Michael Sharpe

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Michael Sharpe, M.A., M.R.C.P., M.R.C.Psych. is a British professor of psychological medicine at St Cross College, Oxford University and formerly at the University of Edinburgh, United Kingdom. His research focuses on the integration of physical and mental healthcare.

Sharpe is first author of the British case definition of chronic fatigue syndrome (CFS) - often called the Oxford criteria - and co-author of the 1994 Fukuda criteria which has been widely used in research. Sharpe also helped develop the cognitive behavioral model for CFS and medically unexplained symptoms.

As one of the principal investigators of the controversial PACE trial, and second author of the main outcome publication, Sharpe was criticized for misrepresenting the study’s findings in favor of cognitive behavioral therapy and graded exercise therapy.

Biography
Michael Sharpe studied experimental psychology at Corpus Christi College Oxford and medicine at Corpus Christi College Cambridge. He was trained in psychiatry at Oxford and became Clinical Tutor in the University Department. From 1997 to 2011 Sharpe was a professor of psychological medicine at the University of Edinburgh. He took up his current posts in Oxford in September 2011.

Currently, Sharpe is a Fellow of Saint Cross College, Oxford and Honorary Professor at the University of Edinburgh. He is an Honorary Consultant in Psychological Medicine and Trust Lead in Psychological Medicine at Oxford University Hospitals NHS Foundation Trust and advisor to Oxford Health NHS Foundation Trust. Sharpe is also President-Elect of the Academy of Consultation-Liaison Psychiatry and Vice-President of the European Association of Psychosomatic Medicine.

Sharpe was awarded Psychiatric Academic of the Year in 2009 and Psychiatrist of the Year in 2014 by the Royal College of Psychiatrists. His work in the field of chronic fatigue syndrome, however, has been the subject of controversy and criticism.

Sharpe's ambition is to “to see psychiatry regarded as an “ordinary but useful” component in the care of medically ill people.”

Oxford criteria
Sharpe is first author of the British case definition of CFS, often called the Oxford criteria. The Oxford criteria have been used in a number of influential British studies, including the PACE trial. They are however considered a broad definition and have been criticized for including patients with fatigue symptoms other than CFS. A 2016 report by the US Agency for Healthcare Research and Quality (AHRQ) wrote that: "“the Oxford (Sharpe, 1991) case definition is the least specific of the definitions and less generalizable to the broader population of patients with ME/CFS. It could identify individuals who have had 6 months of unexplained fatigue with physical and mental impairment, but no other specific features of ME/CFS such as post-exertional malaise which is considered by many to be a hallmark symptom of the disease. As a result, using the Oxford case definition results in a high risk of including patients who may have an alternate fatiguing illness or whose illness resolves spontaneously with time.”"A report issued by a working group on ME/CFS at the National Institutes of Health (NIH) emphasized that “continuing to use the Oxford definition may impair progress and cause harm. Therefore, for progress to occur, we recommend that this definition be retired.”

Fukuda criteria
Sharpe is also a co-author of the 1994 CFS case definition issued by the Centers for Disease Control and Prevention (CDC), often called the Fukuda criteria. This is the case definition that has been the most frequently used in CFS research.

A cognitive theory of CFS
In the 1990s Sharpe helped develop the cognitive behavioral model (CBM) of CFS. This model suggests that “it is not a particular biological process, but rather specific psychological and behavioural mechanisms that are the common factors determining the clinical characteristics of the syndrome.” According to the CBM, CFS patients have become trapped in a vicious, self-perpetuating cycle of excessive rest, symptom focusing and demoralization due to the attribution of symptoms to an incurable neurological disease.. In a newspaper article on CFS patients, Sharpe commented that “It’s wrong to say people don’t want to get better, but they get locked into a pattern and their life constricts around what they can do. If you live within your limits that becomes a selffulfilling prophesy.”

Sharpe has contributed to the CBM by including psychosocial factors that predispose persons to develop CFS, such as perfectionism, a pre-morbid personality characterized by a marked achievement orientation and a family history where emotional distress was seen as a sign of weakness. According to Sharpe and colleagues these precipitating factors may be “the result of an upbringing in which recognition, acceptance and affection were contingent on meeting high standards and parental expectations, and where the admission of difficulty or the expression of negative emotion produced an unsympathetic response.”

