Nick Brown (good science star): My (current) position on the PACE trial

[Sasha]

I hope enough people care about it from a non-ME/CFS point of view, a open data point of view, to push for it to be released, but I worry that without having anything riding on it, the science community will just give up because of the strong resistance from the authors.

Would it be fair to say, @sTeamTraen, that this is the first big test of PLOS One's policy, and of the new open-data movement in general?

That is, does the science community have a lot riding on this, or just us?

 

[Simon]

First off, I was in touch with Nick Brown a few hours ago and he wanted to assure people sTeamTraem is him (apparently there have been issues in the past in the past in controversial areas).

I will be using the nickname "sTeamTraen" and I will wave to Marco in Cognac (from here in Strasbourg) in my post

So let me say that @sTeamTraen is Nick Brown - and welcome!

Again, per my post, I cannot be your ally in any committed sense, although you all have my best wishes

Delighted to have your contribution on that basis, your blog was extremely helpful in explaining many of the issues at stake here.

There is one tiny thing in Simon's summary of my post that I want to... correct? Clarify maybe. It's this:
>>Brown says he's working on the basis that claims by researchers of harassment are true.

I think I'd prefer to say that I'm working on the basis that the claims of harassment are not going to go away.

Apologies, corrected now.

Re 'malicious intent',

This is all about the everyday adventures of people who have to make their way through life while surviving the stupidity of a bureaucracy

I think that depends on how we interpret things. Certainly I believe they now know PACE is seriously flawed - they've repeatedly ignored rather than responded to the most serious methodological concerns, and the results fall way short of what they expected, as laid out in the original protocol.

There again I don't think they are out to harm patients in a Bond villain way. But I do feel they are putting their own careers and preferred theories ahead of allowing a fair appraisal of the evidence take place. Because I think they know their own data will undermine the theories theyve spent years expousing, not least that CBT/GET are effective therapies for most mecfs patients. Whatever, let other scientists decide- not them scrutinise the data and see what that shows.

 

[Sasha]

Because I think they know their own data doesn't support their claims. Whatever, let other scientists decide- not them.

I think the published data are already clear that their interpretations of their results as favouring CBT and GET aren't actually warranted. But independent analysis - especially conducting some of the main outcome analyses and the "recovery" analyses according to the original, protocol-specified analyses, using reasonable thresholds for improvement/recovery - will make that even clearer.

People have suggested that they're trying so hard to suppress the data that they must have reported fraudulent results but I find that highly unlikely. I think their concerns are more likely to be to do with revealing how few patients recovered anything remotely resembling healthy physical function scores (i.e. more like 100/100). Bear in mind that at the end of the trial, both the CBT and GET groups scored a pitiful average of 58/100.

 

[Esther12]

but otherwise, the rules about transparency and all that good stuff were applied only when it didn't inconvenience anyone high up.

I find this so frustrating. So many medical research organisation publicly praising themselves for embracing open data, patient empowerment and participation, looking at their own flaws and biases... but when they're pushed on this in private it's just a torrent of excuses.

Importantly, however, this did not mean that any of the people involved were evil. Indeed, given the nature of the organisation, most of them were classic Guardian or Independent readers.

The word 'evil' can mean lots of different things to different people, and there is a bit of a Guardian/Independent assumption that talk of Evil indicates that the speaker must have a simplistic approach to morality. I think that a lot of people who think of themselves as 'good' still behave badly and perpetuate systems which abuse others. That's a form of 'evil', even if it's sufficiently widespread that some see it as just a part of modern life.

Welcome to the forum. Always good to have different perspectives and views. Thanks for the blog and for your earlier 'positivity' debunking.

 

[A.B.]

I genuinely don't believe that the PACE scientists are acting in any way with malicious intent.

I think PACE authors actions are best understood as tobacco science.

The tobacco industry knew that smoking killed people but engaged in decades long campaign to create doubt on the health risks. They found scientists that were willing to produce misleading science. Did these scientists have malicious intent towards smokers? Probably not, but they didn't care about their well being or the truth either. Tobacco scientists promoted the idea that type A personality, and not smoking, was the cause of heart disease. They promoted the idea that scary articles about smoking in the press were causing heart disease in smokers, not smoking itself. Similar claims have been made about CFS. Psychological explanations are hard to falsify so they were well suited to create doubt. Tobacco scientists denied that smoking was linked to lung cancer while their own research, securely locked away, clearly showed a link.

In the case of CFS, it is the health insurance and reinsurance industry that profits from the views promoted by PACE authors, several of which have been or are employed by some of these corporations.

They only have to create sufficient doubt to achieve their goals. As long as in the perception of the general public there is doubt that it might be psychological in many cases they are in a good position to deny medical investigations, treatment and disability pensions for a relatively common and often life long condition. Huge sums of money are at stake here.

