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virology blog
ABOUT VIRUSES AND VIREAL DISEASE
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
"chronic fatigue syndrome," and a review of many pages of
government documents--in 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's authoritative and
prodigiously researched 1996 account, Osler's 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 (http://j.mp/tLTZmB).
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=97a 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 live 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 virus 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 rather 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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