'ineffective and potentially harmful'
antidepressant prescribed to about 5,000 people in England at a cost to
the NHS of almost £900,000 a year is "ineffective and potentially
harmful", academics have concluded.
discovered that reboxetine, marketed as Edronax by Pfizer, was no more effective
at countering major depression than a placebo sugar pill, after studying
all available data on the drug.
study, published in the British Medical Journal today (WED), the German
researchers found that some trials which failed to show reboxetine worked
well were not submitted for publication by academic journals.
they said, was "a striking example of publication bias" - where
academics or drug companies decide not to publish unfavourable results in
data on nearly three in four patients who took the drug went unpublished,
claimed the researchers, working for the German Institute for Quality and
Efficiency in Health Care.
on 74 per cent of the patients included in our analysis was unpublished,
indicating that the published evidence on reboxetine so far has been severely
affected by publication bias," they wrote.
the studies were taken into account - both published and unpublished - then
the evidence showed that the risks of taking the drug outweighed the benefits.
Their analysis found that those who took reboxetine were more likely to
have "at least one adverse event" than those given a placebo.
However, there was no significant difference in the rate of suicide attempts
between the two groups. They
noted that guidance issued by Britain's National Institute for Clinical
Excellence (Nice), that "reboxetine is superior to placebo and as effective
as other antidepressants" was in their opinion, a conclusion that "can
no longer be upheld".
for Pfizer said: "Pfizer discloses the results of its clinical trials
to regulatory authorities all around the world. These regulatory authorities
carefully balance the risks and benefits of each medication, and reflect
all important safety and efficacy information in the approved product labelling.
will review the meta-analysis relating to reboxetine published in the British
Medical Journal on 13th October 2010 in detail and will provide further
comment after completing the review."
Adams, Medical Correspondent