research program.
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http://www.virology.ws/2011/11/23/chronic-fatigue-syndrome-and-the-cdc-a-lo=
ng-tangled-tale/
Chronic Fatigue Syndrome and the CDC: A Long, Tangled Tale
23 November 2011
by David Tuller
Note: This account draws from interviews, a close reading of a
fraction of the 4608 epidemiologic studies that pop up (as of today;
yesterday it was 4606) on a PubMed search for =93chronic fatigue
syndrome,=94 and a review of many pages of government documents=96in
particular the minutes and testimony from meetings of the Chronic
Fatigue Syndrome Advisory Committee to the U.S. Department of Health
and Human Services, one of many such panels established to provide
guidance to federal health officials. Not much here will be a surprise
to anyone who has read the better ME/CFS blogs, or Hillary Johnson=92s
authoritative and prodigiously researched 1996 account, Osler=92s Web:
Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic. Some
readers might know that I have written a number of articles on chronic
fatigue syndrome as a freelance contributor to The New York Times, so
I want to be clear: The Times has nothing to do with this piece. I
want to thank Professor Racaniello for letting me invade his space to
post this very long story.
David Tuller is coordinator of a new concurrent masters degree in
public health and journalism at UC Berkeley. He was a guest on TWiV
119.
In the early 1990s, Mary Schweitzer, a history professor at Villanova
University near Philadelphia, suffered through successive bouts of
sickness=97mononucleosis associated with Epstein-Barr virus, a stomach
parasite, repeated episodes of bronchitis. One day, while reviewing
student exams in her office, she slumped over and blacked out. Not
long after, she received a diagnosis of chronic fatigue syndrome.
In written testimony to a federal advisory committee a few years ago,
Dr. Schweitzer described how disabled she eventually became: =93On a bad
day, I would never get up at all, or would lie in bed curled up under
the covers=85I experienced pain behind my eyes and in the back of my
neck. It felt as if somebody had hit me in the back of the head with a
baseball bat, and someone else was trying to unscrew my eyeballs with
a pair of pliers.=94
Over the years, Dr. Schweitzer has tested positive for multiple
viruses. She experiences severe lapses in memory, concentration and
other cognitive skills. She suffers from =93neurally mediated
hypotension,=94 a form of low blood pressure arising from nerve
dysfunction, which causes nausea, loss of balance, and fainting. Her
muscle and joint pain can be intense, and she frequently requires a
wheelchair. Her white blood cell counts have been way off; her immune
system is often out of whack. She left her position at Villanova
because of disability and has been unable to work most of the years
since.
Like others with chronic fatigue syndrome, Dr. Schweitzer is used to
having her illness ignored, mocked or treated as a manifestation of
trauma, depression or hypochondria=97not only by doctors, colleagues and
strangers but by friends, family members and federal researchers, too.
So when the U.S. Centers for Disease Control and Prevention reported
last year that people with chronic fatigue syndrome are more likely to
suffer from =93maladaptive personality features=94=97in particular from
=93higher scores on neuroticism=94 and higher rates of =93paranoid,
schizoid, avoidant, obsessive-compulsive and depressive personality
disorders=94=97Dr. Schweitzer dismissed the research as =93incredibly
stupid=94 but =93not surprising.=94 In another recent study, the CDC had
reported=97also incredibly stupidly, from Dr. Schweitzer=92s
perspective=96that childhood trauma, such as sexual or emotional abuse,
was a =93an important risk factor=94 for the illness.
For Dr. Schweitzer, other patients and advocates, and much if not all
of the non-CDC research community involved with the illness, those two
studies symbolize much of what has gone wrong with the agency=92s
research program on chronic fatigue syndrome. As the country=92s leading
public health organization, the CDC has enjoyed remarkable success in
the fight against many diseases. But its history with chronic fatigue
syndrome, commonly called CFS, is a matter of bitter=96and
ongoing=97dispute.
=93We=92re talking about a million people who are really, really sick with
something,=94 said Dr. Schweitzer, 61, in one of a series of recent
conversations. =93And we have been mistreated for years by people who
are convinced that it=92s just personality disorders or stress or some
behavior that we can change and miraculously be well. None of us want
to be sick or are doing this to ourselves.=94
The CDC=92s mandate is to investigate threats to the health and safety
of the population; develop ways to prevent, disable or mitigate those
threats; and disseminate key information to the public, policy-makers,
health care providers and other audiences. Given those varied
responsibilities, the CDC=92s pronouncements about any topic=97in this
case, chronic fatigue syndrome=96exert an enormous impact on policy,
clinical care, insurance reimbursement and public attitudes. Advocates
say that when the agency reports that people with CFS suffer from
paranoid personality disorder, the public remembers the association,
as do other scientists, government officials, health care providers,
and insurance adjusters.
In fact, since the CDC first investigated an outbreak of a
non-resolving, flu-like illness in the Lake Tahoe area in the
mid-1980s, the agency=92s CFS program has been marked by financial
scandal, an epidemiologic strategy rejected as fatally flawed by the
top researchers in the field, and the kind of toxic relationship with
much of the patient community that can undermine the trust and
cooperation needed for effective policy-making and public health
strategies. On a more substantive level, over the past
quarter-century, the CDC=92s research program has yielded little or no
actionable information about causes, biomarkers, diagnostic tests, or
pharmaceutical treatments. Nor has the agency done much to track
long-term outcomes=96such as cancer rates, heart attacks and
suicides=96among people with the illness.
The reason for those failures, critics charge, is that the CDC has
spent years looking in the wrong places. Starting with its 1988 report
on the illness, they say, the agency has downplayed or dismissed
abundant evidence that CFS is an organic disease, or cluster of
diseases, characterized by severe immune-system and neurological
dysfunctions as well as the frequent presence of multiple viral
infections. Instead, say the critics, the agency has focused major
resources on investigating proposed psychiatric and trauma-related
factors and associations=96the personality disorder and trauma studies
were published, respectively, in the journals Psychotherapy and
Psychosomatics and Archives of General Psychiatry=96even though stress
and trauma make people more vulnerable to any number of health
conditions.
Moreover, they charge, the CDC=92s website on the illness has long been
a font of misinformation and has been routinely used by insurance
companies to deny legitimate claims for tests ordered by doctors.
(After years of complaints from patients and doctors, a paragraph that
dismissed the usefulness of many tests, including those for various
infectious agents, was finally changed this month.) Critics also note
that the CDC website does not incorporate much clinical expertise from
doctors who have treated patients for years, but it does highlight a
behavioral form of treatment=97a gradual increase in exercise, known as
=93graded exercise therapy=94=96that is widely discredited in the CFS
community. Patient surveys and anecdotal testimony, as well as an
increasingly robust body of research, suggest that the therapy might
cause severe relapses in CFS patients by encouraging over-exertion.
