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

UK Fibromyalgia Conference & Unique Pamper Weekend

From the FMS Global News Desk of Jeanne Hambleton

With just weeks to go to the final booking date, fibromites from all around the UK are rushing for places at a weekend filled with laughter, fun, relaxation and learning.

Believed to be the first Fibromyalgia Conference in the south east of England working under the FMA UK umbrella, influenced by a yoga teacher working with fibromites, Sarah Owen, the event is offering pampering as a unique part of the programme along with leading speakers in the field of fibromyalgia.

Between 20 and 30 pamper therapists are expected to give free tasters allowing fibromites to try complementary therapies they have not previously experienced prior to booking one to one therapies at reduced cost at conference.

While many visitors are coming for the pamper experience, lots of fibromites have admitted they want to meet like-minded people from other groups with the view to twinning with other UK groups. Living in a world that does not understand fibromyalgia, those suffering with FMS enjoy the company of others suffering with the same condition. The idea of twinning has prompted one small Tee group with just 12 members to be the first group to enlist in a twinning programme with a partner group.

Others are anxious to listen to the speakers, attend workshops and try new treatments in the exhibition for those with disability and needing pain relief. The event will include scooters, adjustable beds, tilt and rise chairs, walk in baths, walkers, wheelchairs, fancy walking sticks and much more.

Dr. Ernest Choy, a consultant rheumatologist from Kings College Hospital, London, who specialises in fibromyalgia, who will travel from the annual meeting of the British Society of Rheumatology to join the conference. The Doctor will talk about new advances in the understanding of fibromyalgia. Other speakers will discuss sleep, pain management, digestive problems, chronic fatigue syndrome, food and mood, nutrition, benefits, and the controversial lightning process used by Esther Rantzen’s daughter for her ME/CFS.

Social highlights of the weekend will be the Fibro Factor, a chance for fibromites to have their moment in the spotlight. Following a gala dinner there will be the Folly Pogs Ball with posh frocks and dickie bow ties or fancy dress options. On Sunday the audience will join a charity auction of donated gifts to raise funds for fibromyalgia research.

Among the visitors will be Pam Stewart, chairman of the board of trustees for FMA UK, who is also the Vice President of the European Network of Fibromyalgia Association. Pam is looking forward to meeting newly diagnosed fibromites, members and group leaders.

“We have every intention on over dosing on laughter, which is the best medicine and has no side effects,” said who is one of the main organisers.

For more information email jeannehambleton@mac.com.

International Fibromyalgia Awareness Day 12th May 2009

From FMS Global News Desk of Jeanne Hambleton (UK)

In the wake of the historic first ever debate about fibromyalgia in Parliament (Westminster Hall) last week on May 5, the Fibromyalgia Association UK, (FMA UK) praised for its work in helping sufferers, has issued a press release.

The Chairman of the Trustees of FMA UK Ms Pam Stewart said, “A year has passed and what has changed?”

EUROPEAN NETWORKS OF FIBROMYALGIA ASSOCIATIONS & NICE REJECTION

In Brussels, the Written Declaration on Fibromyalgia won a majority of votes. This asked all member states to recognise fibromyalgia and ensure diagnosis and treatment is available. It also stated that research funding should be awarded for fibromyalgia.

“It is likely to be some time before we see the results of this as it is a slow process,” said the Chairman.

“In the UK, the recommendation for guidelines for the treatment of fibromyalgia were not considered to be a priority by the National Institute of Clinical Excellence (NICE). This rejection by NICE which is independent from the government is a blow for UK fibromyalgia sufferers,” said Pam Stewart.

CHIEF MEDICAL OFFICER’S ANNUAL REPORT

The annual report from the Government’s Chief Medical Officer Sir Liam Donaldson, which included a whole section on pain and especially chronic pain, gave hope that at least this area of fibromyalgia might be given some attention but it is only part of the range of symptoms and cannot be treated in isolation.

FIBROMYALGIA DEBATE IN THE HOUSE

“We were delighted to have a debate with Ann Keen, Parliamentary Under Secretary of State in the Department of Health, so that questions about the future of fibromyalgia diagnosis and treatment could be assured. This debate was secured by Rob Wilson MP for Reading East and Chair of the All Party Parliamentary Group on Fibromyalgia (APPG).

“Sadly it seemed that complacency with the initiatives already in place means we still have a fight on our hands. Since the Musculoskeletal Service Framework was put in place in 2006, we have not heard that treatment options have improved and we still hear of people being told to go away and live with it.

“We have been told that in one hospital, a mention of fibromyalgia will bar the patient access to further treatment from pain specialists, physiotherapy or other recommended treatment options!

” When asked about training for medical professionals, which Sir Liam Donaldson had mentioned in his report, we were informed that we would have to take this up with the professional bodies involved in accrediting training even though deficiencies in knowledge have been acknowledged,” she said.

DO DOCTORS USE THIS NHS SITE?

However, the new website http://www.NHSevidence.uk was mentioned by the Under Secretary. When fibromyalgia is searched for, this has the European League Against Rheumatism (EULAR) guidelines that were sent to NICE as a beginning for official UK clinical guidance. This is encouraging if medical professionals use this service. This advocates a multidisciplinary approach for the treatment of fibromyalgia. There are some centres around the country that use this but those with fibromyalgia need all PCTs to have the ability to refer patients with fibromyalgia to a multi-disciplinary team of medical professionals for appropriate treatment.

“It is unacceptable that these specialist clinics are not available on the NHS Choose and Book system thereby denying easy access to sufferers. We hope this debate will have raised the profile of fibromyalgia but it has highlighted that there is still much more to do. People in constant pain should have the right to effective treatment. How can between 1.7 and 2.8 million people living with such a poor quality of life be treated so badly?

