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David “PACEman” Tuller in Amsterdam 2018

An interview with David Tuller, DrPH, where he talks about:

  • Patients and advocate like Alem Matthees from Australia.
  • The largest treatment trial for “Chronic Fatigue Syndrome” – the PACEtrial.
  • The Dutch “Chronic Fatigue Syndrome” studies.
  • The British Parliament and the role of Carol Monaghan.
  • The parallels between Trump and PACE-case.
  • Changes and developing, CDC.
  • ME as a fascinating story, a challenging thing.
  • He talks about hope.

 

Concept: Anil van der Zee

Questions by: Roland Cheung, Céline Corsius, Lou Corsius, Mark Vink and Anil van der Zee

Interviewer: Rogier Louwen, PhD

Video, audio and editing: Willem Timmers

English subtitles: Lisa Jarvinen

 

Transcript:

So I’ve met a number of severely ill patients. One who I went to visit in Australia in Perth was Alem Matthees. He’s a really heroic guy because he filed to get the raw data from the Pace trial and fought it through into the tribunal system and won and that’s really what’s helped make a lot of changes. So I went to see him. He’s bed-bound. He wears shades and earplugs to prevent too much stimulus. He can sit up in bed to drink smoothie that his mother makes for him number of times a day. And he can write some notes. He can’t email, he can’t talk, he can‘t read, you know all the stuff that he used to be able to do even though he was fairly sick. It’s horrible to see somebody in that condition and you feel just helpless and terrible you know. And the same with I’ve seen Anil a couple of times. He could only spend a few minutes together and what can you do? It’s heartbreaking. I mean you can’t–what can you say? You know you can’t do anything and it’s … So it’s terrible to see that.

 

What is the PACE-trial and why is it such a big deal?

In terms of the Pace trial, on the page It was the largest treatment trial for treatments for CFS or M.E. whatever we want to call it. And it found or reported that investigators reported in 2011 in The Lancet that their two treatments, Cognitive Behavioral Therapy and Graded Exercise Therapy, were effective in getting people either back to normal as they said or improving a lot in that way. And when you look at the trial, it had a big impact worldwide. It reinforced a lot of the existing treatment plans and guidelines around the world and it influenced others. And it’s still cited frequently and when you look at it, it’s just a piece of bad research. It’s a lot of bad scientific, methodological flaws that shouldn’t have ever been published. So that’s been one of my goals to sort of make sure that that becomes more widely known.

 

In the UK, there has been a debate about the PACE-trial at the Westminster Hall. What is that about?

Yeah, so a Scottish parliamentarian Carol Monaghan — she had a constituent in Glasgow or near Glasgow who was sick with M.E. that she met with earlier this year. And she got interested in the issue so she organized a couple of debates in Parliament. Debates are just where you raise an issue. You get together and discuss it. Usually other members of Parliament who are sympathetic come. The government provides a response. Anyway, she has the second one. She referred to it actually as one of the biggest medical scandals of the 21st century. So there’s already now Parliamentary interest in what happened with the Pace trial because it was a lot of money –five million pounds of UK government money– that went into this. So there’s some interest now. What was it all about? And was it worth it? And what’s going on?

 

You’ve sent an open letter to the Lancet with signatories from over 100 scientists, clinicians, and patient organizations. It seems like the outside world is finally starting to take notice?

So yeah the open letter which I organized this past summer, in the last few months – The Lancet was looking for a fully independent investigation of the data from the trial and in the most recent time–I posted it and sent it three times. In the most recent time there were more than 100 experts and scientists, clinicians, and so on and 10 members of Parliament and also 70 patient organizations from around the world. I think that’s definitely a sign that not just patients but the international scientific community is expressing its opinion about this trial and that it doesn’t like this trial it thinks it’s a bad trial. The Lancet has not responded. You know they don’t seem to have a problem with the trial but they’re really at this point up against a growing number of internationally recognized experts who basically just disagree with them and see that the trial is a piece of garbage.

