PACE Trial BMJ: Freedom of information: can researchers still promise control of participants’ data?

[Dolphin]

Only the start of this is free:

http://www.bmj.com/content/354/bmj.i5053

Freedom of information: can researchers still promise control of participants’ data?

BMJ 2016; 354 doi: http://dx.doi.org/10.1136/bmj.i5053 (Published 21 September 2016) Cite this as: BMJ 2016;354:i5053

Nigel Hawkes, freelance journalist, London, UK

 

[Large Donner]

Such bullshit, when did researchers ever promise "control of participants’ data"? They are only asked to protect participants identity.

Data in a publicly funded trial is public information.

So this article is proposing a scenario wherby people like Peter White gains financial remuneration via publicly funded trials but no one ever gets to see the data because, "the anonomized data belongs to the participants" and anyone who has the same diagnostic label as the participant, or any other outside researchers or affected parties, just has to accept the study conclusions at face value?

MY ARSE!!

 

[Esther12]

First, lets all take a moment to remember how the BMJ covered the release of the PACE trial's results in 2011:

Patients with chronic fatigue syndrome have nothing to fear from CBT or graded exercise, say the authors. Both work as a bolt on to specialist care, although their overall effects looked modest. Less than a third of patients were cured by either treatment (30% (44/148) after CBT and 28% (43/154) after graded exercise therapy).

http://www.meassociation.org.uk/201...-coverage-of-the-pace-trial-23-february-2011/

Seeing as PACE had just released the primary outcomes from their protocol, which had showed only 20% of patients reached the threshold for mere improvement, one would have thought that would leave the BMJ feeling a little sceptical? Keen to push White for details? Not a bit of it. There seems to have been no rush for the BMJ to look over the data for themselves, or consider whether they may have been promoting quackery.

Considering this article is so terrible in its approach, it's pretty good for us that it is so rubbish. It's amazing that no-one at the BMJ took action to stop this coming out.

What is the result of going back to the 2007 protocol? “It makes not a ha’porth of difference,” White says.

LOL.

The PACE trialists, led by Peter White, professor of psychological medicine at the university, had answered critics who have made legitimate scientific points and shared the data with other research groups.

LOL. That's a bold claim for Hawkes and the BMJ to make. I wonder how much time and effort they put in to checking its accuracy?

It was not possible to contact Matthees before this article went to press.

Hmmm... I don't want to pester this God amongst men, but for those who want, his unusual name makes it pretty easy to find his e-mail address.

I really think that PACE is going to fall, and much as they'd like to, the UK medical establishment don't have what it takes to keep propping it up.

In doing so he disregarded the editor of the Lancet, Richard Horton, who argued that there was “a fairly small, very vocal and very damaging group of individuals who have, I would say, actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients. This community actively seeks to identify and attack those who are associated with the PACE trial.”

This from Nigel Hawkes! He's now hiding behind quotes from Horton, when previously he was happy to assert:

Patients are incapacitated for years, unable to move, sometimes bed ridden and fed through a tube. Yet it doesn’t prevent some people, who claim to be its victims, from conducting a relentless personalised attack on doctors and academics who are trying to discover its cause and improve its treatment.

This new piece reads like a nervous and failed attempt at a hit-job. The whole article seems very weak (although I'm not the target audience).

Considering how against us the BMJ seem to be, this is pretty good stuff. I was hoping that they'd reverse course and beg for forgiveness, but I can live with this level of feeble villainy.

 

[hixxy]

Full article: http://www58.zippyshare.com/v/eCqSygf9/file.html

 

[user9876]

This is shocking really in that the BMJ have been pushing open data and the need to publish protocol outcomes. But when there friends fail to do this they rally round in support.

It can't be good for the BMJs reputation. But then I expect to see similar from others in the UK who are prepared to break their principles or stay silent to support their friends.

 

[sarah darwins]

Sounds like the BMJ are sharing a hymn sheet with the NEJM, who have been carrying similar pieces.

Excellent article last month by Ivan Oransky on StatNews .com:

https://www.statnews.com/2016/08/10/data-sharing-science-nejm/

 

[worldbackwards]

Comforting to see that they've moved from the world of spin into outright lies. This can't last, surely.

