Other Articles

Biologics for Spine: Where We Are Now
Dr. Jeffrey Wang, Chief of the UCLA Spine Service and Director of the UCLA Spine Surgery Fellowship, discusses the exciting happenings in spine biologics, including growth factors, the use of different genes, and injecting stem cells into the disc. And then there are the challenges, namely the disc environment and the funding environment.

Physician Medicare Payments: Grandma vs. Docs
The fight over Medicare physician payments in Congress has been reduced to a fight over limited public dollars between Grandma and her physician. Is this a prelude to how public health care policy will be decided in the future? Read about the tussle here.

Spine Niche! Opportunity in the Spinal Deformity Market
Given the myriad of start-up companies pursuing the same patients, product differentiation and solutions for specific target markets could be the key in the future. Using the PearlDiver Patient Records Database we estimate procedure volumes for posterior fusion as a treatment for scoliosis—followed by the results of a study identifying complications associated with instrumented posterior thoracic fusion in treating scoliosis.

AAOS Political Action Committee
Active players in the orthopedic field know the importance of the AAOS Political Action Committee (PAC). On the cusp of hot topics affecting physicians and patients, the AAOS PAC works diligently to provide data to members of Congress and improve the present and future of orthopedics.

Who ARE These Guys?
Every 60 seconds or so a surgeon tears the cover off an Integra LifeSciences package. Quietly, this company has become the seventh largest medical implant manufacturer serving orthopedic surgeons in the world. Where to now? Would you believe $1 billion in two years? How about $2 billion by 2015?

Redemption in a Mechanism of Failure: The TOPS™ Story
Impliant’s TOPS™ System had a “squeaker” in its clinical study. After a voluntary suspension of the study by the company and finding the mechanism of failure, the FDA has approved a resumption of the study. What insider lessons were learned? Class starts here.

Who is Numero Uno in the PearlDiver Database!! Are You Surprised?
The answer may surprise you. Is it sore backs, aching hips, sore knees, fingers? PearlDiver details 3.8 million spine related complaints—complete with demographic information and charging information. But that’s not #1. PearlDiver also lists 3.5 million large joint complaints. Sorry, still not #1. What could the most common orthopedic complaint possibly be? To get the surprising answer…read on.

What the Knees Need: Baby Boomers and Their Options
Knee patients often show up at the doctor’s office with recurrent mechanical symptoms. It is up to the orthopedist, says Dr. Giles R. Scuderi, Director and orthopedic surgeon with the Insall, Scott & Kelly Institute in Manhattan, to thoroughly assess the patient and then determine if nonoperative treatment will do, or if the person needs a unicompartmental or total knee procedure.

Physician: Report Thyself
The government says its healthcare anti-fraud efforts are working and it wants to encourage physicians to self-report possible fraud. How well did the government do in 2007 and what about those deferred-prosecution deals with undisclosed evidence? Read about it here.

Revising the Statistics
The word that orthopedic patients least want to hear is “revision.” Who, in the universe of large joint patients, do we expect to see on the receiving end of this news? If you guessed “the elderly” you would have been wrong. The reality of who is hearing “revision” may come as a surprise. Read what we found when probing PearlDiver’s database.

Where Is Ben Now? Trends in Venture Capital
What is being funded by VCs and why? First of all, spine is having to share the spotlight, says Gary Stevenson, Managing Partner at MB Venture Partners, LLC. Here Stevenson outlines what constitutes an attractive investment…he also highlights issues that are affecting the distribution of VC funding.

The Hounds of Wall Street
Conventional wisdom on Wall Street is that ArthroCare is in a bare-knuckle fight to the finish with short sellers. Which leaves us with the dominating question: If ArthroCare is essentially a “lame duck” growth stock, then why are sales, earnings, and the stock price contradicting the short seller’s dire predictions and even outperforming consensus analyst forecasts? We have the answer.

