September 2009 Issues

European Society of Cardiology (ESC)

Summary: The official theme of ESC this year was prevention, but the practice-changing findings of several important trials overshadowed that message. ESC President Prof. Roberto Ferrari of Italy said it isn't a revolution like angioplasty was, “People will go back (from ESC) and change their practice, not immediately, but they will have a new opportunity to treat patients.”

FDA Panel Recommends Another Hpv Vaccine for Females and One for Males -- Quick Pulse

Summary: The FDA's Vaccines and Related Biological Products Advisory Committee recommended approval of GlaxoSmithKline.s (GSK.s) Cervarix vaccine against human papilloma virus (HPV) in females aged 10-25, and it recommended approval for the use of Merck's Gardasil HPV vaccine to prevent genital warts (condyloma acuminate) in males aged 9-26.

European Congress on Treatment and Research in Multiple Sclerosis (ECTRIMS)

Summary: Patients are already demanding to know when oral MS therapies will be available. But the side effects of most are not insignificant, so neurologists do not yet know how they will use them. ♦ Merck Serono's cladribine could be the first oral agent, and efficacy seems durable, but toxicity means it will need careful risk minimization. The low dose appears to be equally as efficacious as the high dose. ♦ Novartis's fingolimod has very good efficacy, with the low dose both more effective and safer than the high dose. Neurologists are nervous about the side effects, particularly bradycardia, infections, and skin cancer. Novartis has moved a follow-on . BAF-312 . into Phase II testing. ♦ Biogen's BG-12 is a relatively safe oral agent, but it isn.t perceived as having particularly strong efficacy, and TID dosing is a drawback. ♦ Teva's oral laquinimod may be the dark horse. Efficacy is comparable to an interferon (IFN), it can be combined with IFN, and it is safe. ♦ Genzyme/ Bayer's alemtuzumab has remarkable efficacy, which holds out to 4 years. Toxicity is serious but may be manageable. ♦ There are now 13 PML cases with Biogen Idec/Elan's Tysabri, and neurologists are not happy the companies are no longer providing updates on new cases. However, not all the PML patients are dying, and both alemtuzumab and cladribine have seen PML in oncology patients. ♦ Symptomatic therapy is getting more attention, most neurologists expect to use Acorda Therapeutics' fampridine for ~25% of their progressive MS patients, perhaps for fatigue and/or cognition as well as walking.

Plavix Reistance Testing Slow to Catch On -- Quick Pulse

Summary: There is little enthusiasm among cardiologists - medical cardiologists or interventional cardiologists - about either aspirin resistance testing or Plavix (Sanofi- Aventis, clopidogrel) resistance testing. From interviews with a dozen cardiologists around the U.S. and with even more cardiologists at the recent European Society of Cardiology (ESC) meeting in Barcelona, it is clear that they do not see a need for the assays and/or are not convinced the test is sufficiently accurate. It is likely that changing practices to incorporate testing will be very slow and very difficult, if it happens at all.