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

WOMEN IN NETS CLAIMING TO BE TRAPPED IN PAIN IN 8 EUROPEAN CITIES

From the Fibromyalgia News Desk of Jeanne Hambleton

PRESS RELEASE Embargoed until 7.3.09

Brussels, (07.03.2009) – This Saturday has not only been marked by the International Women’s Day but also by the European action day on Fibromyalgia. While normal people were doing their usual Saturday’s shopping, the European Network of Fibromyalgia Associations and its Member Associations gathered together in eight European cities centres to expose their situation as women-patients suffering from fibromyalgia.

Simultaneously at 16:00 (Brussels time) in Paris, London, Amsterdam, Frankfurt, Brussels, Dublin, Milan, Lisbon and Madrid a passive demonstration took place where fibromyalgia community members trod the pavements of these cities.

The actual main issue around Fibromyalgia is that currently in Europe there is no recognized treatment whereas in the USA there are already 3 medicines available.

“This year has been declared the year against fibromyalgia by the European arm of the International Association for the Study of Pain (IASP-EFIC) and for this reason ENFA, as the European umbrella of fibromyalgia organisations wish to inform as much as possible not only diagnosed patients, but the general public, medical professionals, policy makers and politicians” says Pam Stewart, ENFA’s vice-president.

“Early diagnosis, diagnosis, treatments and information are still lacking for the estimated 14 million patients in Europe” says Robert Boelhouwer, ENFA’s president. “We have to keep on mobilizing the general public but also the politicians by having regular action days and awareness campaigns. This is the first event in 2009; the next one will take place in May on the occasion of the “International Fibromyalgia Awareness Day”, then in September and October. We will keep on fighting until we get a full and clear recognition of our disease, starting with a treatment approved for Europe,” he added.

Last December, 418 Members of the European Parliament from the 27 European countries expressed their wish to the European Commission and to the Member States to help raise awareness of the condition and facilitate access to information for health professionals and patients, by supporting European and national awareness campaigns; to encourage Member States to improve access to diagnosis and treatment; to facilitate research on fibromyalgia through the work programmes of the EU 7th Framework Programme for Research and future research programmes; and finally to facilitate the development of programmes for collecting data on fibromyalgia. The European Parliament has been the first European Institution to answer the call of the fibromyalgia community. The European Commission has been also recently been contacted but no reaction has came from them yet.

Fibromyalgia is a complex disease with a variety of symptoms in addition to the defining symptom – chronic widespread pain. These include fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, 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. Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.

Fibromyalgia imposes large economic burdens 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. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations.

Contact:Mr. Robert Boelhouwer President European Network of Fibromyalgia Associations (ENFA)
ENFA contact@enfa-europe.eu – http://www.enfa-europe.eu

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.

European Network of Fibromyalgia Associations

From the desk of Jeanne Hambleton

Members of the European Parliament (MEPs) adopt written declaration 69/2008 on fibromyalgia initiated by five deputies and the European Network of Fibromyalgia Associations (ENFA).

Brussels (16.12.2008) – Written Declaration 69/2008 on fibromyalgia has been a success in the European Parliament by finding the necessary quorum of signatories of 393 deputies giving their support. The Written Declaration was initiated by five key MEPs active on health at the European Parliament: Mr. Adamou, Ms. Brepoels, Ms. Dičkuté, Mr. Popa and Ms. Sinnott. These MEPs decided to launch the declaration during the celebratory meeting of the 1st European Fibromyalgia Awareness Day in May 2008, organized by ENFA

The Written Declaration is calling on the European Union to recognize fibromyalgia in Europe as a disease, as WHO did in 1992. It is estimated that 14 million people in Europe suffer from fibromyalgia and the condition is more prevalent with women (87% of total prevalence).

Fibromyalgia is a complex disease with a variety of symptoms in addition to the defining symptom – chronic widespread pain. These include 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. Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.

Fibromyalgia imposes large economic burdens 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. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations

Thus, the European Parliament is calling through this declaration, for the European Commission and the Council, to help raise awareness of the condition and facilitate access to information for health professionals and patients, by supporting European and national awareness campaigns; to encourage Member States to improve access to diagnosis and treatment; to facilitate research on fibromyalgia through the work programmes of the EU 7th Framework Programme for Research and future research programmes; and finally to facilitate the development of programmes for collecting data on fibromyalgia.

