NCPA - National Center for Policy Analysis


May 10, 2005

If medical research mirrored reality, promising drugs would be tested extensively in patients who need them most: frail, elderly people who also take other drugs. But that's not the way the research world works, says USA Today.

A shortage of elderly patients in clinical studies equals a shortage of evidence, and doctors say the elderly data gap is one of the more challenging medical problems an aging America must confront.

The lack of data means:

  • Doctors, drugmakers and federal regulators cannot always predict how a drug or procedure will affect older patients.
  • Doctors prescribing certain drugs for people 75 and older must base their decisions partly on results from studies in younger patients, partly on their clinical experience and partly on guesswork.
  • Problems may emerge, as with non-steroidal painkillers and Baycol, only after the drugs reach the market.

USA Today says drug companies do not exclude patients from drug trials because they are too old but because they may be more likely to suffer potentially dangerous side effects or because their presence would make it harder for researchers to interpret the study?s results.

The Food and Drug Administration never has formally examined the representation of the elderly in clinical trials, but officials say heart studies include many patients in their 60s and 70s.

The lack of evidence from patients 75 and older has tied the hands of the doctors who write the guidelines other doctors use to guide their decisions. USA Today says doctors must use their best judgment because the guidelines are silent.

Source: Steve Sternberg, "A Bitter Pill for Older Patients," USA Today, May 5, 2005.

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