Scientists trade insults over ME (JHP special issue)

[Stukindawski]

One problem is that the letter posted at Mental Elf wasn't just of poor quality - it contained outright lies. For any self-respecting journal to publish falsehoods, they would have had to commission yet another response exposing it, or risk misleading their readers. So it'd be one more for PACE, but also one more for anti-PACE, and no real change in the balance.

If someone was able to put together very clear evidence of those lies and pass it on to some of the journalists who ran the initial story, might be worth a go. It's obvious they like fairly blatant content.

 

[Esther12]

If someone was able to put together very clear evidence of those lies and pass it on to some of the journalists who ran the initial story, might be worth a go. It's obvious they like fairly blatant content.

'lies' is probably too strong. To me the errors looked likely to be a result of incompetence. eg They worte: "There is also a paucity of reliable objective outcomes for this condition. Even though PACE demonstrates that maximum heart rate or lactate levels remains constant or improves slightly following GET, it is appropriate to ask what it means for the patient."

PACE didn't even measure lactate levels. Apparently they have access to Individual Patient Date from PACE that has not been made public, so they may have been able to look at some data on heart rate that isn't public yet?

I think that the other problems are serious, but less clear-cut.

 

[Robert 1973]

I think this is a significant point. I worry that when patient organisations talk to journalists they give the impression that a problem with the PACE trial is that it assumes a psychological basis for ME. But that is not a vlid criticism. You could say that the rituximab trial assumes a B cell basis for ME or that a calcite trial assumes a viral basis and they might all be equally wrong.

The problem with the PACE trial is that it is a bad piece of science in terms of the methods used.

I understand the point you are making @Jonathan Edwards but I'm not sure the analogy is entirely accurate. The PACE trial explicitly assumes that ME/CFS is a somatofirm disorder which is perpetuated by false beliefs and unhelpful behaviours. That is the hypothesis upon which the trialled inventions are based. It was designed to confirm that hypothesis, as well as to test the efficy of the interventions. If the PACE CBT had been administered in the same way that it is administered for (say) cancer patients, one could have argued that there was no assumption about the cause/nature/mechanism of the illness – that it was merely testing the efficacy of a treatment which may be helpful for people suffering from all types of illness. But that was not the case. An assumption was made that ME/CFS is not a physical disease.

As far as I understand, the Rituximab trial does not assume a B cell basis for ME. An observation was made that B cell depletion therapy appears to alleviate the symptoms of some people who are diagnosed with ME/CFS. The hypothesis, as I understand it, is that Rituximab may help some people with ME to feel better. As a consequence of the Rituximab trials it has been hypothesised that ME may have a B cell basis, but that is not the same the trial being based on the hypothesis about the basis of the illness, as was the case with PACE.

For the PACE authors, the BPS model appears to be not only a hypothesis but axiomatic. If some of the flaws in PACE are due to the authors' unwillingness to question this (arguably unfalsifiable) hypothesis, then it is valid and relevant to raise this point when criticising the trial.

Finally, with reference to the whole physical/psychiatric issue, one of the things that I hope will come out the the PACE trial scandal is a complete overhaul of the methods of research in psychiatric and psychological research. Notwithstanding my comments above, I agree that the methodological flaws in PACE are otherwise independent of the nature of ME/CFS. That raises serious questions about the standards applied to other psychiatric and psychological research – and the extent to which progress in understanding the physiology of psychiatric illnesses such as schizophrenia and bipolar disorder may have been inhibited by unscientific approaches to research.

 

[Esther12]

As far as I understand, the Rituximab trial does not assume a B cell basis for ME. An observation was made that B cell depletion therapy appears to alleviate the symptoms of some people who are diagnosed with ME/CFS. The hypothesis, as I understand it, is that Rituximab may help some people with ME to feel better. As a consequence of the Rituximab trials it has been hypothesised that ME may have a B cell basis, but that is not the same the trial being based on the hypothesis about the basis of the illness, as was the case with PACE.

The PACE authors will often try to present their research in the same pragmatic terms.

