TRANSCRIPT ...... Panorama Taken On Trust Rrecorded from Transmission: BBC-1, 3-10-04

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PANORAMA

 

TAKEN ON TRUST

RECORDED FROM TRANSMISSION: BBC-1 DATE: 3:10:04

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SHELLEY JOFRE: Every one of us uses prescription

drugs at some time in our life. We take it on

trust that these pills are safe. But are they?

 

JUDY BARTLETT: The suicidal thoughts only

happened while I was taking the drug, they've

never happened before or after.

 

JOFRE: Some of the most influential names in

medicine are now asking if we're being told

the truth about the pills that we take.

 

MIKE SHOOTER: It has serious implications for

the whole of psychiatry, it has serious

implications for the whole of medicine.

 

JOFRE: For more than two years, Panorama has

been investigating your concerns about Seroxat,

one of the world's most controversial drugs.

 

SARAH THOMPSON: I'd never thought about suicide

before I took Seroxat and when I was taking it.

I was obsessed about death, it was part of my

every day life.

 

JOFRE: What you've been telling us has exposed

major failings in this country's system of

medicines regulation.

 

CHARLES MEDAWAR: They failed. They failed

miserably and they caused a huge amount of

distress because they did.

 

JOFRE: This man has been inside the secret

world of the medicines regulator. He found

that for years it missed crucial safety evidence

on Seroxat; a failure which must raise concerns

about other medicines we take.

 

RICHARD BROOK: I have little confidence that

the drugs they're licensing day by day are being

licensed in a way I would feel appropriate and

what's even more concerning I have very little

confidence in drugs that have been regulated in

the past.

 

DAVID HEALY: I think in due course we may look

at all of this and think this was one of the

biggest medical scandals ever.

 

JOFRE: Now the regulator's handling of one drug

calls into question whether prescription medicines

should be taken on trust. This dreary office

block in south London is home to a very important

government agency. The Medicines Healthcare

Products Regulatory Agency or MHRA. You've

probably never heard of them. They're a kind

of pill police.

 

Sir ALASDAIR BRECKENRIDGE

Chairman, Medicines Healthcare and

products Regulatory Agency

The primary role of the MHRA is to protect the

public health. It also has got a responsibility

to ensure that only drugs which are effective

and safe come to the market and remain on the

market.

 

JOFRE: The MHRA maintains its one of the finest

regulators in the world. But that boast has been

seriously undermined by your complaints about

Seroxat. It's one of the most widely prescribed

anti-depressants in the UK and was licensed by

the regulator 13 years ago. Over the course of

two years, Panorama has investigated your complaints

and uncovered evidence that Seroxat can cause

aggression…

 

MARTIN HAZEL: I started thinking that everybody

was out to get me. I started to feel angry and

murderous. I wanted to kill my partner and my

family. I've never felt like that before. I sat

on the edge of the bed holding my knees up against

me because I knew that if I moved I would kill

everybody.

 

JOFRE: Evidence it can cause suicide…

 

JAKE EMMS: My father was on Seroxat for four days.

On the fourth day of taking them he was in possession

of a hunting gun and he went to a local wood and shot

himself.

 

JOFRE: Evidence it can harm children…

 

LAURA BANNING: When I was on the tablets I did

self-harm. I would use any sharp thing like

scissors, knife, and I would just put the point

to my arms and just scrape until it bled.

 

JOFRE: And evidence it can leave you hooked.

 

SARAH VENN: I came home for Christmas one year

and forgot to take my drugs with me and within a

day of not having Seroxat I was going absolutely

berserk. I was threatening to drive 100 miles

back home to get a pill - to take it. I was

driving around pharmacists begging them to give

me a packet of Seroxat.

 

JOFRE: Seroxat is one of a group of antidepressants

known as SSRIs which got the Regulator's seal of

approval in the early `90s. They're marketed to

treat all sorts of anxiety, stress and depression

and have helped millions of people. But they're

also hugely controversial. Five times the regulator

has reviewed the safety of these drugs. Five times

they've been given a clean bill of health. But in

the case of Seroxat - each time the regulator got

it wrong; failing to spot crucial safety information,

some of which has been under its nose for 13 years.

It's a story that raises serious questions about

the system of medicines regulation in this country.

 

DONNA WOODMORE: The worst I personally feel is

when I attacked my daughter. I held her head

in my hands and I was hitting her head on the

floor over and over again.

 

THOMAS STEVENSON: I told him explicitly about

the dreams I was having and he just started to

laugh so I said to him, `doctor, I don't find this

very funny because I'm dreaming about murdering

children.

 

JOFRE: This wider picture has only now become

clear because this man – the head of Britain's

largest mental health charity - took a unique

nine month journey into the heart of the

regulatory system.

 

RICHARD BROOK

Chief Executive, Mind

I was putting the consumer voice right to the

heart of drug regulation really in the Seroxat

issue. I think I was quite open-minded in the

early days about what would happen, you know,

I was very hopeful that my inclusion might

actually make a real difference, make real change.

 

JOFRE: Richard Brook was invited to sit on

a sit on a sixth safety review of the SSRIs.

It's become known as the Expert Working Group.

The government ordered it to be set up in April

last year in response to mounting controversy

about the drugs. Richard Brook was the first

patient's representative ever to sit on one of

these reviews, it gave him access to a world that's

protected from scrutiny by draconian secrecy laws,

a world he says where patients'interests come last.

 

BROOK: I think I've been totally let down really

by the regulator. Actually, the most important

thing here, I mean at the of the day it's we..

we're taking the medicine, it should be the most

important thing and it's the least important thing,

they're bottom of the list.

 

JOFRE: One of the first things Richard Brook

discovered was how the MHRA had failed to protect

some of the most vulnerable patients of all,

children. Sarah Thompson was one of nearly two

dozen children who contacted us after our programme

in October 2002. She was just 16 when she was

prescribed Seroxat for depression. Until then

she'd never been suicidal or self-harmed.

 

SARAH: I would cut myself mainly, and then I

started to burn myself and found other methods,

but it was mainly cutting myself to start with.

 

JOFRE: And this was within the first week of

taking Seroxat?

 

SARAH THOMPSON

Yes, it was the very first week I took Seroxat.

 

JOFRE: Had you ever done anything like that

before?

 

SARAH: No, I'd never even thought about it.

