S. Wessely: "PACE trial, which tested interventions with an impeccable safety record"

[Dolphin]

Free full text at:

http://www.foundation.org.uk/journal/pdf/fst_20_07.pdf

The Journal of the Foundation for Science and Technology
Volume 20, Number 7, December 2011

Professor Simon Wessely: Health in mind and body

We now have two treatments that we can recommend with confidence to our patients.

However, the story does not quite end there.

Patient groups rejected the trial out of hand, and the internet was abuzz with abuse and allegations.

The main reason for this depressing reaction was the stigma that attaches to disorders perceived (rightly or wrongly) to be psychiatric in origin, whatever that means.

If one obtained identical results to the PACE trial, but this time with anti-viral drugs, the reaction would have been totally different.

This is exactly what did happen when a very small trial of a drug that modulates the immune system (and which has some nasty side effects) was greeted with acclaim from the same sources that tried to discredit the PACE trial, which tested interventions with an impeccable safety record.

 

[Dolphin]

Regarding S. Wessely's safety claim

Regarding the specific claim by Simon Wessely:

"the PACE trial, which tested interventions with an impeccable safety record."

the following paper would challenge that claim:

Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Tom Kindlon

ABSTRACT

Across different medical fields, authors have placed a greater emphasis on the reporting of efficacy measures than harms in randomised controlled trials (RCTs), particularly of nonpharmacologic interventions.

To rectify this situation, the Consolidated Standards of Reporting Trials (CONSORT) group and other researchers have issued guidance to improve the reporting of harms.

Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) based on increasing activity levels are often recommended for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

However, exercise-related physiological abnormalities have been documented in recent studies and high rates of adverse reactions to exercise have been recorded in a number of patient surveys.

Fifty-one percent of survey respondents (range 28-82%, n=4338, 8 surveys) reported that GET worsened their health while 20% of respondents (range 7-38%, n=1808, 5 surveys) reported similar results for CBT.

Using the CONSORT guidelines as a starting point, this paper identifies problems with the reporting of harms in previous RCTs and suggests potential strategies for improvement in the future.

Issues involving the heterogeneity of subjects and interventions, tracking of adverse events, trial participants compliance to therapies, and measurement of harms using patient-oriented and objective outcome measures are discussed.

The recently published PACE (Pacing, graded activity, and cognitive behaviour therapy: a randomised evaluation) trial which explicitly aimed to assess safety, as well as effectiveness, is also analysed in detail.

Healthcare professionals, researchers and patients need high quality data on harms to appropriately assess the risks versus benefits of CBT and GET.

Bulletin of the IACFS/ME. 2011;19(2):59-111.

Free full text at: http://www.iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk=&tabid=501&forcedownload=true

 

[Wonko]

for a man who says he has no involvement in "CFS" research, and hasnt done for the last 10 years, he doesnt half seem to be vocal on matters "CFS".

 

[Enid]

SW - "psychiatric whatever that means" - Quite ! - can we look forward to a definition now.

 

[pamb]

Wow, this guy just has no shame or conscience does he? (hmmm, con-science?)

 

[alex3619]

Hi pamb, con-science, goes with with non-science which I have been using for a while. Bye, Alex

ps non-science is pronounced "nonsense"

 

[heapsreal]

Free full text at:

http://www.foundation.org.uk/journal/pdf/fst_20_07.pdf

Isnt it funny how he mentions antivirals, maybe he should actually look into it more, maybe dr lerners work and he will find that antivirals have a much greater improvement rate then any PACE stuff. or maybe dr lerners work is just a placebo effect especially how it lowers viral titres. Maybe they should test for viruses and viral titres but they would never do that because they would lose their credibility(although i think they lost that along time ago), they would also say that viral testing is to expensive and wont do it due to expense but wont hesitate to spends a small fortune on PACE treatment that doesnt work.

He's just a boof head!!

 

[alex3619]

Hi heapsreal, if Dr Learners results are just placebo, clearly they are ten times better a placebo than CBT/GET. I want more of those placebos.

Also, seriously, if this were a drug we would accept the results? With five adverse events per patient? A drug company would halt all study, and yank it off the market, not push it with glowing praise. Its a pity we cant attribute all CBT/GET failure and harms to one entity, because those that have been harmed could then launch a class action lawsuit.

Bye, Alex

 

[jonnyboy]

the sheer audacity of this guy is amazing. Just the outright lies he comes out with boggles the mind. I dont think there is a single person with cfs or me who would not be happy if his silly cbt and get worked. But it doesnt work, and wessely just cant comprehend that perhaps he is wrong.

