The following is the Roche Response to the Cochrane Report on Tamiflu
Roche fundamentally disagrees with the overall conclusions of the Cochrane Acute Respiratory Infections Group’s (ARI) report on Tamiflu. We firmly stand by the quality and integrity of our data, reflected in decisions reached by 100 medicines regulators across the world and subsequent real-world evidence demonstrating that Tamiflu is an effective medicine in the treatment and prevention of influenza.
Roche welcomes third-party research and is dedicated to sharing clinical data for our medicines in the interest of advancing science. However, we do not consider the ARI Group, who have identified themselves as inexperienced in dealing with such data, to be the final authority on the value of neuraminidase inhibitors. Roche believes it is important that public health bodies and influenza experts provide their opinion on this review, alongside the totality of Tamiflu data, before any conclusions are drawn.
“We disagree with the overall conclusions of this 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.”
It is disappointing that the patient-level data requested by and provided to Cochrane has not been used to inform this current analysis. A recent study of nearly 30,000 patients in a pandemic setting, published in March 2014 in The Lancet Respiratory Medicine, drew different conclusions about the use of neuraminidase inhibitors, which reinforces the UK Government’s decision to protect the UK with Tamiflu. Furthermore, the Government’s pandemic stockpile was also found to be cost effective by the National Audit Office.
Other trials and real-world data from seasonal influenza and the 2009-2010 flu pandemic have also shown that Tamiflu is effective in reducing the severity and duration of symptoms in those infected with flu. Tamiflu, having been reviewed and approved by regulatory authorities in over 100 countries, has a well-understood safety profile and has been prescribed by physicians and taken by over 130 million patients worldwide.