Friday, December 4, 2009

Dr. Teitlebaum's take on Yesterday's Dr. Oz show

The XMRV research has a number of important implications:

1. CFS is validated within the mainstream medical community as a real, physical and devastating illness.

The XMRV virus study clearly documents that CFS is a real and physical illness, again proving that those who abuse patients by implying that the disease is all in their mind are being cruel and unscientific nitwits. Though the economics may cause a few insurance companies to continue to unethically deny the science, so they can avoid paying for the health care and disability costs they are responsible for, this research should help speed up understanding of the illness. Meanwhile, for those with the illness, their families and their physicians, it is now clear that this is a real and devastating illness!

* * *

As Dr. T notes, the XMRV test is pretty pricey.  If you feel that you need to have something to prove to people that you're physically ill, I've had the C-Reactive Protein test, which shows "infection or inflammation" -- it won't tell *which* virus you have, but will show that there's something physically wrong.

However, I will also tell you that there are some people who are so convinced that CFS is just laziness that even a blood test will not make them change their minds.


Thursday, December 3, 2009

Notes from Dr. Oz Show

Dr. Oz
Could the secret to your exhaustion be a retrovirus?
The reason you're exhausted may have nothing to do with sleep at all. It could be infection from a new retrovirus.
Debilitating symptoms, no cure, linked to one of most baffling and misdiagnosed diseases in women.
Most viruses invade your body and leave, but retrovirus worms its way into your DNA and stays there.
XMRV found in 95% of those previously diagnosed with CFS, and also in 4% of healthy people, putting 10M people at risk for CFS.
Dr. Donnica Moore
This is a real game changer in our understanding of CFS. "This is not all in your head, you don't have depression, you don't have a midlife energy crisis" Neuroimmune.
"Here's what we know – it does not transmit through the air like the flu."
Worry about the blood supply being contaminated.
Animation of how it infects, becomes part of your DNA
How would you know you have CFS? CFS is a very specific clinical diagnosis, with specific criteria. (Which she has placed on the Dr. Oz website)
2-4x more common in women than men.
Gina is one of 300 people who participated in the XMRV study. Video biography of Gina. She had swollen lymph nodes and was even told she had lymphoma. She tested positive for XMRV.
She describes it as "a horrible case of the flu". A normal person would crawl in bed and wait it out, but we can't wait it out. Doctor told her "Not only can we not help you, but it's your fault. If they can't find out what's wrong with you, they will start to blame you." She was already in the study, already knew she was XMRV+, and a doctor sent her to a shrink anyway!
Oz says "if you think something is wrong with you, don't let anyone talk you out of it."
Test costs $400 and we don't know if insurance will cover it.
Good news, we have antivirals for AIDS; we need CDC/NIH/drug companies to do research.
There are lots of diets out there that are purported to help, but none of them are proven; just follow a normal healthy diet.
Oz acknowledges sleep is crucial (though he directs us to sleep hygiene on his website, which most of us find inadequate) and does say "exercise" but does clarify that even walking to the mailbox slowly is exercise. The key is to keep muscle tone. (Which I do with stretching and resistance exercises.)

Wednesday, December 2, 2009

What is Chronic Fatigue Syndrome and How is XMRV Related? | The Dr. Oz Show



The FACTS about Ampligen research in CFS patients

According to the NIH, Poly(I)-poly(C12U), also known as Ampligen, is a type
of antiviral drug called a biological response modifier. These types of
drugs appear to restart human immune defenses against viruses and tumors.
Although there are multiple published studies of Ampligen listed in PubMed,
which is run by the U.S. National Library of Medicine* *National Institutes
of Health, there were only a handful of studies regarding the specific
application of Ampligen in CFS as defined using either the Holmes 1988 or
1994 Fukada definitions. They are listed below:

Ann N Y Acad Sci.<javascript:AL_get(this,%20'jour',%20'Ann%20N%20Y%20Acad%20Sci.');>1993
Jun 23;685:756-7.
RNA drug therapy acting via the 2-5A synthetase/RNase L pathway

Suhadolnik RJ<>,
Reichenbach NL<>,
Hitzges PM<>,
Ablashi DV<>,
Strayer DR<>,
Carter WA<>

Department of Biochemistry, Temple University School of Medicine,
Philadelphia, Pennsylvania 19140.

PMID: 8363281 [PubMed - indexed for MEDLINE]

In Vivo. <javascript:AL_get(this,%20'jour',%20'In%20Vivo.');> 1994
Changes in the 2-5A synthetase/RNase L antiviral pathway in a controlled
clinical trial with poly(I)-poly(C12U) in chronic fatigue syndrome.

