By David Tuller, DrPH
Three years ago this month, Virology Blog published my 15,000-word investigation of the PACE trial, so this seems like a good time for a bit of reflection. I certainly didn’t expect this saga to drag on this long. I’ve kept at it mainly because of the UK academic and medical establishment’s unwillingness to acknowledge what’s gone wrong, its failure to provide reasonable responses to substantive criticism, and its persistence in defending indefensible studies.
I’ve often been asked why I started this quixotic effort to examine the research behind the interventions that have served as the standard of care for the illness or cluster of illnesses variously known as ME, CFS, ME/CFS and CFS/ME. (I realize the questions of nomenclature are divisive and that people hold many different views on the matter.) After all, I have no family members with this devastating condition. My only connection to it before I got involved was through a long-time friend who was diagnosed in the early 1990s.
So how did I latch onto this issue? In 2009, I became intrigued by the controversy over whether a retrovirus might be associated with the illness and started reporting about it. In early 2011, with the retrovirus debate still unresolved, The Lancet published the first results of the PACE trial, which reported that cognitive behavior therapy and graded exercise therapy were effective treatments. That was the first time I’d heard of the study. Two years later, Psychological Medicine published a follow-up paper on purported “recovery” from these two therapies.
At the time, I was mainly focused on other endeavors. But eventually I read commentaries about PACE written by patients and advocates and published as blog posts, letters to The Lancet and other journals, and reports on various sites. The more I read, the more compelling and convincing I found their criticisms of the trial and its methodology. In contrast, the responses from the PACE authors seemed incoherent and non-responsive. Since I am not an epidemiologist or a biostatistician, I consulted with colleagues at Berkeley, Columbia and elsewhere before tackling the issue. These experts were universally shocked at the poor quality of the research.
It is not really difficult to figure out that the PACE trial is an unacceptable piece of science. Anyone with a basic awareness of human nature should be able to grasp that unblinded trials relying on self-reported outcomes, like PACE, are so fraught with bias as to be uninterpretable. That’s why clinical trials with this design are never used as the basis for making decisions about pharmaceutical therapies, and why the strategy of blinding researchers and participants to treatment allocation was developed in the first place.
Of course, it is difficult if not impossible to blind behavioral and psychological treatments, such as the therapies tested in PACE; that’s why it is essential to combine them with objective outcomes. In PACE and other trials in this body of ME/CFS research, objective outcomes have largely failed to support the subjective reports of success. Yet those null findings have been dismissed or ignored by the crowd of avid CBT/GET proponents.
Moreover, trials in which participants have met the thresholds for key outcome variables before they even begin treatment have no place in the published literature. That a study including this unusual feature and other major failings has achieved wide acceptance is—in the words of Carol Monaghan, a member of Parliament from Glasgow—“one of the biggest medical scandals of the 21st century.” That’s why more than 100 experts signed the most recent open letter to The Lancet. The letter, sent and posted on Virology Blog in August, cited the PACE trial’s “unacceptable methodological lapses” and requested a fully independent investigation.
Some patients report that CBT, GET, and a range of other treatments, including the Lightning Process, have helped them improve or even recover from ME/CFS. But in the absence of high-quality evidence, such anecdotal claims should not be the basis for public health policy or clinical guidelines. And the PACE study and related trials cannot be construed as high-quality evidence—no matter how many times Professor Sir Simon Wessely, Professor Michael Sharpe, the UK Medical Research Council, the Science Media Centre and other influential British individuals and organizations repeat such claims.
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My work has obviously not pleased those I have criticized. But the pooh-bahs of UK science and medicine have likely been offended not only by my interpretation of the research but my manner of expressing myself. I have called PACE “a piece of crap”—and sometimes worse. I have suggested that the trial seems to meet the Medical Research Council criteria for research misconduct. I have sent sharply worded letters to respected editors at major journals about their inadequate oversight processes and their ongoing refusal to acknowledge indisputable errors and scientific missteps.
I have referred to PACE supporters as members of the “CBT/GET ideological brigades.” At two public events, I tore a print-out of the PACE trial into pieces and tossed them in the air. I have suggested that the unwarranted adherence to the PACE/CBT/GET approach is a form of insanity. I have said that the situation is a real-life case of the “emperor-has-no-clothes” and that supporters of this treatment paradigm have been stark naked for years.