 

[Molly98]

I understand the point you are making @Jonathan Edwards but I'm not sure the analogy is entirely accurate. The PACE trial explicitly assumes that ME/CFS is a somatofirm disorder which is perpetuated by false beliefs and unhelpful behaviours. That is the hypothesis upon which the trialled inventions are based. It was designed to confirm that hypothesis, as well as to test the efficy of the interventions. If the PACE CBT had been administered in the same way that it is administered for (say) cancer patients, one could have argued that there was no assumption about the cause/nature/mechanism of the illness – that it was merely testing the efficacy of a treatment which may be helpful for people suffering from all types of illness. But that was not the case. An assumption was made that ME/CFS is not a physical disease.

As far as I understand, the Rituximab trial does not assume a B cell basis for ME. An observation was made that B cell depletion therapy appears to alleviate the symptoms of some people who are diagnosed with ME/CFS. The hypothesis, as I understand it, is that Rituximab may help some people with ME to feel better. As a consequence of the Rituximab trials it has been hypothesised that ME may have a B cell basis, but that is not the same the trial being based on the hypothesis about the basis of the illness, as was the case with PACE.

For the PACE authors, the BPS model appears to be not only a hypothesis but axiomatic. If some of the flaws in PACE are due to the authors' unwillingness to question this (arguably unfalsifiable) hypothesis, then it is valid and relevant to raise this point when criticising the trial.

Finally, with reference to the whole physical/psychiatric issue, one of the things that I hope will come out the the PACE trial scandal is a complete overhaul of the methods of research in psychiatric and psychological research. Notwithstanding my comments above, I agree that the methodological flaws in PACE are otherwise independent of the nature of ME/CFS. That raises serious questions about the standards applied to other psychiatric and psychological research – and the extent to which progress in understanding the physiology of psychiatric illnesses such as schizophrenia and bipolar disorder may have been inhibited by unscientific approaches to research.

I agree with much of what you have said here but I think it goes further than hypothesis, it was based on an absolute concrete belief. This is even more evident now that the reanalysis has been done and critics have pointed out flaws as rather than be able to admit the research did not prove their hypothesis, therefore hypothesis is wrong, which is what should be the case, they are fighting tooth and nail to still claim their theory and research is right. This is not just wrong and unethical it is dangerous.

 

[RogerBlack]

In the UK you can't donate blood if you have ME so they must think that is a possibilty

The stated reason is due to XMRV (as far as I found), which certainly is not transmissible (it has not ever occurred in patients, though was a concern at a time of the guideline). It is likely that it's simply not been reviewed at all, since then, rather than there being actual evidence or reasons to suspect transmissibility.

 

[Jonathan Edwards]

As far as I understand, the Rituximab trial does not assume a B cell basis for ME.
For the PACE authors, the BPS model appears to be not only a hypothesis but axiomatic.

Finally, with reference to the whole physical/psychiatric issue, one of the things that I hope will come out the the PACE trial scandal is a complete overhaul of the methods of research in psychiatric and psychological research. Notwithstanding my comments above, I agree that the methodological flaws in PACE are otherwise independent of the nature of ME/CFS. That raises serious questions about the standards applied to other psychiatric and psychological research – and the extent to which progress in understanding the physiology of psychiatric illnesses such as schizophrenia and bipolar disorder may have been inhibited by unscientific approaches to research.

As Esther12 says I am afraid it is Even Stevens on this. All experiments pick a hypothesis and test it. Using rituximab was very much based on the conceptual assumption that B cells were being targeted - requiring the hypothesis that they were responsible. The biopsychosocial hypothesis is incoherent, if it is even a hypothesis, but it is hard to criticise an experiment on the basis of what it was testing, only whether it had any chance of testing it.

Your last paragraph I very much agree with. What has become apparent to me in all this business about PACE is that UK psychiatry has been taken over by people who are too dumb to understand basic scientific methodology. The rest of the world may be the same but in the UK it is having a direct impact on health care policy.

My wife suffered a psychotic illness precipitated by an antimalarial that in the US would have been classified as schizophrenia. She is now completely well but if you want a reason to think hell might be a cosy alternative to reality this is the way to go. The idea that the same bunch are in charge of this sort of illness does not bear thinking about.

 

[user9876]

One problem is that the letter posted at Mental Elf wasn't just of poor quality - it contained outright lies. For any self-respecting journal to publish falsehoods, they would have had to commission yet another response exposing it, or risk misleading their readers. So it'd be one more for PACE, but also one more for anti-PACE, and no real change in the balance.

