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

WOMEN IN NETS CLAIMING TO BE TRAPPED IN PAIN IN 8 EUROPEAN CITIES

From the Fibromyalgia News Desk of Jeanne Hambleton

PRESS RELEASE Embargoed until 7.3.09

Brussels, (07.03.2009) – This Saturday has not only been marked by the International Women’s Day but also by the European action day on Fibromyalgia. While normal people were doing their usual Saturday’s shopping, the European Network of Fibromyalgia Associations and its Member Associations gathered together in eight European cities centres to expose their situation as women-patients suffering from fibromyalgia.

Simultaneously at 16:00 (Brussels time) in Paris, London, Amsterdam, Frankfurt, Brussels, Dublin, Milan, Lisbon and Madrid a passive demonstration took place where fibromyalgia community members trod the pavements of these cities.

The actual main issue around Fibromyalgia is that currently in Europe there is no recognized treatment whereas in the USA there are already 3 medicines available.

“This year has been declared the year against fibromyalgia by the European arm of the International Association for the Study of Pain (IASP-EFIC) and for this reason ENFA, as the European umbrella of fibromyalgia organisations wish to inform as much as possible not only diagnosed patients, but the general public, medical professionals, policy makers and politicians” says Pam Stewart, ENFA’s vice-president.

“Early diagnosis, diagnosis, treatments and information are still lacking for the estimated 14 million patients in Europe” says Robert Boelhouwer, ENFA’s president. “We have to keep on mobilizing the general public but also the politicians by having regular action days and awareness campaigns. This is the first event in 2009; the next one will take place in May on the occasion of the “International Fibromyalgia Awareness Day”, then in September and October. We will keep on fighting until we get a full and clear recognition of our disease, starting with a treatment approved for Europe,” he added.

Last December, 418 Members of the European Parliament from the 27 European countries expressed their wish to the European Commission and to the Member States to help raise awareness of the condition and facilitate access to information for health professionals and patients, by supporting European and national awareness campaigns; to encourage Member States to improve access to diagnosis and treatment; to facilitate research on fibromyalgia through the work programmes of the EU 7th Framework Programme for Research and future research programmes; and finally to facilitate the development of programmes for collecting data on fibromyalgia. The European Parliament has been the first European Institution to answer the call of the fibromyalgia community. The European Commission has been also recently been contacted but no reaction has came from them yet.

Fibromyalgia is a complex disease with a variety of symptoms in addition to the defining symptom – chronic widespread pain. These include fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, anxiety and cognitive dysfunction often referred to as “fibro fog.” All of these symptoms cause serious limitations in patients’ ability to perform ordinary daily chores and work and severely affect their quality of life. Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.

Fibromyalgia imposes large economic burdens on society as well as on affected individuals. A study shows that an average patient in Europe consults up to 7 physicians and takes multiple medications over 5-7 years before receiving the correct diagnosis. The debilitating symptoms often result in lost work days, lost income and disability payments. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations.

Contact:Mr. Robert Boelhouwer President European Network of Fibromyalgia Associations (ENFA)
ENFA contact@enfa-europe.eu – http://www.enfa-europe.eu

A ‘Murky Business’ – Yes it is REAL

AP Associated Press IMPACT:

Drug makers’ push boosts ‘murky’ ailment

Collated by Jeanne Hambleton FMS Global News Desk ©2009        

 

A ‘Murky Business’ – Yes it is REAL

AP Associated Press IMPACT:

Drug makers’ push boosts ‘murky’ ailment

Collated by Jeanne Hambleton FMS Global News Desk ©2009        

 

Business Writer Matthew Perrone for AP: Associated Press has  “set the cat among the pigeons” with his reference to fibromyalgia and ‘murky ailments’. Posted in Washington on February 8 2009, this article has the promise of the same reaction given to the infamous IS DISEASE REAL article on fibromyalgia that appeared in the New York Times.

 

The  above story by NY Times reporter Alex Berenson published January 14, 2008 can be read at  <http://www.nytimes.com/2008/01/14/health/14pain.htmlem&ex=1200459600&en=bac45d5aff5a17d7&ei=5087> 

 

The members of the fibromyalgia community who are somewhat sensitive about questions suggesting FMS is an imaginary illness, has risen to the bait and letters are flocking in from around the USA where the article was published and in the UK, where it has been given coverage by FMS Global News.

 

Matthew Perrone, a business writer, suggests huge sums of money were provided by two drug companies last year in an endeavor to raise awareness of a “murky illness” as well as boost the sales of their medication recently approved by the Food & Drugs Association (FDA.). The writer claims the drug companies have been “drowning out unresolved questions” …. “whether it is a real disease at all”. 

 

Oooophs. That went down like a lead balloon.

 

Matthew Perrone discovered that the two drug companies, Pfizer and Eli Lilly, have in the first nine months of 2008 donated upward of $6 million towards educational events and to supporting non-profit making medical conferences. He claims this sum is greater than funds given to Alzheimer’s and diabetes. Top priority for funding by Pfizer was for cancer, AIDS and the fibromyalgia. Similarly Eli Lilly favoured cancer, depression and fibromyalgia.

 

While reminding readers that the cause for fibromyalgia still not known, with no specific test to confirm diagnosis, patients often showed overlapping symptoms with other neurological diseases. He claimed the specialists are in no doubt about the pain these patients suffer but they cannot agree how it should be treated and what illness it actually is.

 

It is believed by many patients and doctors, says Matthew Perrone, that the actions of the drug manufacturers are helping to solved the mysteries of fibromyalgia within the medical profession. He does acknowledge that patients with fibromyalgia say doctors often disbelieved them claiming the pains are imaginary or “all in your head.”

 

The article adds “critics say the companies are hyping fibromyalgia along with their treatments, and that the grant making is a textbook example of how drug makers unduly influence doctors and patients.”

 

Dr Frederick Wolfe, a member of the panel who helped to definite the criteria for fibromyalgia and adopt the name in 1990, suggests the drug companies are guilty of  “a little disease-mongering” to encourage patients to buy their medication. The business writer reports that the companies have been successful in the actions showing huge increases in sales and profits between 2007 and 2008 for Lyrica and Cymbalta –both approved for the treatment of fibromyalgia by the FDA. 

 

Responding to questions from the author the drug companies say their actions are “just the evolution of greater awareness” of a condition that has been poorly managed and neglected. 

 

The article includes the story of a patient taking both Cymbalta and Lyrica and three other medications. Describing her medicated condition as fibro fog she is quoted as saying she is so medicated she feels as though she is not here. Struggling to find money for her medication she claimed she is receiving free samples of Lyrica from the drug company representative to help her get through the month.

 

The article reports both drug companies spent of $125 million on advertising in the first nine months of 2008.

 

Grants from the drug companies are available for education for doctors, non-profit making groups and advocacy. Some of this money is used for research and patients outreach.

