From the day experts first recognized the threat of coronavirus, they’ve warned that people over 65 are more at risk the ravages of the disease. So it just makes sense that researchers would be studying older people carefully when doing COVID-19 research for developing vaccines and treatments, right? But infuriatingly, this isn’t the case, according to a new analysis in the Journal of the American Medical Association.
After examining age restrictions for 847 clinical trials currently being conducted, the authors found that older adults are likely to be excluded from more than 50 percent of COVID-19 clinical trials and 100 percent of vaccine trials.
Globally, those 65 years and older make up nine percent of the population, yet they account for 30 to 40 percent of cases and more than 80 percent of deaths. Does anyone take those statistics seriously?
The reasoning behind this inconsistency seems to be that some clinical trials could actually be harmful to older people, but could they be more harmful than a disease that has killed a million people worldwide already? Excluding older people from COVID-19 research means scientists can’t evaluate the efficacy, dosage, and adverse effects of the intended treatments, or able to determine the effectiveness of a vaccine.
COVID-19 Research: Not the Only Problem
“It is important we have a trial population that reflects the real-world population,” Ethan Ludmir, a clinician-researcher at the University of Texas MD Anderson Cancer Center, told the medical journal STAT. Ludmir has studied age disparities in clinical trials. “We don’t know if an 18-year-old and a 55-year-old will tolerate [a] treatment differently or respond to it differently.”
The glaring exclusion of older people in medical research has long been an issue. Even though the National Institutes of Health has been pushing an initiative to include people of all ages in clinical research since January 2019, another study, published recently in JAMA Internal Medicine, found that there’s been no change in the participation of older people in cardiovascular studies.
“Older adults bear a lot of the burden of cardiovascular disease in our country and yet are not always included in the study to see whether the drugs are safe for older adults or effective for older adults or have side effects,” said Colette DeJong, chief medical resident at University of California, San Francisco.
The researchers say older Americans must be included in trials because as people age over time, the way they metabolize drugs may change, or they may develop other health conditions that could alter the effectiveness of the treatment.
Older Women? Fuhgettaboutit
Another under-represented group in clinical trials is women, which means older women are doubly disadvantaged.
“Sex influences health and disease in multiple organ systems. It’s not just related to the reproductive tract,” said Nicole Woitowich, associate director of the Women’s Health Research Institute at Northwestern University Feinberg School of Medicine, who has studied the gender disparity.
Stressing the importance of looking at both genders, Woitowich noted that in a recent study of a type of brain tumor where researchers analyzed their data by sex, they found differences in the response to treatment by sex. Other areas where sex makes a difference include heart disease, cholesterol levels, sleep apnea, and Alzheimers.
Despite efforts to increase representation of women in research, there is much progress that still needs to be made. “By not considering by sex in research,” says Woitowich, “it’s a harm to women’s health.”