Saturday, January 17, 2009

CFS Information Website Closing March 31

Hello Everyone,

My website 'CFS-Information International' is still up and running:

Last year I announced that my website 'CFS-Information International'
(CFS-II) was closing, after having been run for more than 10 years. However,
I received many objections and expressions of regret, and for a year extra I
have kept the site running, including updating the site on a regular basis.

The website was created with two purposes in mind. A pool of knowledge,
containing qualified (peer-reviewed) biologically orientated research
organized into appropriate topics. And as a political statement, as in those
days one important political goal was 'visibility'.

Over the years however, it seems that my project has become out of date.
First of all because ME/CFS research has evolved and is branching out in
many directions interacting with research in adjacent areas. A website such
as mine, which specializes in ME/CFS, can no longer in a qualified manner
present the combined knowledge in the field. It is no longer possible for
one person to keep up with the speed of information being published and at
the same time organize the information into relevant topics.

A few years back it was possible for me to write editorials on 'New ME/CFS
research'  basically from using the papers on my own website. This is no
longer possible.
Despite the number of files on my website (each representing a paper on
ME/CFS) is approaching 20,000, there are more 'out there' to consider.

As a result of this I will close the site finally on Mar 31 this year, and
in this case neither regrets nor objections will be helpful.
In order to illustrate how vast and widespread the area of research has
become, I suggest you visit the below topics on the website:

1. Genes

2. Neuroendocrine-Immune

3. HPA

4. Hypothesis oxidation

5. Cytokines

6. Mitochondrial ATP

7. Immunology

8. Inflammation

9. CFS living


Apart from these topics, there are more than 50 other topics on my website,
including those on Hypotheses, Prognosis, Prevalence, Cognitive Therapy,
Ampligen etc.
All of these topics can be found by entering the index page:

I hope the website has been usefull and enjoyable to all visitors.

Best wishes to all,

Mette Marie Andersen, MD  

CoQ10 in Fibromyalgia

Coenzyme Q10 distribution in blood is altered in patients with Fibromyalgia.

Clin Biochem. 2008 Dec 25. [Epub ahead of print]

Cordero MD, Moreno-Fernández AM, Demiguel M, Bonal P, Campa F,
Jiménez-Jiménez LM, Ruiz-Losada A, Sánchez-Domínguez B, Sánchez
Alcázar JA, Salviati L, Navas P.

Centro Andaluz de Biología del Desarrollo (CABD), Universidad Pablo
de Olavide-CSIC, Sevilla, Spain; Centro de Investigación Biomédica en
Red de Enfermedades Raras (CIBERER), ISCIII, Spain; Dpto. Citología e
Histología Normal y Patológica, Facultad de Medicina. Universidad de
Sevilla, Sevilla, Spain.

PMID: 19133251

OBJECTIVE: Coenzyme Q10 (CoQ(10)) is an essential electron carrier in
the mitochondrial respiratory chain and a strong antioxidant. Signs
and symptoms associated with muscular alteration and mitochondrial
dysfunction, including oxidative stress, have been observed in
patients with fibromyalgia (FM). The aim was to study CoQ(10) levels
in plasma and mononuclear cells, and oxidative stress in FM patients.

METHODS: We studied CoQ(10) level by HPLC in plasma and peripheral
mononuclear cells obtained from patients with FM and healthy control
subjects. Oxidative stress markers were analyzed in both plasma and
mononuclear cells from FM patients.

RESULTS: Higher level of oxidative stress markers in plasma was
observed respect to control subjects. CoQ(10) level in plasma samples
from FM patients was doubled compared to healthy controls and in
blood mononuclear cells isolated from 37 FM patients was found to be
about 40% lower. Higher levels of ROS production was observed in
mononuclear cells from FM patients compared to control, and a
significant decrease was induced by the presence of CoQ(10).

CONCLUSION: The distribution of CoQ(10) in blood components was
altered in FM patients. Also, our results confirm the oxidative
stress background of this disease probably due to a defect on the
distribution and metabolism of CoQ(10) in cells and tissues. The
protection caused in mononuclear cells by CoQ(10) would indicate the
benefit of its supplementation in FM patients.

Friday, January 16, 2009

Natural Remedies with Cinnamon and Honey

This just arrived in my e-mail today.  Natural remedies are cheaper and safer than prescriptions, so I use them whenever possible.  (That said, there are things where natural remedies just aren't strong enough for what I need them to do.  A whole bottle of Valerian won't put me to sleep.)

Cinnamon and Honey ~ Bet the drug companies won't like this one 
getting around.~

Facts on Honey and Cinnamon: It is found  that a mixture of honey and
cinnamon cures most diseases. Honey is  produced in most of the
countries of the world. Scientists of today  also accept honey as
a 'Ram Ban' (very effective) medicine or all  kinds of diseases.

Honey can be used without any side effects  for any kind of diseases.

Today's science says that even though  honey is sweet, if taken in the
right dosage as a medicine, it does  not harm diabetic patients.
Weekly World News, a magazine in Canada  , in its issue dated 17
January,1995 has given the following list of  diseases that can be
cured by honey and cinnamon as researched by  western scientists:

