title: Challenges and opportunities: what we are learning from the clinical natalizumab experience.
abstract: The approval of natalizumab for relapsing forms of multiple sclerosis, and the subsequent voluntary suspension of its use due to an unexpected viral infection, is a cautionary tale of how much we have to learn about how to prioritize and perform the necessary research and development of novel therapeutics for human diseases, the ethics of placebo-controlled trials and the relationships between researchers, regulatory authorities and the pharmaceutical industry.
authors.affiliation: USC Keck School of Medicine, 1520 San Pablo Street, 3000 Los Angeles CA 90033, USA. nkachuck@usc.edu
authors.forename: Norman J
authors.initials: NJ
authors.lastname: Kachuck
mesh_terms: D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D017326:Clinical Trials, Phase III as Topic / Q000941:ethics* / Q000379:methods*; D004335:Drug and Narcotic Control; D006801:Humans; D009103:Multiple Sclerosis / Q000188:drug therapy*; D000069442:Natalizumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab