Neel Anand, MD, is clinical professor of surgery and director of spine trauma at Cedars-Sinai Spine Center in Los Angeles. He has research interests in minimally invasive techniques for spine disorders and trauma in adults and children. He has also been a principal investigator in many FDA investigational device exemption studies.
Dr. Anand is fellowship-trained in reconstructive spinal surgery from University of Florida Spinal Health Centers in Gainesville. He also completed a scoliosis fellowship and a trauma fellowship at the Hospital for Special Surgery at Cornell University in New York.
Here Dr. Anand weighs in on spine device innovation and the barriers that exist to getting patients proper care.
Question: Where is spine innovation headed?
Dr. Neel Anand: We are certainly seeing barriers, more than we saw in the past. That’s going to be the biggest critical element for innovation right now. It is not the lack of ideas or input but more regulatory issues that are going to be biggest hindrance.
In terms of the biggest, most influential innovation, it is going to be in biologics. This includes everything from stem cells to biological and genetic alteration of tissues. We are working toward a time where hopefully an injection will take care of degenerative problems. We are a long, long way from there, but it is the future. A lot of research is happening right now. On the flipside, we have to be careful of going down voodoo pathways with stem cells. Hoaxes are being perpetuated, and people need to know that. There is nothing as yet approved by the FDA that has shown to really prove stem cell injections into discs can make them normal again.
The other big thing is going to be minimally invasive spine surgery. Even with injections, there is clearly still a need for surgery. MIS is the biggest input right now. We can do the same procedure minimally invasively today that we used to do with a large open approach. Navigational equipment allows us to navigate the spine and doesn't require opening the protective soft tissue around the spine to operate.
Q: What innovation will face the biggest barriers?
NA: Motion preservation technology was exploding in the early 2000s. However, regulatory issues have completely eliminated that technology, and it's sad. Even though we have two artificial discs approved, the insurance companies have not approved other motion preserving devices such as non-fusion and interspinous devices. So much technology has gotten nowhere despite FDA-approved processes and rigorous trials because it was not approved by insurance. This is a significant issue in terms of innovation that has been curtailed and suppressed. There is still a clear role for those technologies.
Q: How will patient care be challenged, and what needs to be done to curtail this?
NA: It's getting to be extremely onerous and difficult to perform spine surgery. Everything goes up for review, and it's become the norm for insurance companies to deny operations. This puts tremendous burden on the patient who doesn’t understand the mechanics. It causes a delay in care and prolonged anguish for the patient when they are stuck in no-man's land with insurance dictating the terms. It's getting to be difficult even with normal surgeries so innovative technology is being put on the back burner even more.
The best way to get the message across is patient advocacy. Patients have to get up and advocate for themselves. It's time for patients to take charge of their own care and decide what they want. At the end of the day, they are paying the premiums. Unfortunately, we have a third party dictating the terms of care. This is a major stumbling block.
Q: What types of surgery should physicians be focusing on and moving away from?
NA: It's easier to do surgery with good technology in Europe than in the U.S. I understand the costs, but we need to make sure the right surgery is performed. The approval process for devices is onerous right now. Five years ago, you would get one to three denials per month. Now you can have five to 10 a week. We spend more time talking to insurance and, unfortunately, talking to unqualified people about what surgery we need because it doesn't fit some criteria that's listed in their books.
These days we definitely need to move away from fringe technology with hype but no data. People are doing it without knowledge of what they are doing. Unfortunately, some injection technology fits into this category. Platelet-rich plasma is being injected into discs under the guise of stem cells. It's one of the biggest voodoo rackets going on. People are saying they are offering stem cell therapy, but they are not. Patients need to be careful and go to respectable centers. It is imperative that they find an experienced surgeon, not just someone because they say they do stem cell therapy.
I think the time will come that we move away from big, open surgeries we were doing for simple procedures, such as one-level fusions or decompressions. We are already moving away from it and learning to respect the tissue, and I hope the time will come where that will be the norm for all surgeries. No where else on the human body do we fillet muscle and destroy it to do an operation on the bone. The same should apply to spine.
Q: Do you anticipate the device tax impacting your practice?
NA: Yes and no. I have the feeling costs are going to get transmitted to the patient at the end of the day. That money is going to trickle down to the actual cost of healthcare. That's my worry. I don't think it will kill innovation. It's not that big of an amount, but clearly it will trickle down somewhere.
This biggest worry for device innovation is finding funding sources and the approval process. An FDA clinical trial takes $20 million to $40 million to complete for devices. To put all that money in and spend five years for a clinical trial to get approval and then have insurance not approve it destroys technology. It's a big decision today to invest in technology. Funding sources know it's a vicious cycle.
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