A ‘WIN WIN’ FIBROMYALGIA CONFERENCE

April 23/26 2010 South Downs Holiday Village Bracklesham Bay
By Jeanne Hambleton ©

The first ever fibromyalgia conference with a pamper weekend in the SE of England, Bracklesham Bay, last weekend (April 23/26 2010) kept it promises as a memorable weekend with eminent speakers, workshops, a range of therapies and some great evening entertainment. So successful was the event that a reunion date for the next event was fixed on the spot for another conference in 2011 on April 8/11. With this first event a sell out, bookings will be accepted on first come first booked.

Vistors hit by the delayed flights flew in from Germany, Channel Islands and Ireland at the last minute while some missed the conference stranded in Spain and the Carribbean. Some drove from Scotland, Wales and northern England to the south coast to hear leading speakers in the world of fibromyalgia.

Using all of their energy in an attempt not tomiss anything during the intensive programme during the long weekend, many admitted they expected to go home and go to bed for a few days to recover.

“But it will be worth it. We have learned so much, ” said on fibromite.

Carol from Bristol wrote and said, “I just wanted to send you a huge thank you for a great weekend. I came to the conference with my mum who is a fibromite and I have learnt so much. I never knew how complex this condition was and now appreciate the frustrations people have with a) getting the correct diagnosis at all and b) getting the correct medication. It was reassuring to see and hear for myself that there are alot of dedicated people researching and I have been completely “fired up” to a) raise awareness of this condition and b) do what I can to raise funds for research. I expect you are absolutely shattered but you should be so proud of what you achieved. I cannot thank you enough for the knowledge you have given me and I hope that I can continue to support my mum and other fibromites as a result.”

LOTZA LAUGHS
While there was lots to learn the fibromites had fun too. The Fibro Fillies Race Night had folks shouting for their horse to win and the message that came back means we had to do it again. On Saturday the Folly Pogs ‘posh frocks’ Ball and fancy dress competition with great support from the fibromites saw the Nuns from the Order of Discontent (the Irish lasses) amusing the audience. Sunday evening featured the charity auction with paintings, Elvis’ shirt, a valuable wine collection, a champagne hamper and jewellery and more, all donated by visitors, raising money for research.

Partners enjoyed deep-sea fishing with good catches, played golf, went fossil hunting and some enjoyed the workshops, while the fibromites listened to 12 keynote speakers over two days. The climax on Sunday afternoon was Question Time with 4 doctors on stage.

GREAT NEWS
One of the many ‘best’ things to come out of the Fibromyalgia Conference and Pamper Weekend, under the umbrella of FMA UK, was an announcement from Professor John Davies from Guy’s Hospital and the FM Clinics, who sadly was unable to be with us, and Professor Ernest Choy, Kings College Hospital, who was so well received the delegates want him back next time.

The announcement said, “We are pleased to announce a new NHS Fibromyalgia collaboration under the King’s Health Partners (Guys, Tommy’s and Kings NHS Hospitals). Heading this new initiative is Professor Davies and Professor Choy, who share a common objective of creating an integral clinical and research programme to advance the understanding and management of patients with Fibromyalgia.

Professor John E. Davies is Consultant Rheumatologist at Guy’s and Professor Ernest Choy is Clinical Reader in Rheumatology at KCL and Director of the Kings Musculoskeletal Clinical Trials Unit.”

The delegates received the news with cheers and expressed relief that further progress was being made in the recognition of our invisible disability – fibromyalgia.

A DATE FOR THE DIARY
In view of the enthusiasm of delegates to come back and meet the people they met this time, the 2011 event on April 8/11 2011 will be reunion with all they liked and some new speakers. All fibromites will be welcome to the residential weekend. There will be staged payments to help those on benefits to spread the cost.

Other on site activities included various workshops including Maryse Boulles’s sound therapy, Karen Henderson sharing her Bath Hospital experience following a one month stay; Gemma Kingsman from Consultaid who talked about Finding the Funds for Groups; and hygienist Jane Russell who talked about teeth and health. Sheila Green from Motorvate Chichester talked about a gym with a difference. Giselle and Ian Smith from the DWP spoke about the benefit system. Sunday saw two informal ‘Meet the Doctor’ sessions with Dr. Robert Lister and Dr. Ray Perrin. The weekend included Pilates, Tai chi, Yoga with a free pamper taster day, a shopping experience and fibromites arts and crafts. One to one pamper therapy sessions ran over two days at conference discount.

SPEAKERS PRESENTATION SUMMARIES

Most people had come to hear the specialists in the field of fibromyalgia. Everyone claimed they learned so much. Even the doctors found the experience rewarding with feedback from the fibromites worthwhile.

One fibromite said it was a ‘win win weekend’ with everyone getting a great benefit.

The following brief summaries of the hour long presentations are reported by fibromites who attended the conference and helped to provide information for this article. My grateful thanks to the following note takers as it was impossible for me to sit in and listen to any of the speakers due to other conference commitments. I just wish I had been a guest….

Group Leader of West York’s FM SG Denise Rhodes made the following comment.

“Overall, the information from the speakers was delivered with humour, sympathy and great authority. The passion with which much of the subject matter was disseminated demonstrated a level of caring far and above what I expected and definitely above the experience level of many of the GPs and consultants reported to me on the helpline and by colleagues in my group. All speakers made themselves available after their presentations and showed great interest in questions asked and gave detailed responses,” she said.

Report by Leanne Daniels from Horndean FM SG with thanks for her commitment and help during the weekend.

Professor Ernest Choy MD, FRCP is Consultant Rheumatologist at King’s College Hospital and Director of the Sir Alfred Baring Jarrod Clinical Trials Unit in the Academic Department of Rheumatology, King’s College London. He is also Director of Research and Development at King’s College Hospital in London.

Discussing the new advances in the pathophysiological management of fibromyalgia Professor Choy said it was hard to investigate pain with doctors feeling there is nothing they can identify to reach a diagnosis. Many controversies have been removed by trying not to label patients. He said MRI scans show the structure of the subject but not how the organ or tissuing was functioning. Brain functions can be seen and the magnetic properties in the brain are changed by the blood flow. Since the MRI uses magnets the brain functioning can now be seen.

Brain scans have even shown a reaction when red-hot chilli peppers are placed on the skin, with pain registered in certain areas of the brain. Pain results from a pain response and activates areas of the brain. The scan is useful as a tool to see how pain is perceived in FMS using pressure applied to the thumbnails, a sensation for pain against the pressure, can be detected. When this is applied to someone with FMS the signal to the brain can be identified to see if it correlates to the pain felt. So the pain is not just in your head.

In ‘normals’ increased pressure eventually results in pain. In someone with FMS pain is triggered in the brain much sooner. This confirms the patient was not lying.

Professor Choy confirmed there are areas in the brain where normals and those with FMS show differences. Those with FMS were found to have less activity is regions of the brain than ‘normals’.

FMS patients react differently to normals, as their brain inhibitor is not working. They do not respond well to morphine. The brain produces its own morphine-type drugs. As the inhibitor does not work the natural drug produced by the brain is also reduced.

Sleep is very important and there is a link between sleep quality and pain. Good sleep reduces pain to manageable levels but the pain may not go away. Researchers are working towards identifying the relevant pathways and how to clear them. The focus is now on research to improve sleep,

Aims in the treatment of FMS include reducing pain, improving functions, better quality of life, and allowing patients to self manage. It has been identified that FMS is a complex and herogenetic condition and not everyone with fibromyalgia is the same.

Three sub groups within FMS have been identified and this is significant enough to show that blanket or individually tailored treatment would be needed. In trials random meds are given and there have been similar observations about 3 sub groups. Drugs trialed in the USA revealed similar results with sub groups in different pathways. Some patients have more sleep disturbances, mood changes or depression. Depression can lead to poor sleep patterns and hinders the ability to cope. Researchers are trying to develop treatments suitable for each individual pathway for patients. To date there is not one magic cure but with these small steps forward it is hoped that one day there may be one drug to help all fibromites.

Professor Choy said they were trying to educate doctors on what FMS actually is, and explain to the patients’ relatives more about the pain they cannot see.

Exercise may hurt but if you do not exercise you lose muscle tone, which can make fatigue worse. It is important to push on doing gradually more each day. Best time to exercise is in the evening followed by a warm bath and bed to enhance sleep quality.

Professor Choy confirmed medical guidelines could be sent to GPs on request to FMA UK – http://www.fibromyalgia-associationuk.org/general-articles-highlights-208/271-medical-pack-html

Report by Leanne Daniels

Dr Peter Fisher Chirr, MB, FRCP, FFHom is Clinical Director and Director of Research at the Royal London Homoeopathic Hospital, London, Physician to HM Queen Elizabeth II and chaired the World Health Organization’s working group on homeopathy, whose report is due for publication soon.

Talking about fibromyalgia and homeopathy he described this as treatment of like with like. It is different from herbal medicines and is often confused with this. Homeopathic treatment is for the person not the disease. One of the conditions treated may be a bee sting with pain, swellings, relieved by cold and worse with pressure. The preparation to cure the condition would be one part of the mother tincture, and maybe 99 parts of water.

Dr Fisher reported that at the last survey in 1998 8% of the population was using homeopathic remedies with 470,000 users nationwide. This related particularly to the chronically ill. The growth in users is between 12% and 13% annually.

Clinical research on Rhus Toxicoderdron for FMS using double blinds with placebos and homeopathic pills showed 25% of FMS patients responded to treatment in just over a month. Tender Points cannot be reduced but these will respond and get worse if these points feel the condition is getting worse. Overall people did better taking the pills than those on the placebo treatment.

Dr Fisher felt a condition with normal care and homeopathic treatment would work better offering a broader package of treatment than just normal care. He said people went to the Royal Homeopathic Hospital for treatment because other treatments did not work, or gave unwanted side effects, with the majority of patients responding well and improving.

The advantage of using homeopathic treatments was you could do it yourself, based on a small number of typical symptoms, it treats the person and not the disease. There are a limited number of homeopathic remedies, compared to many medications available, and it does not need a practitioner. It also has low dilution content compared to high dilution with meds.

Dr Fisher spoke of the symptoms homeopathic remedies could help and the treatments used. Homeopathic treatment was available on the NHS but it was not easy to get. These treatments seem to work for fibromyalgia. With Choose & Book you can advise your GP you wish to be referred to the Royal Homeopathic Hospital in Great Ormond Street, London, or do it yourself on the Internet.

Denise Rhodes reported -

Professor B K Puri MA (Can tab), PhD, MB, Chirr, BSc (Hones) MathCAD, MRCPsych, DipStat, PG Cert Maths, MMath, is at Hammersmith Hospital and Imperial College London, he has carried out pioneering research work and is a world-leading neuroscience and biochemistry expert.

Professor Basant Puri asked is Fibromyalgia associated with changes in brain anatomy? Previous studies show no grey matter reduction in normal healthy patients and fibromyalgia sufferers. This is in contrast to patients with psychiatric conditions.

His very recent study tested FMS sufferers against a healthy control group and identified loss of grey matter in relation to fatigue.

The tests were carried out using very sophisticated MRI scanners at a higher level than normally used 1.5T(Teslas ) Teslas are measures of magnetic strength. His tests were carried out using 3T and a totally unbiased research method called VBM approach.

His conclusions are that there is degeneration in grey matter in areas of the brain as a result of visual stimulus overload, and problems of coordinating motor and visual tasks, along with problems with sequenced complicated actions.

Denise Rhodes wrote the following reported –

Dr Cathy Price MB BCH, DCH, FRCA, FFPMRCA is a Consultant in Pain Management, Southampton University Hospital NHS Trust and a member of the British Pain Society who has an interest in fibromyalgia said there was a need to focus on patient needs rather than on conditions.

She said pain services offers a multi-disciplinary team approach, which includes psychologists, doctors, physiotherapists, occupational therapists, pharmacists, nurses, acupuncturists and job advisors in order to improve the quality of life. Dr Price said 70% of patients at discharge report positive results as against 30% who feel that it has been of little or no benefit.

Dos and Don’ts for FM –

• Do promote balance in activities
• Manage depression
• Discuss pros and cons of therapies, treatments, and strategies.
• Don’t use opoids
• Use Pain Toolkit booklet

Useful sources for FM information:

HYPERLINK “http://www.patient” http://www.patient.co.uk and /healthyFM.htm
HYPERLINK “http://www.18weeks” http://www.18weeks website dept of health – pain

Dr Price is the clinical lead for the National Pain Audit and argues that getting information into GP surgeries, hospitals and pharmacies is vital, so anything we can do to promote FM in this way will help us all.

She emphasised how important pacing is and how it is difficult to achieve – it may take months and help is so limited. Southampton has dropped organised courses such as 6 weeks on hydrotherapy etcetera, in favour of a cafeteria approach where individuals can take bits of services according to their individual needs. She referred fibromites to ICAS an independent body who will support patients to fight their corner. She also referred us to PALS who are also very helpful.

A question was asked regarding whether the very high number of GPs who are either non-believers, or non-supporters will reduce as further training, younger doctors come into the system. She said that more training and awareness is having an effect, often via e learning – online. She also said that Dr Liam Donaldson, the Chief Medical Officer, is promoting greater awareness of the condition.

Report by Leanne Daniels

Dr Ian H Treasaden MB BS LRCP MRCS FRCPsych LLM Head of Forensic Neurosciences, Lipid Neuroscience Group, Imperial College, London.

Dr Treasaden discussed mood disorders associated with FM and the management of nutrition. He spoke about normal and abnormal depression and FMS and mood disorders. He said Charles Darwin had fibromyalgia. He wrote books about species after years of travels and would suffer a fibro flare when defending his theories.

He believed the causes included hyper exatability of the nervous system, brain functions, and altered brain waves that deal with pain. Management would include a mixture of drugs and non-drug treatments plus antidepressants. On the non-medicines he included walking and exercise, hydrotherapy, CBT (cognitive behaviour therapy) that challenges negative attitudes to symptoms, plus a multi-disciplinary approach, which is rare to find.