I believe another crucial factor which allows all this to happen is the belief in psychogenic illness and the often unstated beliefs that come with it. The belief that patients are not really sick is probably necessary for a disaster like this to occur. Anyone who wishes to do so can find justifications for all sorts of abusive behaviour in this ideology. Social media and articles in the press make it very clear that CFS patients are seen as subhumans by some. CFS patients are a minority group that can still be openly denigrated.

That doesn't mean that everyone aligned with the psychosomatic illness model proposed by PACE authors must be a tobacco scientist. These explanations can also be attractive for other reasons. Some have built a career on it. Others (doctors) cannot handle the idea that not everything is understood and that nothing can really be done at this point in time.

 

[Marco]

In the case of CFS, it is the health insurance and reinsurance industry that profits from the views promoted by PACE authors, who coincidentally, have been or are employed by some of these corporations.

I would agree except for the fact that very few people in the UK rely on or benefit from private health insurance. If anyone benefits from the PACE model of 'pragmatic rehabilitation' its the NHS, DWP and ultimately the government/taxpayer.

 

[A.B.]

I would agree except for the fact that very few people in the UK rely on or benefit from private health insurance. If anyone benefits from the PACE model of 'pragmatic rehabilitation' its the NHS, DWP and ultimately the government/taxpayer.

Yes, thanks for adding this.

Of course the real cost to society for doing nothing about the problem while offering fake treatments as distraction probably outweighs any savings.

 

[Yogi]

Importantly, however, this did not mean that any of the people involved were evil. Indeed, given the nature of the organisation, most of them were classic Guardian or Independent readers. That's another side of this discussion that needs to be considered: I genuinely don't believe that the PACE scientists are acting in any way with malicious intent. They are not, to use a familiar image, sitting in a swivel chair, stroking an overweight white Persian cat. This is all about the everyday adventures of people who have to make their way through life while surviving the stupidity of a bureaucracy. (Small self-promotion: this is exactly what I deal with in my part-time work as a coach.)
".

Welcome to PR. Thanks for your blog on PACE and coming here. It is interesting to hear from a neutral science person and someone not aware of ME. Appreciate you don't want to get into the politics but it is not too complex....as they say "Follow the Money".

This is the malicious intent as it is highly unusual that medical doctors and researchers should be so heavily involved with the insurance industry (pharmaceutical is understandable).

Have you read this investigatory journalist, David Tuller's article into PACE?

http://forums.phoenixrising.me/inde...panies-is-“not-related”-to-pace-really.41309/

 

[user9876]

Once the decision has been made ("we won't give the data to [potential] harassers"), consistency has to be maintained; otherwise cognitive dissonance (one of the few things in psychology that almost everyone agrees on) would set in.

The current situation is that many patients look at PACE and the way they have fiddled with the protocol and immediately won't trust it. The simple way out would be to be transparent and share data - the huge resistance to doing this also damages trust. As an organization QMUL could choose a different strategy to share data and if the data is as they present it would have a better pay off than the costs (both of lawyers, reputation and patient trust of trying to keep the data secret). Wouldn't it be the rational (from a utility maximizing perspective) to change strategy - I realize it is hard for the individuals to do this but that is where the governance structures of the university should step in.

But I believe the real problem is that the PACE authors have over claimed on their research (because they are true believers) . This is particularly true of the recovery numbers where thresholds used were so far from those in the protocol. I do think they didn't think they were doing anything wrong because they believe if is common to change protocols and for researchers to present things in the way that supports their favoured treatments. I don't have sympathy for them because they knew that eyes would be on the results and that they needed to be extra careful about claims made.

 

[elliepeabody]

I would agree except for the fact that very few people in the UK rely on or benefit from private health insurance. If anyone benefits from the PACE model of 'pragmatic rehabilitation' its the NHS, DWP and ultimately the government/taxpayer.

I'm in the UK and my Total Permanent Disability insurance claim was refused on the advice of PDW (working for the re-insurer) who advised my claim be refused as I hadn't had 'optimal treatment' of CBT/GET. PDW was not interested by the fact that my NHS consultant led specialist ME/CFS medical team confirmed that I had tried everything they deemed appropriate in my case (I'm severely affected) or that I had already tried CBT and exercise therapy (and still got worse) or that there are no qualified CBT/GET therapists for PWME in my area. It's a jolly wheeze. If you have already undertaken CBT/GET you are told you have done the wrong sort of CBT/GET, or that as it hasn't worked, you can't have done it properly and haven't tried hard enough so you need to do it again. At one point I even had a jolly conversation with Jessica Bavington, who at the instigation of my insurer wanted to help me.

