Saturday, May 28, 2011

Fiscal Austerity in Spine

"As I lay dying, the woman with the dog's eyes would not close my eyes as I descended into Hades."

One of the many uncertainties in writing or blogging is that one never knows what the publics reaction will be to your post.  That is evident when people attack the messenger rather than read the message. But that is to be expected.  If one believed otherwise, one should not attempt this exercise. The fact remains that most of us formulate our own impressions based on our life's experiences and interests.  Just look at any other blogger, journalist, or writer.  Whether you are attacking Goldman Sachs, questioning the clinical efficacy of a surgical procedure or business model, defending or accusing Lance Armstrong of using performance enhancing drugs, there are those that will side with you, and those who believe that you have some hidden ulterior motive.  None of that could be further from the truth.  It's the story that counts.  It's about getting the information into the public domain so that you the reader and or blogger can make your own decision on what is right, what is wrong, what is fact, and what is fiction.  And let's face facts, most of these topics are out there in the public domain. All TSB does is provide you with a forum.

An economic upheaval is unpredictable, its riddled with anxiety, distrust, anger, and plenty of rationalization.  TSB has been through a few of these experiences.  As unwelcome and uncertain as they may be, one learns to survive and move on, hopefully, never looking back. Hopefully, making you a smarter individual. Whether it has been the economy readjusting itself, a company being acquired, integration and downsizing, or even personal challenges, hopefully life imparts some wisdom, maturity and dignity.  Reality has a way of leaving a bitter taste in everyones palate, witnessed by the many comments that have been directed at people in the last two posts, or even TSB.  Its human nature to defend oneself, but its also human nature to stretch the rules.  Whether its performing a study, attempting to manipulate stock, justify a POD, run a company, or defend one's ability to earn a livelihood, it's human nature to stretch the rules.  No need to reason since history has a way of substantiating our point. As this industry adjusts to an unwelcome harshness, things must change.  Not because we want it, they have to, if we are to survive.

20% growth is a thing of the past.  Those days will truly be remembered as the golden years.  Yes, there are companies out there that report 30-40% growth in their press releases, but look at the size and scope of those ventures. Perspective has its own honesty. Turmoil usually brings division, and chaos ensues.  This division couldn't be any greater than what currently plays out each day on this blog and in our industry. As the the industry has matured, we evolved from true innovation, to duplication, to saturation, to commoditization, and are heading to extermination. The companies that have an inability to innovate, let alone adapt, will die a slow death. If you don't believe it, look around. Modern technology has given man the ability to shape and move markets with incredible speed. The unfortunate aspect of this gift is that balance is an art that our industry finds difficult. We are an industry of extremes, but then, maybe we are nothing more than a by product of a large phenomenon.  Think of an innovative product, not necessarily unique, but different.  By the time that product has picked up momentum and is generating new revenue, there are 5-7 products like it within months or maybe a year. Market data and analysts create unrealistic expectations, because numbers may not lie, they just don't have a human element to them.  If you don't believe, go back and read the original JP Morgan report on the future of artificial disc market, or think about other so-called market makers in our industry and their predictions.  Just like reconstructive orthopedics had its day of atonement with pricing, spine is still in the initial phase or readjustment. As insurance companies squeeze the life out of procedures, as surgeons perform less surgeries, as our business distribution model evolves we are squeezing the life out of the industry. Don't be too upset with the surgeons because, their day will also arrive. Fiscal austerity has become everyone's tag line. There are those few that proselytize in hope of attracting more investment capital using demographics. Unfortunately, the government, the economy and the realities of the market place have an entirely different plan.

Everyone is going to have to tighten their belts.  Judgement day is coming, the uncertainty will be where do we stand when it finally arrives.  No TSB is not talking about the end of the world, the religious right gave us a reprieve by reloading the date in their virtual calendar for sometime in August.  Even Nostradamus wasn't given this many passes.  As Prince once sang, this gives us all a little more time to party like its 1999. What we are finding out is that if one looks at evidence based medicine, change is not merely a thought, it is a reality.  A recent study found that Medicare spends a fortune each year on procedures that have no proven benefit.  Included in this study was two recent randomized trials finding that patients receiving kyphoplasty and vertebroplasty experienced no more relief than those receiving a sham procedure.  Granted, if the studies in question were those sponsored by the government, one must wonder whether those studies were skewed. This would be no different than questioning the outcomes of a study when a group of surgeons are on a company's payroll. Nevertheless, if it costs Medicare an estimated $1 billion dollars a year to manage vertebral compression fractures and the outcomes are not that much better, are we heading in the direction of evidence based medicine?  If dynamic stabilization was proven to be "as effective" as fusion, did we expect the insurance industry to welcome it with open arms? The extent to which Medicare pays for a procedure like kyphoplasty or vertebroplasty with questionable benefits must be quantified.  Maybe evidence based medicine will provide us with better information as to how we manage an America where everyone wants to prolong their youth, and its unacceptable to have arthritic pain, or pain in general.  No one likes pain, but the cold hard facts are that some will have to learn to live with it whether they like it or not.

So as you prepare for this Memorial Day weekend, break open a cold one, go to the beach, drink some good wine, go play a round of golf, throw some shrimp on the bar-be, and spend some quality time with your family, 'cause no matter what you may believe you work to live, and not live to work.

