ME & the CDC -Misnamed, Misconceived & Mishandled for decades....

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HHS.gov

U.S. Department_Health_Human_Services

Chronic Fatigue Syndrome Advisory Committee

(CFSAC) Spring 2012 Meeting.

For more public testimonies in alphabetical order,

see: http://1.usa.gov/PEFd0C

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http://1.usa.gov/NRsc0P

Public Comment

Jerrold Spinhirne

Once again this Committee is meeting to discuss

what should be done about the disease that the

CDC has misnamed, misconceived, and mishandled

for decades.

Unbelievably, here in 2012, the CDC is still promoting

an outdated 1994 case definition for chronic

fatigue syndrome (CFS) [1] which fails to

differentiate between fatigue due to depression, or

an undiagnosed medical condition, and the

neurological disease myalgic encephalomyelitis

(ME).

An accurate case definition is one of the first

principles of epidemiology. It must give the

necessary and sufficient conditions for determining

who has the disease. The CDC has failed even to

get to square one with the epidemiology of CFS.

The CDC does not know how to determine which

patients have the disease and which do not.

Its 1994 Fukuda CFS definition has only optional

symptoms, in addition to inadequately defined

fatigue. It lists no necessary symptoms other than

fatigue.

Consequently, CFS has little credibility with the

medical community and the public.

Almost nothing is reliably known about the disease's

actual nature, its prevalence, its method of

transmission, its pathogens, its etiology, and, most

significantly, its treatment.

Last year, an international group of 26 experts on

the disease from 13 countries published the

landmark International Consensus Criteria (ICC) for

myalgic encephalomyelitis [2], based on the 2003

Canadian Consensus Criteria (CCC) [3].

The differences from the CDC's unproductive

approach are profound. The name CFS has never

reflected the true nature of the disease.

The ICC states:

The label ‘chronic fatigue syndrome’ (CFS) has

persisted for many years because of the lack of

knowledge of the aetiological agents and the

disease process.

In view of more recent research and clinical

experience that strongly point to widespread

inflammation and multisystemic neuropathology,

it is more appropriate and correct to use the

term ‘myalgic encephalomyelitis’ (ME) because it

indicates an underlying pathophysiology.

It is also consistent with the neurological

classification of ME in the World Health

Organization’s International Classification of

Diseases (ICD G93.3).

Contrast this with the educational information

provided by the CDC and the CFIDS Association of

America on the CDC's CFS website.

Various terms are often used interchangeably with

CFS. CFS is the preferred term because it an

internationally accepted case definition that is used

in research and clinical settings.

The name chronic fatigue and immune dysfunction

syndrome (CFIDS) was introduced soon after CFS

was defined; there is no case definition for CFIDS,

and the name implies an understanding about the

pathophysiology of CFS that does not currently

exist. [4]

The authors of the ICC have this to say about the

CDC's " internationally accepted " case definition:

The problem with broadly inclusive criteria [15, 16]

[The 1991 Oxford criteria and the 2005 CDC Reeves

empirical criteria] is that they do not select

homogeneous sets of patients.

The Centers for Disease Control prevalence

estimates increased tenfold from 0.24% using

the Fukuda criteria [17] to 2.54% using the

Reeves empirical criteria [16].

et al. [18] suggest that th are flaws in

Reeves’ methodology because it is possible to

meet the empirical criteria for ME without

having any physical symptoms and it does

not discriminate patients with ME/CFS from

those with major depressive disorder.

Patient sets that include people who do not

have the disease lead to biased research

findings, inappropriate treatments and waste

scarce research funds [19]. [2] [see the paper

for the italicized references.

The authors of the ICC have this to say about the

CDC's " internationally accepted " case definition:

The problem with broadly inclusive criteria [15, 16]

[The 1991 Oxford criteria and the 2005 CDC Reeves

empirical criteria] is that they do not select

homogeneous sets of patients.

The Centers for Disease Control prevalence

estimates increased tenfold from 0.24% using

the Fukuda criteria [17] to 2.54% using the

Reeves empirical criteria [16].

et al. [18] suggest that there are flaws in

Reeves’ methodology because it is possible to

meet the empirical criteria for ME without

having any physical symptoms and it does not

discriminate patients with ME/CFS from those

with major depressive disorder.