..end..

EDITOR’S NOTE: As someone with fibromyalgia I was very pleased to hear Rob Wilson MP had secured this debate. May I also publicly thank the handful of MPs who were in the Chamber to support this plea for support for the neglected people with fibromyalgia. I guess like many of the 2.7 million people diagnosed with fibromyalgia in the UK, I felt the response from the Minister, Department of Health, was a ‘white wash’. As a health professional herself I did believe she wanted to help but it appeared her ‘hands were tied’ by red tape and maybe civil servants’ constraints. She appeared unable to make a commitment sadly.. regardless of pressure from Norman Lamb MP. If there is a will, there must be a way.

Yes I accept there are many conditions causing chronic pain and quite a number who have been given funding for research to find a cure, but we fibromites – the Fibromyalgia Cinderellas, have no funding for research and apparently must endure our pain, a poor quality of life and the huge financial burden that fibromyalgia imposes, not to mention the hoops the Benefits people ask you to jump through.

What makes me mad is the time it takes (at least 2 years) to get a diagnosis and the enormous costs in those 24 months (at least). We spend hours seeing doctors, specialists, having blood tests, x-rays, scans, all in a process of elimination. If over two years we see three or four specialists, doctors and others and it costs, for example, say £5,000 for one person to get diagnosed (I am guessing), just multiply that by 2.7 million people. (Sorry no good at maths.) What a staggering cost that must be when much less could be spent on research in an attempt to save NHS money. Does the Department of Health care about this major drain on resources?

WRITE TO YOUR MP FOR HIS SUPPORT

Send your MP chapter and verse about your aches, pains, symptoms and quality of life or lack of it, the financial burden you face. Urge him to help you by supporting all these cross-party points raised at the debate. It is the MPs who are pulling the purse strings in the ‘corridors of power’.

Ask your MP to support these points and raise them again in Parliament – they are all valid and raised during the fibromyalgia debate on May 5. See the previous story for the full text of that debate.

* Providing better education for doctors enhancing their knowledge about fibromyalgia,

* The importance of fast diagnosis and the provision of treatment,

* For an improvement and wider access to pain management,

* Highlight the lack of focus on the illness in the Department of Health,

* For the Department for Work and Pensions to address the condition and take it more seriously,

* Consideration a nationwide awareness campaign to highlight fibromyalgia syndrome,

As Pam Stewart has said there is much work still to be done.and we have a fight on our hands. You can help from your own home by contacting your MP. Tell him to read the full debate on this website. Be sure to tell him where you live and that you are one of his constituents. He will want you to vote for him at the next election so hopefully he will help you.

How do you contact your MP? Log on to http://www.theyworkforyou.com/ add your post code and click send a message to you MP. Best type it out first and then cut and paste into the little box.

I am considering writing an e petition on the No.10 Downing Street website raising these points. Will you support that and sign it? If so watch this space!

What are you doing on Tuesday,May 12 – our day. Are you celebrating the International Fibromyalgia Awareness Day with some fund raising? Do you have the Fibro What? CD to raise your spirits. If you do nothing else get a copy to help raise funds for research – see http://www.domcollins.co.uk and look at MY SPACE top right hand side. Fibro What? is serious but the three backing tracks will make the family laugh. It is a hoot!

It would be good to hear you have written to your MP. Email me with news from MPs or about Fibro What? on jeannehambleton(@)mac.com. Take care and keep well. Jeanne

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.

FOR MORE HEALTH STORIES SEE http://jeannehambleton77.wordpress.com

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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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

Researchers probe kidney damage, protection in lupus

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

Courtesy utsouthwestern.edu

by Aline McKenzie – 214-648-3404 – aline.mckenzie@utsouthwestern.edu

DALLAS – April 21, 2009

UT Southwestern Medical Center researchers probe kidney damage, protection in lupus. Kidney damage associated with the autoimmune disease lupus is linked to a malfunction of immune cells that causes them to congregate in and attack the organs, researchers at UT Southwestern Medical Center have discovered in a mouse study.

In a separate study with an international team, the researchers also found that a certain set of genes appears to protect the kidneys from a different sort of immune attack in both mice and humans.

“These studies, taken together, uncover two important molecules that underlie the pathology of lupus, particularly kidney disease,” said Dr. Edward Wakeland, chairman of immunology at UT Southwestern and co-senior author of the studies.

“In addition, they highlight a certain molecule as a potential target for treating this disease,” he said.

In the first study, which appears in the April issue of The Journal of Immunology, the researchers examined several strains of mice that mimic human lupus. They found that immune cells in those mice overproduced a particular molecule called CXCR4. In fact, the mice had up to twice as much CXCR4 as their normal counterparts in several types of immune cells. The lupus-prone mice also had more immune-system cells in their kidneys, indicating that the inflammatory action of the immune cells might be causing the kidney damage.

The CXCR4 molecule was already known to play a role in creating various types of blood cells and also has been shown to be active in cancer and AIDS. Cells with CXCR4 on their surface are attracted to another molecule released by cells in various organs, so they migrate toward those organs, including the kidney.

When the researchers treated the lupus mice with a substance that blocks CXCR4, the symptoms of lupus significantly diminished; many symptoms of kidney failure were averted; and the mice lived longer. The increased lifespan was greater when treatment began at an early age.

“This study indicates that drugs acting against CXCR4 might become useful therapies,” said Dr. Chandra Mohan, professor of internal medicine and co-senior author of the studies.

In the second study, published in the April issue of The Journal of Clinical Investigation, the researchers found that some members of a family of genes called kallikreins offered a degree of protection in both mice and humans against a type of kidney damage caused by a different mechanism.

