Standing on the corner

Who will protect us?

We came across FDA warning letters when reviewing regulatory documents for our Cochrane review on the influenza antivirals Tamiflu and Relenza. Specifically, a letter warned Roche, the manufacturer of Tamiflu, not to claim effects on complications such as pneumonia. This was interesting, as ameliorating or preventing complications were two of the most important reasons for using and stockpiling the antivirals.

Roche and friends had made claims that, according to the FDA, they could not make as there was no definition of pneumonia and, in many cases, X-ray evidence. The FDA, quite rightly, would not have it, and using their regulatory powers, they forced Roche to publish a statement to clarify.

For further details, see 

Story of Influenza Antivirals: Part 29

And our review is referenced at the bottom. Of course, this did not prevent public health bodies such as the CDC from continuing to make evidence-free statements or statements based on observational studies actively promoting the drug. Ring a bell?

So, when we started looki…