«How can patient organisations trigger a EU funded rare disease project»

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1 The European Prader Willi syndrome research project «How can patient organisations trigger a EU funded rare disease project»

2 At first : a daily challenging rare disease A rare disease : Prader- Willi syndrome Estimated prevalence: 1 out of to live birth, not so rare First clinical description by Pr Prader, Labhart and Willi in Zurich in Genetic origin identified in the 1980s: microdeletion chr 15, or uniparental disomy, translocation or imprinting mutation. Non inherited in most cases. Lack of diagnosis and care cause early death by respiratory failure, obesity, or following prescription of non-adapted psychiatric drugs Diagnosis possible at birth, genetic test available, extreme complexity: - severe muscle hypotonia at birth, - metabolism, sleeping, breathing, growth, sexual development, body temperature, pain and stress threshold are disturbed, due to hypothalamic dysfunction in the brain Lifelong developmental and behavioural problems, learning disabilities : - Children and adults need less calories than average, and do not feel satiety - anxiety, lack of emotional control, temper tantrums, psychiatric and autistic-like problems 2

3 The establishment of a community bringing together families and professionals As soon as the genetic diagnosis became possible, isolated families began to get together: 1981: PWSA UK, 1986, PWSA Sweden 1990: IPWSO : International PWS organisation: One parent delegate and one professionnal delegate in almost all countries 1996 : Prader-Willi France. Founding member of«alliance Maladies Rares» in 2000, and of Eurordis One of our missions : encourage research 3

4 Prader-Willi France PWSA UK 4

5 Growth hormone treatment : the odyssey of an orphan drug before the orphan drug regulation : first publication in Sweden (4 children), : in the USA, randomised studies published in Sweden, Denmark (29 children) and the USA, Marketing Autorisation in Sweden : European Marketing Autorisation, April 2002 : MA and reimbursement in France, Life expectancy and quality of life improves dramatically. But families understand quickly that more research is needed on LT effect of treatment, treatment of infants and adults, Also identification of genes, satiety, behavioural problems, health problems, social integration, early years and ageing. 5

6 before and after growth hormone treatment 6

7 Further research needed: How did Eurordis and IPWSO help? May 2001 : First European conference on rare diseases in Copenhagen organised by Rare Diseases Denmark : «Toward a comprehensive approach». Bruno Hansen presents the draft FP VI : , which includes a priority for rare diseases; «You have 18 months to bring together scientists and write a project» June 2001 : IPWSO conference in Saint Paul USA : state of the art Research in Europe in fragmented, without a pluridisciplinary approach. Basic researchers do not meet clinicians. Researchers in the US take all benefit from publications First exchanges: C. Nourissier (PWF) and Pr T. Holland (University of Cambridge) 7

8 Putting together an application : another great challenge! March 2002: First scientists meeting in Paris organised by Prader-Willi France, then weekly exchanges with scientists Role of our associations: - contacts established with 14 associations in Europe: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Sweden, Switzerland and the UK - exchange of knowledge of day to day problems living with the disease - financial support for the consultant in Brussels by PWF and PWSA UK Oct 16, 2003: EU network meeting in Paris before the 2 nd European conference on rare diseases Nov 2003: application sent 8

9 Strengthening the network Eurordiscare studies: 2004: access to care 2005: access to diagnosis 2007: access to services Scientists meetings Parents/ Professionals conferences Marseille october 2005: The impact of research on daily life Romania June 2007 Concentrate on the Positive Aspects of PWS 9

10 New contacts in 2006 contacts through IPWSO network with Romania Czech Republic Slovakia, Slovenia Bulgaria Moldavia Croatia 10

11 How did we succeed? By bringing together basic and clinical research, and parents associations Though at the end clinical research has been very scarcely funded: only a data base We never got discouraged from 2001 to 2005 Each National organisation committed itself to support and participate to research studies in its own country 11

12 Project started Dec 1st 2005 for 3 years Future challenges : Entering the data in a standardised way across the EU Permanent funding of databases Pluridisciplinary projects linking basic and clinical research Permanent funding of DNA and brain tissue network Research on social aspects; schooling, social integration, compensation of disabilities, rights of patients with mental disabilities and behavioural problems to improve their quality of life. 12

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