It's not something that had crossed my mind

until I started taking it.

 

JOFRE: At the very first meeting of the Expert

Working Group last summer, Richard Brook was

shown confidential clinical trial data from the

manufacturers of Seroxat, GlaxoSmithKline, he

results of extensive testing of the drug in under

18s from years earlier. It appears this was the

first time the regulator had every investigated

whether Seroxat was safe for children in spite

of the evidence previously uncovered by Panorama.

 

Was there any evidence that the regulator had been

concerned about the effects of Seroxat in children?

 

RICHARD BROOK

Expert Working Group May 2003-March 2004

No, not as far as I'm aware. I mean I've had all

these reviews through the 90s and as far as I know,

they'd always given the drug a clean bill of health

for adults, and although it's not licensed for

children, I mean they knew it was being used, from

the data they had it was being used in children,

it was never causing an issue for them.

 

JOFRE: Most medicines are only licensed to treat

adults but there's nothing to stop doctors prescribing

them to children. The MHRA knew many thousands of

children were being prescribed Seroxat and that concerns

were being voiced about the drug, yet it didn't ask

GlaxoSmithKline to provide evidence that Seroxat was

safe for under 18s. This failure turned out to be

disastrous for teenagers like Sarah Thompson.

 

SARAH: I did attempt suicide. I attempted to slit

my wrist and take an overdose so it did get very

bad. I'd never thought about suicide before I took

Seroxat and when I was taking it I was obsessed about

death. It was part of my every day life.

 

JOFRE: In April last year we put these claims

to GlaxoSmithKline. Their defence of Seroxat

was robust.

 

And you still think that the drug could be safe

for children?

 

Dr ALASTAIR BENBOW

Head of European Psychiatry , GlaxoSmithKline

Panorama interview April 2003

Absolutely. It could be. We haven't got a license

in children yet. I feel sorry for anybody who has

any side effects from treatment or indeed has

experienced the terrible symptoms of depression.

We are trying to help people. The evidence,

however, is clear, these medicines are not linked

with suicide, these medicines are not linked with

an increased rate of self harm.

 

JOFRE: But we now know that's not true and

it's surprising that Doctor Benbow said it was.

Just a month later GlaxoSmithKline sent a

confidential dossier to the MHRA and it was

Doctor Benbow himself who went to meet them to

discuss it's contents. The company was confident

it would lead to a licence extension allowing

Seroxat to be marketed for the treatment of

certain anxiety disorders in under 18s. But

the dossier contained a bombshell.

GlaxoSmithKline's own clinical trial data

revealed that the drug simply didn't work in

depressed children. Worse still it made them

up to three times more likely to self harm and

attempt suicide than depressed children who

were just given sugar pills. This was evidence

the regulator had never seen before.

 

RICHARD BROOK

Expert Working Group May 2003-March 2004

It was really a shock to them. In discussions

directly with me officials were saying we have

defended this drug for a decade. There has never

been a sign as far as we're concerned about an

issue here, and suddenly we're faced with this.

And as that story unfolded it becomes clearer

and clearer that the sort of way the information

is put into the MHRA's possession, all of that

is somewhat suspect to say the least.

 

Prof Sir ALASDAIR BRECKENRIDGE

Chair, Medicines Healthcare and

products Regulatory Agency

It was a very dramatic change in our thinking

about Seroxat in children. Remember Seroxat

has never been licensed in children. It has

never been licensed in children at all, but

nevertheless practitioners have, on their own

behest, have used it extensively. Our best

evidence is that some 7,000 children a year were..

or children and adolescence were receiving Seroxat.

 

JOFRE: Faced with GlaxoSmithKline's evidence

the MHRA acted quickly. Within a fortnight

Seroxat was banned for use in depressed children.

Ever the optimist Doctor Benbow tried to minimise

the damage when we spoke to him in June last year.

 

Dr ALASTAIR BENBOW

Head of European Psychiatry, GlaxoSmithKline

Panorama interview June 2003

This increase is small. It's rather similar to,

if you imagine a school of more than a thousand

children all of whom are deeply troubled by

depression, less than a small class size would

have these suicidal thoughts or attempts, so

it's a small but important signal…

 

JOFRE: A small class of suicidal children!

That's not what Doctor Benbow told us in earlier

interviews or what doctors were led to believe

by the few Seroxat children studies published

in medical journals. This episode has exposed

a dangerous loophole at the heart of the

regulatory system. Believe it or not, there's

no legal requirement for drug companies to publish

their trial results. So if they're not favourable

they often aren't published.

 

If you Accident and Emergency concerned about any

of the issues raised in this programme, an actionline

number will follow. You should not stop or change

any medical treatment without first consulting your

doctor.

 

BBC Action Line

80000 688 456

Calls are free and confidential

 

JOFRE: For Doctor Tim Kendall this almost proved

disastrous. He's part of a team that advises the

NHS on the best treatments for doctors to use.

Last year, using just published trial data, they

were about to recommend that Seroxat and the other

SSRIs could be prescribed to children for depression,

but then the team asked the regulator for the

unpublished trial results. These turned the

recommendation on its head.

 

If you'd relied solely on the published data,

what would your recommendation have been?

 

KENDALL: It would have been that we probably

would have said use these drugs, and then there

would have been children who might well have

killed themselves further down the line as a

result of our recommendation.

 

JOFRE: So what did you think as a scientist

when you realised that there was a huge gulf

between what was published and unpublished?

 

Dr TIM KENDALL

Co-Director, Mental Health Guidelines for

National Institute of Clinical Excellence

We were flabbergasted. We were completely taken

aback. None of us had expected that the outcome

of this would be that we would have completely

changed our recommendations for the use of these

drugs.

 

JOFRE: Six months after banning Seroxat for

children the MHRA banned all the other SSRI

antidepressants except Prozac for use in

depressed children. The President of the

Royal College Of Psychiatrists is appalled

that negative trial results could have been

kept from child psychiatrists like him.

 

 

Dr MIKE SHOOTER

President, Royal College of Psychiatrists

I personally felt cheated and heaven only knows

what the children, adolescents and their parents

and their GPs on the other end of that felt,

very much the same. I also felt very confused

because I know that with some of my patients in

the past the SSRIs have been important in their

recovery as well as all the other things that I

might be doing with them and yet, suddenly, the

balance between risk and benefit was quite clearly

tilted in a different way.

