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.

If you’re going for gold, you won’t find it in writing orthopedic textbooks. You may get a little glory, however. Dr. Jeff Wang, Chief of the UCLA Spine Service and Director of the UCLA Spine Surgery Fellowship, is an experienced textbook editor and author. He notes, “Committing to edit or write a textbook means you’re looking at an incredible amount of work for almost no compensation, so you should do it for educational purposes. While I personally have never been paid to write a chapter for a book, I know of authors who have garnered perhaps $100 for similar efforts. Textbook editors may earn $200 - $500, essentially very little for a significant amount of time and effort. And don’t think you will receive royalties either. That is just not standard practice. Those of us who choose to participate in such work do so because we’re viewing it as a way to contribute to the field. It is a unique opportunity to create something better than what is already in existence. Then there is the advantage of getting one’s name ‘out there.’ For young surgeons just developing their expertise, this can be a real feather in the cap.”

Generally speaking, however, one must be invited to participate. Explains Dr. Wang, “General ideas for orthopedic textbooks are usually conceived by the publisher, who in turn contacts potential editors. There are times, however, when they are set on working with a certain surgeon and allow him or her to select the topic of the book. If you are contacted to edit or write a book or chapter, you would first want to ask yourself, ‘Am I duplicating existing efforts? Am I going to make an impact with my contribution?’ Sometimes, upon examining what is currently available, surgeons come to the conclusion that they can do it better, which may mean a new format. Learning styles have changed; publishers, editors, and authors know this.”

Continues Dr. Wang, “Surgeons may look back to their training days and recall the textbooks they used that were all-encompassing. These were comprehensive books with a routine format that contained a complete history of every type of operation, leading up to how it is done in the present. Nowadays the most exciting books are the ones that don’t spend as much time on history, but go almost immediately to the ‘surgical pearls,’ i.e., the practical tips on various techniques. You will want to be on top of this trend, with lots of helpful pictures, drawings, and intraoperative diagrams that demonstrate surgical techniques. Also important to include is information on potential pitfalls of any particular technique. That will save surgeons and patients time, resources, and trouble. Things have shifted because the nature of our society today is that kids and adults have shorter attention spans and want to get to the heart of things ASAP. This is especially important if, say, you’re treating an emergency patient at 4 a.m. and you need to get to the ‘how to’ section quickly. The other reality is that surgeons’ time is more limited than ever. While it’s nice and sometimes helpful to know about the history of such-and-such technique, it’s vital to have ready access to the most current treatment information.”

If you accept an invitation to edit a textbook, the mantle—and headaches—rest on your shoulders. Says Dr. Wang, “If you assume the responsibility of editorship, this becomes your textbook. The title almost becomes the name of the editors [and there is always more than one]. It’s rather routine that people don’t remember the exact name of the book, but they recall the authors. They’ll say, ‘That’s Wang and Riew’s book on cervical artificial discs.’ It is a significant amount of pressure, as you are held responsible for the content. If something is off base, it falls to you to explain and handle it. Much of what an editor does is ‘ride herd’ over the authors. The trick is to select authors who you know will not delay getting their work in on time. You must stay in touch with the authors and encourage them to remember and honor the deadlines. If they are not progressing you have to find an alternate author. As an editor you must be intimately familiar with the topic at hand and ensure a high-quality book.”

And what of the relationship with the publisher and the other editors? Advises Dr. Wang, “Find out from the publishers how much support you will have from them. Many if not most publishers will assign one or two people whom you can contact at any time for assistance. These individuals send out reminders to authors and do the bulk of gathering the chapters, as well as the mailing. The publisher will contact certain surgeons to edit the book. In spine, it’s a mixture of orthopedists and neurosurgeons so that you achieve a sense of balance. As editor, you would derive the chapter topics, an outline, and a table of contents. Regarding the other editors you’re working with, occasionally you have a situation where one of you is doing the bulk of the work. That has to be sorted out soon so as not to delay the book. Something else that can result in a delay is if the publisher is changed or the point person at the publisher.”

So where do authors fit in? “You first would receive a letter from the publisher that is signed by the editors,” explains Dr. Wang. “First you should determine if the topic they’re assigning is good for you. Also, clarify with the publisher how much help you are allowed to get from others. They will usually provide authors with substantial assistance, including the ability to generate original artwork, tables, and/or graphs, etc. While, for example, you can’t copy tables directly, the publisher will contact the publishers of the original table to get permission for its reproduction. In lieu of this, the publisher will arrange for a similar drawing or table to be done by an artist. Additionally, regarding assistance, you should have a clear understanding of what help you are allowed to get from your residents, fellows, or colleagues. Oftentimes when societies contact me, they specify that they want me alone to be the author of a book. Also important for authors is that the due date be manageable [publishers usually allow six months]. Be familiar with the format and page length the publisher is looking for. The last thing you want is to write 50 pages when they only want 12. Upon completion, the author submits the work, the editor reviews and corrects it for content, and then sends it back to the author for rewrites or deletions. In some cases editors will go ahead and delete things on their own.”

If you are seeking an intellectually rewarding experience that enhances the field, you may want to consider textbook editing or writing. Don’t do it if you can’t do it well, however. Notes Dr. Wang, “If you make that commitment, see it through. If you slack on quality or are not reliable, you will develop an undesirable reputation, something that could ultimately affect your other work.”