Its Criminal

First Do No Harm Ltd – response to the report of the Independent Medicines and Medical Devices Safety Review

Authors : Yvette Greenway Mansfield & Mary McLaughlin – Directors At First Do No Harm Ltd

The Government’s long awaited substantive response to the Cumberlege Review strode silently and without announcement into the public domain on Wednesday 21st 2021.  The contents reveal why a low-key delivery was perhaps deemed necessary, because disappointment at best, and sheer outrage, at worst, are the reactions by the women affected.  It can only be described as a cruel and bitter blow to all affected and to the children of those women who took Valproate during pregnancy.  Just what did the Cumberlege Review achieve in light of the Government’s response?

The Review itself missed crucial opportunities, and, through omissions in its report, appears to have ignored submitted and damning evidence.  It advocated for a no blame approach, (contrary to the feelings of many women), and, for the thousands of women and families harmed by vaginal mesh, Sodium Valproate and Primodos, the lack of noise surrounding such an important response was yet a further reminder that there is far to go before women’s issues are treated with the prominence, equality & respect they deserve.

Let us be clear, when harm and danger was already established, yet continued, as in the case of Valproate, then a criminal investigation should have been conducted.  This was never explored or suggested by the Review, a gross failure on their part to do right by the women they were meant to represent.

Some women affected feel betrayed by many – the Cumberlege Review, MHRA, GMC, Royal Colleges, Ministers, and also the media, who prefer to run with narratives of ‘hope and positivity’, whilst not examining, or reporting upon, the key players catastrophic failures which contributed to avoidable harm in women and for which they received a written ‘tap on the knuckles’.  What requirement to change for the better, when behaving irresponsibly and dangerously does not penalise or encourage a patient first/patient safety approach?

There is a patronising and pitying approach in the foreword by Javid and Dorries, which could, and should, have been replaced with positive action to ensure change for the benefit of all women.  Normal women, whose lives have been changed forever because of medicines and devices whose dangers were known, yet not conveyed.  Women who went unheard.  Women’s voices dismissed.  Women who re-lived their trauma assisting the review.  Women betrayed, gaslighted and coerced.  Women who see their damage passed down to their children and have to live with almost unbearable guilt.  Women whose identities and self-worth have been demolished. Women with damaged emotional health which gets little recognition or discussion.

Many victims are campaigners, devoting every day at the expense of themselves to helping others and driving for change and equality for women.  But even within this arena, victims find their stories hijacked by the privileged and favoured, who are part of groups set up which should be open and transparent but are in fact secret clubs who do not believe in sharing information unless it benefits and escalates their own profiles.

We say NO to no redress, we say NO to dragging victims through the court system, we say NO to financing our own litigation or paying costly sums to solicitors, or trying to engage lawyers on a no win no fee basis, we say NO to further humiliation by a PIP system which is unfit for purpose, we say NO to going anywhere near surgeons who have harmed us again, we say NO to pretending no crimes have been committed, we say NO to letting big pharmaceuticals off the hook and NO to carrying the brunt of procurement gone wrong.

Contact :

Yvette Greenway-Mansfield (Director)
Mary McLaughlin (Director)

The System Set Up To Protect and Safeguard Our Children Actually Disabled Them – Official Government Response to The Cumberlege Review

This week very silently and on the day Parliament left for Summer recess, the Government finally announced the long awaited response to The Cumberlege Review recommendations. For the families affected by Sodium Valproate harm in Pregnancy, this was a cruel, shallow and bitter blow. Despite the high level of evidence of regulatory and Government failures, suppression of evidence , continued ongoing harm to babies, the response provided NO Redress or any Care to the disabled children and their families.

This response was not the response we expected and really blindsided us, following a meeting we had with Health Minister Nadine Dorries on Wednesday 7th July (week before). This meeting was very constructive, engaging, with a firm acceptence from the Minister as to why we campaign so very hard for those harmed by Valproate with her stating

“If I was in your position, I would be alongside you”

” with you guys are on the
outside, campaigning the way you are to make a difference… I’m totally with you.