Suhadolnik RJ<>,
Reichenbach NL<>,
Hitzges P<>,
Adelson ME<>,
Peterson DL<>,
Cheney P<>,
Salvato P<>,
Thompson C<>,
Loveless M<>,
Müller WE<>,
et al.

Department of Biochemistry, Temple University School of Medicine,
Philadelphia, Pennsylvania 19140.

Latent 2', 5'-oligoadenylate (2-5A) synthetase activity, bioactive 2-5A and
RNase L activity were measured in extracts of peripheral blood mononuclear
cells (PMBC) before and during a randomized, multicenter,
placebo-controlled, double-blind study of poly(I)-poly(C12U) in individuals
with chronic fatigue syndrome (CFS) as defined by the Centers for Disease
Control and Prevention. The mean values for bioactive 2-5A and RNase L
activity were significantly elevated at baseline compared to controls (p <
.0001 and p = .001, respectively). In individuals that presented with
elevated RNase L activity at baseline, therapy with poly(I)-poly(C12U)
resulted in a significant decrease in both bioactive 2-5A and RNase L
activity (p = .09 and p = .005, respectively). Decrease in RNase L activity
in individuals treated with poly(I)-poly(C12U) correlated with cognitive
improvement (p = .007). Poly(I)-poly(C12U) therapy resulted in a significant
decrease in bioactive 2-5A and RNase L activity in agreement with clinical
and neuropsychological improvements (Strayer DR, et al., Clin. Infectious
Dis. 18:588-595, 1994). The results described show that poly(I)-poly(C12U)
is a biologically active drug in CFS.

PMID: 7893988 [PubMed - indexed for MEDLINE]
Clin Infect Dis.<javascript:AL_get(this,%20'jour',%20'Clin%20Infect%20Dis.');>1994
Jan;18 Suppl 1:S96-104.

Upregulation of the 2-5A synthetase/RNase L antiviral pathway associated
with chronic fatigue syndrome.

Suhadolnik RJ<>,
Reichenbach NL<>,
Hitzges P<>,
Sobol RW<>,
Peterson DL<>,
Henry B<>,
Ablashi DV<>,
Müller WE<>,
Schröder HC<>,
Carter WA<>,
et al.

Department of Biochemistry, Temple University School of Medicine,
Philadelphia, Pennsylvania 19140.

Levels of 2',5'-oligoadenylate (2-5A) synthetase, bioactive 2-5A, and RNase
L were measured in extracts of peripheral blood mononuclear cells (PBMCs)
from 15 individuals with chronic fatigue syndrome (CFS) before and during
therapy with the biological response modifier poly(I).poly(C12U) and were
compared with levels in healthy controls. Patients differed significantly
from controls in having a lower mean basal level of latent 2-5A synthetase
(P < .0001), a higher pretreatment level of bioactive 2-5A (P = .002), and a
higher level of pretherapy RNase L activity (P < .0001). PBMC extracts from
10 persons with CFS had a mean basal level of activated 2-5A synthetase
higher than the corresponding control value (P = .009). All seven pretherapy
PBMC extracts tested were positive for the replication of human herpesvirus
6 (HHV-6). Therapy with poly(I).poly(C12U) resulted in a significant
decrease in HHV-6 activity (P < .01) and in downregulation of the 2-5A
synthetase/RNase L pathway in temporal association with clinical and
neuropsychological improvement. The upregulated 2-5A pathway in CFS before
therapy is consistent with an activated immune state and a role for
persistent viral infection in the pathogenesis of CFS. The response to
therapy suggests direct or indirect antiviral activity of poly(I).poly(C12U)
in this situation.

PMID: 8148461 [PubMed - indexed for MEDLINE]


In Vivo. <javascript:AL_get(this,%20'jour',%20'In%20Vivo.');> 1994
Ampligen inhibits human herpesvirus-6 in vitro

Ablashi DV<>,
Berneman ZN<>,
Williams M<>,
Strayer DR<>,
Kramarsky B<>,
Suhadolnik RJ<>,
Reichenbach N<>,
Hiltzges P<>,
Komaroff AL<>

National Cancer Institute, Bethesda, MD 20892.

