A ‘WIN WIN’ FIBROMYALGIA CONFERENCE

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SPEAKERS PRESENTATION SUMMARIES

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Report by Leanne Daniels

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

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

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

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

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

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

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

Denise Rhodes reported -

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

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

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

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

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

Denise Rhodes wrote the following reported –

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

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

Dos and Don’ts for FM –

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

Useful sources for FM information:

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

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

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

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

Report by Leanne Daniels

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

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

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

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

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

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

Report by Leanne Daniels

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

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

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

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

Report by Leanne Daniels

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

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

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

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

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

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

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

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

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

Report by Clare Palmer ANOM

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

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

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

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

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

Report by Leanne Daniels

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

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

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

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

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

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

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

Report by Denise Rhodes

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

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

Report by Denise Rhodes

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

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

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

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

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

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

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

Report by Leanne Daniels

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

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

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

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

Use of unlicensed medicines

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

What is “Named-patient Basis?”

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

Off-license/off-label Medicines

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

Why is this relevant?

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

Report by Denise Rhodes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

May 19, 2009 03:00 PM Eastern Daylight Time

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

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

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

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

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

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

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

About the Study

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

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

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

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

This study was sponsored by Pfizer, Inc.

About Lyrica

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

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

Important Safety Information

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

Pfizer Inc: Working together for a healthier world™

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

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

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

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

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

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

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

Courtesy FDA US Food and Drugs Administration – For Immediate Release

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Consumer Inquiries: 888-INFO-FDA

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

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

Lyrica for Fibromyalgia Pain

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

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

Study of Restless Legs Sufferers

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

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

Less Symptoms, More Sleep

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

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

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

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

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

Study Finds Benefits for Fibromyalgia Sufferers

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

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

Few Side Effects, Relatively Inexpensive

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

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

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

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

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

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

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

WHY THE FOCUS ON FIBROMYALGIA?

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

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

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

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

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

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

MILLIONS OF AMERICANS HAVE FIBROMYALGIA

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

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

FUNDING OF DISEASE EDUCATIONAL PROGRAMS MUST BE SCRUTINIZED

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

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

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

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

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Bottled Water: FAQ on Safety and Purity

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

Courtesy WebMD.com. Health and Cooking /em>

By Salynn Boyles -Reviewed by Louise Chang, MD – WebMD Health News

Americans drank 9 billion gallons of bottled water last year, or slightly more than 29 gallons for every man, woman, and child in the country.

They also spent $22 billion on a product that critics of the bottled water industry say they should be getting for free from their home faucets.

Most of the criticism has focused on the environmental impact of bottled water. But an investigation released recently also raises questions about the purity and even safety of commercially available water.

WebMD looked into many commonly asked questions and concerns about bottled water. Here is what we found:

What did the new report find?

The Environmental Working Group tested 10 best-selling brands of bottled water for 170 contaminants and found different mixtures of 38 contaminants, including bacteria, fertilizer, and industrial chemicals at levels similar to those allowed in tap water.

Two of the samples, bought in San Francisco, contained the chemical compound trihalometrane in levels that exceeded the amount allowed in California.

“The bottled water industry really presents this image of purity, but our investigation demonstrated that it is really hit or miss,” Environmental Working Group senior scientist Olga Naidenko, PhD, tells WebMD.

But the International Bottled Water Association, which represents most bottlers, charged that the group’s report contained “false claims and exaggerations” and noted that the group’s sample was not representative of the hundreds of bottled waters on the market.

Joseph Doss, president of the International Bottled Water Association, tells WebMD that California has much stricter contamination restrictions than the FDA. He says the state’s allowed level of trihalometrane is eight times lower than the level allowed by the federal government.

How can I tell if the water I purchase started out as tap water?

Roughly 45% of the water sold in single-serve bottles comes from a municipal water source.

By law, bottled water that comes from a municipal water supply has to disclose this on its label unless the bottler takes steps to further purify the water, which most do. In this case, the label will say “purified water” or “purified drinking water,” but the original source is probably tap water.

Water labeled “spring water” comes from an underground water spring, but it may be piped to the bottling plant.

“Mineral water” comes from an underground source and must contain no less than 250 parts per million total dissolved solids, such as salts, sulfur compounds, and gasses. No minerals may be added to the water by the bottler.

“Artesian water” or “artesian well water” must come from a well that taps a confined aquifer.

How can I tell if there are contaminants in the bottled water I purchase?

You probably cannot. Tap water is regulated by the Environmental Protection Agency (EPA), which requires yearly public reports identifying the contaminants found in local water sources. But bottled water is regulated by the FDA, which has no such requirement.

The Environmental Working Group and the Natural Resources Defense Council, which released its own report critical of bottled water purity in 1999, want the FDA to require bottlers to list contaminants on water bottle labels.

In its report, the National Resources Defense Council noted that the EPA requires more frequent testing of municipal water than the FDA requires for bottled water, and that bottled water rules allow some contamination by E. coli or fecal coliforms, which indicate possible fecal matter contamination.

The report noted that the FDA does not require bottled water to be tested for parasites such as cryptosporidium or giardia; the EPA does require this testing for tap water.

Doss says consumers have a right to know what is in their bottled water, and they can find out by calling an 800 number that appears on every bottle. “If a consumer calls that number and does not get the information they want, they can and should choose another bottled water brand.”

Does calling the 800 number really get you the information you want?

That depends on what you want to know.

WebMD called the 800 numbers found on three best-selling water brands, purchased at a minimart in Nashville, Tenn. In each case, we were able to find out the source of the water and the purification process used by the bottler.

But in all three cases we were told that there were no contaminants in the water we were calling about because of the extra purification. While this may be true, water quality experts say it is unlikely that the purification process removes all contaminants. And the Environmental Working Group investigation showed that some of the bottled waters they tested had the same type and level of contaminants as the tap water source used by the bottler.

The brands we checked included Pepsi’s Aquafina, Coca-Cola’s Dasani, and Deer Park Spring Water, marketed by Nestle.

