00:00:00
George Monbiot describes the treatment of
Myalgic Encephalomyelitis as "the greatest
00:00:06
medical scandal of the 21st century", emphasising
how it "has been maligned and misrepresented on an
00:00:13
industrial scale". According to Monbiot, "this is
about how the scientific and media establishment
00:00:19
closed ranks around bad science, defending it
from legitimate questioning and criticism".
00:00:25
Myalgic Encephalomyelitis (ME), is a serious,
00:00:29
long-term illness that can be profoundly
disabling. It typically follows an infection,
00:00:35
such as the Epstein-Barr virus or the flu.
But it's not simple post-illness fatigue;
00:00:40
it's a complex, multisystem disorder
with a wide range of symptoms.
00:00:45
A key feature of the illness is that
patients have an energy impairment and
00:00:49
an abnormal response to exertion. The hallmark
symptom is called post-exertional malaise,
00:00:55
which means when patients exceed their available
energy, they experience a worsening of symptoms
00:01:01
and reduction in physical function. Patients
often refer to this as a crash, which can last
00:01:07
for days or even weeks, sometimes leading to
a relapse and an increase in illness severity.
00:01:13
While the exact physiology remains
unclear, there is a large body of
00:01:17
evidence that demonstrates biological
abnormalities in multiple systems,
00:01:22
such as the nervous system, the
immune system, and energy metabolism.
00:01:26
ME was recognised as a neurological disease by the
World Health Organisation in 1969. However, in the
00:01:34
late 1980s, an influential group of psychiatrists
and researchers reframed ME as Chronic Fatigue
00:01:41
Syndrome (CFS), a vague condition characterised by
fatigue. They claimed there is no ongoing disease
00:01:48
and argued that patients' symptoms are caused
by unhelpful thoughts and behaviours. Building
00:01:53
on this belief, they developed psychological
and exercise therapies that dominated care and
00:01:59
became the only treatments recommended
in medical guidelines around the world.
00:02:04
Over the last few years, though, major
health agencies in the US and the UK
00:02:09
have withdrawn these treatments because they
are not effective, the research is flawed,
00:02:13
and patients reported they were harmful.
00:02:16
Watch the full explainer video on YouTube.
00:02:16
Watch an explainer video on YouTube.
00:02:16
Here are some of the key events
that illustrate the scandal:
00:02:19
1955.
00:02:21
The Royal Free Hospital in London is
forced to close for several months
00:02:25
after an outbreak of an unknown illness.
No pathogen is found but key investigators
00:02:30
believe it is probably caused by a virus. Dr.
Melvin Ramsay, a consultant at the hospital,
00:02:36
becomes the leading expert on the condition,
which becomes known as Myalgic Encephalomyelitis.
00:02:42
1969.
The World Health Organisation
00:02:45
(WHO) classifies ME as a distinct neurological
disease. This classification remains valid today,
00:02:53
and is important because it underscores
that ME is not a psychological illness.
00:02:58
1970.
Two Psychiatrists publish a damaging
00:03:01
paper that revisits the Royal Free Outbreak.
Without interviewing any patients, they conclude
00:03:07
it was "mass hysteria" because the majority of
people affected were women. The paper influences
00:03:12
how patients are treated by doctors, and helps
lay the groundwork for psychological treatments.
00:03:18
1986.
After decades of research and
00:03:21
clinical experience, Ramsay publishes the first
definition of ME. He recognises that the most
00:03:27
important feature of the illness is a unique form
of fatigability, or worsening after activity, that
00:03:33
must be present for a diagnosis. This abnormal
response to exertion helps differentiate ME from
00:03:39
other conditions and later becomes known as Post
Exertional Malaise, the hallmark symptom of ME.
00:03:46
Ramsay warns that relapses can be caused
by excessive physical or mental exertion,
00:03:51
and recommends that patients
stay within their limits.
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He dismisses a psychological cause
and points to evidence suggesting
00:03:57
it could be linked to a persistent
virus, an abnormal immune response,
00:04:02
or mitochondrial dysfunction —all of which
remain important areas of research today.
00:04:08
1988.
00:04:10
In the United States, the Centers for Disease
Control (CDC) respond to a number of outbreaks.
00:04:16
They recognise that it’s not a new illness
and it's most commonly referred to as ME,
00:04:20
but decide on a new name: Chronic
Fatigue Syndrome. Dr. Anthony Komaroff,
00:04:26
who is part of the group that coins the
name, later admits this was a "big mistake".
00:04:44
1989.