The recently discovered human herpesvirus-6 (HHV-6) is being associated with
an increasing number of conditions in which there is evidence of immunologic
dysfunction. A number of widely available antiviral agents have shown little
or no activity against the virus. We found that Ampligen [Poly (1): Poly
(C12U), a synthetic, mismatched, double-stranded RNA, has potent, previously
unexpected antiviral effects. Cells known to allow replication of HHV-6 were
infected with the virus and treated with Ampligen under various conditions.
When cells were pretreated with Ampligen (concentrations of 100 or 200
micrograms/ml) prior to infection or treated shortly after infection, viral
replication was inhibited by 46-98%. At 100 and 200 micrograms/ml, Ampligen
also inhibited the DNA polymerase activity of HHV-6 by 42-98%. When lower
concentrations of Ampligen (10 and 50 micrograms/ml) were used, only
pretreatment of cells, with Ampligen, followed by virus infection and
carrying the infected cells with Ampligen, significantly inhibited HHV-6
infection (83.7 and 89.1% respectively). Indirect evidence suggests that
Ampligen may inhibit viral attachment to cellular receptors and/or inhibit
intracellular maturation of the virus. The above concentrations of Ampligen
were not toxic to the cells used in the study. Given these in vitro
findings, and the low frequency of toxicity reported with the use of
Ampligen, clinical trials of this drug in patients with evidence of
reactivated HHV-6 infection would seem to be warranted.

PMID: 7893986 [PubMed - indexed for MEDLINE]


Clin Infect Dis. 1994 Jan;18 Suppl 1:S88-95.
A controlled clinical trial with a specifically configured RNA drug,
poly(I).poly(C12U), in chronic fatigue syndrome.

Strayer DR<>,
Carter WA<>,
Brodsky I<>,
Cheney P<>,
Peterson D<>,
Salvato P<>,
Thompson C<>,
Loveless M<>,
Shapiro DE<>,
Elsasser W<>,
et al.

School of Medicine, Hahnemann University, Philadelphia, Pennsylvania 19102.

Chronic fatigue syndrome (CFS) is a physically debilitating illness
associated with immunologic abnormalities, viral reactivation, and
impairment of cognition. In a randomized, multicenter, placebo-controlled,
double-blind study of 92 patients meeting the CFS case definition of the
Centers for Disease Control and Prevention, the response of several
laboratory and clinical variables to an antiviral and immunomodulatory drug,
poly(I).poly(C12U), was determined. Measures of clinical response included
Karnofsky performance score, a cognition scale derived from a
self-administered instrument assessing symptomatology (SCL-90-R), an
activities of daily living scale, and exercise treadmill performance. After
24 weeks, patients receiving poly(I).poly(C12U) had higher scores for both
global performance and perceived cognition than did patients receiving
placebo. In particular, patients given poly(I).poly(C12U) had increased
Karnofsky performance scores (P < .03), exhibited a greater ability to do
work during exercise treadmill testing (P = .01), displayed an enhanced
capacity to perform the activities of daily living (P < .04), had a reduced
cognitive deficit (P = .05), and required less use of other medications (P <

Drugs R D. <javascript:AL_get(this,%20'jour',%20'Drugs%20R%20D.');>2004;5(5):297-304.
Mismatched double-stranded RNA: polyI:polyC12U.

[No authors listed]

Ampligen [polyI:polyC12U] is a mismatched double-stranded RNA that acts by
inducing interferon production (immunomodulator) and by activating an
intracellular enzyme (RNase-L) against viral RNA transcripts (antiviral).
Ampligen, currently under development by Hemispherx Biopharma in the US,
acts on the immunological system through T-lymphocyte stimulation and is
indicated for the treatment of chronic fatigue syndrome and acquired
immunodeficiency deficiency syndrome (AIDS), as part of the combined
therapy. Ampligen is available for licensing worldwide. In February 2004,
Fujisawa Deutschland GmbH, a subsidiary of Fujisawa Pharmaceutical Co.,
entered into an option agreement with Hemispherx Biopharma with the intent
of becoming a distributor for Ampligen for the potential treatment of
chronic fatigue syndrome in Germany, Switzerland and Austria. An option fee
of 400,000 euros was paid pursuant to the terms of the option agreement and
upon execution of the Distribution Agreement, Fujisawa will pay Hemispherx
fees and milestone payments with a potential worth of several millions of
dollars. In September 2003, Hemispherx Biopharma Inc. entered into an
agreement with Guangdong Medicine Group Corporation to organise clinical
trials, marketing, sales and distribution for both of its lead compounds,
Ampligen and Alferon N in the People's Republic of China. The agreement
stipulates that the Guangdong Medicine Group Corporation (GMC) will conduct
clinical trials with Ampligen for the treatment of HIV. All costs related to
the trials are to be covered by GMC. Additionally, GMC has to develop and
implement marketing and promotional programmes. In May 2003, Hemispherx
Biopharma and the Center for Cell and Gene Therapy entered into a research
project agreement that will see Ampligen implemented in a protocol used in
patients with relapsed EBV-positive Hodgkin's Lymphoma. In March 2002,
Esteve and Hemispherx Biopharma entered into a collaborative agreement under
which Esteve will be the sole distributor of Ampligen in Spain, Portugal and
Andorra for the treatment of chronic fatigue syndrome. Under this agreement,
in addition to other terms, Esteve will also collaborate in the drug product
development by conducting clinical studies in Spain in patients coinfected
with HIV/HCV. In July 2001 Hemispherx Biopharma announced that it had formed
a strategic alliance with Empire Health Resources for clinical trials of
Ampligen in the treatment of HIV and hepatitis C virus infections. Empire
Health Resources, a healthcare management firm, will be responsible for
accrual and retention of patients for HIV trials, and protocols for trials
in patients with hepatitis C or both HIV and hepatitis C infections.
Hemispherx has entered into a collaboration with RED Laboratories, and RED
Laboratories NV expects that this will facilitate the continued development
of Ampligen. Hemispherx has also entered into an agreement with Schering
Plough to use a Schering facility as its principal manufacturing platform in
the US. This agreement may be expanded to include other territories.
Hemispherx and AOP Orphan Pharmaceuticals have signed a marketing agreement
for Ampligen for the treatment of chronic fatigue syndrome for Austria, the
Czech Republic, Poland and Hungary. In an arrangement between Hemispherx and
Bioclones, Bioclones has certain marketing rights for Ampligen in the
Southern Hemisphere, UK and Ireland.

