Dr Myhill vs PACE Authors

January 16, 2018

DR MYHILL’S COMPLAINT LETTER re PACE AUTHORS

Template letter for PACE patient support letter follows at the end of this document

 

 

General Medical Council
Fitness to Practise Directorate
3 Hardman Street
Manchester, M3 3AW.

Email to: TStephenson@gmc-uk.org

 

Dear Sir Terence

‘THE PACE STUDY AUTHORS COMPLAINT’

COMPLAINT RE AUTHORS OF PACE STUDY [Reference 1]

 

I am referring such authors of the PACE TRIAL [Reference 1 below] as are subject to GMC regulation to the GMC investigation team.

 

I am not using your standard form of complaint ( https://www.gmc-uk.org/DC6046_Hardcopy_form_52934724.pdf ) as its format does not lend itself to the complexities and details of this case. I would be grateful if you would pass this on to the relevant department.

 

Legal Basis of Complaint

 

I am making this referral on two broad planks:

 

1—Said authors have committed the criminal act of Fraud. This Fraud takes the form of scientific fraud and, by implication, financial fraud through their involvement with the PACE trial.

 

2—Said authors have breached GMC guidelines in that they have breached ‘Good Medical Practice (2013)’ [‘GMP’], ‘Good Practice in Research (2010)’ [‘GPR’] and ‘Consent to Research (2010)’ [‘CR’]’ (both the latter updated in 2013)

 

The complaint of Fraud

 

With respect to the complaint of fraud, it is naturally incumbent upon GMC registered doctors not to break the law, and specific to the act of fraud, this point is codified in Domain 4 of GMP, which requires doctors to ‘be honest’. In addition, the GMC document ‘GMC Thresholds [2016]’ [Reference 2] states that acts of ‘dishonesty’ are likely to meet the required threshold for referral [paragraphs 15 and 16] - http://www.gmc-uk.org/Guidance_GMC_Thresholds.pdf_48163325.pdf

 

There can be no doubt, therefore, that it is within the remit of the GMC investigatory process to investigate claims of Fraud made against GMC registered doctors.

 

The criminal act of fraud has been given a statutory definition in the Fraud Act 2006 [‘The 2006 Act’] and this defines three forms of fraud, namely:

  • "Fraud by false representation" [Section 2 of the Act] – this is a case where a person makes "any representation as to fact or law ... express or implied" which they know to be untrue or misleading. I shall reference in detail how the PACE authors have committed this offence below.

  • "Fraud by failing to disclose information" [Section 3 of the Act] – this is a case where a person fails to disclose any information to a third party when they are under a legal duty to disclose such information. I shall reference in detail how the PACE authors have committed this offence below.

  • "Fraud by abuse of position" [Section 4 of the Act] – this is a case where a person occupies a position where they are expected to safeguard the financial interests of another person, and abuses that position; this includes cases where the abuse consisted of an omission rather than an overt act. I shall reference in detail how the PACE authors have committed this offence below.

In order to support my complaint, I now discuss the nature of Fraud and what needs to be shown and proven to uphold such an accusation.

In each of the 3 cases of Fraud noted above, for an offence to have occurred,

  1. the person must have acted dishonestly, and

  2. they had to have acted with the intent of making a gain for themselves or anyone else, or inflicting a loss (or a risk of loss) on another. [‘The Intent Test’]

A clear test for dishonesty arose in the criminal case of R v Ghosh (1982) 75 CR App. R. 154 where this 2-stage test was marked down as:

  • "Were the person's actions honest according to the standards of reasonable and honest people?" If a jury decides that they were, then the defendant's claim to be honest will be credible. But, if the court decides that the actions were dishonest, the further question is:

  • "Did the person concerned believe that what he did was dishonest at the time?"

However, this 2-stage test was relaxed in the case of  Ivey v Genting Casinos (UK) Ltd t/a Crockfords [2017] UKSC 67 where it was decided that a view of the defendant's belief of the relevant facts must be made, but that it is no longer necessary to consider whether the person concerned believed that what he did was dishonest at the time. In other words, the second stage of the test is now no longer required to prove dishonesty.

 

It is my contention that at all points referenced below it is clear that a reasonable and honest person would conclude that the PACE authors’ actions were dishonest.

