companies have been accused of failing to publish drug trials which
do not give the "right" result.
Some drug research is not
Regulatory bodies found it harder to make balanced decisions when
negative information was not available, the Lancet medical journal
Published research suggested a type of antidepressant drug was
safe for children, but unpublished data indicated it was not, a
The pharmaceutical industry said it was taking steps to solve the
A study by the National Collaborating Centre for Mental Health in
London looked at previous research on selective serotonin reuptake
inhibitors (SSRIs) for children.
It found that
in published studies, all SSRIs appeared to have a favourable ratio
of risk to benefit.
But, after also looking at unpublished trials, it was found that,
with the exception of fluoxetine, the risks exceeded the benefits.
The Department of Health said last year that most SSRIs should
not be given to children.
Tim Kendall, at the centre, said this damaged the role of the
National Institute for Clinical Excellence (NICE) in drawing up
He said: "Drug sponsors who withhold trial data, or do not make
full trial reports available, undermine the guideline programme,
which can ultimately lead to recommendations for treatments that are
ineffective, cause harm, or both."
The Lancet accused pharmaceutical companies of "confusion,
manipulation and institutional failure".
It said Governmental bodies such as NICE require legal powers to
ensure biomedical research is used to improve health even if it does
not lead to profits for pharmaceutical companies.
The Association of the British Pharmaceutical Industry (ABPI)
said it accepted that "things could be better" but that the industry
was taking steps to make improvements.
A spokesman said: "We are aware of the problem, we understand
that the situation is not entirely satisfactory."
However, part of the blame lay with medical journals which were
not keen on publishing negative trial results as they did not make
such good news, he said.
The ABPI lists some unpublished trials on its website and a
Europe-wide register of all unpublished data will become available
to regulatory authorities under a new European Union directive.
The ABPI spokesman added that of the five SSRIs available in the
UK, only one is recommended for use in children and the
pharmaceutical companies would not be promoting them as this was
A Department of Health spokeswoman said: "The UK last year
advised that the treatment of childhood depression with any SSRI,
except Prozac, should not continue, after a thorough review of data.
"The UK is the only country in Europe to have issued
comprehensive advice about the use of all SSRIs in children."
She added: "The Medicines and Healthcare products Regulatory
Agency supports the need for greater transparency from companies and
forthcoming changes to EU and UK legislation will strengthen the law
in this area."