To then receive the response we did, were these words just platitudes?

Recommendation 1: ‘The government should immediately issue a fulsome apology on
behalf of the healthcare system to the families affected by Primodos, sodium valproate and
pelvic mesh.’
Government response – accept. On 9 July 2020, the day after publication of the Review,
the government issued an unreserved apology on behalf of the healthcare system to the
Government response to the report of the Independent Medicines and Medical Devices Safety Review women affected, as well as their children and their families, for the time the system took to listen and respond.

Recommendation 2: ‘The appointment of a Patient Safety Commissioner who would be
an independent public leader with a statutory responsibility. The Commissioner would
champion the value of listening to patients and promoting users’ perspectives in seeking
improvements to patient safety around the use of medicines and medical devices.’
Government response – accept. We have legislated for a Patient Safety Commissioner
through the Medicines and Medical Devices Act 2021. The Patient Safety Commissioner
will act as a champion for patients in relation to medicines and medical devices, adding to
and enhancing the existing work described above. We are now consulting on the proposed
legislative details that will govern the Commissioner’s appointment and operation.

Recommendation 3: ‘A new independent Redress Agency for those harmed by medicines
and medical devices should be created based on models operating effectively in other
countries. The Redress Agency will administer decisions using a non-adversarial process
with determinations based on avoidable harm looking at systemic failings, rather than
blaming individuals.’
Government response – do not accept. We have no plans to establish an independent
redress agency.

Recommendation 4: ‘Separate schemes should be set up for each intervention – HPTs,
valproate and pelvic mesh – to meet the cost of providing additional care and support to
those who have experienced avoidable harm and are eligible to claim.’
Government response – We do not accept this recommendation. Our priority is to make
medicines and devices safer and the government is pursuing a wide range of activity to
further this aim.

Recommendation 5: ‘Networks of specialist centres should be set up to provide
comprehensive treatment, care and advice for those affected by implanted mesh; and
separately for those adversely affected by medications taken during pregnancy.’
Government response – accept in part. NHS England and Improvement has led work to
establish specialist mesh services. There are now 8 specialist centres in operation.
Regarding specialist centres for those adversely affected by medicines taken during
pregnancy, the government’s view is that a network of new specialist centres is not the
most effective way forward. We will in instead take forward work to improve the care
pathways for children and families adversely affected by other medicines in pregnancy. On
valproate specifically, we are taking forward significant work to ensure that valproate is
only prescribed where clinically appropriate.

Recommendation 6: ‘The Medicines and Healthcare products Regulatory Agency
(MHRA) needs substantial revision particularly in relation to adverse event reporting and
medical device regulation. It needs to ensure that it engages more with patients and their
outcomes. It needs to raise awareness of its public protection roles and to ensure that
patients have an integral role in its work.’
Government response – accept. The MHRA, reflecting its corporate Delivery Plan for
2021-2023 “Putting patients first – A new era for our Agency”, has initiated a substantial
programme of work to improve how it listens and responds to patients and the public, to
develop a more responsive system for reporting adverse incidents, and to strengthen the
evidence to support timely and robust decisions that protect patient safety.

Recommendation 7: ‘A central patient-identifiable database should be created by
collecting key details of the implantation of all devices at the time of the operation. This
can be linked to specifically created registers to research and audit the outcomes both in
terms of the device safety and patient reported outcomes measures.’
Government response – accept. We have legislated to create a power for the Secretary
of State to regulate for the establishment of a UK-wide Medical Device Information System
(MDIS) through the Medicines and Medical Devices Act 2021, which creates. Alongside
developing regulations, a package of work is underway to build, test and cost options for
how an MDIS could be embedded into the UK healthcare system, as well as complete a
business case for a 5-year programme of work.