 

CBT/GET proponents criticize the focus on the PACE-trial. Why don’t you agree with that?

Right, so one of the main defenses now of the Pace trial is not that Pace was a great trial but that other studies have found similar findings. And especially people reference the Cochrane reviews which is sort of systematic analyses of a lot of studies and they come up with the same findings even if you take Pace out of those reviews. The problem with that argument is that even though Pace had certain unique problems that I haven’t seen elsewhere, all the studies in this field or most of the studies have similar problems. The main problem is that they use a very broad case definition which basically means that a lot of the people in the study might not have M.E. or Chronic Fatigue Syndrome but they may have chronic fatigue for other reasons. And the second problem is that the studies rely on open label trials. In other words, everybody knows which treatment they’re getting or if they’re not getting treatment at all. And the responses are subjective. So in other words, the response is the outcomes. Or, how do you feel? It’s not that hard to figure out that if you give people the treatment and you tell them this treatment is going to make you better and then in six months you ask those people, do you feel better after the treatment? But [if] you don’t measure anything objectively, more of those people are going to say they feel better than people who didn’t get a treatment that they’re told is going to make them feel better. So that’s the entire structure of all these studies and there’s a reason why other fields of medicine no longer really take evidence based on unblinded studies that rely on subjective outcomes. It’s just not a valid way to do science. In terms of the studies that were looked at for… about CBT and GET before the Pace trial did it, it’s true that the Dutch investigators have a long history of investigating both of these treatments for this condition. And it’s also true that their studies suffer from the same kinds of problems as the studies done in the UK. Basically they‘re open label trials. That means everybody knows which treatment they’re getting and they rely on subjective outcomes. And when the Dutch studies have had objective outcomes, when they’ve measured how far people have moved by using pedometers, those findings actually do not show that people moved any more. Even at the same time as they’re reporting that they feel better and can do more. So there’s a big question with any of these studies, including the Dutch Studies, as to whether these subjective self-reported benefits actually measure anything other than people’s desire or people’s you know wish to say that they’re doing better and to feel better.

 

You’ve recently written about FITNET-NHS which is based on a Dutch trial. What was wrong with the Dutch version of FITNET?

In the UK they’re now doing a trial called FITNET-NHS which is providing online Cognitive Behavior Therapy to children or adolescents with M.E. or CFS and that was based on previous Dutch study also among kids of this online Cognitive Behavior Therapy. That again had the same problems as the other studies. It was an unblended trial and the outcomes were subjective, essentially. They also had going back to school but let’s put that aside for minute. The problem is … they did that study. One of the problems with that study is that they compared it to treatment as usual. In the Netherlands, treatment as usual at this point is Cognitive Behavioral Therapy and Graded Exercise Therapy. And the people who got those treatments did very poorly. The investigators never actually explained why the online CBT people did so much better than people who got what was supposed to be the treatment standard of care which is in-person CBT and GET. One theory they never considered is that maybe the children who stayed home didn’t have to run around town going to interviews. So they actually didn’t get pushed into relapses as often as other children in their study. When you do study you need to consider reasonable explanations for your alternative, reasonable explanations for your outcomes. I think it’s a very reasonable to assume that the children who were not made to go to in-person interviews got more rest and maybe did better, if they did better, because of that. And one other point about that study–that study claimed recovery but it had a post hoc definition of recovery. In other words, they looked at their findings then came up with their definition of recovery. That’s not a good way to promote recovery. You have to actually say what your recovery thresholds are if you want your recovery findings to have any robustness. You have to say before you do your study what your criteria for recovery are. You can’t look at your findings and then post hoc, say–Oh, was that recovery? Because we’re putting the thresholds here.

 

The Dutch Health Council report has recently been released. What has been your overall impression of the report?

