From Tom Kindlon on Co-Cure
PANDORA Org submitted two written comments to the IOM committee for
the first public meeting. The Needs of the Severely Ill has pictures
to show how people suffer with this illness and asks for provisions.
Needs of the Severely Ill: http://bit.ly/1dXFxFd
Critique of the NICE Guidelines (2007): http://bit.ly/1flSfKL
1. Needs of the Severely Ill: http://bit.ly/1dXFxFd
Lori Chapo-Kroger, RN
President & CEO
January 22, 2014
To:Institute of Medicine Committee on Diagnostic Criteria for ME/CFS
Re: Important points to remember during thestudy Needs of Severely Ill in Creating a Diagnostic Criteriafor ME/CFSAs you consider creating or confirming a diagnostic criteria for myalgic encephalomyelitis /chronic fatigue syndrome, we want you to give consideration to the severely ill. Often these individuals are housebound or bedbound and thus invisible to the public’s eye. If they do make a doctor’s appointment, the doctor doesn’t see the suffering they experience on other days.
A 2009 study in the United Kingdom showed that approximately 25% of ME/CFS
patients are largely housebound or bedbound. That study was conducted by
Buckinghamshire New University and National ME Observatory and their conclusion
seems to hold true in other countries.
(2 photos of Ben DePasquale)
Ben DePasquale, before and after. Second photo is him at age 22, when a WHAM 13 news report that said:“Ben is almost completely bedridden. On a good day, he can take a few steps with a cane. At 6’2”, he’s down to 118 pounds. He need others to wash his hair and cut his food. In 2010, he left the house just twice."
(two photos of Laurie Bertrand)
Laurel Bertrand, before and after. Second photo is her video testimony to the Chronic
Fatigue Syndrome Advisory Committee in 2009. She can only speak in a whisper. She
only takes sponge baths.
(Photo of Amberlin Wu)
Amberlin Wu in her mid-30's, undergoing experimental treatments in a hospital in 2010.
For months she had been unable to stand without falling, and then she developed shingles.
The treatment caused headache, nausea and an exacerbation of light and sound sensitivity.
But she did it because she was grasping at any hope. She died within 2 years.
(Photo of Stephen Pagenetti)
Stephen Pagenetti at about age 18 was featured in the movie "I Remember ME." The
narrator said "He hadn't been able to sit up, stand without passing out, or even eat on
his own for two years.
The only way Stephen was able to attend his high school graduation was in a hospital bed
and being transported and monitored by paramedics.
(two photos of Mike Dessin)
Mike Dessin after his recovery when he was severely ill. At his worst, Mike had
pancreatitis, could only lift his head a few inches, weighed 102 pounds at a height
of 6'3", heart failure and a collapsed lung. He had to stay in a pitch black room and
any touch was too much stimulation. He was diagnosed with chronic fatigue syndrome
as the cause.
We show you these images and tell of their condition so you know there are different
levels of disability in ME/CFS that are not identified in most of the existing definitions.
Some other diseases have stages or levels that inform the physician of appropriate
treatments. This is needed in this disease.
Mike Dessin after his recovery and when he was severely ill. At his worst, Mike had pancreatitis, could only lift his head a few inches, weighed 102 pounds at a height of 6’3”, heart failure and a collapsed lung. He had to stay in a pitch black room and any touch was too much stimulation. He was diagnosed with chronic fatigue syndrome as the cause.We show you these images and tell of their condition so you know there are differing levels of disability in ME/CFS that are not identified in most of the existing definitions. Some other diseaseshave stages or levels that inform the clinician of appropriate treatments. This is needed in this disease.
A way to identify the severely ill is important so the physician knows what tests can be tolerated. The 2-day cardio pulmonary exercise test is becoming known for its ability to objectively measure the post-exertional neuro-immune exhaustion that is a hallmark of this disease. However, for the severely ill, this test may not be appropriate because they would not be able to complete the test, especially two days in a row. This does not mean they don’t have post-exertional neuro-immune exhaustion. But in their case,
Just brushing their teeth may bring days of relapse. An objective test that does not require the severely ill to do activity that will bring them harm would be ideal.