Educating healthcare professionals, patients and the public to promote better understanding and management of Fibromyalgia will benefit patients, healthcare providers and the society.
A Written Declaration is a text of up to 200 words on a matter falling within the European Union’s sphere of activities. MEPs can use them in order to launch or relaunch a debate on a subject that comes within the EU’s remit. At the end of the lapsing date (3 months after its launch on 1 September for the declaration 69/2008) the declaration is forwarded to the institutions named in the text, together with the names of the signatories.

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.

PIERRE FABRE MEDICAMENT AND FOREST LABORATORIES TO COLLABORATE ON DEVELOPMENT AND COMMERCIALIZATION

From the Desk of Jeanne Hambleton – courtesy PR-Canada.Net. 

 (http://pr-canada.net/index.php?option=com_content&task=view&id=71522&Itemid=61)

Saturday, 27 December 2008

Forest Laboratories, Inc. and Pierre Fabre Medicament today announced that they have entered into a definitive collaboration agreement to develop and commercialize F2695 in the United States and Canada. F2695 is a proprietary selective norepinephrine and serotonin reuptake inhibitor that is being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.    Under the terms of the agreement, Forest will make an upfront payment to Pierre Fabre of $75 million and will pay future, undisclosed milestone payments. In addition, Pierre Fabre will receive royalty payments based on F2695 sales. Forest will assume responsibility for the clinical development and commercialization of F2695 in the United States and Canada, while Pierre Fabre will fund all preclinical development and drug substance manufacturing activities worldwide. “We are pleased to expand our relationship with Pierre Fabre to include this collaboration on the development of F2695 for the treatment of depression. Pierre Fabre has been an outstanding partner for Forest since we commenced our alliance in 2004,” commented Howard Solomon, Chairman and Chief Executive Officer of Forest. “We are highly encouraged by the strong clinical antidepressant activity and good tolerability exhibited by F2695 in the recently completed placebo-controlled, double-blind Phase II study. We look forward to initiating Phase III studies with F2695 next year. F2695 is the second late-stage product candidate we have licensed this quarter, underscoring our commitment to further building our pipeline and bringing novel therapeutics to the market.” “Pierre Fabre is looking forward to working with Forest on this exciting product opportunity,” said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre Medicament. “Forest has an excellent record of developing and commercializing products for the treatment of depression and we are happy to extend our existing partnership to include F2695.” In a recently completed European placebo-controlled, double-blind Phase II study of F2695 in over 550 patients with major depressive disorder, the compound demonstrated statistically significant improvement compared to placebo (p<0.0001) on the primary endpoint, change from baseline in total score on the Montgomery-Asberg Depression Rating Scale (“MADRS”). Statistically significant improvement for F2695 compared to placebo was also demonstrated using the change from baseline in the Hamilton Depression Rating Scale (“HAMD-17″) and in response and remission rates using both the MADRS and HAMD-17. In addition, F2695 demonstrated improvement compared to placebo within two weeks after treatment initiation. About F2695 F2695 is an isomer of milnacipran and is protected by a method of use patent that extends through June 2023. F2695 exerts its effects by selectively inhibiting the reuptake of both norepinephrine and serotonin, two neurotransmitters known to play an essential role in regulating mood. Forest, in partnership with Cypress Bioscience, Inc. and Pierre Fabre, is currently developing milnacipran; a selective serotonin and norepinephrine dual reuptake inhibitor, for the management of fibromyalgia. The New Drug Application is under FDA review and we continue to plan for a first quarter 2009 product launch meeting About Pierre Fabre Medicament The Pierre Fabre Group, the second largest independent laboratory in France, employs some 10,000 people, and achieved a turnover of 1.7 billion euros in 2007. The lines of business are ethical medicine, family health but also in dermo-cosmetic products with several brands: Avene, Ducray, A-Derma, Galenic, Klorane and Rene Furterer and dermo-cosmetics. Pierre Fabre Medicament, the pharmaceutical branch of the Pierre Fabre Group, made Research and Development its core business and the key to its future. With 1,400 employees dedicated to R&D, Pierre Fabre Medicament has invested 30% of its annual sales to R&D during 2008, in five major therapeutic areas in terms of public health: oncology (the priority R&D area of Pierre Fabre Medicament, with 50% of all R&D expenses), psychiatry, urology, cardio-vascular, rheumatology. To learn more about Pierre Fabre, visit http://www.pierre-fabre.com. About Forest Laboratories Forest Laboratories is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.FRX.com. Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

