You can see what goes on over drug safety, eg vaccines.
Why I resigned over this disgraceful "happy pill" cover-up
For years the government has known Seroxat anti-depressants can be
dangerous. When one expert was asked to hide the truth, he quit.
Here he reveals why.
by RICHARD BROOK
Daily Mail March 23 2004
CHIEF EXECUTIVE OF MIND
LAST week I resigned from the Government's watchdog on
anti-depressants after it tried to cover up its own ten-year failure
to identify serious side-effects of the controversial drug Seroxat.
The Medicines and Healthcare Products Regulation Agency found from
information that had been in its possession for more than a decade
that high doses of the anti-depressant can lead to aggression and
thoughts of suicide.
But instead of revealing the truth to the 17,000 people taking high
doses and the other half-million Britons on a safer dose, the MHRA sat
on its findings.
Astonishingly, I was actually threatened with legal action by
Professor Kent Woods, chief executive of the MHRA, if I revealed this.
Mind, the mental health charity, has been tracking Seroxat for a
decade and found it to be the most problematic anti-depressant.
Side-effects include nervousness, aggression, irrational thoughts and,
in some cases, feelings of suicide.
Although Seroxat has been effective for thousands suffering from
severe depression, there are many who blame tragic events, including
murders and suicide, on it.
Last year, BBC's Panorama showed that despite denials from the
manufacturer people can get hooked on Seroxat and suffer terrible
withdrawal symptoms when trying to come off it.
The drug's manufacturer, Glaxo-SmithKline, has sought to play down its
side-effects, denying until last year that it could be addictive.
Mind along with dozens of people suffering the drug's side-effects
held a demonstration last June outside MHRA's headquarters in London,
calling for the drug regulator to take action.
BY THE end of that week, I had been invited to join its
expert panel to look at the effectiveness of the so-called 'happy
pills', selective serotonin re-uptake inhibitors (SSRIs) drugs
prescribed to tackle depression, anxiety and other psychological
problems. They include Prozac and Seroxat.
I hoped we could issue clear guidance to doctors on how to prescribe
SSRIs safely. But my colleagues at the regulator, all from the medical
establishment doctors, academics and psychiatrists had different
ideas.
They appeared more interested in putting their reputations, and those
of drugs companies, before the safety of patients.
In October, the MHRA reviewed data from the earliest trials of
Seroxat. The information was supplied by GlaxoSmithKline in the late
Eighties, and it was the MHRA's responsibility to analyse the
statistics to inform its decisions.
In four reviews of these statistics over ten years, the regulator had
failed to pick up the vital information that any dose of Seroxat above
20mg a day doesn't work any better but significantly increases the
side-effects. Some 17,000 people were prescribed more than 20mg of
Seroxat last year.
But the panel wanted to kick the findings into the long grass, passing
it to European regulators. It would take months. In that time,
hundreds would be prescribed dangerous levels or Seroxat.
It was then that Professor Woods made clear I faced prosecution if I
revealed what the regulator had found, citing the need to protect the
'commercial confidentiality' of drugs firms.
On the MHRA website, Professor Woods defends the watchdog, saying its
advice is backed by clinical data.
A few days later, I went to see Health Minister Lord Warner to tell
him of my concerns. He said he would speak to the regulator, and soon
after they reluctantly published the findings.
Their statement 'reminded' doctors not to prescribe more than 20mg, as
if it had been common practice all along. Previously, the MHRA's
recommended 'safe' dose was 20mg to 50mg a day.
I resigned. If a regulator will not own up to its mistakes, who knows
if data about other drugs has not also been overlooked, with
potentially fatal results.
Regulators are supposed to be a stop-check for safety issues. But at
the MHRA, many of the people who work there or advise it have ties to
drugs firms. Some have shares in the companies, research departments
funded by them or receive fees for advice.
The only protection is a musical chairs system where you leave the
room if you have an interest in the drug being discussed or its
manufacturer, or you can stay but not vote.
THERE is an urgent need for an independent inquiry into the MHRA. The
Government must also change its culture of secrecy.
Seroxat is far too extensively prescribed, especially for mild and
moderate depression. But anti-depressants including SSRIs do work,
and can prevent suicides in severe cases. However, they are not wonder
drugs.
GPs should clearly outline all the options to sufferers and
anti-depressants shouldn't be the automatic answer. If vital
information such as that the MHRA tried to cover up is not released,
these decisions cannot be fully informed.
Likewise, patients on Seroxat concerned by my findings should consult
their doctor before adjusting their medication.
Mind does a lot of work with the Government, and we have a good
relationship. But I am very concerned that I was put under such
pressure not to reveal the regulator's findings.
My only hope in speaking out is that the regulator will change. It
must listen to people suffering negative side-effects of drugs and to
be more accountable to patients rather than to pharmaceutical
companies.
Dr Alastair Benbow, European medical director at GlaxoSmithKline,
says: 'We remain fully confident in the effectiveness of Seroxat, an
important medicine that has helped many millions around the world lead
fuller lives.'
RICHARD BROOK is chief executive of Mind. REPORTING by Gideon Burrows.
David Wright - 29 Mar 2004 05:27 GMT
>You can see what goes on over drug safety, eg vaccines.
Another fine example of John's dishonesty -- he takes a controversy
over an antidepressant and attempts to smear vaccines.
-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If I have not seen as far as others, it is because giants
were standing on my shoulders." (Hal Abelson, MIT)
Rich Andrews. - 29 Mar 2004 09:54 GMT
wright@clam.prodigy.net (David Wright) wrote in news:2BN9c.34449$Qt4.20145
@newssvr31.news.prodigy.com:
>>You can see what goes on over drug safety, eg vaccines.
>
> Another fine example of John's dishonesty -- he takes a controversy
> over an antidepressant and attempts to smear vaccines.
john whaleto isn't just dishonest. He is a liar and the number of ways that
he lies is almost without bounds. He is a prime example of everything that
is wrong with anti-vaccination group and with many alt-med proponets like
Hulda, Bertha, the CCRG, etc. "If the facts don't fit your agenda, make them
up" appears to be their manifesto.
r

Signature
Nothing beats the bandwidth of a station wagon filled with DLT tapes.
Samy Wang - 30 Mar 2004 22:11 GMT
Why ?
May be he is right, and he would not be the first one then, to be right
with all the others being wrong

Signature
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> >You can see what goes on over drug safety, eg vaccines.
>
[quoted text clipped - 5 lines]
> "If I have not seen as far as others, it is because giants
> were standing on my shoulders." (Hal Abelson, MIT)
David Wright - 31 Mar 2004 05:11 GMT
>Why ?
>May be he is right, and he would not be the first one then, to be right
>with all the others being wrong
If John is right, it'll be an epochal event. He's been cruising along
with a near-perfect record of error so far.
I believe John being right is one of the signs of the Apocalypse.
-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If I have not seen as far as others, it is because giants
were standing on my shoulders." (Hal Abelson, MIT)
>> >You can see what goes on over drug safety, eg vaccines.
>>
>> Another fine example of John's dishonesty -- he takes a controversy
>> over an antidepressant and attempts to smear vaccines.