Michael Sharpe

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, 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 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. The Oxford criteria is considered a broad definition and have been criticized for including patients with fatigue and symptoms that may not be due to CFS, and for not including neurological symptoms Nacul et al. 2017 found that only 1 in 15 who met the Oxford criteria also met the Canadian Consensus Criteria for ME/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 three principal investigators of the PACE trial, and a member of the PACE Trial Steering Committee and PACE Trial Management Group. The PACE trial was a controversial clinical trial that compared CBT, graded exercise therapy (GET), and adaptive pacing therapy (APT) with specialist medical care in patients with chronic fatigue syndrome. The reported findings indicated that CBT and GET were moderately effective treatments for CFS, but the trial design was criticized for using the broad Oxford criteria (developed by Sharpe et al.), and the authors have been criticized for misrepresenting the trials’ results, and even for "investigator bias".

The PACE authors deviated 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 also refused to share the trial's data for independent reanalysis due to concerns that included “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 to the Lancet signed by over 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
In collaboration with Vincent Deary and Trudie Chalder, 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 sensitisation"; 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’.

Functional somatic disorder
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 indicates that symptoms are real but changeable by alteration in thinking and behaviour as well as by a psychotropic drugs.

Hysteria, conversion disorder and functional neurological disorder
In collaboration with neurologist Jon Stone, Sharpe has studied patients with motor and sensory symptoms—such as paralysis, seizures, and blindness—that are unexplained by disease. According to Sharpe and Stone, these patients are common in neurological practice  and 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 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 (SSD)
In collaboration with Richard Mayou, Sharpe wrote a critique of the somatization disorder diagnosis in 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 Disorder 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.

Wessely school
Michael Sharpe has been referred to as a "member" of the Wessely school, a group of British psychiatrists led by Simon Wessely that has 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.

Paid work for insurance companies
Sharpe has done voluntary and paid consultancy work for legal and insurance companies and 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.

In 2002, Sharpe wrote a controversial article in the UNUMProvident CMO Report on functional symptoms and syndromes, which in his view includes ME/CFS. He criticized the “ME lobby” for objecting to rehabilitative treatments and emphasizing the validity and chronicity of the illness. According to Sharpe “a strong belief and preoccupation that one has a 'medical disease' and a helpless and passive attitude to coping is associated with persistent disability...”

Denial of illness or disability benefits
Sharpe has also been paid by a number of health insurance companies seeking to deny or minimize disability health insurance claims or ill health retirement pensions, including Unum and has repeatedly claimed that ME/CFS patients are more likely to improve when they don't have access to disability benefits. In Sharpe's 2002 Unum article, he also claimed that the current system of state benefits, insurance payments, and litigation forms a potentially major obstacle to recovery. Sharpe argued that “benefits and medical services need to be more rehabilitation orientated.”

Malingering and illness deception conference
Michael Sharpe presented at a 2001 Malingering and Illness Deception conference 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 not a psychiatric disorder) suspected of malingering due to day to day fluctuations in illness severity. 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.

The belief in ME
According to Sharpe, “the insistence that 'ME' is an exclusively physical disease, untreatable except by rest, and with a poor prognosis, may in the long run have been unhelpful for sufferers.” He has also argued that extensive laboratory investigation “may be psychologically harmful to the patient by reinforcing their beliefs or concerns about serious physical disease.” Sharpe has criticized doctors for “colluding with the patient's belief that their symptoms are explained by an untreatable disease (such as myalgic encephalopathy…).”  In a book co-written with Simon Wessely and Matthew Hotopf, Sharpe warned that campaigning for more awareness of ME in adolescents might have increased the incidence of young people with such presentations.

Freedom of information act requests
Michael Sharpe has repeatedly criticized scientists and patients who highlighted flaws in his research or used Freedom of Information Act (FOIA) requests to demand the release of unpublished data from his research, including the successful request for unpublished data from the PACE trial. Some of the Wessely school, including Michael Sharpe, have been known to make unpleasant comments about patients in the media.

