Stem Cells in Sports Injuries: A Performance Enhancement? Not Reimbursable? C’mon Man! (Josh Sandberg @ OrthoSpineNews)
By: Jeff Chandler, Sports Medicine Writer at OrthoSpineNews.com
Have you had enough? Let’s see, the last time I checked I thought that Doctors were to supposedly “best” treat our ailments in the US. It certainly appears that today’s governing bodies (i.e. insurers, regulatory, sanctioning committees) are notably limiting the scope of our MD’s care guidelines and it’s not getting any better. Is the US not considered the Leader of the Free-World? Then, why are high-profile US athletes forced to seek promising medical treatment, such as stem cell therapy, outside of the US? Needless to mention that our medical research and early-stage innovation are also being pushed outside the US. Plus, have these bodies developed amnesia and forgot about a minor term known as patient satisfaction?
From Peyton to Kobe to A-Rod to Tiger, our globally recognized action-based celebrities have undergone some form of stem cell or cellular treatment recently in Europe. Anecdotally, they seemed to have recovered faster than with existing US treatments, and returned to their workplace faster and happier with their outcomes. Now was their cellular therapy considered a healing methodology or a performance enhancement? Given the fact that autologous stem cell treatment is not yet approved in the US, these high-performance athletes have exposed a major flaw in our healthcare system. If a guy suffers significant blood-loss resulting from an accident, then preferably he could be administered a transfusion of his own stored blood. Truly that begs the question of what’s the difference, no bridges are burned in autologous cellular therapy? On another note, can we even begin to calculate the negative cascading effects in delayed return to work for today’s US working single mother or the family’s breadwinner given our malicious US economic environment? Really?
Have you ever suffered a significant injury that prevented you from normal activities or even worse your livelihood? Outside of the economic implications, these injuries simply put are “painful” and impairing.” I can attest from personal experience that I want the “best possible” care available to treat my injury. In NCAA sports, I’ve endured numerous painful and debilitating injuries such as sprained ankles and fractured bones, but none more challenging than two sprained thumbs from one game. C’mon man, try doing even the most simple hygienic functions without the use of your thumbs while in two splints for weeks, go figure… Nonetheless, you get the point, “heal faster and improve your quality of life.”
There’s no doubt that evidence-based medicine is imperative overall and mandatory in most cases, however, the practice of medicine remains an art-form. And continuing without the historical development pathways that have yielded significant medical advancement, medicine in the US will be stifled and we’ll all suffer the consequences.
“Sorry, no evidence, no reimbursable payment!” seems to be the tone set by our US 3rd party payors these days. By the way, was the patient’s outcome even considered here? Ouch! 3rd party payors are reluctant to embrace new treatment options and often define them as “experimental”, and thus avoiding reimbursement. “Experimental” terminology is just another way of saying “no to payment,” and mostly with disregard to their customer’s (patient) care and satisfaction. In fact, often times these companies won’t even confirm an appointment on a new therapy from Industry unless there’s significant long-term and evidence-based data.
How much longer are we going to continue to let the “tail wag the dog”? Regardless of which governing body, it seems as though an enormous amount of obstacles have culminated in the pathway of medical break-thru therapies and enhancement of patient satisfaction. How many clinical studies can we truly afford before beating a horse to death? For example, requiring a 10 year $35m-$40m clinical study prior to sanctioning (e.g. FDA 510k clearance, league eligibility, assured reimbursement) a new technology or therapy, or worse yet flushing 20 years of positive clinical data down the toilet due to political differences?
Who’s going to put an end to this nonsense, Industry or MD’s or both? Will AdvaMed lead the charge or are they too busy cow-towing to government officials or policing the amount over-spent on a surgeon dinner? Yes folks, the government officials are not only dictating our policies on medical advancement, but are predominately being hypocritical as well. Aren’t these the same officials (mostly legal counsel) whose firms annually buy luxury suites to every professional team in town and many of whom host lavish business events without their mundane profession being questioned? We’re the highly educated and trained professionals that are in this downward spiral together my friends, and certainly a Call to Arms is required…
So when it boils down to accessing stem cell or cellular therapy, I guess that you’ll have to keep a keen eye out for reduced trans-continental airfares and learn a foreign language… Oh as far as performance enhancement, the last time I checked nobody was given extra-special athletic powers from a “super-ligament or bone fusion”… C’mon Man!
About the Author – jeff@tdg-llc.com
Mr. Chandler is an accomplished medical device industry innovator and executive with over 25 years experience from venture capital backed startups to industry leaders. Most recently, he has been engaged by medical device companies as a consultant focusing on sales, marketing, business development, recruiting, clinical advisory board development, and product innovations. Mr. Chandler features a successful history in directing technologies and companies, developing direct and independent sales channels, and launching paradigm-shift medical technologies and surgical techniques. He draws upon a highly decorated corporate management and sales career, has co-founded startups, driven OTL, OEM, and distribution licensing agreements, and holds patents. Mr. Chandler has an expansive network of global Key Opinion Leaders, recruiting many influential surgeons to a variety of Scientific Advisory Boards and as customers. He offers business expertise in team building, fundraising, operations, marketing, reimbursement, business development, sales/distribution, and IDN/GPO agreements globally. Mr. Chandler has held escalating responsibilities in sales, marketing, and general management in former companies such as Aquarius Medical, Zimmer, Smith & Nephew and Linvatec.