Wednesday, May 25, 2011

Let The Games Begin

The Martin Memorial Health Systems in the State of Florida issued a memorandum dated May 6th, 2011 to all of its providers of medical devices and supplies.  The reference on the memo was regarding PODS. Here is a reprint of the Memo as provided to TSB by one of our bloggers.

Martin Memorial and its affiliates believe that the growing influence of physician owned intermediaries in the medical device and supply industry is inconsistent with the spirit and intent of the federal anti-kickback statute, creating what the OIG has characterized as a "strong potential for improper inducement between and among physician investors, the entities, device vendors, and device purchasers.  The OIG has stated that these ventures should be closely scrutinized under the fraud and abuse laws.

PODS are beginning to appear in hospital supply chains as middle man entities, typically organized as a product distributor or a group purchasing organization, that gives physician investors an opportunity to receive profits from the sale of certain medical products or supplies to hospitals in which the physician investors provide professional services.  After reviewing various recent publications and legal opinions on this subject, Martin Memorial has concluded that it shall be its policy to refrain from entering into business relationship with supply chains that involved physician owned intermediaries. A snapshot of five bullet points follow;

1. Martin Memorial prohibits purchasing items or services for use in patient care including but not limited to pharmaceuticals, implants, instruments and other medical devices from any supply chain that involves a physician owned intermediary with which any affiliated physician or immediate family member has a financial relationship or which otherwise involves physician ownership in excess of 5%.  Exceptions to this rule may only be approved only by the Martin Memorial Audit Committee, in consultation with the CEO, the Chief Legal Officer, and Chief Compliance Officer.

2. No Martin Memorial entity will enter into any agreement for the purchase of medical devices, supplies, pharmaceuticals, or any other item or service if it determines that the transaction is intended to influence the referral pattern from a physician who has, directly or indirectly, a financial interest in the utilization of the item purchased.

3.  Where relationships with physician owned intermediaries is necessary, the relationship must be consistent with fair market value and satisfy all other applicable legal standards.

4.  Vendors of all medical devices and supplies shall be contractually required to disclose to Martin Memorial all financial relationships, whether directly or indirectly, involving physicians who are either employed by Martin Memorial or who serve on the medical staff of Martin Memorial.  Such disclosure shall include non-monetary benefits if the value exceeds $350 annually.  In, addition, contracts with vendors shall contain an ongoing obligation to disclose such future financial relationships,  and shall contain provisions for the prompt termination of the business relationship in the event of a failure to disclose or the disclosure of a prohibited financial relationship. The provisions of this section shall also apply to financial relationships with such physicians' immediate family members.  For the purpose of this policy, the term "immediate family member" shall be defined in the same manner as it is defined in federal regulations related to the anti-kickback statute.

5.  This policy shall be broadly construed such that whenever possible business relationships are avoided where supply chains for medical devices and supplies involve a potential conflict of interest of any kind. If Martin Memorial concludes that any vendor has engaged in an effort to circumvent the spirit and intent  of this policy, Martin Memorial may in its sole and absolute discretion, elect to exclude such vendor from doing business with Martin Memorial or take such other corrective action as it deems appropriate under the circumstances.

Medtronic's Endless Headache

As Medtronic prepares to head into a new fiscal calendar, the potential for additional challenges lie ahead for the once known jewel of the industry. Essentially, growth for the Goliath of the spine industry has been flat across the board.  Wild Bill reported that Medtronic had seen steady growth across most of their businesses and geographies, which was offset by challenging dynamics in the U.S. ICD and spinal markets.  As Wild Bill prepares to hand off the reign of the Evil Empire to Omar Ishrak, oh Omar if only you knew what you were really getting into, the NYT's reported this morning that a new study links spine product, INFUSE, to risk of sterility in men.

The study in question was released Wednesday suggesting that INFUSE poses a risk of male sterility.  This finding is in stark contrast to earlier research by doctors paid by Medtronic who found no connection between the product and a condition that causes sterility.  Now before everyone starts jumping down each others throats, let's get all the facts before the name calling starts.  INFUSE has been widely used and advocated by the surgeon community in spinal surgery since around 2002.  The labeling on this product does note that sterility related complications may be a side effect, but the controversy lies in that Medtronic sponsored researchers published reports attributing the complication to surgical technique and not the product itself.

A study posted Wednesday, on the web site of The Spine Journal by Dr. Eugene J. Carragee urges doctors to counsel men about INFUSE'S risks. Dr. Carragee based his study on 240 patients that he treated with INFUSE several years ago.  The spinal fusion in question is the ALIF.  The sterility complications at issue in Carragee's study affects only men and not women.

The two surgeons who were involved in the original INFUSE trial defended their findings to statements saying that not enough of men had experienced sterility-related complications in their study to statistically link the problem to INFUSE.  The two surgeons that spearheaded this study were Dr. Thomas A. Zdeblick and Dr. J. Kenneth Burkus.  In his web article, Dr. Caragee questioned why Zdeblick and Burkus had not broken out the patients in their study between those who had received INFUSE and those who had not, a method htat he said was a standard way to present a clinical trial result.

In response to Carragee, Zdeblick said the Caragee study was of limited value because it reflected the results of a retrospective look at patients rather than a clinical trial.  Such reports "are notorious for being misleading."  This new study will only add more fire as the intensity and debate surrounding INFUSE continues over having industry financed researchers present study findings in ways that favor the interests of corporate sponsors.  But the question must be asked, IS THERE A BETTER WAY?  How does one subsidize a study, if not by the company that is looking to validate its product's efficacy in the surgical arena?  Whom else does one use, if not those individuals that have the most experience with the product?  If there were "total transparency," would we look at these outcomes with a different lens?  