The Era of “Tell Me Right Now” Dawns at FDA
The FDA wants the next phase of post-market oversight to change from self reporting to proactive surveillance. How? Through the Sentinel Initiative. Read what it means to device manufacturers here.

The Day After Tomorrow: Complication Rates and Instrumentation Trends in Posterior Lumbar Fusion
Could PearlDiver be the Nostradamus of spinal instrumentation? This most commonly performed surgery on the lumbar region of the spine increases fusion rates and improves spinal stability—but what about complications? Using PearlDiver’s database we find the answers. Are you ready for some quatrains about what happens next?

You Try It. No You Try It First: New Technology Adoption
What are the forces working for and against new technology adoption? Youth versus age, risk taking versus conservatism, and the economic realities of the day, says Dr. Rick Guyer, President of the Texas Back Institute.

Cheaper, Thinner, Faster, Stronger
In this, the second of our series of three articles on innovation, we tackle the question: How do you measure medical technology innovation? While difficult, measuring innovation is NOT impossible. Why? Well to start, and in the immortal words of Supreme Court Justice Potter Stewart, “We know it when we see it.”

SAS Crosses the Rubicon in Miami Beach
The SAS 8th Annual Global Symposium in Miami Beach may have crossed the Rubicon. How? Read about the Society’s opportunities for growth and collaboration as its new President lays out a vision for the future.

Dr. Paul McAfee belongs to the “Spine and Wine Society.” With little to complain about in his illustrious career, that would never be confused with the “Spine and Whine Society.” Laughs Dr. McAfee, chief of Spinal Reconstructive Surgery at St. Joseph Medical Center in Towson, Maryland, “Everyone who trained with the incredible Dr. Henry Bohlman was exposed to his love of wine. Rick Delamarter, Paul Anderson, Scott Boden, and Dan Riew, among others—all are part of the Bohlman wine clan. Our reunions have actually been written up in the one of the wine journals. It’s a unique group.”

Even years before he could differentiate a white zinfandel from a syrah, Paul McAfee was surrounded by great minds. “My dad was a famous physician who started the field of nuclear medicine at Johns Hopkins University. He is particularly known for the discovery of Technetium-99m, a tracer used for bone scanning. I had an intense exposure to medicine early on, with our annual New Year’s Eve parties routinely including all the deans from Hopkins. In medical school, whenever I walked into a room and the discussion at hand was related to radiology, people would say, ‘Oh, McAfee’s son is here, let’s ask him.’ You can imagine the pressure. No radiology for me, thank you. There were too many expectations attached to it.”

As an active teenager, Paul McAfee observed and was involved in numerous sacks, takedowns, and ice-pack situations. Meaning, of course, that he was a natural fit for orthopedics, and for spine in particular. “After completing medical school at State University of New York–Upstate Medical Center in Syracuse, I remained there for my residency. Part of the joy of those years was training with Hansen Yuan, who successfully launched numerous physicians bound for work in China, Korea, and Japan. When I went on to my fellowship at Case Western Reserve University in Cleveland, I struck gold with Dr. Henry Bohlman and his training. He imbued the fellows he directed with a sense of the importance of publishing and peer review. One week while Dr. Bohlman was away I wrote three papers on his patients; then during the year he allowed me to review a large series of interesting surgical patients. An impressive man, he was the first surgeon to use an anterior approach to the spine on an incompletely paralyzed patient in order to gain maximum potential neurologic recovery. Dr. Bohlman was also known for allowing trainees to be first authors on publications. When I wrote up a case for the Journal of Bone and Joint Surgery on the retroperitoneal approach to the thoracolumbar spine for burst fractures, he insisted, despite some flak from his colleagues, that my name appear first. All of us Bohlman fellows follow in his footsteps and have our trainees put their names first on publications if they do the bulk of the follow-up work. Dr. Bohlman is a gracious and impressive physician, and his fellows are pretty loyal to him. In fact, we raised over $1 million to create the Henry Bohlman Endowed Chair for Spine Research at Case Western. He is now 71 years old, but he continues to operate and teach others the art and science of orthopedics.”