Patient sets that include people who do not

have the disease lead to biased research

findings, inappropriate treatments and waste

scarce research funds [19]. [2] [see the paper

for the italicized references.

The CDC also claims:

" The name myalgic encephalomyelitis (ME)

was coined in the 1950s to clarify well-

documented outbreaks of disease; however,

ME is accompanied by neurologic and muscular

signs and has a case definition distinct from

that of CFS. " [4]

If this is true, where is the CDC's case definition for

ME?

Why is ME not listed as an exclusionary

condition for CFS research and diagnosis?

Surely the CDC is aware CFS research is de facto

applied to ME patients. Doctors in the US have not

been educated about ME. They have no choice

now but to misdiagnose with CFS patients who

meet the criteria for ME.

Recently, New York Times writer Tuller wrote

a lengthy account of the CDC's involvement with

the disease:

" Chronic Fatigue Syndrome and the CDC:

A Long, Tangled Tale. " [5]

I urge the Committee members to read it. The CDC's

long, checkered history with CFS should be well

known.

In 1985, the CDC sent two inexperienced

investigators to the Lake Tahoe region of Nevada

after reports of an outbreak of an unknown illness.

Based on a small amount of information collected

and inconclusive research, a CDC committee named

the disease chronic fatigue syndrome and

developed the Holmes case definition in 1988. [6]

This case definition listed a total of 11 symptoms

and 3 signs, many of which indicated neurological

and immunological involvement.

In 1991, small group of ideologically

driven psychiatrists in the UK redefined

CFS as only chronic fatigue with no

required neurological or immunological

symptoms, the Oxford definition. [7]

Even though the criteria for the disease were

changed beyond all recognition from the CDC's

Holmes CFS, the group of psychiatrists unethically

continued to call their creation CFS.

They then proceeded to conflate their new CFS,

which was only chronic fatigue, with the

neurological disease ME, recognized by the WHO

since 1969.

They soon moved to the hybrid term CFS/ME in an

attempt to increase their influence over, and seize

control of, the treatment of the neurological

disease ME.

In 1994, the CDC published its Fukuda, or so-called

International, case definition of CFS. One of the

authors of the deceptive Oxford definition of CFS,

psychiatrist Sharpe, was also an author of

the 1994 Fukuda CFS case definition paper. [1]

Another member of the CDC's International Study

Group of advisors was the psychiatrist Simon

Wessely, another Oxforddefinition co-author, with

extensiveties to the insurance industry and the

military.

A third Oxford-definition psychiatrist, White,

director of the behavioral CFS/ME program at Barts

Hospital, London, became an advisor to the CDC's

program.

White, also with major ties to the insurance

industry, advocates denying aid and assistance to

patients disabled by ME because he believes it

impedes their recovery.

He made this and other similar comments, speaking

for the Barts program, on proposed UK NICE

guidelines for CFS/ME:

Where is the warning about dependence being

encouraged and expectation of recovery being

damaged by the message that is given in this

intervention? [Providing equipment and

accommodations such as a wheelchairs, disability

parking permits, or stairlifts.] We are in no doubt

that it is a powerful message for a therapist of any

sort to provide such aids. [8]

Wessely, White, and Sharpe, members of the

psychiatric " Wessely School " based on unscientific

19th-century concepts of disease causation,

believe ME to be a psychosomatic condition best

treated by a version of talk therapy, cognitive

behavioral therapy (CBT), to correct the patient's

false belief that he or she has a physical illness.

With literally thousands of peer-reviewed

papers indicating properly defined CFS and

ME are physical illnesses, the basic premise

of CBT as a treatment for CFS and ME is,

itself, false.

The other psychiatrically based treatment, graded

exercise therapy (GET), is founded on the

unsupported belief that CFS and ME are the result

of fear of activity and deconditioning.

The hallmark feature of ME is an abnormal response

to exertion, as is recognized by the CCC and ICC.

Attempting to treat ME with exercise is like treating

COPD with smoking or diabetes with sugar.