TSB is not going to pass judgement on Zdeblic and Burkus' findings, but one must wonder, does human nature play a role in enhancing ones outcomes?   Other surgeons have come out with opinions regarding the clinical utilization and efficacy of INFUSE, so is there a rational explanation for these differences?  So in closing fellow bloggers the INFUSE saga continues do we believe the Zdeblicks and Burkus' of the world, or, do we believe the Carragee's, somewhere in between these three parties lies the truth.  Omar welcome to the spine industry, where the show never ends.

Tuesday, May 24, 2011

Who's Next?

We'll be fighting in the streets, with our children at our feet
And the morals that they worship will be gone
And the men who spurred us on, Sit in judgement of all wrong
They decide and the shotgun sings the song

I tip my hat to the new constitution, take a bow for the new revolution
Smile and grin at the change all around me, pick up my guitar and play
Just like yesterday, and I'll get on my knees and pray
We don't get fooled again, don't get fooled again

The change it had to come, we knew it all along............................

Yes fellow bloggers, some of you would love to imitate The Who and urinate on a monolithic slab while singing we won't get fooled again. The last couple of weeks have established a precedent in spine, whereas, more acquisitions are coming.  Protecting and solidifying market share is the primary concerns of the Medtronics, DePuys, Strykers, Biomets, Zimmers and Smith and Nephew. These are the companies that hold the key to the Emerald City. DePuys acquisition was a diversification strategy, adding strength across the board, rather than just focusing on spine.  Double D and the BOD at Zimmer must do something or be laughed out of spine.  Smith and Nephew needs to flex its muscle and finally pull the trigger on a spine company.  All talk and no action makes for a bad reputation.  Stryker not only enhanced its portfolio with the recent acquisition of Orthovita,  Vitagel and Cortoss will add more leverage in negotiating deals with its customers.  So, Who's Next?  Who will be the next company to be acquired?  All of these companies have cash reserves that allows each one of them to pull the trigger. Why?  Because contrary to popular belief, they know that a change is coming to the way healthcare will be delivered in the next ten years.

Will it be Globus?  Will it be Nuvasive?  Will it be K2?  If the price is right, TSB believes that someone like Stryker will pull the trigger on another company, unfortunately, TSB does not believe it will be Nuvasive because the Purple People Eaters believe their stock is worth upwards of $50 per share, and contrary to the accusations directed at TSB, Nuva still has the best lateral device in the industry, and until they are unseated, it's good to be king.   So why Stryker? Because they almost pulled the trigger on Globus once before. Because there is too much uncertainty and anxiety exhibited by many people in the industry.  No one is sure whether they will have a long-term job until there is some stability, and that will only happen when all the deals are done. TSB wants to know what our bloggers think, Who's Next?

Remember what Roger Daltry sang;  I'll move myself and my family aside, if we happen to be left half alive, I'll get all my papers and smile at the sky for I know that the hypnotized never lie...... meet the new boss same as the old boss.

Sunday, May 22, 2011

Sunday Funnies

On May 18th, one of our bloggers posted a reprint from an analyst from a small cap network regarding Aphatec.  The commentary was that " when a stock climbs up in share valuation on revenues and growth, month after month, quarter after quarter, it's something that I love to see in the markets." For a stock that has yo-yo'd more than a Duncan Yo-Yo, the Yo-Yo of all Yo-Yo's, one has to wonder what this individual was talking about.  Granted the stock has had an uptick that some would interpret as a surge, but let's face facts, this stock has had a 52 weeks high of $5.82 and an all-time low of $1.85.  To give the impression that all's well that end's well is debatable.

Analysts love to promote a companies stock by emitting optimism.  Their hope is to make the public believe that a stock is on the rise, or that it will continue to increase in value.  The dissenting opinion usually comes from the short sellers, who are pessimistic because they are skeptics, knowing that management is notorious at self-promoting to extremes.  This skepticism is a natural reaction to how a company shows growth when concern is expressed in the public domain.  An example would be understanding how modified accounting rules can alter and infuse some life into revenue.  An example would be Enron, who inflated their number by using "mark to market" to inflate their valuation, or "revenue sharing," the practice of sharing operating profits with a company's employees, or of sharing the revenues resulting between companies in an alliance.

Many analysts that promote companies in the spine industry have little more than anecdotal knowledge, basing their forecasts on their trust and relationships with a company's management team.  Or, they may have heavily invested in this stock themselves.  At best these proclamations are intended to generate enthusiasms for the investor.  But what if hypothetically a publicly traded company had increased its revenue stream by going to a POD model, knowing that there are many questions left unanswered whether this is truly a legal business model.  Would an investor feel that they were being deceived by the company and their management team if they were not informed?  What if a law was enacted that declared all POD's illegal, would the stock and revenue plummet?  Would the corporation have had represented itself in good faith by being honest, sound and efficient with its investors?

So in closing, before one blogs about one's greatness, with the intent of going long, one has to wonder whether this individual has any clue to the dynamics of a specific company, the market, let alone the management team.  You know what TSB is says;

Nibblin' on sponge cake, watchin' the sun bake
All of those tourists covered with oil, strummin' by six string
On my front porch swing, smell those shrimp they're beginning to boil
Wastin' away in Margaritaville...................

