I am a clinically retired orthopedist who completed my residency training in the mid-80s. I trained at a university residency program with faculty who were both forward-thinking and innovative, yet always grounded in evidence-based medicine. It was understood that many traditional concepts in orthopedic surgical care had not been challenged and lacked convincing clinical data to justify their continued advocacy. Examples included post-operative immobilization, avoidance of internal fixation in the presence of infection, and routine surgical repair of medial collateral ligament disruption and Achilles tendon ruptures. One of the foundations of medical-surgical care post-homeopathic philosophical care and allopathic bloodletting was the recognition that clinical evidence provided the basis for retaining or adopting medical-surgical principles. The highest form of such evidence required controlled studies with matched populations and double-blinded participation (participants and evaluators). Short of such evidence, clinicians were to recognize the uncertainties of perpetuating or adopting techniques or modalities in their practices.
Healthy skepticism was not only encouraged; it was and is essential in considering what we might do as practitioners, and the potential for conflict of interest by reporting parties must be considered. In the absence of convincing data, one might take a scientifically based theoretical, traditional-empirical, or cost-based approach in considering competing therapies. This is a reasonable and rational decision-making process until compelling evidence provides a direction for subsequent care.
I can remember visiting a very prominent orthopedic company in the early 1990s and having one of the company’s national sales managers eagerly show me their new product, injectable hyaluronate. He enthusiastically indicated that it was likely to alter non-surgical management of arthritic joints. I was surprised to learn this, as I thought I was reasonably aware of the underlying changes in arthritic joints and had never heard that there was a deficit of hyaluronate associated with these changes. So, skeptically, I asked if there was a published study showing arthritic joints had reduced hyaluronate concentrations. He replied that he could not produce or cite such a study. I assumed that my colleagues would pay little attention to this new therapy, but I was very wrong and naive to think this. I failed to understand the power of marketing on even well-trained medical minds, and within a few years, it seemed as if a largely unjustified portion of my fellow orthopedists were injecting hyaluronate preparations into every arthritic or arthralgic joint they could. Fast forward twenty-five years and substitute mesenchymal stem cells for hyaluronate.
I can remember numerous devices and techniques that were advocated by various companies and their “thought-leader” advocates that were rapidly adopted by otherwise thoughtful and well-trained colleagues but were later discarded as either useless or, worse yet, harmful. We can remember thermal modulation of the intervertebral disc and fibrillated articular cartilage, surface replacement arthroplasties, or graphite ligament substitutes for ACL injuries, to name just a few. In every instance, there was usually advocacy by clinical thought leaders (invariably profiting from commercial concerns) touting the benefits of these untested therapies. At times, it felt as if I was out of step with the times for not adopting the popular practices. Never was this more evident than when I failed to prescribe CPM (continuous passive motion) post-operatively for a close friend on whom I performed a knee replacement. The nurses and therapists could not believe that I was unwilling to prescribe this innovative modality that had become routine and standard-of-care in my medical community, and they made their disbelief known to my patient. So, I had some explaining to do. My failure was that I had read peer-reviewed published articles showing higher incidences of DVTs and greater quadriceps atrophy in patients treated with CPM versus those without, and there was no clear benefit while there were clear medical and financial costs.
In the first decade of this century, the orthopedic surgical community was prepared for the release of a groundbreaking innovation in bone healing intervention, BMP-2. Prior to its clinical approval for general consumption, notable orthopedic researchers (all paid consultants for the commercial enterprise advancing the bone-forming protein) described study after study in which they participated, demonstrating not only its unparalleled effectiveness but also its safety at “doses that were well understood and thoroughly studied.” Soon after its release (for very narrow indications), surgeons were applying BMP-2 in virtually every form of application they could dream of until reality hit the fan. This adoption hysteria occurred with full knowledge of the substantial increase in cost associated with its use. After about two years of wide and relatively uncontrolled use, it became clear that bone resorption, implant subsidence, heterotopic bone formation, neuritis, and massive soft-tissue swelling (life-threatening in the cervical spine) required a more prudent adoption.
As if we could never learn a lesson, when a variety of companies introduced other “ortho-biologics” to compete with BMP-2 and traditional bone graft materials (such as century-old, time-tested autograft and allograft materials), colleagues rapidly incorporated these unproven and costly alternatives, driving a new lucrative market in orthopedics (valued at over 12.3 billion in the U.S. alone). When I attend international surgical conferences that discuss bone graft alternatives, in general, the summary of “bone in the bottle” is that it is convenient, unproven in its benefits over autograft and allograft, and costly. When a university-based spine researcher who specializes in bone graft animal model experimentation states that adding anything to DBM (e.g., mesenchymal stem cells) reduces rather than increases its effectiveness in producing new bone, one must ask why use these more costly alternatives. Yet when I ask what published clinical data can justify their use over traditional cancellous autograft or demineralized allograft, or allograft cancellous “croutons,” the response is usually dismissive and perfunctory: “I find it works well in my hands.” But this type of justification for the enormous costs and absence of clear clinical efficacy should be unsettling to thoughtful surgeon clinicians. We should be practicing based on evidence-based understanding or alternatively at least with a consideration for cost-benefit analysis. It is our collective money we are spending or wasting, and we should be more conscious of how unjustified costly technology is not only failing to produce improved clinical outcomes but is also driving up the cost of medical care. We need to remember that we are stewards of our patients’ health and our nation’s health care dollars.
James Francis Marino is an orthopedic surgeon.