Post Twenty Two. Reblog. An Interview with Dr David Tuller.

A while ago, I can’t remember in which post, I said that from time to time I would be highlighting other articles about ME that I think are worth sharing. This is one of those.

Anil van der Zee is a professional ballet dancer, he 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 contracting a viral infection, and never fully recovered. A few years later he was diagnosed with ME.

I can’t remember how I discovered Anil’s blog, I think on Twitter, or maybe one of his posts was shared in one of the ME Facebook groups that I’m in. But of all the ME blogs I’ve come across, his does stand out. He clearly does a huge amount of research, his posts are very well informed, and educational, for ME sufferers and non-sufferers alike.

In Anil’s most recent post, he interviews Dr David Tuller, an American journalist who has been instrumental in my understanding of the controversial PACE Trial (I wrote about the PACE Trial in Post Seventeen. The PACE Trial Scandal.) A few years before I became ill with ME, Tuller covered the PACE Trial results for The New York Times as health editor. However, he became concerned about the trial and wrote a further article regarding case definitions which resulted in an immediate response from the PACE Trial authors which resulted in him investigating the trial and its authors further after contact with others in the patient community. Tuller is sympathetic toward the cause of the ME patient community. In an article in 2015 he wrote: “In the course of my reporting, I’d realised that the disease was both devastating and widely misunderstood. People were really, really sick – some were homebound for months and years at a stretch. Yet their condition had been saddled with one of the most condescending names ever given a major illness.”

This interview by Anil offers an excellent overview of the current political climate that we, the people with ME, find ourselves in. He has kindly allowed me to share the post here, and it is my hope that it will aid my reader’s understanding of the horrific injustice that ME sufferers face. It makes me angry, and I want it to make you angry too. Angry people take action.

 

David Tuller and the (s)PACE cake eaters, by Anil van der Zee, Published December 26, 2017

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.

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.

To read the rest of the interview please follow this link to the original post, and while you’re there I’d recommend that you take a peek at his previous posts.

http://anilvanderzee.com/david-tuller-and-the-space-cake-eaters/

David Tuller’s Virology Blog. 

In the spring of 2017, Tuller successfully raised money in order to continue investigating and blogging about the PACE trial and and other issues related to ME. The funds raised went to the Center for Scientific Integrity who transferred them to the School of Public Health at University of California, Berkeley, which in turn created a position for Tuller to continue his investigative work.

To read his posts related to ME please follow this link. I’d suggest you scroll down and begin with his first post from 2011.

http://www.virology.ws/mecfs/

For a bit more background about Tuller, and for more of his articles, check out his entry in the MEpedia site.

http://me-pedia.org/wiki/David_Tuller

Post Seventeen. The PACE Trial Scandal.

I have been wanting to write about The PACE Trial for some time, about the background, the controversy and where we are at today. I have tried, but unlike my usual posts it is very technical, involves a lot of research and there’s a lot to cover. I just don’t have it in me, with my brain fog and inability to really concentrate, it’s just too much. Luckily, this morning, a UK newspaper published a really informative and accurate article on the very subject, basically, the journalist in question, Jerome Burne, has done my job for me.

This article was in the most surprising place, The Daily Mail Online. Not only did The Daily Mail publish a good article about ME, but they referred to the illness as Myalgic Encephalomyelitis (ME), this is actually quite ground breaking stuff. Most mainstream articles refer to it as Chronic Fatigue Syndrome (CFS), which isn’t officially inaccurate per se, but CFS is, on the whole, very misleading. For the uninformed, it implies that this illness is simply ‘fatigue’, it perpetuates the myth that we are ‘just tired’. I can’t think of any other major illnesses that are named after only one of their symptoms. A symptom of Multiple Sclerosis is fatigue, but it isn’t called Chronic Fatigue Syndrome. A symptom of Lung Cancer is coughing, but it isn’t called Chronic Coughing Syndrome. A symptom of Alzheimer’s Disease is memory loss, but it isn’t called Chronic Forgetfulness Syndrome. I think you get my point.

What’s worse than CFS, is when it is referred to as ‘Yuppie Flu’. This stems from a ME outbreak in the 1980’s, when it was seemingly mainly young professionals who became unwell with ME, and the term ‘Yuppie Flu’ was born. It is derisive, outdated and offensive, yet it is still frequently used in the reporting of ME. A recent article in The Telegraph actually used ‘Yuppie Flu’ in their headline. Thankfully they changed it shortly after publication, realising how offensive it was (after a lot of complaints from the ME community). You might think that these things shouldn’t be that important, that we are using our limited energy on the wrong battles. That we (people with ME) should be grateful for any scrap of exposure thrown our way. No. These things matter. Language matters. The words we speak have meaning, and impact. When reporting, in the science section of a national newspaper, on a serious health matter, the language used should not reduce the health matter in question to a joke.

