The PACE Trial: “This is not a good day for people with ME/CFS”

Cognitive behavioural therapy as it should be applied is a therapy which can aid sufferers of many serious illnesses by working through distress and managing the changes imposed by the severity of the illness on the life of the patient. However, some governments have caught at CBT as an alternative to the enormous financial burden of mental and physical health care. Therapists in Britain warned in 2008 that the effectiveness of CBT on illnesses such as depression was unproven, yet £173 million was spent by the British government in that year on making CBT widely available. When applied to M.E. as a “cure”, it aims to free the patient of the “misapprehension” that he or she is physically ill. Graded Exercise Therapy operates on the assumption that the physical debility of the M.E. patient is as a result of “deconditioning”, and that full physical functioning can be achieved with a gradual increase in activity.

Once again, the CBT/GET brigade are out in force, scoffing at medical ethics and wilfully putting the health, wellbeing and even the lives of millions of M.E. sufferers at risk. A hugely publicised trial, published today in The Lancet, has been claimed to show that the treatments are safe and effective for “chronic fatigue” patients. Another of its main findings is that pacing, the treatment method judged by the vast majority of M.E. patients to ameliorate their symptoms, is ineffective.

These are hugely problematic and troubling claims on too many levels to cover in one blog post. For one, “chronic fatigue” as defined by the report’s authors means the Oxford Criteria for M.E. This is a hugely inclusive definition which, by design, covers patients with undiagnosed psychiatric disorders and unrelated physical illnesses who do not meet the objective criteria for M.E./C.F.S. Not surprising, then, that one of the report’s authors claimed that “CFS clinic doctors should be trained to diagnose psychiatric disorders”. The report ignores and denies the World Health Organisation definition of M.E. as a neurological disorder (benign Myalgic Encephalomyeltis, WHO ICD-10 G93.3).

In his response to the report, Professor Malcom Hooper stated:

The MRC PACE Trial used no objective measures of outcome (i.e. actigraphy) to show improvement or non-improvement and relies upon participants’ subjective answers to questionnaires. This is an unscientific way to gather evidence.  There can be no empirical science without objective measures – objective measures are at the heart of the scientific method.

This is particularly pertinent because other scientific studies have demonstrated that the CBT/GET approach may not only be ineffective, but harmful. It is worth quoting at length from a comprehensive review of literature on the subject (the full article may be found here):

ME/CFS is considered to be a rather harmless condition by most physicians, but patients with ME/CFS are often more functionally impaired than those suffering from type 2 diabetes, congestive heart failure, multiple sclerosis, and end-stage renal disease.

The (bio)psychosocial model (CBT/GET) has been invalidated by research
a) Two pillars of this model, i.e. “decreased exercise capacity is caused by kinesiophobia (fear of movement)” and “physical deconditioning is a perpetuating factor in ME/CFS”, have been invalidated by research results.
b) Another misconception is the central role of specific personality traits presumed by the (bio)psychosocial model. According to various studies psychological factors play no role at all, or at the least a very minor one… no differences between patients with ME/CFS and rheumatoid arthritis in measures of perfectionism, attitudes toward mental illness, defensiveness, social desirability, or sensitivity to punishment (a concept related to neuroticism) were found. The authors stated their study also invalidated the ‘stereotype of CFS sufferers as perfectionists with negative attitudes toward psychiatry’….psychosocial and environmental factors (including personality, coping style, mood, and psychiatric history) have no significant effect on illness outcomes. According to this study post viral ME/CFS is almost exclusively genetically determined.

The evidence-based success claim for CBT/GET is unjust.

Not only is the evidence-based claim for CBT/GET unjust, there is compelling evidence that CBT/GET is potentially harmful for many ME/CFS patients. Numerous studies support the assertion that exercise and, consequently, GET, can aggravate several characteristic ME/CFS symptoms, e.g. neurocognitive complaints, reduced exercise capacity and widespread muscoskeletal pain, and amplifies pre-existing pathophysiological abnormalities in ME/CFS, e.g. immune dysfunction, induction of the IO&NS pathways, channelopathy and an impaired stress response. Large-scaled patient surveys and clinical practice show that CBT/GET often induces a deterioration of the clinical status of ME/CFS patients and is harmful for many patients. Therefore, it is medically unethical to subject ME/CFS patients to CBT/GET programs or variants, like GET with limits, without assessing biological abnormalities, monitoring functional impairment objectively and measuring the effect of exercise e.g. on the physical and neurocognitive performance.

