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.

FOLLY POGS LOSE THEIR BALL

By Jeanne Hambleton © 2008

 

As I write this on Friday September 12 2008, the Night of the Folly Pogs Ball, I am sipping a stiff drink to drown my sorrows and feeling a bit dejected. 

 

I have even received a good luck message from Marilyn Kellow, Leader of the Christchurch FM SG, as well as voucher for flowers, a bottle of Scotch Whisky, and some money to buy raffle prizes, which have all been returned. It is obvious that our bad news has not reached north of the Watford gap – probably because I am not proud of it. 

 

While I should have been busy pampering myself today, ironing my glad rags and getting ready to go to the Ball like Cinderella, I am afraid it was not to be. Talking about glad rags I had threatened to go to the Ball in sackcloth and ashes as we were hoping there would be some Page 3 girls there, so who would be looking at me. But as it happens I did not have to buy a posh frock. 

 

My ‘normal’ colleague, Sarah Owen, a yoga teacher – no fibro but lots of energy – and I were gutted the event could not take place. As the date loomed nearer and we pushed out more and more press releases and information about what a really great night it would be, we did not have the flood of requests for tickets, which we hoped for.

 

As we were very concerned we met the hotel manager at the Chichester Park Hotel, to seek his professional advice on our low numbers. Although he was going to lose business and Sarah and I were so disappointed, he said, very wisely I thought, it was better to have a disappointment than a disaster. He felt the low number of number of guests would not provide the atmosphere needed to make the evening a good night and allow the comedy cabaret to perform to the best of his ability. People may consider coming again if they got their money back, but if they came and it was a flop we would lose a good reputation. As someone who knows the business we had to agree with his logic.

 

So very sadly we were advised to cancel the Folly Pogs Ball. We are out of pocket (and put that down to experience) and but our personal disaster was not to have raised the £1,000 we hoped for towards research to find a cure.  We can only lay the blame at the door of the economic situation (dare I say the Government?) and the worldwide financial situation. Everyone is feeling the ‘pinch’. So we were just choosing the wrong time and it was not what we were selling but lack of personal funds.

 

It was really beyond our control and although it sounds a poor excuse we must blame the credit crunch. I really could not have done more in the way of publicity. I even had emails from the States about the Ball.

 

We do hope to hold this event when the country’s financial situation is easing. We toyed with the idea of making another date but who knows when this will all end. Having said that Sarah is already planning Pamper Evening for Mother’s Day to raise funds for research.  She is a good friend and used to teach local fibromites yoga. Our web mistress is planning a ghost hunt to raise some funds – so it is an ill wind and all that….

 

It is a shame it did not happen. I am sure if you had come you would have had a great night out with lots of laughs. Maybe next time? Fibro hugs. Jeanne 

EUROPEAN PARLIAMENT DISCUSSES FIBROMYALGIA AS FOLLY POGS PLAN BALL

As the European Parliament in Brussels discuss a written declaration on Monday (September 1st) asking the European Committee to raise more awareness about the consequences of fibromyalgia, UK patients all over the country are writing to their MEPs seeking support.

 

Confirming that they have fibromyalgia and they are supporting the Fibromyalgia Association UK, up to two million people suffering with fibromyalgia, mainly women, should be urging their MEPs to support this written declaration by signing the document at the next plenary session or by going to the EP written declaration office.

 

The declaration has been put forward by Ms Jolanta Dickute, Ms Kathy Sinnott, Ms Frieda Brepoels, Mr. Nicolae Vlad Popa and Mr. Adamos Adamou, all members of the European Parliament, in support of the European Network of Fibromyalgia Association (ENFA), currently representing 11 countries. These are Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Sweden and the United Kingdom.

 

If you want to know who your national European Parliament members are log on to  (http://www.europarl.europa.eu/) choose your language, click on Your MEPs, and then on your country.

 

GLOBAL FIBROMYALGIA SURVEY

On their new website (www.enfa-europe.eu) the ENPA partnered by Pfizer, have published the results of a recent global fibromyalgia survey that revealed a huge percentage of doctors and  specialists dealing with this conditions, have had no training relating to fibromyalgia. It is revealed that the majority of physicians in the eight countries surveyed, reported receiving an insufficient level of fibromyalgia training, except in Mexico and Spain,

 

In the eight countries involved – France, Germany, Italy, Mexico, the Netherlands, South Korea, Spain, and the UK 800 patients and 1,622 physicians were surveyed.

