Trends-in-Medicine


 
Publisher:  Stephen Snyder
  
Writers:  Lynne Peterson
 Marta Weber
 Diana Woods
  
Editors:  Kathleen Snyder
 Betty Teel
 


Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.

Copyright©  2009
No articles may be reproduced without written permission of the publisher.


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March 2009 Issues

FDA Panel Recommends Approval of New Drug for Atrial Fibrillation -- Quick Pulse

Summary: The FDA’s Cardiovascular and Renal Products (Cardio-Renal) Advisory Committee voted 10 to 3 to recommend that the FDA approve Sanofi-Aventis’s Multaq (dronedarone) to treat atrial fibrillation or atrial flutter. The question never was efficacy, just safety, and the panel agreed that dronedarone should not be used in unstable heart failure patients or patients with liver disease. Several panel members also cautioned that dronedarone needs more study and should not totally replace amiodarone until there are more data.

FDA Advisory Committee Recommends Approval of First New Oral Anticoagulant in 55 Years -- Quick Pulse

Summary: The FDA’s Cardiovascular and Renal Products (Cardio-Renal) Advisory Committee recommended approval of Johnson & Johnson/Bayer’s Xarelto (rivaroxaban) for the prevention of blood clots in orthopedic surgery. However, the level of concern within the FDA over possible liver toxicity still may delay approval beyond the FDA action (PDUFA) date, which is May 28, 2009.

Pittsburgh Conference (PITTCON) 2009

Summary: 2009 is likely to be a challenging year for analytical tools companies. They are hopeful that the economic stimulus bill will translate to at least flat year-to-year sales, particularly to academic labs, but prices are under heavy pressure, and all customers are being very cautious about big ticket purchases. ♦ Most laboratories are stretching the life cycle of existing equipment by at least a year, only replacing things when they become unreliable or break. ♦ Pharmas are still buying capital equipment but carefully and cautiously, with heavy oversight on expensive items. Pharma mergers are not expected to affect equipment sales to other pharmas, but universities, contract research organizations, and non-pharma companies, particularly smaller ones, are likely to snap up any surplus pharma equipment. ♦ Food safety is one possible growth area for tools, with a mixed outlook for environmental testing and stem cell research. ♦ Academic labs will have stimulus and NIH money to spend, and one key thing they want is mass spectrometry devices, which may translate to sales by the end of this year. ♦ The new products generating the most interest were hand-held detection devices that can be used to identify contaminants.

American Academy of Orthopaedic Surgeons

Summary: Total joint implants have not yet been affected by the recession, but for 2009 the outlook is for volume to be down 5%. There continues to be hospital pressure on implant prices, but no increase in that. ♦ Industry was a bit circumspect in marketing at AAOS this year, but business was getting done, though no share shifts were apparent. Zimmer, in particular, seemed “back to normal.” ♦ Orthopedic surgeons are likely to be slow to abandon warfarin for newer anticoagulants, but Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) and Boehringer Ingelheim’s Pradaxa (dabigatran) may replace LMWH quickly. ♦ Robotic systems like Mako’s Rio are fascinating, but hospitals are not expected to spend nearly a million dollars for such technology in the current budget environment. ♦ Spine surgeon use of BMP is decreasing, but surgeons are hopeful about stem cell products for the future. Artificial discs are slowly gaining acceptance. ♦ Smith & Nephew is now competing with Kinetic Concepts in negative pressure wound therapy. ♦ CMS will continue to pursue value based purchasing, with an emphasis on patient outcomes. ♦ The FDA is concerned about several off-label orthopedic practices. 

MedCAC Meeting on Genetic Testing -- Quick Pulse

Summary: A Medicare advisory panel told Medicare that genetic tests are more complicated than other diagnostic tests and need tougher proof in order to qualify for coverage. The Medicare Evidence Development and Coverage Advisory Committee (MedCAC) told the Centers for Medicaid and Medicare Services (CMS) that the evidence needed for diagnostic genetic tests is different from that of diagnostic testing in general, and that genetic testing resulting in direct patient-centered healthcare outcomes such as mortality, functional status, and adverse events should be required for a CMS coverage decision.

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