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.

Keith knows knees. And Anesiva knows Adlea™. The company is announcing that it has embarked upon a Phase 3 study to evaluate Adlea in patients after total knee replacement surgery. Adlea is a long-acting, non-opioid analgesic drug candidate. Dr. Keith Candiotti, Associate Professor of Clinical Anesthesiology and Internal Medicine and Director of Clinical Research, Chief, Division of Perioperative Medicine, University of Miami Leonard M. Miller School of Medicine, is an investigator in the study.

In September 2007, Anesiva initiated a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the safety and efficacy of a single 5 mg or 15 mg dose of Adlea or placebo administered into the surgical site in patients undergoing total knee replacement surgery. The company has completed enrollment of the initially planned 80 patients and now converted this trial into a Phase 3 trial by expanding the planned enrollment by approximately 134 patients. The total sample size is now 214 and the number of trial sites has increased, focusing enrollment on the 15 mg and placebo groups.

In the news release, Dr. Candiotti noted, “Total knee replacement is a commonly performed orthopedic surgery that can significantly enhance patients’ quality of life. The effective management of post-surgical pain is critical since patients must begin walking and moving the knee soon after the procedure in order to begin recovery and avoid complications. Adlea may offer additive pain relief and possibly reduce the use of other pain medications such as opioids, whose systemic side effects can interfere with the recovery process.”

Added John P. McLaughlin, CEO of Anesiva, “We now have two pivotal Phase 3 trials in progress for Adlea, in total knee replacement surgeries and bunionectomy surgeries, and expect to have top-line data from both by year-end. We also are conducting a Phase 2 trial in total hip replacement surgeries and plan to initiate a Phase 2 trial in arthroscopic shoulder surgeries to support a broad label of pain management following orthopedic surgery.”

While the safety of Adlea will be evaluated throughout the study, the primary efficacy endpoint of the Phase 3 trial is a time-weighted pain score from four to 48 hours following knee replacement surgery. The study will also evaluate pain scores during the first two weeks following surgery, as well as opioid consumption.

Anesiva has previously completed Phase 1 and 2 trials of Adlea in total knee replacement and bunionectomy surgeries, as well as in osteoarthritis of the knee, elbow tendonitis and Morton’s neuroma.

Adlea is a highly purified form of capsaicin that acts primarily on C-fiber neurons, which transmit long-term pain by binding to and desensitizing the TRPV1 pain receptors. This leads to a prolonged, reversible and localized desensitization of the pain fibers. The drug generally has a short half-life of one to two hours, and it is undetectable in the blood after 24 hours. According to the company, Adlea has the potential to provide pain relief for weeks to months after a single localized treatment. Its mechanism of action results in site-specific efficacy intended to avoid the unwanted side effects associated with systemically administered analgesic drugs such as opioids and NSAIDs.

As indicated by Anesiva, Adlea’s short duration of systemic exposure relative to the longer duration of analgesia may offer a safe, additive treatment option in the management of post-surgical orthopedic pain. In clinical trials to date, adverse events have been similar in patients receiving Adlea or placebo. Adlea is also in clinical development for the treatment of pain associated with moderate to severe osteoarthritis.