 

President of the USA National Fibromyalgia Association Lynne Matallana is quoted as saying lack funding would impact on patients’ care due to lack of money for medical education. Matthew Perrone claims that 40% of the funding for the $1.5 million a year Association’s operations is provided by corporate funds, like those given by Eli Lilly and Pfizer. Lynne Matallana who has fibromyalgia claimed she visited 37 doctors before being diagnosed.

 

In a Pfizer television commercial the drug company acknowledged fibromyalgia is real, but Matthew Perrone says the researchers report it is not that easy. The condition usually known as a syndrome, has been described as a disease, a collection of symptoms and even a behaviour disorder.

 

This description suggesting a behaviour disorder has caused some concern among the fibromyalgia community who insist it is not a mental disorder.

 

It is thought that up to 12million people in the USA may have fibromyalgia in the USA with a large percentage of them women.

 

Market research on behalf of the pharmaceutical industry indicated that possibly 50% of this number are not diagnosed said Dr. Daniel Clauw (University of Michigan).

 

Dr. Don Goldenberg (Tufts University) who has spent 30 years working with fibromyalgia claims it remains a “murky area”.  He said patients preferred to have a name for what ailed them.  It was suggested that while Dr. Goldenberg is a diagnosing patients he said a number of doctors no longer diagnosed FMS patients suggesting it is a “catchall covering a range of symptoms”.

 

A professor at the University of North Carolina Dr. Nortin Hadler believes identifying fibromyalgia can “doom” patients to endure suffering for the rest of their lifetime and just confirms to them that this is a condition with no cure.  Dr. Hadler said the likelihood for patients diagnosed with fibromyalgia improving was “pretty dismal”

 

His view was that fibromyalgia was not a medical disease but a psychological condition (‘having to do with the mind’). He believed therapy should be available instead of drugs and medication, to help patients “unlearn” their problem.

 

Dr. Clauw whose research has revealed patient’ brains reveal  “unusual activity” when suffering pain, confirms fibromyalgia is a legitimate disease and he had no time for experts who analyse definitions instead of helping patients.  He also agreed that the new drugs approved by the FDA do not work for all  patients.

 

This article is a summary of  a story published by AP Associated Press distributed by Google.  © 2009 The Associated Press. All rights reserved.

http://www.google.com/hostednews/ap/article/ALeqM5jZDQjkt1twJK_3GpRKJUbXZ_-oMwD967HPG81

 

Fibromyalgia is not ‘murky’ to millions of people who live with it

Letter to the Editor of CantonRep.com  Posted Feb 13, 2009 

 

I read with interest “Drug makers push boosts a ‘murky’ ailment” (Feb. 9). I am both a patient with fibromyalgia and a physician who specializes in this condition, so I find it incredible when the article refers to so-called experts who are skeptical that the diagnosis even exists and that drug makers are somehow responsible for perpetuating this condition. 



Fibromyalgia is not “murky” to the many millions of patients worldwide who have it, and to the thousands of doctors who diagnose and treat it. It is a real condition with its own insurance code, specific diagnostic criteria and proven helpful treatments. It is recognized by major medical and legal organizations, including the Food and Drug Administration. 



We have not found a cure yet, but ongoing research is necessary to help improve the quality of lives of those who suffer from this chronic disease. To date, the FDA has approved three medicines for treatment of fibromyalgia pain.

These so-called experts mentioned in the article do not believe fibromyalgia exists, thus they never diagnose or treat it. To me, no experience with this condition means no expertise. Fortunately for patients, there are many primary-care doctors and specialists  (in the USA) who understand, research and treat fibromyalgia: the true experts. 



Unlike the critics, these professionals have actual experience and skills in trying to improve lives affected by chronic pain and will prescribe approved medications, not blame drug makers or patients for the pain. The true experts may not be as vocal as the so-called experts, but their efforts to help those with fibromyalgia have spoken the loudest. 


MARK J. PELLEGRINO, M.D., 

JACKSON TOWNSHIP

Reproduced courtesy of CantonRep.com Connecting Stark County

(http://www.cantonrep.com/opinion/letters/x817675485/Fibromyalgia-isnt-murky-to-millions-of-people-who-live-with-it)

 

National Fibromyalgia Association’s Response to

AP Article on Drug Companies & Fibromyalgia

Fibromyalgia & CFS Blog Friday February 13, 2009

By Adrienne Dellwo, About.com Guide to Fibromyalgia & CFS

 

The inaccuracies of the recent AP report, Drug makers push boosts ‘murky’ illness, go even beyond what I pointed out in a recent blog. Here is the response from Lynne Matallana, president of the National Fibromyalgia Association:

“To the editors:

“The recent Associated Press story on fibromyalgia hardly qualifies as news; it merely regurgitates the same arguments that have been published in the past and offers the opinions of the same two men who have built careers out of drawing attention away from the hundreds of scientists who continue to make amazing scientific strides toward understanding the underlying cause(s) and pathophysiology of what fibromyalgia patients experience.

 

“By perpetuating this message, the article implies that it is more acceptable to debate names or labels for this “set of symptoms” and to point fingers at the usual “villains” (i.e.: pharma and the non-profits who accept money from them), than to focus on the millions of desperate patients who deserve to have a voice in the discussion.

 

“The fact is that credible medical institutions and organizations recognize fibromyalgia as a life-altering disease; the fact is that patients who suffer with FM depend on the medical system (including pharmaceutical companies) to help them inform the public that this is a very real illness and that they need treatments, including pharmaceutical agents, to help them get through each day and to look forward to some sort of quality of life in the future.

 

“This article misinforms readers in a way that undermines and victimizes innocent people. By telling only selective parts of the story the author is perpetuating misperceptions and making it difficult, if not impossible, for readers to grasp what is truly important: that we need to stop debating and pointing fingers and start asking why it is perceived as acceptable to stigmatize a patient population just because medical research has not yet provided us with all the information needed to understand that particular illness. Every illness seems to go through a stage of having to prove its legitimacy, but why should the patients be suspect during that phase of research?

 

“Why would AP print information that is simply not true – people with fibromyalgia are “more likely to have a history of mental illness and are economically disadvantaged?” That is totally false, as is the writer’s statement that the National Fibromyalgia Research Association received pharma money to fund Dr. Clauw’s functional MRI study. The money for all of the NFRA’s funded research came from the founder (the husband of a fibromyalgia patient), general donations, and revenue generated from a non-profit bingo game. (Yes, the FM community has had to rely on bingo games to fund our research!)

 

“How can we allow the system to fail millions of people whose only ‘fault’ is to have developed a devastating illness? Along with the rest of the fibromyalgia patient community, I look forward to the day when society (including the medical community, the media, and our government agencies) accepts the responsibility of treating fibromyalgia patients like any other group of chronically ill patients; when it is a given that fibromyalgia will be further studied, that treatments will be developed and made accessible to patients, that the media presents the facts rather than perpetuating threadbare controversies.

“Now that would be news worth printing.

