Saturday, December 15, 2012

Ampligen Meeting 12/20/12 in Maryland

Subject: [CFSupport] Ampligen Meeting in Silver Spring 12/20/12
To: "NOVA CFS/ME, FMS, OI & Gratitude Support Groups" <cfsupport@yahoogroups.com>

Here are two notes we are passing through our list about a DC area event next week pertaining to CFS treatment. At this time, we do not know of anyone in our group who is planning to or able to attend. If interested, please write to the senders Robert Miller or Mary Dimmock for further information or to let them know of your support. Robert can also be reached through his FB page. He has posted to our FB wall so you can find the link to his page at

-Elly


1)

Dear CFS-NOVA,
I am Robert Miller a long time ME/CFS and FM patient & advocate. Next Thursday Dec. 20th, at FDA White Oak campus in Silver Spring, MD, History will be made. A medication will be reviewed by an expert panel for the treatment of ME/CFS. We would like to have as many patients attend as possible. No registration is necessary. I have listed the details below with a link to the FDA website that has the announcement. I would ask that you post on your website or contact your patient community with this invitation.
You can use my contact email 511bobmiller42@gmail.com for anyone who has questions. We have patients coming from across the U.S. to give public testimony. Your support would be greatly appreciated. I have hundreds of patient testimonies to present. If you have patients and/or family who would like to send in their testimony, they can email it to me at the above email address and I will present it with my testimony. I will also post a template email below so patients and/or family can use it as a guide.
Thank you,
Robert Miller
URGENT: December 20, 2012: Arthritis Advisory Committee Meeting Announcement

FDA Agenda

The Advisory committee will discuss new drug application (NDA) 22151, rintatolimod injection (proposed trade name AMPLIGEN) submitted by Hemispherx Biopharma, Inc. for the treatment of patients with chronic fatigue syndrome.

To All ME/CFS and FM Patients living in the DC, Maryland and Northern Virginia area and beyond. On Thursday, Dec. 20th, from 8:00 a.m. to 5:00 p.m.The FDA Advisory Panel will be Meeting to review a drug (Ampligen) for the treatment of CFS/ME.
This will be the "First" drug ever reviewed by an advisory committee for the treatment of CFS/ME. Your presence at this meeting is invaluable. Patients (some are Ampligen some are not) are flying in from across the U.S. to give testimony at a great cost (not speaking of finance). As patients, you understand how limited and valuable our time is with family, many of these patients are dedicating their Holiday family time to this meeting.
We Need Your Support at this meeting. You "do not" have to register to attend, just bring photo I.D. Come and show the advisory committee and the FDA that we need and deserve treatments. Show them that this disease is serious and life threatening to us all. Your attending will speak Volumes. Ampligen approval will legitimize CFS/ME in the minds of the Medical Community. This potential approval is a Game Changer for all ME/CFS Patients. Please come and be a part of ME/CFS history with your "A C T I O N". Link for location and time below. For those with limited ability to attend, you can come at Noon, prior to Public comment and stay as long as you can. The committee will vote at the end of the meeting at 5:00 pm

Info FDA Website: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm
Send To: Email address: 511bobmiller42@gmail.com
Subject line: Ampligen-Treatment for Chronic Fatigue Syndrome CFS/ME

To The Advisory Committee Reviewing Ampligen:
My name is _____________, I have had CFS for more than ___ years. Before I became ill I had a life that was____ your story here__. My life since having CFS has been __your story here_.
After 3 decades, We Need treatment. We deserve treatment and the ability to access it. Just like AZT for AIDS, Chemo for Cancer, Tysarbri for MS or Benlysta for Lupus. We are not second class patients. Reality of CFS, it is Serious and Life Threatening. According to CDC studies, CFS is comparable to MS, AIDS, Lupus, Rheumatoid Arthritis, Heart Disease, Renal Failure, COPD and Chemotherapy. CFS/ME effects every moment of my life. We've seen and heard of patients responding to Ampligen. Give patients Hope by approving Ampligen. We want our lives back.
Thank you,
Full Name
Address Here
Thank you all,
Robert Miller ME/CFS-FM patient/advocate

———————————————————

2)

Hi

My name is Mary Dimmock and I am part of a group that is trying to insure that we have adequate patient representation at the FDA advisory meeting to consider Ampligen. The meeting is on Dec 20 and is in Silver Spring, Maryland.