Recommendation 8: ‘Transparency of payments made to clinicians needs to improve.
The register of the General Medical Council (GMC) should be expanded to include a list of
financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical
interests and their recognised and accredited specialisms. In addition, there should be
mandatory reporting for the pharmaceutical and medical device industries of payments
made to teaching hospitals, research institutions and individual clinicians.’
Government response – accept in principle. We agree that lists of doctors’ interests
should be publicly available, but we do not think that the GMC register is the best place to
hold this information. Our approach is to ensure it is a regulatory requirement that all
registered healthcare professionals declare their relevant interests, and that this
information is published locally at employer. Regarding industry reporting, we agree with
the need for greater transparency and we are exploring options to expand and reinforce
current schemes.

Recommendation 9: ‘The government should immediately set up a task force to
implement this Review’s recommendations. Its first task should be to set out a timeline for
their implementation.’
Government response to the report of the Independent Medicines and Medical Devices Safety Review

Government response – accept in part. We have no current plans to establish an
independent task force to implement the government response. We established a Patient
Reference Group to work with the government to develop this response.

For us here at INFACT, although it is a disappointing response , the Campaign continues. The response given by Government particularly on Redress is not credible nor acceptable. For the Valproate intervention of the Review we have proved

The Science

Culpability

Liabilty

Suppression of Evidence by Successive Governments

Continued Regulatory Failures

Data of children harmed

Answered the Remit (2018 Pre cumberlege) as to why children harmed by Sodium Valproate should be awarded Compensation

Acceptance by the Regulators and Government of the harm Valproate poses

Baroness Julia Cumberlege We are deeply disappointed the government has rejected calls for an independent redress agency or any redress for families whose lives have been devastated by medicines or medical devices. For those families justice has not been done today 😢💔

Summer may have rested for Parliament however it is business as usual and we will continue to work through doing our normal work. We have already had meetings with MPs, Legal Team, Campaigners, Organisation and we want to reassure all our members and families that as always we have great support.

This campaign is not over until our children receive the Redress and support that is rightly deserved

Managing Director Emma Murphy – “The Government response to the Cumberlege Review is a cruel bitter blow to the thousands of children and families harmed by Sodium Valproate in Pregnancy. Despite Government accepting the Science and the damage it causes in Utero to a baby, and the lifelong damaging effects to the children.  The INFACT campaign has proved Government had knowledge of the risks at licensing  (1973) yet suppressed this information to the patient, and continued to allow Valproate  to be prescribed without adequate warnings despite among other things  the proven 40% risk of Autism to the unborn child. The very systems that were set up to protect and safeguard our children, ultimately disabled them.”

General Medical Council &General Pharmaceutical Council – Strengthened Initiatives Surrounding Prescribing of Sodium Valproate

18 June 2021

This week with the announcement of 20,000 women in the UK receiving a letter about the risks of Sodium Valproate in Pregnancy we have worked and liased with the General Medical Council and The General Pharmaceutical Society in producing further communications and a Video to highlight the risk.

Here at INFACT we welcome and thank all involved in this round of communications and continued effort for safer prescribing with Sodium Valproate.

General Medical Council : This case study is about discussing the risk of taking sodium valproate with a mother who’s been prescribed it for several years. 

We’ve developed this case study with the General Pharmaceutical Council and the Nursing and Midwifery Council. While the characters are fictional, the case study is based on several people’s lived experiences, which were generously shared by patients and clinicians.

It highlights the risk of harm created by taking sodium valproate (‘valproate’), a medication for epilepsy that can cause birth defects if taken during pregnancy. Valproate was one of the interventions considered by the Independent Medicines and Medical Devices Safety Review, which reported in July 2020. The Review highlighted that many women had not been properly informed about the risks of taking valproate.  

The MHRA’s strengthened regulatory position should mean that no more women are prescribed sodium valproate without discussing the risks of harm and having a Pregnancy Prevention Plan in place. However, for some women already taking valproate but unaware of the risks this can create complex situations and difficult conversations with their healthcare providers. Repeat prescription (GP) 

Learning overview

Be familiar with guidelines and developments that affect your work. 

