| LONDON, April 10
LONDON, April 10 Researchers who have fought for
years to get full data on Roche's flu medicine Tamiflu
said on Thursday that governments who stockpile it are wasting
billions of dollars on a drug whose effectiveness is in doubt.
The row has drawn in the drugmaker as well as industry
regulators and independent scientists. Supporters of Tamiflu
said the researchers' conclusions were flawed and insisted the
drug is both safe and effective.
The dispute over the benefits of Tamiflu, and to a lesser
extent of GlaxoSmithKline's flu drug Relenza, blew up
with the joint publication by the respected Cochrane Review
research network and the British Medical Journal of an analysis
of trial data, which found no good evidence behind claims the
drugs cut hospital admissions or reduce flu complications.
The review's main findings were that the medicines had few
if any beneficial effects, but did have adverse side effects
that were previously dismissed or overlooked.
"Remember, the idea of a drug is that the benefits should
exceed the harms," said Carl Heneghan, one of the lead
investigators of the Cochrane review and a professor of
evidence-based medicine at Britain's Oxford University. "So if
you can't find any benefits, that accentuates the harms."
But Roche, which has been under fire for several years over
its refusal to allow the Cochrane team unrestricted access to
Tamiflu data, rejected the findings, saying it "fundamentally
disagrees with the overall conclusions" of their study.
"We firmly stand by the quality and integrity of our data,
reflected in decisions reached by 100 regulators across the
world and subsequent real-world evidence demonstrating that
Tamiflu is an effective medicine in the treatment and prevention
of influenza," it said in a statement.
Tamiflu sales hit almost $3 billion in 2009 - mostly due to
its use in the H1N1 flu pandemic - but they have since declined.
The drug, one of a class of medicines known as neuraminidase
inhibitors, is approved by regulators worldwide and is
stockpiled in preparation for a potential global flu outbreak.
It is also on the World Health Organisation's "essential
The United States has spent more than $1.3 billion buying a
strategic reserve of antivirals including Tamiflu, while the
British government has spent almost 424 million pounds ($703
million) on a stockpile of some 40 million Tamiflu doses.
"DOWN THE DRAIN"
Heneghan's team say their analysis is the first based on
full data - from 20 trials of Tamiflu, known generically as
oseltamivir, and 26 trials of Relenza, also known as zanamivir.
At a briefing in London to present their findings, Heneghan
said the money spent on stockpiles "has been thrown down the
drain" because until now, the full data had not been seen by
regulators, governments, doctors or patients.
"The original evidence presented to government agencies
around the world was incomplete," said Fiona Godlee, editor of
the BMJ which has spearheaded a four-year long campaign to force
Roche to reveal all its Tamiflu data.
"And when they (the Cochrane review team) eventually
received the full information on these drugs, the complete
evidence gives a very much less positive picture."
But adding more heat to the row, the European Medicines
Agency (EMA) - which approved the drug for sale in Europe -
disputed the claim they had not seen all the Tamiflu data.
Enrica Alteri, head of medicines evaluation, said the EMA
had seen and reviewed all 20 studies referred to in the review,
adding the latest analysis did not raise any new concerns or
alter the agency's assessment that the benefits of Tamiflu
outweighed its risks.
The Cochrane review found that compared with a placebo, or
dummy pill, Tamiflu led to a quicker alleviation of flu-like
symptoms of around half a day (down from 7 days to 6.3 days) in
adults, but the effect in children was more uncertain.
There was no evidence of a reduction in hospitalisations or
in serious flu complications such as confirmed pneumonia,
bronchitis, sinusitis or ear infections in either adults or
children, Heneghan's team said.
Tamiflu also increased the risk of nausea and vomiting in
adults by around 4 percent and in children by 5 percent, they
said, and there was a reported increased risk of psychiatric
events - described as mood changes - of around 1 percent when
Tamiflu was used as a preventative drug in uninfected people.
Godlee described the battle with Roche as a "really lengthy
cat and mouse, Alice in Wonderland, bizarre experience of trying
to get data on a drug which governments around the world were
busy buying, stockpiling and spending billions of dollars on".
"Why did no-one else demand this level of scrutiny before
spending such huge sums on one drug?" she said. "The whole story
gives an extraordinary picture of the entrenched flaws in the
current system of drug regulation and drug evaluation."
($1 = 0.6028 British Pounds)
(Additional reporting by Ben Hirschler; Editing by Tom