=93The CDC has never taken chronic fatigue syndrome seriously,=94 said San
Francisco writer and former psychotherapist Michael Allen, who
suffered a severe flu in the early 1990s and has never recovered his
health. =93They pay lip service to it being a serious physical illness,
but in their hearts they think it=92s just a form of mental illness.=94
Much of the anger for the CDC=92s perceived failings over the years has
targeted Dr. William Reeves, an epidemiologist and architect of the
CFS research program from 1989 until his abrupt move last year to
another division of the agency. With his gruff and sometimes
dismissive manner, Dr. Reeves was never popular with the patient
community, which came to view him as hostile to the search for viral
or other organic causes of the illness; many non-CDC researchers
echoed that complaint. When it emerged in the late 1990s that the
agency had been diverting funds designated for CFS to other programs
and then lying to Congress about it, Dr. Reeves=97who was in charge of
the program while the financial irregularities were taking
place=96sought and received whistle-blower protection.
Dr. Reeves also enraged the patient community by his refusal to
consider changing the much-hated name of the disease=97a name endorsed
by the CDC in its 1988 paper and aggressively promoted in a public
awareness campaign the agency launched in the mid-2000s. Patients say
the name, like the term =91yuppie flu,=92 reinforces stereotypes that they
are a bunch of self-entitled whiners and malingerers and that the
illness itself is a form of hysteria, the latter-day version of the
Victorian malady known as =93neurasthenia.=94 That=92s why many doctors,
researchers and patients have long promoted a less-stigmatizing
clinical name for the illness that predated the selection of chronic
fatigue syndrome: =93myalgic encephalomyelitis,=94 or ME, which means
=93muscle pain with inflammation of the central nervous system.=94
It is not possible to exaggerate how much patients despise the name
and believe it has hindered public understanding=97and how much they
fault the CDC and Dr. Reeves for championing it. =93If they=92d hired a
focus group to come up with a name that screams =91silly=92 and
=91meaningless,=92 they couldn=92t have done a better job than =91chronic
fatigue syndrome,=92=94 said Dr. Schweitzer.
In an interview with The New York Times earlier this year, bestselling
author Laura Hillenbrand (Seabiscuit, Unbroken), who has lived with
CFS for decades, called the name of the illness =93condescending=94 and
=93so grossly misleading.=94 She added: =93The average person who has this
disease, before they got it, we were not lazy people; it=92s very
typical that people were Type A and hard, hard workers=85 Fatigue is
what we experience, but it is what a match is to an atomic bomb. This
disease leaves people bedridden. I=92ve gone through phases where I
couldn=92t roll over in bed. I couldn=92t speak. To have it called
=91fatigue=92 is a gross misnomer.=94
After Dr. Reeves unveiled a revised epidemiologic method for
identifying people with CFS, the CDC estimated in 2007 that there were
4 million people in the U.S. with the illness=97a remarkable ten-fold
increase over the previous CDC estimate in 2003. Other experts
dismissed this dramatic rise as an artifact of the agency=92s poor
epidemiology. Subsequent research reported that the new CDC approach
misclassified people with primary depression as having chronic fatigue
syndrome, when they did not; that kind of misclassification could
easily lead to increased prevalence rates as well as false and
possibly harmful research results.
In the late 2000s, leading patient, advocacy and scientific
organizations engaged in an increasingly public revolt against Dr.
Reeves=92 leadership. In January of 2010, the CDC abruptly appointed him
as senior advisor for mental health surveillance in another part of
the agency. Dr. Elizabeth Unger, an expert on human papillomavirus who
had worked with Dr. Reeves for years, was named to replace him=97first
temporarily, then permanently=96as chief of the Chronic Viral Diseases
Branch, which currently houses the chronic fatigue syndrome program.
Now, almost two years after Dr. Reeves=92 departure, advocates and
researchers say they have seen a shift in tone=97some believe it is
genuine, others not=96but so far little change in substance. (Requests
to interview both Dr. Reeves and Dr. Unger, conveyed through the CDC
media office, were declined; however, with a press officer acting as
intermediary, Dr. Unger responded to questions via e-mail.)
=93I=92m committed to continuing an aggressive program to address the
needs of CFS patients and families for quality medical care and to
move CFS into the mainstream of public health,=94 wrote Dr. Unger. She
added that the agency is developing new materials about CFS for
medical and health care professionals, and has contracted for studies
that will help clarify questions about how to identify the illness.
Dr. Unger has made a point of meeting with patient, advocacy and
scientific organizations. In contrast to her predecessor, she has
impressed some advocates and researchers with her willingness to
listen to their concerns and seek out joint initiatives. But
reflecting a widespread view, one activist (who preferred to remain
anonymous) said that =93overall, I do not feel much has changed under
Dr. Unger=85I do look forward to changing my mind, though, if
appropriate actions are taken.=94
Another person with a long history of involvement in the CFS issue
offered a similar assessment, noting that Dr. Unger needs to do much
more, and do it more quickly, to demonstrate that she=92s pursuing a
different approach. =93I think she has got a window of opportunity, but
the patient community is only going to give her so long,=94 said this
advocate. =93She can throw off the Reeves mantle and make a break with
the past, or she can maintain the past. But there=92s not a middle
ground here, and she=92s got to make a decision.=94
Kim McCleary, president and CEO of the CFIDS Association of America,
the oldest organization on the illness, said she believes Dr. Unger
=93is trying to restore some credibility to the CDC=92s program.=94 But,
added McCleary, whose organization worked closely with Dr. Reeves for
years but ultimately opposed his leadership, =93she=92s not going to move
quickly, she=92s not going to do anything bold, she=92s going to move
pretty methodically along a linear path.=94
Although Dr. Reeves=92 departure received little public notice, it was a
watershed event for patients and advocates, many of whom blame the
agency for the prolonged lack of significant progress in CFS research.
(They also blame years of inadequate funding from the National
Institutes of Health, but that=92s another long story; it is worth
noting, however, that the NIH online database of spending by disease
category indicates only $4 to $6 million allocated annually for CFS in
recent years, a small amount compared to other illnesses associated
with similar levels of morbidity. While the roles of the CDC and NIH
can overlap significantly, the NIH generally focuses more on basic
research into disease processes than on epidemiology and the
development of public health strategies and interventions.)
The personnel shift at the CDC also occurred during a volatile period
in the scientific domain. In October 2009, the journal Science
published a headline-grabbing study that linked CFS to XMRV, a poorly
understood mouse leukemia retrovirus. The finding thrilled the patient
community because it appeared to offer a plausible explanation for the
disease and to suggest treatment possibilities. Although a second
study found links between CFS and a group of mouse leukemia
retroviruses related to XMRV, other research has failed to support the
proposed association. The Science report was partially retracted
earlier this year, and most researchers now believe the initial
findings were an artifact of laboratory contamination. Results
expected early next year from a large NIH-sponsored study should
settle the XMRV issue, although not the issue of whether another
retrovirus might eventually be linked to cases of CFS.
