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

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

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

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

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

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

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

Study Finds Benefits for Fibromyalgia Sufferers

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

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

Few Side Effects, Relatively Inexpensive

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

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

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

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

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

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

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

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

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

WHY THE FOCUS ON FIBROMYALGIA?

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

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

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

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

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

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

MILLIONS OF AMERICANS HAVE FIBROMYALGIA

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

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

FUNDING OF DISEASE EDUCATIONAL PROGRAMS MUST BE SCRUTINIZED

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

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

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

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

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

SEATTLE–(BUSINESS WIRE)

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

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

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

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

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

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

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

About the Study

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

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

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

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

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

About Lyrica

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

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

Important Safety Information

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

Pfizer Inc: Working together for a healthier world™

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

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

Investor:
Jennifer Davis, 212-733-0717
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Still no treatment in Europe for the 14 million FMS patients trapped in pain!

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

Press Release from ENFA – 29.04.2009

Brussels, (29.04.2009)

Last week was high on activities for the Fibromyalgia community, on one hand the European Network of Fibromyalgia Associations (ENFA) met with the European Health Commissioner Ms Androulla Vassiliou1. And on the other hand the European Medicines Agency (EMEA) gave another negative decision for a treatment for fibromyalgia in Europe2.

Ms. Pam Stewart, Vice-President of European Network of Fibromyalgia Associations (ENFA) and chairman of the trustees of Fibromyalgia Association UK, said one of the biggest challenges that the patients have been facing is the lack of officially recognised medical treatment options in the European Union.

By comparison there are three drugs in the United States of America approved by the Food and Drug Administration: Cymbalta from Eli Lilly, Lyrica from Pfizer and recently authorised Savella from Forest and Cypress (Pierre Fabre).

Last October, Cymbalta received a negative decision from the EMEA and last week was the turn of Lyrica said Ms Stewart. One dossier is still remaining to be evaluated by the EMEA: Savella. Each of these drugs has a limited success and judged alone leads to their failure to get approval.

However with a full range of treatment options, more people with fibromyalgia could have reduced levels of pain. This could enable them to embark on a management programme to significantly improve their quality of life said the Vice President.

“We are constantly hearing from people diagnosed with fibromyalgia that their doctor tells them there is no treatment because no approved guidelines or medications are available. Medical professionals that do not have time to research treatment options should have clearly signposted guidelines for effective treatment options. No one should be sentenced to a life of pain, she said.

“Patients across Europe are currently using these medicines off label. However, the European Medicines Agency told European Network of Fibromyalgia Associations that this is a common situation already faced in other disease areas such as cancer, and the situation with off label use cannot be taken into consideration in the assessment of medicines for which a marketing authorisation is sought.

“The difference with Fibromyalgia is that patients in the UK, for example, are unlikely to be prescribed any of these effective drugs because they have not been officially approved for Fibromyalgia. Patients are left with inadequate treatment options and although these drugs can be purchased over the Internet, this means their use is not monitored and people could be at the mercy of unscrupulous suppliers, which could put their lives at risk,” said Ms. Stewart.

Another example, coming from Germany, concerns the social status of patients since they are labeled as “depressive patient” for their life insurance or health insurance in order to have their drugs fully reimbursed by the National Health Insurance. In order to get any effective medicines, doctors should not diagnose fibromyalgia at all because the medicines are not indicated for fibromyalgia.

At the same time, an ENFA delegation was meeting with the European Health Commissioner Ms. Vassiliou. The meeting was only a natural step, concluding ENFA’s activities on the ‘European Institutions Fibromyalgia Awareness Campaign’ launched in 2008 on World Fibromyalgia Day.

Since the commencement of the campaign last May, with the support from 418 Members of the European Parliament, the Written Declaration on Fibromyalgia was adopted by the European Parliament in December 2008. The written declaration was necessary to raise awareness to all the European politicians from the 27 member states. It also helps create a mapping of the disease status disparity across Europe and increase awareness of better diagnosis and treatment.

