Talk delivered to patients with chronic fatigue/myalgic encephalomyelitis Belfast Castle February 7, 2016 about trial of psychotherapy that failed to demonstrate effectiveness, despite claims to the contrary

1. "The Scandal of the
£5m PACE Trial for
ME: What can be
done?"
James C. Coyne, PhD.
@CoyneoftheRealm

2. 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.

3. If my mom could see me now…

4. “I yam what I yam.”

5. 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.

6. 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.

8. I follow big footsteps.

9. 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.

10. Your struggle is not about me,
but for better or worse, it will
become so at times.

12. 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.

13. 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.

14. 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.

15. 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.

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

17. “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

18. 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.

19. 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.

20. I'm a skeptic.
 Controversies are to be resolved
by looking at the available
evidence.
 I’m skeptical about the quality of
that evidence.

21. 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.

22. 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.

23. 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.

24. Targets of skepticism
 Questionable research practices
(QRPs).
 Questionable publication practices
(QPPs).
 Institutional agenda that promote,
reward, and protect QRPs and QPPs.

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

26. 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.

27. Journalists and the media
Need 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.

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

29. 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.

30. 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.

31. Where did my involvement in
PACE controversy start?

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.

41. 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.

42. Vilification of patients

43. Fiona Fox AKA Fiona Foster

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

45. Michael Sharpe

46. 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

47. “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

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

51. My days as a strategic therapist
guru

52. 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.

53. 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.

54. 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.

55. 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.

57. What next for PACE and
me?

58. Getting PACE trial discredited
in America

59. Call for unconditional
surrender of PACE PLOS
data or retraction.

60. A therapeutic homework
assignment for you.

61. Now live
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@CoyneoftheRealm