Given that some of your members may not be far from that facility, we wanted to check and see if you know of any patients that will be there and if you havent already, if you would be able to provide information to them. If you haven't already but are willing to send out information, the following may be useful.

Thank you in advance. I appreciate it
Mary
  • What: Ampligen is being presented in front of the Arthritis Advisory Committee which is a result of consolidating the review of all drugs for ME/CFS under one division, the division of Division of Pulmonary, Allergy and Rheumatology Products. Additional information can be found here: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm
  • When: Dec 20, 2012 from 8:00 am to 5:00 pm
  • Where: FDA White Oak Campus, Building 31, Great Room (Rm. 1503), White Oak Conference Center, 10903 New Hampshire Avenue Silver, Spring, Maryland
  • Getting there: The Metro 'Red Line' goes to Silver Springs. From there, you need to take a bus or a 20 minute taxi to the FDA campus. There is also a bus that operates in the morning til about 9:00 but you will need to walk up a hill to get to it. Further details can be found here
Mary Dimmock < maryedimmock@yahoo.com >

———————————————————

Friday, December 14, 2012

How normal fatigue differs from CFS

Note: The article below is the corrected version of an earlier one. After
an activist alerted Dr. Jason to errors in the story, he contacted the
reporter and together they worked to correct the mistakes. The article
erroneously stated among other things that "Sleepiness can turn into
chronic fatigue syndrome." Dr. Jason did not say that. The error was
inadvertently introduced during the editing phase.

Please note that from time to time in any article on any subject there can
be errors introduced by an editor who is working on deadline to strengthen,
clarify and potentially shorten an article. Errors are not intentional and
in most cases publications are more than happy to work with a source to fix
such errors. ( This is not the same thing as a source being correctly
quoted, but the reader disagrees with the statements made by the source.)

*
*

*Prevention News*
How Normal Fatigue Differs From Chronic Fatigue Syndrome How Tired Is Too
Tired?

What your fatigue could really mean

by Markham Heid
<http://www.prevention.com/health/sleep-energy/how-normal-fatigue-differs-chronic-fatigue-syndrome#ixzz2F3cqLWQG>

If you're like a lot of people, the last time you hopped out of bed with a
spring in your step was Christmas morning when you were five—and you were
probably tired then, too. Whether it's your nutty schedule, a cat who won't
let you sleep for more than five consecutive minutes, or plain old stress,
it's usually pretty easy to see why you're dragging. Except when it's not:
New research warns that feeling fatigued too often can be a sign of some
eye-opening problems.

Chronic fatigue syndrome (CFS) is a mysterious condition characterized by
ongoing feelings of sleepiness that aren't alleviated with more rest, and
don't seem linked to other health problems. And while researchers have yet
to nail down the cause of CFS, a new study, published in the *Journal of Psychotherapy and Psychosomatics*, suggests that chronic inflammation might actually be behind the problem.

So how can you figure out whether your tiredness is CFS? Keep tabs on how
often you suffer from daytime lulls, says CFS expert Leonard Jason, PhD,
director of the Center for Community Research at DePaul University. Fatigue
for short periods of time is normal, whereas fatigue that lasts for days or
weeks is not.

"If you take a vacation from work, or spend a weekend catching up on sleep,
you should feel better," he says. If that doesn't help, then the issue may
be more serious, he says.

Read more:
http://www.prevention.com/health/sleep-energy/how-normal-fatigue-differs-chronic-fatigue-syndrome#ixzz2F3cbAUVb

PACE and the 27 Signatories

PACE and the 27 Signatories

Susanna Agardy

To The Independent

Re: Letter concerning Chronic Fatigue Syndrome/ME by Dr Esther Crawley et al, 2 December 2012
http://www.independent.co.uk/voices/letters/ios-letters-emails--online-postings-2-december-2012-8373777.html


I refer to the above letter in defence of Prof. Wessely. Its contents
should be seen in the context of Prof. Wessely's central role in the PACE
trial and its promotion, and his recent media offensive against ME/CFS
patients. Patients are not trying to discourage specialist clinicians from
entering the field, particularly ones with appropriate qualifications. They
just don't want inappropriate treatment forced on them. The PACE study
warrants careful examination.