“However, we realised that without any officially approved treatment options available, it was almost impossible to properly raise awareness of Fibromyalgia. The patient petition with over 27,000 signatures from all over Europe that MEP Adamou voluntarily hand delivered to the Health Commissioner, clearly demonstrates the frustration from the fibromyalgia community and strong and urgent needs to have treatment options to be officially available. The Fibromyalgia community is left with one hope to see maybe Savella drug approved before the summer. But unfortunately, the hope for a multiple choice of treatment in Europe seems to be lost.

“The European Network of Fibromyalgia Associations and all its associations have for years raised awareness on Fibromyalgia among national and European politicians, health professionals and the general public, and will keep on being active as long as it is necessary,” the Vice President.

About ENFA

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

About Fibromyalgia

Fibromyalgia is a complex disease with chronic widespread pain as the defining symptom and various additional symptoms including fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, depression, anxiety and cognitive dysfunction often referred to as “fibro fog.” All of these symptoms cause serious limitations in patients’ ability to perform ordinary daily chores and work and severely affect their quality of life. Fibromyalgia imposes a large economic burden on society as well as on affected individuals. A study shows that an average patient in Europe consults up to 7 physicians and takes multiple medications over 5-7 years before receiving the correct diagnosis. The debilitating symptoms often result in lost work days, lost income and disability payments.

In fact, a Dutch study in 2005 estimated that the average annual cost of fibromyalgia was €980 million in the Netherlands. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations.

For more information on the European Network of Fibromyalgia Associations (ENFA) contact Ms. Pam Stewart Vice-President of ENFA Brussels@enfa-europe.eu; http://www.enfa-europe.eu.
1 On Wednesday 22 April in Strasbourg, for more information visit http://www.enfa-europe.eu; 2 On Thursday 23 April in London, for more information visit http://www.emea.europa.eu

Pets for Depression and Health

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

By Kathleen Doheny – Reviewed by Brunilda Nazario, MD – WebMD Feature

Can your depression problems improve when you interact with your pet?

Traffic was unbearable, the workday was long, and the boss unreasonable. But minutes later, as your pet dog wags his tail and yips his welcome, your symptoms of depression lift.

It is not a coincidence, according to psychologists, veterinarians, and researchers, who concur that pets can be good for our mental and physical health. A pet cannot cure symptoms of depression, of course, nor is a pet a substitute for medication or talk therapy. But a pet can help to improve mild or moderate depression in many people, experts agree, as well as provide other benefits, such as better sleep and overall health.

Pets and Depression: What Therapists Say

Pets offer psychological and physical comfort, says Teri Wright, PhD, a psychologist in Santa Ana, Calif., who keeps a parakeet and two hamsters in her office to break the ice with children she treats — but finds that adults like them, too.

Pets, she says, “Just feel good to hold on to.”

Psychologically, she says, “They make you feel important, like you matter.” How, for instance, could you not feel better when your dog wags his tail and pants upon your return, even if you have just returned from a half-hour errand?

Wright has two guinea pigs, Dex (for Dexadrin, the ADHD drug) and Zac (short for Prozac), and feels pretty important when they squeal upon her return home. “No one else gives them parsley,” she says of their favorite snack.

The Power of Pets for Improving Your Mood and Health

The power of pets in improving mood can be summed up in two words, says Alan Entin, PhD, a psychologist in Richmond, Va.: “Unconditional love.”

Dogs, in particular, are always glad to see you, he notes. “When you are feeling down and out, the puppy just starts licking you, being with you, saying with his eyes, ‘You are the greatest.’ When an animal is giving you that kind of attention, you cannot help but respond by improving your mood and playing with it.”

Besides unconditional loves, a pet relieves loneliness, Entin points out. Depression and loneliness can go together as people withdraw. “For many people pets are the only relatives they have. It relieves their loneliness. People with animals tend to relate to them and they feel better.”

Having a pet takes the focus off the owner’s problems, Entin says, since having a pet is a commitment–you need to feed and care for the pet. “When people have a pet in the house, it forces them to take care of another life,” Entin says. With the focus outward, he says, the pet owner may not dwell on their depressed mood as much.

The pet does not have to be a dog or a cat. British psychiatrist Camilla Haw, in fact, recommends pet parrots as ideal pets for some patients with symptoms of depression.