“Sincerely,

“Lynne Matallana

President, National Fibromyalgia Association”

Courtesy About.com

http://chronicfatigue.about.com/b/2009/02/13/national-fibromyalgia-associations-response-to-ap-article-on-drug-companies-fibromyalgia.htm

 

A ‘Murky Business’. Yes it is REAL

http://fmsglobalnews.wordpress.com

 A FIBROMITE’S RESPONSE

 

To the Editor and Business Writer Matthew Perrone Associated Press (info@ap.org).

Dear Sirs,

It is with great distress that I have read the article that denies the existence of this truly horrible illness. I would like to stress firstly that I am not a previous sufferer of mental illness, although I am now being treated for depression, and I am from an economically secure background.

 

Just answer me one question, if this illness is all in my head, how come so many millions of us suffer from such similar symptoms. Are we transmitting then to each other telepathically? We do not suffer identical intensity of each symptom, some us have irritable bowel syndrome worse than others for instance, but we all suffer from unexplained severe pain, terrible tiredness and loss of the quality of our lives.

 

I, sir, am a qualified psychologist who for a long time thought I was going mad, especially as every test I had came back negative. To actually realise that the awful symptoms I was suffering were not a result of “being in my head” came as a great relief and if drug companies are making profits that can be used to find out what causes this and find a cure I say hallelujah!!!

 

Articles like this do nothing to help and indeed set us back and damage us immeasurably in our quest to be taken seriously and find a cure.

 

Yours in despair

Carolyn from Felpham, West Sussex. UK

 

 THE FIBROMYALGIA COMMUNITY RESPONDS

 TO ASSOCIATED PRESS ARTICLE

 

1. The Associated Press article by Matthew Perrone (February 8, 2009, “Drug makers’ push boosts ‘murky’ aliment) has drawn several comments.

Click here to read the article.

Click here to read the NFA’s response, as well as some comments by other readers.

To send a letter to AP business editor Kevin Noble or writer Matthew Perrone, email info@ap.org  (no attachments).

2. The NFA is in the process of contacting media outlets across the nation that published Mr. Perrone’s article. In addition to sharing the disappointment of the fibromyalgia community, our response provides accurate information about fibromyalgia, including the science behind fibromyalgia and the lack of research funding.

3. For a list of 10 ways to respond to negative and false Information about fibromyalgia, click here.

4. Several points made in the AP article were addressed by fibromyalgia experts on February 11, 2009 during a medical talk show produced by Patient Power. Guests included leading FM researcher Daniel Clauw, MD, professor of medicine in the Division of Rheumatology, University of Michigan Health System; Martha Beck, Ph.D., who has been diagnosed with fibromyalgia; and Lynne Matallana, president and founder of the National Fibromyalgia Association. Click here to listen.

5. The NFA has created two information sheets—the Fibromyalgia Fact Sheet and Recognition, Research and Science—for your reference and use in helping dispel misunderstandings about fibromyalgia.

Click here to view the Fibromyalgia Fact Sheet.

Click here to view an overview on Recognition, Research and Science.

6. In addition to a variety of articles about managing FM symptoms, overlapping conditions, and healthy lifestyle choices, the NFA’s 10-year anniversary issue (September-November 2007) includes a special section on the History of Fibromyalgia. Topics include:

The state of FM and how it has changed in the last 10 years

How changing perspectives on FM have impacted the specialties that focus on it  

How patients have succeeded in changing public perception of FM

The latest studies on medications commonly prescribed to treat FM. Click here 

 

Undermining the Validity of FM


Sharon Waldrop – Director, Fibromyalgia Association of Michigan USA

 

My name is Sharon Waldrop. I am the Founder and Director of the Fibromyalgia Association of Michigan, a volunteer nonprofit organization. I am a patient living with fibromyalgia (FM) and I am deeply disappointed in the article that ran yesterday in the Free Press copied off the AP. I am writing to you to ask if you would do a story on fibromyalgia to provide a balanced report on fibromyalgia? 

I am very sad that the millions of people who are suffering and struggling every minute of every day with fibromyalgia never get a chance to give their viewpoint in the media. Instead articles are written to please editors who have a formula that dictates what type of story “gets attention” and therefore gets printed …never taking into consideration or caring about the ramifications that their message will have on millions of innocent people.


The ramifications are that more marriages crumble, friendships (i.e. support systems) end, people lose jobs, people are denied access to care because the opinions of a select few are given mass attention. Credible medical institutions like Johns Hopkins University, the University of Michigan, the National Institutes of Health, (just to name a few), recognize fibromyalgia as a life-altering disease. It is time to treat FM patients with respect. Millions of people suffer from FM.  Millions more are suffering too as they watch their loved one struggle. These people do not need to read stories that FM is not real. They need to read stories about the exciting medical advances in fibromyalgia like the brain imaging study done at the University of Michigan that concretely prove people’s brains with FM act differently than people without FM. 

They need to be given hope and given the treatment they deserve as a human being.

My group has over 800 members in the Metro Detroit area.  We provide support and education to people affected by fibromyalgia.  People come to me in tears because they don’t know where to go for help. I am pleased that for 11 years I have given people a place to go – even if it is just for one night a month. No human being should have to fight an illness and also fight with spouses, friends, employers and yes, even doctors that they are in disabling physical pain. The question is not why do we continue to undermine the validity of FM but why are people afraid to provide support to people suffering from the chronic pain of fibromyalgia?
 In this time of uncertainty in the world, people more than ever need hope and help. Please will you write a story to help your readers understand FM? On behalf of my group we would greatly appreciate it.

 

Is Fibromyalgia Real?
 Andrew Schorr -
Founder Patient Power

We could have predicted it. Naysayers who say that now there are three approved prescriptions medicines for fibromyalgia, a chronic pain syndrome, marketing is fueling hype hype about a condition some people say is all in a patient’s head.

Here we go again. The drug companies are always an easy target. When a drug is a success it can bring in more than a billion dollars a year. Treatments are costly and many people, including millions with no insurance or who are under insured, struggle to pay for them. So the pharmaceutical industry continues to have a public relations problem.

But none of that has anything to do with whether people, primarily women, are suffering with debilitating pain, pain that is effectively treated often by the approved medicines.

Critics including some doctors say that because there is no definitive test for fibromyalgia it is a disservice to rush to treatment with the new drugs when maybe some patients need psychotherapy instead. It is in the patient’s head.

I am not qualified to evaluate who needs the medicines and who does not. But I do know this: the FDA advisory panels and the FDA itself would not have approved the medicines, nor would the drug companies have invested hundreds of millions of dollars on clinic trials, if they had no effectiveness.

After approval the drug companies have hit the airwaves with television commercials and with websites trying to raises awareness for the condition and that there are approved treatments. They also have been funding education programs to connect rheumatologists, who know all about fibromyalgia, with many primary care doctors who don’t. And they are funding patient education in partnership with groups like the National Fibromyalgia Association, founded by a patient and an organization that has cried out for awareness and effective treatments for years.

Is this public and medical education effort a bad thing?

Some media reports suggest it is: getting doctors and the public in a tizzy about a phony or overused diagnosis fueled by greedy drug companies who want to make billions. Oh please! While one could argue such important issues should be debated, I think we should focus on how to help give suffering patients relief from their pain and celebrate that private industry has made huge investments to meet the need.