On mood disorders he said depression causes could be more than a low mood. Periodic low moods can improve over time without treatment. Grief can be confused with depression. The Doctor spoke about Bipolar, which had replaced the manic depressant illness.

Depression symptoms included low mood, no feelings or tears, loss of interest, socially withdrawn and no interest in hobbies or work. In severe cases that can include suicidal thoughts, low self esteem, helplessness and pessimistic, loss of appetite or even weight gain, constipation, lack of sex drive, impotence, poor sleep and paranoid.

Those with FMS and depression often have headaches, worry about their symptoms and are delusional. Management can include counselling, self help, CBT, exercise and antidepressants for 6-9 months. Omega 3 is good for depression, elevating your mood and reducing anxiety. His recommendations included medication to help sleep, exercises, brain exercises and nutritional management.

Report by Leanne Daniels

Dr Nick Avery MB BS LRCP MRCS MFHom from the Natural Practice at Winchester & Eastbourne helps patients within the Health Service benefit from complementary techniques for IBS, CFS, Eczema, Allergies, Asthma and Migraine, using homeopathy for the emotional component of the illness.

Fibromyalgia is a very common condition that is poorly served by conventional medicine. In his experience, the key features are extreme fatigue, muscle pain and emotional disturbance. Interestingly the emotional aspect is the reason why patients suffer – otherwise the illness would just be interesting! Anti-depressants do not deal with this – they can help elevate mood in some patients but they do not address specific emotions. Similarly fixing the underlying fatigue state cannot be helped by drugs, which are mainly designed to block symptoms rather than create energy.

Many patients that Dr Avery treats suffer from underlying mitochondrial failure. Mitochondria are present in most cells of the body and this is where the ATP cycle occurs, providing the energy needed for all cellular functions. A blood test has now been developed which can identify which of the two underlying possible problems is causing the low energy state. There is a lack of raw materials to make the necessary ingredients involved in the process and some kind of block in the circuit usually from a chemical / drug or other toxic substance. The only way to treat these abnormalities is to correct the underlying nutritional problem – there is either an absorption problem or nutrients are lost – or to use some kind of ‘detox’ technique.

Neither of these treatment modalities is available from conventional practitioners – despite the fact that the condition has an underlying demonstrable biochemical explanation. The Doctor showed a scientific approach to the condition, sorting out problems with absorption, retention of nutrition and the use of a variety of treatment modalities designed to improve energy levels, pain and emotional disturbance. Much of the talk is based on 15 years’ experience of helping patients who suffer from fibromyalgia – many of whom (but not all) have done very well. He intends to concentrate on what can actually be done in the light of our current understanding.

Report by Leanne Daniels

Dr Robert Lister BSc PhD FBS C Biol. is a Director of Phyla Ltd, a health care consultancy and Director of Cubic Ltd, which develop innovative medical electronic devices. He is Chairman of the Institute of Brain Chemistry and Human Nutrition at London Metropolitan University.

Introducing Linda Horncastle Dip COT SROT, Group Leader South Bucks FM SG, Dr Lister said due to FM she had stopped work. Thanks to the Alpha-Stim she has returned to work as an Occupational Therapist.

Dr Lister spoke of a pilot study relating to chemical imbalances, which showed a 60% improvement with microcurrent stimulation, but he felt something else was going on in the brain. Many people suggested the pains were a figment of the imagination and various drugs were needed to treat the condition. He felt there as ‘faulty wiring’ on the malfunctioning connections to the nervous system although imbalances may be able to fixed there was evidence that brain stimulation can modify the signals.

Dr Lister referred to the influences we feel and the chemical receivers. But when the muscle or bone is injured the body sets up an electrical current. Electricity can affect the brain. Some elements may be faulty and disconnected but this can be changed by introducing the microcurrent. By changing the electrical status this can alter the way we behave. People with psychological disorders had purely behavioural problems and these could be improved by talking.

The brain is made up of a lot of active centres and neuroscientists were using deep brain stimulations for diseases such as Parkinsons. He made reference to CES Cranial Electric Stimulation, which produced a similar effect to deep brain stimulation at a cost of £250.

Stimulation can provide relaxation in some parts of the brain and stimulation in others. It can block pain, reduce anxiety, increase positive effects and alleviate insomnia. The stimulation can also change the concentration of chemicals, releasing more so the energy levels are increased,

Studies in the USA have helped pain, anxiety, stress, muscle tension and insomnia. In recent trials based on 500 patients the majority received between up to 99% relief of symptoms and headaches. There were moderate improvements on trials involving 2,500 patients in RSD, FMS, myofascial pain and migraines.

Talking about Linda he told her story and said she had FMS for 20 years but was now walking again thanks to the microcurrent. Dr Lister confirmed microcurrents had been used in the USA for 29 years and were safe and claimed 90% success rate. At a lower power than TENS machines the effect is cumulative where the TENS stops when you turn it off. The machines use probes and sticks.

Linda’s group had tried the microcurrent machines and reported improvements in 3 weeks. While it is not a magic cure it should be used most days and then mobility improves and fibro fog disappears. There are no side effects except perhaps some tingling.

Report by Clare Palmer ANOM

Dr Raymond Perrin DO PhD, Hon. Senior Lecturer, School of Public Health and Clinical Sciences, UCLAN, Registered Osteopath and Specialist in CFS. He spent 16 years researching medical and scientific evidence while treating CFS/ME/ Fibromyalgia patients with of the Perrin Technique.

Dr Perrin explained his treatment, based on manual drainage of toxins from the central nervous system, could relieve many of the symptoms of fibromyalgia. Some doctors treat fibromyalgia (FMS) and chronic fatigue syndrome (CFS) separately, while others think they are actually the same thing – or at least, variations of the same condition. According to the Arthritis Foundation, research shows that 50 to 70 percent of people with one diagnosis also fit the criteria for the other.

Raymond Perrin’s earlier research at the University of Salford in conjunction with the University of Manchester, coupled with the hundreds of successful clinical case studies and the latest findings in neurophysiology, has provided strong evidence that CFS involves a disturbance of the drainage of toxins from the brain and muscles? These poisons often enter body in the form of viruses, bacteria and other microbes, parasitic infection or due to environmental toxins such as pesticides. Yeasts, bacteria, viruses, parasites, pesticides and heavy metals have all been implicated in cases on Fibromyalgia.

Osteopath and bioscientist Ray Perrin, who has developed this treatment technique over the past twenty years, showed how simple measures can bring relief to the patient and explained the possible patho-physiological pathways that lead to this terribly debilitating disease. The basis of this condition being a toxic overload of the brain and spine affecting the sympathetic nervous system, can over stimulate the peripheral nerves leading to pain and muscle spasms etc.

Dr Perrin stressed that although The Perrin Technique has brought much relief to many, it is not a cure-all treatment. In cases of fibromyalgia it should be used in conjunction with other therapies such as acupuncture and hypnotherapy. Supplements of vitamins and minerals, omega 3 and 6 fatty acids and pacing are all important in the overall therapy. His best-selling book The Perrin Technique, Hammersmith Press, London, 2007, sold out with a conference discount and is available from most good book supplies.

Report by Leanne Daniels

Andrea Barr MRSS (T) is a Shiatsu teacher/Complementary Pain Specialist, interested in FM, and has lectured in Switzerland, Austria and UK. She runs Pilgrim Hospital Boston Pain Clinic, Lincs. Talking about the logical empowerment approach to pain managements, she looked at the physical symptoms of FMS.

People who eat carbohydrates may suffer from an intolerance of this substance that can also lead to many of the symptoms associated with fibromyalgia she said recommending that oats and rye should be retained but most carbohydrates should be removed from the diet.

Andrea Barr referred to emotional symptoms including questioning yourself, the pressure of time, being self critical if doing nothing, feeling stressed, concerned with details and a low level depression.

The Autonomic nervous system – or fight and flight feelings – often resulted in difficulty expressing feeling, feeling under threat, while our bodies undergo a series of dramatic changes in blood flow, digestive tract, and the muscles. Signs of flight or fight syndrome are poor sleep with an inability to shut down, tight shoulders/neck, digestive upsets, regular headaches. The fight or flight feelings can stem from childhood, long term trauma, too much activity and no calmness, and undetected stress.

Referring to rest, digest and repair Andrea Barr said the heart rate drops, blood pressure falls, respiration slows and deepens. Blood flow is re-established, the immune and lymphatic systems are supported, and you feel relaxed, calm and refreshed if you slept well.

Summarising she said the body can only repair itself during rest and digest. During fight or flight the rest does nothing for the body. Traumas and triggers can put a patient in a fight or flight condition. She described how the brain reacted during this sensation.

Resources to encourage better sleep included EFT, thought field therapy, cognitive behaviour therapy, yoga, medication and breathing, Shiatsu and cranial treatments. For more help email andrea_barr@hotmail.com or ring 01522 521 817.

Report by Denise Rhodes

Dr Nina Bailey BSc, PhD is a nutritional scientist working in dietary health and nutritional intervention in disease, with emphasis on the role of fatty acids in fibromyalgia, depression and ME. She has a DVD, which explains how to manage IBS that at least 50% of FM/CFS/Depressives/chronic headache sufferers experience.

Basically her argument is that there is no perfect dietary cure but findings show that red meat, particularly if seared/charred/barbequed produce carbonation. That produces ammonia, which leads to inflammation in the gut and is extremely bad for IBS just as many sweeteners are, such as xylotomy and sorbitol. Also insoluble fibers such as whole-wheat grains, bran, unpeeled fruit, salad greens, fried foods are in question. An expansion of this is on the http://www.drninabailey.com site. Dr Bailey said information is available on her websites http://www.igennus-hn.com, http://www.drninabailey.com and from ninabailey@aoum.org.

Report by Denise Rhodes

Dr Mageb Agour MB, BS, MRCPsych recently presented his latest research findings into sleep disorders in this area at a major international medical conference in Italy in September 2009, looked at objective sleep management.

The gold standard test is
• In a laboratory where subject is wired up to record all body functions.
• A device that looks like a watch, strapped to the wrist and used in one’s own home. This is programmed to record movement and defines when/when not asleep
• There are 5 stages of sleep with normally 3 – 4 cycles per night.
• The longer we sleep the more we dream. But dream is only achieved in stage 5 (REM)
• Stage 1 light sleep/dozing low eye movement, often slightly aware and easily aroused
• Stage 2 eye movement stops, slower brainwaves
• Stage 3 Delta waves deeper stage
• Stage 4 No eye movement or muscle activity
• Stage 5 REM breathing increases, rapid eye-movement – muscles paralyzed

Babies spend 50% of sleep time in REM but with aging there are fewer REM stages in adults.

• Primary Sleep Disorders
• Narcolepsy
• Sleep apnea
• Abnormal behaviour
• Sleepwalking/talking
• Night terrors
• Secondary Sleep Disorders
• Mental disorder
• General medical conditions
• Substance users anything from caffeine to cocaine and heroin
• Sleep and FM
• Restless leg syndrome – Periodic limb movement – involuntary (if severe may need treatment)
• Bruxism (Grinding teeth)
• Alpha wave intrusion

In Fibromites non-refreshing sleep is a result of Alpha waves intruding into Betawave stage causes REM state to leave. Remedies are to reduce mental activity before bed, avoid reading in bed or watching TV.

Melatonin is seen as a useful tool and is now available from many GPs or online.
Short term sleeping tablets and treating underlying problems. Natural remedies such as Valerian, which performs in a similar way to Oxizipan or St John’s Wort, which is often used for depression.

However, when using alternative and complementary medications it is important to check with GP and/or Pharmacist to avoid clash with prescribed medication.
Chamomile, a Fish Oils High content omega 3 vital.

Report by Leanne Daniels

Andy Pothecary MPharma (Hons), ACPP Pharmacist is a Senior Pharmacist at Worthing Hospital. Andrew’s interest in fibromyalgia began in 2004 when his wife was diagnosed with the condition. He hopes to undertake research and develop a specialist role in this area in the future.

In his Pharmacist Pick & Mix presentation Andy Pothecary spoke about Medicines Licensing in the UK explaining the Drug Company identifies promising new compound, applies for a patent, and carries out further laboratory trials. The company then applies for permission to carry out clinical trials. When completed they apply for marketing authorisation (MA). They can then sell the product within the EU.

He described the types of clinical trials a drug is submitted to.

Phase I: Pre-clinical testing, with healthy male volunteers – first time drug used in humans.
Phase II: Small-scale trial at a limited number of centers, in which the drug is used in patients with the disease.
Phase III: Larger-scale trial across many centers, with a wider range of patients
Phase IV: Post-marketing surveillance – product in use but rare or long-term side effects identified

Use of unlicensed medicines

These are medicines without a PL/MA. This might be because they are undergoing clinical trials, are to treat rare conditions, or because the MA has been withdrawn or surrendered. If unlicensed medicines are used, the prescribing doctor assumes full responsibility and liability for any adverse events that might occur.

What is “Named-patient Basis?”

Process that enables patients to be supplied with an unlicensed drug. “Named patient” means the drug is being supplied (to the hospital, pharmacy, etc) for the use of a specific patient. Depending on the drug concerned, it can be fairly simple to obtain or involve lots of form filling by doctor and pharmacy.

Off-license/off-label Medicines

When a product is granted an MA, this specifies which conditions the product can be used to treat. However the product might also be used to treat other conditions. This use is termed “off-license” or “off-label” because it is not covered by the terms of the MA. Again, this means that the prescribing doctor will assume greater responsibility and liability if anything goes wrong.

Why is this relevant?

How many medicines are currently licensed for the treatment of fibromyalgia in the UK? None! He spoke about the use of ‘old drugs’ normally prescribed for other conditions but used for fibromyalgia although these may not be licensed for this. He also described the various drugs prescribed by GPs.

Report by Denise Rhodes

Gemma Kingsman, professional fundraiser, reported on Finding the Funds – and outlined what funds are available, mainly concentrating on Awards for All, which is the National Lottery.

