Feb 5th, 2016
Why the PACE researchers and their institutions affectation of concern for participants is particularly sickening hypocrisy
In 1990 Sir Iain Chalmers wrote in the Journal of the American Medical Association, “Failure to publish an adequate account of a well-designed clinical trial is a form of scientific misconduct that can lead those caring for patients to make inappropriate treatment decisions.”
(Iain Chalmers. JAMA. 1990 Mar 9;263(10): 1405-8.doi:10.1001/jama.1990.03440100121018)
It could be argued that any Clinical Trial which omits to publish the Primary Outcome Measures as declared and approved in the Protocol ‘is a form of scientific misconduct’; especially if tampering with the outcome measures skews the data and the skewed data is then spun in the media to further exaggerate the findings.
The Declaration of Helsinki states: “36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research.Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.”
The World Health Organization (2004), A Practical Guide for Health Researchers states: “Writing the research protocol
“… once a protocol for the study has been developed and approved, and the study has started and progressed, it should be adhered to strictly and should not be changed. This is particularly important in multi-centre studies. Violations of the protocol can discredit the whole study…”
The Research Councils UK Policy and Code of Conduct on the Governance of Good Research Conduct states:
“All research should be conducted to the highest levels of integrity, including appropriate research design and frameworks, to ensure that findings are robust and defensible.  This code therefore concentrates on entirely unacceptable types of research conduct. Individuals involved in research must not commit any of the acts of
research misconduct specified in this code.”
This includes the inappropriate manipulation and/or selection of data, imagery and/or consents.”
“Misrepresentation, including: misrepresentation of data, for example suppression of relevant findings and/or data, or knowingly, recklessly or by gross negligence, presenting a flawed interpretation of data;”
The Medical Research Council (MRC) Guidelines for Good Clinical Practice in Clinical Trials states: “2.5 Clinical trials should be scientifically sound and described in a clear detailed protocol.
2.6 A trial should be conducted in compliance with the protocol that has received prior Ethical Committee favourable opinion.”
Ben Goldacre remarked in The Guardian, “…in a trial, you might measure many things but you have to say which is the “primary outcome” before you start: you can’t change your mind about what you’re counting as your main outcome after you’ve finished and the results are in. It’s not just dodgy, it also messes with the statistics.” Goldacre added, “You cannot change the rules after the game has started. You cannot even be seen to do that.”
(Ben Goldacre. Clinical trials and playing by the rules. The Guardian, Saturday January 5, 2008)
Most of the £5 million that the PACE Trial has cost, came from public money allocated through the Medical Research Council (MRC); whose Guidelines for Good Research Practice (2005) state: “The MRC’s mission can only be fulfilled if the results of research are communicated effectively. The MRC therefore expects those it supports to play their part in disseminating balanced information on scientific advances and their potential implications for society to the health professionals and policy makers who will be involved in applying them, and to the wider public.”
Now let us see what our fine British Institutions say about the PACE Trial, starting with the MRC themselves. The very institution which handed over millions of pounds of our money. Their website states:
“In 2011, the first findings from the PACE trial showed that CBT and GET benefit around 60 per cent of patients with CFS/ME”
Then there are Queen Mary University of London and Kings College London who both declare on their websites:
“Two effective treatments benefit up to 60 per cent of patients with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis”
The 60% figure claimed by these institutions is false. Furthermore, the claim is in breach of the Declaration of Helsinki and every credible research guideline, including the MRC’s own.
This 60% figure is not just false information about ideas or about objects; it is false information about research participants. It is not just disrespectful, it is an attack on their person and their autonomy.
Anyone with sincere concern for the welfare of PACE Trial participants, who was in a position to do so, would take steps to correct this false representation of participants as a matter of urgency.
The true figure for participants having a treatment affect in the PACE Trial is 15%.
The 15% figure can be calculated from the data published in the Lancet. 15% is even supported in a statement made by Professor Michael Sharpe*: “We have a number needed to treat; I think it's about seven to get a clinically important treatment benefit with CBT and GET.” A ‘number needed to treat’ (NNT) of 7, correlates with only 15% of treated patients getting any benefit.
The whole point of doing a Controlled Clinical Trial is the ‘Control Group’. Their results are subtracted from the treatment arms to give the true treatment effect. 15% is somewhat less than the 60% that is claimed by the MRC, KCL, QMUL; and reports in national and international media who were fed their information by the PACE Trial researchers and the Science Media Centre.
The General Medical Council state in their Good Practice in Research Guide:
· You must help to resolve uncertainties about the effects of treatments. (Paragraph 14f)
· Research involving people directly or indirectly is vital in improving care and reducing uncertainty for patients now and in the future, and improving the health of the population as a whole. (Paragraph 70)
· If you are involved in designing, organising or carrying out research, you must put the protection of participants’ interests first, act with honesty and integrity and follow the appropriate national research governance guidelines. (Paragraph 71)”
When researchers misrepresent data from trial participants, it exploits the trust and generosity of the volunteers and may involve them, most likely against their will and without their knowledge, in misleading other patients, the public and the medico-scientific communities.
Participants are entitled the protection of the Declaration of Helsinki. Tampering with their data and misrepresenting it breaches their right to autonomy and nullifies Informed Consent. For example, a PACE Trial participant whose outcome SF36PF score was 60 and Chalder Fatigue Scale score was 18 would evidently be suffering significant illness and restrictions. How would they feel about researchers claiming that according to their new-fangled criteria, the participant’s health was ‘normal range’? Did they consent to this?
An SF36PF score of 65 was considered bad enough to JOIN the PACE Trial – so participants could get 5 points WORSE but then be called ‘Normal Range’. How is that showing respect to participants?
How might this misrepresentation impact on participant’s medical treatment or entitlement to state benefits? What impact could it have on their trust of medical professionals and researchers? How might it impact on their moral and social and religious values – that they have been used, exploited in a way that could harm the health and interests of their fellow patients and their families?
PACE Researchers and their institutions affect concern for participants as a ploy to refuse sharing the PACE Trial data; even though for 5 years they have misrepresented those same participant’s data. It is a particularly sickening hypocrisy.
Peter Kemp MA