Unite2Cure at the Childhood Cancer International European Conference

 

An excellent three-day event in Belgrade organized by Childhood Cancer International (CCI) Europe ended on a positive and motivated note for the several Unite2Cure members who attended. The general mood was that the message had been understood: the time for action is now!

The Unite2Cure movement was presented in a one hour interactive session by Chris Copland, Anne Goeres and Nicole Scobie.

“We wanted them to really hear what we were saying, really understand the message.” explains Nicole Scobie, from Zoé4life, Switzerland. “It was an early morning session after a late night out the evening before, and we knew people would be tired. We felt if we started out with a long power point on this difficult subject (paediatric medicines regulations), we would lose the audience. We decided to use humour and small working groups to get people talking and thinking about these issues.”

“Not everyone in the audience is a native English speaker,” adds Anne Goeres, from Fondatioun Kriibskrank Kanner, Luxembourg. “We realized that we needed to make sure we used simple, clear terms that everyone could understand.”

When Chris Copland, a teacher from the UK and Unite2Cure founding member began talking to the attentive audience about “loopholes” in the law, Anne quickly broke in to point out that she did not know this term. Chris was ready with his cable, to actually build a real “loophole” and show everyone how there is a hole in the law which allows pharmaceutical companies to avoid their obligations regarding child cancer.

Although the presentation was deliberately entertaining, the message was crystal clear:  we must take action now if we are to have our voice heard. The review of the Paediatric Medicines Regulation is due in 2017 – this means we must act now.

Anne, Chris and Nicole ended their presentation with a call for action:

-become a Unite2Cure ambassador in your country

-mobilize your MEP and your minister of Health

-sign a “golden letter” to the commissioner of Health to the European Union.

 

The golden letters had been prepared ahead of time, with a space for each participant to add in his or her own message within Unite2Cure’s call for change to the PMR. Each letter was then sealed in a golden envelope, which were collected and will be presented to the Commissioner at Unite2Cure’s meeting with him in May.

If you would like to send a “golden letter”, please click here, download the letter, fill in your information, and email it to: unite2cure@gmail.com

If you would like more information on becoming a Unite2Cure ambassador in your country, or in supporting the movement, send us an email at unite2cure@gmail.com

 

 

 

 

Time for Change

There have been many incredible advances in the treatment of adult cancers in the past 10 years, but childhood cancer is losing out for many reasons, including the opportunity for industry to apply for waivers in the drug development process. Investigating new agents in children and adolescents is particularly difficult as their numbers are few, studies are costly and outcomes are not guaranteed. This leads to long delays for companies who answer to shareholders, and so sadly a waiver to avoid having to test efficacy in children is the attractive option for many. The bottom line is that children are often sidestepped in the drug development process because of financial challenges.

It is a well-known fact that most children diagnosed with cancer are treated with chemotherapy drugs which are over 30 years old. If we continue to do this, then current survival rates for the most resistant cancers are unlikely to change, the prospect for cure at relapse remains low, and the toxicities (both acute and long-term) will remain unchanged. By ignoring these issues, we are failing our children. Cancer is the number one cause for death by disease in children and adolescents, but in the adult world it is no longer recognised as the automatic death sentence that it once was. Childhood cancer is genetically a much simpler disease, with lower molecular mutation rates. Children and adolescents also have substantially less co-morbidities given that they have exposed their bodies to fewer toxins in their short lives. All these elements point towards the fact that childhood cancer should be addressed in a much more positive and productive way, which is likely to lead to much greater curative rates than are currently being achieved.

Developing new drugs specifically for children will address many of these issues, but another key element to consider is prioritisation. Although 35,000 children and adolescents are diagnosed with cancer each year in Europe, when this number is attributed to individual diseases and disease sub-categories, the numbers of children and young people in each classification are few. This makes prioritising drug development another key issue, as only the most promising compounds and technologies should be brought to the fore for testing when it comes to these very small populations. Children are precious, and should be treated as such in every regard, including childhood cancer research.

Many parents and charity advocates are extremely knowledgeable on this topic, and have spent years campaigning to bring these issues to light. Unite2Cure is uniting these highly informed people and groups to gather momentum to bring one voice to the European Commission in asking for change to regulation to address these core issues. We recognise that difficulties exist for other stakeholders, but we believe many of these can be overcome by making small but strategic changes to the European Paediatric Medicines Regulation.

Parents who have lost their children to cancer, parents who live in fear of relapse and nurse their children through long term side effects, and charities supporting these desperate families all recognise the need for change and see an opportunity for it to happen. Academics understand the limitations of the current regulation and research landscape. Paediatric oncologists state that they don’t want to be the generation who simply administered drugs to maintain this current curative plateau. Surely those highly skilled, highly paid individuals working within drug development grasp these issues and are keen to change the future of many children diagnosed with this devastating disease?

If only it was considered a good return on investment, then this might be the case.

Show your support by signing our petition.

Leona Knox, Unite2Cure

Time to accelerate

 

Last week several parents, survivors and patient advocates from Europe and the U.S. united in Brussels for the CDDF-ITCC-SIOPE 4th Paediatric Oncology Conference. The title of this year’s meeting was: Accelerating the Development of New Oncology Drugs for Children and Adolescents.

Debbie Binner of Create for Chloë presented the Unite2Cure movement along with Chris Copland, Consumer Representative, National Cancer Research Institute and Nicole Scobie of  Zoé4life. The presentation was very well received, and as Debbie explained later, the conference ended with a general sense of possibility. “Believe me the first CDDF conference was very very different to this one.  Us parents were fighting to be heard – and now there is such a sense of integration and collaboration and a real sense that we are making some progress.  Although obviously there is a long long way to go.”

