Tuesday, June 28, 2011

The Carousel of Biologics

Blogger Nation:

Now that your children have completed the school year, and your college students have come home, hopefully to a summer job, TSB hopes that each one enjoy great quality time with your family.  Life is short, seize the moment, and every now and then, smell the roses.  Now back to the blogging world.

On Tuesday June 28th, 2011, John (God, am I a pain in the ass to Medtronic) Fauber from the Milwaukee Journal Sentinel publish an article entitled; "Researchers Sound Alarm on Medtronic's Infuse Years Ago." A journey back in time brings the reader to 1999 when clinical reports began to surface that a new biological product had surfaced that was going to herald a new modality of treatment that would safely regenerate bone in patients that were subject to back fusions.  Then something naughty happened.  CT scans were starting to reveal unwanted bone formation in the spinal canal. As TSB has asked on numerous occasions, how many of us heard those stories from various surgeons?  The clinical trial that was set to enroll hundreds of patients had to be stopped.  Unfortunately, it would be five years before Medtronic would publish a paper on the halted study.  As the results of ectopic bone formation was published, the paper downplayed the significance of this occurrence.  Based on these findings the question must be asked of our bloggers; "has monetary and commercial progress skewed the medical communities ability to report clinical outcomes in a regulatory and transparent manner?"

David Malone M.D., a Tulsa, Oklahoma surgeon reported that he had two patients that had required multiple surgical revisions.  One patient's biological response was so explosive that he needed a second revision because the boney ingrowth was larger than before the first revised surgery.  Dr. Malone was quoted as saying that the secretaries in the clinic could even identify which patients received INFUSE by assessing the post-op x-rays.  Good ol' Ronnie Pickard, a then top excutive at the Evil Empire agreed to a confidential settlement with the patient.  Obviously, Mr. Pickard was unavailable for comment for the article.  Dr. Malone goes on to report that in 2002 he sent a letter to the FDA making them aware of his experience with INFUSE.  The FDA read the letter into the record and then gave INFUSE its stamp of approval in late 2002.

The 2004 paper has drawn much criticism from the spine community.  Was there a systemic failure by the medical and scientific community by not reporting the various medical complications associated to INFUSE?  As in any battle to conquer the market, collateral damage occurs.  Could Medtronic and the surgeons involved have taken a mercenary attitude in the commercialization of INFUSE, accepting the fact that there would be casualties?  In addition to the many questions surrounding the politics and financial implications surrounding INFUSE, one must ask the question whether ethics, good science and medical advancements take a back seat to commercial interests, especially when the potential of hundreds of millions of dollars are at stake?

Marybeth Thorsgaard, the Mouthpiece of Medtronic, issued a statement on behalf of Medtronic, stating, the patients that were enrolled in the original study, were made aware of potential adverse events related to ectopic bone formation.  The article goes on to identify the usual suspects that have been involved with Medtronic over the years, Reggie Haid, Ken Burkus, and Charlie Branch. None of the aforementioned surgeons responded to e-mails from the Milwaukee paper.  In closing, it looks like the INFUSE saga is just beginning to pick up some momentum.  Considering that Medtronic has experienced flat growth and downsized its workforce, are they in a position to be broadsided by a potential torpedo?  As INFUSE continues to get bad press, will this affect their estimated revenue stream of $1 million dollars per day for this product?  And, did the FDA commit a major faux pas when they failed to acknowledge that INFUSE was a pharmaceutical and not a device? You know what Joni Mitchell once sang;

"And the seasons they go round and round, And the painted ponies they go up and down,
We're captive on the carousel of time, We can't return, we can only look behind from where we came
And go round and round and round in the circle game."

Wednesday, June 22, 2011

Senatorial Assault on Medtronic

As a famous General once said; "we're stormin' the beaches of Normandy and you are worried about a little sand in your boots. Fight on!"

On June 22, 2011 it was reported in the NY Times that our highly esteemed Patricians of Congress, Senator Max Baucus (D-Mont), and Charles "Chuck E's in Love" Grassley (R- IA), had sent a letter to Omar (Welcome to Spine) Ishrak, the newly anointed chairman and CEO of Medtronic, seeking documents related to INFUSE.  Baucus and Grassley are the equivalent of a U.S. artistocracy that intends on protecting the Plebians of our society. A noble cause if there ever was one.