Make sure any repeat prescription you sign is safe and appropriate.

Don’t assume a patient’s already been given the information they need about risks of harm. If you haven’t personally spoken to a patient about medication they’re taking, it may be particularly important to review their decision to take it. 

Scenario

Dr Wright receives a repeat prescription request for sodium valproate from Millie, who is new to the practice. She sees that a valproate annual risk acknowledgement form has not been completed. 

After reviewing Millie’s medical record, Dr Wright becomes concerned because it appears that: 

  • Millie has been prescribed valproate continuously since 2010 
  • she hasn’t seen a neurologist since 2012 
  • she doesn’t appear to be on the pregnancy prevention programme (PPP). 

Dr Wright wonders whether Millie has been advised about the risks of taking valproate during pregnancy. She notes that Millie’s two children were both born before 2018 when the Medicines and Healthcare products Regulatory Agency (MHRA)’s strengthened regulatory position came into force. This made it compulsory for GPs to make sure, each time a repeat prescription is issued, that women of childbearing potential on valproate are: 

Dr Wright wonders whether Millie’s valproate use throughout pregnancy may have adversely affected her children.

She asks the practice receptionist to phone Millie and ask her to attend the surgery for a medication review with Dr Wright as soon as possible.Medication review (GP) 

General Pharmaceutical Council

This week the General Pharmaceutical Council have also reiterated communications to Pharmacists in England Scotland and Wales. In collaboration with GPC we have created a video explaining the role the Pharmacist has when prescribing Sodium Valproate

Valproate updates , 

We wanted to share with you a letter that NHS England & Improvement are sending to all women and girls taking valproate in England. The letter includes a reminder about the risks of taking valproate during pregnancy and the need for an annual review. 

This letter also encourages patients to speak to their doctor or nurse specialist. Your patients taking valproate may also ask to speak to you about the letter and you may want to check with your patients if they have received the letter and if they have any questions about their valproate prescription. 
Medicines in Pregnancy Registry NHS Digital and the Medicines and Healthcare products Regulatory Agency (MHRA) have developed a valproate registry.
Data collected in England between April 2018 and September 2020 shows: 
47,532 females (ages 0-54) were prescribed one or more prescriptions for valproate in one or more months within the reporting period
180 females were prescribed valproate while pregnant  
238 females stopped receiving prescriptions of valproate prior to their pregnancy  

Supplying valproate safely to women and girls Pharmacy professionals have a key role in supplying valproate safely. Valproate must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place.

For women and girls, when they are dispensed valproate, they should expect:to be provided with a Patient Card every time valproate is dispensedfor valproate to be dispensed with a copy of the patient information leaflet, and if repackaged, with a warning on the container supplied to be reminded of the risks in pregnancy and the need for highly effective contraception, and a reminder of the need for annual specialist review to be asked if they have received the Patient GuideYou must make sure that the patient label is not placed over the warning labels or warning sticker on the box. Women taking valproate have shared with us examples of where this has happened. 

When patients are visiting pharmacies for pregnancy tests or emergency hormonal contraception remember to ask them about any medications they are taking so you can provide further advice if their medicines are teratogenic.

Find out more about what you need to do in our Focus on supplying medicines safely: sodium valproate.

Watch our film where we speak to two women whose children were affected by exposure to sodium valproate during their pregnancies, to find out why it’s so important to make sure that women are made aware of the risks when dispensing sodium valproate. Valproate case study This in-depth case study explores patient Millie’s interactions with the different healthcare professionals she meets. It explores how to approach difficult conversations and highlights the important role all healthcare professionals have in prescribing and dispensing valproate safely.  How pharmacies can support women and girls taking valproate Find out more in this example of notable practice on supporting people taking valproate from our Knowledge Hub. 

Our inspectors check the pharmacy team are following the requirements of the Pregnancy Prevention Programme during inspections.