In the US, Ampligen has been granted orphan drug status for the treatment of
AIDS, renal cell carcinoma (phase II, completed), chronic fatigue syndrome
(phase III) and invasive/metastatic malignant melanoma (phase II). In August
2004, Hemispherx announced that it intends to use the proceeds from the
private placement of company stock to complete the clinical work for its
immunotherapeutics/ antivirals Ampligen and Oragens. Previously, Hemispherx
submitted an application to the EMEA for the approval of Ampligen for the
treatment of chronic fatigue syndrome; the first stage of th;) for the
treatment of chronic fatigue syndrome; the first stage of the regulatory
review has been cleared.

In 2000, Hemispherx Europe (Hemispherx) obtained orphan drug status for
Ampligen for the treatment of chronic fatigue syndrome in the EU, providing
Hemispherx with 10 years of marketing exclusivity following the launch of
the drug, as well as potential financial research benefits for the agent. In
February 2000, Crystaal Corporation (now Biovail Pharmaceuticals Canada)
acquired exclusive marketing rights to Ampligen in Canada, where it
submitted an NDA for the agent for the treatment of chronic fatigue
syndrome. In the meantime, Ampligen has been available since May 1996 under
the Canadian Emergency Drug Release Programme for the treatment of chronic
fatigue syndrome and immune dysfunction syndrome by Rivex Pharma (Helix
BioPharma). Bioclones has initiated clinical studies with Ampligen for the
treatment of chronic fatigue syndrome in Australia. The active substance for
Ampligen is manufactured by F.H. Faulding Ltd. Clinical treatment programmes
for chronic fatigue syndrome in other Pacific Rim countries are planned.
Ampligen is available for severe chronic fatigue syndrome on a named
patient, cost-recovery basis in South Africa. Hemispherx has developed a
'ready-to-use' liquid formulation of the drug and has begun treating
patients with chronic fatigue syndrome in ongoing clinical trials.
Hemispherx has also developed an oral version of the drug (Oragen), which is
undergoing preclinical evaluation.

In February 2001, Hemispherx Biopharma announced that it was initiating
phase II/III trials of Ampligen in the treatment of late-stage,
multidrug-resistant strains of HIV in the European Union. Patients treated
in these studies will have exhausted all other treatment options. In July
2001, Hemispherx stated that Ampligen was being evaluated in a phase IIb
trial in patients with HIV in the US. The trial, comprising two studies,
REARMI and REARMII (Research/Evaluation of Ampligen for Retroviral Mutations
I and II), will evaluate the ability of Ampligen to prevent the emergence of
mutated, drug-resistant strains of the virus. 'Several hundred' patients
currently on antiretroviral therapy and at risk of viral relapse will be
enrolled at centres in Connecticut, New York, Florida and California.

A second phase IIb study evaluating the effect of Ampligen on structured
treatment interruptions (STI) is also underway. Final results from this
study were reported in December 2002. NIH sponsored studies of potential
therapies for SARS have identified Ampligen as having unusually high and
consistent antiviral activity against human coronavirus, the pathogen
implicated as the causative agent of the disease. Ampligen demonstrated very
high potency at very low concentrations (0.4 microg/mL) and had a favourable
safety profile.

