Comments on the CDC's CFS Strategic Plan (May 2009)
Tom Anderson
The CDC
has systematically failed its mission to protect the health of the community with
regard to the uncontrolled spread of the pandemic disease Myalgic Encephalomyelitis
and the devastation it has wreaked on the lives of millions of people around
the world since the CDC became negatively involved with this infectious disease
25 years ago while in the midst of the AIDS pandemic.
It
began with a botched investigation of a major outbreak of M.E. in a tourist
village at Lake Tahoe, and continues to the present day with its 25-year experiment
in rebranding the disease as CFS, a “stress-related disorder” using the latest in
a long line of vague criteria, the Reeves “empirical” definition – a subjective
questionnaire about “unwellness”. CFS patient organizations have not stepped up
to the plate either and educated patients about the misrepresentation of M.E.,
they have supported and promoted it.
The CDC is not leading the world as it
claims, independent research has had to step in and it is the Whittemore
Peterson Institute, the Chia Enterovirus Foundation, MEResearchUK and The CFS
Research Foundation that are unravelling this complex disease.
The
objective of the 5-year “CFS” strategic research plan is to continue to subvert
all knowledge and understanding of Myalgic Encephalomyelitis by following the
UK psychiatric model which produced the dangerously flawed NICE Guidelines for
CFS/ME - for vaguely defined “chronic fatigue” patients -and the funding of
chronic fatigue clinics which are detrimental to M.E. patients and deprive them
of the medical care that they would receive if they had any other recognised
neurological disease.
The vague goals of the Draft Strategic Research Plan General Outline use the keywords favoured
by the psychiatric model – psychosocial, psychoneuroendocrinologic, risk
factors, management, intervention, and laughably – to move CFS into the mainstream
of public health concerns.
A decision 25 years ago to alert the public to the M.E.
pandemic as they have done with the current H1N1 flu would have been the
responsible action of the CDC in this regard, and recognition of the biomarkers
discovered in the 1980s would have legitimised the serious nature of the disease.
Knowledge of the previous epidemics would have apprised all medical personnel of
the parallels with poliomyelitis and enteroviral etiology, enabled early
detection, research into pathophysiology and treatments, and the prevention of
long term disability. Medical treatments would be approved now to stop the
suffering and needless deaths that have been ignored or cruelly stigmatized.
Given the failure of the CDC to alert the public and
contain this pandemic, a Congressional Inquiry into this appalling state of
affairs is long overdue and desperately needed - after 25 years the pandemic is
still hidden, the numbers of patients neglected by the medical profession are growing
and the hidden death rate is steadily climbing. The CDC has had every
opportunity to correct this over the last 25 years, and this research plan demonstrates that it is incapable of acting in the public interest.
John Anderson
KG
Comments on the CDC CFS Research Program “Strategic Research Plan”and on Related Concerns, Including Mission
I appreciate the opportunity afforded by the Centers for Disease Control for members of the public to comment on the CDC’s “Chronic Fatigue Syndrome” (CFS) “Research Program” (RP), as reflected in the Draft Strategic Plan presented by the RP. Many people have already given comments at the public meeting or in writing, which deserve full consideration. Some of my comments reflect the benefit of others’ statements, but mistakes are my own.
The Core Problem: Mission - Canaries, or Yellow Flying Animals?
In 2003, members of the CDC’s RP and other CFS investigators published a paper discussing some of the difficulties in application of the 1994 CFS research case definition, and outlining “an approach to guide systematic, and hopefully reproducible, application of the current case definition.” The RP’s goal of producing an “empirical definition” that would operationalize the 1994 CFS research case definition had broad support, as an important step to making research into CFS more consistent, replicable, and comparable. Yet, the so-called “Empirical Definition” produced by the RP, and currently being applied by the RP, is being used only by the RP, and not by other researchers. Why? Because the “Empirical Definition” is inapt.
