Saturday, October 16, 2010
exertion that is relieved by rest, whereas CFS "fatigue" may result from little or no exertion and is not substantially relieved by rest.
...The CDC agreed to study the matter [of a name change] but later announced
that the adoption of a new name is premature. In a catch-22, the present name
trivializes the illness, thereby discouraging the research funding needed to
uncover the pathophysiology of the disorder, which would help determine a more
Friday, October 15, 2010
WSJ Health Blog
By Amy Dockser Marcus
October 15, 2010, 12:09 PM ET
The Chronic Fatigue Syndrome Advisory Committee — which advises the
head of HHS on policy and scientific issues related to CFS — just
wrapped up its latest meeting. During three days of presentations and
debate (you can watch it all here), it was hard to avoid talking or
thinking about XMRV.
That's the retrovirus that was linked to CFS in a study published last
year in the journal Science. Scientists have been debating the finding
ever since, with some labs finding the virus in a majority of CFS
patients and other labs not finding XMRV in a single case.
At the meeting's public comment period, CFS patients pressed for more
funding to study XMRV and to launch clinical trials. Many of the
patients wore shirts with "NIH: What have you done for ME/CFS today?" emblazoned on the front. And some held up "Act Now" placards. ("ME"
refers to myalgic encephalomyelitis/encephalopathy, another term used
to describe the condition.)
For the first time, an extra day was added to the advisory committee
meeting to focus solely on scientific developments; XMRV got prominent
billing. In its final recommendations to HHS, the committee called for
the creation of a national clinical trials network. "When [the science
behind] XMRV gets sorted out, we'll be ready to jump," advisory
committee member Nancy Klimas, a University of Miami professor who
runs a CFS clinic and researches the condition, tells the Health Blog.
The idea, Klimas says, is to set up a network of at least five centers
to serve as a kind of hub for research, clinical care and education.
Doctors would start collecting standardized clinical and research data
from patients at the sites, and teams of investigators would work
together to develop common clinical trial protocols to start pushing
drug development for CFS.
Yet a number of scientists at the meeting expressed caution about
XMRV. Stuart LeGrice, who has helped lead XMRV efforts at NCI, gave
the scientific talk on the virus and urged patients to wait until more
is known before taking anti-retroviral medications. (Some are already
taking the meds, as the WSJ reported recently.) "We're not far from a
controlled clinical trial," he told participants during a Q&A session.
And while XMRV is a hot topic, Christopher Snell, the chair of the
advisory committee, said at the meeting that research on XMRV has
"overshadowed" other possible CFS research avenues. Klimas tells the
Health Blog that research in CFS is finally yielding a number of
possible therapeutic strategies that spring from other hypotheses
unrelated to XMRV.
However, for patients like Robert Miller — who testified at the
meeting — it's clear what's providing the momentum in CFS research.
"This all started because of XMRV," he said.
FROM: Fred Friedberg, PhD
RE: Public testimony given on October 13, 2010
As president of the IACFS/ME, an organization of over 500 biomedical and behavioral professionals, I thank the CFS Advisory Committee for this important opportunity to present testimony. Several weeks ago, the Centers for Disease Control issued a job announcement for Chief, Chronic Viral Diseases Branch. This includes primary responsibility for the direction and substance of the CFS research program. The program contains the largest single US budget for CFS research ($5 million/yr).
This is a critically important position that can influence science, practice, and health policy related to CFS. As such, we need a highly qualified individual to fill the position. According to the head of the search committee at CDC, several candidates will be recommended for further consideration. A new chief will probably be appointed in the next several weeks.
Apart from the necessary scientific credentials, I would like to excerpt a key job requirement from the job announcement:
----The ability [of the candidate] to deal effectively with the scientific community,… national and international health-related organizations, and the public at large.
This critical dimension of leadership has been and still is lacking at the CFS program at CDC. To date, the leadership of the Chronic Viral Diseases Branch has conveyed an attitude of dismissal bordering on arrogance toward the external scientific and professional communities. This attitude has generated mistrust and skepticism of the CFS research program – a mistrust which has been ongoing for the past decade.
IACFS/ME would like to see the position of Chief filled by someone who constructively engages with the scientific community. This important ability would preferably include a shared vision of the direction of biomedical research in CFS--- particularly in the challenging new domains of retrovirology and molecular medicine. These emerging areas of scientific inquiry may lead to new models of intervention that can offer hope and help for long suffering CFS patients.
Overall, we need open communication with the CDC/CFS program and fresh perspectives from their leadership--the qualities that could elevate this position to one that is viewed with renewed respect and credibility.
In keeping with the stated job requirements for the Chief, Chronic Viral Diseases Branch, IACFS/ME recommends the following:
1. All candidates should be required to demonstrate their past experience and future potential to deal effectively with the external scientific community -- especially professional organizations which look to the CDC for enlightened leadership and scientific progress.
2. When appointed , the new Chief should post a statement of intent on the CDC website with the following objectives:
-- to develop cooperative relationships with the external scientific community.
-- to be open to external input in the planning and implementation of studies relevant to CFS.
-- to publish detailed abstracts of their planned and ongoing CFS research in order to inform the scientific community and other stakeholders.
3. The CFS program should schedule regular meetings with scientists and clinicians in order to develop productive relationships on research and clinical management issues. Such regular meetings were part of the CDC's 5 yr. research plan. It's now 18 months since the release of the 5 yr. plan and no such meeting has been held.
4. Finally, the CDC should initiate an extramural grants program so that independent labs can generate innovative research that complements CDC-based studies.
These recommendations are consistent not only with job requirements but also with the Mission Statement of the CDC, which first and foremost emphasizes collaboration and partnerships to create the expertise, information, and tools that communities need to protect their health. The CDC mission also pledges to the American people to treat all persons with dignity, honesty, and respect.
In sum we ask that the candidate selected to head the CFS program be prepared to act in accordance with the CDC's own mission statement as well as the job's requirements: that is, to demonstrate the important ability to deal effectively with the external scientific community.
