MHRA has approved the brand name Xonvea® to be used for marketing Diclectin® in the UK

New NHS drug for “morning sickness”, approved July 2018

Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, announces that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the UK Marketing Authorisation Application for Diclectin®, a prescription product for the treatment of nausea and vomiting of pregnancy.

Alliance also confirms that the MHRA has approved the brand name Xonvea®, which will be used for marketing Diclectin in the UK. As previously indicated, Alliance anticipates Xonvea’s launch in autumn this year as the only medicine licensed in the UK for the treatment of nausea and vomiting of pregnancy.

Xonvea was in-licensed from Duchesnay Inc. of Canada (“Duchesnay”) for the UK in 2015 and for a further nine European countries in 2016 – Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Republic of Ireland and Switzerland.

Nausea and vomiting of pregnancy is the most common medical condition in pregnancy affecting approximately 690,000 women in the UK each year according to the Office of National Statistics and the Royal College of Obstetricians and Gynaecologists. Research shows that up to 40% of pregnant women report symptoms of nausea and vomiting of pregnancy sufficiently severe to interfere with daily life whilst NHS data shows that at least 33,000 women with the condition are hospitalised each year.

The Group estimates peak sales for Xonvea in the UK of approximately £10m and across the other nine European countries a further £30m approximately at peak sales. The Group will incur both upfront costs ahead of the launches in the UK and EU markets and further incremental costs to support in-market growth in these countries. Alliance expects to generate meaningful sales of Xonvea from H2 2019.

Xonvea is the most studied medicine in pregnancy, with a proven efficacy and safety profile from use in more than 30 million women over more than 30 years. Following marketing authorisation in the UK, Alliance is preparing to file the necessary applications for regulatory approvals in continental Europe.

Related : read What you don’t know about a leading morning-sickness drug, by Anne Kingston Oct 23, 2015 on macleans.

Will Brexit harm the NHS ?

Patients lack answers to too many questions about their healthcare after Brexit

Predictions of a smaller UK economy, at least in the short term, and fewer EU healthcare staff present challenges for the NHS after 29 March 2019, argues Anand Menon.

But Graham Gudgin is unconvinced by what he believes are biased estimates promoted by a government pushing for a soft Brexit.

Read Could Brexit harm the NHS? on The BMJ, 26 September 2018.

Is cancer fundraising fuelling quackery ?

Are crowdfunding sites promoting quack treatments for cancer ?

Figures published by The BMJ show how crowdfunding for alternative therapies for patients with terminal cancer has soared in recent years. But there are fears that huge sums are being raised for treatments that are not backed by evidence and which, in some cases, may even do then harm, MedicalXpress reports.

JustGiving’s own figures show more than 2300 UK cancer related appeals were set up on its site in 2016, a sevenfold rise on the number for 2015.

The phenomenon has allowed less well-off patients to access expensive, experimental treatments that are not funded by the NHS but have some evidence of benefit. But many fear it has also opened up a new and lucrative revenue stream for cranks, charlatans, and conmen who prey on the vulnerable.

“We are concerned that so many UK patients are raising huge sums for treatments which are not evidence based and which in some cases may even do them harm.”

The society’s project director, Michael Marshall, said.

Melanie Newman, freelance journalist, London, UK, examines calls to help ensure patients and their donors are not being exploited.

Featured image credit @bmj_company.

UK Government considering banning energy drink sales to children

Many major British retailers already refuse to sell energy drinks to those under 18

In England, 16-year-olds can down a pint in a pub, if having a meal in adult company. But under a new government proposal, it would be illegal for them to buy an energy drink like Red Bull at the corner store, The NY Times reports. This gov.uk consultation closes at 11:59pm on 21 November 2018.

Public asked for views on banning energy drink sales to children

The consultation is part of the government’s plan to reduce childhood obesity and other health problems in children.

The government is seeking views from the public on ending the sale of energy drinks to children and young people in England, the Prime Minister has announced.

The consultation proposes that a ban would apply to drinks that contain more than 150mg of caffeine per litre and prevent all retailers from selling the drinks to children.

It follows the publication of the latest chapter of the government’s childhood obesity plan in June 2018, which outlines a series of measures as well as a commitment to halve childhood obesity by 2030.

Questions in the consultation include:

  • whether the restrictions should apply to children under 16 or under 18
  • whether the law should be changed to prevent children from buying them in any situation

Energy drinks are already banned for sale to children by many major retailers, but children can still buy them from vending machines and many independent convenience stores, for example.

More than two-thirds of 10- to 17-year-olds and a quarter of 6- to 9-year-olds consume energy drinks. A 250ml can of energy drink can contains around 80mg of caffeine – the equivalent of nearly 3 cans of cola. On average, non-diet energy drinks also contain 60% more calories and 65% more sugar than other, regular soft drinks.

Excessive consumption has been linked to a number of health issues in children, including:

  • headaches
  • sleep problems
  • stomach aches
  • hyperactivity

Prime Minister Theresa May said:

“Childhood obesity is one of the greatest health challenges this country faces, and that’s why we are taking significant action to reduce the amounts of sugar consumed by young people and to help families make healthier choices.