(In the meantime, in a bizarre and unsettling turn of events, the
senior author of the original XMRV paper, Dr. Judy Mikovits, is
engaged in a fierce legal battle with her former employer, the
Whittemore Peterson Institute for Neuro-Immune Disease, at the
University of Nevada in Reno. The institute sponsored the XMRV
research but has accused Dr. Mikovits, its erstwhile star scientist,
of stealing laboratory notebooks and other materials=97a charge she has
denied. Public feuding between the institute and Dr. Mikovits
ratcheted up as the hypothesis they jointly championed appeared to be
falling apart. The institute filed a lawsuit against her earlier this
month; she has also apparently been charged with =93possession of stolen
property,=94 according to a news update in Science. Last Friday, Dr.
Mikovits was arrested in California as a =93fugitive from justice=94 and
spent the weekend in jail; she was released on bail after a hearing on
Tuesday.)
Nevertheless, the heightened focus on CFS during the past couple of
years has brought the illness greater attention from a larger group of
scientists, including many infectious disease experts who had not
previously given it much thought (e.g. the host of this blog, Columbia
University virologist Vincent Racaniello). Experts now believe that
one or a combination of viral or other infections, or perhaps other
physiologic insults such as environmental toxins, can trigger an
immune response that never shuts itself off; the immune response
itself is likely the cause of many of the symptoms.
Dr. Racaniello said that when he used to question colleagues about
chronic fatigue syndrome, they would argue that it was an imaginary
illness. =93Every time I asked someone about it, they would say it
doesn=92t exist, it isn=92t a real disease, even as recently as the past
year,=94 he said. =93But once you start paying attention and reading
papers, this looks like a chronic or hyper-immune activation. These
patients have a lot of signs that their immune systems are firing
almost constantly.=94
According to this view, the revved up immune system is actually much
less effective at controlling other infections, and studies have found
associations between CFS and a grab-bag of pathogens, including
members of the herpesvirus, parvovirus, and enterovirus families.
Recent research from Norway has also lent support to the hypothesis
that at least some people with CFS are suffering from a form of
autoimmune disorder, perhaps triggered by one or multiple infections.
Neurological impairments are also virtually always part of the
complex; a study last year in the journal PLoS One found that people
with CFS and a form of Lyme disease have patterns of proteins in their
cerebrospinal fluid that clearly distinguish them from each other as
well as from healthy controls.
In many cases, additional research has failed to confirm associations
from prior studies. Yet there is a reasonable epidemiologic
explanation for such divergent results: Most experts believe that
there are likely many sub-groups or clusters of CFS patients, with a
variety of infectious and possibly environmental exposures; studies
that don=92t account for such distinctions=97and most haven=92t=96are much
less likely to reach consistent results about causation or treatment.
Moreover, different research groups have used different methods of
identifying people with chronic fatigue syndrome, making it even
harder to compare findings across studies=97a situation that can
encourage speculation that the roots of the illness lie in patients=92
psyches.
=93This ambiguity over definitions has made it difficult for researchers
to pinpoint a biological cause,=94 wrote Leonard Jason, a professor of
community psychology at DePaul University in Chicago and an expert in
CFS, in an essay published this year in The Wall Street Journal. =93When
investigators compare very different samples, it is difficult, if not
impossible, to replicate findings from one lab to another. And when
consistent biological findings do not emerge, investigators might
inappropriately conclude that CFS is only a psychiatric problem.=94
In any event, the most promising research into the disease has been
taking place not at the CDC or NIH but at academic medical centers;
much of the new work is being funded by private donors who have family
members with CFS. Researchers from Stanford, Harvard, University of
Miami, Columbia, and other leading institutions are all engaged in
innovative efforts focused on pathogenesis, diagnosis and treatment,
and in particular on such issues as infectious triggers, biological
markers, and medical therapies.
Dr. Derek Enlander, a longtime CFS clinician in New York, recently
helped to launch an ME/CFS research and treatment center at Mt. Sinai
Hospital; his highly regarded team hopes to explore genetic as well as
other factors involved in the illness. The center was founded with the
aid of a $1 million private donation, said Dr. Enlander, adding that
such outside funding allows the group the freedom to pursue promising
avenues of investigation. =93I believe that an independent organization
such as ours, which is not funded by the government or answerable to
the government, can be the leader in new research,=94 said Dr. Enlander.
The Role of Case Definitions
Chronic fatigue syndrome is estimated to afflict about one million
people in the U.S., although most remain undiagnosed. Some patients
improve over time or have periods of better and worse health, but many
remain disabled or even homebound for years. The symptoms include
profound exhaustion, especially following minimal exertion, as well as
disordered sleep, cognitive impairment, sore throat, and swollen lymph
nodes, among others. It is one of a number of so-called =93contested
illnesses=94 that have emerged in recent decades to present thorny
dilemmas for public policy and medical care; others include chronic
Lyme disease, Gulf War syndrome, fibromyalgia, and multiple chemical
sensitivity.
These conditions are characterized by shifting patterns of symptoms, a
lack of agreed-upon biological markers and diagnostic tests, arguments
over the interpretation of evidence, and competing claims of
scientific authority. Patients presenting with these illnesses can
bedevil doctors, who want to help but have few proven tools at their
disposal. They might or might not be willing to try unorthodox
strategies; some doctors clearly take advantage of patients who are
desperate for relief. Such contested illnesses impact millions of
people and their families, cost the U.S. billions in lost
productivity, and consume a significant chunk of health care
resources=97and yet remain poorly understood. With so much at stake,
they often emerge as societal and legal battlegrounds, with patients,
clinicians, researchers, insurers, health officials and government
bureaucrats all seeking to influence and control dialogue, debate and
policy.
This conflict often plays out in struggles over a critical
epidemiologic tool known as the =93case definition=94=97a set of criteria
for research or clinical use that ideally identifies all those who
have a condition and screens out all those who don=92t. Creating a case
definition is easiest when a definitive laboratory test exists, as
with HIV or hepatitis C. With an illness like CFS that is identified
through symptoms, devising a completely accurate case definition is
almost impossible; some people with the illness will always fall
outside the parameters of the case definition, and some who have some
other condition, or nothing at all, will be misdiagnosed=97or will
self-diagnose=96as having CFS. Yet without a case definition that is as
accurate as possible, researchers cannot achieve valid or reliable
results.
=93If you recognize something is happening, you need a case definition
so you can count it,=94 Andrew Moss, an emeritus professor of
epidemiology at the University of California, San Francisco, and an
early AIDS investigator, told me for an article I wrote about case
definitions earlier this year. =93You need to know whether the numbers
are going up or down, or whether treatment and prevention work. And if
you have a bad case definition, then it=92s very difficult to figure out
what=92s going on.=94
Non-CDC researchers say the problem with the agency=92s 2005 method for
identifying CFS cases is that it mistakenly classifies people with
primary depression as having chronic fatigue syndrome instead.
