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

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

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

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

May 19, 2009 03:00 PM Eastern Daylight Time

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

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

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

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

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

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

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

About the Study

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

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

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

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

This study was sponsored by Pfizer, Inc.

About Lyrica

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

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

Important Safety Information

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

Pfizer Inc: Working together for a healthier world™

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

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

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

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

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

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

Lyrica for Fibromyalgia Pain

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

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

Study of Restless Legs Sufferers

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

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

Less Symptoms, More Sleep

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

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

ATTORNEY AT LAW.COM© 2008
(http://www.attorneyatlaw.com/2009/04/fibromyalgia-and-epilepsy-drug-lyrica-helps-restless-leg-sufferers-researchers-say/)

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

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

Study Finds Benefits for Fibromyalgia Sufferers

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

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

Few Side Effects, Relatively Inexpensive

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

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

ATTORNEY AT LAW.COM© 2008
(http://www.attorneyatlaw.com/2009/04/low-doses-of-drug-for-alcoholics-helps-reduce-fibromyalgia-pain-new-research-finds/)

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

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

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

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

WHY THE FOCUS ON FIBROMYALGIA?

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

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

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

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

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

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

MILLIONS OF AMERICANS HAVE FIBROMYALGIA

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

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

FUNDING OF DISEASE EDUCATIONAL PROGRAMS MUST BE SCRUTINIZED

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

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

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

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(http://www.attorneyatlaw.com/2009/02/fibromyalgia-millions-are-spent-to-educate-the-public-about-a-mysterious-condition/)

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Gastrointestinal Symptoms Common in Fibromyalgia

From the FMAS Global News Desk of Jeanne Hambleton

Nearly all fibromyalgia patients had functional gastrointestinal disorder, compared to 39 percent of study controls

Source: Health Day: Apr 16, 2009

THURSDAY, April 16 (HealthDay News) — A large majority of individuals with fibromyalgia also had functional gastrointestinal disorders (FGID), which may be related to psychological distress, according to research published in the April issue of Clinical Gastroenterology and Hepatology.

Cristina Almansa, M.D., of the Hospital Clinico San Carlos in Madrid, Spain, and colleagues analyzed data from 100 patients with fibromyalgia and 100 controls. All completed the Rome II Integrative Questionnaire, to determine gastrointestinal symptoms and FGID, and the Symptom Checklist-90 Revised for psychological distress. Controls also completed the Chronic Widespread Pain Questionnaire to detect potential fibromyalgia cases.

Most fibromyalgia patients (98 percent) had at least one FGID, compared to 39 percent of controls, the investigators found. The strongest association with fibromyalgia was with irritable bowel syndrome, functional bloating and functional fecal incontinence. Those with fibromyalgia had higher levels of somatization, obsessivity, anxiety and depression, the researchers report.

“An interesting hypothesis that could support the striking prevalence of FGID in patients with fibromyalgia would be an increased visceral sensitivity added to the somatic hypersensitivity characteristic of fibromyalgia in certain patients, which may make them more vulnerable to report gastrointestinal symptoms. Previous studies have shown enhanced visceral sensitivity in patients with irritable bowel syndrome when compared with fibromyalgia and healthy subjects, in contrast to patients with fibromyalgia who present with increased somatic sensitivity,” the authors write.

Copyright © 2009 ScoutNews, LLC. All rights reserved.
(http://www.modernmedicine.com/modernmedicine/Modern+Medicine+Now/Gastrointestinal-Symptoms-Common-in-Fibromyalgia/ArticleNewsFeed/Article/detail/593863?contextCategoryId=40127)

ABSTRACT: Volume 7, Issue 4, Pages 438-445 (April 2009)
Authors: Cristina Almansa, Enrique Rey, Raquel García Sánchez, Ángel Álvarez Sánchez, Manuel Díaz–Rubio

Published online 15 December 2008.

Background & Aims

Fibromyalgia is a rheumatologic disorder associated with somatic and psychologic conditions. Although fibromyalgia is associated with irritable bowel syndrome, its relationship with other functional gastrointestinal disorders (FGID) is unclear. We evaluated the prevalence of FGID in patients with fibromyalgia and the role of psychologic factors in this relationship.