 

KENDALL: If we can't be sure if there are trials

that are being withheld or not published for..

you know.. sometimes years on end, this absolutely

shakes the whole foundation of scientific medicine.

 

JOFRE: We wanted to ask GlaxoSmithKline just how

long they'd been aware of the danger Seroxat poses

In a statement they told us they only saw an

indication of a problem in May last year when they

reviewed the results of all the children studies

they'd ever done. But the decision to ban the drug

was based on three depression trials, and the last

one of those finished in July 2001. The company

doesn't explain why it took nearly two years to

pass on the results of these to the MHRA.

 

Did GlaxoSmithKline act promptly in getting this

information to you?

 

 

Prof Sir ALASDAIR BRECKENRIDGE

Chair, Medicines Health and

products Regulatory Agency

This is a matter which we are investigating at

the present time. There is an investigation

and enforcement sector of the agency and with

lawyers to decide whether or not they did.

 

JOFRE: Do you think two years is an acceptable

delay?

 

BRECKENRIDGE: That is what is being investigated

by the lawyers at the present time.

 

 

 

JOFRE: But during that time we both know that

children were being prescribed a drug which we

now know is harmful. What do you say to them

and to their parents about why that was allowed

to happen?

 

BRECKENRIDGE When we received the information

we acted with great rapidity.

 

JOFRE: I understand that but…

 

 

BRECKENRIDGE: We acted within two weeks of

receiving the information.

 

JOFRE: I understand that but why were you not

in a position to get that information from them

earlier? Did you not know that they were doing

studies in children?

 

BRECKENRIDGE: That is what is under investigation

at the present time.

 

JOFRE: Might criminal charges be brought then?

 

BRECKENRIDGE: That is a possibility.

 

JOFRE: Richard Brook believes the only reason

GlaxoSmithKline gave the MHRA the results at all

was because they wanted a children's license.

 

RICHARD BROOK

Expert Working Group May 2003-March 2004

I'm absolutely certain that if Glaxo had not

been going for an extension license the expert

group would not have got the paediatric

information.

 

JOFRE: And so children could still have been

being prescribed a drug that's harmful to them.

 

BROOK: I think that's certainly a hypothesis

that you can actually believe has got a lot of

truth and credibility to it.

 

JOFRE: When the MHRA announced the Seroxat

children's ban last summer it gave no hint that

GlaxoSmithKline could have been aware of the

safety concerns for years. It said the ban was

based on new information. Richard Brook says

this was misleading.

 

BROOK: I felt that the MHRA seemed to suggest

it was new information to them and to Glaxo and

that I didn't think was fair, and I had several

discussions after the press conference on the

very day with the head of post licensing expressing

my concern. We had a meeting subsequently and in

the end we were told that it would be looked at

criminally and the only thing that we did to raise

the issues would be in breach of the procedures

and the law that surrounded these sorts of things.

In other words we were warned off about making a

fuss about it.

 

JOFRE: We got hold of a confidential internal

GlaxoSmithKline memo. It shows that the company

knew that Seroxat, also known as Paroxetine,

didn't work in depressed children as long ago as

1998.

 

 

 

SSB CONFIDENTIAL – FOR INTERNAL USE ONLY – October 1998

" It would be commercially unacceptable to include a

statement that efficacy had not been demonstrated

as this would undermine the profile of Paroxetine. "

 

 

JOFRE: In other words, publishing negative trial

results in children could seriously damage Seroxat's

health and GlaxoSmithKline's profits.

 

What did you think personally when you read that memo?

 

Dr TIM KENDALL

National Collaborating Centre for Mental Health

I was disgusted, horrified, that people could

seriously consider withholding information about

the prescribing of a drug that may do harm to

children and certainly suggest that they don't

work. To withhold that, or to suggest that should

withhold that, I think.. I think is horrific.

 

JOFRE: The company says it didn't withhold the

information, that some of the trial results were

presented at American scientific meetings five

years ago, but none of the results were published

.. The evidence of the danger Seroxat posed to

children was mounting in clinical trials for years,

but the regulator remained blissfully ignorant.

Meanwhile British doctors were allowed to prescribe

a harmful drug to thousands of children.

 

SARAH THOMPSON

Looking back at what happened to me because of

Seroxat and the great effect it has had on my

life and to my relationship with my family and

my future, I don't think that the regulators are

doing their job properly because they allowed me

to take a drug that has in effect taken away a

part of my childhood.

 

JOFRE: The whole children's controversy forced

a complete rethink about the safety of Seroxat.

Straight afterwards the expert review group was

set a mammoth task. To re-examine the original

clinical trials done in all age groups. One of

the first questions the group was asked to consider

was could Seroxat make young adults suicidal too.

Adrian Keegan was 19 when he took Seroxat.

 

CHRIS & DAWN KEEGAN

I used to do some shopping for Adrian. He used

to come to collect I here, but on this Friday

night we decided to take it to his flat and we

got no answer when we knocked on the door, so

we thought he'd gone out. But then on the

Saturday morning we noticed the lights were

still on.

 

I dropped you off and then I went back to the

flat, didn't I Dawn, to his flat, to check on

him. I knocked on his door, got no answer.

And then I looked through his letterbox and I

noticed his keys.. his door keys were on the

storage heater in the hallway. I knew that he

was in so I knocked again, couldn't get no

response so I tried to force the door and I

couldn't, couldn't open the door. So I came

back home and I got a chisel bolster. Ohhhhh…

and then I broke into his flat and… and then

um… I found him then in the bathroom.

He'd hung himself.

 

JOFRE: Adrian's parents contacted Panorama

after our first programme. Dawn Keegan had

originally taken her son to the GP for help

in controlling his temper. She hoped perhaps

to get him on an anger management programme

but Adrian was prescribed Seroxat instead.

His parents noticed a difference straightaway.

 

DAWN: He sort of changed, he was like very quiet within himself.

Even his friends commented it wasn't

Adrian, he was like.. well then he wasn't saying much at all, or

jokey, he wasn't jokey like he used to be.

 

JOFRE: The sixth and most recent review of

SSRI antidepressants has discovered that Seroxat

may indeed make young men like Adrian Keegan

suicidal. The Expert Working Group asked

GlaxoSmithKline to reanalyse its original

clinical trial results. When they did they

found evidence to suggest that 18 to 29 year

olds may be at an increased risk of suicidal

behaviour. So why did it take 13 years to

uncover this crucial information. Again,

Sir Alasdair says they're looking into.

