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

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

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

May 19, 2009 03:00 PM Eastern Daylight Time

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

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

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

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

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

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

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

About the Study

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

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

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

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

This study was sponsored by Pfizer, Inc.

About Lyrica

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

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

Important Safety Information

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

Pfizer Inc: Working together for a healthier world™

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

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

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

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

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

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Fibromyalgia, Diet, and Nutrition – Breaking the Relationship between Them

From the FMS Global News Desk of Jeanne Hambleton

Courtesy of Fibromyalgia Consultant

By Matt Dew

The currant debated issue has been the relation between fibromyalgia, diet, and nutrition. There is no study could exactly explain whether or not fibromyalgia is influenced by diet and nutrition. Hence, this article may give you a bit of enlightenment of the uncertainty of the link between fibromyalgia, diet, and nutrition.

Even though the sufferers of fibromyalgia seem to be growing all over, actually this is not a new condition. There is no way to know just how long people have affected by fibromyalgia, but until lately there was no term to add to the condition.

Nowadays, we recognize that it is a valid concern and that the effects of fibromyalgia are, in fact, very severe for some people. Fibromyalgia can often engage nearly constant pain and fatigue. Some sufferers are unable to involve in their normal activities due to these and other symptoms as well. Some often builds up a deep depression because they are unable to take part in life like they used to.

So far, there have not been many studies into the link between fibromyalgia, diet, and nutrition. It has long been known that diet and nutrition are factors in nearly every kind of condition, but since fibromyalgia research is still in the early stages, the study of fibromyalgia, diet, and nutrition has yet to be conducted in a thorough manner by formal researchers.

Amateur Research Trials

That is not to say that amateur researchers have not been conducting their own studies of fibromyalgia, diet, and nutrition, though. Many people with fibromyalgia have been examining the effects that different foods can have on their symptoms, and they have seen surprising results.

It seems that the relationship between fibromyalgia, diet, and nutrition are quite close. It has been proven since the foods that affect fibromyalgia symptoms are mostly the same ones that can cause other kinds of chronic conditions like migraine headaches. Chocolate, alcohol, caffeine, and processed foods have all been said as possible culprits in the link between fibromyalgia, diet, and nutrition.

These offending foods may exacerbate the symptoms that a sufferer would feel on a normal day, but they are not though to be the cause of fibromyalgia. There may be even more foods that have not yet been linked to the symptoms of fibromyalgia.

Though direct relation between fibromyalgia, diet, and nutrition has not proven yet, eating a balanced diet is one of the best things that you can do to ease your fibromyalgia symptoms. A good balanced diet can do speculates for improving your overall healthiness and allow your body to get on with its normal processes, including healing any diseases or injuries.

Detox Diet to Cure Fibromyalgia – Knowing It’s Efficacy

People often wonder is there any detox diet to cure fibromyalgia since there is believe that nutrition influences the health condition. In most of the cases, healthy diet is proven to help in keeping the body fit but how about detox diet to cure fibromyalgia. Does it really work? Let’s take a look on it!

Up till now, the cure for fibromyalgia has not been known, and lots of the treatment choices cannot effectively take the relief that many patients wish for. That is why many people have turned to alternative methods for treating this chronic condition, and some of these choices have met with success.

One such treatment is a detox diet to cure fibromyalgia, which is worth a serious look since many have sworn by the success of this way of achievement. But what is it, and how to use a detox diet to cure fibromyalgia?

The Basics of a Detox Diet

For those who believe in employing a detox diet to cure fibromyalgia, the idea is that our bodies are crammed with toxins from the polluted air that we breathe and the unhealthy food. These pollutants need to be effectively removed from our bodies for optimal health, but they are not equipped to completely get rid of the many toxins that we absorb now.

By adhering to a detox diet to cure fibromyalgia and a host of other chronic conditions, we are assisting our bodies in the elimination process by allowing our own systems to work at their best. At the same time, we avoid putting any additional chemicals into our bodies by consuming only organic substances that are created to work with our own internal systems for maximum efficiency.

Consuming caffeine-free detox teas said to be one way of detox diet to cure fibromyalgia. This diet contains a combination of herbs for cleansing the system. Other herbs that work well in a detox diet include Echinacea, fenugreek and ginger. To gain energy and aid in the cleansing process of the digestive system, you can intake raw foods, like fresh, organic fruits and vegetables.

Drinking abundance of water is also key to a thriving detox diet program. Some people will feel side effects with a detox diet to cure fibromyalgia at first like nausea, headaches and diarrhea. Nonetheless, if you begin to find a relief from your fibromyalgia symptoms, a bit of discomfort in the beginning is well worth the long term advantages.

Composing a detox diet to cure fibromyalgia should be suited with each person who suffers the disease.

Remember to consult your doctor before beginning any type of diet.

If your doctor says okay, a detox diet to cure fibromyalgia may be just what you have been seeking to finally discover relief from your excruciating symptoms.

Are Fibromyalgia and Weight Gain Closely Related?

Fibromyalgia and weight gain have a strong connection. Majority people who are suffering from fibromyalgia may gain their weight. However, you can take measures to avert weight gain difficulties when you get an idea concerning the connection between fibromyalgia and weight gain.

This article let us discover the triggering factors of weight gain throughout fibromyalgia and then discuss the healthy diet you can follow throughout fibromyalgia. So, it is possible to go through weight management.

