By David Tuller, DrPH
Here is how bullshit replicates itself in today’s medical world: Conduct a flawed trial, declare success despite serious questions, then develop health policy based on these hyped-up claims.
ZonMW, a major Dutch healthcare funding agency, is supporting a new program led by Professor Hans Knoop, a longtime supporter of the fraudulent PACE trial, to develop “therapist training” for a “post-infection fatigue treatment” dubbed “Fit after an infection.” The training is based on a 2023 study, spearheaded by Professor Knoop and published in Clinical Infectious Diseases, called “Efficacy of Cognitive-Behavioral Therapy Targeting Severe Fatigue Following Coronavirus Disease 2019: Results of a Randomized Controlled Trial.”
The trial was unblinded and relied solely on subjective measures for its claims of benefits—a recipe for an unknown amount of bias. As would be expected with such research, the investigators reported modestly positive results for the primary outcome, self-reported fatigue. But the trial yielded null results for the one objective outcome mentioned in the protocol—amount of physical activity, as measured by monitoring devices worn at the beginning and end of the intervention.
The investigators conveniently left that salient detail out of the published trial report–a choice that (in my view) constitutes a form of research misconduct. Instead, they touted the intervention as a success. When online commenters noted the absence of the physical activity results, the investigators acknowledged the null findings for that measure and then offered ludicrous, “dog ate my data”-type excuses for not having included these data in the paper. As I pointed out on social media, I had just seen a terrific London stage production of Arthur Miller’s The Crucible, and the pro-witchcraft arguments in the play were more credible than the excuses offered by the trial investigators for not having mentioned their null objective outcome results.
The most laughable claim was that level of physical activity bore no relationship to self-reported fatigue. Huh??? Professor Knoop himself has stated otherwise in previous papers, so it is hard to take this assertion seriously. If physical activity were really irrelevant, there would have been no reason to measure it in the first place. Had the physical activity outcome supported the positive subjective results for fatigue, the investigators would undoubtedly have mentioned them.
The new training effort is part of a ZonMW initiative to fund projects that build on previous COVID-19 work funded by the organization. The maximum grant under the program is €50,000, or about $58,000. So it’s a modest sum that, in reality, won’t pay for much.
Here is a description of the new program from the ZonMW site:
“Fatigue is common after COVID-19 and can become chronic in a significant proportion of patients, limiting daily functioning. Cognitive behavioral therapy (CBT) can reduce fatigue, concentration problems, and disability in some of these patients…Because there are few other proven treatments for fatigue after COVID-19, there is a need for CBT. The treatment has been successfully implemented at the Amsterdam UMC, but referral options elsewhere are limited. Fatigue is also common after other infections. Fatigue symptoms after other infections may also be treated with CBT…The aim of the current project is to develop a training program for behavioral therapists to treat chronic fatigue following an infection, such as COVID-19. This can promote the nationwide implementation of CBT for post-infectious fatigue.”
And here is the expected outcome:
“The project will produce an evidence-based, transferable treatment protocol and web-based tool for CBT treatment for fatigue. Both will be made available to participants in the training program. The web tool will be offered to multiple intervention software platforms. Trainers will be appointed to deliver the training program, and the program will be offered to continuing education institutes. Accreditation will be sought from the Dutch Association for Cognitive and Behavioral Therapy (VGCT) and the Federation of Healthcare Psychologists (FGzP), making the training attractive to professionals. The plan is to describe the protocol and background in a Dutch chapter and in a journal for behavioral therapists.”
In other words, based on biased trial with predictable subjective findings that were not supported by the one objective measure, the Netherlands would like to roll out a national treatment infrastructure. Makes sense!
Some patient advocates have protested this project on social media. In response to one such complaint, ZonMW explained that these implementation grants are not peer-reviewed and are awarded to ZonMW-funded investigators who want to put their findings into practice on a first-come, first-serve basis:
“At ZonMw we encourage research results from the COVID‑19 program to find their way into practice. That is why ZonMw opened an implementation‑impulse round for projects that previously received funding. Researchers can turn their earlier findings into concrete products such as training materials, guidelines or educational materials. This is a scheme with a process without reviewers or an assessment committee and without patient involvement. This means that the application is assessed by ZonMw for completeness and whether it meets all the conditions and assessment criteria as set out in the subsidy call. ZonMw assesses applications in order of receipt until the subsidy ceiling is reached.”
ZonMW added:
“We are aware that Cognitive Behavioral Therapy (CBT) for chronic fatigue after COVID‑19 is a sensitive topic. Funding implementation activities after the completion of a research project is a standard procedure for ZonMw. Granting this subsidy application is not a position on what causes post‑COVID or other illnesses.”
It is unwarranted to suggest that patients are “sensitive” about CBT. They are “sensitive” about research, like Professor Knoop’s CBT trial, that is flawed from the start and claims to show what it doesn’t. They have a right to demand that health policy be based on quality trials. Apparently, ZonMW has trouble understanding that concept, at least in this domain.
I’ve often said that “We can’t do anything about what people say, and we can’t make them learn.”
It’s how it works with friends and family, but to see medical companies actively misrepresenting a very marginalized illness is criminal.