On (and Off) the Record

Data Tower of Babel Hurting Ortho Research?…Medical Cowboy vs. Playing it Safe…Controversy in Kyphoplasty/Vertebroplasty...Steven Barna, M.D. Joins Florida Orthopaedic Institute…and more.

Bedlam in the Research Arena?

Tom Errico, M.D., is chief of the Spine Service at NYU Hospital for Joint Diseases. He tells OTW, I just had a meeting with yet another group with a database that wants our hospital to participate. Two weeks ago it was a group of neurosurgeons. There are just too many entities out there coming up with databases, and it has created this ‘Tower of Babel’ situation. For example, all lower back patients need Oswestry Disability Index scores, but how various programs are going about it is different—how are we ever going to determine that one process will win out over another? The challenge is that hospitals need something that will provide researchers with meaningful information, while at the same time not be so onerous that patients are turned off. We need to find out the most important questions…it’s almost like we need to decide which is going to be the dominant language. The minimally invasive (MI) society only wants to collect data on MI procedures; many surgeons don’t want to collect data on psychosocial factors, but the nonoperative physicians want that information included. And on and on…In the end the winner is going to be the database that delivers the most results. Once people are pointing at a database program and saying, ‘Look at how effective that is. They have high follow-up with meaningful results, ’ then other hospitals will want to join in. Research drives our field…and if the data collected is flawed or insufficient, then it’s garbage in garbage out.”

Thomas Prescott and Thomas Wilder Join Benvenue Board

Benvenue Medical, Inc. is welcoming Thomas M. Prescott and Thomas C. Wilder to its Board of Directors. Prescott is president and CEO of Align Technology, Inc., and Thomas C. Wilder is president and CEO of Sequent Medical, Inc. Prescott, who will serve as chairman of the board, has been president and CEO of Align since 2002. The company is the inventor of Invisalign and an innovator in digital dentistry, and it has grown significantly under his leadership. Previously, Mr. Prescott was president and CEO of Cardiac Pathways, where he successfully led a turnaround prior to its acquisition by Boston Scientific Corporaton. Prior to Cardiac Pathways, Mr. Prescott held various sales, marketing, management and executive roles at Nellcor Puritan Bennett, GE Medical Systems, and Siemens. Prescott earned a Master of Management from the Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, with emphasis in Civil Engineering, from Arizona State University.

Tom Wilder has served as the president and CEO of Sequent Medical, Inc., a privately held medical device company focused on developing innovative devices for the treatment of neurovascular disease, since 2010. Prior to joining Sequent Medical, Wilder was president and CEO of Photothera, Inc., a private company developing transcranial laser therapy for the treatment of acute ischemic stroke. His experience also include being president and CEO of Micro Therapeutics, a publicly traded company that provided a broad range of advanced interventional products to neurovascular specialists. Prior to Micro Therapeutics, Wilder held several management positions during an 11-year tenure at Medtronic, Inc. He holds a Master of Management from the Kellogg Graduate School of Management at Northwestern University, and a BA in Economics from Stanford University. He also serves on the Board of Endologix, Inc.

Steven Barna, M.D. Joins Florida Orthopaedic Institute

Dr. Steven Barna, an interventional pain physician, is bringing his expertise to the Florida Orthopaedic Institute, and will treat patients in the areas of conservative and non-surgical minimally invasive spine care. Prior to joining Florida Orthopaedic Institute, Dr. Barna worked for more than 10 years as an academic educator at Harvard Medical School. While there, Dr. Barna was an assistant clinical professor of medicine at Brigham and Women’s Hospital and an assistant clinical professor of anesthesiology and medical director of the Center for Pain Medicine at Massachusetts General Hospital. Dr. Barna is board certified by the American Board of Anesthesiology, is a medical graduate of Case Western Reserve University School of Medicine and is currently an assistant professor of orthopedics and sports medicine at the University of South Florida College of Medicine. Previously, Dr. Barna served as secretary of the Massachusetts Society of Interventional Pain Physicians, was an editorial board consultant for the American Journal of Geriatric Pharmacotherapy, and was content leader of pain management for HealthTank, a publishing company in Virginia.