Methods

From a Spanish population, 100 patients with fibromyalgia and 100 matched controls completed the Rome II Integrative Questionnaire to assess the prevalence of FGID and the Symptom Checklist-90 Revised (SCL-90R) to evaluate psychologic distress. Patients completed the Fibromyalgia Impact Questionnaire to evaluate the overall impact of fibromyalgia and controls filled out the Chronic Widespread Pain Questionnaire to detect potential cases of fibromyalgia.

Results

Ninety-three percent of the total study population was female, with a mean age of 50 years. We identified 6 cases of widespread pain among controls. The average Fibromyalgia Impact Questionnaire score for patients was 67.28 ± 14.25. All gastrointestinal symptoms except for vomiting were more frequent in patients. Ninety-eight percent of patients with fibromyalgia had at least one FGID, compared with only 39% of controls. Fibromyalgia was correlated most highly with irritable bowel syndrome. Patients presented with significantly higher scores of psychologic distress than controls, especially those with fecal incontinence.

Conclusions

There is a prevalence of FGID in patients with fibromyalgia and a wider distribution of such symptoms along the gastrointestinal tract compared with controls. We propose that an increased degree of psychologic distress in these patients predisposes them to FGID, especially significant for anorectal syndromes.

Abbreviations used in this paper: FGID, functional gastrointestinal disorder, FIQ, Fibromyalgia Impact Questionnaire, FM, fibromyalgia, GSI, global severity index, IBS, irritable bowel syndrome, PSDI, positive symptom distress index, PST, positive symptom total, SCL-90R, Symptom Checklist-90 Revised

Digestive Diseases Department, Hospital Clínico San Carlos, Madrid, Spain
(http://www.cghjournal.org/article/S1542-3565(08)01235-4/abstract)

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Stanford develops imaging technique to catch arthritis early in onset

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

Courtesy of Stanford School of Medicine USA

BY BRUCE GOLDMAN

STANFORD, Calif. — You come into a doctor’s office with severe knee pain. The physician orders an MRI, which reveals substantial loss of cartilage — osteoarthritis, that is—in your knee joint.

At this point, not much can be done beyond gulping down palliatives and trying to keep your weight off the joint. But the damage may have started building as much as 20 years earlier, possibly due to a traumatic injury to the affected joint.

Just ask Garry Gold, MD, an associate professor of radiology at the Stanford University School of Medicine. Now 45, Gold sustained a knee injury 20 years ago while playing in a pickup basketball game. These days, he is starting to wish his house, currently being remodeled, did not have any stairs.

Gold, who has been diagnosed with osteoarthritis, is working with an imaging technology called sodium MRI to diagnose osteoarthritis as long as decades before the onset of physical symptoms. That may spawn new therapies that could possibly have blocked his disease before it put an end to his basketball days.

Gold is collecting young athletes who have suffered damage to the anterior cruciate ligament, or ACL, in their knee—an injury afflicting several hundred thousand people annually in the United States alone. This knee insult is especially common among female athletes.

“A good fraction of the Stanford women’s basketball and soccer teams either have torn their ACL sometime in the past or will tear it while they are still at Stanford,” Gold said. Even when the initial ligament lesion is repaired surgically, victims remain at almost doubled risk for symptomatic osteoarthritis in the injured knee a decade or two down the road, compared with uninjured people.

MRI now in routine use works by pulsing the area to be observed with electromagnetic energy, at a frequency that preferentially excites the protons in water molecules. As the protons settle back to a relaxed state, they send out an electromagnetic burst of their own, which can be picked up by sensors in the apparatus. Because cartilage has lots of water compared with nearby bone, it shows up on a computer-generated image of the region.

But while standard MRI gives a reasonable display of overall cartilage structure, it does not tell a diagnostician much about the quality of that cartilage.

“If you look into a big house and you see that it is standing up,” Gold said, “you may assume it is going to be safe in the event of an earthquake. But without closer inspection, you do not know much about the integrity of the structure.”

If standard MRI is akin to a view of standing timber in the house, the version Gold is using, called sodium MRI, enables the visualization of dry rot infecting and weakening the wood.

A key structural material in cartilage, called glycosaminoglycan, occurs in a complex with sodium, an elemental metal that has its own set of excitation and relaxation frequencies and is more restricted to cartilage than water is.

Sodium MRI has been around for years, but until recently it could not be used in clinical settings. For one thing, the magnets employed to excite sodium atoms were too puny, making crisp resolution possible only with tiny creatures such as mice.

Gold and his colleague Brian Hargreaves, PhD, assistant professor of radiology, have designed improved magnets and software to scale up the technology for human application.

