Other Articles

Multicenter Clinical Trials: Do They Get the Respect They Deserve?
They’re not fast or sexy, but they are critical…large trials, that is. With multiple sites and principal investigators who donate their time, large trials are more complex—and normally yield more actionable data—than smaller, quicker studies. But large trials don’t always get the respect they deserve. And, says at least one physician-researcher, this could affect the future of the field.

Patent Wars: Medtronic Attacks NuVasive
MSD’s lawsuit came amid a period of declining spinal implant market share – from a peak of 60% in late 1998 (just prior to being acquired by Medtronic) to, we estimate, 36% currently – and a growing sense that MSD’s reign as the king of spine was coming to a close. What’s really behind Medtronic’s attack on its former senior exec? Read on.

Spine Gainsharing Through the Looking Glass
The feds have issued their first opinion allowing a spine gainsharing proposal. In Alice in Wonderland style, Through-the-Looking-Glass logic, they said the proposal was improper but would not impose sanctions. Who is the author of such a plan and what’s her secret? Read here.

PearlDiver Data Raises New Questions About Synovial Injections
Synovial injections for painful knees have been approved for use since 1997. If the goal is to improve the quality of life for the patient, is that being accomplished? The latest numbers from the PearlDiver Patient Records Database cast doubt.

Plantar Fascia: The Annual 3 Million Patient Market
“Plantar Fascial Fibromatosis (ICD-9-D-728.71) is right up there in frequency with pain in the shoulder joint, degeneration of lumbar intervertebral discs, pain in the lower leg joint, and carpal tunnel syndrome. As usual, PearlDiver has this market mapped out.

Orthopedic Incubators: Where Little Ideas Grow Up
Business incubation, also known as acceleration, can be a wild ride. Thus it’s best to approach it armed with the solid advice of experienced professionals. Who should take this ride? What can venture financiers bring to the table? These questions and more are answered by two seasoned VC professionals.

Just Say No to CMS Potential Coverage Decision List
Unless you want to be on the receiving end of a non-coverage letter, just say no to CMS’ proposed list of potential National Coverage Decisions. You’ve got until September 28 to make your case. Read what a leading industry consultant and analyst have to say.

Staking a BIG Claim
Alphatec, the company whose IPO collapse served as an object lesson for all medical device companies, has nearly completed its turnaround. The key? New management and new technology. Exhibit A: OsseoFix™—with it Alphatec stakes a claim to the next big spinal implant market.

The Pennsylvania Orthopaedic Society
The Pennsylvania Orthopaedic Society, 1,000 members strong, tackles a variety of challenges on behalf of patients and surgeons alike. According to AAOS, they were the top state professional society in 2007. Fifty-two years in the making, here is how they did it.

Percutaneous Spine Procedures: Just Setting the Stage for Fusion?
Selective nerve root blocks, laminectomies, and percutaneous discectomies. How many times do these procedures lead to a full blown spine fusion? Using PearlDiver’s Patient Records Database, we longitudinally tracked patients to find out. All we can say is that after surveying the 3.9 million spine patients in the PearlDiver database, the answer may be different from what you’d expect!

Physicians Targeted by Whistleblowers
The whistleblowers that targeted Medtronic in 2006 are now aiming their guns on 136 physicians and distributors as we move into the next era of the “Great Disruption.” Read about their qui tam lawsuit in Boston and what it means for industry and surgeons.

Zimmer’s Bet on Compliance
Is Zimmer’s Enhanced Compliance Program going to cost it market share? Analysts demanded answers from CEO Dave Dvorak during the quarterly conference call on July 23 that also included the announcement of the Durom® cup suspension. Dig in here.

Faculty Compensation in Academic Medicine
Dr. Sanford Emery, Chair of Orthopaedics at West Virginia University, has put his M.B.A. to good use. Delving into the issue of compensation in academic medicine, Dr. Emery and his colleagues surveyed 31 orthopedic programs and conducted in-depth interviews with leaders of eight programs. Their findings include information on the compensation structure and point systems.

Engineering an Unfair Advantage
After $1.2 billion in equity capital, what did the tissue engineering pioneers accomplish between 1990 and 2000? For one thing, LifeCell, Integra and Osiris. For another, a generation of wiser, tougher managers who are targeting the big orthopedic markets. Now all they ask for is an unfair advantage. Are the big guys ready?