When we called the Pepsi number, a customer service agent helped us find the date stamp and production code on the bottle of Aquafina we had purchased.

With this information, she was able to tell us that our water came from a municipal source in Mankato, Minn. She further informed us that the bottler used a seven-step purification process that included reverse osmosis, carbon, and UV light filtration.

When we called the Coca-Cola number, a customer service agent was able to tell us that our Dasani came from a municipal source in Birmingham, Ala., and that the purification process included reverse osmosis filtration.

Our Deer Park call was answered by a customer service agent who told us where our spring water was bottled and how it was purified.

Sarah Janssen, PhD, who is a scientist with NRDC, says the 800 numbers may help you figure out where the water you purchase comes from but not what is in it.

“I cannot imagine that anyone standing in a store trying to make a decision about which water to buy is really going to go to all that trouble,” she says.

Which is safer, bottled or tap water?

Assuming that both the municipal tap water source and the bottler are in compliance with regulations, the experts contacted by WebMD say bottled water is no safer than tap water and tap is no safer than bottled.

The experts point to two cases where bottled water may be recommended — in emergency situations when contaminants in the local water supply exceed permitted standards and in homes where corroded plumbing could cause lead or copper to contaminate drinking water.

In the first instance, water suppliers are required to notify the community and they may even provide bottled water until the problem has been solved. Homeowners worried about their pipes can have their drinking water tested. Halden says most people choose bottled water for convenience, not safety.

“We have invested in the infrastructure to provide pure, safe, drinking water to the population,” he says. “In large cities, water quality is tested hourly, not just once a day.”

While that may be true, a recent report by the Associated Press raised new concerns about the purity of tap water.

Its five-month investigation found evidence of a wide range of prescription and over-the-counter drugs — including antidepressants, antibiotics, anticonvulsants, and sex hormones — in tested samples of municipal water taken from taps throughout the country.

Twenty-four of the 28 water samples taken from major metropolitan area water supplies contained evidence of drug contamination.

The concentrations of these pharmaceuticals were very small. But the report noted that the EPA has not set safety limits for drugs in water and does not require testing for them.

If I drink tap water, should I use a filter?

If you live in a home with older pipes, have odor or taste issues with your tap water, or just want an extra level of protection, a filter may be a good idea. But you have to get the right one for your specific problem, Janssen says.

“It is important to know what you are trying to filter out before you spend the money,” she says. “A reverse osmosis filter will get rid of most contaminants, but charcoal may be enough for odor and taste problems.”

The Natural Resources Defense Council web site is a good source for information on filters.

The consumer watchdog group Consumers Union, publisher of Consumer Reports, also weighed in on commercial filters in a report published early last year.

To find out which filter is best for you, the report recommended consulting the Consumer Confidence Report (CCR), published online each July by the EPA.

The report provides detailed information about where your tap water comes from along with detected levels of dozens of regulated contaminants and the corresponding state and federal limits for these contaminants.

To determine the quality of the water actually coming from your faucet, you will have to have it tested. The EPA’s Safe Drinking Water Hotline (800-426-4791) can provide the names of state-certified testing labs in your area. Or you can do it yourself for under $20 with a commercially available kit sold at most hardware stores.

Is it safe to drink old bottled water?

The FDA considers bottled water to have an “indefinite safety shelf life” if it is unopened and properly sealed, but drinking water quality expert Rolf Halden, PhD, of Arizona State University is not so sure.

“Even water stored for emergency use should be replaced periodically,” he tells WebMD. “You would not want to keep it for 10 years.”

Can chemicals leach from plastic bottles and pose a health risk?

Most experts who spoke to WebMD say there is little to worry about.

The major concerns have involved the chemicals bisphenol A and phthalates.

Bisphenol A is used in the production of multiuse polycarbonate water bottles, but not in single-use bottles used by commercial bottlers.

Likewise, phthalates are not typically found in plastic beverage bottles used commercially in the U.S. But Janssen says phthalates have been found in bottled water, suggesting that it may leach from the plastic cap or liner.

“These chemicals may be in your water, but you would never know because the water companies are not required to test for them,” she says.

Is freezing bottled water or leaving it in a hot car dangerous?

Both of these concerns have circulated widely in emails and on the Internet. One email that has been around for several years warns that freezing bottled water leads to contamination with carcinogenic dioxins.

The email was erroneously attributed to Johns Hopkins University, and it was so widespread that Johns Hopkins’ scientists felt compelled to publicly set the record straight in a news release.

Rolf Halden, PhD, PE, who is an adjunct associate professor with the Johns Hopkins Center for Water and Health, called the claim “urban legend.”

He notes that there are no dioxins in plastics and that freezing actually slows or prevents the release of chemicals.

The industry group representing single-use beverage bottle manufacturers, known as NAPCOR also used the term “urban legend” to describe claims that it is unsafe to drink water that has been left in a hot car.

“The idea that (these) bottles ‘leach’ chemicals when heated in hot cars is not based on any science, and is unsubstantiated by any credible evidence,” the group noted in a recent news release. “This allegation has been perpetuated by emails until it has become an urban legend, but it just is not so.”

Is there fluoride in bottled water?

If it is added by the bottler, the label must say so. But most bottled waters probably do not have as much fluoride as fluoridated tap water.

The CDC has stated that most bottled waters contain fluoride at levels that are less than optimal for oral health. It weighed in on the issue in a news release last February.

“If you mainly drink bottled water with no or low fluoride and you are not getting enough fluoride from other sources, you may get more cavities than you would if fluoridated tap water were your main water source,” the statement noted.

The CDC also warns that preparing infant formula with fluoridated bottled water could cause dental fluorosis, a condition in which permanent white spots occur on the teeth.

EDITOR’S NOTE: Mines a beer please!