What i found amazing was that I went to the optician back in june to have annual checkup for contact lenses. I happened to mention this time that I had just been diagnosed with cfs. Then the optician said, that they are taught in training about the problems cfs/me people have with vision problems. And i thought if opticians can see there is an actual physical problem, how on earth can doctors treat this as psychosomatic? that is insane to me

 

[alex3619]

Here is commentary from the journal this was published in, on their main website http://www.foundation.org.uk/

The Foundation's purpose is to provide a neutral platform for debate of policy issues that have a science, engineering or technology element. The Foundation organises dinner/discussions and workshops on relevant issues when parliament is sitting.

We should test this. We should invite the Countess of Mar, Hooper, Maes, Sheffield, the IACFSME to all respond - if its an unbiased public policy journal, then we have a UNIQUE opportunity to reply, and we need to get the reply from respected researchers, doctors and so on.

Bye
Alex

 

[Sean]

the sheer audacity of this guy is amazing.

It still amazes me after 20 + years of following the debate.

 

[SilverbladeTE]

Alex
10:1 this is a front group or manipulated by such, for the corporations...$$$
Lobbying is big business...
and if there's money and pwoer involved, why should they care about ME, or rather perhaps, why are those who've been screwing us over involved with such, hm....?

wessely's fluffing, as the Titanic goes down, seeking a life raft to avoid being dragged down by the lead-weighted iceberg he made, aimed and fired at us!

 

[Dolphin]

Here is commentary from the journal this was published in, on their main website http://www.foundation.org.uk/



We should test this. We should invite the Countess of Mar, Hooper, Maes, Sheffield, the IACFSME to all respond - if its an unbiased public policy journal, then we have a UNIQUE opportunity to reply, and we need to get the reply from respected researchers, doctors and so on.

Bye
Alex

Would be great if somebody replied.
Who or what is Sheffield? David Sheffield Bell?

 

[alex3619]

Sorry Dolphin, I have an ongoing mental glitch regarding Charles Shepherd, I have repeatedly called him Sheffield. I have no idea why. Bye, Alex

 

[Snow Leopard]

Many of the reasons why we are sceptical of the PACE trial is much the same reasons why we are all sceptical of unblinded drug trials. It is a double standard to 'accept' the results of non-pharma trials but not those of unblinded pharma, alternative health.

Oh yeah and the diabetes trial he was talking about had a 95% confidence interval with a minimum difference of 0.1 - it was barely significant at all. (previous discussion on the forum)

 

[dancer]

...

What i found amazing was that I went to the optician back in june to have annual checkup for contact lenses. I happened to mention this time that I had just been diagnosed with cfs. Then the optician said, that they are taught in training about the problems cfs/me people have with vision problems. And i thought if opticians can see there is an actual physical problem, how on earth can doctors treat this as psychosomatic? that is insane to me

Indeed. I also was pleasantly surprised at my last eye-doc appointment. He said, "Yes, I'm very familiar with CFS. I look at my CFS patients similarly to those who have had strokes. There are often problems with how the brain is communicating with the eyes...fluctuations...etc." Considering the neurologist I saw shrugged off the abnormalities on my MRI, it was refreshing to talk with at least some area of medicine who was knowledgeable, compassionate, and took it seriously. (sorry this is off topic, but the mention of the optician snagged my attention)

 

[biophile]

Health in mind and body (Simon Wessely) http://www.foundation.org.uk/journal/pdf/fst_20_07.pdf

A reasonable sounding start.

SW: Physical and psychological symptoms are closely linked. A study of 40,000 people at Camberwell measured the incidence of chronic fatigue and GHQ (a common depression or anxiety). It found a very close relationship. Further, the greater the number of symptoms, the more likely the patient was to develop a mood or anxiety disorder. These symptoms may be just non-specific markers for distress.

Chronic fatigue is a common symptom of depression and anxiety (and countless other medical diseases and psychiatric diagnoses), so finding such an association between the two is unsurprising. Extrapolating this to all chronic fatigue is inappropriate, but guilt by association and disingenuous discussion of physical factors is Wessely's typical style for CFS discussion. As usual though, no mention of Kisely's work finding the association between number of physical symptoms and prevalence of psychiatric comorbidity exists regardless whether symptoms are either organic or "unexplained".

SW: CFS is a multi-factorial illness. A person can be at increased risk because of genetics, or because of previous depression, for example.

Hasn't the large premorbid depression studies been exposed as flawed? Not that I would reject it out of hand, or find it surprising for broadly defined CFS which is problematically conflated with symptoms of depression and hence the call from some researchers for better criteria to avoid epidemiological artifacts. Perhaps Dolphin can remind me about the national cohort studies.

SW: Various infections, including the Epstein Barr virus, definitely precipitate this condition. Yet to understand why some people do not get better as the months and years go by, one has to look at behavioural and psychological factors. The illness is then a complicated mixture of predisposition, precipitation and perpetuation.

Back to the blanket hyperbole about abnormal illness beliefs and deconditioning.

