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.

 

2016 Changes to how NICE appraises drugs and other health technologies

The National Institute for Health and Care Excellence is an executive non-departmental public body of the Department of Health in the UK

The recent proposals by NICE and NHS England to change arrangements for evaluating and funding drugs and other health technologies not only tidy up the processes, but introduce some important new elements.

The four proposed elements are to:

  1. Introduce a “fast track” NICE technology appraisal process for the most promising new technologies, which fall below an incremental cost-effectiveness ratio of £10,000 per QALY (quality adjusted life year).
  2. Operate a “budget impact threshold” of £20 million, set by NHS England, to signal the need for a dialogue with companies to agree special arrangements to better manage the introduction of new technologies recommended by NICE.
  3. Vary the timescale for the funding requirement when the budget impact threshold is reached or exceeded, risking disruption to the funding of other services.
  4. Automatically fund, from routine commissioning budgets, treatments for very rare conditions (highly specialised technologies) up to £100,000 per QALY (5 times greater than the lower end of NICE’s standard threshold range), and provide the opportunity for treatments above this range to be considered through NHS England’s process for prioritising other highly specialised technologies.

James Raftery: Changes to how NICE appraises drugs and other health technologies, BMJ Blog, 2 Dec, 16.

The first of these is non-contentious and probably should have been introduced long ago. It is estimated to reduce appraisal time by 25%. Some interventions are likely to be cost effective if they are even mildly effective and incur low cost. From 2007 to 2014, around 15% of NICE’s technology appraisals fell at or below £10k per QALY.

Specialised services, of which 146 exist, cover a diverse range of disparate and complex services, from services for long-term conditions, such as renal and mental health problems, to services for uncommon conditions such as rare cancers. Funded by a variety of means and lacking standard data, responsibility for commissioning specialised services was shunted from agency to agency until 2013 when NHS England took on responsibility.

Proposals two and three, which are to do with specialised services, reflect the recent rows over funding drugs for hepatitis C when NICE’s approval of sofosbufir led to delays by NHS England due their total cost impact. Besides a BMJ investigation, this led to a considered review by the House of Commons Public Accounts Committee (PAC).

The PAC showed that between 2013–14 and 2015–16, the budget for specialised services increased from £13 billion to £14.6 billion, or 6.3% a year, well above that for the NHS. By 2020–21, the budget for these services is expected to rise to £18.8 billion, 16% of the total NHS budget.

In 2013–14, NHS England overspent on specialised services by £377 million (2.9%) and in 2014–15, it overspent by £214 million (1.5%). In 2014–15, the Cancer Drugs Fund accounted for £136 million of the overspend.

NHS England told the PAC that about three-quarters of NICE recommended drugs apply to specialised services and that most of the budget increase for 2016–17 was related to NICE approved drugs.

The PAC showed that the arrangements for pricing (Department of Health), appraising (NICE) and funding (NHS England) of specialized services were misaligned. It recommended that the Department of Health and NHS England should, in collaboration with NICE, ensure affordability is considered when making decisions that have an impact on specialised services. Proposals 2 and 3 formalise arrangements between NICE and NHS England for appraising and funding these services.

The fourth proposal marks the most radical change by setting the cost per QALY threshold for highly specialised (as opposed to specialised) technologies at £100k, which is five times greater than the lower end of NICE’s standard threshold range. Although this reflects the higher thresholds that have been allowed for some extreme “orphan drugs,” it lacks any coherent rationale besides political necessity. This leaves NICE with at least three cost per QALY thresholds, one of £20k-30k for standard technologies, one of around £50k for end of life technologies and one of £100k for highly specialised technologies.

NHS increases budget for cancer drugs fund but remove 25 meds from list

Some life-extending drugs to be denied to NHS patients in England as fund overspends

nhs
Cancer Drugs Fund: some life-extending drugs to be denied to NHS patients in England as fund overspends.

The NHS Cancer Drugs Fund (CDF) yesterday (Monday) published the outcome of its review of drugs included in the Fund.

The budget for the CDF will grow from £200 million in 2013/14, to £280 million in 2014/15, and an estimated £340 million from April 2015. This represents a total increase of 70 per cent since August 2014.

