The medical establishment considers multiple sclerosis a young person’s disease. It generally becomes active between age 20 and 50, with more and more MS diagnoses conferred on children, adolescents, and adults over 50. As is the case with many other aspects of our culture, MS drug marketing and patient support programs mainly target twenty- and thirty-somethings.
In medical research, clinical trial subjects generally tend to skew younger than the age of 60. As they are in drug marketing and support apps, these tendencies are deliberate. There are several explanations for this that will be discussed below. But our focus on youth ignores one important fact. According to the World Health Organization (WHO), the fastest growing age group in societies the world over comprises people over the age of 60. What’s more, a far higher number of older people take prescription drugs than younger patients. A 2010 study published in the Am J Pub Health suggests that underrepresentation of the aging population in clinical research happens across disciplines. For example: “…Although two thirds of cancer patients are older than 65 years, only about 25% of cancer trial enrollees have attained this age.” According to the Alzheimer’s Association website, clinical trial participation of older adults is also low in research on Alzheimer’s disease despite the fact that out of the 5.4 million Americans with Alzheimer’s, an estimated 5.2 million people are age 65 and older.
Dr. Herrera’s 2010 study enumerates the reasons for this lack. “Typically,” Herrera writes, “older adults face a combination of obstacles, including comorbidities, economic constraints, underinsurance, lack of insurance, communication issues (e.g., hearing difficulties that interfere with telephone interviews and impaired vision that affects written surveys), and physical immobility that constrains transportation options.” In the end, researchers worry that the trial would be ruined by poor compliance caused by inconsistent attendance and cognitive dysfunction, among other difficulties.
In Europe, geriatricians—those specialists who diagnose and treat diseases of older adults—have taken up this challenge. Manfred Gogol, a geriatrician and former president of the German Society of Gerontology and Geriatrics, remarked that confusing regulations governing elderly trial participants discourages researchers from including them. Last year, the European Medicine Agency (EMA) created an initiative called Geriatric Road Map 2015, which “aims to put greater emphasis on involving more elderly patients in clinical trials.” Here in the US, the American Geriatrics Society also embraces the importance of including older adults in drug trials to ensure safety and effectiveness. Older people are at a higher risk of drug reactions, Dr. Herrera points out, because of the changes connected with aging. Their needs must be accommodated during a trial and that will take some thought and open-mindedness.
Trials for drugs that will be consumed mostly by older people must allow the elderly to safely and effectively participate. Since our bodies handle drugs differently at 65 than they do at 25, it makes little sense to test 25-year-olds to determine the safety and efficacy of a drug only their grandparents will take.
Though the majority of people with multiple sclerosis are under 40, they will age and live a normal or near normal life span. The research community would do well to make the adjustments necessary to integrate elderly people into clinical drug studies. Doing so will better inform a well-monitored integrated health care team and improve the odds that the patient will enjoy optimal benefits of her therapy.1-4