The Man Who Changed ME/CFS Treatment Recommendations

This interview with ME/CFS “knight in shining armor who rode to the rescue” was initially posted on Anil Van Der Zee’s eponymous blog.  Anil was born in Sri Lanka and grew up in the north of Holland. He studied classical ballet at the Royal Conservatory in The Hague before working in several ballet companies in the Netherlands and Switzerland. In 2007 he became ill after a viral infection and never fully recover. A few years later he was diagnosed with Myalgic Encephalomyelitis.

David Tuller and the (s)PACE cake eaters

In 2015 David Tuller, DrPH, a Senior Fellow in Public Health in Journalism at the Center of Global Public Health, School of Public Health at Berkeley University started writing 3 very detailed blogs about the flaws of the now infamous PACE-trial. The patient community has been advocating for years, if not decades against these types of trials of Cognitive Behavioural Therapy (CBT) as well as Graded Exercise Therapy (GET) for ME in general as they seem to be doing more harm than good. Unfortunately, they were mostly dismissed as militants and “vexatious”. They were not being heard or believed. That has dramatically changed since Dr. David Tuller started writing extensively about the subject. A real paradigm shift is happening and I’m beyond honored to have been able to meet him, photograph him and ask him a few questions.

David TullerPhoto by Anil Van Der Zee

Hi David, how are you? Thanks for letting me interview you. For the people who are not familiar with the subject, what is the PACE-trial and why is this trial such a big deal?

The PACE trial was the largest study of “treatments” for what the investigators called chronic fatigue syndrome. The investigators claimed it “proved” that CBT and GET were effective treatments for the illness. Given these alleged findings, the trial has had an enormous impact on what is considered the standard of care in the U.K., the U.S, the Netherlands, and many other countries. Yet the study is so flawed, it includes so many violations of core principles of scientific research that its reported findings are completely meaningless.

What was the reason you decided to start writing about the PACE-trial unlike many of your journalist colleagues? Many are reluctant to write about ME in general.

I started reading the patients’ commentaries about PACE and realized that they were right about the flaws in the trial. I understood why others weren’t interested—it’s very confusing to figure the whole thing out. As a journalist, it’s great to have a topic others aren’t covering, and no one was writing about this. I felt if I started looking into it, I could have an impact on the debate.

Could you explain what the main issues were with the PACE-trial?

There were so many issues, so it’s hard to pick just one! Probably the biggest issue is that they have been very explicit in their protocol about how they planned to measure success. But they changed the main outcome measures after collecting data, and all the changes allowed them to report better results than had they stuck to their original methods from the protocol. Then they refused to provide the analyses that they originally promised to provide so no one could tell what the results would have been had they not changed all their outcomes. When patients asked for these anonymous data, the investigators accused them of being “vexatious” and refused. They only did so after being ordered to do so by a legal tribunal.

What were the results of the reanalysis?

The authors themselves published a reanalysis for their measure of what they defined as “improvement.” The published study reported around 60 % “improvement” with CBT and GET. In the reanalysis, only about 20 % “improved” with these therapies, while 10 % “improved” with the comparison arms. That 10 % difference is most likely due to bias because the two therapies include telling patients that these treatments will make them better. Those in the two comparison arms were not told they would get better.

post trial PACE changes

An outside group reanalyzed the findings for “recovery.” They found that the “recovery” rates for the CBT and GET groups fell from 22 % to single digits. The “recovery” rates for the comparison arms were also in the single digits, and there were no statistically significant differences between the groups. In other words, by dramatically weakening their outcomes, they managed to report in the peer-reviewed “recovery” paper that people had “recovered” when in fact no one had, according to their original measures.

What are the biggest flaws in these type of trials? What is wrong with the model that is being used?

The biggest flaw is that they are conducting open-label or non-blinded trials while relying on subjective outcomes—in this case, the outcomes were self-reported questionnaires about physical function and fatigue. An open-label trial means everyone knows what treatment they’re getting. And if the outcomes are subjective, as in this case, they are always subject to significant bias—especially if the treatment arms include telling participants that they will improve with these treatments. In PACE, they had several objective outcomes—whether people got back to work, whether they got off benefits, whether they could walk farther, and whether they were more fit. All these measures failed to match the positive outcomes they reported for the subjective measures. Because of that, they dismissed their own objective measures as irrelevant or not objective after all.

Why have ME and the PACE-trial become so important to you?

I’ve seen the serious negative impact of this trial and its reported results on patients. No one except patients was really taking it on. I thought I could do something to help and demolish the credibility of the trial. I didn’t expect to keep doing this for more than two years, but it became clear that it would take more time and more reporting and more pushing to achieve the desired outcome—which is that the PACE trial and others from this cabal of “experts” are discredited and hopefully retracted.

No one would ever suggest that CBT can lead to “recovery” from Parkinson’s.

Why is ME, according to you, not a psychological illness or a behavioural disorder??

