January 2009 Issues

American Academy of Cosmetic Surgery (AACS)

Summary: Cosmetic procedures are down 28%, breast implants down 31%, and fillers and Allergan’s Botox each down 16%. Patients are opting for less expensive, less invasive procedures than big ticket items. Doctors are optimistic that their business will rebound in late spring or summer. ♦ Cosmetic surgeons are eager to try Medicis’s new toxin, Dysport/Reloxin, when it gets FDA approval. ♦ Silicone breast implants appear to have found their place, and market share is likely to remain flat over the next year. ♦ Fat transfer is a hot topic, but more for the face than the breast in the U.S. Stem cells for cosmetic purposes remain controversial but bear watching. ♦ Johnson & Johnson’s dermal filler, Evolence, is getting off to a good but not spectacular start. Fillers combined with lidocaine are gaining popularity. ♦ Sales of aesthetic lasers have dropped significantly if not disappeared altogether, and pricing has fallen substantially. Doctors are interested in CO2 fractional lasers when the economy stabilizes or improves. ♦ Liposuction is still popular, but many doctors are returning to traditional liposuction and using the laser lipo devices more for marketing.  

American Heart Association

Summary: Abbott’s fenofibrate, TriLipix, was shown to be safe when given with a statin. ♦ AstraZeneca’s Crestor (rosuvastatin) demonstrated a clear cardiac benefit in normal LDL patients. ♦ Bayer/Johnson & Johnson’s new Factor Xa inhibitor, Xarelto (rivaroxaban), missed its primary endpoint in a Phase II trial – and caused so much more bleeding than placebo that the Phase III trial is using only the lowest doses. ♦ Conflicting studies have created confusion about the safety of Sanofi- Aventis/Bristol-Myers Squibb’s Plavix (clopidogrel) in combination with a proton pump inhibitor (PPI). ♦ Though there were discussions about the safety of Merck/ Schering-Plough’s ezetimibe (Zetia and Vytorin) and doctors appeared slightly reassured about safety, there was nothing really new about this issue. ♦ The value of low-dose aspirin for primary prevention remains uncertain. ♦ Vitamins C and E do not reduce major cardiovascular events. ♦ Home INR testing did not improve mortality in warfarin users.

FDA Panel Recommends New Labels and More Studies on Dermal Fillers and Efficacy Endpoints for Expanded Indications for Energy Delivery Devices -- Quick Pulse

Summary: The FDA’s General and Plastic Surgery Devices Advisory Committee spent the first day discussing label revision for dermal fillers. The panel had significant concern about the safety of dermal fillers, especially the new, longer-lasting fillers, and agreed that labeling should be changed to reflect the types of adverse events found in postmarket studies, that longer studies are needed for longer-lasting fillers, and new indications will require clinical trials.

FDA Mulls Genomic Biomarkers -- Quick Pulse

Summary: The FDA’s Oncologic Drugs Advisory Committee (ODAC) met in December 2008 to discuss the use of genomic biomarkers in cancer trials. The panel was briefed specifically on the use of K-ras for Lilly/ImClone/Bristol-Myers Squibb’s Erbitux (cetuximab) and Amgen’s Vectibix (panitumumab) in colorectal cancer (CRC), but the purpose of the meeting was to look more broadly at the regulatory path for genomic markers in general, not just K-ras.