Do we need to sort out exactly who needs these treatments and who could benefit in other ways? Sure. But to cast the same old aspersions on the drug companies is unfair and if we keep skewering them one day we can kiss drug development goodbye. The next time you swallow a pill that helps, you ask yourself what the world would be like if no one invented or marketed products like that.

 

FIBROMYALGIA Painfully Real 

Frederic Porcase Physician,

Jacksonville USA

 

Monday’s article demeans all of us with fibromyalgia.

The horrible part was the “Mind over Matter?” stating, “Patients diagnosed with fibromyalgia are more likely to have a history of mental illness, be overweight and economically disadvantaged. Some doctors say their suffering may stem from difficult circumstances rather than disease.”

I run a support group for people with fibromyalgia, and that is not the case. We are all type “A” personalities who have been forced to change our lives due to this horrible disease/syndrome.

All of us would give up our “great” disability funds for the more profitable lives we were living before the chronic pain and fatigue. We may be overweight now, due to not being able to exercise, but this was not the case before the chronic pain and fatigue started not after the diagnosis.

We all had the symptoms years before we actually got a diagnosis. No, we are not hypochondriacs. Fibromyalgia is an invisible disease. Thank goodness we don not look as bad as we feel. Walk in our shoes just one day and then say we have a mental disorder.

Courtesy Opinion.jacksonville/com

http://jacksonville.com/opinion/letters_from_readers/2009-02-11/story/letters_from_readers

 

Utterly real

Letters Published: Tue, Feb. 10, 2009 

Taryn Oesch – Raleigh USA

 

I was diagnosed with fibromyalgia when I was 13 by a Duke rheumatologist. It was a struggle to get back to feeling healthy, but it was a relief to know that I wasn’t imagining my achiness and debilitating fatigue. I have always considered myself fortunate to live in a time when fibromyalgia is considered a real syndrome.

The Feb. 9 Associated Press article “Help or hype? Drug makers fibromyalgia grants raise questions,” however, made me realize we still have a way to go.

Apparently, there are still those who would question the diagnosis, despite the fact that it has helped many people. It disturbed me especially that the article seemed to sympathize with the skeptics. Having a complaint of “I’m very tired” is hard enough to try to explain to professors or employers. 

The only press those of us with fibromyalgia need is press that makes everyone more aware that yes, fibromyalgia is real and yes, its diagnosis is backed by medical research.

 

 

Courtesy The News&Observer

http://www.newsobserver.com/opinion/letters/story/1401086.html

READERS: If you are writing to the Editor of Associated Press or the Business Writer Matthew Perrone, please send a copy of the email to me. I am interested and would like to publish your comments. Thanks. Please write to fmsglobalnews@me.com.Jeanne 

 

 

 

AN ELEPHANT AMONG US: THE ROLE OF DOPAMINE IN THE PATHOPHYSIOLOGY OF FIBROMYALGIA

From the  Fibromyalgia Global News Desk of Jeanne Hambleton

Source:The Journal of Rheumatology, Feb 2009

by Patrick B Wood, MD, and Andrew J. Holman, MD - February 13, 2009

 

 

Exploration of the pathophysiology underlying fibromyalgia (FM) has become an exciting field of inquiry as we strive to improve our understanding of this enigmatic disorder.

While evidence of a neuro-dysregulatory state mounts and insights are gained as to potential contribution of specific neurotransmitters, a review of recent literature demonstrates that not all relevant neurotransmitters are being considered equally or with disinterest. Specifically:

• The potential contribution of serotonin and norepinephrine has been emphasized, ostensibly due in part to the qualified success of trials of serotonin-norepinephrine reuptake inhibitors,

• While a general awareness of the potential contribution of dopamine-related dysfunction lags. 

Indeed, the text of recent reviews, and even peer-reviewed continuing medical education test articles, have contained either scant reference or, in a majority of cases, conspicuous neglect regarding the question of dopamine’s role in FM.

Despite the recent European League Against Rheumatism consensus recommendation to consider a dopamine agonist for treatment of FM, most clinicians and even medical authorities in the field routinely fail to acknowledge the mounting evidence for a role for dopamine in the pathogenesis of FM. 

The proposition that a disruption of normal dopaminergic neurotransmission may make a substantial contribution to the pathophysiology of FM was initially based on 3 key observations:

1. FM has been characterized as a “stress-related” disorder due to its frequent onset and apparent exacerbation of symptoms in the context of stressful events;

2. The experience of chronic stress results in disruption of dopaminergic activity in otherwise healthy organisms; and

3. Dopamine plays a dominant role in natural analgesia within multiple brain centers. 

The first hint in the medical literature of a connection between FM and dopamine was provided by Russell, et al, who in 1992 reported lower concentrations of metabolites of dopamine, norepinephrine, and serotonin … 

 

[Note: to read the free full text of this article by the originators of the Dopamine Theory of Fibromyalgia, click here.]

Source: The Journal of Rheumatology, Feb 2009. 36(2). PMID: 19208556, by Wood, PB, Holman AJ. Angler Biomedical Technologies, LLC, Jonestown, Texas; Pacific Rheumatology Research, Inc., Renton, Washington, USA. [E-mail:pwood@anglerbiomedical.com]

Courtesy ProHealth.com

http://www.prohealth.com/library/showarticle.cfm?libid=14320

EUROPEAN NETWORK of FIBROMYALGIA ASSOCIATIONS

From the News Desk of Jeanne Hambleton

PRESS RELEASE -28.01.2009

 

The European Medicines Agency (EMEA) are to  have a consultation with a delegation from the European Network of Fibromyalgia Associations (ENFA) in an attempt to understand the need for medical treatments for fibromyalgia in Europe.

Brussels – Following an invitation by the EMEA, the European Network of Fibromyalgia Associations (ENFA) has agreed to attend a consultation meeting with EMEA, where ENFA representatives will share their knowledge and experiences related to the disease of Fibromyalgia that some 14 million Europeans are suffering from.  One of the biggest challenges that the patients have been facing is the lack of officially recognized medical treatment options in the European Union whereas there are three drugs in the United States of America approved by the Food and Drug Administration: Cymbalta from Eli Lilly, Lyrica from Pfizer and recently authorised Savella from Forest & Cypress.

 

The European Declaration 69/2008 on Fibromyalgia that has been recently adopted by the European Parliament, symbolizing the awareness raised around Fibromyalgia, calls for actions on specific issues from European Institutions to improve healthcare surrounding the disease, e.g. investment in research and provision of better diagnosis and treatment.  In addition, the European Health Commissioner Ms. Vassiliou’s remarks (E-6262/08EN) on the treatment of Fibromyalgia demonstrates encouraging willingness of the European Commission to address various concerns laid out in the Declaration on Fibromyalgia.

“We hope that this new drive on Fibromyalgia awareness will bring the end to the impasse of medical treatment for Fibromyalgia patients in the EU”, said Mr. Robert Boelhouwer, President of ENFA. 