The CBM for CFS has been criticized for a lack of empirical support and relying on unproven assumptions. A 2019 review concluded that “the model lacks high-quality evidential support, conflicts with accounts given by most patients and fails to account for accumulating biological evidence of pathological and physiological abnormalities found in patients.”

Proposed similarities between CFS and psychiatric disorders
Sharpe has studied prognosis, illness beliefs , sleep patterns and fluctuations in perceived energy in patients with CFS. He has argued that CFS resembles a psychiatric or emotional disorder, claiming that "all patients labeled as having CFS can be given a psychiatric diagnosis if one wanted to pursue this approach to its logical conclusion." According to Sharpe, “CFS and psychiatric disorder are alternative diagnoses of the same symptoms.” He considers it likely that “many or all of the symptoms of CFS can be explained on the basis of emotional disorder and associated pathophysiological processes.”  These views are not shared by most experts in the field. The Centers for Disease Control and Prevention (CDC) state that “ME/CFS is a biological illness, not a psychologic disorder.”

Cognitive behavioral therapy (CBT)
Sharpe and colleagues helped develop cognitive behavioral therapy (CBT) for patients with CFS. CBT challenges unhelpful illness beliefs and encourages patients to gradually increase their level of (physical) activity. According to Sharpe, “the aim is to help patients to change their understanding of their illness from an uncontrollable externally caused medical condition with frightening symptoms, to a controllable reversible physiological disorder with symptoms that may be annoying but not dangerous.”

In 1996 Sharpe and colleagues published a randomized trial of CBT and medical care compared to medical care alone. CFS patients in the CBT group reported more improvements but the difference occurred mostly during the follow-up period. The trial has been criticized for not including a credible control condition. Consultant neurologist, Jim Pearce for example commented in BMJ: "Sharpe and colleagues did not compare cognitive therapy with other treatments or placebo, and the improvements (including persistence after the treatment had ended) are compatible with a placebo effect.”

The PACE trial
Sharpe was also one of the principal investigators of the PACE trial, a large study involving more than 600 CSF patients that compared CBT to graded exercise therapy (GET) and adaptive pacing therapy (APT). While the reported findings indicated that CBT and GET were effective treatments for CFS, the authors have been criticized for misrepresenting the trials’ results.

The PACE authors have been criticized for deviating from the methods specified in their protocol, without explaining these changes in full in their publications or how the changes impacted the reported findings. Following inconsistencies in the economic analysis of the PACE trial, health psychologist James Coyne filed a request to the journal PLOS ONE to access the data of the trial, a request that was dismissed as vexatious by Kings College London. PLOS ONE has since issued an expression of concern about the publications in question.

The PACE authors have refused to share the trial's data for independent reanalysis due to concerns that “patients might be personally identified by releasing their data.” During a 2015 first tribunal hearing on the release of the PACE trial data, Professor Ross Anderson defended the PACE authors’ decision by making “wild speculations” about “young men, borderline sociopathic or psychopathic” being attached to criticism of the PACE trial. The tribunal considered these claims to be unfounded. It rejected the appeal by the PACE investigators and ordered the release of some of the anonymized data of the trial. An independent reanalysis showed that the PACE authors had inflated improvement and recovery rates threefold. Sharpe and colleagues responded that they preferred their revised version of recovery over the one specified in the protocol, as it gives “absolute rates more consistent both with the literature and with our clinical experience.” An open letter signed by more than 100 prominent ME/CFS experts including researchers, clinicians, and MPs has called for “an independent re-analysis of the individual-level trial data, with appropriate sensitivity analyses.”

The University of Oxford however has defended Sharp and colleagues. It “considers Professor Sharpe and his colleagues to be highly reputable scientists whose sole aim has been to improve quality of life for patients with ME/CFS. While scientific research should always be open to challenge and debate, this does not justify the unwarranted attacks on professionalism and personal integrity which the PACE trial team have been subjected to.”

One functional somatic syndrome
In an influential 1999 article in the Lancet, Sharpe, Wessely and Nimnuan claimed that syndromes such as CFS constitute an “artefact of medical specialisation.” They argued that there’s a large population of patients with multiple medically unexplained physical symptoms (MUS or MUPS) and that it’s mostly the specialist they see that determines their diagnosis. When seen in gastroenterology patients might be diagnosed with irritable bowel syndrome, in rheumatology with fibromyalgia, in cardiology with atypical chest pain, in neurology with tension headache and in an infectious diseases clinic with chronic (postviral) fatigue syndrome. According to Sharpe and colleagues, there is a large overlap between these conditions and they should, therefore, be viewed together as one functional somatic syndrome.