 

Fibromyalgia Circle of Care Initiative

FROM THE DESK OF JEANNE HAMBLETON UK NFA LEADER AGAINST PAIN

October 25, 2008 08:00 AM Eastern Daylight Time
Johns Hopkins and National Fibromyalgia Association Launch Fibromyalgia Educational Initiative to Bridge Chasm in Diagnosis and Care

Collaborative Program Shifts Paradigm with Evidence-Based Platform to Educate Providers on Fibromyalgia Management

SAN FRANCISCO–(BUSINESS WIRE)–The Johns Hopkins University School of Medicine, The Institute for Johns Hopkins Nursing and the National Fibromyalgia Association announced today the launch of the Fibromyalgia Circle of Care Initiative at the ACR/ARHP Annual Scientific Meeting, October 24-29, 2008 in San Francisco. The outcomes-based educational initiative will educate providers about the disease state and the latest therapeutic options; thus, driving accurate and early diagnosis of fibromyalgia for the ten million U.S. citizens impacted by this disorder.

The multi-interventional series of educational activities is open to primary care physicians (PCPs), rheumatologists, psychiatrists, pain management specialists, nurses (RNs), nurse practitioners (NPs) and physician assistants (PAs). The program is designed to educate providers on disease state awareness, diagnosis, impact of early diagnosis and referral, and multidisciplinary care. Additionally, the initiative will share the latest therapeutic options and strategies, as well as review clinical trials that assess newer therapies for fibromyalgia.

“Many fibromyalgia patients see an average of four physicians—over a duration of five to eight years after the onset of the disease—before an accurate diagnosis of fibromyalgia is achieved. This represents five to eight years of underdiagnosis, misdiagnosis and inappropriate treatment of the patient,” said Victor Marrow, Ph.D., Executive Director, Office of Funded Programs/CME Johns Hopkins School of Medicine. “The Fibromyalgia Circle of Care Initiative will result in improved patient care by minimizing the lack of awareness among physicians which has been responsible for the inability or reluctance to accurately diagnose, contributing to the fragmentation of care.”

The Johns Hopkins University School of Medicine, The Institute for Johns Hopkins Nursing and the National Fibromyalgia Association are collaborating on this unique program to improve fibromyalgia patient outcomes. The integrated educational activities will deliver:

Practical and interactive case-related content
Summaries of clinical data and recommendations on how to implement management strategies into the provider’s practice
Updates on clinical practice guidelines and recommendations
Evidence-based outcomes
Patient communication content and materials
Treatment adherence and compliance strategies
“The Fibromyalgia Circle of Care Initiative is unique in its collaboration among healthcare organizations and leaders to raise awareness of the disease state through an interactive program that effectively drives provider participation and implementation of evidence-based lessons within their own practice,” said Lynne Matallana, President and Founder, National Fibromyalgia Association. “After completion of this program, participants will be fully prepared to use the tools and lessons learned to positively and tangibly impact the quality of life of these patients.”

With fibromyalgia affecting up to ten million people in the United States, or up to six percent of patients seen in general medical practices, the impact to the U.S. economy is significant. According to a 2003 study by I. Jon Russell, et al., healthcare costs range from $12-$14 billion per year and account for a loss of one to two percent of the nation’s overall productivity. The study also found that total annual costs for fibromyalgia claimants were more than twice as high as the costs for the typical insurance beneficiary. Furthermore, the prevalence of disability among employees with fibromyalgia was twice as high as compared to all employees. Lastly, for every dollar spent on fibromyalgia-specific claims, employers spent approximately $50-$100 on additional direct and indirect costs.

For more information or to register to participate in the Fibromyalgia Circle of Care Initiative, e-mail info@circleofcare.md.

ABOUT THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE

In July 2008, U.S. News & World Report ranked the Johns Hopkins Hospital #1 among American hospitals for the 18th consecutive year. In 2006, the Johns Hopkins Office of CME received “Accreditation with Commendation” for six years, the highest ranking issued by the ACCME. Hopkins CME has been recognized as a center for “Best Practices” and as a resource to ACCME-accredited providers. For more information, please visit http://www.hopkinscme.edu or contact Victor Marrow, Ph.D., Executive Director, CME’s Office of Funded Programs at vmarrow@jhmi.edu.