 

[Chrisb]

After a five year battle, patients with chronic fatigue syndrome have forced researchers to release data from controversial research into treatment of the condition. But participants in the trial never consented to this. Nigel Hawkes reports

I would be interested to see the part of the consent form which indicates that participants gave informed consent to having their data misrepresented, and used against them, without any external oversight or redress.

 

[Stewart]

If my memory serves me correctly (and it does) Nigel Hawkes was the first journalist to write about Wessely's 'death threats' and the 'harrassment' of researchers, which was picked up by the BBC (and everyone else) a month or so later.

http://www.bmj.com/content/342/bmj.d3780

He's a freelance journalist with a history of acting as a shill for the SMC. I'm not at all surprised that he wrote this, but I wouldn't have expected the pro-data sharing BMJ to publish it. Ah well, this is the problem with print as a medium - in the time it's taken the BMJ to publish this article, anyone who's following the issue closely can see that the Matthees reanalysis has shown that QMUL really did have something to hide - leaving Mr Hawkes looking a bit of a fool for unquestioningly swallowing their line.

 

[Sidereal]

To anticipate any analysis that Matthees plans, the PACE team published its own this month.3 4 What is the result of going back to the 2007 protocol? “It makes not a ha’porth of difference,” White says. “Cognitive behavioural therapy and graded exercise therapy are still statistically significantly better than pacing or specialist medical care.”

The patient advocacy organisation #MEAction and others have claimed, however, that these new analyses show only a third as many patients improving as the Lancet paper found. “They’re not comparing like with like,” White says. “They are comparing one measure with a completely different one—it’s apples and pears.”

Surreal.

 

[worldbackwards]

To anticipate any analysis that Matthees plans, the PACE team published its own this month.3 4 What is the result of going back to the 2007 protocol? “It makes not a ha’porth of difference,” White says. “Cognitive behavioural therapy and graded exercise therapy are still statistically significantly better than pacing or specialist medical care.”

The patient advocacy organisation #MEAction and others have claimed, however, that these new analyses show only a third as many patients improving as the Lancet paper found. “They’re not comparing like with like,” White says. “They are comparing one measure with a completely different one—it’s apples and pears.”

Does anyone have the faintest idea what he's claiming here? Is he saying the original protocol activity data is comparable to the trial recovery data? Or something?

This is just bollocks now isn't it. This is real bunker at the end stuff.

 

[Daisymay]

This is shocking really in that the BMJ have been pushing open data and the need to publish protocol outcomes. But when there friends fail to do this they rally round in support.

It can't be good for the BMJs reputation. But then I expect to see similar from others in the UK who are prepared to break their principles or stay silent to support their friends.

You have to wonder if some of these people have any principles to break.

 

[Valentijn]

Does anyone have the faintest idea what he's claiming here?

I think he's saying that since different thresholds were used in defining improvement, the numbers can't be directly compared. But he's neglecting to mention that he and his co-investigators agreed upon and sold the trial as measuring apples, then later decided to switch to pears

 

[Snow Leopard]

I think he's saying that since different thresholds were used in defining improvement, the numbers can't be directly compared. But he's neglecting to mention that he and his co-investigators agreed upon and sold the trial as measuring apples, then later decided to switch to pears

Indeed.

They can't claim the methods are vastly different (apples vs pears) when they previously tried to claim the change in methods were not meaningfully different (recovery vs recovery and improvers vs improvers).

 

[BruceInOz]

I think he's saying that since different thresholds were used in defining improvement, the numbers can't be directly compared. But he's neglecting to mention that he and his co-investigators agreed upon and sold the trial as measuring apples, then later decided to switch to pears

I think White got his fruits mixed. They sold the trial as measuring apples but then gave us lemons.

 

[Gijs]

In real science data is the most important thing. Data must be transparant (anonymously!) and available. The participants of the pace trial didn't agree data sharing with Cochrane review either, did they? It is very strange this article -especially from a journalist- did not mention the poor outcomes of the Original protocol. I understand that pseudoscientists like White and Chalder also journalists like Nigel Hawkes wants to protect their scam and 'fraud'.

 

[Solstice]

I think White got his fruits mixed. They sold the trial as measuring apples but then gave us lemons.