SOURCES:
Gary Hemphill, Beverage Marketing Corp.
International Bottled Water Association web site: “Frequently Asked Questions.”
FDA: “Bottled Water Regulations and the FDA,” September 2002.
National Association for PET Container Resources Q&A.
Rolf Halden, PhD, PE, associate professor of civil and environmental engineering, Arizona State University; adjunct associate professor of environmental health and science, Johns Hopkins Bloomberg School of Public Health.
Joseph Doss, president, International Bottled Water Association.
Sarah Janssen, MD, PhD, MPH, scientist, Natural Resources Defense Council.
IWG Bottled Water Investigation, Oct. 15, 2008.
CDC Fact Sheet on Questions About Bottled Water and Fluoride.
WebMD Medical News: “Many Tap Filters Work Well.”
Associated Press: “Drugs Found in Drinking Water,” Sept. 12, 2008.
National Resources Defense Council: “Summary Findings of 1999 Bottled Water Report.”

© 2008 WebMD, LLC. All rights reserved.(http://www.webmd.com/food-recipes/news/20081107/bottled-water-faq-on-safety-and-purity?ecd=wnl_day_041309)

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Diet Plans for Men

From the FMS Global and UK News Desk of Jeanne Hambleton

Atkins vs. Ornish, South Beach Diet vs. the Zone: Does any weight loss plan really work?

Courtesy of WebMD.com

By Peter Jaret – Reviewed by Matthew Hoffman, MD – WebMD Feature

After four years of following one diet plan after another and watching his weight yo-yo up and down, Marv Leicher finally discovered the secret formula for losing weight and keeping it off successfully.

And he is not sharing it with anyone.

“I wasted enough of my own time following somebody else’s idea of the perfect diet plan,” says Leicher, 42, an insurance claims adjuster in Iowa. “I do not want some poor fool following my advice and then wondering why it is not working for him. The real secret is that there is no one perfect diet. What works for one person would not necessarily work for someone else.”

From one diet plan to the next

Leicher began by following a low-fat diet. For a few months, the pounds dropped away. He bought a new set of pants with a slimmer waist. And before long, the numbers on the bathroom scale started climbing again. Frustrated, Leicher took a friend’s advice and started following the Atkins high-protein/low-carb diet. He started losing weight within the first week. After four months, he was back to wearing his new lean and mean wardrobe.

“I really thought, OK, this is it. I am home free.”

Then came the holidays — office parties, family dinners — and when they were over, Leicher had regained 10 pounds and was on his way back to being overweight.

“That is when I said to myself, ‘Wait a minute. I am a capable guy. This is not rocket science. I should be able to figure this out.’”

So Leicher sat down and made a list of the parts of diets that seemed to work for him. He went through all the rest of the advice that he had heard — eat breakfast, do not eat breakfast; choose healthy snacks, avoid snacks — and added the tips that seemed to help.

“I ended up with six rules. Frankly, I would be embarrassed to show them to anyone else. But they were changes I knew I could make without feeling like I was doing penance for some past sins.”

Within three months, he was back down to his college weight. This time, though, he stayed there. “It has been almost a year, and I do not even really think of myself as being on a diet. This is just the way I eat.”

How popular diet plans score

What works? What does not? With some 38,000 diet books in print — and 2,500 new ones hitting the shelves every year — not to mention magazines trumpeting the ultimate new fad diet in every monthly issue, there is plenty to choose from. Lately, even researchers have got into the act. The National Institutes of Health and university medical centers around the nation have spent many years and millions of dollars to test the Atkins diet versus the South Beach, the American Heart Association diet versus the Zone.

Along the way, there have been genuine surprises. The low-fat diet, widely endorsed by many official groups, has not turned out to be as safe or effective as most experts thought. Some people do manage to lose weight on low-fat diets, but usually weight loss is fairly slow — only a pound or two a month. And while levels of bad cholesterol (LDL) fall, studies show that levels of good cholesterol also drop. Many people on low fat diets also see a rise in triglycerides — an independent risk factor for heart disease.

To almost everyone’s surprise, low-carb/high-protein diets — Atkin’s is the model — have proved much safer and more effective than expected. Here was a diet that featured eggs and bacon and warned people away from bread. Yet study after study has shown that for people who are overweight or obese, high-protein/low-carb diets have real advantages.

“These diets push most of the numbers in the right direction,” says Ronald Krauss, MD, a senior researcher at Children’s Hospital Oakland Research Institute and a spokesperson for the American Heart Association.

“Body weight and body fat go down, triglycerides and LDL cholesterol drop, while at the same time good cholesterol levels remain up. Low-carb diets also improve insulin sensitivity even without weight loss, so they offer better protection against diabetes.”

The best news for dieters is that high-protein/low-carb dieters also shed pounds faster, on average, than low-fat dieters. In the latest of a string of studies that have pitted one popular diet against another, researchers at Stanford put the Atkins, Zone, Ornish, and LEARN diet to the test. After 12 months, volunteers on the Atkins diet had lost more weight — twice as much — as people on any of the other diets.

But if you are looking to dramatically change your shape, the numbers were not all that encouraging. The average weight loss was a scant 10.3 pounds.

In a slew of recent head-to-head studies of popular diets, in fact, the Atkins diet has pulled ahead in the first few months, resulting in more and faster weight loss. Many experts have come around to accept the notion that protein-rich foods may be more satiating than carb-rich foods.

Unfortunately, the Atkins lead typically evaporates by the end of a year. In a 2006 British study that compared four popular weight loss plans, for example, volunteers lost weight faster on the high-protein/low-carb plan. But after a year, all four diets had resulted in about the same weight loss, about 13 pounds. What is more, several studies comparing diets have seen very high drop-out rates. Even with scientists looking over their shoulders, it turns out people have trouble sticking with most diets.

The best diet plan

Disheartening? Sure. But lurking behind the generally glum news about fad diets and popular weight loss programs are individual success stories — and important information for anyone looking to lose weight.

“If you look at all these studies, you find that on almost any diet, some people do very well and others do not lose any weight at all,” says Janet King, PhD, professor of nutrition at the University of California, Berkeley,who chaired the 2005 Dietary Guidelines Advisory Committee for the U.S. High-protein diets may have an initial advantage in jump-starting weight loss.