Reduced exercise capacity, diminished cardiopulmonary capacity or post-exertional malaise, is an extraordinary symptom which may be unique to M.E. Healthy people get an increase of oxygen and blood to the brain during exercise, resulting in a feeling of well-being; M.E patients have a reduced level of blood and oxygen to the brain during exercise, resulting in a worsening of their symptoms. GET, therefore, cannot under any circumstances be effective for patients with M.E. In fact, in severely affected patients (a significant minority of about 25% of patients which was completely excluded from the PACE Trial) it may exacerbate symptoms to a critical extent, potentially to death.

So why the enormous disparity of the majority of the literature on the subject and the PACE Trial? Professor Malcom Cooper calls the ethics of the team into question:

Professor White and his co-Principal Investigators all have financial links with the health insurance industry, a matter of grave concern to the former Chairman of a House of Commons Science and Technology Select Committee and former Dean of Biology (Dr Ian Gibson MP); a member of the Home Affairs Select Committee (Ann Cryer MP); a Minister of State for the Environment (The Rt Hon Michael Meacher MP); a former President of the Royal College of Physicians (Lord Turnberg); the Deputy Speaker of the House of Lords (the Countess of Mar), and a former Health Minister and Honorary Fellow of the Royal College of Physicians (Baroness Julia Cumberledge) (Gibson Inquiry Parliamentarians’ Report, 2006). In an obvious reference to Professor White, this Report stated: “There have been numerous cases where advisors to the DWP have also had consultancy roles in medical insurance companies, particularly the company UNUMProvident. Given the vested interest that private medical insurance companies have in ensuring CFS/ME remains classified as a psychosocial illness, there is a blatant conflictof interest here. The Group finds this to be an area for serious concern…”. In Professor White’s case, this blatant conflict of interest remains unresolved, as he is Chief Medical Officer for the insurance giant Swiss Re, and another of the PACE Trial Principal Investigators, Professor Michael Sharpe, is associated with UNUMProvident.

The links between the Wessely school and the insurance industry have been documented for many years.

The depressing reality is that, according to Professor Hooper

The results of the PACE Trial may mean that patients who have genuine ME as opposed to chronic “fatigue” will continue to be denied appropriate investigation and treatment; they may be deprived of State benefits necessary for survival; their insurance claims may be rejected, and they will be condemned to an even lower quality of life.

Dr. Charles Shepard adds, “This is not a good day for people with ME/CFS.” It is to be presumed that the refusal of the British government to provide any funding for biomedical research into M.E. will continue, and other governments will be encouraged to take the same line. This will further restrict research into the links between XMRV and M.E.

The report is certainly one more weapon in the arsenal of the insurance industry and other vested interests in the war against scientific standards, facts, and M.E. patients.

Written for the XMRV News and Views Facebook page’s ME/CFS Blogger Army: PACE isn’t for M.E. challenge. More posts on the issue: Sample letter to send to journalists, doctors and others who should be in possession of the facts on this issue


11 thoughts on “The PACE Trial: “This is not a good day for people with ME/CFS”

  1. Great blog post, with both patients and patient groups uniting against this despicable trial lets hope our voices are finally heard. There has been far too much needless suffering and needless death due these government appointed snake oil salesmen. They need sacking once and for all!

  2. Boo to the insurance companies who want to ignore XMRV, the human retrovirus, and classify ME as a psycho-social disorder(and thanks for the track back).

  3. The take away message is that this is not about medicine or illness at all. It’s purely about money and the puppets who speak for the insurance industry are willing to force a large group of very ill people to continue suffering and losing their lives just so they themselves can have more money. The effort needed is to bring this corruption into public view and force politicians to fix it. ME sufferers and those who care about them need to ask at every opportunity, of every ME denialist “Do you or yours benefit in any way from disability insurers or reinsurers of any kind?” The ones who refuse to answer have given their answer.

    Unum is currently “liquidating stock”, meaning they are buying back stock. This is how they pay off people without declaring dividends. Someone needs to find out how this stock gets into the hands of their puppets so they can sell it back for cash. It’s probably several layers deep and hidden in offshore accounts. Someone needs to dig this out and bring it out into the light.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s