Just two years after seeing his first
00:04:48
patients with ME, Dr. Simon Wessely publishes a
new theory to explain and treat the condition.
00:04:54
He rejects the conventional view that
patients have a poorly understood disease,
00:04:58
and need to limit their activity to prevent
deterioration. Instead, he argues that they
00:05:03
have become unfit due to being inactive. They
may have originally been ill with an infection,
00:05:08
but have rested for too long, and experience
symptoms when they try and resume activity.
00:05:14
According to Wessely, patients mistake
these symptoms for the original infection
00:05:18
and think something is seriously wrong. As
a result, they develop a fear of activity,
00:05:23
and get trapped in a vicious circle of
increasing avoidance and disability.
00:05:28
He recommends Cognitive Behavioral Therapy (CBT)
to convince patients that symptoms are caused
00:05:34
by inactivity, and a graded increase
in exercise to restore their fitness.
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1991.
The Oxford criteria for
00:05:42
diagnosing Chronic Fatigue Syndrome are published
in the UK. The authors are mostly psychiatrists,
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including some who become prominent figures in the
research of the illness. The new criteria are not
00:05:55
specific enough and don’t include worsening after
activity—the hallmark symptom of ME. As a result,
00:06:01
they basically identify people with
unexplained fatigue. This becomes a
00:06:06
major problem for research, as studies using the
criteria can include people who don’t have ME,
00:06:12
which dilutes the sample and skews the results.
For example, while exercise improves health and
00:06:17
function for many conditions, people with ME
experience exercise intolerance, which means
00:06:23
that exercise can actually make their symptoms
worse. Despite this serious flaw, the criteria
00:06:29
become popular in UK research, and distort the
understanding of ME for the next few decades.
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1993.
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Contrary to the WHO classification, Wessely
successfully lobbies the UK government agency,
00:06:42
now known as the Department of Work and Pensions,
to not classify ME as a neurological disorder. He
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argues that the belief in a physical cause
leads to poorer outcomes, and warns of an
00:06:54
increase in cost to the department for disability
benefits. In his view, the worst thing to do
00:06:59
is tell patients to rest, and claiming
benefits can often make them worse.
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1996.
In the UK,
00:07:07
the Royal Colleges publish an influential
report on Chronic Fatigue Syndrome. The
00:07:12
authors are predominantly psychiatrists,
including Wessely, who takes a lead
00:07:16
role. The report is heavily criticised for its
psychiatric bias, as it dismisses a viral cause,
00:07:22
ignores biomedical evidence, and places
undue emphasis on psychological factors.
00:07:28
Despite insufficient evidence, the report
endorses Graded Exercise Therapy and CBT
00:07:33
as treatments. It also recommends that
the term ME should no longer be used in
00:07:38
research or clinical practice. This leads to the
virtual disappearance of ME for the next decade.
00:07:53
1999.
Wessely establishes the first NHS service
00:07:57
for Chronic Fatigue Syndrome, which leads to a
national model that is rolled out across the UK.
00:08:03
Around the same time, the Royal College
of GPs and King's College London,
00:08:07
produce a training video on Chronic Fatigue
Syndrome, which they also refer to as ME.
00:08:13
The video describes patients as "very frustrating"
because you can get into arguments about the cause
00:08:18
of their illness and the type of treatment they
want. It downplays the severity, dismisses a viral
00:08:25
cause, and claims that the illness is perpetuated
by a fear of activity and excessive rest.
00:08:31
In one part of the video, a patient is
advised to exercise even when they "feel
00:08:35
rotten" and "absolutely exhausted",
which is potentially very harmful.
00:08:40
Overall, the video teaches an approach
that invalidates the patient experience,
00:08:45
damages the patient-doctor relationship,
and risks worsening the patient’s condition.
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2005.
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Sophia Mirza dies of severe ME. Prior
to her death, Sophia had been wrongfully
00:08:57
sectioned for refusing to attend a clinic that
treats patients with Graded Exercise Therapy.
00:09:03
The mistreatment during her stay results in a
dramatic deterioration, and she never recovers.
00:09:50
2007.
In the UK, the National Institute
00:09:53
for Health and Care Excellence (NICE) publish
a guideline for ME/CFS that recommends Graded
00:09:59
Exercise Therapy and CBT. The guideline is widely
condemned by doctors, researchers, charities,
00:10:07
and patient groups. They point out a number
of serious issues, such as the evidence being
00:10:12
weak and based on a handful of small studies.
