Former CEO of Hospital for Special Surgery Charged

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

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

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

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

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

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

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

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

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

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

Spine Nation:

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

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

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

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

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

The Last Quarter

Spine  Nation:

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

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