NOV-DEC 2013

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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NEWS & EVENTS ISOTRETINOIN-ASSOCIATED IBD DISPROPORTIONATELY REPORTED BY ATTORNEYS Attorneys were responsible for reporting almost 90% of the isotretinoin-associated cases of IBD that were submitted to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) between 2003-2011. In comparison, attorneys were responsible for just 3.6% of the total drug interaction reports filed during that timeframe. In an oral presentation at the Annual Scientific Meeting of the American College of Gastroenterology (later published in the Journal of the American Academy of Dermatology, September 2013), researchers Derrick J. Stobaugh, BS, BA, et al, from the Center for the Study of Complex Diseases in Evanston, Illinois, shared the results of their study, for which they downloaded a total of 3,338,835 cases—2003-2011—from the FAERS database. These results were queried for IBD cases reported with acne-related isotretinoin usage. They found, "There were 2,214 cases of IBD resulting from isotretinoin. Attorneys reported 1944 (87.8%) cases whereas physicians reported 132 (6.0%) and consumers reported 112 (5.1%) cases (P value < .01). For the entire FAERS, only 87,905 of the total 2,451,314 (3.6%) reports for all drug reactions during the same time period were reported by attorneys (P value < .01). The signal inflation factor for IBD with isotretinoin for attorney-initiated reports was 5.82, signifying a clear distortion." KENKEL NAMED PROGRAM DIRECTOR OF UT SOUTHWESTERN Dallas plastic surgeon Jeffrey M. Kenkel, MD, professor and vice-chairman of the Department of Plastic Surgery at UT Southwestern Medical Center, has been appointed Program Director for the Plastic Surgery Residency Program at the University of Texas Southwestern Medical Center. As program director, he will oversee the training of plastic surgery residents in one of the largest programs in the country. The UT Southwestern plastic surgery residency program offers two pathways. The Independent program is designed for more traditional residents who are board-eligible in general surgery or one of the surgical subspecialties. The Integrated program accepts outstanding medical students directly from medical school and tailors their surgical training toward plastic surgery from the start of their residency. "The whole field of medicine continues to grow at a very rapid pace. We need to ensure that our residents and graduates learn the best possible surgical and non-surgical options in plastic surgery," says Dr Kenkel. "Critical to the educational process is the ability to interpret and discriminate new data and technology. Over 80% of what our residents learn may be obsolete in five years, so learning remains an ongoing process." Dr. Kenkel has served as president of The American Society for Aesthetic Plastic Surgery and is certified by the American 66 NOVEMBER/DECEMBER 2013 | MedEsthetics Board of Plastic Surgery. He specializes in cosmetic surgery of the face, breast and body. JAKUS AWARDED AAD TRANSLATIONAL BIOTECHNOLOGY FELLOWSHIP Jeannette R. Jakus, MD, MBA, has been selected as the 2013 recipient of the American Academy of Dermatology Translational Biotechnology Fellowship, a partnership of the American Academy of Dermatology and Galderma Research & Development, SNC. As part of the fellowship, Dr. Jakus JEANNETTE R. JAKUS, MD, MBA will work in drug development and translational medical research at Galderma's R&D facility located in Sophia Antipolis, France, beginning in Fall 2013. A graduate of Jefferson Medical College, Philadelphia, Dr. Jakus completed a residency in dermatology and a fellowship in pediatric dermatology at SUNY Downstate Medical Center, Brooklyn, New York, and a residency in pediatrics at Mount Sinai Medical Center, New York. She also has a master's of business administration from Columbia Business School. VALEANT PHARMACEUTICALS ANNOUNCES CANADIAN APPROVAL OF JUBLIA Valeant Pharmaceuticals International has received Health Canada regulatory approval for Jublia (efinaconazole 10% solution), a topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO). This is the first regulatory approval worldwide for Jublia. "Jublia represents the first new topical onychomycosis treatment approved in more than a decade, and we are very excited to bring this new treatment option to patients in Canada," said J. Michael Pearson, chairman and CEO of Valeant. "An effective topical therapy like Jublia is a logical treatment option to avoid drug interactions and systemic side effects, and we believe it will position us well to address a growing unmet need." "There is a pressing need for an effective topical therapy for mild to moderate onychomycosis, especially in individuals who cannot tolerate or are not candidates for an oral antifungal," said Aditya K. Gupta, MD, PhD, FAAD, FRCP professor, , department of medicine, University of Toronto, Canada. "The Phase III clinical trial data for Jublia show that it is an effective and safe topical antifungal therapy for mild to moderate onychomycosis." The solution is applied daily to the nail and does not present concerns for systemic side effects such as drug-drug interactions or acute liver injury. The two positive pivotal studies that were the basis for approval were published last year in the Journal of the American Academy of Dermatology and included 1,655 subjects with onychomycosis.

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