Trends-in-Medicine |
||||||||||||||||||||||||||
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. Return Home |
||||||||||||||||||||||||||
April 2009 Issues
Summary: The recession is hurting most practices, and many refractive doctors have already transitioned to other procedures, such as cataract and glaucoma surgery, cut spending for new equipment to little or nothing, and reduced salaries and staff hours. Reimbursement continues to be a problem. ♦ Refractive surgeons are making do with their current lasers and not buying new ones. Although doctors like the Alcon Wavefront technology, they said it is expensive. ♦ Premium IOLs were the hot topic at the meeting, but they are still being put in a small percentage of patients (<10%) because of their cost. Alcon’s ReStor +3.0 was getting the most attention, followed by AMO’s Tecnis. Both will likely cannibalize their own prior lenses, though ReStor may take some market share from Bausch & Lomb’s Crystalens. No doctors interviewed currently use AMO’s ReZoom. ♦ Doctors are delaying getting electronic medical record software for as long as they can, citing unreasonable expense, no advantage for their patients, and lack of standardization. ♦ A new ASCRS task force on LASIK safety, scheduled to publish its results later this month, reinforced the safety of LASIK.
Summary: The FDA’s Endocrinological and Metabolic Drugs Advisory Committee reviewed the safety of two diabetes drugs, Bristol-Myers Squibb’s Onglyza (saxagliptin) on April 1 and Novo Nordisk’s Victoza (liraglutide) the next day. The panel voted 10 to 2 that saxagliptin does not pose a cardiovascular (CV) safety risk, clearing the way for probable FDA approval, but the panel also unanimously agreed that the company must do long-term postmarketing studies in higher-risk patients, and Bristol-Myers Squibb (BMS) pledged to do those trials. The panel was less convinced of the CV safety of liraglutide, and the panel basically said the thyroid safety of liraglutide needs more study. The panel actions and comments by FDA officials during the two sessions suggested that the path has gotten tougher for some other diabetes drugs in development.
Summary: Under the cloud of a federal grand jury investigation of Stryker Biotech’s marketing of OP-1, a spinal putty with a human device exemption (HDE) for certain lumbar spine fusions, the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee rejected premarket approval (PMA) for OP-1 by a 7-1 vote. |
||||||||||||||||||||||||||
1879 Avenida Dracaena, Jensen Beach, FL, 34957, 772-334-7409, Fax 772-334-0856 Email webmaster about site: mike@bookcase.com |
||||||||||||||||||||||||||