Depression and CFS can resemble, overlap and interact with each other
in multiple ways; patients with CFS may get very depressed about their
situation, and depression often causes fatigue, as can many other
ailments. So distinguishing chronic fatigue syndrome from primary
depression=97in other words, depression that preceded and perhaps caused
the fatigue=97is important but tricky, and requires nuanced instruments.
In epidemiologic studies that conflate the two, treatments that are
known to be effective for depression could appear to be effective for
chronic fatigue syndrome, even if they might not be.
A case in point is a treatment called =93graded exercise therapy,=94 a
slow increase in exercise that has been promoted for CFS patients by
the British psychiatric, medical, and insurance establishments; it is
also highlighted as a treatment option on the CDC=92s website and
educational materials.
There is no dispute that exercise can be a very effective treatment
for depression. But people with chronic fatigue syndrome generally
suffer from a distinctive symptom known as =93post-exertional malaise=94=97=
a
disproportionate depletion of energy following minimal activity that
is not a typical feature of depression. (However, the word =91malaise,=92
like the word =91fatigue,=92 is a complete misnomer; post-exertional
malaise is much closer to a serious crash or relapse than a Victorian
fainting spell.) An emerging field of research=97much of it taking place
at the University of Utah and University of the Pacific in Stockton,
California=96indicates that people with CFS suffer from problems with
oxygen consumption, energy production and muscle recovery. So it=92s not
surprising that increasing activity levels could lead in some or many
cases to a prolonged resurgence of their symptoms rather than the
improvement predicted by proponents of graded exercise therapy.
Patients with CFS are very familiar with post-exertional malaise. Many
report having recovered for a period of time, then pushing themselves
too hard and suffering a devastating set-back, repeating the cycle
multiple times before learning to adjust their pace. When Mary
Schweitzer experiences post-exertional malaise, she said, she loses
her formidable communications skills.
=93I get close to incoherent,=94 she wrote in a recent e-mail. =93I can=92t
make sense, and nobody can make much sense out of what I say. I am
used to it now and try to make a joke out of it, but it=92s sad.=94 As a
result, she wrote, she has learned what people with CFS call =91envelope
theory,=92 based on published work from Dr. Jason=92s research group at
DePaul University: how to harness their energy by recognizing their
limits, and not pushing beyond them. That approach is essentially the
antithesis of graded exercise therapy.
=93You learn what will bring on a crash=96sitting upright at a restaurant,
for example=96and you just don=92t do it,=94 wrote Dr. Schweitzer. =93You l=
ive
in what we call your =91envelope.=92 Then if something special comes along
like a birthday, you push the envelope, and if you get a push-back,
you know you still have the same boundaries.=94
Like Laura Hillenbrand, Mary Schweitzer is an author (although the
book she wrote from her doctoral research at Johns Hopkins, Custom and
Contract: Household, Government, and the Economy in Colonial
Pennsylvania, has undoubtedly never reached Seabiscuit-y heights in
Amazon=92s rankings). She grew up in Richmond, Virginia; boogied in the
mud at Woodstock; wooed her future husband, Bob, with home-cooked
lasagna (he was the teaching assistant in an economics course she as
an undergraduate at Duke); and was teaching, conducting research, and
raising two kids when CFS whacked her life upside down.
Dr. Schweitzer said she could never have managed through the years
without the support and devotion of her husband, a professor of
finance and economics at the University of Delaware. But she has also
improved significantly on intermittent treatment with Ampligen, a drug
that appears to be effective for some people with CFS. The drug hasn=92t
been approved by the U.S. Food and Drug Administration, but Dr.
Schweitzer currently receives it as part of an ongoing clinical trial.
She travels twice a week from her home in Delaware to her doctor=92s
office in Manhattan for infusions of Ampligen; unlike in most clinical
trials, she has to pay for the drug, which costs her $16,000 a year.
When off Ampligen, she has suffered major crashes; at one point
several years ago, she tested positive for four
herpesviruses=97Epstein-Barr, cytomegalovirus, HHV-6A, and HHV-7=97and
Coxsackie B, an enterovirus. Whenever she can, she addresses public
forums, in particular the twice-yearly meetings of the Chronic Fatigue
Syndrome Advisory Committee, one of many committees created to offer
guidance to the U.S. Department of Health and Human Services; she
estimates that she has testified to date at thirty hearings,
conferences or meetings. When she speaks, in a public forum or
one-to-one, she is articulate, passionate, loud, tender, demanding,
funny and fierce. In one of her many statements to the federal
advisory committee, Dr. Schweitzer described one of her severe
relapses.
=93I lost the ability to walk normally and we had to bring the
wheelchair back up from the basement,=94 she wrote. =93I dropped things,
and when I tried to load the dishwasher I crashed one glass against
another=85It made no difference that now I knew the names of the various
symptoms=96ataxia, expressive aphasia, short-term memory loss, central
auditory processing dysfunction, etc. My brain had disappeared.=94
A Bit of History
The conflict over the nature and definition of CFS=96between the CDC and
the patient community, as well as between the agency and other
researchers=96dates back to the initial investigations of an outbreak in
Incline Village, Nevada, near Lake Tahoe, of a mysterious illness,
possibly associated with Epstein-Barr virus. The outbreak was one of
many reports in the mid-80s of what was already being called =93chronic
Epstein-Barr syndrome=94 or =93chronic mononucleosis.=94 (Epstein-Barr viru=
s
causes most cases of mononucleosis).
In its 1988 paper on the illness, a CDC-led team of researchers cast
doubt on the Epstein-Barr hypothesis and rechristened the phenomenon
=93chronic fatigue syndrome=94 to discourage unproven assumptions about
viral origins. (Ironically, because CFS began as a suspected viral
illness, the research program has remained housed in the agency=92s
viral section.) The paper proposed a complicated case definition
requiring six months of unexplained fatigue, plus either six of eleven
=93symptom criteria=94 (mild fever, sore throat, painful lymph nodes,
muscle weakness, muscle pain, prolonged fatigue post-exercise,
headaches, joint pain, neuropsychological complaints, sleep
disturbances, and sudden onset of the illness) and two of three
=93physical criteria=94 (fever, sore throat, and palpable or tender lymph
nodes, documented by a physician twice, at least one month apart); or
eight of the eleven symptom criteria, without the physical criteria.
In retrospect, for many patients the CDC=92s first big blunder was in
not calling the Tahoe illness myalgic encephalomyelitis in the first
place. Benign myalgic encephalomyelitis has long been recognized by
the World Health Organization as a synonym for =93postviral fatigue
syndrome,=94 which is listed as a neurological illness. The term was
coined to refer to a similar flu-like outbreak at a major London
hospital in the 1950s (although =93benign=94 has since dropped out of
common usage.) In practice, many patient and advocacy groups now
combine the two terms as CFS/ME or ME/CFS, or use ME alone.