Well, I’m not a clinician or a scientist, so I’m not the one to determine what exactly is causing the illness. It’s just obvious that after 30 years of the CBT/GET paradigm, this approach doesn’t work. The science that is cited to show that it does work is completely bogus—as patients have always known and as I’ve tried to document over the last two years. So in effect, the researchers have disproven their own theory even while claiming their work proves it to be true. On top of that, many very, very smart people have found a host of physiological dysfunctions in patients that make a pretty definitive case that this is not a psychological or behavioral disorder.

CBT and exercise are recommended for other diseases, so why are they so vilified by the patient community and the ME experts?

Patients are not against CBT and exercise per se. CBT is used in many illnesses to help people adapt to their circumstances. And exercise or physical activity—even raising your arm five times from the bed, if that’s what you can do—is important for everyone. Patients object to the form of these approaches when used for ME. The CBT proposed by PACE is premised on the idea that the therapy will alleviate the patient of “unhelpful beliefs” about having an organic disease that gets worse with over-exertion. It’s not the same kind of CBT you get if you have cancer or MS. No one would ever suggest that CBT can lead to “recovery” from Parkinson’s. As far as exercise, it’s the “graded” part that is the problem—the idea that you should keep increasing your activity levels week by week, and that any symptoms are just normal reactions of the body because you’re deconditioned, not a sign that you’re making things worse. But since the core symptom of the illness is not “fatigue” but the relapses patients suffer after over-exerting themselves, then GET is clearly contra-indicated as a treatment.

In the US things are changing. There’s a real paradigm shift happening. Could you elaborate on this?

The U.S. Centers for Disease Control has removed CBT and GET from its recommendations for the illness. That’s a huge change. The NIH is finally spending more money for decent research—although of course not enough. But there is an acknowledgment now that this is a medical disease and that the patients have been poorly served by the longstanding neglect of government agencies. The change is slow and it’s far from enough, but it’s a big shift nonetheless.

quote-first-they-ignore-you-mahatma-gandhi

This is obviously amazing. Huge. Especially knowing your work has been instrumental in helping this movement shifting in the direction that it’s taking and it’s not only in the US. The same is happening in other countries, even in the Netherlands. That must be a fantastic feeling for you?

Yes, definitely. I feel really good about what I’ve done. But of course, others have played instrumental roles as well. I think I was able to help elevate the concerns patients were already expressing to a more prominent level and greater visibility among scientists not involved in the issue. So I sort of bridged a gap between patients and the academic world. Before it was much easier for the PACE team to make it seem like just crazy, anti-science patients were complaining and objecting. Now the conflict is scientists vs. scientists—and that’s a much better place to be. On the basis of the science, they will ultimately lose.

In the Netherlands scientists like Gijs Bleijenberg, Jos van der Meer or Hans Knoop still push CBT and GET as the preferential treatment for ME or rather CFS. They also claim that the PACE-trial was a one-off or that there is actually nothing wrong with it. That there is nothing wrong with the CBT and GET as a whole. Especially with the trials taking place in the Netherlands. Do you agree?

No, of course not. They are just blowing smoke out of their asses. Their studies are as bad as all the others.

So you feel that the Dutch trials, like for example FITNET contain the same flaws as the PACE-trial?

Not all the same flaws, but the basic design flaw is the same. These are mostly open-label trials relying on subjective outcomes. This design will always produce unreliable and biased results. The studies have also shown, with the use of actometers that measure how far someone walks, that the reported benefits from subjective outcomes are not matched by any improvement in this objective measure.

With everything that is currently happening in the US and honestly worldwide it seems very odd that these scientists still keep holding on to these beliefs. As a patient, I sometimes wonder if these Dutch scientists had a little too much space cake. Not the Potato eaters but the space cake eaters. Or in this case, the (s)PACE cake eaters because their claims are completely off. It’s based on smoke and mirrors. Science is moving on.

What do you think is the reason they keep coming up with these claims that are now going against the largest institutes in the world?

The s(PACE)cake eaters.

I think people are easily self-deluded. This is a paradigm shift. Those embedded or invested in the old paradigm will always have trouble giving it up, even in the face of overwhelming evidence. That’s what’s happening here, I think. If you’ve spent decades promoting a certain ideology or belief system, as they have, then acknowledging that this is fatally flawed is an overwhelming blow to their self-identity, ego, and so on. We’re asking these researchers to admit that not only have they been wrong but that their mistakes have harmed many people. That would be difficult for anyone. In that sense, I have some sympathy for them. I mean, not much sympathy, but I understand why what they have to do in order to do the right thing is a very, very difficult thing to do. They will probably keep believing that they were right even as the science tumbles all around them.

The Dutch Health Council is currently deliberating on new criteria and care for people with “CFS”. What would this report need to state in order for you to consider this a success?

