Saturday, April 30, 2011

Another award for our Laura!

 
Last night, "Unbroken" won the Los Angeles Times Book Prize for Biography. Yay!
www.laobserved.com
I guess the lede from Friday night's Los Angeles Times Book Prizes ceremony is that Jennifer Egan and "A Visit From the Goon Squad" won in fiction over Jonathan Franzen's "Freedom" (and three other finalists.) Egan, who also won the 2011 Pulitzer Prize, was in the house at the Times' Harry Chandler
 
* * *
I double-dare anyone to claim that Laura's "too lazy to work" or "work avoidant" or "fear of success"!  :)
 
Congrats, Laura!

Divorce and Diagnosis

 
 
If you're a woman who has recently been diagnosed with cancer or multiple sclerosis, your marriage is six times more likely to end in divorce than if your husband had been diagnosed with those diseases instead.

A study of "partner abandonment" revealed that husbands are six times more likely to leave sick wives than wives are to leave sick husbands. "Men have a much harder time being caretakers than women do," Sember observes. "Men find it hard to juggle that kind of responsibility, particularly if the wife has always been the one to fill that role." Moreover, "often women are more able to take time off from work to care for an ill spouse than men are."

MJ Glantz et al. (2009). Gender disparity in the rate of partner abandonment in patients with serious medical illness. Cancer, 115 (22).


 

Friday, April 29, 2011

Is Your Chronic Pain All in Your Head? - Pain Management Center

 

"The unfortunate fact is that this patient is far from unique. According to the National Centers for Health Statistics, more than 75 million Americans report experiencing pain — more than the number of people with diabetes, heart disease, and cancer combined."

"Patients will often get the message that the doctor can't find anything wrong, so they will just have to live with their condition," says Dr. Clarke, who is also the author of the book They Can't Find Anything Wrong!. "It is enormously frustrating for a patient with real pain not to know the cause, and they may even question their own sanity."

Disabled dating service - Dating4disabled - online community

Wanted: Fewer science nerds, more 'culturally competent' doctors –

Differences Between CFS/ME and Multiple Sclerosis | Suite101.com

 

Wednesday, April 27, 2011

Will You Dance With Me? | Psychology Today

 
 
Coping strategies for chronic illness

Medicare and Blue Cross

I got to cancel my useless Blue Cross policy today. (Yay!)
 
He asked why I was cancelling, did I have a new policy?  Didn't tell him it was Medicare.  He asked when the new policy was effective; first of this month.  I joked whether this meant they were sending me a refund, and to my surprise he said they would if I'd send in a refund request when I fax back the written confirmation of cancellation.
 
My new Medicare card says that I'm covered for hospitalization back to 2005.  Since Blue Crap has been telling me for years that even though all my paperwork says PPO, I'm only covered for hospitalization, I'm going to see if they'll refund everything I've paid them going back to 2005.  Doesn't hurt to ask, and an extra 5 figures in my bank account would be nice.
 
So, make yourself a note that when your Medicare comes through and you cancel your existing health insurance, ask about a refund.

Avoiding the Disability Claim 'Brush-Off' - What You Need to Know

Check out MCWPA $.44 Postage Stamp from Zazzle.com

 
Use these to mail your Awareness Day letters!

Painful relationships: how to stay together when it hurts

 
"75% of marriages involving chronic illness or pain end up failing. The best citation I have for this is a seriously depressing page of statistics.+The eighth point comes from a Centers for Disease Control study, not peer-reviewed research. It's not hard to see why. Both people envisioned a very different life for themselves and with each other, and some simply can't deal with the responsibility of being a caretaker."

NIH Research Funding

 
Here are the numbers referred to in the previous post.

MCWPA Button, I am worth more than $3.64! Pin from Zazzle.com

 
Thanks to Pat Fero for the idea!
 
Buy one, wear it, tell people how little (comparatively) is spent on CFS research as opposed to other diseases.  (statistics in other posts in this blog, or available from Pat)

Pat Fero's report on Funding

National Institutes of Health Funding for Chronic Fatigue Syndrome Grants: A Ten-Year Profile
Pat Fero, MEPD
Executive Director
Wisconsin ME/CFS Association, Inc.
3/26/2011
Bp.fero@charter.net -- contact Pat for the PDF version with the charts

