Trial By Error: BMJ Pushes Back Against New NICE Draft

By David Tuller, DrPH

The BMJ has published an online “editorial” slamming the new draft of clinical guidelines for ME/CFS from the National Institute for Health and Care Excellence. The position expressed is an interesting one: Non-pharmacological treatments for “complex conditions” cannot be adequately measured by randomized trials, according to the two authors. It is, of course, noteworthy that The BMJ is mounting this argument only after an authoritative review commissioned by NICE found the evidence for CBT and GET was mostly of “very low” quality– although some was just of “low” quality.

For years, of course, the PACE trial was widely hailed as gold-standard proof that these interventions were effective. The editorial’s main message seems to be: “Never mind about all that. Look over here instead.” And “over here” they suggest “holistic integrated rehabilitation”–not just CBT, GET, or another specific modality, but a goulash of everything. Apparently the recipe is different for every individual, so it is hard to measure. But the authors, both of whom are rehabilitation specialists, know it works.

In short, the editorial is largely nonsense, a clumsy effort by The BMJ to…well, I’m not quite sure what. It hope that such ill-informed whining will not sway the apparently smart bunch on the NICE committee who decided to discard past claims of effectiveness based on seriously flawed evidence.

This editorial was not externally peer-reviewed. It is not presented as a “comment” or as an “opinion.” It was commissioned by the journal and seems to have The BMJ‘s institutional endorsement. I guess The BMJ dislikes the NICE draft. That is understandable. The draft represents a challenge to medical journals, including several in the BMJ stable, that have published studies they should clearly have rejected. In this context, it makes sense that BMJ editors might feel self-defensive and want to push back.

In 2011, BMJ was among the news organizations that deflected legitimate criticism of PACE by portraying patients as dangerous and unhinged. This disinformation campaign did not protect PACE and the CBT/GET paradigm from increased scrutiny–which inevitably led to their decline in credibility. Now defenders of these interventions seem to have dropped the “hysterical patient” meme in favor of a different approach–attacking the standard methodology of assessing interventions.

The BMJ editorial has drawn several smart rapid responses. Professor Jonathan Edwards, a rheumatologist at University College London and a prominent critic of PACE, was typically blunt in his assessment. “I am sorry to say that I think the recent editorial on the draft NICE guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is ill-informed, confused and unhelpful,” he wrote. He succinctly highlighted some of the editorial’s obvious contradictions, noting the following: “They imply that the evidence for efficacy of therapist-delivered modalities such as CBT and exercise is good. Yet they point out that the types of trial available for evaluation are not appropriate.”

Michiel Tack, vice-chair of 12ME, a Belgian ME/CFS patient organization, also posted a response. Here’s how he rebutted one of the authors’ key arguments:

“They mention that double-blinding is impossible in trials on interventions that require patients’ active participation. In such instances, however, quality criteria usually recommend using objective outcomes (in addition to subjective ones) as these are less prone to various biases. Randomized trials on rehabilitative interventions for ME/CFS have included several objective outcomes such as work resumption, healthcare utilization, actigraphy, and various fitness tests. The results of these objective outcomes were summarized in a review by Vink & Vink-Niese. Overall these showed no clinically significant improvements.”

In short, the editorial is something of an embarrassment, for the journal as well as the authors.

Comments are closed.

Scroll to Top