Regulatory Recognition Key to Moving Forward on Sarcopenia: Interview with Dr. Bill Evans, GSK

Dr. William J. Evans, AIM Scientific Advisory Board Member and Vice President and Head of the Muscle Metabolism Discovery Performance Unit at GlaxoSmithKline, recently shared his thoughts on the work of the Aging In Motion Coalition and on future directions for the assessment, treatment and prevention of sarcopenia and the related functional decline and frailty that can result from age-related muscle loss.

“We’ve known that muscle weakness is one of the primary functional deficits that older people experience,” says Dr. Evans. “While it is much more complicated than we ever would have imagined, it does appear that loss of muscle mass and function is the primary reason that we all lose independence as we grow older.”

Though researchers have made significant advances in understanding the process and underlying causes of muscle loss and functional decline in older patients, serious challenges lay ahead that impede the development of a safe and effective treatment. The lack of a standardized, objective metric to assess and measure an older patient’s functional decline, along with a lack of a mechanism to reimburse physicians for its use, prevents researchers from moving forward on areas of promise.

The AIM Coalition is working for regulatory acceptance by both the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) of a functional capacity measurement in older patients, including gait speed and the SPPB assessment. Securing approval of such a measure is crucial for numerous reasons.

Even a modest level of reimbursement through CMS heightens awareness of the assessment and its importance and will encourage the geriatricians who treat older patients to use the test, which ensures better care and leads to greater independence for aging Americans. An assessment of functional status can help a physician to determine if a patient’s functional decline is related to sarcopenia, or whether it may be caused by another condition, such as anemia, arthritis, heart failure, or balance problems. “This is important because geriatricians spend so much more time with older patients,” says Dr. Evans. “We will have a standard by which all doctors can evaluate their patients. Right now, there is no standard.”

Perhaps most relevant to the development of treatments, a standardized and reimbursable metric can help to identify those patient populations that researchers may be able to target in the development of treatments. As Dr. Evans explains:

The analogy that we often use for sarcopenia is osteopenia and osteoporosis. Doctors really had no way of prescribing an anti-osteoporosis treatment until they were able to measure bone density. [Before] they had a measurement of bone density and could place a risk of fracture based on what an individual’s bone density might be, there was no opportunity to prescribe a medicine. The two went together. In some ways I think this is very similar to that.

With nearly half of the elderly US population affected by age-related muscle loss and functional decline, moving towards a safe and effective therapy to treating diminished muscle function and preventing further losses is critical. “There are exciting new areas of promise around what appears to be a new generation of medicines that might improve muscle function effectively,” Dr. Evans says. “I think the challenge for us is going to be to identify the populations of geriatric patients that may be very responsive to treatment.

“That’s where I think AIM can really contribute,” Dr. Evans continues, “hopefully [to raise] public awareness of some of these issues, raising awareness on the part of the FDA and even with CMS about how important it is to really think about functional status of older people and identify those people who are most susceptible to losing their independence and becoming institutionalized, not because of any cognitive problem they may have, nor not even because of chronic disease, but because they are too weak to function in the community.”

William J. Evans, Ph.D. is Vice President and Head of the Muscle Metabolism Discovery Unit at GlaxoSmithKline. He leads a group of scientists developing new medicines to treat muscle wasting, frailty, and sarcopenia. He is also an Adjunct Professor of Medicine in the Geriatrics Program at Duke University in Durham, NC. He is a Fellow of the American College of Sports Medicine, The American College of Nutrition, and an honorary member of the American Dietetic Association. He is the author or co-author of more than 250 publications in scientific journals. Much of his research has examined the functional and metabolic consequences of physical activity in elderly people as well as dietary needs of older men and women. His studies have demonstrated the ability of older men and women to improve strength, fitness, and health through exercise, even into the 10th decade of life. He is a founding member of the Society on Sarcopenia, Cachexia, and Wasting Disorders and the associated Journal of Cachexia, Sarcopenia and Muscle.