And now we're finally crushing those lemons to make lemonade. Oh yeaaaahhhhhhhh.

 

[user9876]

Does anyone have the faintest idea what he's claiming here? Is he saying the original protocol activity data is comparable to the trial recovery data? Or something?

This is just bollocks now isn't it. This is real bunker at the end stuff.

They are trying to confuse the issue by picking the improvement outcome rather than the recovery one. They had a small significance for improvers but none for recovery. So they don't mention recovery.

 

[Snow Leopard]

They are trying to confuse the issue by picking the improvement outcome rather than the recovery one. They had a small significance for improvers but none for recovery. So they don't mention recovery.

The BMJ article was written before the "recovery" reanalysis...

 

[Yogi]

For the record - Nigel Hawkes of patient militant meme which was rejected by the Judge in August.

http://www.bmj.com/content/342/bmj.d3780.extract

BMJ 2011; 342:d3780 doi: 10.1136/bmj.d3780 (Published 22 June 2011)

Cite this as: BMJ 2011; 342:d3780

Medical Research
Dangers of research into chronic fatigue syndrome
Nigel Hawkes, freelance journalist
London, UK

Nigel Hawkes reports how threats to researchers from activists in the
CFS/ME community are stifling research into the condition

There are jobs that carry a risk, such as volunteering as a human
cannon ball at a funfair. There are jobs that attract opprobrium and
abuse, such as becoming an estate agent, driving a white van, or
selling double glazing over the telephone. And then there is the job
of trying to conduct research into chronic fatigue syndrome/myalgic
encephalomyelitis (CFS/ME).

CFS/ME is a common condition, and very debilitating. The evidence
suggests a population prevalence of at least 0.2-0.4% in the UK. 1
Patients are incapacitated for years, unable to move, sometimes bed
ridden and fed through a tube. Yet it doesnt prevent some people, who
claim to be its victims, from conducting a relentless personalised
attack on doctors and academics who are trying to discover its cause
and improve its treatment.

Simon Wessely, professor of epidemiological and liaison psychiatry at
Kings College School of Medicine in London, has been the target of
such attacks for years. Hes been compared on the internet to Josef
Mengele, the Nazi doctor who performed experiments on inmates of
concentration camps. Hes had threats against his life, been accused
of throwing a boy into a swimming pool to check if his paralysis was
genuine, been bombarded with offensive emails, and had complaints
against him made to his employers and to the General Medical Council.

The campaign has gained new life since the publication in March in the
Lancet of the PACE trial, a comparison of four treatments for CFS that
concluded, to the fury of the campaigners, that cognitive behavioural
therapy and graded exercise therapy can be effective. Pacing, a
treatment favoured by leading ME charities, was found to be
ineffective. 2

The publication prompted a 442 page response to the Medical Research
Council (MRC), which part funded the trial, and a shorter 43 page
rebuttal to the Lancet. Both were written by Malcolm Hooper, emeritus
professor of medicinal chemistry at the University of Sunderland, who
branded the trial unethical and unscientific. He wrote: Entry
criteria were used that have no credibility; definitions and outcome
measures were changed repeatedly; data appears to have been
manipulated, obfuscated, or not presented at all (so it cannot be
checked) and the authors interpretation of their published data as
moderate success is unsustainable.

Both the MRC and the Lancet have considered the submission and
rejected it, the Lancet commenting that the volume of critical letters
it received about the PACE trial smacked of an active campaign to
discredit the research.3 Frances Rawle, head of corporate governance
and policy at the MRC, who spent several days reading the 442 page
rebuttal, says it made many accusations of bias. She adds: I
responded and two weeks later got another list of questions.

Personal attacks

Asking detailed questions about an important trial is a legitimate and
proper activity, though questioning academics integrity and honesty
is not normally part of the process. But far more unpleasant are the
activities of a group of activists who have resorted to threats and
personal abuse.

It is a relentless, vicious, vile campaign designed to hurt and
intimidate, Professor Wessely says. For some years now all my mail
has been x rayed. I have speed dial phones and panic buttons at police
request and receive a regular briefing on my safety and specific
threats.