For this mouse study, the researchers administered antibodies that attack a part of the kidney called the glomerular basement membrane, the portion of the organ that performs its main function of filtering wastes from blood. They then looked for genes that turned on or off in response to the antibody assault.

Nine forms of the kallikrein, or klk, gene became more active, resulting in a two- to sixfold increase in the proteins encoded by the genes in normal mouse strains, compared with lupus-prone strains. When some mice were given substances that block the action of kallikrein proteins, they showed more severe symptoms of lupus, suggesting that kallikreins protect against renal disease.

The researchers also studied 340 German patients with systemic lupus, matched with 400 healthy control subjects. The patients with lupus and kidney damage had klk genes that were different from those in the healthy patients. Similar findings were noted in a larger, more varied group of patients from Europe, the United States and Korea.

“All humans have Klk genes, but our findings show that some of us have a particular version that increases our risk for systemic lupus,” Dr. Wakeland said.

Future research will examine the mechanisms by which CXCR4 and klk genes might be aberrantly regulated in lupus and how they could be therapeutically targeted in human lupus, the researchers said.

Other UT Southwestern researchers involved in the first study were lead author and graduate student Andrew Wang; Dr. Anna-Marie Fairhurst, assistant instructor of immunology; Dr. Katalin Tus, instructor of immunology; former graduate student Srividya Subramanian; Dr. Yang Liu, postdoctoral researcher in internal medicine; Dr. Fangming Li, assistant professor of pediatrics; Dr. Peter Igarashi, professor of internal medicine; and Dr. Xin Zhou, professor of pathology. Researchers from the Université Paris-Descartes and Chemokine Therapeutics, Canada, also participated.
The study was funded by the National Institutes of Health.

Other UT Southwestern researchers involved in the second study were lead co-authors Dr. Kui Liu, instructor of internal medicine, and Dr. Quan-Zhen Li, assistant professor of immunology; Li Li, research associate in internal medicine; Jinchun Zhou, research scientist in immunology; Mei Yan, research associate in internal medicine; Dr. Qiu Ye, former postdoctoral fellow in immunology; Shengxi Liu, senior research associate in immunology; Dr. Chun Xie, former instructor in internal medicine; and Drs. Zhou and Liu.

Researchers from Oklahoma Medical Research Foundation; University of California, San Franciso; Long Island Jewish Health System, Manhasset; Medical University of South Carolina; and University of Alabama at Birmingham also participated, as did researchers from institutes in Sweden, Spain, Argentina, Germany, South Korea, Italy and the United Kingdom.

The study was funded in part by the Alliance for Lupus Research and the National Institutes of Health.
Visit http://www.utsouthwestern.org/rheumatology to learn more about clinical services in rheumatology at UT Southwestern. Visit http://www.utsouthwestern.org/dermatology to learn more about UT Southwestern’s clinical services in dermatology, including autoimmune diseases.

(http://www.utsouthwestern.edu/home/news/index.html)

FOR MORE STORIES ON HEALTH SEE http://jeannehambleton77.wordpress.com

One in seven GPs may be told to retrain under revalidation plans

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

Courtesy of PulseToday.com

On July 2008 the PulseToday.com on line magazine for GPs carried a story concerning compulsory annual assessment for GPs.

Chief Medical Officer Sir Liam Donaldson then formally laid out controversial plans for the revalidation of doctors.

Under the plans, revealed in the report, Medical Revalidation: Principle and Next Steps, GPs will face compulsory annual assessments, and could have their licenses removed if they are judged to be performing poorly.

The process, which has been in the pipeline for over a decade, will require GPs to renew their licenses every five years, with senior doctors asked to assess colleagues who are practicing in their area to ensure they are not putting patients at risk.

Patient feedback will also be used in the assessment process, pilots of which will start next year.

The proposals have been produced by the GMC with the help of the medical colleges, including the RCGP. But critics have warned that the extra scrutiny could lead to the spread of defensive medicine.

GPs will have to clear two hurdles to gain revalidation; recertification – to confirm that they meet standards appropriate for the specialty of their medicine, and re-licensure – to confirm that they practise in accordance with the GMC’s generic standards.

Mandatory annual reviews will look at prescribing habits, assessment of a patient’s condition and any personal issues such drug or alcohol abuse.

Pulse revealed earlier this year that GPs will be assessed using so-called 360-degree colleague surveys, with up to a dozen practice staff and colleagues asked to rate their performance.

The process is expected to be rolled out gradually to all specialities, including general practice, with pilots beginning in 2009.

UP DATE

Last week on 16 April 2009 Gareth Iacobucci wrote an up to datge story for PulseToday.com.

Exclusive: As many as one GP in seven will face having to retrain under the RCGP’s (Royal College of General Practitioners) plans for revalidation, Pulse can reveal.

LMCs (Local Medical Committees) have been told to expect between 5% and 14% of all GPs will fail at least one element of the programme, with some having to do up to 18 months of ‘corrective training’.

The figures, which the college said were in line with its own predictions, could mean up to a third of three-partner practices, and almost half of four-partner practices, having at least one GP who does not pass first time.

Dr Maurice Conlon, national director of the NHS Revalidation Support Team and a GP in Birmingham, told Pulse practices might need to consider rewriting partnership agreements to outline who was financially liable if a partner had to take time out of work to retrain. He said he expected a ‘surge’ of GPs to need some sort of intervention in the first year or two of revalidation, but insisted this would then ‘settle down and tail off’.

He added: ‘A very small number of doctors might find they are in the wrong job, some will have a significant need for remediation and some will need some form of retraining.’

The RCGP expects GPs to begin compiling portfolios from this month for the first five-year revalidation cycle, with the first GPs scheduled to move through the system in 2010/11.

