22/01/2018 Inside Out London

Hello, I'm Sean Fletcher,

and welcome to a special edition

of Inside Out London ?

in which we investigate

the shocking truth behind

the drug sodium valproate.

This medication

is widely used as an effective

treatment for epilepsy.

But for pregnant women it can have

dangerous side effects ?

and in the past many mothers have

taken it while unaware of the mental

and physical damage it was doing

to their unborn children.

In this programme, we'll be

revealing how the authorities

were fully aware of the dangers

the drug presented,

but deliberately chose not

to inform pregnant patients.

And we present new evidence

that suggests that ? tragically -

the drug's harmful effects can be

transmitted down through generations

of the same family.

Deformed, disabled, damaged.

Thousands of babies around

the world, genetically harmed

in the womb by one drug.

She can't go

to the toilet, she can't walk.

She can't talk.

We bring to light the records that

show the Government knew

the drug causes birth defects

yet chose to hide the truth

from expectant mothers.

My mum should

not have had to have the children

that were affected,

if she knew that we were going

to have these conditions.

Now, new scientific research warns

sodium valproate's toxic

legacy could be eternal,

harming generation after generation

In

It's because I took that medication,

grandkids have been affected by it.

So many people's lives have been

affected and ruined.

This is all her fit medicine.

This one here, I have

to give her three times a day,

this one twice a day,

and this one twice a day.

Every morning, first thing,

Karen carefully measures out

the exact amount of medicine needed

to keep her daughter alive,

to save her from falling

into a fatal coma.

Brigit got hiccups.

You gonna swallow it?

I know it's horrible.

You gotta swallow it though.

Brigit is 19.

She still plays with some

of the toys she had as a baby.

This is the photo album I done

for Bridgit when we came home.

Pictures of her in her cot

with her toys around

because she could only just

lay there still with her

head to the side.

Brigit was born with a catastrophic

array of medical ailments,

including brain damage

and spina bifida.

She is paralyzed from

the waist down, even her bowels

are not fully formed.

She can't go to toilet,

she can't walk, she can't talk.

She can't think for herself.

I do all Brigit's overall care.

I, I think for Brigit, I talk

for Brigit, I walk for Brigit.

I live for Brigit.

When Karen was pregnant with Brigit,

she was prescribed a high dosage

of the drug, sodium valproate.

She has epilepsy and the pills

were meant to control the seizures.

But the powerful chemicals that

protected her health

damaged her daughters.

I pop these tablets

into my system and what happens?

Six months down the line,

I'm under ante-natal treatment

and then they turn round

and look at me,

look at the screen

and turn round and say to me

"What do you want to do you?"

"You want to have an abortion, you

are carrying a spina bifida baby?"

Like Bridgit, around 20,000 children

in the UK and thousands of others

around the world are believed

to have foetal valporate syndrome -

after being exposed to the powerful

drug, valproic acid, in the womb.

Some of the children are so severely

harmed they will never develop

beyond the mental capabilities

of a toddler.

Others may appear fine

but will struggle with cognitive

and physical disabilities

throughout their lives.

We know from our research that

children exposed to sodium valproate

can be affected physically,

they can be affected mentally

and they can be

affected psychologically.

These children have an increased

risk of clefting, cleft pallet

and these children are more prone

to spina bifida

or neural tube defect.

We also know that there's

an increased risk of congenital

heart disease and occasionally

an increased risk of

kidney abnormalities.

Concentrate!

At her school in Essex,

seven year-old Beau attends special

PE classes to improve her motor

skills and her ability

to interact with others.

Try to keep your arm

straight ? good girl.

That's enough, perfect.

I've never worked with a childwith

foetal valproate syndrome before.

Beau finds a lot of

things challenging.

She has actually got

a diagnosis of ADHD.

She also we feel has got problems

with her co-ordination so that's

being looked into in terms

of possible dyspraxia.

Can you try with your other

hand and other foot?

At school, Beau needs special,

different treatment

to the other kids.