 

The making of a gain or the inflicting of a loss or risk on another is further defined in the 2006 Act. This definition is as follows - a ‘gain’ or a ‘loss’ is defined to consist only of a gain or a loss in money or property (including intangible property), but could be temporary or permanent. So, for example the payment of a salary or other monies for committing fraudulent offences passes this definition of ‘gain’ and it also passes ‘The Intent Test’ as noted above, since there is clear prior intent to make financial gain when paid a salary or other monies in such circumstances. A ‘gain’ could also be construed as gaining by keeping existing possessions, not just by obtaining new ones, and loss includes losses of expected acquisitions, as well as losses of already-held property.

 

Before laying out the detail of my complaint, the GMC investigators should consider the simple example of salary or monies paid to the PACE authors. If false representation, failure to disclose information and or an abuse of position are proven to have been committed, and dishonesty in such is also proven (as has already been noted above), then the criminal act of Fraud has been proven because the fact that intentional gain was made by the PACE authors is not in doubt, by way only of the fact that they received monies in respect of PACE. This leaves aside the matter of other ‘gains’ (promotions, status etc) for the PACE authors and ‘losses’ for others (eg loss or denial of state and private benefit claimants for CFS/ME sufferers – see below).

 

It is my contention that at all points referenced below it is clear that such a gain or loss was made and that the actions of the PACE authors showed intent on all these points.

 

In summary then a fraud is committed when false representation, failure to disclose information and or an abuse of position, carried out in a dishonest manner, that is dishonest according to the standards of reasonable and honest people, is accompanied by an intentional financial gain, temporary or permanent, made by the fraud perpetrator, or a financial loss or risk intentionally inflicted upon another, as a result of such committal.

 

The arguments as above, taken with the evidence below show clearly that the PACE authors are guilty of all three types of Fraud as defined in The 2006 Act.

The 2006 Act also provides two newly defined offences of fraud, namely

  • the possession of articles for use in frauds (Section 6) and

  • the making or supplying of articles for use in frauds (Section 7).

 

The PACE authors have committed offences under both of these sections of the 2006 Act because they have possessed and authored or reviewed PACE and aided its making and supplying [ie distribution in academic and wider circles]. The GMC investigators should investigate this specific complaint once the other complaints as listed below have been proven.

 

It is, therefore, the first plank of this complaint that the criminal act of Fraud has been committed by the PACE authors. In my submission below, I will reference each submitted line of evidence, where relevant, with the type of fraud, per the 2006 Act, that has been committed in that instance. I shall place these references in bold, underlined and in square brackets after the line of evidence, prefaced by the words ‘COMPLAINT Fraud Act 2006’, followed by the type of Fraud committed. Where such complaints of Fraud are highlighted, the fact that financial loss or gain has occurred has been demonstrated in this letter, eg either by way of gain by the PACE authors or loss for CFS/ME sufferers or others.

 

The sentencing guidelines for the criminal act of Fraud, in such cases as above, provide for sentences of up to ten years imprisonment and unlimited fines.

 

The complaint of Breach of GMP, GPR and CR

It is the second plank of this complaint that breaches of GMP, GPR and CR have been committed by the PACE authors. In my submission below, I will reference each submitted line of evidence, where relevant, with the Domain and Paragraph numbers of GMP/GPR/CR that relate to said evidence. I shall place these references in bold, underlined and in square brackets after the line of evidence, prefaced by ‘COMPLAINT’ and then either ‘GMP’, ‘GPR’ and or ‘CR’ and the relevant Domain and or paragraph.

In forming this plank of the complaint, I have made reference to these documents:

  • Good Medical Practice [2013] [Reference 3]–

http://www.gmc uk.org/guidance/good_medical_practice.asp

  • Good Practice in Research and Consent to Research [2010] [Reference 4] – http://www.gmc-uk.org/Good_practice_in_research_and_consent_to_research.pdf_58834843.pdf

The restrictions on practice (including striking off from the GMC register), required undertakings and or the placing of warnings on GMC registered doctors for breaching GMP, GPR and CR are well known to the GMC investigation team.

