The Epilepsy Drug Scandal: BBC Podcast 2023 File on 4 Investigates

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Below is a Transcript of the Podcast from the BBC. 2023

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BRITISH BROADCASTING CORPORATION RADIO 4
TRANSCRIPT OF FILE ON 4 – “THE EPILEPSY DRUG SCANDAL”
CURRENT AFFAIRS GROUP
TRANSMISSION: Tuesday 18
th July 2023 2000 – 2040
REPEAT: Sunday 23rd July 2023 1700 – 1740
REPORTER: Rachel Stonehouse
PRODUCERS: Jane Fellner & Emma Forde
JOURNALISM ASSISTANT: Tim Fernley
PRODUCTION MANAGER: Sarah Payton
EDITOR: Carl Johnston
PROGRAMME NUMBER: 23VQ6473LH0

20 –
STONEHOUSE: Dale is now getting his son assessed for autism. Dr
Rebecca Bromley is a paediatric neuropsychologist, working for both the NHS and at the
University of Manchester. She studies the risks of medicines taken in pregnancy and the
outcomes for children.
BROMLEY: So, the inter-generational risks, this is where we think
that there could be some almost kind of passing down, so the changes that are induced in the
developing foetus that’s directly exposed to Valproate then become part of that kind of
genome and get passed down to the next generation and so on. We have, I think it’s three
animal studies now all that suggests there potentially is passing down of the risk to the next
generation. In terms of human data, we have a study by a French charity, which is led by
Marine Martin. So, she has 108 who had become parents themselves, and so she put out
some figures to suggest that, you know, maybe 23% of those who went on to have children,
their children had a major congenital anomaly, so a heart defect or a spinal problem, and that
it’s slightly higher at 44% of these children also showed neurodevelopmental difficulties.
I’ve been involved with lots of conversations with colleagues internationally about, you
know, what are the next steps for looking at these inter-generational risks. Again, we feel it’s
something that we have to look at.
MUSIC
STONEHOUSE: The European Medicines Agency has now
commissioned a study to investigate further whether Valproate has a transgenerational effect.
Sanofi told us that the evidence currently available isn’t robust enough to suggest a secondgeneration impact linked to the drug. The results of the study should be reported later this
year. And for Dale, this research cannot come soon enough, to establish if the legacy of
Valproate may be even bigger, and have caused even more harm to the families affected.
DALE: It’s something that needs time taken on it, and certainly
the investment of research. It’s some of the least of what everyone deserves, and it’s very
important as well, so it’s in time for our children’s development, if they have been affected,
then it’s important that it’s put in place sooner than later, so that they can develop through
what’s left of their lives, which is the fairest chance they have of doing hopefully as well as
possible.

2 –
THE ATTACHED TRANSCRIPT WAS TYPED FROM A RECORDING AND NOT
COPIED FROM AN ORIGINAL SCRIPT. BECAUSE OF THE RISK OF MISHEARING
AND THE DIFFICULTY IN SOME CASES OF IDENTIFYING INDIVIDUAL
SPEAKERS, THE BBC CANNOT VOUCH FOR ITS COMPLETE ACCURACY.
“FILE ON 4”
Transmission: Tuesday 18
th July 2023
Repeat: Sunday 23rd July 2023
Producers: Jane Fellner & Emma Forde
Reporter: Rachel Stonehouse
Journalism Assistant: Tim Fernley
Production Manager: Sarah Payton
Editor: Carl Johnston
MUSIC
ACTUALITY AT BEACH, SEAGULLS
STOCKLEY-POLLARD: It is quite choppy today, I must admit. I’m looking at
it, thinking I can get in, I can get in. It’s getting through the initial waves.
STONEHOUSE: It’s a windy day on a beach near Bognor Regis in West
Sussex. We’re with Janet Stockley-Pollard, who’s bracing herself for her first swim of the
day.
STOCKLEY-POLLARD: Basically, anything that is going on back home or in
your life you just forget about, because you’re focused on the here and now. You just float
and your cares can just disappear.
STONEHOUSE: It’s a daily ritual for the 55-year-old mum – her way of
de-stressing.