Professor Steve Field, chair of the college, said the 5-14% estimate was ‘about right’, but that most struggling GPs should be identified via PCT appraisals long before the end of the five-year cycle:

‘Learning needs should be identified each year and additional support given. But nothing will work unless we have effective appraisal.’

Dr Conlon said many GPs requiring retraining would still be fit to practise, depending on how much work was needed, with revalidation targeting areas such as communication problems, absence of an established practice team and lack of engagement with CPD

(Editor’s Note: Doctors have a responsibility to keep up to date. The GMC publishes Guidance on Continuing Professional Development, which sets out the principles on which continuous professional development should be based, and the roles of the relevant organisations involved in its delivery.)

But Dr Conlon warned that GPs might have to fund some retraining themselves if it extended beyond study leave written into their contracts. “Partners could choose to write into agreements that if you run into difficulty, you limit their ability to share profits. I would be very disappointed to see that,” he said.

Kent LMC has begun warning its members of the ‘significant’ effort and cost likely to be involved, after being presented with the failure-rate figures at a meeting between GP educationalists and local PCT managers.

Dr Gary Calver, secretary of Kent LMC, said: “There are big question marks over how it is going to work and be funded.”

Gloucestershire LMC warned: “Partnerships should consider very carefully and put into partnership agreements what is to occur should a partner fail. For instance, would the partnership continue to pay the GP a share of profits while retraining?”

The GPC has stressed the need to ensure all aspects of revalidation, appraisal and remediation are adequately supported, but the Department of Health has given no guarantees.

PULSE READERS’ COMMENTS:

Umesh Prabhu | 18 Apr 09

If the plan is to retrain ‘poorly performing’ GPs then there is no need to worry. The question is how we are going to identify these GPs? Who makes the decision that the GP needs re-training? Who is going to fund it? How do we make sure that there are no ‘hidden’ or personal agendas at local PCT?

Of course, it is important to protect patient safety and their well-being but it is equally important that all doctors are treated fairly and correctly and action taken is proportionate. Big question is who is going to fund the re-training?

THE REVALIDATION PROCESS

Areas where GPs could fail
GPs may demonstrate deficiencies in areas such as communication, poor premises or CPD.

What type of retraining?
GPs could receive educational support from the RCGP, deaneries or other specialised academics for those that need ‘more intensive support’. With significant concerns, and if remediation is required, National Clinical Assessment Services procedures could be used, which can last up to 18 months.

The process
GPs to collect information for revalidation portfolios over five-year period. PCT responsible officers will give a recommendation to the GMC over whether or not to revalidate

Practice staff to rate GPs as part of tougher appraisal

GPs will be scored by colleagues and staff every few years as part of a new process to prove they are qualified to continue practising, said Gareth Iacobucci in Pulse Today.

Verdicts from colleagues form a key part of controversial plans for recertification and will take place either once or twice every five years.

GPs will be assessed using so-called 360-degree surveys, with up to a dozen practice staff and colleagues asked to rate their performance.

Annual appraisal will also be toughened up under the plans, released to Pulse, by the Royal College of General Practitioners’. The current informal appraisal will be replaced by summative assessment and performance management.

The more rigorous appraisals and 360-degree surveys – both of which are bound to be contentious – will feed into the five-yearly recertification process.

Recertification will require GPs to demonstrate the skills and knowledge expected of their profession, and will occur in parallel to the GMC’s relicensure procedures to investigate fitness to practise. GPs will need to clear both hurdles in order to gain revalidation.

The RCGP told Pulse toughening up appraisals was essential to meet the regulatory requirements expected of the profession and ensure it could continue to self-regulate.

The college’s chair, Professor Steve Field, insisted most GPs had nothing to fear: “This is about professional development in the vast majority and, in cases where performance is below standard, identifying those in need of help.”

The college will publish a draft of ‘criteria standards and evidence’ to guide appraisers in judging GP performance. GPs will be judged on the quantity and quality of their portfolio, and expected to detail difficult incidents and lessons learned.

Professor Mike Pringle, professor of primary care at the University of Nottingham, who led the RCGP group examining the criteria to be applied in appraisals, said GPs should feel reassured that they would be judged by peers, not external bodies, during recertification.

“People will sit at a computer, and anonymously rate the GP on a five-point scale on a set of attributes. GPs get an aggregated score so they can see how colleagues view them,” he said .

But some GPs were alarmed by the plans. Dr Cornel Fleming, a GP in Islington in north London, said the system would breed discontent among GPs.

“It is getting ridiculous,” he said. “Appraisals were supposed to be helpful, not disciplinary. It is becoming like a police state.”

The RCGP said detailed proposals would be completed later this year, piloted in 2009 and rolled out in 2010. Appraisals will remain annual, but it is yet to be decided how often surveys will take place over five years.

In the surveys GPs would be ranked by colleagues of their choice, which could include fellow GPs within or outside the practice, practice nurses and practice managers.

Pulse, CMP Medica. All rights reserved.
(http://www.pulsetoday.co.uk/story.asp?sectioncode=23&storycode=4122447&c=2)
(http://www.pulsetoday.co.uk/story.asp?storycode=4118102)

DEBATE

Are recertification plans good for general practice?

The RCGP’s Professor Mike Pringle insists the system will be fair and transparent. But GMC member Dr Krishna Korlipara believes assessment by staff is an inappropriate way of judging clinical competence.

Yes

Are recertification and revalidation really necessary?

Well, my view is that it is no longer sufficient to qualify as a doctor and to pass the MRCGP before, say, the age of 30, and then to practise through to 65 or older with no further question about your competency.

We could rely, as we have in the past, on dodgy doctors ‘coming to light’ through complaints or PCT investigations, but that is not sufficient reassurance to us as colleagues or to the public.

