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.

Youth versus age, risk taking versus conservatism, and funding...always funding. These are just some of the factors that determine whether a patient receives the latest in technology. Says Dr. Rick Guyer, President of the Texas Back Institute and Past President of NASS, “It is true that the adoption of new technology has become faster in the last 100 years. However, the old axiom that people don’t like change is always in play. Except pioneers, of course. Thank goodness for the pioneers.”

And although he sees the future of surgery as cutting edge, alas, the other enduring issue remains: “Who will pay?” Dr. Guyer: “Looking ahead I see things such as a web of electronic data that makes it possible for surgeons to operate remotely on patients regardless of where they live. Widespread electronic medical records would provide up-to-the-second information and streamline medical care across the board. You will be able to get a genotype and identify what diseases someone is susceptible to. In general, new technology will make medical care so efficient that we’ll eventually see the benefits outweigh the costs. But in the meantime the financial issues must be solved.”

And that is hard to do when you have a moving target. Dr. Guyer notes his own experience: “I have been involved in numerous strategy meetings prior to CMS presentations. At times industry representatives were even included in order to see what information they might bring to the table. I have come to learn that it is essentially a shell game involving both CMS and the AMA, the latter of which does the CPT coding that CMS adopts. The problem is that with Medicare, the sustained growth rate (SGR) is zero for physician reimbursement. This means that every time a code comes up that people want adopted, it takes money from another code. Then, making it worse, insurance companies work from what Medicare decided. If Medicare decides on reimbursement for something and if it goes down a certain percent, insurers tee off that. So there’s your downward moving target.”

When Mrs. Jones goes in for spine surgery, she likely has no idea of the economic forces working for and against her. Dr. Guyer: “There are things happening on both a state and a federal level that affect how we care for our patients. One example is in Washington state, which recently held a hearing on fusions and the prospect of limiting them. Now artificial discs are being challenged by that state. To address this issue, NASS, CNS, AANS, CSRS, SRS, and SAS have organized to work together. If such changes occur in one state, it will spread to the rest of the states. And it will happen quickly. The federal government moves slowly, but not the states. Oregon is mounting a Health Technology Assessment in collaboration with 11 other states, something that could affect the treatment landscape of spine patients for years to come. And unfortunately, in some cases, the individuals reviewing the technologies are regulatory people who are not necessarily medically or clinically trained.”

Continues Dr. Guyer, “Many insurers are saying outright, ‘We won’t pay,’ as with the CHARITÉ®, which was approved in 2004. And there is the example of the ProDisc™, which was approved in 2006 and yet still has only a smattering of insurance companies that will pay for it. Two-year data used to be sufficient, then it was five years; we are now moving toward a 10-year data requirement. And this quickly trickles down to the people who are in our waiting rooms. One of my patients brought in a letter from his insurer that read, ‘We understand you had cages (actually it was a successful life-changing artificial lumbar disc) in your spine two years ago, so we are unable to give you insurance.’ In some cases insurance companies do their own technology assessments and then hold out because they are afraid that if they approve the technology it will open a Pandora’s Box. CMS also does technology assessments, where, for example, they end up saying, ‘We are not approving the artificial disc for people age 65 and older. If someone is younger we’ll consider it.’ As a physician I know that while we are having increasing success with older people, there is still a 25% complication rate with some of the more complex deformity reconstructions required. It seems, unfortunately, that the CMS premise is, ‘What can we not pay for?’”

And among some surgeons there is also a bit of conservatism. “When the average spine surgeon finishes training, he or she is comfortable with certain things. He can reproducibly perform these operations and have an attitude of, ‘Why would I want to change?’ The other group, the younger generation in our midst, says, ‘This is cool! I’ll try it.’ They have been ‘brought up’ on new technology and don’t have the hesitation that some older surgeons do. I remember a surgeon who said, ‘In my hands I can get great results with my current technology. I’ll let other doctors try such-and-such until it is proven. Then I’ll use it.’ If everyone thought like this, of course, there would be no progress. Take total hips. Almost 50 years ago Dr. John Charnley dove right in with Teflon-coated hips. While they all eventually had to be revised, he started the revolution of joint replacement that our patients enjoy today. Over 25 years ago when we started the Texas Back Institute and were doing fusions, there were no BMPs or demineralized bone products. We had to wait six to nine months for fusion and then do the opposite (anterior or posterior) and then wait another six to nine months. Nowadays we can do it with BMP and percutaneous pedicle screws, and in about three to four months the patient is well on his way to healing. There will always be something better around the corner. But the field won’t progress if everyone sits on the sidelines with a ‘wait and see’ attitude. You have to do your best with the knowledge and technology you have at the time.”

And just like a red state/blue state thing, new technology adoption depends on the person’s vantage point. Explains Dr. Guyer, “Someone’s comfort level with change is going to depend on his or her career stage. Surgeons who are younger and still building their practices are more likely to incorporate newer technology for the competitive edge, compared to an older surgeon who has a mature practice and does not feel the need to learn newer techniques to build his patient base. Motivating the ‘holdouts’ to step out of their comfort zones, however, is a dose of peer pressure. If I am the last one in my practice to do an open operation when MIS is the standard, for example, then I’m really out of sync with the times. I had better change or I won’t get patients.”

At the core of the issue is what works and what doesn’t. Explains Dr. Guyer, “Take the artificial disc, for example. Its proponents say that the biomechanical evidence shows that it can preserve motion at the affected level and lessen the stress on the adjacent levels compared to fusions. Others say that is a myth. This is why we need extensive data on technologies. But even having sufficient data doesn’t clear everything up. When The New York Times recently published its article on the ProDisc, many people had doubts about the quality of the data. There is no way to alter data with an FDA IDE, however. People want to see unbiased outcome data, but outside of the FDA IDE trials, we are terrible about collecting it as individual doctors.”

And while patients don’t usually ask to see the details of a regression analysis or chi-square test, they are pinning doctors down with pointed questions. “Patients are increasingly savvy about medical technology,” says Dr. Guyer. “They do research on the Internet, shop around for practices that have what they want, check out hospital ratings, and bring printouts to appointments. What tempers all this enthusiasm is insurance, however. If someone wants to travel to another state to see Dr. X, the insurer may put the kibosh on that. And the Internet opens up issues of misrepresentation as in unqualified doctors advertising, for example, minimally invasive surgery.”

Dr. Guyer concludes, “I think new technology will be adopted more easily in the future because we’ll be totally surrounded by it. It will be the expected norm. And as long as it’s done with prudence, patients will benefit tremendously.”