3 –
STOCKLEY-POLLARD: It’s just exhilarating and it just makes you feel alive
and appreciate each and every day, just so glad to be here, and yeah, very, very happy
STONEHOUSE: Life hasn’t always been easy for Janet though. As a
teenager she was diagnosed with epilepsy.
STOCKLEY-POLLARD: I was having really, really bad seizures. One of the
drugs was causing me to have them up to eight times a day, so to be given a drug that meant I
wasn’t having those meant that I didn’t really think about the other things, what it might do
on side effects, because I was just pleased to not have the fits.
STONEHOUSE: The drug she was prescribed was called Sodium
Valproate. It changed everything, allowing her to live a normal life again.
STOCKLEY-POLLARD: I got married at 18 and had my first child at 19, so
when I was pregnant, my mum was a nurse, so she came with me to the doctors and we asked
the question, am I all right having these drugs in pregnancy? And they told me that they’d
contacted the drug company and that there was a very minimal risk of cleft palate, harelip and
spina bifida, and so you have increased number of scans during the pregnancy just to monitor
for spina bifida, so we weren’t too concerned, but that was it, that was all I was told.
MUSIC
STONEHOUSE: Janet went on to have a second child with her first
husband. All seemed relatively normal. So, a decade later in the late nineties, when she’d remarried and had two more children – Cameron and Kyle – it was a shock when both of them
had developmental problems from an early age.
STOCKLEY-POLLARD: They had behavioural problems, from speech and
language, I think one of them was referred from a very, very young age. He wasn’t even two
and he was under speech and language, and he had his first operation just after his second
birthday, because of the sleep apnoea and the breathing, they were trying to resolve things.
He was also found to be deaf with glue ear. And then Cameron had other behavioural
problems and very, very hyper, very accident-prone.

4 –
STONEHOUSE: Then, in 2005, Janet came across an article about the
risks of taking Sodium Valproate in pregnancy. She was distraught.
STOCKLEY-POLLARD: It answered questions that we’d been having for a
while as to why our children were struggling the way they were. But it also, as a mum,
tremendous guilt, because obviously I’m the one that took the medication, and because of the
medication that I took in pregnancy, my children have got lifelong disabilities, and so that
guilt was overwhelming. And anger as well. Anger that we weren’t told, because we always
asked, we always asked the questions when you’re going to maternity check-ups and things
like that, you ask the questions and we were told it was fine.
STONEHOUSE: Her eldest son, Dale is now 35. He remembers what it
was like growing up.
DALE: By the time my two half-brothers were both born and
thereafter, from me being about the age of ten onwards, I had the recognition that they had
great needs and that they were affected a lot by the drug itself and what goes with it, so I kind
of took a back step from how much I asked of my parents.
STONEHOUSE: Janet, I just wonder what it’s like for you hearing Dale
say that?
STOCKLEY-POLLARD: It always just makes me feel really sad, because my
children have all these worries and stresses that could have been avoided. You know, hearing
Dale, we felt guilty that we couldn’t give as much to the older children, because we were so
busy dealing with everything with the younger children.
DALE: I’d just like to say, especially as a parent now myself, I
don’t feel like I missed out on anything really at all. I think they did an all-round great job of
parenting with what they had to deal with, an astronomical amount at that as well. It actually
leaves me feeling proud of them.
STOCKLEY-POLLARD: It’s nice to know that you feel appreciated, so yeah,
love you, Dale.

