PACE Trial Controversy Grows


In wake of David Tuller’s investigation, PACE investigators publish follow up study

Last week, journalist David Tuller published a four-part investigative piece on the 2011 PACE trial, a £5 million (US$8 million) non-blind study of cognitive behavioral therapy (CBT) and graded exercise (GET) as treatment for chronic fatigue syndrome.

In his piece, Tuller quotes top researchers in the US and UK who have found the study to be “fraught with indefensible methodological problems.” Emeritus Professor Jonathan Edwards found it “a mass of un-interpretability.” Bruce Levin, a Columbia University epidemiologist called the study “the height of clinical trial amateurism.” Arthur Reingold, an epidemiologist at the University of California stated that an independent review of the study was “very much in order.” Stanford geneticist Ron Davis questioned how it even got through peer review, given its deep methodological flaws.

Today by coincidence, Michael Sharpe and Peter White, the investigators who designed the original PACE trial, published a follow up to their 2011 study on Tuesday in The Lancet Psychiatry in which they claim that two years later, three quarters of the original trial participants who had been assigned to receive CBT and GET were found in a self-reported survey to have maintained their improvements in fatigue and physical function, suggesting that the purported benefits of those treatments were maintained in the long run.

Science reports on the PACE controversy

However as Jon Cohen reports in an article appearing online yesterday in Science, those who were randomized to the other treatment groups (“specialist care” and “adaptive pacing” therapy) also reported similar improvements to those receiving CBT and GET. Sharpe and White write that this may be because those patients who did not receive graded exercise and cognitive behavior therapy in the study later sought them out. (An alternative hypothesis is that all patients in the study reported similar levels of improvement after treatment because none of the interventions in the original study had any meaningful effects.)

The conclusions Sharpe and White draw in this new study are especially troubling given that in the original trial, participants who were assigned to graded exercise walked fewer meters in six minutes than patients with pacemakers, patients with class II heart failure, and cystic fibrosis patients – a level of function they defined as “recovery.”

The Daily Telegraph touts “exercise and positivity”

The Telegraph published a piece today based solely on the contributions of Prof. Michael Sharpe and Peter White’s press conference. The headline of the piece reads “Exercise and positivity ‘can overcome ME.’” This is the article’s lede:

Chronic Fatigue Syndrome is not actually a chronic illness and sufferers can overcome symptoms by increasing exercise and thinking positively, Oxford University has found.

In it Sharpe describes ME as a “self-fulfilling prophesy” that happens when patients live within their limits. This is in contrast to many patients who find that living within their limits help them to sustain whatever is their baseline level of function.

The Daily Mail reported on the new Lancet Psychiatry study with the headline “All in the mind? ME can be cured by counselling, says Oxford professor who claims some sufferers do not push themselves to recover.”

When asked at the press conference yesterday, Sharpe further said that he didn’t think there was “a growing army of people upset about this” and that he did not understand “what motivates the very vocal minority that gets so upset about this apparently benign bit of moderately helpful treatment.”

Dr. Charles Shepherd of the UK’s ME Association issued a press release stating that the organization stood by its longtime criticism of CBT and GET.

Next steps:

In light of Tuller’s investigative piece, #MEAction has launched petition to demand that the journals that have published studies based on the PACE trial data retract their claims about recovery.

 


Categories: All News, Featured news, Medicine, Research, United Kingdom

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15 comments on “PACE Trial Controversy Grows
  1. Ann OConnell says:

    This is what happens to people with ME/CFS when negative news about the PACE Trial is made available. The UK press back the group of people who created the trial and repeatedly condemn sufferers.

    The Ebola crisis has shown that nurse Pauline Cafferkey could be left with CFS symptoms and it is due to the latent virus becoming active again in different parts of her body. This is what ME experts have been saying for decades with regard to how ME/CFS works.

    A US Doctor, Ian Crozier, who also contracted Ebola, then thought to recover has been left with CFS symptoms, which the New York Times reported in an interview with him. He woke with a Burning sensation in his eyes and worsening blurred vision. Common symptoms of CFS!!

  2. M Goodger says:

    Sharp and White have made many many people suffer needlessly with their Trial. They have wasted good money that have been used for research into the root cause of ME.

  3. Lynne Hayward says:

    This trial has obviously been such a waste of funds based on poor evidence that clearly is damaging to those who genuinely have ME. It’s even cruel to those who desperately need support because all this trial promotes, is actually harmful to those who have a physiological problem that is made worse by even trying to exert more energy.
    After living with my daughter who has had this illness since 2001, it it blindly obvious that she is not lazy or unwilling to try anything. She even tried to deny it a few years, to her cost, because every time she needed energy to sustain over more than a few hours, she would crash and need to sleep for days, often unable to eat.

