Uncovered Tamiflu data shows the drug doesn’t work, says Cochrane

A new review of data for Roche's flu drug Tamiflu has concluded the drug does not reduce hospitalisations and serious complications of the virus – and that it leads to harmful effects in patients.

The conclusion by the Cochrane Collaboration is hugely significant in the ongoing debate around data transparency in the pharma industry, because the clinical trials data in question was the subject of a long-running row between Roche and the independent researchers.

Tamiflu has been used in countries around the world as part of the public health armoury against flu, and huge amounts of the drug have been stockpiled in a number of countries. In the UK, the government spent around £500 million on the drug, but the Cochrane group suggests this was a waste of money.

Roche has hit back at the study's conclusions, calling for other public health researchers to study the evidence before any final conclusions are drawn.

Dr David Tovey, Editor-in-Chief, Cochrane, said: "We now have the most robust, comprehensive review on 'neuraminidase inhibitors' that exists. 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."

Dr Tom Jefferson, Dr Carl Heneghan, Dr Peter Doshi, authors of the review, Cochrane Neuraminidase Inhibitors Review Team, said: "Drug approval and use cannot be based on biased or missing information any longer. We risk too much in our population's health and economy. This updated Cochrane review is the first time a Cochrane systematic review has been based only on clinical study reports and regulator's comments.

Dr Jefferson heralded the review as the first example of open science in medicine using full clinical study reports available without conditions.

"Therefore the conclusions are that much richer. We urge people not to trust in published trials alone or on comment from conflicted health decision makers, but to view the information for themselves."

Cochrane says that guidance on the use of both neuraminidase inhibitors Tamiflu (oseltamivir) and GSK's Relenza (zanamivir) to prevent or treat flu should be revised to take account of the evidence of small benefit and increased risk of harms.

Dr Fiona Godlee, Editor-in-Chief, British Medical Journal, said: "This review is the result of many years of struggles to access and use trial data, which was previously unpublished and even hidden from view. It highlights with certainty that future decisions to purchase and use drugs, particularly when on a mass scale, must be based on a complete picture of the evidence, both published and unpublished. We need the full data from clinical trials made available for all drugs in current use. With the new European Clinical Trials Directive bringing in rules for future drugs, it highlights the enormous challenge we face. We need the commitment of organisations and drug companies to make all data available, even if it means going back 20 years. Otherwise we risk another knee-jerk reaction to a potential pandemic. And can we really afford it?"

Roche responds

Roche has responded directly to the claims, saying it "fundamentally disagrees" with the overall conclusions. It added: "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."

The firm says that it welcomes third-party research and is committed to sharing clinical data – but adds: "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."

The company says public health bodies and influenza experts should 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."

Roche concluded by claiming that other studies, including trials and real-world data have shown the drug's effectiveness.

Links

Europe votes for clinical trial transparency law