It isn't only private health insurance that is involved but disability insurance, which I suspect is purchased more often. There are often significant sums of money involved. Sometimes lump sums. Other times it is payments based on a proportion of salary. IIRC a Norwegian study found that the later ME/CFS age peak was 30 - 39 years. That is a good 2 - 3 decades of insurance payments until retirement for those too ill to work.

My insurer told me that they did not give any weight to any medical reports I paid for as they weren't impartial, funny though they didn't apply the same standards to the medical reports they obtained. The likes of PDW enable and give cover to the questionable practices of insurers. My insurer refused to tell me what in their view my diagnosis was, and what evidence they required to satisfy my claim.

The insurer did pay up in the end, within months of me getting a solicitor involved.

ETA: And this is one of the reasons why there have been machinations to get ME/CFS classified as a mental health condition - many insurance policies have mental health exclusions.

So, I wouldn't underestimate the money at stake in health insurance and disability insurance in the UK.

 

[SOC]

I genuinely don't believe that the PACE scientists are acting in any way with malicious intent.

I think we need to define 'malicious intent' before we can have this discussion. Let's work with a dictionary definition:

full of, characterized by, or showing malice; intentionally harmful;spiteful:

http://dictionary.reference.com/browse/malicious
As Coyne pointed out, these scientists have said many offensive things about ME patients. Based on no evidence, they have created a smear compaign presenting us as violent, terroristic crazy people who should not be supported or even believed . One could argue that that they are doing it simply to save their own careers, which would suffer if the world believed what we are saying about their research and treatment protocols. They need to discredit us to save themselves. That fits the definition of malice.

Was the flawed PACE research malicious? Probably not. It was simply self-serving with no regard for the harm they were doing patients. Not quite the same as setting out to do harm.

This is all about the everyday adventures of people who have to make their way through life while surviving the stupidity of a bureaucracy.

I understand that you want to give the scientists the benefit of the doubt, but in this case I think you have it backwards. This is a group of people manipulating the bureaucracy for their own ends.

But this is all the politics, and not your arena. We are very pleased you are willing to look at the quality of science. We don't need more. However, you might want to be careful where you place your trust. Assuming certain people are telling the truth as best they understand it can be a mistake. There are situations where people (even scientists ) do lie to save their egos and careers. By all means, stick to the Good Science issues, but keep your eyes open and your antennae powered up.

 

[Bob]

My insurer refused to tell me what in their view my diagnosis was

For future reference, it's your right to obtain any information a private body holds about you via a FOI request.
https://ico.org.uk/for-the-public/personal-information/

 

[elliepeabody]

For future reference, it's your right to obtain any information a private body holds about you via a FOI request.
https://ico.org.uk/for-the-public/personal-information/

Thanks Bob, I did make a DPA request to my insurer and the info I obtained was very interesting indeed (including the fact that they had me under surveillance at one point). They didn't want any clarity around diagnosis (even though I had obtained 3 consultant reports confirming my diagnosis of ME/CFS), because where there is a lack of clarity it makes it easier to deny the claim. It was a tactic.

 

[sTeamTraen]

(That's a serious question from one rational person to another, not an attempt at point-scoring. As a neutral newcomer to PACE, I'm genuinely interested in how you see their failure to even flag up that contradiction in the paper, let alone to address it.)

It certainly sounds pretty bad. But I'm not in a position to evaluate it in any meaningful way.

Again: I don't think these people are in any way maliciously intentioned. The behaviour you're seeing is within what I consider the "normal range" (as in, statistically unexceptional, not that I approve of it) of what happens when a group decision has been taken by a bureaucracy, and the machine rolls on.

Bureaucracy doesn't have to appear Kafaesque in its complexity; in fact bureaucracy is very often not about mountains of red tape. It's about loyalty to the continued existence of the organisation and the internal self-stifling of dissenting thought that goes with that. But 90% of that self-stifling of dissenting thought is necessary for any organisation, down to your local chip shop, to function; and identifying the 10% where you maybe have room for manoeuvre is hard. When you're inside such a situation, it's very hard to get any perspective. Certainly, direct criticism is unlikely to change anything; there is a well-known phenomenon in psychology whereby, once people have formed an opinion beyond a certain degree of conviction, almost any contradictory evidence will be turned into supporting evidence.

I think I'm right in saying that there are nine authors on the PACE article. I don't know any of them, but I can be sure that it would take a major, major act of rebellion --- basically, whistleblowing --- for one of them to break ranks, even if the current vote is 8 to 1 in favour of releasing the data. And whistleblowers, whatever the circumstances and whatever the merits of what they did, can expect to have their careers destroyed. So they have created a situation that they can't back out of by suddenly deciding to release the data in response to an N+1th request; in fact, they are probably quietly hoping that some other authority will step in and release the data for them. Honour will be saved, and they will be able to sleep better at night.

 

[A.B.]