In October 2003, Hemispherx announced that, based on these promising new
results, the company will stockpile injectible and/or oral formats of
Ampligen and Alferon N. Independent researchers have demonstrated the
antiviral activity of Ampligen against flaviviruses (West Nile virus, Equine
Encephalitis virus, Dengue fever virus and Japanese Encephalitis virus) as
well as virus classes associated with bioterrorism. In an animal study,
Ampligen was shown to prevent destruction of nerve cells, reduce virus
concentrations in the brain and blood stream and increase survival rates.
Researchers at the Rega Institute in Belgium have published results from an
animal study demonstrating that Ampligen was superior at protecting mice
against coxsackie B3 virus-induced myocarditis compared with pegylated
interferon. In May 2004 Hemispherx announced that it had filed an expanded
US patent application covering the use of Ampligen for the potential
treatment and prevention of severe acute respiratory syndrome (SARS) and
dreaded emerging viruses. Copyright 2004 Adis Data Information BV

PMID: 15357629 [PubMed - indexed for MEDLINE]



In Vivo. <javascript:AL_get(this,%20'jour',%20'In%20Vivo.');> 2005
Impairments of the 2-5A synthetase/RNase L pathway in chronic fatigue

Nijs J<>,
De Meirleir K<>

Department of Human Physiology, Faculty of Physical Education and
Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.

This paper provides an overview of the evidence addressing the impairments
of the 2'-5' oligoadenylate (2-5 A) synthetase/RNase L pathway in Chronic
Fatigue Syndrome (CFS) patients. The 2-5A synthetase/RNase L pathway in CFS
patients appears to be both up-regulated (i.e. increased levels of bioactive
2-5A synthetase and increased activity of the RNase L enzyme) and
deregulated (elastase and calpain initiate 83 kDa RNase L proteolysis,
generating two major fragments with molecular masses of 37 and 30 kDa,
respectively). The deregulation of the 2-5A synthetase/RNase L pathway in
CFS accompanies decreased NK-function and deregulation of apoptotic
pathways. Since various components of the pathway appear to be related to
performance during a graded exercise stress test, some evidence supportive
of the clinical importance of the impaired pathway in CFS patients has been
provided. Studies addressing the treatment of the deregulation of the 2-5A
synthetase/RNase L pathway in CFS are warranted.

FDA did not approve Ampligen

Source: The Street
Date:   1 december 2009
Author: Adam Feuerstein
Ref:    Hemispherx Press release,

Hemispherx's Ampligen dealt FDA blow

PHILADELPHIA (TheStreet) -- Hemispherx BioPharma(HEB Quote) said late
Tuesday night that the Food and Drug Administration refused to approve
the experimental drug Ampligen for use in patients with chronic
fatigue syndrome.

The regulatory agency's rejection of Ampligen is a staggering blow to
Hemispherx, which has pursued the drug's development in a dizzying
array of diseases for more than 20 years with no success.

  From Wall Street, the bad news for Hemispherx was a decisive victory
for bearish investors and company critics (including myself, on a
personal note) who've long contended that Ampligen would never be

Hemipsherx shares plunged 43% to 68 cents in Tuesday's after-hours
trading session.

The FDA's complete response letter to Hemispherx -- summarized in
the company's Tuesday night press release -- essentially instructs
Hemispherx to start Ampligen's clinical trial program from scratch.

The agency's medical reviewers concluded that the two clinical
studies of Ampligen submitted by Hemispherx "did not provide credible
evidence of efficacy," according to the company.

In order to reconsider Ampligen for review, FDA instructed
Hemispherx to conduct at least one additional clinical study in
chronic fatigue syndrome. The study needs to test different doses of
Ampligen for a minimum of six months, including at least 300 patients
on Ampligen dose regimens intended for marketing, according to
Hemispherx's summation of the FDA's letter.

Hemispherx could find meeting the FDA's demands exceedingly difficult
and expensive. If the FDA requires 300 patients treated with Ampligen
in a new pivotal study, for example, Hemispherx would probably have
to enroll 450 total patients at a minimum (assuming two patients
treated with Ampligen for every one patient treated with a placebo to
act as a control.)

By comparison, the Ampligen phase III study submitted and rejected by
FDA enrolled just 230 patients total and took six years to complete.

But the FDA is asking for even more from Hemispherx, including tests
of Ampligen in rodents to rule out the risk of cancer and a safety
study in humans to ensure that Ampligen doesn't cause dangerous
changes to a patient's heart rhythm. Ampligen's manufacturing problems,
previously flagged by FDA inspectors, also remain unresolved, the
company said Tuesday.

Hemispherx tried in vain to put the best face on the Ampligen rejection.