5 –
DALE: I think I love you too, Mum.
MUSIC
STONEHOUSE: Sodium Valproate has been licensed for use in the
treatment of epilepsy since 1972, and for some epileptics it’s the only treatment that allows
them to live a normal life. But, as we’ve already heard, it comes with a risk of serious side
effects. An estimated 20,000 children in the UK – and tens of thousands more around the
world – have been harmed by the drug their mums took during pregnancy. In terms of
numbers, it’s been described by experts as a bigger scandal than Thalidomide.
MARSON: So, we’ve known something about the risk of Sodium
Valproate in the developing child for a long time, but over the years our knowledge has
steadily improved, and we now know that around 10% of children exposed to Sodium
Valproate in utero will have some sort of malformation or other. And even more worrying,
there’s about 30 to 40% of children exposed will have a problem with their learning, which is
often discovered later during childhood.
STONEHOUSE: In this programme, File on 4 asks whether the
manufacturer of the drug, Sanofi, and the UK’s health regulators did enough to pass on
information to patients about the extent of the risks of taking the drug, especially during
pregnancy.
STOCKLEY-POLLARD: It could have been avoided. If I’d have changed
medication, then they could have had a much different life to the ones that they have now,
without the things that constantly pull them down and the struggles that they have. So, it
does make me very, very cross.
STONEHOUSE: And we can reveal that emerging research suggests it’s
not just mums-to-be whose children are at risk of serious side effects, but possibly fathers
too.

6 –
MARSON: What they may have found is a higher risk of
malformations in the child when the men are taking Sodium Valproate compared to other
treatments, so at the moment the company is concerned about it, the regulator’s concerned
about it. It highlights that there might be a problem. It is clearly important that we tell men
about it.
ACTUALITY ON AEROPLANE
CABIN CREW: It’s approaching twenty to ten. Please keep your
seatbelt fastened and remain …
STONEHOUSE: Sodium Valproate is made by Sanofi – a global drug
company based in France.
ACTUALITY AT AIRPORT AND ANNOUNCEMENT IN FRENCH
STONEHOUSE: That’s where we’re heading now – to meet with mumof-two, Marine Martin, who took the drug during both her pregnancies.
ACTUALITY ON TRAIN AND ANNOUNCEMENT IN FRENCH
STONEHOUSE: She lives with her family in Perpignan.
ACTUALITY IN FAMILY HOME, CHATTER IN FRENCH
STONEHOUSE: When did you first start taking Valproate?
MARTIN: So, it’s a long time ago, I was suffering of epilepsy and
for me it was normal since the beginning I took these drugs, and when I become a woman,
surely I asked my doctor if I can have a child with these drugs. All say the same thing – yes,
it’s sure, it’s okay. The only malformation you can have, it’s spina bifida, so I was very
confident. And when she born, I say, oh, it’s, she look a strange face.

7 –
STONEHOUSE: Her daughter, Salome, was born in 1999 and diagnosed
with autism. Three years later in 2002, Marine’s son Nathan was born – also autistic,
hypermobile and with Attention Deficit Disorder.
MARTIN: Nathan, when he was child, need a lot of care, so I
must stop my job.
STONEHOUSE: And then at what point did you make the connection
between the difficulties that your children were having and Sodium Valproate?
MARTIN: So, I put in Google in 2009, ‘drugs dangerous during
pregnancy’ and I finally discover the website of the hospital in Paris and who say that
Valproate. I was crying alone and I call my husband to say I have finally found it’s not a
genetic problem, it’s due to the drug I take for my epilepsy.
STONEHOUSE: Salome and Nathan are now in their twenties. Both
have been diagnosed with a condition called Foetal Valproate Syndrome.
SALOME: I have trouble with writing and more fine actions. I
have attention deficit, so it’s not a heavy impact, but in everyday life it can slow myself down
and I also have interactions problems, so as a kid I had a lot of troubles making friends and
even to nowadays.
NATHAN: Well, I have kind of the same difficulties as my sister,
but in a more significant way. So, I have autism. I have trouble with writing, I have epilepsy.
It will not be easy, it will be hard, but I will be strong and it is what make me different from
other and I am proud of that.
STONEHOUSE: For Marine, it’s defined the last twenty-five years of
her life.
MARTIN: It break my life. I was guilty. I poisoned my child
with this drug. So, it was very, very difficult.