The prevalence of MUS
Sharpe’s research has estimated the prevalence of MUS in neurology and rheumatology clinics at approximately 30%. He reported that MUS patients tend to have more symptoms than patients with a medically explained condition but that symptom count does not adequately discriminate between the two groups.

In collaboration with Chris Burton, Sharpe has studied MUS patients in primary who have been repeatedly (5 times or more in a 5 year period) referred to specialist clinics. Their research indicated this to be a rather small group (0,3% of total patients) but one with a high rate of disability where psychological problems such as depression are undertreated. Sharpe and Burton suggest developing “clinical information systems to remind practitioners that the patient has already had repeated referrals.” They propose a primary care clinic specialized in managing unexplained somatic symptoms with a “holistic” approach that targets symptom-maintaining factors with medication or cognitive behavioral techniques.

Cognitive behavioral model of MUS
Sharpe has developed a cognitive behavioral model of medically unexplained symptoms. The model assumes that if persons interpret benign bodily sensations as an indication of disease they can become locked in an autopoietic cycle characterized by distress sensitization; a reduced threshold for the detection of symptoms. Lack of an explanation is believed to increases anxiety and symptom focus while avoidance of symptoms and symptom-led activity patterns are proposed to lead to further sensitisation through operant conditioning. Sharpe has worked with the Danish team of Per Fink to conduct a randomized trial of CBT for patients with ‘multi-organ bodily distress syndrome’.

A better name for MUS
According to Sharpe and colleagues, MUS is not an acceptable term to patients and doctors: “It defines the patient's symptoms by what they are not, rather than by what they are, and it reflects dualistic thinking – regarding symptoms as either “organic” or “non-organic”/“psychological.” They suggest that ‘functional somatic disorder’ might be a more suitable alternative as it allows  for an “explanation in terms of altered brain functioning (linking to the term functional imaging) demonstrating that the symptoms are 'real' and yet changeable by alteration in thinking and behaviour as well as by a psychotropic drug.”

Functional neurological symptoms
In collaboration with neurologist John Stone, Shape has studied patients with so-called functional neurological symptoms such as non-epileptic seizures or medically unexplained muscle weakness. In a long-term follow-up, they reported that 83% of such patients still had weakness or sensory symptoms or both after a median of 12 years. Only one out of the 42 patients followed had developed a disorder which, in hindsight, explained the original symptom presentation. Sharpe, Stone, and colleagues compared patients with functional and structural muscle weakness and found that these had similar levels of disability, although the former were more likely to be out of work because of their symptoms. Patients with functional muscle weakness were less likely to agree that stress was a possible cause of their illness. Similar results were found in a comparison of patients with epilepsy and non-epileptic seizures.

From hysteria to functional neurological disorder
According to Sharpe and Stone, patients with motor and sensory symptoms—such as paralysis, seizures, and blindness—that are unexplained by disease are common in neurological practice and account for 1-9% of patients. They have argued that these patients are frequently diagnosed with conversion disorder and in earlier times, hysteria. In a systematic review, they reported that misdiagnosis of conversion disorder and hysteria is uncommon with an average of 4% in studies since the 1970s. According to Sharpe and Stone this indicates that Eliot Slater's influential view that “a diagnosis of ‘‘hysteria’’ is a disguise for ignorance and a fertile source of clinical error” is a myth and not supported by evidence. They argue that it “was not hysteria that disappeared, but rather medical interest in hysteria.” Sharpe and Stone have published a guideline for the detection of conversion symptoms which advises doctors to look for inconsistencies and use the Hoover sign. In contrast, a predominance of symptoms on the left side of the body and ‘la belle indifference’, or a smiling indifference to the symptom were not seen as signs indicative of conversion symptoms. Sharpe and Stone proposed to change the name of conversion disorder into functional neurological disorder “as it is relatively acceptable to patients and is the main term used in other medical specialties to refer to this type of symptom.”

