Showing posts with label FMS. Show all posts
Showing posts with label FMS. Show all posts

Friday, October 1, 2010

Nat’l Fibromyalgia Assoc. Needs Help on Xyrem Approval for Fibromyalgia

October 1, 2010

Dear NFA Supporter,

On August 20, 2010 the Food and Drug Administration (FDA) convened an Advisory Panel, made up of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee to contemplate support for the approval of Jazz Pharmaceuticals Xyrem (sodium oxybate), as a fibromyalgia treatment.

At the hearing the panel made up of medical professionals heard testimony from researchers, physicians, and patients relevant to the benefits of this medication in the treatment of fibromyalgia symptoms, especially pain. Positive scientific outcomes were expounded by the researchers. Medical doctors described the exemplary patient treatment outcomes associated with sodium oxybate.

Patients gave personal testimonies revealing their positive responses to the drug. However, even with these affirmative testimonies and shared outcome data from scientific research studies from two previous phase III trials involving a total of more than 1,000 fibromyalgia patients, that demonstrated efficacy in significantly decreasing pain and fatigue and improving daily function, the Panel voted 20 to 2 against approving sodium oxybate for the treatment of fibromyalgia.

Concerns raised by the Panel members included doing additional studies measuring sodium oxybate’s effectiveness against other FDA approved fibromyalgia drugs and instigating more Risk-Evaluation and Mitigation Strategies (REMS) control methods. Sodium oxybate is already approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. It is listed as a schedule III drug and its distribution is restricted through the Patient Success Program, already one of the most stringent REMS processes. Currently, it can only be purchased from a central, mail-order pharmacy and patients are first required to read a letter as well as a brochure plus watch a video about safety precautions and how to appropriately take the medication.

In response to the Panel’s rejection of sodium oxybate, Jazz Pharmaceuticals has created an even more stringent REMS program to address delivery and safety issues. It is also working with the FDA to satisfy the research questions raised by the panel.

On October 11, the next important step in the process for FDA approval of sodium oxybate will take place. Fibromyalgia patients deserve the opportunity for access to sodium oxybate to relieve their pain and other symptoms. Scientific research has shown this medication to be the most efficacious drug ever tested for people with fibromyalgia.

The NFA encourages you to please take a minute and access one of the attached letters in support of FDA approval of sodium oxybate, sign it and send it to the FDA at the provided address.

Click HERE if you are a person with fibromyalgia who has taken sodium oxybate

Click HERE if you are a person with fibromyalgia who supports FDA approval of sodium oxybate

Thank you joining us, as we take action to improve the lives of people living with fibromyalgia.

Sincerely,

Rae Marie Gleason
Executive Director, National Fibromyalgia Association

Wednesday, September 29, 2010

Fibromyalgia News

Editor’s Note:  Fibromyalgia, a neurological condition with chronic widespread pain and other multiple, chronic symptoms, is a presumptive condition for Gulf War veterans.

Some scientists believe that Gulf War Illness is unique from fibromyalgia.  However, even if the two conditions are separate, they do not disagree that they may be closely related and may benefit from some of the same or similar treatments.

Below are some of the most recent new articles by, for and about people suffering from fibromyalgia.

--------

The Fatigue in Fibromyalgia: Not 'Normal Tiredness'About - News & Issues.  The fatigue experienced in fibromyalgia goes beyond "normal tiredness," according to research just published in the journal BMC Musculoskeletal Disorders. ...

The gender gapBoston Globe.  Women suffer disproportionately from irritable bowel syndrome, fibromyalgia, headaches (especially migraines), pain caused by damage to the nervous system, ...
See all stories on this topic »

A Downside to Tai Chi? None That I SeeNew York Times.  The latest and perhaps best designed study was conducted among patients with debilitating fibromyalgia, a complex and poorly understood pain syndrome. ...
See all stories on this topic »

Yoga Can Ease the Chronic Pain of Fibromyalgia — You Web News .…  By youwb.  Fibromyalgia is a chronic pain disorder that affects up to 10 million Americans, most of them women. It was identified in 1816 by a Scottish physician, but wasn't officially recognized by the American Medical Association as an illness ...
You Web News youwb.com - http://www.youwb.com/

Denver Acupuncture Center: Treatments for Fibromyalgia.  Acupuncture is one of the many TCM or Traditional Chinese Medicine treatments that are known and have been proven to be an effective therapeutic method for.
ArticleSlash - Free Article Directory - http://www.articleslash.net/

Negative Emotions Increase PainMedPage Today.  In a cohort study among 121 women -- 62 of whom were diagnosed with fibromyalgia -- pain induced by an electrical stimulus was more keenly felt after the ...
See all stories on this topic

