Wessely & White: Weeping Bitterly

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

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Feature

Medical Research

Dangers of research into

chronic fatigue syndrome

Nigel Hawkes, freelance journalist

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 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.

Simon Wessely, professor of epidemiological and

liaison psychiatry at King’s College School of Medicine

in London, has been the target of such attacks for

years.

He’s been compared on the internet to f Mengele,

the Nazi doctor who performed experiments on

inmates of concentration camps. He’s 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 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.

It’s not representative of the patients as a whole. It’s

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 arguments­

*the trials were biased*­and 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 don’t 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

won’t lead to a case but I’m to make sure to obey

the GMC rules anyway. It sounded as if it thought I’d

got off on a technicality and needed a good telling

off.*

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 don’t 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 Hamilton’s 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 hadn’t the grace to tell me this­it still

hasn’t­but 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 , 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 doesn’t 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 couldn’t

just do the trial in adults. Anyway, we’re 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 didn’t 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 don’t. We have to warn

them there is this stuff out there, and they get very

angry about it­they say we need answers and you

mustn’t 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 it’s perfectly fine. We’ve 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 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.

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 Stoye, a retrovirologist at

the National Institute for Medical Research, as saying:

*It’s 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 isn’t anybody else in my generation who’s

come in and stayed in. If I stop, they’ll have won.*

Dr Shepherd is more sanguine.

*The problems don’t relate to all researchers. There

are some who would say they haven’t had any

trouble. It may discourage some people, those on the

psychiatric side, because they know about White and

Wessely and they know they’re going to get the same

flak.

But what discourages people on the biomedical side is

this atmosphere in laboratories that you shouldn’t be

involved with this at all if you want to advance your

career, that it’s all a psychiatric condition and there’s

no point in searching for a physical cause when we’ve

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 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, they’d love it. They’d 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 don’t even have this

illness at all,*

says Dr Shepherd.

*They have personality problems.*

Professor Wessely says:

*They’re damaged and disturbed, with

an obsession about psychiatry. With

these people, it isn’t that they don’t

want to get better but if the price is

recognising the psychiatric basis of the

condition, they’d rather not get better.*

Dr Hamilton has also been advised by lawyers not to

answer complaints­

*the complainant will simply twist anything you say.*

He says he is at a loss to know how to deal with

them.

*There’s no morality here. The judicial review’s wrist

slap would have made anyone with any conscience

stop playing this game. It hasn’t. I get hate

emails­that’s 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, 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.