"Penn physician argues for 'meaningful' update to national Alzheimer's act" - Medical Xpress. 10/17/2016
Jason Karlawish and Ken Langa say the 6-year-old National Alzheimer Project Act (NAPA) needs to be improved. First, clinical trial research must provide evidence that a drug slows or prevents the disease before being FDA approved. As it is now, drug companies are charged with showing clinical benefit after they gain FDA approval. The researchers say this approach creates divergence of private and public interests and resources around Alzheimer’s treatment. Karlawish and Langa also propose that participants in Alzheimer’s prevention studies should also be enrolled in long-term observational cohort studies that examine functional as well as cognitive outcomes. Karlawish says: “We think the U.S. Advisory Council on Alzheimer’s Research, Care, and Services is the right place for establishing a common set of publicly recognized guidelines for the design and interpretation of studies to establish the benefit of an Alzheimer’s prevention therapy.”