“I have kept pet parrots for 20 years and can recommend them for the house bound, the lonely and patients with depression, especially middle-aged women suffering from the ‘empty nest syndrome,’” she writes in Psychiatric Bulletin. The birds can be loyal, loving, and provide good companionship, she says.

Pets and Depression: Veterinarians Weigh In

Pets often serve as confidantes, says Bonnie V. Beaver, DVM, a professor of veterinary medicine at Texas A&M University.

Pets also can increase social exposure for their owners — another good way to boost mood, she says. Dogs need walks, and that gets their owners out with other people, inspiring social contacts.

“People talk to people with animals,” she says, more so than people without pets.

Easing Stress With Your Pet

Pets help your mental health primarily by decreasing your stress, believes Richard Timmins, DVM, of Camano Island, Wash., and director of the Association for Veterinary Family Practice. Just petting your animals can be soothing, he and others say.

Having a pet in the house can change the entire ambience, as Timmins has discovered. His parents, when they were both 83, decided to adopt a “boutique mutt,” a shih tzu-bichon mix. Timmins and his four siblings were concerned that the puppy would be too much work.

“My mother had difficulty with mobility and we worried the dog would trip her,” he says. “My dad had had cardiac problems and a hip replaced.”

Turns out, the dog was anything but a problem. While his parents were not depressed, they had become less interested in activities, Timmins says. The dog changed all that. “Now they are outside walking the dog a couple times a day. It has given my mother and father topics to discuss with golf buddies.”

Pets and Health: The Research

Studies about the mental health and physical health benefits of pets abound. Among the more recent findings:

The overall health of dog owners is better than those who do not have dogs, according to a study that evaluated women ages 25 to 40 in China. Half of the 3,031 women owned dogs and half did not. Those who had dogs exercised more often, slept better, reported better fitness levels and fewer sick days, and saw their doctors less often. The study is in Social Indicators Research.

Pets provide opportunities for social contact, according to a study in Social Science & Medicine, and that can be good for someone down in the dumps. Researchers asked 339 adults in Western Australia about their social contact and pet ownership. The pet owners interacted more with neighbors than non-owners.

Having a dog — and petting it — may be good for your cardiovascular system, although this research has yielded mixed results. In one study, however, pet owners had lower blood pressure and blood fat levels than non-owners, researchers report in the Medical Journal of Australia. Other research has not found a difference in blood pressure levels among pet owners and non-owners.

Pets and Depression: Caveats

Pets help most when symptoms of depression are mild or moderate, psychologists say.

“If you are already so depressed you cannot take care of yourself, having an animal is going to make it worse,” says Wright.

Another caveat: If someone is not a “pet person,” getting one is not likely to help improve their life, says Timmins.

“There are some people who have not had that pet experience growing up,” he says. “They have never had a relationship with an animal. They would be less likely to benefit.”

“But if the conditions are right, pets can help mental health,” he says. “The benefits have been shown for all kinds of pets,” he said, not just dogs and cats. Even watching fish in an aquarium has been shown to help reduce muscle tension and pulse rate, he says, citing research published nearly 20 years ago.

SOURCES:Alan Entin, PhD, psychologist, Richmond, Va., Teri Wright, PhD, psychologist, Santa Ana, Calif., Richard Timmins, DVM, executive director, Association for Veterinary Family Practice, Camano Island, Wash., Bonnie V. Beaver, DVM, professor of veterinary medicine, Texas A&M University, DeSchriver, M. Anthrozoos, 1990; vol 4: pp 44-48., Wright, J. Epidemiology, September 2007; vol 18: pp 613-618., Wood, L. Social Science Medicine, September 2005; vol 61: pp 1159-1173., Anderson, W. Medical Journal of Australia, Sept. 7, 1992; vol 157: pp 298-301., Haw, C. Psychiatric Bulletin, April 2007; vol 31: pp 154-155., Headey, B. Social Indicators Research, June 6, 2007; vol 87: pp 481-493., Reviewed on December 12, 2008.

