Spending
more on stockpile of controversial anti-flu drugs that has already cost over
£500m verges on the reckless, says MP
 |
| Antiviral drug Tamiflu tablets produced by Roche Pharmaceuticals. Photograph: Per Lindgren/REX |
The
government has spent an additional £49m within the last year on renewing its
stockpile of Tamiflu, the drug which independent scientists say may do nothing
to prevent a flu pandemic.
The
decision to spend yet more money on a stockpile of controversial drugs that has
already cost over £500m "verges on the reckless, given that the evidence
base was already very shaky", according to Richard Bacon, Conservative MP
and senior member of the public accounts committee.
The
revelation of the extra spending came in the government's response to the
committee's report in January, which recommended that no more Tamiflu should be
bought until the Department of Health had reviewed the need for it.
At the
time, the committee was told the department had spent £424m on Tamiflu and
£136m on a similar, but inhaled, flu drug called Relenza. The extra £49m takes
the total spend to £609m.
On
Thursday, independent scientists from the Cochrane Collaboration published an
analysis of all the data from the clinical trials conducted by manufacturers
Roche and GlaxoSmithKline prior to licensing of the drugs, which took them over
four years of negotiations to obtain.
They
concluded that the drugs shorten a flu bout by approximately half a day, but
there is no proof that they prevent hospitalisations or complications such as
pneumonia and, when used to prevent flu, they cause some people serious
complications including psychiatric and kidney problems.
The
companies maintain the drugs are safe and useful, but Bacon says the doubts
about the drugs were evident at the time of his committee's inquiry last year,
before the extra £49m had been spent. A key member of the Cochrane team gave
evidence. "You don't spend £400m to reduce flu symptoms by a day or half a
day. You buy Lemsip for that. You spend millions of pounds on it to prevent
pandemic flu," he told the Guardian. "They should have held off and
waited until the further analysis was available."
In its
response to the PAC report, the government said that the 2013-14 programme to
replace drug stocks going out of date with new batches was already in place.
The decision to go ahead "supports the department's commitment to be ready
for a more severe influenza pandemic and to pay the prices agreed in the
current contract."
The
government also dismissed calls by the committee for all clinical trials – past
and future – to be registered and the data from them made available for wider
independent scrutiny, saying it was "not feasible" to do it
retrospectively.
"What
is wrong with opening it up to wider independent scrutiny?" asked Bacon.
"Are we to believe the work undertaken by regulators has some kind of
magic charm about it and that there is a priestly caste called
government-appointed scientists who have available to them insights that are
not available to others? Are they asking us to go back to the 13th century or
the 16th century or back to alchemy? Is this what they want? That's what it
sounds like to me and I think it is ridiculous."
A growing
number of senior scientists believe the problem lies with the piecemeal way in
which clinical trials are done. They are not set up to answer specific
questions that are of agreed international important, such as, in the case of
Tamiflu, precisely what complications it can prevent and what use it would be
in a pandemic.
Jeremy
Farrar, director of the Wellcome Trust and a professor of tropical medicine at
Oxford University, said regulators, scientists, doctors, policymakers and
others involved in drug development must come together to work out what the
crucial questions are that need to be answered, so that when there are many
trials, often of broadly similar drugs, the results can be aggregated for a
clear picture of what works and what does not. On Tamiflu, he said, "the
honest truth is we simply do not know", because the trials were not
designed to seek the right answers.
We could
learn from the approaches that have been taken to diseases in poor countries,
such as malaria and HIV, he said, where using money and time cost-effectively
to come to the right answers is critical.
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