 

A few key moments:

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Patricia Blanc presents

Patricia Blanc of Imagine for Margo‘s presentation on new incentives for pharmaceutical companies to invest in paediatric research was brilliant. Her voice is powerful and the work of her Working Group on this project has moved forward with an action plan. Nancy Goodman of KidsVCancer gave an excellent and comprehensive update on the successful US Creating Hope Act regulation.

Angela Polanco of Bethany’s Wish participated actively in a round table discussion on the new incentives topic, and explained that parents want to be involved from the very beginning in the process of approving paediatric investigation plans and participating in the development of clinical trials.

 

Chris Copland spoke up several times, passionately advocating for change to the Paediatric Medicines Regulation. He and Anne will be speaking on behalf of Unite2Cure today, January 27th in front of the European Parliament at an event organized by SIOPE in honour of International Childhood Cancer Awareness Day. This influential awareness raising meeting entitled ‘Speeding up Innovation, Saving Lives’ will be hosted by  MEP Ms Glenis Willmott. The goal is to address the development of paediatric cancer medicines and an enabling legislative and regulatory environment. In plain words: we are asking for very specific changes to the regulations NOW.

 

Leona Knox, of Solving Kids Cancer-Europe spoke with a powerful message, summarizing her feelings about the 2 day conference. “I am one of the parents here who won’t be going home to my son tonight. Oscar died, not because he had cancer, but because he ran out of treatment options. We parents have come here on our own time, and have worked so hard to make sure we understand what you have presented.” She told the audience of mostly pharmaceutical company representatives, pediatric oncologists and regulators. “Our goal is to save kids’ lives. We are working so hard to come up with solutions, and I just want to ask you all, to please help us fix this, whatever it takes.”

Both Samantha Schoolar of Bethany’s Wish and Jaap den Hartogh of VOKK spoke very clearly about the long term side effects survivors of childhood cancer experience and the need to speed up better treatments as well as research into late effects. “A real cure means being part of society once more,” explained Jaap, who called for new, better, and less toxic medicines as well as access to long-term follow up care for every survivor in Europe.

 

It was inspiring to hear Peter Adamson, the Chair of the Children’s Oncology Group stand up to remind the audience that the title of this conference was “Accelerating the Development of New Oncology Drugs for Children and Adolescents”, and that, having attended these conferences for the past several years, he did not want to just have the same conversations as every year. It was time to actually accelerate.

 

Gilles Vassal, past president of SIOPE and Director of Clinical and Translational Research at the Institut de Cancérologie Gustave-Roussy made a clear call to “change the mindset“.

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Change the mindset!

The summary of the decisions and plans as a result of the conference are, briefly:

-a strengthening of the  CDDF-ENCCA – ITCC-SIOPE platform with terms of reference, a website and a new name (to be announced!).

-position papers will be created by Working Group 1 on the issues of adolescent inclusion in adult phase one trials and on mechanism of action as a determinant for paediatric investigation plan requirements.

-a position paper is being drafted on Working Group 2’s proposals for new incentives

-a white paper will be put together by Working Group 3 regarding long term follow up for children receiving new drugs. This group met immediately after the conference to continue preparing this document.

Gilles Vassal emphasized that parents and survivors must continue to advocate for change for all of these plans to happen.

He ended the conference with one sentence, that summarizes the event, “We are even stronger if we work together.”

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The view over Brussels on the flight home

 

 

 

 

Unite2Cure petition hits 1,000 signatures .. but we need more

Over 1,000 people have now signed a petition from Unite2Cure, the patient-led movement which is calling for better treatment and better access to treatment for children and young people with cancer.

The petition calls on European regulators to amend the rules governing research into young people’s cancer.  It calls for better incentives for industry to invest in these rarer illnesses; and says that there should be stricter rules to ensure that promising drugs are not dropped from production when they don’t work in the more lucrative adult cancer market.

Support is coming from across Europe; and from as far afield as America and India.

Among high profile supporting organisations are: SIOP Europe, The European Consortium for Paediactric Oncology;  Childhood Cancer International, Pan Care; The Teenage Cancer Trust and the Bone Cancer Research Trust.  There is also support from senior oncologists from leading medical institutions across Europe. Parents, patients, others affected by cancer  and not for profit organisations are also lining up to sign the petition.

Most heartbreaking are the personal stories of families who have faced cancer.  Not only are children dying; but others are left with severe disabilities caused by the toxicity of the treatment used to kill the cancer.  This from a parent of a survivor:

“My 4 year old son was diagnosed with a brain tumour – Medulloblastoma. After 18 months of treatment he is in remission BUT the treatment is brutal. He now has learning difficulties, takes daily medication to treat his damaged Thyroid, has daily growth hormone injections because of a damaged Pituitary gland, has hearing loss, had cataract surgery on both eyes, Still has muscle weakness and fatigue – 2 years into remission. ALL DUE TO THE TREATMENT FOR CANCER. We need new drugs that cure the cancer but do less damage to a childs young body.”

Unite2Cure is calling on all supporters to reach out further into their own networks to continue to strengthen the case for change.  It urges all supporters to ask individual networks to sign our petition and join a wider conversation about how we need to all work together to get better drugs to children and teenagers more quickly.

Everyday in Europe 20 children and young people will die for cancer.  That needs to stop and we need to find the solutions NOW.  To  sign our petition click here.

Regular updates will be sent out on the progress of our petition and the wider work of the Unite2Cure members. If you have a personal story you would like to share please email us at unite2cure@gmail.com

September: International Childhood Cancer Awareness Month

To coincide with International Childhood Cancer Awareness month in September Unite2Cure is calling for immediate change to current European Legislation. This campaign is being supported by doctors and other industry experts across Europe. For a list of supporters and to join our conversation click here!