By David Tuller, DrPH
Last week, two major articles on long Covid appeared in well-known US publicationsâ€”one in the Atlantic, the other in Vox. Like the New York Times Magazine article that ran in January, these stories addressed with nuance the complex and unclear relationship between the varieties of long Covid and the group of entities collectively known these days as ME/CFS. They did not presume patients in either category were suffering from psychogenic symptoms.
Today, The New York Times ran an opinion piece from two women who helped spark the patient-directed long Covid movement. In their piece, Fiona Lowenstein and Hannah Davis made these pertinent observations about some of the inadequacies of the societal response to long Covid:
“Weâ€™ve seen this before with myalgic encephalomyelitis, also known as chronic fatigue syndrome. Because ME/CFS, as it is also called, is difficult to diagnose, many patients have gone uncounted, and research into treatments and cures remains underfunded compared to other illnesses. As a result, clinicians tend to be undereducated and patients are less likely to receive adequate care and government support. Thereâ€™s a risk of repeating this cycle with people with long Covid.”
The UK is still arguing over graded exercise therapy…
In the UK, much of the discourse has been different, so reading stuff from both sides of the Atlantic can be disorienting. Of course “exercise”–in the sense of â€œmovementâ€–is being discussed and debated. It is a standard component of rehabilitative strategies, and variations of â€œexerciseâ€ for the range of long Covid presentations are being exploredâ€”although no one has a real clue about whatâ€™s going on for many or most of these patients. .
What I haven’t noticed in the US is this specific obsession with and controversy over graded exercise therapy (GET). This intervention, at least as designed for ME/CFS, attributes the perpetuation of the symptoms to deconditioning rather than any ongoing organic illness.
Arenâ€™t we all bored with this already? Hasnâ€™t the PACE trial testing this approach to ME/CFS been debunked? Why am I discussing this again? Because the biopsychosocial ideological brigades appear to have mounted a spirited campaign against the forces undermining their former hegemony in this field of medicine. Even Professor Peter White, the Queen Mary University of London psychiatrist and one of the lead PACE investigators, has reemerged from retirement to engage the naysayers. Professor White is one of three co-authors of a letter this week in The Guardian touting the benefits of GET for ME/CFS. For real!
The letter contained this doozy of a statement with no hint of irony or shame: â€œWe know that graded exercise therapy is an effective treatment for chronic fatigue syndrome (or ME), a clearly related condition.â€
It is hard to know how to respond to such a statement from Professor White. In the PACE trial, he and his colleagues reported GET to be â€œeffectiveâ€ only after rampant outcome-swapping. Re-analyses of the PACE data based on the investigatorsâ€™ original outcome measures yielded either null results or very marginal benefits that wore off by long-term follow-up. It apparently needs to be repeated without cease that a study in which participants could be counted as â€œrecoveredâ€ even if they got worse and in which 13 % of participants met an outcome threshold at baseline does not meet the minimal requirements for publication in any journal.
The Guardian letter is part of what seems to be a backlash emerging from some disgruntled folks against the UK’s National Institute for Health and Care Excellence, the agency that issues clinical guidelines for medical conditions. In November, NICE issued a draft for a new guidance that was three years in development. The draft categorically rejected GET or any interventions focused on increased activity and premised on the notion of deconditioning as a causative factor. It also rejected cognitive behavior therapy as a curative treatment, although it allowed for that and other approaches framed as supportive care.
An evidence review conducted for NICE as part of the guidance development process rated the quality of all the findings in support of GET and CBT as either â€œlowâ€ or â€œvery low.â€ They applied a widely used system for this process called GRADE (for Grading of Recommendations Assessment, Development, and Evaluation). Since then, various luminaries in the biopsychosocial and evidence-based-medicine fields have assailed this negative assessment of the research base in statements posted on BMJ.com.
One group argued in an editorial that NICE’s findings were off because standard randomized controlled trials and GRADE are not the best way to assess complex interventions like those tested in PACE. One problem with that argument was that one of the editorial’s two co-authors had previously praised PACE as an excellent test of the interventions. (That was before PACE was publicly discredited. Oops!)
In a response, a second group defended the integrity of GRADE and assailed the authors of the editorial for not appreciating it. They argued that GRADE itself was fine but that the NICE team engaged in a “disastrous application” of the methodology. That these experts can’t agree among themselves about the reasons for their disapproval suggests they are flailing about for counter-arguments to the NICE draft that might stickâ€”so far, without apparent success.
Those waging this debate over ME/CFS actually seem to be arguing about long Covid. The biopsychosocial brigadiers have been losing the argument over ME/CFS, given the questionable body of research they have produced and continue to cite. The NICE draft demonstrated that the tide was shifting in the other direction. With long Covid, they seem to be making much the same arguments over againâ€”and simultaneously trying to un-write the last few years of critical debunking of the PACE approach. As the letter to The Guardian suggests with its call for a trial of GET for long Covid, they hope their efforts to reframe that narrative will help them gain footing and funding in a world awash with patients experiencing persistent and disabling symptoms after a viral illness.
Studies of all sorts of treatments for long Covid are of course warranted. However, the investigators responsible for much of the body of biopsychosocial ME/CFS research do not appear competent enough or knowledgeable enough about legitimate methodology and appropriate ethics to be entrusted with such an important mission.
Is CBT different than the Lightning Process?
As a final point, Iâ€™m having trouble at this point understanding the distinction between the the PACE approach and the Lightning Process (LP). There is certainly a lot of cross-over among the investigators and experts. Professor Esther Crawley, Bristol Universityâ€™s methodologically and ethically challenged pediatrician and grant rainmaker, conducted the methodologically and ethically disastrous trial of the LP for kids with ME/CFS. Professor Trudie Chalder, a CBT expert at Kingâ€™s College London and a lead PACE investigator, has also been involved in LP research.
In a statement supportive of Professor Crawleyâ€™s LP trial, Professor Michael Sharpe, a psychiatrist at Oxford and another lead PACE investigator, drew favorable parallels between cognitive behavior therapy (CBT) and the LP. In Norway, proponents of CBT for ME/CFS are among those pushing for a new study of the LP. And Professor Paul Garner, an infectious disease expert at the Liverpool School of Tropical Medicine, has advised those with long Covid not to listen to sick ME/CFS patients and has directed them instead to Recovery Norway, a site full of LP testimonials. (Professor Garner was a co-signer with Professor White of the Guardian letter.)
As far as I can tell, the operating concept behind the PACE treatment approach and the LP are the same: Positive thoughts are good, negative thoughts are bad. Positive thoughts will heal you, negative thoughts will keep you sick. Being more active will also help.
Thatâ€™s it. Thatâ€™s the theory.