But at home she is just one of three

sisters all struggling

with health problems,

caused by foetal valproate syndrome.

I don't know if it was like denial,

but I just I didn't

when when you see your children

every day you don't see them

as being different ? they're

just your children and for someone

to say there's something

wrong with your child,

you think, no, they're fine,

they're they're perfect ?

but obviously there is issues

and obviously they need

they need extra help.

You know it's hard.

Their eldest daughter,

16-year-old Devon needs to be

constantly watched over.

She suffers from reflex syncope,

a condition which can restrict

blood supply to the brain.

I think I am a bit slower

than other children.

I am slower in, like,

writing than others.

I get extra time when I do

exams because it takes me

like a long time to understand

what the question means.

Devon's younger sister,

11-year-old Sienna is the sibling

most affected by the syndrome,

leaving her with mental and physical

impairments.

It affects me.

I get really stressed out.

I either start just

making lots of noises,

or I just start screaming, screaming

or crying because it is then

just too much for me.

She has accidents, it's not every

single night she has an accident

but there is some kind

of leakage every day.

She's got this condition

because of the medication

I was taking whilst

I was pregnant with her.

She's incontinent

and she soils as well.

This is something

that will go on with her

for the rest of her life.

As a remedy for her epilepsy,

Leanne has always been

prescribed sodium valproate.

Yet both she and her husband say

they were never fully warned that

taking the drug whilst pregnant

could damage their children.

We wasn't told, no way,

shape or form that this

would happen to us.

There was no, there

was no guidelines.

There was no information,

there was nothing.

This is a drug that was

prescribed from a doctor

and this is what happened.

We are the ones living

with the consequences.

Since the anti-epilepsy drug

was launched in the 1960s

under various brand names,

it's estimated that

tens of thousands of women

around the world have taken it

during their pregnancies,

unaware of the dangers.

Karen is one of them.

I didn't think my child

was going to be

like how she is today.

If I had known when Bridgit

was inside me, if I had known now

what I knew back then,

I wouldn't have had my child.

Emma and Janet also took sodium

valproate during their pregnancies.

They say there were not aware

of any warnings and were given no

indication

of the danger by their doctors.

He didn't even tell me to an effect

that I had epilepsy to start with.

When I got my first prescription

there was no warning

When I got my first prescription

there was no warning

in the boxes at that point,

I mean we are talking '83, '84,

in the boxes at that point,

I mean we are talking '83, '84,

so there was nothing for me at all.

My husband and I questioned

the midwives, questioned

My husband and I questioned

the midwives, questioned

neurologists and to just be told

take this medicine, it's the best

neurologists and to just be told

take this medicine, it's the best

to control your seizures ? that's

great to control the seizures

but the baby.

After their children

were born with disabilities,

they set up a charity

to raise awareness.

We started our national campaign

in 2013 and the main aim

was to get warnings on to the boxes,

on the patient information leaflets.

Partly as a result of their campaign

in 2016,

The Medicines and Health

Care Products Regulatory Agency

recommended that warning labels

should be featured on all

valproate-containing medicines.

GPs must only prescribe the drug

to women of child bearing age

as a last option, after

explaining all the risks.

But why has it taken 50 years

to get the warning out?

In the UK, the Government

regulates what information

is provided to patients and,

according to Emma and Janet,

it knew about the dangers

of the drug as far back as 1973.

They discovered the evidence,

deep in the National Archives.

There you go...

That a statement, that a statement

similar to that proposed by ICI

could be included on all relevant

data sheets but not on packaging

inserts, so there would be no

danger of the patients

themselves seeing it.

If they hadn't of

made this decision.

you would have been warned.

I'd have been warned and probably

the boys wouldn't have

been harmed like they were.

The 20,000 affected.

There wouldn't be that today.

It is an extraordinary scandal.

Since the very start

of its licensing in this country,

there was knowledge of risk

and yet a decision to hide that

risk from young mothers,

a totally sort of paternalistic idea

that mothers might worry about it.