Anger and Sadness Increase Pain in Women With and Without FibromyalgiaArthritis Today.  By Jennifer Davis 9/28/10 Researchers who set out to understand the role emotions play in fibromyalgia pain may have ended up dispelling a myth – that women ...
See all stories on this topic »

Wrong & Right Gifts for Someone With Fibromyalgia & Chronic Fatigue SyndromeAbout.com: Health.  Have you ever gotten a gift that you couldn't use because of your fibromyalgia or chronic fatigue syndrome? I get these all the time -- mostly body washes ...
See all stories on this topic »

5 fibromyalgia pain relief tips | Chronic Pain Management.   codedergal.  Five chronic Pain Management Guidelines and Chronic Pain Management Information.
Chronic Pain Management - http://chronicpainmanagement.blognub.com/

Thursday, July 1, 2010

Letter to VA Disability Compensation Advisory Committee Calls for Changes on Fibromyalgia, IBS Compensation

 

DATE:  June 22, 2010

TO:  VA Advisory Committee on Disability Compensation, ATTN: Ms. Ersie Farber, Designated Federal Officer, U.S. Department of Veterans Affairs, Veterans Benefits Administration (211A), 810 Vermont Avenue, N.W, Washington, DC 20420

SUBJECT: Gulf War Related Compensation – Fibromyalgia, Chronic Fatigue Syndrome, Irritable Bowel Syndrome

Dear Committee Members:

While searching the Public Record on another issue, I came across the notice for your public meetings, which concluded today. While my written submission obviously won’t make it to you in time for consideration at the current meeting, I hope that you will take it under consideration for your next meeting, or in the interim.

By way of introduction, I’m a service-disabled veteran, and I’ve been active on policy issues related to deployment, deployment health, and Gulf War veterans’ illnesses for about 15 years. As such, I’m an appointed member of the VA’s Research Advisory Committee on Gulf War Veterans’ Illnesses (RACGWVI), DoD’s Congressionally Directed Medical Research Program (CDMRP) Gulf War Illness Research Program (GWIRP) integration panel, and the newly created VA Gulf War Steering Committee (GWSC), which had its first meeting today.

I’m informed by my more than seven years active duty military service as a member of the U.S. Army special operations community, including service in Somalia and the 1991 Gulf War. my service as a former senior public official with the State of Wisconsin Department of Veterans Affairs, an ex-Congressional aide, active involvement with the Disabled American Veterans (DAV), the State of Wisconsin Council on Veterans Programs, 91outcomes.com (a health/news website I publish for my fellow Gulf War veterans), Veterans of Modern Warfare (VMW), and regular communications with the National Gulf War Resource Center (NGWRC).

Presumptive Claims for Gulf War Veterans. Currently, there are three “ill-defined” illnesses that are presumptive for Gulf War veterans. They are: Chronic Fatigue Syndrome, Fibromyalgia, and Irritable Bowel Syndrome.

I believe that these presumptions are appropriate, and are consistent with countless peer-reviewed scientific studies that have concluded that these conditions and/or their symptom sets have high, unusual prevalence among veterans of the 1991 Gulf War.

The first of three presumptive conditions for Gulf War veterans, Chronic Fatigue Syndrome (CFS), can currently be rated as high as 100% depending upon the level of debilitation. I believe this is appropriate and should remain as it is.

However, the second of the three conditions, Fibromyalgia (FM), can only be rated at a maximum of 40% under the current rating schedule, even though chronic fatigue and other debilitating symptoms can be totally and permanently disabling. And, because CFS is a diagnosis of last resort, a diagnosis of FM excludes a diagnosis of CFS, even if the veteran is clearly suffering from both debilitating chronic widespread pain and debilitating chronic fatigue. In other words, veterans who may be the worst off can only receive a maximum 40% rating if they have the diagnosis of FM, even with all the symptoms of CFS. VA should review these contorted rules so that veterans with FM can be rated as high as 100%, depending upon the level of debilitation.

For the third of the three current presumptive conditions, Irritable Bowel Syndrome (IBS) can be rated to a maximum rating of 30%. This rating can be made in conjunction with a rating for CFS or FM (but not both, as previously stated). VA should also review the rules governing the maximum rating for this condition to allow for higher ratings relative to the actual level of debilitation.

