Bohner Pleads Guilty!

It was reported today that Richard Bohner, the head of Operations for Synthes USA pled guilty to a misdemeanor of introducing and misbranding Norian across interstate lines. Bohner's sentencing is schedule for November 5th. The other members of the Gang of Four are scheduled for sentencing in October.

Out of curiosity, how do four individuals pull off this entire clinical trial without anyone higher up in the chain of command not knowing what was going on? Something just doesn't jibe! If I was a betting man, I would think that all four will do some time, at least 3-6 months based on federal sentencing guidelines, especially if the maximum is 12 months. If the judge has any conscience, he will sentence them to time, there were three people that died. The Spine Blogger wants to know what its readers think?

is This Really News?

Over the last couple of days various newswires and websites reported that Sanford Health, a Sioux Falls, South Dakota healthcare provider received clearance for a posterior lumbar interbody fusion device. Based on recent marketing data why would someone make such a big deal of another "me too" implant. Aren't posterior lumbar interbody fusion (PLIF) approaches on the decline?

Dave Link, Sanford Health Executive Vice-President has an unusual perspective on what constitutes innovation. How can innovation be a product that represents the culmination of a decade of clinical research? Last time we looked at the market, there were plenty of PLIF devices that can produce the same results as the Asfora device. Unless this device is the "Silver Bullet" and can distract and insert itself, is this truly innovative? The Spine Blogger wants to know what its readers think?

The Medical Mafia - What goes on in Vegas stays in Vegas!

It was reported in various media outlets today, that the federal government won a round in an effort to prosecute a cabal of doctors and lawyers who allegedly conspired and schemed to lie in personal injury cases in order to inflate settlements and rip off clients. The investigation that was launched five years ago has resulted in charges that a former army medic and supposed CIA operative, recruited top spine doctors to serve as expert witnesses and treat injured plaintiffs using his (the former medics) sway over lawyers.

In 2007, the government charged Howard Awand and personal injury lawyer Noel Gage with conspiring to protect two compliant surgeons from a malpractice lawsuit after their patient underwent spine surgery and became a paraplegic. The two spine surgeons named were John Thalgott, who turned government witness, and Mark Kabins who was indicted earlier and is awaiting trial. The "Medical Mafia" dubbed by the conspirators, has more twists and turns than a high speed James Bond movie.

Awand is scheduled to go on trial in the fall and Gage is slated to go on trial in February 2010. In light of the governments victory, it is precisely this type of scheme that results in outrageous settlements, resulting in higher premiums for the public. Yet, this case will produce some interesting twists and turns. So who will crack under pressure when the government gets their day? If I were a gambling man, and that's Las Vegas style, I am betting the house that Awand rolls over if he is looking at spending many years in an orange jumpsuit. City Life reported that in early to mid-2000, Awand recruited Kabins and Thalgott to join his network of doctors and lawyers, in August of 2000, Kabins and Thalgott operate on the plaintiff and because of complications she is paralyzed. The plaintiff hires Noel Gage to sue Thalgott and Kabins for medical malpractice, Awand gets wind that the plaintiff is going to sue two doctors in his stable and meets with Gage to persuade him not to sue Thalgott and Kabins. Gage holds a secret meeting with all of the conspirators and they decide to sue an anesthesiologist, and the rest is history.

So here is the million dollar question, why is Senator Grassley and his band of gypsies chasing surgeons like Dr. Polly and Kuklo when there are potentially bigger fish to fry? The Spine Blogger wants to know what its readers think!

So Where is Medtronic Going?

Medtronic reported that during the first quarter of 2010 they had 7% growth in hardware and a 1% decline in their revenue for INFUSE. The question that the Spine Blogger must pose is how does such a conservative management team work to invigorate and reestablish innovate leadership? The only way to reestablish innovate leadership would be to overhaul the management team, doesn't the word innovate mean to make changes in anything established? As stated in a previous blog, this organization is starting to show its age. Years ago this company was a market leader, today, hospitals, surgeons, and distributors are attempting to distance themselves from an organization that once was well respected, innovative and set the bar for the spine industry.

Obviously, there will be those readers that run to their defense. The company is still the market leader, controlling an estimated 40% of a zero-sum market. Yet, where were they five years ago? Having been involved in various litigation (whistle-blowing and patent infringement) that has resulted in a public relations disaster, this company spends more time in court and defending itself in the press than it does in the research and development arena. Maybe their business model is litigating to recoup the cost of the Michelson litigation? There is nothing innovative about acquisitions, it simply results in buying revenue and hopefully garnering a larger share of the market. Unfortunately, when you are a publicly traded company, yes you are a slave to some analyst, an organization is forced to implement strategies and policies that change the culture and the mystique of a company.

So those of us in the industry are sitting back and monitoring what this once respected company will do next? The Spine Blogger wants to know what its readers think?

Doctor, Doctor Give Me the News? We've Got a Bad Case of Stem Cell Blues!