For large pots of money £30,000 eg can be funded for up to 3 years. Smaller pots up to £5,000 can be applied for such as sessional worker funds, equipment needs, marketing the group. She advised ringing lottery help lines for how to submit and what for. They are very helpful.

Grassroots Awards are nationally available but administered locally via a local community foundation. The cash comes from wealthy donator philanthropists and organisations. Groups applying must have a written constitution with clear and simple rules and regulations, be a not-for- profit organisation, able to identify a need in the community, which the group will serve. Can make more than one application in two categories: up to £900 and from £900 – £5.000. The following year application can be made for further cash to support further needs. The Grassroots Grant might be for rent, equipment, refreshments, and volunteer costs regarding running costs.

The Lions Clubs, Rotary Group will respond to a letter for support and the website “Guide Star” is a source of information. Many Disability sites will provide sources of funding. Her company “Consultaid” charges £35 to fill in a grant application form but she referred delegates to free help in the community.

Talking fundraising we are looking for some help from our friends. We believe we can persuade a couple of American FMS doctors to come to conference next year. But we need to pay their airfare and expenses. We may be looking at approximately £500 per doctor. If you are coming next year and are able to do a bit of fund raising towards hearing these USA doctors who are often light years ahead of us in some things FMS, we would love to shout about what you are doing and would really welcome your support. Email me jeannehambleton @ mac.com if you can help. While April 2011 is some while away we need to get in the diaries of these doctors. However small your fundraising is it will all add up. Guess what – I already have two bookings. Thanks Ann and Gina.

THANKS
Finally I would like to thank FMA UK for their great support with help and wonderful conference bags, which members have said they will carry their meetings. Without their help the delegates might have had Tesco plastic carrier bags for their conference papers. Odd everyone liked the bags but no one said anything about the paperwork we spent hours stuffing inside….

Clare Palmer’s Sunday input with doctors was also appreciated. Thanks also to Teresa White and Lorely Day (Chichester FM SG), for their great work with the tombola, raffles and auction. Thanks also to Horndean members Tracy Gibbon and Andy Andrews for their major contribution to the auction with another lady fibromite whose name sadly I did not get.

My gratitude to Pauline Dee and Leanne Daniels who spent hours at the front desk dealing with enquiries. There for the cause, Pauline and Glenna Frost but neither managed to see or hear any speaker or visit a workshop. Thanks also to Glenda Philpott and Martin for spending hours filming speakers to produce a DVD of the event. Watch this space for news of when it is available. Like most conference areas the room was dark for power points and mobile telephone quiet signals may have interfered with the recording but we live in hope.

My apologies to all those who offered help with notes and speakers. I ran out of time and just had no time to get together to work out the details. I am sorry. I am grateful to Denise Rhodes and Leanne Daniels who took notes anyway and fired them off in time for me to get this article out in reasonable time.

Thanks to Bob McKinlay and Gareth Duval for organizing the golf and Chris Crick for sorting out the deep-sea fishermen and lone fisherwoman, and to the fossil hunters who understood when we said their ‘leader’ was grounded in the Caribbean under an ash cloud.

Also thanks to Tony Ede (FMS SAS) and Simon Stuart (Worthing & Ferring FM SG) for taking care of projectors, laptops and power points and making it happen. Gratitude to Bill Craven and friends for the race night. I am grateful to fibromites Karen Henderson who did a workshop and sorry Sam Piggott had a flare. Also thanks to Alan Perry for the photographs of the FollyPogs Ball he has donated and to Nene Valley FM SG who donated £63 to the research fund.

Thanks also to all the speakers who gave their time without reservation, those who ran workshops, the exhibitors, and the pamper therapists. Your support was appreciated by everyone.

I also appreciate those who understood how much work was involved and have volunteered to ‘take a section’ of the conference for next year. Great news and thanks.

South Downs Holiday Village Management, staff and the Head Chef did all they could to make us comfortable. The dining room and kitchen staff were all exceptional and patiently dealt with our special diets. They were more attentive than some expensive hotels I have stayed at giving freely of their usual time off. Well done and hope your company appreciates your high standard of care. We fibromites were really grateful to everyone on site for making us very very welcome.

Finally my gratitude must also go to Sarah, my ‘rock’ that did everything pamper for us and my husband Arthur who worked with me who wrote databases, was tolerant to list bookings and payments and the endless mails. Forgive me if I have missed anyone. I am a fibromite and I do forget. And a huge thanks to those who came. You helped to make the weekend memorable for us. Without your support none of this would have happened. THANK YOU Jeanne

Back Pain – Medication and Addiction

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

Courtesy of WebMD.com

How can we balance the risk of drug abuse with the suffering caused by untreated back pain?

By R. Morgan Griffin – Reviewed by Brunilda Nazario, MD – WebMD Feature

People living with serious back pain have to sort through a lot of mixed messages about opioid — or narcotic — painkillers.

On the one hand, you have heard stories about the seeming epidemic of addiction to these drugs, like OxyContin, Percocet, and Vicodin. All those celebrities checking into rehab for painkiller addiction may give you the impression that the lure of these drugs is irresistible, that we are all just a few pills away from addiction.

But on the other hand, you might have heard that pain is chronically undertreated and many people are suffering needlessly. Which is true?

“They’re both true,” says Lynn Webster MD, medical director at the Lifetree Clinical Research and Pain Clinic in Salt Lake City. “In this country, we undertreat pain and we underutilize opioid painkillers. But we have also had a serious increase in the misuse and abuse of these drugs.”

This leaves many people with chronic back pain — and often their doctors — stuck in the middle. On the one hand, people are afraid of the risks of drug abuse and addiction that come with powerful painkillers. On the other, they are suffering from severe and debilitating pain and need some kind of help.

Opioid medicines can save lives. But they can destroy them too. What is an average person with severe back pain supposed to do?

Who Needs Opioid Painkillers?

Here is one piece of good news: most people with back pain do not need these powerful painkillers to begin with.

Many with back pain often just use non-addictive medications like Tylenol or nonsteroidal anti-inflammatory drugs (NSAIDs). Some NSAIDs are sold over the counter, like Motrin or Advil, and others are sold by prescription. Steroids can also be prescribed for back pain due to swelling and inflammation. These drugs do have some risks of their own, but the potential for addiction is not among them.

Even when powerful opioids like Percocet and Vicodin are necessary, many people only need them in the short term. After an acute back injury or surgery, many just use these drugs to ease the pain enough that they can start moving around and begin physical therapy.

But sometimes, the back pain lingers. Chronic back pain can sometimes develop as a result of arthritis or injuries that cannot be corrected surgically. In the small percentage of people with chronic and hard-to-treat back pain, a doctor may recommend long-term opioid therapy. Others may get opioid therapy if the side effects of other painkillers — like NSAIDs — are too risky.

While some patients and doctors swear by opioids as a treatment for severe chronic back pain, the evidence is not all that strong. One 2007 review in the Annals of Internal Medicine found that while opioids do help with short-term back pain, it is not clear that they help with chronic back pain. A 2007 Cochrane Review found that opioids may not work any better than an NSAID for chronic lower back pain.

How Big Is the Opioid Abuse Problem?

Prescription narcotic abuse is a serious issue, says Jim Zacny, PhD, a professor in the department of anesthesia and critical care at the University of Chicago. He points to the 2007 National Survey on Drug Use and Health. It found that as many as 5.2 million people reported using prescription opioids in the last month for non-medical reasons. That is more than double the number of people who used cocaine.

But many of the people illicitly using these drugs are not in pain. So the important question is this: how high is the risk of abuse for someone living with serious back pain?

There is some good news: the risks of actual addiction may be lower than assumed. “Among people with legitimate pain issues, it is a very small group who actually develop the disease of addiction,” says Webster.

Zacny agrees. “There is this myth out there that if you take an opiate, you automatically become enslaved to it,” he says. “That is not the truth at all.”

However, addiction is not the only issue. Webster observes that a much larger number of these people — perhaps 20%-30% — do wind up misusing or abusing the drug.

Opioid Addiction vs. Abuse

What is the distinction between drug addiction and drug abuse? Many people with real back pain are not addicted, but they begin to use their medication incorrectly. They might take too much, simply because the prescribed dose does not seem to be helping enough. Or they might use their medication to cope in other ways.

“People with pain sometimes take pain medicine inappropriately to feel a little high or improve their mood,” says Karen Miotto, MD, an addiction psychiatrist at the UCLA Neuropsychiatric Institute. “They might take one after a fight with a spouse or a hard day at work.”

Some people with chronic pain also have issues like anxiety and depression. They might start leaning on their pain medication to help them with these conditions too.

While we tend to focus on addiction, misuse and abuse can also be dangerous. Opioids are powerful drugs with real risks.

“In the last three to five years, we have seen a significant increase in the number of unintentional overdose deaths caused by prescription painkillers,” Webster tells WebMD. “At least half of them are in people who have legitimate pain problems with legitimate prescriptions.” Taking these drugs in ways your doctor did not intend simply is not safe.

“Our culture encourages the attitude that if one pill is good, two is better,” Webster says. “With opioids, that can be lethal.”

What Increases the Risk of Drug Addiction and Abuse?

The risks of drug addiction and abuse do not seem to be the same for everyone.

“It is not the pills alone that make an addiction,” Miotto says. She points out that addiction develops from a number of physiological, psychological, genetic, and social factors. A personal history of substance abuse also seems to increase the risk.

Mixing drugs also increases the risk of problems. “If you are taking your pain medicine along with other prescription drugs, you ratchet up the risk of addiction enormously,” says Miotto.

Webster says that pain itself is a risk factor: the greater the severity of the pain, the higher the risk of drug abuse and addiction. “After years of living with severe chronic pain, people will do anything to get rid of it,” he tells WebMD.

The Effects of Addiction and Abuse

Miotto says that drug addiction may seem to start innocently. A person might just occasionally call in a prescription early, or take a spouse’s medication as well as their own. “These behaviors can creep up on people slowly and then, all of a sudden, they have a physical dependency,” says Miotto.

The problem is that people who have a prescription drug addiction do not realize it. “Addiction is a disease of denial,” Miotto says. “It can take years before people realize what is happening to them.”

It pushes people to horrible extremes. Miotto knows one patient who eventually admitted that she pushed for surgery solely because she wanted the opioid painkillers she knew she would get afterward.

There is also another dimension to prescription drug abuse you should consider. Even if you do not abuse the opioid pills you have been prescribed, someone else could.

“A lot of the opioids that get used illicitly — especially by adolescents — come from the medicine cabinets of people who were prescribed the drug for legitimate pain,” says Webster. “People need to understand the potential harm that they can do to communities if these medications are not properly secured.”

Doctor vs. Patient

In part because of the stigma of prescription drug addiction, chronic back pain can sour even the best doctor-patient relationships. The patient can become frustrated by the doctor’s inability to cure his or her pain. Meanwhile, the doctor may become suspicious of someone who is always demanding refills of powerful opioids.

“Doctors are getting sued from both ends,” says Miotto. Some have been sued for providing opioid painkillers that lead to addiction; others get sued for not prescribing them to relieve debilitating pain.

People with a past history of addiction face the most skepticism from their doctors.

“I hate to say it, but when people walk in to the doctor and mention an addiction history, they may not be able to get these painkillers,” says Miotto. “The doctor may just not trust them.”

Alternatives to Opioids for Back Pain

Miotto says that some people with serious pain become too focused on opioids. They come to believe that opioids are the only thing that will help. But sometimes, you need to take a step back.

“If you keep increasing your dose of opioid pain medication but pain is still an 8 or 9 out of 10, it is time to shift gears and try something else,” says Miotto. She points out that at high doses, opioid painkillers can actually make your pain worse — a condition called opiate-induced hyperalgesia.

In addition to NSAIDs and other drug treatments, there are non-drug options for coping with chronic pain. Physical therapy can be invaluable. Miotto notes that treatments like massage, water therapy, and biofeedback can make a big difference with chronic pain. Unfortunately, it can be hard to get insurance to cover these sorts of treatments, Miotto says.

It is also important to treat any other conditions that might be exacerbating your pain. For instance, experts say that many people with chronic pain also struggle with depression and anxiety. “People who feel an increased amount of anxiety also feel an increased amount of pain,” says Webster. Even those who do not have diagnosed psychological condition can benefit from support groups or therapy.

Of course, some with chronic pain will bristle at that suggestion. They believe that it implies that the horrible pain they feel is “all in their heads.”

But Miotto says that is not the case at all.

“Severe, chronic pain makes life terribly difficult,” Miotto tells WebMD. “Therapy is just another helpful tool in getting people to cope better.”

Using Opioids Safely

Clearly, there is no simple advice when it comes to balancing the benefits and risks of opioids for back pain. But if you and your doctor decide to use these medicines, here are some tips for taking them safely.

Follow your doctor’s prescription precisely. Never double up a dose. Never take your medicine for any symptom besides pain.

Find a specialist. Dealing with chronic pain is complicated. Your regular doctor may not be comfortable handing out long-term prescriptions for opioids. So seek out a specialist in pain management or, better yet, a pain management center. This is essential for people who have a past history of substance abuse.

Do not mix opioids with other drugs. If you already use prescription or over-the counter drugs, supplements, or alternative medicines, make sure your doctor knows about every single one. Ask about the safety of using your opioid painkillers with alcohol.

Sign a pain agreement. These documents help build trust between a doctor and patient. A patient might promise to use the medication as instructed and, in some cases, agree to regular drug testing. In return, the doctor agrees to prescribe opioid pain relievers as part of the treatment plan.

Take a screener. Experts now recommend that doctors use screeners — a short series of questions — that help them identify people who might be at higher risk of opioid abuse. Like pain agreements, they help build trust between patients and doctors.

Ask about alternatives. Talk to your doctor about other ways you could reduce your back pain. Might non-opioid medicines help? What about surgery? Or non-traditional treatments like massage or relaxation?

Get support. Consider seeing a therapist or joining a support group for people with back pain.

Keep your medication in a safe place. Remember that it is not only the person in pain who is at risk of abusing opioids. So be careful. Do not keep your medicine where other people — your children, grandchildren, friends, or neighbors — can get to it.