Regardless of how many psychiatrists and other medical professionals sign a
letter to newspapers, the fact remains that about 70% of participants in
PACE did not reach 'normal' results
, even by the convoluted definition of
'normal' in the study. The study does not report a single participant returning to their pre-illness lives (unless this information still awaits publication). Why would ME/CFS patients clamour for a treatment based on
such a study? Besides, they already know that their condition is not
amenable to the proposed treatment
by Cognitive Behaviour Therapy
(CBT) and Graded Exercise Therapy (GET).

Amid the celebration of some 'moderate' improvement in the 30% of
participants and the promotion of PACE as a treatment, the 70% have been
forgotten. (I use the term ME/CFS because at least 51% of participants
reportedly had post-exertional malaise, the major symptom of ME. This
indicates that the intended use of the Oxford Criteria failed because it
did not exclude conditions which do not form part of the definition.)

In the discussions about PACE we do not hear much about the results of the
6 minute walking test, the only objective measure of physical ability in
this trial. The best average results for this test were 379 metres for the
GET group, up by 67 metres and 354 metres for CBT, up by 21 metres. By
definition, some patients would have produced worse results. At the start
of the trial these participants were assumed to be merely deconditioned due
to fear and activity avoidance. They had an average age of 38 years and
received encouragement and training for one year at the average cost of
about £7,800 per head. While those in the GET and CBT conditions fared
better compared with the other study conditions, the big picture is that
they achieved a poor training effect which is well surpassed by patients
with diseases recognised as serious.

The PACE patients' walking distance was less than 400 metres, worse than that of patients awaiting organ transplantation. In a study of patients
with pulmonary disorder (including those needing supplemental oxygen) the 6
minute walking distance was, on average, 60 metres more than that achieved
by participants in the GET treatment in the PACE trial. A distance of 518
metres has been considered abnormally low for healthy elderly people
.
Moreover, there is no report of any assessment of the possibly delayed after-effect
of the walking test in PACE, a most important measurement of ability in
people with ME. How is it that the poor results have been overlooked by
all the medical professionals defending the PACE trial?

Aren't the signatories and other defenders of PACE curious to know why
there was not greater improvement found in the trial? Don't they want to
know what factors held back the performance of these participants?

The hypothesis of PACE was that patients become deconditioned due to fear
avoidance
and unhelpful cognitions. The consequent exercise avoidance leads
to physiological changes. This theory incorporates several assumptions.
Firstly, it is assumed that ME/CFS patients harbour a fear of activity
which is irrational. This is merely a preferred interpretation which is an
alternative to accepting that patients are responding in a responsible way
to their physiological needs. They know from experience the symptoms
instigated by what is for them excessive activity.
Secondly, there is an
assumption of a causal connection between any such hypothesized fear and
lowered activity and the resulting unspecified 'physiological changes'
which are assumed to occur through some unspecified mechanism. The
physiological changes are also assumed to follow, rather than precede, due
to some other cause, the stated psychological reaction. Thirdly, it is
assumed that there is no organic problem worth worrying about, nothing that
some CBT/GET can't fix. There is a significant body of biomedical evidence
to contradict this, showing numerous physical abnormalities in ME/CFS.
This
evidence is never acknowledged by the supporters of PACE.

As if this number of untested assumptions weren't enough it is then assumed
in the PACE trial that these changes are reversible. There is no evidence
in the report that any participant's condition was reversed.

Either the diagnosis of fear avoidance and deconditioning etc. is wrong, or
the treatment is inappropriate.
The authors only contemplate the latter
possibility. They stop short of contemplating the possibility that the
diagnosis is wrong at least for some sections of the sample and that their
model has failed for them at least. They say: 'The effectiveness of
behavioural treatments does not imply that the condition is psychological
in nature.' What is it then?

It is staring us in the face but remains unsaid by the investigators that
ME/CFS might indeed have a strong biological basis which prevents better
performance in the tests used here and that the 'physiological changes'
attributed to deconditioning/fear avoidance, etc. ought to be explored by
appropriate laboratory investigations.

Here is a suggestion: the worst-performing group in the 6 minute walking
test of the PACE study should be invited to participate in a biomedical
study investigating physiological factors which might be at work in their
poor performance. They could be compared with the best-performing group as
well as with healthy controls. Biomedical research into ME/CFS has already
discovered physiological processes relevant to physical and mental
performance. These findings are never mentioned by the authors.
This could
be an elegant follow-up project.