Friday, May 20, 2011

Farewell to Arms

How do you think we're going to get along, without you when you're gone
You took me for the $50 mil that we had and kicked us out on our own
Are you happy, are you satisfied, how long can you stand our heat
Out of the doorway the bullets rip to the sound of the beat
ba ra... ba. ba. ba.  another one bites the dust

The last decade has provided us with some precious moments in spine. There have been (some) winners, yet, many losers. The winners sell their respective technology or company, while the losers rationalize why they were never able to execute the game plan. Some will argue that it was better to have loved and lost, than to never have loved at all.  But one has to question whether there was true passion and love in some of these failures.  Monday morning quarterbacking is America's favorite past time.  Reasons for failure can be predictable.  Usually, a higher force was the impetus, we ran out of money, market dynamics, the FDA (our favorite), and reimbursement to name a few. These are just a few of the eulogies and epithets we have heard and read. What's so interesting is that never, in all the years that TSB has been in the business have we had an admission of failure,  "we mismanaged our capital (a big one), we had a poor strategy and failed to execute, we hired the wrong executive management team (commonplace), we started this venture because we thought we could flip this stat, we move too fast, too soon, we should have never bought that dawg."  Just ask some of the companies that either acquired some of these ventures (Zimmer) or have failed. The challenge in running any business is a true balancing act. Success lies in developing an equilibrium between sales and product development. Moving too fast too can be detrimental in the long run.  What we've learned over the years is that investors and management have a difficult time in pacing themselves, especially when you're running a marathon, and not a sprint.

Lack of accountability exists at epic proportions in this industry.  But then look around us, it has become acceptable to blame someone else, or some higher force when it comes to failure.  Ever think that your idea wasn't really that great of an idea?  Ever think that all you had was, wishful thinking? Maybe it was more about fantasy than reality?  So why is TSB posting on those that have been sold and those that just went cold?  On Thursday, May 19th, 2011 Premia Spine, an Israeli based company (whatever happened to Expanding Orthopedics) announced that it had acquired the assets, including 16 patents owned by Impliant.  The flagship product was known as TOPS technology.  TSB believes that the acronym TOPS stood for Typical Of Products in Spine. After $50 million and a minimum of five years in development one would think that investors would have recouped some of their capital.  TSB bets the house that this was a fire sale, pennies on the dollar.  Buying IP or someone's assets is a nice way of putting someone to rest, and at times IP is only worth the paper it is written on. TOPS had a mediocre run in the U.S. after the initial hype.  So as the consolidation continues one has to wonder who will be next?  If it wasn't for POD's, how many more companies would go under in a heartbeat?  So as Dion once sang, "Anybody here seen my old friend Robin, can you tell me where they've all gone, you hyped a lot of companies and it seems they all die young, you know I look around and their gone."

Abbott Spine (Sold)
Altiva (Sold)
Applied Spine (RIP)
Archus (RIP)
Blackstone (Sold)
Disc Dynamics (RIP)
Disc Motion (RIP)
Endius (Sold)
Facet Solutions (Sold)
Harvest Technologies (Sold)
Hydrocision (RIP)
Impliant (RIP)
Inion (RIP)
Innovative Spine (RIP)
Mekanika (RIP)
N-Spine (Sold/RIP)
Orthovita (Sold)
Scient'x (Sold)
Spinemedica (RIP)
Synthes (Sold)
Surgical Dynamics (Sold/RIP)
Theken (Sold)
Vertebron (Sold/RIP)

Consolidation Nation?  You be the judge?

Thursday, May 19, 2011

Anybody Hear????????

Recently, a few of our avid bloggers inquired whether TSB would cover some other areas of our industry besides POD's, and the state of the union in healthcare.   So in the spirit of debate, who are the companies that are doing something innovative?  And, why?  Are these products game changers?  Are they line extensions?  Who are the contenders?  Or, are there only pretenders?  The past two years have brought us a few technologies that would be considered innovative, but is there truly something out there that is going to change clinical outcomes?  And for you Nuvasive bashers, please, don't attempt to legitimize products like XLiF, it's been around for years and its shoulders are starting to get tired.  Like an old sage once espoused, Is it new, Is it true and Is it really making a difference?  Or, are we entering an era of downsizing and consolidation.  In closing, your answers to this post would be appreciated before you open up the bottle of Milagro Anejo.

Tuesday, May 17, 2011

Me Too? Says Who

Recently Medtronic made a unilateral decision to terminate two group purchasing contracts with Novation and Premier. This decision has precipitated an investigation by the Senate Finance Committee headed up by Senators Baucus (D-Montana), and Grassley (R-Iowa) questioning whether the Evil Empire's actions could result in increasing cost while reducing price transparency.

As in any free market, Medtronic opted to terminate this contract so it can negotiate on an individual basis with those facilities that fall under the umbrella of Novation and Premier.  One of the potential downfalls with GPO's is that these facilities have the ability to compare pricing unless there are confidentiality clauses in their contracts with the vendor.  The GPO's contend that the impetus and rationale for Medtronic's decision was based on increasing the cost of their spinal and cardiac implants.  Senator Baucus' concern is that Medtronic's decision could play a role in undermining the government's efforts in delivering medical care to Medicare patients at the best price.  Whether one agrees with Baucus' assertions, those of us that work in this industry know that transparency in pricing has always been a major issue, especially when it comes to negotiating with a hospital.  Since it has become trendy to call out the government as the boogeyman, (of course until some terrorist threatens your mere existence), the GAO has determined that the overuse of cardiac and spine implants has contributed to driving up Medicare spending.

