Login
Subscribe
There is unequivocal evidence that older adults use more prescription medications than younger people and are therefore much more likely to suffer serious adverse reactions, including death. Despite long-standing but unenforceable recommendations from the Food and Drug Administration that older adults be properly represented in the clinical studies preceding drug approval — so that the benefits and risks in this age group are known before launching these drugs — the lack of such inclusion...
There is unequivocal evidence that older adults use more prescription medications than younger people and are therefore much more likely to suffer serious adverse reactions, including death. Despite long-standing but unenforceable recommendations from the Food and Drug Administration that older adults be properly represented in the clinical studies preceding drug approval — so that the benefits and risks in this age group are known before launching these drugs — the lack of such inclusion continues to be a serious problem.
A recent analysis of clinical studies on, and the prescribing of, four widely prescribed drugs for older people has concluded that “[e]lderly patients are poorly represented in RCTs [randomized clinical trials] of drugs they are likely to receive.”
U.S. sales of the four drugs — cholesterol-lowering rosuvastatin (CRESTOR), blood-pressure-lowering valsartan (DIOVAN), osteoporosis-fighting risedronate (ACTONEL) and anti-diabetic pioglitazone (ACTOS) — in 2010 amounted to $7.2 billion, with 69 million prescriptions filled for patients of all ages.
The authors found that the proportion of patients 65 or older in the trial reports was lower than half the proportion in the treated population. The analysis included all of the appropriate published studies, and the prescribing data were from France. There is every reason to believe that a similar proportion of prescriptions for older people exists in the U.S. as well.
A previous study, examining why older people are underrepresented in such trials, found that “reports of randomized controlled trials published in major medical journals exhibited extensive unjustified exclusion criteria that may have affected the representation of elderly people.”
The authors of the recent study pointed out that “[u]nderenrollment of elderly subjects in trials can have significant safety implications when the results of a trial are applied to management for elderly subjects in routine clinical practice.” They included concerns about unexpected post-approval problems such as older adults with other diseases and those taking other concomitant medications beyond what was observed in the smaller number of older people examined in the clinical trials.
The researchers concluded that it will take a combination of laws and regulations to force, rather than merely recommend, drug companies to study an appropriate, larger proportion of older adults for drugs that will predictably be used by a large proportion of such people.
