Tragedy of children dying from cancer because drug companies won’t include them in trials

Unite2cure has been busy campaigning in the UK this week.

Our message has come across loud and clear: across the word we need better access to newer and kinder drugs for kids with cancer.

We must also immediately ditch lower age ranges for adult trials so that more kids can get a change of better treatments.

6,000 children die of cancer each year in Europe. It is the biggest killer by disease in the under 25 age range. We must unite for change.

The UK media has got our message loud and clear. Firstly there was an hour long documentary on teenage cancer from the BBC’s flagship scientific programme Horizon. This was followed by articles in the national UK press – all highlighting the need for better drugs for these children.

Debbie Binner is one of the founding members of Unite2Cure

 

Here are links to the press coverage and the BBC Horizon full programme:

https://www.bbc.co.uk/programmes/b0b8cdgq

http://www.dailymail.co.uk/health/article-5884939/Tragedy-children-dying-cancer-drug-companies-wont-include-trials.html

https://www.telegraph.co.uk/tv/2018/06/26/horizon-teenagers-vs-cancer-users-guide-review-film-strove/

 

Unite2Cure: calling for FAIR Trials

Our video sets out how young people with cancer are often excluded from research trials, without any just cause. This not only limits their individual options but holds back progress in finding better cures and kinder treatments for generations to come.

What are we doing about this and how can you help?

Unite2Cure has helped set up the  ACCELERATE working group on FAIR Trials in order to Foster Age Inclusive Research . Here we are working  with medical professionals, academic researchers, members of the pharmaceutical industry and those responsible for the ethics of research trials. The group is jointly led by a clinician, Nathalie Gaspar, and a parent, Chris Copland. You can find out more about the group here.

Our key proposal  is for  the age of entry to be reduced to 12 years in adult early phase studies (where medically justified). This may sound a bold target but there is no great obstacle in terms of law, regulation or safety. The issue, rather, is one of awareness and will within the research community. How then can we change this dogma?

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WHAT WE PLAN TO DO

  • Identify trials that are truly age inclusive and publicise these success stories as examples to follow
  • Lobby the pharmaceutical sector, with the help of our supporters within the industry, and put the issues to the wider research community
  • Engage with ethics committees at a local and national level, as well as with international networks like the European Forum for Good Clinical Practice
  • Provide a researchers’ toolkit so that the procedures and paperwork for making trials inclusive become easy options
  • State our case live, in the media and online

HOW YOU CAN HELP

  • If you work in Pharma or Research, complete our survey on current standards: ly/FAIR2018survey
  • Whether you work in Pharma, Research, Ethics or as a Patient Advocate, join our circle of supporters so that we can share expertise and experience
  • Push the arguments in your own networks. Patient advocates are often consulted on the planning of research trials and these are ideal opportunities to bring the issues to the table

Do, therefore  contact me at chriscoplandatyork@gmail.com

We look forward to your active support,

Chris Copland, co-chair of the FAIR Trials working group

 

 

Open letter to the Health Commissioner, Mr. Vytenis Andriukaitis

43 associations from 20 European countries are calling out to the Health Commissioner for urgent action in favour of children with cancer!

Yesterday, 43 associations of parents’ and patients’ representatives from 20 European countries sent a joint letter to the Health Commissioner in oder to advocate urgent action to improve the implementation  and start the amendment process of the Paediatric Medicines Regulation.

You can share this joint letter on your website, Facebook or Twitter because… (so many reasons):

  • Children with cancer deserve our attention
  • The more the merrier
  • If this goes viral, it will have a greater impact
  • Together we are stronger

We have 12 translations of the letter available – check if your country’s national language(s) is available below and share the letter! If you wish to translate the letter in your national language, please contact unite2cure@gmail.com.

Now, we need you to join the plea! Share this letter with the #Unite2cure.

Thank you for your support.

BULGARIAN version

CZECH version

DUTCH version

ENGLISH version

FRENCH version

GERMAN version

ITALIAN version

LITHUANIAN version

POLISH version

PORTUGUESE version open letter

SLOVAK version

SPANISH version

 

Children with cancer still left behind!