8 –
STONEHOUSE: Upset, angry and determined to hold the manufacturer
and the health regulator to account for the lack of information provided to patients, Marine
set up a group to campaign for justice. Eight thousand families who say their children have
been harmed by Valproate have now joined.
ACTUALITY ON PARIS METRO
STONEHOUSE: Her lawyer is Charles Joseph Oudin, whose office is in
Paris, tucked away on a side street in the centre of the city.
ACTUALITY IN OFFICE
OUDIN: Well, in all the red files in this office are the Valproate
cases that are ongoing.
STONEHOUSE: Oh right, okay.
OUDIN: Okay, so this is a lot of red files.
STONEHOUSE: And just putting that into context, we’ve got this huge
shelf which is ten high, there’s probably, just looking now, I don’t know, over a hundred
documents, I would guess, in here, just in this room.
OUDIN: Yeah, probably around one hundred families.
STONEHOUSE: But those folders tell only part of the story. Charles’
legal firm alone is handling claims for compensation from around 900 families. Some have
already been paid out – but not by Sanofi. Payments are awarded by a fund set up by the state
which has an expert team assessing each case, deciding how much should be awarded and,
most importantly, who’s culpable – whether that be Sanofi, the French Government or the
doctor who prescribed the medicine.

9 –
OUDIN: As of today, Sanofi absolutely refused to pay €1, so it
is the French state who is paying. I think as of today, the French state paid around €60 or €70
million on behalf of Sanofi. And this is a scandal in the scandal, that Sanofi refuses to pay.
STONEHOUSE: Sanofi is challenging the payment orders issued by the
court, because it says the health regulator didn’t update information for patients, despite
repeated requests. But in 2022, the court in Paris ruled that from as early as 1984, there was a
probable causal link between the drug and the risks of physical malformation to unborn
children, which Sanofi didn’t tell patients. The court acknowledged there was a scientific
consensus that Valproate was among the best in the world for treating epilepsy, but
concluded that the manufacturer failed in its duty of care by also failing to warn of the extent
of the risk of neurological disorders, which they should have known about in 2001. Sanofi
disputes this and is appealing the judgement around its liability.
OUDIN: The ground against the state and Sanofi is lack of
information, which implies for us to show that there were information about the side effect of
the Valproate and that the state or Sanofi, they knew. Basically, we used documents written
by Sanofi for the public agency where every year they disclose everything that they know
about the drug.
MUSIC
STONEHOUSE: So, these documents are called Periodic Safety Update
Reports, and what they detail is any adverse or harmful effects on the children of patients
who took Sodium Valproate. Now File on 4 producer, Jane Fellner, has been investigating
this story for months and she’s managed to obtain some documents. Jane, what do they
actually tell us?
FELLNER: We have a table and it lists 547 adverse events or
instances of the effects that happened on babies born to mums who’d been taking Sodium
Valproate, children from numerous countries between 1994 and 2005.
STONEHOUSE: Just talk us through some of the specific things they
list.

10 –
FELLNER: You know, we have face malformations, heart defects,
and then developmental delay.
STONEHOUSE: Now presumably these would have been reported to
the British health regulator during that time?
FELLNER: Yes, we understand so. The British health regulator
was in a pilot scheme, so it was getting all the same information that the French regulator was
getting. We’ve looked at all the warnings in the patient information leaflet, and there’s a very
brief mention in 2003 of birth defects, and there’s always been a mention of the risk of spina
bifida, 1% to 2%, but it isn’t until 2005 that all these risks are clearly spelt out. But, you
know, crucially for the families, they didn’t know that Sanofi was gathering all this data
about the adverse events and it wasn’t being relayed to them as potential risk.
STONEHOUSE: Now, it’s important to say that doctors have told us that
anybody who’s taking Valproate shouldn’t stop and that they should discuss any concerns
raised in this programme with a health professional. And there’s more. We shared the
documents with Carl Heneghan, a Professor of Evidence-Based Medicine at the University of
Oxford.
If you’re happy, Carl, we can crack on and start the recording.
HENEGHAN: Sure, go for it, fire away.
STONEHOUSE: Okay, that’s great, thank you.
HENEGHAN: So, this is the sort of information that is the onus is on
the manufacturer and the regulator to collect. First thing is to say there’s underreporting
within this. But what you also have is a column, which I often find interesting. It’s called the
Accountability Column, and people are trying to make a value judgement. Was this causative
or not? But I think the accountability is a real issue here, because what you’re asking is, a
regulatory system that’s funded by industry to look at a problem with a drug which is making
serious amounts of money at any one time, and wherever you do that and look at the system,
it fails to keep people safe. And I think this is a huge problem.

