Dangers of research into chronic fatigue syndrome and ME.
Nigel Hawkes talks of threats by patients. The real threat to those
engaging in biomedical research into ME/CFS is from authorities with
control of the purse strings and career advance. Many good researchers
with valid projects have had their paths blocked; for example Jonathan
Kerr and Elaine DeFreitas. At a recent NIH conference in Bethesday, Dr.
Kenneth Friedman talked on this very subject, and a video of his
submission is available for viewing on YouTube (1).
The single PACE trial cost >4 million sterling, yet the funds for
biomedical research over the whole of the last decade in the UK would
struggle to add up to one quarter of this figure.
The results of the PACE trial (lead researcher Peter White) would
command more respect if outcome measures had not been altered prior to
reporting outcomes. For instance, the SF36 score used to denote a
successful outcome was lowered from 75 to 60, when entry criteria to the
trial was 65 or lower (2,3).
Peter White said recently that PACE was not studying CFS/ME patients,
but CFS patients, a confusing situation created by conflating a
neurological disease (myalgic encephalomyelitis) with idiopathic chronic
fatigue and depressive disorders.
Which brings me to the excellent submission by Ollie Cornes. His
central point is clearly illustrated by the confusion over the cohort in
PACE, which was chosen (in the first instance) by the Oxford Definition
(4). I wholeheartedly agree that the only definition that reliably
diagnoses myalgic encephalomyelitis is the Canadian Consensus (5,6), all
others currently in use conflate the neurological disease with depression
and idiopathic fatigue, a fact that has been perhaps the greatest obstacle
to clarity in the search for understanding of, and effective treatment
for, the discrete disease Myalgic Encephalomyelitis.
2) PD White, MC Sharpe, T Chalder, JC DeCesare and R Walwyn for the
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 Neurology 2007,
3) White, PD; Goldsmith, KA; Johnson, AL et al Comparison of
adaptive pacing therapy, cognitive behaviour therapy, graded exercise
therapy, and specialist medical care for chronic fatigue syndrome (PACE):
a randomised trial; The Lancet, Early Online Publication, 18 February
4) M C Sharpe, L C Archard, J E Banatvala, L K Borysiewicz, A W
Clare, A David, R H Edwards, K E Hawton, H P Lambert, R J Lane; A report-
-chronic fatigue syndrome: guidelines for research; J R Soc Med. 1991
February; 84(2): 118-121.
5) BM Carruthers; A K Jain; KL De Meirleir, MD, PhD; Daniel L.
Peterson, MD; NG Klimas; AM Lerner; AC Bested; P Flor-Henry; P Joshi; ACP
Powles; JA Sherkey; MI van de Sande; Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and
Treatment Protocols; J of Chronic Fatigue Syndrome, Vol. 11(1) 2003, pp.
Competing interests: No competing interests