Elderly excluded from many drug trials for treatments aimed at them

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A new study in the Archives of Internal Medicine shows that 43 percent of 251 clinical trials investigating heart failure show evidence of ageism. According to lead author Dr. Antonio Cherubini, a geriatrician at the University of Perugia Medical School in Italy, a large number of heart failure trials exclude older patients even though the disease targets mostly people over the age of 65. These trials use different reasons to justify their omission of the elderly, with 25 percent excluding this cohort based solely on age, while other studies simply rejected patients who take one or more drugs. In so doing, they effectively ruled out over three-quarters of Americans over 60 from participating in the study.

This is a very serious problem, says ACSH's Dr. Gilbert Ross, as he reminds us that the incidence of heart disease is directly correlated with age. “If you’re going to conduct studies on therapies and devices used to treat heart disease but exclude much of the targeted population — those over the age of 65 — then your results may be to a large degree irrelevant. That means that once the therapy is approved, the older patients for whom the treatments are intended will become guinea pigs since they were never sufficiently studied.”

As life expectancy increases, the need for more clinical trials in older populations will become even more pressing. “It’s time for the FDA to step up to the plate,” says Dr. Ross, “and insist that studies focusing on diseases prevalent in older populations, like heart disease or Alzheimer’s, be required to include a representative sampling of the population subjected to these treatments.”