Fibromyalgia is a complex disease with a variety of symptoms in addition to the defining symptom – chronic widespread pain. It is estimated that 14 million people in Europe suffer from fibromyalgia and the condition is more prevalent with women (87%).  Fibromyalgia imposes large economic burdens on society as well as on affected individuals. The debilitating symptoms often result in lost work days, lost income and disability payments. Due to lack of awareness, on average patients in Europe see 3-4 physicians and take multiple medications over the course of several years before they receive a diagnosis of Fibromyalgia.

Mr. Boelhouwer said, “Increasing awareness of Fibromyalgia among healthcare professionals and patients will bring enormous benefits to patients, healthcare providers and the society in general by managing the burden of the disease.” he continues, “Having this in mind, ENFA welcomes the proactive role that both the European Parliament and the European Commission have taken up in raising the awareness of Fibromyalgia.”

 

 

Contact:  European Network of Fibromyalgia Associations (ENFA)

Mr. Robert Boelhouwer President of ENFA

contact@enfa-europe.eu  - www.enfa-europe.eu

 About ENFA

ENFA is a network of patient association and support groups working in close consultation with the national association in the relevant country. Our joint missions are to conquer the myths and misunderstandings around Fibromyalgia. The network will help collectively push forward the boundaries which currently exist in understanding, experiencing and treatment of Fibromyalgia. Our main goal is to see fibromyalgia receiving the recognition it deserves across Europe as an illness in its own right.

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http://www.europarl.europa.eu/QP-WEB/application/home.do?language=EN

 

 

New UNR center raises hopes for CFS patients

From the News Desk of Jeanne Hambleton 

BY LENITA POWERS • LPOWERS@RGJ.COM • FEBRUARY 5, 2009

People from across the nation and around the world who suffer from Chronic Fatigue Syndrome and other neuroimmune diseases are waiting anxiously for the opening next year of a new medical research center at the University of Nevada, Reno.

The $86 million Center for Molecular Medicine will expand the university’s research capabilities into cancer and other diseases and house the headquarters of the Whittemore Peterson Institute, which offers hope in the form of clinical trials and treatment for people who suffer from such diseases as Chronic Fatigue Syndrome, fibromyalgia and atypical multiple sclerosis.

“I get letters from all over the world, Australia, Spain, Ireland, London,” said Annette Whittemore, founder and vice president of the Whittemore Peterson Institute. “I got an e-mail saying Canada cheered when they heard the news that the institute was going to be a reality.”

The institute plans to conduct clinical trials, but there is no waiting list yet, said Whittemore, wife of Nevada lobbyist, lawyer and developer Harvey Whittemore.

The Whittemores — whose 31-year-old daughter, Andrea, has suffered from CFS since she was 12 — donated $5 million to help build the Center for Molecular Medicine.

“We will actually be able to provide patient care that, right now, is very spotty or nonexistent while also bringing expertise into the field,” Annette Whittemore said.

Except for a one-time allocation of $19 million in state funds, the center will be financed with bonds funded by federal grants and contracts attracted by the center’s expanded research capabilities and some of the nation’s top researchers, said Kenneth Hunter, chairman of UNR’s Department of Microbiology and Immunology.

“With this state-of-the-art facility and equipment, the ability we will have to recruit some of the best and brightest faculty and researchers with this extraordinary new building cannot be described,” he said.

Hunter said the Center for Molecular Medicine received $1.6 million in federal grant money last year for equipment, much of which already is being used in laboratories on campus and that will be moved into the new building when it opens.

First Research Project In Decades

 

The center is the first new medical research facility built at UNR in more than 20 years, and it will bring the university’s research capabilities into the 21st century, President Milton Glick said.

“It’s enormously important in the sense that it also is the first building ever built on this campus dedicated only to research, and that will allow us to generate more research dollars,” he said.

The new center, along with other buildings that have recently opened or are under construction on campus, shouldn’t draw the taxpayers’ ire because they were in the pipeline and partly funded by the state before the economic crisis began, Glick said.

“The student union, the Knowledge Center, the Davidson Math and Science Center, every one of these buildings was approved three to six years ago by the Legislature at a time when the state was still booming,” he said. “And the student union was paid for by the students, who taxed themselves with an extra fee to pay for it.”

The Center for Molecular Medicine will be funded in what is an unusual public-private partnership for the campus, Glick said.

“This is the first new building being constructed on campus where we will have the private sector occupying space they paid for,” he said.

The Davidson Academy for exceptionally gifted students is a public academy started and partly funded by a private foundation, but it is located in the old Jot Travis Student Union, not part of a new construction project, Glick said.

Clinical Trials Draw Funding

 

Hunter said the Whittemore Peterson Institute, which will be headquartered in the new center, will help the university’s medical students, as well as patients.

“Think about having an institute that is one-of-a-kind in the world that is dealing with a highly prevalent condition, but there is really no specific place you can go to get this kind of treatment,” Hunter said.

“Our students will be exposed to cutting-edge diagnosis and treatment for neuroimmune diseases,” he said. “I envision our medical students standing in the clinics next to guys like Dr. Dan Peterson, who is one of the world’s authorities on Chronic Fatigue Syndrome. This will give him an opportunity to run a first-class facility and train our students as well.”

Judy Mikovits, director of research at the Whittemore Peterson Institute, is doing work based on blood samples taken by Peterson during a 1984 outbreak at Incline Village among about 100 people who exhibited symptoms of Chronic Fatigue Syndrome.

Hunter said the problem is that doctors have no test they can run to determine if someone has CFS, but research being done by Mikovits and other scientists that could one day lead to a blood test or other means of diagnosing the disease.

Mikovits, Peterson and other researchers with the institute will be making their presentations at the International Association for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis conference scheduled on March 12-15 in Reno.

Hunter said only recently has enough scientific evidence has emerged to convince physicians and researchers that CFS is a disease and not just a catch phrase for a bunch of symptoms.

“You can imagine how frustrating that is for patients who clearly are suffering,” Hunter said. “They go to a physician who, because this disease hasn’t received acceptance in the medical community that others have, treats them for years for ancillary things other than CFS.

“So if this disease can be validated with research and strong clinical information, it’s going to absolutely affect the lives of so many people in a positive way,” he said.

Counseling, Therapy Offered

 

Whittemore said the institute will offer patients nutritional advice, supplements and physical therapy.

“We’ll do neuroimaging with other partners to look at the brain and try to deliver at one institute as much comprehensive treatment as we can,” she said. “We’ll have counseling, and we would like to have a psychologist on board because living with a chronic disease is tremendously difficult.”

The Whittemore Peterson Institute is a major component of the Center for Molecular Medicine, but Hunter said the center’s mission extends beyond research solely into CFS.

“From the university’s perspective, it will be far broader than that,” he said. “The three departments that predominantly will be working there will have a huge number of federally funded research projects, ranging from cancer to inflammatory diseases and infectious diseases. It’s very synergistic because I think we will benefit just as much in our medical school department by collaborating with the institute.”

Copyright ©2008 Reno Gazette-Journal. All rights reserved.