Make a paste of honey and  cinnamon powder, apply on bread, instead of
jelly and jam, and eat  it regularly for breakfast. It reduces the
cholesterol in the  arteries and saves the patient from heart attack.
Also those who  have already had an attack, if they do this process
daily, they are  kept miles away from the next attack. Regular use of
the above  process relieves loss of breath and strengthens the heart
beat. In  America and Canada , various nursing homes have treated
patients  successfully and have found that as you age, the arteries
and veins  lose their flexibility and get clogged; honey and cinnamon 
revitalize the arteries and veins.
Arthritis  patients may take daily, morning, and night, one cup of hot
wate r  with two spoons of honey and one small teaspoon of cinnamon
powder.  If taken regularly even chronic arthritis can be cured. In a
recent  research conducted at Copenhagen University, it was found that
when  the doctors treated their patients with a mixture of one
tablespoon  of honey and half teaspoon of cinnamon powder before
breakfast, they  found that within a week, out of the 200 people so
treated,  practically 73 patients were totally relieved of pain, and
within a  month, mostly all the patients who could not walk or move
around  because of arthritis started walking without pain.
Take two tablespoons of cinnamon powder and one teaspoon  of honey in
a glass of lukewarm water and drink it. It destroys the  germs in the
Two tablespoons of h oney  and three teaspoons of cinnamon powder
mixed in 16 ounces of tea  water, given to a cholesterol patient, was
found to reduce the level  of cholesterol in the blood by 10 percent
within two hours. As  mentioned for arthritic patients, if taken three
times a day, any  chronic cholesterol is cured. According to
information received in  the said Journal, pure honey taken with food
daily relieves  complaints of cholesterol.
Those suffering from common or  severe colds should take one
tablespoon lukewarm honey with 1/4  spoon cinnamon powder daily for
three days. This process will cure  most chronic cough, cold, and
clear the sinuses.
Honey taken with cinnamon powder cures stomach ache and also  clears
stomach ulcers from the root.
According to the  studies done in India and Japan , it is revealed
that if Honey is  taken with cinnamon powder the stomach is relieved
of gas.
Daily use of honey and cinnamon powder strengthens the immune  system
and protects the body from bacteria and viral attacks.  Scientists
have found that honey has various vitamins and iron in  large amounts.
Constant use of
honey strengthens the white blood  corpuscle s to fight bacteria and
viral diseases. 
Cinnamon powder sprinkled on two tablespoons of  honey taken before
food relieves acidity and digests the heaviest of  meals.
A scientist in Spain has proved that honey  contains a natural '
ingredient' which kills the influenza germs and  saves the patient
from flu.
Tea made with honey and  cinnamon powder, when taken regularly,
arrests the ravages of old  age. Take four spoons of honey, one spoon
of cinnamon powder and  three cups of water and boil to make like tea.
Drink 1/4 cup, three  to Four times a day. It keeps the skin fresh and
soft and arrests  old age. Life spans also increases and even a 100
year old, starts  performing the chores of a 20-year-old.
Three  tablespoons of honey and one teaspoon of cinnamo n powder paste 
apply this paste on the pimples before sleeping and wash it next 
morning with warm water. If done daily for two weeks, it removes 
pimples from the root.
Applying honey and  cinnamon powder in equal parts on the affected
parts cures eczema,  ringworm and all types of skin infections.
Daily in  the morning one half hour before breakfast on an empty
stomach and  at night before sleeping, drink honey and cinnamon powder
boiled in  one cup of water. If taken regularly, it reduces the weight
of even  the most obese person. Also, drinking this mixture regularly
does  not allow the fat to accumulate in the body even though the
person  may eat a high calorie diet.
Recent research in Japan and  Australia has revealed that advanced
cancer of the stomach and bones  have been cured successfully.
Patients suffering from these kinds of  cancer should daily take one
tablespoon of honey with one teaspoon  of cinnamon powder for one
month three time s a  day.
Recent studies have shown that the sugar content of  honey is more
helpful rather than being detrimental to the strength  of the body.
Senior citizens, who take honey and cinnamon powder in  equal parts,
are more alert and flexible . Dr. Milton, who has done  research, says
that a half tablespoon of honey taken in a glass of  water and
sprinkled with cinnamon powder, taken daily after brushing  and in the
afternoon at about 3:00 P.M. When the vitality of the  body starts to
decrease, increases the vitality of the body with in  a week.
People of South America , first thing in the  morning, gargle with one
teaspoon of honey and cinnamon powder mixed  in hot water, so their
breath stays fresh throughout the day. 
Daily morning and night honey and cinnamon powder,  taken in equal
parts restore hearing. Remember when we were kids? We  had toast with
real butter and cinnamon sprinkled on it!

You  might want to share this information with a friend, kinfolks
and  love ones
for green lady info go to events at-
sunwalker,  Alchemist of the Heart.

Podcasts from Calgary Conference

Dear Friends:
Please find below a follow-up announcement from
Dr. Ellie Stein regarding the University of
Calgary Conference held in November 2008.

Update on viewing options for U of Calgary
Conference slides and podcasts (for people not
familiar with these technologies):

Slides for all oral presentations at the 1st
Alberta Symposium on disabling fatigue in Chronic
Illness are available for view at:

The username is: cfs2008 (case sensitive)

The password is: cfs2008 (case sensitive)

Podcasts of the CME course for physicians
(October 24 & Nov 7) and the Public Lecture (November 9) go to:

There are ten podcasts.  Double click on the
"play" arrow for the podcast you wish to
view.  If you do not have Quicktime on your
computer, you will be prompted to load it. To
stop and start while watching the podcast click
on the small "play arrow" next to the speaker
icon (bottom left).  Some people can fast forward
or back by clicking and moving cursor to little
ball at bottom of screen and hold and slide
forward or back.  I cannot get this feature to work.

itunes format for podcasts are also available in
itunes format which download onto your computer
and are easier to manipulate.  To launch itunes
click on the "subscribe in itunes" icon to the
right of the first podcast.  You will be promted
to "choose an application".  Choose
"itunes.exe".  If you don't have "itunes" on your
computer you will be prompted to load it.  Once
in itunes click on the view icon at the top
right, then click the horizontal bar icon next to
it.  This will list all the podcasts
available.  Double click on the rotating arrows
icon at the far right of each podcast to load it
on your computer.  It takes several minutes to
load each one but you can load about 3 at a time
without crashing the system.  Once loaded, the
podcast can be viewed by double clicking on the
line of the podcast you wish to view.

Happy Viewing

Ellie Stein
4523 – 16 A Street SW
Calgary, Alberta T2T 4L8
Phone: (403) 287-9941    Fax: (403) 287-9958

Lydia E. Neilson, M.S.M.
Chief Executive Officer
National ME/FM Action Network
512 - 33 Banner Road
Nepean, ON K2H 8V7 Canada
Tel. (613) 829-6667     Fax (613) 829-8518
Web: www.mefmaction  

Sodium Oxybate for Fibromyalgia

Sodium oxybate relieves pain and improves function in fibromyalgia
syndrome: A randomized, double-blind, placebo-controlled, multicenter
clinical trial.

Arthritis Rheum. 2008 Dec 30;60(1):299-309. [Epub ahead of print]

Russell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia
Syndrome Study Group.

The University of Texas Health Science Center at San Antonio.

PMID: 19116896

OBJECTIVE: To evaluate the safety and efficacy of sodium oxybate for
management of the symptoms of fibromyalgia syndrome (FMS).

METHODS: Patients with FMS (according to the American College of
Rheumatology 1990 criteria) were randomized, after discontinuing
their prestudy medications for FMS, to receive 4.5 gm or 6 gm of
sodium oxybate or matching placebo once per night for 8 weeks. The
primary outcome variable (POV) was a composite score for changes from
baseline in 3 coprimary self-report measures: patient's pain rating
(in daily electronic diaries) on a visual analog scale (PVAS), the
Fibromyalgia Impact Questionnaire (FIQ) score, and the Patient Global
Impression of Change (PGI-C). A beneficial response rate for the POV
composite score was defined as >/=20% improvement in the PVAS and FIQ
scores plus a rating of "much better" or "very much better" on the
PGI-C. Secondary measures included subjective sleep outcomes (on the
Jenkins Scale for Sleep) and quality-of-life measures. The analyses
were based on an intent-to-treat (ITT) population.