Considering that the majority of these products are "me too" what's the big deal in providing transparency especially when one is dealing with the volume that one must assume Novation and Premier purchase?  Companies have unusual karma.  The powers to be believe that by keeping pricing opaque that they will have the upper hand in a negotiation.  Pretzel logic at best. Everyone knows that if you have good sales people, their redeeming quality is keeping their hand on the pulse of their competition and territory. Baucus continues to question whether there has been collusive activity between Medtronic and other companies in the industry.  Medtronic's justification for canceling their contract was to cut expenses.  In addition, Hawkins believed that the cancelled contracts were not adding to market growth.

So June 6th is the date that Wild Bill will have to deliver his response to the Senate, fall on the sword and swear Mea Culpa, Mea Culpa.  Until then, the beat goes on.

Monday, May 16, 2011

Monday Bloody Monday

The silicon chip inside our head gets switched to overload
And nobody's going to work today, we're all going to stay at home
And daddy doesn't understand it, they always said we were good as gold
And we can see no reason, cause there are no reasons
What reason do you need to be shown
I don't like Monday's I want to shoot the whole day down

It's one of those Monday's fellow bloggers.  A tough day for the Orthovita sales force, a jubilant day for Stryker.  On Monday, May 16th,  the Almighty Stryker announced that it had acquired Orthovita for $316 million in cash or $3.85 per share.  A far cry from the days that "La Vita Loca" was hovering over $6.  Some analysts may believe that this was a responsive deal to what's been going on in the industry.  Fortunately for Stryker, they not only acquired Vitoss, but at the same time enhanced their portfolio with Vitagel a surgical hemostat, and Cortoss.  The need for an orthobiologic was desperately needed considering Stryker screwed the pooch on OP-1 to the tune of a few hundred million dollars at best, and their distributors have lost, or have been losing access to Actifuse, contrary to what many skeptics said wouldn't happen, when Baxter acquired Apatech.  It will only be a matter of time before many of the sales reps from Orthovita will be pounding the concrete down on 125th Street looking for employment.  Like any major deal, there will be collateral damage.  A nice way of saying prepare for your walking papers.

Kudos must go out to the brain trust at "La Vita."  Koblish, Marx and Smith were not only able to bring some good products to the marketplace, they were able to execute their objective.  Hopefully there weren't titanium fanged dogs thrown in with the deal.  If anything, maybe, just maybe, some of the wannabe companies in the industry will learn that the race doesn't necessarily go to the swiftest.  About a year ago, many industry professionals knew that there were deals to be had.  This could be the start of something beautiful as we gain consolidation momentum.  Good for some, unfortunate for others.  But remember what TSB always says, when one door closes, another one opens.  So in closing, TSB wants to know what our bloggers think, and how does this effect the industry and does solo flying biologic companies?

PS:  Our apologies for not getting this post out this a.m.... blogspot has been behaving like crapspot lately with technical difficulties, maybe it's time to initiate our own website.

Sunday, May 15, 2011

Weekend Op-Ed Piece

As TSB bloggers attempt to legitimize, question, and expose POD's, the debate rages regarding the legality or illegality of this business model. Proponents of PODS that have sought a legal opinion argue that the law and free markets substantiate the pursuit of this model, while those that dissent argue that not only is this illegal, it is a blatant attack on the industry, and your ability to earn a livelihood.  Regardless whether you agree with POD's or are adversarial, eventually, the validity of POD's will be tested in a court of law. What does not bode well for POD's is that this is no longer a local, or regional business model, this business model is becoming viral, and as it picks up momentum, the national press, OIG and DOJ is paying close attention to how business is done in the spine industry. The battle lines have been drawn.

If one looks at the evolution of the industry, there were many surgeon champions that had been the impetus for today's emerging technologies that have enhanced the publics quality of life.  These individuals were pioneers, scientists, and artists.  Somewhere around the mid nineties, things began to change.  It was a changing of the guard.  It was a generational change. Surgeon no longer viewed themselves as clinicians, they wanted more, they began viewing themselves as entrepreneurs. Surgeons were beginning to question why there wasn't additional financial incentives in their collaboration with corporations.  Of course, corporate America obliged.  Sofamor Danek, DePuy/Acromed, Synthes, Stryker/Osteonics, Biomet, Smith and Nephew/Richards, and Howmedica.  These companies were the breeding ground for the evolutionary change that has transpired. They all had their own footprint as to how business would be conducted.  Let's help surgeons market their practice, let's provide them with educational grants, let's hire them as an educational instructor.  Inducements whether one acknowledges it or not. Welcome consulting hysteria. Overnight,  TSB remembers sales people and distributors changing their sales tactic.  No longer were you selling on features and benefits, you began selling on futures, and surgeons loved it. Royalties existed, and rightfully so, but were never used as a means to an end as it was made famous by Blackstone and by today's denizens. How many of you heard this famous line, "Doc, if you use our product for 30-60 days and are happy with it, we will tender you a consulting agreement." How many surgeons business was bought by feedback on a screw or instrument modification?   A by product of this behavior are the convoluted relationships that make this industry a breeding ground for greed.  And unlike Gordon Gekko, or Mad Money Cramer, greed is not so good. It breeds contempt for rules, and the laws of nature.