Slower Metabolic Process

Fibromyalgia causes weight gain in people is due to a wide variety of aspects which are either directly or indirectly linked to the occurrence of the illness itself. Since fibromyalgia results in hormonal imbalances, it can influence levels of insulin, cortisol, thyroid, and serotonin. Also, it profoundly influences the production of growth hormones. Since there is a clear hormonal imbalance, it affects the metabolism process and makes it slower than normal, which causes weight gain.

Fatigue and Sleep Apnea

Apart from hormonal imbalance, since fatigue is one of the most vital symptoms of fibromyalgia, it also leads to weight gain problems. It has been revealed that there is a strong connection between fatigues of fibromyalgia and weight gain.

People with fibromyalgia may also suffer from sleep disturbances, leading to a poor quality sleep, that makes individuals even more tired and these people simply lack the ability to stay active, which means fewer calories are actually burnt. This also causes problems with weight gain.

Excessively Low Blood Sugar

Insulin sensitivity is increasing in fibromyalgia patients. This leads to an excessive amount of glucose to be transferred from the blood and forced in to the muscles. However, the transferred glucose virtually has no places to go because muscles have a restricted capacity to store glucose.

This leads the body to powerfully construct a fat-depositing system, in which excess glucose become fatty tissue. Opposing to the popular conviction that fatty food contributes to increased weight, it is actually caused by a high-carbohydrate diet.

Helpful Diet

The diet needs to be designed for fibromyalgia patients in such a manner that these factors can be effectively taken under consideration. This is because fibromyalgia deeply influences the maladaptive nature of metabolism and the dysfunctional characteristics of carbohydrate response. A higher carbohydrate diet cannot benefit patients with fibromyalgia, rather it could worsen the condition to a greater level. Since the metabolic rate is much slower, eating less is usually difficult for these people.

The strong connection between fibromyalgia and weight gain is a fact of the truth. Selecting the proper ‘quality’ of foods can provide benefit to patients with fibromyalgia and weight gain. In addition, you must eat your food very slowly and must chew your food well since your metabolism decreases.

The Difference between Fibromyalgia and Polymyalgia – A Confusing Matter

Owing to the similarity between the terms and symptoms, most people are bemused if there is a difference between fibromyalgia and polymyalgia. Once person is diagnosed with fibromyalgia or polymyalgia, he or she may become puzzled thinking whether these two are similar. Are you burned up of the difference between fibromyalgia and polymyalgia? Check this out!

Since the term ‘myalgia’ means ‘pain taking place in the muscles’, both of these conditions are featured by an intense sensation of muscle pain. Yet, there is still a difference between fibromyalgia and polymyalgia. However, let us find out if there are any noteworthy differences between fibromyalgia and polymyalgia.

Causes Are Different

When we try to seek the causes of each disease, there is a significant difference between fibromyalgia and polymyalgia. Even though the precise reason behind the progress of polymyalgia is still unidentified, many scientists convince that polymyalgia is another type of autoimmune disease, during which connective tissues develop into adversely exaggerated by the immune system itself.

Conversely, fibromyalgia develops as a result of maladaptive sensory processing emerging in the central nervous system (CNS). This is why people with fibromyalgia may become tremendously sensitive to the horrible stimuli present in the environment. These people are also very sensitive to ache.

Not All Symptoms Are the Same

The main symptoms of polymyalgia include severe form of stiffness and muscle pain in the neck, shoulders, and hips. People with polymyalgia may feel flu-like conditions as well. On the other hand, people suffering from fibromyalgia experience widespread pain all over the body. There are a large number of tender points in the body. Fatigue, headache, lack of concentration, poor quality of sleep and irregular bowel syndrome are the common symptoms of fibromyalgia.

Prevalence of the Complications

Both fibromyalgia and polymyalgia may occur more in women more than men, so there is no gender specific difference between fibromyalgia and polymyalgia. However, there is a difference in the age factor, since fibromyalgia can occur at any age, whereas, polymyalgia usually occurs in people over 50 years of age.

Treatment Methodologies

The principal mode of treatment for polymyalgia occupies relief from inflammation. Polymyalgia patients may be recommended to undertake Non-steroid anti-inflammatory drugs (NSAIDs), if they are suffering mild degree of polymyalgia. Prolonged usage of this drug may bring bad side effects like intestinal bleeding, stomach bleeding, high blood pressure, etc. Corticosteroids are administered as the severe type of polymyalgia.

In treating people with fibromyalgia, the administration of non-steroid anti-inflammatory drugs may put them out of action. However, narcotics including oxycodone, propoxyphene and codeine are found to be effective in reducing pain. Light exercise and healthy diet is a must in both the cases. There is no difference between fibromyalgia and polymyalgia in such conditions. For more information, please check out links on this Fibromyalgia Consultant site.

(http://fibromyalgiaconsultant.com/fibromyalgia/fibromyalgia-diet-and-nutrition-breaking-the-relationship-between-them/ -
http://fibromyalgiaconsultant.com/fibromyalgia/fibromyalgia-diet-and-nutrition-breaking-the-relationship-between-them/ –

http://fibromyalgiaconsultant.com/difference-between-fibromyalgia-and-polymyalgia/the-difference-between-fibromyalgia-and-polymyalgia-a-confusing-matter/)

Disclaimer: Any views or opinions expressed in this article are those solely of the author/writer and do not necessarily infer endorsement by the News Desk.  Any advice or recommendation of a medical or legal  nature must always be discussed with a qualified professional.  FMS Global News cannot be held responsible for omissions and/or errors. 