My tone and behavior might be atypical in scholarly debate, and I have obviously violated British conventions of decorum and deference. But I don’t care much about politeness and niceties, especially given the stakes for patients. In any event, the domain of social commentary provides much greater latitude for robust argumentation. More importantly, the accuracy of my reporting has withstood the scrutiny to which it has been subjected by those who dislike my views. I have made minor mistakes here and there, as everyone does. Unlike the PACE authors, I have corrected errors when others have pointed them out or when I have noticed them myself. This is standard practice in journalism but apparently not in UK science.
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The most recent front in this international scientific dispute revolves around Cochrane, the organization known for conducting systematic reviews of interventions for a wide range of diseases and conditions. Earlier this month, it was reported that Cochrane had decided to temporarily withdraw its 2014 review of exercise treatments, which found them to be effective. This decision was based on solid scientific and methodological grounds, but I assume that CBT/GET supporters must have been pulling out their hair in distress at the news. They had undoubtedly been exerting enormous pressure and lobbying hard behind the scenes to prevent something like this from happening.
In contrast, patients and advocates were jubilant. They had been expressing concerns about this review since it was published. In particular, two very smart patients—Tom Kindlon and the late Robert Courtney—submitted extensive critiques that were appended to the review when it was republished last year. They pointed out that the authors violated Cochrane’s clear guidelines on how to rate studies for risk of bias, failed to include objective outcomes that would have undermined the review’s conclusions, and changed the assessment strategies described in their own protocol in ways that allowed them to present more positive results. When the lead author provided unsatisfactory responses, Courtney filed a formal complaint with Cochrane.
Many people besides patients have been troubled by this review’s obvious problems. Dozens of scientists, clinicians and other experts signed Virology Blog’s recent statement of support for Cochrane’s decision. When I met with Cochrane editor-in-chief David Tovey this summer, I vigorously pressed the arguments advanced by Courtney, Kindlon and others. From the tenor of this interaction, it was apparent that some sort of action to address the review’s flaws would likely be forthcoming, so I wasn’t surprised at the news.
Yet the media accounts ignored the detailed scientific reasoning that formed the basis of the decision. Instead, they focused on patients’ purported militancy and supposed bullying. The charge that Cochrane made the choice because of patient pressure rather than valid criticism is way off-base. But it is no more surprising than the fact that the powers-that-be have for years hailed this anti-scientific research as authoritative.
Cochrane’s decision was an enormous victory for proper science and a possibly fatal blow to the fortunes of this approach to treatment. That’s why it is disappointing that the intense pushback from the CBT/GET ideological brigades has apparently forced a retreat. Instead of temporarily withdrawing the review, Cochrane has added a notice indicating that the authors will submit a revised version for assessment, most likely later this year. In the meantime, the review stands. Whether the upcoming revision will resolve the serious questions raised by Courtney, Kindlon and others remains to be seen.
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Finally, a few thoughts about my crowdfunding. Last year, a grant that had supported my position at Berkeley ended, as scheduled. Anyone who has worked at an American public university knows that many if not most positions are funded through outside sources of money. The University of California system has been in financial crisis for years, given the state’s abysmal levels of support. So I decided to crowdfund, as is increasingly common in academia. I have conducted two successful crowdfunding campaigns. As a result, I have been criticized in some quarters for having questionable conflicts of interest and for being paid specifically to trash the PACE trial.
In fact, I am being paid to continue my investigation of research into behavioral and psychological interventions for this terrible illness. I’m not responsible for the fact that PACE and so many other studies deserve to be tossed into the dustbin. I pursued this Virology Blog project for two years as an unpaid public service. That work involved three trips to England and one to the Netherlands—all self-funded. During that time, I received $6000 for an 8,000-word piece in Undark, the MIT-based online science magazine, and $100 or so (I can’t remember the exact amount) for my half of the fee for a New York Times opinion piece I co-authored.
No journalist or public health researcher would have embarked on this journey to make money or enhance his or her professional status. I decided to do what I’ve done because those outside the ME/CFS world were ignoring these serious problems and leaving debilitated patients to fend for themselves. I also recognized that the CBT/GET recommendations were based on terrible science and were potentially causing harm, since patients can suffer serious relapses after trivial amounts of exertion. I crowdfunded to support a half-time position, yet I am spending most of my work life on the effort. To suggest that I have taken on this issue and am criticizing PACE for financial gain is ridiculous.
