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.

In spine, not only is the regulatory environment challenging…so is the disc environment. With so many hurdles to cross, it’s amazing that biologics for use in the spine have progressed. But they have. Says Dr. Jeffrey Wang, Chief of the UCLA Spine Service and Director of the UCLA Spine Surgery Fellowship, “Ten years ago the field was 75% traditional rods and plates and 25% biologics. Now it has reversed and we are in a transition period where we’re focusing more on biologics than devices. This is in part because people are increasingly aware of the potential impact of biologics. Even in educational courses we used to relegate biologics to a small section at the end of the course or lecture and people were generally bored by it. The lectures were dry and back then the clinical applications were too far in the future for people to get their heads around it.”

But the visionary of this field saw things clearly early on. Explains Dr. Wang, “I credit Dr. Marshall Urist of UCLA with advancing biologics for the spine. Dr. Urist, the father of biologics in orthopedics, discovered BMPs and changed surgeons’ and patients’ lives forever. Now with the clinical use of BMPs and more emphasis on biologics we know that many more applications are not far off. In basic science labs around the country we are moving at a faster rate, so if there is a promising growth factor or gene we can make better progress than we could in the 60s or 70s. Computers are now smaller and faster, and the technology we use to develop BMPs is speedier. When Urist worked on BMPs in his animal study, he found extracts of human bone and had to work on this for a long time. Now if you see such a phenomenon in the lab you can jump right on in.”

As always, the fundamental questions apply…“Does it work?” and “How much does it cost?” Dr. Wang: “In spinal fusion we are defining the use of different BMPs. BMP-2 has been used off label more so than on; we have used it all throughout the spine and it’s changed how we do fusion. We now rarely take the patient’s own bone; typically we are using a bone substitute. Having BMPs out there raised the bar for weaker biologics for fusion. In the past when companies had demineralized bone matrix (DBM) with osteoinductive proteins, people assumed it would work. Having BMPs available has meant that companies have to test DBM better and show how it is more effective than BMPs. In the allograft world DBM is not as regulated but that is changing. For awhile, as long as you had basic science studies to support it you could mix DBM and sell it. Now people are saying, ‘If I don’t use BMPs and use something else it may work, but how much will it cost? Is it worth it to get a better fusion?’ BMPs range in cost from $3,000 to $5,000, depending on the size of the kit. But it is a well-studied protein. DBM is not as well studied and they are still charging $1,000 to $1,500 for a 10cc vial.”

And the most exciting area of spine biologics? “Disc regeneration,” says Dr. Wang. “With degenerative disc disease (DDD) we’re dealing with an arthritic disc. The new frontier in biologics involves both trying to regenerate the disc or prevent DDD; a lot of companies and basic science labs are working on these issues. Many things are being tried, including growth factors, different genes, and injecting stem cells into the disc. A large trial has been started where OP-1 (BMP-7) was injected into the degenerated disc. They only injected the growth factor, not genes or cells, but it is the first foray into trying to prevent degeneration. The trial is ongoing at several centers in the U.S.; the results are not out yet. I think that growth factor injection is probably not going to be the final treatment. It is a great first step, but growth factors won’t stay around long enough to continue to prevent disc arthritis; repeated injections would be needed. Once we identify the proper growth factor we may be able to put the gene for the growth factor in the disc. Theoretically, that will last longer. It is widely believed that in the future, success will mean a combination of the right genes, growth factors, and stem cells…and even using biomechanical devices for later stages of DDD where the biomechanics are altered.”

And what is holding up progress? Blood flow and cash flow, among other things. “The environment in the disc itself is difficult,” says Dr. Wang. “The ph level is low so cells find it hard to survive. There is no blood supply so nutrients in the disc find it hard to grow cells or regenerate the disc. And as degeneration progresses the biomechanics change, the disc space collapses, and you have more instability. As for funding, government and industry grants have decreased. Industry is cutting back research funding out of concern that it would seem some surgeons are being paid inappropriately. Competition is increasing because the available money is decreasing. Innovative people are reaching into areas outside spine, outside orthopedic surgery, and partnering with people who have good preliminary data. The day of the lone wolf is gone.”

And if those hurdles aren’t enough, orthopedists themselves can present somewhat of a problem. “The biggest challenge,” states Dr. Wang, “is that this is a dry area of basic science that can’t always hold surgeons’ attention. While the possibilities are exciting, getting there involves a lot of detailed work for long periods of time. A lot of surgeons want the Cliff Notes version because it’s not so captivating to study the minutiae of, say, gene sequencing and viral vectors. Put it like this: A Porsche is sexy, but I don’t want to change the oil. Then there is the need to have collaborations. Many surgeons don’t have the connections for such work. And of course, many surgeons are busy enough with their practices. Unless there are other doctors in the practice who can spend the time teaching you, you probably won’t go take classes because you’re running a practice.”

But eventually orthopedic surgeons will be surrounded by biologics. And it will partly come from the people in their waiting rooms holding printouts. Says Dr. Wang, “Patients are more sophisticated now and are asking outright for BMP. When I tell them that the FDA hasn’t approved it for their condition, oftentimes they still demand it. Many patients know that if you use their own bone they can have donor site pain, so they have researched the issue and know their options. On the industry side, companies are advertising because the bar has been raised. As for surgeons, sometimes the doctor in a small town doesn’t have as much competition and contracts for reimbursement are better. The hospital has no competition so it is faring better. But when they use BMP the hospital loses money.”

Dr. Wang’s final comments? “It is important for surgeons to be critical and take the time to understand the scientific evidence in favor of the products they use. If you are going to work with biologics, know how to properly use them to avoid complications. Sometimes there is an attitude à la ‘I’m just going to throw it in there.’ That is what happened with BMP in the cervical spine. In the first years there were five studies showing a high rate of complications, such as swelling and problems breathing and swallowing. Biologics is a delicate area that needs to be thoroughly understood and studied prior to being undertaken.”