So if periodically demonstrating that we are keeping up to date and still fit to practise is necessary, we need to be sure that the system imposed on us is appropriate.

By this I mean that it achieves its aims of ensuring our fitness, and being fair, transparent and feasible.

The first step is to agree what we mean by an acceptable GP, and this is the purpose of the RCGP’s Good Medical Practice for General Practitioners.

The college is asking for your views on the new draft of this at present. The second step is to say what tests will be applied, to what level, and how doctors will demonstrate their compliance.

This is the purpose of a document called Criteria, Standards and Evidence that is being worked up. When it is published, every GP and member of the public will see clearly what is expected.

What follows in this article is a personal view based on the early thinking for Criteria, Standards and Evidence. Whatever the college proposes will be put out for consultation and tested in pilots.

The plans will have to be approved by the GMC, which will want to be sure the college’s plans are fit for purpose and equivalent to those for other types of doctors.

Much of the evidence will be already available to most GPs. It will come through their appraisals, their audits – including significant events – their patient surveys and clinical governance.

Standard process

A new method of measuring continuing professional development is likely to form part of the package. One new element is likely to be multi-source feedback – asking your colleagues to rate you. It is a fairly standard process and such surveys are already part of regular appraisal at the GMC.

“We can design a process that is fair, fit for purpose and transparent”

At each annual appraisal GPs will be asked to share the evidence they are gathering. The appraiser will check both its quantity (is it enough for this phase in the five-year cycle?) and its quality (does it show good enough care?).

If it is insufficient, the appraiser will advise on how to improve it. At each appraisal GPs will plan what to put in the folder for the next year.

At the end of the five-year cycle, GPs will submit the folder of evidence containing enough for relicensure (continuing to be a doctor) and recertification (continuing to be a GP). There will be local sign-off from the PCT and appraiser.

If the folder meets the standards in Criteria, Standards and Evidence, the college will recommend you to the GMC.

As a five-year exercise, this sounds doable, but that will be tested through pilots – as will its effectiveness in sorting the vast majority who are good GPs from the few who are not. If the college cannot recommend a GP for recertification, there is no immediate effect.

The GMC would need to review the evidence and, if necessary, start fitness-to-practise processes. So for the few, the case that they are unacceptable GPs must be proven.

I believe we can design and implement a recertification process that is fair, fit for purpose, transparent and which is not too bureaucratic. I hope all GPs will look out for and comment on the college’s proposals.

The eventual system should be what you decide will be best for GPs and patients.

Professor Pringle is a council member of the RCGP, a member of the RCGP stakeholder group on recertification and a GMC council member

No

Under the current proposals for revalidation, all GPs need to be recertified every five years by the RCGP, in addition to annual appraisals by their local colleagues.

In order to be acceptable to the GMC for purposes of relicensure and revalidation, appraisals are to be based on seven Good Medical Practice criteria – good clinical care, maintaining good medical knowledge, teaching and training, surveys from patient questionnaires, peer questionnaires, probity, and health.

Based on satisfactory outcomes, doctors can expect to be given relicensure.

But the RCGP’s proposals for recertification go further. They rely on feedback from not just one’s peers, but also from nurses, managers and presumably other members of the healthcare team such as medical secretaries, health visitors and social workers.

“The views of staff are subjective and carry the risk of personal bias”

These proposals are seriously flawed in many respects.

Recertification, to be fair and fit for purpose, should be based not on third-party opinions but on an assessment of a GP’s knowledge and skills.

Such assessment should be measured by evidence of their participation in educational activities, the lessons learned from such activities, and an audit of disease management in different clinical areas – such as diabetes, coronary artery disease and COPD (chronic obstructive pulmonary disease ).

The remit of the RCGP is to come up with the criteria, standards and evidence needed to make a good doctor, to guide the appraisers, but not to take over the functions of the GMC, which has the sole responsibility for relicensing and revalidating doctors.

Patient and peer questionnaires can be a valuable tool for revalidation, and should be administered every five years as part of the revalidation process, which is a function of the GMC, not of the Royal College.

Information gathered from surveys of patient questionnaires selected at random can give valuable insight into the listening and communication skills of the doctor and can inform the revalidation process.

Peer questionnaires could also be used for revalidation, specifically to gather a cross-section of opinion from medical colleagues on a doctor’s qualities as a team member, referral patterns and adverse incidents.

But such questionnaires are not appropriate for recertification, which is all about assessment of knowledge and skills, rather than an assessment of a doctor’s continuing fitness to practise.

Wary of bias

We should also be wary of the dangers of seeking feedback from nurses and other members of the primary healthcare team, who may find themselves in an invidious position of either saying all the right things about a doctor with whom they have to work, for fear of offending, or saying things which are not strictly true based on mutual dislike.

Either way these views are unreliable and should not be used even for appraisals. They are too subjective to be of any real value and carry the risk of personal bias.

Doctors have hitherto been led to believe that appraisals will be formative rather than summative, and supportive rather than punitive, so that an appraisee can confidently and confidentially cooperate with the appraiser, knowing that the whole exercise is meant to help the candidate to learn from identified gaps in knowledge.

To retain the confidence of all doctors, appraisals should remain formative and supportive, with the sole exception of cases where a doctor’s performance is found to be so deficient that their continued practice could be a danger to patients.

In such cases – but only in such cases – an appraiser should be bound to share their concerns with the employer. But any more onerous system of appraisal could become a threat to thousands of doctors.

