Friday, December 25, 2009
ME/CFS that the concept of XMRV actually causing the illness almost doesn't
enter their consciousness. Dr. Reeves, head of the CDC project on CFS has
made only one comment to my knowledge, that he "doubted" this would turn out.
What a comment. Why not "Interesting." or "we will see."
Hillary Johnson made some interesting observations. First, "Why wasn't
everyone demanding dozens of replicative tests on the prostate cancer
findings?" Yet when CFS is implicated we will need twenty studies which replicate
the first. And if some poor studies do not find XMRV, they will be given
preferential weight to studies that actually find it.
Thursday, December 24, 2009
Pain Pills Can Be Deadly
I hope that everyone is able to have a good holiday season.
XMRV: Quiet Time
My thanks to all those who came to the lecture December 6th on XMRV, and to all those who have kindly donated to the research group. None of the research group is paid from these funds, and if we were to stop working the money will be forwarded to some other group working on ME/CFS, probably WPI. In the spirit of full disclosure, pizzas and other relatively inexpensive luxuries do come from these funds, but no vacations in Maui. I had wanted to write back to persons who have donated but that has proven impossible.
The December 6th lecture was well attended. The reason I did not tape it or put it on the web is for two reasons. First I do not know how and we are kind of busy and I didn't want to take time to learn. And secondly, I expect that every few weeks the material will change and I want to keep this talk up to date. I expect that six months from now the talk will be completely different.
I have had a few requests to give a talk on XMRV, and I am happy to do so, it is one of the joys of being retired. The material I present will be either published, from very credible public sources, or my own personal opinion. I will not share back room gossip, even if it is the stuff that makes my socks roll up and down. My goal is to insist that good science goes into discovering what role, if any, XMRV has in ME/CFS. I will go anywhere in the US if the supporting group covers costs and offers a small honorarium. I think spin off benefits from these talks will be to re-invigorate support groups. Dr. Klimas said in her last talk that now is the time for people to get active and I completely agree.
ME/CFS Essay: Nature Abhors a Vacuum
I have a patient in my practice by the name of Sandra Cousins (an obviously false name). She developed CFS somewhere around the age of nine, and I can remember her confusion going from doctor to doctor, occasional visits to the psychiatrist and acupuncturist. Over the years she has been diagnosed with Lyme disease, depression, atypical MS, arthritis, migraine, irritable bowel and lupus, but no one knew what she had. Like many patients, she could tell that, when the medical provider attended to the chart and did not look her in the eye while delivering a diagnosis, the provider had absolutely no idea of what was causing her illness. Same old story.
Years went by, and after five years of illness she improved enough to deny the existence of any illness. She was getting by. She could not go out drinking with her college friends because it made her very ill and then have to miss a few days of classes. All she could do was classes and organize her study time well enough to pass. But she was "fine."
Work after college was a disaster, as was her love life. But she got by, she was "fine." She stopped going to doctors because they had little to offer except medications that made her feel more ill. She resented being told she was resistant to the obvious truth that she was healthy as a horse.
About ten years ago, Sandra went through a change. She decided that she was depressed and that the doctors were right. She took low doses of antidepressants which did little good but made her doctor happy. She joined support groups, went to therapy, and committed herself to accepting the truth. Or at least accepting what other people considered true. Lots of things didn't fit, but at least now she wasn't crazy, she had a legitimate diagnosis, she was depressed. Being depressed and making up somatic symptoms (somatisizing) was a lot better than being crazy. She was no longer lost in the never-never land of no-diagnosis. She belonged. She went on social security disability because she was unable to maintain eight hours a day five days a week because of the depression.
When Sandra was evaluated for ME/CFS, she was classic. She did not feel despair, in fact, now that she was "depressed" she felt quite good. Except for the pain, sleep problems, exhaustion, abdominal pain, annoying lymph node tenderness and the foggy memory that is.
Nature abhors a vacuum; it is much better to have an incorrect diagnosis than no diagnosis at all. Even when the immunology testing, orthostatic testing, and 2 day exercise testing essentially confirmed the diagnosis of ME/CFS, Sandra was reluctant to believe it. Being "depressed" for the past ten years made her more happy than some unknown diagnosis that doctors didn't believe in.