Well, of course,

mothers have the right to know.

In a statement The Medicines

and Health Care products

Regulatory Agency said

"At the time, according

to clinical practice

it was for the doctor to decide how

much information a patient was given

about their medicine.

Since then the need for patients

to be fully informed

has been underpinned

by legislation."

But charities say

the system of warning patients

is proving ineffective.

Over the last year hundreds

of babies around the world have been

born with sodium valproate syndrome.

Many pharmacists and health centres

are still issuing the drug

in generic-packaging

with no warnings.

We are now here in 2018

and the scenario is,

that woman are still given

white boxes in which there

are no warnings ?

there is absolutely nothing on them.

The fact that women are

still not being made fully aware

of the risks associated

with the drug is particularly

alarming because amongst affected

families there is growing fear

that foetal valproate syndrome

is actually being passed on,

through the genes,

from one generation to the next.

Three generations

of the same family.

Here today are Grandma, two

grown-up daughters and their kids.

Foetal valproate syndrome has

dominated their lives.

It's because I took that medication

that's why my kids haven't got

a normal life and they struggle

every single day of their life

to fit in and do things.

One of my kids have tried to...

Couldn't cope and tried

to hang themselves.

If I'd known with my first couple

of children that they'd have had

this syndrome I could have then made

that decision whether to go

on and have more children.

Sue took the drug Epilim

throughout her pregnancies.

She only discovered it had

harmed her children after a doctor

visited her at home.

I had

pictures up on the wall of the kids

when they were little and as soon

as she walked into the room

and she seen the pictures then

she said are these the children

and I said yeah and she said yes

they've definitely got the syndrome.

It was they had the facial features

the high forehead the upturned nose

and then an appointment was arranged

for all the children myself to go

down to Exeter to have genetic

testing done and all other kinds

of test done and that

and it was confirmed.

Despite their difficulties,

Sue's daughters now have

children of their own.

In the past, Natalie

was prescribed sodium valproate

to control her epilepsy.

But she says she stopped taking

the pills when she was pregnant.

Tanya has never taken the drug yet

both sisters believe their children

are displaying the symptoms

of foetal valproate syndrome.

There's certain things

that they are doing,

like their behavioural ways,

the way they speaking.

It's just certain things.

I'm like, I remember doing things

like that when I was a kid.

My little boy is nine.

He's got dyspraxia,

learning difficulties,

a bowel condition, sensory

issues, memory problems.

I've got two children,

both have got dyslexia.

My daughter's got

dyslexia and dyscalculia.

She's in special needs school.

Whilst researching this film,

we spoke to several families

who suspect that sodium

valproate is somehow just not

harming their children

but their grandchildren too.

Until now, those suspicions have not

been deemed credible but we've

obtained the results of a major

scientific project in South Korea

which actually supports

the idea that the drug can

harm successive generations.

Chan Young Shin,

a Professor of Pharmacology -

is leading the research

that uses pregnant mice,

injected with the compound.

What does your research

actually prove?

What does your research

actually prove?

They are giving

the indication or one

They are giving

the indication or one

of the evidence that this compound

could cause autism spectrum

of the evidence that this compound

could cause autism spectrum

disorder, trans-generationally,

through the generations.

It can give us some kind

of clue the same thing

is happening to humans.

So it's kind of warning signal.

The experiment indicates

that sodium valproate can travel

through DNA and afflict

successive generations

with mental health problems.

In the UK, the findings

are being carefully considered

by the Government and have already

triggered concern amongst experts

on foetal valproate syndrome.

Dr Rebecca Bromley is a leading

neuroscientist and she believes

the need for more research

in this area is urgent.

That was the first bit

of evidence that had in any species

that potentially might be carried

on to the next generation.

Before this paper came out

we just didn't know.

We had no evidence that it was

going to be an issue

and we were still learning

about the longer term effects

on the individual who had been

exposed directly to the drug.