11 –
STONEHOUSE: We asked the MHRA to respond. It told us its
regulatory decisions are based solely on the safety, quality and effectiveness of the medicine
under review and are in no way influenced by the set fees it charges for the services provided
to the industry.
Do you think there is more accountability then with Sanofi?
HENEGHAN: If you look at the labelling, there was a significant
delay between getting the appropriate information in front of everybody and systems in place
to make it safe, and therefore they should be accountable.
STONEHOUSE: Sanofi told us it investigated the outcomes of all
pregnancies exposed to Valproate in accordance with its regulatory obligations, and that all
the data was analysed using methods required at the time, which were also validated by
health authorities, who carried out their own analysis.
EXTRACT FROM ARCHIVE RECORDING
CUMBERLEGE: Warnings ignored, patients’ concerns ignored, a system
that seemed unwilling or unable to listen, let alone respond; unwilling or unable to stop the
harm.
STONEHOUSE: In 2020, the Independent Medicines and Medical
Devices Safety Review published a damning report, which included evidence gathered
around the use of Sodium Valproate during pregnancy. The review was led by Baroness
Cumberlege – a Conservative Life Peer and former Health Minister.
EXTRACT FROM ARCHIVE RECORDING
CUMBERLEGE: The harm these women and their families have
suffered is irreversible and it’s lifelong.
STONEHOUSE: One of its recommendations was to put in place a
Patient Safety Commissioner in England, a post which was taken up by Dr Henrietta Hughes
last year. We began by asking her about the internal Sanofi documents that we’ve been given.

12 –
HUGHES: We need to know that patients get all the information
when it’s available and it’s been verified by the regulator.
STONEHOUSE: Do you think the health regulator and Sanofi, the drug
company which make Valproate, have failed people?
HUGHES: I think this is a failure of overall regulation. This is not
about one regulator or one healthcare provider, it’s about the entire regulatory system that has
let patients down and has led to their children being harmed and for harm to continue.
ACTUALITY IN GARDEN
PATRICIA: Amelie, come and see this caterpillar Joseph’s found,
it’s a tiny weeny one.
STONEHOUSE: This is Patricia. She knows from bitter experience
about the failures to fully inform patients about all the risks associated with taking Sodium
Valproate while pregnant. She’s now 45, but has been taking the drug since being diagnosed
with epilepsy when she was 20. She lives in Essex with her husband and two children –
Joseph who’s 22, and 13 year old Amelie.
AMELIE: It’s furry.
PATRICIA: Yeah, look, you can see, if you look, all the little holes
in the leaves …
AMELIE: There’s a holey flower.
PATRICIA: … where it’s been munching.
STONEHOUSE: They like spending time in the garden, because leaving
the house can be difficult.