Dr. Reeves was not on hand for the original investigation, but joined
the CDC in 1989 as chief of what was then called the Viral Exanthems
and Herpesvirus Branch. Dr. Reeves received his B.A. in 1965 from the
University of California, Berkeley, where his father was a renowned
expert in mosquito-borne illnesses and served as dean of Berkeley=92s
School of Public Health; he studied medicine at University of
California, San Francisco, earned a masters in epidemiology at the
University of Washington, and worked at a major medical research
center in Panama for a dozen years before joining the CDC in 1989.
A Harvard-led research team described the Tahoe outbreak in far more
serious terms than the 1988 CDC report: the patients, they reported in
1992 in the Annals of Internal Medicine, had abnormal MRI brain scans,
significant alterations in white blood cells counts and functioning,
and signs of active infection with a recently discovered pathogen,
HHV-6. The illness, they wrote, was likely a =93chronic, immunologically
mediated inflammatory process of the central nervous system.=94
In a letter to the journal listing more than a dozen purported
methodological flaws, the CDC=97with Dr. Reeves as the lead
author=97dismissed the Harvard study and its findings in unusually blunt
terms. =93We conclude that the disease=85described is not the chronic
fatigue syndrome or any other clinical entity and that they showed no
association with active HHV-6 replication,=94 wrote Dr. Reeves and his
colleagues.
A pattern appeared to have been established. In a subsequent episode
in the early 1990s, chronicled in detail in Osler=92s Web, the CDC
failed to confirm other researchers=92 reports of a retroviral link to
chronic fatigue syndrome. These and other contradictory results gave
rise on both sides to claims and counter-claims and
counter-counter-claims (etc.) of methodological flaws, unjustified
assumptions, and other scientific sins of omission or commission.
In the early 1990s, a CDC-led team reviewed the complex 1988 case
definition and published a revised and somewhat simplified version.
According to these 1994 guidelines, a diagnosis of CFS required the
presence of six months of disabling, medically unexplained fatigue,
along with at least four of eight other symptoms: impaired memory or
concentration, disordered or unrestful sleep, muscle pain, joint pain,
headache, tender lymph nodes, sore throat, and post-exertional
malaise. Although the definition relied on self-reported symptoms
rather than biological tests or standardized instruments to measure
levels of fatigue and disability, it soon became the most widely used
set of criteria in both research and clinical settings.
The Financial Scandal
Two years after the CDC issued its 1994 case definition, Osler=92s Web
was published to strong reviews. The book documented how the CDC
routinely diverted money slated for CFS research to other projects
because of lack of concern about the illness. (The CDC did not
officially comment on the book at the time, according to a CDC
spokeswoman.) Two years later, Dr. Reeves leveled similar charges
against his superiors, noting that the CDC lied to Congress about how
it spent CFS funding; he received whistleblower protection.
In his statement, he reported that, for example, in 1996 the agency
spent $1.2 million for laboratory equipment and supplies for measles
and polio and charged it to the CFS account. In 1995, he reported, the
agency charged the CFS program $2.6 million for funding spent on
unrelated studies. He had, he stated =93attempted to rectify this within
CDC=94 before going public.
=93I believe that CDC has intentionally misrepresented monies allocated
to CFS research and I cannot ethically support this,=94 wrote Dr. Reeves
in his public statement. =93The misrepresentations involve
systematically charging between $400,000 and $2 million incurred by
unrelated activities to CFS between 1995-97 and reporting to DHHS
[Department of Health and Human Services], Congress and patients that
the monies were used for CFS research.=94
A 1999 report from the inspector general of HHS found that of the
$22.7 million the CDC charged to its CFS program between 1995 and
1998, less than half was clearly spent on the illness. The report
noted: =93CDC spent significant portions of CFS funds on the costs of
other programs and activities unrelated to CFS and failed to
adequately document the relevance of other costs charged to the CFS
program=85As a result of these inappropriate charges, CDC officials
provided inaccurate information to Congress regarding the use of CFS
funds.=94
The inspector general=92s report found that $8.8 million was spent on
non-CFS projects and that the documentation on an additional $4.1
million was so poor that it was impossible to determine whether they
were used to support CFS research or not. Even as the CDC shortchanged
the CFS program, the report noted, it disregarded Congressional
requests to support important research initiatives. As an example, the
report noted that Congress had urged the CDC to expand its
surveillance of CFS among adolescents and to hire a
neuroendocrinologist =93to enable expansion of its research efforts and
pursue promising findings from other Federal agencies and the private
sector.=94
At the time of the inspector general=92s report, however, the CDC had
halted an ongoing adolescent study and had not hired an
endocrinologist=97even as allocated money wasn=92t being spent. The report
noted: =93Internal correspondence=85 indicated that delays were forced due
to a =91lack of available funds.=92 Yet, we found that large portions of
budgeted CFS funds had been held in reserve by the Division Director
during the year, and were not released until after the deadline for
obligations had passed. Thus, while important enhancements were not
being implemented, more than $850,000 of FY 1998 budgeted funds were
never made available to the program.=94
In the wake of the scandal, Dr. Reeves=92 boss left his position; the
agency agreed to reform its accounting practices and restore more than
$12 million to the CFS program over the next several years. Although
Dr. Reeves=92 whistleblower status effectively solidified his position
at the CDC, his statement didn=92t answer all outstanding questions.
Given the revelations from Osler=92s Web in 1996, it seemed unlikely to
many patients and advocates that key officials at the agency could
have been unaware of accounting irregularities=96especially since they
apparently continued through 1998, according to the federal
investigators.
A subsequent investigation in 2000 from the U.S. General Accounting
Office (now called the Government Accountability Office) found that
communication between the CDC and the NIH about CFS research programs
and priorities was poor. The limited coordination, as well as the CDC
misspending, had hampered progress in the search for answers to the
illness, the investigators reported.
The financial scandal left many CFS advocates, patients and
researchers with a lingering distrust toward the CDC. In the following
years, however, some of the CDC=92s work in chronic fatigue
syndrome=97funded by the millions restored to the budget=96received
praise.
In 2003, Dr. Reeves=92 study of CFS in Wichita, Kansas, yielded a
disease prevalence of 235 per 100,000 percent of the adult population,
or about 400,000 overall in the U.S. That figure was below the
generally accepted estimate of one million sufferers, derived from a
community-based study in the Chicago area by Dr. Jason=92s research
group at DePaul University. Yet the new figure was accepted as far
more accurate than the agency=92s earlier estimates, from research in
the 1990s, that less than 20,000 people had the illness; that research
had been criticized for relying on doctors=92 reports of patients with
CFS, a far less effective epidemiologic method of assessing prevalence
than community-based surveys. The Wichita research also provided a
sense of the societal burden of CFS; the CDC team reported that the
illness cost the economy $9.1 billion a year in lost productivity, and
people with CFS lost an average $20,000 annually in earnings.
Also praised was the CDC=92s partnership with Australian researchers on
a study reporting that more than 10 percent of a cohort suffering from
acute viral illnesses went on to develop CFS=96one of the agency=92s few
successful efforts to document viral links. And in 2006, the CDC
published=97with great fanfare=96a set of 14 studies in the journal
Pharmacogenetics, which found significant variations in CFS patients
of gene expression and activity related to how the body handles and
adapts to physical and emotional challenges and stress.
