti-infective capabilites when compared to the current state-of-the art. For years, PEEK has been considered the gold standard in inter-body due to its modulus of elasticity and versatility as a biomaterial. When comparing Silicon Nitride to PEEK the question must be asked, "will the expanded labeling of this product shift the standard of care for  patients that need lumbar fusion?" 

Amedica was quick to take advantage of these articles that were published in Acta Biomaterialia and the International Journal of Nanomedicine, which demonstrated that when comparing Silicon Nitride to PEEK or Titanium (is anyone actually using titanium interbody devices anymore?) there was superior bone formation, osteointegration, as well as anti-infective properties.  Once again, questions abound whether surgeons are unhappy with the results when using PEEK and whatever magic dust is infused into an affected vertebral segment?  Could these recent findings shift current market dynamics?  As the government seeks to place a premium on evidence based medicine, will these findings improve patient outcomes?  Is this much ado about nothing? Could this be another Hail Mary?  Doug Flutie where are  you?  One of the most important statements in this press release focuses on the potential for higher reimbursements for surgeons and hospitals. A strategically placed statement?  You be the judge. Does PEEK actually contribute to the colonization of bacteria which may reduce fusion rates?  What are the infections rate in lumbar spine fusions? 

Yet, before our readers go any further, we would like to know the relationship between Amedica and the surgeons involved in making statements regarding product efficacy (Skidmore) and findings regarding bacterial infections (Webster), a nano of transparency assuages everyones trepidation when reading these PR statements.  TSB is not being a skeptic, TSB is asking the questions so that  the court of public opinion can determine whether Amedica's claims are legitimate or as stated earlier much ado about nothing? Hey Amedica are you feeling lucky? To be? Or not to be? That is the question.

Mild v. Not So Mild or Vertos v. Dr. Fourney

Spine Nation:

If you haven't had the opportunity to read the article by Barry Meier from the NY Times on September 5th, 2012 entitled, "A Clash Over a Spine Treatment," please do take the time.   The article pits Vertos against Dr. Daryl F. Fourney who was a lead researcher in a clinical trial involving the "Mild" Device Kit for relief of spinal stenosis.  It seems the good doctor had an agreement with Vertos to report how his patients had responded to six month post-op treatment involving a decompression procedure of the spine using the Vertos "Mild."

This trial began with promising result, whereby patients showed signs of improvement. But then, Dr. Fourney's patients began complaining about experiencing pain, so severe as stated in the article, that the patients needed to undergo the type of back surgery that they were looking to avoid in the first place.  The essence of this article is providing the public with insight into the contentious world of testing or accumulating data, and the rules that allow companies to market products with little or no data proving the product or procedures long-term effectiveness.  Dr. Fourney may be one of those unusual physicians, he is an outlier in an industry that is blinded by profits over patient care.  It has become apparent that Dr. Fourney may have cared more about the long-term effect that this procedures net for his patients, rather than short-term results that can skew the data. Based on the content of the article, Fourney was compelled to notify Vertos that his report would describe the problems that his patients were experiencing after the six month trial. Vertos' response? The company filed a complaint against Dr. Fourney with the University of Saskatchewan accusing Fourney of scientific misconduct and violating "research ethics," by failing to follow the study's "original protocol" and by "independently" deciding to follow "his" patients for added time without seeking agreement from Vertos. Granted, the public does not have access to the language in the contract between Dr. Fourney and Vertos, but this brings up legal, ethical and moral issues in medicine and research.  Regardless of his participation in this study, the question must be asked, does a corporation have the legal right to dictate to a physician, let alone attempt to intimidate him when it comes to the safety and efficacy of a trial that involves his patients? Is Vertos making the legal claim that since Dr. Foruney was involved in their study, Vertos had legal right to control the outcomes of the  study, and anything less than what they were looking to achieve was unacceptable? Is Vertos response out of line when the company has gone to great lengths to undermine Fourney's reputation with the University? What does it say about the ethics and ulterior motives of Vertos? Could this be a case of look at whom is calling the kettle black? Isn't the surgeon held legally accountable for the safety and outcomes of his patients, regardless of the criteria set in any study? Based on the Citizens United decision, if corporations are people, is Vertos behaving in an ethical, if not amoral manner? Was the intent of the Study to accumulate data as quickly as possible to push this product through for approval and generate revenue in order to appease the investors?   

The "Mild" is a single use disposable instrument kit that is suppose to provide relief for patients with spinal stenosis consisting of seven surgical instruments.  The use of these instruments allows surgeons to use an minimally invasive approach to resect the lamina and remove portions of the thickened ligamentum flavum. Vertos claims that there have been over 10,000 procedures performed and insists that the procedure is safe and effective. But isn't there a difference between claiming that the procedure is safe versus whether the patients receive long-term relief? Is this a short-term panacea, a band-aid remedy or does this place closure on the affected patient? And then there are the other physicians in the study. Who are they? Are they paid consultants?  Do they have personal skin in this venture?  Those in the industry know that any study can be skewed or controlled to net the results appropriate for submission. In 2010 a Dr. Chopko published a short-term report on 75 patients, unfortunately, 30 of these patients have not been followed up because the investigator lost contact with them. Even though this happens in many studies, if Vertos and Chopka wanted to nullify Fourney's findings why not find these other patients to assess their long-term results? Publish the data. Why wouldn't Vertos want to assist Dr. Chopko to identify these patients to nullify Dr. Fourney's own personal results?

