Dr. Keith Geraghty, of the University of Manchester, has published this excellent article on the flaws in the PACE study of ME/CFS. He makes important points about academic integrity that are relevant to all of us (including those who are unaffected by the PACE problem itself; for background, see here and here). Here are two of his more important observations.
First, regarding data transparency, he notes that it took five years for patients to obtain the raw data underlying the PACE study, which ultimately revealed that the results (for the effectiveness of CBT and GET) had been exaggerated by about threefold:
The PACE-Trial stands out as a showcase example of why data transparency is needed in contemporary science. Patients suffering from health conditions like CFS, and independent scientists, should have the right to see the evidence behind the claims of any scientific study, especially if this evidence is used to direct health policy or promote certain treatments – as was the case for the PACE-Trial.
The same can be said of nearly all academic work. Data sharing and data transparency are the ultimate safeguards of accuracy. The refusal or reluctance to share data should be taken as an immediate red flag, no matter the discipline.
Geraghty also makes an important point about conflicts of interest:
‘PACE-Gate’ stands as an example of how science is not always a simple process of discovery and reflects the ills of contemporary science in microcosm. As a result of the PACE-Trial saga, it is likely that patients with CFS will be less trusting of doctors, scientists and psychotherapy practitioners. To win this trust back, the medical-scientific community must learn lessons from PACE-Gate. First, was it wise to commission a small group of scientists that held very strong published views in favour of CBT/GET as treatments for CFS, to be the ones to test the efficacy of these treatments? Conflicts of interest have always been the thorn in the side of clinical trials and a major source of investigator bias [citations omitted]. Funders of future trials must consider the independence of those entrusted to carry out clinical trials.
This is an essential observation. The organizers of the PACE study were all committed in advance to the CBT-favoring outcome, which was an even greater problem because it was an unblinded trial. I have also been told of other conflicts of interest, including the directorship of a company that promotes CBT.
As a legal ethicist, I have spent much of my career attempting to alert lawyers and judges to unrecognized conflicts of interest. Most professionals believe that they are immune to the influence of conflicts, but of course they are not. Doctors and scientists are no different, and in fact they may be even more susceptible to conflicts, due to their profound belief in their own objectivity. People who believe they are impervious to outside influences are in fact the most likely to be affected by them.
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