 

Childhood Cancer professionals and parents say urgent action is vital following release of the European Commission report on 10 years of the EU Paediatric Regulation

SIOPE – the European Society for Paediatric Oncology and the Unite2Cure network of parents of children with cancer welcome the recognition of unmet needs in paediatric oncology in the European Commission’s 10 years Report on the Paediatric Regulation but strongly regret the lack of urgency and concrete proposals on how the Regulation will be amended to improve the cure for children and adolescents with cancer.

Some of the important concerns voiced by the paediatric cancer community and its supporters are acknowledged in the report. These are:

– For cancer drugs at least, the driving force for the pharmaceutical industry remains the drug’s market potential in an adult cancer rather than the needs of childhood cancer;

– Wide-spread use of the Regulation’s ‘deferral’ system, which leads to delays in paediatric drug development, often until their market of an adult cancer indication is secured;

– Shortcomings of the Regulation’s waiver system, giving companies a route to avoid the obligation for paediatric development for a drug even when the way the drug works might be effective in treating certain paediatric cancers.

Crucially, the Commission confirms the possibility of an amendment of the Regulation, which SIOPE and Unite2Cure have been calling for. Nevertheless, we are disappointed by the lack of urgency for change, with more debate planned and no definite proposals expected until the end of 2019.

Cancer remains the leading cause of children’s mortality by disease in Europe with 6,000 young patients dying each year. Lack of access to innovative medicines is a principal problem behind stagnating survival rates and adverse long-term side-effects in survivors.

Introduced in 2007, the Paediatric Regulation intended to meet the therapeutic needs of children through better-evaluated and authorised medicines. However, progress for paediatric cancer has been insufficient, with only two new medicines authorised for cancer affecting children since the Regulation’s entry into force.

Working with multi-stakeholder experts, SIOPE and Unite2Cure identified the weaknesses in the Regulation and ways to improve it. The European Parliament also called for revisiting the regulatory framework and implementation in its Resolution of December 2016.

A targeted revision of the Paediatric Regulation remains a much needed and urgent step to advance more and better cures for children and adolescents with cancer across Europe.

This is all the more urgent since it is clear that children with cancer do not benefit from the Orphan Drug Regulation. By contrast, the RACE for Children Act was recently passed in the United States which requires that new cancer drugs be studied in any paediatric cancers for which the molecular target of the cancer drug is relevant.

In passing the RACE for Children Act in August 2017, the FDA has made the law catch up with the science, which is unfortunately not yet the case for children in Europe.

SIOPE and Unite2Cure remain committed to advancing the necessary changes in cooperation with all stakeholders and call for the set-up of working groups that would work on the improvement of the  Regulation.

Every day, every minute matters to patients – the time to take concrete measures for a brighter future for children and adolescents with cancer is now
ENDS

Link to the European Commission’s 2017 Paediatric Report: https://ec.europa.eu/health/human-use/paediatric-medicines_en

Link to position statement ‘ Paediatric Cancer Medicines –
Urgent need to speed up life-saving innovation’ https://www.siope.eu/wp-content/uploads/2013/06/1.-Paediatric_Reg_Position_paper.pdf

Link to paper ‘Orphan Drug Regulation: A missed opportunity for children and adolescents with cancer’.
Vassal, Gilles et al. European Journal of Cancer , Volume 84 , 149 – 158: https://www.ncbi.nlm.nih.gov/pubmed/28818704

Link to the 6th Accelerate Paediatric Oncology Conference http://www.accelerate-platform.eu/annual-conferences-2/

Unite2Cure
Unite2Cure (www.unite2cure.org) is a network of parents, parent organisations and patient advocates from across Europe, which is calling for better treatment and better access to treatment for children and young people with cancer.
Unite2Cure works in partnership with Childhood Cancer International (www.childhoodcancerinternational.org) which is the largest patient support organisation for childhood cancer in the world, and represents 181 parent organizations, childhood cancer survivor associations, childhood cancer support groups, and cancer societies, in 90 countries, across 5 continents.