If Dr. Fourney has no other personal interests in a competitve product, why is Vertos behaving in this manner? Many questions can be asked to substantiate Vertos' complaint against Fourney. Patient profiling plays an integral role in the success and failure of any study.  Yet, is Dr. Fourney the cause of this debate, or is Vertos the culprit? If the study's protocol was poorly defined, is Vertos now attempting to cover its tracks? And then there is the CEO of Vertos, James Corbett, whom accuses Dr. Fourney of  a "gross misrepresentation of the facts," filing a formal complaint against Dr. Fourney with the University. Obviously Mr. Corbett comes from the school of thought that you can get more accomplished with a flame thrower than honey. The NY Times reports that in an interview, Corbett claims that he is not looking to suppress Fourney's study, he is only interested in making it accurate. As the C+C Music Factory use to say, "Say What?" The the question must be asked of Mr. Corbett, why the guerilla tactics? Could there have been flaws in Dr. Founey's methodology?  Possibly. Based on Dr. Chopko's letter to The Journal of Neurosurgery, he challenges Fourney's methodology.  Unfortunately, Dr. Chopko had a Rudy Giuliani moment and failed to disclose his ties to Vertos claiming "clerical error." Hasn't this become the defense of choice in most of these scenarios? Haven't we learned anything yet?

So in closing one has to ask the proverbial question, is this a case of double standards or not, TSB wants to know what you think?

The Last Quarter

Spine  Nation:

As many of you know, the Dog Daze of Summer give all of us the opportunity to reflect on the end of another summer, as we prepare for the autumnal equinox. It also gave us the time to reflect on Labor Day, a celebration and tribute to the men and women who strengthened and built this nation, creating opportunities for future generations, giving their lives and proudly serving their country to allow all of us to live in the free world.  Unfortunately, based on our behavior over the last twelve years, we have lost our moral compass, we have lost our sense of ethics, integrity, honor, and our social conscience.  Do we understand what it means to be an American?  We have become a disrespectful society, no if's , and's or but's.  We have forgotten that this country was built on the backs of immigrants of all races, colors, or creed.  This was what made us great, this is what made America great.  Regardless whether you believe it or not, we are a melting pot where freedom to choose is an inalienable right, whether it is your choice to believe in some God or no God at all, to love the person whom loves you in return, to motivate yourself to succeed, or choose the career that best suits your interests.  It is your inalienable right as long as no harm is done upon others, or you do not break any laws.  So why have we become such a divisive society?

Many of our readers may disagree, but we have become an amoral society, meaning we have no morals, no restraints, no principles, we have become desensitized to what is right and what is wrong because we rationalize our actions and behavior by our greed. Just look at the last ten years in spine.  We have used every trick in the book to make money, regardless of the outcomes. The Greatest Generation lived by a code of conduct that no longer exists and is unacceptable by today's standards.  We no longer make things, or innovate, today we make deals.  How does this bode for your future, or your children's, or children's children future?  The future does look bleak? Or are you willing to change your evil ways baby?  Why worry about terrorists when we do a wonderful job of terrorizing ourselves, threatening our sheer existence with our selfishness, irrationality and our insanity. We spend more time manipulating the system rather than focusing on what's important, unlike that Greatest Generation.  Are you building a better future for yourself or in spine?  That can be debated.  So as you recovery from a summer of fun, ask yourself, "Am I part of the solution, or am I part of the problem?"  As I reflect on my father's generation today, I am astonished by his hard work and commitment to not only make our lives, but the world a better place.  So as TSB resurfaces after a slight hiatus remember, it's time to ramp up sales to close out the year and keep the powers to be off your backs.  Good Luck and Great Selling!

Mr. Big Stuff Who Do You Think You Are? MDT Sues NUVA

As Jeannie Knight once sang;

Because you wear all those fancy clothes (Cheetah's sing, "oh yeah")
And have a big fine car, oh yes you do now
Do you think I could give you my love now (Cheetah's, "oh yeah")
You think you are higher than every star above
Mr. Big Stuff, Who do you think you are?
Mr. Big Stuff ya never gonna get Medtronic's love

Yes fellow bloggers, it seems that Mr. Big Stuff is being taken to the rack one more time by his former colleagues and friends at Medtronic.  A little home cookin' is being served up to the now defunct oracle of spine Alex Lukianov (David Paul the baton has been passed) and his entourage at Nuvasive.  As has been reported in various media outlets, Medtronic has filed complaints against their former Superstar and his company claiming that CoRoent and Osteocel are infringing upon patents owned by Warsaw Orthopedics and Osteotech which were exclusively licensed to the Big Blue.

As a mere formality, Medtronic is asking for an injunction denying and preventing Mr. Big Stuff from producing its family of spinal implants and bone grafting material.  Medtronic is also requesting compensatory damages and legal fees.  TSB can see Ishrak singing to the Bear.

Dance with me, c'mon dance with me baby

Dance with me, c'mon dance pretty baby

I want you, and you want to be like me

So why can't we get together after the dance.

The Spine Industry: Guilty of Unrealistic Expectations?

TSB would like to thank all of our followers, on twitter, and those that continue to support us anonymously. Based on your feedback, those anonymous posters that do not contribute in a professional manner will be censored. No one is interested in reading baseless accusations regarding surgeon involvement with specific companies, unless that information exists in the public domain. Why?  In order to protect your anonymity, no one has the right to indict individuals by name, unless they are in the news, are under investigations, or have had legal charges levied against them.

MSM has had the privilege to travel and discuss the state of spine with many that carry competitive products.  Since the market crashed in '08, after the analysts' had downgraded growth expectations, your companies and their management teams continue to forecast revenue expectations that are unattainable. Why?  Slaves to the Street?  Most definitely, its about the stock and the shareholders  instead of the products. Adaptability? Not on your life. The reality is that these individuals are living in the past, or, they do not possess the ability to change.  How many of these individuals sold in the heyday of spine, still believing that some things have never changed?