Summary
ME/CFS is characterized by debilitating physical and cognitive symptoms. It is estimated to affect over 800,000 adults in the United States. The
first National Institutes of Health (NIH) grant was awarded for the study of the chronic fatigue syndrome in 1987. Over twenty-four years later,
despite high prevalence rates and the disabling nature of the illness, controversy and speculation shroud this field of scientific investigation at the
NIH.
This report examines NIH funding for CFS for the last 10 years. CFS funding is the same in 2009 as it was in 1991. Once the three CFS research
centers established in 1992 phased out about 10 years ago, funding for new CFS research projects decreased to an average of 2 - 3 awards per
year. In addition, further analysis of detailed grant information reveals that a significant amount of CFS research money is spent on projects where
CFS is not the primary focus. In 10 years, about 36.4 million dollars has been spent on CFS science which is about $3.60 per person per year.
Background
Chronic Fatigue Syndrome is an incapacitating illness. This illness has more recently been referred to as ME/CFS (where ME stands for either
Myalgic Encephalomyelitis or Myalgic Encephalopathy). The persistent nature of ME/CFS often results in a reduction in work and family life
activities, as well as an increase in health care costs. In addition to employment loss, patients with ME/CFS often experience higher costs of health
care due to the search for better diagnosis and treatment that is more effective. It is estimated that the direct and indirect costs of ME/CFS in the
United States is between $18.6 billion and $23.9 billion per year. [1]
Patients question NIH support for scientific investigation. In 25 years, there has been little scientific progress on understanding the etiology of
ME/CFS, little progress on determining biomarkers and no progress on treatments to alleviate symptom severity. Patients look to public health
agencies for answers. The purpose of this report is to explore NIH CFS funding patterns over a ten-year period from fiscal year 2000 through fiscal
year 2009. Using NIH data from several sources, these data suggest an overall pattern of few new awards each year for CFS science. In addition,
data show increased funding for new grants that are categorized as CFS expenditures, but outcomes show that CFS is not the primary focus of
the research.
Few papers examine ME/CFS funding patterns. In 2000, the Government Accounting Office (GAO/HEHS/00-98) issued the final investigative
report on NIH and Centers for Disease Control (CDC) CFS research activities. This investigation was a result of advocates' concerns that the CDC
and the NIH ignored congressional mandates about the direction and level of CFS research. Other reports on NIH CFS funding presented to the
Chronic Fatigue Syndrome Coordinating Committee (1996 – 2001) and to the Chronic Fatigue Syndrome Advisory Committee, the current federal
advisory committee on CFS, have been informal. Several meeting reports focused on inadequate CFS funding and decline in overall CFS
expenditures. However, the NIH Office of Management and Budget (OBM) charts show a pattern of stable or increased budget for CFS studies.
Further data will explain the discrepancy between decline in CFS expenditures and OBM CFS budget reports.
NIH Freedom of Information Act (FOIA) requests centered on three areas of data collection. Table 1 shows the number and funding amount for
new studies and renewal of existing CFS science awards fiscal years 2000-2009. Table 2 shows the number of Chronic Fatigue Syndrome Special
Emphasis Panel reviewed new applications from October 2006 through October 2008, and the number of new CFS science grants funded.
The Chronic Fatigue Special Emphasis Panel (CFS SEP) is one of hundreds of panel review groups within the Center for Scientific Review. After
the Center for Scientific Review receives grant applications, an officer assigns a review group that will read and score submissions and a Council
that will look at scored grants. The CFS Special Emphasis Panel is multidisciplinary. This means that grant applications may be investigations of
sleep, pain and fatigue mechanisms in a multitude of syndromes and disease processes to include fatigue in cancer patients, pain in sensitivity
syndromes and any disorder with disturbed sleep. Table 2 is specific to the CFS SEP because over 99% of grant applications relating to CFS are
assigned to this panel.
Information gathered from other public sources is integrated in Table 2 to provide a more comprehensive picture of CFS funding patterns. The NIH
website < http://report.nih.gov> provides overall statistics for NIH projects, historical data on funding initiatives, and a vast number of links to all
NIH business. A valuable link on the NIH report, Project Reporter, shows specifics about grant award history, the project title, the principal
investigator, dollars awarded, and research results in terms of publications.
Report
The Government Accounting Office investigation of CFS (GAO/HEHS/00-98), finalized in 2000, provides a starting point for this report. Baseline
data as well as GAO summaries and recommendations give context to the questions on funding for CFS. Lastly, meeting minutes from the Chronic
Fatigue Syndrome Advisory Council 2003 through 2009 show ongoing interest and troubling questions from voting members about the level of
National Institutes of Health interest in the pursuit of a CFS science program.
The GAO investigation stated that the CFS Special Emphasis Panel was designed to help facilitate the consideration and scoring of CFS grant
applications. The GAO report shows that in fiscal years 1988 through 1999, the funding rate for CFS was about 24% compared to 28% for all
grants across the same institutes that fund CFS research. The GAO counted only those awards where CFS was the primary focus. [2]
The grant making process through the CFS Special Emphasis Panel has not facilitated CFS scientific investigation. From Fiscal Year 2000
through fiscal year 2009 there were only 24 new awards, about 7.6 million dollars, where CFS is the primary focus. Further analysis from FOIA
requests made in 2006, 2007 and 2008 indicates a funding rate for CFS awards at about 7%. [3] Considering the numbers of people affected, the
severity of daily illness, and societal impact of ME/CFS, 2 – 3 new grant awards per year and the dramatic decline in funding rates since 2000
raises serious questions about NIH commitment to CFS science.
Table 1. A 10-year profile of ME/CFS science grant awards 2000 – 2009
Year New
Studies
New
Funding Renewed
Studies
CFS
Centers
Renewals
Renewal
Funding
Total
Funding
2000 2 $863,805 6 14 $3,414,202 $4,278,005
2001 3 $676,220 6 14 $3,876,723 $4,552,943
2002 1 $329,987 7 12 $4,269,156 $4,599,143
2003 3 $1,188,270 8 Discontinued $2,034,241 $3,222,511
2004 1 $255,301 9 $2,667,530 $2,922,831
2005 1 $641,703 6 $2,344,369 $2,986,072
2006** 6 $1,736,061 4 $2,270,107 $4,006,168
2007 3 $809,875 9 $3,283,159 $4,093,034
2008 3 $795,041 5 $1,734,886 $2,529,927
2009 1 $335,600 8 $2,852,214 $3,187,814
Totals 24 $7,631,863 $28,746,585 $36,378,448
*New studies are often 2 or 3 year grants, so for the next several years after the award, they are included in the renewal funding. Thus, percentage of the total
funding for new CFS studies can be calculated for one year only and not as a whole. See grant details Appendix 1. ** Bump year with 5 million 'new' money
available for CFS grants. 1.7 million was spent.
Scarcity of new CFS grants is not apparent when looking at NIH reported total CFS expenditures. From 2000 through 2007, the Office of the
Budget reports $51 million dollars spent on CFS investigation. [3] In 2008 and 2009, NIH reports an additional $9 million spent on CFS. [4] $60
million dollars spent in ten years does not reflect the actual dollars spent on CFS science as indicated by Table 1. $36.4 million dollars is actual
CFS science expenditure. The $23.6 million dollar difference is money spent on grants where CFS is not the primary focus as indicated by grant
history, outcomes, publications, and PI academic interests.
Because the CFS Special Emphasis Panel reviews over 99% of grants submitted for CFS research, the number of submissions, the number
awarded and the specifics of those awards are key to understanding at least one factor that might explain the difference between actual spending
and reported spending on CFS research studies.
The meeting minutes of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), chartered under the Office of the Director, Health and
Human Services, show repeated discussions from 2004 through 2009 about the efficacy of the CFS Special Emphasis Panel. Decisions about
grant funding made by the CFS Special Emphasis Panel and its chief, the Scientific Review Officer, continue to challenge the CFSAC. CFSAC
meeting minutes show that invited speakers such as Scientific Review Officers as well as other NIH grant experts conclude that the number of
CFS applications are low and submissions are poorly written, ill conceived or lack innovation [5]
Discussions about the CFS Special Emphasis Panel are recorded in the CFSAC meeting minutes November 2007, May 2008, and November
2008. In November 2007, Dr. Ron Glaser, a voting member of the CFSAC, stated that over the last three years only about 15% of the Special
Emphasis Panel reviewers had background related to CFS and none of those reviewers worked on etiology. In May of 2008, the Research
Subcommittee concluded that the CFS SEP review process and the apparent "hurdles" for new project proposals were out of line with a fair review
process. Discussion continued at the November 2008 meeting. The Research Subcommittee concluded that investigators will be discouraged by
the rejection of their research proposals, not because their grants are poorly written, but because of inappropriate reviews. [5]
With a 7% funding rate, over time, CFS researchers and those newly intrigued by CFS science are likely to pursue other areas of inquiry that may
lead to advancement rather than a detriment in career goals.
FOIA data legitimize CFSAC concerns about the CFS SEP. 161 grants were reviewed in 2006, 2007, and 2008 by the CFS Special Emphasis
Panel. Of those 161 grant applications, 11 awards went to CFS researchers for a total of about 3.2 million dollars, a 7% funding rate. In addition,
of those 161 grant applications, 18 awards went to non-CFS researchers for a total of about 6.5 million dollars, an 11% funding rate. This means
that of the 9.6 million dollars awarded in fiscal years 2006, 2007 and 2008, about 33% of the money was for CFS and about 67% was for non-CFS
research. Grant details appear in Appendix 2.
It is troubling that many studies designated as CFS do not have CFS as a primary focus. Principal Investigators state CFS is a priority, but grant
history and research publications do not demonstrate use of funding for CFS. Inappropriate or questionable use of CFS funds is clear when a
researcher uses NIH award money dedicated to a CFS related projects, such as creating a spinal cord and tissue bank, when in fact, there is no
evidence that the project was started or completed. In other cases, the researcher is interested in and publishes on a CFS related symptom such
as hypotension, pain, sleep, and fatigue in an entirely different illness or syndrome. There is no evidence that grant money is used to investigate
that symptom in chronic fatigue syndrome laboratory studies, animal models or in clinical studies. In order to focus on CFS research these non-
CFS grants have been excluded from Appendix Table 1. However, Appendix Table 2 includes funding details for new non-CFS awards.
Conclusion
Controversy and speculation shroud this field of scientific investigation at the NIH. A GAO reported funding rate of 24% in 2000 compared to a 7%
funding rate a decade later shows a steep decline. The efficacy of the CFS Special Emphasis Panel is questionable. A significant amount of CFS
research money is spent on projects where CFS is not the primary focus. Overall, despite high prevalence rates, the disabling nature of the illness,
economic loss and extreme family and community resource hardships, scientific interest in Chronic Fatigue Syndrome at the National Institutes of
Health is not supported by existing data.
There are limitations to this report in gathering accurate information over a period of ten years. Freedom of Information Act requests must be
worded for specific information, which can, unknowingly exclude relevant data. Data about the total number of CFS applications logged in by the
Center for Scientific Review and sent to the CFS Special Emphasis Panel for peer review are not public information through the FOIA process thus
making conclusions inherently risky and sometimes faulty. NIH CFS focused scientific meetings often do not include the public, but decisions
made at meetings may alter grant announcements and the focus of CFS research leaving the public unaware of changes. Lastly, NIH grant
making procedures and data recording evolve over the years. This fluidity demonstrates progressive and continued NIH efforts to serve public
health interests.
A brief with charts and documentation is available upon request.
1. The Economic impact of ME/CFS: Individual and societal costs
Dynamic Medicine 2008, 7:6 doi: 10.1186/1476-5918-7-6 Leonard A Jason, Mary C Benton, Lisa Valentine, Abra Johnson and Susan Torres-
Harding Email: Leonard A Jason - ljason@depaul.edu;
2. The General Accounting Office Report, Chronic Fatigue Syndrome: CDC and NIH Activities are Diverse but Agency Coordination is Limited,
(GAO/HEHS-00-98)
3.National Institutes of Health Freedom of Information Act Requests, 2000 – 2009 # 32335, 33228, 34681, 34777, 34979, 35899
4. < http://report.nih.gov>
5.Meeting minutes 2003 – 2009 http://www.hhs.gov/advcomcfs/meetings/index.html
6. http://projectreporter.nih.gov/project_info_description.cfm
7. /www.bannerhealth.com/Innovations/Sun+Health+Research+Institute/Research+Programs/Arthritis.htm
 

