Nav: Home

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

September 28, 2015

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."

Participants in the online study were randomly given 1 of 5 short descriptions of a recently approved drug. The descriptions were based on an FDA press release for a metastatic lung cancer breakthrough-designated drug conditionally approved based on the surrogate outcome tumor shrinkage. The facts-only description described the drug as meeting the breakthrough-criteria, but did not actually use the term "breakthrough." A second and a third description added the terms "breakthrough" and "promising" respectively, while a tentative explanation used FDA-required language for professional labeling. A final description, classified as 'definitive,' changed "maybe be contingent" to "is contingent." Study participants were then asked to judge the drug's benefit, harm and strength of evidence.

The researchers found that adding either "breakthrough" or "promising" in the description significantly increased the percentage of participants who rated the drug as "very" or "completely" effective compared with the facts-only description (23% and 25% vs 11 %). Adding those terms to the description also significantly increased the number of people who reported believing that evidence supporting the drug is "strong" or "extremely" strong (59% and 63% vs 43%). At the same time, adding either the tentative or definitive explanations significantly reduced the percentage of study participants who believed (incorrectly) that the drug been "proven to save lives" (16% -tentative and 10%-definitive vs 31% - breakthrough).

Finally, when participants were asked which of two drugs -- one described as "breakthrough," the other as meeting the breakthrough criteria--they would take for a potentially deadly condition, 92% chose the "breakthrough" drug.

"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."

The Dartmouth Institute for Health Policy & Clinical Practice

Related Perception Articles:

Algorithms can exploit human perception in graph design
Researchers have recently found an algorithmic approach to automatically improve the design of scatterplots by exploiting models and measures of human perception.
College students' perception of dietary terms could help nutrition education
Researchers from the University of Hawaii and Brigham Young University set out to determine college students' perception of the terms real meal, meal, and snack and how those perceptions might enable more effective nutrition education.
LSD alters perception via serotonin receptors
Researchers from UZH have discovered how the perception of meaning changes in the brain under the influence of LSD.
Did teen perception, use of marijuana change after recreational use legalized?
Marijuana use increased and the drug's perceived harmfulness decreased among eighth- and 10th-graders in Washington after marijuana was legalized for recreational use by adults but there was no change among 12th-graders or among students in the three grades in Colorado after legalization for adults there, according to a new study published online by JAMA Pediatrics.
Hearing with your eyes -- a Western style of speech perception
Which parts of a person's face do you look at when you listen them speak?
Linking perception to action
A neuroscientist maps brain cell activity that occurs during the delay between sensation and action.
Research shows how visual perception slows with age
When older adults tell stories, they often go off on tangents because they have trouble inhibiting other thoughts.
Can we extend healthspan by altering the perception of food?
Researchers have shown a new effect on aging via a small drug-like molecule that alters the perception of food in C. elegans.
Exploring gender perception via speech
Snap judgments of speakers' femininity or masculinity are based on acoustic information from the speakers' voices, but some vocal qualities deemed 'feminine' can overlap with acoustic cues for 'clear speech,' which is a set of changes speakers make when they suspect their listener is having difficulty hearing.
The invisible world of human perception
Perception experts have long known that we see less of the world than we think we do.

Related Perception Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Jumpstarting Creativity
Our greatest breakthroughs and triumphs have one thing in common: creativity. But how do you ignite it? And how do you rekindle it? This hour, TED speakers explore ideas on jumpstarting creativity. Guests include economist Tim Harford, producer Helen Marriage, artificial intelligence researcher Steve Engels, and behavioral scientist Marily Oppezzo.
Now Playing: Science for the People

#524 The Human Network
What does a network of humans look like and how does it work? How does information spread? How do decisions and opinions spread? What gets distorted as it moves through the network and why? This week we dig into the ins and outs of human networks with Matthew Jackson, Professor of Economics at Stanford University and author of the book "The Human Network: How Your Social Position Determines Your Power, Beliefs, and Behaviours".