The PACE Trial (short for “Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation) is, essentially, a medical scandal, not dissimilar to the Andrew Wakefield MMR vaccine controversy. The PACE Trial has impacted on every single person with ME in the UK, and beyond. It is the basis on which the NHS ‘treat’ ME, and due to the influence of the trial’s authors, it impacts heavily on the funding of ME research, which in the UK, is poured into psychiatry, rather than much needed biomedical research. Misconceptions were already there, but The PACE Trial, and the psychiatrists connected to it have actively encouraged the media, the government, medical professionals and the general public to believe that ME is a psychological illness. That it is ‘all in our heads’, that we don’t have an intolerance to exertion but ‘false illness beliefs’, that we have somehow, collectively, all 17 million of us, falsely convinced ourselves that exertion is harmful. In fact anyone with ME could tell you exactly how exertion, both mental, emotional and physical impacts on our bodies. I really don’t understand how it could be ‘false illness beliefs’ that cause my shoulder joints and muscles in my arms to hurt, to the point of tears, after a twenty minute (hands free) phone call. The damage that The PACE Trial has done/is doing to us is immeasurable. The trial has been widely debunked, but until it is officially retracted, the damage will be ongoing, in actual fact, the damage will probably live even after it is retracted.

Anyway, back to the article by Jerome Burne. He did such a good job, and I’m incredibly grateful to him. It’s one of the best articles on this subject that I have read. I have copied the article below, with a link to the original article (just click on the headline to take you to The Daily Mail website). Throughout the article I have added some additional information, and some of my own thoughts, you’ll find these in brackets in blue text.

Why are doctors and patients still at war over M.E.? How the best treatment for the debilitating condition is one of the most bitterly contested areas in medicine

By Jerome Burne for The Daily Mail. 15 August 2017.

Myalgic encephalomyelitis (ME) is a debilitating condition that can leave those affected bedridden for years. It’s linked with as many as 60 symptoms, the most common being a feeling of constant exhaustion — ‘like a dead battery’. (Yes this is a common symptom, but not the defining symptom. The defining symptom is post exertional malaise, an intolerance to exertion, which causes symptoms to flare after the activity. ‘Dead battery’ however is a good description of the exhaustion. The exhaustion is less ‘feeling tired’, but more a severe lack of energy, or severe weakness. I have experienced tiredness previous to having ME, I’ve had insomnia and sleepless nights for years. But it never caused me to be unable to lift my phone, my head, my toothbrush…)

The condition first reached mainstream consciousness in the Eighties following outbreaks in New York and Nevada. By then it was officially known as chronic fatigue syndrome (CFS).

For a time, it seemed everyone knew someone who was affected by it, and it was derisively dubbed ‘yuppie flu’ because it seemed typically to affect young professionals.

For years there’s been a long-running and bitter debate between doctors and patients about its cause and how to treat it.

The lack of a clear physical cause meant many doctors dismissed it as all in the mind. This infuriated patient groups who insisted it was all too real and the result of an infection or immune system failure.

Even now, when it is generally accepted that ME/CFS is a genuine condition, it remains one of the most angrily contested areas of medicine. But the battle lines are no longer drawn just between patients and doctors: the medical community itself is at loggerheads.

The issue: the best way to treat ME. This has huge significance for the estimated 500,000 people in Britain affected by it. The official NHS treatment for their condition is delivered by psychologists and involves a combination of cognitive behavioural therapy (CBT) and graded exercise therapy (GET) which involves doing a little more each day. (Interesting to see the estimated figure as 500,000 rather than the usual 250,000. I learned recently that the ‘250,000’ figure was actually estimated around 30yrs ago, so of course this number has grown.) (As well as providing little benefit, GET is actually harmful and dangerous. This ‘treatment’ has caused many people with ME to experience a severe and often permanent worsening of their symptoms, and has, in some cases, lead to death.)

The idea is that doing regular aerobic exercise would help patients a lot, but that they are held back by ‘fear’ of activity: the CBT is meant to overcome this. (Using CBT to alleviate our alleged ‘fear’ of activity is of course nonsense. I did however find CBT useful in terms of helping me to cope with this huge life-altering diagnosis.)