Problems with the Empirical Definition have been discussed by many commentors, and are evident in the pre- and post-publication comments on the key papers published by the RP applying it to their population studies. There are undoubtedly difficulties with trying to produce a “systematic” and “reproducible” application of the 1994 Research Case Definition, and probably no perfect approach. But the efforts of the CDC RP have produced an entirely unsatisfactory approach. The “Empirical Definition” is not merely imperfect, it misses the mark. Faced with the criticisms about how it has missed the mark, and suggestions for how it might take better aim, the CDC RP has “stuck to its guns” and substituted a different, bigger target.
Much of the frustration expressed by stakeholders may be attributed to this and similar bits of legerdemain by the CDC RP. The RP’s continued insistence on using the “Empirical Definition” and the name “CFS” results in an inefficient use of resources and lost opportunities at the CDC level, inaccuracies in analysis, and confusion and inefficiency in the rest of the world. This is what one would expect if a program to study canaries instead produced an empirical definition of yellow flying animals and proceeded not only to study them, but to call them canaries.
So, from my perspective, discussion of a “Strategic Research Plan” is misplaced, until there is clarity about exactly what the mission of the CDC’s “CFS” RP is.
Proposals
I would urge the CDC, through its Division of Viral and Rickettsial Diseases, to do the following, in consultation with independent external investigators:
1. Promptly clarify the current mission of the RP to refocus its “CFS” research efforts on the illness and patient group described by the 1994 Research Case Definition. This is important to promote consistency of research results and to make efficient progress in determining etiology and pathophysiology.
2. Promptly share all raw data from population studies and any other research with independent external investigators.
3. Promptly establish terminology other than “CFS” that describes the illness / patient group identified by the Empirical Definition in the CDC’s population studies, and clarify in a manner apparent to a lay reader that research results thus far reported by the RP using the “Empirical Definition” are based on that group, and not on 1994 CFS.
4. Determine how best to re-analyze and re-present the results of the population studies to make them of maximum relevance and utility to the research of 1994 CFS.
5. Consider the relative importance and feasibility of using data from the population studies to operationalize the 1994 CFS Research Case Definition, as originally proposed in 2003, and ensure that any resulting operational definition of CFS satisfies stakeholders of 1994 CFS as to its relevance and usefulness.
6. If and when deemed relevant, and in consultation with appropriate groups within and outside the CDC, consider whether the population studies using the Empirical Definition have identified an illness and patient group other than 1994 CFS that warrants further examination by the CDC and, if so, under which program and with what resources, ensuring that resources allocated for 1994 CFS research are not used for that purpose.
7. Endorse and publish the Canadian Consensus CFS definition for clinical, as distinguished from research, purposes.
8. Ensure that any educational programs and intervention trials have broad support from 1994 CFS Stakeholders before committing CDC resources to them. In particular, ensure that these are consistent with the admonition, “First, do no harm.”
9. Develop a strategic plan for the CDC RP that determines how to best leverage the existing resources of the CDC, including raw data and tissue samples, to identify subgroups of 1994 CFS, and the etiologies and pathophysiologies associated with them.
10. In connection with the previous proposal, decide on additional testing to be done on existing and new tissue samples, with particular consideration given to new viral chip technologies and other types of pathogen-related tests.
Thank you for your consideration. 1994 CFS is well known to have a huge economic impact in the U.S., and a huge personal impact on those affected by it. It is important, and urgent, that the CDC better deploy its resources in connection with the understanding, and ultimately control, of 1994 CFS.
KG
Robert Miller
Hi, My name is Robert Miller and I am a CFS/ME patient. I have remained
ill for over 20 years, due largely to the complete Failure of the CDC to do it's
part for this patient population.
CDC stands for Centers for Disease Control and Prevention, of which it (CDC) has
done neither Control nor Prevent this life destroying illness. I am for the most
part Chained to my home due to CFS/ME and dependent upon my wife and two 8 year
old sons, which I am unable to have a normal relationship with. My wife works
fulltime and stands-in for me allowing our boys to have somewhat of a normal
life.
I believe I have done my part to further the science of this illness. I have
given blood, muscle tissue, spinal fluid and a lymphnode to further along
research in CFS/ME. I have also volunteered in FDA approved clinical trials to
test and further along treatments. With that said, It is my opinion in order to
properly "Shape the Strategic Research Plan" One should start at the top.