Those advocating the legitimacy of POD's argue from a Darwinian point of view, believing that this is laissez-faire capitalism at its best,  where all parties are free from state or federal intervention, restrictions, regulations, and enforcement.  It can also be a Machiavellian philosophy where the ends (profits) justify the means (PODS), even though TSB must question whether some of these people even know who Machiavelli was?  In defense of those individuals involved in POD's, they really don't worry about what is right or wrong, all they worry about is whether they are profitable.  A sociopathic behavior?  TSB will leave it to the masses to be the judge. Winning at any cost can, and most of the time, does come back and bite you in the arse, just ask Charlie Sheen.

So as sales people and surgeons battle amongst themselves, the powers to be, corporations, its executives, hospitals, hospital administrators, Wall Street and most of all the insurance industry are laughing all the way to the bank. Suckers!  As you fight amongst yourselves, you perpetuate and condone the aberrant behavior and greed that the aforementioned parties exhibit.  That is where the real power lies. It's not free markets economics that drives a POD, it's an inherent arrogance that makes someone believe that they can do it better, that you can actually effect change. As the insurance industry barrels into its third straight year of record profits, as hospitals continue to prosper, as CEO's continue to manipulate markets, you are getting into a street fight amongst yourselves.  As hospital admissions decrease, insurance premiums increase, and physician reimbursements continue to decrease.  Some of these players are showing their ineptitude, their lack of fight, a lack of vision, blaming some sales rep for driving up the cost of healthcare.  As Clara Peller once said, "where's the beef?" Whom do you think is paying for those $500 dollar bottles of wine that Lukianov drinks?  Whom do you think is paying for the Cohiba's and Cristal that you smoke and drink at the Viscogliosi Brothers soirees?  Whom do you think is paying for your lap dance?  As a student of great civilization, one of TSB's favorite lines is, "Die das opium des volkes."  Unfortunately, greed is the religion, it comforts you, it gives you a higher purpose, it's like a drug that makes one feel good.  So in closing remember what the great John and June Carter Cash sang;

We got married in a fever, hotter than a pepper sprout, We've been talkin' 'bout Jackson ever since the fire went out, we're going to Jackson, we're gonna dig around, we're going to Jackson, look out Jackson town.

So at the end of the day as the delivery of healthcare approaches 22-24% of the GDP, it will be interesting to see how the POD phenomenon plays out.

Saturday, May 14, 2011

Spine Blogger Disclaimer

As a public service announcement to our readers and bloggers, TSB has been barraged with inquiries regarding missing comments.  Sometime on Thursday, May 12th, Blogspot started experiencing some technical difficulties regarding your comments.  Unfortunately, this was out of The Spine Bloggers control.  Hopefully Sergey Brin, Larry Page, and Eric Schmidt could spend less time in litigation with the government, and more time beating the help mercilessly at Google.  There were many of you that sent e-mails or wrote posts, asking, "what happened to all the comments?"   For those of you whose post vanished into the dark void of the internet galaxy, a sincere apology.  As for those that question whether TSB deleted those comments, we will once again state unequivocally, unless your comment is directed in a disparaging way at an individual's family members, or materialize into Dennis Miller like rant, no one individual's comments are ever deleted, this is your blog regardless whether the powers to be within the industry believe that we are, or we like what you say.  Once again, thank you for your support.

"Knowledge is Power, and Power comes from Truth."  Let Your voice be heard.


Tuesday, May 10, 2011

Weekly Update

The last four to six weeks has been a crazy period in spine, indicative of the activity and many stories that have surfaced. The posts that we have published have played like a broken record.  For those of you that don't know what a record is, it was made out of vinyl and played on a turntable, think Grand Master Flash.  As many of you know, the medical device industry spends billions of dollars annually in marketing to physicians.  To paraphrase a well known crusader for POD's, "Surgeons are disenchanted with the amount of money spent on sales, marketing, and distribution of acquiring implants, placing the hospitals and the surgeons at a great disadvantage economically. Oh, really?  Don't surgeons have enough of things on their plate to have to worry about this?  A number of surgeons believe that they can and could distribute and sell implants far better than the current business model.  Would we expect otherwise?  These surgeons claim market forces cannot work in this environment, and that the POD model allows them to do their job more efficiently with less cost to the hospital.  Yet the question must be asked, how does one know that the surgeon is offering the best implant for their patient, at the cheapest price possible to the hospital?  Isn't any decision making process subjective?  As Dr. Steinmann, the Rupert Pipkin of all POD's has stated, "Surgeons are most qualified to be at the center of the hub to make these decisions," obviously because they know quality, their case load, and can hire their own product representative.  Yet, doesn't the hospital have greater negotiating power by leveraging volume in comparison to any one surgeon owned POD?  By developing and implementing this business model the question must be asked, "is the surgeon acting as an independent sales representative on behalf of the companies that participate in this model?  This is a question that Orthopedics This Week's Robin Young failed to ask Steinmann during their nine minute You Tube interview in December of 2010.  Would anyone expect otherwise?  Many industry professionals thought they were watching Matt Lauer lob soft-ball questions on the Today show.  "Compelling business model," pleaaaaasssse, give us a break.  Why wasn't Steinmann asked whether he believed that a POD was a shell entity strictly for the purpose of directing remuneration to the physician, cutting out the sales representative?  Tough question, huh Robin?  We would never want you to compromise your integrity, what integrity, or, challenge a surgeon for the love of orthopedics, would we?  The potential exists that they wouldn't subscribe to OTW, not attend one of your meetings, or use stem cells.  Why wasn't Steinmann asked whether he believed that by having a financial stake in the distribution of product, does the potential exist to distort his and his colleagues decison making process?  There is a fundamental flaw in a business model that allows the surgeon to become a partner, or owner, in a medical distributorship.  Hasn't there always been an issue regarding surgeon's getting paid a dividend?  Isn't this the reason that surgeon investors have never taken a dividend, on their capital investment into a start-up spine company? Isn't a POD another way of redirecting and remunerating a surgeon for their ability to control selection of implants sold through this business model?  Regardless whether the POD is saving the hospital money, isn't the POD model redirecting profits to the POD?

