Is There An Ethical Crisis in Spinal Surgery?
Aaron Filler is one of the world’s leading authorities on nerve and spinal surgery. He is Medical Director of both the Institute for Nerve Medicine and the Center for Advanced Spinal Neurosurgery, and is an Associate of the Institute for Spinal Disorders, at Cedars Sinai Medical Center, in Los Angeles, California. In his book Do You Really Need Back Surgery?: A Surgeon’s Guide to Neck and Back Pain and How to Choose Your Treatment Filler provides an accessible resource for those who suffer from back pain. Below Filler weighs in on some tricky ethical issues.
A well informed patient is most likely to get the best and most effective treatment. This is the position I take in Do You Really Need Back Surgery (OUP). This applies across the spectrum from pilates to pedicle screws – educate yourself and then talk with your doctor. However, what happens when outside financial motives unduly influence what your doctor has to say to you?
Recently, a New York Times article by Reed Abelson – “The Spine as Profit Center; Surgeons Invest in Makers of Hardware” (12-30-06) raised public awareness
of ways in which financial incentives can distort the medical advice of spinal surgeons.
Even more concerning, under the banner of the Association of Ethical Spine Surgeons, Dr. Charles Rosen of University of California, Irvine has called for the resignation of leaders of the North American Spine Society – (NASS) stating that some receive hundreds of thousands – even millions of dollars in incentives from companies that manufacture spinal devices. NASS educational meetings are attended by thousands of spine surgeons. What is going on here?
Joel Press, the President of NASS has posted a web page entitled “Conflicts. What Conflicts?” He takes the position that there may be concerns about disclosure of conflicts but expresses doubt that any patients are being compromised.
Nonetheless, concern about an ethical crisis affecting patients was reinforced by discussions at various professional meetings during 2006. Formal scientific publications on a new type of spinal device had revealed extraordinarily high success rates and explicitly reported “zero” device-related complications (Schnake et al Spine Journal 3:159S 2003). However, a separate study involving only surgeons with no financial interest revealed an unusually high rate of “device related” complications and failures (Grob et al, Spine 30:234, 2005). Patients who had traditional “decompression surgery” alone or who had the traditional surgery plus the device improved, but those that had the device only did not improve. Only the traditional (non-implant) part of the surgery could be proven to help the patient – although most of the income to the surgeon was from implanting the device. The occurrence of unusual new types of complications and the need for reoperations were often due to the device implants. Patients could be harmed by the device with no prospect of benefit.
Differences in reported scientific results seemed to reflect the difference between conflicted versus non-conflicted investigators. Nonetheless, when competing data is reported and conflicts are declared, doctors can make informed decisions on what to make of the data.
Many surgeons receive manufacturer funds to attend training meetings in places like Vail, Cancun and Las Vegas, advertised as academic medical education events. I recently organized a session at one such meeting that brought in several nationally respected neurosurgeons to teach new diagnostic techniques and treatments to reduce the use of implants. Meeting sponsors from the device industry objected and the session was cancelled. How is this sort of training bias disclosed to the patients of those doctors?
When does helpful collaboration between surgeon and manufacturer become a conflict of interest? If a surgeon invents a new product and then recommends its use – there may be a wonderful benefit to the patient even if there is an apparent conflict of interest. This is particularly true if the new device is a huge improvement over previous types of care. However, the new device may be just a minor modification of existing products. “Investor-surgeons” asked to comment on the minor change can later state that they were involved in its design simply to deflect the appearance of purely financial involvement.
Implants (screws, rods, artificial disks) play a crucial role in solving many difficult spinal problems and they are a huge benefit in the spinal surgeon’s set of treatment options. However, over-use and misuse of good devices as well as any use of unhelpful devices are concerns affecting hundreds of thousands of patients every year. In some parts of the United States, the utilization rates for spinal implants is far higher than in other regions. However, epidemiologists such as Richard Deyo say that more device implants does not result in better spine health.
A patient shouldn’t worry too much about the possibility that their surgeon chooses equivalent Device A over Device B because of personal financial motives. However, there is a larger concern when the choice is between a traditional “decompression surgery” (where the surgeon may earn about $1,000) and a complex instrumentation surgery (where the benefits to the surgeons could run into tens of thousands of dollars). Some financial incentives (the surgeon is paid to operate well) are obvious and unavoidable. However, in situations where the surgeon’s choice of the type of treatment is subject to heavy financial influence that may not be apparent to the patient, a meaningful disclosure is appropriate.
This means that any time a spinal surgeon recommends a surgery that involves an implant, the patient should obtain a disclosure from the surgeon revealing financial interests (investment, “research funding,” free travel or industry sponsored conferences, paid consulting arrangements, paid dinners, or other financial benefits outside of the surgical fees). If in doubt, get a second opinion from a spinal surgeon who does not share the conflict of interest.