Sarcopenia and the FDA: A Time for Change?
Rather than retrofit existing regulations, perhaps it’s time to start fresh, taking into account emerging science on muscle performance and it’s impact on healthy aging.There are many studies that show skeletal muscle strength is a good indication of overall health and well-being. Evidence of a product or activity that increases muscle strength is also pretty straightforward. However, there are not many measures showing that increasing muscle strength with a product can improve health, nor are there benchmarks that can be used to get the Food and Drug Administration (FDA) to state that something is not only safe but actually works as claimed.
The reason for the lack of measures has to do with the fact that, to date, the FDA has not reviewed or approved a product to treat sarcopenia or cachexia—the two conditions characterized by a loss of muscle mass and function—or to reduce or slow frailty associated with both illnesses.
Ironically, though, as we found out at the The Aging in Motion (AIM) Coalition meeting to discuss the development of FDA metrics linking muscle function to better health, there are plenty of measures; they just have not been given much consideration by the FDA or the industry as a whole. That’s all the more reason that Myos appreciates the AIM sponsorship of what is the first round of discussion and collaboration.
“At present, the FDA does not have an official policy on sarcopenia, nor has it approved any drugs for the treatment of this condition,” noted AIM Coalition Chair Dan Perry at the meeting. “The AIM Coalition has dedicated its efforts to changing this through collaboration, education and creating a common consensus on appropriate therapy development strategies. Our meeting with the FDA is a first important step in demonstrating that we are on the right path to accomplishing our goal.”
During discussion breaks at the event, it became clear that there is a fairly broad consensus on what tests can be used to measure changes in muscle strength and function, and that it’s relatively easy and inexpensive to administer said tests. Leaders from industry and academic backgrounds as well as the National Institutes of Health agreed that grip strength is a good indicator that can be made more precise with greater use. The question is whether the FDA will or could use grip strength to measure clinical benefit from improving muscle function or whether other outcomes will be required. Hence, part of the meeting focused on whether patient-reported outcomes could be developed to measure response.
It was clear from the discussion that researchers would need a standard measure for responses that can vary by individual and a complex range of other factors. One possible approach: a standard questionnaire called the SF-36, which asks patients before and after a treatment about their quality of life. The SF-36 has been used quite often in tracking people in the real world, but the FDA is often limited to measuring things in clinical trials. So it could be that the real challenge is not to find a new measure that fits existing regulations, but to imagine new regulations that take into account the emerging science of muscle performance and it’s impact on healthy aging and disease.