Finally, the most important way to assure that you are using your medicine safely is to have a trusting and open relationship with your doctor.

“Anyone with chronic pain needs to find a physician who is compassionate and understanding,” says Webster. Trust between a doctor and patient is the basis of any good pain management.

(©2005-2009 WebMD, LLC. All rights reserved.

http://www.webmd.com/back-pain/features/back-pain-medication-addiction?ecd=wnl_cbp_052109&em=amVhbm5laGFtYmxldG9uQG1hYy5jb20=)

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Addition of Lyrica Significantly Improved Generalized Anxiety Disorder Symptoms in Patients Who Responded Only Partially to Previous GAD Treatments

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

First Large, Placebo-Controlled Study to Demonstrate Efficacy of Lyrica as Add-on Therapy Strategy in Difficult-to-Treat GAD Patients

May 19, 2009 03:00 PM Eastern Daylight Time

SAN FRANCISCO–(BUSINESS WIRE)–The addition of Pfizer’s Lyrica® (pregabalin) capsules CV to other generalized anxiety disorder (GAD) treatments significantly improved the symptoms of the condition in patients who responded only partially to previous treatments, according to a study presented today at the American Psychiatric Association annual meeting in San Francisco, Ca. In this study, patients treated with Lyrica showed significant improvements in both their psychological and physical symptoms of anxiety.

Generalized anxiety disorder is a chronic, debilitating anxiety disorder affecting nearly seven million Americans and is characterized by persistent, excessive, uncontrollable worry about everyday things. Patients also frequently experience physical symptoms such as muscle tension, fatigue, sleep disturbance, and other aches and pains.

The condition is complex and often difficult to treat, with 40 percent to 60 percent of patients failing to achieve remission after six months of treatment in clinical studies with serontonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) – two common classes of FDA-approved GAD treatments.

“These data are very encouraging for the high percentage of GAD patients who still struggle with debilitating symptoms despite treatment,” said Dr. Rakesh Jain, one of the study’s investigators and director, adult and child psycho-pharmacology research, R/D Clinical Research, Inc. “It is clear we need additional effective, well-tolerated options to address this difficult to treat condition.”

This is the first large, placebo-controlled trial to demonstrate the efficacy of an add-on therapy strategy in patients who had failed to respond to two different courses of GAD monotherapy with a SSRI, SNRI or benzodiazepine.

The study found that patients treated with Lyrica in addition to their baseline SSRI/SNRI therapy had a significantly greater improvement in overall anxiety symptoms as well as individual psychological and physical symptoms compared to baseline therapy alone as measured by the Hamilton Anxiety Scale (HAM-A), an interview scale that measures the severity of a patient’s anxiety. Over the eight week treatment period, patients receiving add-on Lyrica therapy had, on average, an anxiety score that was 1.2 points lower on the HAM-A compared to baseline therapy alone (P=0.012).

Significantly more patients receiving add-on Lyrica treatment (50 percent) showed at least a 50 percent reduction in their anxiety symptoms compared to SSRI/SNRI treatment alone (37 percent) (P=0.023). Lyrica was also shown to be well tolerated as an add-on therapy in this study.

About the Study

This study was a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of adjunctive Lyrica in 353 patients with a primary diagnosis of GAD. To be included in the study, patients had to have a HAM-A score greater or equal to 22, and to have not responded, or only minimally responded, to treatment with a SSRI, SNRI or benzodiazepine prior to the study.

These patients were then treated with a different SSRI/SNRI for eight weeks. At the end of the eight week open-label treatment period, patients who had shown only a partial response to treatment (as defined by a HAM-A score of greater than or equal to 16, less than 50 percent decrease in HAM-A score, and a Clinical Global Impression Improvement score of less than 3) were then randomized to an additional eight weeks of double-blind treatment with either Lyrica (150 to 600 mg/day) or placebo while continuing treatment with the existing background SSRI or SNRI therapy.

The primary endpoint was the mean change score on the Hamilton Anxiety Rating Scale. The SSRIs and SNRIs used in this study included escitalopram, paroxetine and venlafaxine XR.

The most common side effects in the study compared to other GAD treatments plus placebo were dizziness (11.7 percent vs. 5.7 percent), headache (9.4 percent vs. 4 percent), and somnolence (8.3 percent vs. 3.4 percent).

This study was sponsored by Pfizer, Inc.

About Lyrica

In the United States, Lyrica is approved for the management of fibromyalgia, painful diabetic peripheral neuropathy, postherpetic neuralgia (pain after shingles), and for the adjunctive treatment of partial onset seizures (a type of epilepsy) in adults. Lyrica is not approved for GAD in the U.S.

Outside of the United States, Lyrica is indicated in adults for the management of peripheral and central neuropathic pain, treatment of generalized anxiety disorder, and adjunctive therapy for partial seizures with or without secondary generalization.

Important Safety Information

Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse reactions include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally. There have been post-marketing reports of angioedema and hypersensitivity. Like other anti-epileptic drugs, Lyrica may cause suicidal thoughts or actions in a very small number of people.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

DISCLOSURE NOTICE: The information contained in this release is as of May 19, 2009. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about the use of Lyrica for GAD, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by the Food and Drug Administration (FDA) regarding whether and when to approve any supplemental drug application that may be filed for a GAD indication for Lyrica as well as the FDA’s decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.

(Contacts: Pfizer Inc Media: Sally Beatty, 212-733-6566
Permalink: http://www.businesswire.com/news/home/20090519006509/en)

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What Is Pain? What Causes Pain?

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

Courtesy of MedicalNewsToday.com

Written by Christian Nordqvist

The English word ‘pain’ probably comes from Old French (peine), Latin (poena – meaning punishment pain), or Ancient Greek (poine – a word more related to penalty), or a combination of all three.

In medicine pain relates to a sensation that hurts. If you feel pain it hurts, you feel discomfort, distress and perhaps agony, depending on the severity of it. Pain can be steady and constant, in which case it may be an ache. It might be a throbbing pain – a pulsating pain. The pain could have a pinching sensation, or a stabbing one.

Only the person who is experiencing the pain can describe it properly. Pain is a very individual experience.

Types of pain

Acute pain – this can be intense and short-lived, in which case we call it acute pain. Acute pain may be an indication of an injury. When the injury heals the pain usually goes away.

Chronic pain – this sensation lasts much longer than acute pain. Chronic pain can be mild or intense (severe).

How do we classify pain?

Pain can be nociceptive, non-nociveptive, somatic, visceral, neuropathic, or sympathetic. Look at the details below.

Pain

Nociceptive: Somatic – Visceral: Non-Nociceptive: Neuropathic – Sympathetic

Nociceptive Pain – specific pain receptors are stimulated. These receptors sense temperature (hot/cold), vibration, stretch, and chemicals released from damaged cells.

Somatic Pain – a type of nociceptive pain. Pain felt on the skin, muscle, joints, bones and ligaments is called somatic pain. The term musculo-skeletal pain means somatic pain. The pain receptors are sensitive to temperature (hot/cold), vibration, and stretch (in the muscles). They are also sensitive to inflammation, as would happen if you cut yourself, sprain something that causes tissue damage. Pain as a result of lack of oxygen, as in ischemic muscle cramps, are a type of nociceptive pain. Somatic pain is generally sharp and well localized – if you touch it or move the affected area the pain will worsen.

Visceral Pain – a type of nociceptive pain. It is felt in the internal organs and main body cavities. The cavities are divided into the thorax (lungs and heart), abdomen (bowels, spleen, liver and kidneys), and the pelvis (ovaries, bladder, and the womb). The pain receptors – nociceptors – sense inflammation, stretch and ischemia (oxygen starvation).

Visceral pain is more difficult to localize than somatic pain. The sensation is more likely to be a vague deep ache. Colicky and cramping sensations are generally types of visceral pain. Visceral pain commonly refers to some type of back pain – pelvic pain generally refers to the lower back, abdominal pain to the mid-back, and thoracic pain to the upper back (see below for the meaning of referred pain).

Nerve Pain or Neuropathic Pain

Nerve pain is also known as neuropathic pain. It is a type of non-nociceptive pain. It comes from within the nervous system itself. People often refer to it as pinched nerve, or trapped nerve. The pain can originate from the nerves between the tissues and the spinal cord (peripheral nervous system) and the nerves between the spinal cord and the brain (central nervous system, or CNS).

Neuropathic pain can be caused by nerve degeneration, as might be the case in a stroke, multiple-sclerosis, or oxygen starvation. It could be due to a trapped nerve, meaning there is pressure on the nerve. A torn or slipped disc will cause nerve inflammation, which will trigger neuropathic pain. Nerve infection, such as shingles, can also cause neuropathic pain.

Pain that comes from the nervous system is called non-nociceptive because there are no specific pain receptors. Nociceptive in this text means responding to pain. When a nerve is injured it becomes unstable and its signaling system becomes muddled and haphazard. The brain interprets these abnormal signals as pain. This randomness can also cause other sensations, such as numbness, pins and needles, tingling, and hypersensitivity to temperature, vibration and touch. The pain can sometimes be unpredictable because of this.

Sympathetic Pain

The sympathetic nervous system controls our blood flow to our skin and muscles, perspiration (sweating) by the skin, and how quickly the peripheral nervous system works.

Sympathetic pain occurs generally after a fracture or a soft tissue injury of the limbs. This pain is non-nociceptive – there are no specific pain receptors. As with neuropathic pain, the nerve is injured, becomes unstable and fires off random, chaotic, abnormal signals to the brain, which interprets them as pain.

Generally with this kind of pain the skin and the area around the injury become extremely sensitive. The pain often becomes so intense that the sufferer daren’t use the affected arm or leg. Lack of limb use after a time can cause other problems, such as muscle wasting, osteoporosis, and stiffness in the joints.

What is referred pain?

Also known as reflective pain. When pain is felt either next to, or at a distance from the origin of an injury it is called referred pain. For example, when a person has a heart attack, even though the affected area is the heart, the pain is sometimes felt around the shoulders, back and neck, rather than in the chest. We have known about referred pain for centuries, but we still do not know its origins and what causes it.

How do you measure pain?

It is virtually impossible to measure a person’s pain objectively. Most experts say that the best way to find out how much pain a person is enduring is by a subjective pain report. A comprehensive assessment of pain should include:

* The identification of all the pains.

* This must include the most important ones.

* The site, quality, and radiation of pain

* What factors aggravate and relieve the pain


* When the pain occurs throughout the day


* What impact the pain has on the person’s function


* What impact the pain has on the person’s mood


* The sufferers’ understanding of their pain

There are many different methods for measuring pain and its severity. Health care professionals say it is important to stick to whatever system or tool you chose for a specific patient all the way through. If a patient is unable to report his pain, such as an infant, or a person with dementia, there are a number of observational pain measures a doctor can use.

Here is a list of some pain measures used today:

* Numerical Rating Scales

* The patient is given a form which asks him to tick from 0 to 10 what his level of pain is. 0 is no pain, 5 is moderate pain, and 10 is the worst pain imaginable.

* Please rate the pain you have right now
0 2 3 4 5 6 7 8 9 10
No pain Moderate pain Worst pain imaginable

The Numerical Rating Scales are useful if you want to measure any changes in pain, as well as gauging the patient’s response to pain treatment. If the patient has dyslexia, autism, or is very elderly and has dementia this may not be the best tool (see the ones below).

Verbal Descriptor Scale

This type of scale exists in many different forms. The patient is asked questions and responds verbally choosing from such terms as mild, moderate, severe, no pain, mild pain, discomforting, distressing, horrible, and excruciating.

Elderly patients with cognitive impairment, very young children, and people who respond better to verbal stimuli tend to have better completion rates with this type of scale, compared to the written numerical scale. Children respond even better to the faces scale (description below).

Faces Scale

The patient sees a series of faces. The first one is calm and happy, the second less so, etc., and the final one has an expression of extreme pain. This scale is used mainly for children, but can also be used with elderly patients with cognitive impairment. Patients with autism may respond better to this type of approach – people with autism tend to respond to visual stimuli well.

Brief Pain Inventory

This is a much more comprehensive written questionnaire. Not only does it gauge current level of pain, but also records the peaks and troughs of pain during previous days, how pain has affected mood, activity, sleep patterns, and how the pain may have affected the patient’s interpersonal relationship. The questionnaire also has diagrams which the patient shades – the shaded parts being where the pain is located and where it is most severe.

McGill Pain Questionnaire

This questionnaire measures the intensity (severity) of the pain, the quality of the pain, mood, and understanding of the pain. It is also known as the McGill Pain Index. It is a scale of rating pain developed at McGill University by Melzack and Torgerson (1971).

Look at the 20 groups below.

Circle one word in each group that best describes your pain.
Circle only three words from Groups 1 to 10 that best describe your pain response.
Choose just two words in Groups 11 to 15 that best describe your pain.
Just pick the one in Group 16.
Finally, choose just one word from Groups 17-20.
You should now have seven words. Those seven words should be taken to your doctor. They will help describe both the quality and intensity of your pain

Group 1 – Flickering, Pulsing, Quivering, Throbbing, Beating, Pounding
Group 2 – Jumping, Flashing, Shooting
Group 3 – Pricking, Boring, Drilling, Stabbing
Group 4 – Sharp, Gritting, Lacerating
Group 5 – Pinching, Pressing, Gnawing, Cramping, Crushing
Group 6 – Tugging, Pulling, Wrenching
Group 7 – Hot, Burning, Scalding, Searing
Group 8 – Tingling, Itching, Smarting, Stinging
Group 9 – Dull, Sore, Hurting, Aching, Heavy
Group 10 – Tender, Taunt, Rasping, Splitting
Group 11 – Tiring, Exhausting
Group 12 – Sickening, Suffocating
Group 13 – Fearful, Frightful, Terrifying
Group 14 – Punishing, Grueling, Cruel, Vicious, Killing
Group 15 – Wretched, Binding
Group 16 – Annoying, Troublesome, Miserable, Intense, Unbearable
Group 17 – Spreading, Radiating, Penetrating, Piercing
Group 18 – Tight, Numb, Squeezing, Drawing, Tearing
Group 19 – Cool, Cold, Freezing
Group 20 – Nagging, Nauseating, Agonizing, Dreadful, Torturing

Measuring pain when the patient is cognitively impaired

In this case doctors say that the patient’s subjective pain report is the most effective and accurate way of evaluating pain. If the severely cognitively impaired patient is observed carefully it is possible to pick out clues as to the presence of pain, e.g. restlessness, crying, moaning, groaning, grimacing, resistance to care, reduced social interactions, increased wandering, not eating, and sleeping problems.
What are the treatments for pain?