No one ever said that man has the necessary skills to adapt to a changing environment. At the end of the day, man is a creature of habit, and old habits die hard. Your life's experiences are ingrained in your personalities. The spine market was already evolving before the Great Crash of '08.  Hardware innovation was grinding to a halt. With that in mind, everyone loves to say that they embraced change, they did it in the 2008 election, unfortunately none of us were are willing to make the sacrifice, because change is good as long as it doesn't effect you or me. Call it selfishness, call it greed, call it human nature. It's in our gestalt to deflect blame on someone else rather than look oneself in the mirror. But for those of you that compete in this "zero-sum market," contrary to what the new oracle of spine David Pavid may predict, exponential growth is not a sure thing, even if you believe that you can create 20 new products, or come up with creative ways to buy the business. MSM hears it from the distributors and their sales people who are sustaining marketshare but losing revenue, due to pricing pressures, to reimbursement issues, insurance denials, lack of innovation, in addition to having to compete in this cesspool that we call spine. Some of you will disagree. So how do you adapt and change in a hostile environment that has you pitted in a game of blink with your customers on one side, and your company on the other. The ability to sustain existing business or one's marketshare without losing a customer may actually be a testament to your character. Someone whom has built a reputation and a business on integrity, education, commitment, and a passion for one's craft. TSB can hear Doctor Famous ready to jump off the altar and attack. "What value do you bring?" "You are driving up the cost of healthcare!" Surgeons deride your skills, yet ironically, when their children do not possess the proclivity to follow their parents into medicine, where do they turn? Where else? The industry that they criticize, because by hiring their offsprings, you are going to drive down the cost of healthcare. They turn to the Medtronics, the DePuys, the Zimmers, the AlphWrecks, the Globus' to name a few. TSB calls them "children of entitlement" regardless that some will accuse TSB of envy. Walk a mile in my or your shoes and then you have the right to mouth off. Even in the adversarial climate that exists within America's hospitals your loyal customers know your true value.  Running sets around, getting up at 4:30 a.m. to cover a case, having to buy another lunch for an ungrateful office staff, even if its an outright violation of the laws. TSB does not see things getting better until we hit rock bottom, and only then will  the industry realize that the old ways of doing things just don't work anymore. Yesterdays dreams, are today's challenges.

So as we turn the corner and head into the last quarter of the fiscal calendar, who will be the market leader when we enter 2013?  Who will back up their promises with innovative products that will improve patient outcomes?  Where do we go from here?  Has spine's heyday come and gone or do we have some more life left in the old girl?  TSB wants to know?  

Sunday Editorial

The last few weeks have reared the ugliness and immaturity that exists in our country and in spine, this has become indicative by the vulgarity and sophomoric humor (to some) that has surfaced on TSB's blog. So let TSB share some wisdom, the definition of freedom means exemption from "control, interference, or regulation." If you notice TSB put those words in quotations. The time has come to implement regulation. Contrary to what some think, this is not your blog, neither is this a forum to spew vulgarities and non-sense..  You don't control the blog, neither do you have a "right" to spew the non-sense that comes out of some of your foul mouths. The purpose of this blog has been to provide everyone with a forum that no other platform has or ever will provide for the industry. You don't see it on OrthoWorld, Orthopedics This Week, or Orthospine News.  If the intent of the few is to destroy the blog or drive readers away, the necessary measures will be taken to incarcerating your thoughts or opinions. Censorship is a beautiful thing.  If you want to spew your non-sense develop your own blog, or better yet log on to Medical Holocaust, but then again no one follows or reads that second rate blog because no one likes crazy people. Yes that's right, CRAZY PEOPLE. Your rights and freedoms are nothing more than a fleeting moment.  So in closing, like the Times, the Wall Street Journal, The New Republic, or any other publication, it you want censorship remember what TSB says, "So I say to you, ask and it will be given to you; seek and you will find, knock too hard and the door will be slammed in your face."  TSB will not tolerate the disgusting and vile non-sense that the few of you write, neither do our readers welcome this aberration. Patients, Physicians, Public Officials, Attorneys and the General Public read this blog. If this vile and disgusting language does not cease TSB will block your IP address so you never have access again.  TSB wants to know what our readers think about these few individuals from North Carolina, Alabama and California that exemplify the unprofessional people that have infiltrated this industry.  This is your blog and TSB wants to know what you think,  It's time to let these people know what you think!

Profits Over Patients

Spine Nation:

As another season comes to a close, as the melancholy sets in for the many that love summer, it has become apparent that everyone is anxious to get closure on the upcoming election. Politics like the spine industry is not for the faint of heart. Confusion reigns when it comes to Medicare, and many ask why does the government continually attempt to stick its fork in an industry that has resembled the wild wild west. In many respects this weeks national and local news exemplifies the environment that we all will be challenged with in the years to come, regardless of whomever wins the upcoming election.  Whether you concur or dissent, the current healthcare environment is not sustainable even if the smartest guy in the room believes otherwise.  This weeks news was that there were more distributor cuts on the general orthopedic side at Biomet/EBI and the fallout from the DePuy/ Synthes merger says it all. "Legacy" reps, what a joke. After years of loyal dedication and commitment, a swift boot in the butt speaks volumes about the mercenary attitude that corporations continue to exhibit to those that gave their blood, sweat, and tears. Loyalty is a word that doesn't exist in the corporate lexicon.  Yet, for all the hoopla surrounding those companies, the investigation by the DOJ into HCA Hospitals speaks volumes about why healthcare continues to place profits over patient care, and why the government is compelled to intervene.

