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.

Raised under the watchful eye of his grandmother and the strict discipline of his military grandfather, Dr. Hyun Bae had no choice but to succeed. “My family emigrated from Korea to the U.S. when I was two years old,” says Dr. Bae, an orthopedic surgeon at The Spine Institute in Santa Monica, California. “My grandmother had married an American soldier, so we all took up residence on an army base in Lawton, Oklahoma. The first 10 years of my life were on that base, followed by eight years of living ‘in town.’ As far as I knew, base life was what everyone did. And my step grandfather being strict and regimented wasn’t anything very new. Korean families are often regimented, so that was normal for me. I was also surrounded by my parents, electrical engineers who could not find work in their field in the small town. They took odd jobs in order to take care of the family, which included a lot of cousins. At times they hated to see me coming because I was the youngest and was the one who ‘told’ on everybody else.”

As far as his career, Hyun Bae thinks back to an early propaganda campaign by his family. Laughs Dr. Bae, “While I wanted to be a doctor from an early age, I was probably brainwashed by my parents. This choosing a career for a child would have been fairly typical for a first-generation family from Korea. Once in college I asserted myself by studying biomechanical engineering, but then realized that this field was not for me. I talked to a number of engineers who told me that engineering in the real world involved going into business or administration. The other option was doing pure research, but that meant I would have to stay at a university, something I did not want.”

Upon graduation from Columbia University in 1990, Hyun Bae began medical school at Yale. His most memorable moment during those years? “The Show.” Says Dr. Bae, “As do many medical schools, we produced an elaborate second year show/roast in which we made fun of absolutely everyone and everything. We raised $13,000 to put on the show, which included an orchestra, script, makeup, and costumes. It is a famous annual event that proves to be quite a release for the second-year students, who at times feel like punching bags.”

Just like the decision to attend medical school, the choice of orthopedics did not come after an extended detour through other specialties. “While still an undergrad at Columbia I worked in an orthopedic research lab under the mentorship of Van C. Mow, a very highly regarded engineer. I really sunk my teeth into orthopedics, and I was particularly stimulated by issues of stability and wear. Being exposed to all of the residents and medical students who rotated through his lab also made significant impressions on me. Thus when I reached medical school, orthopedics was my default. I did try a couple of other specialties, but they only confirmed my decision to be an orthopedist. Also leading me in that direction was the year I took off during medical school to do research at the NIH. I engaged in cellular biology research where we sought out molecules that could prevent cancer. I worked with a number of future orthopedic surgeons on topics such as TGB beta, which is in the same superfamily as BMP. This work would later prove to be invaluable for my future research.”

Continues Dr. Bae, “I began my residency at the Hospital for Special Surgery (HSS) in New York in 1995. It was a fantastic place that was bursting with tradition and history. Part of this came from the living quarters at 310 East 71st Street. For 30 years orthopedic residents had lived in this apartment building and suffered through residency. It was great to talk to attending surgeons and hear their stories of life at ‘310.’ Some of their kids even grew up there. One of my classmates actually lived at 310 when he was a kid. Then there was the mountain getaway. Many years ago a person name Caspary donated a summer house in the Catskills to the HSS residents. That further imbued the program with a sense of history and a feeling of ‘we’re all in this together.’ At HSS there was no hazing, only a feeling that you didn’t want to disappoint the senior residents or your peers.”

Now poised for advanced study, Dr. Bae would learn that trial by fire is sometimes a great learning experience. “In 2000 I started a fellowship at Case Western under the tutelage of the venerable Dr. Henry Bohlman. In my second week at the VA we had a difficult case involving an infection of the thoracic spine. I went to Dr. Bohlman, hoping for a helping hand—specifically, his hand. Instead, he gave me an article he had written on the topic and said, ‘Read this word for word. Good luck.’ Many beads of perspiration later, the case ended well. When we presented it in conference the next week we mentioned that it had taken six hours. Dr. Bohlman quipped, ‘What took you so long?’ I replied, ‘Well, the procedure only took an hour, but it took us five hours to read the article!’”