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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)

Chili Pepper Compound Can Bring Pain Relief

From the FMS News Desk of Jeanne Hambleton

COURTESY usnews.com Health Day – Monday March 16

Capsaicin works on nerves to ease joint discomfort, scientists say

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

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

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

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

More information

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

Finding Effective Treatment for Your Chronic Pain

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

By January W. Payne

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

EU COMMISSIONER FOR HEALTH ANSWERS QUESTIONS ON FIBROMYALGIA

From the News Desk of Jeanne Hambleton

 

I have just received the following Q&A information. While this is not a recent conversation, it is evidence that fibromyalgia is being discussed in the Europe.

 

EU QUESTIONS AND ANSWERS

 

On 28 October 2008, European Commissioner for Health, Ms Androulla Vassiliou answered questions put to her by EU member Mr. Florin Popa  (Romania) on EU recognition for fibromyalgia, the need for treatments in Europe for fibromyalgia and the need for more data from research. 

 

QUESTION:

Can the Commission state its position on fibromyalgia, as the WHO did in 1992? Does the Commission think that there is a need for action at European level, in the interests of European citizens, in order to avoid the disparities in diagnoses and treatment that exist in all Member States?

ANSWER:

In accordance with the Treaties, the benefits that Member States provide under their health systems and the conditions applicable are up to Member States to determine, including with regard to the benefits and treatments provided for specific conditions such as fibromyalgia.

QUESTION:

Can the Commission comment on the lack of availability of approved treatments in the EU for fibromyalgia? Millions of people suffering from fibromyalgia across Europe do not have the same access to medicines to treat fibromyalgia as in the US. Following its October meeting, the Committee for Medicinal Products for Human Use (CHMP) took a negative decision regarding the first medicine for the treatment of fibromyalgia in Europe. Patients across Europe were disappointed to hear that a license to approve a drug for fibromyalgia had not been granted. Yet the reality is that in Europe patients are taking medicines off-label. What solution does the Commission see for this specific problem?

ANSWER:

The fact that the Committee for Medicinal Products for Human Use (CHMP) proposed a negative decision regarding the market authorisation of a medicine for the treatment of fibromyalgia in Europe does not preclude future authorisation of other proprietary medicines that meet the safety, efficacy and quality requirements laid down in EU legislation.

QUESTION:

In order to obtain a treatment for fibromyalgia, there is a need to collect EU data. Can the Commission help collect and receive data and also help with the coordination of national expertise?

ANSWER:

The Commission already pointed out that under the current health programme 2008‑13 a proposal for surveillance of and information on musculoskeletal diseases, including fibromyalgia, has been selected and a contract is under negotiation. This project, if the contract can finally be successfully concluded, is expected to contribute to improvement of European data on incidence and prevalence of fibromyalgia as well as information on best practice of diagnosis, treatment and care.

BACKGROUND

 

European Commissioner for Health, Ms Androulla Vassiliou on her website said she was honored to have the opportunity to work on issues which  ‘intimately touches EU citizens’ everyday lives”.

 

She writes, “As Commissioner for Health, my portfolio covers three broad areas: public health, feed and food safety and animal health and welfare. Many challenges lie ahead. We need, for example to improve the legal certainty on patients’ rights in cross border health care, to contribute to reducing organ donation shortages, to help combat rare disease in the field of public health or to implement a comprehensive strategy on animal health. 

I know I can count on the dedication of my services working in the Directorate-General for Health and Consumers and I look forward to a close co-operation with national authorities in the Member States. 
On my side, I will put all my energy into addressing these important issues. 
 Working on health at EU level can bring about results that can not so easily be achieved by Member States working alone.”

 

(http://ec.europa.eu/commission_barroso/vassiliou/index_en.htm)

 

There is a contact box on this website if you have any questions. I could find no references to fibromyalgia. Might have been fibro fog on my part? JH

 

Mr. Florin Popa, EU Member (Romania) was one of the five MEPs active in health issues at the European Parliament, who helped to initiate the Written Declaration relating to fibromyalgia in conjunction with the European Networks of Fibromyalgia Associations.

 

EUROPEAN NETWORK of FIBROMYALGIA ASSOCIATIONS

Press Release


Members of the European Parliament (MEPs) adopt written declaration 69/2008 on fibromyalgia initiated by five deputies and the European Network of Fibromyalgia Associations (ENFA).

Brussels 16.12.2008 – Written Declaration 69/2008 on fibromyalgia has been a success in the European Parliament by finding the necessary quorum of signatories of 393 deputies giving their support. The Written Declaration was initiated by five key MEPs active on health at the European Parliament: Mr. Adamou, Ms. Brepoels, Ms. Dickuté, Mr. Popa and Ms. Sinnott. These MEPs decided to launch the declaration during the celebratory meeting of the 1st European Fibromyalgia Awareness Day in May 2008, organized by ENFA.

The Written Declaration is calling on the European Union to recognize fibromyalgia in Europe as a disease, as WHO did in 1992. It is estimated that 14 million people in Europe suffer from fibromyalgia and the condition is more prevalent with women (87% of total prevalence).

Fibromyalgia is a complex disease with a variety of symptoms in addition to the defining symptom – chronic widespread pain. These include fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, 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. Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.

 

Fibromyalgia imposes large economic burdens on society as well as on affected individuals. A study shows that an average patient in Europe consults up to 7 physicians and takes multiple medications over 5-7 years before receiving the correct diagnosis. The debilitating symptoms often result in lost workdays, lost income and disability payments.

