The Sound of Silence

A great deal of noise has been made over various things the authors of the PACE study have claimed in publications or spoken statements. What has received much less attention is the remarkable extent to which they have remained silent on very significant aspects of that trial. The continuing stream of papers based on the flawed primary study prompts me to explore this neglected aspect.

Did anyone notice the extent to which those PACE results required substantial selection of patients other doctors considered "CFS patients"? No matter what the authors think about diagnosis of "CFS", what other doctors think will continue to determine which patients are shunted into this treatment option. This makes the question of how you separate the patients for which the suggested treatment is useful, from those for whom it is not, very pertinent, particularly when considering costs. Most of the presently-available information can be found in Figure 1 of that paper.

They chose only about 898 out of an initial intake of 3158 patients recommended for possible inclusion. Of these only 641 agreed to participate, and one withdrew consent after the trial started. I'm making a reasonable assumption that patients who refused to participate in the trial would be especially unlikely to benefit. Even with that degree of selectivity, the authors themselves appear to say, in some public statements, that some 40% of patients did not respond to their favored treatments. (It is hard for anyone else to classify responders and non-responders, based on released data.) This might mean that the PACE results only apply to 384 patients out of 3158, assuming it means anything. What do they recommend for the rest of those patients?

The authors were not terribly forthcoming on the subject of exactly what physiological conditions should be tested for as exclusionary. The cost of this testing is nowhere apparent in this sequence of publications, including an economic analysis.
One can only assume this testing and these costs are shifted to regular NHS doctors and service. (Externalizing costs is one popular way to improve your bottom line, ask any accountant.) The same publication assumed the benefits of PACE had been shown to be substantial and lasting. I've already expressed my opinion on the negligible clinical significance of the reported results, but stopped short of considering lasting effects, for which no data at all are available. The idea that significant positive effects are lasting is based on nothing more than wishful thinking, which always helps economists touting nostrums for economic ills. A naive reader of that economic analysis would never guess this without digging much deeper than most professionals are likely to go.

This reliance on regular NHS doctors and services, even extending to the suggestion that CFS patients can be treated by "less senior doctors" (less competent ones?) to reduce costs by half, is an apparent contradiction to the suggestion by some of the same authors in a paper on misdiagnosis which finds rates of diagnostic error around 30%, (though the authors are convinced that missed psychiatric diagnoses are twice as common as making them in error.)

If we are to start comparing rates of diagnostic error between competing teams of psychiatrists we can have a field day, even when we consider better-established diagnostic categories like schizophrenia. The implicit assumption that the PACE authors have an error rate of 0%, without ordering any physiological tests, when even pathologists examining actual tissues removed from patients have an error rate of 1% is ludicrous. What are they doing, reading patient auras?

A publication by Byron Hyde is more forthcoming on the subject of undiagnosed physical conditions found in patients sent to him as CFS patients, and indicates he had no trouble finding undiagnosed and untreated disease, even including syphilis. Note that Dr. Hyde did not require a team of collaborators and millions of pounds to study an unbiased sample of patients referred to him as CFS patients.

One patient in an unfiltered sequence of 53 was even found to be missing a substantial chunk of brain nobody had previously noticed. (How he was able to fit "false illness beliefs" into the remaining volume will no doubt be explained in later publications by the PACE authors.)

Dr. Hyde did find 16% of patients with psychiatric disorders, though not necessarily the one called CFS. (My numbers above indicate that he may actually have sent a higher percentage of patients to psychiatrists than the PACE group.) This does not rule out secondary physical problems, which are virtually ignored in PACE. Must be somebody else's problem.

If you examine a group of diagnosed psychiatric patients without finding undiagnosed and untreated physical illness in 9% or so, you are not trying very hard to find it.

By the way, while we're on the topic of omissions, has anyone ever found a source for the 70% capacity rule used in the APT arm of PACE, other than the PACE authors themselves? That should also count as a very curious omission since pacing was allegedly at the center of this trial. In the absence of such a source we must assume APT was created purely to serve in a straw-man argument.

A final omission is the fact that at the time of the study one specialist in statistics listed as an author was a PhD. candidate with a dissertation which depended on PACE. One might compare the composition of the committee which recommended awarding that degree with the list of authors. This is not a person in a position to make judgements independent of senior authors. Was independent review of statistical practices any more significant than checking arithmetic applied to data declared valid by those senior authors?


This and your previous blog entry would be excellent rapid responses to the Lancet.

I really don't think they're that worried about diagnostic accuracy. There seems to be an underlying assumption that like 'medicinal compound' CBT is 'useful' regardless of the condition.
According to the Wessely school of psychiatry "There is only one functional somatic syndrome" (1). That justifies using the same treatment approach for every unexplained health problem (this is how somatization disorder is essentially defined), which coincidentally gives these psychiatrists a large number of patients and conditions to work with.

