This is the second installment of a series of roundtable discussions about the future of orthopedic surgeon-device company relationships. You can view the first installment answering the question "Will There Be a Place for Orthopedic Surgeons and Device Companies to Have a Relationship in the Future?" here.
This article gathers expert responses to the question of what appropriate post-reform relationships between orthopedic surgeons and device companies might look like.
Bruce Darden, MD, Spine Surgeon at OrthoCarolina, Charlotte, N.C. I think the types of agreements you will see going forward will be those where everything the physician does with their time is well documented. These relationships are becoming more structured and I think, personally, any physician with any potential for financial gain from the company should not participate in the studies of the company's products. If there is any chance you're going to gain financially based on the outcome of a study, you should excuse yourself from participating, which will be the cleanest thing going forward. There are examples that the FDA has brought up where physicians might not have had a direct conflict, but their relationships with the companies still didn't look good.
I don't think at this point we do enough with our patients to talk about the potential conflicts. None of the physicians at our practice profit from the implants we use, but I think going forward the patients need to know directly our relationships with companies, even if they aren't financial. There has been some disclosure, but I think we can do a better job of having that information available upfront for patients.
Eric Muehlbauer, Executive Director, North American Spine Society. Well, first of all, these relationships now will actually "look" like something — they will be visible, which is a marked improvement over the recent past where relationships were hard to identify and evaluate. In this new, post-disclosure world, collaborations will be obvious and have defined beginning and end points, with specific duties and compensation.
Medical professionals who choose to work with device companies will have a clearer understanding of their roles and rewards. Instead of amorphous, long-term relationships, these physicians will have contracts that specify time periods and tasks and be paid fair market value for their work. This type of transparency and visibility will benefit all, but most especially patients, who must be able to trust in the medical profession.
Todd Albert, MD, Spine Surgeon and President, Rothman Institute (Philadelphia). Transparency is a great thing and it's upsetting to me that people right now are lacking transparency. It may not be that people are trying to hide their relationships, but they accidentally lack disclosure. Every journal has a different form and it can sometimes be hard to fill them all out. What would be great is to have a single book of truth: everyone would have the same disclosure form and surgeons could make this form available to anyone who wanted to view it. The American Academy of Orthopaedic Surgeons has a particularly good disclosure form for surgeons.
Surgeons should be obligated to disclose this information. I don't want anyone to have any questions about what my conflicts are. More transparency rather than less is better because it takes away any questions about the source. It's a great equalizer.
Tom Hackett, MD, Sports Medicine Surgeon, The Steadman Clinic (Vail, Colo.). In 2007, the American Academy of Orthopaedic Surgeons set out the standards of professionalism for orthopedists' relationships with the industry and those outline specifically the types of relationships that should and shouldn't occur and how to do disclosures. These might change in the future, but for now they are a foundation we can lean on. I think these relationships are critical for our profession to allow it to progress. We cannot advance it ourselves. We need help doing that, but we also need to make sure we are following the highest ethical standards while doing so.
Bill Kolter, Corporate Vice-President of Government Affairs, Public Affairs and Corporate Communication, Biomet. There are tremendous unmet clinical needs out there — orthopedic disorders are the number one source of disability and lost work days in the United States, and it's a huge strain on our economy and quality of life. For that reason, it's not only necessary for orthopedic surgeons to collaborate with manufacturers to develop treatments and provide care, but it's something that's in the best interest of the healthcare system and the quality of care for people in this country. The collaboration is highly beneficial and something that is very necessary.
Related Articles on Orthopedic Surgeons:
Will There Be a Place for Orthopedic and Spine Surgeon Relationships With Device Companies in the Future? 6 Responses
Orthopedic and Spine Device Industry Post-Reform: 6 Challenges
Neurosurgeon Under Investigation After Potentially Inappropriate Ties to Spine Device Company
Bruce Darden, MD, Spine Surgeon at OrthoCarolina, Charlotte, N.C. I think the types of agreements you will see going forward will be those where everything the physician does with their time is well documented. These relationships are becoming more structured and I think, personally, any physician with any potential for financial gain from the company should not participate in the studies of the company's products. If there is any chance you're going to gain financially based on the outcome of a study, you should excuse yourself from participating, which will be the cleanest thing going forward. There are examples that the FDA has brought up where physicians might not have had a direct conflict, but their relationships with the companies still didn't look good.
I don't think at this point we do enough with our patients to talk about the potential conflicts. None of the physicians at our practice profit from the implants we use, but I think going forward the patients need to know directly our relationships with companies, even if they aren't financial. There has been some disclosure, but I think we can do a better job of having that information available upfront for patients.
Eric Muehlbauer, Executive Director, North American Spine Society. Well, first of all, these relationships now will actually "look" like something — they will be visible, which is a marked improvement over the recent past where relationships were hard to identify and evaluate. In this new, post-disclosure world, collaborations will be obvious and have defined beginning and end points, with specific duties and compensation.
Medical professionals who choose to work with device companies will have a clearer understanding of their roles and rewards. Instead of amorphous, long-term relationships, these physicians will have contracts that specify time periods and tasks and be paid fair market value for their work. This type of transparency and visibility will benefit all, but most especially patients, who must be able to trust in the medical profession.
Todd Albert, MD, Spine Surgeon and President, Rothman Institute (Philadelphia). Transparency is a great thing and it's upsetting to me that people right now are lacking transparency. It may not be that people are trying to hide their relationships, but they accidentally lack disclosure. Every journal has a different form and it can sometimes be hard to fill them all out. What would be great is to have a single book of truth: everyone would have the same disclosure form and surgeons could make this form available to anyone who wanted to view it. The American Academy of Orthopaedic Surgeons has a particularly good disclosure form for surgeons.
Surgeons should be obligated to disclose this information. I don't want anyone to have any questions about what my conflicts are. More transparency rather than less is better because it takes away any questions about the source. It's a great equalizer.
Tom Hackett, MD, Sports Medicine Surgeon, The Steadman Clinic (Vail, Colo.). In 2007, the American Academy of Orthopaedic Surgeons set out the standards of professionalism for orthopedists' relationships with the industry and those outline specifically the types of relationships that should and shouldn't occur and how to do disclosures. These might change in the future, but for now they are a foundation we can lean on. I think these relationships are critical for our profession to allow it to progress. We cannot advance it ourselves. We need help doing that, but we also need to make sure we are following the highest ethical standards while doing so.
Bill Kolter, Corporate Vice-President of Government Affairs, Public Affairs and Corporate Communication, Biomet. There are tremendous unmet clinical needs out there — orthopedic disorders are the number one source of disability and lost work days in the United States, and it's a huge strain on our economy and quality of life. For that reason, it's not only necessary for orthopedic surgeons to collaborate with manufacturers to develop treatments and provide care, but it's something that's in the best interest of the healthcare system and the quality of care for people in this country. The collaboration is highly beneficial and something that is very necessary.
Related Articles on Orthopedic Surgeons:
Will There Be a Place for Orthopedic and Spine Surgeon Relationships With Device Companies in the Future? 6 Responses
Orthopedic and Spine Device Industry Post-Reform: 6 Challenges
Neurosurgeon Under Investigation After Potentially Inappropriate Ties to Spine Device Company