The news [see BBC web-link below] on October 15th 2010 that Dr Sarah
Myhill is to be suspended from medical practice for a year is utterly
disgraceful and simply beggars belief. Dr Myhill properly submitted her
mitochondrial ME/CFS work to peer-review and is an outstanding and
conscientious medical professional. If this General Medical Council
(GMC) ruling is allowed to stand and not successfully challenged by
judicial review then de-facto state-directed medicine has arrived in the UK.
Yesterday was a black day for ME/CFS patients, a black day for clinical
freedom, a black day for genuine medical science and a black day for the
country. It is shameful.
Progressive science-based forces must not be disheartened by such a
travesty. We must re-group, fight back and stand up for one of the best
and most outstanding doctors in UK general practice.
For further information see:
[Permission to repost]
Tom Hennessy's (entire) CFSAC Testimony from October 13, 2010
Thursday, October 14, 2010
Journal of Infectious Diseases [finding] no link between the virus and
the CFS'; however only one of the studies dealt with CFS, the other
two were on HIV/hepatitis C and prostate cancer patients, with the
prostate cancer study reporting positive results.
CFS Panel Wants Name Change for Disorder
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: October 14, 2010
WASHINGTON -- A federal advisory committee unanimously endorsed a recommendation Thursday to change the name of chronic fatigue syndrome (CFS) to CFS-ME, citing a need to make the disease sound more serious.
The ME can stand for either myalgic encephalomyelitis or myalgic
encephalopathy, the panel said.
For its part, no member of the Chronic Fatigue Syndrome Advisory
Committee -- a committee of outside experts meant to advise the
Department of Health and Human Services (HHS) -- questioned the
validity of CFS.
The 11-member panel, which meets several times a year, wrapped up its
three-day meeting by endorsing two recommendations for HHS, one of
which was to add the "ME".
Using both the "CFS" and the "ME" is somewhat controversial to those
in ME groups because ME is seen by some as the more serious condition.
That is partly because it has a clearly identifiable trigger -- viral
illness -- whereas the causes of CFS continue to stymie the medical
community, and physicians diagnose CFS based entirely on symptoms.
But patients pleaded with the panel on Thursday to either change the
name altogether or else tack on the "ME."
"Fatigue is just one symptom of the disease," one CFS patient told the
panel via telephone. "You don't call Parkinson's 'shaking disease' or
Alzheimer's 'forgetting disease.'"
Panelist Susan Levine, MD, a physician and researcher who treats CFS
patients, agreed that the name "chronic fatigue syndrome" doesn't
accurately reflect the seriousness of the disease.
"If it has a more scientific name, we might receive more funding than if it has a name that sounds just like you need to take a nap," she said.
The panel also endorsed a recommendation for HHS to create a national
CFS-ME network of treatment centers in order to expand access to care,
to develop educational initiatives, and to allow researchers to share
The panel has voted on a similar recommendation numerous times, but so
far, no such networks exist.
While there was a good amount of discussion of the role of xenotropic
murine leukemia virus-related virus -- XMRV for short -- in CFS, and
the recent rash of studies relating to the XMRV, the panel didn't
mention the retrovirus in any recommendations.
XMRV was first linked to CFS in 2009, when a paper in Science reported
finding evidence of XMRV in 67% of patients with the syndrome and 4%
of healthy controls.
That study has prompted CFS patients to call for more research into
the link, and some patients have reportedly been taking antiretroviral
agents off-label to treat their CFS.
More recently, a rash of studies have failed to confirm that XMRV has
any link to CFS.
A Dutch study from earlier this year failed to find any trace of the
retrovirus in the blood of CFS patients, leading the researchers to
conclude that the findings "cast doubt on the claim that XMRV is
associated with chronic fatigue syndrome in the majority of patients."
And just this week, three additional studies published in the Journal
of Infectious Diseases found no link between the virus and the CFS.
However, in another recent small study, blood samples from more than
80% of patients with chronic fatigue syndrome were found to have viral
gene sequences similar to those of murine leukemia virus (MLV).
Wednesday, October 13, 2010
My Testimony to the CFSAC Committee
I keep using the word village, placing it in words and parts of speech where it doesn't belong: I just saw that movie I Am Village. My parents have a Village on the Upper East Side. I love your village.
Apparently, my disease has some unhealthy obsession with community.
My doctor doesn't look at me when he talks. At least, not anymore. When I was twenty he smiled broadly, and promised me a thousand better days. But now, he just reads blood work: Epstein Barr. Elevated. 300% Above Normal. HHV6A. Elevated. 160% Above Normal. Mycloplasma Pneumonia. Elevated. 300% above normal…
I can't write it down fast enough.
Maybe he's grown tired of patients that never get any better. Or maybe it's that I'm getting older and he knows the statistics: Suicide. Mean Age. Thirty-nine. Heart disease. Mean Age. Forty-nine. Cancer. Mean age. Fifty-nine….
Sometimes, they just lie down and never get up.
How ironic it is to have this heart placed beating so badly in a body that is always breaking down. I probably could have ruled the world, climbed Mount Everest, lived for a thousand nights like a Bedouin in the desert, but now, all I do is sleep. When I dream, I dream of cures. When I wake, the bed is soaked.
Aaron brings me cupcakes from Crumb. You need to eat more, the doctor says. All I eat is frozen fruit. Nothing tastes right, but the cold of the frost numbs my burning tongue, and soothes my scratching throat.
I'm tired of being sick.
I toss around this concept called life in my head. But, my dog is in Heaven waiting by the swimming pool. My grandmother dances like a child in the lawn. My grandfather waves as he grills hot-dogs from the porch.
And my friends, my friends, left long ago are also on their way.
From: Herman Salton
Sent: 13 October 2010 21:45
Subject: NOT: International Survey on CFIDS/ME - invitation to fill in anonymous questionnaire
I am a researcher preparing a book on CFS/ME/CFIDS and I am trying to get as many experiences from CFS patients as possible, with the aim of giving voice to them in the book. I was wondering whether any of you could help?
I have already gathered several experiences from the Spanish-speaking, French-speaking and Italian-speaking world, with the aim of showing in the book that the experiences/problems faced by patients are very similar throughout the world, and I would be keen on gathering experiences from the US as well.
