Spinal surgeon, implant industry and patient care: Where do we draw the line!
Correspondence Address: Source of Support: None, Conflict of Interest: None DOI: 10.4103/0028-3886.181560
Source of Support: None, Conflict of Interest: None
The present era in surgery, and in particular spinal surgery, reflects newer scientific developments, better understanding of biomechanics and needless to say, a technological boom. The present technological boom is created by the popularity of the microscope, diagnostic imaging, intra-operative neural monitoring, minimally invasive spinal instrumentation, endoscopy, laparoscopy, and more recently, the use of robotic surgery.
It is mandatory for every surgeon to keep updated with the latest knowledge in order to be well informed of the medical advances and have knowledge of the technological upsurge, which has resulted in the creation and marketing of newer gadgets for spinal surgery. It is heartening to note that such advances have benefited patients the most, resulting in reduction in morbidity and the recuperative time spent in the hospital. The increasing trend of using smaller surgical corridors has stimulated spinal surgeons to experiment with and to start newer surgical techniques. Two of the forerunners of this trend have been the Minimal Access Spinal Techniques (MAST) and the use of implants.
The trends of innovations within the spinal implant manufacturing industry, like fusion devices in the past versus motion-preservation devices in the present era, suggest that implant manufacturing, production and marketing are dynamic processes and must cater to the evolving and changing expectations of the surgeon and the patients who expect a faster recovery from the procedure.
For full evaluation of newer implants, randomized clinical trials are necessary. Prior to implantation, medical devices are subjected to rigorous testing to ensure their safety and efficacy. The battery of testing protocols for implantable spinal devices includes steps like testing for biocompatibility, evaluating biomechanical and clinical performance of the device, mechanical testing, optimization of the design, prediction of performance, evaluation of durability, and finally philosophizing on the efficacy of the device.
The market has become very competitive and fierce and it is generally felt that there is a greater interest from the industry in promoting spinal instrumentation that results in their greater usage by spinal surgeons. Statistics have proven that such an attitude on behalf of the industry has led to an over-usage of many spinal implants.
The first chemonucleolysis was performed by Smith (1969), by injecting chymopapain into the annulus fibrosus to remove the herniated disc by enzymatic hydrolysis. It is considered as the first minimally invasive technique of spinal surgery. The concept of using bone grafts for fusion was pioneered by Klienberg. Hence, to achieve arthrodesis in the realms of usage of spinal instrumentation, newer technologies such as bone graft substitutes, interbody cages and Bone Morphogenic Protein (BMP) came into existence. But, as we all know, there are always two sides to a coin. For example, on one hand, BMP aids in reducing re-operation rates and helps in hastening return to activities of daily living; on the other hand, the use of BMP involves a high operative cost for the patient and may cause complications like post-operative swelling, post-operative radiculitis, post-operative nerve root injury, antibody formation, hematoma formation, and ectopic bone formation. The product also has carcinogenic potential.
Michele and Krueger first documented the technique of pedicle screw fixation in 1949. While pedicle screw fixation has revolutionized the field of fusion procedures in spinal surgery, there are certain grey areas in its usage. Pedicle screw fixation involves a significant para-spinal muscle dissection, which may cause ischemic necrosis of the muscles and can cause relentless chronic low back pain. With the introduction of percutaneous access to the pedicle screws, the issue of muscle ischemia has been taken care of. MAST allows surgeons to bury the screw heads deep within the recess of the transverse process junction allowing for a lower rod profile. It also helps in reducing the incidence of disruption of adjacent facet joints above and below the construct. However, an unintended durotomy is a frequent complication of the MAST procedure. Currently, pedicle screws are extensively used all over the world. They often include innovative actions such as maintenance of dynamic motion. Due to their extensive usage, the pedicle screw market has become extremely competitive, further resulting in significant increase in their usage rate. Statistics has now proven that pedicle screws are overused. According to the Burton report, “It is sad to reflect that many spinal surgeons have completely lost sight of the real goal….” Such a nexus between the spinal surgeons and industry has resulted in establishment, in some countries, of the Associations of Ethical Spinal Surgeons.
Plated and non-plated anterior cervical discectomy and fusion (ACDF)
Non-plated versus plated anterior cervical disectomy and fusion (ACDF) is another dilemma that has always intrigued spinal surgeons. The western world routinely uses plates even in a single level ACDF. The Eastern world is not so much convinced of using a plate to augment fusion for a single spinal segment. To facilitate graft compression and to further improve the fusion rates, dynamic plates were devised. The plate movement decreases graft shielding and increases graft compression. The “value added” by the plates, that includes reduction in the anterior graft extrusion, was thought to be a big gain for the surgeon. But there is hardly any difference between the fusion rates utilizing plated versus non-plated ACDF with the fusion rates being 95% and 90%, respectively, in the two procedures. This makes us think twice regarding the utility of a plate in a single-level ACDF.
The plate is also supposed to reduce the incidence of post-operative kyphosis but this fact has not yet been conclusively proven.