RESULTS: The ITT population included 188 patients with FMS, 78% of
whom completed the trial. Significant benefit was observed with both
dosages of sodium oxybate, according to changes in the POV and
subjective sleep quality. Improvements in the PVAS score were
significantly correlated with sleep outcomes. Sodium oxybate was well
tolerated overall; dose-related nausea (</=28% of patients) and
dizziness (</=18% of patients) tended to resolve with continued therapy.

CONCLUSION: Sodium oxybate therapy was well tolerated and
significantly improved the symptoms of FMS. Further study of sodium
oxybate as a novel therapeutic option for FMS is warranted.

Functional Symptoms have Organic Basis

Inflammatory and oxidative and nitrosative stress pathways
underpinning chronic fatigue, somatization and psychosomatic symptoms.

Journal: Curr Opin Psychiatry. 2009 Jan;22(1):75-83.

Author: Maes M.

Affiliation: Clinical Research Centre of Mental Health (CRC-MH),
Antwerp, Belgium.

NLM Citation: PMID: 19127706

PURPOSE OF REVIEW: The aim of this paper is to review recent findings
on inflammatory and oxidative and nitrosative stress (IO&NS) pathways
in chronic fatigue and somatization disorder.

RECENT FINDINGS: Activation of IO&NS pathways is the key phenomenon
underpinning chronic fatigue syndrome (CFS): intracellular
inflammation, with an increased production of nuclear factor kappa
beta (NFkappabeta), cyclo-oxygenase-2 (COX-2) and inducible NO
synthase (iNOS); and damage caused by O&NS to membrane fatty acids
and functional proteins. These IO&NS pathways are induced by a number
of trigger factors, for example psychological stress, strenuous
exercise, viral infections and an increased translocation of LPS from
gram-bacteria (leaky gut). The 'psychosomatic' symptoms experienced
by CFS patients are caused by intracellular inflammation (aches and
pain, muscular tension, fatigue, irritability, sadness, and the
subjective feeling of infection); damage caused by O&NS (aches and
pain, muscular tension and fatigue); and gut-derived inflammation
(complaints of irritable bowel). Inflammatory pathways (monocytic
activation) are also detected in somatizing disorder.

SUMMARY: 'Functional' symptoms, as occurring in CFS and somatization, have a genuine organic cause, that is activation of peripheral and central IO&NS pathways and gut-derived inflammation. The development of new drugs, aimed at treating those disorders, should target these IO&NS pathways.

Coping with Chronic Pain and DSS

                                For many of us, chronic pain is exactly that - chronic. Meaning it's here to stay, it's settled in - it's not going away. What changes when you can't be cured?
                                I recently heard William Breitbart, Chief of Psychiatric Services at the world-famous Memorial Sloan-Kettering Cancer Center, speak about "Pain and End of Life." He spoke about changes that occur when someone is given a terminal cancer diagnosis. He presented 10 items people wanted when "cure" wasn't an option.
                                1. symptom control
                                2. focus on the quality of life which still remained
                                3. a dignified death
                                4. reflect on the meaning of their life
                                5. strive for inner peace
                                6. reconciliation with others
                                7. forgiveness of others and asking for forgiveness for themselves
                                8. don't die alone
                                9. die at home
                                10. understand what their legacy will be

I began to see these as relevant to chronic pain, too. Here's how I would revise them for chronic pain.
                                1. symptom control, as much as possible
                                2. quality of life, even with pain
                                3. dignified life and dignified treatment
                                4. take advantage of the challenge of chronic pain to reflect on the meaning of life
                                5. strive for inner acceptance
                                6. request and accept help from others
                                7. forgiveness of your own body for not healing; forgiveness of your medical team for not curing you; forgiveness of others' imperfect understanding of your pain
                                8. don't suffer alone
                                9. access to the least invasive treatment possible, but availability of more intensive treatment (for example, a day hospital rehab program) if needed
                                10. understand the meaning of your illness to you

                                The DSS Umbrella
                                A Pioneer
                                Muhammad Yunus, MD, a rheumatologist and professor of medicine at the University Of Illinois College Of Medicine, Peoria, was a pioneer in the study of fibromyalgia. As long as a decade ago, Yunus sought to describe a link between fibromyalgia (FM) and several diseases that share some the same characteristics, for instance chronic fatigue syndrome (CFS), irritable bowel syndrome (IBS), tension headaches, migraine, and restless leg syndrome. These diseases were grouped by Yunus under an umbrella he called "Dysregulation Spectrum Syndrome," which he defined as a, "a common biophysical syndrome characterized by endocrine dysregulation and dysfunction."
                                Defining the Paradigm
                                Yunus uses the following ideas to define the DSS paradigm:
                                *Clusters are seen of those with similar symptoms within a given patient group where symptoms occur more often than in the general population.
                                *Patients share similar clinical characteristics.
                                *In these patients exists a state of heightened sensitivity to pain.
                                *There is an absence of a classic disease model: illness cannot be detected on clinical examination, lab tests cannot confirm the presence of disease, and there is no cure or relief that can be achieved by conventional treatment.
                                *There is an absence of any typical psychiatric model.
                                *A common neuroendocrine mechanism exists.
                                *There is a common genetic link.
                                *There is a shared response to neuromodulating drugs and treatments.
                                Statistics prove the wisdom of Yunus' contentions. For instance, the medical community has proven that the symptoms of IBS, headache, and menstrual difficulties occur more often in those with FM than in that of the general population. There is such a great disparity between those in the general population who experience these symptoms and those with FM that it is impossible to attribute the difference to chance. An example of such disparity can be seen with restless leg syndrome, which affects 31% of those with FM as opposed to 15% of those with rheumatoid arthritis, and only 2% of the general population.
                                IBS is more common in those suffering from FM and the converse is also true: more people with IBS suffer from FM. However, the same cannot be said of the inflammatory bowel diseases, for instance, Crohn's disease and ulcerative colitis. One third of those with rheumatoid arthritis suffer from FM.
                                There are 10 conditions in the DSS umbrella: FM, CFS, IBS, tension headaches, migraine headaches, primary dysmenorrhea (painful period cramps), periodic limb movement disorder, restless leg syndrome, temporomandibular pain syndrome (TMDJ), and myofascial pain syndrome. Dr. Yunus argues against the classification of FM as a depressive illness.
* * *
Just this morning, I saw an ad about depression with the tag line to the effect of "if it were cancer, they wouldn't say 'Just Get Over It'."  I thought it would've made a great ad for CFS, too, and I'm rather sorry our PR folks didn't think of it first.
I cannot "just get over" CFS any more than positive thinking alone can cure any other physical ailment.  Thinking positive, convincing myself to just keep trying harder to do things, is what landed me in every relapse I've had.  My body was telling me that I needed to rest and get well, and I just kept pushing to go to work.
The sooner we can get across to people that CFS and fibromyalgia are biological conditions, and not psychiatric or character flaws, the better off we will be.  People will no longer pressure us to "just get over it", or offer advice that "going back to work will occupy your mind so you no longer have time to dwell on how you feel", or all the other BS that's thrown at us by people who think we're just too lazy to try, and who thus coerce us into proving to them (which they never believe the proof) that we've given it our all and are still unable to function up to their expectations.