So, First:
Replace the current head of the CFS program Dr. Reeves. I am appalled by Dr.
Reeves, as I have attended CFSAC meetings in which Dr. Reeves head of the
CDC's CFS program does not even have the respect or decency to stay and listen
to the testimony of CFS patient who have traveled and suffered to attend just to
give their testimony. When it is time for public comments Dr. Reeves RUNS out of
the meetings before CFS patients begin to speak. We must start at the Top to
change the direction of this program. No matter how much money the program has,
it will be a failure until the head of this program is changed.
Second: CDC
should make available ALL data it has collected to any and all researchers
requesting such information.
Third:
To expedite Clinical studies, Lab studies and Provider education the CDC needs
to support and fund Centers for Excellence like patients have for HIV and
Cancer. There is such a center being built as we speak, with the support of
mostly private and state funding. It is The Whittemore Peterson Institute for
Nueroimmune Disease in Reno, Nevada. There are also universities such as the
University of Miami which Dr. Klimas is part of along with UCSF that we know
have the infrastructure in place.
I applaud all of the patients who made the trip and those who have called. Due
to my health I was unable to attend. It does not surprise me that several of
today's callers (CFS patients) are unable to participate even via the phone,
this is very draining and hard to do for us. I am fried and fatigued just
sitting here trying to follow along. I also applaud the husband of Allison who
is a caregiver, it is a very hard thing to do and I appreciate
him. Thank you.
Robert Miller
Mary Schweitzer
* A completely new group should be created to operate and run
the CDC's program on CFS. In the 25 years since the CDC was first contacted
about the mid-1980s cluster outbreaks, the agency has done absolutely nothing to
help a single patient, and done much that has harmed patients. At least one
million American adults have this disease. CDC admits that at least 85% of
patients do not have a diagnosis at all, and half of all patients cannot work
because of the severity of the disease. That's a failing grade by anybody's
scale.
This is a travesty. This is a disease that is as severe as multiple sclerosis.
The CDC's behavior over the past quarter-century towards these patients is
completely unacceptable.
* CDC should immediately adopt the Canadian Consensus Document
for clinical work. It could use
updating, but it still paints a much more accurate picture of this complex and
baffling illness. U.S. Drs. Dan Peterson, Nancy Klimas, and Martin Lerner were
on the committee. And it does not rest on the theories of the narrow
"biopsychosocial" school of British psychiatry. A summary of the Canadian
consensus document can be downloaded here:
http://www.mefmaction.net/Portals/0/docs//ME-Overview.pdf
* In 1994, The Annals
of Internal Medicine published
what has come to be called the Fukuda Definition for research into the disease
Chronic Fatigue Syndrome. Almost
all the useful research on CFS was done using this definition. [Fukuda et al,
"The chronic fatigue syndrome: a comprehensive approach to its definition and
study."
Annals of Internal
Medicine, (1994) 121:953-959.]
However, in 2005-2006 the CDC shifted to the Reeves
"international empirical" definition. The
main difference between the Reeves definition and the Fukuda definition is that
the Fukuda definition did not admit patients who had a diagnosis of depression
for research purposes. Dr. Reeves lifted that constraint, with the proviso that
the bout of depression have resolved at least
five
years before the onset of fatigue. [Reeves
et al. "Identification of
ambiguities in the 1994 chronic fatigue syndrome research case definition and
recommendations for resolution."
BMC
Health Services Research (2003)
3:25.
http://www.biomedcentral.com/1472-6963/3/25]
The "empirical" part of the definition refers to a set of
questionnaires. Unfortunately,
the questionnaires do not achieve the stated goals of the international
committee to revise the Fukuda definition. The questionnaires
were verified during a two-day hospital stay in Wichita, Kansas, where they were
only able to find
6 patients identified with CFS-Fukuda who could
be diagnosed with CFS with the questionnaires. They added another 4 patients who
had "insufficient symptoms of fatigue" during the Wichita surveillance study who
now met both the Fukuda and Reeves definitions of CFS - but that was it.