 

The findings confirmed that fibromyalgia might have a negative effect on the patient and cause disruption to their life.  There can also be significant financial implications for those suffering, if they are unable to work and earn an income. The survey revealed being diagnosed can take up to three and a half years but in Korea the average is a little over seven months. Specialists admitted diagnosing fibromyalgia is very difficult and the condition is often misdiagnosed.

 

In Mexico and all of the European countries patients reported that fibromyalgia has a big impact on their life. This affects the overall quality of life, mobility, moods, memory and concentration, and drive and motivation to do things. On average patients can experience between six and eleven different symptoms.

 

An executive summary revealed that 96% of physicians and 87% of specialists in the UK were not confident in discriminating symptom of fibromyalgia from other conditions. These figures showed a higher percentage than physicians and specialists questioned in the other countries

 

In the UK on average it took over 2 years to be diagnosed with fibromyalgia and a patient was likely to see four physicians. Also 63% of specialists and 82% of physicians had little or no training in fibromyalgia. Most patients wait up to five months before seeking advice in the hope the symptoms will go away. Approximately one in five patients were unable to work.

Up to 68% of patients claimed that fibromyalgia had a very strong or strong impact on their quality of life. Half reported fibromyalgia strongly effected their concentration, memory, mobility, moods, motivation, drive, and their ability to do their hobbies.

The most common symptoms among UK patients were headaches, low back pain, chronic widespread pain, and stiffness.

 

The survey revealed the biggest problem for UK physicians and specialists was identifying the symptoms. Up to 93% of the physicians reported they were not comfortable diagnosing fibromyalgia and needed to focus more on this condition.

 It was agreed that physicians should spend more time with patients to achieve a diagnosis. It was also reported that physicians reported patients found it difficult to communicate the symptoms.

 

FIBROMYALGIA AWARENESS WEEK

While 11 countries are busy in Brussels raising fibromyalgia awareness, Saturday (September 6) is the start of the UK Fibromyalgia Awareness Week. Patients and members of over 100 support groups throughout the UK will be manning information tables in shopping malls and superstores, hosting coffee mornings and other events to spread the word – fibromyalgia.

 

In Chichester a group of fibromites are organising a Folly Pogs Ball at the end of the Awareness Week on Friday (September 12) to raise funds for research. There is no cure for fibromyalgia and no government funding for research.

 

Chairman of the Folly Pogs aka East Hampshire Borders Fibromyalgia Philanthropists Support Group, Jeanne Hambleton, said, “With no help from the government to find a cure, the Folly Pogs, a dedicated group of volunteers with pain 24/7, chronic fatigue, suffering sleepless nights and poor concentration, have taken it upon themselves to ‘move a few mountains’.

 

“The Ball, which has been hit by the credit crunch, has taken months to prepare and we need a full house to make it a really memorable night. The ball has a comedy cabaret, laughter, fun, nonsense, not to mention mirth and merriment. We are even giving prizes for the daftest dickie bow, the funniest fancy dress and the best joke told by a visitor. We even have ‘embroidered unmentionables’ in our charity auction.

 

“Frankly my members will do almost anything to find a cure. They want to play with their children, go cycling and dancing, do their own housework instead of relying on others. We are not lazy – we just do not have the strength to do these things.

 

“The public can help us find a cure by supporting the Ball. All these super mums, perfectionists, and workaholics, suffering with this miserable invisible disability, do desperately need a cure.”

 

From this week Chichester Festival Theatre are previewing the new Calendar Girls play and seven stars - Lynda Bellingham, Patricia Hodge, Gaynor Faye, Sian Phillips Elaine C Smith, Brigit Forsyth and Julia Hills - are to be invited to a late supper after their show as guests of the Chichester Park Hotel to meet the fibromyalgia Calendar Girl. This is the second year Bianca Embley has produced ‘girlie’ calendars using some fibromyalgic models to raise awareness. Bianca will be at the ball to meet the stars from the Calendar Girls.

 

For more information about the Folly Pogs Ball email follypogs@me.com or telephone 0845 345 5942. 

PHONEY TEXT – WHAT NEXT?

by Jeanne Hambleton © 2008

NFA Leader Against Pain-Advocate

 

 

An email arrived at my inbox this morning warning of the dangers of too much information.

As if it is not enough with our Govt.  taking money from us without our permission, we now have to put up with more ‘robbing hoods’ stealing our money from the bank.

 

This information which is called cell phone advice is certainly worth recommending to friends and family.  