The Pain of Fashion! 4 Million Patients Every Year and Growing
Eighty-eight percent of all women wear shoes that are too small. Fifty-five percent developed bunions. Despite costs that can reach as high as $20,000 per procedure, four million patients every year seek surgical relief. Want to know the footprint of this market? Read on.

Oxiplex® – “Not Approvable”
The FDA’s Orthopaedic and Rehabilitation Devices Advisory Panel said FzioMed’s Oxiplex gel was safe but not proven to be effective, and therefore, not approvable. Did statistics get in the way of something that’s needed, works for some and is safe? Decide for yourself.

Tiger’s Knee and the Cruel Twist to the Sport of Golf
At the U.S. Open in June, Tiger Woods played through intense knee pain to stay on the leader board. His next appointment is with an orthopedic surgeon. Last year there were 103,000 golfing related orthopedic injuries reported. That’s $2.4 billion in medical care. For more on this important and growing market segment read on.

Many of us can recall being screened for scoliosis as children. And when someone was diagnosed, then as now, one of the options was bracing. But does it work? Dr. Stuart Weinstein, the Ignacio V. Ponseti Chair and Professor of Orthopaedic Surgery at the University of Iowa, has set out to answer that question.

Born in Chicago, Dr. Weinstein would first explore wider horizons before delving into medicine. “Both in high school and at the University of Illinois I was heavily involved in sports,” says Dr. Weinstein. “When not on the court or the field, I was reading up on political science, my major, or history, my minor. My strong math and science skills led me to initially pursue engineering, but after a year I decided to switch to a pre-law track because of my interest in political science. It was the early ‘60s, the Vietnam years, however, and my mother had a talk with me and suggested medicine. I was open to that and thus visited our family doctor, a general surgeon at Northwestern. I could see how appealing it would be to help a lot of people and personally make a difference in people’s lives. I returned to college and spent my electives taking premed courses. In particular I discovered a love of zoology and comparative anatomy, two things that confirmed my interest in pursuing a career in medicine.”

Thanks to his diligence and solid guidance, in 1972 Dr. Weinstein had a medical diploma in hand. “A standout mentor from my medical school days was Dr. Michael Bonfiglio. Mike, who was essentially the reason I chose orthopedics, made me realize that orthopedic surgeons are not just surgeons but practice the cognitive aspect of medicine, too. He stressed that the majority of the time they don’t operate, and thus they must have excellent skills in the realms of examinations and differential diagnoses. After my medical school experience I went out West to do an internal medicine year at the University of California, San Francisco. I had actually only applied for internal medicine residencies because of my role models and because I was fascinated by complex problems. But then I took an elective orthopedic surgery rotation, after which I knew this field was for me. I reveled in the hands-on nature of it and liked that it was clear when one was making a difference. After UCSF, I did a residency at the University of Iowa. One of my residency mentors was the department chair and past President of AAOS, Dr. Carroll Larson. He allowed faculty to grow, did a superb job of facilitating our careers, and took no credit. He didn’t need the glory; his success was in seeing his faculty succeed. Also instrumental in my professional development was Dr. Reginald Cooper, who taught me leadership skills that I would carry throughout my career. He understood the issues and could guide one’s decision making with information. You would start out with a different opinion but with his command of the issue he could persuade you with the power of argument and knowledge. And then there was Dr. Ignacio Ponseti, my mentor in pediatric orthopedics. He made me think about what would happen to a given patient if she were not treated, and, if we were to intervene, what the results would be. He was very concerned with what’s causing the problem and what might we learn via research.”

Continues Dr. Weinstein, “My residency was quite a nurturing environment with real professionals at the helm. The faculty’s entire reason for being here is teaching and research in the context of patient care. The folks here were always concerned about my education and about producing the finest orthopedic surgeons in America. Here at Iowa we have always had national leaders in orthopedics such that there is a culture of high expectations…it’s like when you sign on you’re joining the Yankees. Winning is the norm, accompanied by an expectation that you give back at some point.”

Not one to change a good thing, Dr. Weinstein has been on the faculty at Iowa since 1976. A full spectrum orthopedist, he treats patients, teaches, and does research. “When I work with patients I try to keep in mind what I would expect for my family. I act as a patient’s partner, working alongside him or her to decide what might be the best treatment options. As orthopedists we should strive to help patients navigate through the system and be open to a thorough dialogue with them.”

