Digestive Disease Week

Summary: Digestive Disease Week focused on the latest scientific developments in gastroenterology, endoscopy, and GI surgery. Highlights included the newest endoscopic techniques and devices, including capsule endoscopy, clips, disposable endoscopes, minimally invasive treatments for gastroesophageal reflux disease, new tests for gastrointestinal cancer detection and trial results for new drugs for Crohn’s disease, ulcerative colitis, and hepatitis C.

  FDA's CardioRenal Advisory Committee Recommends Approval of NitroMed's BiDil - Quick Pulse

Summary: The first race-based medication was FDA approved in June 2005. The FDA's CardioRenal Advisory committee voted unanimously on June 16, 2005, to recommend approval, and the FDA action (PDUFA) date was June 23, 2005. This report reviews that panel meeting.

  22^nd International Papillomavirus Conference

Summary: Prophylactic HPV vaccines are far ahead of therapeutic vaccines, with Merck’s Gardasil likely to be approved in 2006 and Glaxo-SmithKline’s Cervivax in 2007. ♦ Gardasil covers more strains of HPV and prevents genital warts, which could make it useful in boys as well as girls; but Cervivax has crossprotection for other HPV strains and is likely to be less expensive. The time between booster shots also could differentiate these vaccines. ♦ Uptake of any HPV vaccine will be highly dependent on a recommendation for use by the American College of Immunization Practices (ACIP), but it is expected to act quickly following FDA approval. ♦ The initial target will be adolescent girls (age 10-15), but adult women are likely to demand vaccination as well. ♦ No physician specialty has taken the lead in HPV vaccination, and a significant effort will be needed to educate doctors and parents. ♦ The link between HPV and sexuality/sexually transmitted disease is likely to be politically and socially problematic.

  Medicare Coverage Advisory Committee Wants More Studies on Vertebroplasty and Kyphoplasty - Quick Pulse

Summary: The Medicare Coverage Advisory Committee (MCAC) called for long-term clinical studies on both vertebroplasty and kyphoplasty, two procedures used to treat spinal fractures and deformities, particularly in osteoporosis patients. The panel concluded that both procedures are effective -- at least in the short term. Although the panel said it does not have any say in national Medicare coverage for the procedures, it is influential in reimbursement decisions made by the Centers for Medicare and Medicaid Services (CMS).

  European Stroke Conference (ESC)

Summary: AstraZeneca/Renovis’s Cerovive is the first neuroprotective to show a positive benefit in a Phase III trial, but the effect is modest, and price may limit usage. However, it does appear to make t-PA safer to administer. The results need to be replicated in the ongoing SAINT-2 trial. ♦ The Phase II data look promising for Paion/Forest’s desmoteplase in ischemic stroke, and it is now moving into Phase III. ♦ Novo Nordisk’s NovoSeven (rFactor VIIa) looks promising for intracerebral hemorrhage. ♦ Bayer’s repinotan failed to show clinical benefit, and development has been discontinued. ♦ Development in acute ischemic stroke is continuing for two generic agents: diazepam and magnesium. & Ferrer still has confidence that citicoline will prove beneficial and is beginning a large trial, ICTUS, with results expected in 2008.