J
John
Guest
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.
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.