"The Scandal of the £5m PACE Trial for ME: What can be

done?"James C. Coyne, PhD.@CoyneoftheRealm

Special thanks Julie Rehmeyer. Without her gentle nudging,

I would not be in this fight. David Tuller. Tom Kindlon. Alem Matthees. The many sufferers of CFS, ME, and PVF

who are teaching me a lot of what I am trying to teach others.

If my mom could see me now…

“I yam what I yam.”

To dispense with some misconceptions

I am just a lightly armed, quite dyslectic old man who is not making any money causing all this trouble.

You are not my Army, and I have no tanks and planes.

I am a kind of academic sniper, feared for my ability to aim at and take down bad research.

To dispense with some misconceptions

I am not your Savior. There are some things I can do for you only because you will someday be rid of me.

I will sometimes offend you, and even when I don’t, you can still distance yourself from what I do with “what a naughty boy!”

It is necessary for me to cause some offense in what I do.

I’m an awkward guy and sometimes I will cause great offense when I don’t intend to.

I follow big footsteps.

It is important that I am an outsider.

More willing to break ranks.

As an American, I don’t play by some British academic rules, some of which they don’t even recognize themselves.

Your struggle is not about me, but for better or worse, it will

become so at times.

The UK is a small place with an overly tight elite.

Lack of boundaries between “peer” review and funding of grants, conduct of research, peer review of papers, integration of results of clinical trials in scientific review papers, evaluation in the media.

There is a strict, but undiscussed hierarchy that determines who is allowed to speak and who will be ignored or vilified if they try.

The UK is a small place with an overly tight elite.

Strict rules about not criticizing or naming names.

Addressing critics without naming them.

A lot less democracy and free speech.

Some of the things that occur between British academics and me are unpredictable and can become ferocious when we feel shared assumptions have been violated.

There are some things that British academics can see about what I’m doing that I cannot because I am an American and take my way of doing things is the way to do them.

I’m willing to sacrifice my existing relationships with British academics for my principles and attaining these goals.

“Jim I have tried very hard to keep things professional but it's just not working. I really don't know why you are quite so rude on Twitter. I don't think it helps and it's not you. But I don't want to be part of this any longer so am going to block you which I do very rarely. Pity, might have liked that beer. If you change your mind you know how to find me.”

-Simon Wessley

Things the British establishment know about me

Have published over 350 articles. Over 36,000 citations to my work,

H-index = 86. Academic Editor at PLOS One. Promoter of Open Access,

PubMed Commons.

About me

Teacher of scientific writing and critical appraisal skills.

Critic of quality of the scientific literature and publication practices.

Blogger with Science-Based Medicine and PLOS’s Mind the Brain.

I'm a skeptic.

Controversies are to be resolved by looking at the available evidence.

I’m skeptical about the quality of that evidence.

I don't think these are controversial statements.

Many positive findings in biomedicine and science are ultimately shown to be exaggerated or outright false.

There is a crisis in the trustworthiness of the scientific literature.

Evidence based is…

“Evidence-based” is too often an ill-gotten branding based on weak evidence generated by promoters of treatments who want us to ignore their conflicts of interest.

Efforts at reform Preregistration of clinical trials make it more

difficult to hide negative trials or alter analytic plans after results are known.

More transparent and detailed reporting of what goes on in clinical trials so results can be independently evaluated.

Full disclosure of investigator conflicts of interest.

Greater patient involvement in interpretation and reporting of results of clinical trials.

Targets of skepticismQuestionable research practices

(QRPs).

Questionable publication practices (QPPs).

Institutional agenda that promote, reward, and protect QRPs and QPPs.

Politics

Bad science is being published with exaggerations of its significance and without challenge. This can often only be understood with reference to politics.

Politics

Who gets into what publications and which forums.

Who can be critical and be heard.Who gets ignored.Who suffers retaliation and by

whom.

Journalists and the mediaNeed to

Serve as trusted sources to interpret scientific and biomedical claims.

Avoid churnalism. Filter exaggerated claims of investigators and

their University press offices. Introduce independent evaluations from

experts who are not invested in particular claims.

Developing Citizen-Scientists

Citizen-scientists are bombarded by dubious claims and need to develop the critical skills and resources to decide for themselves.

My activism Identify and rectify questionable research

practices.

Promote open access and data sharing.

Strengthen post-publication peer review.