Dr Korlipara is an elected member of the GMC and former chair of the GP consultative group on revalidation

Pulse, CMP Medica. All rights reserved
(http://www.pulsetoday.co.uk/story.asp?storycode=4118904)

FOR MORE HEALTH STORIES SEE http://jeannehambleton77.wordpress.com

Minister calls for pain indicators in QOF (Quality

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

Courtesy of PulseToday.com

By Nigel Praities -21 Apr 09

A Government minister has invited applications for new pain management indicators for the QOF in a parliamentary debate held yesterday.

Health minster Ann Keen said the inclusion of pain in the QOF was a ‘key issue’ and that she hoped organisations would submit proposed indicators for the next review.

The debate was proposed by Anne Begg MP, the chair of the recently formed All-Party Parliamentary Group on Chronic Pain, who said pain should be considered as a ‘vital sign’ for PCTs and incentivised through the QOF.

‘The inclusion of pain assessment in the QOF would strongly encourage health professionals to be proactive and to ask a patient about their pain, treat it promptly and reassess it to ensure that the treatment given is effective, rather than expecting the patient to raise it first,’ she said.

Ms Begg also criticised the complete withdrawal of co-proxamol by the MHRA, and quoted figures revealed in Pulse earlier this year that showed an increase in morphine and tramadol prescriptions as a result of the withdrawal.

In response, Ann Keen said Ms Begg had made a ‘persuasive and eloquent case’ for pain indicators in the QOF and she hoped pressure groups, such as the Chronic Pain Policy Coalition – would press for its inclusion.

‘I understand that the next opportunity to submit suggestions for new indicators to NICE will be this summer. I hope that the chronic pain policy coalition will take the opportunity to suggest specific indicators at that stage,’ she said.

A spokesperson from the Chronic Pain Policy Coalition confirmed it would submit a proposal for new QOF indicators for the routine management and assessment of pain to NICE later this year.

‘Given the important role GPs have to play in the early identification, diagnosis and management of patients with pain, we strongly believe that this is an area in which greater incentivisation through inclusion within the QOF indicators would have a considerable positive impact,’ he said.

(http://www.pulsetoday.co.uk/story.asp?sectioncode=23&storycode=4122478&c=2&cid=pain042209#)

IN THE HOUSE OF COMMONS 20 April 09 (Hansard source/TheyWorkForYou.com)

In the House of Commons on April 20 MP Anne Begg spoke about the Pain Management Services (England) as reported by Hansard and TheyWorkForYou.com

She said, “In the United Kingdom, 7.8 million people live with pain, day in and day out; that is the equivalent of about one in seven people in every single parliamentary constituency. I have asked for this debate in order to draw attention both to their problems and, more importantly, to some solutions that would not only improve the quality of life of so many of our constituents, but also reduce public expenditure on health, social care and incapacity benefits.

“If anyone is wondering why I, as a Scottish MP, am raising the issue of pain management services in England when health is a devolved issue, it is because I am the chairman of the recently set up all-party group on chronic pain. I suppose I should also declare an interest: I am one of the 7.8 million people in the UK who live with chronic pain.

“There could not be a better opportunity to consider the problem and suggest solutions. People in pain and the health professionals helping them have been pushing at a closed door for many years now. They have argued for early recognition of the needs of people in pain, early access to expert advice and treatment, and referral to a specialist pain clinic when necessary. That door was closed until recently; suddenly, it looks as though it is opening, and I am grateful to the chief medical officer for beginning that process.

MAJOR INITIATIVE

“His latest annual report, only just published, includes a chapter called “Pain: breaking through the barrier”. Sir Liam Donaldson looks at the issue of people living with pain in a sensitive and comprehensive way, and concludes with this statement:’A major initiative to widen access to high-quality pain services would improve the lives of millions of people.’ “

Ms Begg also said, “The evidence suggests that although pain services do exist in most secondary care NHS trusts, they are patchy, and variable in their resources and in the services that they provide. Crucially, the CMO’s report makes this point: each year, more than 5 million people in the United Kingdom develop chronic pain, but only two thirds will recover. Clearly, much more needs to be done to improve outcomes for patients. He reminds us that pain affects 7.8 million people, and that more than a third of households have someone in pain at any given time. Those figures are rising. Indeed, recent surveys suggest that chronic pain is more common now than it was 40 years ago.
Pain is becoming more common, but the effect that it has on individual lives is immense.

“The CMO highlights the fact that pain has a major impact on people’s lives, causing sleeplessness and depression, and interfering with normal physical and social functioning. That often leads to unemployment. He points out how it affects all age groups. Perhaps most worryingly, he states that 8 per cent. of children experience severe pain, that back pain alone costs the economy £12.3 billion per year and that early intervention may prevent pain from becoming persistent. In fact, it has been shown that the cost of chronic pain is greater than that of heart disease or diabetes.

“Looking at the limited number of specialist pain clinics, the CMO points out that systems and infrastructure do not meet need or demand, and that better co-ordination of services, and services designed around patients’ needs, are essential. Pain needs to be considered in its own right, because it is often the pain that dominates the patient’s life, not the illness or condition that causes the pain.

As one patient has said: ‘At first I presumed the pain would eventually go away and I would get better. I didn’t expect to develop chronic pain, or that it would stop me working and lead me to consider suicide. I just want my life back.’

Another said: ‘I am in constant and debilitating pain, often unable to do even the most simple activity such as making myself a cup of tea. I have daily bad headaches, and have no quality of life. It is making me very depressed and life is hell.’

Clearly, we have a duty to ensure that the individual has access to the right treatment as early as possible. That treatment has to come from a properly trained professional, and a multidisciplinary team if needed.

“I was surprised by the amount of interest that this debate has generated. I have been contacted by a number of organisations wishing me to raise their concerns. Age Concern and Help the Aged have particular issues relating to the elderly.

