"Medicines watchdog 'under fire'", BBC News, October 3, 2004,
Link: http://news.bbc.co.uk/1/hi/health/3708264.stm

The agency responsible for monitoring the safety of medicines in the
UK faces allegations it is failing to protect patients.

A BBC Panorama investigation claims vital information relating to the
anti-depressant Seroxat was overlooked.

It suggested the drug could be addictive and increase suicidal
feelings in young adults

The Medicines Healthcare products Regulatory Authority (MHRA) has
rejected the criticisms.

Panorama claims that trial results contain evidence that Seroxat can
leave a quarter of all users addicted, that it may increase the risk
of suicide in young adults and that rapid increases in dosage can
cause serious side effects.

Some of this is evidence that Panorama claims the regulator could have
spotted years ago as it had some of the confidential clinical trial
information since before the drug was licensed 13 years ago.

The chief executive of the MRHA, Professor Kent Woods said: "There is
concern in children and adolescents that there is an increased risk of
suicidal ideas, specifically on Seroxat.

"And for that reason we gave advice to doctors and their patients in
June of last year that the drug was contra-indicated in children and

"But in adults the evidence is not clearly there and we are talking
purely on a precautionary basis that this form of treatment - as with
any other form of anti-depressant treatment - should be carefully
monitored during the early weeks," Prof Woods told BBC News24.

He said Panorama's claim that the regulation of drugs was a secretive
business which does not put safety of patients first was "completely

Outlining the scientific and parliamentary scrutiny that the MRHA
operates under, Prof Woods added: "The suggestion that we are
secretive or that we are not being forthcoming in relation to data on
patient safety is quite false."

Concerns about the drug have been raised by patients and medical

The head of a leading mental health charity also told Panorama that
the MHRA, the UK's medicines watchdog, was not doing its job properly
on drug regulation.

Richard Brook, of Mind, said he had "little confidence" drugs were
being licensed in a way he found appropriate.

He was part of a group reviewing the safety of anti-depressants and
was the first patients' representative ever to sit on one of these
reviews, but resigned from the MHRA earlier this year.

'Serious implications'

Mr Brook told the BBC: "I have little confidence that the drugs
they're licensing day-by-day are being licensed in a way that I would
feel appropriate and I have very little confidence in drugs that have
been regulated in the past."

Speaking about the debate surrounding Seroxat, Dr Mike Shooter,
President of the Royal College of Psychiatrists, said: "It has serious
implications for the whole of psychiatry, it has serious implications
for the whole of medicine.

"I think a few years down the line we are going to be talking about
this with many more sorts of medication."

An internal MHRA investigation is currently considering whether
GlaxoSmithKline, which makes Seroxat, acted promptly enough in handing
over crucial safety information about Seroxat.


GlaxoSmithKline said it hoped people would not be deterred from
seeking treatment for depression and other psychiatric disorders.

It added: "Seroxat is a serious medicine designed to treat serious
psychiatric diseases that cause many thousands of premature and often
preventable deaths around the world every year.

"The effectiveness of Seroxat has been demonstrated in clinical trials
involving more than 24,000 people and through its use in tens of
millions of patients over more than a decade.

"As with all important medicines, Seroxat and other SSRI
anti-depressants can cause side effects in some people."