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Drug companies fail to give negative results in drug
trials23 Apr 2004
An
article in the Lancet says the drug companies fail to publish
negative results from drug trials. This makes it more
difficult for regulatory authorities to make well informed,
balanced decisions because the ‘cons’ (disadvantages,
negatives) are not all there.
One example is research
that was published about an antidepressant, it said the drug
was safe for children. However, the unpublished part of that
research said completely the opposite, it said the drug was
not safe for children.
Drug companies say they are
taking measures to make sure this sort of problem is sorted
out.
The National Collaborating Centre for Mental
Health, London, UK, looked at research that had been carried
out on SSRIs (selective serotonin reuptake inhibitors) for
kids.
They discovered that if you just looked at the
published data from the studies, the risks tipped the balance
in the children’s favour - the benefits to the kids outweighed
the risks. When they included the unpublished material they
found quite the opposite, the risks were greater than the
benefits – for kids. The exception was fluoxetine, this still
looked a safe bet for kids. Last year the Dept of Health of
the UK told doctors not to give kids SSRIs with the exception
of fluoxetine.
Tim Kendall, National Collaborating
Centre for Mental Health, 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 article in the Lancet really has a
go at the pharmaceutical industry, accusing them of confusion,
manipulation and institutional failure.
The article
goes on to say that such bodies as NICE (National Institute
for Clinical Excellence, UK) should have more powers so that
it can make sure that research is primarily carried out to
improve human health rather than just help the pharmaceutical
industry make a load of money.
The ABPI (Association
of the British Pharmaceutical Industry) said that its members
were taking steps to make improvements. It acknowledged that
things were not as good as they could be. "We are aware of the
problem, we understand that the situation is not entirely
satisfactory" said a spokesperson.
The spokesman added
that medical journals were partly to blame because they prefer
to publish good trial results as they tend to help increase
circulation.
Under new European Union law, all
unpublished data will become available in a register to
regulatory bodies.
The UK is the only country in
Europe to advise its doctors not to give kids SSRIs (apart
from fluoxetine). |
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