Trial By Error: NICE Rejects Current Guidance, Plans “Full Update”

By David Tuller, DrPH

Let’s give credit where it’s due. Apparently someone with decision-making authority at the National Institute for Health and Care Excellence (NICE) has a grasp on reality and is willing to challenge the claims of the biopsychosocial ideological brigades. That’s the only logical explanation for last Wednesday’s welcome but unexpected announcement that the agency would pursue a full update of the guidance for the illness it calls CFS/ME. From what I gather, that means NICE will essentially start the whole guidance development process from scratch.

In announcing the decision, NICE noted the many concerns stakeholders raised about the existing guidance, which was developed in 2007 and promotes treatment with cognitive behavior therapy (CBT) and graded exercise therapy (GET). At the same time, NICE rejected the recommendation of the internal team to which it had delegated the task of reviewing the literature and producing what was called a surveillance proposal consultation document. That consultation document concluded that no changes should be made to the guidance, After NICE released the consultation document in July, it invited input from stakeholders. The agency had previously indicated that it would announce its decision in October.

I have covered the NICE issue here, here and here. I also sent an e-mail to Sir Andrew Dillon, who heads the seven-member NICE guidance executive, with my questions about the consultation document and the review process. I critiqued the topic expert reports commissioned by NICE, which I received through a freedom-of-information request. One reason I wanted to keep on top of the issue was to make sure NICE was aware that its actions were being observed, and not just in the UK.

The NICE announcement was overshadowed by the same-day release of Professor Esther Crawley’s ludicrous study of a psychobabble technique called the Lightning Process as a treatment for kids. The Lightning Process is a mish-mash of positive affirmations, neurolinguistic programming and related doggie poo. That Professor Crawley received approval for this experiment on minors is unfortunate. Despite some credulous media coverage, the results cannot be taken seriously, for reasons others have documented.

I might be too optimistic, but I think the NICE decision is a game-changer. It suggests that the PACE authors and their colleagues, despite their enormous influence, have lost control of the narrative, even on their home turf. They can no longer count on those in powerful positions to provide monolithic support for their bogus claims that CBT and GET are effective treatments. That doesn’t remotely mean that the struggle is over. There are lots of remaining hurdles, especially the central task of ensuring that any new guidance is based on sound evidence. But this is still a significant moment in the ongoing demise of the PACE/CBT/GET paradigm.

The NICE statement about the decision highlighted stakeholder concerns about the Oxford criteria and the CBT/GET evidence base, among other issues. Key trials (particularly PACE [Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation], but also Cochrane reviews of CBT and GET) have been criticised for inflating the efficacy of interventions, declared the statement. Issues include that some studies only require fatigue in the case definition, which may incorporate other fatiguing conditions with the potential to complicate results.

NICE reported that 39 stakeholder organizations submitted comments. Nine of them–including professional associations like the Association of British Neurologists and the Royal College of Psychiatrists–supported the recommendation to leave the guidance as is. No patient organizations took that position. The stakeholders collectively submitted about 300 pieces of new evidence. NICE selected thirteen that met its criteria for inclusion in its surveillance review.

This group includes a study criticizing the Oxford criteria as overestimating illness prevalence and two studies about the role of postural orthostatic tachycardia syndrome, or POTS, a key symptom ignored in the 2007 guidance. Also included is Keith Geraghty’s analysis of surveys about CBT, GET and pacing. The CBT/GET cheerleaders have generally dismissed the results of such surveys because the respondents are self-selected, so the inclusion of this study of patients’ real-world experiences is welcome.

The NICE decision is a slap in the face to the PACE authors and Sir Simon Wessely, who have routinely protrayed critics as vexatious, irrational and dangerous. It is also a possible set-back for Professor Crawley, who served on the 2007 guidance committee and believes PACE is a great, great trial. The consultation document highlighted Professor Crawley’s ongoing FITNET-NHS study of Internet-delivered CBT as an important future source of data. (Gee, I wonder who promoted the importance of FITNET-NHS to the surveillance team?) Since last week’s decision suggests that NICE is aware of and concerned about the methodological flaws afflicting the CBT/GET research field, FITNET-NHS could turn out to be irrelevant to the new guidance.

The NICE decision occurred not long after the Medical Research Council rejected an application from Professor Crawley’s much-ballyhooed Big Data project, the ME/CFS Epidemiology and Genomics Alliance. These successive events suggest that the public controversy over PACE and related CBT/GET studies might have reached a tipping point. Perhaps the anti-scientific arguments advanced by these researchers are finally losing credibility, even among academic and medical colleagues. Maybe there’s a growing awareness that open-label trials relying on subjective outcomes cannot provide reliable evidence. I mean, maybe not, but I hope so.

The topic expert reports revealed the profound shallowness of the NICE surveillance team’s efforts. The fact that three of the seven experts were psychiatrists and four were members of the 2007 guidance committee did not inspire confidence in the panel’s objectivity. None of the experts appeared to appreciate the extent to which research on physiological dysfunctions and the PACE debunking have transformed the debate in the last two years.

In fact, Expert #6 even argued that there was increasing acceptance among British patients and clinicians that the illness is an emotionally driven disorder, a claim so stupid and ill-informed that it should immediately have disqualified this person from being deemed an expert. It was troubling but unsurprising that the NICE surveillance team found this narrow range of purported expertise to be sufficient input for such a critical decision.

Developing a new guidance could take quite a while. And that’s a good thing, if it means getting it right. Considering the range of issues outlined in NICE’s statement, the new guidance committee will have to include experts who can argue forcefully on behalf of basic scientific principles. These experts will have a tough job. Those who have dominated the field for years touting research riddled with flaws will obviously demand a place at the table. But I have a sense that higher-ups in the NICE hierarchy are acutely aware that stacking the committee with CBT/GET hardliners would doom the effort to irrelevance and failure, not to mention damage the agency’s international reputation.

I have not written to the PACE authors themselves in a while. Given the significance of this development, however, I decided to make another effort to extract a comment. I haven’t heard back, of course, nor do I expect to. But that’s no reason not to pose the questions.

Here’s the message I sent to Professor Chalder, Professor Sharpe and Professor White:

    I am writing a post for Virology Blog about NICE’s announcement this week that it is planning a “full update” of the guidance for the illness we have been debating. I am interested if any of you would like to make any comments about this decision. 

    Here are some of my questions: Are you surprised? Do you think this means NICE will remove CBT and GET from the updated guidance? Do you believe the CDC’s recent “dis-endorsement” of the treatments has influenced NICE’s decision-making? Do you believe the decision is an indication that the CBT/GET paradigm for treatment of the illness is collapsing, even in the UK? Do you believe the decision represents a rejection of the reported PACE trial results? 

Thanks!, David


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