[Ip-health] Drug giants warned: Tell the truth on medicines

[Ira Glazer]

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By Jeremy Laurance, Health Editor
*Wednesday, 27 February 2008*

The pharmaceutical industry came under assault from senior figures in
medical research yesterday over its practice of withholding information to
protect profits, exposing patients to drugs which could be useless or
harmful.

Experts criticised the stranglehold exerted by multinational companies over
clinical trials, which has led to biased results, under-reporting of
negative findings and selective publication driven by the market, which was
worth =A310.1bn in the UK in 2006, amounting to 11 per cent of total NHS
costs.

The latest attack was triggered yesterday by an analysis of published and
unpublished trials of modern antidepressants, including Prozac and Seroxat,
showing they offer no clinically significant improvement over placebos
(dummy pills) in most patients. But doctors said patients on the drugs
should not stop taking them without consulting their GPs.

It was the first time researchers =96 from the UK, Canada and the US =96 ha=
d
successfully used freedom of information legislation to obtain all the data
presented to regulators when the companies applied to license their drugs.
In some cases it had not been made public for 20 years. Over the past two
decades the drugs, known as selective serotonin re-uptake inhibitors
(SSRIs), have been among the biggest selling of all time, earning billions
of pounds for their makers. Yesterday's finding suggests that the money may
have been misspent. Drug companies are required by law to provide all data
on a drug, published and unpublished, to the regulatory authorities when
applying for a licence. But this requirement does not apply to the National
Institute for Health and Clinical Excellence (Nice), which assesses cost
effectiveness and recommends which drugs should be used by the NHS.

Peter Littlejohns, the clinical and public health director of Nice, said:
"The regulatory authorities have access to everything. Obviously we have
access to the published data and we do ask the industry for unpublished
data, but it is up to the companies whether to deliver it or not. We have n=
o
power to demand it. The issue is that it relies on the good will of the
industry."

Professor Mike Clarke, the director of the UK Cochrane Centre, an
international collaboration between researchers in 100 countries which has
published more than 3,000 systematic reviews of published trials to
establish best medical practice, said lack of co-operation from the drug
industry was damaging medical care.

"When we ask for details of a trial the company might tell us nothing. We
have even less power than Nice. Researchers trying to make sense of trials
for decision-makers need to have access to this data. If we have only got
access to half of the data, when we see evidence that a drug works we don't
know whether to believe it or not.

"It makes us doubtful =96 that's the big worry. The companies are in the
business of making profits =96 but they are also in the business of providi=
ng
safe, effective health care."

Legislation to compel the drug industry to publish its results was included
in Labour's manifesto at the 2005 election and last month the Commons Healt=
h
Select Committee demanded that Nice be given unfettered access to all
clinical trial results.

Yesterday, the Government said it had been told that compelling the industr=
y
to publish trial data would not be allowed and it was instead pursuing a
voluntary approach, developing a "searchable register" of all trials that
have taken place in the UK and pressing the EU to make its own confidential
register public.

A spokesman for the Department of Health said: "The Government has
consistently supported open access to information about research when the
findings could affect decisions about treatment or health outcomes. We
planned to support the principle of mandatory registration of clinical
trials in the UK, but legal advice stated this would be illegal under EU
law." A World Health Organisation working group is examining how to improve
reporting of clinical trials and is expected to announce a consultation
shortly.

The pharmaceutical industry was unrepentant about its strategy yesterday.
Richard Tiner, the head of medicines at the Association of the British
Pharmaceutical Industries, said: "The regulatory authorities have access to
all the data =96 absolutely everything. Nice is not a regulatory authority =
=96
it is making decisions on whether medicines should be available on the
NHS... There is no reason why the companies would restrict access =96 it
depends what they are asked for. The industry is very much more transparent
than it was 10 years ago."

GlaxoSmithKline, maker of Seroxat, said yesterday it "fully endorsed public
disclosure of all clinical trial results" and had published all data
relating to Seroxat on its website "regardless of study outcome".