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.

According to Doctor’s Guide (“Rare Tendon Complications Linked to Statin Use,” March 24, 2008), results published in the March 15, 2008, issue of Arthritis Care & Research indicate that rare tendon complications may be somehow related to statin use.

Working with 96 cases of tendon complications that were attributed to statin use, Catherine Noblet of the University Hospital in Rouen Cedex, France, and colleagues retrieved data from the French pharmacovigilance database on patients treated between 1990 and 2005. Information was gathered on patients' medical histories; additional medications, particularly those known to increase statin concentrations; onset, pattern, and severity of condition; and dosage and type of statin taken.

The results indicated that 4,597 adverse events were associated with statin use, and nearly 2% of those were attributed to tendon complications. Symptoms usually occurred within eight months of initiating statin therapy.

According to the article, the association with statin use was determined because symptoms appeared after statin therapy was initiated, but they improved when the use of statins ceased; symptoms also recurred in patients who restarted the therapy.

The researchers found that most patients within the 2% had tendonitis, while some also suffered ruptured tendons. The most common tendon affected was the Achilles tendon, with pain, swelling, warmth, and stiffness as the most common symptoms. Some patients (n = 17) had symptoms severe enough to warrant hospitalization.

As pointed out in the article, tendon complications due to statin use may go unreported. While there were no reported cases during large therapeutic trials of statins in more than 30,000 patients, the authors suggested that controlling for factors that predispose patients to tendon conditions may explain that result.

The investigators found an increasing number of patients with complications in tandem with the growing number of prescriptions between 1990 and 2005. While they note that the prevalence of tendon problems in connection with statin use is low, the researchers suggested that all types of statin use, even at the recommended dosages, could potentially cause tendon problems.

The authors were quoted as saying, "Our study suggests that a regular tendinous clinical examination may be required in statin-treated patients, particularly during the first year following statin therapy initiation.” The article noted that interrupting statin therapy before strenuous physical activity such as marathon running also may need to be considered.

While it is not clear how statin use may contribute to tendon injury, the article suggests that blocking cholesterol synthesis may reduce the cholesterol content of tendon cell membranes and make them unstable. The researchers also suggested that statins may either reduce the levels of proteins involved in maintaining tendon cells or destroy vascular smooth muscle cells.

The authors commented that physicians should be aware of the adverse events associated with statins, which may include tendon complications. "We also suggest that patients who are at risk of developing statin-associated tendon manifestations and who require statins be routinely questioned about symptoms consistent with tendon involvement," they were quoted as saying. They also noted that postmarketing surveillance could be a major tool for early detection of safety problems with a new drug.