I have developed a questionnaire in several languages (attached please see the English version) and I was wondering whether you would be willing to fill it in and distribute it as widely as possible? I have explained both the questionnaire and the reasons behind it in the document. The questionnaire is anonymous and also be filled in online at http://www.surveymonkey.com/s/HHBB75P
I should also point out that I myself suffer from CFIDS, so I obviously have a very strong interest in this matter and no interest whatsoever in speculating on other fellow sufferers. I only want to raise the awareness of this very insidious disease and, since I am still able to write and I am an academic, shake up a bit the medical establishment in the process!
Thank you very much in advance for your help and please do not hesitate to contact me, should you need further information.
With my warmest regards and very best wishes for your health!
Dr Herman Salton
BA (Italy), MPhil (Oxford), PhD (Auckland)
*(permission to repost)*
Four fifteen in the morning and I'm thinking; what will it take for a
phoenix to reach us here ? I hold Linda, my wife's, hand as Florencio
Avalos emerges from the escape capsule ; his young son bursting into tears.
Children have been denied to us, by ME.
Linda, herself , has been trapped underground now since 1993.
The two of are buried deep . 2362 feet beneath the surface : that's a good
an estimate as any. Our Doctor called yesterday and admitted that her life
has not one of the ordinary pleasures that, well, make life even bearable.
Food, drink, socializing, music, reading, cinema, theater, walking...
joining me on my morning bike ride.
Both of us have a classy Dawes Galaxy : serious bikes. One time, before
she got ill for 17 years, Linda, head held high, flew off down a hill at
such speed I could not catch her up. Well she would, she used to cycle 18
miles a day to work. She's got the build of an athlete. This woman whose
days consist in surviving on cold salad and moving from bed to chair, in a
miasma of exquisite pain and paralysis. ...
...whose spider-infested bike lies long buried, down the shed, under years
of flowerpots, discarded lawnmowers and cardboard boxes....2362 feet beneath
the wicked, deliberately placed rock pile that is "CFS".
Each time someone uses the word "CFS" - or "forward slash CFS" , to
describe this disease, another rock is added to the hardening , growing
Down, down deep in the darkness here , though, lies "ME", like that three
thousand year old seed that was found in a portion of a tree, in an
ancient Egyptian tomb, back in the nineteenth century, Ramsay -defined ME,
with all its promise of serious research lies dormant . We were doing so
well back in the day , until the CDC came along .
That seed grew though , even after three thousand years.
We need people to know we are here. Peggy Munson's blog :
on what we can learn from the AIDS community, is the best thing I've read
yet on how to make ourselves heard.
Meanwhile, waiting here on a phoenix, with as much fierce courage as those
miners, we can at least begin to dig ourselves, if not out, at least no
(The Lived Experience of Severe ME)
Tuesday, October 12, 2010
I got the same thing from the doctors who thought it was just post-divorce depression. I got a pep talk about needing to believe in myself, and "you'll be surprised how much you can do if you try", then got cut off when I tried to clarify that "I can't" doesn't mean "I'm afraid to", it means "I've repeatedly tried and repeatedly failed".
And since that didn't fit what he wanted to hear, he also cut me off every time I tried to explain how my symptoms affected my ability to work. A divorced woman who wants lifetime alimony isn't going to try to work, so he had to prevent me from telling him that I was working.
Monday, October 11, 2010
Knowledge or Belief?
9th October 2010
Four forthcoming events may significantly affect the lives of people with
ME/CFS: the results of the MRC PACE Trial on "CFS/ME" are expected to be
published soon; the General Medical Council (GMC) is shortly to decide
whether or not to launch a full inquiry into the alleged misleading of the
High Court during the Judicial Review of the NICE Clinical Guideline 53 by a
member of the NICE Guideline Development Group (GDG); on 29th November 2010
the Fatigue Service at St Bartholomew's Hospital will hold a training day
and a birthday party in the Great Hall of Barts to celebrate 25 years of
Professor Peter White's services to those with "CFS/ME", and in December
2010, using the same GDG members, NICE is to consider if there has been any
new research that necessitates a revision of its much criticised 2007
Guideline CG53 on "CFS/ME".
The common thread between these events is, of course, the beliefs of the
Wessely School about ME/CFS (which they invert and refer to as "CFS/ME") and
their continued refusal to engage with the extensive biomedical and
scientific knowledge about ME/CFS that identifies damage, deficits and
dysfunction in major bodily systems, particularly in the neurological,
immune, endocrine and cardiovascular systems.
At the Barts Fatigue Service celebrations, Professor Wessely's talk is
entitled: "Where we were then, where we are now" and Professor White is to
speak on: "PACE Trial: is knowledge more useful than belief?"
Is knowledge more useful than belief? Not, it seems, where ME/CFS is
Why not? Because where the Wessely School is now in relation to ME/CFS is
little different from where it was 25 years ago – their beliefs remain
static and they have resolutely not moved forwards in the light of
They perversely and irrationally reject the ever-increasing body of
biomedical knowledge that ME/CFS is a serious neuroimmune disease and
continue to believe that it is a somatoform disorder which is curable by
their favoured interventions of cognitive restructuring and incremental
aerobic exercise. Professor Peter White claims that "a full recovery is
possible" (Psychother Psychosom 2007:76(3):171-176); the PACE Trial CBT
participants' Manual informs people that the PACE Trial therapies are
curative, and it is elsewhere asserted that "many people have successfully
overcome their CFS/ME" with such behavioural interventions ("Information for
relatives, partners and friends", page 123). Such a belief is not supported
With the publication of the PACE Trial results being imminent, it is worth
recalling the already-published results of its sister trial, the FINE Trial
(Fatigue Intervention by Nurses Evaluation) that was funded entirely by the
MRC and had 296 participants: the FINE Trial was a resounding failure on all
fronts, so it is difficult to see how the PACE Trial results might be
The FINE Trial results clearly showed that "pragmatic rehabilitation" (PR,
based on CBT/GET) was minimally effective in reducing fatigue and improving
sleep: it did so only whilst participants were engaged in the programme and
there was no statistically significant effect at follow-up. Furthermore,
pragmatic rehabilitation had no statistically significant effect on physical
functioning; equally, its effect on depression had diminished at follow-up.