The OIG an the DOJ have expressed serious concerns, unfortunately, the government's bark is always louder than its bite when it comes to punishing a potential white collar crime.  Isn't this model providing physicians another method to earn an economic benefit in exchange for ordering their own implants?  By participating in this model, isn't the surgeon nothing more than a paid sales representative?  Based on the anti-kickback statutes,  it can be argued that an investment by a surgeon into a POD is an inducement for the investing surgeon to order specific implants for their patients.  How noble for the Rupert Pipkin's of the industry to argue that they are only concerned with saving the hospital money.  But isn't the real intent of the POD to increase the participating surgeon's profitability?  State of mind, Rupert, state of mind, in addition to intent.  Let's face it, POD's have questionable motives and features at best. If surgeons are disgruntled and believe that the cost of implants continue to escalate while their reimbursements decrease, why don't they go after the hand that feeds them, large corporations?  Because it compromises their ability to leverage their skills in exchange for another method of making money off of the industry.  If surgeons are so concerned about the escalating cost of delivering healthcare, why don't they send out an olive branch and agree to take a cut in their fees for service?  Regardless whether our readers agree to disagree, socialized medicine is only a stone's throw away, and it won't matter whether it is a Democrat or Republican in the the Big House.

On another note, NuVasive reported 14% growth for the quarter.  Now TSB understands that there are some NuVa minions that accuse TSB of being a NuVa basher, actually, TSB likes the people at NuVasive. Just because the powers to be are a bit delusional makes it all the more enjoyable in poking fun at them.  We love all those buzz words like, "speed, laser like focus, a prolific product innovator, etc.."  TSB has to wonder, if one backed out the benefit that NuVa received in the modifications to the accounting rules for how they account for their loaner sets, what would real growth look like?  Contrary to what the oracles of Wall Street say about the stock, it is rather disingenuous to talk about growth when one does not define what is real and what is make believe.  Many of our bloggers have discussed the potential of NuVa being acquire, unfortunately, Alex believes that the stock is worth $50 per share, hopefully, he doesn't believe in the tooth fairy.  If NuVa was going to be acquired, IT WOULD HAVE ALREADY HAPPENED.  So as we start another day, get out there and sell something, because you never know when a POD is going to be coming to your town.

Wednesday, May 4, 2011

It's a Sin to Tell A Lie

Just be sure, it's true, when you say I love you
It's a sin to tell a lie, millions of hearts have been broken
Just because these words were spoken,
I love you, yes I do, I love you, If you break my heart I'll die
So be sure that it's true, when you say I love you, it's a sin to tell a lie.

On Wednesday, May 3rd, 2011, it was reported by the New Jersey State Board of Medical Examiners that Thomas J. Errico, M.D., Richard A. Balderston, M.D., and Jeffrey A. Goldstein, M.D., three prominent orthopaedic spine surgeons in the metropolitan New York, New Jersey area were fined for failing to disclose to their respective research institutions the financial interest that they held in the ProDisc spinal disc device.  As Gomer Pyle use to say, Surprise, Surprise, Surprise!

Errico and Goldstein were fined and all three blind mice must now complete an ethics course, LOL!  Errico agreed to pay $60,000 in civil penalties (pocket change), and $17,500 to reimbuse investigative cost (gas money for the boat), while Goldstein agreed to pay $30,000 in civil penalties and $10,000 in cost.

Attorney General Paula Dow admonished see no evil, hear no evil, and speak no evil by stating that, "undisclosed confiicts of interest on the part of these three doctors undercuts public trust in the medical profession."  But here's an interesting question for our readers, based on the fact that these fine surgeons had a financial stake in the the outcome for this product, how much of their findings were influenced by money?  Another question that needs to be asked is, what would provoke Errico to have to obfuscate his involvement in the study?  Is it  his use of the Rudy Giuliani defense, "to the best of my recollection, I cannot remember being involved in a study for the ProDisc," or, did he use the Jeff Wang defense, "I forgot to report it."  Was he hiding something?  Either way, for someone as successful and intelligent as Errico, based on his humble background, his role as President of SAS, his success as a surgeon, and his war chest of IP, did he actually believe that he was beyond reproach?  Money does breed a certain arrogance, but you know what Joe South once sang;

Oh the games people play now, every night and every day now
Never meaning what they say now, never saying what they mean
And they wile away the hours, in their ivory towers,
T'ill they're covered up with flowers, in the back of a black limousine

Oh we make one another cry, break a heart and then we say good bye,
Cross our hearts and we hope to die, that the other was to blame

Yes fellow bloggers, it is another chapter in the great spine saga, and the hits just keep on comin'!