FDA Approves another Fibromyalgia Medication

Source: Trading Markets
Date:   January 14, 2009

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

NEW YORK and SAN DIEGO, Jan. 14, 2009, 2009 /PRNewswire-FirstCall via
COMTEX/ -- New treatment option for the estimated 6 million Americans
living with this chronic, debilitating condition.

Forest Laboratories, Inc. and Cypress Bioscience, Inc. today announced
that Savella(TM) (milnacipran HCl), a selective serotonin and
norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and
Drug Administration (FDA) for the management of fibromyalgia.

Fibromyalgia is a chronic condition characterized by widespread pain and
decreased physical function, afflicting as many as six million people in
the United States. The safety and efficacy of Savella was established in
two US pivotal phase III clinical trials involving over 2,000 patients
with fibromyalgia. The studies showed that Savella doses of 100 mg/day and
200 mg/day demonstrated statistically significant and clinically
meaningful concurrent improvements in pain, patient global assessment, and
physical function. The companies expect Savella to be available in
pharmacies by March 2009.

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

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

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

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

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

Data Highlights

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

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

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

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

About Savella

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

About Fibromyalgia

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

Important Safety Information

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About Forest Laboratories

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

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

About Cypress Bioscience

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

For more information about Cypress, please visit the Company's website at

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

About Pierre Fabre

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

(c) 2009 The Connors Group, Inc.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Source: Reuters
Date:   January 15, 2009

FDA approves fibromyalgia drug

NEW YORK, Jan 14 (Reuters) - Forest Laboratories Inc (FRX.N) and Cypress
Bioscience Inc (CYPB.O) said on Wednesday that the U.S. Food and Drug
Administration approved their drug Savella for the management of

Fibromyalgia is a chronic condition characterized by widespread pain and
decreased physical function, afflicting as many as six million people in
the United States.

The safety and efficacy of Savella was established in two U.S. pivotal
Phase III clinical trials involving over 2,000 patients with fibromyalgia,
the companies said.

They expect Savella (milnacipran HCl), a selective serotonin and
norepinephrine dual reuptake inhibitor, to be available in pharmacies by
March 2009.

Stock in both companies soared in after-hours trading. Forest was trading
at $27.52, after closing the day at $24.23 on the New York Stock Exchange,
and Cypress was up to $11.95 from its close of $7.21 on the Nasdaq.

(c) 2009 Reuters

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Source: San Diego Union Tribune
Date:   January 15, 2009
Author: Terri Somers <>

Cypress Bioscience drug OK'd to treat pain from fibromyalgia

A new drug for the pain disorder fibromyalgia developed by tiny San
Diego-based Cypress Bioscience was approved by federal regulators

The drug, Savella, gives an estimated 6 million Americans with
fibromyalgia another option in treating their complicated and often
debilitating chronic pain disorder. It is expected to be available in

"Fibromyalgia is a complicated chronic pain condition, so it is important
that physicians and patients have access to treatments that have been
shown to help manage the symptoms," said Dr. Daniel Clauw, professor of
anesthesiology and rheumatology at the University of Michigan.

Shares of Cypress jumped 66 percent in after-hours trading.

Of the three drugs approved for the disease, Savella was the first in
which clinical trial participants reported they experienced pain relief,
improved ability to function and improved sense of well-being.

Cypress raised the regulatory bar on itself when it told the Food and Drug
Administration that it would seek to improve all three areas, said Dr.
Philip Mease, a rheumatologist at the University of Washington, Seattle,
who was involved in the clinical trials.

Fibromyalgia is a largely misunderstood disease because it affects the
central nervous system, but symptoms can include joint and muscle pain,
sleep disruption, mood disorder and decreased physical function, said
Sabrina Johnson, the company's chief operating officer. Many times
patients see their primary physician about their problems, and the doctors
find nothing wrong with the joints and muscles, Johnson said.

The cause of fibromyalgia is unknown, but researchers believe it involves
a chemical problem in the brain and spine that increases pain perception.

Savella, which has been called milnacipran through the clinical trials,
works on adjusting the levels of two chemicals in the brain, serotonin and
norepinephrine, associated with mood and pain.

"It turns down the volume control and helps patients experience less pain
in their day-to-day lives," said Michael Hufford, Cypress' vice president
of corporate development.

Cypress, with 37 employees, first licensed the rights to Savella in 2001
from Pierre Fabre Laboratories in France. It signed a collaboration deal
in 2004 with New York-based Forest Laboratories, which contributed cash
and expertise for late-stage clinical trials, submission of the new drug
application and for marketing. Under that agreement, Cypress stands to
receive as much as $205 million from Forest for the approval and if it
meets sales goals. It could receive $45 million more if the drug is
developed for other uses. Cypress shares were up $4.74 at $11.95 in
after-hours trading. They closed at $7.21 in regular trading.

Although Cypress was the first company to approach the FDA to begin
clinical trials on the drug in 2002, pharmaceutical giants Pfizer and Eli
Lilly soon initiated development programs on fibromyalgia drugs. Pfizer
was the first to have its product, Lyrica, approved. The drug was
originally approved for epilepsy. Eli Lilly's drug, Cymbalta, originally
developed as a depression drug, was approved in June to treat

(c) 2009 Union-Tribune Publishing Co.

