Oops, I was trying to add line gaps to that and it got posted by accident before I had a chance to complete the competing interests section.

I also hadn't finished checking for typos, etc. before it was prematurely posted, hence some embarrassing spelling mistakes, etc.

In their recent editorial "Does Conflict of Interest Disclosure Worsen Bias?", the PLoS Editors concluded that [1]:

"Indeed, if disclosure worsens bias, then this is a game-changer for discussion and debate about managing conflicts of interest in medicine.

Journals, professional associations, clinical guideline developers, and others need to worry not just that disclosure provides a band-aid to the real problem of the COI itself, but that any attempt to stem the trouble through disclosure policies may actually be worsening the problem".

Several years ago, Ioannidis pointed out that [2]:

"Conflicts of interest and prejudice may increase bias, u.

Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported.

Prejudice may not necessarily have financial roots.

Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings.

Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure.

Such nonfinancial conflicts may also lead to distorted reported results and interpretations.

Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma".

Three authors of this paper [3], who are also the inventors of GET and CBT for "CFS", and the principal investigators who designed and obtained funding for the PACE study [4], declare interests which apparently conflict with their involvement in their own trial.

The main competing interests are described by them as having "done voluntary and paid consultancy work" for Government and Insurance Companies.

On the topic of competing interests (or Conflicts of Interest), Resnik has argued that: "Indeed, one of the best ways to destroy trust is to not disclose a relevant financial (or other) interest to a subject when they are being recruited for a study, only to have the subject find out after the study is underway or has been completed. A patient (or subject) who learns about important information that was not disclosed is likely to feel betrayed or manipulated.

"Researchers should always strive to help subjects understand and interpret information, whether it is information about benefits, risks, and alternatives, or information about COIs".

The following brief extracts may give some idea about the nature and quality of advice to Insurance and Government by one (or more) of the Principal PACE investigators [6]:

"ref:059874 there is strong evidence that symptoms and disability are shaped by psychological factors".

"ref: 059874 social factors are almost certainly of great importance in shaping functional illness"

"ref: 059874 The current system of state benefits, insurance payments and litigation remain potentially major obstacles to effective rehabilitation".

"ref: 059874 The demands such persons make on health service, social benefit systems, and insurers are likely to increase".

"ref: 059874 how much is it costing you doing nothing?"

"Research in several functional syndromes has found that a strong belief and preoccupation that one has a 'medical disease' and a helpless and passive attitude to coping is associated with persistent disability"

"Some persons appear to exaggerate symptoms but this is often hard to prove".

"A shift towards a more consumer-based approach to health is also likely to increase the prominence if not the prevalence of such syndromes as the authority of medicine to define what is a legitimate illness is diminished.

Indeed, increasingly consumer oriented and privatised doctors will collude with the patient’s views that they have a disabling and permanent disease".

"Relevant factors include the information patients receive about the symptoms and how to cope with them.

This information may be helpful or may stress the chronicity of the illness and promote helplessness.

Such unhelpful information is found in “self-help” (!) books and increasingly on the Internet (see for example www.meassociation.org.uk).

Unfortunately, doctors and especially “specialist private doctors” and complementary therapists may be as bad.

Other social factors that perpetuate illness are anger with the person or organisation the illness is illness attributed to, or toward the insurer for not believing them.

It has been pointed out that: “if you have to prove you are ill you can’t get well”.

Both State and private insurers pay people to remain ill.

Recent systematic reviews of randomised controlled trials have confirmed that psychologically informed rehabilitative treatments (often called cognitive behaviour therapy or CBT) and “antidepressant” drugs have some effectiveness in treating most functional syndromes.

There is however a great shortage of skilled providers of CBT in particular and rehabilitative facilities in general.

Obstacles to recovery

In practice, even if treatment is available, there may be obstacles to recovery.

Over time, the patient’s beliefs may be become entrenched and be driven by anger and the need to explain continuing disability.

The current system of state benefits, insurance payments and litigation remain potentially major obstacles to effective rehabilitation.

It is often unrealistic to expect medical treatment alone to overcome these.

Furthermore patient groups who champion the interest of individuals with functional complaints (particularly for chronic fatigue and fibromyalgia) are increasingly influential;

they are extremely effective in lobbying politicians and have even been threatening towards individuals and organisations who question the validity and permanence of the illness they champion.

Again the ME lobby is the best example".


It is not obvious from the available documentation that participants were exposed to and hence helped to understand and interpret the above relevant (for some) and non-esoteric information relating to aspects of the investigators self-declared conflicting (or competing) interests.

If the PACE researchers did not strive to help subjects understand and interpret information about the conflicting interests of all three main PACE investigators, it is rather difficult to understand how fully-informed consent could have been secured.

Given that it was the UK tax-payers money being used for this experiment, some 5 or 6 million GBP, perhaps the main investigators might like to take this opportunity to explain more fully how and why doing voluntary and paid work for Government and Private Insurance Companies constitutes a Conflict of Interest?


[1] Does Conflict of Interest Disclosure Worsen Bias? Barbour V, Clark J, Norton M, Simpson P, Veitch E. 24.04.12
http://www.plosmedicine.o...

[2] Why Most Published Research Findings Are False John P. A. Ioannidis 30.08.05
http://www.plosmedicine.o...

[3] Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis McCrone P, Sharpe M., Chalder T., Knapp M, Johnson A, Goldsmith K, White P. 01.08.12

[4] White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, et al. (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377: 823–836 http://www.ncbi.nlm.nih.g...

[5] Disclosing Conflicts of Interest to Research Subjects: an Ethical and Legal Analysis Accountability in Research 2004; 11: 141-59. David B. Resnik, JD, PhD http://ukpmc.ac.uk/abstra...

[6] UnumProvident: Trends in Health and Disability 2002 Chief Medical Officer’s Report
Functional Symptoms and Syndromes: Recent Developments Michael Sharpe
http://issuu.com/dtdocs/d...