Wednesday Op-Ed Piece.

Spine Nation:

As the administrator of this blog site, the past few years has been an interesting journey, to say the least.  Our goal has been and always will be a search for the truth (Scully and Mulder where are you when we need you). Regardless, whether our bloggers agree or not.  In a democracy, you as the reader, have the "free will" to determine whether what is posted has substance, or is merely hearsay.  Unlike other platforms that vie for your readership, TSB never intended to be a blog that is a slavish follower, I believe the word would be lackey, of the status quo.  We are not interested in reporting how many cases has Company X performed with Brand Y, we want to know whether the product is good and is it enhancing the patient's quality of life.  We would like to believe that this is what makes our readers return to this site each day.  When an individual continually fails and still gets hired for an integral position, we call them out on the carpet, regardless, whether they like it or not.  TSB provides the venue, while you become the jury.  Hopefully, the blog has been informative to many of you that have tenure in this industry, and sheds some much needed wisdom to those that are still "wet behind the ears." Youth brings out the bravado, while age brings out reason. The blog has provided many of you, including TSB, with a snapshot into how this industry has evolved during the last decade.  What we have learned is, that the many good things that we do, are often overshadowed by our behavior.  But then, TSB wouldn't expect otherwise considering that words like morality and ethics are not taught in business school (lip service at best), whereas greed and avarice are promulgated indicative of the behavior that is exhibited by many. Spine is just a microcosm of a much bigger happening. But like every great dynasty, eventually, there is a moral and ethical decay. History has taught us that. So what's the point of this Op-Ed piece?

Based on the many comments that have been elicited over the past week, due to the angst and anxiety over the announcement of J&J acquiring Synthes, one has to wonder whether some of your comments have anything to do with what was posted on the blog?  Specifically, how does a post on SAS, Globus "when will they go public" Medical, and Centinel Spine digress into name calling about individuals that do not have anything to do with the topic?  As TSB has always stated, "this is your blog."  And, you as a blogger have every right to call anyone out on the carpet, TSB included.  You have every right to voice your opinion, but when it does not pertain to a specific post, one has to wonder whether our readers are drinking grain alcohol rather than absinthe?  Outside of your own intentions, do you believe that any of us really care?  If anything it exposes your vulnerabilities.  This behavior confirms that those that are divided are always manipulated by those that are united.  How can you influence change or control your own destiny if you are fighting amongst yourselves?  So for those of you that are tenured industry professionals, remember, we have only ourselves to blame for we have coddled and created a generation of sales reps that are part of the entitlement generation.  Twenty years ago, we never heard of something called, "a cover rep."  Companies actually spent time and money on educating sales people.  You had to actually sell features and benefits to your peers before you were let off your leash.  Long-term viability took precedence over short-term profitability.  Unfortunately, the industry drank Wall Street's kook aid (I meant kook aid) a long time ago. No longer are we builders, we have become dealers, and we are proud of it.   Some of you may take this as a verbal spanking by TSB, it's a dirty job and someone's got to do it.  Now go out and sell something today!

Tuesday, May 3, 2011

That Was The Week That Was

That was the week that was, let it go, it's over
That was the week that was, it started way on top and it finished way below
That was the week that was, let it slide
That was the week that was, I took him at his word, he took me for a ride
Like Tuesday we met up at Vegas you know, it was SAS and we all had to go
Globus was there attempting to make a big scene, a new copectomy device a secret that's keen
Don't have an invitation, can't see our creation, that was the week that was.......

No fellow bloggers, TSB is not singing the opening song to the 60's satirical television show hosted by David Frost.  It was another ho-hum meeting at SAS, or is it now called IsASS?  It seems that Globus "when are they going public" Medical, was attempting to one up the meeting by launching a highly classified device by invitation only.  TSB was impressed that they hired some mercenaries from Xe, formerly known as Blackwater.  As Peggy Lee once sang, "is that all there is David Paul?"

In addition, rumor was circulating that Centinel Spine was facing some liquidity problems...again...
only to be informed that John Viscogliosi is back on the Bar-B-Q Trail in Memphis,Tennessee from May 12-14th in a World Championship competition, and on May 29th-30th, he'll be at the Rock City Rib Fest in Rochester, NY.  On June 11-12th you are all invited to the Big Apple Bar-B-Q Party.   Will the Purple Pork Master bring his sidekick Sancho Panza?  You know what they say about the color purple, it is continually associated with suffering and pain.

The J&J acquisition of Synthes has led Larry Biegelsen, an analyst for Wells Fargo to state that this acquisition would lead to some disruptions in the spine market that could benefit Zimmer. You know what the great Jimmy Durante once said, "everybody wants to get into the act."  Come on Larry,  we know you get paid by Wells Fargo to make these observations, but can you get serious, there isn't anything in Zimmer's spine portfolio that would be worth maximizing on.

With Medtronic initiating layoffs, its only a matter of time before the Synthes and DePuy sales force is faced with the reality that two's a crowd and three's a party.  Regardless of what the powers to be are telling you, there will be collateral damage.  It's management's job to feed you propaganda (everybody is safe, at least for the time being) in an attempt to preempt any moves that you may be thinking about.  TSB's advice, start shopping your relationships around, the only loyalty you have is to your customer and yourselves.  If you're not looking at your options, there's no time like the present to begin your search.  You know what Arnold use to say "listen to me now, or hear me later."