The CDF review announced yesterday also will create projected savings of approximately £80 million through a combination of negotiated price reductions and improved clinical effectiveness. If action had not been taken to review the CDF drugs list, the Fund is projected to have grown to around £420 million next year, necessitating offsetting cuts in other aspects of cancer treatment such as radiotherapy, cancer diagnoses, cancer surgery, and other important NHS services for other patient groups.

A national panel – comprising oncologists, pharmacists and patient representatives – independently reviewed the drug indications* currently available through the CDF, plus new applications. They carried out a detailed assessment of the evidence, looking at clinical benefit, survival and quality of life, the toxicity and safety of the treatment, the level of unmet need and the median cost per patient. In cases where the high cost of a drug would lead to its exclusion from CDF, manufacturers were given an opportunity to reduce prices.

The result of the review is that 59 of the 84 most effective currently approved indications (clinical ‘uses’) of drugs will rollover into the CDF next year, creating headroom for new drug indications that will be funded for the first time. These are Panitumumab, a treatment for bowel cancer; Ibrutinib, a treatment for Mantle cell lymphoma, a type of non-Hodgkin lymphoma; and Ibrutinib for use in chronic lymphocytic leukaemia (CLL).

Following these changes, four important patient protections are in place:

  • Any patient currently receiving a drug through the CDF will continue to receive it, regardless of whether it remains in the CDF.
  • Drugs which are the only therapy for the cancer in question will remain available through the CDF.
  • If the CDF panel removes a drug for a particular indication, some patients may instead be able to receive it in another line of therapy or receive an alternative CDF approved drug.
  • Clinicians can apply for their patient to receive a drug not available through the CDF on an exceptional basis.
Professor Peter Clark, Chair of the Cancer Drugs Fund (CDF) and a practising oncologist, said:

We have been through a robust, evidence-based process to ensure the drugs available offer the best clinical benefit, getting the most for patients from every pound.

“There were drugs that did not offer sufficient clinical benefit so we simply cannot go on funding those. There were others that offered some benefit but were costly and I am pleased that a number of pharmaceutical firms worked with us to make prices more affordable, saving millions of pounds that can now be reinvested in other treatments.

“These are difficult decisions, but if we don’t prioritise the drugs that offer the best value, many people could miss out on promising, more effective treatments that are in the pipeline.”

Further information

  • * An ‘indication’ is a medical term for a condition or set of symptoms for which a drug is provided – a drug may be used for several indications.
  • Most cancer drugs are routinely funded outside of the CDF. The CDF – set up in 2010 and currently due to run until March 2016 – provides a supplementary funding route for some other cancer drugs. NHS England is working with cancer charities, the pharmaceutical industry and NICE to create a sustainable model for the commissioning of chemotherapy.
  • Following public consultation, action is being taken to ensure a sustainable future for the CDF and to get maximum value for patients by ensuring every pound is spent on the most effective drugs available.
  • NHS England has set up an appeals process by which pharmaceutical companies can challenge the process of decision making.
  • A national taskforce will produce a refreshed five year cancer plan for the NHS, headed by Harpal Kumar, chief executive of Cancer Research UK.

Sources and more information

  • NHS increases budget for cancer drugs fund from £280 million in 2014/15 to an expected £340 million in 2015/16, NHS News, 12 January 2015.
    Outcome of consultation on proposed changes to Cancer Drug Fund Standard Operating Procedures, NHS News, 12 January 2015.
  • Cancer Drug Fund decision summaries, NHS News, 12 January 2015.
  • Cuts to cancer treatments announced, BBC News Healtn, 12 January 2015.
  • Cancer Drugs Fund: Life-extending drugs to be denied to NHS patients in England as fund overspends, The Independent, 12 January 2015.
  • 25 cancer drugs to be denied on NHS, The Telegraph, 12 January 2015.

