MAGICAL MEDICINE: HOW TO MAKE AN ILLNESS ... - Invest in ME

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“Outcome choice bias: Sometimes RCTs evaluate outcomes that are easy to measure, rather than the outcomes that are
relevant (measurement bias).
“One variant of this is the time term bias in which short‐term outcomes are measured rather than the
important long‐term outcomes”.
Other biases listed include withdrawal bias; bias introduced by inappropriate handling of withdrawals,
drop‐outs and protocol violations; missing data bias; publication bias; moral bias; values bias; printed word
bias (when a study is overrated because of undue confidence); prominent author bias (when the results of
studies published by prominent authors are overrated, including esteemed author bias and esteemed
professor bias); multicentre collaborative trials (when the results are overrated); vested interest bias;
cherished belief bias and empiricism bias (‘I am an epidemiologist’ bias).
The authors conclude: “RCTs can never be completely objective. They should be carried out with humility;
the investigator should be up‐front, explicit and transparent as possible about his or her motivations for
choosing to carry out the trial”.
Where is the evidence of this in the PACE Trial?
According to Ioannidis (PLoS Medicine 2005:2:8:e124), “a research finding is less likely to be true when…there is
greater flexibility in …definitions (and) when there is greater financial and other interest and prejudice”.
Ioannidis defined bias as “the combination of various design, data, analysis and presentation of factors that tend to
produce research findings when they should not be produced”.
He said: “Conflicts of interest and prejudice may increase bias…Scientists in a given field may be prejudiced
purely because of their belief in a… theory or commitment to their own findings…Such conflicts may 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 own findings, thus condemning their
field to perpetuate false dogma….Prejudice may prevail in a hot scientific field, further undermining the
predictive value of its research findings. Highly prejudiced stakeholders may even create a barrier that
aborts efforts at obtaining and disseminating opposing results”.
Ioannidis continued: “Let us suppose that in a research field there are no true findings at all to be discovered.
History of science teaches us that scientific endeavour has often in the past wasted effort in fields with
absolutely no yield of true scientific information…Of course, investigators working in any field are likely
to resist accepting that the whole field in which they have spent their careers is a ‘null field’. However,
…advances in technology and experimentation may lead eventually to the dismantling of a scientific field”.
Will the day soon dawn when it will be conclusively shown that the Wessely School have spent their
careers in a “null field” in relation to their efforts to designate ME/CFS as a behavioural disorder?
Apparent misrepresentation in the PACE Trial?
The related issues of apparent coercion, misrepresentation and informed consent in relation to the MRC
PACE Trial deserve close attention.
Hawkins and Emanuel (Hastings Centre Report 2005:35:5) are clear: “if the potential subject is competent to give
informed consent, three requirements must be satisfied: there must be full disclosure, the subject must understand
what is disclosed, and the subject must consent voluntarily…Consent may be invalid ….(if) the disclosure was
inadequate…When disclosure is intentionally absent or inadequate, we have a case of deception”.