SW (on the PACE Trial): For those who appreciate these things, the trial is a thing of beauty, and the results confirm previous smaller studies and follow ups.

Ah, another comment from Wessely about how "beautiful" the PACE Trial is. I have to agree with him for different reasons, because it was a more robust design for a microcosm of the macrocosm of nearly everything wrong with CBT/GET research which does make it an item of beauty for exampling.

Excessive reliance on the patients' subjective perception which authors previously deemed as distorted/unreliable, ignoring the contamination of questionnaires by reactivity bias, exaggerated effect sizes of subjectively reported improvements which are refuted by objective measurements, authors' fear-avoidance of actigraphy which would have embarrassed them, strawmanning the rival therapy ie pacing, obscuring safety data in between ineffectiveness and persistent severe declines ie CBT/GET is "safe" because it is deemed OK to suffer a 20/100 point reduction in function for up to 4 weeks at a time and/or patients don't have to increase activity as presumed in a somewhat similar sense that a toxic drug is also safe when patients don't have to take it if they don't want to, et cetera.

SW: Patient groups rejected the trial out of hand, and the internet was abuzz with abuse and allegations. The main reason for this depressing reaction was the stigma that attaches to disorders perceived (rightly or wrongly) to be psychiatric in origin, whatever that means.

So it isn't because of the biopsychosocialists' poor track record, nor because the patients these organizations represent commonly report adverse effects in real world applications of CBT and GET, nor it is the dozen or so problems identified with the PACE Trial (some before it was published because of the protocol); wise Simon says the answer is, it was simply rejected out of hand mainly because of the stigma of mental illness!? Where did Wessely gain this impression from anyway; relying on his own prejudices, or reading biased newspaper coverage on the issue, or browsing the comments and forum posts? The internet was also "abuzz" with legitimate criticisms which exposed flaws in his pet therapies that he built his reputation on. Wessely's own research shows the stereotype of ME/CFS patients as anti-psychiatry is inaccurate, so I guess he is referring to an unspecified small group of people rather than the entire ME/CFS community?

SW: If one obtained identical results to the PACE trial, but this time with anti-viral drugs, the reaction would have been totally different. This is exactly what did happen when a very small trial of a drug that modulates the immune system (and which has some nasty side effects) was greeted with acclaim from the same sources that tried to discredit the PACE trial, which tested interventions with an impeccable safety record.

Wait a minute, wasn't the effect of Rituximab significantly stronger than the effect of CBT/GET, and unlike the PACE Trial, blinded or placebo controlled? So no, the comparison is not about "identical results". And didn't the Rituximab study show that it was safe anyway? I assume the "same sources" Wessely refers to are patient organizations and internet buzz? I can't speak for other patients but I do have serious concerns about the safety of any drug for CFS because I've become sensitive to them in general.

I can't deny that more skepticism was applied to PACE than Rituximab, when generalizing the responses from the online ME/CFS community. However the Rituximab researchers aren't coming from a background of decades of double speak and spin doctoring and misleading promotion of their treatments, all which make it harder for patients to trust the results of CBT/GET. Further, the Rituximab researchers are from a more mainstream field, they aren't coming from the academically-incestuous fields of psychology and psychiatry where there is a darkly colourful history which is both long in general and recent when it comes to ME/CFS in particular.

The patient community welcomed the Rituximab study not just because of the apparent benefits of the drug but also because it provided clues about actual disease mechanisms which could advance the field, compared to the disputed assumptions about the role of abnormal illness beliefs and deconditioning which are mostly hot air from professional psychobabblers that has stagnated the field. We are desperate for promising leads, not a consolidation of gyroscopic spin and suffocating influence.

PACE itself is a good example of why the erosion of trust continues. Researchers who greatly widen up the outcome goalposts after seeing the worse than expected data from the FINE sister trial don't attract the trust of patients. Researchers who claim that 60/100 points in physical function (PF/SF-36) is "significant/severe disability" for the purposes of CFS diagnosis and trial entry but somehow "normal" for the purposes of a successful outcome (while in the real world about 84% of healthy people of similar age are scoring 80/100 or more and usually 95/100), do not deserve trust or even respect on the issue. CBT proponents who claim full recoveries are routinely occurring, while ignoring 6MWD and actigraphical data which suggest no improvements whatsoever, do not inspire confidence in their therapies.

 

[justinreilly]

God. Shame on all of these journals and doctors for not closing the door on this psychopath. Lies about patients, diseases and treatments from a discredited sadist are just fine for a journal article, but any positive study on XMRV/HGRVs must be retracted despite a lack of clear flaws?

Let's write this journal: fstjournal@foundation.org.uk

 

[biophile]

justinreilly, I saw your name on mecfsforums.com with a certain Star Trek avatar titled "Wessley Crusher" and just had to laugh out loud, LOL! Thanks.

 

[justinreilly]

Glad to be of service!