But all weight loss plans have one thing in common: They restrict certain kinds of foods and thus limit calories. “Most diets work in the short-term, and the reason is that they simplify decisions about what you’re going to eat,” says King. “They take variety out of the diet. Some restrict carbohydrates. Some restrict fat. But the end result is that they offer a way to eat fewer calories.”

The reason some people succeed is also simple: motivation. “What really matters is compliance, which is another way of saying someone is motivated enough to stick with a diet,” says King.

The best diet plan, in other words, is the one that you are most likely to be able to follow for the long haul. And that is likely to be different for different people. Men who are basically vegetarians are going to have a tough time following the Atkins diet. Steak-and-eggs men are not going to stick with a low-fat, mostly veggie diet plan for long.

Kathleen M. Vohs, a psychologist at the University of Minnesota, believes choosing a regimen that most closely matches the way you like to eat is crucial. She offers a provocative reason.

“Studies show that self-control is a limited resource,” says Vohs. “People may have an easy time giving something up the first time. But when people are repeatedly asked to exhibit self-control, that ability begins to erode.”

It is easier to eat a healthy meal for breakfast, in other words, than to stick with a diet plan once dinner rolls around, especially if it means saying no to foods you love. And by extension, it is easier to stick with a diet that does not eliminate most of the foods you love.

One man’s diet plan

That is a lesson Marv Leicher took to heart when he decided to abandon popular diets and fashion his own weight loss regimen. “Basically, I picked and chose from the strategies that seemed easiest for me to follow,” he says. “It was no big deal to give up soft drinks and fruit drinks, so I did that religiously. No liquid calories. I’m not the kind of guy who can eat just half of what’s in front of him, so I gave up trying to divide portions. Instead, I decided, no desserts. At lunch, I used to go out with people from the office. Now I bring a cup of yogurt and some trail mix, and if the weather is good I take a half hour walk and eat a quick lunch. Little stuff like that.”

Little stuff. But for Leicher, it adds up to big results. Over the past year, he’s lost 30 pounds. Best of all, he’s keeping them off.

©2005-2009 WebMD, LLC. All rights reserved.
(http://men.webmd.com/guide/diet-plans-men?ecd=wnl_men_040709)

Vitamin and Mineral Supplements for Men
Why multivitamins and other dietary supplements can be hazardous to your health

Courtesy WebMD.com

By Arthur Allen -Reviewed by James E. Gerace, MD – WebMD Feature

More than half the adults in America regularly use multivitamins and other supplements to boost their immune systems and enhance nutrition, supporting an industry worth more than $20 billion annually. Grocers stock every conceivable vitamin, mineral, and herbal “boost,” and every neighborhood seems to have its own supplement store.

So are vitamins and mineral supplements for men really necessary?

Based on the current evidence, the answer is a definitive “no.” “For me,” says Christian Gluud, MD, a vitamin researcher at Copenhagen University Hospital in Denmark, “the simple answer is do not use them.”

“Except for certain defined population groups,” says Irwin H. Rosenberg, MD, director of the nutrition and NeuroCognition Laboratory at Tufts University, “there is no evidence that supplemental vitamins and minerals are beneficial for your health.”

He goes on to tell WebMD, “There is no indication that a poor diet is going to be made into a good diet by taking multivitamins.”

Vitamin and mineral supplements can lead to early death

It is not just that vitamin and mineral supplements provide little benefit for the healthy middle-aged man. Large doses of the pills can actually make you sick and reduce your lifespan. A review of 68 randomized trials of high-dose antioxidant supplements such as vitamins C and E found a 5% higherrisk of death in those who took them.

The study, published in February in the Journal of the American Medical Association (Gluud is the lead author), found an even greater risk of death for vitamin users in a subset of 47 carefully conducted trials.

At first glance, this seems contradictory. Over the past three decades, many studies have found that eating fresh fruits and vegetables, which contain high amounts of antioxidants and other vitamins and minerals, can add years to a healthy life. But there are obviously components of a healthy lifestyle that can not be bottled.

“Multivitamins are not a shortcut,” Gluud says. “You are better off eating a varied diet instead of risking the increased mortality of taking these supplements.”

Multivitamins and the middle-aged man

To be sure, vitamin supplements can be beneficial for certain groups of people. After the age of 55 or so, your body starts to lose the capacity to make vitamin D from sunshine, and adding a vitamin D pill may be a good idea.

The elderly also lose the ability to absorb vitamin B12 from their diet, and some of this deficiency can be met by taking a B12 supplement. Cancer patients, or people eating fewer than 1,000 calories a day, may have vitamin deficiencies. Vegans may need some B vitamins and iron unless they are meticulous about getting these nutrients from their diet.

“There really is no strong evidence to support the need of the average 35- to 55-year-old man to take a multivitamin,” says Cheryl Rock, MD, professor of nutrition in the Department of Family and Preventive Medicine at the University of California, San Diego, School of Medicine.

“If you’re concerned about your nutritional levels, a doctor can order tests. It is quite easy to find out, for example, if you are deficient in B12 or vitamin D. And usually one visit with a dietician will be covered by health insurance.”

So far, the evidence of benefit, and harm, from supplements comes from careful studies of large doses of particular vitamins and minerals. There is almost no evidence of health effects from multivitamins. Taking a once-a-day vitamin pill is probably as harmless as it is pointless, except for the manufacturer that can produce a bottle of pills for a few cents and market it for $9.99, nutrition experts say.

Do multivitamins work if you think they do?

There can be, of course, a placebo benefit from a multivitamin or other supplement — the benefit of feeling in control of your health and hopeful of the results. “Even in the face of evidence that multivitamins lack efficacy, people are still going to take them,” says Marion Nestle, PhD, professor of nutrition at New York University and author of What to Eat.

“You’re dealing here with something that goes beyond science and has to do with belief systems.”

Nestle notes that when the recent JAMA study came out, many scientists interviewed about its findings said they would still keep taking vitamins. (Nestle, for one, does not regularly take supplements: “Sometimes when I need a placebo, I’ll pop one.”)