AGEING PROCESS

“They say that pain is not a normal part of the ageing process, and we should not accept it as such. We should challenge discrimination and ageist attitudes with regard to pain in older people. They say that constant pain can lead to a loss of dignity. Some 90 per cent. of calls to Arthritis Care’s helpline concern pain, most of them from people in severe pain. In the UK, pain crises account for 60 to 80 per cent. of emergency presentations in hospital admissions for sickle cell disorder.

CO-PROXAMOL WITHDRAWAL AND NAMED PATIENTS

“This is not the first time I have had an Adjournment debate on the issue of pain. Ever since the Government first indicated that they intended to withdraw the analgesic co-proxamol, I have been trying to persuade Ministers that it should not be completely withdrawn as a small group of people still has not been able to find an alternative and certainly not anything so effective. These are all people who suffer chronic pain, who are saying that only co-proxamol works not because they want to be awkward but because it allows them to carry on with their life.

“One person in that position has said: ‘With co-proxamol I had pain but it was bearable, now I can walk only a few steps before being forced to rest; before I managed to tend my flower garden, now I can only sit and feel depressed with pain and frustration’.

“I have several constituents who depended on co-proxamol but cannot now get access to it. While the Government say that co-proxamol is available on a named patient basis, that is of cold comfort to those whose GPs are refusing to prescribe the drug at all. GPs are not comfortable prescribing off licence as they do not always feel that they have the specialist knowledge. But consultants at pain clinics do.

“The main reason the Government gave for withdrawing co-proxamol was the suicide statistics. As it is now extremely difficult for even those who need the drug to access it, the incidence of suicide attributed to co-proxamol is now tiny. However, the use of stronger pain relief and particularly opiates has grown. A recent Pulse article says that there has been a 44 per cent. rise in prescriptions for morphine and a 61 per cent. rise in tramadol prescriptions. That cannot be good pain management, so I ask the Minister to look at this issue again.

“I have not, however, sought this debate to lay blame at the Government’s door on this matter: rather, I hope to encourage the Minister to consider the recommendations laid out in the chief medical officer’s report and to give due regard to their feasibility. I do not have time to discuss them all, but I do want to take this opportunity to bring some to the Minister’s attention.

PAIN TRAINING SHOULD BE EXTENDED

“First, training on chronic pain should be included in the curriculum for all health professionals who deal with patients. However, it is vital that this core training is extended to all health professionals, and in particular to GPs who, at the very least, should have pain training as part of their standard undergraduate education.

“Secondly, consideration should be given to the inclusion of the assessment of pain and its associated disability in the quality and outcomes framework—QOF—in primary care. That is an extremely important point, because the inclusion of pain assessment in the QOF would strongly encourage health professionals to be proactive and to ask a patient about their pain, treat it promptly and reassess it to ensure that the treatment given is effective, rather than expecting the patient to raise it first.

“A recent report on osteoarthritis found that 50 per cent. of people said that they would need to be in frequently unbearable pain before considering seeing their GP—clearly this is a significant barrier.

FIFTH VITAL SIGN – PAIN SCORE

“Another recommendation was that a pain score should become part of the vital signs monitored routinely in hospital. Indeed, the Chronic Pain Policy Coalition has been campaigning for some time now for pain to be adopted as the fifth vital sign. If implemented, this recommendation would ensure that health professionals become proactive in asking their patients about pain. People would recover faster and reduce the burden of care on others.

MODEL PAIN SERVICE OF PATHWAYS OF CARE

“The final recommendation I want to highlight relates to the development by experts of a model pain service of pathways of care with clear standards. The work could build on the excellent 18-week cross specialty chronic pain pathway developed by patients and clinicians that has been supported by the Department of Health.

“It is an important step forward and should be extended to ensure that all patients are offered comprehensive treatment options. That would improve rapid access and reduce the current variability in treatment that patients receive. Patients need to be confident that they can be offered effective options wherever they live.

“Commitments have already been made both in Scotland with the ‘Getting to GRIPS with Chronic Pain’ report and in Wales under the ‘Designed for Life’ programme to assess and improve the services available for patients with chronic pain. I hope I have shown the Minister that there are patients, third sector organisations such as Arthritis Care and health professionals in England anxious to get hold of these recommendations and take them forward. They will need encouragement and flexibility in the way in which integrated services are funded and in how outcomes are measured.

PAIN CHAMPION DEMANDED

“Above all, people in pain need a champion. Tsars such as Mike Richards for cancer and Roger Boyle for cardiology have shown how such champions can make a difference. Pain affects cancer patients and heart patients as well as millions of others with back pain, arthritis, pelvic pain and a multiplicity of conditions. Surely the numbers involved and the importance of early intervention demand a pain champion.

“I know that the concerns I have raised in this debate are shared by a number of my hon. Friends and indeed by many of their constituents. I thank the Minister for hearing me out, and I hope that she can give consideration to the points I have raised.

REPLY

Replying Ann Keen (Parliamentary Under-Secretary (Health Services), Department of Health; (Hansard source) congratulated Miss Begg on securing this Adjournment debate on a “most important topic, which Professor Sir Liam Donaldson chose to highlight recently in the 150th report of the chief medical officer.”

She said, “The report of the chief medical officer is an independent report to Government on aspects of the nation’s health and, as such, draws attention to a number of different major health challenges. In his annual report for 2008, the chief medical officer called for a major initiative to widen access to high-quality pain services to improve the lives of millions.

NATIONAL PAIN DATABASE

“I am delighted to inform my hon. Friend and the House that I received a letter from Professor Black, the chair of the advisory group, just before the Easter recess, and it recommended that the national pain database, run jointly by the Royal College of Anaesthetists and the British Pain Society, should be funded as part of the national clinical audit programme.”