Somatic symptom disorder
In collaboration with Richard Mayou, Sharpe wrote a critique of the somatization disorder diagnosis in the Symptom Disorders Work Group for the Diagnostic and Statistical Manual of Mental Disorders (DSM-4). They argued it should be abolished as it is considered unactable by patients and the psychogenic theory behind it is poorly supported by evidence. As an alternative, they proposed that disorders defined solely by somatic symptoms could more appropriately be classified as functional somatic symptoms and syndromes. Sharpe subsequently became a member of the Somatic Symptom Disorders Work Group for the DSM–5. This resulted in a new category of somatic symptom disorder (SSD), which broadens the former definition of somatization disorder and deemphasizes the centrality of medically unexplained symptoms. Others have criticized the diagnosis of SSD for being too loose and overdiagnosing psychiatric illness in those medically ill.

Bodily symptoms
Sharpe has argued that bodily symptoms should be considered in their own right, not just as manifestations of either bodily pathology or psychopathology. According to Sharpe, there is only a weak relationship between severity of symptoms and severity of pathology, and some symptoms such as fatigue are poorly understood in a purely biomedical model. He has argued that the lack of accepted bodily disease can result in stigma and a morally uncertain position and that this explains the opposition of CFS patients to a psychosocial explanation of their complaints, a hypothesis that is contested by others. Sharpe and colleagues have argued that diagnosis should not be the sole basis of clinical practice and that a focus on prognosis and predictors of outcomes may be more useful.

Fatigue after cancer or a stroke
Sharpe has studied fatigue in patients who had cancer or a stroke. His research indicates that approximately a third of patients have persistent fatigue following cancer or a stroke. Sharpe also conducted SMaRT oncology 1, a large randomized trial that studied the management of depression in cancer patients. The results were reported in The Lancet in 2008 and indicated the intervention was effective in reducing self-reported symptoms of depression, fatigue, and anxiety.

Notable studies

 * 1994, The chronic fatigue syndrome: a comprehensive approach to its definition and study. International Chronic Fatigue Syndrome Study Group (Abstract) - known as the Fukuda criteria


 * 1997, Chronic fatigue syndrome. A practical guide to assessment and management (Full Text)


 * 1998, Doctors' diagnoses and patients' perceptions. Lessons from chronic fatigue syndrome (Abstract)


 * 2002, The report of the Chief Medical Officer's CFS/ME working group: what does it say and will it help? (Full Text)

PACE trial publications:
 * 2007, Protocol for the PACE Trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy
 * Main trial outcome


 * 2011, Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
 * Other PACE trial publications 


 * 2012, Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis


 * 2013, Recovery from chronic fatigue syndrome after treatments given in the PACE trial


 * 2013, A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan


 * 2013, The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial


 * 2014, Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome


 * 2015, Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial


 * 2015, Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial


 * 2015, | Longitudinal mediation in the PACE randomised clinical trial of rehabilitative treatments for chronic fatigue syndrome: modelling and design considerations
 * 2017, Long-term economic evaluation of cognitive-behavioural group treatment versus enhanced usual care for functional somatic syndromes (Abstract)
 * 2019,  Chronic fatigue syndrome and an illness-focused approach to care: controversy, morality and paradox - (Full text)

Letters

 * PACE trial authors' responses


 * 2011, The PACE trial in chronic fatigue syndrome – Authors' reply


 * 2015, (response) Author's reply - Methods and outcome reporting in the PACE trial


 * 2016, (correspondence) Authors' reply - Patient reaction to the PACE trial


 * 2017, Response to: "Do more people recover from chronic fatigue syndrome with cognitive behaviour therapy or graded exercise therapy than with other treatments?" (Abstract)


 * 2019, The PACE trial of treatments for chronic fatigue syndrome: a response to WILSHIRE et al (Full text)

Books

 * 1999, Chronic Fatigue and its Syndromes
 * 2003, Distinguishing Malingering from Psychiatric Disorders (book chapter), in Malingering and Illness Deception

Oxford criteria
Prof. Michael Sharpe is author of the Oxford criteria for chronic fatigue syndrome, which is controversial for not excluding patients with symptoms that could be caused by psychiatric disorders, and for excluding patients with a neurological disorder - despite the fact that myalgic encephalomyelitis/chronic fatigue syndrome/post-viral syndrome are all regarded as neurological disorders. The Oxford criteria have been used in a number of influential British studies, including the PACE trial and Deale, Chalder and Wessely (1995), the cognitive behavioral therapy (CBT) study given the highest evidence rating in the York Review of evidence used to justify the recommendation of CBT in the UK's NICE guidelines used by the NHS.