Sodium Valproate: The Fetal Valproate Syndrome Tragedy

Written by Sharon Hartles

In this article, Sharon Hartles reflects upon the significant impacts of avoidable harms that have been perpetuated for decades as a result of medical negligence on behalf of the regulator (Committee on Safety of Medicines) that advised the UK Licensing Authority on the safety of medicines and the manufacturer of Epilim (Sanofi). Sharon Hartles is a member of the Open University’s Harm and Evidence Research Collaborative.

Sodium Valproate

Sodium valproate, marketed as Epilim in the UK, has been linked to physical, developmental and neurological harms in the human fetus.

ALAMY https://www.thetimes.co.uk/article/sinn-f-in-senator-urges-inquiry-for-epilim-babies-hr6vlklmf

In the UK, Epilim is the dominant sodium valproate medication used to treat patients at risk of epilepsy associated convulsions. Epilim is an effective anti-convulsant medicine (epilepsy drug) and for this reason it has been licensed for usage since 1973. However, Epilim is also a teratogen; thus exposure to this drug causes an increased risk of physical, developmental and neurological harms in the human embryo or fetus.

Given the fact that sodium valproate is harmful, wherever possible it clearly should not be prescribed to female patients of childbearing age.  Despite this, the regulators and Sanofi, the company responsible for manufacturing and marketing Epilim (Sanofi acquired the company from Reckitt-Labaz in or around 1980) chose to keep patients in the dark for decades and did not disclose the known associations. As a consequence, patients were unable to make informed choices, which has resulted in the preventable fetal valproate syndrome tragedy.

According to The independent Medicines and Medical Devices Safety Review, congenital birth defects associated with in utero exposure to sodium valproate include:

  • Neural tube defects (NTDs), such as spina bifida 
  • Cleft lip and palate
  • Facial and skull malformations
  • Heart, kidney, urinary tract and sexual organ malformations
  • Limb defects
  • Developmental delay
  • Autism Spectrum Disorders (ASDs)
  • Attention Deficit Hyperactivity Disorder
  • Ear malformations and auditory processing
  • Skeletal malformation
  • Arthritis in older children
  • Effects on the endocrine system
  • Sexual identity problems (which occur due to a mismatch between genital development and neural / sexual identity development).
  • Psychomotor issues.
  • Withdrawal symptoms – associated with prenatal sodium valproate exposure.

Fetal valproate syndrome harms are widely accepted within the clinical and regulatory community, including by: the National Institute for Health and Clinical Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

During the 1960s and 1970s, articles were published drawing attention to the concerns about the teratogenicity and anti-epileptic (anti-convulsant) medication this included research by: Lawrence, 1963Janz and Fuchs 1964Meadow 1968Speidel and Meadow 1972,  Lowe, 1973Fedrick 1973Hill 1974Barr, 1974 and Hanson and Smith 1975. Yet, despite the known harms, documents uncovered from The National Archives revealed that in 1973, the Committee on Safety of Medicines (a precursor to the  Medicines & Healthcare products Regulatory Agency) thought it best not to make patients aware of the dangers because “it could give rise to fruitless anxiety”. 

The controversy surrounding the abhorrent failure to communicate the preventable risks to clinicians and patients was evidenced again because by the early 1980s the regulator and manufacturer was in possession of sufficient information to conclude that Epilim increased the risk of congenital abnormalities. Even though the links between the exposure to sodium valproate and the increased risk of harms to a fetus were well-documented, patients were not informed directly of the link until 2005. In some cases care pathways for women of child-bearing age were not established until 2016. In February 2018, the European Medicines Agency put in measures to avoid valproate exposure in pregnancy.