  4. Tanya Marlow says:

    Thanks so much for this excellent and helpful round-up. The proposed action sounds like a good one – thank you.

  5. Laina Saul says:

    Thank you for keeping us up to date with these developments. This headline, particularly as it appears in the UK which had been one of the countries leading the way for accepting ME as a “legitimate” illness, is devastating for those who suffer with this disease.

    The statement is so completely erroneous as to be laughable. I practice positivity and exercise on a daily basis. Of course, the daily includes built in recovery time that has a 3 and 4 to 1 ratio of exercse output required for me to get back to baseline so no, this is not how I am going to recover but is how I live my life to the best of my ability.

    I look forward to signing the petition and ask, as I have elsewhere, is there any way to get a celebrity involved with this? Laura Hillenbrand, who has publicly stated she suffers with this, would be a perfect person to be the public face of our illness.

    In any case, thanks again for your efforts.

    1. Jocelyn Murray says:

      As a person who has suffered from ME/CFS for over 25 years (and never had a sick day in my life prior) this is utterly ridiculous and such a waste of funds. And as people have noted above, it again, hurts any progress we’ve made in getting main stream medicine to recognize and validate our disease. I’m in support of asking for a retraction, but let’s focus our limited energy on supporting and promoting the legitimate studies and research that are making a difference.

  6. Unsurprisingly, neither Science nor the Daily Telegraph allows me to submit a comment. This is what I want so say.

    There exists no disease entity named ME/CFS.

    ME is a specific neuroimmune disease, classified at G93.3 by the WHO, with a viral cause. The correct treatment includes antivirals and immunomodulators (Lerner, Montoya, Fluge & Melle, and so on). Without proper treatment, patients tend to get worse over time, as longitudinal data show (Stichting ME Research). No ME patients participated in the PACE trial, since everyone with neurological signs was excluded. In fact, no clinical trial ever tested CBT/GET on ME patients. And none ever should, since it would be entirely unethical.

    CFS is not a specific disease but stands for unexplained fatigue and malaise. In contrast to ME, CFS is not a clinical diagnosis but is solely intended to select patients for research (Fukuda, 1994). It is coded R53.82 in the ICD-10-CM and explicitly excludes ME. In general, once the cause of the medical complaints is known, the diagnosis of CFS no longer applies.

    There are far more CFS patients than ME patients, reflecting the poor state of medical pratice. If our physicians and labs did a better job, there would be no CFS patients. Medical complaints always have a cause, but it is not always found. Since most illnesses are not as bad as ME, however, most CFS patients tend to improve over time.

    The ‘vocal minority’ within the combined group of ME and CFS patients are, of course, the ME patients. All of them. They would be a lot more vocal still if more media would be willing to give hem a floor.

    Mind you, most CFS patients do not profit from CBT/GET either. The method has no merit whatsoever, which was already shown in the 18th century, and it often does harm (Kindlon). The authors of PACE are once again attempting to mislead the audience by mispresenting their data. There is no evidence for their statement that the other participants must have seen the light and turned to CBT/GET after all, nor for the assumption that because there was some improvement, that must have been caused by CBT/GET. More likely, these were the patients that saw the light and turned to genuine treatments, perhaps because they finally received the correct diagnosis.

    Guido den Broeder
    ME Vereniging Nederland (Chair)
    http://www.mevereniging.nl

  7. Esther Siebert says:

    In order to choose a course of action regarding these PACE issues, as upsetting as they are to us, It is critical that we assess how much damage what is happening in the UK is likely to cause our efforts to get equal research funding here. It may be a mistake to turn our focus in the US to this issue which will only draw more attention to it and could cause us to take our eyes off the prize which is equal research funding here. We don’t want to step on our own message.

    It may be that elected officials here will be unaware of this controversy if we don’t draw attention to it ourselves. Although we should be prepared to respond if the issue comes up (and the IOM report and David Tuller’s investigation provide a sufficient response), bringing this up and fighting this battle might be counter productive to our goals here in the states. So we should carefully consider what is in our best interest to do.

    Here are some ideas if we decide to directly and publicly confront this issue:

    Is it time to go after these UK health psychiatrists with an expose on their failures to disclose their conflicts of interest and their financial interests in perpetuating their scientifically flawed theories?

    Is there some way to get ME/CFS experts in the states and elsewhere like Drs. Montoya, Kogelnik, Klimas, Peterson, etc. and/or members of the IOM committee to hold news conferences refuting these doctors?

    Might it be a good idea to have a separate petition or a letter for ME/CFS researchers, IOM Committee members and clinicians to sign and publish. Could someone from the NIH, using their public relations organization, speak about US biomedical findings and isolate the UK approach to ME/CFS as invalid and out of the mainstream?

    Would Dr. Clayton, chair of the IOM committee, be willing to release a statement refuting the UK findings and its approach to treatment?