This is something now that

needs to be looked at it

as quickly as possible to give

the families some reassurance.

The consequences are incalculable.

How extraordinarily distressing this

must be for the families affected.

The knowledge that this is now

in within the DNA of that family

and potentially transferable

from generation to generation.

At home in Liverpool,

Tanya and Natasha

want to get their children formally

diagnosed but like many families

they are struggling to find a doctor

who even knows the syndrome exists.

I went to the doctors

the other day and I asked my doctor

a question and I said can

you tell me is there a possibility

this could be a part of my FACS?

My GP turned round and said,

"Sorry, what is FACS?"

I was like, "I have to keep

repeating myself"

and I should not have to do that.

I said, "I should not

have to be your teacher"

and I walked out of the room.

I thought, that is not my place

to explain to you what FACS is.

Read my notes.

Couples that have come to see me

in the South West of England,

some have really struggled

to get their GP to refer them,

I know that for a fact.

Just stand down next

to mum and we will try

and measure your head.

It partly depends on really

the first hurdle if you

like, whether family

doctor or GP has some

knowledge or awareness

of the condition at all.

Back in London, Bridgit

is becoming weaker -

the drugs are no longer working.

Her brain is brain damaged

so she has only one

part of her brain that works

and the doctor have turned

round and said now, a neurologist

doctor has turned around and said

they can't give her any

more medication no more.

She has different kinds

of seizures ?

and now she could die any day.

I love you!

Karen says

Bridgit isn't expected to survive

beyond a few more months and insists

that when that fatal moment comes,

she must be allowed to die in peace.

If she was to stop breathing,

she is not to be resuscitated;

she is to be rest in peace.

No-one will bring her back

alive ?

that's what these

letters say on this door.

It will be more of a relief for me

as a mother to let my little girl

rest in peace knowing that every day

I see my little girl having

a seizure in so much pain as I do.

That's more painful to watch

than seeing my little girl probably

go from me and be at peace.

Today, Tanya and Natasha

are heading to Liverpool's

Walton health centre -

they want to get their

children assessed

for foetal valproate syndrome.

I am a little bit anxious to know

what is going to happen,

what he's going to say.

I just think we need to know

whether these have got the syndrome,

because if these have got it

and we haven't took the medication,

if these have got it,

is it going to get passed

on to their children?

Is it going to stay

in the family for

as long as the family carries on?

I'd like to try this next one

for me, please.

Neuropsychologist,

Professor Gus Baker is the lead

author of the most comprehensive

research programme ever

conducted into children born

to mothers with epilepsy.

We've

actually looked at the children

from birth and followed them up

over a six-year period,

assessing their development,

their neuro development,

in terms of how well their brains

are working, their development

of their language, their memory

and their intellect.

So talk us through the assessment,

what are you going

to do today, exactly?

What I want to be

looking at is how this young boy

is developing.

The first one is really

straightforward.

Can you write your name for me?

I'll be

trying to get an overall picture

of how he is developing

in relation to, for example,

how his peers are developing.

Can you draw me a house?

How many bedrooms

has it got upstairs?

Two bedrooms.

And I drew

some flowers, some leaves,

a gate and a path.

So, I know you cannot give us

a definitive diagnosis,

but what are your thoughts

after that assessment?

Well, obviously,

it is going to take me a little

while to score up the test

results but when I have done that,

I'll be looking at his strengths

and weaknesses and I'll be

identifying them and trying to map

them on to what we understand

about sodium valproate and how it

affects children and then I'll

probably be in a good position

to provide a formulation

of what I think has happened to him

and what we might be able to do

to ameliorate those difficulties

that he is clearly having .

Even though it

could be years before the full

extent to which her grandchildren

extent to which her grandchildren

are affected is known, Sue believes,

the drug she first took nearly four

decades ago has caused infinite

damage to her families lineage.

I do think my grandchildren

have been affected by it.

I have had my worries

my kids growing up.

I've got the worry

again with my grandkids.

