BMJ Study: "Don't Give Tamiflu to Children"
VERACARE
Promoting Openness, Full Disclosure, and Accountability
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FYI
An Oxford University study, published in the British Medical Journal (BMJ),
led by David Mant, analyzed four studies involving children aged one to 12
who were prescribed Tamiflu. They found that the risks associated with
Tamiflu are not outweighed by the insignificant benefits:
"The downside of the harms outweigh the one-day reduction in symptomatic
benefits."
The researchers reviewed four earlier clinical trials -- two with Relenza
and two with Tamiflu -- for influenza treatment covering 1,766 children 12
or younger. More half had confirmed cases of type A flu. They also reviewed
three other trials in which the drugs were given to children who had been
exposed to the virus but showed no symptoms.
The BMJ report comes 10 days after Britain's Health Protection Agency (HPA)
reported that more than half of 248 students given Tamiflu after a classmate
fell ill with swine flu suffered adverse side-effects such as nausea,
insomnia and nightmares. Most of the students did not have the flu when they
were given the drug. Thus, it cannot be argued--as the manufacturer of
Tamiflu does--that the symptoms were illness-related.
The UK Independent reports (below) that "the researchers found that using
anti-virals preventatively had little effect - reducing transmission of flu
by 8 per cent.
This means 13 children would have to be treated to prevent one additional
case of the flu."
Given the minimal benefit--reduction of flu symptoms by half a day (at most
one day), they conclude that a "more conservative strategy" is probably in
order.
Dr Carl Heneghan, a GP and clinical lecturer at Oxford University, who was
also involved in the study, said the current policy of giving Tamiflu for
mild illness was an "inappropriate strategy:"
The study authors noted that the children were being treated for normal
seasonal flu but Dr Matthew Thompson, a GP and senior clinical scientist at
Oxford University, said the findings would extend to the current swine flu
pandemic. "I don't think we have got any reason to think our results would
be any different," he said.
"The current swine flu is generally a mild flu illness...it does not seem
that different from current seasonal flu. We would be happy to say our
results apply to the current swine flu strain."
However, the UK Department of Health spokesman dismissed the Oxford
researchers' claims that their findings would also apply to swine flu.
"The BMJ review is based on seasonal flu and not swine flu," he said. "As
the authors note, the extent to which the findings can be applied to the
current pandemic is questionable - after all, we already know that swine flu
behaves differently to seasonal flu, and past pandemics have hit younger
people hardest."
"Whilst there is doubt about how swine flu affects children, we believe a
safety-first approach of offering anti-virals to everyone remains a sensible
and responsible way forward."
An investigation is in order to find what, if any, hidden persuaders
(undisclosed stakes) are at work influencing public health policy--in the
UK, the US, and the UN.
Why are public officials promoting the premature, medically unsupportable
use of (1) an inadequately tested vaccine, H1N1, and (2) the use of
anti-viral drugs whose "benefit" vis-`-vis the flu, is merely reduced mild
symptoms by between half a day and one day?
See: Matthew Shun-Shin, Matthew Thompson, Carl Heneghan, Rafael Perera,
Anthony Harnden, David Mant. Neuraminidase inhibitors for treatment and
prophylaxis of influenza in children: systematic review and meta-analysis of
randomised controlled trials, BMJ, Aug 10, 2009 Available free at:
http://www.bmj.com/cgi/content/full/339/aug10_1/b3172?q=w_pandemic_flu
See: http://anthraxvaccine.blogspot.com
See also, http://www.ahrp.org/cms/content/view/619/9/ and
http://www.ahrp.org/cms/content/view/626/9/
Contact: Vera Hassner Sharav
vera...@ahrp.org
212-595-8974
http://www.independent.co.uk/life-style/health-and-families/health-news/dont
-give-tamiflu-to-children-1770154.html
THE INDEPENDENT
'Don't give Tamiflu to children'
By Jane Kirby, Press Association
Monday, 10 August 2009
"There is a lot of concern amongst health authorities that people might buy
counterfeit drugs"
Children should not be given the anti-viral drug Tamiflu to combat swine
flu, Oxford University researchers said today.
They urged the Department of Health to urgently rethink its policy on giving
the drugs to youngsters affected by the current flu pandemic.
Some 300,000 people in England, including children and adults, have received
courses of Tamiflu through the Government's National Pandemic Flu Service
for England.
Today's study, published in the British Medical Journal (BMJ), warned that
Tamiflu can cause vomiting in some children, which can lead to dehydration
and the need for hospital treatment.
