Experts accuse drug companies of suppressing results of clinical trials

Concerns about the safety of leading psychiatric drugs were raised
again last week when MPs heard claims that pharmaceutical companies
suppress the results of clinical trials that do not suit their
interests.

Drug companies “ghost write” about half of all drug research
papers, offer bribes to doctors not to publish damaging results,
and pay “opinion leaders” to persuade others not to publish,
parliament’s health committee was told.

Richard Brook, chief executive of Mind, recalled his “scary and
painful” experiences as an appointee on the Medicines and
Healthcare products Regulatory Agency, where he fought for two
anti-depressants to be withdrawn.

For two years, the manufacturers of Seroxat and Effexor withheld
trial data from the MHRA which suggested that they might pose a
suicide risk in children, Brook said.

“Every time we made a difficult decision there was always this
issue that the pharmaceutical company would sue us if we got it
wrong. That dimension was always more on the minds of officials
than the interests of patients.”

Even after both drugs were banned for use on under-18s, a
Department of Health official visited the MHRA to voice concern
that “we no longer have anything to prescribe to children”, Brook
said.

He also criticised the MHRA for not obtaining data on adverse drug
reactions from the regulators in other countries.

Psychologist Professor David Healy said he had uncovered data
showing that the anti-psychotic Zyprexa had the highest number of
suicides in a clinical trial for any current psychotropic drug. But
data on “suicidal acts” were being suppressed by the US Food and
Drug Administration, he said.

Thoughts of suicide were often hidden in trial data under
euphemisms such as “nausea”, or “emotionally labile” in the case of
children, said Healy, while violent aggression in children was
sometimes coded as “hostility”.

Professor Andrew Herxheimer of the UK Cochrane Centre, Oxford,
argued that responsibility for monitoring adverse drug reactions
should be taken away from the MHRA and given to an independent
agency, funded by a tax on drug sales.

Graham Vidler, head of policy for the consumers’ group Which, said
Britain’s system for regulating drugs was “weak and
unco-ordinated.”