Nine spine surgeons discuss whether it is possible to continue innovation despite the scrutiny on relationships between surgeons and the device industry.
Ask Spine Surgeons is a weekly series of questions posed to spine surgeons around the country about clinical, business and policy issues affecting spine care. We invite all spine surgeon and specialist responses. Next week's question: What percentages of your procedures do you/could you perform in an outpatient ASCs?
Please send responses to Laura Miller at laura@beckershealthcare.com by Wednesday, April 4 at 5pm CST.
Shay Bess, MD, Rocky Mountain Scoliosis & Spine, Denver: I think spine surgeons will be able to continue innovating and having relationships with device companies. It really depends on what the relationship is and what it entails. Much of the research I do is sponsored by various resources, including device companies, because research is expensive. Within the industry, there is funding available. However, the research must be directed by the investigators and physicians without an underlying agenda. Spine surgeons must be above board with their disclosures, and they must be ethical. There have been a few instances where people were not above board or had a hidden agenda that ruined this relationship.
We have the capacity to be ethical when we choose to do so. Surgeons and industry working together is very important. The results will benefit patients, surgeons and industry members. We need to demonstrate we can do this ethically; otherwise, there will be a broad mandate from the government saying we can't work together. Having complete, transparent disclosure and encouraging questions during peer review is essential. Disclosing financial sources is important, and in our contracts we must state that the investigators will have control over the data and data reporting, not the industry.
It's best to have all the data reported. Research is very expensive, and if it can only be done by a select few people there will be bias. We need to work with industry ethically to continue advancing the field of spine surgery.
Ara Deukmedjian, MD, Founder, Deuk Spine Institute, Melbourne, Fla.: Yes. There will always be great surgeon innovators as most surgeons are driven by a passion to give their patients their absolute best. This passion for excellence will shape new technology and inspire new treatments for old problems. Boundaries are being defined and this is good for everyone. It is the fear of the unknown that is keeping many of our best minds from coming forward with new ideas right now. We must remember that our country was made great by the innovative discoveries of brave pioneers. As scientists, we should embrace and thoroughly assess new ideas especially those with the potential to change so many lives.
Michael Duffy, MD, Spine Surgeon, Texas Back Institute, Plano: In this era of changing economic times, medicine itself is under significant scrutiny. From healthcare policy to reimbursements, the entire system is in flux. In regard to surgeon innovation, there are multiple hindrances in the orthopedic world, and scrutiny of the physician-industry relationship is one of them. Unfortunately, several suspect relationships were discovered which contributed to the heightened scrutiny, and subsequently place true innovation at risk. Pay-for-use relationships or consulting agreements without true consulting have tainted this sector of a surgeon's life. These types of relationships are absolutely unethical and violate federal laws. Due to these situations, all relationships with industry are now scrutinized, as they should be.
On the positive side, there are still opportunities for an innovative idea to take shape. Companies still maintain active research and development teams that require surgeon involvement and intellectual property; however, the ability to get federal approval of new devices is a much more arduous process due to several other factors. All things considered, innovation in spine is still possible; it simply takes more paperwork and more time to mature.
Walter Eckman, MD, Founder, Aurora Spine Center, Tupelu, Miss.: You cannot read the surgeons mind. You must judge his/her heart based on their private conversations, actions and commitment to innovations being considered. The surgeon who truly wants to make surgery better and safer and achieve better outcomes for the patients should succeed. The surgeon who simply wants to add income is not going to be helpful to the whole process.
J. Brian Gill, MD, Spine Surgeon, Nebraska Spine Center, Omaha: If you look at other industries, innovators exist and develop products that attract corporations to either invest in the product or purchase it outright. Yet, there is little to no scrutiny surrounding those transactions. Since our field involves the health of individuals, we are held to a different standard and rightfully so. Nonetheless, it is still possible for innovation to occur despite the scrutiny that the medical field faces as collaborative efforts between companies and surgeons will always be needed to advance the medical field. Proper disclosure to our patients is needed in order to gain their respect as their physician.
Michael Gleiber, MD, Founder, Michael A. Gleiber, MD, PA, Jupiter, Fla.: I have developed several devices without the assistance or resources of device companies. Yes, I do believe this is possible but it would be easier with the financial assistance and resources of major implant companies.
Kris Radcliff, MD, Spine Surgeon, Rothman Institute, Philadelphia: I think there absolutely is a place for spine surgeons to stay engaged in developing products that would benefit patients. Full disclosure of all relationships or perceived conflicts of interest is essential to patients, peers and all other parties involved. When in doubt, surgeons should err towards more disclosure.
The direction of innovation may change from previous years. Surgeons have unique insight into evidence based medicine, clinical indications and outcomes. Without surgeon input, companies will not have real insight into what is successful beyond the operating room: postoperatively, in clinic and long term. I think we are going to see an increased interest from device companies collaborating with surgeons along principles of evidence based medicine outcomes assessment. Previous innovation was largely directed toward improving the technical aspects of surgery.
Companies are increasingly interested in evidence based medicine to prove the clinical rationale behind the rational application of their implants and products. As we move forward with healthcare reform, it will be important for all parties to show the value of their contributions to patient care.
Khawar Siddique, MD, Spine Surgeon, Beverly Hills Spine Surgery, Calif..: Yes! We have been actively involved in this effort. Transparency is the key to avoid governmental investigation.
Paul Slosar, MD, President, SpineCare Medical Group, San Francisco Spine Institute: You can't create or improve spine surgery technologies without surgeon input and surgeons alone can't produce an innovative implant. The physicians must be transparent about their relationships with the companies. Although the media and those in government may not, patients understand that advances in surgery often come about due to these collaborative relationships.