Comments
33 responses to “Three Years On…”
Thank you for this and, once again, for all you do!!
David, your work is so important to so many. Lives are at stake. I am a severe patient and I am praying the whole Cochrane debacle works out in our favor. Stay with us if you can at all and thank you for seeing the plight of patients and being so passionate and hard working on our behalf.
Thank you David for your tireless and accessible analysis and commentary, which has been such an important part of bringing to the fore the bizarre kowtowing of the medical and academic establishment to what has become a cult of psychobabble in relation to ME/CFS. Like any cult it has reacted with abuse and insult to reasonable criticism, but fortunately you have persisted.
The door for change is ajar, and hopefully a few more good pushes and it will open fully.
David, thank you for all you’ve done and will do. It has made a huge difference to us – you may not realise how much. We are so grateful.
Do you know what can be done, if anything, with regard to this NICE guidelines review committee panel? It seems all but 2 are of the biopsychosocial crap. So, it would seem that this NICE review is another farce. This psychobabble loading is not only very heavily weighted against us, it also shows their disdain for us.
Like others, I’m at the end of my tether. The majority of us cannot tolerate this any more.
Plus, I was successful in getting our HSE (Health Service Executive) to remove the NICE guidelines (of GET & CBT) from its website around April/May 2017. Our HSE is awaiting the result of this NICE review. People everywhere are affected by what’s done by these power-hungry, money-grabbing, award-receiving, crap-making, unethical egotists
This review committee needs to be filled with experts in M.E. How else can a review of M.E. be done without M.E. experts? It’s ridiculous and harmful.
I would like to thank you too. You have made an enormous impact on moving the conversation forward.
As patients we are all aware that many many advocates have been working for years & holding the Wessely School to account. Hooper and Williams, for example, have created countless documents around the spurious activities of the BPS crowd and others have furthered that dialogue as we have come into the C21st. Sometimes all the shouting in the world doesn’t help if we’re shouting into a bucket. The conduit to take these concerns to a wider audience and hold people to account has been twofold: the rise of social media has been very significant giving few places for miscreants to hide and it has also given rise to ‘blogging and ‘vlogging’ whereby anyone can take their message to that wider crowd. The second important moment happened when a journalist (of the ‘traditional’ sort.. ie one who investigates to draw out truth rather than spinning a pre-determined ‘line’) noticed what was going on. Suddenly we stopped shouting in a bucket. Someone was listening. Someone with credentials and links to solid academia. Someone who could cross-check his concerns with his colleagues in other august institutions, as well as his own. Someone whose concerns could not be silenced as easily as those of ‘patient-advocates’ at the mercy of being gas-lighted by the very ‘profession’ that was supposed to help them: the medical profession.
This 3 years seems to have come and gone so quickly. But in that time, whilst vested interest still tries to trump reality, many with ME will have died. Amongst them some who have advocated most strongly. And that is a stain.. and one I hope will have to be accounted for in time and in the right place. Preferably a court.. because imo Carol Monaghan is right: this is a huge scandal, and huge scandals need proper redress.
But, on your ‘3rd birthday’ of working to access the truth (nothing more and nothing less) I salute you, David, for your efforts. All I want, all we want, is the truth. Because the truth will be our salvation.
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With respect to the Cochrane malarkey, I do find it implausible that any sensible review can be created in the time that has been indicated. Reviews take a great deal of time and effort to create (or at least they do if done properly, and ‘Cochrane’ has a name to maintain in that regard) . So how will it be possible to wrangle a new ‘Review’ from the mess of the ‘data’ they chose to look at in the first instance? It’s seems to me to be an impossible task. Less impossible, of course, if the BPS crew have wielded their weight to make what they want to happen happen. The old chestnut attributed to Gandhi of ‘first they ignore you, then they laugh at you, then they fight you, then you win’ comes to mind. The Wessely School have been kicking back very hard in the last year. They are clearly on the back foot and feeling defensive and beleaguered. I’m guessing that’s a good sign.
Pooh-bahs indeed! Yes I suspect you have not ‘considered the sensibilities of middle england’ (as a boss once told me, to which I retorted, they’ve not considered that they’re totally in error and on the wrong side of the law, ‘even so’ he said, ‘even so’. sigh).
