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.

His introduction to medicine was like a Norman Rockwell painting. Says Dr. Rick Guyer, President of the Texas Back Institute (TBI), “From the age of six I followed my father, a general surgeon, while he did his work. On weekends we did house calls, a time when I truly began to understand that a physician is a ‘health servant.’ When I was 12 he took me to the hospital where I actually assisted in an appendectomy. I also recall a time when my dad performed open heart massage and saved a patient’s life. I was so struck by how grateful the person was. In the end, it was the doctor/patient relationship that grabbed me. I saw the satisfaction that my father took from taking care of patients…and I saw how they revered him. As for my dad, even in the last year of his life he went to medical meetings. And my mom was incredibly supportive. My parents always stressed learning and made it clear that if I ever wanted to further my education, they would pay for it.”

Rick Guyer took his parents up on that offer when he entered the University of Pennsylvania School of Medicine. “Whereas I had been top dog at Ursinus College, a small institution, at Penn Med I was surrounded by a plethora of extremely bright people. Instead of being at the top of my class I was now in the middle. I became interested in the sciences and enjoyed physiology and anatomy. It was a research-oriented culture where there was an attitude that unless you went with internal medicine or pediatrics, you weren’t a good doctor. I decided to rotate with Dr. Joe Lane, who, when I told him I wanted to go into pediatrics, recommended pediatric orthopedics. He was the kind of teacher who inspired you and used the Socratic method as a path to learning. Dr. Lane would ask a question and if you were off the mark, he’d say, ‘That’s not quite right but what else could you think of?’ He was so positive. Even if it took you four times to get to the right answers he would say, ‘Oh, you’re so bright.’ He had the enthusiasm of a kid and I wanted to emulate his fun nature. He also taught me that I could be a ‘smart doctor’ without doing internal medicine.”

The fun would have to wait, however, as Dr. Guyer’s next career stop would be intense. “Once I finished my Penn program I headed to Parkland Hospital in Texas for an internship. I had wanted trauma and boy did I get what I was looking for. It was like watching ER, but this was no television show. I got thrown in to do incredible things, including a Christmas Eve open heart massage on a gunshot victim. The most emotional and intellectual experience was on the burn unit, however. There was a tremendous mortality rate because a burn over more than 50% of someone’s body meant they weren’t going to survive. I would stay up all night with the patients and then have to talk to the parents. I wasn’t emotionally prepared for such things, however, and that, coupled with being on call every other night, meant that I was completely drained.”

But it was no time to slow down. The learning would go into high gear in the next few years. Says Dr. Guyer, “In 1976 I returned to Penn for my residency. There I was met by the loyal Dr. Jim Nixon. By loyal I mean that he always protected the residents, but if you did something wrong he would rake you over the coals. On one occasion an internal medicine doctor was giving me a hard time and Dr. Nixon stepped in and defended me. He later pulled me aside and asked if I had done what the other doctor said I did. I replied, ‘Yes,’ and he said ‘Don’t you ever do that again.’ He would let you make mistakes but he’d never let it go too far. I also learned from Dr. Dick Rothman, one of the first spine surgeons in Philadelphia. He taught me that unlike people in the orchestra who play the same piece over and over trying to get the note right, you should practice every step of an operation so that no mistakes are made. I teach my fellows this today, i.e., be prepared for every possible variation. At the time there was zero tolerance for mistakes and you had to give 100% all the time. Consistently working at such a high level made me a better doctor. I don’t cut corners and can handle stress well as a result of this training.”