In 2006 three private equity firms bought HCA for $33 billion, proceeding the $1.7 billion fraud settlement between HCA and the U.S. Government.  With new ownership came a new strategy. Under the auspices of these firms and their representation on the board of HCA, the alleged strategic plan was how can HCA get more money out of private insurance companies, patients, and the U.S. government?  Did TSB say the U.S. government?  It seems that many common folk would like the government to stay out of healthcare, yet, maybe the powers to be love the government more than they are willing to allude to? Could new ownership at HCA have been looking for creative ways to aggressively increase their billing? Like any new owner, HCA immediately looked to reduce its emergency room services to those that were not qualified as emergent, in addition to cutting to its overall expenses, along with a reduction in staff.  The result of these policies was a compromise in patient care. The public can fully support profiling non-emergent patients and directing them to another provider, but inadequate staffing in critical areas and placing profits over patient safety is unacceptable.  As more and more hospitals are gobbled up by for profit organizations the question must be asked, are these entities even qualified to make the necessary decisions to influence the delivery of healthcare? What tactics will these for profit hospitals employ as lower reimbursements become a reality. If companies like Kravis, Kohlberg and Roberts have a 40% stake in HCA, as Cerebus Capital and the Blackstone Group acquire other healthcare systems, what is the future of medicine?  

At the heart of HCA's problems was the introduction of a new coding system for its emergency room care. Overnight the billing coming out of HCA emergency rooms was alleged coding for sicker patients. Doctors complained of quotas and financial objectives mandated by the powers to be at HCA. In addition, patients in HCA facilities were getting more bedsores, wounds, infections and complications.  In an independent survey, HCA owned eight of the top fifteen hospitals in patients developing bedsores. There were complaints regarding a shortage of nurses.  So the question must be asked of our readers, is this the future of modern medicine?  Who needs the government to take away your healthcare, you can go to a HCA hospital for a first hand experience. So TSB wants to know what our readers think?  Is this a healthy antidote?  For Profit Hospitals by For Profit Private Equity Groups?

Another long summer's come and gone,
I don't know why it always ends this way
The boardwalks quiet and the carnival rides
Are as empty as my broken heart tonight
But I close my eyes and one more time
We're spinning round and you're holdin' on tightly

Sunday Op Ed

The last couple of weeks in spine have been nothing less than sensational.  Dirk Kuyper is no longer running the good ship AlphaWreck, Spinal Elements has come up with a potentially "game-changing" vertebral inter body device (just kidding, isn't every product that comes out in spine game-changing), and David Paul can stand on the Aircraft Carrier Globus Medical declaring, "Mission Accomplished." With twenty, ahem, new products in the pipeline will he have the time to spend all of that money? Who knows, maybe he can enter the Presidential race. He is a CEO isn't he? And if running a company qualifies you for the highest office in the land, there is hope. Can anyone say, "birth certificate?" Who knows maybe he can legislate some policies that would take us right back in time when the industry didn't have to worry about pricing, or whether there would be any scrutiny by the insurance industry when it came to rubber stamping back surgery, when reps didn't have to worry about a reduction in commissions. But austerity has become our mantra. Pass the blame on everyone else except those that are running the companies themselves. It's time for those CEO's to personally tighten their belts and commit the necessary resources toward new technologies. Unfortunately many still would like to live in the past. You know what period TSB is talking about. Investors showered every insane idea or company with capital in hopes of the Holy Grail. How we long for them old 5-7X days. Those were the days my friends, we thought they'd never end. Not only were private investors throwing their millions at you, surgeons stopped being surgeons and became investors, subsidizing companies and protecting their investment by finding enough of patients to keep their investment and the company solvent. How many of those still exist?  Can someone say Mississippi? Maryland? South Dakota? California? Outside of Globus, where have any these other ventures gone? Nowhere. TSB is sure that some pompous small growth company CEO will rationalize that his intent was to never sell the company, unfortunately those individuals rarely stop to look in the mirror. When it comes to change, spine is an obstinate industry. Many of our readers blame the FDA, some even blame the current Administration, some are even willing to blame those that provide access to capital resources, but the truth is that the party is coming to an end regardless of whichever party takes office in January of 2013.  Our only saving grace lies with David Paul and Alex Lukianov so that they can finally put their difference aside and run for office. It's never too late. They are CEO's, aren't they? That automatically qualifies them to get the country out of the doldrums. Hey we could move all manufacturing to India and the Soviet Union. On second thought, that just isn't going to happen since their egos are larger than the Capitol's rotunda.

So where do we go from here?  If you believe Spinal Elements and Dr. Kitchell, they may have created the "ideal" environment for bone healing.  Don't believe it?  Imagine the novelty of an implant that has been sprayed with a titanium porous coating. Why didn't Globus, Nuvasive, or DePuy Synthes ever think of that?  Isn't it absurd and embarrassing that educated men tout this "new" product offering as "an exciting new technology?" How desperate can they be?  Taking a step forward?  Come on fellas, if this is all you have to offer, it's a wonder that SE has gotten this far. In all likelihood, this is another company that is on a bridge to nowhere. Is there anything innovative?  Have we had bad results with the current line up of interbody products?  Thank goodness for amateur marketing.  It was reported in another industry rag that the company's first two product were called Lucent and Crystal.  Maybe therein lies the problem, someone was doing too much crystal.  But you know what Tug McGraw use to say, "you gotta believe!"  By the way, for you young uns, Tug McGraw was Tim McGraw's   daddy.  So in closing, as the dog daze of summer are upon us, and everyone is gearing up for the silly season when we embrace the Spine Technology Awards and NASS, TSB wants to know, where's the beef?  Who has the keys to the Emerald City?

You sit in you big fancy house baby and you drive your fancy car

You treat us like we're not there, but I guess that's who you are

I'm on the the bridge to better days, better days are coming now

Globus: Did David Slay Goliath? Or Did He Get Something He Never Wished For?

