July 31, 2014

Drug Studies MUST Include Seniors

I was pleased to see a recent op-ed piece in the New York Times -- "You’re Never Too Old to Be Studied" -- that made an important plea: Include seniors regularly in tests for drugs and medical devices.

How do we know that seniors are under-represented in clinical tests? In 2007, the Journal of the American Medical Association reviewed randomized controlled trials conducted between 1994 and 2006, and discovered that about 40 percent of those studies completely excluded people over 65 years of age.

The authors of the New York Times piece – Donna Zulman and Keith Humphreys – reminded readers that Americans 65 and up now represent about 13 percent of our population.  By 2030, that percentage will reach 20 – one in five Americans.

How can doctors confidently prescribe a course of action for such a big chunk of their patients when that group has essentially been excluded from the very tests designed to help healthcare professionals determine and recommend a medical plan?

Excluding seniors from these important tests has been a mistake… a misstep – thankfully – that can and should be corrected.

Women, Too
The same foolish under-representation has applied to women, too.  Only in 1993 – hard to believe, just 21 years ago --  did the National Institutes of Health (NIH) begin requiring studies to include women. Just two months ago, the NIH urged study leaders to include more female lab animals in their research… another step in the right direction.

As we’ve seen with women, seniors often need different treatments – and certainly reduced drug dosages – than the healthy younger patients who swell the study ranks. Like women, seniors usually weigh less than those younger study subjects. Seniors typically have reduced liver and kidney function, and therefore process medications differently. As a result, seniors are more likely to experience adverse reactions – dizziness, drowsiness, depression… or worse – than their younger cohorts.

In the past, study leaders have excluded seniors for some of those very reasons, citing the complex health issues they thought created ethical or practical problems for their studies.

But, as Zulman and Humphreys write, “Advanced age is not a reliable proxy for poor health.” Excluding any group of people from studies must not be based on age alone.

Continuing the present exclusionary practices based only on age can only make it harder for doctors to create useful, reliable treatment plans for American seniors.

The To-Do List 
The authors make three recommendations at the end of their article:
  1. NIH – and other agencies that fund medical studies – must no longer exclude study subjects based on age alone… in the same way those agencies now make it illegal to exclude women and minorities.
  2. The FDA must require testing on seniors before any new drug or treatment plan is approved.
  3. Tests that have excluded seniors must indicate that omission, and explain how it could affect results.
 Progress... if we make it happen.

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I've written about related topics before. Here are a few:

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