 

Research in the UK has shown that diagnosis and positive management of fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations.

Thus, the European Parliament is calling through this declaration, for the European Commission and the Council, to help raise awareness of the condition and facilitate access to information for health professionals and patients, by supporting European and national awareness campaigns; to encourage Member States to improve access to diagnosis and treatment; to facilitate research on fibromyalgia through the work programmes of the EU 7th Framework Programme for Research and future research programmes; and finally to facilitate the development of programmes for collecting data on fibromyalgia.

 

Educating healthcare professionals, patients and the public to promote better understanding and management of fibromyalgia will benefit patients, healthcare providers and the society. A Written Declaration is a text of up to 200 words on a matter falling within the European Union’s sphere of activities. MEPs can use them in order to launch or relaunch a debate on a subject that comes within the EU’s remit. At the end of the lapsing date (3 months after its launch on 1 September for the declaration 69/2008, the declaration is forwarded to the institutions named in the text, together with the names of the signatories.

 

Thank You MEP’s, Thank you fibromyalgia supporters!

The written declaration 69/2008 about fibromyalgia reached the quotum on December16th 2008, to be accepted by the European Parliament. This acceptance means that the first but important step on a long way to get fibromyalgia recognised in all the European countries, has been taken.

The awareness of the condition of fibromyalgia by the members of the European Parliament could be an example for national politicians for actively addressing their national governments. ENFA and their members are more than willing to support such activities.

 

 

 

 

 

 

 

F.D.A. TO PLACE NEW LIMITS ON PRESCRIPTIONS OF NARCOTICS

From the News Desk of Jeanne Hambleton

By GARDINER HARRIS -Published: February 9, 2009

WASHINGTON — Many doctors may lose their ability to prescribe 24 popular narcotics as part of a new effort to reduce the deaths and injuries that result from these medicines’ inappropriate use, federal drug officials announced Monday.

A new control program will result in further restrictions on the prescribing, dispensing and distribution of extended-release opioids like OxyContin, fentanyl patches, methadone tablets and some morphine tablets.

These products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the Food and Drug Administration and the Drug Enforcement Agency. But the current restrictions have failed to “fully meet the goals we want to achieve,” said Dr. John K. Jenkins, director of the F.D.A.’s new drug center.

“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products,” Dr. Jenkins said in a news conference on Monday. “This is going to be a massive program.”

Hundreds of patients die and thousands are injured every year in the United States because they were inappropriately prescribed drugs like OxyContin or Duragesic or they took the medicines when they should not have or in ways that made the drugs dangerous. The agency has issued increasingly urgent warnings about the risks, but the toll has only worsened in recent years.

The blame for this is shared among doctors who prescribe poorly, patients who pay little attention to instructions or get access to the medicines inappropriately, and companies that have marketed their products illegally.

The F.D.A. this year will hold meetings with manufacturers, patient and consumer advocates, and the public to ask for advice on how to carry out the new control program, officials announced. The first meeting will be on March 3, and no immediate changes in access to the drugs is planned.

The 24 medicines under review had 21 million prescriptions written for them in 2007, to 3.7 million patients, Dr. Jenkins said. They are extremely effective in reducing pain, which many medical studies suggest is widely undertreated in patients suffering serious illness. (A complete list of the drugs is at www.fda.gov/cder.)

But many doctors prescribe the drugs far too cavalierly, Dr. Jenkins said. The F.D.A. has received reports of patients’ being prescribed such medicines to treat something as simple as a sprained ankle, he said. In such patients, the medicines can be dangerous.

Part of the problem is marketing. Several reports, for instance, have suggested that Purdue Pharma, the maker of OxyContin, helped fuel widespread abuse of the drug by aggressively promoting it to general practitioners not skilled in either pain treatment or in recognizing drug abuse.

The company has denied such a connection, but a holding company connected with Purdue and three top Purdue executives pleaded guilty last year to criminal charges that the company had misled doctors and patients by claiming for five years that OxyContin was less prone to abuse because it was a long-acting narcotic.

Doctors are also to blame. A common reason for disciplinary actions at state medical boards is the use of narcotics in patients who show clear signs of addiction or for whom the drugs are obviously inappropriate.

The F.D.A. generally avoids interfering with the practice of medicine because doctor behavior is governed by state medical boards. Instead, the agency usually tries to provide doctors with the best and most current information, and then allows them to decide how to use it.

Most of the drugs withdrawn over the last 20 years, however, were taken off the market because doctors continued to use the medicines in ways that the F.D.A. warned against.

For decades, the agency’s armory in these battles held only a popgun and a cannon — the popgun being the issuance of widely ignored warnings; the cannon being its ability to force a medicine’s withdrawal. But a law passed in 2007 gave the agency a new, intermediate weapon — Risk Evaluation and Mitigation Strategies. Known as REMS, these programs allow the agency to place strong restrictions on the distribution of certain drugs.