The Dutch Health Council had a panel that looked at all the data and studies. And it was very contentious and controversial. And the report that came out basically said that Graded Exercise Therapy should not be offered in the Netherlands. We don’t recommend Graded Exercise Therapy in the Netherlands. And it was much more equivocal [on] cognitive behavior therapy. It was kind of, well, maybe, and so on. And it bears [keeping] in mind that Cognitive Behavioral Therapy is a little more complicated in a way. Because cognitive behavior therapy normally, if you have a serious illness, you might get cognitive behavioral therapy to help you adapt to your horrible illness. If you have M.S. or cancer or Parkinson’s you might get it as well as an adaptive help, you might get Cognitive Behavioral Therapy. In the Pace trial and in the theoretical formulations of the Dutch investigators as well, the Cognitive Behavior Therapy [was] specifically designed to alleviate you of your unhelpful beliefs about having a medical illness. So in other words it’s supposed to … the presumption is that you’re somewhat deluded about your own medical state. And you think you have an illness and you have unrealistic ideas about the illness. And you have to sort of alleviate yourself of those so you can get back to your normal life. That’s why what they’re offering here is not regular CBT. I think that’s why nobody wants to say CBT is bad because for someone with a serious illness it can be very good. It’s just not going to cure your illness or make you recover from your illness which is mainly the claim that these investigators have made.

 

The NICE guidelines are up for a full review. One of the studies that was presented by the stakeholders was a Dutch study called FatiGo that has been reviewed by Dr. Mark Vink. There was again cherry picking going on and the objective measures were dropped in the end results. What’s up with that?

There’s a question of what’s appropriate science with a lot of the studies in this field – in the M.E. field or CFS field. Especially with these groups of researchers. There have been a number of studies. They traditionally you want to have objective study findings as we talked about because self-reported findings are just not that valid. It’s hard with this illness given that there’s no blood test, there’s no biological measures that we have at this point that can be used for diagnostic or for testing purposes. We have to find some other ways to measure biological– as a measure of objective measures. So some of the ones that have been used are — do people get back to work? How far can they walk? How fit are they? (measured by doing a step test). And one of the ways that has been used in Dutch studies as we mentioned is the use of a pedometer to measure in the week at the end of treatment how far people have moved in the course of a week. Those three studies–I think all of them are Dutch and I think the key goal might be one of them–have all shown that there’s no difference. But the people are not – they’re making statements about their subjective health that are not corresponded to by the fact that they moved more. So we really have to question whether there are any objective findings for any of these studies. The Pace authors also basically dismissed their objective findings as not objective after all once they didn’t actually work out to prove that people were getting better. Then they just relied on the subjective findings. This is a big problem in science. If you write a protocol and you do a study and you promise in your protocol you’re going to provide XYZ subjective findings and XYZ objective findings, it’s completely improper to just report the best findings and withhold the ones that would cause people to raise questions about your results. And that’s what is done routinely in this field of research by the Dutch investigators and by the British ones. And it’s disgraceful as a matter of science.

 

What do you think of the British General Medical Council refusing to take action against PACE-researchers?

There’s been a lot of – a number of complaints to the General Medical Council in the UK over the years about the conduct of the Pace trial. Or maybe there haven’t been. There’s been a number of complaints to various bodies. I know that there is an ongoing complaint to the General Medical Council and I’m not sure… I know that it’s been rejected and I think it’s under appeal by Dr. Myhill who’s the one pursuing that. You know I think without commenting on the specifics of her complaint, I do think there needs to become sort of investigation. I think there’s a lot that’s gone wrong with this trial and a lot of taxpayer money spent and a lot of really anti-scientific ways in which the study was conducted. And I think somebody needs to–there needs to be some sort of investigation and somebody needs to be held responsible. Or you know it has to be explained. How could this have happened if the whole thing is a total disaster and a total waste of money? And I think the researchers should be asked or called to account for that in some way.

 

Do you think that Peter White, Michael Sharpe and Simon Wessely will ever apologise to people with this disease for the agony and sorrow they have caused?