 

SIOPE
SIOPE, the European Society for Paediatric Oncology (www.siope.eu), is the only pan-European organisation representing all professionals working in the field of childhood cancers in close cooperation with parents, patients and survivors. With more than 1,600 members across 35 European countries, SIOPE is leading the way to ensure the best possible care and outcomes for all children and adolescents with cancer across Europe.
The SIOPE Strategic Plan – endorsed by all partners in the field – aims to a future where no child dies of cancer and survivors live to the fullest. As the ‘European Childhood Cancer Plan’, it is based on seven key objectives and will inspire all future initiatives in this field.

Contact : office@siope.eu

 

A September Update

Most of you know by now: September is paediatric cancer awareness month.

The 2017 edition is very special: our community of parents, patients and caregivers is waiting for the European Commission’s report on the assessment of the Paediatric Medicines Regulation (to be published around the end of October 2017).

What has Unite2Cure been up to these past few moths?

We have been meeting with the Commission and many other EU officials to convey our message that an amendment to this Regulation could be a game changer for kids with cancer, giving them a swifter and safer access to innovative drugs.

Let’s continue our awareness work on this topic: we need to have a clear legal framework to make sure all kids cancers become curable in the 21st century.

Dear followers, keep spreading our messages and supporting our actions 💛💛💛

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Accelerating Together

Last week, Unite2Cure participated actively in the ACCELERATE Paediatric Oncology Conference in Brussels. This event is a unique occasion for high-level experts to reflect upon and discuss concrete proposals to accelerate new oncology drug development for children and adolescents.

The conference is part of a unique multi-stakeholder joint initiative, the ACCELERATE multi-stakeholder Platform. Co-organised by CDDF, ITCC and SIOPE, this platform provides a transparent forum enabling patients and parents’ organisations, academic paediatric oncologists and haematologists, pharmaceutical companies and EU regulatory network representatives to collaborate and jointly address specific obstacles to faster and more effective treatments for children and adolescents with cancer, including the needed changes to the Paediatric Medicines Regulation.

Innovative therapies could target several paediatric malignancies and, thus, save many young lives. However today less than 1 in 10 children in relapse with a terminal cancer has access to these types of medicines, and investment in paediatric oncology drug development is insufficient.

Paediatric drug development is currently regulated in Europe via the EU Paediatric Regulation. 2017 is the year of the 10th year report by the European Commission on this Regulation: 10 years of learning, 10 years of success and failure, 10 years of interaction between stakeholders. A huge experience to build upon in order to accelerate innovation for children and adolescents with cancer.

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The Accelerate Conference provided us with a valuable opportunity to discuss successes and failures in paediatric development, as well as to discuss the strategies to accelerate new oncology drug development. It was also a chance to share experience, harmonize and strengthen the collaboration between all stakeholders at the international level (Parents, Academia, Regulators, Pharmaceutical Industry). This year was the 5th anniversary of the conference, and a wonderful chocolate cake was served to commemorate the event.

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Angela Polanco, one of Unite2Cure’s founding members, described her overall feeling about the conference: “It was an amazing few days spent with colleagues, friends and new friends. There exists so many possibilities for change and the people to make it happen includes you and me. Change can only be made with passion, dedication and consistency and by not being afraid to have a voice, even when the challenge seems so great. We are excited to see the progress made in the upcoming year, for all those children that deserve to live long and happy lives free from cancer.”

Some points that were presented and will remain a priority for Unite2Cure:

 The waivers for adult-only diseases are not relevant in oncology and must be amended: what is most important is the mechanism of action of a given drug,
 There must be prior discussions to select the most suited drugs in order to match the best available therapies with children suffering from rare or refractory malignancies,
 The delays must be reduced in starting paediatric development of potentially life-saving innovative drugs,
 The rewards must be more effective and flexible to increase the interest the development of new and specific paediatric medicines,
 We must get rid of the 18-year dogma and allow adolescents to participate in adults trials.

Delphine Heenen spoke to the audience about “Raising awareness and the EU political agenda” with a very well thought-out and moving presentation which drove home our message. She will be representing Unite2Cure again today at SIOPe’s ICCD in Brussels.

