Regulator ‘ignored’ drugs research claim

The UK medicines regulator ignored evidence that antidepressants
can make adults prone to suicide, a scientist has claimed.

Dr Ivar Aursnes, of the University of Oslo, said the Medicines and
Healthcare products Regulatory Agency (MHRA) showed “no interest”
last year in his initial findings that paroxetine, a class of SSRI
(selective serotonin reuptake inhibitor) that includes the drug
Seroxat, could increase suicidal tendencies among adults as well as
children.

This week he published a report claiming that people taking the
drug were seven times more likely to attempt suicide than those
taking a placebo. The MHRA said it would review the evidence, but
for now its advice on SSRIs remains the same.

In 2003 it ruled that every SSRI bar Prozac was unsafe for
under-18s. But last year, after a lengthy investigation, it decided
there was “insufficient evidence” that adults were affected in the
same way.

Aursnes claimed data supplied by GlaxoSmithKline (GSK) from
clinical trials of patients taking Seroxat did not separate those
who had attempted suicide from those contemplating suicide.

He said he had contacted the MHRA during its investigation, telling
it of his concerns and requesting the trial data, but was in effect
ignored. He later acquired the data from the Norwegian authorities.

The MHRA denied it ignored Aursnes’s approach.

GSK said the study was no more than a sub-analysis based on data
collected 15 years ago.