As regards the Pace investigators, Michael Sharpe and Peter White and their friend and colleague Simon Wessley, I have a hard time understanding what’s going on with them. I assume that they believe they’re doing good science and that they’re doing the right thing. I have to believe that. They’re wrong but I’m not sure how they would be behaving this way if they actually realized how bad their science was. I’ve tried not to, you know, think about what people’s motivations are or whatever. I really tried mostly to focus on the science and whether, you know, whether it seems to be warranted or good science or not. You know I can’t say what they think. I think they think that they’re doing a good job and that they’ve helped people and they probably think that I’m [?] you know harming patients. I would guess but I don’t know. I know they think that if we take these treatments away then patients will be harmed. They seem to have said that so I don’t really know what’s going on in their minds and I prefer not to really speculate.

 

You had interviewed survivors of the Outbreak in the London Royal Free Hospital. When will that be published?

I’ve done a couple of interviews with two people who were the patients in the Royal Free Outbreak which was in the mid-1950s. I have a lot of stuff I’ve done that I just haven’t gotten it together just timewise to do. So I do hope to write those up. I should do that … but I don’t have any timeline, you know, for doing that. One of the interesting things about that was that one woman that I talked to who was –she’s a retired GP– she’s I guess 86 now something like that. She got sick towards the end so she was patient number 234 as she remembered and they were you know in the two upper 200s. I think over–I can’t, I forget the total number. So by then they already knew that people who went back to work too soon relapsed. So they put her to bed for six months and didn’t let her come into work at all nothing and she just rested. And she never really had another thing of anything. So she thinks maybe that she got the right treatment because she came towards the end and they knew to make her rest. And she sort of rested it off and she’s had a couple of little things here and there but nothing that ever made her think she actually had a lifelong case of M.E. So that was an interesting thing to find out.

 

What has been the most rewarding part of your journalistic work for ME?

So there’s been a lot of rewarding aspects of this work as a journalist and as a public health person. You know, often you’re writing about stuff and you don’t necessarily know if it’s having an impact or you write journal articles and nobody reads them. Or even write newspaper articles which I’ve done a lot of my life. And someone reads them and whatever but this is a project where I really feel like people have felt that I’m helping them. I hear that a lot and so that it’s largely what’s inspired me to continue doing it. You know, nobody outside the field really has any idea what I’m doing because they don’t understand it and …. It’s a very rewarding project just because I feel like I’m helping people and it’s really interesting too. I mean it’s been very interesting watching an entire field of science built on nonsense. It’s just–it’s craziness and… I keep really seeing a lot of comparisons between Trump, my president, and the kind of insanity reality he tries to create. And the PACE people it’s like they’re just saying up is down and black is white just like the President of the United States. You know the logic is very parallel or the bad logic is very parallel and I kind of constantly–it’s very weird– I’m constantly seeing, I’m going back and forth from the UK often in the US and I see the parallels between. You know ridiculous claims made by the Pace authors and Donald Trump tweeting something ridiculous out.

 

Has this whole trajectory changed your opinion of science and of scientific integrity?

It’s made me think that it would be nice if there were some scientific integrity, actually. I’ve been really kind of shocked. You know, my father was a doctor and I grew up with medical journals around the house. You’re a reporter, you’re also sort of taught, Oh, well, if something’s published in peer-reviewed journal, that’s sort of a bar … a threshold of where you can start to assume it’s true. In a in a sense I mean nothing’s really true ever because it can always be unproven. But that you can take it with a certain measure of veracity that that is a true finding if it’s in The Lancet for example which is one of the premier medical journals. So the fact that not only did they publish this bad stuff but that once you start pointing it out you get treated like you’re an insane person. And you get threatened with being called libelous and you get–you have people complaining to your university. I mean I’ve had complaints to Berkeley about my work. When all I’m doing is criticizing bad science so I find that really shocking that academics can behave in a way. And then you can point out to them that hey, in this study people could be recovered on a main outcome measure at baseline that automatically disqualifies the study. You can’t then say well, it doesn’t matter but that’s essentially what all the journals have done. It’s really incredible and it’s really shocking. And yeah, it’s really disturbed me in away and you know I’m not sure what I can believe now what I read in medical journals. Or certainly not what I read about this illness. I have to think in other fields of illnesses they’re doing a better job.