The importance of a Guardian Angel

Another patient recently observed to me that at a crucial time, when she needed to be able to think and speak clearly, it was like a guardian angel helped her to do just that.
I also believe that I have a guardian angel looking after me.
Things were going straight downhill for me.  The doctors I had weren't willing to do anything useful (even when I told them what to do), no other doctor was interested in taking on a CFS patient, and the CFS specialists in town (now both retired) weren't taking new patients (and hadn't been for quite some time).
Then a very dear friend died, and within a week it was clear she had marched right up, tugged on The Lord's sleeve, and said "my friend needs help".  A new doctor was willing to see me -- he's not a CFS specialist, but he's willing to learn.  Another doctor advertised for patients to join a clinical trial of experimental sleeping pills -- exactly what I'd asked the other doctors for and they'd refused to even consider it -- and those pills worked for me.  One thing after another fell into place once Kat got to Heaven.
She even directs my workflow.  At the times I'm sickest, either there's nothing coming in or there's nothing with a crucial deadline coming in.  When I have it in me to work, she sees to it that I have just enough; there's very rarely more than I can handle.  And, after a couple years of me trying to manage on my own without backup, I'm convinced that it was Kat who led a friend -- who'd been resisting my efforts to get her into the business -- to a job where she learned to do exactly what I do, and, once she'd learned the necessary skills, got her into another job where she could do proofreading on the side.  On the rare occasions that I have to hand off work, I now have someone competent and reliable to give it to.
I've even had a client promise me time-critical work "over the weekend", I don't feel up to working over the weekend, and the work doesn't actually materialize till I feel better, because something happened to prevent the client from doing her portion of the job over the weekend -- making it her fault, not mine, that the deadline was missed.  Or should we say, my Guardian Angel's fault?
When I had to replace my fridge, extra work came in that just about covered the cost.  The same when I've had to replace my computer.
From time to time, when I've not felt up to concentrating on work at all, no work has come in.  Yet, as another patient/activist has observed, at times that she's too sick to do anything else, somehow she is able to write, and I have noticed the same thing.  Three decades ago, even though I typed pretty fast/accurately with the four-finger method, a one-semester Personal Typing class fit into my class schedule, and I came out of it a touch typist.  Which means that I can now lie in bed on days I'm too sick to lift my head off the pillow and type first drafts of articles with my eyes closed.  (OK, that happened before Kat got involved, but someone made sure I would have that skill when I needed it.)
Lately, I've been tossing around some possibilities, and it's pretty clear I have the go-ahead from on high, because one day this past week my horoscope made reference to one of them and yesterday it made reference to the other.  And not just vague reference, either -- it spelled out exactly the project I've been working on, and said it would be successful.

Wednesday, January 14, 2009

The 2001 study on abuse and "fatigue" (as referenced in last post)

J Nerv Ment Dis. 2001 Oct;189(10):709-15.

Sexual abuse, physical abuse, chronic fatigue, and chronic fatigue syndrome:
a community-based study.

Taylor RR, Jason LA.

Department of Occupational Therapy, University of Illinois at Chicago,
60612, USA.

Using a randomly selected community-based sample, this investigation
examined whether histories of childhood sexual, physical, and death threat
abuse predicted adulthood outcomes of specific medical and psychiatric
conditions involving chronic fatigue. This study also tested prior
suggestions that most individuals with chronic fatigue syndrome report a
past history of interpersonal abuse. Multinomial logistic regression was
used to examine the relationship between abuse history and chronic fatigue
group outcomes while controlling for the effects of sociodemographics.
Compared with healthy controls, childhood sexual abuse was significantly
more likely to be associated with outcomes of idiopathic chronic fatigue,
chronic fatigue explained by a psychiatric condition, and chronic fatigue
explained by a medical condition.
None of the abuse history types were significant predictors of chronic fatigue syndrome. A closer examination of individuals in the chronic fatigue syndrome group revealed that significantly fewer individuals with CFS reported abuse as compared with those who did not. The implications of these findings are discussed.

PMID: 11708672 [PubMed - indexed for MEDLINE]
* * *
Once again, the intentional confusion of "chronic fatigue" and "Chronic Fatigue Syndrome" in order to prove what they want to prove, regardless of the validity of that conclusion.
"Chronic fatigue" can be caused by any number of things, both physical and psychological, and even laziness.  "Chronic Fatigue Syndrome" a/k/a Myalgic Encephalomyelitis is caused by one thing and one thing only -- an infection that causes Central Nervous System dysfunction.

Disordered Patients or Disordered Research?

By Pamela Weintraub on January 13, 2009 in Emerging Diseases
    Last week Emory University issued a press release that reverberated in newspapers and media throughout the world: 
    "Childhood trauma is a potent risk factor for development of chronic fatigue syndrome (CFS), according to a study by researchers at Emory University School of Medicine and the Centers for Disease Control and Prevention (CDC).  The study is published in the Jan. 5, 2009 Archives of General Psychiatry.
  Results of the study confirm that childhood trauma, particularly emotional maltreatment and sexual abuse, is associated with a six-fold increased risk for CFS. The risk further increases with the presence of posttraumatic stress disorder symptoms."
  Somehow the news that the majority of people with chronic fatigue syndrome had been subject to child abuse struck me as outrageous --could this really be? Having come through the Lyme wars, where patients are routinely mislabeled "psychiatric," this kind of assertion is always a red flag to me.
  For some perspective, I contacted Hillary Johnson, author of Osler's Web: Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic --the investigative tour de force that laid out an extensive body of scientific evidence for the biological origins of physical dysfunction of what most scientists now call chronic fatigue and immune dysfunction syndrome (CFIDS) or, in Great Britain, Myalgic Encephaloyelitis (ME).
  Johnson told me that the CDC -and the Emory study it funded-- had broadened the definition of the disease to include not just those with the actual immune syndrome, but also people who were, well ...simply fatigued. "That is why, in their paper, they call the disease simply chronic fatigue syndrome, or CFS," she says.  This broader group muddied the waters on the true etiology of the specifically-defined syndrome to which other research refers. "The CDC has created a definition that does not match any disease entity, much less the disease they claim to be studying. They have essentially medicalized 'fatigue,' defining 'fatigue' as a specific disease," Johnson states.
  As for alternative studies, Johnson says "there are dozens of scientific papers published about the actual chronic fatigue syndrome every month in more distinguished journals, all of them worthy of being covered in the mainstream media, but the only research on this disease that gets covered comes out of the CDC. "Why is that? For one thing, its because the agency pays a ton of money to a PR newswire to publicize their papers on CFS worldwide. This is part of a long-time strategic effort to promote the agency's longstanding propganda that M.E. is a personality disorder. It's the latest in a continuum of miguided, money-wasting research by epidemiologists who aren't really qualified to be undertaking basic research into such a complicated and serious disease," Johnson states.
  She is disturbed that the study uses healthy controls when the true measure should be other disease states. "The correct controls would have been people disabled with MS, or Parkinsons, ALS, Alzhimers, congestive heart failure, or other infectious diseases like AIDS and Hep C." Then the study could have asked whether disease in general is more likely in those facing trauma -or just this "disease" alone.
  She also explains that "trauma and abuse are very vague, very subjective. This is simply not acceptable science from a major American health agency. This is pushing your agenda forward. It's sick, it's cruel and it's hurting millions of people around the world whose lives have been utterly and permanently shattered by this illness."  Indeed, she is critical that the study was done at all. "It is a waste of public funds, given the fact that there are over 5,000 research papers demonstrating CFS is a serious neurological and imuunologic disease --papers that the press has ignored," she states. 
  Perhaps the most notable thing about the Emory study, Johnson points out, is that it fails to cite a study performed in 2001 that asked the identical question. That study demonstrated that people with CFS actually have a lower incidence of childhood abuse and trauma than controls.
  "It's doubtful that the patients in the CDC study even have chronic fatigue syndrome as defined by scientists elsewhere --but even if they did, why look at them through the prism of childhood abuse and trauma," Johnson asks. "Why not study something about the disease that is actually quantifiable? Why not investigate why gray matter atrophies and blood perfusion in the brain is remarkably reduced? Or why spinal fluid has protein in it? Or why so many people with this disease get lymphoma? Or have virulent, active HHV6 and HHV6-A infections? Or have severe Natural Killer cell deficiencies? Or are dying in their 40s and 50s? All are topics with a significant body of scientific publications behind them --papers that were authored by academic scientists greatly more credentialed than the group that has put out the child abuse theory now. 
  "If there was any doubt before, this paper suggests the agency's research program on CFS should simple be shut down because it's hurting more than it's helping," Johnson believes.
  Pamela Weintraub is senior editor at Discover Magazine and author of Cure Unknown: Inside the Lyme Epidemic, St. Martin's Press, 2008

