College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5355 (Published 30 August 2013)
Cite this as: BMJ 2013;347:f5355

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I struggle to see the logic here, mainly because I can't think what specifically would be minuted in a professionally-conducted meeting that could not be shared subsequently, once the usual conditions have applied about 3rd party information and data still being prepared for publication. The debate might move on with some specific, even if fictitious, examples.

Most people are (rightly) deeply suspicious about non-specific appeals to academic freedom or sensitivity of information as an explanation for opacity in public life.

Competing interests: None declared

Allan House, academic psychiatrist

University of Leeds, Charles Thackrah Buuilding Leeds LS2 9LJ

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I'd just like to add a link to the FOI request mentioned in my response for those interested https://www.whatdotheyknow.com/request/6min_walking_test_results_for_re#...

Competing interests: None declared

anna k wood, student

na, na

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As an academic with a background in science I cautiously welcome the judge's decision that publication of minutes of meetings during clinical trials could impede academic freedom.

However, as an ME patient applying my scientific knowledge to understand the current state of the art in treatment for this condition, I am dismayed that requests for details about the trial that were omitted from the published papers were denied.

These included basic information that any patient considering these treatments would want to know, such as the number of people who were able to resume full-time employment, or stop claiming benefits.

My own Freedom of Information (FOI) request, concerning the data from the six minute walking test, was born purely out of scientific interest (and certainly not '“part of a campaign ... as a means of advancing an argument” as the judge suggested). It was rejected on dubious grounds.

In a trial which cost £5 Million, and has huge implications for the treatment of tens of thousands of people, I believe it is vitally important that a complete data set (with context where necessary) is made available. This would enable other researchers to further scrutinise and analyse the data from a range of different angles. Such debate is surely an essential element of academic freedom as well as necessary for further scientific development.

Competing interests: None

Anna Wood, Part-time student

None, 2 huxley Place

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The views of any tribunal judge, in matters of scientific openness are irrelevant. Readers of scientific papers will decide for themselves, what weight to give to the work of researchers who hide evidence under the skirts of judges.

In this case, the accusation that those who seek to know the full extent of research that authors have chosen to hide from the public, are being "malicious", is, in my opinion, libellous in itself.

Truth will out.

Competing interests: None declared

Steve Hawkins, unable to work

none, London Rd Luton

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Greatly criticised by the ME Community and virtually all ME Charities, the PACE Trial allegedly :

1. Brought together (conflated) two diseases that the WHO rightly categorizes separately-neurological "ME/PVFS" (ICD-10-G93.3) and psychiatric "Fatigue Syndrome" (ICD-10-F.48.0) - and misrepresented the latter as the former. (Hooper 2011)
2. Mixed at least three taxonomically different disorders in the trial cohort-those with ME/CFS (ICD-10 G93.3), even though the entry criteria exclude such patients; those with fibromyalgia (ICD-10 M79.0) and those with a mental/behavioural disorder (ICD-10 F48.0). (Hooper 2011)
3.Excluded children and those who are severely affected. The results of any trial that excluded those who are severely affected cannot be taken seriously. (Hooper 2011)
4. Included, (PACE Trial) a large number of participants, 47% - who were found to be suffering from one or more psychiatric disorders.
5. Took no biological measurements. Studies of CBT in other conditions including HIV/AIDS and cardiovascular disease, routinely collect data on immune markers or other biological measures in an attempt to understand how and why CBT works in the context of the condition studied.
6. Abandoned the use of an actometer, an instrument to measure activity , which would have provided unequivocal objective evidence of improvement or non-improvement.
7. Found that "pragmatic rehabilitation" (based on CBT/GET) was minimally effective in reducing fatigue and improving sleep only whilst participants were engaged in the programmeand that there was no statistically significant effect at follow-up.
8. Did not conclude CBT/GET/PACING were even cures for the loosely defined CFS or even "effective" treatments for it; they said they were "only moderately effective".
9. Did not return the participants to their health or even close to it.
10. The only reported improvement, an increase of being able to walk an extra 20 steps, cost the nation £5 million.

Every study of CBT and GET, including my own (Crowhurst 2005) reveals that the pacing protocol recommended by the PACE Trial - based on the premise that patients need to change their maladaptive "illness beliefs" is incredibly harmful to people with ME. Some patients have been rendered bed bound for years as a result.

The ‘psychosocial ‘model used to influence ME service provision, one which emphasises “beliefs, coping styles, and behaviours”, colours the perception of Myalgic Encephalomyelitis (ME) right across the board in the UK, from the 2007 NICE Guideline, to the policy of government agencies such as the Department of Work and Pensions and NHS Plus has cost us dearly.

My wife who was Severely Affected has now been diagnosed with Very Severe ME, her life is one of constant, indescribable suffering, yet she is simply left to get on with it; it has been twenty years now with no treatment, no research, no cure - and no hope. This is a gross injustice.

That is why these outcome measures matter so much to us ; it is no exaggeration to state that it is very much a matter of life and death .

References

Crowhurst G (2005) One of the biggest medical scandals in history : a survey of those most severely affected by ME/CFS. Submission to the Parliamentary Inquiry into progress in the scientific research of M.E., by the 25% Severe ME Group http://www.25megroup.org/.../25%25%20submission/25%20final%20sub%20to%20Gibson%20(2).doc

Hooper M (2011)Report: complaint to the relevant executive editor of the lancet about the pace trial articles published by the lancet http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm

Competing interests: None declared

Greg P Crowhurst, Carer

None, The Cottage

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What is right about using £5million grant money and then not publish correct findings? This cover up of an illness that is viral/bacterial related has gone on for over 30 years and must be stopped. We need to know the truth.

Competing interests: Suffer 26yrs

jacqui butterworth, retired

member ME and Lyme group , 15 lady lane

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One of the reasons the minutes are sought for this trial is to find out why outcome measures were changed. None of the three primary outcomes have been reported as in the protocol (1). The recovery criteria in the protocol are a lot different from what have been reported on (1,2).

Non-pharmacological therapies are not as well regulated as pharmacological interventions. For example, there is no equivalent to the yellow card system for adverse events observed with such interventions. This makes the reporting in trials of such therapies more important. Reporting of harms in trials of cognitive behavioural therapy (CBT) and graded exercise therapy (GET) for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has generally been poor (3). Harms reporting in the PACE Trial was much improved but some issues still remain (3,4).

Outside of trials, significant numbers of individuals with ME/CFS have reported being made more ill by such interventions but this largely been ignored, most likely due to the fact that the therapies are non-pharmacological (3). Not surprisingly, this can make such people, and people who know them, frustrated.

This was a very significant trial: £5m of taxpayers' money was invested in it. One might say it was supposed to be the definitive trial. I think it's understandable that some people have been focused on getting as much information from the trial as possible.

References:

1. White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group. 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. BMC Neurol. 2007 Mar 8;7:6.

2. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M; PACE Trial Management Group. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013 Jan 31:1-9.

3. Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Bulletin of the IACFS/ME. 2011;19(2):59-111.

4. Kindlon T. The PACE trial in chronic fatigue syndrome. Lancet. 2011 May 28;377(9780):1833

Competing interests: I work in a voluntary capacity for the Irish ME/CFS Association

Tom Kindlon , Assistant Chairperson

Irish ME/CFS Association, PO Box 3075, Dublin 2, Ireland

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