Word 'breakthrough' dramatically affects perceptions of a new drug's effectiveness

http://www.eurekalert.org/pub_releases/2015-09/tdif-wd092815.php

Public Release: 28-Sep-2015
Word 'breakthrough' dramatically affects perceptions of a new drug's effectiveness
The Dartmouth Institute for Health Policy & Clinical Practice

When it comes to our perception of a new drug's benefits and effectiveness, "breakthrough" just may be the "magic" word. Dartmouth Institute researchers Lisa Schwartz and Steven Woloshin and Tamar Krishnamurtia and Baruch Fischhoff from Carnegie Mellon University, took a look at how catchphrases such as "breakthrough" and "promising" affect public perception of a new drug. And, the findings of their research study, published recently in JAMA Internal Medicine, show the answer is pretty significantly.

In everyday usage, the term "breakthrough" represents a highly significant or definitive advance. However, since the U.S. Food and Drug Administration (FDA) Safety and Innovation Act became law in 2012, the FDA can assign the breakthrough designation to a drug that "treats a serious or life-threatening condition" and "may demonstrate a substantial improvement...over available therapies" based only on preliminary evidence. Such drugs often receive what's known as accelerated approval.

And, in fact, since the creation of the Safety and Innovation Act, all FDA press releases announcing the approval of a breakthrough-designated drugs have used the term "breakthrough" while about half use the term "promising."

"Today, patients and their families can easily find FDA press releases on the Internet, or they often hear about them in the news," Woloshin said. "But the reality is that unless patients fully understand how the FDA is using the term 'breakthrough,' they may have unwarranted confidence in the evidence supporting drug claims. So, we thought it was important to test how these terms affect the judgement of people without medical training."

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"Our findings clearly indicate that words like 'breakthrough' and 'promising' increase people's beliefs in a drug's effectiveness (sometimes incorrectly)," Schwartz said. "In light of (the findings), press releases with neutral terms and that clearly explain the limited evidence supporting what breakthrough-designation and accelerated approval mean might help consumers make more accurate judgements about these drugs."

tags: influence