Monday, January 12, 2009

New ME (CFS) Videos on YouTube

*please repost* *please repost* *please repost* *please repost*

The three new videos are:

1. 'Some facts about Myalgic Encephalomyelitis (and me)'  04:20

A brief description of some basic facts about M.E. and my experience with
having M.E. for the last 13 years.

To download audio or text versions see:

2. 'What getting Myalgic Encephalomyelitis feels like (to me)' 07:24

Some brief comments on what it feels like to get M.E. This video also
highlights the importance of avoiding overexertion if you have M.E.

To download audio or text versions see:

3. Treating Myalgic Encephalomyelitis: The basics 07:37 and 06:33

Some of the basics of how to live with, cope with and treat M.E.

Part 1:
Part 2:

The MP3 audio file of this video is not yet available as I'm having some
problem with my conversion program, Realplayer. It will be available in the
near future however


CFS Physician Course

CFS Physician Course Scores Amazing Results

Quite quietly and under most patients radar the CFIDS Association of America has been rewriting the rules on how to educate physicians about this disease. Not happy with the CDC's old course they released a new physician education course on Medscape about three months and the results just came in; the course has been suprisingly successful.

Thus far over 13,000 health professionals have taken it. Since a study shows that each of them treats about 3 CFS patient a week this means the
course is positively impacting about 36,000 patients a week (!)

One of the goals of the course was to teach doctors how to differentiate CFS from depression. This means fewer people with CFS are being shunted by ignorant doctors into the depressed category. (Hasn't virtually everyone experienced that one!)  Hopefully they're also catching these patients before they're exhausting all their reserves - as so many of us did - and bottoming out in a horrendous crash.

This is the first widely disseminated educational course actually created by CFS physicians (Dr. Lapp and Dr. Bateman) for CFS patients. Not surprisingly its very different from the CDC course and its already more popular; almost ten times as many physicians have taken the CAA's new course in the first four months of its existence than took the CDC's course in its first four years. The people at Medscape are reportedly very happy and sound rather surprised at the success of the course thus far.

The success of the course thus far suggests that physicians are eager to learn about CFS if it is presented to them properly. The course also, of course, presents an opportunity for people who already know they have this disorder to get their physicians some good information. More people that know they have this disease means more clout for us as well.

This is all good news for the ME/CFS Community. For more on this  

Cort Johnson

Fibromyalgia/CFS Conference Videos available

(see next post down for conference summaries)
[Tom: Dr. Kathleen Light has a NIH CFS grant  ,
She was recently also awarded a grant by the CAA  :
"Kathleen Light, PhD, a research professor at the University of Utah Health
Sciences Center. Light and her team will try to uncover the mechanisms
involved in the chronic pain that afflicts 40%-70% of CFS patients. This
study will confirm or negate preliminary evidence Light gathered during an
NIH-funded study demonstrating that
receptors located on blood cells are increased and overactive in people with
CFS, causing increased pain sensitivity. Light theorizes that increases in
specific receptors following exercise may be blood-based biomarkers for CFS
and could lead to a medical test to identify CFS patients. The study will
also examine a combination of blood receptors to help identify subtypes of
CFS and guide treatment of specific patient subgroups".]

(From OFFER (Utah))
Donations help us in our efforts to provide information you can't find
anywhere else.  Please take a moment to make a donation.  All donations are
tax-deductible and every little bit helps.  Thank you!
(Link to Paypal)

(From January E-news from OFFER (Utah))


Thanks to Scott Stevens, an OFFER Board Member and Executive Committee
Member, OFFER's September 2008 Patient Conference presentations are now
available for viewing on the OFFER website.  Please click on the following
link to view these informative presentations:



Thanks again to months of effort on the part of our webmaster, Scott
Stevens, for an all new OFFER website.  Scott has added numerous video
presentations from previous OFFER Conferences and OFFER EDUCATION MEETINGS
plus much more.  Please click on the following link and let OFFER know how
you like our new look (and sounds):


OFFER 2008 Conference
Listed below are presentations made during the 2008 Conference. "Living with
Fibromyalgia" Daneen Akers and Stephen Eyre, makers of the film "Living with

click here to see

"New Research and Biomarkers for FMS/CFS"  Kathleen Light, PhD, University
of Utah Pain Research Center

click here to see

"Updates in Diagnosis and Treatment of FM"  N. Lee Smith, M.D.

click here to see

"Updates in Diagnosis and Treatment of CFS" Lucinda Bateman, M.D.

click here to see  i.e.


Feel free to forward this email to anyone who might be interested.  To start
your subscription to this free newsletter, send your request to: ,

-or- fill out the online form on our website at the following link:

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so that your E-news does not get filtered as spam.

You may unsubscribe at anytime by clicking the link at the bottom of the
E-news.  At no time will OFFER ever sell or give you email address or any
other personal information to anyone

(From OFFER (Utah))
Donations help us in our efforts to provide information you can't find
anywhere else.  Please take a moment to make a donation.  All donations are
tax-deductible and every little bit helps.  Thank you!
(Link to Paypal)

Fibromyalgia/CFS Conference Summary

[Tom: Dr. Kathleen Light has a NIH grant, "Stress and Neuroimmune
Dysergulation in Chronic Fatigue Patients"  i.e. . She was recently also awarded a grant by the CAA.]