An unhealthy dose of heavy metal

But buyers beware. Some pills contain less or more of a vitamin than promised, and it is not unusual to find heavy metals like lead in the pills, according to chemical analyses by the commercial laboratory ConsumerLab.com, which tests vitamins for sports teams and others.

To be sure, the existence of a vast industry selling products that are potentially dangerous and probably of marginal value strikes some as troubling. We have Congress to thank for the virtually unregulated state of the supplement industry.

The 1994 Dietary Supplement Health and Education Act effectively handcuffed regulation of dietary supplements by the Food and Drug Administration. The term “supplements” includes everything from vitamins and minerals to herbal supplements such as ephedra, saw palmetto, ginkgo biloba, and other substances, some of which have powerful pharmacological effects. Purveyors of these substances are not required to prove their efficacy, and the FDA must show they are dangerous before removing them from the market. The supplement maker has no obligation to test the safety of the product.

Since passage of the bill, the market in vitamin and mineral supplements has ballooned from an estimated $3.3 billion in 1990 to well over $20 billion.

How did vitamin and mineral supplements get such a good rep?

A body of research conducted in the 1980s and 1990s seemed to show benefit from vitamin and mineral supplements in preventing chronic diseases like cancer and osteoporosis and heart disease. But reviews of these studies showed that much of the benefit attributed to supplements was actually attributable to the overall better health practices of those who took them. In other words, people who took vitamin supplements also tended to eat better, smoke less, and get more exercise, says Rosenberg.

Many people have started taking supplements containing antioxidants because of research gathered over the past three decades showing these compounds help slow cell damage. But a well-fed population is already ingesting enough to overcome oxidative stress, and adding more antioxidants probably would not lower the risk of chronic diseases, says Rock.

Foods rich in antioxidizing compounds range from walnuts, blackberries, artichokes, and pecans to brewed coffee and chocolate cupcakes. Yet these products are not equally good for you, and you obviously would not want to build a diet exclusively around antioxidants.

SOURCES: Bjelakovic, G. et al., Journal of the American Medical Association, Feb. 28, 2007; vol 297(8): pp 842–57. Huang et al., American Journal of Clinical Nutrition, 2007; vol 85 (suppl): pp S265–S268. Gad, S.C. and S.E., International Journal of Toxicology, 2003; vol 22: pp 381–385. Fletcher, F., JAMA, June 19, 2002; vol 287(23): 3116–3126. Halvorsen, B. et al., American Journal of Clinical Nutrition, 2006; vol 84: pp 95–135. Morris, M.C. et al., Archives of Neurology, April 2005; vol 12: pp 641–645. Christian Gluud, MD, Copenhagen University Hospital. Irwin H. Rosenberg, MD, director, Nutrition and NeuroCognition Laboratory, Tufts University. Cheryl Rock, MD, professor of nutrition, Department of Family and Preventive Medicine, University of California, San Diego, School of Medicine. Marion Nestle, PhD, professor of nutrition, New York University; author of What to Eat (North Point Press, 2007). Paul M Coates: testimony before the Committee on Government Reform, US HR, March 9, 2006. ConsumerLab.

©2005-2009 WebMD, LLC. All rights reserved.
(http://men.webmd.com/guide/vitamin-mineral-supplements-men)

Alert: MedWatch – Digoxin (Caraco brand) – Recall of tablets because they may differ in size

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.

The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.

FDA Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability
Courtesy FDA (http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html)
Contact: Daniel Movens: (313) 871-8400 – Thomas Versosky: (313) 556-4150

FOR IMMEDIATE RELEASE — DETROIT, March 31, 2009

Caraco Pharmaceutical Laboratories, Ltd. (NYSE AMEX: CPD), a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the Food and Drug Administration.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to their pharmacy or place of purchase.

Product Identification

Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with “437”

Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:

Digoxin Tablets, USP, 0.125 mg
57664-437-88 (100-count)
57664-437-18 (1000-count)

Digoxin Tablets, USP, 0.25 mg
57664-441-88 (100-count)
57664-441-18 (1000-count)

Patients using Caraco’s Digoxin tablets, USP, 0.125 mg or 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Retailers who have this product should return the product to their place of purchase. Retailers can call Caraco customer service at (800) 818-4555, Monday through Friday, 8:00 a.m. – 5:00 p.m. EST, for instructions on how to return the affected product or for any other inquiries related to this action.

Any adverse reactions experienced with the use of all affected product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/medwatch.

EDITOR’S NOTE: In the UK, should you experience any serious problems with Digoxin, you should contact your doctor, NHS Direct, or call an ambulance.

Top 6 Myths: About Bottled Water

From the FMS Global & UK News Desk of Jeanne Hambleton

Courtesy of WebMD – Feature from “Marie Claire” Magazine

By Anndee Hochman

Bottled water — already a more than $10 billion industry — is the fastest-growing beverage category in the U.S. But is it good for you? Here’s the pure truth.

Myth #1: BOTTLED WATER IS BETTER THAN TAP

Not necessarily. While labels gush about bottled water that “begins as snowflakes” or flows from “deep inside lush green volcanoes,” between 25 and 40 percent of bottled water comes from a less exotic source: U.S. municipal water supplies. (Bottling companies buy the water and filter it, and some add minerals.) That’s not really a bad thing: The Environmental Protection Agency oversees municipal water quality, while the Food and Drug Administration monitors bottled water; in some cases, EPA codes are more stringent.

Myth #2: PURIFIED WATER TASTES BETTER

The “purest” water — distilled water with all minerals and salts removed — tastes flat; it’s the sodium, calcium, magnesium, and chlorides that give water its flavor. The “off” taste of tap water is the chlorine; if you refrigerate it in a container with a loose-fitting lid, the chlorine taste will be gone overnight.

Myth #3: BOTTLED WATER WITH VITAMINS, MINERALS, OR PROTEIN IS MORE HEALTHY THAN REGULAR WATER

“Vitamins, color, herbs, protein, and all the other additions to water — those are a marketing ploy,” says Marion Nestle, Ph.D., professor of nutrition studies at New York University. Plus, the additives are usually a scant serving of the vitamins you really need in a day, adds Amy Subar, Ph.D., a nutritionist with the National Cancer Institute. Enhanced waters usually contain sugars and artificial flavorings to sweeten the deal and can pack more calories than diet soda. When it comes to providing fluoride, tap water usually wins, though that element is increasingly being added to bottled waters.

