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Editorials

WHO downgrades status of oseltamivir

BMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3266 (Published 12 July 2017) Cite this as: BMJ 2017;358:j3266

Rapid Response:

Re: WHO downgrades status of oseltamivir

“Man is so intelligent that he feels impelled to invent theories to account for what happens in the world. Unfortunately, he is not quite intelligent enough, in most cases, to find correct explanations. So that when he acts on his theories, he behaves very often like a lunatic.”
― Aldous Huxley

The global scare of a pandemic was an opportunity. It smoothly allowed a poorly studied research molecule into getting regulatory clearance in record-breaking style. No one since then has had the courage to revisit this mistake and make necessary corrections to disallow a dangerous precedence taking shape.

The sanctity of a well designed Randomised Controlled trial lies in the selection of a clinically valid outcome that truly represents a clinical need. How is it that evidence from a trial that just had the reduction in subjective "symptoms" for an arbitrary figure of "30 hours" become clinical evidence to get regulatory clearance and be permitted sales across the globe?

Regulatory processes need to give due credit to scientific research methodology that attempts at bringing out true pragmatic evidence for a treatment benefit. It SHOULD NOT just look for compliance with Good Clinical Practices and Good Manufacturing Practices; both creation of a dangerous pharma - policy maker - regulatory nexus.

Competing interests: No competing interests

13 July 2017
Alben Sigamani
Clinical researcher
Narayana HEALTH
BANGALORE