Since PACE was published this has become more intense, and at present
the police are looking into two cases in which specific threats have
been made to my physical safety. These people are sulphurous, vicious,
horrible.

Professor Wessely is not alone. All of those who approach CFS/ME from
a psychiatric perspective are the targets of critics who believe the
disease has a physical cause that would have been discovered by now if
the debate, and the research money, had not been cornered by what they
see as a conspiracy of psychiatrists, characterised by them as the
Wessely school.

This point of view, if not the actions it inspires, is defended by
Charles Shepherd, medical adviser to and trustee of the ME
Association. The anger and frustration patients have that funding has
been almost totally focused on the psychiatric side is very
justifiable, he says. But the way a very tiny element goes about
protesting about it is not acceptable.

Its not representative of the patients as a whole. Its a very very
tiny minority50 to 100 people, maybe. What they do is not pleasant
and totally unacceptable.

Dr Shepherd has good reason to know, as he has been the target of
attacks. One website claimed he had a psychotic illness, was
physically violent, and a medical failure. He consulted the police.
More recently his scepticism about the claim that CFS/ME is caused by
the retrovirus XMRV has exposed him to further attacks.

The personalised nature of the campaign has much in common with that
of animal rights activists, who subjected many scientists to abuse and
intimidation in the 1990s. The attitude at the time was that the less
said about the threats the better. Giving them publicity would only
encourage more. Scientists for the most part kept silent and
journalists desisted from writing about the subject, partly because
they feared anything they wrote would make the situation worse. Some
journalists have also been discouraged from writing about CFS/ME, such
is the unpleasant atmosphere it engenders.

While the campaigners have stopped short of the violent activities of
the animal rights groups, they have another weapon in their
armouryreporting doctors to the GMC. Willie Hamilton, an academic
general practitioner and professor of primary care diagnostics at
Peninsula Medical School in Exeter, served on the panel assembled by
the National Institute for Health and Clinical Excellence (NICE) to
formulate treatment advice for CFS/ME.

Our report, based on a solid review of the evidence, was that graded
exercise and cognitive behavioural therapy were the best, indeed only,
treatments. This position was resisted vociferously by the patient
representatives on the committee, using a very strange mixture of
quasi-scientific argumentsthe trials were biasedand utterly
unscientific claptrap.

Actually, it was a visceral fight not to allow graded exercise and
cognitive behavioural therapy to be approved by NICE. Why? To this day
I dont know.

The NICE guidance was taken to judicial review, its opponents claiming
that the experts were biased or had conflicts of interest. The case
was dismissed, the judge, Mr Justice Simon, warning that: Unfounded
as they were, the allegations were damaging to those against whom they
were made and were such as may cause health professionals to hesitate
before they involve themselves in this area of medicine.

After this, the argument got even more personal. I was reported to
the GMC, says Dr Hamilton. The complaint was risible. I was accused
of breaking almost every rule in the GMC rulebook. And of course the
GMC fell totally into the trap.

Instead of accepting that its complaints process can be hijacked by
pressure groups, it treats all complaints the same. So I had all the
rigmarole of a formal complaint, which naturally dragged on for
months. Eventually it was chucked out and I got an utterly ungracious
letter from the GMC saying the complaint wont lead to a case but Im
to make sure to obey the GMC rules anyway. It sounded as if it thought
Id got off on a technicality and needed a good telling off.

Peter White, professor of psychological medicine at Barts and the
London School of Medicine, was the principal investigator of PACE. He
says the campaign against the trial has gone on ever since it was
first funded. There was a campaign by the ME Association, lots of
letters to organisations involved, not least the MRC, and a petition
to No 10 Downing Street.

It did upset our ability to recruit patients, and it took up a lot of
time. Complaints and Freedom of Information requests have to be dealt
with properly. The paradox is that the campaigners want more research
into CFS, but if they dont like the science they campaign to stop it.
They want more research but only research they agree with.

Professor White has been accused of coercing patients, paying general
practitioners to enlist patients, having conflicts of interest, and
accepting improper financial contributions. These accusations, which
he insists are all untrue, have also been sent to his employers. In Dr
Hamiltons case, the dismissal of the complaint to the GMC was
followed by Freedom of Information requests for the evidence the GMC
had gathered from his five employers and in its case handling. The
GMC hadnt the grace to tell me thisit still hasntbut my employers
did, he says. As far as I know this stage still grumbles on.