ABOUT THE INSTITUTE FOR JOHNS HOPKINS NURSING

The Institute for Johns Hopkins Nursing designs and delivers leading-edge continuing education for nurses. The Institute accesses the expertise of faculty and nurses from both the Johns Hopkins University School of Nursing and Johns Hopkins Hospital, including over 2,500 highly skilled clinicians in 10 clinical and countless subspecialty areas who are also world-renowned researchers and educators. For more information please visit http://www.ijhn.jhmi.edu.

ABOUT THE NATIONAL FIBROMYALGIA ASSOCIATION

The National Fibromyalgia Association (NFA) is a nonprofit 501(c)(3) organization whose mission is to develop and execute programs dedicated to improving the quality of life for people affected by fibromyalgia. The NFA publishes a quarterly magazine, Fibromyalgia AWARE, and hosts an award-winning website at http://www.FMaware.org.

Contacts
Amendola Communications for MJ Consulting Group
Kate Donlon, 619-876-2654
kdonlon@ACmarketingPR.com
or
Jan Shulman, 480-664-8412, ext. 12
jshulman@ACmarketingPR.com

Permalink: http://www.businesswire.com/news/biospace/20081025005016/en

EUROPEAN FIBROMITES ARE DENIED CYMBALTA/DULOXETINE

By Jeanne Hambleton © 2008

News that the drug Cymbalta/Xeristar, a medicine containing the active substance duloxetine, will not be approved in Europe as the first official drug to treat fibromyalgia has been announced, causing grave concern to those who suffer with pain 24/7. This has led to fears that the decision may lead to more delays in a UK approval of new drugs to bring relief to fibromyalgia patients. There are currently no approved drugs for the treatment of Fibromyalgia available to UK patients.

This follows news that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency have adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Cymbalta/Xeristar 30 mg and 60 mg gastroresistant capsules for treatment of Fibromyalgia.

Cymbalta is the first medication for Fibromyalgia treatment that has been filed in Europe by Eli Lilly for the treatment of this invisible disability. The medicine was approved by the US Food and Drug Administration (FDA) for Fibromyalgia in June 2008.

The European Network for Fibromyalgia Associations suspect that the misperception, even among some medical professionals in Europe, that fibromyalgia is not a real medical condition may have contributed to the decision. Despite the fact that the World Health Organisation (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 slow to recognise Fibromyalgia as a disease.

Cymbalta/Xeristar is a medicine containing the active substance duloxetine. It is available as gastroresistant capsules. Cymbalta/Xeristar was authorised for this purpose in December 2004. It is also used for adults with major depression; pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes); and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

In the European Medicines Agency press release from Canary Wharf, London, it states the major concerns that led the committee to recommend the refusal of the change to the marketing authorisation, came from concern that the effectiveness of Cymbalta/Xeristar in treating fibromyalgia had not been shown sufficiently. The results of five studies involving a total of 1,718 adults with fibromyalgia were submitted to the CHMP. Four of these were short term and one long term involving 307 patients.

In the short-term studies, the CHMP considered that the effect of Cymbalta/Xeristar was too small to be relevant for patients. There was no clear demonstration of improvement in symptoms and the modest effects of Cymbalta/Xeristar could be due to the medicine’s effect of improving the patients’ mood. The CHMP also concluded that the long-term study was insufficient to show the effectiveness of the medicine and that a long-term study comparing Cymbalta/Xeristar with placebo would be needed.

The CHMP was of the opinion that the benefits of Cymbalta/Xeristar in the treatment of fibromyalgia did not outweigh its risks and recommended that the change to the marketing authorisation be refused.

Mr. Robert Boelhouwer, President of the European Network for Fibromyalgia Associations (ENFA), expressed his concern following months of work in Brussels with the European Parliament to raise awareness, establishing a declaration for acceptance by the ENFA countries and promoting a petition for the recognition of Fibromyalgia.

He said, “The ENFA encourages the regulatory agency and its professional committee members to recognise the sufferings that the patients have been enduring and approve other effective and safe treatment options as soon as possible. This negative recommendation has put the 14 million Fibromyalgia patients in Europe in despair. They 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.”

The latest ENFA press release suggests that the misperception even among some medical professionals in Europe that fibromyalgia is not a ‘real’ medical condition may have contributed to the decision. Despite the fact that the World Health Organisation (WHO) has recognised Fibromyalgia as a disease in 1992, and several well respected medical organisations 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 slow to recognise Fibromyalgia as a disease.

