Even peer-reviewed research can be heavily biased and, sometimes, completely wrong – as was the case with research conducted in 2011 and published in The Lancet in search of a cure for Chronic Fatigue Syndrome (CFS). Critics of the research have voiced their concerns since the publishing date of the study, but their cries did not echo largely due to the bureaucracy surrounding access to the original data for this study on CFS.
Still, persistence from CFS sufferers led research analysts to sift through the muck. These researchers concluded, after obtaining court-ordered data from London’s Queen Mary University, that the conclusions asserted by the team of researchers in the CFS PACE trial (the name of the original research effort) are too biased and poorly conducted to yield any usable information.
What Went Wrong in the PACE Trial?
The PACE trial for CFS began with the ideal experimental standard in medicine: a randomized, controlled trial with a clear goal and plausible hypotheses. Researchers assigned patients randomly to a group that received one of four experimental treatments, one group of which was a control group that received a false treatment.
However, as the CFS study continued, and as researchers collected and analyzed data, problems began to surface:
- Poor measurement criteria - The baseline scores pertaining to the symptoms that characterize the condition used to determine entry into the experiment simultaneously qualified 13% of patients to be labeled recovered even before research began.
- Interference in the experiment – Researchers compromised the integrity of their data by publishing a newsletter for patients with enthusiastic testimonials about how well the treatment was working. They included information about a U.K. government committee, on which a PACE investigator was sitting, recommending the experimental treatments.
- Criteria changes – After the experiment had begun, researchers continued to modify the criteria for entering the recovered category. Thresholds were reduced to include a larger sample of the patients in recovered data, and patient requests for related findings were continually rejected.
- Subjective results – The PACE trial team investigating CFS drew conclusions based on subjective data from patients and dismissed the data they had originally labeled as objective, citing it as irrelevant and unreliable. Only the subjective data supported their claims.
- Conflicts of interest – Patients who signed agreements that allegedly provided information about possible conflicts of interest in the study received no notification of ties with insurance companies that had stood between investigators and disability insurance providers long before the experiment began.
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| CFS affects at least 1 million Americans each year. Source: cdc.gov |
The Wake of PACE Trial Criticism
Even one of the listed issues is grounds to dismiss the legitimacy of the data from the trial. Peers in the medical community condemned the actions of The Lancet as a publisher and questioned the integrity of the research team. Medical blogs and online journals wrote open letters questioning the motives and ethics of the researchers.
Patients in the study who suffered from CFS and did not experience improvements in the PACE trial left the experiment confused and hopeless. The exposure of the research team's failure may have cleared some of the uneasiness and misunderstandings, but it leaves sufferers still in dire need of answers.
However, the failed research has inspired continuing, well-documented, legitimate research to unfold. The Institute of Medicine has declared CFS a real disease and outlined more rigid characteristics of the disorder for diagnosis. A Science Advance study also established possible biological roots for the disease. Interest in finding a cure for Chronic Fatigue Syndrome, or at least a treatment, seems to have reawakened, and it's not a moment too soon.
