Eleven spine surgeons weigh in on experimental therapies and how they handle discussions with patients who want to try some of these therapies.
Question: What to say when your patient wants to pursue experimental therapy? And what do you say when you know it won't work?
Rolando Garcia, MD. Spine Surgeon at Orthopedic Care Center (Aventura, Fla.): I explain to patients that experimental therapy is a treatment method that is new and not previously tested, such as injection of stem cells into degenerated discs. The safety and effectiveness of such treatment is unknown.
This is not the same as an investigational treatment which is currently under evaluation. A treatment that is, for example, under FDA trials. And although the long-term effectiveness and safety has not been determined, there is some scientific evidence to support its use. It is rare for me to recommend a truly experimental treatment. Experimental treatments, in my opinion, are usually reserved for cases in which established treatments are not acceptable to the patient. On the other hand, investigational treatments may offer promising advantages, which may justify their use.
Thomas Errico, MD. Chief of the Spine Division at New York University Langone Medical Center: Well, all experimental treatments are not equal. There are some "experimental treatments" that have some limited evidence and certain well-meaning physician advocates. Insurance companies may not choose to pay for them and the patient has some financial decisions to make. I generally recommend patients get multiple medical opinions before proceeding.
There are other "experimental treatments" that are apparently a "triumph of technology over reason." Often times, these have a zealot advocate either domestic or international who also has a significant financial gain with the treatment. For patients considering these treatments, I advise to proceed at their own risk and will council strongly against the technology.
William Taylor, MD. Director of Spine Surgery, Vice Chairman of the Division of Neurological Surgery at University of California, San Diego: There are two separate issues here. I actually encourage my patients to seek out alternative therapy options. Quite often, in my practice, that amounts to alternative exercise, diet, acupuncture and similar therapies. Except in rare cases, there is little lost in their pursuing these options at their own risk.
The second issue focuses on therapy that is financially motivated or pseudoscience, with significant overlap between both. I am firm about both of these and the financial devastation that can occur with "cash pay" scenarios promising results that cannot be delivered.
Counseling our patients when this option is presented is difficult but I try to identify the financial gain for the groups proposing the treatment. Secondarily, I try countering pseudoscience with actually academic arguments.
Richard Kube, MD. Founder and CEO of Prairie Spine & Pain Institute (Peoria, Ill.): If I am not familiar with the treatment, I let them know I am not familiar and cannot comment. If I am familiar with the treatment, I provide my honest opinion with whatever relevant medical literature available. When the treatment in known to be ineffective, I am honest with the patient. I am respectful of their questions and let them know that the choice is ultimately theirs, but I let them know that there is no medical evidence to support the treatment.
Ara Deukmedjian, MD. CEO and Medical Director at Deuk Spine Institute (Melbourne, Fla.): As a practicing neurosurgeon, I would never consider recommending a treatment that is known to me to be of no benefit to my patient. Sometimes patients do ask me to perform treatments I believe are not appropriate for them and I always tell them the truth. I say, "I don't think that treatment will work for you. You are free to do as you wish but I will not prescribe a treatment that I am certain will not help you. You will need to go elsewhere if you want the treatment you are requesting because we will not provide it for you here."
There are times patients ask me to perform surgery when I believe they need a safer, less invasive treatment that has a reasonable chance of working and I tell them not to have the surgery but to consider undergoing the non-surgical treatment first to see if it will work for them. Sometimes they leave my care because I refuse to do the surgery I don't think is necessary and they go to another surgeon who will perform the treatment they want. I can live with losing an unreasonable patient or two. The doctor-patient relationship is one built on trust. My patients don't have to do everything I recommend or prescribe for their pain, especially if they feel their symptoms don't warrant the treatments I have offered them, unless there is a risk of self injury.
Patients are free to chose what they believe is best for themselves. Under no circumstance would I ever recommend or perform a treatment I know doesn't work. This would go against everything I believe is right. Deuk Spine Institute is dedicated to serving the best interests of our patients. We do not fulfill ill-conceived notions.
Brian R. Gantwerker, MD. Founder of The Craniospinal Center of Los Angeles: I think some of the interesting experimental therapies that are now available present a possible frontier of medicine. My usual response is as long as its not patently dangerous or quackery, I am willing to discuss and comment. I try to manage their expectations for the efficacy, especially if it is a patient that I am seeing that has had other surgeons do multiple operations and they have reached a desperate state. I counsel them and offer more standard and accepted treatments.
Since I see a fair number of failed back syndromes, for example, post-laminectomy and flat back deformities, especially in an octogenarian population, I try to listen to them and see what it is that is bothering them, and what their goals are in pursuing this treatment. Oftentimes, simple physical therapy is called for, or spinal cord stimulation. Patients are goal driven, just like we are, and it may take five to 10 minutes of just listening to and understanding them.