Our plans to tackle obesity are already world leading, but we recognise much more needs to be done and as part of our long-term plan for the NHS, we are putting a renewed focus on the prevention of ill-health.

With thousands of young people regularly consuming energy drinks, often because they are sold at cheaper prices than soft drinks, we will consult on banning the sale of energy drinks to children.

It is vital that we do all we can to make sure children have the best start in life and I encourage everyone to put forward their views.”

Public Health Minister Steve Brine said:

“We all have a responsibility to protect children from products that are damaging to their health and education, and we know that drinks packed to the brim with caffeine, and often sugar, are becoming a common fixture of their diet.

Our teenagers already consume 50% more of these drinks than European counterparts, and teachers have made worrying links between energy drinks and poor behaviour in the classroom.

We are asking the public for their views on the matter, to ensure energy drinks are not being excessively consumed by children.”

Assisting Baroness Cumberlege in ref Review into Primodos, Sodium Valproate, Vaginal Mesh

Submission to the Cumberlege Review Concerning the Safety of Medicines and Medical Devices in the UK on behalf of the Organisation for Anti-Convulsant Syndrome (OACS Charity) and #FACSaware

Introduction

” This document contains the legal and moral arguments for a Public Inquiry into medicine and devices regulation to focus on valproate as a case study.

The history of the licensing and regulation of valproate is particularly enlightening and highlights that we as patients were not informed of the risks associated with valproate and neither were many of our Doctors. “

Emma Friedmann,
FACSaware

The Scope of this Submission

This submission is made on behalf of the Organisation for Anti-Convulsant Syndrome (known as OACs), the Foetal Anti-Convulsant Network (known as #FACSaware) and the individuals and families that both groups represent.

An outline of the essential work undertaken by these groups is provided below.

This submission is made to Baroness Cumberlege in her role as chair of the Government ordered Review announced by the Secretary of State for Health, Jeremy Hunt, on 21 February 2018. The purpose of this Review is to consider – in the context of medicinal products/devices identified as, Primodos, Sodium Valproate and Vaginal Mesh:

  1. ‘Firstly, the robustness and speed of the processes followed by the relevant authorities and clinical bodies to ensure that appropriate processes were followed when safety concerns were raised;
  2. Secondly, whether the regulators and NHS bodies did enough to engage with those affected to ensure their concerns were escalated and acted upon;
  3. Thirdly, whether there has been sufficient co-ordination between relevant bodies and the groups raising concerns; and
  4. Fourthly, whether we need an independent system to decide what further action may be required either in these cases or in the future’.
    Mr Hunt explained; ‘This is because one of the judgments to be made is whether, when there has been widespread harm, there needs to be a fuller, or even statutory, public inquiry. Baroness Cumberlege will make recommendations on the right process to make sure that justice is done and to maintain public confidence that such decisions have been taken fairly’.

This submission relates to Sodium Valproate. It aims to help Baroness Cumberlege to consider these focal issues as they relate to Sodium Valproate.

The Purpose of this Submission

It is now well established by clinical researchers, in medical literature and across the regulatory community that Sodium Valproate is a teratogen; and that children exposed to this drug in utero suffer an increased risk of physical, developmental and neurological injuries. That cluster of injuries is known as ‘Foetal Valproate Syndrome’ (FVS).

With adequate warnings directed at both the users of Sodium Valproate preparations and their treating clinicians, FVS was, and is, an almost entirely avoidable injury. Yet, as at the date of this submission, as many as 20,000 individuals in the UK have been diagnosed with (or may suffer from) FVS.

In our submission the persistence of FVS as a diagnosis in the UK, and the number of individuals affected, is evidence of a long history of regulatory and legal failure in the prescription of Sodium Valproate as an anticonvulsant in the UK.

Those affected by FVS continue to pay the highest price for that failure:

‘I am mourning my child now and will be mourning the death of her when she’s gone, this is the result of Valproate, no parent wants to see their child slowly die in front of them’

They do so without any acknowledgment on the part of the manufacturer or regulator of the role that they have played in creating and perpetuating the incidence of FVS in the UK; and crucially they do so without compensation.

Against that backdrop, this submission sets out; the legal case for a Public Inquiry into the regulatory and legal failings exposed by FVS and describes both the urgent need, and moral imperative, for compensation to be paid to all those affected by FVS in the UK.

To achieve that purpose this submission is divided into 3 chapters:

  1. Chapter 1; provides the background on the clinical history and impact of Sodium Valproate in the UK;
  2. Chapter 2; sets out the legal case for a Public Inquiry and is focussed upon dealing with the first three issues raised by Mr Hunt in his announcement on 21st February 2018: These are the Governmental, regulatory and legal failings that have resulted in FVS and have necessitated the 40-year old campaign for justice led by groups such as OACS Charity and FACSaware.
  3. Chapter 3; sets out the moral imperative for the creation of a Compensation Fund, identifying the clinical and psychological needs of those affected by FVS and possible mechanisms through which such compensation could be awarded.