Many patients and doctors claimed this combination provided little if any benefit.
This dispute has now broken out into the public arena in an extraordinary fashion. Two weeks ago the Journal of Health Psychology published what was effectively an attack on the official NHS treatment. (You can find the journal online here ‘Journal of Health Psychology, Volume 22, Issue 9, August 2017. Special Issue: The PACE Trial‘)

Three editors resigned from the journal in protest at this stance. In a leaked email, one of the resigners was described as a ‘disgusting old fat neo-liberal hypocrite’ and an ‘ol’ sleazebag’ by an editor who supported the journal’s approach.

But the insults swing the other way, too — recently, a scientist described patients critical of the CBT approach as ‘borderline psychopaths’ and likened them to animal rights activists. (Remember, these are professional scientists who are referring to the very people they claim to be ‘working for’ as ‘borderline psychopaths’, simply for questioning their claims.)

The row is about a trial published in The Lancet in 2011 that helped form the official guidelines on treating the condition. This was a large trial, called PACE, involving 641 patients, costing £5 million. It was paid for by the Government and carried out by psychologists at Queen Mary University in London. (Interestingly the trial was also part funded by the The Department for Work and Pensions (DWP), the only clinical trial they have ever funded, I believe. Could it be that The PACE Trial was less ‘science’ but more a cost cutting exercise for the government? With the aim of reducing benefit and insurance claims? It is in fact not at all uncommon for the DWP to turn down disability benefit applications from people with ME who refuse CBT and GET…)

PACE found that patients being treated with the combination treatment — 14 sessions with a therapist over a six-month period — improved by 60 per cent, while the ‘recovery rate’ (which implied a ‘cure’) was 20 per cent. (It is worth noting here that the researchers changed, throughout the trial, what constituted as ‘improved’ and ‘recovered’, because they weren’t getting the results they wanted. Participants could end the trial being more unwell than when they started, yet they were still categorised as ‘recovered’. Also, they used the Oxford Criteria for diagnosis of the participants, as opposed to the Canadian Consensus Criteria. The Oxford Criteria is widely considered to be overly broad. It does not include the defining symptom of ME, post exertional malaise, rather, it lists ‘fatigue’ as the main symptom. So, did the participants actually have ME to begin with?)

“For every 15 patients selected under Oxford criteria, 14 will be false positives when compared to Canadian Consensus Criteria” me-pedia.org

(There is now an even more up to date clinical criteria for ME. The ME International Consensus Criteria, published in the Journal of Internal Medicine in 2011. This is an update of the Canadian Consensus Criteria, which was published in 2003. You can read more about The ME International Consensus Criteria in my blog post, Post Seven. Symptoms)

But a new analysis of the data has suggested that patients experience just a 20 per cent improvement, and only 5 per cent are classed as recovered. (Would a pharmaceutical drug with such low odds for improvement or recovery be approved as an NHS treatment?)

‘This has cast serious doubts on the recovery rates being claimed,’ adds Dr Charles Shepherd, honorary medical adviser to the charity the ME Association (Dr Shepherd was also a member of the Chief Medical Officer’s Working Group on ME/CFS and the Medical Research Council’s Expert Group on ME/CFS research).

‘The trust of patients has been lost. PACE needs to be withdrawn.’

In fact, patient campaigners have been claiming for years that the psychological approach is profoundly wrong because it implies the problem is the way the patient thinks about it. They consider that they’re suffering from a physical disorder.

The re-analysis of the PACE data has set the cat among the pigeons. A challenge to evidence supporting a NICE-approved treatment is unusual, not least because the data was only made available after a protracted battle by patients.

Ever since its publication in The Lancet, the PACE trial had been questioned by patient groups. They wanted to see all the data the trial had gathered to check the statistics.

For five years patient advocates and some doctors sent letters and Freedom of Information requests to the researchers — Professor Peter White (of Queen Mary University of London), Professor Michael Sharpe (Oxford University) and Professor Trudie Chalder (King’s College London) — without success.

Grounds for refusal included risk of revealing patient identities and claiming the demands to hand over the data were vexatious or a form of harassment.

Indeed, one expert witness for the researchers drew parallels between these ME/CFS ‘activists’ and animal rights groups, suggesting there was a serious risk of violence to researchers if the data was released. But then the Information Commissioner’s Office became involved and the university was ordered to cough up the data. It refused and then spent more than £200,000 to have the order dismissed.