They are on the right track, said Ari Borthakur, a University of Pennsylvania scientist who is not involved in Gold’s research but has done pioneering work with sodium MRI since writing his PhD thesis on it some years ago.

“Everything his lab has developed is going to be applicable in the clinics,” said Borthakur. “As America ages, we are expecting to see a huge increase in osteoarthritis, and any technique that could be used for its early diagnosis, or that could help developing therapies for curing it, or even slowing the progression of cartilage loss, would be tremendous.”

Gold and Hargreaves’ project is being conducted with funding from the National Institutes of Health and GlaxoSmithKline, an international pharmaceutical company. Neither researcher owns stock in, or receives consulting fees from, the company.

Working with Hargreaves, Gold has imaged the knees of about a dozen volunteers who have suffered a recent ACL injury. In every case so far, significant losses of glycosaminoglycan can be glimpsed under sodium MRI scanning, despite the absence of any sign of damage to cartilage observed with standard MRI. Almost invariably, sodium MRI scans of the injured knee—but not of the other, uninjured one—reveal glycosaminoglycan deficits within three years of the injury, potentially enabling a vastly accelerated diagnosis.

This ought to speed the development of new therapies, and radically lower the cost of doing so, Gold said. The idea is to be able to use glycosaminoglycan loss as a “surrogate marker” of impending osteoarthritis, much as high LDL levels are used to flag people at risk of heart disease—perhaps years before actual symptoms of heart disease manifest. While not everybody with elevated LDL develops cardiovascular disease, this marker has been sufficiently predictive of that condition that regulatory authorities routinely approve drugs based on their ability to lower LDL.

Catching osteoarthritis during its stealth phase may spur clinical trials that would be prohibitively time-consuming and costly if standard MRI were employed, because of the huge lag from the time of an ACL injury until the time cartilage deterioration can be detected by that old method.

With sodium MRI, cohorts of treated vs. untreated at-risk patients could be imaged over time to see if, within a few years of the injury, a drug or a lifestyle change is reducing or arresting the loss of glycosaminoglycan from the ligament. Once promising drugs or lifestyle changes are identified, they could then be administered to at-risk patients long before symptoms surface, Gold said.

As for Gold himself, he has yet to see what his own damaged knee looks like under sodium MRI. The 6-foot-6 once-avid amateur basketball center’s knee is too big for even his improved new experimental apparatus to fit. It’s probably too late for any kind of imaging to do Gold much good now, anyway. He already knows he’s got arthritis. “I don’t even want to look,” he said.

The Stanford University School of Medicine consistently ranks among the nation’s top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

(http://med.stanford.edu/news_releases/2009/january/sodium.html)

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Inexpensive drug appears to relieve fibromyalgia pain in Stanford pilot study

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

Courtesy Stanford University Medical Center and Eurekalert.org

Margarita Gallardo -17-Apr-2009

STANFORD, Calif. — For Tara Campbell, the onset of her fibromyalgia began slowly with repeated sore throats, fevers and fatigue. By the time she was diagnosed, a year later, she had become so debilitated by flulike symptoms and exhaustion that she often could not get off the couch all day.

“Fall, a year ago, I hit my very, very worst,” said Campbell, 39, of Walnut Creek, Calif. “I felt overall pain to the point that even when my children or husband just touched me it hurt.”

Campbell’s symptoms still linger, but since taking part in a Stanford University School of Medicine clinical trial in the spring of 2008, she has improved enough that she has gone back to working again as an interior decorator and even headed up the fundraising auction at her daughters’ school.

“I am really, really good,” Campbell said. “Having said that, I am still not 100 percent. I am still not that person I was before.”

Campbell was one of 10 women with fibromyalgia to take part in a small pilot study at Stanford over a 14-week period to test the new use of a low dose of a drug called naltrexone for the treatment of chronic pain. The drug, which has been used clinically for more than 30 years to treat opioid addiction, was found to reduce symptoms of pain and fatigue an average of 30 percent over placebo, according to the results of the study to be published April 17 online in the journal Pain Medicine.

“Patients’ reactions were really quite profound,” said senior author Sean Mackey, MD, PhD, associate professor of anesthesia and chief of the pain management division at Stanford University Medical Center. “Some people decided to come off other medications. Some people went back to work really improving their quality of life.”