Continues Dr. Bae, “I also learned from Dr. Jung Yoo, now Chair at the University of Oregon, a solid researcher who knew how to dig into the scope of a problem and was not hesitant to try different things. Also important to my career development was Dr. Sanford Emory, who is today Chair at West Virginia. He is a true gentleman who was loved by patients and staff alike. He taught me that not only is it the right thing to pay attention to people, but because you are running a business, it is the smart thing.”

After the fellowship Dr. Bae would hang up his orthopedic toolbox for a month and hang ten. “My wife and I took off for a month and honeymooned in Hawaii. We lived on the beach and windsurfed in Maui all day. I then returned to California where I joined The Spine Institute with Ed Dawson, Rick Delamarter, and Michael Kropf. Frankly, I was completely lost at first. I had to train fellows but I was only one year older than them. It also took time for me to realize the business aspects of what we were doing, along with the inevitable clinical complications. Prior to this I was a step back from the clinical results because it was always someone else’s work. Now it was mine. They were excellent mentors, however, and helped me learn how to walk the fine line between being confident in my skills and humble.”

Now settled into his role as a teacher, Dr. Bae enjoys the challenges of leading fellows. “I find working with fellows very stimulating and entertaining. Whereas cases can seem very similar after awhile, the fellows change every year. The great thing about fellows is that they ask you questions like, ‘Why are we doing this?’ This sounds pretty basic, but a lot of times it makes you think things through. As a rule I always tell them to think about what the patient is going through. I want them to ask themselves what is reasonable for each patient, as that does vary with the person.”

Another variable in his work falls within the realm of research. Dr. Bae: “I am so thrilled to have a basic science lab where we do a lot of clinical trials for companies. One of the most difficult studies involves growth factors for spinal cord injuries. One of our most important findings is that BMP-2 has a positive effect on functional recovery after spinal cord injury in rats. The problem with all of these injury studies is that you have to injure the rat and follow it for three months. Now we are trying to develop a screening assay where we can rapidly screen more molecules in the first 24 hours, along with a panel that lets us know which ones are promising.”

Continues Dr. Bae, “In the industry today I think we’re so concentrated on one growth factor, whatever it is, to the exclusion of others. As we get more sophisticated with testing methodologies, the successful outcomes will involve a combination of growth factors and some type of cellular therapy. Gene therapy can have both good and bad effects. In fact there has been catastrophic death associated with gene therapy. Due to the traumatic nature of spinal cord injuries, however, gene therapy can be justified. For surgeons it is a difficult problem to address, because it is the cell response after injuries that causes the aftereffects of spinal cord injuries. On another front, we are using BMPs for disc regeneration. At four different sites we are using BMP-7 in a phase-one drug study and are thus far finding an effect. When you look at an MRI there are dark discs and white discs; we’re injecting BMP-7 into the dark discs in patients with low back pain. We have seen some changes in these patients’ MRIs, primarily involving rehydration. It’s early to call but it’s interesting to say there’s something going on.”

Dr. Bae also sees evidence of change on the insurance front. “I think spine is going through a metamorphosis now. There is a fine line between industry being involved and too involved. The advances coming from industry are great, but industry is getting very involved and these technologies aren’t cheap. We need to balance out who pays for health care. As it is now, private insurance companies are not carrying their fair share. I think it’s a phase, however, and that we will see private insurers paying more in the future. Patients will also have to bear some of the costs. When you go to the dentist you expect to pay something, so why not at the M.D.’s? It can’t just be the physician who pays, otherwise the system will go bankrupt.”

On the home front, Hyun Bae does his fair share. “Hobbies? It’s basically daddy day care. I shuttle our three girls from one birthday party to another. My wife Mimi and I have a great time as parents. When I do get a free block of time I head to the golf course and try my best not to embarrass myself.”

Dr. Hyun Bae…a case of parental brainwashing gone terribly right.