An underlying disorder, if treated effectively, will also get rid of the pain, or at least reduce it. If you have an infection and take antibiotics, the antibiotics may get rid of that infection, resulting also in the elimination of pain. Even if an underlying problem can be treated, you may still need analgesics (pain relievers).

Analgesics are good at relieving nociceptive pain, but not neuropathic pain. Chronic pain – long-lasting pain – may need other non-drug treatments as well.

Opioid Analgesics

Opioid analgesics are also known as narcotics. These are the strongest painkillers and are commonly used after surgery, for cancer, broken bones, burns, and various other situations. Even though opioids are not commonly used to treat non-cancer pain, their usage for non-cancer pain is becoming more widespread and acceptable. Some patients do not respond well to opioids and should not take them.

The patient will be given opioids in gradually increasing dosages. The ideal dose is reached when the pain is relieved and the side-effects are tolerable (increase any higher and the side effects become too much for the patient). Dosages should be generally much lower for older patients and infants.

The patient is administered opioids every few hours – each dose coinciding with the moment just before the pain starts becoming severe. Some patients are given higher dosages if the pain becomes more intense, while others are given other medications alongside the opioid. Pain can become more intense if the patient needs to move about, or if a wound dressing needs to be changed.

The dosage goes down if the pain intensity drops, until if possible, the doctor switches to a non-opioid analgesic.

People with kidney failure, liver problems, COPD (chronic obstructive pulmonary disease, dementia, tend to have more side effects when given opioids. The most common opioid side effects are drowsiness, constipation, nausea, vomiting, and itching. Generally, the side effects lessen as after time. Taking too much opioid can be dangerous. Patients who take opioids for long period become physically dependent and will have withdrawal symptoms when treatment is stopped – it is important that their dosage is tapered off gradually.

Nonopioid Analgesics

Nonopioid analgesics are used generally for mild to moderate pain. They are not addictive and their pain-relieving effects do not dwindle over time.

NSAIDs (nonsteroidal anti-inflammatory drugs)

These may be obtained either OTC (over-the-counter) or as a prescription medication, it depends on the dosage. Low dosage NSAIDs are effective for headaches, muscle aches, fever, and minor pains. At a higher dose they help reduce joint inflammation. There are three main types of NSAIDs, and they all block prostaglandins – hormone-like substances that cause pain, inflammation, muscle cramps, and fever.



Traditional NSAIDs – the largest subset of NSAIDs. As is the case with most drugs, they do carry a risk of side-effects, such as stomach upset and gastrointestinal bleeding. The risk of side effects is significantly higher if the patient is over 60. At higher doses, they should only be taken when monitored by a doctor.




COX-2 inhibitors – these also reduce pain and inflammation. However, they are designed to have fewer stomach and gastrointestinal side-effects. In 22004/2005 Vioxx and Bextra were withdrawn from the market after major studies showed Vioxx carried increased cardiovascular risks, while Bextra triggered serious skin reactions. Some other COX-2 inhibitors are also being investigated for side-effects. The FDA told makers of NSAIDs to highlight warnings on their labels in a black box.




Salicylates – these include aspirin which continues to be a popular medication for many doctors and patients. If your plan to take aspirin more than just occasionally you should consult your doctor. Long term high dosage usage of aspirin carries with it a significant risk of serious undesirable side effects, such as kidney problems and gastrointestinal bleeding. For effective control of arthritis pain and inflammation frequent large doses are needed. Nonacetylated salicylate is designed to have fewer side effects than aspirin. Some doctors may prescribe nonacetylated salicylate if they feel aspirin is too risky for their patient. Nonacetylated salicylate does not have the chemical aspirin has which protects against cardiovascular disease. Some doctors prescribe low dose aspirin along with nonacetylated salicylate for patients who they feel need cardiovascular protection.

View drug information on
Bextra – http://www.medilexicon.com/drugs/bextra.php
Vioxx – http://www.medilexicon.com/drugs/vioxx.php

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

(http://www.medicalnewstoday.com/articles/145750.php)

FDA Requires Additional Labelling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

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

Courtesy FDA US Food and Drugs Administration – For Immediate Release

The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labelling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research.

“However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labelling do not address all of the labelling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of April 28 2009.

Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

Source: FDA
OTC Pain Relievers – Acetaminophen: Tylenol & other Brands
NSAIDS – Aspirin: Bayer & other brands, Ibuprofen: Advil, Motrin & other brands. Naproxen: Aleve & other brands.

To read the final rule on the relabeling of OTC pain relievers and fever reducers, go to

http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf

To read the FR Notice announcing the FDA Advisory Committee meeting, see link below:

http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9380.pdf

Consumer Inquiries: 888-INFO-FDA

(http://www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html)

MPs CALL FOR FIBROMYALGIA EDUCATION FOR DOCTORS IN FIRST EVER FMS DEBATE IN UK PARLIAMENT

From the FMS Global News Desk (UK)

Courtesy/Source Hansard

by Jeanne Hambleton Copyright 2009

FIBROMYALGIA THE CINDERELLA CONDITION

Fibromyalgia made history on May 5 with a first time debate on the condition in the House of Commons Westminster Hall, prior to International Fibromyalgia Awareness Day (May 12).

Rob Wilson MP, chairman of the all party parliamentary group on fibromyalgia, called on the Parliamentary Under-Secretary of State for Health, Ann Keen MP, to assist fibromyalgia sufferers by providing better education for doctors enhancing their knowledge about fibromyalgia. He urged the Department of Health to consider a nationwide awareness campaign to highlight fibromyalgia syndrome, the importance of fast diagnosis and the provision of treatment?

“Do the millions of people who suffer with this illness not deserve at least that from their NHS. It is unsatisfactory that many GPs are not confident or able to diagnose the illness in a timely fashion,” he said.

Stressing education about fibromyalgia is urgently needed and that the Government, through the NHS, could be the catalyst, Rob Wilson suggested the condition is a significant drag on the economy. There were also calls for an improvement and wider access to pain management, and it was felt that there was clearly no focus on the illness in the Department of Health.

Norman Lamb MP described fibromyalgia as something of a Cinderella condition. It is widely misunderstood and there is a great deal of ignorance about it, which has a significant impact on those who suffer from it. He called for the Department for Work and Pensions to address the condition and take it more seriously.

It was reported by Rob Wilson that there were 2.7 million people in the UK suffering with a very common illness – fibromyalgia. It is in fact as common as rheumatoid arthritis and can be even more painful he said.

He said a survey of five European countries had shown that fibromyalgia affects between 2 per cent and 4.5 per cent of the population, or at least one in 50 people, from children to the very elderly. Fibromyalgia had been shown to have more impact on patients’ lives than many other forms of widespread pain and chronic illness.

“I believe that the sheer scale of the illness and the suffering that results from it mean that it is high time fibromyalgia was taken seriously as an issue,” he added.

Rob Wilson made reference to constituent Jean Turner who has been without a diagnosis for years. “I am sure that we would all agree that the 13 years taken to reach a diagnosis in Jean’s case was far too long,” he added.

He suggested that all Jean and other sufferers would ask is to be believed when they say that they are in pain and are not hypochondriacs. Sufferers want support to be available from the NHS. They want guidelines finally to be produced by NICE, and they want GPs to be trained properly in diagnosing the condition.

Describing fibromyalgia as a very common illness Rob Wilson suggested fibromyalgia is in fact as common as rheumatoid arthritis and can be even more painful. A staggering number of people in the UK who suffer from fibromyalgia may not hold down a paying job or enjoy a social life.

Although the cause of fibromyalgia has yet to be found, he suggested the disease often develops after some sort of trauma that seems to act as a trigger, such as a fall or car accident, a viral infection, childbirth, an operation, a huge emotional event or without any obvious trigger. Research had identified a deficiency in serotonin in the central nervous system, with a resulting imbalance of substance P, a spinal fluid that transmits pain signals. The effect of that is disordered sensory processing. The brain registers pain when others might experience a slight ache or stiffness.

“We can only hope that research will discover the cause and result in more effective treatment in the years to come,” he added.

Discussing diagnosis Rob Wilson suggested it is difficult to identify the illness by standard laboratory tests or X-rays. Blood tests and scans will return a negative result and a patient will not necessarily look ill. Many of the symptoms are also found in chronic fatigue syndrome, rheumatoid arthritis and osteoporosis. It is not surprising that fibromyalgia has been dubbed ‘the invisible illness’.

“The problem comes when doctors do not have the experience or expertise to make a diagnosis. Nearly half of all specialists reported fibromyalgia as being ‘very or somewhat’ difficult to diagnose,” said the MP. “The average time taken for diagnosis is more than two years, and patients report seeing between two and four physicians before a diagnosis is reached. That lengthy period can be very worrying, frustrating and upsetting for patients.

“Despite the fact that several specialist fibromyalgia syndrome clinics are provided by NHS consultants around the UK, most of those do not appear in their own right on the NHS choose and book system. Even those GPs who know about the condition—and there are too few of those—who are looking for specialist help within the NHS cannot always refer patients directly to consultants with an interest in and knowledge of fibromyalgia. One of the immediate actions that the Minister could take today is to rectify the situation. Those clinics could be added to the ‘choose and book’ system, and the NHS could build and provide an extensive list of accepted specialist NHS services around the country.”

Currently fibromyalgia treatment reduces pain and improves sleep. Treatment focuses on the symptoms not the condition. The best that a doctor can do is give guidance on ways of coping with and treating some of the symptoms.

“I hope that it does not appear that I am criticising GPs, specialists or the NHS in general. That is not my purpose, as I believe that they do fantastic work under immense pressure; however, a major problem is that GPs get little or no training on the condition, and even consultant rheumatologists, who would usually diagnose fibromyalgia, often have little or no specific training. Professional development is currently hampered by out-of-date medical tests containing erroneous information. Much of the fibromyalgia information that is used by the NHS is provided by voluntary organisations such as the Fibromyalgia Association,” said Rob Wilson.

He pointed out that the NHS Direct online information had been brought up to date on fibromyalgia in 2008 by FibroAction, a charity supporting the syndrome.

Rob Wilson insisted, “It is clear that things need to change. Getting an accurate diagnosis is difficult, and about half of our GPs admit that the condition is often misdiagnosed. They highlight a lack of confidence in their ability to recognise the symptoms of fibromyalgia, or to differentiate the condition from others with similar symptoms. The problem does not rest with GPs alone. It is widespread in the medical profession. Education on the condition is urgently needed; the Government, through the NHS, could be the catalyst.”

Philip Hollobone MP said the NHS needs to provide as much help and support for GPs as possible. If it is difficult for specialists to identify the condition, it must be near to impossible for GPs.

Rob Wilson continued, “I also know that the Minister’s heart is in the right place, and that she is anxious for the NHS to help.”

He pointed out recent parliamentary questions from Members throughout the House have had a less than encouraging response. In June 2008, the Member for Twickenham (Dr. Cable) asked what plans the Department of Health had to improve treatment for people with fibromyalgia. The answer came, “There are no specific plans to improve the treatment for those living with fibromyalgia.”—[Official Report, 30 June 2008; Vol. 478, c. 655W.]

Another Member asked how many people were diagnosed in his constituency, the region and nationwide since 1997. The answer was: “Information on the number of people diagnosed with fibromyalgia is not collected.”—[Official Report, 21 November 2007; Vol. 467, c. 998W.]

He said, “Among other things, I asked the Minister what steps were being taken to raise awareness of fibromyalgia, and what progress there was on diagnosis and treatment. The response was: ‘We have made no assessment of the progress being made by the National Health Service into improving the diagnosis and treatment of fibromyalgia. We have taken no recent steps to raise the awareness of fibromyalgia among the general public and health professionals.’ ”—[Official Report, 9 October 2007; Vol. 464, c. 516W.]

Suggesting there is a discernible pattern Rob Wilson said there is clearly no focus on the illness in the Department, and no focus on it in the NHS, yet the condition acts as a significant drag on the economy. In 2006, through a parliamentary question, Rob Wilson discovered that 8,400 people who were claiming incapacity benefit or severe disablement had been given a primary diagnosis of fibromyalgia.

“We know that that is the tip of an iceberg, as most fibromyalgia sufferers on benefits will have been diagnosed with something else. The economic cost of the failure to diagnose the problem swiftly does not affect only the Department for Work and Pensions; the cost to the NHS and local authorities, too, will be huge. Better awareness and education of health professionals would considerably reduce that financial burden,” said Rob Wilson.

MPs paid tribute to the work of all local supports groups including Kettering Nene Valley support group.

Rob Wilson recognised the ongoing work of many groups that work tirelessly for the sufferers of the condition, and do their best to raise its profile but the message regularly comes back that there is a problem in raising the profile. Raising the profile of the condition is difficult without the support of the relevant authorities.

He spoke about an application made almost two years ago to National Institute for Health and Clinical Excellence (NICE). The aim was to establish clear guidelines on fibromyalgia.

“In May 2008, FMA UK had still not received a response, and asked me to intervene. Despite my intervention, still no response was received. Suddenly, and incredibly coincidentally, in the last couple days—since today’s debate was arranged—FMA UK has finally been contacted by NICE. FMA UK was informed that its application had been unsuccessful,” reported Rob Wilson.

