by Richard Brook
Chief Executive, Mind
The so-called recent independent enquiries into the safety of
SSRI's, a type of antidepressant - which include Seroxat - have been
beset by scandal and failure.
These drugs have been reviewed by the UK government regulator
five times over the last decade yet the most recent review has
highlighted some disturbing facts.
First, in March 2003, the Medicines Control Agency (MCA) expert
group had to be reconvened after it was revealed that two members of
the group held shares in GlaxoSmithKline, the manufacturer of
Seroxat, one of the very drugs they were supposed to be
Secondly, in June 2003, I was quite horrified when
GlaxoSmithKline handed the Medicines and Healthcare Products
Regulatory Agency (which replaced the MCA) evidence demonstrating
that Seroxat can cause some young people under 18 to become
Richard Brook resigned from an expert group
examining the safety of SSRIs in
Yet, this evidence came from studies predominantly carried out in
the late 1990s and the last one completed by early 2001.
Thirdly, in March this year, I learnt that the agency had
possessed information for more than 10 years about significant
withdrawal effects if Seroxat was taken in doses of more than 20mg.
This had been included in the original data submitted by
GlaxoSmithKline from which the licence for Seroxat had been first
awarded a decade previously.
Around 17,000 people were taking a dose of more than 20mg, but
the MHRA had failed to take action before this.
I was, at this time, serving on the MHRA's expert group examining
the safety of SSRIs, and felt no option but to resign.
The MHRA had tried to pressurise me not to publicly reveal that
it was, in my view, effectively ignoring data from 10 years ago. I
was not prepared to go along with such secrecy over what is a matter
of public safety.
The agency then accused me of causing unnecessary alarm by
revealing the truth. Either the agency didn't understand the full
implications of the medical data or, worse, that the data was fully
understood and they failed to act.
Whatever way you look at it, by enclosing itself in secrecy the
MHRA was failing its duty to the public. This is unforgivable.
Despite the previous four major regulatory reviews during the ten
years and considerable consumer concern in the media, the public has
never heard the truth about Seroxat - something that is the
responsibility of the MHRA.
I said at the time of my resignation that the MHRA was either
guilty of extreme negligence or worse dishonesty, and I stand by
It was only this week a woman told me how her 18-year-old
daughter committed suicide shortly after starting to take Seroxat
again and days before it was banned for children and young people.
If that ban had been in place earlier it would have meant that
she wouldn't have used it during the last two years of her life.
Do not stop taking medication without seeing a
This mother was convinced that if she and her daughter had known
about the risks of Seroxat she would not have taken it.
She will always be haunted by wondering whether her daughter
would be alive today if she had not taken a drug which, we were all
told, had no dangerous side effects.
My job at Mind is to try and act on behalf of mental health
service users. The MHRA should, at the end of the day, be doing the
same for all patients.
There should be a public enquiry into drug regulation. If the
sorry story of Seroxat is not convincing enough, look at past
Remember the scandal in the Eighties of the benzodiazepine drugs,
such as Valium, when tens of thousands of people told of their
horrors of addiction?
People who took benzodiazepines complained - and still do - of
blackouts, epileptic seizures, memory loss, brain damage, insomnia
and personality change. At first the drug regulators did not accept
benzodiazepine addiction, or "dependence".
It was only when, once again, Mind teamed up with another TV
programme, "That's Life", to survey evidence from thousands of
benzodiazepine users that the regulators were forced to face up to
the scourge of addiction.
Subsequently, in 1988, the Committee of Safety of Medicines
advised for benzodiazepines not to be prescribed for more than four
weeks. Too late, I'm afraid, for thousands of people up and down the
We must urgently establish an independent drug regulatory agency
which is supported with adequate government funding and operates
independently from the drug industries' influence.
This is even more vital considering that more than 90 per cent of
published research into antidepressants is funded by pharmaceutical
firms. Yet, their raw data is often hidden away, unavailable to
scrutiny from independent researchers.
At the moment, the MHRA receives its entire funds from drug firm
licence fees, and some of the professionals sitting on key MHRA
committees own shares in or work in institutions that receive
research grants from pharmaceutical firms.
Having shares does not prohibit you from serving with the MHRA.
It just means you must not give your opinion on the particular drug
whose manufacturer you own shares.
Upset and angry
This arrangement is simply not robust enough to give us
confidence that undue influence does not occur.
The MHRA also only takes seriously clinical trials and clinical
data and, in reality, ignores the experiences of people actually
using the drugs they regulate.
Shocking testimony of those who say their lives have been ruined
by horrendous side effects of Seroxat is abundant, and much of it
has been recorded on side-effect reporting cards - called "Yellow
Cards - submitted to the agency. In light of the lack of influence
they have had, these Yellow Cards might as well have been thrown in
It makes me upset and angry that no real action is as yet
resulting from this tragedy unfolding before our eyes. I am not
against the prescribing of any medicines including anti-depressants
that are beneficial and work for individuals.
But I am against inappropriate and dangerous prescribing brought
about by the failure to license medicines adequately.
If you are taking Seroxat or any other prescribed drug and
have concerns about your treatment you should always discuss them
with your doctor. Do not stop or change medication without medical