On (and Off) the Record

Dear OTW Reader:

Synthes CEO to Get $54 Million+…Research from HSS on adverse effects of early postoperative mechanical loading...Deferred prosecution agreement for Exactech…Dr. Izzy Lieberman’s take on the status of adult spinal deformity work…and more…

Synthes CEO to Get $54 Million+

According to an article in Der Sontag (Elena Logutenkova, December 11, 2011) Michel Orsinger, chief executive officer of Synthes Inc., the company that will be acquired by Johnson & Johnson (JNJ), will get payments of more than $54 million from both companies. According to Orsinger’s new work contract with JNJ, he will get $17.2 million in shares that he has to hold for three years and $500, 000 in cash, the newspaper reported, citing documents released by the U.S. markets regulator. The manager, whose new annual salary will be $700, 000, will also receive a one-time payment equal to three times his 2011 salary and bonus, it said. Synthes will also pay him a loyalty bonus of $36.3 million in cash, shares and tax refunds, according to the newspaper.

How Can We Make Tissue Heal Better?

Dr. Scott Rodeo, a clinician-scientist and Co-Chief of the Sports Medicine and Shoulder Service at Hospital for Special Surgery (HSS), tells OTW, “Our lab is doing some interesting work in the area of biologic and soft tissue healing. We are asking—and are getting answers to questions such as: ‘How we make tissue heal better? How can you replace tissue?’ In particular, the potential for cell based approaches to augment tissue regeneration has huge potential. While there has been little information published on this topic, we are beginning to make progress. For example, our work thus far is showing that mechanical loading done too early postoperatively can adversely affect soft tissue healing. In the past ten or 15 years it has been popular to take an aggressive approach to postop joint mobilization, but it looks like that could be detrimental to healing. It can lead to scar tissue, and excessive loading appears to prolong inflammation—something that may delay healing. Our job is to try to understand the mechanism by which the inflammation interacts with loading. We are looking at ACL reconstructions in the knee and at rotator cuff repairs in the shoulder. Regarding the latter, reattaching the tendon to the bone is the weak link as it is slow to heal. It is a delicate balance, because while early, excessive motion could have an adverse effect, excessive immobilization to protect the repair can have a detrimental effect as well. There are even implications here for the immediate period following an injury…should you get someone moving right away or immobilize them? Time will tell.”

Is African Heritage Linked to Vitamin D Levels?

Researchers at Loyola University Chicago Stritch School of Medicine have received a five-year, $2.8 million grant from the NIH (Nationl Institutes of Health) to study vitamin D deficiency in people of African descent. The team, led by Ramon Durazo, Ph.D., will evaluate the relation between low vitamin D levels and risks for certain chronic diseases, including osteoporosis and heart disease. Researchers will determine whether lower vitamin D levels in African and African-descent populations compared with whites should be considered abnormal, or whether this disparity represents an ethnic-specific trait. The study also will evaluate whether vitamin D deficiency is related to bone density and factors that contribute to heart disease, including obesity, high blood pressure and blood sugar levels.

Surgeons Not Eying the Literature Critically Enough?

Dr. Charles L. Cox, M.D., Assistant Professor in the Department of Orthopaedics and Rehabilitation at Vanderbilt University Medical Center, says that orthopedists should bring their most critical eye to the reading of any type of professional literature. He tells OTW, “When considering the presence of clinical equipoise, one must ask, ‘Within the expert clinical community is there a consensus on the comparative merits of treatment A versus treatment B?’ If you are considering adopting a new treatment, there is an ethical obligation to critically appraise the existing literature prior to implementing a change in practice? If treatment A is shown in a trial to be superior to treatment B, one must possess the skill set to determine whether the scientific merits of the study were valid or flawed (i.e., Is the study internally valid?). Next, one must determine if the patient population within the study is comparable to one’s own patients (i.e., Does the study possess external validity?). Finally, there is an obligation to determine the cost of implementing the new technique as compared to existing techniques. If a study’s findings pass these three tests, then one can consider changing clinical practice. When reading published literature in any journal, we have an ethical obligation to review it with a critical eye prior to changing clinical practice. We have a moral obligation to first do no harm.”

