Low back pain: Controversy over back surgery and Prodisc
The January 30 issue of the New York Times included a lengthy critique of the conflict of interest that has been uncovered with the artificial spinal disc "Prodisc". The artificial disc sells for about $10,000.00 and has generated significant profits for its manufacturers and investors, even though Medicare and many private insurers will not pay for its use or the expensive surgery to install it.
The Times reported that it has recently come to light that the medical researcher/doctors who endorsed the Prodisc and who were involved in the study that purportedly demonstrated its effectiveness were also investors in the product. Thus, there is substantial question whether they were neutral, objective researchers with regard to the effectiveness of the surgical installation or the analysis of the resulting data.
The study relied on 240 patients. 162 of the patients received a disc, while 80 patients underwent spinal fusion, the basic alternative. An additional 50 patients in whom Prodiscs were installed were excluded from the results of the study as "training cases", and 21 other patients were excluded for undisclosed reasons. Critics of the study point out that this represents a substantial proportion of the surgical implant patients and the exclusion of these results may taint the research--particulary where about one-half of the participating surgeons had a significant financial investment in the success of the product.
The latter investment occurred when the product was under development with a venture capital firm called Viscogliosi Bros. According to the Times, doctors at The Texas Back Institute, for example, had invested almost 170,000 dollars in the potential new product. Other researching physicians had investments as large as $250,000.00.
Investments of this nature by researching physicians are supposed to be disclosed to the FDA, which normally examines the resulting data and conclusions more closely. The FDA is currently checking to see if there was proper disclosure in this case, however, allegations from a malpractice lawsuit that brought the entire problem to light suggest that the financial interests of the researchers were not properly disclosed.
Dr. Charles Rosen, from the Medical School at the University of California, Irvine, acknowledged the obvious when he suggested that in some cases, physicians and researchers are simply "too cosy" with medical product manufacturers. Rosen is the creator of an organization entitled the Association for Ethics in Spinal Surgery. He is hoping that by publicizing the many entanglements between surgeons, hospitals and device manufacturers, he can help members of the public make reasoned choices about medical care. All too often, such choices are influenced by recommendations from medical professionals who do not feel obligated to explain the fees they receive from product manufacturers. Some other examples of these financial entanglements are described elsewhere in this blog--particuarly with the discussion of pacemakers.
Surgical care of low back pain has always been a source of controversy. While certain conditions must be treated surgically, many physicians feel that most low back pain should not be treated surgically and that "no condition is made better by interposing scar tissue upon it". The delicate decision-making necesssary to assess whether and when to operate on the spine should not be confused or distorted by a conflict of interest--or even an apparent conflict of interest.
There should be mandatory legal disclosure of all financial investments, paybacks, fees and kickbacks associated with the practice of medicine and medical research. When a patient sees that he or his insurer has paid several thousand dollars for a surgeon's expertise, he should know if anyone else is paying the doctor for research or consulting, or if the doctor stands to gain financially by use of a particular procedure or device.
You may read the New York Times article Financial Ties Are Cited as Issue in Spine Study here.