Still no treatment in Europe for the 14 million FMS patients trapped in pain!

From the FMS Global News Desk of Jeanne Hambleton (UK)

Press Release from ENFA – 29.04.2009

Brussels, (29.04.2009)

Last week was high on activities for the Fibromyalgia community, on one hand the European Network of Fibromyalgia Associations (ENFA) met with the European Health Commissioner Ms Androulla Vassiliou1. And on the other hand the European Medicines Agency (EMEA) gave another negative decision for a treatment for fibromyalgia in Europe2.

Ms. Pam Stewart, Vice-President of European Network of Fibromyalgia Associations (ENFA) and chairman of the trustees of Fibromyalgia Association UK, said one of the biggest challenges that the patients have been facing is the lack of officially recognised medical treatment options in the European Union.

By comparison there are three drugs in the United States of America approved by the Food and Drug Administration: Cymbalta from Eli Lilly, Lyrica from Pfizer and recently authorised Savella from Forest and Cypress (Pierre Fabre).

Last October, Cymbalta received a negative decision from the EMEA and last week was the turn of Lyrica said Ms Stewart. One dossier is still remaining to be evaluated by the EMEA: Savella. Each of these drugs has a limited success and judged alone leads to their failure to get approval.

However with a full range of treatment options, more people with fibromyalgia could have reduced levels of pain. This could enable them to embark on a management programme to significantly improve their quality of life said the Vice President.

“We are constantly hearing from people diagnosed with fibromyalgia that their doctor tells them there is no treatment because no approved guidelines or medications are available. Medical professionals that do not have time to research treatment options should have clearly signposted guidelines for effective treatment options. No one should be sentenced to a life of pain, she said.

“Patients across Europe are currently using these medicines off label. However, the European Medicines Agency told European Network of Fibromyalgia Associations that this is a common situation already faced in other disease areas such as cancer, and the situation with off label use cannot be taken into consideration in the assessment of medicines for which a marketing authorisation is sought.

“The difference with Fibromyalgia is that patients in the UK, for example, are unlikely to be prescribed any of these effective drugs because they have not been officially approved for Fibromyalgia. Patients are left with inadequate treatment options and although these drugs can be purchased over the Internet, this means their use is not monitored and people could be at the mercy of unscrupulous suppliers, which could put their lives at risk,” said Ms. Stewart.

Another example, coming from Germany, concerns the social status of patients since they are labeled as “depressive patient” for their life insurance or health insurance in order to have their drugs fully reimbursed by the National Health Insurance. In order to get any effective medicines, doctors should not diagnose fibromyalgia at all because the medicines are not indicated for fibromyalgia.

At the same time, an ENFA delegation was meeting with the European Health Commissioner Ms. Vassiliou. The meeting was only a natural step, concluding ENFA’s activities on the ‘European Institutions Fibromyalgia Awareness Campaign’ launched in 2008 on World Fibromyalgia Day.

Since the commencement of the campaign last May, with the support from 418 Members of the European Parliament, the Written Declaration on Fibromyalgia was adopted by the European Parliament in December 2008. The written declaration was necessary to raise awareness to all the European politicians from the 27 member states. It also helps create a mapping of the disease status disparity across Europe and increase awareness of better diagnosis and treatment.

“However, we realised that without any officially approved treatment options available, it was almost impossible to properly raise awareness of Fibromyalgia. The patient petition with over 27,000 signatures from all over Europe that MEP Adamou voluntarily hand delivered to the Health Commissioner, clearly demonstrates the frustration from the fibromyalgia community and strong and urgent needs to have treatment options to be officially available. The Fibromyalgia community is left with one hope to see maybe Savella drug approved before the summer. But unfortunately, the hope for a multiple choice of treatment in Europe seems to be lost.

“The European Network of Fibromyalgia Associations and all its associations have for years raised awareness on Fibromyalgia among national and European politicians, health professionals and the general public, and will keep on being active as long as it is necessary,” the Vice President.

About ENFA

ENFA is a network of patient association and support groups working in close consultation with the national association in the relevant country. Our joint missions are to conquer the myths and misunderstandings around Fibromyalgia. The network will help collectively push forward the boundaries which currently exist in understanding, experiencing and treatment of Fibromyalgia. Our main goal is to see Fibromyalgia receiving the recognition it deserves across Europe as an illness in its own right.

About Fibromyalgia

Fibromyalgia is a complex disease with chronic widespread pain as the defining symptom and various additional symptoms including fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, depression, anxiety and cognitive dysfunction often referred to as “fibro fog.” All of these symptoms cause serious limitations in patients’ ability to perform ordinary daily chores and work and severely affect their quality of life. Fibromyalgia imposes a large economic burden on society as well as on affected individuals. A study shows that an average patient in Europe consults up to 7 physicians and takes multiple medications over 5-7 years before receiving the correct diagnosis. The debilitating symptoms often result in lost work days, lost income and disability payments.

