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Cochrane review questions benefit of Tamiflu

Ministers should review the use of a widely used anti-flu medication, researchers have said after their review questioned the efficacy of the drug oseltamivir (Tamiflu).

The study suggested that oseltamivir shortens flu symptoms by between a day and half a day – little better than the effect of taking paracetamol.

But the authors said there is “no good evidence” to support claims that it reduces flu-related hospital admissions or the complications of influenza.

The researchers, from The Cochrane Collaboration, also claimed that taking the drug – known as a neuraminidase inhibitor, along with zanamivir (Relenza) – could increase a person’s risk of nausea and vomiting.

“Tamiflu seems to lead to harmful effects that were not fully reported in the original publications”

David Tovey

In addition, when used as a preventative treatment it can stop people developing flu symptoms but may not prevent them from spreading flu to others, the authors said.

The findings of the review may cause further questions to be raised about the government’s stockpile of the drug.

David Tovey

David Tovey

The Department of Health began accumulating oseltamivir in 2006 in response to the increasing concerns about bird flu. Official estimates suggest that ministers have spent £424m backing up supplies of the flu drug.

The researchers reviewed data from 20 clinical study reports on oseltamivir.

They found that taking oseltamivir led to an alleviation in flu-like symptoms an average of 16.7 hours quicker when compared to taking a placebo.

But they said that they did not observe any evidence in the reductions of hospital admissions or flu complications such as pneumonia or bronchitis.

The researchers also found that taking oseltamivir increased the risk of nausea and vomiting by about 4% in adults and 5% in children.

They said: “In prophylactic studies oseltamivir (Tamiflu) reduces the proportion of symptomatic influenza.

“In treatment studies, it also modestly reduces the time to first alleviation of symptoms, but it causes nausea and vomiting and increases the risk of headaches and renal and psychiatric syndromes.

“The trade-off between benefits and harms should be borne in mind when making decisions to use oseltamivir for treatment, prophylaxis, or stockpiling.”

Cochrane’s editor-in-chief Dr David Tovey 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.”

But pharmaceutical company Roche said it “fundamentally disagrees” with the latest review.

“Neuraminidase inhibitors are a vital treatment option for patients with influenza”

Daniel Thurley

Roche’s UK medical director Dr Daniel Thurley said: “We disagree with the overall conclusions of this report.

“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.”

The Department of Health said that oseltamivir has a “proven record” of safety, quality and efficacy and health officials regularly reviewed all published data, and therefore would consider the latest Cochrane review “closely”.

A DH spokeswoman said: “Tamiflu is licensed around the world for the treatment of seasonal flu and is a licensed product with a proven record of safety, quality and efficacy. We regularly review all published data and will consider the Cochrane review closely.”

“This new report does not convince me that the risks of taking Tamiflu or Relenza would outweigh the benefits”

Wendy Barclay

Professor Wendy Barclay, an influenza virology expert at Imperial College London, said: “The report concludes that the drugs did shorten the time to when adults felt better by about one day (16 hours) and in healthy children this was also the case (29 hours).

“Although one day does not sound like a lot, in a disease that lasts only six days, it is. In the community this gets people back to work and school, and having the drugs available also serves as a safety net to treat people who get sick enough to go to hospital.

Wendy Barclay

Wendy Barclay

“It would be awful if, in trying to make a point about the way clinical trials are conducted and reported, the review ended up discouraging doctors from using the only effective anti-influenza drugs we currently have,” she warned.

“Most of the controversy surrounding these drugs is about whether they should be stockpiled for pandemics. If another pandemic came tomorrow, and the government had no drug with which to treat thousands of influenza infected patients, I imagine there would be a public outcry,” she added.

“This new report, taken alongside a lot of other data collected in different settings, does not convince me that the risks of taking Tamiflu or Relenza would outweigh the benefits.”

Readers' comments (7)

  • Big Pharma is just a corrupt and criminal activity when you delve into them. In the early stages of the Swine Flu pandemic the vast majority of Vietnamese doctors who were at that time working at the 'coal-face' stated that Tamiflu was 'USELESS'. They should have known as they were fighting the killer virus more than most at the time. But Big Pharma never learns and is basically a law unto themselves, always taking and not giving back in return to the vast majority of humanity (but giving back plenty to their rich shareholders and executives and that's all that counts -

    http://worldinnovationfoundation.blogspot.co.uk/2013/12/possibly-most-important-keynote-speech.html


    http://worldinnovationfoundation.blogspot.co.uk/2013/12/global-pharmaceutical-giants-have-made.html


    The big problem also is that because the industry is an annual US$ 1 Trillion+ industry, our politicians back them in everything that they do behind closed doors. And that's the biggest problem of all to get over if it ever can.