Moreover the other intervention being tested ("supportive listening" or SL)
had no effect in reducing fatigue, improving physical functioning, sleep or
Notwithstanding, the investigators are already seeking further funding to
test their hypothesis that providing more sessions might improve the
effectiveness of pragmatic rehabilitation which they state "will inform the
next phase of our work….The first phase of this work will be in conjunction
with the Greater Manchester CFS Service".
The PACE and FINE Trials, as well as the recommendations in the NICE
Guideline CG53, were predicated on the Wessely School's beliefs, not on
existing biomedical knowledge.
The existing knowledge is that the interventions do not work, but the belief of the investigators is that they ought to work, thus belief triumphs over knowledge.
Of particular note is what Professor Wessely said on 26th July 2010 during
the final of "Debating Matters" filmed in India. The subject was
"Alternative Medicine is Quackery"; discussing people who make what he
regards as false claims about the success of alternative medicine and
comparing them with the scientific rigour of modern medicine, Wessely said,
apparently without a trace of insight: "They do not change their beliefs or
their practice on the basis of the evidence, that's the difference that
we're talking about. It's the ability to move from dogma to science and to
say yeah, it sounded good at the time, but the evidence shows that it isn't,
so we move on, we research, we try and progress, that's the difference we're
talking about" (http://www.spike.com/video/alternative-medicine/3439367). It
has been said, and might still be said, that this is precisely the argument
that has been levelled against the Wessely School in relation to ME/CFS –
the behavioural modification approach may have sounded good at the time, but
the evidence shows that it isn't, so it's time to move on. They, however,
refuse to do so and steadfastly hold on to their own blind beliefs. The
tragedy for people with ME/CFS is that the Wessely School seem unable to
apply the same logic they require of others to themselves.
In relation to the GMC, if the complaint about the GDG member is upheld, it
would, according to one of the lawyers "be strong grounds for re-opening the
(Judicial Review) and would seriously undermine NICE".
Eight years before the NICE Clinical Guideline 53 was published, the British
Medical Journal carried a compelling article on Clinical Guidelines
(Potential benefits, limitation, and harms of clinical guidelines; Steven H
Woolf et al; BMJ 1999:318:527-530).
The article provides a clear warning of the dangers arising from an
uncritical adherence to clinical guidelines:
"Over the past decade, clinical guidelines have increasingly become a
familiar part of clinical practice. Every day, clinical decisions…and health
spending by governments and insurers are being influenced by guidelines".
"Many believe that the economic motive behind clinical guidelines is the
principal reason for their popularity".
"The most important limitation of guidelines is that the recommendations may
"Practices that are sub-optimal from the patient's perspective may be recommended to help control costs, serve societal needs, or protect special interests (those of doctors…or politicians, for example)".
"The promotion of flawed guidelines by practices, payers, or healthcare
systems can encourage…the delivery of ineffective, harmful or wasteful
" Recommendations that do not take due account of the evidence can result in
sub-optimal, ineffective, or harmful practices".
"Flawed clinical guidelines harm practitioners by providing inaccurate
scientific information and clinical advice, thereby compromising the quality
of care….Outdated recommendations may perpetuate outmoded practices".
"Guidelines can harm medical investigators and scientific progress if
further research is inappropriately discouraged".
"Guidelines developed by specialists may seem to be self-serving (and)
"Naïve consumers of guidelines accept official recommendations on face
value, especially when they carry the imprimatur of prominent professional
groups or government bodies. More discerning users of clinical guidelines
scrutinise the methods by which they have been developed".
"…those concerned with improving quality should redirect their efforts to
identify the specific barriers…that stand in the way of behaviour change".
The evidence for retroviral involvement in ME/CFS is becoming impossible for
NICE to dismiss, for example, from 1st November 2010 there is to be a
lifetime ban in the UK on people with ME/CFS donating blood, a paradigm
shift that was reported nationwide and worldwide, even in The Himalayan
nned+from+donating+blood&NewsID=260959) so NICE cannot claim to be unaware
of the significance of it. Moreover, given the known intercourse between the
UK and the US about ME/CFS, NICE can hardly be unaware that world experts in
ME/CFS such as Professor Nancy Klimas (principal investigator of the
National Institute for Health's Centre for Multidisciplinary Studies of
(ME)CFS Pathophysiology at the University of Miami) are clear: "…there is a
chronic inflammation, neuro-inflammation, and it upsets the whole balance of
your systems…the patients become terribly ill…. The immune system is really
cranked up; it's a tremendous amount of inflammation. I think that if
doctors could get this in their heads that it's sort of like lupus or one of
these really inflammatory disorders…it is that level of inflammation.
There's a tremendous amount of inflammatory stuff going on, and there's a
lot of inflammation in the brain itself"
The evidence of inflammation in people with ME/CFS is important because the
incremental aerobic exercise recommended by the Wessely School and
encapsulated in NICE's Clinical Guideline 53 is contra-indicated in cases of
inflamed and damaged tissue and inevitably results in post-exertional
relapse with malaise, which is the cardinal symptom of ME/CFS.
Can NICE credibly continue to ignore the warning that was carried in the BMJ
eleven years ago about the harm caused by flawed guidelines, or will it
continue to prefer belief to knowledge?
Do entrenched beliefs that continue to be held in defiance of knowledge
cause harm to patients?