(From OFFER (Utah))
Donations help us in our efforts to provide information you can't find
anywhere else.  Please take a moment to make a donation.  All donations are
tax-deductible and every little bit helps.  Thank you!
(Link to Paypal)
~~~~~  i.e.



SEPTEMBER 13, 2008

by Linda Milne

"What Fibromyalgia Taught Me."

          Daneen Akers

Central to this year's conference was the free screening of a new DVD
entitled "Living with Fibromyalgia".  The 70-minute film, created by
husband-wife team, Daneen Akers & Stephen Eyers. played to a packed house at
the Broadway theatre.   Following the film, Akers, a daughter of an FM
patient, launched the afternoon conference with "What Fibromyalgia Taught
Me."   Her wit and warmth, not to mention the quality of her own struggle to
understand FM and assist her mother, set a tone for the conference that
could be understood by one and all - patient and family.

To an audience of nods and smiles, she described FM and the guest who came
to dinner and never left.  Her personal frustration at her mother's
unexplained pain and fatigue was a challenge to overcome, especially as she
watched her mom deal with skepticism and dismissive attitudes from the
doctors she sought out for help.

The family joined together in their desire to understand this illness and
the havoc it was introducing into the life of their formerly active,
athletic mother - and of course their own.  They searched for something the
family could learn from together.  They culled the Internet, talked with
others and in the end realized they would make a film intended for patient
and family.  According to Akers "little did we know what that would entail!"

Akers noted our culture does not understand chronic, cyclical pain; but, our
culture does understand and believe what we see in film.  Because their
creative effort chose this media they have been successful in giving us
something the entire family can view together to build understanding and
support.  Ask anyone coping with FM and they will tell you that family
validation is perhaps even more precious than self-validation.

Akers shared with the audience the lessons she has learned from FM:  1)
Ignorance is NOT bliss; 2) knowledge is power, especially for family
members; 3) patience is indeed a virtue, as witnessed by her own family that
had bad or worse news re FM for more than 12 years, 4) we need each other,
we must do more to help each other understand that our value is not based on
our bodies or our productivity; 5) things are changing and it is for the
better; 6) we all do better when we find ways of getting outside of
ourselves and our pain; and, 7) FM patients are courageous, strong and
heroic individuals.   She reminded us, "Hope is the thing with feathers that
perches in the soul and sings the tune without the words, and never stops at

As an inspiration for us all, Akers shared pictures of her mom's first 10k
marathon since FM joined the family.  This was the realization of her
long-held goal of running in the Kona, HI marathon.

As a footnote to the film screening and the keynote address, OFFER sold out
of the DVD "Living with Fibromyalgia."  You can purchase this item directly
from Akers/Eyers by using the link here in e-news.  Go to:

"New Research and Biomarkers for FMS/CFS"

Kathleen Light, PhD, University of Utah

"New Hopeful Biomarkers in Chronic Fatigue/Fibromyalgia Syndromes'' is a
report on the investigative work at the University of Utah of the
husband/wife PhD team of Alan & Kathy Light along with colleagues Ron
Hughen, B.S., Adrea White, PhD and Lucinda Bateman M.D.

Genes are likely to be involved in FMS and CFS in two ways:  inherited genes
may give you a constitutional vulnerability; then you may be exposed to a
life event (such as an infection, trauma/accident, or major life stressor)
that influences gene expression and the triggering onset or worsening of

Sensory pathways involved in muscle pain and fatigue (even amount the
healthy) are still not understood.   Pain from working muscles that are not
obviously damaged is something we all have experienced, but the pathways
involved are only beginning to be documented.  The same is true of muscle
fatigue; and, like pain, this is a vital protective sensory experience, but
even less is known about these pathways.

There is a paradox in FMS & CFS regarding exercise.  Gradual increase in
whole body exercise is one of the most effective treatments to slowly reduce
symptoms and normalize function.  Yet exercise, even at a moderate level
causes worsening of pain and fatigue symptoms in these patients at 24 and 48 hours later (and sometimes much longer).

A standardized bicycle exercise protocol to at least 85% of predicted
maximum heart rate was repeated twice 24 hours apart in six CFS patients and
six normal controls. Expired gases were collected throughout the test so
that the following values could be determined: Peak oxygen consumption
(VO_2peak  ml/kg/min), oxygen consumption at anaerobic threshold (VO_2 @AT
ml/kg/min),  peak respiratory quotient (RQ), and percentage of age-predicted
maximum heart rate  (beats/min).

The controls in the study showed only 2-3% change in oxygen consumption from
Test 1 to Test 2 while CFS patients declined by an average of 22-27%.  Based
upon the premise that test-retest variability should not exceed 8%, this
study indicates significant impaired metabolic capability 24 hours after
initial exercise test in CFS patients. This occurred at the same time period
when CFS and FMS patients report increases in muscles pain and fatigue even
at rest or during simple movements.

This raises the question: can changes seen after exercise be one way to get
at biomarkers of CFS?
  Can Blood-based biomarkers be found that are
associated with this exaggerated delayed onset muscle pain and fatigue in
CFS & FMS patients?   Why blood-based markers?  Because these tests are
traditional in medical practices and are considered objective, hard
evidence.  Such an approach avoids legal concerns about subjectively,
malingering or biases from secondary gain (insurance or disability).

The same mild exercise task to achieve the same level of heart rate and
blood pressure may have very different effects in patients with CFS & FMS
vs. healthy, pain-free individuals.

RESULTS:  Beginning at 30 minutes after exercise and continuing at 8, 24 and
48 hours after exercise, CFS patients with and w/o FMS increased one ion
channel receptor (type P) to 4 times its pre-exercise level.  Healthy
subjects showed no increases at all.  Based on Alan Light's animal research,
this type of receptor seems especially sensitive to fatigue.

RESULTS:  Beginning at 30 minutes after exercise and continuing at 8, 24 and
48 hours after exercise, patients with FMS as well as CFS increased one ion
channel receptor (type A) to 2 times its pre-exercise level.  Again, healthy
subjects showed no increases at all.  This type of receptor seems sensitive
to both muscle pain and fatigue.

RESULTS:  Both CFS & FMS patients also showed increases in receptors that
detect sympathetic nervous system activity (adrenergic receptors) that were
2-6 times their pre-exercise levels.   Kathleen Light and Wm Maixner also
found that very low dose propranolol led to reductions in clinical pain in
FMS and TMD patients.

RESULTS:  Those patients who were involved in exercising on a regular basis
showed some reduction in their post exercise increases in these ion channel
receptors and in their beta adrenergic receptors, although they were still
higher than normal.  This may be one way that exercise training helps reduce
pain and fatigue symptoms.

RESULTS: Among CFS patients, those who were higher in fitness (which
overlaps with being lower in fatigue and pain symptoms) had lower
anti-inflammatory and pro-inflammatory cytokines, especially at the 8-hour
post-exercise time point.  There was an association between having more
normal ion channel receptors and more normal cytokines

Light at the end of the tunnel.  Alan and Kathy Light have hope that these