XMRV Study Notes:
In a recent note by Suzy Chapman on Co-Cure, she quotes Dr Charles Shepherd as writing "...Not surprisingly, the first stage of the attempt to replicate these results has resulted in various international groups almost entering a race to see who could replicate or refute the WPI results first. And this has meant they have gone for an easy and immediate source of patient material - stored blood samples. I am not aware of any stored blood samples here in the UK that are from patients who meet Fukuda plus Canadian criteria and I doubt if there are any.
This brings up really important issues in interpreting the results of studies that will come out over the next six months. In my practice over the years, I have seen the whole range of patients from kind-of tired to bedridden orthostatic intolerance. Despite what the different criteria attempt to prevent, much of the diagnosis is based upon using the "force". There are some clinicians who diagnose CFS and I have absolutely no idea of what their patients are like. Through years of observation, I do have a concept of what Dan Peterson's patients are like.
So is XMRV in really severe ME? CFS? Orthostatic intolerance? CFS plus POTS? Mild fibromalgia? Atypical MS? CFS with or without depression? Chronic Lyme disease? Multiple chemical sensitivities? And what about stored samples? Samples taken in EDTA or heparin? And so on.
So what does this mean? It means that if someone can't find XMRV in a study, it is either because it is not in the patients they tested, or their lab could not detect it even if it was there. Or the strain might be different, or they used the wrong tubes, or the diagnosis was wrong. And on and on. Again using the "force", I would not be surprised if some of the quickest replication studies fail to confirm XMRV. But as long as people do not jump to conclusions too quickly, science will win out. Truth will win out. That's all I am looking for.
Changing Standards to Establish Cause of ME/CFS
Dr. J Silver in a review in Journal Watch said, "XMRV might be a cofactor in another infectious process, or the immunologic problems of CFS patients may increase their susceptibility to XMRV infection. Patients with depression also have impaired immune function; could psychiatric illness predispose to XMRV? The 4% prevalence of XMRV infection in the control group might indicate that XMRV infection is a risk factor for development of CFS."
I am amazed how mainstream medicine is so fixed in their biases against ME/CFS that the concept of XMRV actually causing the illness almost doesn't enter their consciousness. Dr. Reeves, head of the CDC project on CFS has made only one comment to my knowledge, that he "doubted" this would turn out. What a comment. Why not "Interesting…" or "we will see…"
Hillary Johnson made some interesting observations. First, "Why wasn't everyone demanding dozens of replicative tests on the prostate cancer findings?" Yet when CFS is implicated we will need twenty studies which replicate the first. And if some poor studies do not find XMRV, they will be given preferential weight to studies that actually find it.
Her second point was that "HIV was hailed as the cause of AIDS in the U.S. in the spring of 1984, after the NCI found isolates in fewer than fifty patients. A few weeks later, an NCI scientist isolated the virus from the blood of a nurse in Los Angeles who fell ill with AIDS after a blood transfusion and the virus was found in the donor blood. That's all it took." Dr. Dan Peterson said at the recent CFSAC meeting that a transfusion case of CFS and XMRV has already been found and traced back to the donor.
During the next six months we will know. I am confidant that enough good scientists will try to replicate the WPI study that a bad study here and there will not bury the subject. Meanwhile, what is happening? It is possible that the skepticism is so great that absolutely nothing is happening now. But my hope is that in back rooms across the world scientists are quietly working on this, designing studies to test blood banks, designing treatment studies. Right now is "quiet time"; I hope they are using this quiet time to make some real progress.
Question and Answer
Question: How does XMRV fit in with slow onset ME?
Answer: I have no idea. But in six months to a year we will know. First option is that XMRV has nothing whatsoever to do with ME, it was a fluke, and no one, anywhere, will be able to find it even when they are looking without bias, and in good patients, and with good science. Secondly, XMRV may have either no symptoms, or relatively minor symptoms, and slowly affects NK cells and lymphocytes, permitting reactivation of other viruses over some time.
The Australian government and the CDC may have already done the study revealing the answer, the "Dubbo" study (Hickie I, Davenport T, Wakefield D, et al. Post-infective and chronic fatigue syndromes precipitated by viral and non-viral pathogens: prospective cohort study. BMJ 2006;333.)