 

It reads, “I never thought of this…
This lady has changed her habit of how she lists her names on her mobile 
phone after her handbag was stolen.

 

Her handbag, which contained her cell 
phone, credit card, wallet… etc… was stolen.
Twenty minutes later when she called her hubby, from a pay phone telling him 
what had happened, hubby says ‘I received your text asking about our Pin 
number and I’ve replied a little while ago.’


 

When they rushed down to the bank, the bank staff told them all the money was already withdrawn.         The thief had actually used the stolen cell phone to text ‘hubby’ in the contact list and got hold of the pin number. 
Within 20 minutes he had withdrawn all the money from their bank account. 



 

Moral of the lesson : *Do not disclose the relationship between you and 
the people in your contact list. Avoid using names like Home, Honey, 
Hubby, Sweetheart, Dad, Mom, etc…. And very importantly, when 
sensitive info is being asked through texts, CONFIRM by calling back.

 


Also, when you’re being text by friends or family to meet them somewhere, 
be sure to call back to confirm that the message came from them. If you 
don’t reach them, be very careful about going places to meet ‘family and 
friends’ who text you.



 

PLEASE PASS THIS ON

I never thought about THAT!  As of right now, I no longer have ’home’ named on my cell phone.”

 

The moral of this story is get your own PIN number and do not share it with anyone. Take care and beware. Jeanne 

Folly Pogs and Fibro What

Hi

Sorry I have neglected you but I have been a bit busy – where does the time go? I bring you good news about Fibro What?  The words Fibro What have proved a success and folk seem to love the slogan. As a result I have been requested to provide tee shirts and these are now available in white and red. Fibro What? tee shirts are available in red and white; but My F Word – Fibromyalgia is only available in red.

 

With plastic bags disappearing or becoming precious in the supermarket we felt tote bags had a future for us and would offer a great advertising opportunity. So we now have totes with both slogans – Fibro What and My F Word.  Apart from raising awareness and helping to fund research for FM, we must be seen to be a bit ‘green’ and the totes were thought to be in line with this idea. Fibromyalgia Support Groups up and down the country have bought lots of totes and we hope this has meant more people are becoming aware of this rotten invisible disability. If you want more details, cost, sizes or pictures email fibrowhat@mac.com. 

 

Well how have you been? The warm sunshine has certainly helped my aches and pains. I feel so much better when the weather is good. I hate the cold and wet weather and on bad days I just want to snuggle down under the duvet – don’t we all?

 

Another bit of news for those who live in the south of England, anywhere near Chichester, we are starting a new support group called the East Hants Borders Fibromyalgia Philanthropists Support Group-what a mouthful? We really just call ourselves the Folly Pogs – we don’t need reminding we have fibromyalgia thanks very much.

 

We are dedicated to fund raising for research but are happy to share our support with fibromites with monthly social lunches. Of course it could develop from there subject to how many people join us and what these fibromites want. Also what they are prepared to do towards it. So it is all very exciting. Initially we hope to meet at The Selsey Tram public house for lunch and chat. This is off the A27, about half a mile down the A.286. At the first mini roundabout turn left towards Selsey and the Tram is on your left.  You could enjoy a run down to the coast (about 7 miles) while you are in this direction, or a look at Chichester, the other side of the roundabout. You can bring your husband, wife or carer – these folk are almost as involved with FM as we are. 

 

With enough support the first meeting could be on a Thursday in July. If you are interested and can get to Chichester please email me on fibrowhat@mac.com but if you remember please put FIBRO LUNCH in the subject. Please let me know who is the fibromite and who else is coming with you. Thanks.

 

Talking about fund raising the Folly Pogs Ball is planned for Friday September 12th at the Chichester Park Hotel, Westhampnett - just off the A27 near Chichester.  This will be an exciting evening with a celebrity comedy cabaret, dinner, dancing, lots of fun, joy, mirth and merriment.  It will be a good evening and we hope it will become an annual event. The profits will go towards funding research and we are running a charity auction and hope to boost the research funds.  If you have any nice goodies you would like to donate – artwork, pictures, trinkets, collectables, please email me. We would be grateful for any help. 

 

If you would like to join us, we would love to see you, by the coach load, as a party of ten or 12, or as a couple. If it is your birthday in September, or anniversary or you have a reason to mark a special occasion why not share your celebrations with us. I am sure 250 people will be happy to sing Happy birthday to you or maybe Congratulations and Jubilation.