It would need to do what the CDC did—remove CBT and GET from the recommended treatments. The problem is that people in health care don’t like to admit that they have nothing to offer. If CBT and GET are removed, then what treatments can take their place? We don’t really have anything yet. So I understand why that’s hard for those involved in making these decisions. Many people feel, well, better to offer something rather than nothing, and they might think these “therapies” are benign, so what’s the harm of keeping them until we have something better? But of course the recommended treatments are not benign, so they need to be removed even if something great isn’t available yet.

Professor Steve Lubet wrote a guest blog on the Virology blog about ME patients being militant. Do you feel ME patients are militant or are they simply fighting for their health and as professor Lubet mentioned are in fact pro-humanity, much like the gay community has battled against psychiatry at some point?

“Militant” can sound negative, but it’s not negative if the militancy is in service of an important cause. Of course, patients should be militant in insisting that they have not gotten the treatment they deserve. They are right to be militant, just as gay people were right to be militant about getting homosexuality removed from the list of psychiatric disorders.

Since you started writing, the discussion has shifted from patients vs.scientists to scientists vs scientists. It seems like portraying patients as militants is rather a distraction from any valid criticism?

Yes, of course, that’s the case. And it’s not just portraying patients as “militant” but as hysterical, crazy, anti-science, harassing, and death-threat-making. Of course, some patients have been so enraged that they might have expressed themselves in ways that we would prefer they hadn’t. But the PACE folks and their admirers have used that meme as a way of dismissing criticism they don’t like. They still try to do that, as Professor Esther Crawley has in her disgraceful presentations, but now it’s clear that this frame of the debate is not accurate.

 

https://youtu.be/6zWnVB_2lUU

In your “Tear it up” talk at the ‘Invest in ME conference 2017’, you mentioned how you always trusted the system almost blindly. How do you feel about that now? Some major scientific journals like the Lancet made some huge mistakes and have not yet cleaned up their act.

Well, I don’t know if I said I trusted the system “blindly”! If I did, I was probably over-emphasizing to make a point. I understood that studies had problems and often needed to be corrected and that various interests obviously would try to steer studies in their favored direction. What has shocked me is confronting an entire medical-academic establishment that absolutely has refused to acknowledge the flaws, no matter how obvious they are. I didn’t realize just how difficult it was to get journals to correct or retract what are clearly bogus findings, by any standard. That has made me much more skeptical about any studies I read.

In the conclusion of the reanalysis of the PACE-trial by Wilshire et al, they said the following: “The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments.”

Do you feel the medical community has been misled as much as the patients by these types of treatments?

Well, the medical community has certainly been seriously misled. Most doctors don’t have time to read all the studies and patient blogs and correspondence and all that. They see headlines or just get information filtered down through clinical guidelines or recommendations from NICE or the CDC or wherever. They expect to be able to rely on this information as sound. So I don’t blame clinicians who have adopted these approaches based on what they believed was authoritative evidence.

What needs to be done to rectify this?

Changes in clinical guidelines help a lot. The current NICE guidance is up for a full review. When that happens, it will have a big impact. But these organizations also must actively disseminate news of any changes. In the U.S., the CDC has done nothing so far, from what I can tell, to inform clinicians and medical organizations about the change in recommendations. They have been dishonest brokers, and they are still dishonest brokers. Officially, the CDC says it removed CBT and GET because people were “confused” about what the agency meant in recommending them. That’s just bullshit. They won’t admit that they made a mistake, backed the wrong science, and issued terrible recommendations. And as far as I know, they are not proactively reaching out to the organizations and medical centers that continue to recommend CBT and GET.

What are you hoping that will happen next? What should happen next? Where to “PACE” from here?

Getting rid of PACE and the CBT/GET paradigm is a necessary step but won’t make patients better. It will just prevent them from being recommended treatments that can be harmful. The real advances will come when the scientists now researching the physiological parameters are able to narrow in on accurate biomarkers and effective pharmaceutical treatments. I don’t know how long that will take, but certainly, it will be easier if the CBT/GET era is behind us.

David Tuller Pac manPhoto by Anil Van Der Zee. The PACEMAN t-shirt was a present from Anil to David for talking at the Dutch premiere of the documentary Forgotten Plague in Amsterdam.

I want to thank you for taking the time to answer these questions. I also want to thank you for coming to talk at the Dutch première of the Forgotten Plague in 2016 and the screening of Unrest in Leiden 2017. I was not able to attend either event but you were so kind to come and visit me in person at my bedside. I think that I can speak for everyone in the patient community that we are eternally grateful for what you’ve done and for what you’ve accomplished. I don’t think words can describe our gratitude…

Thank you, David Tuller, or how we like to call you by your alter ego superhero name. Thank you PACEMAN!!!

Anil van der Zee

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

You may also want to read:

ANSRewire helped me get to 80% recovery

People with ME/CFS exhausted at cellular level

How I conquered low energy and leaky gut

 

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