David Chandler, MD. Spine Surgeon at Andrews Institute for Orthopaedics & Sports Medicine (Gulf Breeze, Fla.): When a patient is interested in experimental therapy, we discuss the evidence that supports the therapy, the conditions of the appropriate therapy, the parameters and then share the decision-making process. The intervention may not be recommended for the patient if the intervention is not appropriate for their condition, if they have a contraindication or if the considered intervention lacks scientific support or foundation.
If a patient wants the intervention, they are directed to reputable practitioners who perform them. Before that happens, the patient and I agree that future physician-patient discussions will not deviate significantly from the original one in my office. Some patients may persist in seeking a particular intervention and will eventually find someone who will perform it even if it's not recommended or in their overall best health interest.
Vladimir Sinkov, MD. Spine Surgeon at New Hampshire Orthopaedic Center (Nashua): It depends on the therapy and exactly how "experimental" it is. Some well-established and clearly beneficial therapies such as sacroiliac joint fusions and disc replacements are still considered experimental by insurance companies. I usually only suggest treatments that are supported by good scientific evidence. If I think a particular therapy will not work, I simply tell the patient why I do not think it will not help them and usually quote a study or two supporting my decision.
Stephen Hochschuler, MD. Co-founder of Texas Back Institute (Plano): In general, when I talk to patients I want to make them comfortable and feel at ease. Normally, when they come in, they are worried and I try to make them comfortable. I tell them I have 40 years of experience in the spine care field and that I have also been a patient myself. I also tell them that it's my job to tell them want I think should be done for their condition and what the alternatives are. It's an open dialogue.
I also give them the names of internet sites that I know will give them reliable information. I let them see that I am resource. I always tell them what I think the outcome will be of an experimental therapy, but I encourage them to get a second opinion.
I try and lay out the information for them, but I also make sure they understand the decision is theirs, not mine.
But if I truly don't believe in an experimental therapy and if there is the possibility of harm, I tell them I think it won't help but they can do it if they want. If I thoroughly disagree with what they want to do, I tell them, but let them know it's their decision in the end.
I am a consultant, I tell them that. I also always take them back if they do go try something I disagree with and end up with complications. I try not to bad mouth anybody, but I am honest if I think a procedure won't work.
Brian Cole, MD, MBA. Section Head of the Cartilage Research and Restoration Center at Rush University Medical Center (Chicago): Our job as physicians is to be an impartial educator for our patients. In the broad field of regenerative medicine, there is a perception problem by patients largely due to the lens through which they wish to see innovative options and a desire for better solutions in combination with confusing messaging on the part of some providers. The relatively low regulatory barrier that currently exists from the FDA for allograft products, such as donor tissue, and autologous options, typically blood, bone marrow and fat obtained from the patient, has allowed rapid expansion and clinical adoption of products and procedures that profess to have efficacy in treating a variety of diseases under the auspices of "regenerative medicine."
If a novel solution lacks scientific evidence of a positive or negative effect, that must be conveyed properly. The more rare and debilitating a condition is, the more desperate a patient may become to try something that is considered safe, yet unproven.
We have an obligation to educate patients to a level where they can clearly understand the risks and benefits associated with their decision. Some patients come in with perceptions that are simply not realistic. I try and paint a reality of what these therapies will and will not deliver. Where there is a paucity of evidence, we are actively investigating potential indications with autologous stem cells with basic science and clinical studies, such as the investigation of reduced re-tear rates following rotator cuff repair and in the treatment of osteoarthritis.
One issue with experimental therapies is, of course, safety and the other is cost-effectiveness. Many of these therapies are not covered by insurance and they might have associated complications. Responsible patient-centered education remains the mainstay of decision-making as physicians are often the primary resource for patients and can overcome the limitations of internet content and direct-to-patient marketing efforts.
Michael J. Musacchio, Jr., MD. Neurosurgeon at NorthShore Neurological Institute (Chicago): There are many experimental procedures aimed at treating low back and spine conditions that a patient may come across online or in other media. It is important for a patient to understand that many of these experimental treatment options lack the long-term studies or follow-up to prove efficacy and safety.
Patients must understand the benefits simply are not proven in many cases, so there is a sense of buyer-beware. Additionally, many experimental treatments lack FDA-approval, which means their insurance carriers and Medicare benefits likely will not cover the treatments. While these treatments may sound promising — and many may indeed be promising — the patient should know that results are unproven and they will likely have to pay most, if not all, of the cost of treatments.
At NorthShore Neurological Institute, we have several clinical trials that we review with patients who would be most appropriate to benefit from them. We take the time to explain the pros and cons of the study and any cost to the patient associated with them.
In my practice, when a patient inquires about an experimental treatment that I know won't work, I tell them so. I then encourage them to do their own research.
Pioneering medicine is important and advancements in our field depend on experimentation; however, some of these can seem too good to be true, and patients should be careful spending a lot of money on something that is very unlikely to be successful.