Back in September, researchers cautioned against overhyped language in FDA press releases about new meds, saying that using the terms "breakthrough" and "promising" in statements could sway individuals' expectations about a drug. Now scientists are adding more words to the wise, showing that news stories often use rosy descriptors that aren't necessarily warranted.
Researchers at Case Western University School of Medicine and the National Institutes of Health's (NIH) National Cancer Institute (NCI) ran a Google news search between June 21, 2015, and June 25, 2015, scouring the Internet for 10 adjectives including "breakthrough," "miracle," "cure," and "home run" used along with the phrase "cancer drug." The FDA officially uses the term "breakthrough" for a program designed to speed development of drugs that treat serious illnesses and have no market precedent, so mentions of the word "breakthrough" in the Google search partly come from people referring to that designation.
Scientists also divided the meds into different classes and looked at whether they'd been approved by the FDA, whether data were from human trials or preclinical trials, and whether a doctor, journalist, industry expert or patient quoted the information about the product in the stories.
The researchers found 94 news articles from 66 different outlets that made 97 superlative mentions of a drug. Half of the treatments with hyped descriptors have not been approved by the FDA and only a handful had been through human testing. Three stories didn't even name the med they were describing, according to the JAMA Oncology study.
Out of the different drug classes, targeted cancer therapies such as Pfizer's ($PFE) Ibrance were linked to the most impressive descriptions, with 39 out of 97 used to describe those meds. For example, the word "groundbreaking" was used 6 times to describe Ibrance, "game changer" was used twice, and "revolutionary" and "miracle" also cropped up one time each, respectively.
But immunologic checkpoint inhibitors such as Bristol-Myers Squibb's ($BMY) Opdivo--particularly, a recently tested combo with Yervoy--also turned up their fair share of inflated language, with 37 out of the 97 enthusiastic mentions. In the case of BMS' Yervoy-Opdivo combo, "breakthrough" showed up 7 times, "miracle" was used 5 times, "game changer" was used 5 times and "revolutionary" showed up two times in new stories linked to the med.
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| Vinay Prasad |
Journalists were mostly to blame for the inflated words, the study authors said, with more than half of the glowing adjectives coming from reporters "who may not have the expertise to identify the most promising medical therapies, or what magnitude of benefit warrants a superlative," the study authors said in the JAMA report. Still, journalists weren't the only offenders. Doctors, industry experts, patients and one member of Congress weighed in on the meds using glowing language.
"Some of the drugs are actually very excellent drugs. It's reasonable to feel excited about them," Vinay Prasad, an assistant professor of medicine at the Oregon Health and Science University and a co-author on the study, told The Washington Post. "But you want to balance that against reasonable expectations. You want hope, but realistic hope. That's what we all strive for."
The study comes a little over a month after researchers at Dartmouth College's Geisel School of Medicine and Carnegie Mellon University showed that using the terms "breakthrough" and "promising" in FDA press releases could change individuals' ideas about a med. The scientists had 600 American adults read short descriptions about a hypothetical lung drug and found that more individuals thought the drug was effective if the words "breakthrough" and "promising" showed up in a statement, according to the JAMA study.
Even though "breakthrough" is an official FDA term, peppering statements with that word could still do damage in the minds of consumers, Dr. Joseph Ross and Rita Redberg said in an accompanying editorial.
"To protect patients from spurious hopes for miracle cures, Congress and the FDA should abandon the adoption of terminology like 'breakthrough' and focus on strengthening the evidentiary requirements for meaningful clinical data to ensure the promise of new drugs and devices," Ross and Redberg wrote in the editorial.
- read the JAMA Oncology abstract
- here's the Washington Post article
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