Myth #4: YOU NEED EIGHT 8-OUNCE GLASSES OF WATER EACH DAY

The Institute of Medicine recommends about 91 ounces (a little more than 11 8-ounce glasses) of fluid daily for women. But here is the thing: It expects 80 percent of that to come from water, juice, coffee, tea, or other beverages and the remaining 20 percent from food. That means if you drink a 12-ounce cup of coffee and a 12-ounce can of diet soda, you only need 48 more ounces (three 16-ounce glasses, or four soda cans’ worth) for the day.

Myth #5: AFTER AN INTENSE WORKOUT, BOTTLED WATER IS BEST

There is a reason volunteers hand out Gatorade during marathons. If your workout lasts longer than an hour, you need to replace the water and electrolytes, such as sodium and potassium, that you have lost (that is what sports drinks generally do). For less intense workouts, regular water is fine.

Myth #6: WATER BOTTLES ARE EASY ON THE ENVIRONMENT BECAUSE THEY CAN BE RECYCLED

Wouldn’t it be nice? And it is not just the bottles. Eco-costs include manufacturing, trucking, shelving, and marketing. And meeting the annual U.S. demand for plastic bottles requires enough oil to keep 100,000 cars on the road for a year, says Janet Larsen of the Earth Policy Institute. Sure, the 70 million empty water bottles the U.S. produces per day can be recycled, but the sad truth is, about 86 percent of them end up in the trash. Hardly worth it, for what flows out of the tap and into a reusable glass for free.

(http://www.webmd.com/food-recipes/features/top-6-myths-about-bottled-water?ecd=wnl_day_033109)

EDITOR’S NOTE: Often known as Adam’s Ale, as presumably he had nothing else to drink, did you know that water covers 70% of the earth’s surface and that water makes up between 60% to 70% of the human body. (http://encyclopedia.farlex.com/Adam’s+ale)

If you are really interested in learning more about Adam’s Ale, water, and wells, read Chapter 14 of Maybole, Carrick’s Capital Facts, Fiction & Folks by James T. Gray, Alloway Publishing, Ayr, first published 1972, reprinted on the following link below:
(http://www.maybole.org/history/Books/carrickscapital/adamsale.htm)

Chronic Opioid Therapy Guidelines Offer Direction for Physicians

From the FMS Global News Desk of Jeanne Hambleton

Courtesy of Fibromyalgia Network – February 2009

While patients are rightfully concerned about not receiving adequate pain relief, physicians harbor fears about drug abuse, safety issues, and government oversight. New clinical guidelines for the use of chronic opioid therapy in chronic non-cancer pain patients, developed by consensus of the American Pain Society and the American Academy of Pain Medicine, may ease both patient and physician concerns.

The guidelines, published in the February issue of the Journal of Pain, offer a roadmap for physicians on how to safely prescribe opioids to patients with moderate to severe pain.* The authors specifically state that their report applies to patients with “chronic non-cancer pain conditions, including common conditions such as back pain, osteoarthritis, fibromyalgia, and headache.”

Throughout the guidelines, physicians are urged to evaluate their patients’ pain and function on a regular basis. And, if doctors are worried that a patient is abusing or misusing the prescribed opioid, they may need to reduce the time between scheduled office visits. In addition, physicians are encouraged to look at all of the available options for treating patients’ chronic pain, including the use of opioids, and it is emphasized that this class of medications will seldom provide sufficient pain control. This means that patients placed on opioids will likely need to be prescribed medications from other drug classes as well as non-drug therapies. And, physicians who do not have the skill-set to prescribe opioids need to coordinate their patients’ care with another doctor who is experienced in providing this therapy.

The American Pain Society emphasized the following three points to all its members this month:

The guidelines are comprehensive and evidenced-based to assist physicians in managing chronic opioid therapy, according to the American Pain Society President Charles Inturrisi, Ph.D

“Regular monitoring of chronic opioid therapy patients is warranted because the therapeutic benefits of these medications are not static and can be affected by changes in the underlying pain condition, coexisting disease, or in psychological or social circumstances,” said Gilbert J. Fanciullo, M.D., director of the division of pain and palliative care at Dartmouth Hitchcock Medical Center.

Cochair Perry Fine, M.D., professor of anesthesiology at the University of Utah Medical Center, added that doctors do not have to solely rely upon patient self reports. Pill counts, urine drug screening, family member or caregiver interviews, and prescription monitoring data may all be used to check for possible abuse or other opioid-related problems.

The message is clear that under most circumstances, there are reasonable ways for physicians to prescribe chronic opioid therapy for their patients in pain while emphasizing safety issues and minimizing side effects or the potential for drug misuse. The guidelines offer physicians 25 recommendations with detailed explanations on how to follow them—all to help doctors prescribe opioids to their chronic pain patients in a responsible fashion. In addition to the key points already made, here are other highlights from the published guidelines:

Clinicians may consider a trial of chronic opioid therapy (COT) for moderate to severe pain that is having an adverse impact on a patient’s function or quality of life as long as the therapeutic benefits outweigh the risks (abuse, misuse and addiction). Three different patient screening tools (questionnaires that are easy to administer) are included with the guidelines to help doctors assess potential risks associated with COT for a given patient (the SOAPP, the ORT, and the DIRE).

Before initiating a trial of COT, physicians should provide their patients with informed consent, which alerts patients to all of the potential risks associated with taking opioids. After informed consent, doctors should discuss with their patients a COT management plan that outlines the goals of therapy, expectations, monitoring requirements, etc. A sample consent form and management plan are included in the guideline.

Initial treatment with an opioid should be regarded as a therapeutic trial to determine if COT is effective. If the first opioid does not work or produces adverse side effects, other types of opioids may be tried, but patients need to keep in mind that opioids are prescribed on a trial basis.