Still, Mackey and his colleagues remain cautious about recommending the drug this early on in the research process. “People need to understand that while we are excited about preliminary results, they are still preliminary, and we need to do longer studies with more patients. There is still a significant amount of work to be done.”

The researchers are moving ahead with a second, longer-term trial of 30 patients who will be tested during a 16-week period.

The drug is particularly promising, the study states, because of the few treatment options available for fibromyalgia patients, its low cost of about $40 a month and its limited side effects. Vivid dreams were reported by a few participants.

Still considered a controversial diagnosis, fibromyalgia is a disorder classified by chronic widespread pain, debilitating fatigue, sleep disturbance and joint disorder. Advocates and doctors who treat the disorder, estimate it affects as much as 4 percent of the population.

“The symptoms of fibromyalgia are commonly seen in a number of other diseases, and there is no well-established and objective blood test to confirm the diagnosis,” said Jarred Younger, PhD, the study’s lead author and an instructor in anesthesia and pain management at Stanford.

“In the meantime, new treatments that work particularly well for fibromyalgia go a long way toward validating the usefulness of the diagnosis.”

The idea to explore the use of a low-dose of naltrexone as a treatment for fibromyalgia began about two years ago when Younger began searching for relief for patients with the disorder. “I was asking patients, ‘Does anything work for you?’” he recalled. “A lot of people in support groups were saying, ‘Yeah, I tried naltrexone and it works for me.’ It just kept coming up.”

The use of naltrexone to treat pain at first seems counterintuitive, Younger said, because at normal doses the drug actually blocks the body’s pain relief systems. However, naltrexone appears to have the opposite effect when given at a lower dose. Naltrexone, at these lower doses, is thought to work by modulating glial cells in the nervous system, Mackey said. Glial cells provide support and protection for neurons and act as a link between the neuronal and inflammatory systems.

“We are learning more and more that maybe by modulating these glial cells we can impact the abnormal processing of pain in these patients,” Mackey said.

During the study, the women used a handheld electronic device to capture their symptoms on a daily basis. They took a placebo for two weeks and then the drug for eight weeks, but they were not told when they were taking the drug or the placebo.

Some of the women, including Campbell, have continued to take the drug after the end of the study because the results were so positive, Younger said.

“Even after the study, it just got better and better and better,” Campbell said. “I think my improvement was about 40 percent during the study. When you are not capable of doing much of anything, that is a lot. I still have localized pain, but I do not have the overall body pain. I can live with that if I do not have the fatigue and flulike symptoms. I am much more back to normal.”

(http://www.eurekalert.org/pub_releases/2009-04/sumc-ida041309.php)
(http://paincenter.stanford.edu/.)(mjgallardo@stanford.edu)

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Chili Pepper Compound Can Bring Pain Relief

From the FMS News Desk of Jeanne Hambleton

COURTESY usnews.com Health Day – Monday March 16

Capsaicin works on nerves to ease joint discomfort, scientists say

(HealthDay News) – University of Buffalo scientists say they have found how capsaicin, the compound that gives chili peppers their fiery flavor, also works to relieve joint and muscle pain.

In a study appearing Tuesday in the journal PLoS Biology, researchers found that capsaicin flips on nerve-ending receptors that sense both pain and heat.

“The receptor acts like a gate to the neurons. When stimulated it opens, letting outside calcium enter the cells until the receptor shuts down, a process called desensitization,” study leader Feng Qin, an associate professor at the university’s School of Medicine and Biomedical Sciences, said in a news release issued by the institution.
The flood of calcium changes the levels at which the receptors detect pain signal. “In other words, the receptor had not desensitized per se, but its responsiveness range was shifted,” Qin said.

While capsaicin has been used in folk medicines for generations, knowing how it works in relation to PIP2 may lead to developing other analgesics that ease pain without first causing irritation on their own, the team said.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about capsaicin .
(http://health.usnews.com/articles/health/healthday/2009/02/25/chili-pepper-compound-can-bring-pain-relief.html)

Finding Effective Treatment for Your Chronic Pain

Studies are underway to look into the effectiveness of alternative ways of delivering pain medications

By January W. Payne

Chronic pain is a problem that—when healthcare, lost income, and lost productivity are taken into account—is estimated to cost about $100 billion in the United States each year. More than a quarter of Americans age 20 or older, or about 76.5 million people, say they’ve experienced pain that lasted longer than 24 hours, according to the American Pain Foundation—and 42 percent have endured pain lasting longer than a year. Nobody keeps good long-term national stats, but if North Carolina’s experience is any guide, the numbers are on the rise.

