Friday, June 7, 2013

Thursday, June 6, 2013

FDA Drug Development Meeting Transcripts and Summary

Note: All of the following and more are located on the following page-

Transcript: Thursday, April 25, 2013 (PDF - 2MB)

Transcript: Friday, April 26, 2013 (PDF - 1.88MB)

Drug Development Meeting for Chronic Fatigue Syndrome and Myalgic
Encephalomyelitis Meeting Summary

On April 25 and 26, 2013, FDA held a public meeting with patients,
patient representatives and scientific, industry and regulatory
experts to discuss important issues regarding the development of safe
and effective drugs for the treatment of patients with chronic fatigue
syndrome (CFS) and myalgic encephalomyelitis (ME). CFS and ME are
serious conditions with no approved drug therapy currently available.
Below summarizes these two days of meetings:

Day One (April 25): This portion of the meeting focused exclusively on
gathering patients' perspective. FDA heard directly from patients
about their experiences with this debilitating condition. Discussion
focused on two key topics: 1) disease symptoms and daily impacts that
matter most to patients, and 2) the patient perspective on treatment
of this condition. Participants were also able to provide input,
through an open public comment session on additional issues with
regard to drug development.

This facilitated discussion with patients with CFS and ME provided a
particularly valuable opportunity for FDA to hear in patients' own
words about how they experience their disease. For instance, one
patient, when discussing a clinical term associated with the disease,
"post-exertional malaise," noted that she considered this aspect of
ME-CFS to be more like "post-exertional collapse," with exacerbation
of multiple disease symptoms. Many patients shared stories of having
had successful and productive lives prior to contracting CFS and ME
but now struggle with even the simplest tasks of daily life. They also
shared stories of debilitating episodes of CFS and ME that last days,
weeks, months, and even years, before abating.

Day Two (April 26): The second day expanded the discussion to include
input from the broader expert community, including health care
professionals, academics, researchers, pharmaceutical manufacturer
representatives, and FDA staff. Main discussion areas included 1) an
FDA review of the tools used by the agency to expedite the development
and approval of drug therapies for serious diseases such as CFS and
ME, 2) current treatments used to help patients with CFS and ME, 3)
challenges involved in conducting research that can help lead to the
development of effective drug therapies, and 4) creating a path
forward to achieve success in finding effective drug treatments for
patients with CFS and ME.

Among other things, this day's discussion underscored how widely
diverse each patient's symptoms of CFS and ME can be, and how these
disparities create challenges in designing useful studies that can
demonstrate the effectiveness of a medication being tested as a
potential treatment for the disease. Despite these challenges, a
number of outcome measures and trial designs exist that could be used
in clinical trials supporting drug development.

Day One was conducted in support of FDA's Patient-Focused Drug
Development initiative, an FDA commitment under the fifth
authorization of the Prescription Drug User Fee Act (PDUFA V) to more
systematically gather patients' perspective on their condition and
available therapies to treat their condition. As part of this
commitment, FDA is convening at least 20 public meetings over the next
five years, each focused on a specific disease area. Building on the
perspectives expressed on Day One, Day Two was a scientific workshop
to discuss how best to facilitate and expedite drug development for
CFS and ME.

To view a complete video of the meetings, visit A complete
transcript of the meeting will be posted at!documentDetail;D=FDA-2012-N-0962-0004.
Members of the public unable to attend either meeting can contribute
their comments via the meetings' docket:!documentDetail;D=FDA-2012-N-0962-0004
until August 2, 2013.

Cognitive Performance and CFS

Clin Rheumatol. 2013 Jun 5. [Epub ahead of print]

Cognitive performance is of clinical importance, but is unrelated to
pain severity in women with chronic fatigue syndrome.

Ickmans K, Meeus M, Kos D, Clarys P, Meersdom G, Lambrecht L, Pattyn N, Nijs J.


Pain in Motion Research Group (PIM), Department of Human Physiology,
Faculty of Physical Education and Physiotherapy, Vrije Universiteit
Brussel, Building L, Pleinlaan 2, 1050, Brussels, Belgium.