Tuesday, April 26, 2011

April is IBS (Irritable Bowel Syndrome) Awareness Month

 

To March into Hell for a Heavenly Cause

 
Periodically, even the staunchest CFS activist wonders "why am I beating my head against the wall?"  It would be so easy to just lay down the sword and go back to bed where we belong.
 
Then you talk to another activist – Tom Hennessy estimates he's gotten over 25,000 letters, e-mails and faxes from patients at their wits' end, Pat Fero tells heartbreaking stories of people who call and cry because they have nowhere else to turn, I open my own e-mail and there are pleas from people who need words of comfort and understanding from someone who believes them that they are really and truly sick.  And you remember why you're doing it.
 
Because someone has to do it.
 
Because some of us, with four Fire Signs and some Gemini glibness and a dose of Libra sense of justice, are better suited to the job than the quieter patients.
 
My late bestest friend in the universe, a shy Southern belle, kept asking wasn't I scared?  Number one, I don't scare easily.  Number two, what can anyone do to me that the disease hasn't done already?  It's stolen my career, my self-image, my financial security, my body, and, at times, my brain.  A jail cell is 125% larger than the bed I was effectively confined to for a couple of years, during which I did my time in solitary confinement.  Torture?  Bring it on; can't be any worse than 24/7 level 10-of-10 pain that I had for months.  Psychological abuse?  You mean worse than years of people calling me lazy and crazy and ordering me to stop faking and go back to work?
 
Noblesse oblige, I have a duty to the less-able amongst us to fight for us all.  It's simply the right thing to do.
 
To dream the impossible dream ...
To fight the unbeatable foe ...
To bear with unbearable sorrow ...
To run where the brave dare not go ...
To right the unrightable wrong ...
To love pure and chaste from afar ...
To try when your arms are too weary ...
To reach the unreachable star ...
 
This is my quest, to follow that star ...
No matter how hopeless, no matter how far ...
To fight for the right, without question or pause ...
To be willing to march into Hell, for a Heavenly cause ...
 
And I know if I'll only be true, to this glorious quest,
That my heart will lie will lie peaceful and calm,
when I'm laid to my rest ...
And the world will be better for this:
That one man, scorned and covered with scars,
Still strove, with his last ounce of courage,
To reach the unreachable star ...

20 Things Not to Say to an Ill Person : Invisible Illness Awareness

Statistics – Chronic Illness : Invisible Illness Awareness Week

IACFS/ME BIENNUEL CONFERENCE 2011 AGENDAS

IACFS/ME BIENNUEL CONFERENCE

Hosted by the NATIONAL ME/FM ACTION NETWORK

Translating Evidence into Practice

September 22-25, 2011 • Ottawa, Ontario, Canada

AGENDA

Conference Highlights

Latest Research on XMRV/MLVs

The case FOR Human Gamma Retroviruses (HGRV) in CFS/ME

The case AGAINST Human Gamma Retroviruses (HGRV) in CFS/ME

Debate

·   F    Fibromyalgia: Are Tender Points Necessary?

Research

·           New findings: Blood XMRV Working Group on Blood Safety

·          Latest findings

o   immunology

o   virology

o   genomics

o   brain and neuroendocrine function

o   pediatrics

o   exercise physiology

Clinical Practice Sessions

·          Difficult Clinical Cases

·         IACFS/ME Clinical Practice Guidelines: A New Primer

Professional Workshops

·      Treating Sleep, Pain and Fatigue in ME/CFS Patients

·      Fibromyalgia Theory, Assessment and Practice

·      Behavioral Assessment and Treatment of ME/CFS

·      Pediatrics and CFS/ME

·      Exercise Intolerance: Guide to Management and Treatment

·      How to Apply for Grants

It is anticipated that this event will be accredited for continuing medical education for Category 1 CME (physicians), CNE for nurses, and CPE for pharmacists.

Patient Agenda – September 22nd, 2011

Patient Conference Highlights

New Developments in Possible Causes of ME/CFS

New Research on What Helps People Cope with ME/CFS

Fibromyalgia: Current Status

Breakout Session: For parents of children with ME/CFS

Legal Aspects of Disability

Latest Research on the Pathophysiology of ME/CFS

Effective Management of Activity Intolerance

New Developments in Pharmacologic Treatments

Invited Speakers:

Anthony Komaroff, MD

Nancy Klimas, MD

Leonard A. Jason, MD

Charles Lapp, MD

Lucinda Bateman, MD

Rosamund Vallings, MB, BS

Hugh Scher (Attorney)

Annette Whittemore, WPI


For further information and registration for the conferences, please visit: http://www.iacfsme.org

Lydia
Lydia E.  Neilson, M.S.M. , Founder
Chief Executive Officer
NATIONAL ME/FM ACTION NETWORK
512 - 33 Banner Road
Nepean, ON K2H 8V7 Canada
Tel. 613.829.6667
Fax 613.829.8518

NATIONAL ME/FM ACTION NETWORK - HOST OF THE IACFS/ME INTERNATIONAL RESEARCH & CLINICAL CONFERENCE - OTTAWA, CANADA

SEPTEMBER 22 - 25, 2011

Pupil findings in a consecutive series of 150 patients with general

 
"The pupils are often affected in autonomic neuropathy, although this is not always apparent either to the patient or to their doctors."
 