Here is just a small part of Delphine’s speech “When my son Raphaël was diagnosed with cancer in 2013, the comforting words most people felt obliged to say were really often the same: “I am so sorry but nowadays, treatments are making such progress, it’s going to be OK”. And I thought it was true. The irony is that IT IS NOT TRUE FOR CHILDREN. My son relapsed end 2015 and when I started inquiring more specifically into the best treatment options for his relapse, I was quite shocked to realise that the most recent drug he had received in 2013 dated back from 1988 -25 years! And the treatment for his relapse was not quite more innovative with the most recent drug being from 1998.
Children are treated with old drugs. They are left out of the innovation we read about almost every week in the papers for adult cancers.
I apologise for the comparison but the situation is shocking; hence shock is what I want to convey: cancer cures are not like movies. There should not be an “adult-only” section. Children and cure belong together!
And we can do better.”

 

 

Unite2Cure’s immediate goals following the conference are to continue to push for changes to the Paediatric Medicines Regulation in line with the Resolution adopted by the EU Parliament in December 2016. We will also begin working on the 18 age limit dogma – as there are no medical, legal or ethical reasons for adolescents not to be included in adult trials.

Together, we can make a difference!

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Fireworks for International Childhood Cancer Day

February 15th was International Childhood Cancer Day and one way we chose to celebrate was by dispatching our reply to the European Commission’s Consultation on the Paediatric Regulation on the same date as the ICCD call to action. This was the climax of weeks’ of work, cooperating with patient advocacy groups in Spain, Italy, France, Britain, Switzerland and across Europe to push home a set of common messages about the need for better research for children with cancer. You can read a copy of the U2C reply here.

Also on February 15, a feature was broadcast on French TV which showed how cancer affected one Belgian family. Featuring U2C activist, Delphine Heenen, and set up with the assistance of Anne Goeres, this demonstrates why there is a need for ‘more support for childhood cancer research, cure and care.’ You can watch the film at the link here.

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The soundtrack is in French or German, so if you do not speak either of these languages, you will have to ask a friend who does. If you do not have such a friend, then make one.That is what this project is all about.  😉

EUROPEAN CANCER COMMUNITY WELCOMES EUROPEAN PARLIAMENT SUPPORT FOR CHILDREN WITH CANCER

Unite2Cure, Cancer Research UK, and the European Society for Paediatric Oncology (SIOPE) – representing the united voice of parents, researchers and health professionals active in childhood cancer – welcome the adoption of this resolution seeking to improve the current EU Regulation on Paediatric Medicines.

The European Parliament adopted the Resolution during its plenary session in Strasbourg. A key aim of the Resolution is to limit pharmaceutical companies’ scope to avoid the obligation the existing law imposes on them to investigate and develop drugs for children.

Today, companies can ask for a waiver from the obligation to investigate the potential benefit of a drug in a child if the adult cancer for which the drug was originally developed does not exist in children. However, such drugs can still be used to treat other childhood cancer types. For example, – a new drug for adult lung cancer  can benefit children with neuroblastoma.

The Parliament Resolution proposes that the existing Regulation is revised by the European Commission to reflect this important distinction, ensuring that the Regulation goes as far as it can for children with cancer in the UK and across Europe.

The Resolution was tabled by Members from across a range of political groups in the European Parliament. It calls on the European Commission to modernise the current legislation to better address the needs of children and adolescents with a life-threating disease, facilitating a more rapid and better prioritised development of innovative therapies for children including for childhood cancer.

Cancer is the leading cause for death by disease among children, with 6000 young people dying of cancer every year in Europe[1]. It is vital that European legislation allows for a more enabling environment when it comes to the research and development of new cancer drugs and medicines for children.

“We, parents and patient advocates want our children to have a chance at a long and healthy life. We will not give up on this. But the problem is that there is still not enough research, not enough drugs and not enough options. At Unite2Cure, we are calling for very specific changes to the Paediatric Regulation to develop more drugs and save our children” commented Patricia Blanc, Anne Goeres, Nicole Scobie, Chris Copland and Delphine Heenen – just some of the many parents and patient advocates at Unite2Cure.

Professor Pamela Kearns, clinical adviser for Cancer Research UK and SIOPE Board member said: “The adoption of this Resolution, advocating important changes to the current regulation, is essential to support a regulatory environment that safely enables and promotes the development of new cancer drugs for children. We urgently need more studies into new cancer treatments for children to improve the lives of children and adolescents diagnosed with the disease.”