"Management is pleased to have received specific advice on the remaining
issues and is looking forward to making a thorough but expedited
response its top priority, and plans to take all appropriate steps to
seek approval and commercialization of Ampligen," the company said, in
its statement.

Conspicuously absent were any direct quotes or comments from Hemispherx
CEO Bill Carter. In the past, Carter has excoriated critics of the
company for not understanding the science behind Ampligen and calling
into question the drug's efficacy. At other times, he's suggested that
staffing shortages at the FDA were the cause for a delay in Ampligen's
approval and insisted that 80% of drugs that reach the FDA are approved
(implying somehow that this boded well for Ampligen's approval.)

Ampligen in its current form has been around since the late 1980s,
touted for its antiviral and immune system-boosting properties. At
various times, Hemispherx has promoted and tested Ampligen as a treatment
for smallpox, HIV, ebola, avian flu and most recently, swine flu, or the
H1N1 virus.

The company's biggest push has been in chronic fatigue syndrome, a
poorly understood disease with no known cause that starts with flu-like
symptoms and progresses to chronic weakness and fatigue (hence the
disease's moniker.)

Hemispherx submitted Ampligen to the FDA for approval in October 2007.
An approval decision date of Feb. 25, 2009, was extended to May 25,
2009. But that date came and went with no word from the FDA, although
Hemispherx claimed the agency requested "one or two more weeks" to
make a decision. That short 14-day delay eventually stretched for seven
months, culminating in Tuesday's announcement.

(c) 2009 The Street

Tuesday, December 1, 2009

CFS/XMRV on Dr. Oz on Thursday Dec. 3

In some places, if you miss the show, there is a repeat later that day or the next morning
If you become a fan of the Dr. Oz Facebook page you can post your thoughts about the Dec. 3rd CFS segment -- I would recommend that people hold off on sending comments until you have actually seen the show.  Then you can pick specific nits, and not just leap to conclusions based on the promos, which are often misleading.


Exercise Guidance for Doctors

The Exercise Guidance Note below is intended to be a short summary of
exercise issues in ME/CFS, which I hope can be easily read by doctors
and patients.  The pacing program and other statements are adapted
from Dr Lewis's book (Reference 2.)  The article has appeared in
Emerge, the major Australian ME/CFS newsletter.

May be reposted


FOR Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Compiled by Susanna Agardy

People with ME/CFS react to exercise/activity differently from
healthy people.  While healthy people and even those with other
medical conditions find exercise invigorating and strengthening,
people with ME/CFS are unable to sustain activity/exercise for normal
periods and become exceptionally exhausted.  Exhaustion may set in
immediately or it may be delayed by as much as one or two days.  This
reaction is called payback or post-exertional malaise. It may be
triggered by relatively minor physical exertion such as a walk,
attending a family function, or mental effort and stress which could
have been easily tolerated before the onset of ME/CFS.

Post-exertional malaise is the most exceptional feature of ME/CFS.
Other common  symptoms are: fatigue, sore throat, cognitive
dysfunction, sleep disorder, pain, inability to stand for any length
of time (Orthostatic Intolerance), sensitivities to food, drugs and
chemicals, and many others.  Exercise may be followed by exhaustion
and additional pain, with tingling and twitching of muscles.  Many
other symptoms may also get worse, even symptoms which are not
normally thought of as being the result of exercise (eg. cognitive
dysfunction).  Recovery may take days or weeks, depending on the
extent of exertion.  For this reason, levels of activity which are
excessive for the particular person cannot be repeated day after day
without risk of serious relapse.

Research has shown that symptoms of ME/CFS are related to impaired
immune, neurological and hormonal responses, infections,
mitochondrial dysfunction, channelopathy, oxidative stress and
more.  There are heart, brain, muscle and other body system
irregularities.  The aerobic pathways in people with ME/CFS are also
damaged.  These make it impossible to maintain and recover from
exercise in normal fashion.

People with ME/CFS are affected to varying degrees, with varying
exercise capacity and with differing symptoms. Some are able to work,
some are capable of moderate activity such as shopping and social
activities, while others are housebound or bedridden.  The condition
can fluctuate and people with ME/CFS can improve significantly, some
remain the same for many years, while others become worse.

Recommendations of Graded Exercise Therapy (GET) for ME/CFS are
controversial and are mostly based on the assumption that the illness
is the result of dysfunctional thought processes, abnormal illness
behaviour and physical deconditioning.  Studies of GET do not ensure
that the participants included suffer from serious symptoms of ME/CFS
such as post-exertional malaise and mostly use loose, fatigue-based
criteria, allowing mixed groups of fatigued participants to be
included.  Although overall improvement of fatigue is usually
reported, there is no evidence in any study that GET improves
post-exertional malaise and other symptoms of ME/CFS.  Possible
adverse effects are ignored even when there are high rates of
dropping out and non-compliance.  More seriously affected people
would be unable to participate in such studies, yet, the results are
generalised to them.  Recommendations for GET ignore the risk of harm
indicated by other research and the frequent worsening of symptoms
following exercise reported by people with ME/CFS.