As if Baucus and Grassley don't have better things to do like, worrying about the debt ceiling, helping over 15 million unemployed people have an opportunity to find a job, convincing the POTUS to draw down the troops in Iraq and Afghanistan, boy would that be a financial relief, pressure the banks to start pulling that TARP money out of securities and start INFUSING capital into the economy, or simply spend some of that lobbyist capital to stimulate the economy, the noble Senators are attempting to do everything in their power to ensure companies aren't concealing serious medical complications from patients just to increase profits.  Now that has never happened before, has it?

Our good old friend at Medtronic, Mary Thorsgaard acknowledged that the Senators were seeking information on side effects related to, abnormal bone growth, now has anyone ever heard of that side effect, swelling in the neck and throat, and a form of sterility.  Those of us looking for a new form of contraception might be willing to take a shot at the title with that one.  But on a much more serious note, how many of our bloggers have heard of boney in-growth, in or around the spinal foramen or canal as far back as 2002 or 2003.  As someone once quoted a spine surgeon to TSB, "I have had a few incidence occur, but I would never say anything considering that I am a consultant on this project."  Imagine, all for the love of medicine.

A July 11th, deadline has been set, requesting all documents and communications with researchers, medical journals, the FDA, advisory board members, concerning any and all adverse effects.  The good Senators are looking for e-mails that potentially could result in a smoking gun, good luck on spending more of the taxpayers money, where were you eight or nine years ago?  The most entertaining aspect of the article was that Medtronic reported that it had $15.9 billion dollars in sales last year, with $3.1 billion in profits.  A formidable war chest, now would be the time to start funneling money to Baucus and Grassley from your representatives on K Street. Unfortunately for the Senators, Medtronic claims it does not break out sales by products, which is the biggest crock of BS that anyone has ever read.  So in closing, TSB would like to welcome Omar Ishrak to the wacky and wonderful world of spine, where there are plenty deals to be had.  Hopefully, now that your buddy Immelt is on the President's advisory committee someone will finally cut your company a break, so you can get back to restructuring your organization all for the love of the shareholders profits.  TSB wants to know what our readers think?

Saturday, June 18, 2011


It was announced on Friday, June 17th, 2011, a day that will live in on in Orthofix lore, that Alan Milanazzo, the current CEO, will resign effective August 1, 2011. The press release did not specify the primary reason for the resignation, but, the company lauded him as "a tireless worker and terrific leader." But it does make one wonder, with the black cloud that has followed Orthofix since the time of the Ramius’ brouhaha over Board members being replaced, the cluster f*&k over the Blackstone Medical acquisition, the DOJ penalty for bone stim improprieties and an employee exodus, could it be that with the appellate court's decision to overturn the lower court's decision in the Blackstone Medical/Orthofix whistleblower case, was this the straw that finally broke the camel’s back?

If one looks at chronological events, it seems that once things started to cascade at OFIX, it was one issue after another that led to Milanazzo’s demise.  As recent as December of 2008, Ramius, LLC, a hedge fund, threatened the stability at Orthofix by calling for a special meeting of the shareholders, with the intent to overthrow, or more aptly described, to replace four of the ten then current board members. Ramius wanted to remove Milanazzo, Gero, Hewett, and Von Wartburg, replacing them with a fresh set of eyes and ears.

In March of 2009, Milanazzo was able to rebuke Ramius' attempt, publicly stating that Orthofix was headed in the right direction. Milanazzo believed that the Ramius candidates were duplicative of expertise as the current board members.  What Milanazzo failed to understand or knew in hindsight was that  the potential existed that Ramius did understand what was going on, and that a new set of eyes and ears were desperately needed to right the ship.  In addition to this argument, Milanazzo espoused that OFIX had improved its core business of Sports Medicine, Bone Stimulators, and Orthopedics. Milanazzo was intent on defending his decision and the Boards to acquired Blackstone.  Considering that everyone in the industry knew of the nefarious schemes that had been going on at Blackstone, one must ask the question, wasn’t there a better deal to be had?  If one considers the unforeseen challenges of a major whistleblower case looming over Blackstone, where was the due diligence?  Milanazzo and the Board's rationale for acquiring this albatross was based on price ($330M), technology (what technology) and distribution.  The $50 million that was placed in escrow upon completion of the deal may not be enough to cover the potential settlement in the whistleblower litigation.  In addition to these decision, Milanazzo never secured the relationship that Blackstone had with Osteocel/Osiris.  As Milanazzo claimed Osteocel was less than $3 million of Blackstone's revenue prior to the acquisition.  The question must then be posed, "what was OFIX paying $330 million dollars for," a house of cards?  Those of us in the industry know that Blackstone had nothing more than a "ME2" portfolio.  How many of our readers have argued, why does our industry love to bring industry outsiders (Boston Scientific) to run an orthopaedic operation only to have them step on their own d*#ks. 

