NOT!
Negative drug research 'withheld'
Some drug research is not published Drug companies have been
accused of failing to publish drug trials which do not give
the "right" result. Regulatory bodies found it harder to
make balanced decisions when negative information was not
available, the Lancet medical journal said.
Published research suggested a type of antidepressant drug
was safe for children, but unpublished data indicated it was
not, a study showed.
The pharmaceutical industry said it was taking steps to
solve the problem.
A study by the National Collaborating Centre for Mental
Health in London looked at previous research on selective
serotonin reuptake inhibitors (SSRIs) for children.
The UK is the only country in Europe to have issued
comprehensive advice about the use of all SSRIs in
children
Department of Health 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But, after also looking at unpublished trials, it was found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 guidelines.
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."
Manipulation
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The ABPI lists some unpublished trials on its website and a
Europe-wide register of all unpublished data will become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 illegal.
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."
Editor's response
Deborah Glover, editor of the Journal of Wound Care,
dismissed the idea that medical journals were reluctant to
publish negative trial results.
She told BBC News Online: "I rather think the ABPI spokesman
may be confusing the academic, research focused,
professional journals with tabloid newspapers.
"I have in previous editorials called for industry to
allow the publication of the less than positive results
from their research as I believe that not only will this
give our readers the information they require, but
demonstrates an integrity and confidence on behalf of the
industry that facilitates trust between themselves,
clinicians and patients.
"The ABPI should now 'name and shame' the journals who
appear to be only after the sensational headlines. I would
be interested to hear about them as having undertaken a
straw poll amongst my colleagues, I can only find those who
refute their claims."