Given the predominance in epidemiological studies of Gulf War veterans complaining of upper and lower respiratory, digestive, and neurological symptoms, and conditions, VA should review the rules to grant presumptive service-connection for upper and lower respiratory, digestive, and neurological conditions to grant presumptive service-connection for these conditions, including but not limited to Gastro-Esophageal Reflux Disease (GERD), diagnosed respiratory disorders including but not limited to asthma, bronchitis, bronchiolitis, and chronic obstructive pulmonary disease (COPD), and diagnosed neurological disorders involving pain, cognition, and other symptoms widely reported symptoms among Gulf War veterans.

Finally, VA should work hard to establish an appropriate listing of presumptive illnesses for Gulf War veterans disability claims – the gateway to their VA health care.

Thank you for your service on behalf of all veterans.

Sincerely,

Anthony D. Hardie

Tuesday, April 28, 2009

Ashok Gupta Explains the Amygdala Retraining Program for Gulf War Syndrome, ME/CFS/FM, and Associated Illnesses

by Ashok Gupta*
April 28, 2009

Ashok GuptaMedical researcher Ashok Gupta has raised much interest with his ‘Amygdala Hypothesis’ for ME/CFS/FM and associated illnesses, and the Amygdala Retraining™ techniques he believes have helped him and many others to 're-set' a chronic over-stimulation of the brain's unconscious alarm and protection responses. He says the techniques do offer hope of improvement or recovery now for many with these illnesses, and further medical research is required to develop supporting treatments.

Once you have reviewed the following information, Ashok Gupta invites you to submit questions here for his consideration in preparation for a future Live Chat Q&A in the ProHealth.com Community Chat Room.

____________________________

I have suffered from ‘chronic fatigue syndrome’ (ME/CFS) myself. Around 10 years ago, I developed it while studying at University.

Since then, I have dedicated my life to finding an effective treatment for ME/CFS and associated conditions such as fibromyalgia, multiple chemical sensitivities, Gulf War Syndrome, etc. I have been completely well for years, and I successfully treat patients at my clinic in Harley Street in Central London (www.guptaprogramme.com; e-mail: Info@guptaprogramme.com).

To help you understand the process that I believe has helped me and many others to improve, I will look at:

An overview of The Amygdala Hypothesis – a “vicious cycle” that, once triggered by severe stressors in people with certain risk factors can perpetuate neurological overstimulation, physiological dysfunction, and many physical symptoms.

An explanation of major symptoms in the context of this hypothesis.

A brief summary of Amygdala Retraining concepts - how patients may break the vicious cycle by applying techniques that encourage the amygdala and associated brain structures to discontinue the hypothesized overstimulation - and pilot results observed at one year.

Links to six free YouTube videos from the Retraining Program DVDs, which cover the entire hypothesis in depth.

THE AMYGDALA HYPOTHESIS

My medical research seems to indicate that ME/CFS is a neurological condition, and may be caused by abnormalities in a brain structure called the “amygdala,” which is deep in the unconscious brain.



One of the amygdala’s roles is to protect the body from potential threats.

• Research on the amygdala has traditionally focused on physiological or emotional threats,

• Whereas recent research is showing that the amygdala is involved in protection mechanisms related to chemical and immunological threats as well.

This hypothesis serves as a potential unifying model for the various observations in patients. I published my hypothesis in the peer reviewed journal Medical Hypotheses in 2002. (It is available to read online here: www.guptaprogramme.com/html/medicalPaper.asp )

Below, I will go through a basic explanation of the medical paper in layman’s terms using the following diagram:




PRECIPITATING FACTORS

Genetic and Environmental Risk Factors (1)
Right at the top, let’s start with the predisposing factors to developing these illnesses - i.e., the risk factors. These may include genetic factors and environmental factors yet to be fully determined.

Then there are two other precipitating factors which contribute to these illnesses developing in someone.

Triggers: Acute Psychological Stress (2) & Viral, Bacterial, or Other Triggers (3)
The start of the illness is often accompanied by psychological or physical stress, as well as some kind of acute physical illness.

• In the case of ME/CFS, that physical illness might be a particularly difficult virus or bacterial infection (e.g., Glandular Fever, gut enteroviruses, etc.), or another kind of illness.

• In fibromyalgia, the physical trauma may be an accident, or ongoing chronic pain in a part of the body.

• In MCS, the trigger may be heavy exposure to a toxin.

There will be crossovers in symptoms between these three conditions, according to the theory. The theory predicts that the pattern of symptoms in the body will be different, but that the underlying cause may be the same. The theory still holds if there is a gradual onset versus a specific onset (see medical paper for further details.)

Gulf War Syndrome may represent a combination of all three illnesses to varying degrees, as at the time there was exposure to immunizations, toxins, and physiological stresses all at the same time.