There are many medical issues to be addressed in ME/CFS and some
treatments may assist although there is no cure.  A health
professional who is knowledgeable about the illness should be
consulted.  Managing total activity levels is one essential step in
dealing with the illness.  This includes self-care, housework,
employment, social activities and mental activity as all activity
makes demands on energy. The level of activity/exercise  needs to be
carefully managed at all phases of the illness to avoid
It needs to be accepted that many people with ME/CFS
may not regain their pre-illness capacity.

Pacing, or keeping within your boundaries, is designed to ensure that
you do not overdo activity/exercise and at the same time avoid
deconditioning.  Pacing, as shown in the steps below, is recommended:

     * Establish the total exercise/activity level you are capable of
without any payback or post-exertional malaise.  A pedometer or
actimeter may be helpful in measuring the amount of physical activity
you have done on any day.

     * To begin with, you need to do less, so that eventually you
increase the chance of doing more.

     * Maintain the level of activity/exercise that you can manage
and stay on this plateau until you have a reserve of energy. The
correct level of activity/exercise is that which can be repeated the
next day without any payback.

     * Do not move to the next level of activity/exercise  until you
have the reserve which enables you to increase your activity level
without payback.

     * Repeat the pattern of staying at the next plateau of
activity/exercise until you are able increase it without payback. You
may reach a limit which should not be exceeded.  You may need to stay
at this level of activity.

     * Balance physical and mental activity with rest, dividing
activity into short segments, alternated with rest.  Rigid schedules
of activity/exercise should be avoided and activity should be
tailored to your level of ability.

     * If you have overdone activity/exercise or suffer a relapse for
any reason, decrease your activity/exercise and rest more. Repeatedly
overdoing it may cause a severe and long-lasting relapse, bringing
with it a worsening of many ME/CFS symptoms.

     * You need to do the correct type of exercise:

Aerobic exercise can be damaging and should be avoided unless you can
already do this every day without payback.  Aerobic exercise includes
running, swimming and cycling - any exercise which causes an
increased heart-rate;

Anaerobic exercise is recommended.  This involves exercise such as
lifting and  stretching, which can be done more easily without payback.

Listen to your body, do not push beyond your limits and get plenty of rest!


1. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Clinical
Case Definition and Guidelines for Medical Practitioners. An Overview
of the Canadian Consensus Document.  Bruce M Carruthers, Marjorie van
de Sande. 2005.

2.  Chronic Fatigue Syndrome / ME Turning Disability Toward Ability.
Dr DP Lewis         CFS Discovery Pty Ltd  Melbourne

3. Abnormal Impedance Cardiography Predicts Symptom Severity in
Chronic Fatigue Syndrome. Arnold Peckerman; John J Lamance; Kristina
A Dahl; Rahul Chemitiganti; Bushra Quereshi; Benjamin H Natelson. The
American Journal of Medical Science 326(2):55-60, Aug 2003

4. Chronic Fatigue Syndrome and Mitochondrial Dysfunction, Sarah
Myhill; Norman E. Booth; John McLaren Howard Int J Clin Exp Med

5. Using Serial Cardiopulmonary Exercise Tests to Support a Diagnosis
of  Chronic Fatigue Syndrome, VanNess, J. Mark; Snell, Christopher R
; Stevens, Staci R;  Bateman, Lucinda; Keller, Betsy A. FACSM.
Journal: Medicine & Science in Sports & Exercise: Volume 38(5)
Supplement May 2006 p

6. Chronic Fatigue Syndrome: Exercise Performance Related to Immune Dysfunction

Jo Nijs; Mira Meeus; Neil R. Mcgregor; Romain Meeusen; Guy De
Schutter; Elke Van Hoof; Kenny De Meirleir Medicine and Science in
Sports and Exercise®

Published: 11/16/2005

7.  Demonstration of Delayed Recovery from Fatiguing Exercise in
Chronic Fatigue Syndrome. Loma Paul; Leslie Wood; Wilhelmina MH
Behan; William M Maclaren; European Journal of Neurology 1999 6:63-69

8.  Does Graded Exercise Therapy Improve Post-Exertional Malaise in
CFS? Susanna Agardy  Archives 30 March 2005

9.  Randomised controlled trial of patient education to encourage
graded exercise in chronic fatigue syndrome. Pauline Powell, Richard
P Bentall, Fred J Nye, Richard HT Edwards. BMJ 2001; 322: 387.