This was rejected by a tribunal (as for the claim of threats being made, under cross-questioning the expert witness admitted there hadn’t been any). (The witness lied about the ME community threatening them. There have been no threats.)

When the trial data was finally re-analysed and checked by two independent academics, Philip Stark, a professor of statistics at the University of California, Berkeley and Professor Bruce Levine from the Department of Biostatistics at Columbia University, it ‘revealed that the study contained little evidence that CBT and graded exercise add anything to standard medical care in terms of patient recovery’, according to Professor Levin.

This was backed by Jonathan Edwards, an emeritus professor of connective tissue medicine at University College London.

‘The results of the re-analysis shows that the call for access to the PACE data for independent analysis was justified,’ he said. ‘It confirms that this study failed to provide reliable evidence for useful, sustained benefit from either CBT or graded exercise therapy.’

Sir Simon Wessely, Regius professor of psychiatry at King’s College London, has long been identified with the psychological approach. When he was asked about the data re-analysis last year, he was quoted as saying: ‘OK folks, nothing to see here, move along please.’ (He is unable, or unwilling, to back up his data, or to provide any evidence.)

He added that patients did improve and that the treatments were moderately effective. (Again, he has nothing to back up his claims.)

ARTHRITIS DRUGS MIGHT HELP

The Journal of Health Psychology gave the original researchers the right to respond to the criticisms — they said they stood firmly by their findings, and that ‘the PACE trial… along with other studies provide patients, healthcare professionals and commissioners with the best evidence that both CBT and GET are safe and effective treatments’.

But what about the ‘biological’ theories of ME/CFS and the new research published recently suggesting a link with raised levels of molecules linked to inflammation?
Commenting, Dr Alan Carson, reader in neuropsychiatry at the University of Edinburgh, said what wasn’t clear is whether a higher level of these molecules ‘necessarily make you feel worse’.

He added: ‘It’s highly unlikely it will lead to a blood test any time soon.’

Yet Professor Edwards, who has described the PACE trial as ‘poorly designed, poorly executed and inappropriately interpreted’ believes that studies are needed.

‘Here in the UK we’ve spent far too much on the psychological aspect,’ he says.

‘Understanding the biology is what’s going to lead to an effective treatment.’

Professor Edwards, a rheumatologist, has previously found that patients with ME/CFS as well as rheumatoid arthritis reported great improvement when they were treated with the powerful anti-inflammatory drugs used for their arthritis. A trial of this is now under way. (This drug is called Rituximab. It is used to treat some autoimmune diseases and some types of cancer)

Meanwhile, PACE continues to have support among psychiatrists and psychologists. It seems unlikely that it will be withdrawn, and so the struggle between the doctors and patients continues.

UPDATE: COULD IT BE CAUSED BY INFLAMMATION?

At the heart of the issue is what causes ME. Patient activists and some doctors consider it a physical disorder.

This ‘biological’ theory appeared to be reinforced by recent research from Stanford University in the U.S. that identified a new set of ‘messenger’ molecules in the blood that are part of the immune system and behave differently in ME/CFS patients. (You can read about it here ‘Researchers identify biomarkers associated with chronic fatigue syndrome severity, Stanford Medicine News Center‘)

New, sophisticated equipment allowed a team to run a very detailed analysis of the blood of 192 patients, comparing it with nearly 400 healthy people. They found that immune system messenger molecules (cytokines) that trigger inflammation and produce flu-like symptoms were higher in patients with the most severe symptoms.

An independent expert, Gordon Broderick, a systems biologist at Rochester General Hospital in New York, commented that it was a ‘tremendous step forward’.

~~~

Again, I’d like to thank Jerome Burne for writing this article. It means a great deal, and it brings me hope when ME is reported in the mainstream media in such a fair, balanced, accurate, informative and sympathetic manner. More articles like this will help to change the general perception of ME and hopefully result in this debilitating illness to be taken more seriously.

 

Further Reading

PACE Trial, MEpedia

The Making of the PACE Scandal, Centre For Welfare Reform

The PACE Trial: The Making of a Medical Scandal, The ME Association

‘No confidence’: Charities reject NICE ‘no update’ proposal for ME/CFS guideline, VADA Magazine

Getting It Wrong On Chronic Fatigue Syndrome, The New York Times

Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back, STAT News

How a study about Chronic Fatigue Syndrome was doctored, adding to pain and stigma, The Conversation

James Coyne “lays waste” to PACE trial in Edinburgh, Phoenix Rising