In total, the questionnaires identified 43 patients as having
CFS, and at most only 10 could have been categorized as "CFS" using the Fukuda
definition. That is a slim basis
for a new definition, and a very slim basis on which to market a set of
questionnaires. [Reeves et al. "Chronic fatigue syndrome - a clinically
empirical approach to its definition and study."
BMC Medicine (2005) 3:19.
http://www.biomedcentral.com/1741-7015/3/19
DePaul psychologist Leonard Jason demonstrated recently that,
when applied to a set of patients
in Chicago diagnosed using Fukuda, the questionnaires missed the sickest of the
CFS patients, and a third or more
of the
patients now included had a
major depressive disorder. Setting aside the depression, they still would
not have met the Fukuda definition. [Jason et al, "Evaluating the new Centers
for Disease Control's Empirical Chronic Fatigue Syndrome Case Definition,"
Journal of Disability Policy
Statistics (online first
10/21/08).]
Clearly this new definition represents not improvement but regression. I wonder
just who will be helped by it - because patients with depression who are
misdiagnosed as CFS are not going to be helped either, just as the worst
cases of CFS will be left behind.
Therefore, I join with other patients in calling for a
GAO investigation and/or
Congressional Hearings
into the inequitable treatment CFS patients have received from CDC regarding
both the allocation of funds, and their creation of a definition that ignores
the sickest of the patients (who had been included in the Fukuda definition),
and brings in patients with a professional diagnosis of major melancholic
depression.
* The Fukuda article does not just set a definition for "chronic fatigue
syndrome."
Fukuda assumed that the
patients diagnosed using this definition would represent a heterogeneous set,
and that the next order of business was to go about identifying subgroups making
use of biomarkers and objective measures. That the CDC has steadfastly refused
to do - instead turning to the new Reeves definition that actually makes the
population even more heterogeneous than it was.
---------------------------------
*My own history with ME/CFS:
I have had CFS since 1994, when I suffered a blackout in my office. When I came
to, I could not understand a single work of the bluebooks in front of me. I was
a tenured professor - you could say I made my living reading, analyzing,
writing, and giving lectures. But now I could not read, could not think, could
not write, and could not express myself.
I prefer to use the designation M.E. for myself because I fit the Ramsay 1988
description of Myalgic Encephalomyelitis (M.E.), the Hyde descriptions (1992,
2006), and the technical definition in Stedman's medical dictionary. I also meet
the Canadian consensus document's criteria for ME/CFS. M.E. and CFS are
classified together under neurology in WHO's ICD-10 at G93.3. However, since the
CDC does not recognize M.E., I will use "CFS" for the purposes of this essay.
For the record, in 1996 Dr. Simon Wessely informed me that I would not fit the
definition for CFS used in his practice because I had too many physical
symptoms.
The next four years I went downhill very quickly. By the fall of 1998 I had
severe cognitive dysfunction, including expressive dysphasia, poor short-term
memory, dyslexia, ataxia, and severe confusion. I could not pass a simple
Romberg test. As an example of the severity of the cognitive dysfunction, I once
poured a pot of coffee into a silverware drawer absolutely convinced it was a
cup. At night I would fall into dreams where I could walk again, and awake to
realize I could not.
I had constant pain behind my eyes and in the back of my neck, headaches that
sometimes reached the level of migraines, muscle aches, and sore, swollen
glands. On a bad pain day all I could do was lie in the dark, listening to my
favorite movies.
In the fall of 1998 I was diagnosed for the 37kDa Rnase-L defect, yet another
bout of active Epstein-Barr Virus, and active Human Herpesvirus 6, Variant A.
In February 1999 I began treatment with the experimental drug Ampligen, an
immune modulator that also works as an effective antiviral. Within six months my
symptoms had improved dramatically, and the three biomarkers disappeared. I
could drive, I could walk, I could read a newspaper. I danced with my son at his
wedding.
I went off Ampligen for a year, and then relapsed severely. So when I went back
on Ampligen I was determined to stay on it, even though it cost my family
out-of-pocket $20,000 a year.
