Story of Influenza Antivirals: Part 27

Reflections on the term “placebo”

This is the latest in a series of posts telling the story of the discovery of unseen trials on the anti-influenza drugs Tamiflu and Relenza, published in Trust the Evidence and cross-posted in Maryanne Demasi reports. This post contains further reflections on the glib word “placebo”, frequently used in biomedical literature without further examination or thought.

In the antivirals story, we got to the point when the European regulator (EMA) released the clinical study reports (CSRs) of 15 Tamiflu (Oseltamivir) trials in late 2011. This was followed by the first version of our Cochrane review and fed intense media coverage of the story.

Of the 15 Oseltamivir trial CSRs held by EMA, only one was complete. The trial, known as WP16263, consisted of 8545 pages, more than 1000‐fold greater than its published version (Dutkowski 2010), which consists of 7 pages. The trial had been carried out on healthy volunteers to assess any cardiotoxic properties of Tamiflu.

None of us had ever read that man…