Stand with Breakthrough BC and demand a fair price for life-extending drugs

Call for the UK Government to demand a fair price from pharmaceutical companies and create a system of access and approval that will ensure cancer patients get the drugs they need at prices the NHS can afford

The Facts

  • Over the last two years, a number of secondary breast cancer drugs have been rejected for use on the NHS on the basis of cost.
  • These drugs have been proven to give women with secondary breast cancer more freedom from side effects and, crucially, more precious time with their families.
  • Some of these drugs have been made available through a special fund – the Cancer Drugs Fund – in England. But they are not available in Wales, Northern Ireland or Scotland.
  • The system isn’t working. And breast cancer patients and their families are paying the price. We can’t afford not to act.

Help Breakthrough BC change the System

Breakthrough BC logo image
Call for the UK Government to demand a fair price from pharmaceutical companies and create a system of access and approval that will ensure cancer patients get the drugs they need at prices the NHS can afford.
  • Every breast cancer patient should have access to the best available treatments, wherever they live in the UK.
  • We urgently need to change the way the system works so that all women in the UK with breast cancer get the best treatments, at prices the NHS is able to pay.
  • The pharmaceutical industry needs to work with government to make sure the prices it sets for new drugs are affordable to the NHS.
  • The UK Government must fix the system and with a general election approaching, we need all three major parties to commit to tackling the problem.
  • Sign up to show your support.
Sources and more information:
  • DEMAND A FAIR PRICE FOR LIFE-EXTENDING DRUGS,
    Breakthrough BC, Join our Campaign.
  • Cancer Drugs Fund ‘papers over cracks’, says charity,
    BBC News, 29 October 2014.
  • NHS Cancer Drugs Fund ‘no longer fit for purpose’, charity warns, independent, 29 October 2014.

UK Health Secretary promises £80M Boost to Cancer Drugs Fund for the next Two Years

David Cameron’s flagship cancer drugs fund receives an £80million boost but clinicians will assess whether treatments represent value for money for the first time

image of UK Health_Secretary_Jeremy_Hunt
UK Health Secretary Jeremy Hunt has asked NICE to work with cancer charities in the hope that more life-extending drugs will be approved for us.

Thousands more cancer patients in England will be offered vital treatments in a £80 million boost to the Cancer Drugs Fund (CDF), the UK Department of Health said today.

The fund, which has helped more than 55,000 cancer patients since it was set up four years ago, will be increased from £200 million a year to £280 million a year for the next two years to improve access to drugs currently deemed too expensive.

The increase in funding means two new cancer drugs will be made available and many more patients with rare conditions will benefit from life-extending drugs recommended by their doctor.

More Information:

  • Hunt demands shake-up to stop NICE blocking life-extending drugs for cancer: Health Secretary will also announce 40% increase in resources to pay for treatments,
    DailyMail, 27 August 2014.
  • Cancer drugs fund subject to ‘value for money’ assessment for first time, The Telegraph, 28 Aug 2014.

Antidepressant use in Pregnancy associated with higher Risk for ADHD in Children

Prenatal antidepressant exposure associated with risk for attention-deficit hyperactivity disorder

Abstract

image of antidepressant-use-in-pregnancy
Antidepressants are not usually recommended during pregnanc ; the study shows they could increase the risk of a child suffering ADHD.

The study – “Prenatal antidepressant exposure is associated with risk for attention-deficit hyperactivity disorder but not autism spectrum disorder in a large health system” – suggests a potential link between women taking antidepressants during pregnancy and an increased risk of ADHD, but not ASDs, in their children. The limitation to this type of study is that factors other than the antidepressants, such as the depression itself, or genetic factors increasing both depression and ADHD risk, might be causing the effect seen.

The researchers used various methods to take this into account, but acknowledge that other factors could still be having an effect. While the link with ADHD remained significant after taking maternal depression into account, it did not remain significant after taking into account measures of how severe the woman’s illness was.

Other limitations to the study include the following:

  • It could only assess what prescriptions the mothers received, and not whether they took them.
  • It could not directly assess how severe a woman’s illness was; they had to rely on data that was routinely collected on the types of treatment she was receiving and her previous diagnoses. This is unlikely to capture severity as well as a more direct assessment could.
  • If children or mothers were diagnosed or treated outside of the healthcare grouping being assessed, this information would not be available to the researchers, and this could affect results.