10.  Randomised controlled trial of graded exercise in patients with
the chronic fatigue syndrome. Kathy Y Fulcher, Peter D White.  BMJ
1997; 314:1647-1652.

11. Randomised controlled trial of graded  exercise in chronic
fatigue syndrome. Karen E Wallman, Alan R Morton, Carmel Goodman,
Robert Grove, Andrew M Guilfoyle. Med J Aust 2004; 180(9): 444-448.

12.  Randomised, double-blind, placebo-controlled treatment trial of
fluoxetine and graded exercise for chronic fatigue syndrome.  AJ
Wearden, RK Morriss, R Mullins, PL Strickland, DJ Pearson, L Appleby,
IT Campbell and JA Morris. British Journal of Psychiatry  (1998) 172, 485-490.

13.  A review on cognitive behavorial therapy (CBT) and graded
exercise therapy (GET) in myalgic encephalomyelitis (ME)/ chronic
fatigue syndrome (CFS): CBT/GET is not only ineffective and not
evidence-based, but also potentially harmful for many
patients with ME/CFS.  Frank N.M. Twisk, Michael Maes.
Journal:  Neuroendocrinol Lett 2009; 30(3): 284–299 PMID:
19855350  NEL300309R02

14.  Evidence that the Guidelines Development Group that Produced the
NICE Guideline on CFS/ME (CG53) Failed  to Filfill its
Remit  (particularly in relation to the potential dangers of graded
exercise therapy) Margaret Williams   2008   (pp 19-32, effects of
Graded Exercise Therapy)


Monday, November 30, 2009

CFSAC testimony available online

All of the public testimony presented at the October CFSAC meeting has been posted on the CFSAC website.  It may be easier for some patients to read through individual testimonies separately rather than listening to the webcast.

It includes all of the written testimony submitted as well as the oral testimony given at the meeting, either in person or by phone. Dr. Bell's presentation on Facticious Disorder and CFS in Adolescents is also available.

Jill McLaughlin

Sunday, November 29, 2009

XMRV: What do we know? What don't we know?

Version 4 of The ME Association position statement on XMRV clarifies some of the points and queries raised in the previous three summaries. 

Version 4 also updates the situation on XMRV research initiatives here in the UK, patient selection criteria for XMRV research studies, testing for XMRV in Europe, and refers to our on-going correspondence with the Chief Medical Officer regarding the safety of blood supplies and blood donation.

The summary is intended to be a balanced account of the current situation.  It therefore not only raises questions but is also very cautious when it comes to drawing any firm conclusions at present about the role of XMRV in ME/CFS as either a diagnostic marker, causative agent, or abnormality that requires active treatment with antiviral medication.

Full text available on the home page of the MEA website at:

NB:  XMRV research will be on the agenda when the All Party Parliamentary Group (APPG) on ME meets at the House of Commons on Wednesday 2 December.  Department of Health Minister, the Rt Hon Mike O'Brien has agreed to attend this parliamentary meeting, which is open to the public.  More information on time, venue, access to the House of Commons etc is contained in our XMRV position statement.

Dr Charles Shepherd
Hon Medical Adviser, MEA


Malpractice Data Closed to Public

20 Years of USA Doctors' Malpractice Data Closed To Public

More than 20 years ago Congress created a federal database to track incompetent and unprofessional health-care practitioners. The database, compiled by the U.S. Department of Health and Human Services, includes some 460,000 records of malpractice lawsuits whose judgments total $69.7 billion. It includes information on 23,788 patient deaths, 8,100 major permanent injuries and 3,896 cases that resulted in quadriplegics, brain damage or lifelong care. Much of the data is closed to the public. The doctors' names remain hidden, preventing patients from using the data to look up information on their practitioner. "If the data bank is reliable enough for state medical boards to use on a daily basis, why should it be considered too incomplete for curious patients?" asked Sidney Wolfe, a physician and director of the Health Research Group for Public Citizen, a nonprofit consumer advocacy organization out of Washington, D.C.
Gavin Off, Tulsa World


* * *

According to my state medical board, the doctors who did me the most damage have no complaints against them.  I know complaints were made, because I made them.  However, the medical board wrote back saying essentially that because I'd lost neither life nor limb, it wasn't serious enough to spend their limited funds investigating.  The fact that I lost "life as I knew it" and was rendered permanently disabled wasn't enough to justify an investigation!

That figured into my decision to sue for malpractice.  If I couldn't make a public record of their crimes in one way, I'd make a record in another way.