The sky lit up in Audubon, PA this weekend.  One could smell the thrill of victory and not the agony of defeat.  Yes fellow bloggers, Glo-bus finally went public. Maybe just maybe, once and for all, we have heard the last of our obnoxious blogger, whom we have taken an affinity too, asking our readers the proverbial question, "when will Glo-bus go public?" In retrospect it will be interesting to assess how many shares were really sold, and whether or not the Dr. Famous' of this world who invested in this company will keep on giving the gift of giving by using Glo-bus products? Whoever said there wasn't any monetary incentive in using a specific companies product if there wasn't a potential payout in the end?

It has been a long and arduous journey for David Paul. A trek that spans many continents, the travails of leaving the company that you thought once loved you under the harshest of all circumstances, a rift amongst family members, being sued, and sued, and sued, and sued, and finally arriving at that magical moment when the stars all do align themselves for that one bright shining moment. So everybody have fun tonight, everybody Wang Chung tonight. With all that capital, who knows, maybe Globus will settle with the many plaintiffs that have filed suit against the Glo-bus for allegedly violating their patents, and move on. That would be wishful thinking. Maybe David Paul will now acquire another assistant to assist his trust worthy aide, Tatoo, or maybe he will really shock us at this years NASS meeting and arrive with pomp and circumstance, that would be pretty funny. Could a Jenna Jameson spokes model be in the picture? TSB could see the new Glo-bus booth, make no mistake.  A shining new sign will be up declaring that GMED is now a member of the NYSE. Maybe those that did not believe that this day would happen will be invited into the booth for some Naan, Roti, Tandoori Lamb Chops and Palak Chaat, one of TSB's all time favorites.  Who knows maybe David will hire TSB to cook for him? What a better way to get to know the man, the legend, the genius as his caddie McAfee calls him. Maybe McAfee will finally become his concubine? For one thing, TSB is relieved that everyone will no longer have to listen to McAfee embarrass himself at the podium declaring that "David Paul is a genius."

In closing, it was a fun weekend for those of us who had any stock or acquired some stock in the new kid on the block. But the mystery question is, will the Glo-bus be able to sustain success or will they just become another me too company? With 12-20 new products on the horizon, depending on whose propaganda you believe, poor David must not have any time to enjoy the fruit of his success. Who knows? Was he burning the midnight oil? Probably not.  In the end, after all the pomp and circumstance dies down and David takes the time to reflect on his success there will be that moment of clarity when he realizes that after all is said and done, he has become everything that he once detested about his former employer Synthes. Don't believe it?  Just ask Lukianov. Congratulations to all our friends at Globus, we'll be looking to stop by the booth at NASS to interview you.  As Bogie once said, "Here's looking at you kid!"

AlphaWreck: The Carousel of Spine

Yesterday a CEO came out to wander, caught an aging spine in a jar
Fearful when the sky was full of thunder, and tearful at the falling of a star
And the seasons they go round and round, like Healthpoints ponies they go up and down
You're captive on the Carousel of Spine, you can't return you can only look behind
From where you came and go round and round and round in the circle game.

Yes fellow bloggers, if word on the Street is true, Dirk Kuyper became another casualty at AlphaWreck. Do I hear $1.76 per share? Are there actually any buyers?  TSB's recommendation is dump the stock and run. Ever since Les Cross was promoted to CEO and Dirk was demoted, it was just a matter of time before the old Healthpoint Sociopaths came to roost. What is it about this company? Considering that this dog has been dragging its tail for the last year or so, maybe Mr. EBITDA himself will be able to create a buzz considering this stock has underperformed (did I actually say that) ever since the underwriters pulled a fast one on the investing public. As Elias use to say, "the worm has turned." With vendors complaining about lack of payment, who knows maybe Healthpoint can lend them some money, but then on second thought, maybe not. Considering that the scuttlebutt was that they were doing business with PODS, its a wonder that the DOJ hasn't paid them a visit.  In fairness to Dirk he wasn't a bad guy, he just worked for and with some crazy people. So in closing Dirk, remember you can't return you can only look behind and go round and round and round in the circle game,

"It's a bright horizon and your awaking, you will see yourself in a brand new way

The sun is shinin' the clouds are breaking, you can't lose now, there's no game to play"

Good Luck!

Stryker, Pomona Hospital and OP-1

Where's Steve MacMillan when you need him?  Considering that Stryker finally sold off OP-1 to Olympus in a deal that smelled fishy and included the V Brothers, once again Stryker just can't rid itself of its Albatross, also known as  OP-1. On July 25th, 2012, it was reported in various media outlets that more than a dozen patients may have be the subjects of secret medical experimentation (that sounds nefarious) alleged to have taken place at Pomona Valley Hospital, in Pomona California.  A letter dated July 24th, 2012 was issued by the attorney for the plaintiff, April C. Cabana to the Office for Human Research Protection at the United States Department of Health and Human Services.

Based on the aforementioned complaint, once again, we are revisiting the off-label use of OP-Putty and Calstrux.  Even though the complaint seems to absolve Stryker, it seems that the Almighty Stryker can't get rid of that dog OP-1. The allegations in this complaint center around the truff, as Mike Tyson would say, regarding Pomona Valley Hospital at first denying that an IRB had not been approved by the hospital.  Unfortunately for Pomona and the surgeon involved, recently obtained documents suggest that there was a "secret research project" taking place at the hospital regarding OP-1 and Calstrux. It seems that the hospital's Vice-Chair person asked the lead investigator "if efficacy is obvious should the research project and randomization be continued." 