 

Prof Sir ALASDAIR BRECKENRIDGE

Chair, Medicines Healthcare and

products Regulatory Agency

That is a matter which is under investigation

just now, whether or not there was evidence

at that time in different age groups which we

did not have access to.

 

JOFRE: Well there was information, did you

just not analyse it at the time, or was it

not presented to you?

 

ALASDAIR: This is a matter which is under

investigation at the present time. Whether

or not the evidence was presented, whether it

was analysed and what happened to it, this is

part of the ongoing investigation.

 

JOFRE: GlaxoSmithKline keeps its own database

of side effects that doctors and patients report

to them and it says these are passed on to the

regulator. We've discovered these reports, some

of which go back many years, support what's in

the original trial data. They suggest that young

adults and males may be at an increased risk of

self harm, hostility and suicidal behaviour within

the first month of taking Seroxat. Adrian Keegan

was on the drug for just 26 days. But the patient

information leaflet that accompanies the drug

carries no warning addressed to young adults.

 

Would it have made a difference do you think?

 

CHRIS KEEGAN: Yes, because you'd be able to

keep an eye on the person that's taken the

medication for a start off. You'd be able to

monitor and be able to look after them properly,

I think so.

 

DAWN KEEGAN: I wouldn't have let him go on it

if that information had been put on it. I

wouldn't have took the risk. It's just.. it's

not worth it.

 

JOFRE: The leaflet which is approved by the

regulator didn't warn Adrian and his family.

Even now doctors haven't been properly warned.

The only clue is on the MHRA website and all

that says is that doctors should carefully monitor

young adults after prescribing Seroxat.

 

It's appeared on your website since April but

why isn't it in the patient information leaflet?

 

BRECKENRIDGE: The patient information leaflet

will be altered when the current review is complete

which will be towards the end of this year.

 

JOFRE: But that's quite a delay. I mean you've

known this information for a while, why are you

waiting to tell people.

 

BRECKENRIDGE: In fact in the.. as you say, on

the website this information is available, it is

available ah…

 

JOFRE: Yes, but patients don't tend to read

the MHRA website. Why is it not in the patient

information leaflet?

 

BRECKENRIDGE: Well there are several aspects

of the patient information leaflet which are

currently being revamped at the present time

and this will be one of them.

 

RICHARD BROOK

Expert Working Group May 2003-March 2004

The regulator may well have created a situation

where people have died. It makes me very sad

for the families and the people that I've got

to know during this time dealing with Seroxat.

Very sad that they've encountered such tragedy

and we'll never know whether that tragedy could

have been prevented by better regulation. We'll

never know but we'll always have the question.

 

CHRIS & DAWN KEEGAN

We worry about the other children not on a weekly

basis or a day to day basis – on a minute and

second basis. Totally affected us. Changed our

personalities, changed our lives, everything,

hasn't it Dawn.

 

 

JOFRE: Remember, the information about young

adults was in the original trial data given to

the regulator in the late 80s. So how could

it have missed such an important signal? The

answer may lie in the licensing process. The

MHRA takes an awful lot on trust when it makes

its decisions about a medicine's safety.

Each clinical trial produces a huge amount of

information and this raw data is summarised by

the drug companies. The regulator then relies

on these summaries. It rarely studies the raw

data itself. With the SSRIs though, there have

been five safety reviews since 1991. Each one

of these was an opportunity to spot what was

missed originally. Richard Brook says that

none of these reviews examined all the raw data

either.

 

How rigorous do you think the previous reviews

of the SSRI anti depressants were?

 

 

BROOK: Well sitting here in 2004 they're not

really worth the paper they're written on.

The reasons for that are complex but basically

it seems that they were not robust, they were

not rigorous and they didn't look at original

data, and so they seemed to be as much use as

paper in a waste bin.

 

JOFRE: Panorama can reveal that this current

review is the first time the raw data from the

original clinical trials has been properly analysed.

The Expert Working Group is now considering whether

there is evidence lurking among this data that

Seroxat may make adults suicidal. The group is

expected to publish its findings later this year.

But one of the most respected figures in British

psychiatry is already convinced a link exists.

 

I think the evidence that these tablets can

cause suicidal feelings is now absolutely clear.

I don't think really we can dispute it.

 

 

Prof PETER TYRER

Head of Psychological Medicine

Imperial College

In our own work we found that it's related to the

sort of person you are. Your personality determines

whether you have the problems whereas some people

without certain types of personality characteristic

don't have them. So we need to identify the people

who are at risk and then we can say well look, I'm

not going to prescribe this for you, even if you

wanted it, because I think it could induce suicidal

behaviour.

 

JOFRE: One psychiatrist above all others has

insured that we've heard information about Seroxat

that its manufacturer would rather we hadn't. On

Panorama's previous programme Doctor David Healy

explained what he'd found in the secret archives

of GlaxoSmithKline during an American legal action,

evidence he says proves the company has known all

along that Seroxat can make all age groups suicidal.

 

Dr DAVID HEALY

North Wales Department of Psychological Medicine

The data that went in from the clinical trials

on these drugs done 15 to 20 years ago makes it

absolutely clear when you add the whole thing

up that actually the rates at which people become

suicidal on these drugs, and this isn't just

children or young adults, this is any age group

at all, is 2 ½ times greater on the drug than it

is in people taking placebo.

 

 

JOFRE: Doctor Healy only saw this data after he

was granted a court order as an expert witness

in the legal action. He told the British regulator

what he found five years ago.

 

If you Accident and Emergency concerned about any

of the issues raised in this programme, an actionline

number will follow. You should not stop or change

any medical treatment without first consulting your

doctor.

 

BBC Action Line

80000 688 456

Calls are free and confidential

 

 

HEALY: Back when I approached the regulator

first at the end of 99 I thought this is an

issue that could have been sorted out with him

some months. I guess pretty well every year

for the last five years I've thought it'll get

sorted this year. But it's still not sorted.

 

JOFRE: Not only is it still not sorted but

Doctor Healy's professional reputation has

 

 

 

 

HEALY: I've heard myself being branded as a

'hired gun' and a bunch of other things as well.

I had people call me from literally the four

corners of the world and say " Hey, we've had

people come through here recently who've said

that really we oughtn't to have any links to

Healy at all because he's trouble and he's

going to be in trouble " .