Serious questions are raised about the committee,
00:10:17
with a large proportion having previously shown
bias in favour of the psychological approach,
00:10:22
including some with financial interests. There
is also major concern about the risk of harm,
00:10:28
as surveys consistently report that Graded
Exercise Therapy makes patients worse.
00:10:33
February 2011.
The results of the controversial
00:10:37
PACE trial are published. Costing £5 million, it
is the largest trial ever conducted on ME/CFS,
00:10:44
and the only medical trial to be part funded
by the Department of Work and Pensions. The
00:10:49
authors claim the trial shows that Graded Exercise
Therapy and CBT are effective, and in some cases
00:10:56
the treatments can even lead to recovery. As a
result, the trial has significant implications
00:11:01
for patients, influencing treatment guidelines,
and insurance policies around the world.
00:11:07
Despite this impact, the trial faces
widespread criticism. For example,
00:11:11
Dr. Ron Davis, one of the world’s leading
geneticists, says, “I'm shocked that The
00:11:16
Lancet published it… The PACE study has so many
flaws and there are so many questions you'd
00:11:21
want to ask about it that I don't understand
how it got through any kind of peer review.”
00:11:26
In fact, the trial is so flawed that it goes on
to be used in textbooks and university seminars
00:11:32
as a case study of bad research. Serious
concerns are raised but are dismissed,
00:11:37
as can be heard in this interview with
Richard Horton, the editor of The Lancet.
00:12:16
July 2011
Following strong
00:12:18
opposition to the PACE trial, the Science
Media Centre (SMC) start a campaign in the
00:12:24
media that portrays ME/CFS patients as dangerous
activists who harass and threaten researchers.
00:12:31
Routinely used by every news organisation
in the UK, the SMC provide journalists with
00:12:36
expert information about science and have
considerable influence over how science
00:12:41
is covered by the media. However, critics argue
that the SMC spoon-feed information to reporters,
00:12:48
who often fail to question the material
or explore different points of view. This
00:12:52
is particularly concerning as the SMC have
also been criticised by several academics
00:12:57
and researchers for being biased in
favour of government and industry.
00:13:02
A clear example of their bias is the
active promotion and defence of the
00:13:06
psychological approach to ME/CFS. This
is not surprising, given that Wessely,
00:13:11
who has a vested interest in the research, holds
significant influence within the organisation as
00:13:17
both a founding member and a scientific advisor.
He also later joins the board of trustees.
00:13:23
The SMC begin their campaign by giving a story
to the BBC about the abuse of researchers.
00:13:29
A document reveals their aim is
to “engineer coverage” and “frame
00:13:32
the narrative” of reporting on ME/CFS
research. The follow-up is “huge,” with
00:13:38
almost every newspaper and influential
magazine covering the story in some way.
00:13:42
The articles sensationalise the behaviour
of a few individuals, and portray legitimate
00:13:47
criticism as an unjustified attack on science.
Patients are depicted as misguided fanatics
00:13:54
opposed to a psychological explanation of the
illness or any involvement from psychiatry.
00:13:59
They are likened to anti-vaxxers
and animal rights extremists,
00:14:03
and Wessely claims they are so dangerous
he feels safer in Iraq and Afghanistan.
00:14:07
Wessely features in many articles, including
the original story the SMC gave to the BBC,
00:14:13
yet they fail to mention his
connection to the organisation,
00:14:17
a clear conflict of interest
that should be disclosed.
00:14:20
The harassment narrative has a broad and lasting
impact as it continues in the media over the next
00:14:26
decade. It discredits patients, promotes
prejudice, and garners support from other
00:14:31
scientists—ultimately diverting attention
away from valid concerns about research.
00:14:37
December 2011.
Renowned Cancer Researcher and MP,
00:14:40
Dr. Ian Gibson, explains why there is a reluctance
to fund biomedical research into ME/CFS.
00:15:05
Just over a week later, a study reveals that
delivering psychological treatments for ME/CFS
00:15:11
can be challenging because patients don’t
accept the rationale behind the approach.
00:15:15
One supervisor commented that some nurses
were so frustrated that they got angry at
00:15:20
the patients. The nurses felt that patients
should be grateful and follow their advice,
00:15:25
but when they were resistant, it led to attitudes
such as, “the bastards don’t want to get better”.
00:15:31
February 2015.
In the United States,
00:15:34
the Institute of Medicine, known for
its rigorous and impartial reviews,
00:15:38
publish a landmark report on the evidence base
for ME/CFS. An expert panel examines over 9,000
00:15:45
studies and concludes that ME/CFS is a “serious,
chronic, complex, and multisystem disease”;
00:15:52
firmly stating it "is a medical — not a
psychiatric or psychological — illness".