    These ideas came to me first in the throes of my anger and frustration. It felt good to imagine fighting this out.

    But on further reflection, I think we need to be careful to not create a distraction in this country from what is a promising situation given the IOM report, the well-reported research out of Columbia, the Tuller article and our excellent argument for funding equality given the severity and numbers of people affected with ME/CFS.

    Let’s keep our eyes on the prize. Ultimately this may be the best gift we can give to our sick siblings in the UK.

  8. Holly says:

    Is there a discussion group here where we can leave any written responses we come up with that others are welcome to share and use. A unified, measured, clear response is in order. We are all angry . I would actually describe it as a righteous indignation but we need a clear, concise rebuttal. We have remarkable links at our disposal between David Tuller, Washington Post, The Atlantic, the Forgotten Plague, Canary in a Coalmine, IOM report and many others. Let’s use them to our full advantage.

    Those purporting the benefits of GET have had years to devise strategies. With all the press coming out about the seriousness nature of ME and that GET can cause harm , I am sure they have devised a strategy to respond. They even managed to reference a vocal minority and essentially dismissed any who disagree as ridiculous. They have already given everyone who reads the article a lens through which to view our response. Let us make our response be strong, measured, clear, and given in a way that it bursts through any preconceived notions of a “vocal minority”

  9. Debbie Iverson says:

    I have to admit how painful it is to read about so much misinformation.

    I lived with ME/CFS for ten years before I was diagnosed. I never knew what ME/CFS was because I never read a single sentence about it — even though it popped up in all the online symptom checkers. I dismissed CFS as a fake disease because of things I had heard (who knows where) and so never suggested it to my doctors and, until this year, no doctor had ever suggested screening me for it.

    For ten years, I never gave up hope that I could make myself better. I knew that if I just kept moving and pushing through, whatever autoimmune disease it was that I had would be discovered and treated. For ten years, my symptoms worsened to the point that I can no longer do the basic things of life–work, socialize, take care of my family, take care of myself.

    If what they say is true, shouldn’t “exercising more and thinking positively” have helped me?

    It so clear that science needs to smack this nonsense down. Help science help!

  10. Ellen says:

    I tried to explain on LBC that the key symptom of ME is the worsening of symptoms after minimal exertion. Ergo, GET is inappropriate, just as trying to treat a person with lung cancer by getting them to gradually increase the number of fags they smoke. That the theory is irrational (based on a theory involving pigeons, from the 1950s and the assumption that by pretending to be ill you get loads of benefits and attention.). Yes, bot GET and the Chalder CBT protocols are based on conditioning theory. I also pointed out that the participants were selected if they had fatigue (Oxford criteria), so not CFS, but had no time to add that this means we have no idea if any also had ME. (They did NOT use the London criteria, 52% met their modified version which probably can’t distinguish between ‘ME’ and depression). Also no time to explain that the averages on the two main measures were still well below normal. Half remained on benefits at 52 weeks (not exactly a cure then) and we have no data that anyone did increase their activity levels as they did not use a pedometer or other measure of activity. Jargon is, we have no evidence of fidelity to the protocol. Other research indicates no one really manages GET and ends up pacing. So I see this trial as I did when I first saw the protocol: deeply flawed. I can’t understand how many people don’t see the high fatigue scores and realise that the patients remained quite symptomatic. If one claims one can ‘cure’ ME, this is against the GMC rules so I hope no doctor is doing that.

    I’m still trying to work out how the self-fulfilling prophesy of a fear of exercise leads to hypoperfusion in the brain (Costa et al 1995) and weakened muscle strength 20 hours after exertion (Paul et al 1994?). And ofcourse, there is more evidence of abnormal responses to activity e.g. in immune system (Sorensen et al 2003 etc), ergo rationale for pacing. There’s little you can say in two minutes, and then, oh joy, lady came on who was cured by the Lightning Process.

  11. M.E. sufferer says:

    Please, send the petition that will be done ( can no wait to sign it ) to Cochrane France too :
    we have not any serious association for PWME/CFS patient in France, and Cochrane is the UNIQUE reference for French doctors ( who do not know actually absolutely nothing about M.E. ) Thanks in advance !!!

  12. Ruddy Red says:

    I find it amusing that the PACE trial is suddenly news again a good three years after its publication. of course none of the aformentioned articles bother to report on Tuller’s work, instead a rehash of PACE’s failed strategies.

  13. Beth from Oz says:

    Why is there an assumption that if you belong to a minority and/or are vocal then you are wrong?

    One can be loud, and correct.
    One can be a lone voice, and correct.

  14. I’d like to read something similar with other illness and check reactions. For example:
    Diabetes sufferers ‘can overcome symptoms of Diabetes with positive thinking and sugar’. Same bull#hit.

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