Yes, this would mean turning to the biomedical model for assistance, so far
not countenanced by the authors. It would also mean turning away from the
biopsychosocial model as it is currently applied, with the dominance of the
'psychosocial'. But, evidence has failed to support the paradigm favoured
by the authors. In accordance with good scientific principles it would be
appropriate to discard this paradigm and try another, the biomedical one,
which shows promise. Why cling stridently to the wreckage of a failed
paradigm? This shift could also be seen as a rebalancing of the
biopsychosocial paradigm by restoring the 'bio' to it. The psychosocial
needs of patients can still be cared for in accordance with the ideals of
the model.

Susanna Agardy
Australia

Thursday, December 13, 2012

SSD issue on Huffington Post and Psychology Today

From Suzy Chapman for http://dxrevisionwatch.com

December 12, 2012


Considered comments welcomed on both sites (both are moderated) but if reading or posting comment on Huff Po, please also click on the Psychology Today blog and leave a comment there, too, if you can, as Dr Frances wants to demonstrate, via numbers of PT post hits, the level of interest in this issue. We'd like to make it over 6000 hits by the end of today.



Huffington Post blogs


http://www.huffingtonpost.com/allen-frances/mislabeling-medical-illne_b_2265198.html

Allen Frances
Professor Emeritus, Duke University


"Mislabeling Medical Illness As Mental Disorder: The Eleventh DSM-5 Mistake"

Posted: 12/11/2012 6:00 pm


Also on Psychology Today at:

http://www.psychologytoday.com/blog/dsm5-in-distress/201212/mislabeling-medical-illness-mental-disorder


--------------------


Response at:

http://www.madinamerica.com/

Featured Blogs

http://www.madinamerica.com/2012/12/the-dsm-5-anachronistic-before-its-time-boycott-the-dsm-5/

"Boycott The DSM-5: Anachronistic Before Its Time"

Jack Carney, DSW | December 10, 2012

When plans for the DSM-5 were first announced about ten years ago, most folks' reaction was "Why?". Many of us asked that same question several times as the publication date for the new tome kept on getting pushed back. Finally, the curtain enshrouding the DSM-5 Task Force and its several committees began to part and proposed revisions/additions began to appear on its website. To our dismay, we found our question answered.



Suzy Chapman
_____________________

me.agenda@virgin.net
http://dxrevisionwatch.com
http://twitter.com/dxrevisionwatch
http://meagenda.wordpress.com
http://www.facebook.com/MEagenda

Next letter from Countess of Mar to Wessely

Permission to repost

http://www.meactionuk.org.uk/Lady-Mar-to-Simon-Wessely-12th-Dec-2012.htm

http://www.meactionuk.org.uk/Lady-Mar-to-Simon-Wessely-12th-Dec-2012.pdf

From: MAR, Countess

Sent: 12 December 2012 10:36

To: 'Wessely, Simon'

Subject: My letter of 5 December 2012
http://www.meactionuk.org.uk/Lady-Mar-to-Simon-Wessely.htm

Dear Professor Wessely

I am sure you will appreciate the importance of my letter of 5 December
2012. Please will you answer the central question: do you still believe that
ME/CFS is "perpetuated predominantly by dysfunctional beliefs and coping
behaviours"?

The rancour that persists seems to result from the incompatible and,
seemingly, irreconcilable views about why patients with ME/CFS continue to
experience exercise intolerance, fatigue, pain and other incapacitating
symptoms for long periods following a viral infection or other environmental
exposure.

The psychological model, which you first proposed, argues that these
symptoms result predominantly from physical deconditioning secondary to fear of activity. Almost without exception, this model is not consistent with the experience of patients with a diagnosis of CFS/ME; nor is it consistent with the data from the FINE and PACE trials, as well as a significant bio-medical evidence base, which all suggest that the patients are correct.

It is my hope that we can find a way out of the current impasse; that we
clarify where we agree and disagree, and that we find the means to advance
the science of ME/CFS to the benefit of millions of patients worldwide who
are now living their lives in the shadows of despair.

I look forward to hearing from you soon.

Yours sincerely

Mar

-----------------------------
http://www.meactionuk.org.uk/
-----------------------------
* * *
 
That's certainly my experience.  When I relapsed this time, I went from being able to walk 2 miles to work to needing to take the bus to being so exhausted after walking 2 blocks from the bus stop that I had to rest for an hour before doing any work, all in a matter of weeks.
 
When I brought it up to a doctor -- regretfully not my own -- he confirmed that it is impossible for a healthy human to decondition that rapidly.
 