Much of the research focused on genes associated with the
hypothalamic-pituitary-adrenal axis, which regulates the body=92s stress
responses, among other functions. At a press conference introducing
the studies, Dr. Reeves outlined his understanding of the illness:
=93The working hypothesis is that the HPA axis and the brain is a
plastic organ which changes its actual physical architecture depending
on stresses accumulated over the lifetime,=94 he explained. =93So as
people experience stress, and that can be childhood abuse, it can be
childhood infections, it can be multiple injuries=85to some extent the
genetics determine how you are going to react to them, they determine
how your allostatic load [a stress-related indicator] may accumulate,
and more importantly, they actually determine your subsequent reaction
to stress applied at a later time during the lifespan.=94
Dr. Reeves himself declared the illness to be a matter of great public
health concern and expressed empathy for patients. =93People with CFS
are as sick and as functionally impaired as someone with AIDS, with
breast cancer, with chronic obstructive pulmonary disease,=94 he told me
in 2007, when I wrote my first story about the disease for The New
York Times.
Some advocates welcomed the genetics studies for providing evidence
that the illness had a biological basis and was not a figment of
patients=92 imaginations. But a news article in Science about the
Pharmacogenetics papers reported that other scientists had raised
serious methodological questions about the CDC=92s approach, with one
prominent researcher calling the new findings =93meaningless.=94 Others in
the CFS community feared that the focus on stress and trauma as major
factors left the door open for the CDC to focus on a wide range of
psychologically and behaviorally oriented approaches in the search for
both causes and treatments=97and they note the recent personality
disorder and childhood abuse studies as proof of their concerns.
The Rejected Empiric Criteria
Other CDC efforts, such as the multi-million-dollar public awareness
campaign to brand the name =93chronic fatigue syndrome,=94 dismayed much
of the patient and advocacy community, given ongoing and fervent
attempts to have the illness officially renamed ME. And in a highly
controversial move, Dr. Reeves spearheaded in 2005 the creation of the
new, purportedly more precise method of identifying patients; critics
feared the approach would wreak havoc with epidemiologic studies by
mixing a lot of people with depression but not CFS into samples of
people all presumed to have chronic fatigue syndrome.
During the 2000s, researchers=97including many clinicians who actually
treated patients and understood how seriously ill they could be=97had
continued to be dissatisfied with the 1994 case definition, which they
felt imprecisely described the condition. For one thing, the
definition allowed for but did not require the presence of
post-exertional malaise (reminder: read =93relapse=94 or =93crash,=94 rathe=
r
than =93malaise=94). Yet it was increasingly apparent that post-exertional
malaise, and not fatigue alone, was a cardinal symptom for many if not
most patients, and one that clearly helped distinguish CFS from
primary depression, as well as other chronic illnesses. The CDC
definition also allowed for but did not require the presence of
cognitive and neurological problems, although these appeared to
afflict almost everyone with the condition.
Other research groups were using their own case definitions, making it
hard to compare results. The =93Oxford criteria=94 developed in Great
Britain required only the presence of six months of disabling fatigue;
that single-symptom criterion was criticized as so broad that it was
likely to identify many people with primary depression rather than
CFS. A more detailed 2003 case definition developed in Canada focused
on post-exertional malaise as a cardinal symptom of what it called
ME/CFS. Required symptoms also included disordered sleep, pain, and
neurologic symptoms, as well as signs of dysfunction in the immune,
endocrine and autonomic nervous systems.
Earlier this year, a team of top researchers=97not surprisingly, without
any participation from the CDC=96published a new =93international
consensus=94 case definition, which adopted the name myalgic
encephalomyelitis and abandoned chronic fatigue syndrome altogether.
Using the Canadian definition as a jumping-off point, the new
international definition also dropped the construct of =93fatigue=94 in
favor of requiring post-exertional malaise, which they renamed
=93post-exertional neuroimmune exhaustion.=94 Other required symptoms
include neurological and energy production impairments.
In contrast, the 2005 effort by the CDC to =93operationalize=94 the
earlier 1994 case definition=96by introducing standardized
questionnaires and measurement scales to assess levels of fatigue and
functional impairment=97has found no support outside the CDC itself. In
suggesting specific instruments and scales, Dr. Reeves and his
research team proposed cut-off points to represent sufficient grounds
for identifying CFS.
Yet when the CDC researchers applied these new =93empiric=94 criteria, as
they called them, to a population in Atlanta in 2007, they found a
prevalence of 2.54 percent of the adult population. Extrapolated
nationwide, that meant that four million people=97in other words, ten
times the CDC estimate from its Wichita research just four years
earlier, and four times the widely accepted figure of about one
million=97had the illness. Dr. Reeves and his co-authors defended the
new numbers, attributing the increased prevalence estimates to a broad
sampling strategy and =93application of more sensitive and specific
measures of the CFS diagnostic parameters.=94
Others outside the CDC dismissed the new numbers as absurdly inflated
and argued that the empiric criteria, like the Oxford criteria but
unlike the 2003 Canadian case definition, blurred and expanded rather
than clarified the disease boundaries. While some advocates believed
the increased estimates would focus more attention on the illness and
should therefore be embraced, many others=97including leading
epidemiologists=96believed that the expanded category could make it
harder to isolate physiological correlates; that failure, in turn,
would make it more likely that others would continue to perceive it to
be largely a psychiatric illness.
One study from Dr. Jason=92s research group at DePaul University,
frequently cited by advocates, found that 38 percent of a group
suffering from major depression but not chronic fatigue syndrome were
misdiagnosed as having CFS using the new empiric case definition. The
researchers reported that the scales, measurements and cut-off points
indicated by the CDC group did not sufficiently distinguish between
emotional and physiological sources of fatigue and disability; in
other words, someone could be identified as having CFS under the new
method solely because of fatigue or disability arising largely from
psychological causes, such as depression.
=93Given the CDC=92s stature and respect in the scientific world, this new
definition might be widely used by investigators and clinicians,=94
wrote Dr. Jason and his co-authors. =93This might result in the
erroneous inclusion of people with primary psychiatric conditions in
CFS samples, with detrimental consequences for the interpretation of
epidemiologic, etiologic, and treatment efficacy findings for people
with CFS.=94 The authors also noted pointedly that the population
prevalence for CFS calculated using the empiric definition was close
to that for major depressive disorders.
Although the empiric case definition was published six years ago, it
has not found any favor outside the CDC, raising questions about the
comparability of CDC data derived from its use to results from other
studies. Dr. Unger wrote in her e-mail response that she knew of no
other researchers who had adopted the empiric criteria, although she
noted that =93others have started applying case definitions using
instruments as tools, recognizing the improved ability to get
consistent results.=94 Three major ongoing CDC studies have samples
selected through use of the empiric criteria.