© 2008 WebMD, LLC. All rights reserved.
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“Walk in My Shoes™” for Fibromyalgia

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

Courtesy Newswiretoday.com

NewswireToday – /newswire/ – Anaheim, CA, United States, 04/22/2009

For anyone who has ever felt helpless watching a loved one suffering from chronic fatigue syndrome, fibromyalgia, Gulf War illness, multiple chemical sensitivities, environmental illnesses, and chronic Lyme disease, “Walk in My Shoes™”.

Hosted by P.A.N.D.O.R.A. (Patient Alliance for Neuroendocrineimmune Disorders Organization for Research and Advocacy, Inc.) a non-profit charitable organization founded in 2002 to create awareness and address the needs of persons in the U.S. diagnosed with the above mentioned illnesses, “Walk in My Shoes™” will be held on May 23 at the C.B. Smith Park in Pembroke Pines.

The fundraiser is P.A.N.D.O.R.A.’s first hosted walk, and aims to attract participants who will make the 5K walk on behalf of friends, co-workers and family members with chronic illnesses.

“Acknowledging and understanding the real pain of a loved one suffering with these chronic illnesses is one of the most important things that friends and family members can do to show their support,” said P.A.N.D.O.R.A. founder Marly Silverman, who was diagnosed with chronic fatigue syndrome (CFS) and fibromyalgia in 1998.

“’Walk in My Shoes™’ also recognizes the important role that caregivers play in the lives of those with these debilitating illnesses.”

“Healthy persons may never be able to truly understand the debilitating body wide pain and fatigue, brain fog/cognitive impairment and flu like symptoms experienced on a daily basis by people with CFS, fibromyalgia and other chronic pain illnesses, however, helping raise much needed funds to continue the work of advocacy groups like P.A.N.D.O.R.A. brings us another step closer to finding a cure,” Silverman added.

WALK REGISTRATION

Check-in for “Walk in My Shoes™” begins at 7:30 am to 8:30 am. The walk starts promptly at 9:00 am. The C.B. Smith Park is located at 900 N. Flamingo Road in Pembroke Pines.

About P.A.N.D.O.R.A., Inc.

Patient Alliance for Neuroendocrineimmune Disorders Organization for Research & Advocacy
P.A.N.D.O.R.A. (pandoranet.info) was founded on July 1, 2002 by Marly C. Silverman, a Chronic Fatigue Syndrome and fibromyalgia patient. Our mission is to raise awareness of the plight of persons with chronic fatigue syndrome, fibromyalgia, Gulf War illness, multiple chemical sensitivities, environmental illnesses, and chronic Lyme disease and advocate on quality of life issues. P.A.N.D.O.R.A. is Built on Hope – Strong on Advocacy – Finding a Cure through Research.

Contact: Corin Walson – info[.]walsonpr.com – 714-970-2268
(http://www.newswiretoday.com/news/49839/)

Researchers probe kidney damage, protection in lupus

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

Courtesy utsouthwestern.edu

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

DALLAS – April 21, 2009

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Courtesy of PulseToday.com

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

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

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

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

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

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

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

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

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

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

UP DATE

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PULSE READERS’ COMMENTS:

Umesh Prabhu | 18 Apr 09

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

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

THE REVALIDATION PROCESS

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

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

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

Practice staff to rate GPs as part of tougher appraisal

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

DEBATE

Are recertification plans good for general practice?

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

Yes

Are recertification and revalidation really necessary?

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

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

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

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

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

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

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

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

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

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

Standard process

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

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

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

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

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

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

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

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

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

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

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

No

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

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

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

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

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

These proposals are seriously flawed in many respects.

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

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

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

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

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

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

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

Wary of bias

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

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

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

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

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

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

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

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Minister calls for pain indicators in QOF (Quality

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

Courtesy of PulseToday.com

By Nigel Praities -21 Apr 09

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

MAJOR INITIATIVE

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

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

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

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

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

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

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

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

AGEING PROCESS

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

CO-PROXAMOL WITHDRAWAL AND NAMED PATIENTS

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

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

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

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

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

PAIN TRAINING SHOULD BE EXTENDED

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

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

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

FIFTH VITAL SIGN – PAIN SCORE

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

MODEL PAIN SERVICE OF PATHWAYS OF CARE

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

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

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

PAIN CHAMPION DEMANDED

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

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

REPLY

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

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

NATIONAL PAIN DATABASE

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

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

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

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

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

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

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

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

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

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

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

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

Enduring chronic stress can destroy brain cells

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

COURTESY OF KELOWNA CAPITAL NEWS – bclocalnews.com

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

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

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

Stress is much more than feeling uptight about life.