My own doctor avoided the deconditioning argument and instead went for "you're just depressed, you can do more than you think you can" while ignoring that I was still thinking like a healthy person and thought I could do a lot more than my body would allow me to do.
 
 

Monday, December 10, 2012

Free books

Erica Verrillo has left a new comment on your post "Mislabeling Medical Illness As Mental Disorder | P...":

You have a great blog! It may interest you to know that "hysterical paralysis," that mainstay of the Victorian era, is now called MS.

I'm giving the CFS/ME community a Christmas present. It's the second edition of CFS: A Treatment Guide. (The first edition was published by St. Martin's Press in 1998.) It has now been updated and I am giving it away. (It's perfectly legit. I own it, so I can give it away for free.)

If you can, please post this. I'd like as many people with CFS/ME as possible to have a healthier 2013.

On December 22nd and December 23rd 2012, Amazon.com will be giving away free copies of Chronic Fatigue Syndrome: A Treatment Guide, 2nd Edition. Dr. Charles Lapp calls this "the book every patient should have." The book includes over 100 effective treatments, spanning the full range of pharmaceutical and complementary modalities, an in-depth discussion of symptoms with cross-referencing to appropriate treatments, the latest research into the causes and mechanisms of the illness, doctors' protocols, coping techniques, special sections for managing chemical sensitivities, dietary restrictions and the special needs of children, as well as extensive appendices covering resources, locations of doctors and clinics, local, national and international organizations, and internet ordering information. The book also features over 2600 useful links to further reading, research articles, and patient reviews. Don't miss out on this opportunity!

For more information go to: http://www.cfstreatmentguide.com.
Blog: http://cfstreatment.blogspot.com/

Finally, One Link Established: Chronic Fatigue Syndrome (CFS), Lupus


 
"

Does HPA Affect Fibromyalgia And Chronic Fatigue Syndrome?


Abnormal levels of certain chemicals regulated in the HPA axis area of the brain system, have been proposed as a cause of Chronic Fatigue Syndrome and also have some influence in Fibromyalgia. This system controls important functions, including sleep, stress response, and depression. Of particular interest to researchers, are the chemicals and other factors listed below that are controlled by the HPA axis.
The HPA axis is involved in the neurobiology of mood disorders and functional illnesses, including anxiety disorder, bipolar disorder, insomnia, post-traumatic stress disorder, borderline personality disorder, ADHD, major depressive disorder, burnout, chronic fatigue syndrome, fibromyalgia, irritable bowel syndrome, and alcoholism. Antidepressants, which are routinely prescribed for many of these illnesses, serve to regulate HPA axis function. All of these conditions and their symptoms are commonly seen in Chronic Lyme disease patients that contain a host of infections and neurotoxins that block serotonin receptors in the brain.

The theory for Chronic Fatigue Syndrome having a viral cause is not based on hard evidence, rather, on an ever-growing series of observations that suggest this association:
Chronic Fatigue Syndrome as well as Fibromyalgia and Autoimmune disease patients are often found with elevated levels of antibodies to many organisms that cause fatigue and other Chronic Fatigue Syndrome symptoms. Such organisms include those that cause Lyme disease, Candida (“yeast infection”), herpes virus type 6 (HHV-6), human T cell lymph tropic virus (HTLV), Epstein-Barr, measles, coxsackie B, cytomegalovirus, or parvovirus.
Many of these infectious agents are very common; however, none have emerged as a definitive cause of CFS. Well-designed studies of patients who met strict criteria for CFS without any known cause have not found an increased incidence of any specific infection(s).
In up to 80% of cases, CFS starts suddenly with a flu-like condition. In the U.S., there have been reports of cluster outbreaks of CFS occurring within the same household, workplace, and community (but most have not been confirmed by the Centers for Disease Control and Prevention). However, most cases of CFS occur sporadically in individuals, and do not appear to be contagious. These all have the pattern of infections and more importantly, complexes of infections taking over the patient’s immune system, which is clearly seen in the depressed CD57 markers found in almost all of this population.

Sunday, December 9, 2012

Mislabeling Medical Illness As Mental Disorder | Psychology Today

 
A MUST READ: "Do we really want to burden and stigmatize seriously ill people with an additional diagnosis of mental illness, just because they are worried about being sick and are vigilant about their symptoms? Might patients with life threatening diseases become reluctant to report new symptoms that might be early indicators of recurrence, metastasis or secondary disease – for fear of attracting a diagnosis of 'SSD'?"