How long is it going to go on for?

It's not fair, not fair at all.

It's so wrong.

So many people's lives have been

affected and ruined.

The trans-generational impact

of foetal valproate syndrome

could potentially remain

with families for centuries

and as the first generation

of children to be born

with the condition mature

into adults, there is growing demand

that the Government should pay

for their care and support.

In France a charity-led campaign

for compensation is being

supported by the Government.

The Government decided

to create a special fund

to help victims.

There is a fund that is organising

all the expertise, to appoint

the doctors and pay the doctors

and who are going to say

who will have to pay.

Until now

a campaign in the UK

for compensation to help affected

children has failed to receive

any Government backing.

But recently the

Department of Health has initiated

a conversation with charities

and key MPs who have been fighting

for a public inquiry.

We are in a good dialogue,

The Minister, Lord O'Shaughnessy

appears to have taken this

very seriously,

is willing to engage with us.

He appears to be completely

conscious of the need to stop this

scandal continuing

and the need to recognise

what is happening in France.

Something similar has to happen

here and without delay.

Unbelievable that the English

democracy does not work properly

and does not help the people.

The people must put pressure

on their Government for that.

and in

It's a rallying call that charities

in the UK are championing.

Emma and Janet are

at the forefront of the campaign.

The care package is more

important because of

the trans-generational link now.

The fact that our grandchildren

could be affected, you know

with neuro-development disorders,

possible heart malformations,

they need care and support.

For us it is a Government issue,

The Government has to take

responsibility on that matter

and make sure these children

are fully looked after.

As a parent in particular

my two are a lot older now

they are in their 20s and it's

a worrying factor for me,

I'm not always going to be

here to take care of the kids

and to live an independent life

is going to be really,

really difficult for them.

Janet's two grown-up sons,

both of whom suffer

with the syndrome, are completely

dependent and still live at home.

Philip is more seriously affected.

I am 25 now and symptoms are

I can't concentrate for long,

When I go outside my social

interaction is zero

and I am very apprehensive

with going anywhere, really.

Both of Janet's sons have suffered

with neurological problems

since birth and two years ago

doctors discovered that Philip,

like many maturing sufferers

of foetal valproate syndrome,

had developed yet another condition.

After I have finished

my college course that

I had been on for eight years;

I was diagnosed with epilepsy,

stress-related epilepsy.

It is really hard for me,

it's really hard for me...

It's hard

for me to describe the symptoms

but I know it's really

difficult to live with.

I think it is disgusting

the way the Government are acting.

I think they should pay compensation

to all these babies that have

grown up now into young adults

that are struggling.

Any kind of apology and compensation

might come too late

to help children like Bridgit.

It breaks my heart.

I picked this plot because it

is a lovely cemetery.

I didn't want to choose a cemetery

yet but because of how my daughter

is deteriorating so rapidly,

I needed to do it because I won't

be able to do it once

she does pass away.

Mother's shouldn't have

to bury their daughter no

mother should do that.

My family are mourning

now and will be the day

I lose my little girl.

If you are concerned

about any of the information

you have seen in this film,

please contact your GP urgently.

Do not stop taking any medication

prescribed by your doctor

without speaking to them first.

And that's about all

for tonight's Inside Out.

Before we go though,

let's have a quick look at what's

coming up on next week's show.

London is getting noisier.

Good

living in the capital put you're

hearing at risk. This

living in the capital put you're

hearing at risk. This is the big

storyline at the stock well. It's

absolutely deafening.

Could living in the capital be

putting your hearing at risk?

Is London too noisy?

The fight to get fit -

we set one family the challenge

of being more active.

And ? how Brixton became home

to London's last working windmill.

It's really special to be in a

building that is much as it was a

hundred years ago. It's amazing to

see what we achieved over 200 years

ago.

Tonight's programme will be

available on the iPlayer -

just head to our website -

bbc.co.uk/InsideOut ?

just click on London.

Thanks very much for watching

? I'll see you again next week.