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

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

The answer here folks is an undeniable YES.

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

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

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

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

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

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

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

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

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

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

Chronic stress also effects immune system function.

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

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

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

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

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

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

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

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

Seating is limited to 10 participants.

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

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

© Copyright Black Press. All rights reserved
(http://www.bclocalnews.com/lifestyles/43195802.html)

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

Caffeine Myths and Facts

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

Caffeine myth or caffeine fact? It is not always easy to know. Chances are you have some real misperceptions about caffeine. For starters, do you know the most common sources of caffeine? Well, maybe two of the sources are not too hard to name — coffee and tea leaves. But did you know kola nuts and cocoa beans are also included among the most common caffeine sources? And do you know how much caffeine content can vary from food to food? Turns out it is quite a lot actually, depending on the type and serving size of a food or beverage and how it is prepared.

Caffeine content can range from as much as 160 milligrams in some energy drinks to as little as 4 milligrams in a 1-ounce serving of chocolate-flavored syrup. Even decaffeinated coffee is not completely free of caffeine. Caffeine is also present in some over-the-counter pain relievers, cold medications, and diet pills. These products can contain as little as 16 milligrams or as much as 200 milligrams of caffeine. In fact, caffeine itself is a mild painkiller and increases the effectiveness of other pain relievers.

Want to know more? Read on. WebMD has examined some of the most common myths about caffeine and gathered the facts to shed some light on those myths.

Caffeine Myth No. 1:

Caffeine Is Addictive

This one has some truth to it, depending on what you mean by “addictive.” Caffeine is a stimulant to the central nervous system, and regular use of caffeine does cause mild physical dependence. But caffeine does not threaten your physical, social, or economic health the way addictive drugs do. (Although after seeing your monthly spending at the coffee shop, you might disagree!)

If you stop taking caffeine abruptly, you may have symptoms for a day or more, especially if you consume two or more cups of coffee a day. Symptoms of withdrawal from caffeine include:

headache
fatigue
anxiety
irritability
depressed mood
difficulty concentrating

No doubt, caffeine withdrawal can make for a few bad days. However, caffeine does not cause the severity of withdrawal or harmful drug-seeking behaviors as street drugs or alcohol. For this reason, most experts do not consider caffeine dependence an addiction.

Caffeine Myth No. 2:

Caffeine Is Likely to Cause Insomnia

Your body quickly absorbs caffeine. But it also gets rid of it quickly. Processed mainly through the liver, caffeine has a relatively short half-life. This means it takes about four to five hours, on average, to eliminate half of it from your body. After eight to 10 hours, 75% of the caffeine is gone. For most people, a cup of coffee or two in the morning would not interfere with sleep at night.

Consuming caffeine later in the day, however, can interfere with sleep. If you are like most people, your sleep would not be affected if you do not consume caffeine at least six hours before going to bed. Your sensitivity may vary, though, depending on your metabolism and the amount of caffeine you regularly consume. People who are more sensitive may not only experience insomnia but also have caffeine side effects of nervousness and gastrointestinal upset.

Caffeine Myth No. 3:

Caffeine Increases Risk for Conditions Such as Osteoporosis, Heart Disease, and Cancer

Moderate amounts of caffeine — about 300 milligrams, or three cups of coffee — apparently cause no harm in most healthy adults. Some people are more vulnerable to its effects, however. That includes such people as those who have high blood pressure or are older. Here are the facts:

Osteoporosis and caffeine

At high levels (more than 744 milligrams/day), caffeine may increase calcium and magnesium loss in urine. But recent studies suggest it does not increase your risk for bone loss, especially if you get enough calcium. You can offset the calcium lost from drinking one cup of coffee by adding just two tablespoons of milk.