 

Courtesy New York Times (Money & Policy – Health Alert) Copyright  & All Rights Reserved 

(http://www.nytimes.com/2009/02/10/health/policy/10fda.html?_r=1&emc=tnt&tntemail1=y)

 

 

NEW DATA ON THERAPIES FOR PAIN AND INFLAMMATION FROM PFIZER

By Jeanne Hambleton © Fibromite NFA Leader Against Pain

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

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

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

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

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

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

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

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

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

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

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

Fibromyalgia

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

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

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

Rheumatoid Arthritis

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

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

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

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

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

Osteoarthritis Pain

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

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

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

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

About Celebrex

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

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

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

Gastrointestinal Risk

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

About Lyrica

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

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

GULF WAR VETERANS NEED YOUR SUPPORT

by Jeanne Hambleton © 2007
NFA Leader Against Pain-Advocate

Have you ever come across the R.E.S.C.I.N.D. website. Started in the 1990s by Tom Hennessy (now a very sick man who thought up the idea of an International Awareness Day – May 12) and his friends Nancy Solo, Paula Carnes, Maryka Ford, Lucie Dorais, Roger Burns and Chip Davis

It is important that I stress no copyright infringement is meant as this is not published for any financial gain, however I do have the permission of Tom Hennessy to use material from the websites.

But possibly due to Tom’s long and protracted illness the site has found a new home and appears to have been revamped. We wish you well Tom.

http://www.geocities.com/capitolhill/4277/

It appears this site is right up to date with the latest news about the problems associated with the Gulf War Syndrome and CFS/ME, FMS and other related problems thanks to Eileen Marshall and   Margaret Williams. I have apparently missed this news in my two newspapers. Perhaps I should give up reading the comic strips. But seriously….

Obviously a public inquiry relating to the Gulf War Syndrome has been rumbling on for some time and eventually the Lloyd Report from the Public Inquiry, carried out by the Rt. Hon. Lord Lloyd of Berwick, was published in November 2004. The brief was “To investigate the circumstances that have led to the ill health and in some cases death, of over 6,000 British troops following deployment to the first Gulf War, and to report on it.”

For more details of the report look at the Gulf War Illnesses Public Inquiry website.
http://www.lloyd-gwii.com/
According to the new R.E.S.C.I.N.D. website at ‘geocities’ above and Eileen Marshall and   Margaret Williams
http://www.counciloftruth.com/content/view/154/65/
The Ministry of Defence is to officially recognise Gulf War Syndrome after a 17-year campaign for justice by ex-military servicemen.

For 17 years the Ministry of Defence refused to recognise that Gulf War Syndrome existed. However, now Defence Minister Lord Drayson has backed down following pressure by Manchester peer Lord Morris. Lord Drayson said: 
“The issue of Gulf War Syndrome will be fully recognised by the Ministry of Defence and I accept on behalf of the MoD that this issue has not been handled well from the
beginning.

“The department was slow to recognise the emerging ill-health issues and to put measures in place to address them. We have apologised for this and I repeat that apology today.”

The belated apology has come too late for many servicemen. Thanks to government cover-ups many of these servicemen lost their lives for serving their country.

The website claims the Ministry of Defence are experts at covering up their failures and obstructing justice – now they need to follow the recommendations in the Lloyd Report and compensate the servicemen who suffered Gulf War Syndrome.     

Watch the video “Gulf War Syndrome – Killing Our Own”:
 If you log on to this website you can see the video.

http://www.counciloftruth.com/content/view/154/65/
Linking with this address you can keep the pressure on Gordon Brown too by signing this petition.

Before you do, it is interesting to read this website’s definition of the Gulf War Syndrome symptoms – sounds familiar?

GULF WAR SYNDROME (GWS)
Gulf War illnesses are a collection of disorders that for the most part can be
diagnosed and treated, if effective programs exist to assist veterans, and in some
cases their immediate family members. Although these illnesses are complex and have
multi-organ signs and symptoms, a proportion of these patients can be identified as
having Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) and/or Fibromyalgia Syndrome (FMS).
Nicolson GL, Nicolson NL, Institute for Molecular Medicine

Log on to this address for access to the petition

http://www.counciloftruth.com/content/view/154/65/ and click where it talks about Gordon Brown and the petition. This will take you to
http://www.petitiononline.com/gwsdrb/petition.html%20 In the Search box type Gulf War Syndrome Petition and click Search
This will reveal a number of on-line petitions but the one you want is the first one
“Gulf War Syndrome Implement the Recommendations of the Lloyd Report” and this will reveal the petition. It takes no time at all and you are asked to verify your signature. So easy all on line.
http://www.petitiononline.com/gwsdrb/petition.html
Do remember these lads are fellow sufferers who fought for their country. They need our support. I believe it has been running about 5 weeks and it has a poor 95 signatures. We can do better than that, can’t we?
The Petition is also on Facebook as a Group at
http://www.facebook.com/group.php?gid=5383334893
It reads:
To:  Gordon Brown, British Prime Minister
******************************
Petition British Prime Minister Gordon Brown to implement the recommendations of The Lloyd Report on Gulf War Syndrome ******************************

The gauntlet laid down for Gordon Brown:

Some 250,000 of the returning allied forces from the first Gulf War in 1991 (15 per cent) went down with illness that they insist was related to their service in that war. Of these, 10,000 are already dead.

Successive governments over the years have refused to recognise the existence of a single condition called Gulf War Syndrome and so the impasse continues.

On 14 June 2004 it was announced that there was to be a Public Inquiry into the illnesses suffered by veterans returning home from the first Gulf War.

This public inquiry was chaired by The Rt Hon The Lord Lloyd Of Berwick and on 17 November 2004, the inquiry published its report -The Lloyd Report on Gulf War Illnesses, commonly referred to now as The Lloyd Report.