Physicians should anticipate, identify, and track common opioid-associated side effects. Constipation is the most frequent problem, and unfortunately it does not go away or get better with continued use of the medication. With this in mind, doctors should recommend stool softeners or increased fiber intake when issuing patients an opioid prescription. Nausea or vomiting may occur but tends to diminish over a few days. If it lasts longer, doctors can prescribe a medication to treat this side effect. Sedation and clouded thinking usually goes away with continued opioid use, while reduction in sex hormones may appear down the road with COT. If a patient begins to experience a decrease in libido, sex hormones can be checked and supplemented if necessary. Other side effects may also occur, so patients and physicians need to be on the lookout for them.

Chronic pain is often a complex condition and physicians who prescribe COT should routinely promote other therapies, such as psychotherapy (pain can be awful to cope with), physical and occupational therapies for restoring function, and other non-drug approaches in addition to prescribing other non-opioid medications. The purpose of this recommendation is to treat the whole person and improve the odds that a patient with chronic pain will achieve a more fulfilling life.

Doctors need to counsel patients prior to starting COT and continue until a stable dose is reached or if the dose is later increased as the patients’ cognitive skills may be impaired for a short period of time. If clouded thought processes do occur, driving should temporarily be avoided … so patients might want to start an opioid on a weekend when they do not have to drive. After a stable dose is reached, there is no evidence to suggest that patients on COT should be restricted from driving or engaging in most work activities.

The opioid guidelines give your doctor the “how to” advice for prescribing opioids, including sample copies of patient screening questionnaires, a consent form, management plan, and full details on how to responsibly prescribe opioids. However, they also assume that the prescribing physician is already knowledgeable about issues concerning this class of medications (i.e., the guidelines cannot possibly convert a novice into an expert on COT). Neither the patient nor physician should feel awkward about the consent and management forms, or random urine tests. Doctors who follow these guidelines should be better equipped to implement opioid therapies for their chronic pain patients (such as fibromyalgia) in a safe manner.

* Chou R, Fanciullo GJ, Fine PG, et al. J Pain 10(2):113-130, 2009.

Calling the Kettle Black
… editorial comment

By Kristin Thorson, Editor, Fibromyalgia Network

Posted: February 27, 2009

If your newspaper ran the February 8th Associated Press article “Drugmakers’ push boosts ‘murky’ ailment,” implying that the drug industry has fabricated fibromyalgia in an effort to churn a profit, you have every right to be furious!1 Controversy sells, and that was what the reporter, Matthew Perrone banked on. Perrone sought out Fred Wolfe, M.D., of Wichita, KS, because he knew from the January 14, 2008 front-page article in the New York Times that Wolfe had a track record for trashing patients with fibromyalgia and big, bad pharma as well. It is ironic, however, that Wolfe would make derogatory statements about the drug industry when he is heavily funded by six drug companies himself.

Wolfe is the director (and paid employee) of the National Data Bank for Rheumatic Diseases, a nonprofit registered as The Arthritis Research Center Foundation, Inc. Its mission is “conducting ongoing research to improve conditions for people with arthritis, fibromyalgia, lupus and other conditions.” He openly declares in his research papers, in which he is testing the effectiveness and safety of drugs for rheumatoid arthritis, that he is funded by Centocor, Aventis, Pfizer, Bristol-Myers Squibb, Amgen, and Abbott. So perhaps Wolfe’s dislike is not so much for the drug industry as it seems for fibromyalgia.

Prompted by mixed reports on increased cancer rates in people with rheumatoid arthritis (RA), Wolfe conducted an observational study on the incidence of cancer in RA patients who took the tumor necrosis factor (TNF) blocking agents Enbrel (etanercept) or Remicade (infliximab).2 His findings were derived from information in the National Data Bank (NDB) and per the NDB’s agreement with Centocor, the maker of Remicade, the drug company was allowed to review Wolfe’s manuscript prior to publication. But Wolfe does not just cater to Centocor. His NDB organization has similar contractual agreements with Bristol-Myers Squibb and Sanofi-Aventis.

Wolfe’s study contradicted earlier reports of increased cancer risks for RA patients taking Enbrel or Remicade. It also confirmed that TNF blocking drugs are linked to skin cancers, including potentially deadly melanomas. Instead of using his findings to alert the medical community that these drugs may pose a health hazard, Wolfe went on record with WebMD as stating: “The drugs, at this moment, do not seem to add any risk except for skin cancer and melanoma. This is a small overall risk and I do not think people should be concerned.” He also added that the risks did not outweigh the benefit for patients who truly need the new drugs.3

While there is no argument that people with RA deserve effective therapies, do you not think it is odd that Wolfe is the one pushing drugs on RA patients while in the recent AP article he bashes the drug industry for fabricating fibromyalgia to boost their sales? Yet he is quoted in the AP article as saying, “I think the purpose of most pharmaceutical company efforts is to do a little disease-mongering and to have people use their drugs.” Further in the article he says, “The underlying purpose here is really marketing, and they do that by sponsoring symposia and hiring physicians to give lectures and prepare materials.” Wolfe’s negative sentiments about fibromyalgia appear clear in a February 2009 report in which he writes, “Recently, regulatory authorities have approved treatments for fibromyalgia, offering some de facto support, although no proof, for fibromyalgia as a distinct disorder.”4 However, there was a time when RA had no “proof,” but that does not mean that the patients who suffered with it years ago did not have a real disease.

It is true that Wolfe was the lead author for the 1990 American College of Rheumatology criteria for fibromyalgia, but that was 18 years ago and much has changed.5 In 1990, the number of rheumatologists who were skeptical about the realness of fibromyalgia far outnumbered the believers. I should know, because I hosted an information booth on fibromyalgia at the annual rheumatology meetings throughout the 1990s, and in the early years I can attest to the ugly controversies surrounding this disease.

