MPs voice
concern after report into decision to stockpile Tamiflu finds discussions about
effectiveness hampered by practice
The Guardian, Rajeev Syal, Friday 3 January 2014
A review of 20 existing studies into Tamiflu by the Cochrane Collaboration concluded it 'did not reduce influenza-related lower respiratory tract complications'. Photograph: Clive Gee/PA |
Clinical
trial results are being routinely withheld from doctors, undermining their
ability to make informed decisions about how to treat patients, an influential
parliamentary committee has claimed.
MPs have
expressed "extreme concern" that drug manufacturers appear to only
publish around 50% of completed trial results and warned that the practice has
"ramifications for the whole of medicine".
Their
conclusions have emerged in a public accounts committee report which examined
the Department of Health's decision to spend £424m on stockpiling the flu drug
Tamiflu, before writing off £74m because of poor record keeping.
The MPs
found that experts failed to agree on how well Tamiflu works, but discussions
were hampered because important information was held back.
Richard
Bacon, a senior member of the committee, said the practice of holding back
results was undermining the ability of doctors, researchers and patients to
make informed decisions about treatments. "Regulators and the industry
have made proposals to open up access, but these do not cover the issue of
access to the results of trials in the past which bear on the efficacy and
safety of medicines in use today," he said. "Research suggests that
the probability of completed trials being published is roughly 50%. And trials
which gave a favourable verdict are about twice as likely to be published as
trials giving unfavourable results.
"This
is of extreme concern to this committee. The department [of health] and
Medicines and Healthcare products Regulatory Agency [MHRA] must make sure,
prospectively and retrospectively, that clinical trials are registered and the
full methods and results of all trials are available for independent wider
scrutiny by doctors and researchers."
The
committee noted that an NHS National Institute for Health Research review in
2010 estimated that the chance of completed trials being published is roughly
half. Trials with positive results were about twice as likely to be published
as trials with negative results.
Dr Fiona
Godlee, editor-in-chief of the British Medical Journal, told the MPs that the
pharmaceutical industry published more positive results than negative ones from
their trials. She noted that the journal had published very clear summaries of
systematic reviews of data on individual medicines or classes of medicines
where, "when you add together the published and unpublished evidence, you
get a very different picture of the quality and effectiveness of those
drugs".
A review by
the non-profit Cochrane Collaboration into 20 existing studies into Tamiflu
found it "did not reduce influenza-related lower respiratory tract
complications" but did induce nausea.
It is now
receiving full clinical study reports from manufacturer Roche, which are being
used to complete a further review of the effectiveness of Tamiflu. The results
of that should be used by government, the MHRA and the National Institute for
Health and Care Excellence to review the drug's use, MPs said.
They also
called on ministers to take action so that full trial results are available to
doctors and researchers for all treatments currently being prescribed and carry
out regular audits of how much information is being made available.
Bacon
added: "There is still a lack of consensus over how well the antiviral
medicine Tamiflu, stockpiled for use in an influenza pandemic, actually works.
The lack of transparency of clinical trial information on this drug to the
wider research community is preventing proper discussion of this issue among
professionals. We are disturbed by claims that regulators do not have access to
all the available information.
"The
case for stockpiling antiviral medicines at the current level is based on
judgment rather than on evidence of their effectiveness during an influenza
pandemic. Before spending money in future to maintain the stockpile, the
department needs to review what level of coverage is appropriate. It should
look at the level of stockpiling in other countries, bearing in mind that the
patent for the medicine runs out in 2016."
An MHRA
spokesman said the body would work with partners in the UK and in the EU to
ensure greater transparency in the dissemination of clinical trials
information.
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