Be a Medical Cowboy or Play it Safe?

Paul Girard, M.D. is an orthopedic traumatologist with the University of California, San Diego. He tells OTW, “There is a movement in orthopedics to have us ‘own’ the treatment of fragility fractures associated with osteoporosis. It has traditionally been left up to individual surgeons to determine what they are most comfortable doing on their own versus getting input from their medical colleagues. We are split into at least two groups—those who attempt to handle all of the medical part of fragility fractures and those who tell the patient, ‘Talk to your primary care physician.’ I typically start the patient on calcium and Vitamin D, have them learn about fall prevention, and then refer them to a primary care doctor or endocrinologist.”

“The leaders in orthopedics tend to be in the more aggressive camp, either taking the route I take or totally doing it themselves. There are several high profile orthopedists who are big proponents of taking total control the entire process. The issue is that to properly manage the medical aspects of this condition you need a full metabolic bone disease service. As for patients, they like to walk out of a doctor’s office with something in hand, whether it’s a recommendation for a dose of calcium or a Dexascan. This carries more weight rather than if the surgeon says, ‘Just talk to your primary care physician.’ I recommend that surgeons in the emergency department who do fracture work try to develop a system to identify patients at risk of an osteoporotic fracture, and then do something for them.”

Botched Vertebroplasty/Kyphoplasty?

Adam Wollowick, M.D. is an adult and pediatric spine surgeon at Montefiore Medical Center in New York. “A hot issue now, ” Dr. Wollowick tells OTW, “is how to approach vertebroplasty and kyphoplasty research. The studies from the last few years, in particular the two New England Journal of Medicine articles from 2009, still have people shaking their heads and saying, ‘How did they come to those conclusions?’ Each of these studies has significant limitations which has increased the controversy. One study had significant crossover of patients into the vertebroplasty group and both had relatively small numbers. It’s not clear if the results of those studies are valid for a larger sample size and for patients with more acute injuries. Furthermore, it appears that at least some of the patients were not so profoundly affected by their fractures. Many of us, on the other hand, have patients that are almost bed ridden because of their fractures. In my experience, they do very well with cement augmentation, so we need studies that address the patients that are most profoundly affected by vertebral compression fractures.”

“Part of the problem is the difficulty in removing the various forms of bias, including the influence of industry, from these studies. Those interested in this issue need to do studies independently, either looking at two treatments head to head or a noninvasive/nonsurgical treatment versus an invasive procedure. We need better multicenter trials with large numbers of patients stratified by activity level. Patient selection is critical in terms of time from injury as well as impact of injury on the person’s life.”

Physicians Lagging in Concussion Education

Dr. Kathleen Weber, M.D. is the director of Primary Care/Sports Medicine and Women’s Sports Medicine at Rush University Medical Center. Dr. Weber is also the only female Major League Baseball (MLB) team physician, and serves on the MLB concussion committee. She tells OTW, “I have been very surprised to see that despite the MLB being very forthright and proactive in addressing concussions, there are many lay people who are still not taking concussions as seriously as they should be. It’s often the parents who want the player to get back in the game because their child has a big tournament…and while you can see a broken bone on an X-ray and can tell them the return to play timeline, you can’t say the same of a concussion. But it’s also been interesting to see that survey results we’ve collected from targeted physician specialties on their understanding of concussion management—the ones that are suppose to be clearing athletes for play—revealed that some of these physicians don’t have a good understanding of how to treat these injuries. My colleagues and I are now in the process of putting several publications together on concussion for the MLB…articles that will definitely add to the literature. While it used to be a badge of courage to get your bell rung, nowadays it beginning to be seen as a potentially serious injury.”