“The fact that FMA UK has received an answer does not excuse the arrogance or incompetence—or both—that NICE has shown until now. Frankly, it is insulting and deeply frustrating for those who work tirelessly to raise the profile of the condition to have to wait for a debate such as today’s before the relevant authorities take them seriously. A delay of two years is not good enough,” he said.

It is imperative that a clear medical framework is set out for GPs. It is more than long overdue. Although he urged NICE to consider the matter again he requested the Minister to give fibromyalgia sufferers some hope by confirming that she will intervene, asking NICE to ensure a clear set of guidelines for the diagnosis and treatment of the illness are approved?

On this he added, “It is not acceptable that NICE has only just acknowledged FMA UK’s application to provide a clear and unequivocal set of guidelines for GPs. Those guidelines could be used in the training of the medical profession and could reduce the stressful experience currently associated with diagnosis”.

It was suggested that many fibromyalgia sufferers look to the Department of Health for leadership and support. They were gratified that the chief medical officer, Sir Liam Donaldson, recognised the impact of fibromyalgia and its prevalence in the UK as a cause of chronic pain in his annual report of 2008.

Sir Liam’s annual report, published in March 2009, had said: “Chronic pain reduces the quality of life more than almost any other condition. The impact of pain on people’s lives is significant, bringing emotional and financial burdens to patients and loved ones. A major initiative to widen access to pain services is badly needed.” He stated that FM sufferers require information, and access to NHS tailored services.

Tribute was paid to Professor John Davies at Guys Hospital, the Russells Hall Hospital in Dudley, good multi-disciplinary teams at the Royal Bolton and Poole hospitals, and an eight-week course for fibromyalgia patients that is being run by southwest Essex community services in conjunction with Basildon University Hospital. Rob Wilson made reference to Lindsey Middlemass, the chair and founder of FibroAction and referred to her long struggle for a diagnosis and her work with NHS Direct and new guidelines.

In February 2005, Dr. Ernest Choy and Dr. Serena Carville, from King’s College London, produced a nine-point recommendation for the management and treatment of fibromyalgia. It is a credible report and is worth mentioning for that reason. Choy and Carville concluded that a full understanding of fibromyalgia requires an assessment of pain, function and the psychological impact on patients.

They also believe that individually tailored exercise programmes, including aerobic exercise and strength training, can be very beneficial, as well as other therapies, such as relaxation and physiotherapy. Relaxation works very well for almost everyone affected by this condition. It reduces tension in the mind and body and calms the symptoms, especially the pain. Choy and Carville concluded that, ultimately, medical professionals need to be able to listen to, and believe in, an individual’s experience of pain. Only then can a programme of treatment be established to reassure them and reduce stress and anxiety.

Asking the Minister to help those with fibromyalgia Rob Wilson suggested, “It is clear that we need to work towards providing greater education for general practitioners. It is unsatisfactory that many GPs are not confident or able to diagnose the illness in a timely fashion. Timely diagnosis is key to helping people with this condition. Secondly, it is not acceptable that NICE has only just acknowledged FMA UK’s application to provide a clear and unequivocal set of guidelines for GPs. Those guidelines could be used in the training of the medical profession and could reduce the stressful experience currently associated with diagnosis.

Martin Horwood MP said he was taken aback by some of the statistics that Rob Wilson gave, which were new to him. He felt there is the risk—this was the experience with drugs for dementia and other illnesses—that NICE will use the lack of a good evidence base as a reason for refusing to recommend treatment. Is that a risk, given some of the issues that mentioned, about credibility, belief and so on?

“We are looking not for advice on drugs, but for a set of guidelines so that people can be diagnosed quickly and GPs can properly understand their functions in this regard,” Rob Wilson said.

Effective treatment needs to be available throughout the country, but that should be signposted by the NHS, rather than third-party organisations. The profile of fibromyalgia desperately needs to be raised.

“As I mentioned before, despite its dedication, the voluntary sector can only do so much. We all have a part to play in raising awareness, but help from the Government is much needed. As we have seen, fibromyalgia is a complex condition with numerous contributing factors, and although research has advanced our understanding, it is clear that much work remains to be done.

“I know that the Minister has many pressures on her time and that there are also many pressures on the resources of the NHS. However, I know that she understands the chronic pain and suffering affecting millions of people throughout the UK and that she will do her utmost to provide assistance. I hope that today’s debate will help to raise the profile of this ‘invisible’ illness. That is the very least that I can do to help to support the many campaigners who have done their best to raise its profile,” added Rob Wilson.

Roger Williams MP said part of the problem for sufferers is that the condition takes so long to be recognised by the health services that they often come to believe that they are in some way responsible or guilty.

“They exhibit symptoms but are without the support necessary to bring some relief….. we have very little idea of what causes the condition—whether it is the genetic make-up of the individuals or an environmental aspect that they have experienced. Evidence is now being gathered relating the absence of serotonin to the symptoms of the disease. If that can be established, a much more profound and substantial method of treatment could be achieved. I have seen evidence that meeting other sufferers to discuss their experiences, symptoms and treatment can give individuals great confidence that there is a possibility that something can be achieved to alleviate their symptoms.

“The Minister would do well to take on board the comments made by the hon. Member for Reading, East and do what she can to ensure that the condition is recognised, that GPs diagnose it earlier than in the past and that provision is made for help through pain relief and encouraging good sleeping patterns, which make such a difference to the sufferers. I ask the Minister to take on board all those concerns,” said Roger Williams.

Norman Lamb suggested this was one of those occasions when all the parties can come together to make the case for improving awareness of fibromyalgia both among the public and the medical profession—particularly in primary care.

Fibromyalgia is something of a Cinderella condition. It is widely misunderstood and there is a great deal of ignorance about it, which has a significant impact on those who suffer from it. It is right to acknowledge fibromyalgia awareness day, which is on 12 May. It is a moment to concentrate minds and to focus the attention of the Department of Health, the National Health Service and NICE on a more effective approach to tackling the condition.

He said, “Sufferers often have a sense that no one believes them, especially when they have to apply for benefits because they cannot keep their employment. They feel that no one believes that the condition is disabling, so they are left utterly alone. It is a chronic condition, and one that applies particularly to women. Its impact on relationships, social lives and the capacity to work is substantial. It is often the case that conditions such as fibromyalgia, myalgic encephalomyelitis and chronic fatigue syndrome have a greater impact on people’s lives and their capacity to function as human beings, than many conditions that attract much greater attention in public discourse and in Parliament. It was a breakthrough when the Chief Medical Officer acknowledged the significance of the condition and made a clear plea for action to be taken…… a major initiative to widen access to pain services is badly needed.”

Norman Lamb continued, “It is hard to convince GPs and others that the problem is genuine. A newspaper article quoted Julia Fitzgerald, who, after eventually securing a diagnosis, was offered antidepressants. That was the medical profession’s response to her condition. Moreover, the fact that it takes between two and four clinicians to secure a diagnosis is simply unacceptable….. the priority must be to improve the training of GPs and other members of the medical profession, to ensure that when a patient presents with the condition they receive greater understanding. It is not good enough just to look at the training of new doctors coming through the system. We need to focus on continuing professional development for those who are already in post and who are all too often failing to give their patients an adequate or accurate diagnosis….. one cannot escape from the sense that the Department of Health has a lack of interest in the issue, so this is a good occasion for the Minister to reassure us that that is not the case.”

Following talk about getting the referral from primary care to a specialist centre right, Norman Lamb said the problem is not unique to fibromyalgia. Persuading the NHS to make the right referral can be a real challenge. Changing or adapting the ‘choose and book’ system to ensure that when any clinician across the country is faced with a patient with such a condition—or has the potential to suffer from it – they can point the patient to the right specialist centre wherever they live would be an enormous advance.

Returning to the role of NICE he said, “It is scandalous that it has managed to ignore for two years a clear request for guidance on the treatment of fibromyalgia. We hear that the application was unsuccessful. I now ask the Minister to engage with NICE?”

Ann Keen, (Parliamentary Under-Secretary (Health Services), Department of Health, replied that NICE was an independent body and Members had accepted the importance of that independence.

Norman Lamb accepted the absolute importance of the independence of NICE, but asked the Minister if she was able to request that it investigate a particular condition and consider providing guidance?

Ann Keen said the importance of NICE’s independence makes things difficult. But she was confident that the debate will assist in other ways.

Norman Lamb insisted a request would not challenge NICE’s independence—it is not an order. He asked would the Minister request NICE to investigate the possibility of preparing guidance on the treatment of fibromyalgia? That would be a very valuable step for her to take.

Bob Spink MP suggested NICE will be aware of political indifference in the House and prejudice in the NHS against what is a debilitating condition. Consequently, the Benefits Agency does not take the issue as seriously as it might, which disadvantages people with real, debilitating conditions who deserve better.

Norman Lamb recommended NICE could take from the debate a clear message that MPs want it to take the condition seriously and to come up with clear recommendations for its treatment. It was right to identify the importance of the Department for Work and Pensions taking the condition more seriously. There can be nothing worse for a person who is unable to work because they suffer from a debilitating condition than benefits officers not to accept or believe that the condition is serious. That has to be addressed.

He pointed out that pain management services are not part of the 18-weeks target and many people in the country are left waiting a scandalously long time for access to them. Given how debilitating the condition is, it is important that access to pain management is improved.

He quoted Sir Liam Donaldson’s recent annual report, “Chronic pain reduces the quality of life more than almost any other condition. The impact of pain on people’s lives is significant, bringing emotional and financial burdens to patients and their loved ones.”

Pointing out the impact of the condition on whole families Sir Liam had said, “A major initiative to widen access to pain services is badly needed.”

Norman Lamb suggested the Minister could provide enormous reassurance to those who suffer from the condition if she announced the clear initiative for which Sir Liam Donaldson has called.

Anne Milton MP Shadow Minister, Health, paid tribute to the FMA UK website and the variety information adding she was extremely impressed. She said the website also raised the difficulties of diagnosing and treating children, and the problem of education.

“The economic cost in terms of benefits is just one of the problems. I put together a flow chart of how someone with fibromyalgia might feel. It starts with pain—people do not know the origin of the pain—and goes on to reduced mobility and social isolation. The lack of diagnosis causes depression; people lose their employment and families break down. Both lead to reduced income. Furthermore, the impact on family, carers and friends is immense. Fibromyalgia and other undiagnosed chronic conditions take a significant toll on the spouses and children of the people who have them. In an ideal world, we would have increased awareness, early diagnosis and intervention, treatment, support and rehabilitation. That applies to fibromyalgia and many other chronic conditions,” she said.

The debate had done much to highlight the problems faced by fibromyalgia sufferers. The belated response from NICE, to which many Members referred, was not the answer they wanted, but it demonstrates that these debates are useful. They raise awareness and get the Minister’s attention – she has a significant brief.

“Sometimes, particularly at the moment, the House gets something of a knocking from the press and the public, but opportunities such as this debate are extremely important. They demonstrate that we can make a difference,” said Anne Milton.

She continued, “I hope that the Minister will confirm and re-establish that the Government take the condition seriously. Specifically, what steps is she taking to ensure that the training of doctors in particular includes a greater awareness of the significance of the signs and symptoms with which patients might present?

“As medical care and treatment become increasingly specialised, it is important that the Government take steps to ensure that GPs receive continuing professional education so that they can be confident in recognising and accessing treatment for such conditions. It involves not only GPs but all health care workers. The issue could also, in some instances, be addressed in schools. There has never been a greater need for awareness of the implications of signs and symptoms in the minds of the public sector workers who work with and meet the people affected.

“What specific plans does the Minister have for improving the treatment of fibromyalgia and access to secondary referral? I am sure that she will take steps to address that. Raising the profile and awareness of fibromyalgia among the groups that I mentioned is vital. Will she give the matter personal attention and demonstrate that the Government is aware that people with the syndrome are not getting the attention that they deserve, and will she take steps to ensure that attitudes from the Department of Health downwards change so that people get the care that they deserve and need?

“This is also a useful opportunity for the Minister to clarify the position of NICE. As she said, NICE is independent, which is extremely important. However, as I understand it, it works within a framework put together by the Government. Although we broadly welcome NICE’s independence and much of the work that it does, there are situations in which access to treatment regimes is not being made available by NICE. Response is slow. I am sure that she will take this opportunity to clarify those issues and demonstrate that she can do something to improve the lot of people with fibromyalgia,” said Anne Milton.

Ann Keen acknowledge that fibromyalgia had not discussed in the House before. She said she knew Rob Wilson had worked extremely hard to champion the cause of people living with fibromyalgia, not least as chair of the all-party parliamentary group on the condition.

“I am grateful to him for giving us the opportunity to debate it today. Every one of us wants the best for those suffering from that chronic, distressing, uncomfortable and painful condition,” said the Minister.

“I recognise how distressing fibromyalgia can be to those living with the condition and to their families, and I know that much of that distress is caused by difficulties recognising, acknowledging and accepting the condition and its impact. Like other chronic conditions, fibromyalgia can significantly affect physical and emotional well-being and disrupt work, social and family life.

“What can we do to raise the profile of fibromyalgia? I believe that this is the start of an important dialogue, particularly with the all-party group. I think that Members, particularly Front Benchers, recognise that setting NHS must-dos is not easy, as such things affect every one of us and every part of our bodies. The Department of Health must be sparing in setting those priorities centrally because of the criticism that we often receive when we attempt to do so. I know that everyone in this Chamber is here in good heart, but it is important to put it on the record that if we were to keep giving the NHS priorities, my list, let alone those of the rest of the ministerial team, would be long.

“The Department has set up the National Quality Board to advise Ministers what priorities the National Institute for Health and Clinical Excellence should adopt in setting NHS standards, as well as which conditions require the Department’s closer attention. The priorities are likely to be based on an objective assessment of the burden of disease and an analysis of the gap between the quality of existing services and best current practice. That is something that we can work with.

