Roche has strenuously denied a new report that claims its flu drug Tamiflu is not as effective as previously thought.
The review, carried about by the independent research group the Cochrane Collaboration, claims ‘there is no good evidence to support claims that [Tamiflu] reduces admissions to hospital or complications of influenza’.
The conclusion is particularly damaging considering the role Tamiflu has played in national public health programmes; the UK government has spent also £424m stockpiling 40 million doses.
Cochrane carried out its review after discrepancies between different regulatory bodies’ views on the drug raised questions about its safety and effectiveness.
This led to a long battle between Cochrane and Roche for access to the trial data for Tamiflu, which was eventually granted in April 2013 although only after a growing move towards pharma transparency that has been spearheaded by the AllTrials campaign.
Now that Cochrane has had a chance to review full internal reports of 20 Tamiflu trials it has concluded that Tamiflu carries an increased risk of suffering from nausea and vomiting.
On top of this, Cochrane said that when Tamiflu was used in prevention trials there was an increased risk of headaches, psychiatric disturbances, and renal events.
‘Although when used as a preventative treatment, the drug can reduce the risk of people suffering symptomatic influenza, it is unproven that it can stop people carrying the influenza virus and spreading it to others,’ determined Cochrane.
Dr David Tovey, editor-in-chief, Cochrane, said: “Initially thought to reduce hospitalisations and serious complications from influenza, the review highlights that Tamiflu is not proven to do this, and it also seems to lead to harmful effects that were not fully reported in the original publications. This shows the importance of ensuring that trial data are transparent and accessible.”
Responding to Cochrane’s review, Roche said it ‘disagrees with the overall conclusion’ of the report.
“Roche stands behind the wealth of data for Tamiflu and the decisions of public health agencies worldwide, including the US and European Centres for Disease Control & Prevention and the World Health Organization,” said UK medical director Dr Daniel Thurley. “The report’s methodology is often unclear and inappropriate, and their conclusions could potentially have serious public health implications. Neuraminidase inhibitors are a vital treatment option for patients with influenza.”
Roche also pointed out a study involving 30,000 patients in a pandemic setting, published in March 2014 in The Lancet Respiratory Medicine, which demonstrated a more positive profile for the drug.
Roche also produced a video in response to Cochrane’s review. It features interviews with two UK-based Roche scientists: Barry Clinch, principal clinical scientist, and Dan Thurley, medical director. You can view it below or on YouTube.