H1N1: BMJ Medical Experts Debunk Tamiflu effectiveness and usage

The ongoing investigation of antiviral drugs and their unproven effectivenesss continues.

UK medical experts from the British Medical Journal (BMJ) are questioning the effectiveness of antiviral drug Tamiflu commonly used against the swine flu virus spreading across the globe, according to a study reported in Britain Tuesday.

An investigation by the British Medical Journal acknowledges that the drug oseltamivir, which trades as Tamiflu, has "a very modest effect in reducing flu symptoms and infectivity in otherwise healthy adults."

But "researchers say there is insufficient published data to know if oseltamivir reduces complications in otherwise healthy adults," the media groups said in a joint statement.

The use of flu drugs like oseltamivir has increased dramatically since the A(H1N1), or swine flu, pandemic began in April 2009, with government rushing to stockpile treatments while persuading people to have vaccinations.

The global death toll since the virus was uncovered in April approached 8,770 in early December, with confirmed infections in 207 countries, according to World Health Organisation figures.

Claims about the effectiveness of drugs like Tamiflu against flu complications have been a key factor in governments' choosing to spend millions of dollars to hoard them, the British Medical Journal said.

The British government has spent about 500 million pounds (813.9 million dollars) on such drugs, they said.

But research on the drugs by scientists from Australia's Bond University was hampered by a "paucity of good data" available from Swiss pharmaceutical giant Roche that produces oseltamivir.

"As a result, they conclude that they have no confidence in claims that oseltamivir reduces the risk of complications of influenza in otherwise healthy adults, and believe it should not be used in routine control of seasonal influenza."

The researchers called on governments to set up studies to monitor the safety of drugs like Tamiflu, which are called neuraminidase inhibitors.

A team from the University of Birmingham concluded meanwhile that oseltamivir may reduce the risk of pneumonia in otherwise healthy people who contract flu.

"However, the absolute benefit is small, and side effects and safety should also be considered," the statement said.

Professor Nick Freemantle from the University of Birmingham said he saw "very little evidence to support the widespread use of oseltamivir in the otherwise healthy population who are developing signs of influenza-like illness."

"We have remarkably few resources in this country to spend on pharmaceuticals on health and it's surprising to see such widespread use of oseltamivir," he said.

British Medical Journal editor-in-chief Fiona Godlee warned that the review left unresolved important questions about effectiveness of the drugs.

"Governments around the world have spent billions of pounds on a drug that the scientific community now finds itself unable to judge," she said.

Roche has estimated sales of 1.6 billion pounds this year alone from the drug, the statement said.

Check out previous blogs on this subject

H1N1: Tamiflu results questioned by the UK BMJ

Research published in the British Medical Journal (BMJ) has confirmed that the antiviral oseltamivir, is only effective in reducing influenza A symptoms by 1 day. (normally Influenza A symptoms persist from 7 - 10 days)

It also confirmed that there was no evidence that oseltamivir prevented the most fatal complications, pneumonia and severe respiratory disorders.

It comes after the Government and GPs failed to reach an agreement on the swine flu vaccination programme for under-fives, with health visitors and district nurses now set to be asked by local NHS managers to step in.

The BMJ research has questioned the validity of research from Roche, the pharmaceutical giant that makes oseltamivir (Tamiflu).

More than a million courses of antivirals including Tamiflu have been given out to people across Britain since the start of the swine flu pandemic.

A review of 20 existing studies was carried out by a team led by experts from the Cochrane Collaboration, which last reviewed the evidence in 2005. Their updated study found Tamiflu "did not reduce influenza-related lower respiratory tract complications".

The drug was found to induce nausea while evidence of adverse reactions to the drug were "under-reported", they said.

Tamiflu was claimed to be effective in treating people preventatively, i.e. after they had come into contact with somebody who was infected, and shortened the length of symptoms in those with swine flu.

But the study criticised some of the evidence available and said Roche had not been able to "unconditionally" provide the information needed. As a result, the team dropped eight trials that were included in their earlier review because they were unable to independently verify the findings.

This leads to further speculation that the mass innoculation of peoples is commercially based, adding to the profits of the pharmaceutical companies, without there being sound medical evidence to back it up.