Deferred Prosecution Agreement for Exactech

Exactech, Inc. has agreed to enter into an amendment to its Deferred Prosecution Agreement (DPA) with the United States Attorney’s Office (USAO) for the District of New Jersey that extends the term of the Deferred Prosecution Agreement for three months, ending on March 8, 2012. In accordance with the DPA, an independent monitor was appointed to review and evaluate Exactech’s compliance and the company agreed to extend the term, at the request of the USAO, in order to allow the monitor additional time to further test the implementation of compliance systems. The USAO has not alleged any breach by Exactech of any of the terms of the Deferred Prosecution Agreement, and, other than extending its term, the amendment makes no other changes to the DPA.

Adrian Adams New CEO, President at Auxilium

Auxilium Pharmaceuticals, Inc. has announced that Adrian Adams has been appointed chief executive officer and president of the company. Adams, who has also been appointed to the company’s Board of Directors, has more than 30 years of experience in the pharmaceutical industry, most recently serving as chairman and CEO of Neurologix, Inc., a biotechnology company engaged in the development of innovative gene therapies for disorders of the brain and central nervous system. Prior to that, he served as president and CEO of Inspire Pharmaceuticals, Inc., where he oversaw the commercialization and development of prescription pharmaceutical products and led the company through a strategic acquisition by Merck & Co. Prior to Inspire, Mr. Adams served as president and chief executive officer of Sepracor Inc. beginning in 2007 until its acquisition by Dainippon Sumitomo Pharma Co., Ltd in 2010. Prior to joining Sepracor, Mr. Adams was president and chief executive officer of Kos Pharmaceuticals, Inc. from 2002 until the acquisition of the company by Abbott Laboratories in 2006.

Adult Deformity Getting Attention it Deserves

Isador “Izzy” Lieberman, M.D., M.B.A., an orthopedic surgeon with the Texas Back Institute, tells OTW, “I am particularly gratified to see the increased recognition of adult spinal deformity as a substantial problem. To see so much brain power trying to figure out the right thing to do, keeping in mind economic, physiologic and psychological issues. More papers are being presented, there are new algorithms for treatment, etc. If you peruse the abstracts of the Scoliosis Research Society (SRS), AAOS [American Academy of Orthopaedic Surgeson], etc., from about 15 years ago there are hardly any looking at adult deformity issues. In fact, we still quote those papers as the standard. SRS is leading the charge to change things, and has established a morbidity and mortality database. We are seeing a lot more people showing up in our offices with adult scoliosis or adult De Novo scoliosis. Up until now doctors have for the most part told patients, ‘You’re old…what do you expect?’ But at age 65 these patients are just retiring and want to enjoy this time. Fortunately, regulators, payers, scientists, and implant developers are all looking at this as a serious problem that merits attention.”

Don O’Hearn Now Senior VP of Sales in the Americas

K2M, Inc. has announced that Don O’Hearn is the new senior vice president of sales in the Americas. O’Hearn has more than 20 years of medical industry expertise with 17 of those in the medical device field across the U.S., Canada and Latin America. His medical device expertise includes sales and operational leadership positions at AGA Medical and Medtronic. O’Hearn holds an MBA from the University of Chicago Graduate School of Business with a concentration in Finance and Marketing, a Master of Science in Biochemistry and Biophysics from Yale University, and a Bachelor of Science in Molecular Biology from the University of Wisconsin.

Fewer Orthopedists Participating in Sports Teams?

Dr. Mark Drakos, an orthopedic surgeon with Hospital for Special Surgery in New York, is concerned that the economic pressures in the field are leading to orthopedists renouncing their positions with athletic teams. He tells OTW, “It’s really a domino effect…people are concerned about the proposed cuts in reimbursements and how the new health care policy will affect physicians. This means that physicians have to re-examine the things in one’s practice that don’t generate revenue. There is a fine tradition in sports medicine of doctors taking care of high school and community teams out of their love of sports and sports medicine. Unfortunately, there is a lot of pressure these days on sports medicine doctors to reevaluate some of those relationships. Many schools do not have adequate coverage from sports medicine trained physicians.”