In May of 2009, upon Jeff Yielding of Little Rock, Arkansas plead guilty to two counts stemming from a healthcare kickback scheme in the Dr. Chan case. Another in the long list of famous Blackstone consultants. Though OFIX was implicated in the scheme, no allegations or wrongdoing were noted by U.S. Attorney Jane Duke.  But anyone that follows corporate litigation understands that where there’s smoke, there’s fire.  In addition, one must wonder what ever happened to the investigation surrounding the mysterious death of Kelly Yielding?  Mrs. Yielding was a distributor for OFIX Bone Stimulators and mysteriously died days before her testimony in front of a Grand Jury.  One must wonder was this coincidence, and if so, what's the statistical probability of something this rare happening to someone involved in a case involving so many scandalous characters.

In December of 2010, OFIX announced on behalf of itself and Musculoskeletal Tissue Foundation that they had reached a comprehensive settlement with NuVasive and Osiris Therapeutics regarding Trinity Evolution.  Though the specific terms of the settlement were confidential, one must wonder was this just another nail in the coffin for Milanazzo?  In addition to the settlement, during this process, OFIX announced a major reorganization related to employee termination benefits resulting in a charge of $ 4 million in the fourth quarter of 2010, but claiming that the reorganization was expected to save the company $6-$7 million dollars per year beginning in 2011 in operating profits.  One must love the pretzel logic of the accounting world, addition by subtraction all for the love of its shareholders.

In May of 2011, it was reported that OFIX had settled with the DOJ for an estimated $43 million pertaining to improprieties regarding the sale of Bone Growth Stimulators, and as reported on TSB the Appellate Court over turned a Lower Court's decision to allow the civil action in the whistleblower court to move forward.  In all likelihood, whether the powers to be admit ir or not, it will probably be in their best interest to resolve this matter in an amicable way, rather than potentially test the uncertainty of the Supreme Court, would they even want to adjudicate this matter, or risk going to trial?  In the end, Milanazzo was a terrific leaders and tireless worker, unfortunately, he may not have been leading and working on the things that mattered most.  TSB wants to know what our bloggers think?  

Tuesday, June 14, 2011

The New Paradigm in Selling


No fellow bloggers, TSB is not singling out Paradigm Spine, TSB is talking about the ongoing metamorphosis of selling medical devices in the good ol' U.S. of A healthcare system.  Upon reading the pro's and con's in response to POD's, again, TSB believes that the investigation into POD's by the OIG and the U.S. Senate's eventual ruling will determine the future of all U.S. spine companies business model.  As someone so aptly described, the focus on this topic has made us look foolish and divided.  That's what usually happens when things begin to spin out of control. It is apparent that there has been a paradigm shift in what has been describe as our industry's revenue model. Questions abound regarding the longevity of what was, and what could truly be the future.  If one believes in unfettered markets, well look no further, the spine industry is the perfect model.  No rules or boundaries, minimize regulations, avoid accountability, erode science while emphasizing marketing.  Hocus Pocus, we have resurrected our own three witches. Some of you will agree, while others will dissent, while some of you cry out  to PLEAAAASE STOP THE INSANITY!

So what lies in store for the industry?  How do we compete in an environment where the system is gamed, by our customers, and, our own peers?  Will the strongest survive, while the weak perish?  Has competition and free markets as once defined in America reared its ugly head?  As Linda Richmond use to say, "can we talk, gather around."  While we debate whether POD's are legal or illegal, surgeons attempt to paint themselves as altruistic by claiming that there only concern is to save the hospital money as the industry's "new gatekeepers," Rome burns.  If profits are not the motivation behind their actions, then what is?  The love of medicine, LOL!