More Articles on Spine Surgeons:
4 Spine Surgeons on Opportunities for Expanding Ancillary Revenue
5 Spine Surgeons on Responding to Coverage Denials
15 Spine Surgeons Discuss Patient Satisfaction
Please send responses to Laura Miller at laura@beckershealthcare.com by Wednesday, April 4 at 5pm CST.
Q: Is it still possible for spine surgeons to innovate given the recent scrutiny on their relationships with device companies?
Shay Bess, MD, Rocky Mountain Scoliosis & Spine, Denver: I think spine surgeons will be able to continue innovating and having relationships with device companies. It really depends on what the relationship is and what it entails. Much of the research I do is sponsored by various resources, including device companies, because research is expensive. Within the industry, there is funding available. However, the research must be directed by the investigators and physicians without an underlying agenda. Spine surgeons must be above board with their disclosures, and they must be ethical. There have been a few instances where people were not above board or had a hidden agenda that ruined this relationship.
We have the capacity to be ethical when we choose to do so. Surgeons and industry working together is very important. The results will benefit patients, surgeons and industry members. We need to demonstrate we can do this ethically; otherwise, there will be a broad mandate from the government saying we can't work together. Having complete, transparent disclosure and encouraging questions during peer review is essential. Disclosing financial sources is important, and in our contracts we must state that the investigators will have control over the data and data reporting, not the industry.
It's best to have all the data reported. Research is very expensive, and if it can only be done by a select few people there will be bias. We need to work with industry ethically to continue advancing the field of spine surgery.
Ara Deukmedjian, MD, Founder, Deuk Spine Institute, Melbourne, Fla.: Yes. There will always be great surgeon innovators as most surgeons are driven by a passion to give their patients their absolute best. This passion for excellence will shape new technology and inspire new treatments for old problems. Boundaries are being defined and this is good for everyone. It is the fear of the unknown that is keeping many of our best minds from coming forward with new ideas right now. We must remember that our country was made great by the innovative discoveries of brave pioneers. As scientists, we should embrace and thoroughly assess new ideas especially those with the potential to change so many lives.
Michael Duffy, MD, Spine Surgeon, Texas Back Institute, Plano: In this era of changing economic times, medicine itself is under significant scrutiny. From healthcare policy to reimbursements, the entire system is in flux. In regard to surgeon innovation, there are multiple hindrances in the orthopedic world, and scrutiny of the physician-industry relationship is one of them. Unfortunately, several suspect relationships were discovered which contributed to the heightened scrutiny, and subsequently place true innovation at risk. Pay-for-use relationships or consulting agreements without true consulting have tainted this sector of a surgeon's life. These types of relationships are absolutely unethical and violate federal laws. Due to these situations, all relationships with industry are now scrutinized, as they should be.
On the positive side, there are still opportunities for an innovative idea to take shape. Companies still maintain active research and development teams that require surgeon involvement and intellectual property; however, the ability to get federal approval of new devices is a much more arduous process due to several other factors. All things considered, innovation in spine is still possible; it simply takes more paperwork and more time to mature.
Walter Eckman, MD, Founder, Aurora Spine Center, Tupelu, Miss.: You cannot read the surgeons mind. You must judge his/her heart based on their private conversations, actions and commitment to innovations being considered. The surgeon who truly wants to make surgery better and safer and achieve better outcomes for the patients should succeed. The surgeon who simply wants to add income is not going to be helpful to the whole process.
J. Brian Gill, MD, Spine Surgeon, Nebraska Spine Center, Omaha: If you look at other industries, innovators exist and develop products that attract corporations to either invest in the product or purchase it outright. Yet, there is little to no scrutiny surrounding those transactions. Since our field involves the health of individuals, we are held to a different standard and rightfully so. Nonetheless, it is still possible for innovation to occur despite the scrutiny that the medical field faces as collaborative efforts between companies and surgeons will always be needed to advance the medical field. Proper disclosure to our patients is needed in order to gain their respect as their physician.
Michael Gleiber, MD, Founder, Michael A. Gleiber, MD, PA, Jupiter, Fla.: I have developed several devices without the assistance or resources of device companies. Yes, I do believe this is possible but it would be easier with the financial assistance and resources of major implant companies.
Kris Radcliff, MD, Spine Surgeon, Rothman Institute, Philadelphia: I think there absolutely is a place for spine surgeons to stay engaged in developing products that would benefit patients. Full disclosure of all relationships or perceived conflicts of interest is essential to patients, peers and all other parties involved. When in doubt, surgeons should err towards more disclosure.
The direction of innovation may change from previous years. Surgeons have unique insight into evidence based medicine, clinical indications and outcomes. Without surgeon input, companies will not have real insight into what is successful beyond the operating room: postoperatively, in clinic and long term. I think we are going to see an increased interest from device companies collaborating with surgeons along principles of evidence based medicine outcomes assessment. Previous innovation was largely directed toward improving the technical aspects of surgery.
Companies are increasingly interested in evidence based medicine to prove the clinical rationale behind the rational application of their implants and products. As we move forward with healthcare reform, it will be important for all parties to show the value of their contributions to patient care.
Khawar Siddique, MD, Spine Surgeon, Beverly Hills Spine Surgery, Calif..: Yes! We have been actively involved in this effort. Transparency is the key to avoid governmental investigation.
Paul Slosar, MD, President, SpineCare Medical Group, San Francisco Spine Institute: You can't create or improve spine surgery technologies without surgeon input and surgeons alone can't produce an innovative implant. The physicians must be transparent about their relationships with the companies. Although the media and those in government may not, patients understand that advances in surgery often come about due to these collaborative relationships.
More Articles on Spine Surgeons:
4 Spine Surgeons on Opportunities for Expanding Ancillary Revenue
5 Spine Surgeons on Responding to Coverage Denials
15 Spine Surgeons Discuss Patient Satisfaction