With Myalgic Encephalomyelitis the sufferers and their parents/carers have enough to contend with.

So why are some groups and individuals advocating a change of name to Myalgic Encephalopathy?

Why is there a debate on changing the established name which is recognised by the World Health Organisation as a neurological illness?

Background to Myalgic Encephalomyelitis

ME is formally recognised by the World Health Organisation code ICD-10-G93.3 as a neurological illness.

The illness has been called Myalgic Encephalomyelitis in the U.K. since 1956. Although the USA called it CFS other countries such as Canada and countries in Europe also referred to it as Myalgic Encephalomyelitis.

See Dr. Byron Hyde's description of ME from the Invest in ME Conference 2006.

"Publicly funded research data are a public good, produced in the public interest, which should be made openly available with as few restrictions as possible in a timely and responsible manner.
To enable research data to be discoverable and effectively re-used by others, sufficient metadata should be recorded and made openly available to enable other researchers to understand the research and re-use potential of the data. Published results should always include information on how to access the supporting data."

UK Medical Research Council (MRC) 2011policy on data sharing and preservation

So it is even more incongruous that in all of the recent discussions the MRC and other funders of this trial have been so silent regarding this clear breach of guidance, this utter waste of money, this total waste of years of opportunity for good research into ME?

Although it doesn't surprise us the silence is, nevertheless, indicative of an establishment organisation whose policy toward ME research is being led by those who do not serve the interests of patients.

So what should happen now?

The FOI request to release data from the trial needs to be acted upon.

A petition to force the Lancet to retract claims made by the PACE Trial has been created and has already reached 10,000 signatures.

Retraction of the claims and release of the raw data for other scientists to review would no doubt mean that the whole mess around the PACE trial would have consequence elsewhere - as it is not just about one paper but the influence on health policies across the world that it has had.

It would also send a strong message that misleading research is not tolerated nor should it be used as a means to bolster the universities’ Research Excellence Framework (REF) as has been the case now.

QMUL Impact case study (REF3b) 2014 states -

“Since publication of the PACE trial in 2011, NICE have publicly affirmed their recommendation of GET (and CBT)” [6]

QMULImpact case study (REF3b) 2014

Kings College REF 3b 2014 states

“King’s College London (KCL) research on the prevalence of Chronic Fatigue Syndrome (CFS) and its treatment led to the key conclusion that general fatigue can be managed in primary care and CFS can be treated in secondary care with either Cognitive Behaviour Therapy (CBT) or Graded Exercise Therapy (GET). Prior to this work chronic fatigue was thought to have a poor prognosis but KCL research led to the more optimistic view that patients can recover and that the effects of treatment can be sustained.” [7]

UK Medical Research Council (MRC) 2011policy on data sharing and preservation

Oxford University REF3b 2014 states

“This Oxford based research has had a positive impact on people with CFS in three important ways. It has: [a] changed how the illness is viewed, from untreatable; [b] provided an evidence-based treatment that is recommended in current NICE and other guidelines; and [c] has become a standard treatment delivered through NHS CFS/ME treatment centres.” [8]

UK Medical Research Council (MRC) 2011policy on data sharing and preservation

University of Edinburgh REF3b 2014 states

“By showing the benefits of accurate identification and targeted treatment of chronic fatigue syndrome, UoE research has influenced worldwide medical practice and stimulated public and governmental debate.”[9]

UK Medical Research Council (MRC) 2011policy on data sharing and preservation

Although supporting the sentiments of the petition demanding retraction of the claims in the PACE Trial we do, however, believe that the seriousness of the way this whole research has been conducted, and the consequences still remaining as referenced research, requires that the PACE Trial paper itself has to be retracted.

Retracting the whole paper will send a message that poor quality research, especially when it is designed to influence healthcare policy, cannot be allowed.

The Lancet, which fast-tracked the first of the PACE trial papers in 2011, needs to act now.

This will be difficult for the Lancet to agree to. Therefore, another option has been produced - by a select group of scientists who have written to the Lancet requesting that an Independent review of the PACE Trial be performed by non-UK researchers, with no links to psychiatry [10].

