ENFA Press Release October 2008
I have attached a copy of the Press Release regarding the rejection from the European Medical Agency, of Fibromyalgia .
It is important to the sufferers of Fibromyalgia to be reccognised of the debilitaing illness and pain we suffer, for the Government to sit up and listen and act, for dedical proffessionals to be trained, or retrained to diagnose and treat Fibromyalgia patients, that would in the long term future save the health department thousands of pounds.
And the plan will start from constituants, to the Local Councillors, to the Governmant, and finally the European Government.
Our aim for the future, is to campain to put this plan into action, We would like your support with this.
Derby Fibromyalgia Support Group Executive Committee
PRESS RELEASE
24. 10. 2008
Fibromyalgia patients are in despair after the rejection from the European medical agency of the first medicine to treat Fibromyalgia in Europe.
Brussels - The Committee for Medicinal Products for Human Use (CHMP) has submitted a negative recommendation on Cymbalta (common name: Duloxetine hydrochlorideis) today (24.10.2008) to the EMEA, the European regulatory agency for medicines. Cymbalta is the first medication for the treatment of Fibromyalgia that has been filed in Europe by Eli Lilly for the treatment of Fibromyalgia. The medicine has been approved by the US Food and Drug Administration for Fibromyalgia since June 2008.
The reason for the negative recommendation has been disclosed to the public on the EMEA website. However it is suspected that the misperception even among some medical professionals in Europe that fibromyalgia is not a real medical condition must have contributed to the decision. Despite the fact that the World Health Organization (WHO) has recognized Fibromyalgia as a disease in 1992, and several well respected medical organizations including the European League Against Rheumatism (EULAR), the American College of Rheumatology and the American Pain Society (APS) have developed criteria and guidelines for the classification and treatment of fibromyalgia, some medical professionals and some governments in Europe have been resistant to recognizing Fibromyalgia as a disease.
“This negative recommendation put the 14 million Fibromyalgia patients in Europe in despair, who have been hoping to have access to the first innovative medicine to treat their disease. I cannot believe that Fibromyalgia patients in Europe cannot have an access to the medicine that has been helping the patients in the US and other countries in the world.” Mr. Robert Boelhouwer, President of the European Network for Fibromyalgia Associations (ENFA), expressed his frustration “ENFA encourages the regulatory agency and its professional committee members to recognize the sufferings that the patients have been enduring and approve other effective and safe treatment options as soon as possible,” he continued.
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 large economic burdens on the 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 estimates that the average annual cost of fibromyalgia is €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
It is estimated that about 12-14 million people in Europe suffer from fibromyalgia and the epidemic is more prevalent with women (87% of total prevalence). However, due to complex pathology of the disease, a comprehensive diagnosis requires multi-disciplinary approach. A recent global survey showed that healthcare professionals lack confidence in diagnosing and managing Fibromyalgia. Educating healthcare professionals, patients and the public to promote better understanding and management of Fibromyalgia will benefit patients, healthcare providers and the society. Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.
Currently, two medicines have been approved in the US to treat Fibromyalgia. The US Food and Drug Administration, the equivalent of the EMEA in Europe, has approved the first medicine Lyrica (pregabalin) in June 2007 for specifically treating fibromyalgia and Cymbalta (duloxetine hydrochloride) in June 2008. Both Lyrica and Cymbalta are proven to reduce pain and to improve function in people with Fibromyalgia.
Update friday 14th November 2008
Petition for a European recognition of fibromyalgia disease
ENFA and the European Federation of IASP Chapters are joining together their efforts around fibromyalgia by launching a European petition. We are welcoming everyone to sign this major act of contribution to support the raise of awareness around fibromyalgia. Please click for more infomation and to sign the petition.....
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