A just-published study in the Archives of Internal Medicine found that the prevalence of chronic low-back pain in the state more than doubled, to 10.2 percent, between 1992 and 2006. Paul J. Christo, assistant professor and director of the Multidisciplinary Pain Fellowship at the Johns Hopkins University School of Medicine, calls undiagnosed, untreated, or undertreated pain a “significant public-health problem.”

Chronic pain encompasses a multitude of ills, from back pain, headaches, neck pain, and conditions like arthritis and fibromyalgia to pain that develops as a result of cancer treatment and lingers for months or even years. Low-back pain, migraines, and joint pain (particularly in the knees) are among the most common complaints, according to the National Center for Health Statistics. knee pains,

Still, while it may have different origins, chronic pain “can be viewed as an illness in its own right because of its effect on function,” says Russell Portenoy, chairman of the department of pain medicine and palliative care at Beth Israel Medical Center in New York City.

Studies have shown that some people with chronic pain have brain abnormalities, though the connection between that and pain is not well understood. One recent study, for instance, showed that women with fibromyalgia had blood flow abnormalities in a region of the brain known to discriminate the intensity of pain that were not observed on CT scans done in healthy women.

Another study showed that chronic pain may harm the wiring of the brain, as demonstrated on functional MRIs. Chronic pain may also be caused by a problem with the “fight or flight” response, Christo says. “We believe that in certain pain conditions . . . the stress response can worsen pain because that stress response releases a chemical called noroepinephrine. . . . And noroepinephrine binds to certain receptors in the body that trigger pain.”

“Pain is essentially an alarm system that is designed to grab your attention, and when it works properly, it signals harm or healing,” says Scott Fishman, professor and chief of the division of pain medicine at the University of California-Davis School of Medicine. When the body heals, the pain should dissipate, but “the nervous system can become injured,” Fishman says. “That’s when the symptom of pain becomes the disease of chronic pain.”

Finding relief can take quite an effort, since the causes are often not immediately clear and there is not a sure-fire treatment. The battle can require a team of experts, so the multidisciplinary pain clinics or pain management programs that have sprouted up at hospitals, rehab centers, and in free-standing facilities over the past decade or so may be of particular help.

The clinics provide an all-in-one setting for care that, in addition to pain management specialists who may be trained as neurologists, psychiatrists, physiatrists, or anesthesiologists, may include physical therapists, family and vocational counselors, and massage therapists, for example. (The American Chronic Pain Association offers advice on selecting a pain clinic.)

After a full assessment, tailored treatment may include medications from anti-inflammatory drugs to antidepressants to opioids. Since commonly prescribed opioid medications such as oxycodone, fentanyl, and morphine can cause addiction, the American Pain Society and the American Academy of Pain Medicine have just released the first comprehensive clinical practice guidelines to help physicians make treatment decisions.

The guidelines, published in the Journal of Pain, suggest that physicians regularly assess people taking long-term opioids and do periodic drug screenings of patients who are considered to be at risk for abuse or addiction. Meanwhile, the Food and Drug Administration announced plans this month to require the brand-name and generic makers of morphine, oxycodone, fentanyl, and methadone to assist with a plan to reduce the risks associated with the drugs.

Other treatment options include injections of steroids or other medications, nerve blocks that interrupt pain signals, physical therapy, alternative therapies, and psychological interventions such as cognitive behavioral therapy, biofeedback, and guided imagery and other relaxation techniques. Acupuncture, which some people with pain find helpful, is thought to ease pain by raising the level of endorphins in the body, Christo says. “Endorphins are sort of like opioids. . . . They are natural pain relievers,” he says.

“They are released when the body experiences pain—when you sprain your ankle, cut your finger, in response to injury.” Still, research offers conflicting conclusions about the pain-relieving effects of acupuncture. A review of 13 studies published last month in British Medical Journal found that acupuncture offered only a small level of pain relief for people with low-back pain, migraines, knee osteoarthritis, and postoperative pain.

Jennifer Phillips, 41, of Providence Forge, Va., saw 54 doctors before the fibromyalgia that caused her pain was diagnosed in 1996. Finally, after seeing an internist whose nurse had fibromyalgia, she found a routine that works for her: a combination of proper sleep (achieved, in part, using the tricylic antidepressant amitriptyline), daily supplements of vitamins, magnesium, and potassium, plenty of water, and a low-carb diet.

