Feature Antiviral Drugs

Oseltamivir: another case of regulatory failure?

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2591 (Published 09 April 2014) Cite this as: BMJ 2014;348:g2591
  1. Deborah Cohen, investigations editor
  1. 1BMJ, London, UK
  1. dcohen{at}bmj.com

Governments around the world stockpiled oseltamivir for a flu pandemic despite uncertainty about its harms. Deborah Cohen investigates what the regulators knew and whether their response was adequate

When two Birmingham public health consultants wrote to the BMJ to describe the mass use of oseltamivir for prophylaxis during the 2009 influenza pandemic as “irrational, indefensible, and ineffective” their comments drew fire from UK health authorities.1

The authors, Jacky Chambers, then director of public health at the Heart of Birmingham NHS Primary Care Trust, and Andrew Rouse, a Birmingham public health consultant, had been ordered by the Health Protection Agency (HPA) to give oseltamivir for prophylaxis and treatment to pupils and staff for up to seven days after symptoms appeared at a local school.

This had gone against the public health doctors’ clinical judgment—that the likely benefits did not outweigh the likely risks. Rouse was also concerned that consent was not always clearly obtained. He suspected that “10% of recipients will get nausea, vomiting, diarrhoea, abdominal pain, and headaches.”2

The HPA hit back in a letter just over two weeks later (on 10 July). “Prophylactic oseltamivir reduces the risk of contacts becoming symptomatic, shedding the virus and infecting others. There is also scientific evidence that treating symptomatic people with oseltamivir can reduce infectiousness,” they wrote.3

The agency added that it had been open about side effects. “We are conscious that there are limited data available, hence the importance of encouraging reporting of side-effects through the MHRA yellow card mechanism,” it wrote.

But what did the “limited data” on the drug’s harms show? Whatever it was, it apparently hadn’t curtailed stockpiling or made governments cautious about recommending mass prophylaxis. At the time of stockpiling oseltamivir was a black triangle drug in the UK—a symbol that denotes the need for …

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