'm in the UK and my Total Permanent Disability insurance claim was refused on the advice of PDW (working for the re-insurer)

PDW = Peter White, PACE trial author.

 

[Bob]

Hi Nick,

A huge welcome to forum, and thanks for posting your thoughts.
Thanks for your sensitive blog. It's great to have more people take an interest in the issue.

Like @Marco, I was uncomfortable reading about the issue of death threats etc., because they are a distraction, but the accusations have been flying around Twitter over the past couple of days, so I understand why you felt they needed to be addressed, and I think you made a great job of rebutting the arguments that have been made on Twitter. (i.e. the argument that the data shouldn't be released because of the 'ever-so-dangerous' patients.)

Like Simon, I especially appreciated your point about Muslims being harassed on a plane. The point being that a whole population should not be held in contempt and discriminated against because of the alleged behaviour of one or two isolated and unrepresentative individuals.

It seems to be basic common sense that patients should have access to (in this case, publicly-funded) data that informs and decides the nature of their health care and national health care policies.

It's a bit like a government withholding data on the basis some citizens behave badly. Or a school withholding exam data because some pupils were unruly. Or a public library refusing to issue books because a customer dropped some litter.

I genuinely don't believe that the PACE scientists are acting in any way with malicious intent. They are not, to use a familiar image, sitting in a swivel chair, stroking an overweight white Persian cat.

They thought they were doing science, and now they also have to cope with the socio-political fallout. Most of them didn't sign up for this.

Oh, we look back to our innocent pasts when we assumed exactly the same. I think that was the starting point for all of us. We've had some very hard lessons.

But perhaps there is always a fine line where bureaucracy and group-think combined with personal ambition and self-preservation can become so damaging to others that it unintentionally becomes systematic abuse. It's a bit of a philosophical discussion.

 

[Sasha]

It certainly sounds pretty bad. But I'm not in a position to evaluate it in any meaningful way.

Fair enough.

Again: I don't think these people are in any way maliciously intentioned. The behaviour you're seeing is within what I consider the "normal range" (as in, statistically unexceptional, not that I approve of it) of what happens when a group decision has been taken by a bureaucracy, and the machine rolls on.

I'm a bit confused by your reference to a "bureaucracy" in regards to PACE. My assumption is that the principal authors have been making the decisions and don't answer to anyone else. Who do you regard as the bureaucracy in this case?

I think I'm right in saying that there are nine authors on the PACE article. I don't know any of them, but I can be sure that it would take a major, major act of rebellion --- basically, whistleblowing --- for one of them to break ranks, even if the current vote is 8 to 1 in favour of releasing the data. And whistleblowers, whatever the circumstances and whatever the merits of what they did, can expect to have their careers destroyed. So they have created a situation that they can't back out of by suddenly deciding to release the data in response to an N+1th request; in fact, they are probably quietly hoping that some other authority will step in and release the data for them. Honour will be saved, and they will be able to sleep better at night.

Bit confused again. If the vote was 8 to 1 in favour of releasing the data, isn't it the 1 who has broken ranks and is rebelling? I take your point about what happens to whistleblowers but I don't understand why the majority wouldn't rule here.

I think I've misunderstood you somewhere!

 

[A.B.]

It certainly sounds pretty bad. But I'm not in a position to evaluate it in any meaningful way.

As SOC said, you don't have to evaluate the politics. Or try to guess the true motivations of the authors. Feel free to ignore these aspects.

An argument against PACE and the associated psychosomatic model can be made on scientific grounds alone. If you can manage to draw more attention to the problematic claims and practices that would be very helpful. We want to see this bad science dismantled and we can't do it alone because hardly anybody listens to us patients. Coyne seems to fully understand all aspects of the problem which is a miracle... but even he can't do it alone.

 

[Sasha]

As SOC said, you don't have to evaluate the politics. Or try to guess the true motivations of the authors. Feel free to ignore these aspects.

I agree - I don't care whether they're stroking white cats in their swivel chairs but I do care about them being stopped from doing bad science on my disease. There's no need to get down into the weeds of the past politics of this disease, which will take you down an endless rabbithole - we want scientists focusing on the bad scientific practices and getting them dealt with.

It's not about the researchers - it's about the research.

 

[A.B.]

we want scientists focusing on the bad scientific practices and getting them dealt with.

It's not about the researchers - it's about the research.

We also want a proper biomedical research program to identify biomarkers, subgroups, and treatments. This is hard when a group of psychatrists is squatting on the issue and pretending to have an explanation and working treatment when they actually have no such things.

We actually have several eminent scientists, including nobel laureates, that would love to study the disease but cannot get adequate funding. ME/CFS is severely underfunded. In the US, the NIH spends just $5 million per year on research. It should be about $120 to 250 million if one takes disease severity and the estimated number of patients, many undiagnosed, into account.

Just to put things into wider context.