Alzheimer’s disease (AD) represents a large and growing public health crisis that demands a fast-tracked response to developing new drugs. Two doctors from the Food and Drug Administration (FDA) published a statement this week in The New England Journal of Medicine (NEJM) that made the federal agency’s case for relaxing some of the requirements needed to test and approve new drugs for the condition.
Nicholas Kozauer and Russell Katz, both medical doctors, said that the FDA has focused increasingly on patients who don’t yet show symptoms of the disease in an effort to stop AD’s development in its tracks. The attempt to develop drugs that treat advanced cases has been, in a word, “disappointing.”
According to their proposal, in the past the FDA has required researchers to prove that any new Alzheimer’s drugs improve daily function as well as preserve or recover memory and cognition. When doing studies on patients who haven’t yet lost any ability to function on a day-to-day level, this criterion would be impossible to meet. Hence, this rule can and should be relaxed without any harm to drug testing studies or to patients participating in the clinical trials.
New York Times science Gina Kolata said that other researchers have agreed. The older regulations crippled innovation, according to Dr. Eric Siemers, a researcher on Alzheimer’s disease for drug giant Eli Lilly & Company. “This is really a huge advance. Kudos to the FDA,” he said to Kolata.
It might seem like regulatory nitpicking, but anything that slows down the research can be a huge problem. As The Inquistr has previously reported, the aging worldwide population means that the rates of AD could triple by 2050.
At the moment, desperate seniors and their families are often grasping at straws, trying anything from drinking green tea to getting more sleep in an effort to ward off the symptoms of Alzheimer’s disease.
[PET scans courtesy Klunkwe and the University of Pittsburgh]