We support the open letter to the Lancet should the Lancet be unwilling to retract.

To this end we have written to the editor of the Lancet - the letter can be seen here

In this day and age it is unacceptable that research performed with public funding can be allowed to be controlled by anyone who is not transparent and open in their treatment of data related to the research.

In order for a new beginning to occur we feel that the following needs to be considered –

  • All parties involved in the PACE trial need to retract their claims
  • The Lancet should retract the paper or accede to an independent review of the data
  • Policies within the NHS which have been based on PACE results need to be altered accordingly
  • NICE needs to revisit the CFS/ME guidelines
  • If raw data from the trial shows that the public has been misled even more than so far identified then there should be a public inquiry
  • The MRC invests in research on behalf of the UK tax payer.
  • The taxpayer has been ill-served by the PACE Trial.
  • The MRC should therefore examine the possibility of having the funds for the PACE Trial returned in part or in full to the public – and from there to be allocated to biomedical research into ME.
  • It must be considered whether the Principal Investigators of the PACE Trial be barred from receiving any further public funding for future research into ME.
  • The MRC need to review the management of this trial and procedures for deciding how funding for research into ME is decided to be allocated. The refereeing system for reviewing research applications for ME needs to be overhauled and made transparent.
  • It is obvious that those responsible for ME research in the MRC have no accountability - this must change.
  • Those in the MRC who have been responsible for research into ME over the last ten years must, if still in positions of influence with regard to ME research, be replaced. The MRC policies have been a shambles and valuable years of research possibilities have been wasted - along with a monumental loss of scarce public funding.
  • Conflicts of interest of those in the MRC who have any influence on ME research need to be declared and examined.
  • Consideration ought to be made for a government inquiry, or parliamentary committee to scrutinise the conduct of the MRC with regards to its policies, research grant applications and grants for ME made over the last 13 years since the CMO’s report was made.

This scandal has gone on long enough.

The principal architects of the misery being given out to people with ME need to be replaced or held to account.

We are sure none of this will happen. The establishment looks after its own.

But it seems impossible to see how, after the way the MRC has operated over the last ten years, ME patients or carers or ME patient groups or ME charities could possibly have any faith in an organisation such as this unless it is reformed. We fail to see how any healthcare professional or researcher can have faith in the Lancet until the PACE Trial is recognised for the farce that it has become.

References

  1. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, et al. (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377: 823–836. doi: 10.1016/s0140-6736(11)60096-2
  2. http://www.virology.ws/2015/10/21/trial-by-error-i/ http://www.virology.ws/2015/10/22/trial-by-error-ii/ http://www.virology.ws/2015/10/23/trial-by-error-iii/ http://www.virology.ws/2015/10/30/pace-trial-investigators-respond-to-david-tuller/ http://www.virology.ws/2015/10/30/david-tuller-responds-to-the-pace-investigators/ http://www.virology.ws/2015/11/09/trial-by-error-continued-why-has-the-pace-studys-sister-trial-been-disappeared-and-forgotten/
  3. http://www.telegraph.co.uk/news/health/11959193/Chronic-Fatigue-Syndrome-sufferers-can-overcome-symptoms-of-ME-with-positive-thinking-and-exercise.html
  4. https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1560081/fs_50565190.pdf
  5. Professor James Coyne http://blogs.plos.org/mindthebrain/2015/10/29/uninterpretable-fatalflaws-in-pace-chronic-fatigue-syndrome-follow-up-study/-
  6. http://impact.ref.ac.uk/casestudies2/refservice.svc/GetCaseStudyPDF/18135
  7. http://impact.ref.ac.uk/casestudies2/refservice.svc/GetCaseStudyPDF/41185
  8. http://impact.ref.ac.uk/casestudies2/refservice.svc/GetCaseStudyPDF/17492
  9. http://impact.ref.ac.uk/casestudies2/refservice.svc/GetCaseStudyPDF/23887
  10. “An open letter to Dr. Richard Horton and The Lancet""http://www.virology.ws/2015/11/13/an-open-letter-to-dr-richard-horton-and-the-lancet

Last Update November 2015

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