In fact, a Dutch study in 2005 estimated that the average annual cost of fibromyalgia was €980 million in the Netherlands. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations.

For more information on the European Network of Fibromyalgia Associations (ENFA) contact Ms. Pam Stewart Vice-President of ENFA Brussels@enfa-europe.eu; http://www.enfa-europe.eu.
1 On Wednesday 22 April in Strasbourg, for more information visit http://www.enfa-europe.eu; 2 On Thursday 23 April in London, for more information visit http://www.emea.europa.eu

EUROPEAN NETWORK of FIBROMYALGIA ASSOCIATIONS

From the News Desk of Jeanne Hambleton

PRESS RELEASE -28.01.2009

 

The European Medicines Agency (EMEA) are to  have a consultation with a delegation from the European Network of Fibromyalgia Associations (ENFA) in an attempt to understand the need for medical treatments for fibromyalgia in Europe.

Brussels – Following an invitation by the EMEA, the European Network of Fibromyalgia Associations (ENFA) has agreed to attend a consultation meeting with EMEA, where ENFA representatives will share their knowledge and experiences related to the disease of Fibromyalgia that some 14 million Europeans are suffering from.  One of the biggest challenges that the patients have been facing is the lack of officially recognized medical treatment options in the European Union whereas there are three drugs in the United States of America approved by the Food and Drug Administration: Cymbalta from Eli Lilly, Lyrica from Pfizer and recently authorised Savella from Forest & Cypress.

 

The European Declaration 69/2008 on Fibromyalgia that has been recently adopted by the European Parliament, symbolizing the awareness raised around Fibromyalgia, calls for actions on specific issues from European Institutions to improve healthcare surrounding the disease, e.g. investment in research and provision of better diagnosis and treatment.  In addition, the European Health Commissioner Ms. Vassiliou’s remarks (E-6262/08EN) on the treatment of Fibromyalgia demonstrates encouraging willingness of the European Commission to address various concerns laid out in the Declaration on Fibromyalgia.

“We hope that this new drive on Fibromyalgia awareness will bring the end to the impasse of medical treatment for Fibromyalgia patients in the EU”, said Mr. Robert Boelhouwer, President of ENFA. 

Fibromyalgia is a complex disease with a variety of symptoms in addition to the defining symptom – chronic widespread pain. It is estimated that 14 million people in Europe suffer from fibromyalgia and the condition is more prevalent with women (87%).  Fibromyalgia imposes large economic burdens on society as well as on affected individuals. The debilitating symptoms often result in lost work days, lost income and disability payments. Due to lack of awareness, on average patients in Europe see 3-4 physicians and take multiple medications over the course of several years before they receive a diagnosis of Fibromyalgia.

Mr. Boelhouwer said, “Increasing awareness of Fibromyalgia among healthcare professionals and patients will bring enormous benefits to patients, healthcare providers and the society in general by managing the burden of the disease.” he continues, “Having this in mind, ENFA welcomes the proactive role that both the European Parliament and the European Commission have taken up in raising the awareness of Fibromyalgia.”

 

 

Contact:  European Network of Fibromyalgia Associations (ENFA)

Mr. Robert Boelhouwer President of ENFA

contact@enfa-europe.eu  - www.enfa-europe.eu

 About ENFA

ENFA is a network of patient association and support groups working in close consultation with the national association in the relevant country. Our joint missions are to conquer the myths and misunderstandings around Fibromyalgia. The network will help collectively push forward the boundaries which currently exist in understanding, experiencing and treatment of Fibromyalgia. Our main goal is to see fibromyalgia receiving the recognition it deserves across Europe as an illness in its own right.

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http://www.europarl.europa.eu/QP-WEB/application/home.do?language=EN

 

 

Declaration of the European Parliament on fibromyalgia (1.26.2.)

From the News Desk of Jeanne Hambleton 

Bulletin EU 1/2-2009 - Health and consumer protection (2/3) PROVISIONAL VERSION

1.26.2. Declaration of the European Parliament on fibromyalgia.

Adopted by the European Parliament on 13 January. Parliament called on the Council and the Commission to:

develop a Community strategy on fibromyalgia in order to recognise this condition as a disease;
 

help raise awareness of the condition and facilitate access to information for health professionals and patients, by supporting EU and national awareness campaigns;
 

encourage Member States to improve access to diagnosis and treatment;
 

facilitate research on fibromyalgia through the work programmes of the seventh framework programme for research and technological development and future research programmes;
 

facilitate the development of programmes for collecting data on fibromyalgia.

