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

[Guest guest]

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NB: THIS TRANSCRIPT WAS TYPED FROM A TRANSCRIPTION UNIT RECORDING AND NOT COPIED FROM AN ORIGINAL SCRIPT: BECAUSE OF THE POSSIBILITY OF MIS-HEARING AND THE DIFFICULTY, IN SOME CASES OF IDENTIFYING INDIVIDUAL SPEAKERS, THE BBC CANNOT VOUCH FOR ITS ACCURACY.........................................................................PANORAMA TAKEN ON TRUSTRECORDED FROM TRANSMISSION: BBC-1 DATE: 3:10:04........................................................................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 BRECKENRIDGEChairman, Medicines Healthcare andproducts Regulatory AgencyThe 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 BROOKChief Executive, MindI 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 THOMPSONYes, 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 BROOKExpert Working Group May 2003-March 2004No, 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 BENBOWHead of European Psychiatry , GlaxoSmithKlinePanorama interview April 2003Absolutely. 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 BROOKExpert Working Group May 2003-March 2004It 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 BRECKENRIDGEChair, Medicines Healthcare and products Regulatory AgencyIt 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 BENBOWHead 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 Line80000 688 456Calls are free and confidentialJOFRE: 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 KENDALLCo-Director, Mental Health Guidelines forNational 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 SHOOTERPresident, Royal College of PsychiatristsI 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 BRECKENRIDGEChair, Medicines Health andproducts Regulatory AgencyThis 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 BROOKExpert 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 KENDALLDirectorNational Collaborating Centre for Mental HealthI 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 THOMPSONLooking 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 KEEGANI 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 BRECKENRIDGEChair, Medicines Healthcare andproducts 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 BROOKExpert Working Group May 2003-March 2004The 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 KEEGANWe 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 TYRERHead of Psychological Medicine Imperial CollegeIn 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 HEALYDirectorNorth 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 Line80000 688 456Calls are free and confidentialHEALY: 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 BENBOWHead 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 SHOOTERPresident, Royal College of PsychiatristsI 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 BRECKENRIDGEChair, Medicines Healthcare and products Regulatory AgencyThere 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 2004BRECKENRIDGE: 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 TYRERHead of Psychological MedicineImperial CollegeYes, 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 ALDREDWhen 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 BROOKExpert Working Group May 2003-March 2004When 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 MEDAWARAuthor "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 HERXHEIMEREmeritus Fellow, Cochrane Centre OxfordMAN: 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 BRECKENRIDGEChair, Medicines Healthcare andproducts Regulatory AgencyWhen 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 MEDAWARAuthor "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 HERXHEIMEREmeritus Fellow, Cochrane Centre, OxfordHalf 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 KEEGANThat 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 BROOKExpert Working Group May 2003-March 2004They 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 BRECKENRIDGEChair, Medicines Healthcare andproducts Regulatory AgencyThere 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 TYRERHead of Psychological MedicineImperial CollegeFor 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 HEALYDirector North Wales Department of Psychological MedicineWhen 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 VENNIf 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 TYRERHead of Psychological MedicineImperial CollegeAfter 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 BRECKENRIDGEChair, Medicines Healthcare andProducts Regulator AgencyThey 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 habitforming 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 VENNI 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 BROOKExpert Working Group May 2003-March 2004It 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 MEDAWARAuthor "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 AgencyThere 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 KEEGANDAWN: 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 toldeverything about the medicines we take.RICHARD BROOKChief Executive, MindI 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 SHOOTERPresident, Royal College of PsychiatristsOh no it has huge implications, I think once again we're seeingthe 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 whatabout 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 firstconsulting 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 =======

=======

..

..

[Guest guest]

--- SSRI-Research wrote:

 

 

> SSRI-Research

> Thu, 7 Oct 2004 17:44:37 -0500

> [sSRI-Research] TRANSCRIPT ...... Panorama

> " Taken On Trust " Rrecorded from Transmission:

> BBC-1, 3-10-04

>

>

> .

> NB: THIS TRANSCRIPT WAS TYPED FROM A TRANSCRIPTION

> UNIT RECORDING AND

> NOT COPIED FROM AN ORIGINAL SCRIPT: BECAUSE OF THE

> POSSIBILITY OF MIS-

> HEARING AND THE DIFFICULTY, IN SOME CASES OF

> IDENTIFYING INDIVIDUAL

> SPEAKERS, THE BBC CANNOT VOUCH FOR ITS ACCURACY.

>

......................................................................

>

>

> PANORAMA

>

> TAKEN ON TRUST

> RECORDED FROM TRANSMISSION: BBC-1 DATE:

> 3:10:04

>

......................................................................

>

> 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

> Director

> 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

> Director

> 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

> Director

> 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

>

> ==========================.

> .

>

> [Non-text portions of this message have been

> removed]

 

>

>