Imagine if studies on the effects of eating dog food looked only at its effects on cats. While it sounds outrageous, that is the logic currently employed by many medical researchers studying treatments for a vast array of chronic illnesses. Chronic illnesses affect older people at a higher rate than younger people. At the same time, seniors make up a growing portion of the population which is most in need of the treatment of chronic disease. Moreover, by continuing to conduct studies that rarely include older patients, researchers become part of the picture of a concerning trend in America of excluding seniors: ageism in elderly clinical trials.
For many years, when it has come to participating in medical trials, the elderly have experienced ageism and discrimination. As a result, these studies may fail to reach conclusions that are truly applicable to the elderly population. A strong case exists for ageism in elderly clinical trials.
1. 39% of medical trials from 1994 to 2006 excluded people over age 65 (*1)
Dr. Ken Covinsky, a researcher at the University of California in San Francisco, told the New York Times in 2011, “In taking care of older patients, we’re often guessing the best therapy on insufficient data.” Consequently, this is a major problem for older patients, their families, and their doctors.
(*1 source: “Clinical Trials Neglect the Elderly” Paula Span, New York Times, August 2011)
2. Of the trials that don’t have age limits, almost 50% use other criteria that limit senior patient participation (*2)
Age restrictions notwithstanding, there are plenty of other factors that keep our elderly out of medical trials. On a disproportionate basis, patients over 65 are routinely excluded from participation based on other factors common to the elderly. These include varied factors from suffering from illnesses and to non-inclusion of patients living in nursing homes. Thus, it would seem that removing age limits in medical trials is not the only impediment to inclusion.
(*2 source: *“Examining the Evidence: A Systematic Review of the Inclusion and Analysis of Older Adults in Randomized Controlled Trials” Journal of General Internal Medicine, July 2011)
3. One in four people prescribed medication are 65 or older, but less than 10% of medical research findings are specific to older patients (*3)
Unfortunately,the likelihood we will need prescription medication increases as we age. Interestingly, while seniors use more prescribed medicine, the vast majority are also more likely to ask for and study information from their doctors about the effectiveness of OTC drugs.
(*3 sources: “Prescription Drug Use Among Midlife and Older Americans” Linda L. Barrett 2005; “Ageism: How Healthcare Fails the Elderly” Alliance for Aging Research;“Disparate Inclusion of Older Adults in Clinical Trials: Priorities and Opportunities for Policy and Practice Change”Am J Public Health. 2010 April)
4. 2/3 of cancer patients are over 65, but only 25% of cancer trial participants are over that age (*4)
While the elderly account for 60% of new cancer patients, study after study shows that they account for a disproportionately small segment of research trials. Obviously, this restricts our ability to determine if newly discovered treatments are effective for the group suffering from cancer the most—the elderly.
(*4 source: Simonetta Alvino, Senior Medical Director at inVentiv Health Clinical)
5. Between 1985 and 1999, only 2 OUT OF 60 heart disease treatment trials included enough older patients to make valid conclusions (*5)
As indicated by this shocking statistic, the group most likely to suffer from heart failure —people over 65—is the LEAST studied in treatment trials. Accordingly, this means that the results may not be easily applied to people over 65.
(*5 source: Simonetta Alvino, Senior Medical Director at inVentiv Health Clinical)
Since the elderly are often frail, it is understandable that researchers are reluctant to include them. By including this high-risk population in trials, researchers will obtain more reliable results for all sufferers. Fortunately, as noted above, there are more and more of studies that are relaxing their criteria to include older participants.
Even with medical trials becoming more inclusive, newer research suggests that a very large percentage still have rigid age limits. There is real ageism in elderly clinical trials. With our the aging of baby boomers, elderly underrepresentation in clinical trials demands attention.
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