Financial and nonfinancial relationships between any surgical implant manufacturing industry, the spinal surgeon, investigators, and academic institutions are common and generally considered essential and healthy for the advancement of spinal surgery. For example, I have personally devised several spinal implants and have modified existing implants to suit our circumstances and needs. Having thought of newer concepts, I had to first discuss my idea with the industry and find out if they had the technical capability of manufacturing the implant. As a result, I have a healthy relationship with surgical firms like GESCO in India, SYNTHES in Switzerland, PARADIGM SPINE in Germany, etc., My interest is purely for the advancement, development and propagation of newer concepts, which could be useful for spinal surgeons.
Conflict of interest
However, such ties, at times create a conflict of interest with professional judgments that may get unduly influenced by secondary interests. The conflict of interest in policies typically focuses on financial relationships, which in many cases, are relatively objective and quantifiable. Other kinds of conflicts of interest do exist which include the desire for professional advancement, the desire for personal achievements to be recognized, and to carry out favors for friends and colleagues. The conflicts of interest arising from ties between the industry and surgeons may potentially bias research, influence medical decision-making and even jeopardize the patient's health and as a consequence, the public trust in medicine.,,,,
Time has come for the spinal surgeons to show more transparency in their dealings with the industry. If a line is not drawn early, the sanctity of the patient's trust in the spinal surgeon will be compromised.
Currently, reporting disclosures of conflicts of interest has become mandatory for authors of medical publications and presenters during scientific meetings. This provides their audience information regarding the industry-doctor alliance, and permits the formation of a fair and free opinion. It gives the reader/audience the opportunity to appreciate the results of the author/presenter in the light of the disclosures revealed.,,
However, the disclosure process is not applicable to the reviewers and editors of scientific journals, nor to abstract reviewers of medical conferences. Several publications have demonstrated the occurrence of bias in the peer review process as a result of conflict of interest. It is not clear as to what extent this exists in editorial boards. Medical journals strive to be objective and be disseminators of reliable sources of scientific information. They, therefore, go to great lengths to ensure scientific integrity of their publications. However, instances have occurred when a surgeon has criticized a particular implant or technique while he is having a financial tie-up on a similar product with a different company.
Conclusions drawn in a manuscript pertaining to the use of a medical device might be misinterpreted; or, the editorial board members could reject the manuscript itself due to their financial ties with other industries producing competing devices. This point can be better explained in cervical disc arthroplasty where several sophisticated and expensive implants have flourished in a fiercely competitive market.
Ties between the pharmaceutical or medical device industry and the scientific journals are essential for sharing state-of-the-art scientific knowledge and for maintaining momentum in research in the field of spinal surgery. Many universities cannot afford grants for diverse projects and one sees the practical reality of many research projects being financed by the industry. The solution is good for the advancement of knowledge but such ties, many a times, have created a conflict of interest, compromising the objectivity of the project and thus resulting in a bias.,,,,
In order to increase transparency, professional bodies, institutions, journals and reviewers should strive to minimize bias while performing their respective role in any project. Financial relationships between them are not necessarily unethical but at least full transparency and awareness are necessary to maintain integrity in research and public trust.,,
So far, little attention has been paid to the effectiveness of implants in spinal surgery in creating better clinical outcomes. With escalating costs of both implants and medical care, spinal surgeons in the future would be expected to participate more intently in correlating clinical outcomes, patient satisfaction, relative cost of implants, cost of medical care and fusion rates.
Any implant must first be critically tested in the laboratory and evaluated well before its clinical use. Often, a new technology is touted as the perfect solution but subsequently, following its widespread use, we find that less than favorable results have been obtained. In the United States, Healthcare Technology Assessment (HTA) is the multidisciplinary evaluation of medical implants with regard to their efficacy, safety, feasibility, cost-effectiveness and indications. Unfortunately, spinal surgeons often continue to use newer implants without much knowledge of their benefits. This reinforces the problem of propagating an implant without knowing its benefits when similar established ones in the market already have shown proven benefits.
Influenced Spinal Surgeons
It is generally believed that the thinking and behavioral pattern of spinal surgeons focuses on the desire for professional advancement, on trying to acquire a reputation as the providers of high-quality and cutting-edge care, and most importantly, on the financial gain. When reimbursements are high, physicians and hospitals often move quickly to use newer implants. A burning example is spinal arthrodesis, and particularly, instrumented lumbar inter-body fusion. The rate of this surgical procedure, all over the world, is very high, is increasing every year and does not correlate with the rising incidence of patients who actually require it. All the available evidence suggests that the implants are being overused. Reimbursements remain high and spinal instrumented fusion procedures have continued to increase.
The surgeons often have increased social interaction with the medical community at professional conferences that include industry representatives. They often have close ties with medical organizations and industry. This behavioral pattern by spinal surgeons has helped to create false statistics that propogates the overuage of implants. As philosopher Mark Twain said, “There are lies, dammed lies and statistics.”
The surgeons' responsibility
Surgeons have an important role in the adoption, utilization and choice of newer implants. They should also have advanced training in adhering to the proper processes involved in the utilization of newer implants or machinery. They should be well apprised of both the clinical value and the profitability of the newer products.
The market is flooded with new implants and machinery. The transactions have become very competitive. The spinal surgeons have to be extremely vigilant and exhibit complete transparency if they have to regain the trust of their patients, which at present appears definitely tarnished.