Use of word “unprecedented” in the media coverage of cancer drugs: Do “unprecedented” drugs live up to the hype?

Introduction The narrative surrounding new and investigational cancer drugs is frequently optimistic. Recently, the term “unprecedented” has been used to describe some such agents. Unlike other superlatives, “unprecedented” has a specific meaning—no previous therapy has worked as well. We examined empirically how often cancer drugs were hailed as “unprecedented” when they had been preceded by a more advantageous agent. Methods We performed systematic searches of the lay press (Google News and Medscape) to identify the use of “unprecedented” referring to a specific cancer drug indications. For each term, we identified if the drug had received US Food and Drug Administration approval for that indication, and whether a randomized controlled trial had been conducted. If an RCT was found, we searched for a prior RCT in that setting with more advantageous hazard ratio. Results We found 96 instances of the term “unprecedented” referring to 48 specific cancer drug instances. Only 25/48 drugs (52%) hailed as offering an “unprecedented” benefit were FDA approved as of February 2017. 54% (26/48) had been tested in randomized trials, though in 6/26 (23%) of cases, we could find a prior therapy with superior hazard ratio. In 2/26 cases the drug failed late phase testing or other confirmatory test. Conclusion We found just 40% (19/48) of drugs hailed as “unprecedented” were tested in a randomized trial where no superior study could be found or which did not fail in phase 3, and nearly half had not earned FDA approval. The use of the word “unprecedented” in the lay press is often inaccurate and frequently overstates the importance of findings from the scientific literature.