FDA's Terminology Is Confusing and Misleading
Written by Editor   
Thursday, October 29, 2015 10:46 AM

Use of the terms "breakthrough" or "promising" in US Food and Drug Administration (FDA) press releases on new drugs may make the public think the drug is more effective than it actually is, hints a new study.  Experts not involved in the research believe that healthcare professionals are also likely to be misled.

The FDA Safety and Innovation Act, passed in 2012, allows the drug regulator to give certain drugs "breakthrough" status.  Breakthrough drugs are those intended to treat a serious or life-threatening condition and for which there is preliminary evidence of a substantial improvement over existing therapies on at least one clinically significant endpoint. These clinical endpoints can be surrogate outcomes, which may or may not prove clinically meaningful.

All FDA press releases announcing approval of breakthrough-designated drugs use the term 'breakthrough,' and about half use the term 'promising,' when describing these drugs.  The researchers found that adding "breakthrough" or "promising" increased the percentage of adults rating the drug as "very effective" or "completely effective" compared with a facts-only vignette.  Adding these descriptive terms also significantly increased the percentage of people believing that the evidence supporting the drug was "strong" or "extremely strong."

The investigators also asked all participants which of two drugs they would take for a potentially life-threatening illness: one was described as "breakthrough," and the other was described without using the term. The vast majority – 92% – chose the "breakthrough" drug.

Using the terms "breakthrough" and "promising" to describe the drug resulted in people having "unwarranted confidence" about the drug's effectiveness, "which could prevent them from making a fully informed decision about whether to take the drug or not.

It is entirely reasonable to expect that patients, as well as health care professionals, will similarly perceive drugs as more promising based on this terminology, authors point out.


Source:  http://www.medscape.com/viewarticle/851469