The search is on for greater relief. Studies are underway to look into the safety and effectiveness of alternative ways of delivering pain medications, such as an inhaled form of fentanyl that would get the drug into the patient’s system more quickly. For older people who have fractures of the spine, vertebroplasty and kyphotlasty—two minimally invasive techniques in which bone cement is injected into the collapsed bone in the spine—can result in “significant pain reduction,”

Christo says. In the ongoing debate over how best to handle back pain, a study just published in the Journal of the American Academy of Orthopaedic Surgeons finds that the most effective way to treat most degenerative disc disease cases is to combine physical therapy and anti-inflammatory medications, rather than having surgery.
While it may seem counterintuitive, people with chronic pain should try to get exercise. Experts say it is important to keep moving, both for the usual cardiovascular reasons and in order to avoid muscle atrophy. A supervised, individually designed exercise program, incorporating stretching or strengthening, may improve pain and functioning in people with chronic low-back pain, according to a 2005 study published in Annals of Internal Medicine.

A physical therapist or personal trainer can offer the necessary advice. In fact, staying in bed for more than a day or two can make back pain worse, according to the National Library of Medicine’s MedlinePlus.

Jeff Nance of Indianapolis, whose chronic pain is caused by degenerative disc disease and spinal stenosis of his lower back, recalls that he barely wanted to leave his home three years ago. Then he discovered the Meridian Health Group pain clinic in Indianapolis. Now he is working full time again, and he recently participated in an annual bike ride across the state of Indiana. Nance goes back to the clinic every few months for a check of his medications, and he sees a psychologist a couple of times a month.

“What we try to do is really recognize that people can have pain for all kinds of reasons, [and we] find as many of those causes as possible and treat them in the most specific fashion as possible,” says Michael Clark, associate professor and director of the Chronic Pain Treatment Program in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins Hospital. “Ultimately, you’d like to get somebody well.”

(http://health.usnews.com/articles/health/pain/2009/02/10//finding-effective-treatment-for-your-chronic-pain.html?loomia_ow=t0:a41:g2:r2:c0.160667:b22273524&s_cid=loomia:chili-pepper-compound)

Copyright © 2009 U.S.News & World Report LP All rights reserved.

Fibromyalgia can no longer be called the ‘invisible’ syndrome

From the FMS News Desk of Jeanne Hambleton

Courtesy Eureka Alert

Reston, Va.—Using single photon emission computed tomography (SPECT), researchers in France were able to detect functional abnormalities in certain regions in the brains of patients diagnosed with fibromyalgia, reinforcing the idea that symptoms of the disorder are related to a dysfunction in those parts of the brain where pain is processed.

“Fibromyalgia is frequently considered an ‘invisible syndrome’ since musculoskeletal imaging is negative,” said Eric Guedj, M.D., and lead author of the study. “Past imaging studies of patients with the syndrome, however, have shown above-normal cerebral blood flow (brain perfusion) in some areas of the brain and below-normal in other areas. After performing whole-brain scans on the participants, we used a statistical analysis to study the relationship between functional activity in even the smallest area of the brain and various parameters related to pain, disability and anxiety/depression.”

In the study, which was reported in the November issue of The Journal of Nuclear Medicine, 20 women diagnosed with fibromyalgia and 10 healthy women as a control group responded to questionnaires to determine levels of pain, disability, anxiety and depression. SPECT was then performed, and positive and negative correlations were determined.

The researchers confirmed that patients with the syndrome exhibited brain perfusion abnormalities in comparison to the healthy subjects. Further, these abnormalities were found to be directly correlated with the severity of the disease. An increase in perfusion (hyperperfusion) was found in that region of the brain known to discriminate pain intensity, and a decrease (hypoperfusion) was found within those areas thought to be involved in emotional responses to pain.

In the past, some researchers have thought that the pain reported by fibromyalgia patients was the result of depression rather than symptoms of a disorder. “Interestingly, we found that these functional abnormalities were independent of anxiety and depression status,” Guedj said.

According to Guedj, disability is frequently used in controlled clinical trials to evaluate response to treatment. Because molecular imaging techniques such as SPECT can help predict a patient’s response to a specific treatment and evaluate brain-processing recovery during follow-up, it could prove useful when integrated into future pharmacological controlled trials.