“Like other chronic conditions, fibromyalgia can significantly affect physical and emotional well-being, which in turn affects the social and financial economy of the family, the community and the country. Sadly, there is no cure, so treatment aims to ease symptoms as much as possible and improve patients’ quality of life. However, we all know that care for people with fibromyalgia varies widely, as has been demonstrated by Members today, particularly those representing rural areas. In the worst cases, people with the condition are left feeling that the health care system does not recognise their illness. I can understand why patients would feel that way. I acknowledge the points made today. The case has been made that better services, quicker diagnosis and better understanding can make a major difference to the quality of life of people with fibromyalgia. I want to respond as positively as I can to the issues raised.

“Let me be clear that we want to ensure that people with the condition live as well as possible. Their quality of life is important to all health professionals, particularly Ministers with responsibility for health. I pay tribute to the hard work and dedication of the voluntary sector in helping people with fibromyalgia, especially FibroAction and the Fibromyalgia Association UK. It is important to raise awareness among the medical profession and the public at large, and such organisations have been at the forefront of improving knowledge of this distressing condition.

“As a health professional, I know that it is unnerving to be faced with a patient who knows more about their condition than I do, but in these days of technology, the Internet provides access to wider knowledge and patients feel that they have more autonomy. To receive no response is thus even more frustrating. I totally acknowledge what has been said today, and I am confident that there are people present here who could enlighten us even further.

“There is comprehensive information on the care of people with fibromyalgia specifically for health professionals on NHS Evidence, which is the new web-based portal that provides all health and social care professionals with authoritative clinical and non-clinical evidence and best practice. It provides access to a range of information, including primary research literature, practical implementation tools, guidelines and policy documents,” she said.

The Minister continued, “The NHS Choices website provides information to help put patients in control of their health care. It contains a number of sections that deal with fibromyalgia. There is detailed information on diagnosis, treatment and on living with the condition. NHS Choices has launched a free training programme for health professionals to improve their understanding of all the features available on NHS Choices, including how to direct patients to local services and how to access NHS accredited information about healthy living and conditions.”

Norman Lamb asked the Minister if she would will she speak about ‘choose and book’? Patients can now make choices about where they go and doctors can advise them on what might be best. Will she explore whether the system can guide clinicians to the right specialist services, wherever they are in the country?

Ann Keen admitted this was a valid point. She said she believes that best practice happens in certain areas. As with any new initiative, some places take the reins quicker and more effectively than others.

“We are working towards that being addressed. Hon. Members have mentioned awareness of the condition among GPs and other health professionals. I am sure that all hon. Members are aware that the Department does not specify the content of training curricula. That is done by the royal colleges and is determined by regulatory requirements and the needs of the service. Nevertheless, we expect all health care staff to learn and to get the training and skills that they need to deal with all their patients. Obviously that includes those with fibromyalgia.”

Rob Wilson thanking the Minister for her replies so far said, “I am interested by the NHS Evidence web portal. I believe that it is for health professionals. Is it possible for members of the public or parliamentarians to look at what it advises general practitioners to do so that we have a clear view of the situation?”

Ann Keen said NHS Choices and NHS Evidence are certainly becoming more transparent and open.

“Although we cannot direct the curriculum, we expect all health care staff to get the training and skills that they need. Education and training for health care staff is, and always has been, a priority for the Department of Health. However, we accept that there is room for improvement. As will be obvious from Lord Darzi’s review of the NHS, we are looking at the content of curricula for undergraduate and postgraduate training in health and social care. That is important because of how long-term conditions will be treated in the community in future, as the hon. Member for Guildford (Anne Milton) said. We are looking at this matter, but we cannot dictate it.”

Anne Milton said she appreciated that the Government do not dictate the curricula, and asked, “Does the Minister not accept that there are issues, not only with fibromyalgia, but with many chronic conditions? There is an issue with GPs getting time off to do adequate training. Some GPs need training, but do not volunteer for it. There are issues for other health care staff and for nurses in particular. There can be problems with the ring-fencing of training budgets and with their use to cover shortfalls elsewhere. I am worried that we will slip backwards on training issues because NHS finances are quite tight. That would be a false economy. Money for continuing professional development is vital.”

Ann Keen replied, “That point was well made and it is well taken. The safety and quality that are required in the NHS cannot be provided, nor the professionalism of the health care team maintained, without the knowledge that is required. I am confident that it will be accepted that nurses are at the centre of that team and that they direct it.

“The transparency that we have asked for replaces ring-fencing and is much better than it. We will be able to see where the money is spent and whether education and training are given priority. The settlement for the NHS has been made up to 2010-11. We have always said that investment in education and training is paramount in everything we do, particularly at this difficult time. I should ask the Conservatives whether that investment will continue during the recession under their pledges on NHS funding. Some health professionals are not aware of conditions that may present at their practices in the way that they could and should be. We must correct that situation,” the Minister said.

Norman Lamb said he was grateful for the Minister’s generosity in continuing to give way and he understood that NHS Evidence was a new portal that was developed primarily by NICE. Given that NICE has been fairly unhelpful in its willingness to provide guidance on this condition, he asked if the Minister knew what NHS Evidence says about the treatment of this condition or what advice it gives to GPs? Should that be investigated to ensure that NHS Evidence is giving helpful guidance, he said?

Ann Keen replied that Lord Darzi’s review of the NHS will look at the content of the curricula for undergraduate and postgraduate training in health and social care. Fibromyalgia diagnosis and care will benefit from that work. She hoped that gave reassurance to Members and to sufferers.

“The hon. Member for Reading, East (Rob Wilson) will be aware that in 2003 the Chief Medical Officer issued a newsletter to all doctors in England to raise awareness of the condition and the extent to which it affects the population. We can send out such directives, but it is difficult to monitor how they are received. However, we know that it was well received by patients and health professionals. I have asked officials to look into the feasibility of reporting that exercise. We want to look at what has happened with that exercise since 2003, and to report back, and we are able to repeat that exercise easily, especially given what the Chief Medical Officer has said about pain, which has been acknowledged on both sides of the House today.

“Guidance has been mentioned, particularly the use of NICE guidance in securing improvements and reducing variations in the quality of care. As the hon. Gentleman and others have said, the Fibromyalgia Association UK has asked NICE, as part of its topic selection process, to consider developing clinical guidance on the diagnosis and management of fibromyalgia. Hon. Members have acknowledged the importance of NICE’s independence, but I have also been asked other questions. Both FMA UK and the hon. Gentleman have expressed concern at the slow progress in receiving a response from NICE, and I can confirm that the association has now been informed of the outcome of this topic. I have been asked whether I can intervene. Anyone can write to NICE with a request, but after matters are considered by the panel of experts, they are passed to Ministers for approval, so it is difficult for Ministers to intervene at the beginning of the process.

“In 2006, we launched the musculoskeletal services framework, which sets out guidance to provide high-quality and integrated services for people with musculoskeletal conditions, including fibromyalgia. The framework will help to improve the assessment and diagnosis of, and treatment for, fibromyalgia and other musculoskeletal conditions. It will encourage the giving of more support to help people to manage their own conditions, and it will get across better information and advice. It will also provide a clearer focus on the needs of children and families. The framework also supports an 18-week target for the time from referrals from GPs to the start of hospital treatment.

“Pain is a common, distressing and often disabling symptom in many musculoskeletal conditions, including fibromyalgia. The Department of Health has already supported the work of the NHS on the management of chronic pain through a number of important initiatives, including the musculoskeletal services framework, the 18-week commissioning pathway for the management and treatment of chronic pain, and the NHS Choices website. I must correct the hon. Member for North Norfolk (Norman Lamb) on one point: the development of the 18-week commissioning pathway for pain, in particular, assists commissioners in delivering the appropriate services for their populations. The pathway for chronic pain, which was developed with leading pain clinicians and with the consensus of a wide range of key stakeholders, will help to transform services with examples of good practice. It recommends the use of the brief pain inventory to assess the level and impact of pain, which is an important tool in assessing the patient,” the Minister added.

“I worked for many years as a community and district nurse, and I observed at first hand, when I told patients that their test results had come back negative, the guilt that they experienced for feeling pain when their test was negative. My practice, at all times, was to accept that the patient had the pain that they said they had. Those are the only criteria on which health professionals should operate. These issues are so mixed, especially when psychological aspects are taken into consideration. The fact that some patients are prescribed antidepressants, rather than analgesia, as has been mentioned, shows the need for pain to be managed differently, and I commend the Chief Medical Officer for his statement.

“I recently responded to an Adjournment debate in the main Chamber that had been secured by the chair of the all-party group on chronic pain, my hon. Friend the Member for Aberdeen, South (Miss Begg). I certainly think that the two all-party groups should talk together. On that evening, the chair was supported by the Chronic Pain Policy Coalition, and I met them at the end of the debate to say how important work on pain is. It should not be something that one puts up with; there is a limit. Pain is subjective, and it is important to have the correct measuring tools. I remember that one of the most distressing parts of my work as a practising nurse was to leave someone in pain without having an answer for them—that is no longer acceptable.

“Officials are currently scoping regional events to support the voluntary sector in influencing commissioners to provide better pain services locally, and to engage with professional bodies to raise awareness about chronic pain and about the needs of patients with chronic pain. The development and content of those events is being taken forward with the third sector, and I will ask officials to ensure that fibromyalgia groups are involved in that process. Once again, I thank the hon. Member for Reading, East for bringing this important issue to the attention of the House, and particularly for the manner in which he has done so.”

EDITOR’S NOTE: My apologies for the length of this report but it is almost a full transcript of the 75 minutes debate actioned by the chairman of the All Party Parliamentary Group (APPG) for Fibromyalgia, MP Rob Wilson. Said to be the first ever fibromyalgia debate in Parliament (Westminster Hall) this was a historic event which is why I have run the story at length.

I am sure you will recognise many things that have been said and it is good that the national organisation, FMA UK, has been acknowledged. Personally I feel without ‘gentle persuasion’ by Jean Turner, FMA UK Trustee, and Rob’s constituent, this might not have happened. Well done Jean T. You did a grand job. All we want now is some results.

It appeared to me that on the whole the Minister, as a health professional, had every sympathy with the requests for change and support for FMS. However I could not help but feel her hands were tied. For this reason we must keep up the pressure – raising awareness this week for May 12 International Fibromyalgia Awareness Day, and reminding our MPs who missed this debate even though you asked them to attend. This IS much work still to be done.

If you would like to see the 75 minute video, get a stiff drink, sit comfortably and log on to http://www.fibromyalgia-associationuk.org/content/view/385/1/

It would be good to hear your views about the debate? Email me at
jeannehambleton(@)mac.com. Please omit the brackets – I am fighting the cyberspace robots.

My thanks to Hansard and TheyWorkForYou.com as the sources for this helpful information.

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FDA MedWatch – Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B): Boxed Warning required

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

Courtesy of FDA/Center for Drug Evaluation and Research

FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.

FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication.

UPDATE
Follow-up to the February 8, 2008, Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)

This information reflects FDA’s current analysis of available data concerning these drugs.

As the result of an ongoing safety review, FDA has notified the manufacturers of licensed botulinum toxin products of the need to strengthen warnings in product labeling, and add a boxed warning, regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.

FDA also has notified the manufacturers that development and implementation of a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the product outweigh the risks. The REMS would include a Communication Plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers.

In addition, FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

Botulinum toxin products have been approved by FDA for one or more of the following uses: temporary improvement in the appearance of glabellar lines (frown lines between the eyebrows), treatment of strabismus (crossed eyes), blepharospasm (abnormal tics and twitches of the eyelids), cervical dystonia (involuntary sustained or repetitive contraction of the neck muscles), and primary axillary hyperhidrosis (severe underarm sweating). For these uses, botulinum toxin is injected into the skin or into muscle tissue.

Postmarketing Review

The following information summarizes FDA’s review of postmarketing safety data obtained from the manufacturers of botulinum toxin products, and all existing data within the Agency regarding these adverse events:

In pediatric postmarketing adverse event case reports, botulinum toxin products were mostly used to treat muscle spasticity in cerebral palsy, a use that has not been approved by the FDA. The reported cases of spread of botulinum toxin effect beyond the site of injection were described as botulism, or involved symptoms including difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression. Serious case reports described hospitalizations involving ventilatory support and reports of death.

The majority of the adult postmarketing case reports of distant spread of toxin effects occurred following use of botulinum toxin for the treatment of spasticity (an unapproved use) or cervical dystonia. Some cases resulted in hospitalization, including several cases that required placement of a gastric tube or mechanical ventilation. Although there were several deaths in adults, it is not possible to attribute them to the botulinum toxin because the patients also suffered from complications of their pre-existing conditions. In addition, there have been reports where some symptoms could be consistent with distant spread of toxin effect following dermatologic use. However, no definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of Botox at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been identified.

Recommendations

FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication; that healthcare professionals who use botulinum toxin products should:

Understand that dosage strength (potency) expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one botulinum toxin product to another.

Be alert to and educate patients and caregivers about potential adverse events due to distant spread of botulinum toxin effects following local injections including: unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

Understand that these adverse events have been reported as early as several hours and as late as several weeks after treatment.

Advise patients to seek immediate medical attention if they develop any of these symptoms.

FDA urges both healthcare professionals and patients to report side effects from the use of Botox and Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B), and Dysport (abobotulinumtoxinA) to the FDA’s MedWatch Adverse Event Reporting program through:

Online at http://www.fda.gov/medwatch/report.htm
By returning the postage-paid FDA form 3500 available in PDF format at http://www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
Faxing the form to 1-800-FDA-0178
By phone at 1-800-332-1088

EDITOR’S NOTE: In January 2008 the Public Citizen Health Research Group presented a citizens petition led by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Shiloh Stark, B.A. Sidney Wolfe, M.D. that requested the Food and Drug Administration (FDA or Agency) immediately to require the Biologics License Application (BLA) holders of all formulations of botulinum toxin to issue a ‘Dear Health Care Professional’ (DHCP) letter to “alert physicians to serious problems, including hospitalizations and deaths, resulting from the spread ofthe toxin from the site of injection to other parts ofthe body” (Petition at 1).