While psychiatrists and those who work with them have been the main
targets, others also come into the activists sights. Esther Crawley,
a paediatrician and consultant senior lecturer at Bristol University,
is principal investigator for the SMILE trial, which aims to
investigate a treatment called the Lightning Process. Developed by
Phil Parker, an osteopath, the process claims to combine the
principles of neurolinguistic programming, osteopathy, and clinical
hypnotherapy to treat a variety of conditions, including phobias and
CFS/ME. There has been no proper medical study of whether it works.

Critics of the method opposed the trial, first, Dr Crawley says, by
claiming it was a terrible treatment and then by calling for two
ethical reviews. Dr Shepherd backed the ethical challenge, which
included the claim that it was unethical to carry out the trial in
children, made by the ME Association and the Young ME Sufferers Trust.
After re-opening its ethical review and reconsidering the evidence in
the light of the challenge, the regional ethical committee of the NHS
reiterated its support for the trial.

Dr Crawley says it doesnt make sense to argue that the trial should
not be carried out in children. The aetiology of CFS in children is
different, and so is the prognosis. Ninety four per cent of children
get better, while only a third of adults do. So you couldnt just do
the trial in adults. Anyway, were recruiting teenagers, not
children.

The attacks soon turned personal. They said I was having an affair
with a lightning practitioner, they doctored a video I appeared in,
they reported me to the GMC. It was very harassing. The GMC said I
didnt have a case to answer.

Research threatened

Dr Crawley runs the biggest CFS/ME service for children in the UK,
seeing about 200 a year. If the Lightning Process is dangerous, as
they say, we need to find out. They should want to find it out, not
prevent research.

I expected families and patients to have a twisted view of research,
given the amount of stuff [criticisms, personal abuse, etc] there is
on the internet about CFS, but they dont. We have to warn them there
is this stuff out there, and they get very angry about itthey say we
need answers and you mustnt be stopped.

Professor Wessely, whose research interests have moved away from
CFS/ME, still sees patients and agrees that their attitudes are
completely different from those of the campaigners. I still do the
clinic, and its perfectly fine. Weve seen 2000 patients, with very
few complaints. The service is the least complained about in the
Maudsley [hospital].

The underlying belief of the campaigners is that CFS/ME has a real
cause, which would have been discovered by now if serious efforts had
been made. So there was great excitement in 2009 when a US team from
Whittemore Peterson Institute in Reno, Nevada, published a paper in
Science claiming a link between CFS/ME and the XMRV retrovirus. The
paper said that they had found the virus in 68 out of 101 CFS/ME
patients tested. Annette Whittemore, whose husband made money in
property and who has a daughter with CFS, had funded the institute.
She was joyful at the discovery. It ends the debate, she said. CFS
is not and never was a psychological disorder. Those who are ill have
always known this.

Alas, at least 10 follow-up studies, including one in the BMJ,4 have
now failed to reproduce the original results, prompting Science to
issue an expression of concern. But some of those who failed to
reproduce the finding have found themselves the object of the same
intimidatory behaviour as the psychiatrists. John Coffin from Tufts
University in Boston, whose team showed that XMRV is a laboratory
hybrid, has said that nobody went in with the intention of disproving
the link between CFS/ME and the virus. Criticisms of his motivations
from patient advocates had been painful to read.

Professor Wessely says that scientists have been appalled at their
treatment and that some have sworn never to work in the field again.
Many scientists end up being threatened if they publish any research
that gives the wrong results. So most just stop.

Pretty typical is a response posted on the ME Association website to
the republication of a Nature story reporting the failure to reproduce
the XMRV results. It quoted Jonathan Stoye, a retrovirologist at the
National Institute for Medical Research, as saying; Its a bust.
People who are interested in this condition will have to move on. The
comment, posted by somebody calling himself Soloman, reads: Will HE
move on to some decent research instead of just knocking down others
work? And what do we move on tomore nonsense from the
psycho-terrorists?

Dr Crawley admits she did get very low as a result of the pressure
and was planning to leave the field. But there isnt anybody else in
my generation whos come in and stayed in. If I stop, theyll have
won.