At issue are State and Federal laws and regulations that mandate that researchers receive informed consent of subjects or patients prior to enrolling them in a research project. The complaint states that Ms. Cabana was never informed that she was going to be enrolled as a subject in this project.  As many of you are aware, surgeons can use their professional discretion for off-label use.  The smoking gun seems to be the correspondence between the hospital and Ms. Cabana's surgeon.  So how did Pomona, the surgeon, and Ms. Cabana get to this point?  OP-1 a potent bone morphogenic protein supposedly delivered the knock out blow by accelerating boney growth in and around her nerves resulting in remedial surgery that was not successful. Not only does Ms. Cabana suffer agonizing pain, she is on permanent disability. But this raises a greater concern.  If Ms. Cabana was made aware of being enrolled in the so-called "research project,"and that OP-1 and Calstrux would be used, would she had  the acumen to make an educated decision about the use of these products during her initial surgery?  Consumer Medicine?  Bah Humbug! Once again, the Cabana case brings to light the complexities that exist in modern day spine surgery, successful fusion no matter at what cost.  How many Ms. Cabana's exist that we never hear of?  Based on this complaint, there are potentially a few more to be reckoned with since Pomona had at least 16 other patients enrolled in the OP-1/Calstrux project.

So TSB must ask the proverbial question, what happens to Pomona? What happens to Dr. Famous? Does the government have the "chutzpah" to take action or will they attempt to quietly deal with this, sweeping it under the rug.  TSB doesn't know about our readers, but knowing what we know, if this was my loved one, there would be some serious ass kicking going on. 

Money, Money, Money, Money

Some people got to have it,

Hey, hey, some people really need it

Hey listen to me, y'all do thangs, do thangs, do thangs, bad things with it

Talkin' 'bout cash money, dollar bills y'all come on now.

Lanx: Fear and Loathing in Broomfield

"Absolute Truth is a very rare and dangerous commodity in the context of journalism."

No fellow bloggers, Hunter Thompson, aka Gonzo has been long and gone, but his spirit still lives on, at least with The Spine Blogger.  It was reported on July 23rd, in the year of the Lord, that Lanx "No Thanx" has taken it on the chin as it lost its bid to toss out a breach of contract lawsuit filed against it by "faster than a speeding cheetah, able to leap tall buildings at a single bound, it's a bird, it's a plane, no it's Alex Lukianov and Nuvasive for "allegedly" raiding its sales force.  Raiding its salesforce?  Stealing its top Bagman? Je ne said quoi!

No sympathy for the devil, keep that in mind, buy the ticket and take the ride, and if it get occasionally heavier Lanx, than what you had in mind, chalk it up to forced conscious expansion, tune in, freak out and get beaten.........Round 1 Nuvasive by a TKO.....looks like another love TKO Lanx.  TSB wants to know what our readers think?  I'll have a double shot non fat Cappuccino.

Spineology: Good Times, Bad Times

If there ever was a product that was slick before slick was a popular word in spine, it had to be the OptiMesh developed and marketed by Spineology. TSB remembers the first time Spineology presented its technology seeking an infusion of investment capital. The year was 2003.  Since then, the company has gone through an up and down evolution.  The OptiMesh was a deployable pouch inserted via a cannulated tube into stable vertebral defects.  The objective was to contain grafting material in place.  The material that this pouch was manufactured out of is PET which has since been used in the Dynesys System Cord.  Unfortunately for Spineology things have changed.

On July 5th, a complaint was filed for damages and demand for jury trial in the United States District Court of Indiana against Spineology.  The plaintiffs are Debra and Thomas Day and their civil action is brought on behalf of the the plaintiffs for personal injury and damages sustained as a direct result of negligent and otherwise wrongful conduct by the defendant, Spineology, Incorporated in connection with its design, development, manufacturing, testing, packaging, promotion, marketing, distribution, labeling and sale of OptiMesh what was implanted in the plaintiff.

The facts surrounding the case do not bode well for Spineology.  Based on the law, "any person who seeks to introduce a medical device into interstate commerce must prove that it is safe and efficacious for its intended use or that it is substantially equivalent." The challenge that the Spineology legal team will have will be proving that its product was not used off label rendering it adulterer and misbranded, since manufacturing adulterating or misbranding a product into interstate commerce is prohibited under the law 21 U.S.C. Sec. 331 (9-c), (g), (2003).

The Medical Device Amendment to the Food, Drug, and Cosmetic Act of 1938 require medical manufacturers to undergo premarket approval by the FDA, mandating that manufacturers must design and implement a clinical investigation.  As many of you know, the only way a device may by pass the PMA process is if there is a "substantially equivalent product," or predicated device in interstate commerce prior to May 12, 1976.  As this complaint unfolds the contentions bring to light the many challenges that companies have in properly adhering to FDA requirements. Spineology sought to market OptiMesh without conducting trials and obtained approval via a 510(K). Their submission asserted that they intended to market the product to maintain the relative position of bone grafting material and that it did not impact the stability of the vertebral body and did not include the end plates.

Spineology was warned in November of 2003 by the Office of Device Evaluation that there were reasonable concerns that the device would be used for an intended use not identified in the proposed labeling, and such use could hold harm.  Based on Spineology's labeling, the company did just that by indicating contradicted use of the OptiMesh. In August of 2007 Spineology received another warning letter for promoting OptiMesh for use in Kypho and Vertebroplasty. The complaint stated that since Spineology promoted and introduced OptiMesh into interstate commerce for uncleared indications the product was rendered adulterer under section 501(f)(1)(B) of the FDA.  It was also misbranded because Spineology did not notify the FDA of its intent to introduce the device into commercial distribution.

From June 9, 2010 thru June 30, 2010 the FDA conducted an investigation at one of Spineology's clinical investigation sites.  This investigation was performed to ensure the the Spineology data and information would be accurate and valid scientifically.  On 9/22/10 a warning letter was sent to Spineology which revealed serious violations.  The letter informed Spineology that its clinical investigator was not adhering to the study's protocol.  Despite these warnings, it is alleged that Spineology conceded this information from its physician surgeons as well as the plaintiff.