It is medically dangerous, and the harm caused goes

largely unreported. [9] Sadly, American medical

centers, such as the Mayo Clinic, have been misled

by the muddled approach of the CDC into adopting

the false UK psychiatric model of the disease and

recommending these ineffective and medically

dangerous treatments.

There have been positive changes on the CDC's CFS

website, such as removal of the list of not

recommended medical tests and removal of a link to

the psychiatrically oriented UK NICE guidelines.

However, the CDC continues to claim CBT and GET

are appropriate treatments for CFS. There is still a

link on the CDC website to an outdated and

unscientific pamphlet on GET produced by the Barts

CFS/ME program. [10]

In defiance of the Committee's past

recommendations, the CDC continues to do alleged

CFS research using the Reeves empirical criteria.

[11]

The CDC has misused funds intended for CFS

research doing these invalid studies, mostly with

collaborators from the Emory University Department

of Psychiatry and Behavioral Sciences where

Reeves of the CDC received a faculty

appointment.

Such cronyism and deceptive research is

unethical and constitutes scientific mis-

conduct.

In view of the new information published in the

International Consensus Criteria, I request the

Committee to make the following recommendations

to the Secretary of Health and Human Services:

1. The name chronic fatigue syndrome, which has

never been adequately defined, should be phased

out in favor of the name myalgic encephalomyelitis.

The term CFS, because of the invalid Oxford and

Reeves CFS criteria, has lost all meaning and should

be abandoned.

2. The International Consensus Criteria should be

adopted as the standard case definition for ME for

both research and diagnosis. Only research using

these criteria should be funded by the CDC and

NIH. The most severely affected bedbound and

homebound patients should be included in ME

research cohorts as a requirement to obtain

funding.

3. The CDC should remove CBT and GET from the

list of treatments for CFS on its website and

caution against their use.

4. The DHHS should request the CDC to issue a

statement that research done using the Oxford and

Reeves criteria is invalid for both CFS and ME. The

CDC's Wichita and Georgia cohorts selected using

the Reeves criteria should not be used for further

CFS or ME research.

References

1. Fukuda K, Straus SE, Hickie I et al. Chronic

fatigue syndrome: a comprehensive approach to its

definition and study. Ann Intern Med 1994; 121:

953–9.

2. Carruthers BM, van de Sande MI, De Meirleir KL et

al. Myalgic encephalomyelitis: International

Consensus Criteria. J Intern Med 2011;

270:327–38.

3. Carruthers BM, Jain AK, De Meirleir KL et al.

Myalgic encephalomyelitis/chronic fatigue

syndrome: clinical working case definition,

diagnostic and treatment protocols. J Chronic

Fatigue Syndr 2003; 11: 7–116.

4. CDC CFS website. Course 3151: A Primer for

Allied Health Professionals. Accessed May 9, 2012:

http://1.usa.gov/OhlEsZ (~jvr: page not available

anymore)

5. Tuller, . Chronic Fatigue Syndrome and the

CDC: A Long, Tangled Tale. Published online,

November 23, 2011, in Racaniello's Virology

Blog: http://bit.ly/usLskj

6. Holmes GP, Kaplan JE, Gantz NM et al. Chronic

atigue syndrome: a working case definition. Ann

ntern Med. 1988; 108:387-389.

7. Sharp MC, Archard LC, Banatvala JE et al. A

eport – chronic fatigue syndrome: guidelines for

esearch. J R Soc Med 1991; 84: 118–21.

8. National Institute for Health and Clinical

Excellence CFS/ME. Consultation draft, comments

on chapter 6, September 29 – November 24, 2006.

p. 302. http://bit.ly/OhmQg8

9. Kindlon T. Reporting of harms associated with

graded exercise therapy and cognitive behavioural

therapy in Myalgic Encephalomyelitis/Chronic

Fatigue Syndrome. Bulletin of the IACFS/ME.

2011;19(2):59-111.

10. CDC CFS website. CFS Toolkit - Graded Exercise

Therapy. Accessed May 9, 2012.

http://1.usa.gov/Ohn077

11. Nater UM, Maloney E, Heim C, Reeves WC:

Cumulative life stress in chronic fatigue syndrome.

Psychiatry Res 189:318-320, 2011.