FIBROMYALGIA: FIRST STEP FORWARD IS EU RECOGNITION SAY MEPS

FROM THE DESK of Jeanne Hambleton – October 27 2008

Just imagine what would happen if the word ‘fibromyalgia’ was casually dropped into conversation. Chances are there would be a lot of blank faces staring back. So just think what its like for the 14 million people in the EU, whose condition, fibromyalgia, is at the moment not even recognised as a disease.

It is hoped by sufferers that this is all set to change, as Members of the European Parliament sign up to a petition for recognition of fibromyalgia across the European Union. Even though the World Health Organisation has formally recognised the condition – whose symptoms includes chronic musculoskeletal aches, pain and stiffness in addition to soft tissue tenderness, general fatigue and sleep disturbances – since 1992, fibromyalgia is not yet recognised at an EU level.

Euro-MP for the North East Fiona Hall warns that this lack of recognition not only hinders a formal diagnosis and treatment of the condition, but also limits research into the causes of the disease and new treatment methods.

Says Fiona,

“Recognising fibromyalgia as a disease is the first step towards making life that little bit easier for those suffering from the condition. A formal recognition would also provide comfort to those sufferers, who have for many years, been met with blank stares when trying to discuss the condition.

“Hand in hand with this, there is still little understanding of the disease in terms of both cure and effective treatment available at the moment. More research facilities are needed to try to determine the cause and effect of fibromyalgia and I am confident that putting a name to the disease would allow this to happen.

“A formal recognition of fibromyalgia could also make it easier for patients to apply for Disability Living Allowance. Holding a regular job is hard for people suffering from the condition. Fibromyalgia is a real disease and should be treated as such.”

UK sufferers such as Gemma Rouston, who was diagnosed in 2007, support the MEP’s actions and calls for more widespread understanding of the disease.

Gemma, who is membership secretary of the Liberal Democrat Disability Association (LDDA) said,

“It was such a relief to be told that I was not imagining things. However, I was not given any real idea of how to cope with the condition apart from taking painkillers and exercise.

“It is very difficult to cope with fibromyalgia; it varies everyday and every hour. I am in my early forties, and have to use a walking stick. I have two disabled children, who I am supposed to care for, but they look after me.

“Even if you get a formal diagnosis, the Department of Work and Pensions are reluctant to help out financially. Fibromyalgia makes it difficult to do any work on a regular basis. No employer will be willing to be as flexible as I need them to be, especially the way that things are at the moment.”

“Having fibromyalgia means that my family are restricted in what we do and where we go. I cannot really plan what I will do each day, even if it is just myself.”

Ends

Lucy Towers

Press Officer to Fiona Hall MEP
Regional Media Co-ordinator for the Liberal Democrats in the North East

55a Old Elvet
Durham
DH1 3HN
0191 383 2269 / 07776 256333
lucy@fionahallmep.co.uk

http://www.fionahall.org.uk

MEP RESPONSES TO PARLIAMENTARY FIBROMYALGIA DECLARATION

By Jeanne Hambleton © 2008

This week up to two million people suffering with mysterious aches and pains which confused doctors and specialists all over the world, will be writing to their European Members of Parliament in Brussels urging them to sign a declaration to support raising awareness about fibromyalgia

The declaration has been put forwarded by the European Network of Fibromyalgia Associations representing 11 countries – Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Sweden and the United Kingdom.

In a response to a request from the East Hants Borders Fibromyalgia Support Group aka Folly Pogs, two south east of England MEPs have supported the campaign to achieve greater recognition for this disease across Europe.

Sharon Bowles MEP, wrote, “I agree that it is essential that more is done to raise awareness. Access to information for both health professionals and patients is a key element in achieving a more effective and efficient system to treat this disease. With greater awareness and knowledge, sufferers will receive more support from medical professionals and hopefully achieve greater confidence to tackle this disease with a more positive outlook.”

Dr Caroline Lucas, MEP, confirmed her earlier support for fibromyalgia groups, would sign the declaration and “welcomed the activity to raise awareness and improve understanding of fibromyalgia across Europe.”

Andrew Reed on behalf of Nigel Farage, MEP, who apparently declined to sign the declaration, wrote, “ UKIP’s position, in this matter, is conditioned essentially by the consideration that the European Union, whose initiative you recommend, lacks the democratic accountability necessary to avoid its constitution as a fearsome autocracy, endangering freedom, justice, prosperity and peace; and that the primary effect of its legislation is to accelerate its progress towards that condition. Whatever the merits, or otherwise, of some of the EU’s legislation, and declarations, therefore, it is incumbent upon UKIP’s representatives, in the EU’s consultative assembly – both on principle and as the expression of their electoral mandate – to oppose them and any aspect of them, which increases their scope. I trust that you will bear this in mind, however pressing you may consider the subject of any particular declaration, or piece of EU-legislation, to be.”