Other Articles

How to Get the Surgeon’s Attention
Understanding relationship dynamics and having the chutzpah to put your best creative foot forward can garner you real success as a sales rep. Find out how to bring inventiveness to the sales process so as to attract and retain the surgeon’s attention.

Death Spiral
Since January, ReGen Biologic's stock has fallen from $0.95 per share to $0.04 per share. The number of shares outstanding is up 45% in 9 months. In one case, the company paid a $24,000 vendor bill with 68,572 shares of stock. Still, a couple of particularly savvy orthopedics investors have bought roughly 7% of the stock. Can ReGen survive?

Diving in to the Future
Since 1996 total knee procedures have risen 77% to 455,000 annually. A study presented at AAOS estimates that by 2030 that number grows to 3.48 million knee replacements a year! If infection rates continue to rise at current rates, however, that future will not be nearly as rosy for either patients or industry. Read on.

Selling Yourself: Career Advancement for Sales Reps
Are you considering becoming a distributor or do you plan to advance within a company? Either way, you need to be ready. You will want to know how to make product line choices, hire a sales force, and lead others, among other things.

Mission Unaccomplished: Are the Wheels Coming Off at the FDA?
The FDA is no longer able to fulfill its mission and its wheels are coming off. So says the FDA’s own Science Board in a scathing report. We looked under the hood of the report and here’s what we found.

“Back” to the Future Part II: Technology and the Vertebral Compression Fracture Market
In Part I, our inquiring analyst, Matt Menze, highlighted opportunities for spinal implant manufacturers in the vertebral compression fracture (VCF) market. Now he tackles the thorny issue of new and emerging VCF technologies. What’s on the horizon? Read on.

Second Careers for Orthopedic Surgeons
How should you plan for a change in focus later during your career? You may want to continue utilizing your research, managerial, or presentation skills. Find out what Drs. Ray Linovitz and Stephen Hochschuler have to say about how to stay involved in the field at any stage of one’s career.

Finally, Consolidation in the Allograft Industry
So, where’s Adam Smith’s enlightened self interest when you need it? For about the length of the average U.S. Presidency it’s been clear to anyone who could read an income statement that one important market sector was in need of consolidation. That sector is allograft. With RTI and Tutogen merging, it may finally be happening. Read on.

The Smell of Favoritism, Political Interference, and Back-Room Dealing Alleged in Ortho Deferred Prosecution Deal in Jersey
Amid charges of political favoritism, New Jersey Congressmen call for investigation of ortho deferred prosecution agreements. It’s Jersey and the fur’s flying, read about it here.

The Match Process: Let the Courtship Begin
In the first of three articles, two medical students describe their experiences of the residency match process. Learn their thoughts on interviewing, letters of recommendation, and of course, the pressure to match.

A New “Wave” of Extremity Treatment?
Addressing a market of more than a quarter of a million patients annually with a $5-8,000 treatment sounds like the next multi-billion market. FDA approved, but controversial. What is Extracorporeal Shock Wave Therapy and why should we care? Read on.

Avoiding the Perp Walk, or How to Keep the Justice Department From Knocking on Your Door
We’ve all seen the “Perp Walk” on TV. The defendant cuffed and trying to hide his or her face from the cameras. Will Justice Department and congressional investigations of industry and physician relationships result in a doc taking that walk? Read what a federal prosecutor says about avoiding that indignity.

Breaking the hold of hip fractures … Novartis Pharmaceuticals announces the results of the first-ever clinical study in osteoporosis patients who have had a hip fracture. The study shows that a once-yearly infusion of Reclast® (zoledronic acid) injection reduced the risk of subsequent fractures by 35% compared to placebo.

This study, known as the Recurrent Fracture Trial, included more than 2,100 men and women and was an international multicenter randomized, double-blind placebo-controlled phase III study. The risk of death was reduced by 28% (a statistically significant difference) in the Reclast group compared with the control group (101 vs 141 deaths, respectively). The study was published online on September 17, 2007 as an early-release article in The New England Journal of Medicine and presented simultaneously at the annual meeting of the American Society for Bone and Mineral Research (ASBMR).

In the news release, Ethel Siris, M.D., professor of clinical medicine at Columbia University Medical Center, comments, "Experts agree that the serious consequences of osteoporosis can be prevented, yet the condition is often under-diagnosed and under-treated. This study underscores the importance of more aggressive evaluation and management of patients with osteoporotic fractures, including hip fracture. We know that such patients are at very high risk of future fractures and it is critical that we lower that risk to reduce the human suffering and economic costs from this disease worldwide.”

Added James Shannon, M.D., global head of development at Novartis Pharma AG, "This study builds upon the body of evidence for Reclast and is the first to show that osteoporosis treatment after a hip fracture can have a positive impact on the lives of patients. Reclast is an important new treatment option for millions of people who suffer from the potentially life-threatening consequences of osteoporosis."

Patients between the ages of 50 and 98 years who had experienced a recent hip fracture sustained with minimal trauma were randomly assigned to receive a once-yearly infusion of Reclast or placebo within 90 days of undergoing surgery to repair the hip fracture and every 12 months thereafter for up to three years. According to Novartis, the primary endpoint of the study was the effect of Reclast on new clinical fractures following baseline hip fracture. Secondary endpoints included the change in bone mineral density (BMD) in the non-fractured hip measured annually; spine, non-spine, and hip fractures; and prespecified safety endpoints, including death.

The risk of new spine fractures was reduced by 46%, and the risk of new non-spine fractures by 27%. Although the study was not designed to measure significant differences in hip fracture, the researchers noted a trend toward reduction in new hip fractures (30%). The investigators saw a decrease in mortality, with fewer patients who received Reclast dying following a fracture than those treated with placebo (9.6% vs 13.3%, respectively). They hypothesize that this reduction may have many causes but could be partly related to reduction in subsequent new fractures after the hip fracture. The researchers recommend further investigation.

As indicated by the company, this study further supports the demonstrated safety profile of Reclast. Analysis of key safety parameters, including kidney and cardiovascular safety (including atrial fibrillation) showed Reclast to be comparable with placebo. Incidence of renal events was similar between the Reclast and the placebo group (6.2% vs 5.6%, respectively). Atrial fibrillation, considered a serious adverse event, occurred in 1.1% of Reclast-treated patients compared to 1.3% of placebo-treated patients. No cases of osteonecrosis of the jaw were seen in the study. The most common adverse events with Reclast were transient post-dose symptoms (eg, fever, muscular pain).

Approved by the FDA on August 17, 2007 as the first and only once-yearly treatment for postmenopausal osteoporosis, Reclast was also given a positive opinion recommending approval in the European Union in July 2007 under the brand name Aclasta®. Reclast, already approved in more than 60 countries for the treatment of Paget's disease of the bone, is undergoing more studies to examine its use to treat corticosteroid-induced osteoporosis, male osteoporosis, and bone loss in postmenopausal women with osteopenia.

Data from this new study will be submitted to regulatory authorities worldwide by the end of 2007 to broaden the treatment indication for Reclast.

Patients should speak with their physicians regarding dosing, potential side effects, and contraindications.