Additionally, a way to measure the level of severity is important to knowing how much and what type of activity a person should do. “A subset of people with CFS are so severely ill that they're largely housebound or bedbound. They require special attention, including a modified approach to exercise. Hand stretches and picking up and grasping objects may be all that can be managed at first,” says the Centers for Disease Control Preventionin reference to activity level for the severely ill. A more moderately ill person may need to do 30 minutes of housework a day. A more mild case might be recommended to work part time with some accommodations. A way to identify those in different levels will ensure they are given the correct activity recommendation for their case.
It’s hard to imaginesomeone who is bedbound and unable to feed themselves for days at a time must struggle to get disability benefits. But this does happen with this disease. This is because of misperceptions of the nature of the disease that the name causes and physician lack of knowledge. It’s also due to the relapsing and remitting nature, “push –crash,” experience so that occasionally a person looks well, even though they may end up in a relapse for days or weeks just from one outing. It’s also because the severely ill are largely invisible to the public, even doctors.Identifying those severely ill will not only help educate physicians, but it gives a basis for those severely ill to more quickly receive disability benefits, which is needed not only for income but continued health insurance.
How it’s done in other diseases:For precedent, you might consider these examples: ·
Acute leukemia and chronic leukemia·
Cancers with or without distant metastases or inoperable, unresectable or recurrent·
Breast cancer either inflammatory or not·
Alzheimer’s either early onset or not·
Multiple sclerosis either malignant or relapsing-remitting, primary-progressive, secondary-progressive or progressive-relapsing
Most of these have objective measures, such as the level of blood markers, extentof damage in the body or likelihood of improvement or rate of progression.
What We Recommend:
Ideally we think three or more levels or stages of the disease should be developed and included in the diagnostic criteria. Ideally, an objective measure of these levels should be identified and included in the criteria.
/s/ Lori Chapo Kroger
Lori Chapo-Kroger, RN
President and CEO of PANDORA Org
firstname.lastname@example.org 2. Critique of the NICE Guidlines (2007)
January 22, 2014 Critique of NICE Guidelines (2007):
The reason these United Kingdom Health Service guidelines are flawed and harmful is because they are based on outdated and flawed research and flawed interpretation of research results.NICE Guidelines Include Harmful Treatment Recommendations
NICE Guidelines 2007 states that cognitive behavioral therapy and/or graded exercise therapy should be offered to people with mild or moderate ME/CFS and provided to those who choose thee approaches. It says these are the interventions for which there is the clearet research evidence of benefit.
This is an inaccurate statement as graded exercise, the type that includes pushing beyond fatigue, has been shown to not be beneficial. It is actually harmful. This is revealed in a report conducted by International Association of CFS/ME (IACFS/ME) where the reporting of harms associated with graded exercise therapy an cognitive behavioural therapy in these patients is found to be lacking in the research conducted and highlights that healthcare professionals, researchers and patients need high quality data on harms to appropriately assess the risks versus benefits of CBT and GET. 1 http://www.iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk%3D&
Additionally, the Centers for Disease Control and Prevention recommends pacing activity and cutting back on activity if the activity level exacerbates symptoms. In some cases, this might mean only stretching in a supine position an small increments of body weight (legs and arms) lifts for strength. Someone more able can do more activity. But pushing is discouraged as being harmful.
Moreover, the subjective research upon which NICE relies on to support the view of graded exercise does not take into account the most recent biological research findings that ME/CFS patients have:·
Oxidative stress 2·
Muscle fibre abnormalities and muscle damage 3·
Oxygen transportation impairment·
Circulatory and cardiac abnormalities 5·
Moreover, NICE guidelines continue to be predominantly influenced by subjective psychological research conducted by the same individuals who have a hand in developing the guidelines in the first place.