 

We are hoping to have some special guests to bring some sparkle to the evening so it should be lots of fun. Rooms at the hotel for a stay over are available. There is also a holiday break for two at the hotel to be won. 

 

Although we are not actually moving mountain at present, we are moving in the right direction.  Why not join us and become a Folly Pog?  We look forward to hearing from you. Tickets for the ball are £30 and should be available   from mid June. You can book a table for 10- or 12 if required. Write soon. Take care. Jeanne.

 

 

Jo Guest

Article regarding Jo’s interview on ‘This Morning’ TV

http://www.itv.com/Lifestyle/ThisMorning/Health/JoGuest/default.html

TOGETHERNESS

Thanks to Hana who at her peril has made me co-author.  Hope she does not regret it when people start to talk about the terrible twins. But it will be great to have  two fibromites working together with the same aims – we can bounce ideas off one another and welcome comments from our friends out there. I have already had a bit of a say about the new Fibro What? CD – you can read that in my comments written when I was invited as a guest. I wish Hana lots of luck with this site and her website and I am sure we are in for some fun – after all laughter IS the best medicine.

But while I have your undivided attention there is something I would like to mention.  I have found three other like minded fibromites  who believe they have become ‘experts’ in fibromyalgia.  They think this because they know the symptoms, the pain, what medication works for them, how it plays havoc with family life and the depression and upset about not being able to do the things you used to. Yet we STILL hear stories of doctors who tell undiagnosed patients that, “It is all in your head.” Still they believe we are all mad malingerers. Even when I pointed out to one doctor that the American Rheumatology College had agreed the criteria for fibromyalgia in 1990 and the World Health Organisation had accepted it as a disease in 1993 in Copenhagen, he still thought I was imagining my pains.  At that time I had been diagnosed and paid for the privilege and it was in my notes….. Of course I should have told him in the mid 1880s that Florence Nightingale had what is today known as fibromyalgia and May 12th is her birthday.

Recently I heard about a fibromite called Linda Allen who lives in Stoke, who had been asked by her GP to talk to first year medical students about long term chronic pain (fibromyalgia). Linda spent two hours with these students and not one of them had heard of fibromyalgia before. She has repeated her tutoring three times now and she has not found one med student who knew what she was talking about before their meeting.  The same thing has happened with physiotherapists and even head teachers who believe children with fibromyalgia are just playing truant. I have heard several cases like this. So there is a whole big wide world out there to educate about fibromyalgia, chronic fatigue, sleeplessness, cognitive problems and fibro fog, IBS and all the other nasties that cohabit with FM.

What we hope to do is encourage folk who have fibromyalgia to offer themselves to their medical centres and hospitals as a Practice Patient – allowing the training  doctors, nurses and medical staff to ask questions about the condition, to help them learn how to diagnose FM. Most fibromites are happy to talk about their aches and pains and it is a bonus to find someone who really wants to listen. If you have a hospital or GP appointment booked soon and feel you would like to become a Practice Patient, take the first step. Speak to your doctor or the secretary of one of the rheumatologists or someone in charge of training med. students explaining you want to help. Already we know  2% of the population suffer with fibromyalgia and it is thought that up to another 10% may be walking  about not knowing what ails them. With stress and trauma being  two of the main triggers  to set off this rotten disease,  I believe fibromyalgia shows no signs of going away. It can only get worse and the numbers increase. We desperately need to support research to find a cure, for the fibromites of tomorrow  and our children. Yes they believe it may be hereditary.

If the answer  is yes you want to be involved  and if  they would love to interview you as a Practice Patient, we can  help  you find the necessary websites and links to provide background material  for your meeting. I am waiting for a date from my own surgery.  How about it – are you willing to describe yourself as an  expert? Make it your new May 12 International Fibromyalgia Awareness Day resolution. We will back you all the way. If you want to know any  more about the Practice Patient email me at jeannehambleton@mac.com  or lindajaneallen@hotmail.co.uk.
Take care. Talk soon.
Jeanne

Hello world!

Welcome to UKFibro Aware!  A Non-Profit Organisation aiming to promote awareness of Fibromyalgia Syndrome in the United Kingdom.

UKFibro Aware has a website at http://www.ukfibroaware.webs.com/

Also a site on MySpace http://www.myspace.com/ukfibroaware  and

A presence on FaceBookat http://www.facebook.com/pages/UKFibro-Aware/10335813878?ref=nf

With a Profile page at  http://www.facebook.com/profile.php?id=721940554

Please contact me for further information

Gentle Hugzz

Hana