 

Summary of complaints

This is a complex case with a long history. This document is laid out in such a way that first it tells the narrative of that history [‘Summary of Case’ as below]. Complaints are referenced throughout this narrative. Then secondly the core evidence base is presented [‘The Evidence Base’, as below] and once again, complaints are referenced throughout this evidence base. All the preceding comments on the nature of Fraud and the GMC’s Guidelines, GMP, GPR and CR should be taken as supporting the narrative below.

In summary, the complaints being made concern the committing of criminal acts and or breaches of GMC guidance as follows -

  • Offences under section 2 Fraud Act 2006 – Fraud by false representation

  • Offences under section 3 Fraud Act 2006 – Fraud by failing to disclose information

  • Offences under section 4 Fraud Act 2006 - Fraud by abuse of position

  • Offences under sections 6 and 7 Fraud Act 2006 - the possession of articles for use in frauds (Section 6) and the making or supplying of articles for use in frauds (Section 7).

  • Breaches of GMP Domain 2 ‘Safety and Quality’

  • Breaches of GMP Domain 4 ‘Maintaining Trust’

  • Breaches of GMP paragraph 67 – ‘act with honesty and integrity’

  • Breaches of GPR ‘Research Design and Practice’, paragraphs 7-14

  • Breaches of GPR ‘Protect from Harm’, paragraphs 15-20

  • Breaches of GPR ‘Honesty and Integrity’, paragraphs 21-25

  • Breaches of GPR ‘Conflicts of Interest’, paragraphs 26-27

  • Breaches of CR ‘Sharing information’, paragraphs 4-6

  • Breaches of CR ‘Give information in a way people can understand’, paragraphs 7-8

Considering the sheer volume, extent and nature of these complaints, I would add to this list further overarching complaints vis:

  • Breach of GMP Domain 1 – Knowledge, skill and performance

  • Breach of GMP, paragraph 7 – ‘you must be competent in all aspects of your work, including management, research and teaching’

  • Breach of GMP, paragraph 11 – ‘you must be familiar with guidelines and developments that affect your work’

  • Breach of GMP, paragraph 12 – ‘you must keep up to date with, and follow, the law, our [sic GMC] guidance and other regulations relevant to your work

 

Summary of Case

 

The PACE study was one of the largest psychotherapy trials ever carried out on the chronic fatigue syndrome /myalgic encephalomyelitis (CFS/ME) patient community. Its aim was to assess the efficacy of cognitive behavioural therapy (CBT)and graded exercise therapy (GET) in the treatment of patients with CFS/ME.

 

This study was published in the Lancet in 2011 [Reference 1]. The PACE study concluded that 59% of CFS patient receiving CBT and 61% receiving GET had improved with an accompanying editorial suggesting that 22% of patients had recovered. As a result of the PACE study, National and indeed International Guidelines for the treatment of CFS/ME have evolved based on psychological therapies. Moreover, because of the perceived ‘gold standard’ of PACE, CFS/ME became generally regarded as a primarily psychological condition.

 

For example, NICE [National Institute for Health and Care Excellence] Clinical Guideline [CG53] ‘Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management’ recommends both CBT and GET in section 1.6.2 - https://www.nice.org.uk/guidance/cg53 [Reference 5] It is of note that said NICE Clinical Guideline is currently under review by NICE, as a result of the issues concerning PACE raised in the evidential base as recorded below. 

 

See here for the NICE decision on such a review of this Guideline – ‘Surveillance report 2017 – Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management (2007) NICE guideline CG53’

https://www.nice.org.uk/guidance/cg53/resources/surveillance-report-2017-chronic-fatigue-syndromemyalgic-encephalomyelitis-or-encephalopathy-diagnosis-and-management-2007-nice-guideline-cg53-4602203537/chapter/Surveillance-decision [Reference 6].

 

There is thus clear linkage between PACE and NICE guidelines for the treatment of CFS/ME because such a review of NICE CG53 has been precipitated by concerns over PACE, as expressed in ‘The Evidence Base’ below. The corollary is that CFS/ME patients have been harmed by the PACE authors because their treatments have been determined by PACE [via NICE CG53] and evidentially those treatments recommended by NICE CG53 [CBT and GET] for CFS/ME patients are harmful – references to the harm caused by CBT and GET can be found in Reference 8 but I am also highlighting 2 papers in the references section on the issue of harm as follows –

 

  • ‘Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome’ - http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx [Reference 9] and

  • http://journals.sagepub.com/eprint/hWSxVIBTzDtqisvafkhE/full [Reference 10].

