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

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.

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

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NEW DATA ON THERAPIES FOR PAIN AND INFLAMMATION FROM PFIZER

By Jeanne Hambleton © Fibromite NFA Leader Against Pain

While I am a great believer in positive thinking, I have to accept that medication can be the only way that allows some people to live with pain and this impossible invisible condition called fibromyalgia. From this point of view I must say I am pleased that the drug companies are continuing to find ways of easing our pain and hopefully one day will find a cure.
This morning I received a press release from Pfizer who are working to help those of us with fibromyalgia and arthritic problems. I wanted to share this with you and the full report is listed below.

Having read this one of my greatest hopes is that the UK medical authorities will, in the near future, give its blessing to Lyrica, Cymbalata and now Esreboxetine.

Let us hope if these new drugs are approved in the UK that there will be no ‘post code lottery’ by the NHS for the prescription of these medications. Currently British fibromites are victims of the lack of approval of any specific fibromyalgia drugs. While American patients are able to gain relief from the new drugs, it seems the UK fibromites must suffer in silence.

In recent years I have read and signed numerous epetitions appealing to the Prime Minister Gordon Brown to bring some relief to those of us with fibromyalgia. The epetitions have asked for research, better education of doctors and specialists, fibromyalgia clinics and much more – but all have met with lame excuses. This has nothing to do with the current financial crisis. We have been writing to Prime Ministers – Tony Blair and Gordon Brown -for years. What do we have to do to get attention – camp out in our wheelchairs outside the Houses of Parliament? We might get more press coverage that way!

I am not surprised that Guy Fawkes chose to blow up the Houses of Parliament on November 5 if this was the only way he could get the attention of those working inside that building. Maybe we need a fictional Gun Powder Plot to enlighten the Government and spur the MPs into allocating funds for research to find a cure for fibromyalgia. But it does appear that nothing seems to stir those in the ‘corridors of power’.

A little correction here – according to Hansard and TheyWorkforYou on October 14 Dr John Pugh MP (Shadow Minister, Treasury; Southport, Liberal Democrat) is reported to have said, “…I was recently approached by someone in my constituency who suffered from a disease called Fibromyalgia, which had to be explained to me. That person found that there was wholesale ignorance of the disease in all parts of the NHS and many parts had been accessed about the condition.”

Hooray for John Pugh. Shall we all write to our MPs and talk about the ‘F’ word? You do know I mean F for fibromyalgia, I hope! I am not into writing about politics but for goodness sake if someone wants to win the next election they should become our champion – do something about the plight and despair of the fibromites. That should get them at least 2 million votes plus their families and friends. I wonder why are we treated as second class citizens? Just because we have an invisible disability it does not mean we have no feelings and do not deserve some respect. What do you say?

As a matter of interest something like 10 years ago the public were ignorant about ME. Today everyone has heard of it? We must spread the ‘F’ word – fibromyalgia. I have banned the other ‘F’ word in my house. Now we all say ‘fibromyalgia’ when we lose our temper and burst into fits of laughter.

Results from Clinical Trials Show Promise for Innovative Therapies in Rheumatoid Arthritis and Osteoarthritis Pain and Fibromyalgia

SAN FRANCISCO–(BUSINESS WIRE)–Pfizer will present data on three investigational compounds that represent potential new mechanisms for targeting pain and inflammation. These data will highlight tanezumab, a molecule designed to target nerve growth factor, a key pain mediator; CP-690,550, a JAK-inhibitor that suppresses immune-related inflammatory response; and esreboxetine, a highly-selective norepinephrine reuptake inhibitor which plays a role in controlling the activity of this important neurotransmitter. These data will be presented at the 2008 American College of Rheumatology Scientific Meeting in San Francisco, California.

“Pfizer has an established track record of bringing innovative therapies to patients suffering with pain and inflammation,” said Martin Mackay, Ph.D., president, Pfizer Global Research and Development. “Data to be presented at ACR confirm our clinical approaches in developing these three compounds – CP-690,550, esreboxetine and tanezumab – as potential new medicines to provide relief from these serious medical conditions.”

Fibromyalgia

Pfizer is a pioneer in the study of fibromyalgia, investing many years of research into treatment options for this complex pain condition. In June 2007, Lyrica (pregabalin) CV became the first FDA-approved treatment for the management of fibromyalgia. Data supporting that approval showed Lyrica patients experienced significant reduction in pain as early as week one in some patients.
While widespread pain is the cornerstone of fibromyalgia, the condition is also characterized by other hallmark symptoms such as fatigue and difficulty concentrating.