00:15:58
They recognise that Post-Exertional Malaise, the
worsening of symptoms after physical or mental
00:16:03
exertion, is a defining feature of the illness
that helps distinguish it from other conditions.
00:16:09
They make it essential for diagnosis in their
new criteria, which are later adopted by the CDC.
00:16:15
The report marks a significant turning point,
00:16:17
influencing guidelines and treatment
recommendations around the world,
00:16:21
as well as helping to reshape the
understanding of the condition.
00:16:25
October 2015.
The long-term follow-up results
00:16:28
for the PACE trial are published. The authors
acknowledge there is no difference between groups,
00:16:33
which means patients did just as well with
standard medical care as they did with Graded
00:16:38
Exercise Therapy or CBT. The authors continue
to argue that the treatments are effective even
00:16:44
though there was no long-term benefit. In support
of the paper, the Science Media Centre run a press
00:16:50
briefing and publish a single expert reaction
from a colleague of the PACE authors. Patients,
00:16:56
experts, and charities criticise the results, but
the media report on the treatments as a success.
00:17:03
2016.
After Queen Mary
00:17:05
University of London refused multiple Freedom
of Information requests, a court orders them
00:17:10
to release part of the PACE trial data to Alem
Mathees, an Australian ME patient. Alem had to
00:17:16
complete a course of Graded Exercise Therapy
and CBT to qualify for disability benefits,
00:17:22
but became skeptical of their effectiveness after
his health deteriorated following treatment.
00:17:28
During the tribunal, the University uses
claims of harassment and a serious risk of
00:17:33
violence to try and keep the data hidden,
but these claims are found to be "grossly
00:17:38
exaggerated”. The only actual evidence they
are able to provide is that Trudie Chalder,
00:17:42
one of the PACE authors, was heckled
during a seminar. Chalder acknowledges
00:17:47
that while unpleasant things have been said, no
threats have been made to the PACE researchers.
00:17:53
The long and unnecessary legal battle takes a huge
toll on Alem’s health. The ordeal lasts over two
00:17:59
years, and the excessive reading and
writing contributes to a severe relapse.
00:18:03
Alem never recovers, eventually becoming
bedbound, sensitive to light and sound,
00:18:08
and unable to read or speak. After many
years, he remains in this state today,
00:18:13
only managing to sit briefly to consume a liquid
meal or use a portable toilet next to his bed.
00:18:19
May 2017.
Merryn Crofts dies of Severe ME. Merryn’s mum,
00:18:24
Clare Norton, is very critical of the PACE
trial and the NICE guideline. She strongly
00:18:29
believes that if Merryn had received the advice
to slow down and rest earlier, she might not have
00:18:34
progressed into Severe ME. Clare also speaks
about the ‘torture’ of watching her daughter
00:18:39
waste away and die from ME, all while doctors
tried to insist her illness was psychological.
00:19:05
July 2017.
In the United States, the CDC remove
00:19:09
their recommendation for Graded Exercise Therapy
and CBT. Losing the endorsement of the country's
00:19:15
leading health agency marks a major step forward
in the rejection of the psychological approach.
00:19:22
August 2017.
00:19:24
Keith Geraghty publishes an analysis of
multiple treatment surveys. Over 50% of
00:19:29
the 6,000 respondents reported that Graded
Exercise Therapy made their condition worse.
00:19:35
February 2018.
Carol Monaghan
00:19:38
leads the first of 3 debates about ME in the UK
Parliament, including one about the PACE trial.
00:20:39
March 2018.
Using the data released by the tribunal,
00:20:43
a re-analysis of the PACE trial reveals that the
results were exaggerated. Partway through the
00:20:48
original trial, the authors deviated from their
published plan and lowered the thresholds they
00:20:53
used to measure improvement and recovery. This had
a dramatic effect on the results. For example, the
00:21:00
original trial reported that the improvement rate
for Graded Exercise Therapy was 61%. But when the
00:21:07
data is re-analysed using the authors' original
criteria, the improvement rate falls to just 21%.
00:21:14
An earlier re-analysis found that
one of the thresholds used to
00:21:17
measure recovery was lowered to such
an extent, that 13% of patients were
00:21:22
already considered 'recovered' on a key
measure before the trial had even started.