13 –
PATRICIA: They’ve both got a number of difficulties. Some
overlap one another, some are different. He was the first baby in the family, so we just
thought that Joseph had some quirky ways and things that we knew he found difficult, but we
weren’t overly alarmed about because we didn’t think that there was any need to be.
STONEHOUSE: When she became pregnant with Joseph in the year
2000, Patricia asked several doctors whether it was safe to carry on taking her medication.
None of them warned against it. She was told about a tiny chance of spina bifida and cleft
palate – potential conditions that could be monitored during pregnancy – so she was happy to
continue taking the drug. But after Joseph was born, his numerous conditions slowly made
themselves apparent.
PATRICIA: My son has shortened Achilles, he’s also got problems
with his joints. He has autism. He has dyslexia
STONEHOUSE: Despite Joseph’s difficulties, still nobody was linking
it with the Sodium Valproate Patricia was taking to manage her epilepsy. Nine years later,
she became pregnant again. Once again she asked the questions and once again she was told
any risks were minimal. But when Amelie was born, she displayed the same conditions as
her brother.
PATRICIA: You’d need to come and live in our lives and see the
amount of support that our children need, the amount of medical appointments that we have
to attend, how difficult it is to even leave the house to get my daughter to go to medical
appointments, how difficult it is for her to even try and think about leaving the house to go to
school – all these sort of things. We believed the doctors. We hadn’t been warned of any
risks, so I had no reason to disbelieve that until I did find out about it, which was when my
oldest was 15.
STONEHOUSE: It was only when Patricia completed an online survey
aimed at women who’d taken Valproate during pregnancy that she finally made a connection
between the medication and the problems her children were facing.

14 –
PATRICIA: I feel aggrieved that for 15 or 16 years of my children’s
lives and the time that I was pregnant, I didn’t know any of this. I wasn’t warned of it
beforehand before becoming pregnant, so I feel aggrieved, I feel angry. What concerns me
and my husband is that we are the only support that our children have, so we have to think
about what, what will happen to them when the time comes that we’re not here to look after
them. We need to make sure that they’ve got the financial support that they need and
somebody to help care for them, because we can do that until the day we die, but they’ll still
need caring for.
MUSIC
STONEHOUSE: File on 4 asked Sanofi for an interview about the
concerns raised in this programme. So, they declined and instead they’ve sent us an email
with a four-page response. I’ve got it here in front of me, and in it the company says that
there are many factors to consider to establish if an adverse – or harmful – event was caused
by children being exposed to Valproate, and that it’s even more difficult if it was some time
after the pregnancy. They go on to say that from 1990, the Drug Information for Healthcare
Professionals warned about the possibility of congenital malformations. Now, the MHRA
and Sanofi both say the patient information leaflet that comes with Sodium Valproate
mentioned the risk of birth defects and neurodevelopmental disorders in 2003, and that there
were then clearer warnings introduced in 2005. The MHRA added there was no clear
evidence of what it describes as ‘significant neurodevelopmental harms’ until 2013. But
Patricia says she didn’t know about the warnings because often her medicine was dispensed
into unbranded packaging, and so basically there was no patient leaflet.
Professor Carl Heneghan at Oxford University says that Sanofi and the MHRA were too slow
to react. Since the early 1980s, there have been dozens of studies into the impact of taking
Valproate during pregnancy, and he has analysed them all.
HENEGHAN: When you combine all those studies, what you can also
do is something called a cumulative meta-analysis. What this means is, you basically put
them in order from the first study, which the first study was in 1983, and then you add in the
second study when that occurred, and the third study, and the fourth study. And why that’s
important is because in this area, what’s important is what was known when, by whom. And
it was very clear by 2004, there was a signal that actually this drug, Sodium Valproate, led to