Countless people with ME/CFS and their families know the answer to that
Final full text will be linked from:
Patients with chronic fatigue syndrome performed worse than controls in a controlled repeated exercise study despite a normal oxidative phosphorylation capacity
Author: Ruud Vermeulen, Ruud Kurk,Frans Visser,Wim Sluiter,Hans Scholte
The aim of this study was to investigate the possibility that a
decreased mitochondrial ATP synthesis causes muscular and mental
fatigue and plays a role in the pathophysiology of the chronic fatigue
Methods: Female patients (n=15) and controls (n=15) performed a
cardiopulmonary exercise test (CPET) by cycling at a continuously
increased work rate till maximal exertion. The CPET was repeated 24 h
Before the tests, blood was taken for the isolation of peripheral
blood mononuclear cells (PBMC), which were processed in a special way
to preserve their oxidative phosphorylation, which was tested later in
the presence of ADP and phosphate in permeabilized cells with
glutamate, malate and malonate plus or minus the complex I inhibitor
rotenone, and succinate with rotenone plus or minus the complex II
inhibitor malonate in order to measure the ATP production via Complex
I and II, respectively. Plasma CK was determined as a surrogate
measure of a decreased oxidative phosphorylation in muscle, since the
previous finding that in a group of patients with external
ophthalmoplegia the oxygen consumption by isolated muscle mitochondria
correlated negatively with plasma creatine kinase, 24 h after
Results: At both exercise tests the patients reached the anaerobic threshold and the maximal exercise at a much lower oxygen consumption than the controls and this worsened in the second test.
This implies an increase of lactate, the product of anaerobic
glycolysis, and a decrease of the mitochondrial ATP production in the
patients. In the past this was also found in patients with defects in
the mitochondrial oxidative phosphorylation.
However the oxidative phosphorylation in PBMC was similar in CFS/ME
patients and controls. The plasma creatine kinase levels before and 24
h after exercise were low in patients and controls, suggesting
normality of the muscular mitochondrial oxidative phosphorylation.
Conclusion: The decrease in mitochondrial ATP synthesis in the CFS/ME
patients is not caused by a defect in the enzyme complexes catalyzing
oxidative phosphorylation, but in another factor.
Trial registration: Clinical trials registration number: NL16031.040.07
Credits/Source: Journal of Translational Medicine 2010, 8:93
Permission to Repost
This is the letter which was sent by Professor Malcolm Hooper,on the 7th
October, to The Rt Hon Dr Vince Cable MP, Secretary of State with
responsibility for the Medical Research Council(MRC), relating to the
failure of the MRC to respond to his formal complaint on the PACE Clinical
Trial, which he first lodged on the 11th February 2010. May be reposted.
The Rt Hon Dr Vince Cable MP
Secretary of State
Department for Business, Innovation and Skills
1, Victoria Street
7th October 2010
By Special Delivery
Dear Dr Cable,
re:Complaint about the MRC PACE Trial on "CFS/ME"
Mindful of your record of commitment to and concern about the serious plight
of people with the neuroimmune disorder myalgic encephalomyelitis/chronic
fatigue syndrome (ME/CFS), I ask that in your position as Secretary of State
responsible for the Medical Research Council (MRC), you will respond
promptly and fully to this letter.
Having received no response from the Medical Research Council to our
concerns about the PACE Trial that purports to be studying this disorder, on
11th February 2010 I lodged a detailed complaint with the Minister then
responsible for the MRC, The Rt Hon The Lord Drayson, enclosing a bound copy
of my 442 page fully referenced report "Magical Medicine: how to make a
disease disappear" setting out the evidence that forms the basis of my
He replied by letter dated 8th March 2010 (his reference being
2010/0013270POLD), advising that I should raise the matter formally with Dr
Morven Roberts of the MRC Clinical Trials Unit, which I duly did by letter
dated 30th March 2010, with which I enclosed a further bound copy of my
I specifically asked Dr Roberts for an informed and considered response and
not the standard and dismissive pro forma MRC letter that has been sent to
numerous people who have already written to the MRC expressing their
concerns about the inappropriateness of the PACE Trial, the false beliefs of
the small but influential group of psychiatrists upon which it is
predicated, and its very real potential for iatrogenic harm.
My letter and the accompanying report were sent by Special Delivery and were
received by the MRC on 1st April 2010, for which the Royal Mail provided a
I did not receive the courtesy of an acknowledgement, so six weeks later, on
18th June 2010, my research assistant telephoned the MRC and asked to speak
to Dr Morven Roberts. When my assistant explained that the enquiry related
to my formal complaint about the PACE Trial, she was informed that there was
no-one of the name of Dr Morven Roberts in the Clinical Trials Unit and was
met with a total refusal to discuss the matter, the MRC employee saying: "I
think I'm going to have to put the phone down", which she rudely did. The
episode was a quite extraordinary response to a simple and polite request to
speak to Dr Morven Roberts in relation to a complaint about an MRC trial.
The following day, Dr Morven Roberts sent me an email (incorrectly addressed
to Professor "Cooper") in which she wrote: "I understand you have recently
tried to contact me in regard to your complaint lodged with me as Clinical
Trials Manager about the PACE Trial. I can let you know that the MRC are
working through the large document you have sent and will respond in due
Despite it being over six months since I lodged my complaint and four months
since Dr Morven Roberts assured me I would receive a response, I have heard
nothing from the MRC. I am sure you will agree that such a delay in such an
important matter is unacceptable.
On 5th October 2010, my research assistant telephoned your Department,
quoting the reference number on Lord Drayson's letter of 8th March 2010, to
seek your personal commitment to pursue this issue as a matter of urgency,
only to be informed that there is no record of my complaint as Lord
Drayson's reply to me has been lost and that I must start my complaint all
over again. She was informed that someone from your office would ring her
back that same day; you may not be surprised to know that no-one bothered to
Reasons why this complaint is now urgent
The MRC PACE Trial intentionally used the Principal Investigators' (PIs')
own entry criteria for "CFS" (the 1991 Oxford criteria), yet these criteria
lack diagnostic specificity, have been shown to have no predictive validity,
and select a widely heterogeneous patient population which may or may not
include people with true ME/CFS. It is virtually unheard of for studies to
use criteria that have been superseded; indeed, one of the PIs himself,
Professor Michael Sharpe – who was lead author of the Oxford criteria --
stated in 1997 that they "have been superseded by international consensus"
(Occup Med 1997:47:4:217-227).
Of equal concern is the fact that the PIs and other psychiatrists involved
with the PACE Trial continue to regard ME/CFS as a behavioural disorder and
refuse to engage with the extensive biomedical and scientific evidence that
identifies damage, deficits and dysfunction in major bodily systems of
patients with ME/CFS, particularly in the neurological, immune, endocrine
and cardiovascular systems. For over two decades they have asserted that ME does not exist (and that it is merely an "aberrant belief" that one has a disorder called ME); they equate it with chronic "fatigue", a completely different disorder classified by the WHO as a psychiatric disorder in ICD-10 at F48.0, whilst ME/CFS is classified as a neurological disorder at ICD-10 G93.3.