[Note: Most patients don't make enough to afford $20,000 for a single
medication. Many of my friends live alone on less than $12,000 a year; many of
them have no health insurance - public or private - at all.]
A year ago February I lost Ampligen. It is supposed to be reviewed by FDA in
May, unfortunately before the new FDA head will be in place. I have not been
able to get it back, even paying for it - and I fear I will lose it forever.
By September I was in relapse. I have suffered from a low-grade fever for
months, the severe pain in the back of my neck and behind my eyes is back, with
the headaches. I have returned to the wheelchair. I cannot drive.
We can now add cytomegalovirus to the list of diseases. I scored 16 on a VO2 MAX
stress test, which by itself would categorize me as permanently disabled
according to social security. A SPECT scan showed "decreased activity in left
lateral temporal lobe and occipital lobes," and we can add a low natural killer
cell count and function to the list of immune problems. We tried Vistide for the
cytomegalovirus, but my liver rejected it.
I do not have a single day without pain. I do not have a single day without
confusion.
I have testified to the CFSAC for ten years about these biomarkers, symptoms,
and treatment. Did the CDC respond with interest in a possible subgroup? No.
With deeply flawed statistical analysis that must have Popper whirling in the
grave, and a naive interpretation of Occam's Razor, they take each possible
biomarker and test it on a sample of CFS patients, then report back that
everybody didn't have it, so it's not worthy of further study.
Well, yes. Everyone didn't have it. That is what you would expect out of a
subgroup, isn't it?
------------------------------
*We do not have a "fatiguing" illness.
We were assured when the
Holmes committee came up with the name
"chronic
fatigue syndrome" in 1987 that it
did not mean fatigue writ large,
that clinicians, researchers, and the public would understand it was a discrete
illness, different from "fatigue."
Now the CDC has even betrayed that promise, creating the category of
"fatiguing illnesses" and plopping CFS down in it as the poster child. I don't see leukemia there, or
congestive heart failure. Just other poorly understood illness that - frankly -
impact women far more often than men.
The current group's insistence that CFS is primarily a
"fatiguing illness" shows the absence of any real
knowledge of - or interest in - the disease as it exists for us out here, as we
have it. We can't find doctors. Nobody
understands what this is. That
Reeves himself would dally with the concept
of "fatiguing illnesses," especially
in
concert with British psychiatrists, shows that he either does not understand
the disease - although surely he knows everything I know about it - or he does
not really care. If you look at
the
pamphlets that CDC sends out to
medical personnel who request information on CFS, you will find that they
state starkly "There are no tests
and there are no treatments." That is simply not true.They devote an
inordinate amount of print to
"CBT"
(Cognitive Behaviour Therapy) - a
type of analysis developed by British psychiatrists, using a different
definition entirely for CFS, who claim that they need to "learn better illness
beliefs,"
GET (Graded Exercise
Therapy), which claims to be able
to return patients to work with graded exercise, no matter how sick they start
out,
and the omnipresent SSRIs.
Imagine telling a roomful of patients with MS they would be fine if they just
learned to "quit the sick role" and began to exercise again. What must Dr.
Reeves think of us?
-----------------------------------------------
* Shouldn't the definition at least fit the patients it was commissioned to
describe?
The Reeves definition would omit the patients in the Incline
Village cluster outbreak. The
name chronic fatigue syndrome was created in response to requests for attention
to a number of cluster outbreaks, perhaps the best known of which occurred in
north Lake Tahoe, on both the Nevada and California sides.
After 25 years, many of those patients remain severely ill,
and others are doing okay only because they are on medicines that are either
targeted at viruses or the immune system. They are developing new diseases,
abnormal for their age cohort. We need people at CDC who want to be aware of
this.
None of them would fit
in the new Reeves definition.
As I descend into Hades for the third time in my life, I beg you to
please start over with this
disease, and this time take Dr. Fukuda's imperative seriously - cooperate with the independent
research centers that are already creating subgroups with biomarkers that also
relate to a proposed etiology.
