Is the FDA overpromising and underdelivering? A recent study shows that when the agency uses terms such as "breakthrough" or "promising" in statements about a med, it could sway individuals' perceptions about how well the drug actually works.
The agency's vaunted "breakthrough" designation could be a culprit, according to a study by researchers at Dartmouth College's Geisel School of Medicine and Carnegie Mellon University. They asked 600 American adults to read short descriptions about a hypothetical lung cancer drug called a "breakthrough." One vignette contained only facts about the med, including information about clinical trial size and about the drug's long-term effects. Another included the same facts, but added that the FDA had called the treatment a "breakthrough." A third description used the word "promising" along with the factual information, Reuters reports.
About 25% of participants thought the drug was "very effective" at treating lung cancer if they saw the words "breakthrough" or "promising" in the release, compared with 11% who read the just-the-facts statement. Up to 60% said the evidence supporting the "breakthrough" or "promising" drug was "strong." Those who saw the bare-bones factual statement were more skeptical; only 43% called the evidence "strong," according to the JAMA Internal Medicine study.
The FDA uses the "breakthrough" tag to speed up development of drugs that treat serious illnesses and carry an advantage over existing therapies. But the agency is not required to use terms like "promising," Tamar Krishnamurti, study coauthor and a research scientist at Carnegie Mellon University in Pittsburgh, told Reuters. And using the word "breakthrough" could still do some damage, raising consumers' hopes about a med without the proper evidence, 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.
But the FDA doesn't see a problem with its language. Statements about new drugs "are written to be factual and non-promotional, with the intention of conveying as much information as possible to all of the audiences," the agency told Live Science. And the agency only uses the word "breakthrough" to designate a product on that approval pathway, it added.
Still, the debate comes as more patients push back at pharma's marketing of new drugs. DTC ads for certain products can come across as inauthentic, talking up benefits while masking unpleasant truths, and some patient advocates say sunny representations of new meds can backfire, creating expectations that are then disappointed if a drug doesn't deliver 100%. Creating an open, honest dialogue with patients could fix the problem, creating campaigns that are more tailored to patients' expectations, Todd Kolm, SVP of consumer health firm Wego Health Solutions, told FiercePharmaMarketing earlier this year.
"By establishing the deeper connection with the patient or patient community, the companies are more likely in the long run to develop a stronger relationship that commands brand respect and loyalty," Kolm said. "They're starting off with not only a mouth, but an ear. And that's what patients appreciate."