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'Breakthrough' drugs are assumed to be better, says study


A study has revealed that the use of terms like "breakthrough" and "promising" for fast tracked medications in FDA press releases makes the public perceive the medicines as more effective than when such terms are not used, MedPage Today reports.

The study was conducted by Tamar Krishnamurti, of Carnegie Mellon University in Pittsburgh, and colleagues.

The Findings were published in the Journal Jama Internal Medicine.

Under the study, 597 participants were made to read one of five vignettes, whose wordings ranged from facts only language to actual FDA releases. It was found that when words like "breakthrough" were used, the participants rated the drug more effective by as much as 24 points.

"Not surprisingly, inclusion of the terms breakthrough or promising without any other change in vignettes led to higher ratings of the drug's effectiveness and perceptions of the strength of supporting evidence," wrote Joseph S. Ross, MD, of Yale University in New Haven, Conn., and Rita F. Redberg, MD, of the University of California San Francisco, in an accompanying editor's note. "It is entirely reasonable to expect that patients, as well as healthcare professionals, will similarly perceive drugs as more promising based on this terminology."

Under the provision of the 2012 FDA Safety and Innovation Act, drugs and devices that treat "a serious or life-threatening condition" and might be better than the treatments available can be given "breakthrough" status and can be sent to market without the final rigorous scientific processes.

"When patients learn about "breakthrough therapies" from FDA press releases, should we not expect them to request that their physicians prescribe these therapies instead of other available therapies, even if the evidence to support their use is less robust?" Ross and Redberg wrote. "Similarly, should we not expect physicians to preferentially adopt their use?"

Ross and Redberg also suggested that drug and device manufacturers might intentionally use this terminology for direct-to-consumer and healthcare professional advertising.

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