15 –
HENEGHAN cont: more than double the risk of congenital malformations.
And when you get a signal like that – and it was a consistent signal, more than 25 studies had
accumulated – at that point there should have been concerted action by the regulatory system
and the health system to ensure patients, pregnant women were safe. The key, though, is it
took another 14 years for effective prevention programmes to come into place. But the line
comes down in the sand for me in 2004 that the onus now goes on the regulators and the
health system to change practice for everybody, to basically make it impossible for you to
prescribe this unless you go through certain situations.
MUSIC
STONEHOUSE: The programme he’s talking about is the Pregnancy
Prevention Programme. Launched across Europe in 2018, it’s designed to stop women who
use the drug becoming pregnant. They should be seen by a GP or specialist at least once a
year to review medication and discuss effective contraception. They should also sign an
annual risk acknowledgement form. But a report published last year, following an audit of
pharmacies across England, revealed that almost one in five patients hadn’t had that
discussion in the previous 12 months. And File on 4’s also done some of its own research; a
questionnaire shared with two patient groups – the Organisation for Foetal Anticonvulsant
Syndrome and the national Valproate campaign, INFACT. There were only 125 respondents,
so it’s not scientific. But, of the 64 who said they were taking Valproate, 14 weren’t on the
Pregnancy Prevention Programme and only 16 of them had signed an annual risk
acknowledgement form in the last year. Crucially though, only a quarter of them had seen a
specialist in the last 12 months. Patient Safety Commissioner, Dr Henrietta Hughes.
HUGHES: There’s still a long way to go to get this right for every
single patient who’s at risk, and we know that there are problems in terms of patients getting
access to annual reviews, that patients don’t always get the right information, that people find
themselves in a situation where they’ve become pregnant and it’s only at that point that
they’re given information about the risks of Sodium Valproate, and I think that’s completely
unacceptable. There are three babies a month still being born exposed to Sodium Valproate,
so every month that goes by is another three children whose lives may be affected either
through physical or through learning disability.

16 –
STONEHOUSE: Now the Department of Health has asked Dr Hughes to
investigate the possibility of setting up a compensation fund in the UK, which might look
similar to the one in France.
HUGHES: What I’ll be doing is I’ll be providing information to
ministers about different types of redress schemes and I’ll be publishing a report later in the
year that will set out all of the information around redress. I think this a really positive step
forward and, you know, I’m really clear that I believe that people who have been affected by
the injustice of the lack of regulation around Sodium Valproate should be entitled to redress.
STONEHOUSE: Sanofi says information regarding the effects of
Valproate has developed over time and it reported the adverse effects to the MHRA.
MUSIC
STONEHOUSE: In December last year, further safety measures around
the use of Valproate were announced by the MHRA. They proposed that two specialists
should sign off on whether the drug be prescribed, and for those already on it, two specialists
should consider if there’s an alternative medication. The plans have provoked an angry
response from epilepsy charities, who say Valproate saves lives and for many it’s very
effective. For the first time, the MHRA has also said it wants men to be warned about the
risks associated with the drug. There are more 60,000 men under the age of 55 in England
alone taking Valproate. The MHRA says it’s recommending greater clinical oversight of
prescribing Valproate due to the lack of awareness of the risks of male infertility.
LAUREN: And we have just been picking up bits and pieces as,
you know, kind of payday comes, we keep a wee list of the things that we’d be looking at.
So, we’ve got some lovely wee kind of mittens, some wee hats.
BEN: Yeah, I look at all the technology. It’s my day job, so
I’m all looking at reviews on baby monitors and prams and all these things to make sure I get
the right one.

17 –
STONEHOUSE: Ben and Lauren live about an hour from Glasgow.
They’re expecting their first baby in October, and it’s been quite a long journey for them to
get to this point after struggling to get pregnant. Ben’s 34 and has been taking Sodium
Valproate for the last 20 years. Epilepsy can affect fertility, but Valproate can affect the
number of sperm and the way they move. But Ben says it’s not something he was ever made
aware of.
Has anybody discussed with you the medication you take and how that could potentially
impact your fertility?
BEN: No, not at all. It was never, never even discussed that
it was possible. There was never really a discussion topic or even anything that this might
potentially be the cause.
STONEHOUSE: He shows us the boxes of Valproate in his bathroom
cupboard.
BEN: So, this is my, the 500s. I take them twice – two times,
twice a day, so this is the bigger tablet that you get.
STONEHOUSE: On the packaging is a prominent logo of a pregnant
woman with a cross through it. Inside, a patient information leaflet lists all the warnings and
side effects.
BEN: I mean, that’s the leaflet there, which again quite
apparent bits about pregnant women, but there’s a section there – can be a contributing factor
in male fertility. That’s all it says, that’s the whole, what’s that, a four-page leaflet, and
there’s like one sentence on it. It would have been nice to have a conversation about it and
just kind of weigh it out on the table and just say, these are the possibilities and this is your
options, and then allow you to make that informed choices.
STONEHOUSE: And there’s another worrying development. The
summary of a new study published in May suggests children of men taking Valproate could
be twice as likely to have neurodevelopmental disorders compared to children fathered by
men taking other epilepsy medications.