But what about hospitals?  What about these bastions of modern day healthcare?  Have they helped the current environment, or, are they the culprits behind perpetuating this chaos?   Explain the rationale for taking away a surgeon's ability to use whatever product he or she desire, if we truly believe in free markets?  Isn't the surgeon the one that has spent endless hours and hundreds of thousands of dollars to be the gatekeeper?  As hospitals BS surgeons that they must work together, they manipulate the environment to only benefit themselves.  If the hospital is footing the bill for implants, isn't it their responsibility to negotiate a fair and equitable price, and not the surgeons?  Or is this just another ploy to keep the surgeon's focus off of the eye of the tiger.  Slowly but surely, they are becoming the hospitals slave.  As Michael Corleone once said, "every time I try to get out, they pull me back in."   How many times have you sat across from a hospital administrator that has informed you that regardless what Dr. Famous would like to use, you are not a preferred vendor?  WTF does that mean?  TSB wants to know what MBA, CPA, JD, or MD came up with that BS description? How many times have you been told that in order to get your product into the facility, you will have to meet with the Product Evaluation Committee (PEC), only to find out that the next meeting will take place in four weeks, if you are lucky?  How about the facility that informs you that you will have to wait until the end of the year to submit an application for preferred vendor status. WTF is that all about?   If there is one thing that we have learned is that PEC's only exist to stonewall a potential vendor from getting into the facility. What happens if you really had something that was truly innovative or clinically advantageous to the patient's care, would any of us want to wait if it was our health at question?  What happens if you can offer comparable technology with added cost savings to the facility? If price containment is the impetus behind POD's, and surgeons are willing to use a product that saves the hospital money, does it really matter what product one uses, as long as they are comparable?  How many times have we heard that a screw is a screw, a cervical plate is a cervical plate, etc., etc., and so on?  A bit of a paradox. The apathy that exists at hospitals is a study unto itself.  Can anyone make a simple decision? Brain surgery isn't this complex. Are we experiencing the death of common sense?

As hospitals squeeze us on pricing, they continue to reap the benefits.  Ever sell a pedicle screw for $800 dollars, only to find out that the hospital billed the carrier $ 8,000 per screw.  What other industry can do that?  Ever sell BMP for $5,000 -7,500 only to find out that the facility billed the carrier $22,000 and an additional $8,000 for some TCP sponge?  Let's face facts, medicine is no longer based on care, it is based on profits. And that my friends is why whether one believes it or not, or agrees with it or not, the system will eventually evolve into a one payor system. The current system cannot sustain itself, and the faster we come to grips with reality, the faster we can move on.  It won't be called socialism, it won't be Obamacare, it will be called survival.  As healthcare delivery consumes 25% of the GDP, does anyone truly believe that it happened in the last two years?  As Arnold use to say, "listen to me now, or hear me lader."

Global consolidation has changed the rules of engagement.  Commentators that have eulogized those bloggers that have objected to POD's are only adding fuel to the Senate inquiry or an OIG investigation into the legality of this model.  Exhibiting one's hubris has been known to come back and bite you in the ass, if you don't believe it, ask Anthony Weiner.  So in closing, what will the new model evolve into?  Will forecasts be realigned to meet the markets structure, or will we continue to live in the past?  How does one continue to grow in a stagflated market?  As a commentator to our blog love's to espouse, "you sales people are living in the past," maybe, that individual is only half right. Maybe its the executive management teams at these companies that are living in the past, creating the illusion that all one has to do is keep the status quo and things will be alright.  But then again, maybe its the same people that have created this monster, that are now attempting to figure out how to survive.  Two years, three years and its on to the next scam.  You can throw all the marketing studies and procedural databases out the window, there's a new paradigm shift in selling, and if don't believe it, you won't survive.

First I was afraid I was petrified, thinking I could never live without you by my side
But I spent so many nights thinking how you did me wrong, I grew strong, I learned how to carry on
And so you're back from outer space, I just walked in to find you here, with that sad look on your face
I should have changed that stupid lock, I should have made you leave your key
If I'd known for just one second that you would be back to bother me......  I will survive.

