F.D.A. Panel Recommends M.S. Drug Despite Lethal Risk -READ MORE
New York Times: "The committee voted 7 to 5 that the drug could be used as an initial therapy, rather than only after one or more other drugs had been tried without success. All patients getting the drug will be entered in a registry. They and their doctors will have to sign forms acknowledging the risk. Biogen had proposed making the registry voluntary but the F.D.A. staff objected. Drugs will be distributed directly to authorized infusion centers. Before each monthly infusion a nurse will go through a checklist with patients to make sure they have no new symptoms that could indicate P.M.L. Some panel members said they thought patients might cover up symptoms to keep getting Tysabri."