 

JOFRE: Isolated from mainstream medical opinion

Doctor Healy has also been ridiculed by

GlaxoSmithKline.

 

So you're absolutely confident that Doctor Healy

is wrong on this issue and will be shown to be

wrong.

 

 

Dr ALASTAIR BENBOW

Head of European Psychiatry, GlaxoSmithKline

Panorama interview April 2003

Yes, absolutely. Not only that but Doctor Healy

has made the same claims about a range of other

medicines. He made the same claims about Prozac,

he made the same claims about Prozac, he made

the same claims about a range of other SSRIs.

On every occasion he has been found to be wrong.

 

JOFRE: Now though, Doctor Healy is attracting

support from the very highest level in British

psychiatry.

 

Dr MIKE SHOOTER

President, Royal College of Psychiatrists

I think that anybody like David Healy, who has spent

many years now, trying very hard at great personal

cost, to put over what patients are saying, to put

over the cause of freedom of information, to point

out that we might not have all the information,

that there might be less therapeutic benefit and

greater risk than we currently understand deserves

my admiration.

 

JOFRE: Do you think he's been vindicated?

 

SHOOTER: I think David's day is here.

 

JOFRE: But the Chairman of the MHRA is still

completely at odds with Doctor Healy. He says

a recent analysis of 300 clinical trials – all

proves the drug is safe in adults over 30.

 

 

Prof Sir ALASDAIR BRECKENRIDGE

Chair, Medicines Healthcare and

products Regulatory Agency

There is very good clinical trial evidence that

these drugs do not cause suicide, they do not

cause suicidal thoughts in adults. There is a

JOFRE: They might cause them in young adults,

they do cause them in children, but they absolutely

definitely don't cause them in people over 30?

 

BRECKENRIDGE: In the adult population the drugs

are effective. There are many, many studies to

show that. There are.. in over 300 studies which

have been analysed and studies using epidemiological

databases the drugs do not cause suicide, they do

not cause suicidal thought.

 

JOFRE: The database Sir Alasdair refers to actually

reveals that the risk of suicidal behaviour increases

in the first month after starting Seroxat. But he

claims that is because of the illness, not the drug.

 

Source: Journal of the American Medical Association,

July 2004

 

BRECKENRIDGE: There is a period of time when

the drug does not act, it takes a period of

3 or 4 weeks before effect.

 

JOFRE: But it's in your bloodstream immediately.

Are you suggesting it has no effect on you?

 

BRECKENRIDGE: It has no beneficial effect for

some 3 or 4 weeks.

 

JOFRE: But it might have a detrimental effect.

 

BRECKENRIDGE: And during that period of time

there is a risk of suicide which remains from

the period as before, and that is the period

when the practitioner must monitor the patient

very carefully.

 

JOFRE: From Professor Tyrer's careful monitoring

of his patients he's seen even that Seroxat can

cause suicidal feelings, feelings quite distinct,

he says, from the patient's illness.

 

In your view does Seroxat make some adults self

harm and become suicidal?

 

Prof PETER TYRER

Head of Psychological Medicine

Imperial College

Yes, I've had a patient that I treated myself who

found this effect. He found it only on a certain

dose and when the dose was changed it disappeared,

but the fact is, it was clearly related and she

actually experimented with the dosage and found

that she could almost predict the suicidal effects.

 

JOFRE: When Graham Aldred's wife was prescribed

Seroxat 3 years ago she was depressed and anxious

but not suicidal. Rhona Aldred was initially

worried about taking an antidepressant. Her

husband reassured her.

 

GRAHAM ALDRED

When Rhona brought the drug home, she said to me

she had some reservations about it, and I said

" Don't be silly, this is England, this is a country

where you can trust medical regulation. " Now she

was right and I was wrong.

 

JOFRE: Shortly after starting on Seroxat Rhona

became very restless, agitated and had terrible

nightmares. After 11 days of mental turmoil she

drove to a secluded country lane and killed herself.

 

 

ALDRED: This is what the regulator doesn't seem

to understand, that there are people on the end

of all this, there are people who's lives should

have continued, there are people whose wife,

whose sister, whose mother, whose children even,

should be alive now and happily functioning in

the family.

 

RICHARD BROOK

Expert Working Group May 2003-March 2004

When people take Seroxat they don't know what

the implications are and they don't know if

they're one of these people that maybe so

adversely affected by this drug. And of course

if they are, and they don't recognise it, and

it doesn't work for them, then in a sense it's

just like Russian roulette, they risk pulling

the trigger, the bullet being in the barrel and

it going off, and I think that's the reality of

the situation, and I don't think the regulator

sees it that way at all which makes it double risky.

 

JOFRE: The MHRA's responsibility for making sure

drugs are safe doesn't end once they're licensed.

It's also supposed to monitor their safety when

they're on the market and widely used.

 

BRECKENRIDGE: It's very important that since

safety is an issue which is built up as more

experience is gained with the drug, that safety

is kept under review and this is why we insist

on post marketing surveillance of a drug, which

means that its safety is kept under review during

its lifetime.

 

JOFRE: The way the regulator has kept Seroxat

safety under review though has raised concerns

that were supposed to have been resolved 40 years

ago, after a scandal where thousands of women

took a drug that hadn't been properly tested and

gave birth to babies that were deformed, that

drug was called Thalidomide.

 

[Footage of thalidomide toddlers]

 

Their mothers took Thalidomide to prevent morning

sickness, as a result of the tragedy that followed,

an early warning system was set up that's called

the `Yellow Card Scheme' if doctors suspect a drug

has caused a serious side effect they're supposed

to report it to the MHRA on a yellow card. In our

Scheme, two experts who appeared on that programme,

asked the regulator afterwards to show them all the

Yellow Card reports gathered on Seroxat. Normally

secrecy rules prevent access to this data, so they

were astonished when the answer was `yes'.

 

 

CHARLES MEDAWAR

Author " Medicines Out of Control? "

We jumped up and down with glee, we thought this

is the first time that any such analysis had ever

been done, and of course at the back of our minds

was the feeling that we were not only now in a

position to evaluate how well the regulators had

understood the problem of Seroxat, but also how

good the Yellow Card system was.