As does Dr. McAfee. “When training fellows I lead by example and leave out the pontificating. I watch, listen, and learn from them. In fact, I believe that my greatest contribution to the field is the people I have trained. Our fellows leave here and they are the stars of every other program they join.”

Dr. McAfee’s influence spans the globe, thanks in part to his practice of training clinician-scientists from other countries. “I run the basic science lab at St. Joseph’s Hospital in Baltimore, where we are known for having trained many talented Asian surgeons, including five heads of universities in Japan. One impressive individual who spent time at our lab is Dr. Zhuo Dwei, a general who is currently the head of China’s aerospace military hospital in Beijing. I am also proud to say that we have the most advanced facility in the world for animal testing. At any one time, we have 60 baboons with lumbar disc replacements and can handle up to 1000 sheep and 1000 goats, the latter of which have cervical disc replacements. We are blessed to have access to a huge farm where the NIH does its work. This research resulted in the Volvo award one year for our work on the reaction of bone to metallic spinal implants.”

Continues Dr. McAfee, “My dad always told me that the real satisfaction of a doctor’s day-to-day work is helping patients, but that for long-term gratification, one should work toward the greater good by doing research. I am fortunate to have worked with a number of talented basic science engineers. One of these is Jeürgen Harms of Germany, whose work on deformities entailed finding different ways of using pedicle screws. He taught me that these screws allow you to align all three columns of the spine if you operate from the back and can get purchase on the anterior column. Over the last 10 years, I have developed one of the first cervical disc replacements, the Porous Coated Motion (PCM) artificial disc, a collaborative process with Helmut Link at Cervitech. Another gifted engineer I’ve worked with is David Paul, the CEO of Globus Medical. Together we have developed a number of motion preservation products, including a flexible posterior rod system [Transition] and the XPand, a PEEK product that allows surgeons to replace vertebral bodies. The XPand is extremely versatile. It can be used to replace the cervical, thoracic, or lumbar spine.”

Running an active lab located close to Washington, D.C., Dr. McAfee has a bird’s eye view into the FDA process. And it gives him a deep appreciation for their work. “I believe in the FDA process. Through the years I have known some wonderfully dedicated FDA employees who are committed to the goal of patient safety. Many times industry thinks of the FDA as obstructive, but in my experience, they are truly concerned about safety. If they ever approve a product that turns out to have problems, they are of course upset. It’s really a thankless job and I respect them. My work in other countries has also shed light on the efficacy of the FDA approval process. I have done disc replacements in 37 countries, and I am convinced that the FDA system is the best thing going for patient safety. There are a lot of misconceptions about the FDA; the agency often gets caught in the middle between doctors and industry.”

Even when he is not inventing, Dr. McAfee’s life doesn’t settle into a routine. When asked about his typical day, he replies, “One of the people I respect most has a saying: ‘Every day is a dog fight.’ Despite planning, things go awry at the last minute and must be dealt with. Maybe a patient is open and all the hooks are in, but the rods are too short. Our excellent team will scramble to get the right equipment. If that requires having something flown in by helicopter at a moment’s notice, so be it. Any hint of a routine is broken up by my overseas work, which often involves trips to Brazil. There I work with my colleague and friend Dr. Luiz Pimenta. It’s a fast-paced but rewarding experience. I leave Dulles Airport at 9 pm, land at 6 am, and operate at 7:30 am. We typically do 10 to 15 interesting cases in three days. And the ability to tailor implants is impressive. It’s not unusual to have a prosthesis in someone’s neck that won’t fit and then we take it to the hospital production facility, where they custom fit it for the patient.”

And when he lands back at Dulles Airport, Dr. McAfee may then fly off to see one of his two children. “I have one son in law school and another who is an entrepreneur in the computer industry. My other loves are golf and the Spine and Wine Society. I get pretty competitive on the golf course, actually. My handicap is eight…I’ll take anybody on.”

Any takers?