 

An Excellent Letter from Jo

Dear Mr Horton,

I am writing to urge you to accept the personal invitation you have been given to attend the annual international conference on biomedical ME research hosted by the charity Invest in ME next month, as your comments about patients with ME in your recent interview on Health Report were remarkable for the ignorance they implied of the depth and breadth of published and cutting edge scientific ME research, and I am sure you will agree that you have a professional obligation to redress that dearth of knowledge if you are going to discuss the subject so freely in the media.

I wonder whether your comments stem from some confusion you may have over the important differences between the disease myalgic encephalomyelitis (aka chronic fatigue syndrome) and chronic fatigue, which is symptom of many different illnesses and disorders. You said the investigators were comparing conventional treatments for chronic fatigue. Cognitive behaviour and graded exercise therapies are available to patients with other chronic conditions such as cancer and heart disease. They are adjunctive therapies, offered alongside drug treatment and/or surgery – they are not considered as treatments for disease.

Pacing should not be described as a treatment either – pacing is merely a strategy that people with ME/CFS have to use in order not to exacerbate symptoms, in the absence of cure or treatment for the disease. The cardinal symptom of ME is post-exertional malaise (PEM). This is what distinguishes ME from other illnesses and this is why ME patients and experts in ME – scientists and doctors – object to the way the results of the PACE trial have been over-stated and misrepresented, as they know that exercise and over-exertion is indisputably physically harmful to genuine ME patients, just as it would be to patients with untreated heart and lung disease and patients with active viral infection. Patients learn how to pace through trial and error, according to their individual symptom profile, illness severity and circumstances - it is not an exact science or something that most people can stick rigidly to – it is often said that life gets in the way of a good pacing regime. Contrary to popular belief, people with ME, including adolescents, tend to do too much, not too little, and suffer the physical consequences arising from PEM. One of the problems of judging how much a patient can do is that the "payback" of PEM often does not onset until up to 48 hours after the activity itself. Again, this is another area where PACE results were unreliable – there was no account or measurement taken, of PEM following CBT and GET.

PEM is measurable and could be used as a diagnostic marker for ME. There is a high rate of over-diagnosis and mis-diagnosis of ME/CFS because biomedical disease markers for ME are not used by the NHS. In a study at Dundee University of patients with ME/CFS diagnosis, 12% were found to have a potentially treatable psychiatric disorder that could account for their symptoms, 7% had fibromyalgia, 21% had muscle, connective tissue and endocrine disorders. A second study at Newcastle University showed that 44% of patients had other conditions such as sleep apnoea, or depression and anxiety, to account for their symptoms. None of those conditions would produce the PEM so characteristic of ME. This is one reason why therapies seem to be effective for some patients and not others – they do not all have the same condition but are given the umbrella diagnosis of ME/CFS.

You said that the PACE researchers were: "really stepping back and comparing two philosophies, not just two treatments, two philosophies of what chronic fatigue syndrome was".

I hope you can now see how illogical that comment was. Medical research should be concerned with science, not philosophy. Its aim should be to establish cause, effective treatment and prevention of disease. The researchers were not assessing two treatment approaches, as APT is not the same as pacing, it is more akin to GET. If you are suggesting that the two philosophies are the physical v psychological debate, then a study that only assesses the supposed treatments that are based on the psychological model can only prove or disprove that model. In which case, PACE soundly refutes the psychological model of ME, as you must realise from analysis of the results and a critical appraisal of the study protocol. CFS is a different matter, as it was invented in the 1980s by the small group of psychiatrists to which Peter White and Michael Sharpe belong. CFS will include people with mental health related fatigue because they wrote the criteria. As you know, criteria for inclusion in PACE effectively ruled out patients with ME. You know that ME is classified by WHO as a neurological disease yet neurological signs were not necessary for the entry criteria. Research has also shown that adults and children with ME have persistent viral infection yet patients with signs of active infection were also excluded from the study.

You said: "Yeah, I mean adaptive pacing therapy essentially believes that chronic fatigue is an organic disease which is not reversible by changes in behaviour. Whereas cognitive behaviour therapy obviously believes that chronic fatigue is entirely reversible. And these two philosophies are kind of facing off against one another in the patient community and what these scientists were trying to do is to say, 'Well, let's see. Which one is right?'"

You are completely mistaken by assuming that people with ME do not adapt their behaviour to the illness – that is exactly what pacing (not APT) is. They are forced to adapt their normal pattern of daily living in order to avoid deterioration and in the hope of recovery. Those who are working typically relinquish all leisure and social activities, partly as they are simply not well enough to participate any longer and partly as they need to reserve all their physical and mental energy for work. Their limitations put a strain on family life and relationships. With the more severely affected, unable to continue working, there are elderly parents who have to care for their adult children with ME and there are children who have to care for their parents with ME. As there is no treatment on the NHS that "reverses" ME, as you put it, those who can afford to, spend several thousands of pounds on trying to find the root cause of their symptoms and trying various treatments, both on the NHS and in private practice. Some of these are informative and helpful at alleviating symptoms, sadly, others are scams claiming to be cures that prey on the desperation of patients and parents of patients to recover. The average person with ME is far removed from the image you are portraying here as feeble-minded people who do not believe they can recover and give in to the limitations of their illness. I can assure you that many ME patients could write the book on CBT themselves.

You said: "the .. ME, population our critics claim contains a substantial number of people who are bedridden. Given the fact that treatments are being offered which do regard chronic fatigue as reversible, then that somehow undermines the view that ME is a neurological condition. There is this feeling that ME, being an organic disease in the views of some patients, that means that any view that contradicts that and offers a treatment against that particular perspective must therefore by definition be unethical".

By using the word "claim" are you suggesting that people are making up that a substantial number of ME patients are bedridden? Exact numbers of people with ME are unknown as the DoH has never seen fit to collate these statistics, and there is the aforementioned problem of over-diagnosis and misdiagnosis of ME/CFS. Estimates vary from 150,000 to 250,000. Twenty or so years ago, before the psychological model of ME had taken hold, estimates were that about 25% of ME patients recovered, about 25% had it so severely that they were immobile and unable to speak or swallow and about 50% had ME to a mild or moderate level all their lives, whereby they could continue with daily life with adjustments to allow for the limitations and effects of the disease, which may be similar to the pacing model and may also include strategies, medications or therapies to help alleviate some symptoms. It was known that ME could be relapsing, remitting and also variable. It is not unique among diseases in that regard. It is notable that in those days, recovery was not a result of any treatments, but the natural healing processes of the body itself, as generally occurs with any viral infection. WHO classification at ICD-10 G.93.3 is Post-Viral Fatigue Syndrome: Benign Myalgic Encephalomyelitis.