The potentially harmful results of the PACE Trial for those with ME/CFS are
particularly important in the light of the findings of the strong
association between ME/CFS and a retrovirus (XMRV) of the same family as
HIV/AIDS. The findings of that paper, published one year ago in the journal
with the highest impact factor of any scientific journal worldwide (Science
2009:326:585), have been confirmed and strengthened by further research
published in August 2010 in the Proceedings of the National Academy of
Sciences (PNAS 10.1073/pnas.1006901107) showing polytropic murine leukaemia
virus-related viral sequences (MLV) to be present in the blood of 86.5% of
The over-riding international concern is that when the PACE Trial results
are eventually published, they will deliver what has long been known to be
the PIs' intention and primary objective, ie. the results will confirm the
PIs' favoured intervention of "cognitive restructuring" (which incorporates
graded aerobic exercise) as the intervention of choice. This is an
intervention that is specifically designed to disabuse ME/CFS sufferers of
their (correct) perception that they suffer from a serious, multi-system
The cognitive modification is directive, not supportive, ie. it is not
offered as adjunctive psychological support for those dealing with a
life-wrecking illness because the PACE Trial Manuals claim that it is
curative: the chief PI, Professor Peter White, claims that "a full recovery
is possible" (Psychother Psychosom 2007:76(3):171-176); the participants'
CBT Manual informs people that the PACE Trial therapies are curative, and it
is asserted that "many people have successfully overcome their CFS/ME" with
such behavioural interventions ("Information for relatives, partners and
friends", page 123).
To recommend behavioural modification strategies for those suffering from such devastating organic illness would be inhumane and inexcusable: if such an intervention were to be imposed on those with other neurological diseases (such as motor neurone disease or multiple sclerosis) to force them to change their correct perception that they suffer from a serious organic disorder, it would be roundly condemned as unethical.
You may already be aware that a world expert on both HIV/AIDS and ME/CFS is
on record as stating:
"I hope you are not saying that (ME)CFS patients are not as ill as HIV
patients. I split my clinical time between the two illnesses, and I can tell
you that if I had to choose between the two illnesses I would rather have
HIV" (Nancy Klimas, one of the world's foremost AIDS and ME/CFS physicians;
Professor of Medicine and Immunology, University of Miami; New York Times,
15th October 2009). In addition, in a radio interview on 19th September
2010, she stated: "…there is a chronic inflammation, neuro-inflammation, and
it upsets the whole balance of your systems…the patients become terribly
ill…. The immune system is really cranked up; it's a tremendous amount of
inflammation. I think that if doctors could get this in their heads that
it's sort of like lupus or one of these really inflammatory disorders…it is
that level of inflammation. There's a tremendous amount of inflammatory
stuff going on, and there's a lot of inflammation in the brain itself"
This is important, because the incremental aerobic exercise recommended by
the PACE Trial Principal Investigators is contra-indicated in cases of
inflamed and damaged tissues and inevitably results in post-exertional
relapse with malaise, which is the cardinal symptom of ME/CFS.
Furthermore, in a lecture on 24th April 2010, Anthony Komaroff, Professor of
Medicine at Harvard and another world expert on ME/CFS, said on record in
answer to the question whether or not he would consider ME/CFS a
neurological illness: "…there is now abundant evidence of measurable
abnormalities in the central nervous system and the autonomic nervous system
in people with this illness. That makes it neurological…That's why I think
it makes sense…to call it Myalgic Encephalomyelitis…because I think those
two words adequately classify or describe an underlying biology that tests
have shown to be the case" (http://www.masscfids.org/news-a-events/2/221 ).
As the evidence for retroviral involvement in ME/CFS becomes impossible to
dismiss, it becomes paramount to prevent the potentially damaging PACE Trial
results from being applied nationally to anyone with the label "CFS/ME" who,
given the indisputable heterogeneity of the PACE Trial cohort, may have
either chronic tiredness for which psychological interventions may be
appropriate or a multi-system neuroimmune disorder for which behavioural
modification is contra-indicated.
I trust you will appreciate the gravity and urgency of the current situation
that adversely affects an estimated 240,000 people in the UK (for
comparison, the Multiple Sclerosis Society estimates that there are 83,000
sufferers in the UK) and that your own involvement will be both prompt and
efficacious. The situation is particularly pressing now that people with
ME/CFS are embroiled with new legislation that many fear – and some have
already found – is threatening to remove state benefits they currently
receive that are vital to support their severely sick and damaged lives.
It is completely unacceptable that Dr Roberts and the MRC can be permitted
simply to ignore this complaint (which has received worldwide academic
attention, comment and support) in order to protect the unsustainable
beliefs of a handful of psychiatrists who work for the medical and permanent
health insurance industry and the scandalous waste of over £5 million,
especially given that the effects of the interventions on over 3,000
patients were already known to be at best ineffective and at worst to be
actively harmful in 50% of cases (for references, see "Magical Medicine" --
the copy that was sent to Lord Drayson should still be in your Department
but I will provide a further copy if necessary).
I ask that you give this matter your urgent attention; that you will
intervene to expedite the promised response from Dr Morven Roberts and that
you personally will supervise and approve her response.
cc. Dr Morven Roberts, Clinical Trials Unit, MRC, 20 Park Crescent, London
time and effort. The following was sent to CFSAC; HHS: Secretary
(HHS) Sebelius, Asst Secretary for Health Dr. Howard Koh, NIH Director
Francis Collins, NIAID Director Anthony Fauci, CDC Director Thomas
Frieden; my Senators and Congressional Representative.
I will not be attending the October, 2010 CFSAC meeting and
I am relinquishing my reserved spot to speak. This meeting does not
adequately cover the important issues or reflect even the
'state of the science' in the science portion.
Last years meeting was stunning, with standing room only
crowd. Dr. Dan Peterson received a standing ovation for
his presentation of the work being accomplished by the WPI,
who had just had their collaborative paper published in Science.