Continues Dr. Guyer, “During my time with Dick Rothman I thought I was headed for total joints. To further this, I accepted a faculty position at the University of Texas in Houston doing total joints on kidney failure patients and individuals with connective tissue disease. After six months, however, I was looking for a change. Dr. Stephen Hochschuler, who was one of the residents during my internship at Parkland, called me up around this time. He announced that he and a colleague were going to start a spine center, but at the time I was set to go to England for a total hip internship with John Charnley, the father of total joint replacement. My plan was to then go to Germany for a trauma fellowship at the AO Foundation. My wife nixed that idea, however, so I pondered my options and came to the realization that I really loved spine work. I could see that it was a significant intellectual challenge and looked forward to the process of attempting to figure out where the pain emanates from. I contacted Dr. Hochschuler and let him know that while I would like to join him and Ralph Rashbaum, I would have to do a spine fellowship first. Case Western was my next stop, where I came into contact with Dr. Henry Bohlman, who taught me spine and trauma for three months. I then spent six months in California with Dr. Leon Wiltse, one of the grandfathers of modern spine surgery. He was 70 years old during my fellowship, but he still displayed a superb inquisitiveness at all times. We harvested spines and did research on dissections. He was also very caring with his patients. For example, he taught me that instead of making notes in a chart while standing outside the exam room, do it while with the patients because it makes a better impression on them. Training with him made me think of all the good times I had learning from my father.”

He would become a spine man indeed. Dr. Guyer, the most recent President of the North American Spine Society, began his career in spine not just as a physician, but also as a leader. “Starting the Texas Back Institute was a whirlwind. In 1982 we started with a back school and physical therapy practice called the North Texas Back Institute (NTBI). We joined our clinical practice, North Texas Orthopedics Associates with NTBI in 1985 and changed our name to Texas Back Institute. From just three surgeons and nine employees we had grown to 300 employees. We expanded to California, but when the workers’ compensation laws changed we sold off our rehab centers there. Now we’re primarily concentrated in and around Dallas and one office in Phoenix. In all we have seven sites and will most likely continue to expand. Our team of spine surgeons, physiatrists, occupational medicine specialists, pain medicine experts, neurologists, anesthesiologists, general surgeons, psychologists, physical therapists, and chiropractors works as a close-knit group to attend to the needs of our patients.”

Along the way, they would learn to persevere—even when their colleagues were set to throw tomatoes. “When we started the TBI research foundation we did a lot research in discography and essentially popularized it. It was like we had targets on our backs, however, because some of our colleagues would say things like, ‘This isn’t science, it’s BS.’ As the years passed it eventually became more universally accepted. And even though it remains controversial it helped us understand that the disc is a more complicated structure than just a shock absorber. There have been a lot of terrific milestones here, including our many IDE studies, being the among the first to do cages, being the lead site for the CHARITÉ®, and being one of the main sites for the ProDisc™. We were also one of the early sites for percutaneous discectomies, which we did with Dr. Parvis Kambin (who I trained with during my residency). He taught me that it’s not necessary to move your hands quickly in order to carry out efficient surgery. Dr. Kambin could do a perfectly beautiful total hip in one-and-a-half hours.”

Of his favorite current research Dr. Guyer notes, “I am most excited about the biological research going into disc physiology. We have just initiated a study where we hypothesize that by injecting material into the disc the chondrocytes will regenerate the nucleus of the disc. This type of work is particularly useful for people in their late teens and early 20s.”

As Fellowship Co-Director at the Texas Back Institute, Dr. Guyer has the chance to watch young minds bloom and connect the dots. “We have had fellows since 1987. In total we have trained over 65, with another 15 to 20 international fellows. It’s just great to see their faces when the lightbulb goes on. They enter the program with varying degrees of experience and leave with a great deal of sophistication. Someone who works with fellows should be very patient and willing to treat them a bit like children, in that you must give them responsibility so that they will learn. There are many fellowships, however, where the fellows do nothing because the leadership won’t let them. It’s important to let them go out on a limb without hurting patients.”

Sometimes he stops to smell the roses…other times, he blows right by them. Says Dr. Guyer, “I am very passionate about cars and have taken a number of driving courses. For Christmas one year my office staff bought me 10 laps at a Nascar track. My ultimate goal is to do every Formula 1 track in the world. I used to raise roses and am still a nut about photography. It’s really the opposite of 200 miles per hour.”

But he likely wouldn’t take the newest addition to the family for a ride in the race car. “My wife and I have three children and are celebrating the birth of our new granddaughter. My wife is really a bedrock of strength. No matter how bad of a day I’ve had when I come home she reminds me that the glass is always half full. We have our health, our family, and I didn’t harm anybody. Whenever work-related politics is taking its toll, I think of these things.”

Dr. Rick Guyer…an old-fashioned surgeon who stays on the cutting edge.