TRAUMA TO THE AMYGDALA

The combination of these precipitating factors changes the circuitry of the amygdala, making it continually over-stimulate the body (4).

During the trauma:

• The amygdala learns to be hyper-reactive to any symptoms detected in the body, in association with the “insula” (another brain structure).

• This conditioning happens unconsciously without a person actually realizing it is happening.

CHRONIC STIMULATION OF THE AROUSAL SYSTEM

From then on, the amygdala continually over-stimulates the sympathetic nervous system directly (5)

The sympathetic nervous system is the emergency response of the body to threats. When it is triggered, the parasympathetic nervous system (bodily repair, detoxification, digestion, etc.) is switched off and energy is diverted to the emergency.

• It over-stimulates the hypothalamus and the whole HPA (Hypothalamic-Pituitary- Adrenal) Axis, which subsequently downgrades as a result, making it difficult for the body to respond to stress.

• The amygdala also over-stimulates the whole brain, keeping many brain circuits in a state of hyper-arousal. This adversely affects the levels of neurotransmitters in the brain, including serotonin and dopamine.

• There may also be conditioning in the immune system. This means that aspects of the immune system are inappropriately re-triggered in a unique pattern individual to each patient.

• Finally, this over-stimulation causes higher levels of oxidative stress in the body, and a compromised immune system.

A continual unremitting stimulation can cause symptoms which can severely affect every single organ and system in the body, including the endocrine (hormonal) system, and the immune system. (See the Appendix detailing "How the Different ME/CFS/FMS Symptoms are Created with Continual Amygdala Stimulation.")

Furthermore, continual stimulation can cause secondary effects in the body, which then lead researchers to think that those physical observations are the cause of the condition, whereas they are simply symptoms of a deeper underlying brain abnormality.

SYMPTOMS AND SECONDARY ILLNESS CYCLES

Hyper-arousal of the body then causes the symptoms (6) and creates Secondary Illness Cycles (7).

Over-stimulation can cause adaptation in receptors so that systems are down-regulated, or certain systems may simply exhaust due to over-stimulation, as is the case with the adrenal glands. Nitric oxide levels may rise (as per the observations of Professor Martin Pall), which can cause a whole host of secondary effects and symptoms in the body, including mitochondria dysfunction, perpetuating the entire vicious circle. Because the immune system is responding inappropriately, opportunistic viruses such as HHV-6 have the opportunity to flourish, increasing symptoms.

Finally, at 7, secondary illnesses such as allergies and chemical sensitivities can occur due to the hypersensitivity of the entire system.

Where I differ from Professor Martin Pall’s Nitric Oxide hypothesis of ME/CFS and other “unexplained" illnesses is that in his NO/ONOO- hypothesis, the Nitric Oxide effects are mainly local.

• I do not believe that this could explain such a pervasive illness with such wide-ranging symptoms.

• Instead, I believe that the Nitric Oxide theory reflects yet another secondary illness cycle rather than the underlying cause of the condition.

Sympathetic over-activity means that sleep rhythms are affected, so the restorative “delta” sleep required for bodily repair is not effective. This has also been shown in Post Traumatic Stress Disorder, an illness where the amygdala has also been heavily implicated. This causes a patient to feel unrefreshed the next morning, causing severe exhaustion, and contributing to pain in fibromyalgia.

PERPETUATING FACTORS

These symptoms are detected by the sensory thalamus/cortex and the insula cortex - the parts of the brain that receive incoming information from the senses (8).

And to complete the cycle, incoming signals are magnified by the amygdala, which keeps the brain and nervous system in a state of hyper arousal. (9)

• The insula may be involved in interpreting the emotional meaning of the symptoms, and passing that representation on to the amygdala.

• At 9, the amygdala is traumatized by any symptoms that it detects in the body, and instantly re-stimulates bodily systems at 4 again.

Note that this central nervous system sensitivity (and resultant abnormal sensory processing causing heightened pain awareness) is gradually becoming a more accepted hypothetical model in fibromyalgia. This then perpetuates into the vicious circle as in the diagram.

FACTORS DETERMINING SYMPTOMS & SEVERITY

If the circle becomes particularly vicious, a patient can become bed-bound. If the cycle is milder, the patient may be able to function to a varying degree. The symptoms in each patient will depend on three factors:

• The severity of the conditioning effects in the amygdala and associated brain structures.

• The specificity of the conditioning; that is, what symptoms and what reactions were going on in the body at the time of the original trauma.

• The specific timing of the trauma – although symptoms can change over time.