00:21:27
The new paper finds no evidence that Graded
Exercise Therapy or CBT are effective,
00:21:32
or that they lead to recovery, as previously
claimed. If the authors had kept to their
00:21:37
original plan, the PACE trial could
not have been reported as a success.
00:21:42
The Science Media Centre try and discredit the
paper by publishing a fact sheet for journalists.
00:21:48
It describes PACE as a "good quality trial",
and attempts to diminish the credibility of
00:21:53
papers critical of PACE by saying they are
published in low impact factor journals.
00:21:59
June 2018.
Emma Shorter gives
00:22:02
evidence in the Scottish Parliament and describes
her experience of Graded Exercise Therapy.
00:22:49
Professor Jonathan Edwards also
submits evidence and writes:
00:22:52
"The patient community has been publicly
vilified by the trial authors and colleagues
00:22:56
but they have turned out to be right.
They have identified a serious weakness
00:23:00
in the quality of both science and peer
review in psychological medicine."
00:23:05
August 2018.
00:23:07
David Tuller publishes a third version of
his open letter, requesting an independent
00:23:11
re-analysis of the PACE trial. The letter,
signed by over 100 academics and 70 charities,
00:23:18
highlights several major flaws and unacceptable
errors, but the Lancet fails to take any action.
00:23:25
October 2021.
NICE publish a new guideline for ME/CFS. Following
00:23:30
a comprehensive review, they find serious flaws in
the evidence for Graded Exercise Therapy and CBT.
00:23:37
A lot of the research is downgraded because the
study design was not blinded and relied on patient
00:23:43
questionnaires to measure the effectiveness of
treatments. Blinding is important in research
00:23:48
because it hides whether a patient is receiving
treatment, which reduces bias and improves
00:23:54
reliability. For example, when patients are aware
they are receiving treatment, they might report
00:24:00
improvements simply because they expect to feel
better. In studies of Graded Exercise Therapy
00:24:05
and CBT though, blinding is not possible, so to
ensure reliability, the outcome measures have
00:24:12
to be objective, such as activity levels or
fitness. However, when objective measures are
00:24:17
used in studies of Graded Exercise Therapy and
CBT, they fail to show any meaningful benefit.
00:24:24
Research that used diagnostic criteria
that did not require Post-Exertional
00:24:29
Malaise is also downgraded. This is because it
00:24:32
could include patients with other illnesses
who may respond differently to treatments.
00:24:38
After the review, NICE finds all the evidence
for Graded Exercise Therapy and CBT is of 'Low',
00:24:44
and 'Very Low' quality. There is also considerable
evidence of harm from patient surveys,
00:24:49
as well as concerns about trial safety
data due to poor reporting. In the end,
00:24:54
they conclude that there is no
evidence that Graded Exercise Therapy
00:24:58
or CBT are effective and that Graded
Exercise Therapy is harmful. As a result,
00:25:04
the new guideline makes it clear that Graded
Exercise Therapy should no longer be used,
00:25:10
and that CBT should only be offered to help
patients cope with the effects of their illness.
00:25:16
Thirty years after it was initially proposed,
00:25:18
major health agencies have rejected the
psychological approach. Patients and
00:25:23
advocates who criticised the research have
been vindicated; they were right all along.
00:25:28
But the impact has been devastating. Graded
Exercise Therapy has harmed thousands of patients,
00:25:34
many who could previously walk ended up
needing wheelchairs, or have become bedbound.
00:25:39
It has led to widespread misunderstanding.
According to a 2021 survey, 80% of doctors
00:25:46
wrongly believe that ME/CFS is either
partly or entirely psychological.
00:25:52
It has added to the stigma,
00:25:54
promoting the view that ME/CFS can be cured
solely by a patient's attitude and effort.
00:25:59
Doctors often blame patients for not helping
themselves, are dismissive, and deny support.
00:26:05
In 2023, The Times reported that the Department of
Health told the NHS to ‘stop blaming ME patients
00:26:12
for being ill’, and warned that 'ME patients
risk dying of starvation' under NHS care.
00:26:18
Patients that refused treatment have been denied
benefits and insurance claims. Some have even
00:26:23
been sectioned, and parents of children with
ME/CFS have faced child protection proceedings.
00:26:29
Millions of pounds have been wasted on
flawed research and inappropriate treatments,
00:26:34
while biomedical research has
been held back. Despite ME/CFS
00:26:38
being common and around for decades,
patients have no effective treatments,
00:26:43
and no drugs are expected to become
available in the near future.
00:26:47
Thanks for watching, references are
available in the transcript linked below.