 

JOFRE: They were given unprecedented access to

every single reported side effect ever lodged

about Seroxat, and it's one of the most complained

about drugs in the schemes history. These were

reports that were supposedly scrutinised during

each of the previous safety reviews.

 

MEDAWAR: It hadn't been properly analysed, it

hadn't been properly followed up, it was full

of the kind of jargon that obfuscated meaning,

it made things very unclear and uncertain, and

it would be hard to imagine a sort of less helpful

construction of the data that there was.

 

Dr ANDREW HERXHEIMER

Emeritus Fellow, Cochrane Centre Oxford

MAN: What amazed me was the haphazardness of it,

for some things there was a lot of detail, for

other things there was nothing, and it took a

long while to make sense of it.

 

JOFRE: They found 91 Yellow Card reports from

doctors who suspected Seroxat had prompted their

patients to become suicidal, to self harm or to

kill themselves.

 

[Yellow Card Report]

He clearly stated that he had not thought about

suicide until taking Seroxat.

 

WOMAN: Even when a report ran only to one line,

there was often little evidence it had been

investigated further by regulatory staff.

 

[Yellow Card Report]

A patient short himself a few days after starting

medication.

 

MEDAWAR: You think for heavens sake, I mean what

is happening? Is this an extraordinary callous

doctor reporting, you know, on a tragic event with

indifference or actually isn't what the doctor is

saying is: " Here's the reason to come and see me,

this needs to be followed up. "

 

[Yellow Card Report]

We have evidence that the suspect drug drove patient

to suicide.

 

 

Prof Sir ALASDAIR BRECKENRIDGE

Chair, Medicines Healthcare and

products Regulatory Agency

When information like this comes in this is

investigated. The way that we.. we firstly we

investigate individual reports and then we take..

 

JOFRE: And how do you do that, you go back to

the doctor and follow it up?

 

BRECKENRIDGE: Yes.. yes.

 

JOFRE: And that happened in all of these cases?

 

BRECKENRIDGE: Not in all of them at.. in the

appropriate.. in the appropriate cases, this is..

these patients are followed up. The follow up rate

for Yellow Card reports is some 48% - 49%.

 

JOFRE: The MHRA says that all suicides have now

been followed up, if not straightaway, then as

part of the current safety review. But what about

the previous safety reviews, why didn't they

investigate every reported suicide then?

 

CHARLES MEDAWAR

Author " Medicines Out of Control? "

These people, working in secret, had assured the

public, through Ministers, that they had done

three investigations into this particular problem,

suicidality, and each time the drug came out with

a clean bill of health, and they were not warranted..

I mean they were absolutely not justified in drawing

that conclusion.

 

JOFRE: Not only has the regulator failed to follow

up some signals that suggests Seroxat has driven

some patients to suicide, the research has uncovered

something else in the Yellow Card reports, another

potential risk that hadn't been identified by the

regulator, evidence that suggests the risk of suicide

could be closely related to changes in dose.

 

[Yellow Card Report]

Dose increased from 10mg after two weeks on treatment.

On the fourth day of starting the 20mg dose patient

committed suicide by hanging himself.

 

Dr ANDREW HERXHEIMER

Emeritus Fellow, Cochrane Centre, Oxford

Half of the suicide reports that we looked at were

associated with some change in dosage, either when

the drug had first been started, when the drug was

building up in the body in the first few days or

after a dose change had occurred - either an increase

or a decrease in dose - so that was the relationship

which hadn't been spotted before.

 

[Yellow Card Report]

Patient committed suicide after having increased

dose from 20mg to 30mg.

 

JOFRE: On the day that Adrian Keegan died, he

told friends he'd taken three 20mg tablets of Seroxat

instead of the usual one in the hope it would make

him feel better. His parents now believe that's why

he hung himself.

 

CHRIS & DAWN KEEGAN

That is what's happened to Adrian.. Adrian has

increased his dosage, now some might say he did it

himself, but if he had have known he wouldn't have

done it - so the increase of dosage killed Adrian.

 

JOFRE: Advice to doctors has always been that

depressed patients should be started on 20mg of Seroxat,

in practise the dosage is often increased. But last

October the Expert Working Group discovered something

shocking; firstly there's no evidence that Seroxat

actually works any better above 20 milligrams for

depression, but secondly, rapid increases in dose are

much more likely to cause serious side effect. This

was spotted, according to the MHRA, after staff took

a more rigorous approach to clinical trial data they'd

had for 15 years.

 

RICHARD BROOK

Expert Working Group May 2003-March 2004

They looked at the data and discovered that the data

they had from that original submission indicated that

Seroxat had little benefit above a 20mg dosage. And

the side effects, particularly around withdrawal,

increased quite dramatically post 20mg.

 

JOFRE: As the patients representative on the Expert

Working Group Richard Brook felt this information

should be released straightaway, but for four months

nothing happened. Eventually he told the MHRA that

if they wouldn't tell patients he would even though

he could be breaking the law.

 

BROOK: It's one of those moments where you have

to say: " Actually if I don't do this I can't really

live with my own conscience and my own views. "

 

JOFRE: Although he was trying to help patients,

the MHRA threatened Richard Brook with legal action.

A letter from the Chief Executive warned he could be

prosecuted if he published the new dosage information

about Seroxat.

 

BROOK: Clearly, it's got huge implications, I mean,

you know, clearly it potentially is around my job,

my livelihood, my reputation, my career, it affects

my family, my daughters, my wife so huge.. huge

implications, it wasn't like this is something you'd

do lightly.

 

JOFRE: In the end, Richard Brook got his way the

regulator wrote to doctors about the groups findings,

curiously though, this crucial new information was

presented as a reminder.

 

BROOK: It lacked honesty, what they actually did

was say: " After extensive review, we have discovered

this is a reminder we ought to give to people. " That

was absurd, I mean the information had been around,

the MHRA just didn't admit to the fact that either

they'd missed it or even worse, they hadn't actually

bothered to tell people.

 

Prof Sir ALASDAIR BRECKENRIDGE

Chair, Medicines Healthcare and

products Regulatory Agency

There was a difference in views as to whether the

agency had sat on information, and Richard felt I

think that the agency had sat on information on dose,

and we were quite clear.. the agency is quite clear

it had not sat on information on dose.

 

JOFRE: You're not quite getting Richard Brook's

point are you, that patients need to know this

information as soon as it becomes available, it's

their health.

