| Tamiflu Manufacturer Refuses To Disclose
Evidence Suggesting Zero Effectiveness
Roche, the manufacturer of Tamiflu, has made it impossible for
scientists to assess how well the anti-flu drug stockpiled around
the globe works by withholding the evidence the company has gained
from trials, doctors alleged.
Review published in British Medical Journal accuses flu drug manufacturer
Roche of withholding evidence from trials
A major review of what data there is in the public domain has
already found no evidence Tamiflu can prevent healthy people with
flu from suffering complications such as pneumonia. Tamiflu has
actually been found to cause
pneumonia and respiratory failure.
Staunch critic of the drug, Dr. Jonathan Lackow stated "unpublished
preliminary evidence suggested that Tamiflu had zero effectiveness
and it's obvious why they don't want to make that evidence public."
The investigators say It is impossible to know whether it prevents
severe disease because the published data is insufficient. Roche
has failed to make some of the studies carried out on the drug
publicly available, the scientists say.
A recent study conducted by the National Institute for Viral Disease
Control and Chinese Center for Disease Control and Prevention
has found that Tamiflu (oseltamivir) boosts
H1N1 viral infection.
"Governments around the world have spent billions of pounds
on a drug that the scientific community now finds itself unable
to judge," said Dr Fiona Godlee, editor of the British Medical
Journal, which published the new review online and collaborated
in a joint investigation with Channel 4 News, shown this evening
.
Roche has made a fortune out of the drug, with sales of £1.6bn
this year alone. The British government has stockpiled enough
for half the population.
In the review, Professor Chris Del Mar, from Bond University
in Australia, analysed 20 published trials that focused on prevention,
treatment and adverse reactions. The authors say they were hampered
by the "paucity of good data".
The reviewers were forced to leave out eight trials because they
had not been published, and Roche offered them "under conditions
we thought unacceptable, and what was offered to us was insufficient
to analyse properly."
Because they did not have full access to all the trials, the
reviewers say previous evidence on the effects of Tamiflu and
other drugs of this class (the neuraminidase inhibitors) may be
unreliable. They call on governments to set up studies to monitor
the drugs for safety.
A second review was carried out in the UK at Birmingham University
by Professor Nick Freemantle and Dr Melanie Calvert, who analysed
a series of observational studies Roche provided. (These are studies
of people who took the drugs, but without a comparison group of
people who did not take them.)
Freemantle 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."
He added: "We have remarkably few resources in this country
to spend on pharmaceuticals on health, and it is surprising to
see such widespread use of oseltamivir. But I suppose that once
you've gone and bought lots of doses, then it's a bit like the
situation with gun control in the US. If you have a gun in the
house, it is much easier to use it. But it does not mean it's
the right thing to do."
Dr Godlee and Professor Mike Clarke, director of the UK Cochrane
Centre, call in the BMJ for new global legislation to ensure all
trial data on drugs that have been granted a licence must be published
in full.
Roche has now undertaken to put summaries of all the Tamiflu
study data on a password-protected site.
Reference Source 147, 241
December 10, 2009
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