“Fibromyalgia may be related to a global dysfunction of cerebral pain-processing,” Guedj added. “This study demonstrates that these patients exhibit modifications of brain perfusion not found in healthy subjects and reinforces the idea that fibromyalgia is a ‘real disease/disorder.’”

According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, fibromyalgia syndrome is a common and chronic disorder characterized by widespread muscle pain, fatigue and multiple tender points. Tender points are specific places—for example, on the neck, shoulders, back, hips, and upper and lower extremities—where people with fibromyalgia feel pain in response to slight pressure. The syndrome is one of the most common causes of musculoskeletal pain and disability and affects three to six million, or as many as one in 50, Americans. Between 80 and 90 percent of those diagnosed are women.

Although fibromyalgia is often considered an arthritis-related condition, it does not cause inflammation or damage to the joints, muscles or other tissues. Like arthritis, however, the significant pain and fatigue caused by fibromyalgia can interfere with a person’s ability to carry out daily activities.

Coauthors of “Clinical Correlate of Brain SPECT Perfusion Abnormalities in Fibromyalgia” include Eric Guedj, Serge Cammilleri and Olivier Mundler, Service Central de Biophysique et de Médecine Nucléaire, AP-HM Timone; Jean Niboyet, Patricia Dupont, Eric Vidal and Jean-Pierre Dropinski, Unité d’Etude et de Traitement de la Douleur, Clinique La Phocéanne, all of Marseille, France.

About Society of Nuclear Medicine – SNM

SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today’s medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.

SNM’s more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit http://www.snm.org.

Contact: Amy Shaw – ashaw@snm.org – 703-652-6773 – Society of Nuclear Medicine

FIBROMYALGIA AND PFIZER

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

Pfizer, the manufacturers of Lyrica, the first fibromyalgia drug to be approved by the American Food & Drugs Associations (FDA), have decided to end human testing on a late-stage experimental drug, esreboxetine, which may have improved the cognitive function of patients with fibromyalgia. A second drug also to be withdrawn from the testing programme is associated with general anxiety problems. Both of these conditions are among the many symptoms of fibromyalgia.

The company announced it would stop further testing on these experimental primary care medications, now in the late stages of development, as they were other drugs available to treat these conditions.

The decision follows a move to ‘shift funding’ to alternative experimental drugs that have a greater profile.

The Wall Street Journal website, (http://blogs.wsj.com/health/2009/02/24/pfizer-drops-two-drugs-from-late-stage-pipeline/trackback/) overnight, on February 24, 2009, announced Pfizer Drops Two Drugs from Late-Stage Pipeline.

Sarah Rubenstein wrote two drugs in Pfizer’s late-stage pipeline are biting the dust.

The company said today it is ending development of esreboxetine, for fibromyalgia, and a drug known as PD 332,334, for generalized anxiety disorder.

In announcing the decision, Pfizer made a between-the-lines reference to the increasing pressure from insurers and regulators on the drug industry to pour research resources into products that make a real difference for people’s health rather than just add on to crowded categories. The economic-stimulus bill, for instance, offers up $1.1 billion for research comparing drugs and other treatments to each other.

Based on the data on the two drugs, “along with current market dynamics,” Pfizer said, “it was considered unlikely that either compound would provide meaningful benefit to patients beyond the current standard of care.” It added that safety was not the issue.

That said, there are not a lot of drugs on the market for fibromyalgia: Pfizer’s Lyrica was the first to win approval for fibromyalgia, and Lilly’s Cymbalta got the nod too. But fibromyalgia, a condition characterized by long-standing pain, has been the subject of controversy over its legitimacy, despite being recognized as a disease by the FDA and insurers.

Pfizer said today it is still seeking approval for Lyrica for generalized anxiety disorder, despite the demise of PD 332,334. In this case, though, there is a lot out there. The Mayo Clinic lists a bunch of drugs used for the disorder, including Cymbalta and Forest Labs’ Lexapro and generic versions of Lilly’s Prozac and GlaxoSmithKline’s Paxil.

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NEW DATA ON THERAPIES FOR PAIN AND INFLAMMATION FROM PFIZER

By Jeanne Hambleton © Fibromite NFA Leader Against Pain

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

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

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

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

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

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

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

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

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

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

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

Fibromyalgia

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

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

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

Rheumatoid Arthritis

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

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

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

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

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

Osteoarthritis Pain

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

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

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

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

About Celebrex

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

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

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

Gastrointestinal Risk

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

About Lyrica

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

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