 

BRECKENRIDGE: It is a matter of regulatory and

practical judgement as to when information should

be transmitted. When it is in the public's interest

that information should be transmitted rapidly, we

will do it.

 

JOFRE: For Richard Brook the MHRA's attempt to gag

him was the final straw, he resigned from the Expert

Working Group the day after the dosage information

was finally released.

 

BROOK: I have regrets it didn't get it out as clearly

as I think it should do, and I have regrets it hasn't

yet pushed the regulator to understand that it needs

to change its processes and its approach to regulation,

but I hope those things will come. So it's a decision

I don't regret, but I didn't find easy and I still don't

find easy thinking about it.

 

JOFRE: Do you regret the fact that Richard Brook was

threatened with legal action for revealing any of this?

 

BRECKENRIDGE: That was.. that was unfortunate,

I regret Richard leaving the committee because he

was a very valuable member of the Expert Working

Group and we certainly hope to maintain contacts

with Richard and to obtain the benefit of his advice.

 

JOFRE: The controversy surrounding Seroxat hasn't

stopped it becoming the most profitable drug that

GlaxoSmithKline has ever made. Just six years after

launch it became the company's first billion dollar

product, a triumph some believe of marketing over

science.

 

Prof PETER TYRER

Head of Psychological Medicine

Imperial College

For a time, even only in a matter of a few years,

almost critical scepticism, the objectivity were

suspended in favour of the all out rush to develop

these new drugs and develop new markets.

 

JOFRE: Because there was such an excitement created

about them.

 

TYRER: Yes, as the head of GlaxoSmithKline once said:

" There's a lot of runway space out there for Seroxat

you know, let's get the planes down. "

 

JOFRE: Getting the planes down, would the company

hoped, lead to their second billion. It applied to

extend Seroxat's licence for the treatment of five

more illnesses, some familiar like obsessive compulsive

disorder, some not so familiar like social phobia.

Each of Glaxo's planes landed safely with the regulator's

full approval. As more and more people are being

prescribed Seroxat for a bewildering array of illnesses,

another massive problem has emerged, a problem not as

devastating as suicide, but one that affects a much

larger number of patients, many people on the drug

say they've become hooked. Again, the regulator has

failed to issue proper warnings, even though the

evidence has been staring them in the face for years.

When Seroxat was first licensed it was marketed with

the regulator's approval as a safe non addictive drug,

back then even Dr Healy believed the hype.

 

Dr DAVID HEALY

North Wales Department of Psychological Medicine

When the drugs came out first I had absolutely no

concerns at all that there might be withdrawal

problems with the pills. I think probably like

almost all clinical psychiatrists here in the UK,

I would have actively reassured people that they

could go on these drugs without any risk of withdrawal

at all, that this group of drugs was very, very

different to drugs like Valium and Librium that had

actually gone before them, to which people could get

hooked.

 

JOFRE: That's what Sarah Venn was told, she was

prescribed Seroxat for dizziness seven years ago,

but whenever she tries to come off it the withdrawal

symptoms just knock her sideways.

 

SARAH VENN

If I forget to take my pill for just one day, by the

afternoon I've started to run a fever, then my vision

.. I look like I'm having fits and spasms and I get

incredibly depressed and I have never been depressed

before, and it's ironic that I'm taking an antidepressant

and it's made me suicidal on occasions.

 

JOFRE: In the late 1980s, before Seroxat was licensed,

GlaxoSmithKline funded a clinical trial into the drugs

affects on depressed patients. The man they asked to

conduct it was Professor Peter Tyrer a world expert on

drug dependence. He came across a problem that would go

on to affect millions of patients around the world.

After six weeks on Seroxat some of his patients were

feeling better, but some of them were also hooked.

 

Prof PETER TYRER

Head of Psychological Medicine

Imperial College

After the trial ended they said: " Can we continue on

these tablets because we feel we've got to have them

because they seem to be so effective " , but more

concerning.. was more concerning to us was the fact

that they were saying: " I cannot tolerate the symptoms

when I stop it " .

 

JOFRE: As far as you were concerned then were these

people dependant on Seroxat?

 

TYRER: They were showing yes signs of dependence...

 

JOFRE: And this was after..

 

TYRER: ..after only six weeks.

 

JOFRE: ...just six weeks on the drug.

 

TYRER: Yes.

 

JOFRE: Some of the withdrawal effects were very disturbing.

 

TYRER: They also felt more anxious, they felt this

feeling of dysphoria, the feeling of being depressed

and in some cases entertaining suicidal thoughts.

 

JOFRE: That sounds pretty serious then if people were

thinking of suicide when they stopped.

 

TYRER: Yes it is serious and in particular we were

led to believe that these drugs were particularly

effective against suicidal thoughts and therefore,

having them at any stage during the course of treatment..

and on withdrawal was a matter of great concern.

 

JOFRE: Professor Tyrer didn't investigate these

problems any further at the time, but he did tell

GlaxoSmithKline what he found, he says they weren't

very interested.

 

TYRER: It was very important to concentrate on the

positive, so we didn't expect that they would rush in

and investigate this problem as a matter of priority.

 

JOFRE: And as far as you're aware they didn't

investigate the problem.

 

TYRER: No.

 

JOFRE: We asked GlaxoSmithKline if further studies were

commissioned as a result of Professor Tyrer's findings

on withdrawal. They didn't say. What they did tell us

was `The company reviewed reports of such symptoms in

all its clinical trials as a matter of course'. If the

drug company didn't investigate it, what about the

regulator? Since the early 90s its Yellow Card scheme

has been throwing out signals that many patients are

hooked on Seroxat, the drug has attracted more Yellow

Card complaints about withdrawal problems than any other

prescription medicine. The MHRA says: " Patients should

have been well aware of the risks before they started

taking it. "

 

Prof Sir ALASDAIR BRECKENRIDGE

Chair, Medicines Healthcare and

Products Regulator Agency

They were warned from the time the drug was licensed that

there was a risk of withdrawal. This has been mentioned

in every review, every publication coming from the Committee

in Safety of Medicines, the problem of withdrawal, that has

been publicised in patient information leaflets that there

is a problem with withdrawal.

 

JOFRE: Really, up until last year the patient leaflet said

that withdrawal symptoms were " not common " and " you cannot

become addicted to Seroxat " . The leaflets wording was

approved by the regulator.