On Wednesday, the Spine Blogger posted a blog in response to a reader's question whether I could explain the difference between Osteocel (Plus) and Trinity. Much to my surprise, this is a real hot potato of a topic. Based on the response, the Spine Blogger wants to know whether there are their any surgeons that can provide us with their analysis on whether these products are new? true? and, can they make a difference?

Stem cells have become a phenomenal buzz word in our industry. Yet, what are we marketing when we take cancellous bone chips and mix them with demineralized bone? Stem Cells? Think of what it costs to inventory these products. The hospital has to purchase an expensive refrigerator. The OR has to thaw out the product. And in the end, all you are getting is what was stated earlier, cancellous bone chips with demineralized bone! So is this really technology or pure marketing?

The Spine Blogger wants to know whether there is a Doctor in the House? We need to hear from someone with an M.D..... Otherwise why not use Bone Marrow Aspirate and Synthetic Products? Will someone let us know!

Is it a DBM? An Allograft? or a Stem Cell? WHAT IS IT?

On Tuesday August 25th, the Spine Blogger had reported that Dr. Polly had resigned his post as a AAOS board member. Much to our surprise, one of our readers posed the question in the comment section whether I could explain the difference between Osteocel and Trinity. How did that question pop up after reading that blog? I need to know. Like our readers, I believe that I have some understanding about the science behind these products, yet, many questions exist that still have not been answered, not just from the clinical podium, but by the companies that sell these products. Like autograft, aka "the gold standard," both of these products market themselves as osteoinductive, osteoconductive and osteogenic. Meaning that in order for a therapeutic result they must meet certain conditions to be effective. Basically, the product must have the ability to send a signal, recruit the appropriate cells, differentiate, proliferate (multiply) and function properly during the healing process while avoiding harming the patient. Obviously from a marketing perspective it makes it sound like BMP's. These products incorporate the aforementioned "biologic buzz words" necessary to successfully market the product and spark commercial interest.

Osteocel is a bone matrix, (a point of origin), that preserves stem cells found in bone marrow. These cells are harvested from a donor (within the first 72 hours), processed by demineralization and usually combined with a milled femoral head (remember the good old days when surgeons did that in the OR). The controversy surrounding both Trinity and Osteocel, is how many viable stem cells are delivered in each dose? Meaning how many have survived the harvesting process and the cleansing which in itself is an incredible purification process?

Trinity is marketed as an allograft product that has been processed (demineralized), from a deceased donor, resulting in a source of cells. It all starts to sound similar. Allogenic stem cells carry with them all the safety issues of any allograft product. The donors have to be adequately screened, cells must be tested for the presence of any virus or bacteria while the principal safety concern is the risk of tissue mismatch or infection in the recipient. Just like Osteocel, the controversy surrounding Trinity also centers around how many stem cells are viable or alive when delivered in each dose at the point of delivery. If Orthofix/Blackstone claims > 50,000 MSC/cc would that mean that there are 250,000 MSC in a 5cc dose? Are they all alive?????

Are physicians questioning any of these claims?

Marketing is a wonderful art. Unfortunately, when it comes down to these two products it's all show, all dough, and all anyone can say is STEM CELLS. Whenever I hear Osteocel Plus, I always wonder if that is the equivalent of pulling up to the Sunoco station and asking for the Ultra. Are you willing to pay more to get the same performance. The Spine Blogger wants to know what our readers think about these products!

Polly Resigns from AAOS

On August 24th, 2009, The Star-Tribune, a Minneapolis, Minnesota newspaper reported that in a letter to the President of the American Academy of Orthopedic Surgeons, Dr. David Polly resigned as a member of the Board of Directors. Dr. Polly cited the ongoing investigation into his consulting activities as a "unnecessary distraction" to the important efforts of the AAOS.

Dr. Polly has defended his compensation vigorously. In an interview with a prominent journalist at Orthopedics This Week, Dr. Polly defends himself by saying his oversight was an honest mistake. He is quoted as saying, "there was no intent to mislead or deceive, but there is a perception that full transparency wasn't achieved."

Dr. Polly goes on to explain that the fix would be for the Government to provide disclosure sheets to people testifying before Congress allowing them (the physicians) appropriate disclosures. Of course at a time when everyone is railing at the Government, in some respects it makes it sound as though Dr. Polly is deflecting his lack of transparency at that moment in time at the Government. If he wasn't such a savvy industry veteran, that defense would probably stand up. Yet, it is obvious as this drama plays out, surgeons like Dr. Polly and Dr Kuklo (what is it about these military doctors?) are the villains, while Senator Grassley is portrayed as the White Knight rescuing the healthcare industry from potential improprieties.

Today, as another page in the ongoing saga turns, lawyers across America are lining up to take advantage of a situation that has itself turned into a lucrative segment of the law. And we expect tort reform? So remember doctor, be transparent, don't be greedy, remember the more companies you represent the better off you will be, and don't forget whom you work for. In the end it is the patient that matters. The only question that the Spine Blogger must ask is, when standing on that podium in front of your peers, do you have the ability to differentiate between clinical marketing and clinical efficacy and that is the million dollar question? The SpineBlogger wants to know.