(http://www.rgj.com/article/20090205/NEWS10/902050339/1321/NEWS)

FDA APPROVES NEW FIBROMYALGIA DRUG

From the FMS Global News Jeanne Hambleton 

Forest and Cypress Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia

Posted January 14, 2009

New treatment option for the estimated 6 million Americans living with this chronic, debilitating condition

NEW YORK and SAN DIEGO, Jan. 14, 2009 /PRNewswire-FirstCall/ — Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) today announced that Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as many as six million people in the United States. The safety and efficacy of Savella was established in two US pivotal phase III clinical trials involving over 2,000 patients with fibromyalgia. The studies showed that Savella doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function. The companies expect Savella to be available in pharmacies by March 2009.

“Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia,” said Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan. “The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis.”.

“Savella is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia, including pain, patient global assessment and physical function. Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint,” said Jay D. Kranzler, MD, PhD, Chairman and CEO of Cypress Bioscience.

Howard Solomon, Chairman and Chief Executive Officer of Forest said, “We and our partner Cypress Bioscience are very pleased to receive marketing approval for Savella, following a first-cycle review, from the FDA. Fibromyalgia is a chronic and often debilitating condition with a significant need for new therapies. Savella is a valuable new treatment for patients afflicted with fibromyalgia. Its effectiveness was evaluated based upon the multiple symptoms included in the responder analysis.”

“This approval is crucial for Pierre Fabre Laboratories as milnacipran is one of the flagship products of our portfolio and represents another product of Pierre Fabre research registered in the United States,” said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre SA.

Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.

Data Highlights

The clinical development program for Savella was unique in its use of a composite responder analysis as the primary endpoint. This endpoint required individual patients to demonstrate concurrent improvement to multiple validated measures, including pain (visual analog scale), patient global assessment (patient global impression of change), and physical function (Short Form-36 Physical Component Summary).

The efficacy of Savella was established in two US pivotal Phase III clinical trials involving 2,084 treated patients (1,460 Savella; 624 placebo), which showed that Savella demonstrated clinically significant improvements compared to placebo in treating fibromyalgia. The first study was 6 months in duration and the second study was 3 months in duration.

In both studies, a greater proportion of patients in the Savella treatment arms (100 mg/day and 200 mg/day) as compared with placebo treatment, at 3 months, experienced at least a 30% reduction in pain from baseline and also rated themselves as “very much improved” or “much improved” based on the patient global assessment. In addition, a greater proportion of patients treated with Savella as compared with placebo treatment met the criteria for a treatment response as measured by concurrent improvements in pain, physical function, and patient global assessment. In both studies, some patients who rated themselves as globally “much” or “very much” improved experienced a decrease in pain as early as week 1 of treatment with a stable dose of Savella that persisted throughout these studies.

The clinical development program demonstrated that Savella was safe and generally well tolerated. The most frequently occurring adverse reaction was nausea. Other common adverse reactions reported in these clinical trials were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth and hypertension. The majority of adverse reactions reported were mild to moderate in nature.

About Savella

Savella is a dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin (in-vitro), two neurotransmitters thought to a play a central role in the symptoms of fibromyalgia. Savella will be marketed by Forest and its licensor, Cypress Bioscience. Pierre Fabre, who originally developed and sells milnacipran outside the U.S., licensed the rights for North America to Cypress Bioscience.

About Fibromyalgia

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and decreased physical functioning. According to the American College of Rheumatology fibromyalgia is estimated to affect over 6 million Americans. It is most often diagnosed in the primary care setting and is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this condition, there are limited treatment options specifically approved for fibromyalgia in the United States.

Important Safety Information

Savella is a selective serotonin and norepinephrine inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients.

Savella is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) concomitantly or within 14 days of discontinuing treatment of an MAOI or in patients with uncontrolled narrow-angle glaucoma.

Development of a potentially life-threatening serotonin syndrome may occur with agents that inhibit serotonin reuptake, including Savella, particularly with concomitant use of serotonergic drugs (including triptans and tramadol) and with drugs which impair metabolism of serotonin (including MAOIs). The concomitant use of Savella with serotonin precursors is not recommended.

Blood pressure and heart rate should be monitored prior to initiating treatment with Savella and periodically throughout treatment. SNRIs, including Savella, have been associated with reports of increases in blood pressure and heart rate. Pre-existing hypertension, tachyarrhythmias and other cardiac diseases should be treated before starting therapy with Savella. Savella should be used with caution in patients with significant hypertension or cardiac disease. For patients who experience a sustained increase in blood pressure or heart rate while receiving Savella, either dose reduction or discontinuation should be considered.

Savella should be prescribed with caution in patients with a history of a seizure disorder, mania or controlled narrow-angle glaucoma.

Savella has been associated with mild elevations of ALT and AST. Rarely, fulminant hepatitis has been reported in patients treated with milnacipran. Savella should be discontinued in patients who develop jaundice or other evidence of liver dysfunction and should not be resumed unless another cause can be established.

Savella should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.

As with other SNRIs and SSRIs withdrawal symptoms have been observed following discontinuation of milnacipran. A gradual dose reduction is recommended.

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Savella. Discontinuation should be considered for patients with symptomatic hyponatremia.

SSRIs and SNRIs, including Savella, may increase the risk of bleeding events. Patients should be cautioned regarding the risk of bleeding associated with concomitant use of Savella and NSAIDs, aspirin, warfarin or other drugs that affect coagulation.

Male patients with a history of obstructive uropathies may experience higher rates of genitourinary adverse events.

Savella is unlikely to be involved in clinically significant pharmacokinetic drug interactions. Pharmacodynamic interactions of Savella with other drugs can occur.

Savella contains FD&C Yellow No. 5, which may cause allergic-type reactions in susceptible persons.

In clinical trials, the most frequently occurring adverse reaction was nausea. The most commonly occurring adverse reactions (greater than or equal to 5% and twice that of placebo) were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.

About Forest Laboratories

Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.FRX.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

About Cypress Bioscience

Cypress Bioscience, Inc. provides therapeutics and personalized medicine services, facilitating improved and individualized patient care. Cypress addresses the evolving needs of specialist physicians and their patients by identifying unmet medical needs in the areas of pain, rheumatology, and physical medicine and rehabilitation, including challenging disorders such as fibromyalgia and rheumatoid arthritis. This approach to improving patient care creates a unique partnership with physicians.

For more information about Cypress, please visit the Company’s website at http://www.cypressbio.com.

This press release, as well as Cypress’ SEC filings and website at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of Savella to treat fibromyalgia syndrome and its availability in pharmacies by March 2009. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress’ Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that Savella may not achieve market acceptance.

About Pierre Fabre

The Pierre Fabre group, France’s second biggest independent pharmaceutical laboratory, achieved a turnover of 1.7 billion euros in 2007. It employs nearly 10,000 people including 1,400 in the research sector. Its business sectors are ethical products, healthcare products and dermocosmetics with the brands Avene, Ducray, A Derma, Galenic, Klorane and Rene Furterer. The Pierre Fabre group dedicates 25% of its annual turnover to R&D in five main therapeutic directions: oncology (PFM’s priority R&D sector with 50% of the over all R&D budget), the Central Nervous System, cardiology, internal medicine /urology and dermatology.