Executive Summary

  • Sodium Valproate medicines are used to treat various conditions such as epilepsy, the manic phase of bipolar disorders (since 2009) and severe migraines (this application is off label use in some EU countries).
  • In the UK the primary use of Sodium Valproate is, and has always been, in relation to epilepsy as an anticonvulsant (AED).
  • There is little doubt that Sodium Valproate is an effective medication in treating patients at risk of epilepsy associated convulsions.
  • Sodium Valproate is marketed internationally under a range of brand names. In the UK, Epilim is by far the most dominant Sodium Valproate preparation available.
  • Epilim was first licensed for usage in the UK in 1973. The company responsible for manufacturing and marketing the drug in the UK is now known as Sanofi.
  • It is now accepted across the clinical and regulatory community by, for example, the National Institute for Health and Clinical Excellence (NICE), the MHRA and European Medicines Agency (EMA) that Sodium Valproate is a teratogen and that wherever possible prescription should be avoided in female patients of childbearing age.
  • The 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.

It is important to understand that this list is not exhaustive.

  • When these congenital abnormalities, either singularly or in combination, are identified in children exposed to Sodium Valproate in utero they are diagnostic signifiers of FVS.
  • The controversy surrounding Sodium Valproate is focused upon the teratogenic potential of the drug and the historic failure of the regulator and manufacturer to communicate that potential to clinicians and patients.
  • It is submitted that by the early 1980s the regulator/manufacturer was in possession of sufficient information to conclude that Sodium Valproate was a teratogen which increased the risk of congenital abnormalities above the risks associated with epilepsy in general or where alternative AEDs were used.
  • However, this information was not communicated directly to patients until as late as 2005; whilst, in our submission, appropriate care pathways for women of child-bearing age using Sodium Valproate were not instituted by the regulator/manufacturer until as late as 2016.
  • That failure of the regulator/manufacturer constituted a dereliction of their statutory duties under the Medicines Act 1968, and successive legislation, to safeguard patients and warn of the adverse risks associated with medications.
  • That failure also created a fundamental ‘Information Gap’ between regulator/manufacturer-clinician/patient out of which the tragedy of FVS has developed.
  • An info-graphic describing this ‘Information Gap’ is provided at Appendix B and in Chapter 2 of this submission. The case for a Public Inquiry into medical product regulation in the UK is made with reference to the creation and maintenance of this ‘Information Gap’ which is exposed through the history of FVS in the UK.
  • Those affected by FVS and their families have complex care needs and are in the unusual position of having to cope with children with often profound disabilities whilst dealing with the fact of their own epileptic and or mental health condition.
  • For many of the mothers with epilepsy who are caring for children affected by FVS, stress is a trigger for their epileptic convulsions; the fact that they have been unheard and uncompensated for so long, despite their persistent campaigning, has often exacerbated their own clinical condition – this has added injury to injury.
  • We describe, in Section 15, the Double Disability which the mothers of FVS children experience; the fact of their own epilepsy in addition to the problems experienced by their children with FVS, a condition brought about by the Epilim which has enabled them to live normal lives. This imposes a significantly greater burden on these women than would be the case if they did not suffer from epilepsy.
  • Setting aside the emotional and psychological costs; the physical care needs of those affected by FVS place significant financial demands on the individual families affected and upon the NHS and/or Local Authority, who have been left to shoulder the significant cost burden associated with FVS.
  • Sanofi, the manufacturer responsible for Sodium Valproate, has made very significant profits as a result of its marketing of Sodium Valproate in the UK without shouldering any of the consequential costs of FVS injuries.
  • Litigation initiated against Sanofi on behalf of those affected by FVS and their families was discontinued when the Legal Aid Agency decided to withdraw legal aid funding in 2010, three weeks before Trial: Consequently, FVS sufferers have been denied access not only to compensation but also the opportunity to bring the fact of the manufacturer’s and regulator’s failures into the public domain.
  • This contrasts with the experience of FVS sufferers in other jurisdictions.
  • In 2016 the French Government instituted payments to FVS sufferers through a centrally constituted Compensation Fund.
  • The recent reparative actions of the French Government in respect of FVS, contrast with the historic inaction of successive UK Governments: This contrast is noteworthy given that both jurisdictions have had to deal with:
    • the same drug (Sodium Valproate)
    • the same injuries (FVS)
    • the same manufacturer (Sanofi); within
    • the same legislative framework- by virtue of the European wide Product Liability Directive.
  • The scale of the task of compensating UK FVS sufferers is hard to estimate; however, the moral imperative to facilitate such compensation is abundantly clear:

‘I can tell you from my experience of 32 years that there has never been enough support/facilities within the community to cover the needs of my daughter or any other person with learning difficulties/special needs or disabilities. There has been a continuous lack of understanding of the complexities of FVS’

  • In summary, this submission seeks the following outcomes:
    • A compensation and care package for all those affected by FVS;
    • A Judge led Public Inquiry into the regulation and licensing of medical products within the UK, focussing upon FVS as a case study; and
    • Scrutiny of how consumers can be better safeguarded and, if necessary, compensated, in a revised regulatory framework post-Brexit.

Download the whole document via FACSaware group on Facebook.

 

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