PACE excluded the severely and even many moderately affected, in that participants had to be able to attend clinic for appointments – some moderately affected patients are housebound if not bedbound. This is only significant in that this was not emphasised in the commentary and media hype following publication of the results – i.e. the results cannot be extrapolated the whole ME population, aside from the valid criticisms that, given the entry criteria and subsequent changes to the entry criteria, results cannot be reliably applied to any ME patients at all. It is also worth noting that some of those patients who are now severely affected and bedridden deteriorated to that level of severity following CBT and GET. This is why medical and scientific experts on ME, as well as the patient community itself, are so concerned about the implications of the overstated and misrepresented results of PACE – i.e. they are being used by NICE as evidence that its guideline for ME does not need to be reviewed, whereas other research evidence shows, as do the PACE results if correctly interpreted, that there is urgent need for review. An example of this is a study published in September showing that researchers at Dundee University found evidence of persistent viral infection in children with ME/CFS – the same as had been found previously in research involving adults. These findings accord with expert Dr. Nancy Klimas, greatly experienced in working with both HIV and ME/CFS patients, who emphasises in her training for doctors, the high degree of inflammatory response in ME/CFS patients, which would contraindicate the value of GET, and her own recently published study showed that CBT and GET are of no value for ME/CFS patients.

You say that ME is reversible by CBT and GET, yet you have no scientific evidence of this – PACE certainly does not support your belief.

Dr. A. Martin Lerner, an infectious disease specialist, says anything that raises the heart rate of someone with ME/CFS is dangerous, unless they are well on their way to recovery (at a 7 on his EPIS® chart.) He says this from his experience of patients in practice that shows that ME/CFS involves the heart. Dr. Lerner has published studies about abnormal heart function in people with ME/CFS, showing dysfunction even at normal daily levels of exertion, abnormal movement both at rest and under stress, and T-wave abnormalities distinct enough to provide a diagnosis. I believe research in this area was presented at last year's IiME conference in London, and that a test that would show the damage to the heart in ME patients that mainstream cardiologists could use, was being developed.

Expert Dr. Paul Cheney has pioneered clinical research in CFS (ME) over 25 years. He has lectured around the world and is an internationally recognized authority on the subject. Dr. Cheney says:

"The most important thing about exercise is not to have them do aerobic exercise. I believe that even progressive aerobic exercise, especially in phase one and possibly in other phases is counter-productive. If you have a defect in mitochondrial function and you push the mitochondria by exercise, you kill the DNA".

Contrary to your unsubstantiated belief that ME is reversible by CBT and GET, the damage done by CBT and GET can be irreversible. One such case (of many) is the late Lynn Gilderdale, who died in 2008 aged 31 by her own hand with the assistance of her devoted mother, after 17 years of illness, having contracted ME at the age of 14. I urge you to read the book written by her mother Kay and published by Ebury, called One Last Goodbye. You can buy it via Amazon or by calling 0845 155 0720 (free p&p) or you could ask your local library to order a copy.

I also urge you read the case of Sophia Mirza, who died aged 32 in 2005, which her mother Criona Wilson has made available at this website: http://www.facebook.com/l/02851s2njPQMzCPtyuH-jWP7RGw/www.sophiaandme.org

The coroner recorded Sophia's cause of death as renal failure due to CFS (ME). Post-mortem showed damage to the spinal cord and basal root ganglia. At Lynn's post-mortem, the pathologist discovered dorsal root ganglionitis – infected nerve roots – and nodules of Nageotte, which Kay explains are little tombs of dead cells, in her spinal cord that would have caused her terrible pain and sensory nerve damage. Both post-mortems provide unequivocal evidence of the true pathology of ME and show that the classification of this disease by WHO is correct.

You said, "This is why I think the criticisms about this study are a mirage. They obscure the fact that what the investigators did scrupulously was to look at chronic fatigue syndrome from an utterly impartial perspective."

This statement is simply not supported by the evidence. The scientific evidence (over 4,000 papers) shows that ME is a serious and potentially fatal neurological disease of the central nervous system of infectious onset with multi-systemic effects, affecting the heart, brain and other organs. It is unreasonable to expect that an organic disease of this complexity and seriousness can be "reversed" as you describe, by therapies such as CBT and GET. Given that these therapies were not being compared to drug or surgical interventions, your claims that the investigators were "scrupulous" and that their perspective was "utterly impartial" is simply unfounded.

You said: "The issue here which I still fail to understand is that nobody is claiming that chronic fatigue syndrome is an invented illness. It's taken just as seriously as any other condition."

This statement is incorrect on three counts. Firstly, there are those who claim that CFS is an illness that was invented in the 1980s by the small group of psychiatrists that includes Simon Wessely, Peter White and Michael Sharpe. This claim is based on the fact that they conflated CFS with the already well documented and well-defined disease myalgic encephalomyelitis. There was no need to rename and redefine an existing disease. The effects of this group of psychiatrists' involvement with ME have been catastrophic for ME patients in terms of both research and treatment.

Secondly, the protocol for the CBT used in PACE is based on the premise that the patients' ongoing symptoms are psychosomatic and that they have become stuck in a pattern of helplessness and dependency, hence the idea that symptoms can be reversed by the patient changing their illness beliefs. The idea behind GET is that patients have become deconditioned and have developed a fear of activity. There is plenty of evidence in the training materials for health professionals and information leaflets given to patients at ME clinics run on these lines, that these are the ideas behind CBT and GET. In this sense, patients are seen as inventing their symptoms.

Thirdly, ME is not taken seriously by NHS doctors and other health professionals who have been influenced by the Wessely group school of thought about ME. On the contrary, they are actively encouraged not to take it seriously. They are advised to "perform the minimum number of investigations" as sending the patient for lots of tests will validate their mistaken belief that they are ill. The basic battery of tests recommended by NICE are tests of exclusion for other conditions, not tests to positively diagnose ME, and many GPs do not even authorise those basic tests. You can see how, with this guidance, there is such a high degree of misdiagnosis, over-diagnosis and missing of treatable conditions, with often serious implications for the health of patients, as relatively easily-identified conditions go undiagnosed, such as thyroid disease, endocrine dysfunction, Ehlers Danlos and other syndromes, liver disease, postural orthostatic tachycardia syndrome, which one third of ME patients are estimated to have. Some of these conditions may be ME-related due to the multi-systemic nature of ME and ME patients often develop auto-immune diseases for example, and also rare cancers - and some are separate conditions. Many doctors tell their patients there is no such thing as ME. There have been cases of people collapsing in the street and paramedics refusing to take them to hospital when they are told the person has ME/CFS, and others where patients have made it to A&E only to be sent home with no investigation of the cause of their collapse when the doctor is told they have ME. So, you are wrong that the illness is taken seriously by any other than those few doctors who either know that ME is an organic disease and treat it accordingly with symptom management, or who have no knowledge of ME but take their patients seriously and are willing to learn by treating their patients as individuals in relation to their symptom profile and management plan.

You said: "Not this kind of orchestrated response trying to undermine the credibility of the study from patient groups, but also the credibility of the investigators, and that's what I think is one of the other alarming aspects of this. This isn't a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study."