Thursday, June 9, 2011

POD Surgeons To Be Probed by U.S. Senate

If you have ever had a physical when all is well, it can be an exhilarating experience. Unfortunately, being probed can be a real pain, especially when you are on the receiving end. Surgeons involved in POD's are about to get a check up from the U.S.Senate Committee on Finance led by no other than Senator Orrin Hatch, (R-Utah).

WSJ Article Link

For those of you that haven't read today's Wall Street Journal, sleuth reporter John Carreyrou reported that the Senate Finance Committee will launch an investigation into the legality of Physician Owned Distributorships. As per the article, it is estimated that POD's exist in at least 20 states with as many as 40 in the state of California. Rumor has it that the East Bay of San Francisco is ground zero, the breeding ground for POD's.

It will be interesting to hear our readers reactions,as the potential for a legal battle ensues. On one side you have Hooper & Lundy, a California bases law firm that has provided legal guidance for POD's, on the other side, the people, hopefully properly represented by the Senate Finance Committee that intends on shedding some light on this issue. Will this pit industry insiders against one another? Will Dr.Steinmann and his band of renown make a guest appearance on the Hill? How soon before this escalates into a free for all, as cynics of the government frown upon one group of corrupt officials setting out to investigate another group, whom claim that their intentions are sincere and that they are doing this to save the hospital money. Regardless of whom you side with, pull up a chair, grab some popcorn, and fasten your seat belts because the shows about to start.

Wednesday, June 8, 2011

Condolences to The Guyer Family

Dear Dr. Guyer:

It is with deepest sympathy that those of us at TSB send you and your family our sincerest condolences on the loss of your son.  By the sound of Jeff's blog, and the many nice things said about him, he must have been a great young man. To lose a parent or a spouse is painful, but nothing compares to the pain that we experience when losing a child.  TSB can understand. Though the pain never goes away, keep his memory in your heart and no matter how bad things get remember that great smile and the warmth and love that he brought into each of your lives.  God Bless You and Jeff's loved ones.  May his soul rest in peace.

Tuesday, June 7, 2011

The Verdict

A cadre of attorneys sat amongst the defendants. How much time, money, and energy has gone into a trial and a sentencing hearing?  For what?  As the sentencing hearing for three current and one former Synthes employees unfolded, one must ask oneself, what provokes us to act this way, and in the end, was it really worth it?  Regardless of Judge Davis' decision to incarcerate or not, Norian was sold to Kensey Nash for $22 million dollars, a wash, considering Synthes was slapped with a $23.6 million dollar fine for its complicity in this debacle. These four men and their families stand to have their lives altered, forever, by actions that could have been and should have been averted.  But as one looks at these four individuals, what about the victims?  The fact remains that three innocent people died, their families lives changed forever.

The attorney for Tom Higgins, Adam Hoffinger, argued that the evidence of intent was insufficient.  Unfortunately, the conspirators were complicit in a cover-up. With the exception of one local attorney, the attorneys surrounding the convicted were from high powered Washington, D.C. law firms. Attorneys would like Judge Davis to utilize a strict definition of the "Responsible Corporate Officer doctrine."   The RCO doctrine are legal principles that typically shield corporate officers and its shareholders from direct possible liability for legal violations by the company, consistent with what has been argued that a corporation has a distinct and separate legal liability. Yet, based on recent activity in the media and by the government, authorities may be planning a more aggressive use of this doctrine.  Will Judge Davis' decision to incarcerate establish a new precedent?

TSB spoke to a few attorneys regarding this trial, and the common theme seems to be that whenever a death occurs, judges seems to be less lenient. Judge Davis even reprimanded one of the attorneys for attempting to introduce evidence during the hearing. But then one must ask oneself, will Justice succumb to corporate influence and philanthropy? Synthes and Hansjoerg Wyss are known as pillars in the Philadelphia area. As one of our bloggers posted on Monday, if corporations want campaign finance reform, Citizens United v. Federal Election Committee, changing the rules of money in politics, providing the corporation with the equivalent of free speech as an individual, the time has come that they be treated like individuals when it comes to accountability and culpability in breaking the laws, especially when death is a by product of greed.