Data presented at ACR will highlight the results of a phase 2 proof of concept study with esreboxetine, a highly selective norepinephrine reuptake inhibitor in a fibromyalgia population.
Data from this study showed that esreboxetine may be effective in relieving in key fibromyalgia symptoms, including pain, function and fatigue and was generally well tolerated. In the study, 43 percent of patients receiving esreboxetine reported their condition was much improved or very much improved as compared to 23 percent of placebo-treated patients.

The most common side effects compared to placebo were constipation, insomnia, dry mouth, headache and nausea. The proportion of patients who discontinued as a result of adverse events was 8.2 percent in the esreboxetine group and 2.3 percent in the placebo treatment group.
Fibromyalgia has been recognized by the professional community for over 30 years as a common, chronic widespread pain condition and is now thought to affect up to six million Americans. Recent evidence suggests a neurological basis to fibromyalgia, as demonstrated by brain scans and altered levels of certain neurotransmitters.

Rheumatoid Arthritis

Data is being presented from several clinical trials studying CP-690,550, an oral medication that inhibits the Janus Kinase enzyme (JAK). This enzyme plays a major role in controlling the activation and proliferation of white blood cells, key elements of the immune system, which play a major role in rheumatoid arthritis (RA). CP-690,550 has shown encouraging results for the treatment of rheumatoid arthritis at doses that don’t appear to be associated with excessive immune suppression.

Investigators will present interim results from a late-breaking Phase 2B study evaluating the activity of CP-690,550 in combination with methotrexate, the most commonly-used RA treatment. Approximately 60 percent of patients on doses at or above 3 mg of CP-690,550 responded to treatment as compared to 37.7 percent on placebo. These data confirm and extend the promising data seen in an earlier phase 2A study to this longer, 12 week study, and to patients who are already taking methotrexate to treat their rheumatoid arthritis.

Also being presented is a pharmacokinetic drug interaction study which showed that CP-690,550 and methotrexate can be co-administered without dose adjustment. In addition, preliminary results from an open label extension study will be presented.

In these studies, the most commonly reported adverse events were nausea, headache, dizziness, disorientation, hot flushes, urinary tract infections, diarrhea and liver function tests. Larger and longer phase 3 studies are expected to start in 2009 to help further define the benefits and risks of CP-690,550 as a potential treatment for rheumatoid arthritis.

According to the Arthritis Foundation, 1.3 million Americans live with rheumatoid arthritis, a type of arthritis that can be severe, debilitating, deforming and even shorten life.

Osteoarthritis Pain

Pfizer continues to research new ways of treating osteoarthritis pain. Two studies to be presented highlight a new compound in development and new data for Celebrex (celecoxib) in the treatment of osteoarthritis pain.

Results from a Phase 2 study exploring the safety and efficacy of tanezumab, a novel biologic designed to block nerve growth factor, show that treatment once every eight weeks may significantly decrease pain in patients suffering from moderate to severe osteoarthritis pain in the knee. In the trial, approximately 75 percent of patients in both the tanezumab 100 and 200 μg/kg treatment groups experienced a 50 percent reduction in knee pain as compared to 26 percent of patients in the placebo group. In the study, the most common adverse events associated with tanezumab include headache, upper respiratory tract infection, paresthesia (abnormal sensations), hypoesthesia (decreased sensations) and arthralgia (joint aches).

Another late-breaking study evaluated continuous use of daily Celebrex treatment over a 22-week period compared to intermittent use of the medicine in preventing spontaneous OA flares. The study showed that continuous use resulted in 42 percent fewer OA flare episodes than the intermittent use. The results from the study also demonstrated that there were no significant differences in overall adverse events between the intermittent and continuous use groups.

According to the Arthritis Foundation, osteoarthritis affects 27 million Americans. Recent data show that one in two Americans are at risk for knee osteoarthritis over their lifetime. Loss of joint function as a result of osteoarthritis is a major cause of work disability.

About Celebrex

CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis in adults and ankylosing spondylitis, and for the management of acute pain in adults.

Cardiovascular Risk
All prescription NSAIDS, including CELEBREX, may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.

All prescription NSAIDs, including CELEBREX, are contraindicated for the treatment of perioperative pain in coronary artery bypass graft surgery.

Gastrointestinal Risk

All prescription NSAIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

About Lyrica

LYRICA is indicated for the management of Fibromyalgia, neuropathic pain associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and as adjunctive therapy for adults with Partial Onset Seizures. There have been post-marketing reports of angioedema and hypersensitivity. Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse events include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally.

About Pfizer’s Investor Briefing at ACR (American College of Rheumatology)
On Tuesday, October 28 at 6:00 p.m. PCT, Pfizer will host a briefing for analysts and investors to review data presented at the meeting on candidates in Pfizer’s pain and inflammation portfolio

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.

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?

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