This is an unsubstantiated and unfair comment. Let's look at the facts. We live in the modern world and the age of the internet and the FOI Act. Individual patients who previously had no access to study protocols and research papers at source, had restricted access to information in general, and were, in many cases, confined to their homes and beds by ME, now have this direct access, and are able to judge for themselves and to communicate directly with each other as never before. Patient groups have been unable for the past 25 years to reintroduce a common sense approach to ME in the NHS. The upshot has been 25 years of medical and social abuse and neglect, misappropriation of MRC funds to proponents of the biopsychosocial model of ME away from biomedical research that may result in proper treatment. You may know that patients, such as Sophia Mirza, have been forcibly removed from their homes for psychiatric assessment and the very treatments that you have such confidence in, which in fact have shown what they already knew – they did not have a psychiatric disorder but an organic disease. You may know that this includes children, such as Ean Proctor, under the care of Simon Wessely at the time and famously put in a swimming pool on the basis that he would be forced to move his limbs to avoid drowning, which he could not do as he was genuinely immobile and mute at the time, and had to be saved from drowning. In-patients have been denied food for days on end and not taken to the toilet, again on the basis that need will force them to get up and move for themselves. A recent case of such mistreatment was that of Theda Myint in Australia, as reported in WAToday last week. Without proper medical treatment for her organic disease, she is in serious danger of becoming yet another death from ME.

Objections to the PACE trial itself and the misrepresentation of its results cannot be described as orchestrated, simply because patients have had enough of this artificially constructed "debate" about the underlying causes of ME and of millions of pounds of public funds being wasted on researching and providing treatments that we now know from these years of direct experience are at best unhelpful at treating ME and at worst, harmful to a majority of ME patients.

"The accusations that are being made about them is that they have behaved unethically, breached international standards of ethics, and indeed in a few examples allegations have been made to professional authorities, the General Medical Council here in the UK, about the work of these scientists, on the basis of the flimsiest and most unfair allegations. And indeed the study cost 4-million pounds to undertake but the allegations and the freedom of information requests and the legal fees that have been wrapped up over the years because of these vexatious claims has added another 750,000 pounds of taxpayers' money to the conduct of this study."

This is a cheap shot at critics of PACE. If patients meekly accept this wastage of public funds that could be used for biomedical research and remain submissive to treatments that they know to unhelpful and harmful, then they remain in a limbo of medical neglect and abuse, the prospect of a real cure or real treatments ever more distant as the years pass. If they speak up and object, making use of their democratic and legal right to freedom of information, they are subject to allegations of making vexatious complaints and of costing yet more money.

You said: "Indeed, and I think this is where one sees a real fracture in the patient community. One is seeing a very substantial number of patients very willing to engage in this study, desperate to get good evidence on which to base their future treatment. But one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have, I would say, actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients."

Here, you are perpetuating the myth of discord within the patient community – a method of divide and rule that has been used as an excuse for not progressing biomedical research and treatment. Every single patient with ME wants to recover and is willing to try anything and go to any lengths to improve their health status. They prove this by spending thousands of pounds of their own money in the process, or as much as they can afford. You are missing the point that the reason patients object to CBT and GET is that studies of these therapies have been done before and that many patients have already undergone these therapies under the NHS and thereby know from experience that they do not work and can be harmful.

Your implication that patients who are critical of PACE are not themselves desperate to get good evidence on which to base their treatment is totally unfounded. There is already a wealth of such good evidence, which patients want NICE to take account of and which is being wilfully ignored in favour of the Wessely school psychiatrists' approach. The patient critics of PACE are fighting for their lives by campaigning to the best of their limited abilities for long-awaited funding for biomedical research that may lead to treatment (likely to be anti-virals or immune modulators) and for adoption of the Canadian Consensus Criteria for ME/CFS, which can be used for both diagnostic and research purposes.

You said: "Well, what we're doing right now is waiting for the formal response from the authors to this 43-page attack on their integrity and the study, and the request for a retraction. We plan to publish their response to that attack. We will invite the critics to submit versions of their criticisms for publication and we will try as best as we can to conduct a reasonable scientific debate about this paper. This will be a test, I think, of this particular section of the patient community to engage in a proper scientific discussion."

Your language is emotive and hardly conducive to the reasonable scientific debate that you claim to seek to engage in. Patients have been subjected to 25 years of systematic institutionalised abuse and neglect as result of the "philosophy" of the PACE trial investigators, and yet you describe their valid criticisms of this trial as attacks and plan to subject them to a test against seasoned professionals. This is quite extraordinary. Would you put patients with cancer or AIDS or any of the other neurological diseases such MS, Parkinson's and Alzheimer's to such a test? I also note that you have already declined to publish letters of response to your publication of PACE, which does not accord with your stated intention to engage patients in debate.

The simple fact is that your journal has published a research paper of which there is widespread criticism among a global community of patients, patient representatives, scientists and doctors. The paper and the criticisms can be debated in the interests of progressing scientific knowledge and bearing in mind that any research should be for the benefit of patients, not the researchers.

I find the remarks you made in the interview with Dr. Swan for Health Report insulting to a patient community that was not represented at the interview with a fair right of reply and verging on slanderous, as your assertions and allegations were unfounded and mis-representative of a disease and those afflicted by it. You have thus contributed to the mis-information about ME that is routinely propagated via mainstream media and have unfairly and unprofessionally maligned a whole community of patients. You should now issue a public apology.

You have an opportunity for insight into the world of biomedical research by attending the Invest in ME conference next month and once again, I urge you to accept that invitation.

Your sincerely,

Jo Best
Patient Advocate

Monday, April 25, 2011

Living with Chronic Pain - Laura Hillenbrand

A Sentence of ME -- Awareness Week Project

PERMISSION TO FORWARD, USE IN NEWSLETTERS AND RE POST ON FACEBOOK PAGES

Our project, launched in plenty of time for M.E. Awareness Week (8-15
May) 2011, "A sentence of
M.E.", has a deliberately obvious double meaning: The horrible
experience of this largely
invisible and unpredictable disabling illness that seems to some like a
prison sentence is,
literally, just that for the most severely affected, who are housebound
or bedridden.

So, we are asking people, who are affected by M.E, (Myalgic
Encephalomyelitis), not only as
sufferers but also their carers, family, friends, maybe even doctors and
nurses, doing their
best to care for them, to express how it is in just one sentence, in
order to improve public
knowledge and raise awareness.

You may wish to use your sentence to tell everyone about a single
episode, or about how it is
to endure M.E. day after day, year in year out. It's up to you. And you
can submit as many
sentences as you like. You can do so in your own name or anonymously if
you prefer (say, just a
first name, or a made up name, or "M.E. sufferer, 10 years, London").
We'll put them all on our
website, Facebook, Twitter and M.E. sufferers from all over the world
are invited to take part.

There is a universally recognised International M.E. Awareness Day on
12th May every year but,
for us, every day is M.E. Awareness Day. So, there is no closing date
for this one. Send any
sentences you have to drjohngreensmith@mefreeforall.org with "A sentence
of M.E." in the
subject line.

[Note: we have sent this letter to a number of newspapers and magazines
in the UK and to other countries that have English language newspapers
but if you would like to make sure that we have sent it to your
favourite magazine or newspaper (or translated into your native language
if you can provide a translation), send us the e-mail address of the
editor or letters page and we'll get it to them.]