The ENFA claim 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). Due to the 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.
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 seven 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

The ENFA describes Fibromyalgia as 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.

As with all new medication the patient’s information leaflet and details of potential side effects should be read before taking any medication.

New Research Funding CD is ready for production.

My own personal CD is ready to start raising research funding for our planned concert. Watch http://www.fibrohugs.org and http://fmsglobalnews.wordpress.com for news of the CD being in production and ready for sale.

Music? Now your talking my language! I grew up in Detroit during the 60′s and 70′s and played guitar for numerous “garage bands” and met my share of talented people over the years. Some of the most talented musicians in the Detroit area are just now coming out and getting noticed. I have some projects set up with some of the area’s best talent in the near future. Watch for news of a “special project” I have in the works this spring.

FMS Global News began early one morning in May of 2006 while Ken Euteneier, a close friend and webmaster of fibrohugs, located in Regina, Saskatchewan, and I were discussing ways to promote fibromyalgia awareness over our morning coffee. At the time, there was very little in the way of reliable news regarding fibromyalgia syndrome (FMS) and chronic fatigue syndrome (CFS), so Ken and I decided to become an online news agency. About 9 months later the news blog, http://fmsglobalnews.wordpress.com was added, and became the worlds first “global” source of fibromyalgia and chronic fatigue syndrome news available world wide and in any number of languages. Months later we were joined by Jeanne Hambleton, a journalist from the UK, and we began bringing news and articles from around the world about fibromyalgia and chronic fatigue syndrome. Jeanne’s unique style of writing and the wealth of data we were able to introduce to the web, became our signature trademark. We began adding RSS feeds to a number of fibromyalgia and chronic fatigue sites, becoming the “source” of news for a number of web sites. FMS Global News Google Groups began this feed service and we were soon up and running with a number of web sites picking up the feed and a number of subscribers receiving their news by e-mail. We have some really awesome plans for 2008 and you won’t want to miss any of this, so keep reading and we’ll drop you a few hint’s about what’s coming up next.

Who I’d like to meet:

Anyone interested in promoting gulf war syndrome and fibromyalgia news, research, and awareness…Musicians that can really rock

Rick

If you would like to help:

To donate to the Gregory Shane Fibromyalgia Fund:

Please earmark your donation “Concert Fund Attn. Dr. Dan Clauw”

Call toll free 866-860-0026 or local (in Michigan) 734-763-6433.

E-mail IntMed-Development@med.umich.edu.

Donate online at Michigan Online Giving and

enter the fund’s name on the donor form.

Both private and Corporate donations are welcome.

http://www.med.umich.edu/painresearch/about/gift.htm

Musicians supporting gulf war syndrome and fibromyalgia research (free downloads).

FMS Global News

Fibrohugs Support

Tenderpoints Newsletter

SHIRLEY GOODNEST AND MARCY

by Jeanne Hambleton © 2008
NFA Leader Against Pain – International Advocate

This little story was sent to me by a fibromite who described the tale as charming. I do agree with her. In a world full or woes and wars, this is story of pure innocence that is quite heartening. Enjoy.

A mom was concerned about her kindergarten son walking to school since he did not want his mother to walk with him.
 
She had an idea of how to handle it.  She asked her good friend if she would follow him to school, staying at a distance so he would not notice her.  

The friend said since she was up early with her toddler anyway, it would be a good way for them to get some exercise, so she agreed.  

The next school day, the friend and her little girl set out following Timmy as he walked to school with another neighborhood boy he knew.  She did this for the whole week.

As the boys walked along, kicking stones and chatting, Timmy’s little friend noticed the same lady following them.  

Finally he said to Timmy, “Have you noticed that lady following us to school all week?
Do you know her?”
 
Timmy nonchalantly replied, “Yes, I know who she is.”
 
The friend said, “Well, who is she?”
 
“That’s just Shirley Goodnest and her daughter Marcy,” replied Timmy.
 
“Shirley Goodnest?  Who’s the heck is she and why is she following us?” asked his friend.
 
“Well,” Timmy explained, “every night my Mom has me say the 23rd Psalm with my prayers ‘cause she worries about me so much.  And in the Psalm, it says, ‘Shirley Goodnest and Marcy shall follow me all the days of my life’, so I guess I’ll just have to get used to it!”
 
May Shirley Goodnest and Marcy be with you today and always?