Interesting development with Cochrane. Must have been embarrassing for them for the relevant author to go public – but it’s difficult to see how a review is an appropriate next move rather than removal given the actual science available that trumps the pyschobabble. Still, actual science is progressing that’s replicable, so in due course the truth will out. Question is, will it out fast enough to keep the patient cohort alive?
We knew they wouldn’t like what you have to say but because you said it, they realize the only defense they have, is to try and discredit you. These are professionals within the community who were rewarded for their PACE Trial. People who laughed at us, sectioned us, lie about us, and killed us with their pseudoscience. Even now they are stacking the table for the NICE Review Panel by refusing ME Experts who were also criticized for doing their jobs. “First do no harm” comes to mind when I read tweets written by the wife of a PACE Trial Author. We are sick not stupid. David – you have opened a gate for millions around the world and we are forever in your debt. Thank you isn’t strong enough but it’s all we have.
Thank you. You write so clearly. You’ve given me, and many others, hope, but we have more battles ahead, I believe
The NICE panel, Cochrane review, and no doubt many other battles to face to get the truth out and vanquish graft.
Thanks for taking our struggles out to a wider, knowledgeable and unbiased audience. We’ve suffered too long under the manipulations of the big influential fish in our small pool
Thank you again. It is sad the U.K. press and scientist (the real ones) and everybody that could support these patients, do not, and that somebody from another country has to intervene for all of us.
U.K. Shame on you for the attitude and the lack of support. Right now the most important thing is to address the review panel for NICE, make a scandal on the obvious bias, this affect us all world wide.
David, your contribution to exposing the abuse, neglect and malignment of some of the most seriously ill people I have ever come across will go down in history. Of that I have no doubt. The UK cabal of which you speak will rue the day you happened across their paths. They, and their many cheerleaders, should pay dearly for what they have done to serve their own interests and careers on the back of people with Myalgic Encephalomyelitis.
The latest attempt at stacking the deck is, of course, the NICE guideline review panel which is loaded with psychobabblers. It’s like history repeating itself. One of them is even a PACE author! I know you have lots on and are being pulled in lots of directions but I really hope you can find the time to blog about the panel and the biased make-up. Most of us, in our own way, are challenging it but as you so rightly point out, patients are too easily dismissed by this shower and having you, with your credentials and record weighing in, would help enormously.
Thank you for staying with us David. You seriously deserve so many accolades and I know you always so ‘I’m just doing my job’ but we all know you have gone above and beyond that.
Thank you, that you, for all your dog-with-a-bone hard work. Your approach is just what’s needed against these deluded tyrants, so please don’t go away!
Hi David, re your comment: “In early 2011, with the retrovirus debate still unresolved…”, I wondered if you were still of the same opinion? Do you think that funds should be made available now to conduct decent research exploring the retroviral issue? Prof Racaniello stated in an interview with the Chicago Tribune in December 2010 that the XMRV/ retroviral connection to ME was ‘dead’. This news went around the world like wildfire. However, within 24/48 hours he realised he had been ‘mistaken’ in his judgments and commented in the mass of lengthy comments of his blog on the XMRV: “I do not believe that the four Retrovirology papers prove that XMRV is not involved in human disease.” If I had the link to his comments I’d include it here but I’m sure you could find it.
Here’s a comment I left for him in January this year: Professor Racaniello, this came up in ‘my memories’ section on fb from 2010 and I was wondering if you would consider having a TWIV with Dr Judy Mikovits now? It would seem to be appropriate considering all the developments and further retroviral findings eg Montoya’s results from the Lipkin Multicentre Study. It could be another way of exposing Crawley and others of her ilk from wasting time and research funds whilst the retroviral elephant in the room continues to stampede. Lives are being ruined and lost, not least those of children, whilst some folk on antiretroviral drugs and supplements are faring well – maybe you could interview some of those folk as well? In response to ‘Kati’ 7 years ago, you wrote: “I will try to have a TWiV next year with Dr. Mikovits – it’s up to her to agree. I do agree that the speed with which the press has dismissed XMRV based on yesterday’s reports is disheartening. I think most of the stories were simply repeating press releases which were negative.”