“Patients would surely be to produce so many complaints”
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. He claimed that “many of the activists trying to have scientific papers they don't like retracted are not patients. Patients would surely be too ill to produce so many complaints and FOI requests to journals, funders, and universities.”  Sharpe's tweet led to over 100 Australians from the ME/CFS community requesting an apology, pointing out that Alem Matthees had been bedridden for 2 years since winning the FOIA tribunal that led to the release of the PACE trial data, a decision that Sharpe had opposed. Sharpe deleted the tweet as a result of the open letter, which had been signed by Alem Matthees's family.

Sharpe has also referred to patients opposing his research as "militant" ME patients, and used "activists" as a disparaging term. Blease and Geraghty (2016a, 2016b) found "epistemic injustice" and "ethical failures" in the treatment of ME patients, and in 2018 reported they could not find any evidence of "militancy" among ME/CFS patient groups.

Comparing critics to climate change deniers
Sharpe has described those who opposed his research as a co-ordinated "pressure group" who are "against science", similar to climate change deniers. In a lecture abstract Sharpe said that the use of “co-ordinated pressure group action against science was prominently seen in the field of climate change research but is now emerging in other areas. Chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME for short) is one of these.”

In 2019, Sharpe and Greco has argued that even “the well-intentioned campaigning for better recognition of CFS inadvertently reinforces the social and cultural conditions that made that recognition more difficult in the first place."

Unbecoming of an MP and retraction requests
In 2018 member of parliament (MP) Carol Monaghan raised the issue of the PACE trial in British parliament. Afterward, she received an email from Michael Sharpe saying her actions were "unbecoming of an MP." Monaghan responded in parliament by stating: “if listening to my constituents, investigating their concerns and taking action as a result is ‘unbecoming’, I stand guilty.”

When in 2019 the Health Research Authority’s report on the PACE trial indicated no regulatory concerns , Sharpe sent e-mails to at least two US publications requesting a retraction or major correction of articles critical of the PACE-trial. Sharpe’s e-mails accused the writers of the articles of suggesting that PACE was “fraudulent.”

In 2018 journalist Amy Maxmen wrote an article for Nature about ME/CFS which included recent criticism on the efficacy of psychosocial interventions. Sharpe and colleagues responded with a letter in which they argued that “there is no place for stigmatizing any avenue of research or therapy that might help us to improve the lives of people with this long-term debilitating illness.”

Regarding the revision of the Cochrane review on graded exercise therapy, Sharpe has claimed that the Cochrane editor “wilted badly… under direct pressure from activists”, despite email correspondence indicating this to be untrue. The Cochrane editor in question, David Tovey, had explicitly stated that “this [sic] not about patient pressure.”

Retirement from CFS research
In March 2019, Reuters journalist Kate Kelland published an 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.

Books

 * 1995, Mayou R, Bass C, Sharpe M. (Eds). Treatment of Functional Somatic Symptoms. Oxford University Press.
 * 1999, Wessely S, Sharpe M, Hotopf M. Chronic Fatigue and its Syndromes. Oxford University Press.
 * 2000, Campling F. and Sharpe M. Chronic Fatigue Syndrome (CFS/ME). The Facts. Oxford University Press.
 * 2003, Mayou R, Sharpe M, Carson A. (Eds). ABC of Psychological Medicine (ABC Series). Wiley-Blackwell.
 * 2003, Distinguishing Malingering from Psychiatric Disorders (book chapter), in Malingering and Illness Deception.  New York: Oxford University Press.
 * 2006, Campling F. and Sharpe M. Living with a Long-term Illness: The Facts. Oxford University Press.

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

Publications unrelated to 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)
 * Other publications


 * 2006, Occupational Aspects of the Management of Chronic Fatigue Syndrome: A National Guideline (Full text) External Assessors: Professor Michael Sharpe and Professor Peter White.

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)

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 - Oct 28, 2015
 * 2016, Michael Sharpe: Psychiatry was "no waste of a career" - The BMJ Confidential - Aug 10, 2016
 * 2019, Online activists are silencing us, scientists say  - Reuters Special Report - Mar 13, 2019
 * 2019, Michael Sharpe on BBC Radio 4 Today programme  - Mar 18, 2019 - unofficial transcript
 * ME and the perils of internet activism  - The Guardian - Jul 28, 2019

Online presence

 * Twitter
 * PubMed
 * Researchgate

Learn more

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