The power of the pharma lobbyists is such that this conspiracy to defraud the public has extended into the medical and political hierarchy and large incentives are being offered to executives, politicians and medical authorities that support the exploitation of this pandemic.

Confusion over giving antivirals to children with flu

Another pertinent study from the BMJ casts doubt over the UK's strategy to combat H1N1 Swine Flu, is well founded.

Specifically, whether all children suspected of having H1N1 Swine flu, should be given antiviral drugs such as oseltamivir (Tamiflu) or zanamivir (Relenza).

The UK government Health Ministers, insist that everyone suspected of having H1N1 Swine flu should be offered antivirals as part of a "safety first" strategy but the BMJ study, published in their journal, suggests the strategy is misguided, at best.

Small help
It concludes that treating children under 12 with antivirals does very little, shortening the duration of disease by just a day or so, and decreasing by just 8 per cent the likelihood that an infected child will spread it to others.

Also, Tamiflu causes additional vomiting in 5 per cent of children already vomiting because of their illness. Nor does it bring any benefits for asthmatics, as implied by advice from the UK government's Health Protection Agency.

"The results show the beneficial effect is fairly small for most children," says Matthew Thompson of the University of Oxford, who led the research.

His team's advice is for parents to treat mild flu symptoms with the usual medicines and the priority is in controlling the high fever, ensuring the patient gets plenty of rest and their fluid intake is maintained.

Beneficial Value unknown
Even if complications develop, the beneficial value of giving antivirals to children is unknown, the researchers say. "What we need are studies large enough to let us know if antivirals reduce the risks of serious complications such as pneumonia or hospitalisation in children," Thompson says.

Another bonus of limiting treatment in children is that it will reduce the risk of the mutating virus developing resistance to the drugs.

UK Government's response
Responding, the British government's Department of Health said that the BMJ study is based on seasonal flu and so may not apply to swine flu. This is a very weak knee-jerk response with little substance.

"Whilst there is doubt about how swine flu affects children, we believe a safety-first approach of offering antivirals to everyone remains a sensible and responsible way forward," said a spokesperson. "However, we will keep this policy under review as we learn more about the virus and its effects."

The government can see their ass-covering strategy diminishing in the face of evidence based criticism.

Viral Influenza A
Thompson accepts that his review only looked at seasonal flu. "But about two-thirds of the studies were influenza A, which is what the current strain is," he says. "So we would expect our results to be applicable to swine flu."

Sharp shooting
Thompson says that other countries are deploying a more considered and targeted approach, unlike the scattergun approach in the UK. "Canada, Ireland and the US are only recommending antivirals for patients at particularly high risk, or with severe illness," he says.

Good Advice
"It may be worth the UK Department of Health taking the new research on board and consider having a more targeted approach to the use of antivirals, or urgently conducting randomised controlled trials of children and adults to identify whether there are subgroups of children who will benefit from antivirals, and whether they do have an impact on severe complications such as pneumonia or hospitalisation," says Thompson.

Fortunately, the decisions lie not only with the UK Government. "I hope the evidence from such trials will help parents and family doctors make sensible decisions about which children to treat."

Results and Conclusions from BMJ Study: BMJ, DOI: 10.1136/bmj.b3172

Review methods: Eligible studies were randomised controlled trials of neuraminidase inhibitors in children aged 12 in the community (that is, not admitted to hospital) with confirmed or clinically suspected influenza. Primary outcome measures were time to resolution of illness and incidence of influenza in children living in households with index cases of influenza.

Results: We identified four randomised trials of treatment of influenza (two with oseltamivir, two with zanamivir) involving 1766 children (1243 with confirmed influenza, of whom 55-69% had influenza A), and three randomised trials for postexposure prophylaxis (one with oseltamivir, two with zanamivir) involving 863 children; none of these trials tested efficacy with the current pandemic strain. Treatment trials showed reductions in median time to resolution of symptoms or return to normal activities, or both, of 0.5-1.5 days, which were significant in only two trials. A 10 day course of postexposure prophylaxis with zanamivir or oseltamivir resulted in an 8% (95% confidence interval 5% to 12%) decrease in the incidence of symptomatic influenza. Based on only one trial, oseltamivir did not reduce asthma exacerbations or improve peak flow in children with asthma. Treatment was not associated with reduction in overall use of antibiotics (risk difference –0.30, –0.13 to 0.01). Zanamivir was well tolerated, but oseltamivir was associated with an increased risk of vomiting (0.05, 0.02 to 0.09, number needed to harm=20).