The following are the 3 R’s of The Lloyd Report that Gordon Brown needs to accept:

1. REALISATION – realisation it IS Gulf War Syndrome
Paragraph 283 of the Lloyd Report:
283. It seems to us that with the termination of any legal proceedings against the MOD, and with the results of the three epidemiological surveys to hand, now is the time to reach agreement with the veterans. This was the strong thrust of Lord Craigís evidence. The MOD could initiate the process by taking the following steps: -
(1) The MOD should acknowledge publicly that the veterans who have made
claims (other than the 272 who have had their claims rejected) are indeed
suffering injury or disease as a result of their service in the Gulf.
(2) Since the name of the injury or disease is only a label for wrapping the
symptoms from which the veterans are undoubtedly suffering, the Ministry of
Defence should accept the name favoured by the veterans, i.e. Gulf War
Syndrome, as the most convenient label.

2. RECOMPENSE – Recompense Veterans

Paragraph 283 of the Lloyd Report continues:
(3) The MOD should set up a fund out of which ex gratia payments should be
made on a pro-rata basis to all those who have made successful claims.
(4) The 272 Claimants who have had their claims rejected should have those
claims reviewed in the light of this report.

3. RECOMMENDATION – The Government needs to follow the Recommendations of The Lloyd Report

Paragraph 224 of the Lloyd Report:
…. the picture is already sufficiently clear to enable the MOD to acknowledge forthwith that the illnesses of the Gulf War veterans, who have had their claims accepted, are attributable to their service in the Gulf. To wait for further research into the pathology would, after fourteen years (***now 16 years***), be a denial of justice to the veterans.

Is it no wonder that Dr B has been in touch with Sir Sean Connery, Jerry Weintraub, SKG and others with A View To A …Film! What happened to Nixon after Watergate and All the Presidents Men?

This year we have seen pressure on the Government as follows:
*28 January 2007: Wartime “forces sweetheart” Dame Vera Lynn branded the “endless” legal wrangling over payments to veterans of the first Gulf War a scandal. Dame Vera and ex-Formula One champion Sir Jackie Stewart wrote to the then Chancellor, Gordon Brown, accusing the Ministry of Defence of “haggling”.

*8 May 2007: A recent poll of 121 MPs from all parties found that more than 70 per cent thought that the Government’s actions towards ex-Service people suffering from Gulf War Illnesses had been very poor or inadequate.

The Lloyd Report resume also nails the need as follows:

“10. We come last to the question of compensation. This did not figure largely in the evidence of the veterans themselves. But it figured in the evidence of Lord Craig, Major General Craig, Paul Tyler MP, Michael Mates MP, Colonel Terence English and others. Lord Craig (Lord Craig of Radley, Marshal of the Royal Air Force, Chief of the Defence Staff throughout the Gulf War) said that the absence of closure after so many years was now indefensible. ‘A little magnanimity’ was called for, and an ‘imaginative one-off approach’. Mr Mates told us that what was needed was a political act of will.

“A minister has to say ‘this will be done’ and then it is done.”

We call on Prime Minister, Gordon Brown, to intervene now, without further delay

If you wish to call on Gordon Brown for “a little magnanimity”, to implement the recommendations of The Lloyd Report, then this is the petition to sign!
Sincerely,

The Undersigned

I believe this is just wonderful news and I really hope it does materialise. Let us also hope this a precedent and will bring benefit to our soldiers who are currently at war elsewhere on our behalf.

There is lots more to read on the Internet if you type in Gulf War Syndrome petition.

Please sign now – tell your friends, family, everyone you email, stir up some magnificent support. Our troops deserve our backing – it would seem the Government has been slow in giving them any backing.

Do it now. I have.

Jeanne

Additional Information:

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Tenderpoints Newsletter

New insights into inflammation in osteoarthritis

Contact: Amy Molnar
amolnar@wiley.com
John Wiley & Sons, Inc.

Study indicates role of inflammatory mechanism distinct from joint cartilage

The most common degenerative joint disease, osteoarthritis (OA) is marked by the breakdown of articular cartilage, which is the type of cartilage that lines the ends of most limb bones. It can afflict any joint—fingers, toes, wrists, ankles, elbows, shoulders, and the spine, as well as the weight-bearing knees and hips. As OA progresses, sufferers often experience inflammation around the affected joint. This inflammation has been attributed to bits of cartilage breaking off and aggravating the synovium, the thin, smooth membrane lining a joint. Yet, MRI detection of prominent synovitis in early OA—when joint cartilage appears normal—suggests that other joint structures may be involved in triggering this inflammation. Recent studies of inflammation in spinal arthritis implicate the enthesis, which is the attachment site of ligament or tendon to bone as being a potential driving factor in joint inflammation.

Intrigued by the potential role of tendon or ligament attachment sites in synovitis, Professors Michael Benjamin of Cardiff University and Dennis McGonagle of the University of Leeds decided to investigate the extent to which different entheses could contribute to inflammation by forming a functional unit and destructive partnership with adjacent synovium. Featured in the November 2007 issue of Arthritis & Rheumatism (http://www.interscience.wiley.com/journal/arthritis), their findings shed light on a potential novel mechanism for synovial inflammation in degenerative arthritis. This is based on a structure that the authors have called the “synovial-entheseal complex” (SEC). Basically insertions have a different type of cartilage called fibrocartilage near the bone. Although this is different from articular cartilage that lines the ends of bones, the authors speculated that this type of cartilage could also derive nourishment from synovium. However, this close integration although desirable in health could have unfortunate consequences if the enthesis was damaged.