    Dr David Hill
    CEO
    World Innovation Foundation

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  • World Innovation Foundation (WIF)

    Published online 23 January 2008 | Nature 451, 382-383 (2008) | doi:10.1038/451382a
    News

    'A very mysterious foundation

    Shroud of secrecy surrounds innovation organization.'

    Declan Butler

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  • 'In 2009, a lack of access to available trial data hampered the efforts of the Cochrane researchers to verify the safety and effectiveness of oseltamivir and led to questions over decisions to stockpile the drug while the risks and benefits remained uncertain.'
    'Inadequate reporting put most of the zanamivir studies and half of the oseltamivir studies at a high risk of selection bias. There were inadequate measures in place to protect 11 studies of oseltamivir from performance bias due to non-identical presentation of placebo. Attrition bias was high across the oseltamivir studies and there was also evidence of selective reporting for both the zanamivir and oseltamivir studies. The placebo interventions in both sets of trials may have contained active substances.'
    Ref: http://www.docguide.com/oseltamivir-provides-no-real-benefit-patients-influenza?tsid=5

    Let's hope that the success of 'Alltrials' ensures that results of every trial are published, the bad as well as the good (often selective).

    'Europe votes for clinical trial transparency 2nd April 2014 It’s soon going to be the law in Europe that drug clinical trials are publicly registered and results reported.'
    'No excuse not to publish: MPs tell doctors regulator 2 April 2014 MPs on the House of Commons Health Committee called on the UK doctors regulator, the General Medical Council, to make it explicit to doctors that withholding trial results is misconduct and actionable.'
    Ref: http://www.alltrials.net/

    Cochrane signs up to AllTrials initiative to campaign for registration and reporting of all clinical trials.
    Ref: http://www.cochrane.org/features/cochrane-signs-alltrials-initiative-campaign-registration-and-reporting-all-clinical-trials

    Let's hope that in future we will have more informed and accurate choices based on more truthful data, on all medicines.

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  • Tiger Girl

    'Although one day does not sound like a lot, in a disease that lasts only six days, it is'

    From Wendy Barclay: I'm wondering if she has ever had a bad atatck of flu, herself ? I still 'shout at the TV' whenever a football manager says 'he's got a touch of flu today, but he'll be fine for the weekend' (that 'flu' ISN'T like the flu I had !).

    It might last 'for 6 days' but those 6 days are very different - I can recall 'about a day' of feeling absolutely terrible, when I had flu as a kid. I was laying in bed, soaked in sweat, muscles aching, headache, virtually too weak to stand up, and if I tried to close my eyes, it felt as if someone had tied a rope to my ankles and was swinging me round in a circle. I'm not sure that shortening the overall length of the illness by a tiny bit, would be a good trade if the side effects of this drug are 'it causes nausea and vomiting and increases the risk of headaches' - I wouldn't take that trade-off, knowing how bad I was anyway (in the 24 hours directly before the 'fever breaks and you just feel weak/drained for many days' stage).

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  • michael stone

    I'm with Tiger Girl on this: I had very nasty flu when I was younger, and you can be really ill - NOTHING LIKE 'a bad cold'.

    There was once a campaign on TV, telling people 'to not visit their GP if they only had a cold - only go to the GP if you've got the flu' and I used to feel like throwing something at the TV (when I had the flu, there was no way I could have gone anywhere on my own two feet !).

    So taking a relatively ineffective medicine that ALSO had side-effects that make you feel even more awful, seems very flawed.

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  • you most definitely shouldn't go to the GP if you have 'flu as you will spread it everywhere on the way there and all around the practice, other patients in the waiting room and staff as well who will then pass it on to other patients - it is known as an epidemic! besides if you have proper 'flu you would not be well enough to get to any surgery or sit in a waiting room. If you are really ill you doctor needs to visit you or you call an ambulance, and if you are not you do not have 'flu and you do not need a doctor!

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  • I understand that the Cochrane team applied, argued and managed to obtain only some of the unpublished trial data after 5 years.
    5 years!!
    Its almost as if they didn't want those results looked at independently...:/

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