The Petition also requested that FDA require BLA holders of botulinum toxin products to provide “additional warnings in the form of a black box” to product labeling regarding the risk of distant spread of the toxin effects from the site of injection and provide an FDA-approved Medication Guide for patients, to be dispensed by physicians at the time of injection. The request was based on rates of dysphagia and muscle weakness in preapproval clinical trials and postmarketing adverse event reports of dysphagia, aspiration, and/or pneumonia.

In April 2009 the Department of Health and Human Services Food and Drug Administration in Rockville MD 20857, replied. To read the full text log on to:

http://www.fda.gov/cder/drug/early_comm/botulinum_CP_response.pdf

The FDA reply includes the following information:

Spread of Botulinum Toxin Effects

Botulism is a serious bacterial toxin-mediated neuroparalytic illness whose onset is typically marked by cranial nerve dysfunction (resulting in double vision (diplopia), inability to control or coordinate the muscles used in speaking (dysarthria), and/or difficulty swallowing (dysphagia)), followed by progressive descending muscle weakness or paralysis that can lead to respiratory failure and death.6 Thebotulism syndromes may result from absorption of botulinum toxin through a mucosal membrane (intestine or lungs) or from a wound.7 The clinical use of licensed botulinum toxin products presents the potential for iatrogenic botulism, which may be described as the appearance of one or more clinical manifestations of botulism that has the potential to be clinically serious.8

Local extension of effect of the botulinum toxin to anatomical structures (nerves and muscles) adjacent (contiguous) to the site of injection may occur and is described in product labeling.9 For example, dysphagia (difficulty swallowing) is described in product labeling as a “commonly reported adverse event following treatment with all botulinum toxins in cervical dystonia patients.”l0 However, dysphagia may also be a sign of distant spread of botulinum toxin effects when the botulinum toxin is administered at a site other than the neck.

Details of references can be found on the website link.
(http://www.fda.gov/cder/drug/early_comm/botulinium_toxins200904.htm)

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Fibromyalgia and Epilepsy Drug Lyrica Helps Restless Leg Sufferers, Researchers Say

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

Courtesy of attorneyatlaw.com Legal Briefs

Lyrica, the Pfizer drug for treatment of the chronic pain disorder fibromyalgia and preventing epileptic seizures, also appears to benefit people who cannot get to sleep because of restless legs syndrome, new findings suggest.

A recently completed clinical trial found that pregabalin, the active ingredient in Lyrica, is “a promising alternative to current treatments” in terms of helping people with restless legs syndrome get more quality sleep, according to research unveiled this week at a meeting of the American Academy of Neurology.

Lyrica for Fibromyalgia Pain

In 2007, Lyrica became the first FDA-approved treatment for fibromyalgia, a debilitating condition which affects as many as six million Americans, mostly adult women. Fibromyalgia victims tend to experience chronic or long-lasting pain as well as muscle stiffness and tenderness, the FDA said.

Restless legs syndrome is a neurological disorder which causes burning or tugging sensation in the legs, sometimes called parethesias or dysethesias, particularly when the person is lying down at rest. The sensations can range from uncomfortable to extremely painful.

Study of Restless Legs Sufferers

Researchers from the Sleep Research Institute in Madrid, Spain studied 58 patients who suffered from restless legs syndrome. The patients were given placebo pills for two weeks then half were given 150 to 600 milligrams daily doses of Lyrica, while half continued to receive placebos for another 12 weeks.

The researchers monitored the severity of restless legs syndrome and sleeping habits of both groups and found that those taking Lyrica experienced less severe symptoms of the syndrome.

Less Symptoms, More Sleep

Using the International Restless Legs Syndrome Rating Scale, people on Lyrica saw their scores on the disease severity index decline from 19.8 to 6.8, while scores for participants on placebo treatments declined from 21.5 to 11.2, the researchers said.

Also, people in the study who were taking Lyrica spent significantly more time sound asleep in what is called deep slow wave Stage 3 sleep and less time in light sleep, called state 1 or 2 sleep, compared to people not taking the drug, the researchers said.

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(http://www.attorneyatlaw.com/2009/04/fibromyalgia-and-epilepsy-drug-lyrica-helps-restless-leg-sufferers-researchers-say/)

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

Low Doses of Drug for Alcoholics Helps Reduce Fibromyalgia Pain, New Research Finds

Courtesy of attorneyatlaw.com Legal Briefs

Taking low doses of a drug commonly given to alcoholics and drug addicts reduces pain and fatigue in some people battling the chronic-pain condition fibromyalgia, Stanford University researchers say.

In preliminary research, the drug, naltrexone, reduced the pain and fatigue in fibromyalgia patients by an average of 30 percent, researchers said. The findings are an encouraging development for millions of Americans who suffer from fibromyalgia, a somewhat mysterious disorder for which there is no reliable cure or treatment.

However, larger and more detailed studies are needed before naltrexone can be recommended for treating fibromyalgia, researchers said.

Study Finds Benefits for Fibromyalgia Sufferers

The Stanford University study focused on 10 fibromyalgia patients. Some of the patients received low doses of the drug at bedtime while some were given placebos. Those taking naltrexone reported significant drops in daily pain, highest pain, stress, fatigue, and improved pain thresholds, according to the study.

On average, patients given naltrexone had their fibromyalgia symptoms reduced by 32.5 percent, compared to improvement of 2.3 percent in patients given placebo treatments.

Few Side Effects, Relatively Inexpensive

Naltrexone treatments resulted in few side effects, although some participants reported experiencing vivid dreams after taking the drug. Researchers are excited about the prospects of naltrexone as a fibromyalgia treatment because there currently are few treatment options for such patients and the drug is relatively inexpensive, costing about $40 a month.

A second, longer-term study of the effects of naltrexone on fibromyalgia symptoms and including 30 patients tested over a period of four months is set to begin soon, Stanford researchers said.

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(http://www.attorneyatlaw.com/2009/04/low-doses-of-drug-for-alcoholics-helps-reduce-fibromyalgia-pain-new-research-finds/)

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

Fibromyalgia: Millions Are Spent To Educate the Public About a Mysterious Condition

Courtesy of attorneyatlaw.com Legal Briefs

Two of the world’s biggest drug companies have paid millions of dollars to promote a chronic pain syndrome about which little is known, prompting some critics to accuse the companies of hyping a mysterious condition hoping to sell more drugs.

In the first nine months of 2008, drug makers Pfizer and Eli Lilly gave more than $6 million in grants to nonprofit groups to sponsor medical conferences and educational campaigns focused on fibromyalgia.

That sum tops the amount spent by the companies to raise awareness of more established diseases, such as diabetes and Alzheimer’s, and trails only AIDS, cancer, and depression in terms of educational spending from drug companies, officials said.

The problem, critics say, is that no one is exactly sure what fibromyalgia is. There is no known cause of the disease, critics note, and there are no tests for confirming its presence. Fibromyalgia patients most often may also be diagnosed with more widely understood conditions, including chronic fatigue syndrome.

Therefore, drug companies may simply be trying to drum up more patients for a disease that is treated by Lyrica, Cymbalta, and other popular drug brands, critics allege.

WHY THE FOCUS ON FIBROMYALGIA?

Why are drug companies paying millions of dollars to educate the public about a condition that even medical experts tend to agree may or may not even exist?

Are the drug companies engaging in the common practice of trying to influence the medical community into accepting and promoting a disease whose treatment might include the companies’ drugs, as critics allege?

Or, as the drug companies contend, are they simply exposing a newly developing disease which affects millions of Americans, just like depression, which went widely misunderstood and untreated for decades?

By convincing doctors to diagnose patients with fibromyalgia, Pfizer, Lilly and other drug companies figure to pocket billions in sales of drugs designed to treat the disorder. In fact, sales of Cymbalta, an antidepressant approved in June 2008 as a fibromyalgia treatment, and Lyrica, an anti-epileptic seizure drug also approved for fibromyalgia, have spiked amid the public-awareness campaigns.

In 2007 and 2008, sales of Pfizer’s Lyrica increased from $395 million to $702 million, while sales of Cymbalta, made by Lilly, were boosted from $442 million to $721 million, officials said. The drugs can help reduce pain in fibromyalgia patients, although researchers are not exactly sure how they work.

At the same time, the drug companies also poured millions of dollars into advertising the fibromyalgia drugs. Lilly spent about $128.4 million in the first half of 2008 to promote Cymbalta, while Pfizer shelled out more than $125 million on advertising for Lyrica, according to some estimates.

MILLIONS OF AMERICANS HAVE FIBROMYALGIA

According to the American College of Rheumatology, between six million and 12 million people in the U.S. currently have fibromyalgia. Women are more likely to have the condition, accounting for more than 80 percent of all cases.

Symptoms of fibromyalgia include widespread muscle pain, fatigue, headache and depression. However, despite more than 30 years of studying the condition, researchers say the understanding of fibromyalgia remains “murky.”

FUNDING OF DISEASE EDUCATIONAL PROGRAMS MUST BE SCRUTINIZED

The policy of drug companies issuing grants to nonprofit groups to conduct educational campaigns about diseases and conditions is fraught with potential abuses. It is not hard to see why companies like Pfizer and Lilly want to get the word out about fibromyalgia, since the companies make two of the drugs most commonly prescribed to treat the disorder.

By convincing physicians to diagnose cases of fibromyalgia and prompting patients to ask their doctors if fibromyalgia might be the reason for their unexplained pain, the companies have already earned millions of dollars in sales of the drugs.

The FDA must keep closer tabs on this practice to ensure that drug companies are not acting improperly in funding work to promote diseases or conditions. In the end, such practices may prove harmful to patients and drug users who are grasping at straws and desperate to find answers to their nagging pain.

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Lyrica Significantly Reduced Pain and Improved Other Symptoms of Post-Traumatic Peripheral Nerve Pain, New Data Show

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

SEATTLE–(BUSINESS WIRE)

Patients suffering from post-traumatic peripheral nerve pain treated with Lyrica® (pregabalin) capsules CV experienced significantly reduced pain compared to those taking placebo, according to new data presented today at the American Academy of Neurology annual meeting. The data also showed that patients treated with Lyrica reported less pain interference with sleep and were significantly more likely to report feeling better overall at the end of the study compared with placebo.

Post-traumatic peripheral nerve pain is a difficult to treat condition that occurs after nerve damage due to trauma from accidental injury or surgery. It can be a chronic condition, affecting the injured area with pain persisting long after the initial injury has healed. Traumatic injury causing long-lasting changes to the peripheral nervous system – the communications network that transmits information to and from the central nervous system (the brain and spinal cord) and every other part of the body – is believed to be the cause of this persistent pain.

Post-traumatic peripheral nerve pain can have a wide array of symptoms, including numbness, tingling and prickling sensations, sensitivity to touch or more extreme symptoms including burning pain.

“The findings of the study are good news for the many patients who suffer from this painful and debilitating condition,” said Robert van Seventer, MD, Chair of the Department of Anesthesiology and Director of Amphia Pain Clinic and Research Centre, Amphia Hospital, the Netherlands.

“Post-traumatic peripheral neuropathic pain has historically been a challenging condition to treat so this data demonstrating the ability of pregabalin to provide relief for patients is encouraging.”

The study found patients treated with Lyrica experienced significantly reduced pain compared to those taking placebo. At the end of the study, patients receiving Lyrica had, on average, a pain score that was 0.62 points lower on an 11-point scale compared to placebo.

Patients receiving Lyrica reported less pain interference with sleep compared to placebo. At the end of the study, patients receiving Lyrica had an average self-reported weekly pain-related sleep interference score of 2.73 (from a baseline of 4.1) on an 11-point scale measuring how much pain had interfered with sleep during the past 24 hours, compared to 4.13 for placebo (from a baseline of 4.8). Additionally, at the end of the study, significantly more patients receiving Lyrica (64 percent) reported feeling “improved” compared to placebo (41 percent).

About the Study

The multi-center, double-blind, placebo controlled study of Lyrica in 254 adult patients with post-traumatic peripheral neuropathic pain randomized patients to receive flexible dose Lyrica 150 mg to 600 mg daily for four weeks of dose optimization, followed by fixed dosing for four weeks.

The study was conducted at 60 sites across Canada and Europe. The average Lyrica dose was 326 mg daily. Patients had to experience persisting, neuropathic pain for at least three months following a traumatic event such as an accident, surgery, amputation or a nerve injury and have a pain score greater than or equal to 4 on an 11-point scale. Patients remained on existing treatments during the study.

Patients were asked to measure their pain on a scale of zero to 10; the average baseline scores for study participants were 6.0 in the pregabalin group and 6.3 in the placebo group on this 11-point scale. A score of 4.0 to 7.0 is considered moderate pain and a score of greater than 7.0 is considered severe pain.

The primary endpoint was the difference in average self-reported pain score at the study’s conclusion between patients treated with Lyrica and placebo. Secondary endpoints included the effects of Lyrica compared to placebo on co-morbid symptoms of post-traumatic peripheral neuropathic pain including anxiety, patients’ self-reported pain-related sleep and patients’ self-reported overall improvements.

The most common side effects in the study versus placebo were dizziness (43.3 percent vs. 9.4%) and somnolence (15.7 percent vs. 6.3%), followed by headache (11.8 percent vs. 11.0%), fatigue (11.8 percent vs. 7.9%) and dry mouth (11.0 percent vs. 4.7%). The study was funded by Pfizer Inc.

About Lyrica

In the United States, Lyrica is approved for the management of fibromyalgia. Lyrica is also indicated for the management of painful diabetic peripheral neuropathy, postherpetic neuralgia (pain after shingles), and for the adjunctive treatment of partial onset seizures (a type of epilepsy) in adults.

Outside of the United States, Lyrica is indicated in adults for the management of peripheral and central neuropathic pain (NeP), treatment of generalized anxiety disorder, and adjunctive therapy for partial seizures with or without secondary generalization.

Important Safety Information

Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse reactions include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally. There have been post-marketing reports of angioedema and hypersensitivity.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Contacts Pfizer Inc
Media:
Sally Beatty, 212-733-6566

Investor:
Jennifer Davis, 212-733-0717
Permalink: http://www.businesswire.com/news/home/20090429006303/en

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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