In closing, the tension and anxiety that Huggins, Higgins, Boehner and Walsh are experiencing must be agonizing at best, yet, one must still ask oneself, was it really worth it?  The sweet smell of freedom is worth more than $22 million dollars.  The freedom of a cold beer on a hot summers day, watching your children smile, or just smelling the roses is priceless. In the end maybe we will all learn something, unfortunately, TSB finds that hard to believe, because as Einstein once said the definition of insanity is doing the same thing over and over expecting different results.

Saturday, June 4, 2011

Weekend Op-Ed Piece

It is no doubt true that there are many cases in which the criminal could not have known that he was breaking the law, but to admit excuse at all would be to encourage ignorance where the law maker has determined to make men know and obey, and justice to the individual is rightly outweighed by the larger interests on the other side of the scales.

                                                                            Oliver Wendall Holmes

One doesn't need to be a good man to perceive what's lawful, but with that said, what would a week in spine be without more tabloid sensationalism? BNET, the CBS interactive business network reported on Friday, June 3, 2011 that a federal appeals court ruled that the trial judges from the First District Court in Boston have applied the false-claims and anti-kickback statute too strictly. The appellate court's ruling follows a string of seven federal court decisions which had required that conspirators "expressly" acknowledge they are breaking the law when fraudulently applying for reimbursement from the government for medical expenses. Medicare, insurers and healthcare providers would have to find a written confession in order to demonstrate that they were being ripped off.

The ruling in question pertains to a qui tam case involving two former industry employees and Blackstone Medical.  The whistleblowers allege that Blackstone Medical, its corporate officers and management team paid spine surgeons between $1,666 and $8,000 per month to ensure that they use Blackstone implants on their patients.  The defendants argued that the payments were officially used to recruit surgeons for Blackstone's Medical Advisory Board.  The case hinges on proving that these payments were made in return for surgical volume.  All surgeon contracts were signed by Blackstone President Matt Lyons. The smoking gun in the case seems to be e-mails that were sent between a former regional manager, and Vice President of Sales.

The e-mail between the aforementioned manager and VP related to padding more hours for a surgeon advisor. Unless there is a pre-trial settlement, this suit could pit former managers against the executive management team, resulting in choice. Will the parties agree to cooperate or protect a former employer?  Ignorance is no excuse for a lack of jurisprudence.  In order to be vindicated of any culpability the parties in question will have to prove that they didn't know that what they were doing was wrong, or, that the law didn't apply to them. The potential of jail time looms large. The defense of "I was just doing my job" just doesn't cut it. As for the government, it has acted as an amicus curiae, an advisor, a friend of the court. But could there be more than meets the eye?

This week may turn out to be the week that CEO's in the medical device industry, pharma, and nursing homes wake up to the fact that jail time may be awaiting them when their companies are involved in Medicare and Medicaid Fraud.  One could hear the outcry from our bloggers.  "That damn government is at it again, meddling in places that they shouldn't be meddling in." The double standard that exist within the business world is sheer insanity. CEO's and top executives are usually in the position of leadership for the simple fact that they are supposed to lead. Numerous books have been written on this subject. Leadership means taking ownership and responsibility. It means integrity, transparency and honesty, knowing your employees, to name a few traits.  So the question must be asked, how does someone whom is supposed to lead and guide an organization be so unaccountable when things go astray?  There are obvious exceptions to the rule. Usually when a company develops a reputation for questionable business practices one must wonder is it in their DNA, and, who ultimately pays for these transgressions?  Is this a victimless crime? "Ignorantia juris non excusa, Ignorance of the law excuses no one." As William Jennings Bryan once said, "destiny is no matter of chance, it is a matter of choice." There is a fundamental imbalance in the judicial system when someone robbing a gas station for $50 receives a 10 year sentence while some executive goes on to his next venture just because the company can pull out its check book and write a check with many zeros. Save us the outcry, because contrary to popular belief, their are some exceptional CEO's in this industry, unfortunately, it takes a minority to tarnish the reputation of the majority. Defense attorneys will argue that an individual cannot be held criminally accountable, or lose their jobs simply by the virtue of their status. Not when there is a smoking gun.