EDITOR’S NOTE: On behalf of the fibromyalgia community living with chronic pain, numbering around two million, mainly women, me included, and those of us who survived thanks to co-proxamol, I would like to thank Anne Begg MP publicly for speaking out on our behalf.

Had I known Miss Begg was to initiate this debate I would, of course, have asked her to include fibromyalgia in her chronic pain list. Hopefully she will read this somewhere, sometime, and might think kindly of us when next raising chronic pain and co-proxamol.

For many of us co-proxamol, when it was £2.79 for 100 tablets, was an inexpensive painkiller. Had we known this it would have been cheaper than the prescription charge if we had been able to buy it. This was before the Government got involved. It was a life saver for those with fibromyalgia, and many others. In those days we had some relief…now it is pain 24/7 thanks those who meddled against the wishes of many doctors, consultants, a number of MPs and the patients. They did not give a jot about us at the ‘coal face’ living with pain for the rest of the life. Yes I have tried the alternatives and they disagreed with me and my IBS and gastric problems. They should have tightened the rules allowing those who really need it to be able to get it, prescribed without litigation problems.

Today albeit your GP knows you are in pain and you should be a named patient, after years of safely taking co-proxamol without a hint of any problems, he will not prescribe it due to the risk of litigation involved with prescribing an unlicensed drug. Mr. B. sitting comfy in his armchair (free of pain) with all found, at No.10, your Government has a lot to answer for…….. the loss of co-proxamol is most certainly one of them.

Letters to Anne Begg at begga@parliament.uk would I am sure be much appreciated by her especially if you make reference to her debate in the House of Common on 20 April 200 and give her more ammunition about your problems with co-proxamol and fibromyalgia. Maybe you will send a copy to me please -fmsglobalnews@me.com. Thanks.

For the background to the Co-proxamol debate and MP Anne Begg.
SEE: http://fmsglobalnews.wordpress.com/2009/03/13/co-proxamol-a-controlled-drug/

http://fmsglobalnews.wordpress.com/2009/03/24/prescriptions-for-opioids-jump-following-co-proxamol-ban/

http://jeannehambleton77.wordpress.com/2008/01/03/no-u-turn-on-co-proxamol-withdrawal/

http://jeannehambleton77.wordpress.com/2007/12/05/co-proxamol-bungled-withdrawal-is-a-farce/

http://jeannehambleton77.wordpress.com/2007/11/26/co-proxamol-withdrawal-debate/

SEE: http://jeannehambleton77.wordpress.com for more health stories

Enduring chronic stress can destroy brain cells

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

COURTESY OF KELOWNA CAPITAL NEWS – bclocalnews.com

By Annie Hopper – Kelowna Capital News- April 18, 2009

Does stress damage the brain? Accumulative stress not only affects your ability to remember and learn but research scientists have now discovered that chronic stress actually damages and kills brain cells.

Eliminating sources of stress and finding ways to reverse and minimize the effects of stress is our number one health challenge.

Stress is much more than feeling uptight about life.

Unhealthy forms of stress can be emotional (consistent fear, anger or worrying), mental (obsessive thought patterns, negative self talk) or physical (like a car accident, accumulative chemical exposure, virus, infection or chronic pain).

Is it possible that these stressors are at the very root of many life ailments?

The answer here folks is an undeniable YES.

Accumulative stress, in all of its forms, can have a damaging effect on brain function and structure.

This results in faulty brain wiring that not only causes impaired brain function, but can also manifest as a variety of health challenges as well as a maladapted response to stress.

A surprising consequence to brain function as the result of stress is that it can impair the normal neuronal sensory input and the circuitry in the brain can become interrupted or cross-wired.

What this means is that the regular function for a specific part of the brain becomes impaired somehow. The degree of impairment is directly related to how the brain has “crossed its wires” so to speak.

In the case of chronic pain this can mean that the pain signals keep occurring despite lack of a trigger or tissue damage.

We literally get stuck in impaired brain pathways that “feel” real.

Travelling down this impaired pathway also triggers us to think in specific ways in order to protect the perceived injury.

Our thoughts become consumed with how we can avoid pain, and worrying about what might happen if we trigger the pain.

This “protective” thinking strengthens and reinforces this abnormal pathway.

This protective thinking can also set off a cascading effect of stress in the body that not only causes more pain, but can also set off a cascading effect in the body.

Chronic stress also effects immune system function.

The good news here is that the brain has the ability to change and heal itself.

This is known as neuroplasticity and it is the greatest breakthrough in neuroscience in the last four hundred years.

Through practiced mental and behavioural training we have the power to act back on the brain and alter the neuronal patterns that are at the root of many illnesses. And I am not just talking about learning how to meditate here, although meditation is always a valuable tool to have in your wellness tool kit.

I am talking about tools that will help you retrain your brain, transform your health and reclaim your life.

Tools that will assist you in creating your personal health makeover—both internally and externally.

On May 8 to 10, I will teach a three-day brain training workshop called the Dynamic Neural Retraining System at the Hotel Eldorado.

In this workshop, I will show you how to promote radical, positive neuroplastic changes in the brain and how to decrease the body and brain’s stress response.

I consider this workshop extremely valuable for people with Chronic Fatigue Syndrome, fibromyalgia, chronic pain syndromes, multiple chemical sensitivities, electro-magnetic sensitivities and a host of anxiety disorders.

Seating is limited to 10 participants.

Please contact me for more information or to register. Early bird registration is until April 27.

Annie Hopper is a Core Belief Counsellor in Kelowna. 250-862-1766. http://www.anniehopper.com

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(http://www.bclocalnews.com/lifestyles/43195802.html)

SEE: http://jeannehambleton77.wordpress.com for more health stories