FMS Global News

Fibrohohugs Support

Tenderpoints Newsletter

FIBROMYALGIA – IS IT REAL?

by Jeanne Hambleton © 2008
NFA Leader Against Pain-Advocate

An article, suggesting that fibromyalgia is not real, has appeared in the New York Times in the last few days, has certainly opened a can of worms among the FM community. The story, written by Alex Berenson and called ‘Drug Approved. Is Disease Real?’ refers to the approval of Pfizer’s Lyrica as the first FDA recognised fibromyalgia drug and suggests the pain we feel is not caused by a disease.

Everyone but everyone is getting hot under the collar about these suggestions, so why shouldn’t I? I have sent my comments to the Editor of the New York Times on our behalf but this is not quite as good as some comments I have read so far. But then I am not an MD who has been working in rheumatology and with fibromyalgia since the 1980s and possibly before. Anyway I thought we were all suffering from a syndrome not a disease – that is as it maybe – all I know is I am sick of the pain, I am NOT imagining this and I have been diagnosed.

The article quoting various sources suggests that fibromyalgia does not exist and suggests FM is a physical response to depression, anxiety, stress and social anxiety. Just to put the cat among the pigeons one MD is quoted as saying the ‘disease does not exist’ and suggests that those who take the new drug from Pfizer (Lyrica) and other drugs do not need the medication. Wow…

Dr Rodger Murphee, a well known Internet authority on fibromyalgia, in his email newsletter concerning the controversy refers to the article’s comments that the
worldwide sales of Lyrica reached $1.8 billion in 2007, up 50 percent from 2006. It is believed in 2008 this will rise an additional 30 percent helped by advertising.  It is claimed Pfizer spent $46 million on advertising Lyrica in nine months in 2007.

Dr. Murphee suggests, “Sadly, The New York Times and other print media have elected to take a different slant. Instead of helping dispel the myth that those with fibromyalgia are crazy, lazy, or depressed, they have elected to focus on the minority of doctors who think fibromyalgia is not real. I encourage you to write The New York Times and let them know that fibromyalgia is real and is only made worse by arrogant doctors who help perpetuate the idea that the syndrome is psychosomatic in nature.”
He also states that Lyrica does not suit everyone and there can be side effects. So yes, please everyone with fibromyalgia email the New York Times. No excuses please. The address and link to the article are shown below.
To read the article link to http://www.nytimes.com/2008/01/14/health/14pain.htmlTo send your feed back on health try http://www.nytimes.com/gst/emailus.htmlTo add to those comments a Canadian physiotherapist, Iris Wevermann RPT, sent a copy of this letter with the comment “I love it!” This apparently appeared in the New York Times following the controversial article. Co-written by a well known FM authority this comes from Robert Bennett MD, FRCP, FACP, Professor of Medicine and Nursing and Kim Dupree Jones PhD, FNP Associate Professor of Nursing.

“Yesterday’s New York Times article, “Drug Approved. Is Disease Real?” has created quite a stir with both patients whose lives are impacted by fibromyalgia, and the health care community who must diagnose and treat this common disorder.
 
Here at Oregon Health & Science University (OHSU) we have a quarter century of experience in researching and treating fibromyalgia. Yesterday’s article was a poorly informed opinion piece that reminded us of the articles when we and other researchers first started on the quest to understand this disorder in the 1980s.  It, unfortunately, ignored much of the scientific progress that has resulted from this research and the current widespread acceptance of fibromyalgia as a common, well-defined chronic pain disorder.
 
For instance fibromyalgia is recognized as a diagnosable disorder by the National Institutes of Health, the American Medical Association, the American College of Rheumatology and the Social Security Administration. The American Boards of Internal Medicine has fibromyalgia on the curriculum for physicians seeking Board Certification.  

Epidemiological studies worldwide provide a similar fibromyalgia prevalence of 2-7%, some 10 million people in the US suffer the debilitating effects of fibromyalgia. Over 4,000 scientific and clinical papers have been published on this topic since 1980.
 
The sub-title “some doctors dispute the existence of a pain” is especially duplicitous. One does not have to be a doctor to know that pain is “real”, even if it doesn’t show up in an imaging study or blood test. Pain is always a subjective sensation, whatever its cause. Do those doctors who question the reality of pain without a diagnostic test also dismiss the reality of headaches or menstrual cramps? 
 