As people complain of government spending, the escalating cost of entitlement programs like medicare, social security, and unemployment,  it is the alleged actions as mentioned that contribute to the fiscal burden that is placed on the U.S. credit card. The defense that a corporation is a legal entity having its own liabilities and privileges can be argued.  Though not a person, someone must be held accountable for the actions of the corporation.  Without people and their actions would the corporation thrive? Is justice served when a company pays a $46 million dollar fine when it probably earned 10X in profits?  Just look at the current healthcare environment, there have been some companies that have been caught not once, but multiple times.  Some have submitted false claims, marketed drugs that have not been properly tested for their safety and clinical efficacy, and paid kickbacks to doctors. The usually response by a CEO is that they had were not cognizant of what was going on.  Unfortunately, when your signature or signatures are on specific documents, ignorance is no excuse for lack of jurisprudence.  Why would any individual be responsible for running a company if they did not understand the law?

Before everyone starts blaming the government, or the POTUS, or TSB, or the whistleblowers in this case, scrutiny of the spine industry is being driven by those in the rank of file.  People are tired of the games that those on top seem to continue getting away with, while some reap the rewards and discard the collateral damage, as business as usual.  People are not a commodity where you chew them up, and spit them out. It's tough enough getting up every morning, it is even tougher when barriers and obstacles are placed at every step. So as another door closes, another chapter begins. Someone is going to pay the price for some past indiscretions.  This time, maybe $50 million in escrow will not be enough to bail someone out of doing some time, yet, justice must be served, until then, the party continues.

So in the end, maybe there is a lesson to learn in all or this. It takes less energy to be nice to people, than it does to be a prick.  If you treat your fellow man with an ounce of dignity and respect, rather than arrogance and disdain, one of these days the big dog is not going to come back and bite you in the ass. Karma is a bitch.

Thursday, June 2, 2011

Hot Fun in the Summer Time

End of the Spring and here she comes back
Hi, HI, Hi, there
Them summer days, those summer days

That's when I had most of my fun, back
high, high, high, high there
Those summer days, those summer days

On cloud nine when I want to, Out of school, yeah
County Fair in the country sun, and everything it's true, ooh yeah
Hot Fun in the Summertime

Yes, fellow bloggers to quote Sly & the Family Stone, as the spring winds down, another summer of hot fun lies around the corner.  It will be interesting to see what a new season will bring the industry.  Yesterday's announcement that Mike Mogul has taken the CEO position at DJO is another sign that one should expect the unexpected.  After a stellar twenty-two years at his beloved Stryker, Mike has decided to move on.  One of the good guys in the industry, Mogul has survived more changes than Lady Gaga.  But what does it say about this chameleon?  Could this mean that there will be additions by subtraction at Stryker?  Who'd thunk it that M2 would ever leave Stryker? His replacement, spit shined and polished right out of the J&J playbook. One doesn't need to hear Les Cross sing Mike's praises.  One company's loss is another company's gain.

On a much lighter note, let's monitor how the Integra and Sea Spine acquisition and merger unfolds.  Bloggers have to be entertained when an "effusive" Stu Essig is quoted as saying "Sea Spine is an ideal strategic fit for Integra, as the combination brings two well-respected innovators in the spinal fusion market." C'mon Stu, you may be able to soft-shoe your friends on the Street with your Aztec-Two Step, but let's get serious, those in the industry are not some gullible analyst.  If innovation equates acquiring two companies known for commodity products, TSB must admit, you definitely epitomize innovation. Essentially, you hopefully bought into a market.  Word on the Street in Vegas was that you couldn't give the product away in the City that could never pass up a fusion that they didn't like. Name one product in your portfolio that would equate to being best in class?  By the way, whatever happened to that tortured baboon?

Now onto something more serious.  Readers have wanted a discussion on Interspinous Process Devices.  The current crop of products come in all shapes and sizes.  So which products have the optimal design? Which system has the exceptional instrumentation?  Is Lanx and Medtronic leading the pack when it comes to market share?  So here they are, and if there are any that we have missed our apologies, but we're sure someone will inform us of a potential faux pas.

Lanx - Aspen
Medtronic - XStop
Globus - Flexus
Paradigm - Coflex
X-Spine - AXLE
Life Spine - (Updating the website would help)
Vertiflex - Superion (What happened to Moti)
Osteomed - PrimaLOK SP