The plaintiff was treated in December of 2009 with an XLIF for instability at L4-L5 presenting with right leg pain which was resolved with the surgical procedure.  Nearly one year later, the plaintiff presented with left leg symptoms similar to her right leg pain.  The surgeon treated her conservatively unexpectedly developing a L5-S1 asymptomatic disc herniation.  On January 21, 2011, the plaintiff underwent  a surgical revision which included the partial removal of her right posterior instrumentation and a TLIF using the OptiMesh, since and XLIF procedure was not amenable to implantation at L5-S1. After 4-6 weeks the plaintiff began experiencing right buttock pain and leg pain.  A lumber CT verified extrusion of the bone graft into the right lateral recess with right nerve root compression at S1.  On 4/26/11 the plaintiff underwent exploration of the epidural space.  During the exploration it was determined that the OptiMesh had a tear posteriorly in the pouch.  The surgeon notified Spineology.  On 4/26/11 the plaintiff's pain returned. A subsequent CT on 6/7/11 demonstrated complete extrusion into the epidural space, with implant removal on 6/13/11.

There are many questions that need to be answered in order to determine whether or not Spineology acted accordingly in how they presented and marketed their product. Unfortunately, based on their track record with the FDA, Spineology may be swimming against the current. Corporations are no longer viewed as ethical or acting with integrity by juries, especially when it comes to adjudicating a product liability case involving loss of consortium. No one really knows why these events occur to some patients. Is it a quality issue? Is it a training issue? Is it an off-label issue? Is it surgical technique? But then it does raise our  defense of the importance of having a properly trained sales rep in the room. These questions will be difficult to prove because the attorneys nor the jury were in the operating room at the time of the event. Yet, off-label use is a no brainer especially when there are issues concerning structural support. The plaintiffs attorneys have a substantial amount of negative facts as to how Spineology has managed its day to day business, it will be interesting to see where everyone lands at the end.   In these types of cases no one wins, the patient suffers and the company loses credibility.  TSB wants to know what our readers think?  OptiMesh or OptiMess?  

"Good Times, Bad Times......you know I had my share"

Spine: In The Newsroom

Spineophiles, if you haven't had the opportunity to watch the Newsroom on Sunday nights, take the time to surf over to HBO and give this series a look with an objective mind. Is that possible? By now many of you are wondering, is TSB becoming a television critic?  In order to assuage your cynicism, the answer is unequivocally NO. In many respects, "The Newsroom" is an indictment of the current state of news, regardless of whether you are a liberal, conservative, or independent, but who cares about labels, hey? Just ask some of our readers. The Newsroom questions our objectivity as we transition from a nation state to a market state, more concerned about sponsors feelings rather than delivering the truth.  It questions accuracy, our insanity as a nation, along with business, politics, the media, and the government's failure in reporting the truth, even if it means offending some peoples feelings or beliefs. So how does this pertain to Spine?

The vast majority of people that work in this industry are hard working professionals. It is the 20%, a minority, that truly tarnish our industry. These are the same few individuals that snicker and sneer, while espousing free markets wrapping themselves in the American Flag, as long as it doesn't hinder their ability to game the system.  Ever read a comment and wonder how someone can go off on a tangent and introduce a topic unrelated to the blog? What does it say about that individual's ability to focus, let alone do their job? Why can't TSB challenge this unholy industry when it is warranted?  Where have all the geniuses gone from the last ten years which TSB calls the lost decade in spine.  Have we learned anything from the pitfalls of success? What began as an innovative industry led by young visionaries has mutated into an industry that is bloated and bureaucracy laden.  Spine is about as aberrant of an industry as anyone can work in. Our industry rewards executives that strangle ideas rather than reward creativity, because creativity or out-of-the box thinking may threaten the established order of things.  Today, the start-ups and early growth stage companies are mirror images of their big brothers.  Fiefdoms and internal politics have emerged as a key to ones success and longevity. God forbid you point out a deficiency or inadequacy of a system or implant, or ask why the company is spending capital with no return on their investment?  Some of our current CEO's would better meet the criteria for psychoanalysis rather than an expose in Harvard Business Review.  No one individual is bigger than the sum of its parts.

Turnover has become rampant. Rather than sustain continuity and realistic growth expectations, many of these companies go five steps backwards to go one step forward. Question my decision making, you're fired, even if the individual's decision making SUCKS. If you don't listen to your customers needs, you will never succeed. But then again, it is always easier to blame someone else than take responsibility for ones actions or decisions. Just ask Ken Lay, Jeff Skilling or better yet the former CEO's of Vertebron, Archus, CardoMedical, or IST. It was always someone else's fault. Never have I heard anyone admit, "I just wasn't prepared." Even the BOD and Investors buy into their BS. Some of our readers believe that they know TSB or our motives for this blog. Those are usually the smartest guys in the room accusing TSB of being anti-business. On the contrary, those that contribute to your blog love making money. The difference is that we do not justify making money by behaving unscrupulously with no conscience. Our response is that those few individual are entitled to their opinion, and they could keep reading OTW the mouth piece for the industry.

The industry has lost its nimbleness, it has lost its passion.  It will blame everyone else except itself.  It's the FDA's fault. It's Obama's fault. It's the sales persons fault. What about the people that truly drive the industry? What about the greed exhibited by our illustrious CEO's and our surgeon customers? "You bring no value. You are overpaid. You are the cause of the United States healthcare crisis."  But what about their own contributions to an industry once revered now loathed. Where are all the visionaries that lacked the wherewithal to properly assess where healthcare was heading?  It's churn and burn baby. What happened to all the innovation? Another pedicle screw? Another cervical plate? Another inter body device? We no longer innovate to improve clinical outcomes?  We are now focused on improving existing technology asking the question, "how are we going to use this to make more money?" Today, at day's end, you are more concerned with your stock price and whether it has gone up or down than whether you had a productive day.