We were all expecting a continuation. This meeting is a huge step
backwards and right back to business as usual.
Since then, the work has progressed at an astonishing pace. XMRV
is known to be infectious and oncogenic, and associated with
neurologic and immune system abnormalities. This retrovirus is the
3rd human retrovirus in addition to HIV/AIDS and HTLV (leukemia).
Even very conservative doctors in the trenches have come out and
said that this is probably the cause.
This meeting does not reflect the seriousness and significance of this
research, and more importantly, the urgency of determining the effect
on public health.
The WPI has done more in a couple of years than HHS has done in over 20, and it was their discovery. They were not invited. Why?
The WPI has not received any government funding for XMRV research.
Why is this? They have collaborated with well known researchers from other
federal agencies and published in prestigious journals.
Why has there been no intramural research on XMRV at NIH or NIAID.
Why have there been no expedited epidemiological studies to determine the
incidence, prevalence and mode of transmission of the virus and mechanisms
Why have there been no RFA's (which should have been issued immediately) for
Why have there been no clinical trials, when there are effective antiretrovirals
available? Patients have no access to any treatment.
In fact, with federal agencies involved in these findings, why has CDC been not
only ignoring them in terms of policy but going further in the opposite direction.
Why the change to the CDC website to include psychological interventions
as treatment, and GET, which may be very harmful. Why is the CDC's 5 year
research plan still in place, given the strength and seriousness of this
research, and when IACFS/ME (the international professional organization)
had strenuously voiced objections to this plan?
Where are discussions on children? There have been no studies and no
information, and CDC is prominently placing their adverse event studies
on children on the website.
Where is the discussion on funding, which is crucial, as it has been virtually
non-existent in relative terms to other illnesses and given the morbidity and
Where are discussions about CFSAC recommendations, which
have gone mainly unnoticed, or discussions of how to rectify this?
Why is the Assistant Secretary not wanting to participate in or at least attend these
meetings, given the current situation and strength and significance of the
findings and serious implications to public health and safety of the blood supply.
Patients are suffering, bedridden and some are dying. From our experience,
the illness is progressive and people are going to continue to get worse
the longer they go without treatment. So literally spending more time on rehab
and vocational training and cognitive issues than XMRV? You cannot
rehabilitate someone who is seriously ill. Or to put another way, focus on
proper diagnosis, testing and treatment, which we now realistically have
the means to accomplish, the rest will somewhat take care of itself.
If this committee is not adequately fulfilling its mission and taking up the most
important issues (i.e., a retrovirus and the significance of the very likely role
it plays in this illness), then as a community we must address them elsewhere.
With XMRV/HGRAD, there's a whole re-education process coming for the medical profession. They're going to have to swallow their pride and admit our problem is not IAIYH, it's another word that starts with I-A-, iatrogenic -- doctor-caused -- made worse by doctors who insist that we exercise our way out of the alleged depression, who give us inappropriate medication, who order us to keep working instead of going on Disability... if we'd stay in bed till we feel better, and only then try to increase activity in small amounts, a lot fewer of us would have years-long relapses caused by being urged to "push through" and "prove to me that you're not just lazy".
Catch up on the latest news, upcoming events and new features.
The CFIDS Association of America
working to make CFS widely understood, diagnosable, curable and
Sunday, October 10, 2010
* * *
By Amanda Korman, Berkshire Eagle Staff
Updated: 10/10/2010 07:40:00 AM EDT
Sunday October 10, 2010
NEW LEBANON, N.Y. -- The problems hit her in April of last year:
severe fatigue, headaches, nausea, fevers, insomnia.
Seventh-grader Victoria Lehtonen went to her primary-care doctor and
was prescribed a short course of antibiotics, but once the medication
was used up, her symptoms returned.
Victoria proceeded to doctor after doctor with her mother, Karla, but
was diagnosed with "post-infectious fatigue syndrome" and was sent
home, still suffering.
Since several of Victoria's friends had been diagnosed with Lyme
disease after they were playing in the woods together, Karla believed
Victoria had Lyme too, even though Victoria's doctors thought
differently because she had tested negative for the disease and did
not exhibit tell-tale signs such as partial facial paralysis or a
Karla, who was working on her nursing degree and a master's in
biomedical sciences, started doing her own research on the illness.
"I realized she wasn't post-infectious. ... She was still running a low-grade fever, still heading into bed for days at a time," her mother said. "To me she showed signs of an active infection that was undiagnosed."
Victoria eventually tested positive for Lyme and several related
infections and has undergone treatment with doctors outside of the
A year and a half after her pain began, many of Victoria's most
debilitating symptoms have improved. But the New Lebanon resident, now
13, still suffers from frequent fatigue, hasn't been able to return to
school at Berkshire Country Day in Lenox, and is being home-tutored
for two hours a day by the New Lebanon Central School District.
"I'm really tired," she said on a recent rainy afternoon. "There's no oomph."
Because of the difficulty of Victoria's case, the Lehtonens have found
themselves in the middle of a controversy about the proper diagnosis
and treatment of Lyme, an infectious disease transmitted by ticks that
feed on deer and small rodents.
Difficult to sort out'
Disagreements about the effectiveness of tests for Lyme disease and
the existence of chronic Lyme have calcified into two camps that often
are bitterly opposed.
On one side is the Infectious Disease Society of America (IDSA), a
group that puts out Lyme treatment guidelines widely referred to by
physicians. The guidelines suggest treating only in the presence of
objective symptoms and do not advise antibiotic treatment for more
than four weeks, even if symptoms persist.
On the other side are a growing number of medical professionals and
laypeople who refer to themselves as "Lyme literate" and are
associated with the International Lyme and Associated Diseases Society
ILADS has published alternative guidelines that suggest Lyme can be
diagnosed from more subjective symptoms, and that a longer course of
antibiotics may be necessary to help battle what they refer to as
Dr. Paula Aucoin, an infectious disease specialist who works at the
Berkshire Medical Group in Pittsfield, said she is an advocate of the
newest recommendations from the IDSA.