Please note that I am primarily interested here in internal contradictions, and conflicting evidence from other sources. You don't have to make any judgment on the definition used to discern that the authors have arrogantly assumed that other doctors are wrong 30% of the time on this subject, while they themselves are never wrong.

Those other doctors are part of the NHS which is left with the responsibility of weeding out those patients which would be harmed by suggested treatments. On the one hand the authors are saying the NHS is terrible at handling this problem, on the other hand they are implicitly handing them the much larger part of the problem of identifying and treating those patients who did not meet the research requirements of this study.

If these uncooperative patients, who persist in saying they are sick, are denigrated, neglected or ignored, few doctors are outraged. I'm wondering how those doctors feel about deliberate attempts to bamboozle those professional peers who don't go to the trouble to examine one or two levels of references behind the claims in any particular paper by this group. There should also be pointed questions about attempts to mislead funding agencies which paid for research about what you are going to do with public moneys, what you actually accomplished, or what the economic effects of applying your recommendations will be.
Thanks. This kind of internal contradiction is rife in the PACE articles. That in part was why I started writing my book, though its not looking likely I will ever finish just now. The number of contradictions rises once you add in other papers and claims by the authors, media statements, and related literature including those cited in the papers. Its a barrel of irrationality rubber stamped with a dogmatic seal of approval.
did they take into account the psychiatric desire to medicalise the most trivial of human natures . as in you don't like large crowds so you have a mental disorder. rather than yes a great many people don't like the hustle and bustle you get in a large crowd. so i take any report of missed psychiatric "illnesses" wiyh a pinch of salt.
The psychologist Leonard Jason wrote about errors like this in Stephen Straus's paper on "CFS" long ago, so this is not a case of a monolithic psychological/psychiatric block attacking patients.

Straus was looking for evidence of preexisting psychological problems in CFS patients, and claimed this applied to the vast majority of patients, based on a study of fewer than 30 patients chosen by him on no particular basis for diagnosis except that he thought they were CFS patients. Straus listed quite a number of problems indicating preexisting conditions, but took no note of their incidence in the general population. Some like ordinary phobias are so common they are not by themselves considered mental illness.

He was also sloppy about time of onset of illness which he considered to be when he saw them. Since many well-known medical conditions have long prodromal periods this meant he failed to distinguish problems caused disease from preexisting psychological problems. I would note that Straus had no training in psychiatry beyond that given to other MDs. This did not stop him from getting this published, and sending out press releases to hundreds of media outlets describing this as authoritative evidence.

That the professional accepted these tactics should count as a mark against them.
Your comments are as informative as ever.

One of many things I do not understand is why I have never seen this paper from 1989 quoted against White.
Fatigue syndrome: neurasthenia revived. P. White

"Studies of patients with fatigue of longer duration showed that two thirds had a recognisable psychiatric disorder"
Therefore one third had no recognisable psychiatric disorder. As there is a widespread belief that some depressive conditions are alleviated by exercise, one might when setting up an experiment consider the possibility of different responses to exercise and establish appropriate groups. It is surprising that researchers seem surprised that 40% showed no benefit from the PACE trial. This seems very close to what might have been reasonably foreseen as a possible outcome.

Is there anything to suggest that this was taken into account in the setting up of the trial? One might have expected that those responsible for grant funding and ethics would have considered this and made appropriate stipulations as to the conduct of the trial. Or do they not concern themselves with a researcher's former papers?

You ask " What do they recommend for the rest of those patients?" White's earlier response was "we should treat what we know is treatable while keeping an open mind about aetiology". It is hard to see how he can know anything from his trial about the non responders, but the same treatment seems somehow to be appropriate for all.

One might also question why , if one third have no psychiatric disorder, it is considered appropriate for their "treatment" to be overseen by psychiatrists.
Please note that the estimates of responders and non-responders in PACE are not based on data anyone but the authors have been able to examine. It was also the authors who winnowed the original 3,158 patients referred for CFS down to roughly 900, from which they were only able to get 640 participants who completed the trial. Presumably, their eagle-eyed diagnostic skills would have eliminated any who did not have treatable psychiatric conditions.

If you check the bibliography of that article by White you will find that he also references Straus, who lacked special psychiatric credentials. You would have to go another level deeper to find the embarrassing paper by Straus flogged to hundreds of news outlets as "the answer" to the question of CFS. As Leonard Jason remarked "I didn't think a paper that bad could get published."

As for the bait-and-switch that took place between the proposals that funded PACE and final publication, that is simply too much to discuss in such a limited format as this.

In his mini-review of the history of neurasthenia, White omits reference to use of the term prior to Beard's paper. In those publications it was used to literally mean "weak nerves". Two definite organic illnesses we know now were included in this: multiple sclerosis and myasthenia gravis. Both show autoantibodies, even if ultimate etiology remains uncertain. The defining publication on MS, as "sclerose en plaques", had only appeared in French in 1868, so it is doubtful Beard was aware of it.

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