As you may remember, a small percentage of persons developed ME/CFS after Epstein-Barr virus, Ross River virus or Q fever. They must have saved blood from those who came down with ME/CFS and those who did not. Test the blood for XMRV. If it is in the ones who came down with ME/CFS, but not present in the blood of those people who had regular mononucleosis and quickly recovered, we would have the answer. Ah…if only it were that simple…
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Disclaimer Any medical advice that is presented in the Lyndonville News is generic and for general informational purposes only. ME/CFS/FM is an extremely complex illness and specific advice may not be appropriate for an individual with this illness. Therefore, should you be interested or wish to pursue any of the ideas presented here, please discuss them with your personal physician.
© 2009 David S. Bell
David S. Bell/Lyndonville News
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Wednesday, December 23, 2009
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ME/CFS is not a psychiatric
Letter to Prime Minister
Derek Enlander M.D.
860 Fifth Avenue
New York NY 10065
212 794 2000
23 Dec 2009
Dear Prime Minister
New medical research, relating to M.E. (myalgic
encephalomyelitis) and the XMRV virus, have
shattered the MRC belief that M.E. is a psychiatric
The Chief Medical Officer( CMO) and MRC have for
many decades adhered to the idea that these
patients could be lined up as a psychiatric problem.
Certain British psychiatrists used this notion for their
own self interest in obtaining government research
grants and conflict of interest payment from
disability insurance companies.
The recent M.E. research is not necessarily related
to the resignation of Sir Liam Donaldson from the
post of Chief Medical Officer(CMO) together with the
resignation of the chief executive of the Medical
Research Council, Sir Leszek Borysiewicz.
These resignations however give the present or next
government a chance to clean house.
Both these gentlemen have failed the thousands of
patients who suffer from myalgic encephalomyelitis
(M.E.), not only failed to recognize their disease but
have gone one step further and labeled them as
psychotic or neurotic.
They have thus been deprived of proper treatment
and relegated to a psychological cognitive training or
worse still a Graded Exercise Therapy (GET), both of
which are defined in medical literature as useless
and in some cases dangerous.
Both these gentlemen failed to react or examine the
motives of psychiatrists promoting these methods.
M.E. is a physical disease and British Medical
establishment must recognize the fact and
underwrite proper research rather that promote
useless psychiatric methods.
Dr Derek Enlander
explain - CFS is actually neither. "We know in part" pretty much describes
all of medicine, but it doesn't automatically make it enigmatic.
Although the research water is muddied by the partially successful
career-long attempts by psychiatric liasons Simon Wessely and Peter Denton
White to use CFS and other similar organic diseases to illustrate the
principles of psychiatrist George Engel's biopsychosocial theory, the
biomedical evidence is no more enigmatic than that of other organic
Biomedical researchers have no biomarkers and/or objective tests for
Alzheimer's Disease, Huntington's Disease, diabetes or Parkinson's Disease for example, but no one uses the term enigmatic or enigma to describe them. Nor is the etiology of many organic diseases known including that of most of
the diseases listed above, but once again, no one uses the term enigma or
enigmatic to describe any of them.
PHILADELPHIA, Dec. 16, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.
(NYSE Amex:HEB) (the "Company"), stated that on December 11, 2009, the
Company, via its manufacturing subcontractor, in Spokane, WA, submitted
comprehensive new data to the regional office of the Food and Drug
Administration ("FDA"), Seattle, WA, which Hemispherx management believes
demonstrate that certain manufacturing issues noted in earlier pre-approval
inspections at the facility have been fully addressed. The referenced
reports on Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic
being developed for potential treatment of Chronic Fatigue Syndrome ("CFS"),
are the combined work-product of the staffs at Hemispherx and its
subcontractor. These are the same manufacturing issues sited in previous
10-Q's and the recent 10-K. These manufacturing issues were also part of a
Complete Response Letter from the FDA described in a December 1, 2009 press
About Hemispherx Biopharma
Chronic Fatigue Syndrome is an enigmatic, profoundly debilitating and
potentially life-threatening disease with which a new retrovirus was
recently associated. Researchers are investigating the possible role of this
virus in the symptomatology of the disease using Ampligen(R) as an
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company
engaged in the manufacture and clinical development of new drug entities for
treatment of seriously debilitating disorders. Hemispherx's flagship
products include Alferon N Injection(R) (FDA approved for a category of
sexually transmitted diseases) and the experimental therapeutics Ampligen(R)
Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent
experimental RNA nucleic acids being developed for globally important
debilitating diseases and disorders of the immune system. Hemispherx's
platform technology includes large and small agent components for potential
treatment of various severely debilitating and life threatening diseases.