To learn more about the Pierre Fabre group, visit http://www.pierre-fabre.com.

SOURCE Forest Laboratories, Inc.; Cypress Bioscience, Inc.

(http://www.fiercebiotech.com/press-releases/forest-and-cypress-announce-fda-approval-savella-tm-management-fibromyalgia)

Dual action

From Jeanne Hambleton’s FMS Global News Desk
By Sandra Flahive (FiftySomething) January 10 2009

Bill and Susan Steffey of Grimes both have seen great physical improvements since they began exercising together at the Wellness Center at Mercy Medical Center.

Susan, 55, first started a regular workout regimen in July on the advice of her rheumatologist. Bill, 60, joined her a couple months later, hoping to lose weight and lower his cholesterol.

Three days a week, the couple attends a low-impact aerobics class that’s especially tailored to older adults. They warm up on the treadmill before class. Afterward, Bill hits the weights while Susan gets on the elliptical machine.

Both have lost weight since they began exercising regularly. Susan, who has arthritis, fibromyalgia and a pulmonary disease, says her muscles and joints are stronger and her lung capacity has improved.

Through weight training, Bill says he has been able to strengthen his bad knee and can now get up stairs without using the handrail to pull himself up.

“Neither one of us will go without the other one,” Susan says of their workouts. “That’s a huge motivator because you feel guilty. And we’ve made great friends.”

It has also given them a chance to spend more together and become closer, she says.

Because his wife’s health and stamina have improved, they are considering taking vacations, Bill says. That includes travelling to Indianapolis for a NASCAR race in July.

“Now that she is working (out) … she has got a little stronger, and we are talking about doing those things again together,” he says.

What a difference a year makes. A year is about how long Ankeny couple Bill Riley Jr. and his wife, Bridget, have been regulars at the Aspen Active Fitness Center in the West Glen Town Center.

With the help of their respective personal trainers, the Rileys say their lives have changed dramatically. The two – who were not regular exercisers – now give each other workout tips, regularly check on one another’s progress and have bought fitness equipment to use at home.

They say they feel better, have replaced body fat with muscle, eat more healthfully and are excited about the future.

“We are enjoying this. We are feeling that we are doing something for ourselves and not just letting ‘old man time’ chip away at us,” says Bill, 51. “We are feeling a lot better about being 60, 65, 70. We plan on being very active … and you cannot do that without your health. We made the decision to start that now, and we are glad we did it.”

In the past, fitness clubs had been intimidating and uncomfortable places for him and his wife, Bill says. Then he met certified personal trainer Mickey Pesek at Aspen Athletic Fitness Center.

“The personal training has made a huge difference in our outlook and opinions of joining a gym,” says Bill, whose triglycerides, cholesterol and blood pressure have decreased.

Bridget, an oncology nurse, says several factors influenced her to join her husband in getting fit: turning 50, her mother having a massive stroke a year ago and seeing how good her husband was feeling.

Bridget works with certified personal trainer Trista Manikowske. “She makes me feel confident and accomplished,” she says. “It is probably the best I have felt health-wise since I was 20.”

She says she feels healthier, has a better attitude about herself and sleeps better. The couple rarely eats out anymore, she says, and have added more fish and protein to their diet.

“We talk about growing old together and walking together and being outdoors. We talk about doing vacations that involve a lot of walking … and keeping our hearts healthy and blood pressure good,” Bridget says.

Setting goals together helps the two individuals be supportive of, and accountable to, each other, says Manikowske, the personal trainer. It is also a good idea to write down those goals.

“People with written goals accomplish five to 10 times as much as people who have never taken the time to actually write them down. It helps you remember what they are,” she says.

7 Tips for Exercising in Tandem
Certified trainers Trista Manikowske and Mickey Pesek offer these suggestions for couples working together toward physical fitness.

• Make a plan together and stick to it. Devise a workout schedule and, if you are working out separately, ask each other questions about your progress.

• Decide on a reward for meeting your goals. Looking forward to a vacation, for example, can motivate and encourage you.

• Find fun physical activities you can do together.

• Plan healthful meals, shop for groceries and cook as a couple.

• When going out to eat, split portions with each other.

• Get the whole family involved in eating more healthfully and exercising.

• For a spouse or significant other reluctant to get more physically active, give a gym membership as a birthday or anniversary gift or invite the person to work out with you. Some personal trainers offer “buddy sessions,” where two people get personal training together for an hour.

Good advice….My thanks to the Desmoine Register http://www.desmoinesregister.com/article/20090110/FIFTYSOMETHING/301110005/-1/SPORTS12

PIERRE FABRE MEDICAMENT AND FOREST LABORATORIES TO COLLABORATE ON DEVELOPMENT AND COMMERCIALIZATION

From the Desk of Jeanne Hambleton – courtesy PR-Canada.Net. 

 (http://pr-canada.net/index.php?option=com_content&task=view&id=71522&Itemid=61)

Saturday, 27 December 2008

Forest Laboratories, Inc. and Pierre Fabre Medicament today announced that they have entered into a definitive collaboration agreement to develop and commercialize F2695 in the United States and Canada. F2695 is a proprietary selective norepinephrine and serotonin reuptake inhibitor that is being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.    Under the terms of the agreement, Forest will make an upfront payment to Pierre Fabre of $75 million and will pay future, undisclosed milestone payments. In addition, Pierre Fabre will receive royalty payments based on F2695 sales. Forest will assume responsibility for the clinical development and commercialization of F2695 in the United States and Canada, while Pierre Fabre will fund all preclinical development and drug substance manufacturing activities worldwide. “We are pleased to expand our relationship with Pierre Fabre to include this collaboration on the development of F2695 for the treatment of depression. Pierre Fabre has been an outstanding partner for Forest since we commenced our alliance in 2004,” commented Howard Solomon, Chairman and Chief Executive Officer of Forest. “We are highly encouraged by the strong clinical antidepressant activity and good tolerability exhibited by F2695 in the recently completed placebo-controlled, double-blind Phase II study. We look forward to initiating Phase III studies with F2695 next year. F2695 is the second late-stage product candidate we have licensed this quarter, underscoring our commitment to further building our pipeline and bringing novel therapeutics to the market.” “Pierre Fabre is looking forward to working with Forest on this exciting product opportunity,” said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre Medicament. “Forest has an excellent record of developing and commercializing products for the treatment of depression and we are happy to extend our existing partnership to include F2695.” In a recently completed European placebo-controlled, double-blind Phase II study of F2695 in over 550 patients with major depressive disorder, the compound demonstrated statistically significant improvement compared to placebo (p<0.0001) on the primary endpoint, change from baseline in total score on the Montgomery-Asberg Depression Rating Scale (“MADRS”). Statistically significant improvement for F2695 compared to placebo was also demonstrated using the change from baseline in the Hamilton Depression Rating Scale (“HAMD-17″) and in response and remission rates using both the MADRS and HAMD-17. In addition, F2695 demonstrated improvement compared to placebo within two weeks after treatment initiation. About F2695 F2695 is an isomer of milnacipran and is protected by a method of use patent that extends through June 2023. F2695 exerts its effects by selectively inhibiting the reuptake of both norepinephrine and serotonin, two neurotransmitters known to play an essential role in regulating mood. Forest, in partnership with Cypress Bioscience, Inc. and Pierre Fabre, is currently developing milnacipran; a selective serotonin and norepinephrine dual reuptake inhibitor, for the management of fibromyalgia. The New Drug Application is under FDA review and we continue to plan for a first quarter 2009 product launch meeting About Pierre Fabre Medicament The Pierre Fabre Group, the second largest independent laboratory in France, employs some 10,000 people, and achieved a turnover of 1.7 billion euros in 2007. The lines of business are ethical medicine, family health but also in dermo-cosmetic products with several brands: Avene, Ducray, A-Derma, Galenic, Klorane and Rene Furterer and dermo-cosmetics. Pierre Fabre Medicament, the pharmaceutical branch of the Pierre Fabre Group, made Research and Development its core business and the key to its future. With 1,400 employees dedicated to R&D, Pierre Fabre Medicament has invested 30% of its annual sales to R&D during 2008, in five major therapeutic areas in terms of public health: oncology (the priority R&D area of Pierre Fabre Medicament, with 50% of all R&D expenses), psychiatry, urology, cardio-vascular, rheumatology. To learn more about Pierre Fabre, visit http://www.pierre-fabre.com. About Forest Laboratories Forest Laboratories is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.FRX.com. Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