I think they should have published it once the factual errors were corrected. Obviously if the authors refuse to correct errors (or demonstrate they are not errors) then it should not be published.

The arguments they put forward were not really worthy of a reply and obviously weak.

 

[user9876]

If the PACE CBT had been administered in the same way that it is administered for (say) cancer patients, one could have argued that there was no assumption about the cause/nature/mechanism of the illness – that it was merely testing the efficacy of a treatment which may be helpful for people suffering from all types of illness. But that was not the case. An assumption was made that ME/CFS is not a physical disease.

I think if PACE CBT had been administered to other patients it would be the same hypothesis that changing beliefs about illness will lead to recovery, that is what their version of CBT is about.

 

[Wolfiness]

The biopsychosocial hypothesis is incoherent, if it is even a hypothesis

In my personal communication with a PACE PI I was told that they "currently" don't have one. I hope that isn't betraying confidentiality.

 

[Wolfiness]

I think if PACE CBT had been administered to other patients it would be the same hypothesis that changing beliefs about illness will lead to recovery, that is what their version of CBT is about.

I would say "improvement", but yeah. They consider it to be a universally applicable intervention.

 

[Barry53]

What has become apparent to me in all this business about PACE is that UK psychiatry has been taken over by people who are too dumb to understand basic scientific methodology. The rest of the world may be the same but in the UK it is having a direct impact on health care policy.

I begin to wonder if it is more than simple dumbness, but also that they just don't give a fig about basic scientific methodology, especially if proves an impediment to their personal ambitions.

 

[Deepwater]

I begin to wonder if it is more than simple dumbness, but also that they just don't give a fig about basic scientific methodology, especially if proves an impediment to their personal ambitions.

I agree. This bad psychiatry is only impacting healthcare because it is perceived by the powers that be as a way of keeping down healthcare costs and disability benefits, not because it sounds more plausible than good psychiatry. Psychiatrists prepared to engage in it, and fiddle their research to provide an evidence base for its implementation, have been amply rewarded for doing so. So some of them may be dumb, and some of them may just be ruthless and self-serving.

 

[Robert 1973]

The biopsychosocial hypothesis is incoherent, if it is even a hypothesis, but it is hard to criticise an experiment on the basis of what it was testing, only whether it had any chance of testing it.

Is the fact that PACE was based on an incoherent hypothesis (if it is even hypothesis) not a valid criticism?

Sorry to hear about your wife's experience, but pleased to hear it had a positive outcome. I believe Paul Merton had a similar experience. As a lay observer, such cases emphasise to me the biological basis of much psychiatric illness and the incoherence of arguing that an illness cannot be psychiatric because it has a biological cause/mechanism. ME/CFS is not a psychiatric illness because its defining characteristics are not predominantly psychiatric. Bizarrely, it seems to be the BPS psychiatrists who are most confused about this issue of definition, as they are with so much else. Many seem to use the terms psychiatric, psychological and somatoform interchangeabley, which is not my understanding of the terms. Sorry, I'm drifting off topic...

 

[alex3619]

The stated reason is due to XMRV (as far as I found), which certainly is not transmissible (it has not ever occurred in patients, though was a concern at a time of the guideline). It is likely that it's simply not been reviewed at all, since then, rather than there being actual evidence or reasons to suspect transmissibility.

This might be a stated reason, but another I recall reading, for the UK, is the concern it might put too much stress on sick CFS patients. Bans were in place before XMRV if I recall correctly.

 

[Countrygirl]

http://www.miningjournal.net/life/2...yndrome-reality-conflicts-with-medical-study/

There is quite a good article about the recent shenanigans above:

From the mining journal ( mining?? )

Here is part of the article:

Chronic fatigue syndrome reality conflicts with medical study
LIFE
AUG 1, 2017

CONWAY MCLEAN, DPM
Special to the Journal

Conway McLEAN, DPM

Medical research is a funny thing. I don’t say that in the literal sense: research generally is as much fun as having a tooth pulled. It is in regard to the statistical analysis required of any medical study that I refer.