Conclusions: Neuraminidase inhibitors provide a small benefit by shortening the duration of illness in children with seasonal influenza and reducing household transmission. They have little effect on asthma exacerbations or the use of antibiotics. Their effects on the incidence of serious complications, and on the current A/H1N1 influenza strain remain to be determined.

Tamiflu not suitable for Children: TV Personality's daughter 'almost died'

pa.press.net
Health Secretary Andy Burnham has defended giving swine flu drug Tamiflu to children as TV presenter Andrew Castle said his daughter "almost died" after taking it.

Mr Burnham was confronted by Castle on GMTV after research cast doubt that the anti-viral drug's benefits outweighed its side-effects.

The presenter said: "I can tell you that my child - who was not diagnosed at all - she had asthma, she took Tamiflu and almost died."

Fatal Consequences

Castle said his daughter, Georgina, had a severe reaction, "respiratory collapse" and "suffered very heavily" after being "just handed" the drug without having been properly diagnosed.

All this is in the light of last week, when a 2 yr old child died of Meningitis, after being wrongly diagnosed as having Swine Flu. She and her parents were dismissed and turned away by off-hand, hospital, medical staff.

Sympathy on Offer

Mr Burnham sympathised with Castle, saying it must have been "very worrying", but maintained that the current advice being given to parents to treat swine flu with Tamiflu, remained unchanged, despite the wave of severe doubts and criticisms coming from consultants and specialists alike.

Given that swine flu had a "disproportionate effect" on children, he maintained that Tamiflu was "our only line of defence" or, the only line of defense being considered. A policy that puts children in as much danger from the cure as from the disease.

Specialists Warn against Tamiflu

On Monday, Oxford University researchers made a serious announcement that children should NOT be given the anti-viral drug to combat swine flu. They urged the Department of Health to urgently rethink its policy on giving the drug to youngsters affected by the current flu pandemic.

The study, published in the British Medical Journal (BMJ), warned that Tamiflu can cause severe vomiting in some children, which can lead to dehydration and the need for emergency hospital treatment.

Cure worse than Disease

The researchers stated strongly that children should NOT be given the drug if they have a mild form of the illness. In such cases the cure is worse than the disease. They urged parents and GPs to remain vigilant for signs of complications and to avoid 'off the shelf' solutions and knee-jerk reactions.

50% of Young Children Suffer Side Effects from Tamiflu

pa.press.net

More than half of children taking Tamiflu suffer side-effects such as nausea, insomnia and nightmares, researchers have said.

Two studies from experts at the Health Protection Agency (HPA) showed a "high proportion" of British schoolchildren reporting problems after taking the anti-viral drug.

Data was gathered from children at three schools in London and one in the South West who were given Tamiflu earlier this year after classmates became infected.

The researchers behind one study said that, although children may have attributed symptoms that were due to other illnesses to the use of Tamiflu, "this is unlikely to account for all the symptoms experienced".

Their research, published in Eurosurveillance, looked at side-effects reported by 11 and 12-year-old pupils in one school year in a secondary school in South West England. The school was closed for 10 days in response to a pupil being confirmed with swine flu on return from a holiday in Cancun, Mexico.

A total of 248 pupils took part in the study and were given Tamiflu prophylactically. Compliance with prophylaxis was high, with 77% of children taking the full course, the researchers said. But they added: "Fifty-one per cent experienced symptoms such as feeling sick (31.2%), headaches (24.3%) and stomach ache (21.1%).

The researchers said "likely side-effects were common" and the "burden of side-effects needs to be considered" when deciding on giving Tamiflu to children prophylactically. The researchers concluded that a "high proportion of school children may experience side-effects of oseltamivir (Tamiflu) medication".