To validate the widespread formation and to explore further, the possible inflammatory function of SECs, researchers collected ligament and tendon attachment samples from 60 cadavers, 35 male and 25 female, with a mean age of 84 years at death. 49 different entheses—19 from the arms, 26 from the legs, and 4 from the spinal column—were preserved for examination. To exclude cartilage degeneration as a trigger for synovial inflammation, 17 of the selected entheses were not immediately adjacent to joint cartilage. Each sample was studied for evidence of inflammatory cells and soft tissue microdamage, as well as for the composition of SECs.

At 82 percent of the entheses, the formation of a SEC was found. As expected, this occurred in entheses very close to joint cartilage, where the synovium was often part of the joint itself. However, a SEC was also detected in 47 percent of the sites separated from joint cartilage. For example, the SEC found at the Achilles tendon was formed with synovium that protruded from a cavity called a “bursa”, located a considerable distance from the ankle joint.

Joint insertions are sites of high mechanical stressing and the authors speculated that this could lead to damage within them, including their fibrocartilage This is exactly what the authors found. Degenerative changes—at least one and sometimes several—were detected on the soft tissue side of attachment sites. Most notably, cell clustering and/or fissuring was found in 76 percent of entheses. In 85 percent of SECs, the synovial component also showed evidence of mild inflammatory change. Finally, in 73 percent of the attachments, small numbers of inflammatory cells were present in the enthesis itself. Therefore the authors suggest that joint degeneration of fibrocartilage at insertions could trigger inflammation within SECs.

As Professors Benjamin and McGonagle note, one their most striking findings was the large number of attachment sites with evidence of changes in the entheses mirroring those typically seen in joint cartilage in OA—fibrocartilage cell clusters, cell hypertrophy, and fissuring among them. “Such changes at certain entheses could be directly relevant to older subjects with joint symptoms due to degenerative disease,” Professor McGonagle observes, “and some of the symptoms could be emanating from the SEC.”

Affirming the concept of a “synovio-etheseal complex” as widely applicable at many sites in the body, both right next to and removed from joint cartilage, this study also supports the idea that biomechanical factors related to the enthesis could play an important role in synovial inflammation in both degenerative and inflammatory arthritis.

###

Article: “Histopathologic Changes at ‘Synovio-Entheseal Complexes’ Suggesting a Novel Mechanism for Synovitis in Osteoarthritis and Spondylarthritis,” Michael Benjamin and Dennis McGonagle, Arthritis & Rheumatism, November 2007; (DOI: 10.1002/art.23078).

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F IS FOR FIBROMYALGIA

by Jeanne Hambleton © 2007

Hello. It is me again, waffling on about fibromyalgia and this and that.

This morning I am feeling very up beat as I now have three new friends. I have received lovely emails from fibromites including an invitation from a lady called Kathy to visit Arizona and stay with her. Elle has written to me from Playa Blanca to say, “I remember these rains you suffered. Our electricity was blowing every half hour whilst it was all going on grrrr!”

So it really must have been the worst weather in 20 years. Apparently now the weather there is a “scorchio”. Elle said she enjoyed reading the holiday article but I wonder does she have fibromyalgia?

Pamela, a journalist, has written from the Canary Island of Tenerife to say it is cold where she lives in the north of the island. Houses are built for the heat, not the cold, and have no heating. She says around 35,000 people on the island suffer with fibromyalgia which is not recognised for disability or benefits. The island’s population is 852,945 (2006 census) according to Wikipedia, so if this is about 2.5% (I hope that is right) – it is more than the 2% in the UK. Sorry but maths never was my strong subject – too busy flicking ink pellets at the boys in maths lessons. It is all coming out now – warts and all – WYSIWYG!

Born in the UK, Pamela, who is a journalist, still believes she is better off living in Tenerife, even though she wears four layers of clothing in the winter. She believes she could not survive the UK cold winters. I must say I am beginning to think that way too.

Kathy who is another writer, said, “I blog but don’t write professionally anymore, because my fibro is too severe, but I read about you looking for a place without rain, etc., so I wanted to write to let you know about the state in which I live, Arizona. The winters are mild, and so there is no snow, although it has ‘snowed’ twice since I’ve lived here for the last 27 or 28 years, but it was only for a few minutes.

“So if ever you decide you want to ‘test’ my state, please do let me know, because you are free to stay with me, although I don’t know if I’d be a very good hostess since when I’m in a flare, as I am now, I can barely care for myself.”

My new friends wrote to sympathise with the 10 days rain and 4 days sun I ‘enjoyed’ when I last had a holiday in the Canary Islands…global colding I called it.

I will write to my newfound friends but I would like to say here that I believe friendship springs from fibromyalgia. Thanks to Pamela, Kathy and Elle – it was good to hear from you.

Contrary to public belief, we fibromites are no different to other folk, except maybe we hurt a lot more and perhaps grunt and groan a bit when we try to get up from a chair. Most of us have given up tennis, jogging and running marathons but some claim to be okay at cards, chess, in the casino and other less strenuous pursuits.

We still have families and kids with husbands who either stay the course and understand or others who just do not have the stomach for it and cowardly walk away. Perhaps I should explain that people who are diagnosed with fibromyalgia are usually women although children and men are diagnosed with FM. Fibromyalgia strikes high achievers, super mums, workaholics and those living with constant stress overload. I fall into most of those categories – I love my work. I was a high achiever and was always very ambitious, meeting deadlines and looking for the front-page scoop. But I like to think I was a super mum too – but you would have to ask my children about that. Suffice to say – our lovely kids are all employable, do not take drugs, are not violent, respect their elders, and are none the worse for the discipline we imposed on them. Sorry I am getting all sentimental now…. must move on and not be a family bore.