 

So was it helpful to tell patients that they couldn't become

addicted to Seroxat?

 

TYRER: No it wasn't.

 

JOFRE: What do you think patients would have understood

by that?

 

TYRER: Well they would have understood that it wasn't habit

forming and that really when the time came for them to stop

their drugs they would have no problem in stopping them, and

clearly, the evidence didn't support that.

 

JOFRE: Do you think the regulator should have insisted on

something clearer in the patient information leaflet?

 

TYRER: Yes.

 

SARAH VENN

I am absolutely fuming that this drug was allowed to be

put on the market with completely misleading information

that people like me were taking it, believing what we

were told, doctors believing what they were being told.

There is no reason why I should be sitting here today in

the state that I am because the regulators knew about this

problem. GlaxoSmithKline knew about this problem, but they

did nothing and they have changed the course of my life

and thousands of other lives.

 

RICHARD BROOK

Expert Working Group May 2003-March 2004

It was clear from the information, that certainly I saw,

that the original trial data showed there were quite severe

withdrawal issues. It was clear the studies were not done as

well as they could be done compared to modern day standards,

but ultimately there was no mistaking, there was a very clear

issue that withdrawal really affected people particularly at

higher dosages and at long periods of using the drug. And that

information has been in the vaults of the MHRA for over a

decade and known to the manufacturer indeed for over a decade.

 

JOFRE: In June last year the leaflet underwent a dramatic

transformation, the claim that you cannot become addicted

to Seroxat was removed and startling new statistics about

the frequency of withdrawal affects were added. Out of the

blue patients were told that one in four people could now

experience withdrawal problems, some of them very severe

indeed, so why did a proper warning come 12 years after

the drug was first licensed?

 

BRECKENRIDGE: It takes time for clinical trial evidence to

become available.

 

JOFRE: It takes 12 years to find out that a quarter of

people taking one of the most widely prescribed

antidepressants will suffer withdrawal problems.

 

BRECKENRIDGE: The problem of withdrawal..

 

JOFRE: Is that your position?

 

BRECKENRIDGE: The problem of withdrawal was highlighted

early on. We were unable to give precise figures, as time

has gone one...

 

JOFRE: Why were you unable to.. you're supposed to protect

the public, you're supposed to listen to the public, why

were you unable to give a figure?

 

BRECKENRIDGE: Because we did not have reliable information

available to us on which to base advice

on figures.

 

JOFRE: GlaxoSmithKline says it gave the regulator the results

of some clinical trials in the year 2000, it was from these

that the one in four figure was drawn and added to the patient

leaflet three years later. However, neither the company nor the

MHRA will tell us when these studies were originally carried out.

 

CHARLES MEDAWAR

Author " Medicines Out of Control? "

The regulator should be covered in shame to admit that they had

failed to spot an adverse effect which people had been sounding

off about on the internet in.. by their thousands and thousands,

and suddenly to admit that this side effect is real after all

and that it affects a quarter of all users. The regulator

should be deeply ashamed.

 

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare

and products Regulatory Agency

There is no other agency which has kept these.. these drugs under

such constant and careful review since 1990 as we have done and

we will continue to do so in the interests of the public health.

 

JOFRE: For years patients and their families have tried to tell

the regulator about dependence, about self harm, about the risk

to children, about the risk of suicide and for years they've been

ignored.

 

Do you trust the regulator?

 

CHRIS & DAWN KEEGAN

 

DAWN: No not any more, no I don't.

 

CHRIS: How can you trust them? You know, when someone in that..

as much authority as they've got, they're supposed to be looking

after everybody in the country is lying about the information

that they've got, you cannot trust them, it's impossible to trust

them.

 

JOFRE: Without trust we can't be sure we're being told

everything about the medicines we take.

 

RICHARD BROOK

Chief Executive, Mind

I think this is actually an issue that probably goes beyond

Seroxat and I find it hard not to believe there aren't other

drugs that might be in the same category as Seroxat, that have

lacked that robust clear analysis that's allowed us to make a

decision about how they should be used, what information people

need before they use them - so I actually think this is a major

issue for us in the UK.

 

JOFRE: Do you think this whole episode has wider implications,

it's not just about Seroxat or antidepressants?

 

Dr MIKE SHOOTER

President, Royal College of Psychiatrists

Oh no it has huge implications, I think once again we're seeing

the SSRI's being the focus for something much wider in psychiatry

and we're seeing psychiatry being the focus for something much..

much wider in medicine as a whole. I think, you know, a few years

down the line we're going to be talking about this with

many more sorts of medication than psychotropic medication.

 

JOFRE: So you think this has ramifications right through medicine

as a whole.

 

SHOOTER: Right through medicine.. right through medicine.

 

JOFRE: There's no doubt Seroxat helps many people, but what

about those who have been harmed, it was the regulator's job

to protect them. Its failure to do so must raise

serious concerns about whether the regulator's advice on other

prescription medicines can be taken on trust.

 

..

You shouldn't stop or change any medicine without first

consulting your doctor. You can call the BBC action line on

08000 688 456 if you want to be put in touch with an

organisation that can help you. Calls are free and confidential.

If you want to comment on the programme you can visit our website.

 

_________

 

 

www.bbc.co.uk/panorama

 

 

CREDITS

 

Reporter

SHELLEY JOFRE

 

Camera

STEPHEN FOOTE

CLIVE NORMAN

 

Sound

TONY PASFIELD

WILLIAM CURSHAM

 

VT Editor

BOYD NAGLE

 

Colourist

STEVE LUCAS

 

Dubbing Mixer

DAMIAN REYNOLDS

 

Production Co-ordinators

ROSA RUDNICKA

CLAIRE CHANG

KAREN HOOPER

JOANNE WADE

 

Web Producer

ADAM FLINTER

 

Research

KATHLYN POSNER

AMANDA VAUGHAN-BARRATT

 

 

 

Film Research

KATE REDMAN

 

Post Production Co-ordinator

LIBBY HAND

 

Production Manager

GINNY WILLIAMS

 

Production Executive

EMANUELE PASQUALE

 

Film Editor

MARK SENIOR

 

Director

MARY MOSS

 

Associate Producer

ELEANOR PLOWDEN

 

Producer

ANDY BELL

 

Deputy Editors

ANDREW BELL

FRANK SIMMONDS

 

Editor

MIKE ROBINSON

 

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