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Is There An Ethical Crisis in Spinal Surgery?

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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.

By Aaron G. Filler, MD, PHD

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 Back_surgery
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.

Recent Comments

  1. University Update

    Is There An Ethical Crisis in Spinal Surgery?

  2. Bill Henry

    The author of this article advises the patient to “obtain a disclosure from the surgeon revealing financial interests.” Are surgeons leagaly obligated to disclose this information? If so is there a database that one can search through for this information?

  3. Susanne Christie

    I walked around with a dislocated and locked sacrum for 4 years due to my first pregnancy. I told many OBGYNm, doctors and eventually spine specialist about my symptoms and they were ignored, and or deemed impossible. Today everyone looks at the MRI instead of taking a complete spinal x-ray which would have shown that my spine was out of normal alignment. I was told to get the Charite disk repalcement surgery for three severely degenerated disks which was evident on the MRI. My gut told me that surgery would do no good and I refused this surgery. Eventually, I found the right gym equipment; the hip abductor and adductor which helped me realign my sacrum releiving me of exruciating pain. I’m glad that I held stedfast, yet, I do have severe degeneration as a result of this dislocated joint that is located in the pelvis and houses the spione. That what happened to me did not need to be prolonged had I had a supportive spouse and physicians who were willing to listen and to hear the symptoms described. I was often told they were not possible. Yet, I did eventually find online the symptomsthat I had been describing for four years and is called SI joint Syndrome.

    Even communicating to doctors can be problematic if they choose not to beleive and or hear the validity of their patients.

    I hope this information might help some other person who might find this useful before going under the knife.

    Best to all,
    Susanne
    Hopefully no other human being needs to go through such pain for naught. Be your own best advocate since only you know how you feel.

  4. Calli Spheeris

    Thank you for this site – I will buy the book.
    After 2 neurosurgeons telling me I need 4 (FOUR!)
    level spinal fusion, I did some research to find
    how risky this truly is and how the outcomes are
    poor. I am working with a physical therapist, chiropractor, and acupuncturist. Although this
    takes time, I am committed to the non-surgical
    route.

  5. John Gittelsohn

    Here’s an update on the issue of spine doctors investing in a spinal product company: http://www.ocregister.com/articles/allez-companies-company-2038487-products-spinal

  6. Dr. Hans-Rudolf Weiss

    The best indication for having a spine surgery seems to have a spine…
    Today there is less evidence for scoliosis surgery than for conservative management, however in the professional spine literature (surgeon driven via selected editorial boards) this information is suppressed. SRS surgeons have published an article on “Professional opinion on bracing in scoliosis management” demonstrating their bias against conservative management: About 50% of those “professionals” did not believe in bracing although there is more evidence for bracing than for having spinal fusion surgery for scoliosis in peer reviewed literature.
    As to my opinion this fact needs to be enlightened further more…

    [1] Weiss HR.Is there a body of evidence for the treatment of patients with Adolescent Idiopathic Scoliosis (AIS)?
    Scoliosis. 2007 Dec 31;2:19.
    [2] Weiss HR.Adolescent Idiopathic Scoliosis – case report of a patient with clinical deterioration after surgery.
    Patient Saf Surg. 2007 Dec 19;1:7
    [3] Weiss HR, Goodall D.The treatment of adolescent idiopathic scoliosis (AIS) according to present evidence. A systematic review.
    Eur J Phys Rehabil Med. 2008 Jun;44(2):177-93
    [4] Weiss HR.Adolescent idiopathic scoliosis (AIS) – an indication for surgery? A systematic review of the literature.
    Disabil Rehabil. 2008;30(10):799-807.
    [5] Weiss HR, Goodall D.Rate of complications in scoliosis surgery – a systematic review of the Pub Med literature.
    Scoliosis. 2008 Aug 5;3(1):9.

  7. crotti francesco

    I’m agree with the opinions that are here expressed. As peripheral nerve and spine surgeon, i believe that in many spinal cases is there an involvement of perpheral nerve entrapment (PNE). For many reasons the degenerative lumbar spine is able to create PNE by exstending the pattern of myofascial trigger points inthe muscular frame outside of columna 1), by chronic poor posture that changes the environment of the nerve in the canals 2), by eventually, the Sympathertic nervous system involvement 3). Meanwhile the lumbar pain and leg pain can be meimickated and activated by PNE. For the failed back surgery syndrome, in the most of cases (frozen back surgery syndromes and neuropathic pain syndrome), is hidded a peripheral nerve compression syndrome.

  8. Scott Lederhaus, M.D.

    It is my opinion that a surgeon receiving money (kickbacks) for using a particular spinal implant should be considered criminal. The conflicts of interest for such behavior are obvious and should be stopped. Surgeons should not receive either kickbacks or consulting fees for use of spinal implant products. It is truly appalling what is going on with spinal surgeons. A patient would not know if a surgeon is paid anything for implants. Be careful when selecting a surgeon.

  9. Jane

    What about the patient whose “device” or “screw” fails?

    What “incentive” does that doctor have to truly assess the situation and report a negative outcome? Wouldn’t that doctor try to hide a negative outcome if he/she has any kind of investment in its success?

    Doctors already inflate success rates by cherry picking the patients that they feel are more likely to have positive outcomes. They reject those that have long-standing, complex, and/or chronic spinal conditions, even when surgical intervention is clearly indicated.

    Medicine is BIG business. When it all comes crashing down due to greed, ego, and a lack of cash paying patients, and the government takes over the industry, they’d better have a back up plan….

  10. dr vikas tandon

    it seems that the above mentioned comments are all against the doctors for using the implants.
    No this is not true, there are clear indications and has been proved repeatedly that spine surgeries where implant is necessary yeild better results as compared to there non implanted counterparts. yes you need to take the decision as to where it is required and where not, probably here the issue of ethics come into play.

  11. Dianne Lauf

    The key is having the right neurosurgeon. I was quickly losing my ability to walk, stand, and even lift a plate of food. Dr. Srinath Samudrala performed a perfect anterior cervical discectomy and fusion at three levels (ACDF) and I reclaimed my life. I experienced no pain following surgery or for the past 2 years. We need more neurosurgeons with the insight, talent, and integrity of Dr. Samudrala.

  12. Samantha

    It’s surprising such a high percentage of people don’t seek non-surgical treatments first. Sometimes they work, but sometimes spine surgery is inevitable. Solutions can’t be rushed and there is no need to foolishly undergo surgery.

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