Researchers found FDA coining a drug as a "breakthrough" may lead physicians to misinterpret the drug's actual benefits, according to WedMD.
Researchers surveyed nearly 7,000 physicians. Journal of the American Medical Association published the results.
Here are five points:
1. Researchers found if drugs were labeled as a breakthrough, physicians often thought the drugs were supported by stronger evidence than the law requires to achieve that designation.
2. In the survey, nine out of 10 physicians chose one hypothetical drug over another identical solely based on the breakthrough designation.
3. Of those surveyed, 52 percent falsely believed that strong evidence from randomized trials is needed to achieve breakthrough designation.
4. Researchers also found a widespread lack of understanding about what FDA approval for a new drug means. Nearly seven in 10 physicians believed FDA approval entailed comparable effectiveness to other approved drugs, and statistically significant and clinically important effects.
5. However, FDA approval does not necessarily mean it is tested against other available drugs. The drug may be detested against placebo.
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