David Davis comments on parliamentary scrutiny of Tamiflu

As published in the Financial Times:
Scientists say ministers wasted millions on flu medicine

Scientists have accused the government of throwing more than £600m “down the drain” by stockpiling emergency flu treatments despite there being little evidence to show they are more effective than paracetamol or aspirin.

The Department of Health spent £473m on Tamiflu, an antiviral medicine developed by Roche of Switzerland, and another £136m on GlaxoSmithKline’s Relenza between 2006 and 2013 in readiness for a flu pandemic.

Yet, in a big independent review published on Thursday, scientists said the medicines offered only a small benefit to flu victims, with no evidence that they reduced the risk of hospitalisation or death.
Researchers from the Cochrane Collaboration, a network of academics who review drug data, and the British Medical Journal analysed results from 46 clinical trials to reach their conclusion.

“There appears to be no evidence for patients, clinicians or policy makers to use these drugs to prevent serious outcomes, both in annual influenza and pandemic influenza outbreaks,” the authors said.

David Davis, the Tory MP who has spearheaded parliamentary scrutiny of Tamiflu, said: “If these findings are correct, Roche should be repaying the money spent by the British taxpayer.”

Roche said it “fundamentally disagrees” with the Cochrane conclusions and pointed to a University of Nottingham study, funded by the company, which last month found Tamiflu cut the risk of death during the H1N1 swine flu pandemic in 2009 by 19 per cent. The Cochrane authors said this study was unreliable.

GSK said: “We continue to believe that data from Relenza’s clinical trial programme support its effectiveness against flu.”

The Cochrane study acknowledged that the treatments reduced the duration of flu symptoms by an average of about half a day but said it was not clear that this was superior to anti-fever medicines that could be bought over the counter.

Carl Heneghan, professor of evidence-based medicine at Oxford university and co-author of the review, said the UK and other governments should stop stockpiling the drugs and urged the World Health Organisation to remove Tamiflu from its list of essential medicines.
“[The money] has been thrown down the drain,” he said.

Governments around the world rushed to buy antiviral drugs in response to the avian and swine flu scares of recent years. “There was a political imperative to have something to offer, but in terms of clinical health we would say it is not value for money when you think what else [the money] could have been spent on in the NHS,” said Fiona Godlee, editor-in-chief of the British Medical Journal.
The Department of Health said it would “consider the Cochrane review closely” but insisted Tamiflu had “a proven record of safety, quality and efficacy”.

“The UK is recognised by the World Health Organisation as being one of the best prepared countries in the world for a potential flu pandemic. Our stockpile of antivirals is a key part of this.”
Wendy Barclay, an influenza expert at Imperial College London, said it remained prudent to stock Tamiflu and Relenza. “We have only two drugs with which we can currently treat influenza patients, and there is some data to suggest they can save lives.

“If another pandemic came tomorrow, and the government had no drug with which to treat thousands of patients . . . there would be a public outcry.”

Uncertainty over the benefits of Tamiflu has lifted calls for the drugs industry to open clinical trial data about new medicines to greater independent scrutiny. “There are no good reasons to withhold data from policy makers and researchers,” said Mr Davis. “Any commercial interests that companies might have to keep data under wraps are overridden by the interests of patients.”

Roche versus reviewers – what each side claims
On prevention
Roche cites a study showing that Tamiflu is up to 92 per cent effective in preventing flu in adolescents, adults and the elderly if it is taken once a day. Marketing literature says: “Tamiflu can provide immediate protection for people who have been exposed to the virus.”
The Cochrane review said the trial used to establish the drug’s preventive powers was poorly designed. “Our findings . . . suggest a minimal effect on prevention. Based on this, there is little to support [use of Tamiflu as a preventive agent] . . . during influenza epidemics.”

On recovery times
Roche says: “Trials and real-world data from seasonal influenza and the 2009-10 flu pandemic have . . . shown that Tamiflu is effective in reducing the severity and duration of symptoms in those infected with flu.” The impact on duration is especially significant if treatment is started within 48 hours of symptoms arising.

The Cochrane review acknowledges that Tamiflu reduces the duration of symptoms, but adds: “The size of this effect is small, approximately half a day. It is unclear whether this is superior to treatment with commonly used [over-the-counter] medications.”

On risk of complications
Roche says: “Studies show that, overall, early treatment with Tamiflu improves the chance of patient survival . . . and can reduce the likelihood of severe outcomes.” A Nottingham university study funded by the company last month reported that Tamiflu cut risk of death by 19 per cent during the swine flu epidemic.

The Cochrane review said the Nottingham study was unreliable because it was based on observational patient data rather than a controlled clinical trial. “We did not find any credible evidence that [Tamiflu reduces] the risk of complications of influenza . . . nor [reduces] the risk of hospitalisation or death.”

Tamiflu still drug of choice for treatment
Many Britons will have encountered Tamiflu for the first time five years ago, when several people fell victim to swine flu contracted overseas and the drug emerged as the treatment of choice, writes Sarah Neville.

In an incidental insight into UK social class divisions and long-haul foreign travel, younger victims were disproportionately concentrated in expensive private schools, where parents were handed batches of the drug to administer as a precautionary measure.

The range of possible side-effects was mythologised by a student at Alleyn’s School in Dulwich, south London, who composed the song “Ode to Tamiflu”, which briefly became an online hit.
The school closed for a week, during which it rescheduled A-level exams. A Battersea prep school, The Dolphin School, and South Hampstead High School also closed briefly as they were caught up in the outbreak.

Despite the concerns about the efficacy of the drug raised in the latest research, the official health department guidance about its use in a pandemic remains much as it did in 2009. The UK Influenza Preparedness Strategy says that antiviral medicines, such as Tamiflu and Relenza “can reduce the length of symptoms and usually their severity”.

It says “evidence suggests that when antivirals are taken within two days of the onset of symptoms, the total duration of illness is reduced by around a half to one full day”. This, it suggests, may reduce “the burden on primary and secondary healthcare services”, while also delivering health benefits such as cutting the number of “complications”.

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