18 –
BEN: If they’ve got issues, we’ll have to face them and we’ll
just do that as a family. Whatever happens will happen, we’ll just have to face it when it
comes.
STONEHOUSE: And as a man expecting a baby with your wife, do you
think that more research is needed into this?
BEN: 100%. I think there’s not enough out there and more
understanding of the impact and how bad could it be. What support is out there and what sort
of treatment you can get and things like that to reduce that risk.
STONEHOUSE: Sanofi says that the new study has limitations and more
analysis is needed before conclusions can be drawn. That hasn’t stopped them issuing
warnings about a higher risk of neurodevelopmental disorders in children fathered by men
taking Valproate. After seeing the new study in May, they issued guidance to healthcare
professionals in Australia, New Zealand and Singapore, suggesting those who prescribe the
drug should inform patients of this potential risk. Tony Marson is a consultant and Professor
of Neurology at the University of Liverpool.
MARSON: What they may have found is a higher risk of
malformations in the child when the man is taking Sodium Valproate compared to other
treatments, so at the moment there’s clearly concern – the company’s concerned about it, the
regulator’s concerned about it. It highlights that there might be a problem. It is clearly
important that we tell men about it. But what we can’t tell men is that we’re sure that there is
a problem. We’re therefore in a really difficult situation where we have a lot of uncertainty
and we have to try and manage that uncertainty, so we have some very complicated
conversations to have with men either starting Valproate or who are already on Valproate, to
say that this might affect your fertility, but we’re not sure. More research is needed. This
could affect children born to you if your partner becomes pregnant whilst you’re taking it, but
we’re uncertain. So, the challenge here is to manage that uncertainty. I fear that we’re going
to be managing this uncertainty for a number of years.
MUSIC

19 –
STONEHOUSE: The MHRA says the study is being re-analysed and it
will scrutinise the full results as soon as they’re available with a view to providing guidance
to patients. This isn’t expected until next year. Governments in Wales, Scotland and
Northern Ireland say they’re also awaiting further information.
ACTUALITY AT SEASIDE
STONEHOUSE: That was fun, not quite as cold.
STOCKLEY-POLLARD: No, 18 degrees. Sorry, I’m out of breath now. It’s all
the wave jumping.
STONEHOUSE: We’re back in Bognor Regis with Janet and her son
Dale, who we met at the start of this programme, because there’s more of their story to tell.
In the last couple of years, Dale’s discovered that it’s not just his two younger brothers
who’ve been affected by Foetal Valproate Syndrome, as he too now has a diagnosis.
DALE: I had that assessment and I’m actually really glad that
we took the time out to do that. It’s super important and I urge the same for anyone else that
has any idea if they may well have been affected in the same way. And yeah, I’m really glad
that we both took the time out, my mum and I, to go through that and get to where we are
now with it.
STONEHOUSE: And it was this diagnosis that then led Dale to consider
some of the struggles his own son has, and whether the impact of Valproate is passed even
further through the generations.
DALE: It’s really quite extraordinary how it’s like a mirror
image of his own learning difficulties, which are very symmetrical to what I had as a child.
It’s just, yeah, it’s like looking back over my childhood with the difficulties he has, just basic
learning needs and the struggles he has with the learning.

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