Side effects and effectiveness of ‘wonder-drug’ Tamiflu under the microscope as Department of Health faces awkward questions over mass prescriptions
Last updated at 4:44 PM on 17th January 2012
Health officials are to face questions about whether they prescribed Tamiflu on a mass scale too quickly in the wake of the 2009 swine flu outbreak.
A two-year review into the widely prescribed drug will reveal findings about the effectiveness and side-effects of the swine flu ‘wonder-drug’.
The conclusions made by the Cochrane Collaboration could pose uncomfortable questions for the Department of Health as to whether they rushed into mass prescriptions of Tamiflu when swine flu hit the nation in 2009.
Reports at the time of the swine flu outbreak in Britain listed a number of side effects associated with the antiviral, such as nausea, nightmares in children, and other reactions.
As well as questioning issues surrounding Tamiflu, researchers behind the review also claimed the makers of the drug refused to hand over raw data to help them with their appraisal.
Swiss pharmaceutical giant Roche claimed Tamiflu reduced the number of patients who needed to be hospitalised after becoming infected with swine flu.
The comprehensive appraisal by Cochrane, a non-profit group who analyse medical evidence through results from the world’s best medical research studies, aims to challenge Roche’s claim when its findings are released tomorrow.
Cochrane Collaboration founder Sir Iain Chalmers said Tamiflu makers Roche ‘refused to provide data’
The Cochrane Collaboration, considered by experts to be the ‘gold standard’ of medical evidence, also reported problems obtaining data from Roche back in 2009.
Professor Sir Iain Chalmers, a founder of the Cochrane Collaboration, told The Bureau of Investigative Journalism: ‘We have invested millions of pounds on stockpiling Tamiflu on the basis of a paper that presented the results of 12 trials, only two of which have been published.
‘The investigation… shows Roche refused to provide data to evaluate these trials.
‘Investigators got some data through the European Medicines Agency, but this doesn’t answer all of the questions they have.’
He added: ‘It is a disgrace that Roche have not provided this data.’
A teenage girl left disabled by the swine flu treatment Tamiflu did not even have the virus, it was revealed today.
Samantha Millard, 19, became critically ill after suffering a severe allergic reaction to the tablets, which she took on the advice of the controversial NHS helpline.
Within 72 hours of taking three pills, doctors put her on life support.
Samantha spent a month in hospital after developing the life-threatening Stevens Johnson syndrome, which causes the skin to peel off, and later developed toxic epidermal necrolysis syndrome, which has damaged her sight.
Roche responded by saying it has provided Cochrane with access to 3,200 pages of detailed information as part of their review.
TAMIFLU – Wonder cure of dangerous drug?
Tamiflu is a medicine which is used to prevent and treat influenza. It was discovered in 1999, by Gilead Sciences, a Californian biotech company set up by doctor Michael Riordan in 1987 and is manufactured by Roche.
The influenza virus gets into the body through the mouth or nose. It replicates itself in the cells lining the airways. The viruses then spread to more and more cells making the infection more serious.
Tamiflu blocks the effects of a chemical called neuraminidase that is made by the influenza virus, which it uses to spread. So the sooner it is taken after symptoms develop the better the chance of warding off the worst effects of flu.
This makes it easier for the body’s immune system to clear-up the infection.
It can cause side-effects, although not everyone will experience them.
‘The most common ones are nausea, vomiting and stomach ache,’ says GP Wendy Denning of London’s the Health Doctors clinic. ‘Tamiflu should be taken after food. However, if a person is sick within an hour of taking it, it is likely to be ineffective.’
Roche revised the Tamiflu patient information warning that it can cause hallucinations, delirium or abnormal behaviour, which sometimes ‘results in fatal outcomes’.
This was after the Japanese government warned doctors in March 2007 that Tamiflu should not be prescribed to teenagers for fear that it can lead to bizarre and self-destructive behaviour, after investigating the deaths of 18 Japanese children.
The Swiss firm said it made full clinical study data available to health authorities as part of the licensing process.
A spokesperson for Roche said today: ‘Roche stands behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu.’
A Department of Health spokesperson said: ‘At the end of last year we published a major review of the scientific evidence base, which showed a clear benefit in offering antivirals to those with severe illness and those with additional risk factors.
‘Our priority has always been to minimise the risk of serious illness and death from seasonal flu.’