As the cliche goes ‘numbers can lie’. The term “Evidenced Based Medicine” basically refers to the use of medical studies to indicate whether some treatment is beneficial or worthwhile. When a scientist or physician has some theory or method they want others to utilize (regardless of the motivation, be it profit or something beneficent), they construct a study which explores and evaluates this new method……although, as most people realize, statistics can be manipulated to reveal most anything.

Take Samantha, for example. She was a healthy middle-aged woman, a vital productive member of society, who came down with some sort of viral infection, which changed everything. Samantha developed a condition so debilitating that any activity whatsoever was impossible. Her days of mountain biking and painting became days, then weeks, of lying in bed, unable to even sit up or answer the door. She began experiencing severe joint pain, and constant unremitting exhaustion, so profound that turning over in bed had to be planned hours in advance. Whenever she did try to push herself, her symptoms got worse, so she lay there for months, staring at the walls in the room, wondering what had happened.

Samantha was diagnosed with chronic fatigue syndrome, a complicated disorder characterized by extreme fatigue that can’t be explained by any underlying medical condition. Chronic fatigue syndrome is one of the most controversial conditions known. Researchers, doctors and patients struggle to agree on its name, its definition or even whether it exists. But to those diagnosed with CFS, the prognosis is not good. A recent analysis, which followed patients for up to five years, concluded that the recovery rate is 5 percent.

Because there is no clear biological mechanism, the condition has often been claimed to have a psychological cause: psychiatrists in the 1970s put it down to “mass hysteria”, while in the 1980s the press cruelly nicknamed it “yuppie flu”. This latter term implied that sufferers were spoilt young people too lazy to work. Diagnosing chronic fatigue syndrome is made difficult by the fact the symptoms can mimic so many other health problems, and even more so because there is no single test to confirm it. A physician must rule out a number of other illnesses before a diagnosis of chronic fatigue syndrome can be made.

To meet the diagnostic criteria of chronic fatigue syndrome, someone must have unexplained, persistent fatigue for six months or more, along with various other signs and symptoms. These can include loss of memory or concentration, sore throat, enlarged lymph nodes, unexplained muscle pain, extreme exhaustion lasting more than 24 hours after physical or mental exercise, and others. The fatigue may worsen with physical or mental activity, but doesn’t improve with rest. It has also been called myalgic encephalomyelitis and, more recently, systemic exertion intolerance disease, although there is notable variation between these disorders

 

[Barry53]

Great to see ME/CFS getting aired in a journal not closely associated. It would seem the JHP special issue is creating some waves .

 

[Valentijn]

Maybe this is why Mayo is so keen to update their website's misinformation, after refusing for years:

Despite the many errors in study methods and statistical analyses, the study (known as the PACE trial) became part of the recommendations by such influential institutions as the CDC and the Mayo Clinic. That is, until a major investigation lead to an expose published by a San Francisco journalist, in which deep methodological flaws in the entire PACE trial put its validity in serious doubt.

No "controversy" here, just researchers versus the PACE authors :

The research community, on the other hand, has rejected the psychiatric model epitomized by PACE. They instead are looking for a physiologic explanation, whereby there is some actual, physical phenomenon at work.

An excellent article, especially coming from a regional newspaper.

 

[Mithriel]

On the question of whether ME is infectious or not, Myalgic Encephalomyelitis was described as a disease that happens in EPIDEMICS. Any theory of causation has to take that into account and it is the reason that many long term researchers were dubious about XMRV.

The early hysteria work was about MASS HYSTERIA not individual psychological problems. In the early eighties Eleanor Bell wrote a compassionate paper about cases that were not epidemic (I can't remember the word for that) and we now see more individual cases. (It has been suggested that this is because of universal vaccination against polio)

These epidemics were closely related to polio epidemics and it was thought likely that ME was an abnormal reaction to a common infection, like measles encephalitis.

Now it may be that more sophisticated science has shown that ME is an outcome in the body that can come from many different insults but infection has to be one of the main causes.

To suggest that the Royal Free epidemic was caused by a whole crowd of medical people spontaneously developing exercise phobia like lemmings jumping together off a cliff comes close to a Monty Python world.

Mithriel

 

[lansbergen]

To suggest that the Royal Free epidemic was caused by a whole crowd of medical people spontaneously developing exercise phobia like lemmings jumping together off a cliff comes close to a Monty Python world.

Yep