Dr Shepherd is more sanguine. The problems dont relate to all
researchers. There are some who would say they havent had any
trouble. It may discourage some people, those on the psychiatric side,
because they know about White and Wessely and they know theyre going
to get the same flak. But what discourages people on the biomedical
side is this atmosphere in laboratories that you shouldnt be involved
with this at all if you want to advance your career, that its all a
psychiatric condition and theres no point in searching for a physical
cause when weve had so many negative results.

Dr Shepherd is pleased by a new initiative by the MRC, which has set
aside 1.5m for CFS/ME research. He credits Stephen Holgate, an
immunopharmacologist at Southampton University, who set up an expert
group to advise the MRC, with moving the process forward. Professor
Holgate believes that a lack of good scientists working in the field
has held up progress, and the new MRC funding is designed to rectify
that. Proposals, which had to include at least one scientist who does
not already work on CFS/ME, had to be submitted to the MRC by 7 June.
Whoever wins the grants will have tremendous support from patient
groups, Dr Shepherd promises.

Time will tell if his optimism is justified, but it does little to
help those who have been categorised as enemies by the activists. The
law appears relatively powerless, just as it did for many years during
the campaigns against scientists working with animals.

I regularly go to see a lawyer on the Medical Defence Union, says
Professor Wessely. They say, Yes, it is a gross libel. But if you
took them to court, theyd love it. Theyd get what they want. I did
get an injunction against the person who was comparing me with
Mengele. That was a particularly nasty example, because my
grandparents may actually have been murdered by Mengelethey were
transported to the camp where he worked and never seen again.

The motivation of the most persistent campaigners puzzles those who
are their target. My gut feeling is that some dont even have this
illness at all, says Dr Shepherd. They have personality problems.
Professor Wessely says: Theyre damaged and disturbed, with an
obsession about psychiatry. With these people, it isnt that they
dont want to get better but if the price is recognising the
psychiatric basis of the condition, theyd rather not get better.

Dr Hamilton has also been advised by lawyers not to answer
complaintsthe complainant will simply twist anything you say. He
says he is at a loss to know how to deal with them. Theres no
morality here. The judicial reviews wrist slap would have made anyone
with any conscience stop playing this game. It hasnt. I get hate
emailsthats what the delete button is for. The GMC need to realise
they are losing the trust of the medical profession by its procedures.
Very few doctors feel they will receive natural justice from it.

As for Professor Wessely, he gave up active research on CFS/ME 10
years ago. He now specialises in the problems of war veterans. I now
go to Iraq and Afghanistan, where I feel a lot safer, he says.

Competing interests The author has completed the ICJME unified
disclosure form at www.icmje.org/coi_disclosure.pdf (available on
request from him) and declares no support from any organisation for
the submitted work; no financial relationships with any organisation
that might have an interest in the submitted work in the previous
three years; and no other relationships or activities that could
appear to have influenced the submitted work.

Provenance and peer review: Commissioned; not externally peer reviewed.

1 NICE. Chronic fatigue syndrome /myalgic encephalomyelitis: NICE
guideline. http:// guidance.nice.org.uk/CG53/NICEGuidance/doc/English.

2 White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC,
et al on behalf of the PACE trial management group. Comparison of
adaptive pacing therapy, cognitive behaviour therapy, graded exercise
therapy, and specialist medical care for chronic fatigue syndrome
(PACE): a randomised trial. Lancet 2011;377:823-36.

3 Patients power and PACE. Lancet 2011;377:1808.

4 Van Kuppeveld FJ, de Jong AS, Lanke KH, Verhaegh GW, Melchers WJ,
Swanink CM, et al. Prevalence of xenotropic murine leukaemia
virus-related virus in patients with chronic fatigue syndrome in the
Netherlands: retrospective analysis of samples from an established
cohort. BMJ 2010;340:c1018.

Cite this as: BMJ 2011;342:d3780

http://forums.phoenixrising.me/inde...ing-pwme-as-threatening-psych-patients.11076/


However Nigel Hawkes did not declare his competing interest.

I have read and understood and BMJ policy on declaration of interests and have no relevant interests to declare.