However, research does show some links between caffeine and hip fracture risk in older adults. Older adults may be more sensitive to the effects of caffeine on calcium metabolism. If you are an older woman, discuss with your doctor whether you should limit your daily caffeine intake to 300 milligrams or less.

Cardiovascular disease and caffeine

A slight, temporary rise in heart rate and blood pressure is common in those who are sensitive to caffeine. But several large studies do not link caffeine to higher cholesterol, irregular heartbeats, or an increased risk of cardiovascular disease.

If you already have high blood pressure, though, have a discussion with your doctor about your caffeine intake. You may be more sensitive to its effects. Also, more research is needed to tell whether caffeine increases the risk for stroke in people with high blood pressure.

Cancer and caffeine

Reviews of 13 studies involving 20,000 people revealed no relationship between cancer and caffeine. In fact, caffeine may even have a protective effect against certain cancers.

Caffeine Myth No. 4:

Caffeine Is Harmful for Women Trying to Get Pregnant

Many studies show no links between low amounts of caffeine (a cup of coffee per day) and any of the following:

trouble conceiving
miscarriage
birth defects
premature birth
low birth rate

At the same time, for pregnant women or those attempting pregnancy, the March of Dimes suggests fewer than 200 milligrams of caffeine per day. That is largely because in limited studies, women consuming higher amounts of caffeine had an increased risk for miscarriage.

Caffeine Myth No. 5:

Caffeine Has a Dehydrating Effect

Caffeine can make you need to urinate. However, the fluid you consume in caffeinated beverages tends to offset the effects of fluid loss when you urinate. The bottom line is that although caffeine does act as a mild diuretic, studies show drinking caffeinated drinks does not actually cause dehydration.

Caffeine Myth No. 6:

Caffeine Harms Children, Who, Today, Consume Even More Than Adults

As of 2004, children ages 6 to 9 consumed about 22 milligrams of caffeine per day. However, energy drinks that contain caffeine are becoming increasingly popular.

Studies suggest that up to 300 milligrams of caffeine daily is safe for kids. But is it smart? Many kids are sensitive to caffeine, developing temporary anxiety or irritability, with a “crash” afterwards. Also, most caffeine that kids drink is in sodas, energy drinks, or sweetened teas, all of which have high sugar content. These empty calories put kids at higher risk for obesity.

Even if the caffeine itself is not harmful, caffeinated drinks are generally not good for kids.

Caffeine Myth No. 7:

Caffeine Can Help You Sober Up

Actually, research suggests that people only think caffeine helps them sober up. For example, people who drink caffeine along with alcohol think they are OK behind the wheel. But the truth is reaction time and judgment are still impaired. College kids who drink both alcohol and caffeine are actually more likely to have car accidents.

Caffeine Myth No. 8:

Caffeine Has No Health Benefits

Caffeine has few proven health benefits. But the list of caffeine’s potential benefits is interesting. Any regular coffee drinker may tell you that caffeine improves alertness, concentration, energy, clear-headedness, and feelings of sociability. You might even be the type who needs that first cup o’ Joe each morning before you say a single word. Scientific studies support these subjective findings. One French study even showed a slower decline in cognitive ability among women who consumed caffeine.

Other possible benefits include improved immune function from caffeine’s anti-inflammatory effects and help with allergic reactions due to caffeine’s ability to reduce concentrations of histamines. Some people’s asthma also appears to benefit from caffeine. These research findings are intriguing, but still need to be proven.

Limited evidence suggests caffeine may also reduce the risk of the following:

Parkinson’s disease
liver disease
colorectal cancer
type 2 diabetes

Despite its potential benefits, do not forget that high levels of caffeine may have adverse effects. More studies are needed to confirm both its benefits and potential risks.

SOURCES: International Food Information Council Foundation: “Caffeine & Health: Clarifying the Controversies.” Nutrition Action Health Letter: “Caffeine: The Good, the Bad, and the Maybe.” European Food Information Council (EUFIC): “Myths and Facts about Caffeine.” Johns Hopkins University Bayview Medical Center: “Information About Caffeine Dependence.”

©2005-2009 WebMD, LLC. All rights reserved.
(http://www.webmd.com/balance/caffeine-myths-and-facts?ecd=wnl_day_042009)

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