Dr. Unger appeared reluctant to whole-heartedly endorse the estimate,
based on the empiric criteria, that 4 million people in the U.S. have
CFS, but she did not back away from it either. =93No single study or
approach can be considered sufficient to determine the true population
prevalence of an illness as complex as CFS,=94 she wrote. =93Like all
studies, the 2007 prevalence estimates of CFS based on the Georgia
surveillance study are subject to the limitations of the study design.
However, the Georgia study, along with those from other investigators,
does demonstrate the public health importance of CFS and it is the
CDC=92s most recent study on the prevalence.=94
Dr. Unger indicated that the agency =93is in dialogue with other
investigators about instruments and methods to best characterize and
stratify CFS patients.=94 The agency is also launching studies with
several investigators to enroll and characterize patients from seven
clinical practices headed by leading CFS physicians to help clarify
issues involving the case definition as well as the name.
=93We are planning to collect standardized data on all the domains of
illness included in the Canadian Consensus Criteria of CFS/ME, the
1994 CFS definition and the newly proposed International ME
definition,=94 she wrote. =93We anticipate that this data will assist
researchers and clinicians in considering further refinements of the
case definition.=94 With regards to the name of the illness, she wrote:
=93Opinions of advocates, clinicians and researchers remain divided
about whether CFS and ME are the same or different entities. However,
we are following the discussions with interest and would consider any
consensus that is reached by patient groups and the scientific
community going forward.=94
The Website Conflict
Another conflict that has dogged the agency involves its CFS website.
Advocates and patients have long complained that it conveys serious
misinformation, in particular on aspects of diagnosis, treatment and
management of the illness. For example, until this month the website
included the following language: =93No diagnostic tests for infectious
agents, such as Epstein-Barr virus, enteroviruses, retroviruses, human
herpesvirus 6, Candida albicans, and Mycoplasma incognita, are
diagnostic for CFS and as such should not be used (except to identify
an illness that would exclude a CFS diagnosis, such as mononucleosis).
In addition, no immunologic tests, including cell profiling tests such
as measurements of natural killer cell (NK) number or function,
cytokine tests (e.g., interleukin-1, interleukin-6, or interferon), or
cell marker tests (e.g., CD25 or CD16), have ever been shown to have
value for diagnosing CFS. Other tests that must be regarded as
experimental for making the diagnosis of CFS include the tilt table
test for NMH, and imaging techniques such as MRI, PET-scan, or
SPECT-scan.=94
Advocates and patients appealed to the CDC many times over the years
to remove the language. They acknowledged that these and other tests
were not diagnostic for CFS but insisted that wasn=92t the point; even
though the tests couldn=92t be used to confirm that a patient had CFS,
they were important weapons for disease management. Experienced
clinicians, like Dr. Enlander at Mt. Sinai and Dr. Nancy Klimas, a top
researcher at the University of Miami, have long used tests such as
these to identify CFS sub-groups and individualize treatment
strategies, given their patients=92 histories of immune dysregulation
and viral infections. Yet clinicians report that they have received
letters from insurance companies citing that paragraph in rejecting
claims for tests they have ordered, in some cases as recently as last
summer.
The agency finally removed that language this month, after an advisory
group reviewed the website and requested a host of changes. =93They [the
reviewers] provided useful feedback in early October and CDC is
incorporating this feedback into our ongoing efforts to improve the
CFS website,=94 wrote Dr. Unger. Replacing the old language is a new
passage that suggests that some of the same tests once disallowed for
diagnosis of CFS can be useful for disease management=97as advocates
have been saying all along. Patient groups welcomed the change, but
some advocates said it was minimal and long overdue, given that many
insurance claims had been rejected unfairly in years past.
Another major complaint about the website has been the agency=92s
longstanding promotion of two treatments developed and championed in
the United Kingdom: graded exercise therapy and cognitive behavior
therapy. In the U.K, mental health professionals have dominated
research into and treatment of chronic fatigue syndrome; they use the
Oxford criteria, requiring only six months of unexplained fatigue. A
major British study using this case definition and published earlier
this year indicated some improvement with graded exercise therapy and
cognitive behavior therapy. But U.S. experts on the illness, at least
those outside the CDC=92s immediate orbit, generally believe that the
U.K. case definition=97like the CDC=92s empiric definition=96is likely to
define a cohort that includes a lot of people with depression, and not
actual CFS, as their primary complaint.
To those convinced that CFS is a condition of psychogenic and not
organic origin, it probably doesn=92t matter if people with depression
are mixed up in a study sample. In the framework of chronic fatigue
syndrome endorsed by the British medical establishment, the prolonged
fatigue and associated illness are largely considered to be caused by
the patient=92s inability or unwillingness to maintain an active
lifestyle=97an avoidance triggered by some form of stress, psychological
issues or perhaps even an infectious illness. That avoidance of
activity then leads to a physiological deconditioning that impacts
multiple body systems and organs.
=93It=92s a psychological model,=94 said Dr. Jason of DePaul University, of
the British view of CFS. =93It=92s an illness that might be caused by some
kind of virus or trauma, but what=92s maintaining it is that you have
some sort of phobic avoidance of activity. The idea is your bone and
muscle mass decrease, you become weak. So if you can get a person to
slowly increase the amount of activity that they do, they will break
this phobic avoidance.=94
In the U.K. framework, graded exercise therapy is often paired with
cognitive behavior therapy in the treatment protocol for CFS.
Cognitive behavior therapy is a treatment modality with widespread
application, and is likely to be useful to many people undergoing
major stresses=96whether from cancer, a back injury, an existential
crisis, fear of sex, migraines, a bad divorce, or cognitive fatigue
syndrome. However, the kind of cognitive behavior therapy prescribed
in Great Britain to treat people with CFS=97as Dr. Jason and other
researchers have repeatedly noted=96is largely geared toward convincing
patients to overcome their avoidance phobia and increase activity
levels; in other words, to encourage them to participate in something
very much like graded exercise therapy.
But for people who experience post-exertional relapses of their
symptoms, graded exercise therapy could be harmful, not helpful; in
addition to the emerging research about post-exertional malaise,
patient surveys in the U.K. have indicated a high degree of
unhappiness and increased morbidity among those who have been through
a course of graded exercise therapy. And, say critics, cognitive
behavior therapy could also be harmful, if the goal is to convince
patients to engage in graded exercise therapy or otherwise ramp up
activity levels.
Dr. Unger wrote in her response that she was aware of patient concerns
about including information on graded exercise therapy and cognitive
behavior therapy on the website, and that the agency was reviewing
those sections. The goal of the information, she wrote, was to let
patients know about treatment options they could discuss with their
health care providers. =93Though these approaches may not work for
everyone, the scientific literature shows that they provide some
benefit to some patients,=94 she wrote.