Best wishes
drjohngreensmith@mefreeforall.org
Dr John H Greensmith
ME Free For All.org

To read the letter from Dr John Greensmith
and see details of other organisations' plans for M.E Awareness week
click
http://mefreeforall.org/wp/m-e-awareness-week-2011-events-around-the-world/


Follow us on Twitter
http://twitter.com/#!/MeFreeForAllOrg

Join us for a mix of serious and fun stuff on Facebook
http://www.facebook.com/profile.php?id=100000948699086#!/profile.php?id=100000948699086

Cheers
John
drjohngreensmith@mefreeforall.org
Dr John H Greensmith
ME Free For All. org


Tips for Students with Chronic Fatigue Syndrome

 

Sunday, April 24, 2011

A Race to solve CFS

Note to moderators: re-sent with dates.

This is a message from Claudia Goodell, an organizer of the 2nd Annual
24 Hours in the Enchanted Forest: A Race to SolveCFS to be held on
June 18, 2011 in McGaffey, New Mexico.

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

2nd Annual 24 Hours in the Enchanted Forest: A Race to SolveCFS

Hi everyone,

I was diagnosed with ME/CFS 6 years ago. After many years of mountain
biking and competing I thought there ought to be a cycling event that
could benefit ME/CFS, so I contacted a race director I knew and told
her about myself, ME/CFS, and my idea. She replied saying that she
wanted to start New Mexico's first 24 hour mountain bike race, and
that she had also been diagnosed with ME/CFS. Well, the relationship
and the planning commenced, and together with 3 other staff members
and 80 volunteers, the 2010 24 HITEF was a huge success.

With about 250 racers we raised over $9,000 in cash and over $20,000
worth of in-kind donations, which all went to The CFIDS Association of
America. This year we expect to double pariticipation and I have
ramped up the fundraising efforts. Donations will continue to benefit
The CFIDS Association of America.

You can Help!
Please consider sending a downloadable letter to friends, family,
current or previous co-workers, etc. The more people who know about
this event the more we can circulate awareness about ME/CFS and
increase our fundraising power. Instructions can be found below, or on
the event website under the link for Fundraising.

This is a portion of what I have sent out to my non-patient contacts.

There are several things you can do.

1) You can register to race competitively or recreationally
2) You can sign up to volunteer a block of time at the event
3) You can purchase some very nice glass mugs, which are sand etched
and hand painted by Brad Goodell, who has generously agreed to donate
a portion of the proceeds to SolveCFS. They can be viewed and
purchased through the Shop link on the website.
4) You can easily run your own fundraising campaign. On the
Fundraising link you will find downloadable fundraising template
letters /forms for racers, patients, and others. These can be shared
with family, friends, co-workers, etc. via snail mail, email, or
Facebook. Students can run a fundraising campaign (providing awareness
that there are pediatric patients as well).

Please consider supporting this event however you can, and please
share this email with others.

Thank you,
Claudia Goodell
Fundraising 24 HITEF
aracetosolvecfs@24hitef.com

http://www.24hitef.com/
Find us on Facebook-
https://www.facebook.com/pages/24-Hours-In-The-Enchanted-Forest-A-Race-To-SolveCFS/305134717195
Follow us on Twitter-
http://twitter.com/24EnchantForest

"New research rattles hopes for many patients with chronic fatigue syndrome."

Below is the text of an email I sent to the author of the Chicago
Tribune article
"New research rattles hopes for many patients with chronic fatigue
syndrome."

Gerald R. Campbell, Ph.D.


----- Forwarded Message ----
From: Jerry Campbell <jerrycamz@yahoo.com>
To: ttsouderos@tribune.com
Sent: Fri, March 18, 2011 11:06:24 PM
Subject: re: New research rattles hopes for many patients with chronic
fatigue syndrome

Sir;
In regard to your article "New research rattles hopes for many patients
with chronic fatigue syndrome"
March 17, 2011, I feel that you have been led astray. As the original
researchers used the same reagents, primers and lab facilities in
analyzing both patient and control samples, any contamination would have
affected both classes. This would have led to a high rate of XMRV being
found in both populations, not only in one but not the other. I am
disturbed that a knowledgeable reporter, such as you appear to be, would
not even consider the experiment beyond what you got in one interview.
The CDC has been set on getting ME/CFS classified as a psychological
illness, ever since their two investigators went to Lake Tahoe and skied
the week away, and failed utterly to investigate the outbreak in Incline
Village some 30 miles away. By claiming that XMRV and related mouse
retroviruses are not present in the population they can continue to
pursue their dream of getting rid of any CFS research. Nor is this the
first time. They have succeeded in eliminating HHV-6a as a potential
factor by deliberately using a reagent that reacts both to HHV-6a and
HHV-6b (HHV-6a is present in about 80% of CFS patients, and MS patients,
while present in only <5% of healthy controls. They have thus not only
kept real research in CFS from going forward, they have also blocked
some research avenues into MS.

They have launched personal and professional attacks on honest
researchers who found evidence of immune system abnormalities, viral
infections and other physical factors, while simultaneously pushing
their own agenda - even to the extent of changing the very definition of
the disease itself. They have misappropriated earmarked Congressional funds for their own use, and when questioned about it stated that they would repay the embezzled funds just as soon as Congress had earmarked more funds for CFS research - effectively almost stating that they would embezzle any new grants.


Should you want a good investigative research article, I would commend
to your attention the story of how a chronic and debilitating illness
that affects more people than AIDS, has been systematically kept from
effective investigation. "Osler's Web" by Hillary Johnson would be a
good starting point.


Gerald R. Campbell, Ph.D.

Some theoretical factors to consider when analysing research findings in CFS

Some theoretical factors to consider when analysing research findings in CFS

Some researchers appear to think it worthwhile to mention whether CFS research participants are in receipt of state benefits or insurance payments, are awaiting an appeal to settle a claim, are members of a support group and what their 'beliefs' are about the cause of their illness.  I imagine such researchers consider these 'secondary gains' and/or motives for remaining, or appearing to remain ill that could influence the outcome of research.  The following are some other factors that might be worth considering when weighing-up research results.

1. Coping effect of CBT unrelated to treatment of illness

A selling point used by some, is to inform people with CFS that CBT is used for other illnesses; i.e., MS, diabetes, etc.  CBT helps some people with those illnesses to cope better but it does not cure the disease.  Therefore a certain degree of coping effect must be deducted from all reports or measures of improvement with CBT for CFS; because at least some proportion of any improvement recorded only relates only to coping and not to treatment for the illness.  I imagine that some Wessely school theorists would claim that CFS is only in fact; an illness of not coping and therefore improving coping is affective or even curative.  However, the evidence from biomedical research and the results of the PACE Trial, suggest this is an erroneous belief.

2. Inclusion of non-target patients in research.

It is notable that in their retrospective analysis of their 2008/9 patients by applying the Fukuda criteria for Chronic Fatigue Synfrome (CFS), Newton et al (2010) found that 40% of all fatigued patients referred to the Newcastle CFS clinic were subsequently found not to have CFS.  47% of these were found to have a chronic disease and 20% a primary sleep disorder and 15% psychological/psychiatric illnesses causing their illness.  The entry criteria in the PACE Trial was CFS diagnosed by the Oxford criteria which does not diagnose CFS as many authorities understand it.  It might be a sensible precaution to view outcome data sceptically to allow for the inadvertant inclusion of non-CFS, psychologically ill participants and those deconditioned by a sleep disorder.