The 2011 Pacing, graded Activity an Cognitive behavior therapy: a randomized Evaluation (PACE) Trial in England, led by psychiatrists, that was a randomized controlled trial that compared cognitive behavior therapy (CBT), graded exercise therapy (GET), adaptive pacing therapy an specialized ecdical care. Its flawed results have been touted as confirming the NICE guidelines for this disease, whereas it does not. The PACE trial once again focused on subjective responses of patients and is heavily influenced by a behavior-focused erroneous paradigm.
The paper was found to omit the reporting of harms as identified by the IACFS/ME 6. Furthermore, conflicting results by similar larger scale research conducted by the ME Associaton at the same time as the PACE Trial is not considered in the formation or modification of NICE guidelines. Pacing is rated very strongly as the most effective form of management and is consistent with several other surveys of patient opinion and a large amount of anecdotal reports, incuding an ME association 2010 survey. 7·
Results for CBT: 25% improved; 55% reported no change; 20% made worse (sample size=2137)·
Results for GET: 22% improved; 21 reported no change; 57% made worse (sample size=997)·
Results for pacing: 71% improved; 24% no change; 5% made worse (sample size=906)
A similar study to the PACE trial, which was carried out in Spain and published in January 2011, found no benefits from CBT and GET when compared to standard medical care. 8
Contrary to the assumptions of many, physical deconditioning does not seem to be a perpetuating factor in CFS. 9
The NICE guidelines fails to take into considering the conflicting research findings on GET and CBT and pacing, as well as biological research findings into the benefit and harms of exercise. Guidelines shoud not be based on just subjective research alone conducted by the same individuals that have a hand in creating the guidelines.
Lastly, the ME Association identifies that the form of adaptive pacing used in the PACE trial is not the same as the model they recommend and which is favoured by the overwhelming majority of people with ME/CFS. 10 Clarification of what pacing, gradual activity and, graded exercise actually specifies to needs clarification for both research and clinical recommendation.
NICE Guidelines Harm
Because its foundation is outdated, flawed limited research, the NICE guidelines on ME/CFS fail to educate physicians on the true nature of the disease. It fails to confirm the multi-system dysfunctions and the appropriate World Health Organization classification of the disease as neurological, which is supported by preponderance of research evidence. 11
By not addressing what the disease is biologically, the NICE guidelines perpetuate the erroneous idea that the disease is a group of “medically unexplained symptoms,” which clinicians assume means it is psychological. Of course, this is contrary to the ample biological research in the last 20 years.
Patients are time an time again not treated with respect and understanding of the biology, severity and impact of their symptoms by neurologists and general practitioners who operate within the NICE guidelines.
Additionally, the guidelines aim of “influencing practice in the real world” is discredited by their failure to acknowledge the physiological abnormities identified by the available research. The gap between research and practice remains vast. Further investigation into patients symptoms are prevented from being investigated by NICE guidelines. In practice patients are receiving no investigation into symptoms or testing as used in research which finds abnormalities, and therefore receiving no assistants in better managing the symptoms that arise.
Nice guidelines 2007 states that referral to specialist CFS/ME care should be offered:
11 Categorised available research by abnormality. http://www.cfs-ireland.com/listing.htm
· Within 6 months of presentation to people with mild CFS/ME
· Within 3-4 months of presentation to people with moderate CFS/ME symptoms
· Immediately to people with severe CFS/ME symptoms.
This does not happen in a large majority of cases, as identified by Action for ME investigation into England’s National Health Services specialist services. 12
Similarly, the Aviva Health of the Nation Study in 2011 cited M.E/CFS as the most difficult condition for GPs to refer; exactly the same as it did in a similar report in 2003. This is hardly surprising given the admission by most PCTs that they have not complied with either the National Service Framework (NSF) for Long Term Conditions or the NICE Guidelines for ME/CFS.
While such an outline for referral to an ME/CFS specialist is good, in the U.S., no specialty has embraced the diseases leaving patients lacking expert knowledgeable care.
/s/ Lori Chapo Koger
Lori Chapo-Kroger, RN
President and CEO of PANDORA Org