Develop innovative crowd-sourced post-publication peer-review such as Pubmed Commons and PubPeer.

My activism Identify, challenge, and change editorial

practices that make it easy to publish bad science and hard to do anything about it, once it is published.

Get corrections and erratum statements for undisclosed conflicts of interest.

Request retractions.

Where did my involvement in PACE controversy start?

Bad science of PACE

Being badly mispresented by the investigators.

Going unchallenged. Uncritically passed on by journalists and the

media. With clear harm to patients. Murky politics about who can speak and who

is silenced.

First steps I initially focused on bad science and

investigators’ deliberate misinterpretation of the follow up study.

I sought open dialogue and debate.

I published my critique in Lancet Psychiatry.

From criticism to seeking data

I noticed PACE investigators published a paper in PLOS One where they had to promise data would be available hupon request.

I requested the data. They refused, calling my “vexatious.” An internationally watched standoff.

Bad research practices in PACE trial

“Pre-registered” trial after data collection started.

Changed endpoints after peeking at data.

Suppressed analyses that don’t support views.

Ignore international and British requirements for sharing data.

PACE: A scientifically unsound study

Discredited Oxford diagnostic criteria meant high psychiatric comorbidity.

Poorly matched control group led to any nonspecific/placebo effects to be attributed to intervention.

Self-report outcomes highly susceptible to presence of depression, anxiety, and lack of appropriate control group.

PACE: a wasteful train wreck of a study

Investigators with conflicts of interest designed a study virtually assured to produce misleading results.

Tampered with process and outcome variables to make sure their preordained conclusions would be supported.

Likely harms to subgroup of patients obscured.

A cynical view of PACE trial?

Investigators know it did not show that psychotherapy for MECFS works.

They don’t care if it does.

They want to claim therapy is effective so patients can lose their benefits if they are not enrolled in therapy.

Things I want to accomplish

Obtain and re-analyze the PACE PLOS data or get paper retracted.

Stop the abuse, stigmatization, and vilification of CFS/ME patients.

Get recognition for scientist and citizen-scientist CFS/ME patients.

Getting screwed

You have been and continue to get screwed and I can help you see better how.

I am in a position to comment on it in ways that you cannot.

How PACE investigators violated patient rights.

Failed to disclose financial conflicts of interest in consent forms.

Failed to anonymize data.

Stored data in unlocked drawers from where some was stolen.

Vilification of patients

Fiona Fox AKA Fiona Foster

Please recognize the human rights issues in ways patients are portrayed and treated.

Michael Sharpe

Mind games Orchestrated and well-funded harassment

campaigns against researchers working in climate change and tobacco control are well documented. Some hard-line opponents to other research, such as that on nuclear fallout, vaccination, chronic fatigue syndrome or genetically modified organisms, although less resourced, have employed identical strategies.” [Emphasis added]

http://www.nature.com/news/research-integrity-don-t-let-transparency-damage-science-1.19219

“The public record, sadly, contains ample evidence that opposition to research in those areas goes beyond robust discussion or intense scrutiny, with death threats being received by researchers measuring the fallout from the Fukushima nuclear disaster and by medical researchers working in the area of chronic fatigue syndrome to cite but two examples.”

http://www.shapingtomorrowsworld.org/lewandowskycfs.html

Mind games

Think of yourself like black people or gays or patients with HIV/AIDS who just have not been organized yet.

My days as a strategic therapist guru

What I learned from a patient

My perspective is shaped by not appreciating that I am only temporarily able-bodied.

At some point, yours was probably also.

Double bind An emotionally distressing dilemma in which

an individual (or group) receives two or more conflicting messages, and one message negates the other.

Creates a situation in which a successful response to one message results in a failed response to the other (and vice versa), so that the person will automatically be wrong regardless of response.

Double bind theory

The essential hypothesis of the double bind theory is that the ‘victim’…finds him or herself in a communicational matrix, in which messages contradict each other, the contradiction is not able to be communicated on and the unwell person is not able to leave the field of interaction.

Double binding MECFS patients

Sharpe: Only a minority of patients are dissatisfied with PACE.

[11,000 patients and supporters sign petition to retract PACE Lancet paper].

Criticisms of PACE are disqualified because they come from organized effort.

What next for PACE and me?

Getting PACE trial discredited in America

Call for unconditional surrender of PACE PLOS

data or retraction.

A therapeutic homework assignment for you.

Now live

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