December 2009 Issues

FDA Public Meeting on Opioid Risk Management

Summary: The FDA is not impressed with industry’s proposals for opioid risk management. ♦ The FDA will hold an advisory meeting sometime in spring 2010. ♦ The industry proposal is for a phased-in risk management program over several years, but the proposals appeared to be weaker – focusing on patient medication guides, letters to healthcare practitioners, and voluntary training – than the FDA would like. ♦ Industry also wants to link physician training to physician Drug Enforcement Agency (DEA) certification, which would be a daunting task because Congress would have to pass a law requiring it and because strong opposition is expected, even from the DEA itself.

 38th Global Congress of Minimally Invasive Gynecology hosted by the American Association of Gynecologic Laparoscopists (AAGL)

Summary: Use of robots like Intuitive Surgical’s da Vinci is increasing, not only in urology but also in gynecology; 85% of hospitals checked already have at least one da Vinci, and 21% plan to get another in the next 1-2 years. ♦ Single incision surgery doesn’t have tremendous appeal in gynecology because many procedures already are done laparoscopically with small incisions, but patient demand could drive a change. ♦ Better contraceptive devices, particularly Bayer’s Mirena IUD, are so good and so popular that growth is projected to be relatively flat over the next year for permanent contraceptive devices – such as Hologic’s Adiana or Conceptus’ Essure. Mirena is even affecting endometrial ablation procedures, so no growth is expected for Hologic’s NovaSure. ♦ Bayer’s Yaz birth control pill remains popular despite lawyers trolling for clients who have had an adverse event. ♦ Mesh remains a useful tool in female surgery, but use of vaginal mesh is down slightly due to safety concerns. However, use of minimally invasive slings with mesh is increasing.

American Heart Association (AHA) Scientific Sessions

Summary: More bad news for Merck’s ezetimibe – lack of efficacy and a safety signal in the ARBITER- 6-HALTS trial. ♦ Niacin and HDL-raising drugs are getting new attention, though cardiologists are waiting for the AIM-HIGH trial to prove that raising HDL is beneficial. ♦ More data were presented confirming the efficacy and safety of AstraZeneca’s antiplatelet agent Brilinta (ticagrelor) and Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran). But the CHAMPION trials of The Medicines Company’s cangrelor didn’t hold out much hope for that IV platelet inhibitor, and platelet resistance testing is unlikely to take off without data from a large outcomes trial, if ever. ♦ In anemia, more bad news for Amgen’s Aranesp, with new data that mortality was higher in stroke survivors who took Aranesp vs. placebo. But IV iron may be more helpful than previously thought, especially in non-anemic heart failure patients. ♦ CardioDx has an interesting gene test for obstructive coronary artery disease, Corus CAD, but so far cardiologists are skeptical. ♦ Continuous flow LVADs – and destination therapy – got a big boost with new data on Thoratec’s HeartMate-II showing 58% two-year survival.