post exercise blood-based measures can help us develop biomarkers for CFS
and for FMS.  They also offer clues as to possible targets for future
interventions to reduce muscle pain and fatigue.

Caveat:  We still need to know if these patterns of responses are specific
to CFS/FMS but may occur in other disorders e.g. MS, post cancer fatigue.

Updates in Diagnosis and Treatment of FM"

          N. Lee Smith, MD, Lifetree Pain Clinic

Dr. N. Lee Smith, MD, Director of Stress Medicine at Lifetree Pain Clinic
presented Understanding FM and Related Disorders:  New Possibilities.

FM is caused by a combination of primary injury and secondary effects.
Neuropathic pain as a factor in FM is manifest as a dysfunction of the
nervous system.

FM is diagnosed by chronic widespread pain affecting at least 11 of 18
specific tender points and overlapping hypersensitivity disorders.  Studies
that make a comparison of pain thresholds reveal that FM patients are
hypersensitive to pain and are a prototype of central nervous system
hypersensitization.  When inhibition is lacking, the nervous system
hypersensitizes.  Factors that can contribute to having FMS are: genetics
(8.5 times more likely); predisposition; neurotransmission/sleep
abnormalities, triggering events such as painful trauma, infections, stress
& disordered sensory processing.

Sleep abnormality is often a factor in FMS.  Most patients should be
screened for sleep apnea, as about 20% have it.  Some meds are effective in
improving deep sleep in some patients.

Pain levels can be graded from a nuisance at levels 1-3, distraction at 4-7,
disabling at 8 to 9, with the worst pain being 10.

Drugs of choice are a variety of neural modulators:  neural stabilizers,
antidepressants, topical or injected anesthetics and other neural
modulators, separately, or in combination.

Which medications to start with depends upon dominant patterns of problems.
Using meds with complementary mechanisms in lower dose may be better than
high doses of one mechanism.  Some drugs have been studied and are negative
for FMS relief. At present only two medications have received FDA approval
for FMS treatment, Lyrica (Pregabalin) and Cymbalta (Duloxetine).  Both
raised patient functioning and lowered the perception of pain.  Other meds
are prescribed as off-label applications.

There is strong evidence that non-pharmacological treatments such as
education, carefully paced exercise, and cognitive-behavioral therapy are
helpful in treating FMS.  There is some evidence that biofeedback, hypnosis,
massage and hot baths may help some patients.  Minimal evidence exists for
ultrasound, electrotherapy, chiropractic, acupuncture and nutritional for

Ask yourself: Who Am I - the little I or THE BIG I?  1) Do I see myself as
pain or illness?  Do I need fixing?  2) Pain is a part of me, but it is not
me; I am more. 3) I'm part of something much larger.  I am free and I am
connected.  Pain is but a small part of the BIG I.

Early treatment is of key importance regardless of approach.

"Updates in Diagnosis and Treatment of CFS"

          Lucinda Bateman, MD, Fatigue Consultation Clinic

Salt Lake City internist Lucinda Bateman, CFS & FMS specialist, offered an
update in the diagnosis and treatment of CFS, opening with a brief review of
three case definitions: the 1994 CDC definition, the CFS pediatric and the
Canadian definition. She went on to summarize the difference between CFS and
FMS saying it is largely based upon whether the major symptom is widespread
pain and/or debilitating fatigue.  Both syndromes are heterogeneous, with
symptoms that are not mutually exclusive.

Some quick facts about CFS:  PubMed lists more than 4,300 peer reviewed
scientific publications about CFS, with 467 of them published since January
2007.  For comparison she found 4,800 FM articles, with 667 of them coming
since 1/07.  It was thought CFS afflicts less than 1 million Americans.
However, up-to-date CDC research, based upon the patient studies conducted
in Wichita and random digit dial calls in the state of Georgia, tells us it
is closer to 4 million.  Direct costs (treatment) are estimated to be
$2,000-$8,000 -- that's $2-7 billion per year in US.  When indirect costs
(lost wages, productivity decline, etc,) are added, the cost is a staggering
$18-24 billion per year.

Science has clarified what specialist providers have long suspected -- the
illness is not a form of depression.  CFS is typified by low-grade immune
activation.  MRI, PET and SPECT scans of the brain reveal abnormal white
matter, abnormal brain metabolism, and something CFS patients know all too
well, abnormal cognitive function (processing efficiency, memory and
attention).  Dr. Bateman explained the HPA (hypothalamics, pituitary,
adrenal) axis and how the neuroendocrine system being blunted or
dysregulated effects reaction to physical and psychological stress.

An international conference held in June 2008 presented research linking
some CFS to viruses such as herpes, enteroviruses and other pathogens such
as EBV, HHV-6, CMV, Lume, Ross Rives, Q fever and others
.  The search
continues for objective markers that will lead to better diagnosis and
effective treatments. There was also discussion of a 'superantigen' as a
trigger to CFS.  Data from treadmill testing, cytokine analysis, gene
expression and other viral markers is still pending and will be announced at
a later date. At present, treatment remains supportive, directed toward
symptom management.

RNA from blood samples studied by one international researcher, London
doctor Jonathan Kerr, found 88 genes differentiated ME/CFS study
participants from normal controls.  These expressions included both
hematological and immunological disease and function, cancer, cell death,
immune response and infections.  His studies found seven genomic subtypes of
CFS/ME: 1) cognitive, musculoskeletal, sleep, anxiety/depression; 2)
musculoskeletal, pain, anxiety/depression; mild symptoms; 4) cognitive; 5)
musculoskeletal, gastrointestinal; 6) post-exertional; and, 7) pain,
infectious, musculoskeletal, sleep, neurological, gastrointestinal,
neurocognitive, anxiety/depression.

There is a symptom treatment hierarchy, according to Dr. Bateman.  It begins
with activity management (pacing); followed by sleep; mood/cognition; pain;
fatigue; physical conditioning; orthostatic intolerance and the
micromanagement of all medical problems.

Acknowledgement was given to Peggy Allen, CNM, for her recently published
work entitled "Chronic Fatigue Syndrome: Implications for Women and their
Health Care Providers During Childbearing Years."   Her teenage daughter,
Lauren, who has CFS, inspired her mother, a medical professional, to fill in
this important gap in scientific literature.

The ultimate solution?  More money for research.   Examples demonstrate the
challenge we face.  Muscular Dystrophy, affecting about 200,000, collected
$65 million in its 43rd telethon this year.  Breast cancer research,
afflicting about 2,400,000 in US, collects nearly $1 trillion each year from
public and private funding.  In contrast, CFS lags sadly behind.  Funding
mandated by congress through the NIH and CDC is considerably down from the 2005 high of approximately $12 million.
A private fund drive launched by the
CFIDS Association has raised $1 million dollars in 2008 for a variety of
research.  Pharmaceutical research has brought 2 FM- indicated drugs to the
market this year, with more in the pipeline.  By contrast, pharmaceutical
efforts have produced experimental intravenous drug, Ampligen, which has yet
to be approved by the FDA and Valcyte, an oral experimental drug under
clinical trial at Stanford.

In closing, these helpful resources were offered: ; ,  to access the CFS
Advisory Committee that reports directly to the Secretary of Health and
Human Services in Wash DC, , the premiere advocacy and
information organization in the US and  to
access the Trans-NIH (Nat'l Institute of Health) Working group on CFS, under
the Office of Women's Health.

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