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?