Professor Racaniello didn’t respond to my comment. If he doesn’t want to interview Dr Judy Mikovits then maybe you should? Also, perhaps an interview with Elaine deFreitas, re her 1991 Wistar Institute retroviral findings, would also be appropriate?
Thank you for all you do for us. It has been a tough road with much more to come. I wish I had the funds to help you as your work is super important to our lives. Sending warm hugs, and huge thanks. Xoxoxo
Lady Shambles says exactly what I and many others feel, only more eloquently than I could manage. You have brought the issues very much out of the bucket and into the open. For that we will be eternally grateful. Well, maybe “eternal” may be a bit tricky, but definitely grateful.
Three words
Thank you David
David- we can’t thank you enough for everything you have done for PWME in the last couple of years.
Honestly, if I didn’t absolutely have to get involved to fight for what may be left of my life, I can’t imagine getting into these dirty trenches willingly.
It’s frustrating, depressing and disillusioning. This week with the Cochrane news, I was beginning to think maybe we WERE getting somewhere. It would have been a major step to better science and better care. Now it seems that’s not happening, and the powerful BPS lobby is literally doing this over our dead bodies, one at a time.
Where to go from here? I don’t know. But we’re not giving up, because we can’t. I hope you’ll be here with us for a while longer, though I couldn’t blame you if you needed to step back at some point.
Again, THANK YOU.
The word that comes to mind that best describes your cogent takedowns of how the GET / CBT folks continue to defend the indefensible is agnotology, or the study of the deliberate creation of ignorance and doubt. It was coined by Robert Proctor (Stanford) and he used it to describe the strategy used by the tobacco industry for so many years to prevent a true reckoning of the health hazards of smoking. As we now know, far too many scientists collaborated on that effort and far too many lives were lost during the years that the industry misused or misrepresented scientific data. I have the utmost respect for the difficult work of advancing scientific knowledge but when the powers that be allow travesties such as this, it’s little wonder that we have crises of authority in regards to public health measures. When health authorities or researchers implement bad policy or commit serious errors, these need to be publicly rectified and accounted for. Otherwise their authority is really based on authoritarianism, not expertise and they cease to deserve the social niceties of deference and much less so, respect.
Thank you for fighting the good fight.
Thanks again, David. Due to some change of formatting or coding recently, I can’t like or share or like comments here anymore on my iPad. I was disappointed your “and finally” didn’t address the make-up of the NICE review committee, but I feel sure you’ll be working on that!
David, on behalf of myself and my son ALEM Matthees, I thank you with all our hearts
You have kept this battle alive on behalf of so many ill ME patients who themselves are unable to fight
You give us hope and strength to see the light at the end of the tunnel
Times are changing and its you and many others who are making this happen
THANK YOU!!!
We who have ME/CFS (or whatever you want to call it today) are so lucky to have a bulldog like you digging into OUR cause. Shoddy pseudo-science often doesn’t get attacked or retracted – and we, the patients affected, don’t have the energy to take on the ‘research’ establishment it represents; some days I don’t have the energy to brush my teeth!
And we’ve often been sick so long (almost 29 years for me) that the fight we have left is used for getting through each day.
Thank you for having found our cause, and especially for sticking to it. Your name is already legendary among us.
I’m an historian who’s been involved in faction fights over some minor points of British history during the 1930s, and its fascinating that although my side of the dispute has demolished the other side’s arguments on many occasions, they will not accept that their findings are, as we have proved, based on secondary and minor factors, and that they ignore the primary factors that we use to prove our point.
It’s the same with the Wesselyans with ME/CFS, with the difference that their stubbornness has a great deal more impact. They are increasingly faced with solid fact-based information that shows that the illness is physiological and that psychological factors are symptoms and not causes, yet they ignore all this and refuse to accept that they’ve been barking up the wrong tree for 30 years or so. And like my opponents in the historical world, I believe that the Wesselyans today are not arguing in good faith: they now instinctively know they they are wrong but cannot accept it.
Perhaps the Wesselyans are worried that their reputations will go up in smoke if they admit that they are wrong. I would think much more of them if they had the courage to admit their errors. I believe that we people with ME/CFS would be sufficiently magnanimous to accept an apology, despite all the bother that the Wesselyans have been causing us all these years with their erroneous theories and resulting ineffective and often counter-productive treatments.