The reason you read TSB is because we make you think.  We stimulate you to ask the right questions and hopefully hold your companies accountable for what they do well, and what they do poorly.  You are the engine that drives the machine on a daily basis, not the shareholders or hedge funds that play roulette with your companies shares. The reason Spine is in this state is because shareholders and BOD's place more value on bean-counters than the individuals that understand the clinical and development side of the business.  They don't want a product guy, they want a businessman or woman that can cut a deal or put another marketing spin on a me-too product.  As we enter the dog daze of summer it will be interesting to assess where we are and how we intend on adapting to an ever shrinking market place?  Vacation time is over and its back to the grind.  Have a great week, and sell something will you the investors are getting antsy.

Spine = Easy Money? Just Ask BAXANO

The events that had transpired over the last few days validates the tension and uncertainty that exists in the spine industry. As information becomes viral, it has become apparent that the spine industry might be ready for another casulty of spine. As was posted in the comment section and verified by our sources on the Street, Baxano may be in trouble. After letting 20% of its workforce go due to inadequate funding and sales, you the readers continually validate the many issues that need to be cleaned up if the spine industry is to revitalize itself in an uncertain healthcare environment.

TSB published a blog about Baxano in early 2010 questioning the efficacy and reimbursement of this product. Your many comments in reply validate how much more knowledgeable the masses are in comparison to those that have an ability to make hoards of money and throw it around at the industry like if we were a casino.  The question must be asked, "who are these people listening to?" Who are these experts? $30 million in Series C. How much more capital in their previous rounds?  Laugh all you want, better yet, get angry at TSB, but in the end the market rules. Did anyone really believe that attempting to perform a foraminal decompression with the equivalent of a Gigli Saw was going to fly?  There were a few optomists back in 2010 that spoke about flossing their teeth and never being able to live without it.  That comment was pretty funny considering that flossing your teeth is much easier that threading a needle through a haystack. So why is it that Baxano is potentially in the initially stages of shut down?

Having spent many years fighting the insanity of our industry here are our observations;

• Investors are no longer interested in recapitalizing companies in the spine industry
• Reimbursement! Reimbursement! Reimbursement!  We called it in 2010
• Improprerly trained distributors
• Poor surgical technique (There are only that many Ozzie Smith´s out there
• Patient Complications

The word on the Street was that Baxano generated $5 million in sales last year, and was looking for a 300% increase in sales for this fiscal calendar.  If there is any truth to that number, one must question the intent of that forecast.  Was it to appease the investors?  Considering that start úps like Baxano do not possess the same fire power as a Medtronic, DePuy, Nuvasive, or Globus, time is not on their side.  So TSB wants to know what do our readers think?  $30 million plus?  Smartest guys in the room, you be the judge. In closing TSB bids our readers a good day and remember

Way down here you need a reason to move
Feel a fool running your stateside game
Lose your load, leave your mind behind
Oh Mexico, it sounds so simple I just got to go
The sun's so hot, I forgot to go home
Guess I´ll have to go now................Adios Amigos

Independence Day - July 4th

Today commemorates the day that these United States adopted and declared its independence from the United Kingdom, July 4th, 1776.  It would be interesting to gauge the reaction of our Founding Fathers if they could see the evolution of their Declaration. Who are we? What have we become as a Nation? How many people have actually read the Declaration in its entirety?  How many have reflected on the meaning of those words? Originally intended to declare our independence, this document is also a statement on human rights. The following words alone speak volumes,

"We hold these truths to be self evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty, and the pursuit of happiness."

These words did not ring truth when the Declaration was signed.  The irony was  that there was contradiction in those words, "all men are created equal." Hypocrisy? Perhaps. Jefferson himself owned slaves at a that time, potentially echoing the old expression, "do as I say, not as I do." But isn't that a coat of arms that all politicians love to wear? As in the days of the American Revolution leading to the signing of the Declaration, today, we have our own kings who believe that they have inalienable rights. There should be no checks nor balances. No restrictions in doing whatever they desire. Wrapping themselves in their American Flag lapel pins, declaring their patriotism, love of God, family and money.  Yes fellow bloggers, there are many kings in our industry who believe in their own divine right. There lies the challenge in a world that is constantly changing as to what are your natural or legal rights. As the world morphs from nation states to market states, a world based purely on commerce, the founding fathers would be fascinated that we are not modifying nor amending our laws to create more checks and balances than what they intended.

In the past we depended on laws and regulation, today there is no assurance of equality but a maximization of wealth by those in power.  Globalization is screaming for a new global constitution, a global declaration to find balance and order in a chaotic world.  As market states open new opportunities, it makes everyone vulnerable. Jobs are outsourced, manufacturing is outsourced, all for the love of the Almighty Dollar and shareholder value. The financial meltdown of 2008 has been validated by the tremors that still exist on a global level, especially in the fragile European markets.  It is for this reason alone that government must adapt and create a new Declaration. As the financial sector downsizes its workforce, moving services to India, Malaysia, or the deep south, as average Americans lose confidence in the markets every time something new comes up, America loses. In many respects we have lost our integrity. We have lost our moral character, we no longer possess a code of conduct. 

So today, as you break open a cold beer, and BBQ whatever it is that you desire, and go to your local fireworks display, think of how lucky you are that we do have freedom in an imperfect world. TSB wishes everyone a Happy Fourth of July!