In 1994, Wolfe orchestrated a consensus conference (paid by the insurance industry) whose primary goal was to trivialize fibromyalgia and restrict patient care.6 Why he wanted to turn his back on fibromyalgia is still unknown, but his efforts failed. During the past eight years, the rheumatologists have rallied to increase the legitimacy of fibromyalgia by developing guidelines for improving the quality of research and for testing therapies to treat this patient population. Today, Wolfe and many of his colleagues do not see eye to eye when it comes to issues concerning fibromyalgia. At age 74, he appears to get his jollies by trash-talking fibromyalgia to headline-mongering reporters.

For all of you who were subjected to the AP story, I hope my comments help you understand the nonsensical nature of the article and that you can ignore any future reports that happen to quote Wolfe. I also want to make three additional points about the AP article:

Although Wolfe’s own nonprofit takes money from the drug companies, this does not mean that all nonprofits and organizations that help patients must do the same to stay afloat. Fibromyalgia Network and its sister organization, the American Fibromyalgia Syndrome Association (AFSA), have never received money from the pharmaceutical industry or other companies that could bias the way these two organizations operate.

Daniel Clauw, M.D., of the University of Michigan, did receive a small grant award from the National Fibromyalgia Research Association (NFRA) in Salem, OR, but the NFRA should not be confused with the National Fibromyalgia Association (NFA). NFRA does not receive money from the drugmakers.

The article implies that Clauw’s brain imaging research, which has documented many brain processing abnormalities over the past ten years, was tainted by drug money. That simply is not true because the funding for these studies came from government grants based on the merits of his proposals. “Most of us conducting research in the field of fibromyalgia were here ten years before the drug industry even took notice of this disease,” Clauw points out.

Perrone M. Associated Press © hosted by Google, Feb 8, 2009; (AP article).
Wolfe F, Michaud K. Arthritis Rheum 56(9):2886-2895, 2007.
DeNoon DJ. WebMD Health News Aug. 29, 2007; (WebMD article).
Wolfe F, Michaud K. J Rheumatol First Release Feb. 15, 2009; doi:10.3899/jrheum.080897.
Wolfe F, et al. Arthritis Rheum 33(2):160-72, 1990.
Wolfe F. J Rheumatol 23(3):534-9, 1996.

Kaufmann I, et al. Rheumatol Int [epub ahead of print] December 4, 2008.
Kaufmann I, et al. Clin Immunol 125:103-111, 2007.

(http://www.fmnetnews.com/basics-news.php#opioid)
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Fibromyalgia Network, P.O. Box 31750, Tucson, AZ 85751 (800) 853-2929.
This site is provided for informational purposes only. To remain unbiased, we do not accept endorsements, advertisements, or pharmaceutical industry grants. Patients should always consult their physician for medical advice and treatment.

Cymbalta Promotion Questioned

From the FMS News Desk of Jeanne Hambleton
Without prejudice
Courtesy of NewsInferno.com
Date Published: Wednesday, March 18th, 2009

Eli Lilly recently spent millions promoting Cymbalta as a treatment for the controversial disease, fibromyalgia. Now, the Epoch Times places the figure donated by the company to nonprofits to “educate” doctors about the disease at nearly $4 million. Fibromyalgia, a chronic, widespread pain condition of unknown origin, is a controversial diagnosis with no biological diagnostic tests, nor links to any environmental or biological causes.

Some criticized Lilly for seeming to ignore established diseases such as diabetes and Alzheimer’s in order to fund research on fibromyalgia, said the Epoch Times, noting that Cymbalta—generically known as duloxetine—is Lilly’s second highest selling drug.

Cymbalta has long been linked with suicidal problems, yet is being researched for a wide and growing array of ailments. Approvals are expected for its use in the treatment of chronic knee and low-back pain and, said the Epoch Time. According to the report, it is also being studied as a treatment for binge eating, social phobia, chronic fatigue, restless legs disorder, seasonal affective disorder, migraines, attention deficit disorder and childhood depression. Research is also looking into Cymbalta as a possible remedy for PMS, menopause, alcoholism, panic disorder, obsessive compulsive disorder, kleptomania, and tennis elbow.

The drug, which is linked to serious pediatric risks, continues to be looked at for treatment of childhood depression, the Epoch Times said.

The Epoch Times detailed some troubling situations involving Cymbalta (some were outlined in the February 2008 Journal of Clinical Psychopharmacology by four physicians from the Department of Psychiatry and Behavioral Sciences at the University of Kansas Medical Center), including:

* The hanging death of a 19-year-old test subject in a Cymbalta Clinical Trial at the Lilly Clinic in 2004 who had no prior history of mental illness.

* The carbon monoxide suicide attempt by a man in his late 30s after taking Cymbalta for back pain for a couple of months

* Suicidal ideation in a 63-year-old man with no prior history of such ideation and who was prescribed Cymbalta for fatigue, insomnia, and sadness.

* A Texas man prescribed Cymbalta for peripheral neuropathy suddenly killed himself.

* A 19-year-old college student recently prescribed Cymbalta hanged himself after completing some routine job search tasks.

* A 21-year-old college student recently prescribed Cymbalta, took his own life three minutes after speaking to his family while driving home and sounding fine.

Soon after the first suicide, an unflinching U.S. Food and Drug Administration (FDA) approved Cymbalta as an antidepressant and for diabetic nerve pain in 2004, said the Epoch Times. It 2007 it was being prescribed for general anxiety disorder and maintenance treatment of depression; and, in 2008, it was being prescribed for fibromyalgia.

WA Today reported that in Australia, Lilly was making a “concerted effort” to promote Cymbalta off-label at up to “twice the approved dose” for depression-related physical pain. In that country, WA said that Lilly was fined $100,000 and had to remove all promotional material. Lilly appealed, claiming its material was “educational”; the appeal was dismissed. Lilly mailed an apology to all Australian doctors for “any unintentional confusion” over the marketing of Cymbalta, admitting the material might have been misleading, and might have suggested using a higher than appropriate dose of the drug, reported WA Today.

Eli Lilly has faced scandals over drug promotions before. It recently agreed to pay $1.42 billion in the U.S. to settle claims it illegally marketed Zyprexa.

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