Tamiflu stockpiling ‘unjustifiable’ and wasted £424m
pharmafile | April 10, 2014 | News story | Medical Communications, Research and Development, Sales and Marketing | BMJ, Cochrane, Tamiflu, alltrials
Governments around the world may have squandered hundreds of millions of pounds on stockpiling Tamiflu, according to a review by The Cochrane Collaboration which has been published today by the British Medical Journal.
Since the H1N1 swine flu virus outbreak in April 2009, the US has spent more than $1.3 billion (£774.2 million) buying a reserve of antivirals, while in the UK the government has spent almost £424 million.
But the new Cochrane analysis found that Tamiflu (oseltamivir) shortens the symptoms of influenza by just half a day – and finds there is ‘no good evidence’ that it reduces admissions to hospital or complications, such as pneumonia or bronchitis, arising from the virus.
“This raises further questions about the most effective way to support drug regulation and public health policy decision-making,” the report says. “Claims about the effectiveness of Tamiflu against complications were a key factor in decisions made by governments around the world to stockpile these drugs in case of a pandemic.”
Roche has hit back at the Cochrane and BMJ analysis, calling the report’s methodology ‘often unclear and inappropriate’.
“We disagree with the overall conclusions of this report,” said the manufacturer’s UK medical director Daniel Thurley. “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.”
The Basel-based manufacturer also points to a study of nearly 30,000 patients, paid for by the company and published last month in The Lancet Respiratory Medicine, which supported Roche’s claims for the drug.
The firm added: “It is disappointing that the patient-level data requested by and provided to Cochrane has not been used to inform this current analysis.”
Withholding data
Data about Tamiflu was the source of great friction between the parties, with Cochrane and the BMJ saying Roche was withholding information.
The Cochrane review says that there was an increased risk of nausea, vomiting and psychiatric events when Tamiflu was used to prevent influenza, adding that taking generic paracetamol would be just as efficacious, and a more cost-effective option.
“We now have the most robust, comprehensive review on neuraminidase inhibitors that exists,” said David Tovey, Cochrane’s editor-in-chief.
“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,” he added.
And although Cochrane accepts the drug can reduce the risk of people suffering symptomatic influenza when it is used as a preventative measure, “it is unproven that it can stop people carrying the influenza virus and spreading it to others”.
The Cochrane analysis concludes: “There is little to justify any belief that it reduces hospital admission or the risk of developing confirmed pneumonia. Along with the evidence of harms from the medication, it raises the question of whether global stockpiling of the drugs is still justifiable given the lack of reliable evidence to support the original claims of its benefits.”
Transparency debate
The question of greater access to data has been dominating discussion of pharma more generally over the last couple of years: in a vote from the European Parliament last week, the EU will from 2016 no longer view clinical trial data as commercially confidential, meaning it can force pharma to give up its study information.
This may help, said Fiona Godlee, editor-in-chief of the BMJ. “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,” she said.
“We need the full data from clinical trials made available for all drugs in current use. 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?” she asked.
Last year the UK’s Parliament’s Public Accounts Committee began looking more deeply into whether the £424 million the government spent on Tamiflu was a good use of taxpayers’ money.
Speaking in January, committee member Richard Bacon MP said there was still a lack of consensus over how well Tamiflu worked.
“The lack of transparency of clinical trial information on this drug to the wider research community is preventing proper discussion of this issue among professionals,” he added. “We are disturbed by claims that regulators do not have access to all the available information.”
He added that the case for stockpiling antiviral medicines at the current level is based on judgment rather than on evidence of their effectiveness during an influenza pandemic.
“Before spending money in future to maintain the stockpile the Department of Health needs to review what level of coverage is appropriate,” Bacon said. “It should look at the level of stockpiling in other countries, bearing in mind that the patent for the medicine runs out in 2016.”
Adam Hill
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