Hemispherx has in excess of 50 patents comprising its core intellectual
property estate and a fully commercialized product (Alferon N Injection(R)).
The Company wholly owns and exclusively operates a GMP certified
manufacturing facility in the United States for commercial products. For
more information please visit
Information contained in this news release other than historical
information, should be considered forward-looking and is subject to various
risk factors and uncertainties. For instance, the completion of the NDA
filing process with Ampligen(R) and the receipt of a Complete Response
Letter from the FDA do not imply that the Company will be able to
successfully comply with any or all of the requirements requested in that
Letter or that the product will ever be approved for commercial sale. In
addition, the strategies and operations of Hemispherx involve risk of
competition, changing market conditions, change in laws and regulations
affecting these industries and numerous other factors discussed in this
release and in the Company's filings with the Securities and Exchange
Commission. Any specifically referenced investigational drugs and associated
technologies of the Company (including Ampligen(R), Alferon(R) LDO and
Oragens(R)) are experimental in nature and as such are not designated safe
and effective by a regulatory authority for general use and are legally
available only through clinical trials with the referenced disorders. The
forward-looking statements represent the Company's judgment as of the date
of this release. The Company disclaims, however, any intent or obligation to
update these forward-looking statements. Clinical trials for other potential
indications of the approved biologic Alferon N Injection(R) do not imply
that the product will ever be specifically approved commercially for these
other treatment indications; Similarly, the completion of NDA filing process
with Ampligen(R) does not imply that the product will ever be approved
Psychological Medicine, Volume 40, Issue 01, January 2010, pp 172-173
doi:10.1017/S0033291709991413 (About doi), Published Online by Cambridge
University Press 08 Oct 2009
Sharpe, M, Stone, J, Hibberd, C, Warlow, C, Duncan, R, Coleman, R, Roberts,
R, Cull, R, Pelosi, A, Cavanagh, J, Matthews, K, Goldbeck, R, Smyth, R,
Walker, A, Walker, J, MacMahon, A, Murray, G, Carson, A (2009).
Neurology out-patients with symptoms unexplained by disease: illness
beliefs and financial benefits predict 1-year outcome
Can be read for free at:
If those links I used don't work, follow the link on the home page for the
issue which is a free, open access issue:
(The start is a little difficult to read but don't let that put you off.
Well done to Simon. Tom)
Tuesday, December 22, 2009
27 N. Wacker Drive, #416
Chicage, Illinois 60606
Read the VerticalResponse marketing policy.
Sunday, December 20, 2009
Chronic Fatigue Syndrome.
Authors: Jason, L.A., Timpo, P., Porter, N., Herrington, J., Brown,
M., Torres-Harding, S., & Friedberg, F. (2009).
Journal: Journal of Mental Health, 18, 549-556.
Background: Self-report data collected through interviews has been one
of the primary ways of assessing symptoms of patients with chronic
fatigue syndrome (CFS). An alternative way to collect data involves
activity logs, which involves patients writing down the pattern,
intensity, and qualitative nature of activity over several days.
Aims: We examined the associations between activity, evaluation of
activity and symptoms.
Methods: Activity log data over a two day period of time were used in
the present study using a sample of patients with diagnosed CFS.
Results: Findings indicated that the percent of time spent feeling
fatigued was positively associated with a higher percent of time in
pain and doing activities that were fatiguing. However, time spent in
meaningful activities was associated with less fatigue.
Conclusions: These findings and others suggest that activity logs can
provide investigators and clinicians with valuable sources of data for
understanding patterns of behavior and activity among patients with CFS.