 

Fibromyalgia Circle of Care Initiative

FROM THE DESK OF JEANNE HAMBLETON UK NFA LEADER AGAINST PAIN

October 25, 2008 08:00 AM Eastern Daylight Time
Johns Hopkins and National Fibromyalgia Association Launch Fibromyalgia Educational Initiative to Bridge Chasm in Diagnosis and Care

Collaborative Program Shifts Paradigm with Evidence-Based Platform to Educate Providers on Fibromyalgia Management

SAN FRANCISCO–(BUSINESS WIRE)–The Johns Hopkins University School of Medicine, The Institute for Johns Hopkins Nursing and the National Fibromyalgia Association announced today the launch of the Fibromyalgia Circle of Care Initiative at the ACR/ARHP Annual Scientific Meeting, October 24-29, 2008 in San Francisco. The outcomes-based educational initiative will educate providers about the disease state and the latest therapeutic options; thus, driving accurate and early diagnosis of fibromyalgia for the ten million U.S. citizens impacted by this disorder.

The multi-interventional series of educational activities is open to primary care physicians (PCPs), rheumatologists, psychiatrists, pain management specialists, nurses (RNs), nurse practitioners (NPs) and physician assistants (PAs). The program is designed to educate providers on disease state awareness, diagnosis, impact of early diagnosis and referral, and multidisciplinary care. Additionally, the initiative will share the latest therapeutic options and strategies, as well as review clinical trials that assess newer therapies for fibromyalgia.

“Many fibromyalgia patients see an average of four physicians—over a duration of five to eight years after the onset of the disease—before an accurate diagnosis of fibromyalgia is achieved. This represents five to eight years of underdiagnosis, misdiagnosis and inappropriate treatment of the patient,” said Victor Marrow, Ph.D., Executive Director, Office of Funded Programs/CME Johns Hopkins School of Medicine. “The Fibromyalgia Circle of Care Initiative will result in improved patient care by minimizing the lack of awareness among physicians which has been responsible for the inability or reluctance to accurately diagnose, contributing to the fragmentation of care.”

The Johns Hopkins University School of Medicine, The Institute for Johns Hopkins Nursing and the National Fibromyalgia Association are collaborating on this unique program to improve fibromyalgia patient outcomes. The integrated educational activities will deliver:

Practical and interactive case-related content
Summaries of clinical data and recommendations on how to implement management strategies into the provider’s practice
Updates on clinical practice guidelines and recommendations
Evidence-based outcomes
Patient communication content and materials
Treatment adherence and compliance strategies
“The Fibromyalgia Circle of Care Initiative is unique in its collaboration among healthcare organizations and leaders to raise awareness of the disease state through an interactive program that effectively drives provider participation and implementation of evidence-based lessons within their own practice,” said Lynne Matallana, President and Founder, National Fibromyalgia Association. “After completion of this program, participants will be fully prepared to use the tools and lessons learned to positively and tangibly impact the quality of life of these patients.”

With fibromyalgia affecting up to ten million people in the United States, or up to six percent of patients seen in general medical practices, the impact to the U.S. economy is significant. According to a 2003 study by I. Jon Russell, et al., healthcare costs range from $12-$14 billion per year and account for a loss of one to two percent of the nation’s overall productivity. The study also found that total annual costs for fibromyalgia claimants were more than twice as high as the costs for the typical insurance beneficiary. Furthermore, the prevalence of disability among employees with fibromyalgia was twice as high as compared to all employees. Lastly, for every dollar spent on fibromyalgia-specific claims, employers spent approximately $50-$100 on additional direct and indirect costs.

For more information or to register to participate in the Fibromyalgia Circle of Care Initiative, e-mail info@circleofcare.md.

ABOUT THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE

In July 2008, U.S. News & World Report ranked the Johns Hopkins Hospital #1 among American hospitals for the 18th consecutive year. In 2006, the Johns Hopkins Office of CME received “Accreditation with Commendation” for six years, the highest ranking issued by the ACCME. Hopkins CME has been recognized as a center for “Best Practices” and as a resource to ACCME-accredited providers. For more information, please visit http://www.hopkinscme.edu or contact Victor Marrow, Ph.D., Executive Director, CME’s Office of Funded Programs at vmarrow@jhmi.edu.

ABOUT THE INSTITUTE FOR JOHNS HOPKINS NURSING

The Institute for Johns Hopkins Nursing designs and delivers leading-edge continuing education for nurses. The Institute accesses the expertise of faculty and nurses from both the Johns Hopkins University School of Nursing and Johns Hopkins Hospital, including over 2,500 highly skilled clinicians in 10 clinical and countless subspecialty areas who are also world-renowned researchers and educators. For more information please visit http://www.ijhn.jhmi.edu.

ABOUT THE NATIONAL FIBROMYALGIA ASSOCIATION

The National Fibromyalgia Association (NFA) is a nonprofit 501(c)(3) organization whose mission is to develop and execute programs dedicated to improving the quality of life for people affected by fibromyalgia. The NFA publishes a quarterly magazine, Fibromyalgia AWARE, and hosts an award-winning website at http://www.FMaware.org.

Contacts
Amendola Communications for MJ Consulting Group
Kate Donlon, 619-876-2654
kdonlon@ACmarketingPR.com
or
Jan Shulman, 480-664-8412, ext. 12
jshulman@ACmarketingPR.com

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