Professor Gilles Vassal, SIOPE Past President and Board member said: “The need to accelerate the development of safe and effective innovative anticancer therapies for children and adolescents as well as the need for more studies to obtain paediatric information for paediatric medicines is today a matter of consensus supported by the pan-European paediatric haemato-oncology community and at the global level”

We call on the European Commission to revise the 2007 Regulation on Paediatric Medicines and introduce measures facilitating the testing and developing of new drugs that could potentially be beneficial for children and young people.

 

 

AWARENESS RAISING CAMPAIGN:               

Social Media Campaign “Let’s Do #More4KidsCancer

                                                                                              https://www.thunderclap.it/projects/51040-let-s-do-more4kidscancer                                     @SIOPEurope @CR_UK @Unite2Cure #More4KidsCancer          

   

USEFUL Links/Documents:

SIOPE Website

Urgent need to speed up life-saving innovation – Proposal by the                                                                                            Stakeholders (Jan. 2016)

 

About SIOPE

The European Society for Paediatric Oncology represents more than 1,600 professional members across 34 European countries. SIOPE is the leading organisation in Europe fighting to ensure a brighter future to children and young people with cancer, by increasing their cure rate and the quality of their lives on the long-term. Learn more:  www.siope.eu.

 

About CR UK

  • Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
  • Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
  • Cancer Research UK receives no government funding for its life-saving research. Every step it makes towards beating cancer relies on every pound donated.
  • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last forty years.
  • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
  • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
  • Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

 

About Unite2Cure

Unite2Cure (www.unite2cure.org) is a network of parents, parent organisations and patient advocates from across Europe, which is calling for better treatment and better access to treatment for children and young people with cancer. This network is supported by many doctors, paediatric oncologists and researchers from all over Europe.


[1] G. Vassal, M. Schrappe, R. Ladenstein et al., The SIOPE strategic plan: A European cancer plan for children and adolescents, Journal of Cancer Policy, Volume 8, pp 17–32, March 2016, http://dx.doi.org/10.1016/j.jcpo.2016.03.007

URGENT: Call on your MEP to support children with cancer

Dear Supporter

We have just received news that, within days, Members of the European Parliament will vote on a resolution vital for the future of children with cancer. We are asking you to contact your MEPs now, urging them to support the Resolution on the Regulation on Paediatric Medicines on December 15.

Our Toolkit here provides a simple ‘two- click’ procedure that will get a message to your elected representatives fast. It also gives plenty of background on what the Resolution is about.

This is a once in a decade opportunity to transform research into childhood cancers and other young people’s illnesses. Please call on your MEP to represent you and all those that have been affected by cancer by voting YES to the Resolution on December 15.

Thank you from all at Unite2Cure

Let’s Do #More4KidsCancer – Support Our Campaign by 15 Dec 2016

Between now and Thursday 15th December 2016, support our online campaign Let’s Do #More4KidsCancer to act in favour of children and young adults with cancer.

more4kidscancerSIOPE, CRUK and Unite2Cure are calling for EU institutions and civil society to speed up the development of safe and effective anticancer therapies for children and adolescents, as the European Parliament is voting on a Resolution about the EU Paediatric (Medicines) Regulation.

In Europe, less than 1 in 10 children with a terminal cancer have access to potentially life-saving innovative medicines. Ten years after its approval, the EU Regulation did foster progress in paediatric drug development but remained insufficient for paediatric oncology. Too few drugs targeting childhood cancers are currently under development, despite cancer remaining the first cause of children’s death by disease in Europe.

Support our cause by clicking here: it takes 5 seconds to join our campaign and it is very easy to do.

For our campaign, we are using the “Thunderclap” tool: it allows people to pledge a Tweet/Facebook message with our important message, and unleash them all at the same time on 15th December, thereby “flooding” the web. Think of it as a “Twitter flash mob”.

If you are active on social media, we would like to ask you to add your support via Twitter or Facebook, by using #More4KidsCancer, or even posting something gold/a golden ribbon to show that you understand the fundamental importance to increase cure and quality of treatment for children with cancer.

With your contribution, our voice will be stronger!

Thank you very much,

SIOPE, CR UK and Unite2Cure