David i have been investigating the dark sde
David i have been investigating the dark side of m.e and cfs for 28 years-you need to know [if you dont already] that prof Andrew Llyod and an australian psychiatrist named Hickie are behind nearly all the exercise exploitation they never ,never ever diagnose M.E just all C.F.S and then they enrol the hapless patients into the exercise clinic they own and run
Llyod is the senior member of the usa -aust commitee that meets twice yearly to discuss their stratergy’s
ask yourself why the CDC granted Lloyd all that money to do the Dubbo study years ago
for 28 years
Thank You David,
for the incredible work you have done and continue to do.
Thank you for this important work. Is it still possible to donate to your crowdfunding?
Crowd funding relies on people in believing in what you do, and hoping it might make a difference. Crowds are usually right! Many thanks for continuing the fight.
David, thank you so much. As Graham says, Lady Shambles has eloquently expressed what a lot of us think and feel. I was diagnosed around 17 years ago and have been on the internet for all of that time. Throughout that period, I’ve seen many patients and carers working hard to get the disease taken seriously – many of them are sadly no longer with us.
The questions that puzzle me are how did UK medical research become so dire as to allow this hocus-pocus to gain a foothold in the first place, and why is there no UK investigative journalist on the case?
Thank you for everything.
Your efforts have been amazing. I have had it for thirty years at the chronic stage and in a mild way since age seven. I never expected patients would have to endure such a long fight for recognition. We have been doing it on our own and feel relieved to have you take on the challenge of dismantling the PACE Trial.
I met you in Perth, Western Australia and thought your presentation was fantastic.
Thank you for using your excellent investigative and journalistic skills on behalf of ME/CFS patients.
For anyone to accuse you of doing this for financial gain or recognition is preposterous! Those who get involved in work related to ME/CFS usually get scoffed at. It’s not exactly a subject many, outside of the patient community, give much thought or respect to.
As for financial gain, that is almost laughable! You could be doing lucrative work on other matters with your background and experience. Are those who throw such accusations your way working in their respective fields for free and also without input from those their work will affect? I think we know why the mud is being thrown. You are getting closer to the actual truth of the studies. They don’t like this threat of exposure. They will do everything in their power to try to keep the covers over it all.
I, for one, am happy to support the important work you are doing. I hope you will be able to continue to uncover and expose the faulty research that keeps other researchers, medical professionals, as well as family and friends of patients, from fully believing the level of disability ME/CFS patients suffer. The suffering and loss are deep and seemingly endless. The shoddy science that promotes treatments that in most cases would make a patient sicker need to be exposed.
I am on the HIV Aids HAART medications Viread, Isentress, Darunavir & Ritanovir and the ME is in full remission after 20 years of illness as these drugs target the exogenous viral protein particles of the Ruscetti/Mikovits XMRVs/MLVs,and by the way HAART likely cannot effectively reverse any endogenous rv activity to the point of remission.My fifth year almost on these meds now daily.Mikovits says Lipkin kept her in the dark when she was coerced and tricked by him.On Fauci’s orders apparently.Too big a problem.
History :
Science 2009 XMRV paper by HTLV discoverer Ruscetti et al thanks to whom HIV was isolated using HTLV techniques.
Four negative XMRV papers ensued the first one from UK psychiatrists invited to NIH NIAID name changing n policy committees in 80s n 90s.
More negatives. Tons.
Three or so positive (Lo Alter, Hanson Bell, German throat study)/neutral studies. Just a trickle.
Lipkin mbio 2012 paper declared fraud by coauthors Mikovits & Ruscetti in 2014 as more details came to light on problems with Lipkin study.
More negatives.
Very few patients take ARVs. They get better. Few can get them. At least 3 or 4 needed. You can only get so far on 1 or 2 for long term ME.
Iranian and Indian papers 2016 2017 detect xmrv in Aids and Prostate cancer. Not funded by eye winks out of the university window to big pharma and government, nor handshakes in the corridor of POWER.
Thank you for trying to help us.
Thank you for persisting in this pursuit, David. Your voice and your ability to bring other non-ME/CFS people along is making a difference where we can not.
“Although the facts were plain for all to see, numbers alone rarely make an argument compelling when an established culture is firmly wedded to their ideas.”
from “Unwell – What Makes a Disease a Disease?” by Mike McRae, p63