A visual warning of the pregnancy risks (in the form of text) with other warning symbol on the outer carton

A visual warning of the pregnancy risks (in the form of text) with other warning symbol on the outer carton.

https://www.chemistanddruggist.co.uk/cpd-article/valproate-pregnancy-prevention-programme

The fetal valproate syndrome tragedy (medical negligence) was entirely avoidable, resulting from a regulation failure and decades of inaction by successive governments to safeguard patients. The true number of individuals’ harmed by sodium valproate in utero since it was licensed in 1973 in the UK is unknown, however, the consensus estimate is around 20,000.  More recent evidence suggests that the medical problems associated with fetal valproate syndrome may be passed down the generations.

The role that the regulator and the manufacturer Sanofi have played in creating and perpetuating this tragedy is evident, therefore financial redress should be paid to all those affected by fetal valproate syndrome.

Currently, 27,000 women of child bearing age are taking valproate in the UK. On 2nd March 2021, in the House of Lords, James O’Shaughnessy, Vice-chair for the All-Party Parliamentary Group for First Do No Harm, reported that since June 2020, 150 babies had been born suffering harms due to sodium valproate exposure. Therefore it is imperative that the Government find ways to minimise the risk of harms to future babies. Beyond this, lessons must be learned and mechanisms put into place to ensure avoidable systemic failures on this scale do not happen again. 

Letter released to women and girls taking Sodium Valproate

NEWS RELEASE 14/6/21

NHS Issues Advice To Girls And Women Taking Sodium Valproate For Epilepsy

20,000 women and girls will this week be reminded of risks during pregnancy while taking an epilepsy drug, as part of the NHS’s drive to increase patient safety.

Over the coming days letters are being sent to females in England aged between 12 and 55 who are currently recorded as having an active prescription for the drug, Sodium Valproate, outlining a number of actions to take if they are pregnant, trying for a baby or have not had a recent medication review.

Sodium valproate is a drug that can be used to treat epilepsy and bipolar disorder, however babies can be harmed if the person taking the drug becomes pregnant.

The NHS is now sending reminder letters as part of the organisation’s drive to inform patients and prevent future risks.

The letter from the NHS Director of Patient Safety, Dr Aidan Fowler, will urge those with an active prescription to continue their treatment course until their doctor tells them otherwise, but to:

  • Continue to take contraceptive measures, ideally the implant or coil, while they are taking valproate;
  • Speak to their GP immediately if they think they may be pregnant;
  • Seek a medicines review from their GP if they haven’t received one in the last 12 months, and;
  • Speak to their doctor if they are keen to try for a baby, before coming off contraception.

The reminder is part of the NHS’ ongoing response to former health Minister Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review, published last year.

A new data registry has also been established, managed by NHS Digital, to better track prescriptions to women.

NHS Patient Safety Director, Dr Aidan Fowler, said:

“Valproate is the best treatment available for a small group of people with very complex illnesses, so it’s vital those who have an active prescription for it to continue taking it until they are told otherwise by their GP or consultant.

“It’s vital too however that everyone understands the risk that doing so poses to your unborn child if you are pregnant, and this letter is a reminder of information that every woman and girl of childbearing age should receive from their doctors when the drug is first prescribed”.

Sodium valproate was approved for use in 1974 and has always carried warnings for doctors about the possible risks if it is taken while pregnant. These have been strengthened over the decades as more data has become available about higher rates of physical birth defects, autism and child developmental problems.

Due to this risk, in 2018 the heads of all medicines agencies in the UK issued a joint edict saying that all women and girls who could potentially conceive should be provided with and urged to use contraception for as long as they are taking valproate, even if they are not sexually active.

Doctors are expected to discuss the risks with patients as part of the shared decision around prescribing valproate, and put in place a pregnancy prevention plan to eliminate risk if it is prescribed, or use other forms of treatment if the patient wishes to have a baby.

Emma Murphy – Managing Director of INFACT

“We welcome this letter of communication being sent to all females of childbearing age informing them of the risks of Valproate in Pregnancy. This is something that should have been done from the very beginning and it has been a long and arduous campaign by INFACT to reach this goal. We are not only glad for ourselves that now Governing Bodies are taking these steps but most importantly for the patients prescribed the drug and the potential damage to the lives of unborn children”