It is important to know that no one factor is likely to cause ADHD or ASD. These conditions are complex, and we are not yet entirely sure what causes the majority of cases. Both genetic and non-genetic (known as “environmental”) factors are thought to potentially play a part.

Medications are used sparingly in pregnancy to reduce any risk of harm to the developing foetus. However, if a woman’s condition could have serious consequences if untreated, then the woman and their doctor may decide that the benefits outweigh the harms.

NICE has guidance on how to treat depression in women planning pregnancy, during pregnancy and while breastfeeding. In general, it recommends considering alternatives to antidepressant treatment, and considering doctor-supervised withdrawal of antidepressants for women already taking them. However, under certain circumstances it advises considering antidepressant treatment, such as if the women has not responded to non-drug therapies.

Sources and More Information:

  • Antidepressant use in pregnancy linked to ADHD, NHS Choices, Mental Health, August 27 2014.
  • Prenatal antidepressant exposure is associated with risk for attention-deficit hyperactivity disorder but not autism spectrum disorder in a large health system, Nature, Molecular Psychiatry , doi:10.1038/mp.2014.90, 26 August 2014.
  • Pregnant women who take anti-depressants ‘could raise their child’s risk of ADHD‘, DailyMail, health/article-2734926, 26 August 2014.

Kadcyla Breast Cancer Drug Trastuzumab Emtansine not approved on NHS

The breast cancer drug trastuzumab emtansine (also known as Kadcyla) will not be made routinely available on the NHS following a failure to reach an agreement on price between the National Institute for Health and Care Excellence (NICE) and the drug’s manufacturer, Roche.

The National Institute for Health and Care Excellence (NICE) says it cannot recommend a life-extending breast cancer drug due to its high price. The drug trastuzumab emtansine (also known as Kadcyla) costs around £90,000 per patient. Pharmaceuticals giant Roche said that “NICE is the first organisation to say no to Kadcyla”.

More information
  • Listen to @steve_lefevre talking about the cost of Kadcyla with Dr Seeruthun from @Roche on breakfast, BBC Radio tweet.
  • Pressure grows on Roche to lower breast cancer drug price,
    NICE news, 08 August 2014.
  • NHS says no to new breast cancer drug Kadcyla,
    BBC News Health, 08 August 2014.
  • Disappointment as breast cancer drug not approved on NHS, Cancer Research UK, News Report, 08 August 2014.
  • Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer,  NEJM, 10.1056/NEJMoa1209124, November 14, 2013.
  • Watch more pharma videos on our YouTube channel.

A UK £400m Fund will enable a Scheme providing Life-enhancing Cancer Drugs to continue until 2016

The CDF will be extended until 2016

Cancer drugs fund 'to be extended' until 2016
The CDF will be extended until 2016

An emergency £200m-a-year fund for life-enhancing cancer drugs is to continue until 2016 – after the NHS’s rationing body failed to clear any medicines sent for approval in the past year – the prime minister has announced.

The Cancer Drugs Fund (CDF) was set up in 2011 to help patients in England access certain drugs before they get approval for widespread NHS use – and/or pay for treatments denied to NHS patients by the National Institute for Health and Care Excellence (NICE).

Read Cancer drugs fund ‘to be extended’ until 2016
BBC News Health, 28 Sept 2013

Read NICE under fire for veto of ELEVEN new cancer drugs as £2m fund to tackle illness is extended, 28 Sept 2013

New early Breast Cancer Test guiding adjuvant Chemotherapy Decisions

Oncotype DX is only suitable for certain types of breast cancer

'Chemotherapy-sparing' test offered
Breast cancer is the most common cancer in the UK

A new breast cancer test – Oncotype DX – that could spare thousands of women the ordeal of chemotherapy has been approved – by the National Institute for Health and Care Excellence (NICE) – for use in the NHS in England and Wales.

The test works out the odds of a some tumours spreading round the body and should help doctors decide more accurately which patients will need chemotherapy.

Read Chemotherapy-sparing’ test offered, by James Gallagher, BBC News, 26 Sept 2013

Sources: Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat
NICE, September 2013

DES and Breast Cancer: