Trust the Evidence

Trust the Evidence

Describe the intervention

The evidence

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Tom Jefferson and Carl Heneghan
Sep 02, 2025
∙ Paid

Recommendation 3: The intervention and placebo must be described in detail, together with adjuvants, delivery vehicles and excipients (if any)

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In the antivirals story, a crucial moment occurred when the European Medicines Agency released the clinical study reports (CSRs) of 15 Tamiflu (Oseltamivir) trials in late 2011. 

Of these, only one CSR was complete, encompassing 8,545 pages. By chance, we found a Certificate of Analysis, which certifies the constituents, quality, colour, and purity of a product. It detailed the appearance of Tamiflu and placebo capsules, noting that the Tamiflu capsule had a light yellow cap versus an ivory-colored one for the placebo, which also contained dehydrocholic acid to simulate the bitter taste of the active compound. While we could not determine whether the different-coloured capsules affected the results, it raised questions about the integrity of the study's "double-blind" labelling. 

For GSK’s Relenza, we noted that the placebo blister of Zanamivir co…

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