In various chronic pain populations, decreased cognitive performance
is known to be related to pain severity. Yet, this relationship has
not been investigated in patients with chronic fatigue syndrome (CFS).
This study investigated the relationship between cognitive performance
and (1) pain severity, (2) level of fatigue, and (3) self-reported
symptoms and health status in women with CFS. Examining the latter
relationships is important for clinical practice, since people with
CFS are often suspected to exaggerate their symptoms. A sample of 29
female CFS patients and 17 healthy controls aged 18 to 45 years filled
out three questionnaires (Medical Outcomes Study 36-Item Short-Form
Health Survey, Checklist Individual Strength (CIS), and CFS Symptom
List) and performed three performance-based cognitive tests
(psychomotor vigilance task, Stroop task, and operation span task),
respectively. In both groups, pain severity was not associated with
cognitive performance. In CFS patients, the level of fatigue measured
with the CFS Symptom List, but not with the CIS, was significantly
correlated with sustained attention. Self-reported mental health was
negatively correlated with all investigated cognitive domains in the
CFS group. These results provide evidence for the clinical importance
of objectively measured cognitive problems in female CFS patients.
Furthermore, a state-like measure (CFS Symptom List) appears to be
superior over a trait-like measure (CIS) in representing cognitive
fatigue in people with CFS. Finally, the lack of a significant
relationship between cognitive performance and self-reported pain
severity suggests that pain in CFS might be unique.

PMID: 23737111 [PubMed - as supplied by publisher]

Monday, June 3, 2013

The M.E. Meme

Permission to re-post in its entirety only and crediting Eddie Lewisohn as the author.

The M.E. *Meme

The meaning of M.E. is plain
It's inflammation of the brain.
So why on earth, patients insist
Would we need a psychiatrist?

A medical insurance co.
Still thought we do, and so
To add to everyone's distress
M.E. was re-named "CFS"

It was a mighty cunning scheme:
"CFS" became a meme,
And though M.E. remains a virus,
Psychiatrists can now say "Hire us!"

You'll never hear a shrink confess
The M.E. isn't "CFS".
They know they're way out of their league
But will still treat you - for "fatigue".

©Eddie Lewisohn 2013

*a meme is a meaningless phrase repeated ad nauseam.

When a Facebook friend dies -

For the many of us who have "met" good friends online who we will never meet in person....

Sunday, June 2, 2013

Sleep-specific phenotypes and CFS


BMJ Open 2013;3:e002999 doi:10.1136/bmjopen-2013-002999

Are there sleep-specific phenotypes in patients with chronic fatigue
syndrome? A cross-sectional polysomnography analysis
Zoe M Gotts1, Vincent Deary1, Julia Newton2, Donna Van der Dussen3,
Pierre De Roy3, Jason G Ellis1

1Northumbria Centre for Sleep Research, Department of Psychology,
Northumbria University, Newcastle, UK
2Institute for Ageing and Health, Newcastle University, Newcastle, UK
3Fatigue Service, VermoeidheidCentrum Nederland bv, Lelystad, The Netherlands

Correspondence to Dr Jason G Ellis;

Received 5 April 2013
Revised 24 April 2013
Accepted 25 April 2013
Published 1 June 2013


Objectives Despite sleep disturbances being a central complaint in
patients with chronic fatigue syndrome (CFS), evidence of objective
sleep abnormalities from over 30 studies is inconsistent. The present
study aimed to identify whether sleep-specific phenotypes exist in CFS
and explore objective characteristics that could differentiate
phenotypes, while also being relevant to routine clinical practice.

Design A cross-sectional, single-site study.

Setting A fatigue clinic in the Netherlands.

Participants A consecutive series of 343 patients meeting the criteria
for CFS, according to the Fukuda definition.

Measures Patients underwent a single night of polysomnography
(all-night recording of EEG, electromyography, electrooculography, ECG
and respiration) that was hand-scored by a researcher blind to
diagnosis and patient history.

Results Of the 343 patients, 104 (30.3%) were identified with a
Primary Sleep Disorder explaining their diagnosis. A hierarchical
cluster analysis on the remaining 239 patients resulted in four sleep
phenotypes being identified at saturation. Of the 239 patients, 89.1%
met quantitative criteria for at least one objective sleep problem.
one-way analysis of variance confirmed distinct sleep profiles for
each sleep phenotype. Relatively longer sleep onset latencies, longer
Rapid Eye Movement (REM) latencies and smaller percentages of both
stage 2 and REM characterised the first phenotype. The second
phenotype was characterised by more frequent arousals per hour. The
third phenotype was characterised by a longer Total Sleep Time,
shorter REM Latencies, and a higher percentage of REM and lower
percentage of wake time. The final phenotype had the shortest Total
Sleep Time and the highest percentage of wake time and wake after
sleep onset.

Conclusions The results highlight the need to routinely screen for
Primary Sleep Disorders in clinical practice and tailor sleep
interventions, based on phenotype, to patients presenting with CFS.
The results are discussed in terms of matching patients' self-reported
sleep to these phenotypes in clinical practice.
* * *
Dr. Rodger Murphree has a theory that the pattern of your sleep disturbance reveals what body chemistry needs to be changed.  It worked for me.
No one can get their heads around it why my quacks weren't sending me for a sleep study when I kept saying I wasn't sleeping.  The answer is that if they'd done that they would've had to admit there was a problem; if they didn't do a sleep study, they could continue to insist I was just exaggerating.