We saw the sun this week in Washington for the first time in about a month. It was great fun. One hopes that the clearing of the gloom will have other effects.
Lots happened this week. Here are a few things that caught my eye:
- FDA Approves First Combo Therapy for Diabetes and Cholesterol – Today the agency announced approval of the first combination therapy intended to treat Type 2 diabetes as well as high cholesterol. Called Juvisync (sitagliptin and simvastatin), the pill is manufactured by MSD International GmbH Clonmel, Co. in Tipperary, Ireland. The agency release states that while “[t]he FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes. However, the prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.”
- FDA Issues Report on Medical Devices – In July of this year, the Institute of Medicine issued a consensus report that concluded that the system for FDA’s approval of medical devices was “flawed based on its legislative foundation” and recommended that rather than modify the existing system, the agency devise a new integrated system for device approval and monitoring. This week, the FDA however, issued a report of its own “highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products” which the agency said “offers a look at the work FDA engages in every day to help foster science that enables and supports innovation and sound medical product development.”
- FDA Approves Cialis for BPH - Yesterday the agency announced the approval of Lilly’s Cialis for the treatment of benign prostatic hyperplasia (BPH). That may be of interest to those suffering from the condition and for those treating the condition, but as the press release from the FDA notes, the FDA has approved eight other drugs to treat BPH. It is always difficult to predict when the agency is going to issue a press release around an approval but it seems rare when there are already so many treatments approved for the condition. Also in connection with the approval, the manufacturer Lilly issued a multimedia news release that has video, photos and links, though no Facebook share function. One can expect to see more such releases in the future.
- No More Prostate Screening for Healthy Men? – And in a related note, the United States Preventive Services Task Force has been reported to have formulated a draft recommendation against regular PSA screening for healthy men that will be issued next week. The feeling is that the test does not save lives, but it will likely face strong headwinds from those who feel the test did in fact do just that.
Enjoy the sunshine in your life wherever you are, even if the sun is not showing itself at the moment. Have a good weekend everyone.