But many of us who have all the problems associated with fibromyalgia – and I will not bore you with the list – would give their eye teeth to be normal like other folk.

My mind is wandering off and I am visualising lots of people with gaunt drawn in faces, no back teeth, and others pointing and saying, “Look at their faces, they have got fibromyalgia.” Well there is one thing – fibromyalgia would not be invisible any more and we would NOT look so well.

(If only I could paint a picture!) But at least that would do something to raise awareness even though we would all have indigestion from not chewing our food properly. What do you think they would do with 35,000 pairs of eye teeth on the island of Tenerife? The mind boggles.

Sometime ago a sick young lady, fed up with her isolation, depression and fighting the battle, threatened to have the word ‘fibromyalgia’ tattooed on her forehead. I wonder if she did it? People have tattoos in the oddest places these days – not that it appeals to me. It doesn’t wash off.

Might be great to have the word ‘fibromyalgia’ on your butt. If it is one of those days when you have a headache (and we do get a lot of those) you could just roll over, reveal the word and your partner would get the message, without you having a crossed a word.

You could have this message on your butt – F is for fibromyalgia – but that would take a lot of space and might be a bit cheeky –ooh, excuse the pun!

In days gone by if you had something wrong with you and if you were a leper – you were an outcast and shook a bell to let everyone know you had something wrong and you were contagious.

Well fibromyalgia is not contagious – you cannot catch FM– so you are quite safe if you are not one of us. However you can get “catch” it (I should say trigger it) if you ignore the stress overload in your life.

I strongly believe my fibromyalgia was triggered by a very stressful job. After a major show down with my numerous bosses, oddly enough on 5th November (I refer to it Guy Fawkes plot) I became immediately ill with what the doc said was a “virus”. After a month that “virus” became a “post viral infection” and then “stress”. This was the name on my sick note when I reached rock bottom and had my melt down. I could not walk –I am sure my legs belonged to someone else – and boy did I feel sorry for myself.

I claimed my family were thinking, “What are we going to do with her?” No one mentioned wheelchair but I could feel that conversation coming.

This is ridiculous I thought. I have always been a fighter so why should I give in now. I was referred to a specialist, for which I paid consultant’s fees. But he got it in one. After lots of drawing on bits of paper illustrating the pain chain which goes around and around, he told me I had fibromyalgia.

What a relief – I am sure those of you who have been diagnosed know the feeling. I was going to live. Fibromyalgia does not kill you…I have since discovered that if some deadly virus or bacteria attacks your immune system, you can die “indirectly” from fibromyalgia. Last year a lady with CFS died “indirectly” from her disability when something nasty carried her away. But for now we will all live with the FM pain and chronic fatigue for the rest of our lives.

The specialist also suggested, when I asked for more information about this condition I had never heard of, that I go to libraries and the Internet. He recommended I should not join any support groups as these were all doom and gloom. I will always be grateful to that specialist for telling me I would not die from what ailed me, but his advice about the group was certainly not good advice.

So now what was I going to do with my life and the invisible disability – yes I looked very well – but felt so urck! By now I had lost interest in writing and was devoid of ideas (fibro fog). Call it coincidence or an act of good faith, but a former colleague rang me, said they were in trouble and needed someone to minute a meeting. Could I possibly help? I said yes without another thought.

I found something nice to wear, added a bit of paint and powder and tousled my hair ‘exclusively’ as they say, and I was away. It was the step forward I needed. I began writing again and I carried on doing work for my friend. I was back at the computer and the keys were on fire. I joined the Surrey & Sussex Fibromyalgia Support Group (www.fibromyalgia-south.com) and found help, advice, and relief. I was able to talk to people about my pains – people who understood – folk who had been there, done that and even got the tee shirt. Not only did I get tea and sympathy, but also help was always available.

This strong bond of friendship can become a way of life and groups all over the world reach out by telephone or email to those with FM who never leave home. They offer companionship and a new look at life for some who had almost given up. Going to the meetings can become something you look forward to – reading FM books from their library – hearing medical speaker – ringing the helpline to find out if the pain you have is something to do with fibromyalgia. You have nothing to lose except perhaps some pain.

My advice is go for it – even if you only get a magazine, access to a helpline, free advice and medical information – this is the way to gain knowledge about your condition and find out who are the good doctors in your area. You might even do some fund raising for your group or write to your MP or Senator about funding for research. If there is not a group where you live and you have friends who are disabled or have fibromyalgia, start a group. Why not meet once a month in someone’s house for coffee?

Unlike my doc (who obviously does not know everything) I highly recommend joining an FM group. Consider this – I have found new friends by just writing about my fibromyalgia. It would be even better if we were able to lunch together.

For me joining the group has been great – I write for their bi-monthly magazine and sometimes subscribe to their website… we all do. I have even been involved in organising a charity skydive by a fibromite and a very nervous flying teddy bear, and this raised over £1,000 for the group. But that is another story that I might tell you sometime. The teddy bear, now sitting on my desk in his flying gear, is called Groupie. A delightful little bear, a bit tatty, but with a heart of pure gold.

Will talk again soon. Jeanne

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