The researchers said children should not be given the drug if they have a
mild form of the illness although they urged parents and GPs to remain
vigilant for signs of complications. Parents of children with a compromised
immune system or a condition like cystic fibrosis should discuss the harms
and benefits with their GP, they said.
But overall, the researchers said, children who were otherwise healthy could
suffer more harm than benefit from taking Tamiflu or another anti-viral,
Relenza.
They found the drugs had little or no effect on asthma flare-ups, ear
infections or the likelihood of a youngster needing antibiotics.
The researchers also found that using anti-virals preventatively had little
effect - reducing transmission of flu by 8 per cent.
This means 13 children would have to be treated to prevent one additional
case of the flu.
However, anti-virals could reduce symptoms by between half a day and one
day.
Dr Carl Heneghan, a GP and clinical lecturer at Oxford University, said the
current policy of giving Tamiflu for mild illness was an "inappropriate
strategy".
He added: "The downside of the harms outweigh the one-day reduction in
symptomatic benefits."
He and Dr Matthew Thompson, a GP and senior clinical scientist at Oxford
University, analysed four studies involving children aged one to 12.
The children were being treated for normal seasonal flu but Dr Thompson said
the findings would extend to the current swine flu pandemic.
"I don't think we have got any reason to think our results would be any
different," he said.
"The current swine flu is generally a mild flu illness...it does not seem
that different from current seasonal flu.
"We would be happy to say our results apply to the current swine flu
strain."
He said children with mild symptoms should be treated in the same way as if
they had any other mild flu - with drinks to cool high temperatures and
rest.
Dr Heneghan said the only benefit found in the study was that children were
back to normal half a day to one day earlier if taking Tamiflu or Relenza.
He said his advice to GPs was "not to rely on Tamiflu as a treatment to
reduce complications" or to think of it as a "magic bullet".
And he warned that widespread use of Tamiflu could result in the flu
becoming resistant to the drug.
"What is a problem going forward - like with antibiotics - is you run into a
resistance issue.
"Going forward we have a treatment which is ineffective because we've given
it to everybody."
Both researchers called on the Department of Health to review its current
policy.
Dr Thompson said: "It's possible a more conservative strategy (such as)
reserving these anti-viral drugs for people, for children who are more
likely to have complications of the illness might be a more sensible
strategy." Dr Heneghan added: "I think the Government should be looking at
this urgently, this week."
The experts said the studies had been publicly available to the Government
before it formulated its current strategy with regard to Tamiflu.
And they said the Government should have demanded more data from the
pharmaceutical companies which manufacture the drugs - Roche, which makes
Tamiflu, and GlaxoSmithKline, which makes Relenza.
Today's research was published in the British Medical Journal (BMJ) and
follows two recent studies which found that more than half of children
taking Tamiflu suffered side-effects such as nausea, insomnia and
nightmares.
Experts from the Health Protection Agency (HPA) found a high proportion of
British schoolchildren reporting problems after taking the anti-viral
preventatively.
The experts behind one of the studies said that although children may have
attributed symptoms which were due to other illnesses to the use of Tamiflu,
that was "unlikely to account for all the symptoms experienced".
That study was carried out in April and May - before the Government decided
to stop using Tamiflu preventatively.
Only those with suspected or confirmed swine flu are now getting the drug
and are being urged to get access to Tamiflu through the Pandemic Flu
Service, which is accessed online or via a telephone helpline.
Children are known to be at high risk of catching the flu, with more than
40% of pre-school children getting the virus and 30% of school-age children
doing so, the researchers said.
A Department of Health spokesman dismissed the researchers' claims that
their findings would also apply to swine flu.
"The BMJ review is based on seasonal flu and not swine flu," he said. "As
the authors note, the extent to which the findings can be applied to the
current pandemic is questionable - after all, we already know that swine flu
behaves differently to seasonal flu, and past pandemics have hit younger
people hardest.
"Whilst there is doubt about how swine flu affects children, we believe a
safety-first approach of offering anti-virals to everyone remains a sensible
and responsible way forward."
He said the policy would be kept under review and people with mild symptoms
"may find bed rest and over-the-counter flu remedies work for them.
"But for those who experience severe symptoms, the best scientific advice
tells us that Tamiflu should still be taken as soon as possible - and to
suggest otherwise is potentially dangerous. "If people are in any doubt
about whether to take Tamiflu, they should contact their GP."
Liberal Democrat health spokesman Norman Lamb said: "This analysis needs to
be taken extremely seriously and demands an immediate response from the
Government. "An urgent review must be carried out into whether the benefits
of prescribing certain anti-viral drugs are worth the risks when it comes to
our children's health."
A total of 36 people in England have died after getting swine flu.
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