Due to the secondary effects of the condition on the body, food intolerances can develop, as well as general sensitivities. This is because when the brain and body are on high alert, the amygdala (in association with other brain structures) is prone to learning new responses to stimuli it would not normally care about.

When the sympathetic system is aroused, digestive and detoxification systems are turned down or switched off, which may explain why many patients complain of feeling “toxic” inside.

A patient will also find that stress can exacerbate the symptoms - simply because it “speeds up” the vicious circle, and the body does not have sufficient resources to deal with that stress. The stress can be mental, emotional or physical.

With some patients, the conditioning effects are not particularly severe, which is why some patients seem to regain their health through general changes in lifestyle. For others, the conditioning in the brain is severe and causes chronic long term illness.

RETRAINING THE AMYGDALA – BASIC CONCEPTS

I wish to emphasize that I believe ME/CFS, fibromyalgia and MCS are real physical conditions, and are in no way psychological. The sensitivity conditioning mainly occurs unconsciously.

As I indicated above, Gulf War Syndrome may represent a combination of all three illnesses to varying degrees, as at the time there was exposure to immunizations, toxins, and physiological stresses all at the same time.

Currently, I do not believe that there are any pharmaceuticals which could target such a specific reaction in the brain. Most pharmaceuticals or supplements target the symptoms rather than the underlying cause. If the conditioning effects are mild, successful treatment of symptoms may bring full recovery, but in the majority of cases, this will probably not occur.

The unconscious brain reaction involved in amygdala dysfunction is not normally under a patient’s control, but I believe that some novel “brain retraining” techniques derived from NLP (Neuro-Linguistic Programming), breathing, meditation techniques, and others, can target the reaction and control the amygdala. The techniques are highly specialized, and do not fit under any one category, which is why I refer to them as "Amygdala Retraining Techniques."

Luckily the amygdala constantly communicates with other parts of the brain, and that’s where retraining can take place.

In animal models, it is understood that the amygdala can be controlled with new neurons being formed, connecting from the pre-frontal cortex to the amygdala, to subdue and control its reactions.

• Some studies have shown that patients with ME/CFS have lower grey matter volume in this part of the brain (pre-frontal cortex).

• Other studies have shown that regular meditation can increase the volume of this part of the brain, showing that “brain” exercises can alter the structure of the brain.

All the Amygdala Retraining techniques are now available as an interactive DVD recovery programme.** I found that most patients could not afford to come to the clinic for treatment, so I wanted to create something that was affordable and easy to use at home.

PILOT RESULTS TO DATE

I recently conducted an initial Clinical Audit on the techniques, and the study seems to show that over 90% of patients significantly improved as a result of the treatments, and that two-thirds of patients (67%) reached a full recovery or close to that mark within one year. The average number of years with the illness was 10.5 years.

This paper has been submitted for peer review and will be published in a medical journal later in 2009. There was no control group - as this was simply an initial pilot to stimulate funding for a larger randomized, controlled trial.

FREE VIDEOS DETAILING THE HYPOTHESIS

If you are interested in finding out more about the hypothesis, you can view videos online at YouTube which are taken from the home-study programme and cover the entire hypothesis in depth:

Session 2: PART 1
http://www.youtube.com/watch?v=SEtyMHbf08U

Session 2: PART 2
http://www.youtube.com/watch?v=OYuOXdjaSJY

Session 2: PART 3
http://www.youtube.com/watch?v=8GKA3h56VWc

Session 2: PART 4
http://www.youtube.com/watch?v=JU-rOvhTZxA

Session 2: PART 5
http://www.youtube.com/watch?v=1YhI9eXkTic

Session 2: PART 6
http://www.youtube.com/watch?v=01srRrDqj54


Finally, see the accompanying article, "How the Different ME/CFS/FMS Symptoms are Created with Continual Amygdala Stimulation," for an explanation of each physical, emotional, and cognitive symptom commonly associated with these and related illnesses.
___
* Ashok Gupta's Amygdala Retraining Clinic - Harley Street Solutions, LTD - is located at No.1 Harley Street, London W1G 9QD, UK. To contact the clinic, visit www.guptaprogramme.com or e-mail Info@guptaprogramme.com.

** Amygdala Retraining is available as a home study interactive DVD Recovery Programme, which includes DVDs, a CD, and a book, as well as access to a recovery forum and further support. The programme comes with a one-year money back guarantee. For further details, visit www.guptaprogramme.com.

Note: This information has not been evaluated by the FDA. It is for general information only, and is not meant to diagnose, prevent, treat or cure any illness, condition, or disease. It is very important that you make no change in your healthcare plan or health support regimen without researching and discussing it in collaboration with your professional healthcare team.