However, Dr. Unger declined to comment specifically on the contested
scientific literature from the U.K. that actually reported the modest
benefits from these therapies, noting that =93as a rule, CDC doesn=92t
comment on research not conducted by CDC.=94
The View from the Chronic Fatigue Syndrome Advisory Committee
The growing dismay about Dr. Reeves=92 leadership and the agency=92s
problematic CFS research program are evident in the minutes and
testimony from the twice-yearly meetings in the late 2000s of the
Chronic Fatigue Syndrome Advisory Committee of the Department of
Health and Human Services. The mandate of the committee, with a
rotating membership of clinicians, researchers, patients and
advocates, is to offer guidance and recommendations to the department.
In 2007, the committee requested financial records from the CDC=92s CFS
program. Dr. Jason, a member of the CFSAC, and Dr. Reeves, an ex
officio member as the CDC=92s representative, sparred publicly over
access to the records.
By the time of the next CFSAC meeting, in October of 2008, Dr. Reeves
had been replaced as the CDC=92s ex officio member (although he retained
his CDC position). Another CDC official at the meeting said he hoped
the change would help =93to leave behind past tensions to make a fresh
start.=94
At that meeting, however, Kim McCleary, the head of the CFIDS
Association of America, testified that the CFS program, based on a
review of the CDC financial documents that the committee had sought,
suffered from =93shameful scientific leadership, zero accountability,
invisible outcomes and millions and millions of dollars stuck in
suspended animation, if not wasted=85Only the government contractors
seem to be benefiting from millions spent for which there are no
worthwhile outcomes for American taxpayers, or CFS patients.=94
The largest chunk of the program=92s funding, reported McCleary, went to
a single private research organization, Abt Associates in Cambridge,
Massachusetts, in sole-source or no-bid contracts for the
epidemiologic research that was being widely criticized by other
scientists. At least $2.7 million committed to Abt was =93in
limbo=94=96obligated to specific projects but remaining unspent=97and work
on other projects was proceeding slowly and at great cost, she
testified. The financial mismanagement, testified McCleary, =93has
resulted in program management coming often to this committee and
telling other investigators that no funds are available for new
projects or collaborations.=94
(The CFIDS Association of America had been criticized by some other
advocates over the years for its previous close association with Dr.
Reeves. The organization had provided essential public support for Dr.
Reeves during the accounting scandal in the late 1990s; in the
mid-to-late 2000s it implemented the agency=92s controversial
multi-million-dollar CFS public awareness campaign at a time when
others were seeking to change the disease name. McCleary=92s public
rebuke of Dr. Reeves=92 leadership, therefore, was viewed as a
significant blow to the CFS program and found a welcome audience.)
McCleary=92s report further shredded support for Dr. Reeves among
committee members; some were researchers struggling with their own
funding issues. The financial accounting appeared to confirm a
frequently heard complaint about the CDC and Dr. Reeves=97that they were
not taking full advantage of opportunities to collaborate with outside
scientists at academic research centers.
Christopher Snell, a professor of sports sciences at the University of
the Pacific in Stockton, CA, and a committee member, stated, according
to the minutes: =93As somebody who works on a shoe string budget, when I
start to look at some of these numbers, I was somewhat appalled=85 It
just does not seem to be the best use of the funds. The thing that we
asked for at a couple of previous meetings was for the CDC to consider
more collaboration with outside entities. We meant people who work a
lot cheaper. It would seem that there are people out there with great
ideas who would love to work with the CDC for much less money.=94
Dr. Klimas, also a committee member, noted that she had been
collaborating with the CDC on a study comparing people with CFS and
Gulf War illness, and that the agency had failed to finish its testing
on samples, citing funding problems. She also unleashed another common
charge: that the CDC was simply not interested in the role of
pathogens. According to the minutes, =93Dr. Klimas said that CDC has
made it known that the agency has no intention of looking for
infectious agents. She added that other research organizations are
pursuing identification of pathogens and that CDC should be
embarrassed not to be looking for them as well=85despite the evidence,
the CDC is still saying that viruses don=92t matter in the illness even
though people are already being treated for them. She said that the
science is there to provide options way beyond the CDC=92s recommended
behavioral treatment and exercise.=94
At its meeting in May 2009, the committee unanimously voted to
recommend =93progressive leadership=94 for the CFS program; although the
recommendation, in an apparent nod to decorum, did not cite Dr. Reeves
by name, the intent was clear. The request for a top personnel
change=97essentially a vote of no-confidence in the current
leadership=96was considered an aggressive move for this kind of federal
advisory committee. At the same meeting, the International Association
for CFS/ME, a leading scientific and research organization, endorsed
the call for new leadership.
In October of 2009, Dr. Reeves committed what many in the CFS world
regarded as a major public gaffe: an off-hand remark to a New York
Times reporter (not this one) about the mouse retrovirus research that
had just sparked a wave of excitement. In the interview, which
occurred shortly after the publication of the Science paper reporting
the link between XMRV and CFS, Dr. Reeves said his research team would
look for the retrovirus but that they were unlikely to find anything.
He told the Times: =93If we validate it, great. My expectation is that
we will not.=94
For a scientist to predict his team=92s outcomes in a contested field of
research during a highly public and volatile debate is not the best
way to demonstrate impartiality and open-mindedness (notwithstanding
that the XMRV hypothesis appears not to have panned out). Even more so
for someone like Dr. Reeves, who was already facing coordinated calls
for his ouster from almost every corner.
At the CFSAC meeting later that month, the committee again approved a
recommendation for new leadership and emphasized the urgency of the
issue. According to the minutes: =93CFSAC considers that recommendation
important and would like to get some feedback, including whether or
not the recommendation is being considered. This has become more
important because of certain quotes that have been made in The New
York Times concerning the retrovirus by the person in charge of the
CDC program.=94
The committee also formally rejected the CDC=92s empiric case
definition=97the centerpiece of Dr. Reeves=92 epidemiologic approach=97and
recommended support for =93a national effort to arrive at a consensus
definition of CFS that is accurate, standardized, and reflective of
the true disease.=94
Within months, Dr. Reeves was gone from his position, although no
public explanation for the move was offered. For the most part, the
elements of the CFS program that Dr. Reeves championed=97the empiric
criteria, the name of the illness, (most of) the disputed website
information, etc.=97remain in place under Dr. Unger.
Reaction to Dr. Unger=92s efforts appears decidedly mixed so far. Yet
some members of the research community express optimism about being
able to develop, with Dr. Unger, the kind of cooperative framework
that many felt was absent when Dr. Reeves ran the program. Dr. Fred
Friedberg, president of the International Association for CFS/ME, said
that Dr. Unger was =93way more responsive=94 than Dr. Reeves, noting that
she had attended the association=92s annual conference this fall in
Ottawa.
=93We reached out to her and she has been very accommodating and engaged
in conversation to talk about some joint efforts,=94 said Dr. Friedberg,
a professor of psychology at Stony Brook University Medical Center.
=93It remains to be seen what goals she=92s going to set up and what kind
of studies she=92s going to do exactly. So this is kind of a work in
progress, but the level of cooperation is pretty good. For the first
time in years, there=92s an opening.=94
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