By: Bob Temple, M.D.
Alzheimer’s disease is one of America’s most pressing and rapidly growing public health problems.
Therefore I announce with great pride and respect that one of FDA’s leaders in the field of Alzheimer’s disease research and drug development has been nationally recognized for his contributions to combating this progressive and debilitating disease. I cannot think of a more deserving individual than Dr. Russell Katz, “Rusty” to us, to be so honored.
At its recent National Alzheimer’s Dinner, the Alzheimer’s Association awarded Rusty the Ronald and Nancy Reagan Research Award, which honors researchers who are leading the way in promising and innovative approaches to Alzheimer’s treatment, prevention and care. He joins a distinguished list of past honorees from the Mayo Clinic, University of Virginia, Johns Hopkins University School of Medicine, Harvard Medical School, and many other outstanding organizations.
Dr. Katz first joined FDA in 1983. Today, he is director of FDA’s Division of Neurology Products, the division that reviews and approves drugs for neurological conditions, including those for patients with Alzheimer’s disease.
One in eight older Americans suffers from Alzheimer’s disease (AD), the sixth-leading cause of death in the United States. As Rusty has noted, “The aging of the baby boomers is fueling what could turn a public health problem into a public health crisis.” If no treatments are developed to prevent, cure or slow the progression of AD, the number of Americans suffering from this pernicious disease will grow from 5.4 million to as many as 16 million by 2050, according to estimates by the Alzheimer’s Association.
Dr. Katz has been a critical figure in the advancement of research and drug development for Alzheimer’s disease, building strong partnerships in the Alzheimer’s community and strengthening the science needed to evaluate the safety and effectiveness of potential new drugs.
He has been particularly instrumental in helping drug developers focus on ways to study drugs in the early stages of AD, and when there is hope that disease progression can be stopped or delayed before too much damage is done. With his colleagues he drafted an FDA “guidance” on conducting studies in early stages of AD. It addresses difficult questions, such as these: how do we select patients for clinical trials for early-stage AD drugs despite the fact that early stages of the disease are hard to diagnose? And how can we determine the effectiveness of a drug for early-onset AD when symptoms are difficult to define?
FDA is devoted to seeing new treatments for AD enter the development pipeline. No one has been more instrumental in helping to implement that vision than Dr. Katz. We thank him for his dedication and hard work, and along with the Alzheimer’s Association, applaud him for all that he does to advance public health.
Bob Temple, M.D., is Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research.