What are the major changes you have noticed in recent years, both positive and negative?

So there have been some changes in recent years I think you know. Obviously in the US the Centers for Disease Control removed CBT and GET from its recommended treatments for the illness which is a big step. The press is obviously getting more aware. And I think there’s been even in the UK– I think in the U.S. we’ve had some better press for a while but even in the UK there’s been better press coverage in the last year or so. I think the open letters that I put together have helped. I think once the investigators were forced by a court order to release, or by their university–Queen Mary University of London– was forced to release the raw trial data and have got reanalyzed in a paper that was published this past spring. I think that also showed that not just patients were claiming that the findings were bogus but that the reanalysis showed that if you re-analyzed everything according to the original protocol it really didn’t get much in the way of findings. And that everything that they published was basically manipulated data made to look better by making changes to your outcome thresholds which you cannot do in good science.

 

You clearly care a lot about the fate of these patients. Besides correcting bad science, what has been the driving force to keep pursuing this work so passionately?

So I’ve kept pursuing this for a number of reasons. One it’s just been a fascinating story. It’s not that often that you get as a journalist or someone in public health that you get to sort of smack down a Lancet paper. So that’s been professionally very rewarding. Also as I said — I get emails and I get messages from people telling me that it’s helping them. And this also keeps me going. As people know I crowdfunded to continue doing this. So at this point I mean I have a financial obligation to keep doing it at least till next summer. And then… but I mean I feel nobody else is … Again as a reporter or someone [in] public health you like having something that people aren’t really looking at and in terms of [this] as a reporting thing it really hasn’t been something that more recently anybody’s taken on. Now Hilary Johnson in the 90s was reporting on this way back when … 20 years ago. She is still reporting on it but it’s not something that anybody’s really looking at in a big way. So I’ve been able to do that to some degree and that’s been very nice to be able to do.

 

What are your future plans for the next coming years?

So my future plans– I’m only planning right now until next June 30th. I crowdfunded, just the second year, I crowdfunded to do this for a year. So for the next period of time I have a batch of other things I’m trying to write about. I’m trying to keep up with some of the science. I’m trying to keep up with the NICE guidelines and what’s going on in the US and people’s disability and all this kind of stuff. So I feel like I’ve got way too much to try to think about doing. And I’m also trying to work on couple peer-reviewed papers so that also takes time. So you know I’ll keep doing this and then I’ll figure out at some point in the spring if I’m going to keep doing it again for another year– if there’s the need for that. You know, where things are at that point.

 

Any final words?

So one thing I wanted to say is that sometimes people ask me why I am even working on this. It’s not something that you get a lot of… People don’t know about it. You mention chronic fatigue syndrome, you can sort of see their eyes roll in their head and they’re kind of like already bored. And you know it’s not something you want to necessarily… talk about a cocktail party…Like, oh you know — but… it’s a challenging thing. And that’s reflected in how editors respond if you try to pitch articles about it too. So it’s not something that… Certainly there’s no public health… when I was you know at public health school, you know… at Berkeley nobody’s researching it. Nobody knows about it. So it’s something that I felt I kind of stumbled into just because of a friend who was sick. And I started looking into it and I really–it’s been a great privilege for me to be able to work on it. And to be able to… if what I’ve done is give people hope then that’s really an amazing thing. And I really — that means a lot to me so those are reasons why I’ve kept doing it also.

 

Interview 2017:

PACEman

Anil van der Zee

Former professional ballet dancer, teacher, aspiring choreographer & photographer.
Currently life on hold; Myalgic Encephalomyelitis.
Blogging out of necessity.

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