News

Sport

Argument

Education

Money

Jobs

Travel

Enjoyment

News

UK
Crime
Environment
Health/Medical
Legal
Media
Politics
This
Britain
Transport
Ulster
Europe
World
Environment
Politics
Sci/Technology
Africa
Americas
Asia
Australasia
Middle
East
Robert
Fisk
Business
News
Analysis
& Features
Comment
Citywire
People
Obituaries
Profiles

Home  > News > UK > Health/Medical

Across the site

Related links

Pharmaceutical
companies accused of manipulating drug trials for profit

The
link between industry, authors and their results

Firms
become more aggressive as productivity crisis takes its toll

Leading
article: We have a right to know when the drugs don't work

Editor's Choice

Then there was one
From now, Neil Hannon is The
Divine Comedy

Simon Carr
Our leader will resign in the summer -
you heard it here first, I hope

Kill Bill Vol. 2
For first time,
Tarantino
hits us
where it hurts

Questions please ...
..for Alison Lapper, the
disabled model for Trafalgar Square's statue

Anthony Sampson
We meet the master anatomist
of power

Book Group
Join Independent forum

Also from this section

Fall
of the sun king: professor is sacked for saying UV rays can be good
for you

The
link between industry, authors and their results

Firms
become more aggressive as productivity crisis takes its
toll

Childhood
glandular fever linked to multiple sclerosis

Skin
virus 'could be natural cure for acne'

Pharmaceutical companies accused of manipulating drug
trials for profit

By Jeremy Laurance Health Editor

23 April 2004

The multibillion-pound global pharmaceutical industry is accused today
of manipulating the results of drug trials for financial gain and
withholding information that could expose patients to the risk of
harm.

The stranglehold that the industry exerts over research is causing
increasing alarm in medical circles as evidence emerges of biased results,
under-reporting and selective publication driven by a market worth more
than £10bn a year in the UK.

In cancer, heart disease, mental health and related fields the industry
has sponsored trials of new drugs which have held out great promise for
patients. But when the same drugs have been tested in independent trials
paid for by non-profit organisations - governments, medical institutions
or charities - they have yielded different results.

Heart drugs prescribed for abnormal heart rhythm introduced in the late
Seventies were estimated to kill more Americans each year by 1990 than the
Vietnam War. Yet early evidence which suggested the drugs were lethal, and
might have saved thousands, went unpublished.

Expensive new cancer drugs introduced in the last decade and claiming
to offer major benefits have increasingly been questioned. Evidence
published in the Journal of the American Medical Association showed
that 38 per cent of independent studies of the drugs reached unfavourable
conclusions about them, compared with just 5 per cent of the studies
funded by the pharmaceutical industry.

In the latest case, researchers commissioned by the National Institute
for Clinical Excellence (Nice) to develop guidelines for prescribing
antidepressant drugs to children, say they were refused access to
unpublished trials held by the pharmaceutical companies.

Published evidence suggested that the antidepressant drugs called SSRIs
(selective serotonin re-uptake inhibitors) were safe and effective for
children.

But when researchers obtained the unpublished evidence by contacting
individual researchers who had worked on the trials, a picture emerged of
increased risk of suicidal ideas and attempted suicide. Only one drug,
Prozac, was safe.

Antidepressants, though not recommended for children, were widely
prescribed until last year when the Medicines and Healthcare Products
Regulatory Agency (MHRA) issued a warning to doctors, prohibiting their
use. This followed safety concerns raised by campaigners and taken up in
two BBC televisionPanorama broadcasts.

Writing in The Lancet, the authors say: "On the basis of
published evidence alone, we could have considered at least tentatively
recommending use of these drugs for children and young people with
depression. However, our review of combined published and unpublished data
... suggest that these SSRIs are not efficacious. Moreover a possible
increased risk of suicidal ideation, serious adverse events or both,
although small, cannot be ignored."

Tim Kendall, from the Royal College of Psychiatrists, said the
researchers had been "unnerved" by the possibility that Nice could have
issued wrong or harmful advice because it did not have access to the full
data.

The same concerns would apply to advice issued about other drugs in
other specialist areas, he said. Guidelines were being drawn up for the
use of antidepressants in adults based on 1,000 published trials but it
was possible there were tens or hundreds of unpublished trials they had
not seen.

The Lancet says the possibility that the suicide of a child
could be provoked by a supposedly beneficial drug would be a "catastrophe"
and the idea of the drug's use being based on "selective reporting of
favourable research" should be "unimaginable." It says the story of
research into SSRIs in childhood "is one of confusion, manipulation and
institutional failure."

It cites an internal GlaxoSmithKline memo, published in the Canadian
Medical Association Journal last month, referring to a study of the
antidepressant Seroxat (paroxetine) in children. The memo said: "It would
be unacceptable to include a statement that efficacy had not been
demonstrated, as this would undermine the profile of paroxetine."

Billions of pounds are spent on the basis of published evidence,
assembled by organisations such as Nice, The Lancet says. Global
sales of GlaxoSmithKline's Seroxat amounted to $4.97bn last year.

Andrew Dillon, chief executive of Nice said: "The institute's ultimate
objective is to be given and to be able to use freely all data relevant to
the guidance which it is asked to develop. We continue to work to that
objective."

The Association of the British Pharmaceutical Industry said it was
prevented under Nice's rules from supplying unpublished data for the
preparation of clinical guidelines. But, it has set up a register of
clinical trials, and regulations to be introduced next month under the
European clinical trials directive would make monitoring easier.

Search this
site:

Printable Story

Terms of
Use | Privacy
Policy, including use of cookies | Sign up
for our free daily news update
Freelance
contributions | Advertise
in print | Other
Digital sites | Contact
us

© 2004 Independent
Digital (UK) Ltd