Fukuda criteria for Chronic Fatigue Syndrome
Prof. Sharpe is co-author of the heavily used Fukuda criteria for chronic fatigue syndrome, which was adopted by the CDC.

Freedom of information act requests
Michael Sharpe has repeatedly criticised both scientists and patients who have highlighted flaws in his research, or used Freedom of Information Act requests to request the release of unpublished data from his scientific research, including the successful request for the unpublished data from the controversial PACE trial.

Denigration of ME patients
In 2018, a tweet by Sharpe claimed that some Freedom of Information Act requests and scientific criticism could not have been made from patients since they would have been too ill to do so. Sharpe's tweet led to over 100 Australians from the ME/CFS community requesting an apology and pointing out that Alem Matthees had been bedridden for 2 years since winning the PACE FOIA tribunal which led to the release of the PACE trial data, which Sharpe had opposed. Sharpe deleted the tweet as a result of the open letter, which had been signed by many of Alem Matthees's family.

Smearing critics
Prof. Sharpe has repeatedly made ad hominem attacks on critics, including in a 2017 ethics lecture Prof. Sharpe described those who opposed his research, presumably including the scientists calling for the PACE trial to be retracted from The Lancet, as a "co-ordinated campaign" who were "against science", and compared them with climate change deniers.

Denial of illness or disability benefits
Prof. Sharpe has undertaken work for the UK's Department for Work and Pensions, a conflict of interest disclosed in the publication of the PACE trial but not disclosed to participants in the trial. He has also been paid by a number of health insurance companies seeking to deny or minimize disability insurance claims or ill health retirement pensions, including Unum and has repeated claimed that ME/CFS patients are motivated to stay ill in order to continue receiving disability benefits.

Malingering and Illness Deception meeting
Michael Sharpe presented at a Malingering and Illness Deception meeting funded by the UK's Department for Work and Pensions on the topic of distinguishing malingering from psychiatric disorders, a topic that later became a chapter of a book published in 2003 by the same name. Sharpe's chapter gives an example of the case of a woman with Chronic Fatigue Syndrome, which is classified as a not a psychiatric disorder. Other contributors to the book include Simon Wessely, Peter White, Mansel Aylward, all of whom became members of the PACE Trial Steering Committee a few years later.

Retirement from ME/CFS Research
In March 2019 Kate Kelland published in interview with Professor Michael Sharpe in which he claimed to have given up research in ME/CFS due to abuse and harassment from ME activists, however, the article was published less than a week after the publication of Sharpe et al's response to the PACE trial re-analysis by Wilshire et al. The same article was criticized for repeating the claim that Sir Simon Wessely has previously given up research into ME/CFS, despite his continued research publications indicating otherwise.

PACE trial
Prof. Sharpe was one of the three principle investigators in the controversial PACE trial, and a member of the PACE Trial Steering Committee and PACE Trial Management Group. The PACE trial was criticized for using the Oxford criteria developed by Sharpe et al, and Sharpe has been accused of "investigator bias" in relation to the PACE.

Wessely school
Michael Sharpe is often referred to as a "member" of the Wessely school, a group led by British psychiatrist Simon Wessely who have been criticized for their dismissal of biomedical research into ME/CFS, promotion of the biopsychosocial model, and close ties with the UK welfare benefit system and the health insurance industry. Some of the Wessely school have been knowing to make unpleasant comments about patients.

Books

 * 1995, Treatment of Functional Somatic Symptoms
 * 1999, Chronic Fatigue and its Syndromes
 * 2003, ABC of Psychological Medicine (ABC Series)
 * 2003, Distinguishing malingering from psychiatric disorders (book chapter)
 * 2008, Chronic Fatigue Syndrome (The Facts)

Media coverage and interviews

 * 2011, Comparison of treatments for chronic fatigue syndrome - the PACE trial -ABC.Net.AU Radio (with transcript)
 * 2013, Chronic Fatigue Syndrome 2 - Lancet TV on YouTube (about the PACE trial)
 * 2015, Chronic fatigue patients criticise study that says exercise can help - Guardian 28 Oct 2015

Online presence

 * Twitter

List of publications

 * PubMed
 * University of Oxford - Michael Sharpe

Learn more

 * 2005, A Response to Michael Sharpe
 * 2001, Quotable quotes by Michael Sharpe - Margaret Williams