She said there is no scientific evidence that ongoing symptoms after a
maximum of four weeks of antibiotics are attributable to Lyme disease,
of which the number of reported cases in Berkshire County has more
than doubled since 2000.
"There is a subset of patients, probably a lot smaller subset than
you'd get from reading literature, that have longstanding symptoms
that are probably not due to Lyme disease," she said. "But it can be
very difficult to sort out how much Lyme is contributing, and how much
[it's] chronic fatigue or post-infection."
To patients with long-term symptoms that have no other discernible
source, Aucoin recommends pursuing treatment for improving the
symptoms. For example, if a patient suffers from chronic insomnia,
there are medications that can help alleviate trouble sleeping.
Aucoin said a diagnosis of "chronic fatigue" or "post-infection" can
be disheartening, but she said she doesn't believe there is a "chronic
Lyme" or that a prescription for long-term antibiotics is helpful.
"It would be a lot simpler to give 12 months of antibiotics, but I
don't think that's effective," she said.
Aucoin said she has seen significant toxicity and infection from
long-term access catheters that administer the antibiotic --
Doxycycline, for instance -- as well as side effects from the
antibiotics themselves. There also is a concern for the development of
Some patients improve, but some, uncommonly, become chronically
disabled, she said. "And that's why people look hard for alternatives,
and why people are drawn to Lyme disease specialists who feel very
strongly that they're offering benefit."
Seeking outside help
The Lehtonens said they could not find a doctor in Columbia or
Berkshire counties who would treat Victoria for Lyme based on the
ILADS guidelines, which say the disease can be diagnosed clinically
instead of by a set of objective symptoms.
Aware that Lyme left untreated can result in more severe symptoms,
Karla made an appointment with Dr. Kenneth Liegner, a Lyme specialist
in Westchester County, N.Y.
Liegner, an internist, has fought for Lyme disease treatment reform
since the early 1990s and has called the IDSA's standard of care
"When I first started treating, I treated by the book, but it became
very clear those regiments weren't working," Liegner said. "It was a
gradual process from observing my patients that it began to dawn on me
that the treatment we were giving wasn't treating the infection."
Liegner said he treats many patients like Victoria, who come to him
after being refused treatment by other doctors.
Like some other high-profile doctors who treat for chronic Lyme,
Liegner has come under criticism for his practices; in 2000 the New
York Office of Professional Medical Conduct initiated an investigation
of him and other doctors for their treatment practices, but no action
"This has not been a field for the faint of heart," Liegner said. "But
on the other hand, it's very rewarding and gratifying to help these
people who have no place to turn."
The climate of the Lyme debate has begun to shift in the Northeast and
elsewhere. Legal action against "Lyme literate" doctors such as
Liegner has come under fire, resulting in laws protecting their right
to treat patients via the alternative guidelines.
Gov. Deval Patrick recently signed into law a protection for
Massachusetts doctors to treat Lyme disease with antibiotics for
longer than the four weeks recommended by the IDSA. California,
Connecticut and Rhode Island all have recently passed similar laws.
The Massachusetts legislation, which went into effect July 1, allows
doctors to diagnose Lyme when it presents "other acute and chronic
signs of symptoms of Lyme disease as determined by the treating
physician," even if the illness doesn't present itself along the
criteria of the national Centers for Disease Control and Prevention.
This new legislation comes at a time when Massachusetts is seeing an
increase in the disease. Statewide, there were more than three times
as many cases reported in 2009 than in 2000, according to the
Massachusetts Department of Public Health. Lyme disease cases in
Berkshire County rose from 51 in 2000 to 105 in 2009.
In Columbia County, N.Y., an area known for its high incidence of the
disease, numbers are on the downturn, although still high. A total of
357 cases were reported in 2009, compared with 595 in 2000.
In Columbia County, N.Y., an area known for its high incidence of the
disease, numbers are on the downturn, although still high. A total of
357 cases were reported in 2009, compared with 595 in 2000.
Columbia County's population is about half of Berkshire County's, and
some have attributed the high rate of Lyme to a large deer population.
57 pills a day
While health officials in Columbia County are happy about the lower
incidence of Lyme, Victoria Lehtonen doesn't get to share in the good
news -- she's bored with only being able to play computer games and
Simply put, she's tired of being tired.
Victoria is now seeing a doctor in Florida who studies Bartonella and
Babesiosis, lesser-known infections related to Lyme disease.
Victoria takes 57 pills a day, including numerous supplements, Chinese
herbals, antimalarials, antibiotics and probiotics.
"She's on higher doses of almost every supplement," Karla said.
"Normally she'd be taking a Flintstone."
But things are getting better. Victoria now lives in a way that was
out of the question a year ago. She can hang out with friends or go to
salsa lessons, even if she can dance for only 15 minutes before
feeling so worn down that she has to quit.
And as the medical community works through how to solve cases such as
hers, she's also waiting.
"I just want them to figure it out," she said. "I want it to just go away."
To reach Amanda Korman:
Lyme is the most common tick-borne illness in North America and
Europe. The disease derives its name from Lyme, Conn., where the full
spectrum of the illness was first described in 1975.
There are significant disagreements about the diagnosis and treatment
of Lyme disease:
Infectious Disease Society of America (IDSA): "The great majority" of
people with Lyme develop a bull's-eye rash.
International Lyme and Associated Diseases Society (ILADS): Fewer than
50 percent of people with Lyme will recall a rash.
IDSA: 95 percent of people treated early with 10 to 28 days of oral
antibiotics are cured.
ILADS: There is more than a 40 percent relapse rate in patients
treated with a short course of antibiotics.
IDSA: People who continue to have symptoms after the short course of
Never had Lyme.
Had another infection simultaneously and were treated only for Lyme.
Have contracted a new illness unrelated to but with similar symptoms to Lyme.
Have again been bitten by a tick carrying Lyme.
ILADS: Persistent symptoms likely are caused by an ongoing Lyme infection.
IDSA: Long-term antibiotic therapy may be dangerous.
ILADS: The consequences of untreated chronic Lyme outweigh potential
consequences of long-term antibiotic therapy.
Sources: IDSA, ILADS, Mayo Clinic