Doing his part to offer his patients the latest in treatment, Dr. Weinstein devotes some of his time to puzzling over uncooperative vertebrae and the mysteries of spinal deformity. “My research has primarily been on understanding the natural history and long-term outcomes of pediatric orthopedic conditions. Some of these conditions include adolescent idiopathic scoliosis; Scheuermann’s kyphosis, a curvature in the sagittal plane; and developmental hip dysplasia. At present, I have a substantial NIH R01 grant to study the question, ‘Does non-surgical treatment of scoliosis work?’ With additional contributions from the Canadian equivalent of NIH and Shriners Hospital, we are undertaking our first year of the study, accruing patients that are being randomized into bracing or watchful waiting groups. The project, which will last five years, should answer a fundamental question that applies to hundreds of thousands of children who are diagnosed with scoliosis every year. School screening is currently mandated in 22 states. If bracing proves to be effective, then screening should be mandatory in all 50 states. If not, then we should save those healthcare dollars and put them elsewhere.”

Continues Dr. Weinstein, “In 2003 my colleagues and I published a 51-year follow-up of untreated adolescent idiopathic scoliosis. Our findings were that while the patients were functioning well, they had nearly twice the incidence of back pain as the general population. And then there was the deformity aspect of the problem. Patients reported dissatisfaction with how they looked, as well as issues of self-esteem.”

Another integral part of Dr. Weinstein’s days in the lab is his work on hip problems. “I have done several developmental hip dysplasia studies, in which we have found that only if the hip is perfect will it last a lifetime. This means that early diagnosis in the nursery is critical; otherwise the patient’s risk for developing arthritis is extremely high. Early intervention can make all the difference. When used on an infant for six weeks, a Pavlik harness will give a patient a 95% chance of having a normal hip. We have followed patients for 40 years after hip dysplasia, so we have some great data.”

Mindful of his duty to those following in his footsteps, Dr. Weinstein tries to ensure that his charges can think independently and understand the subtleties of the field. “I tell residents and fellows that the key to success and enjoyment in the field is ongoing education. These days one must sift through hordes of information in order to determine what will stand the test of time. I stress to my students that they must learn how to read the literature and understand the importance of levels of evidence. Most surgical disciplines don’t have high levels of evidence. They are going on expert opinion instead. We teach residents and fellows how to think and how to make solid decisions so that they are not going with the last lecture they heard. I tell them, ‘Just because I said it doesn’t mean it’s true. Challenge everything.’ It is common for a young doctor to attend a seminar, hear an ‘authority’ speak, and then apply what he heard to his patient without analyzing it. When I lecture at a conference I make certain what I say has evidence or I tell them that the evidence is scanty and this is only my opinion. Unfortunately, not a lot of lecturers do that. We are in a position of responsibility, however, and must help the audience out as they vary in their sophistication.”

Significant responsibilities also come with titles. And for Dr. Weinstein, there have been many: Past President of the American Academy of Orthopaedic Surgeons (AAOS), The American Orthopaedic Association, The American Board of Orthopaedic Surgery, The Pediatric Orthopaedic Society of North America, The United States National Action Network of the International Bone and Joint Decade, and The International Center for Orthopaedic Education (ICOE). Says Dr. Weinstein, “All of these positions offered a chance to move the profession forward, and each entailed tremendous responsibility―not to be just a caretaker leader but also to provide true leadership. My goal was always to have a positive impact on the profession while strengthening each organization. Leadership in organizations is not about the leader but the organization and its mission. It is imperative that the mission and vision of each organization be continually evaluated in the context of the internal and external environment to ensure that the organization maintains true value for its members or constituents.”

As for his little patients, Dr. Weinstein says, “Working with kids has been one of the greatest experiences of my life. They are vulnerable, in a stressful situation, and want to get out of the hospital as soon as possible. Unlike adults, they are not interested in getting out of work or missing school. Much of my work involves spinal deformity surgeries. Improving these children’s quality of life is just amazing. It changes their lives and their parents’ lives…and it has changed me.”

On the move constantly, Dr. Weinstein keeps going when he hits home. “I jog daily and can often be found climbing mountains. A particularly exhilarating experience was climbing in the Grand Tetons with some friends. My wife should be beatified soon. One could never lead the life I lead without an extremely supportive family. That includes our son, who is just a wonderful person.”

Dr. Stuart Weinstein…bringing forth knowledge and hope.