There is now undisputable scientific evidence that fibromyalgia patients have a functional disorder of their central nervous system in which pain and other sensations are amplified before reaching the conscious areas of the brain. The quoted opinion that fibromyalgia patients’ problem is “an inability to adapt to the vicissitudes of life”, is a generalization that has no scientific basis. All chronic pain disorders take a psychological toll as well as a physical one; those who adapt well fare better in life, but still have pain.  
 
Just like diabetes and high blood pressure there is no cure for fibromyalgia at this time, but there are some newer treatments, such as Lyrica, Cymbalta and milnacipran, that provide scientifically validated improvements in pain and other symptoms. Castigating the pharmaceutical companies who have spent millions in developing these drugs, because they “hope to make a profit”, is naïve and disingenuous.
 
The symptoms of fibromyalgia are common and real—and it is for this very reason that information to the public should be offering hope, not doubts and questions.

An email to me from Dominie Bush who is responsible for a very comprehensive fibromyalgia website and newsletters, reported a comment from one of her readers on the New York Times article. This referred to the AOL news site inviting people to vote on this issue.
“Just got this from a reader!  Click on the link and VOTE on “IS FIBROMYALGIA REAL?” - Dominie http://www.fms-help.com
http://news.aol.com/story/_a/drug-approved-is-disease-real/20080114101709990001?ncid=NWS00010000000001
The reader said, “Drug Approved. Is Disease Real? – AOL News  – Just passing this along and wondering when they are gonna find something to help with this horrible thing called fibromyalgia.  These people make me sick.  What did thousands of people say?  Let’s all say we have the same thing and invent something.  Makes me so mad that no one listens.  The only people that understand are the people living with this.”
The AOL News website invited readers to consider if they believe fibromyalgia exists by answering, ‘yes’, ‘no’ or ‘I am not sure’. When I voted along with 10,449 others, the polls showed a majority of those voting confirmed that FM does it exist. The poll indicated 57% – 41,039 – said yes; 24% – 17,304 – said no; and 19% – 14,093 – said they were not sure.
The poll also revealed 58,017 – 85% confirmed they knew someone who had been diagnosed with FM and just 15% – 68,467 said they did not know anyone with fibromyalgia. That says quite a lot for awareness!

Going back to the article in the Times by Alex Berenson it is reported that the vice president of Pfizer, a psychiatrist Dr. Steve Romano said it was expected that Lyrica would be prescribed by doctors a neurologists. The Doctor suggests if medications are well tolerated this dispels reluctance on the part of the prescriber.

He suggests that the new drugs from Lilly and Forest that are being considered for fibromyalgia were developed as antidepressants. Both drugs work by increasing the levels of serotonin and norepinephrine, brain transmitters that affect mood. Cymbalta from Lilly is currently available in the US but milnacipran is not available but can be purchased in other countries.

Alex Berenson writes that the manufacturers of Cymbalta claim it is effective with fibromyalgia pain although it is an antidepressant. Dr Amy Chappell at Lilly says that FM patients report pain relief even if they are not depressed.

Dr. Chappell suggests the effectiveness of all three drugs – Lyrica, Cymbalta and Milnacipran are all similar and it is thought that some of the drugs may be used as a combination.

As a passing thought among all this controversy, it has been pointed out that there is no proven prevention for this disorder. However, over the years, the treatment and management of the disease has improved.

As for my six pennyworths I wrote to the New York Times and said fibromyalgia stole my life when I would never walk again. It took a year to be diagnosed – privately I might add. Since that time I have spent 5 year researching this syndrome and there is no doubt IT IS REAL. Stress and trauma might be triggers but brain imagining has proved our brains are ‘wired differently’ and it is in the genes. That is REAL.

When people say to me “Fibro what?” I could scream. The problem is lack of awareness. Thanks to the New York Times for highlighting the discussions and problems surrounding this invisible disability (we look so well) and I was always taught as a news reporter that any publicity (good or bad) is good publicity. So do not despair all you fibromites, we are raising awareness albeit there is a difference of opinion. At least people are now reading about fibromyalgia.

We KNOW what it is like to suffer with fibromyalgia, don’t we? I am writing a self-help book on fibromyalgia. Would I waste my time if I thought FM was not REAL? The answer is NO. What we need is for some celebrities to ‘come out’ and admit they have fibromyalgia! The publicity would help raise awareness. Why isn’t Oprah in this debate? Please write to me. I would love to hear your views about real fibromyalgia for the book. jeannehambleton@mac.com