As I sat on the phone waiting for the chance to testify, imagine how I felt to
have you segue into swine flu (an "important" subject), and away from us. If the
patients with swine flu end up with chronic viral infections or immune disorders
like the one we have, will they also be completely abandoned by CDC?
There are good private research centers already out there,
often in concert with a clinic - as examples, Dr. Nancy Klimas' CFS study group
in Miami, and the new Whittemore-Peterson Institute (WPI) in Reno, Nevada. The
WPI does not even have a building, but they are already producing cutting edge
research into the viruses and immune dysfunctions surrounding this disease,
using new tools made available for the study of molecular medicine. So there is
reason for patients to be hopeful.
------------------------------
*What should the CDC be doing?
I see the role of the CDC not as primary researcher, but rather as the center
that can pull in information from top researchers, in this case coordinate
with the international research organization IACFS/ME to establish clinical
definitions and identify subgroups, and then use the strength of the federal
government to require the reporting of cases nationwide.
Currently you will not find a single article on the CDC's website for CFS that
has not been authored by a person who was a member of CDC at the time. Most of
the CDC's "bibliography" has Dr. Reeves' name on it.
The CDC should not be someone's
personal resume. Compare the
CDC's bibliography on CFS with the bibliography on the back page of the Canadian
Consensus Document (see above). The second bibliography ranges over a number of
specialties and many authors. It is not a platform for a single person, or
single point of view. THAT should
be what doctors see when we go to CDC's website.
Rather than trying to do everything themselves, the CDC needs to go
off-campus and make use of what's already there. As one example, there has recently
been a lot of research, ignored by CDC, into what happens when more than one
virus is activated at the same time. It would have been nice if CDC had funded
more of that research, then paid attention to the results, BEFORE this new
epidemic, wouldn't it?
As was suggested by the CFSAC (Chronic Fatigue Syndrome Advisory Committee
toDHHS) in 2003,
CDC should adopt
the ICD-10 classification of CFS under neurology, together with Myalgic
Encephalomyelitis (M.E.). The
Canadian Consensus Document, recommended above, was written in response to
ICD-10.
Finally, there is evidence that at some point in its lifetime "CFS" is
contagious. Again, the CDC has ignored that - but they never really considered
it. Hopefully they will do so before another 25 years has passed.
Please be aware that many of us have serious immune defects and are therefore
more endangered by the possibility of a swine flu epidemic than the average
citizen. We are especially concerned that there will be patients left damaged
by this new flu strain who will, like us, still be sick 20 years from now.
In December I joined with a group of online ME/CFS patients to "meet" to discuss
health care reform for the Obama-Biden transition team. The team chose a report
from each state to publish on their website; ours represents my home
state of Delaware. While the report was intended for the DHHS, the CDC obviously
plays a prominent role. You can read the report at:
http://healthreform.gov/communityreports/delaware/delaware_19711.html
Thank you again for allowing me this time.
Mary M. Schweitzer, Ph.D.
Pat Sonnett - For the Miami CFIDS Support Group INFECTIOUS DISEASE: More work needs to be done in the area of CFS
as an infectious disease, since it clearly is at some point during the
course of the illness, and several viruses have been linked to CFS
including EBV, HHV6, enteroviruses, Borna disease virus, and Ross River
virus.
POPULATION: The studies of defined populations need to be broadened
to include more clinic populations across the country instead of relying
so heavily on the Wichita and Georgia studies which are different than
the clinic populations.
DATABASES: National and international research network databases
should be established so current information is more readily available
to assist in furthering research and treatment.
PUBLIC HEALTH AGENCIES: More emphasis needs to be placed on
reaching out to various state and local public health agencies to
educate them about CFS and provide them with updated information on the
CDC web site as well as links to other relevant web sites.
MEDICAL SCHOOLS: More pressure and encouragement needs to be
directed to all medical schools to include a course on CFS as part of
the educational curriculum.
Thank you for soliciting our input on your five-year plan. We trust the
items above will be taken into consideration.
Sincerely,
The Miami CFIDS Support Group