3.  Use of subjective measures.

In the PACE Trial CBT and GET explain CFS symptoms with theories of fear avoidance, abnormal illness beliefs, deconditioning, etc.  Yet the PACE Trial used almost entirely subjective measures such as quality of life, symptom and fatigue questionnaires to assess baseline and treatment effect.  So although the theories underpinning the interventions on trial imply that people with CFS are incompetent to assess and interpret their symptoms; the PACE Trial used these same people's assessment as evidence in a controlled clinical trial.  It is notable that patients wanted more objective measures in the PACE trial - but the researchers actually reduced the use of objective measures.

4. Client deference and subjective measures

When research uses a one-to-one, client/therapist scenario a therapeutic alliance occurs in which the balance of power is unequal.  How participants rate subjective questionnaires may be influenced by how a client feels about their therapist, whether they like, dislike or possibly even fear them.  In "Clients' Deference in Psychotherapy", Rennie (1994) identified 348 instances of client deference to the therapist occurring in just 16 therapy sessions.  These most commonly related to the client's, "Concern about the therapist's approach", followed closely by "Fear of criticising the therapist".  Rennie also noted that therapy provided free of charge (as in research) was a factor likely to engender deference.  In the context of CFS psychosocial research, this suggests that participants (who may have been subjected to pressure to doubt their own experience and rationality) may rate subjective measures deferentially; i.e., in a way that they believe the therapist would approve of.

5.  Natural improvement not associated with treatment.

The National Institute for Clinical Excellence in association with Royal Society of Medicine (2002) state: "It is generally recognised that prognosis is variable.  Many patients improve quite quickly. However, in those who do not improve quickly, the illness can persist for a long time.  The prognosis tends to be worse for severely ill patients than for less severely ill patients."  This shows that research into CFS that does not use a representative sample (i.e. including 25% severely affected and long-term patients) cannot be extrapolated to the patient population as a whole.  It also suggests that participants who have been ill for (guestimate) less than 2 years are potentially confounding - because many of these are expected to naturally improve.  In the PACE Trial, 45% of participants in the control group spontaneously improved.

6. Chronic Infectious Mononucleosis.  (This factor might combine with or be separate from 6 above)  Professor White, Principal Investigator of the PACE Trial was a co-author of Candy et al (2002) which states, "The prevalence of prolonged illness after IM varies, from 1.5% to 56%.  The symptom consistently reported to have longest duration was fatigue.  One of the two largest prospective studies found that, six months after onset of IM, physical fatigue was present in 40% of subjects and 9% to 22% had a CFS" (the latter was also White's research).  Candy et al also remark, "Physical deconditioning may play a key role in causing prolonged symptoms".  According to Thompson et al (1969, cited by Candy et al), 56% IM cases reported fatigue at 6 months, and 16% at 11 months.  Therefore, many chronic IM patients spontaneously improve and might be expected to respond to rehabilitation.  The inclusion of chronic IM patients could confound research of interventions in CFS by biasing results towards improvement.  Research that does not state that such patients have been identified for sub-grouping or exclusion might require more sceptical examination.

7. Willingness to participate

Some patients may feel reluctant to refuse participation in research if their medical professional suggests they consider taking part.  Given the difficulty that people with CFS sometimes have in getting medical support it is not difficult to imagine that some may be very reluctant to appear to be going against their medical professional's wishes when research participation is mentioned.  Then, once enrolled, in the participant's mind there might be a sense of a parallel relationship influencing them; as if their medical professional were looking over their shoulder, as it were.  Aside from the possibility that this might constitute a form of invisible coercion; it could also influence how a participant reports the effect of interventions.  They may not want to appear uncooperative or critical, but if they don't improve they might compensate for the conflicting pressures they are feeling by indicating modest improvement.  This could be face-saving for both the referring doctor and the patient.  The latter, because they do not have to confront their vulnerability or how this could have led to their reluctant participation.  If correct, this would indicate that some participants might rate subjective measures in a political context.  Ironically, the Wessely school researcher's attention to benefits claimants and support group members seems to be suggesting precisely this type of problem; but in their case they see the problem as resulting in 'worse' results for their therapies; whereas some participants that feel coerced might be distorting results by making them look better than they really are.

Some researchers give consideration to 'Double-Vulnerability'.  This occurs when potential participants have more than one disempowering factor making them especially vulnerable; so that what might be considered acceptable encouragement and  persuasion for others is felt as, and operates like coercion.  Due to the considerable disability and losses often seen in CFS plus the disenfranchising nature of the diagnosis with stigma and prejudice, people with CFS should be considered to have Double-Vulnerability.  Methods of recruiting participants with the illness require careful consideration.

8. Participant conflicts of interest.  When Wessely school researchers report participant factors such as benefits or insurance claims and support group membership (which they associate with negative outcome) they do not appear to question: why did patients with apparently conflicting interests enrol in the first place?  Did they join just to spoil the research or is there some form of coercion going on?  Or perhaps: do patients who are informed and supported by fellow patients feel empowered to be more critical in their analysis of a treatment?  And maybe: what does the additional stress of a benefits claim do to a vulnerable and disabled patient's illness when it threatens support that they are dependent upon?  These rational questions do not appear to receive consideration.

9. Reporting research results. The PACE Trial results have shown quite convincingly that Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) are not effective interventions for patients with Chronic Fatigue Syndrome (CFS).  Only 14% -16% more participants in the GET or CBT groups improved compared to the control group.  The results of this major controlled clinical trial do not support the recommendation of either of these therapies.  Yet some in the media have reported this £5 million experiment as though it indicated that GET and CBT are useful; apparently because of the way the results were represented to them.  It seems that the press conference paid little attention to the failure of the therapies to make any significant difference over and above the Control Group, but focussed on the difference between GET or CBT when compared to Adaptive Pacing Therapy (APT).  This resulted in some of the media reporting the research as though it suggests that people with CFS simply need to do more exercise; when what the results actually show is that such behaviour modification makes no difference to the majority of patients.

10. Competing interests don't just mean 'money'.  There are sound reasons for the requirement for researchers to declare 'conflicting interests'.  These sometimes relate to financial matters; yet vested interests are not limited only to 'money'.  Professional credibility could be equally important.

Some of the researchers in the PACE trial espouse theories derived from what is referred to as the - 'Wessely school', in that they are proponents of Professor Simon Wessely's theories about CFS.  Professor Wessely's theories of CFS include hysteria and phobia.  In 1994 he stated; "I will argue that ME is simply a belief, the belief that one has an illness called ME".

Wessely school theories underlie the professional practice of some involved in the PACE Trial research, as well as 2 of the therapies being tested.  If the research results contradict Wessely school theories it might be humiliating to those whose professional practice is based on these theories.  It could show that they have wasted time and money and involved participants in futile research.  It might indicate that theories about, and treatment of patients has been inadequate or even completely inappropriate.  To some, this might appear to be a competing interest.

Peter Kemp



REFERENCES



Candy, B., Chalder, T., Cleare, A., Wessely, S., White, P.D., Hotopf, M. 2002. Recovery from infectious mononucleosis: a case for more than symptomatic therapy?  A systematic review.  British Journal of General Practice.  October.



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