PACE

Trial By Error: The 7th Anniversary of My Expose About the Fraudulent–i.e. Misleading, Deceptive–PACE Trial

29 October 2022 by David Tuller

By David Tuller, DrPH

*October is crowdfunding month at UC Berkeley. If you like my work, consider making a tax-deductible donation to Berkeley’s School of Public Health to support the Trial By Error: project: https://crowdfund.berkeley.edu/project/33528

This month marks the seventh anniversary of Virology Blog’s publication of my 15,000-word investigation of the egregiously flawed and fraudulent (i.e. misleading, deceptive) piece of crap known as the PACE trial. (Incidentally, it is also the one-year anniversary of the new and much-improved guidelines for ME/CFS from the National Institute for Health and Care Excellence.) To write that piece, I spent more than a year reading and interviewing people about the trial, traveled to England to meet with PACE participant and others, and consulted extensively with academic colleagues in epidemiology, biostatistics, and infectious diseases. And as I have always acknowledged, I relied extensively on the knowledge and wisdom of the amazing ME/CFS patient community.

(The PACE authors and the editor of The Lancet, which published the first results, refused to talk with me.)

Trial By Error: Research From GET/CBT Ideological Brigades Shows No Improvements in Work Status

30 September 2022 by David Tuller

By David Tuller, DrPH

Last year, Mark Vink, a Dutch physician with ME/CFS, and Friso Vink-Niese, an independent researcher, published a review of occupational outcomes among ME/CFS patients after treatment with either graded exercise therapy (GET) and cognitive behavior therapy (CBT). The results were not pretty. When viewed specifically through the perspective of employment status, the treatments bombed.

Trial By Error: The UK Health Research Authority’s Missteps on PACE and the Declaration of Helsinki

14 April 2022 by David Tuller

By David Tuller, DrPH

*April is crowdfunding month at UC Berkeley. If you like my work, consider making a tax-deductible donation to Berkeley’s School of Public Health to support the Trial By Error project: https://crowdfund.berkeley.edu/project/31347

*Note: To give credit where it’s due, Magical Medicine: How to Make an Illness Disappear, an exhaustive investigation from Malcolm Hooper and Margaret Williams, first mentioned the PACE team’s violations of the Declaration of Helsinki 20+ years ago.

The PACE authors and their allies routinely cite the UK’s Health Research Authority as having given this boondoggle of a trial a clean bill of health. The HRA, which oversees research ethics processes and procedures, conducted a review of PACE and issued its findings in January, 2019. The agency assessed PACE as having been conducted properly, but it noted that its purview was limited to “whether the study was properly approved by the Research Ethics Committee (REC),” and questions about the “quality of the study” were beyond its scope.

Trial By Error: The Lancet Publishes Whine de Coeur from Impassioned GET/CBT Defenders

14 February 2022 by David Tuller

By David Tuller, DrPH

The Lancet has just published an anguished whine de coeur from supporters of the graded exercise therapy/cognitive behavior therapy/ [GET/CBT] approach to ME/CFS. (Or CFS/ME, as these authors insist on calling the illness in what those familiar with the debate will recognize as a childish fit of pique.) These impassioned members of the GET/CBT ideological brigades, all from northern European countries, are metaphorically stomping their little feet over the new ME/CFS clinical guideline from the UK’s National Institute for Health and Care Excellence.

Trial By Error: Professor Chalder Messes Up Again in New Paper on CFS and Employment Outcomes

7 December 2021 by David Tuller

By David Tuller, DrPH

Same-Day Update: In re-reading the new paper, I noticed that the discussion section also features errors involving the percentages. It includes this sentence: “About 9% of individuals who were not working at baseline had returned to work at follow-up.” And this one: “Further, 6% of those working at baseline were no longer working at follow-up.” Both of these statements are categorically wrong. These are percentages of the total sample, not of the sub-groups of those working and not working at baseline.

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The discredited PACE trial of psychological and behavioral interventions for chronic fatigue syndrome (CFS) included four objective outcomesâ€”a six-minute walking test, a step-test for fitness, employment/educational status, and whether the person was receiving social benefit. All four outcomes failed to match the positive reports on the subjective measures of fatigue and physical function. That’s why the authors completely ignored them in assessing the efficacy of the interventions and declared victory anyway.

Trial By Error: PACE Authors Now Blame “Misunderstandings” for GET/CBT Criticisms

23 October 2021 by David Tuller

By David Tuller, DrPH

It is hard to know what to make of the news that a peer-reviewed journal has actually accepted a PACE-reunion paper from the three lead investigatorsâ€”Professors Michael Sharpe, Trudie Chalder, and Peter White. Even more so for a paper titled–without irony, it seems–“Evidence based care for people with chronic fatigue syndrome and myalgic encephalomyelitis.” This surprising event occurred on October 1st, according to a notice on the website of Kingâ€™s College London, Professor Chalderâ€™s home base.