 

Furthermore, DWP [Department for Work and Pensions] Guidance on CFS/ME "Continuing Medical Educational Programme, Chronic Fatigue Syndrome/Myalgic Encephalomyelitis(CFS/ME) Guidelines for the Disability Analyst: Version 8”, dated 2015, contains advice that CBT and GET should be recommended AND this Guideline references the PACE study to this effect. DWP assessors use this guidance to determine state benefit eligibility with regard to CFS/ME 

 

https://www.whatdotheyknow.com/request/313702/response/770712/attach/html/4/RED%2013%20MED%20S2%20CMEP%200017%20Mod%206%20Chronic%20Fatigue.pdf.html [Reference 7.

 

Therefore, there is clear linkage between PACE and DWP assessments for the provision of state benefits for CFS/ME sufferers. By simple inference such linkage exists between the provision of private health benefits and PACE – indeed I have seen as much in my practice. The corollary is that CFS/ME patients have lost financially as a result of the actions of the PACE authors, as demonstrated below.

 

Following a Freedom of Information Act search, the raw data from PACE was made public. It took patients 5 years to extract this evidence base from PACE authors who tried to block this request on the grounds that they viewed such requests as vexatious. [COMPLAINT – Fraud Act 2006 – Fraud by failure to disclose information] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25 – in blocking these requests the PACE Authors acted without integrity] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’ – in blocking these requests the PACE Authors acted without integrity]

 

Fresh analysis of this data by independent scientists has shown that the PACE study was scientifically and procedurally flawed. The PACE authors had manipulated the data in order to boost the trial’s apparent success rate. See the August 2017 Journal of Health Psychology Vol 22 Number 9 – which can be accessed in full here - http://journals.sagepub.com/toc/hpqa/22/9  [Reference 8]

 

This has been damaging to patients in many ways: 

  1. The PACE trial has effectively determined CFS/ME as a psychological condition. As a result, patients who suffer what is in fact a serious and debilitating physical condition, have been subject to therapies which at best are ineffective and at worse exacerbate the condition. Indeed, the concept of GET is an oxymoron because CFS/ME is a condition which by definition is worsened by exercise [COMPLAINT – GMP Domain 2 Safety and Quality - CBT, GET worsen CFS/ME]] [COMPLAINT GPR ‘Protect from Harm’, paragraphs 15-20 - CBT, GET worsen CFS/ME]

  2. Because PACE has reinforced the perception that CFS/ME is psychological, patients have been refused financial benefits for disability. Often this has been on the basis that they refuse to engage in CBT or GET. This is not surprising since other studies have clearly shown these therapies worsen their condition. [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated and this has caused loss to CFS/ME sufferers] [COMPLAINT – GMP Domain 2 Safety and Quality – CBT, GET worsen CFS/ME] [COMPLAINT GPR ‘Protect from Harm’, paragraphs 15-20 – CBT, GET worsen CFS/ME]

  3. For the same reasons, patients have been denied proper compensation for CFS/ME caused by conditions in the work place (typically poisoning by toxic chemicals) [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated and this has caused loss to CFS/ME sufferers]

  4. Patients have been denied effective physical treatments because they have been referred to psychiatrists instead of physicians who are knowledgeable in the physical treatment of CFS/ME [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated and the PACE authors have gained from this] [COMPLAINT – GMP Domain 2 Safety and Quality - CBT, GET worsen CFS/ME] [COMPLAINT GPR ‘Protect from Harm’, paragraphs 15-20 - CBT, GET worsen CFS/ME] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27 – PACE authors have gained fraudulently]

  5. Resources to explore biomedical physical therapies for CFS/ME have been diverted to what we know to be useless and often harmful psychological treatments. [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated and the PACE authors have gained from this] [COMPLAINT – GMP Domain 2 Safety and Quality- CBT, GET worsen CFS/ME] [COMPLAINT GPR ‘Protect from Harm’, paragraphs 15-20 - CBT, GET worsen CFS/ME] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27 – PACE authors have gained fraudulently]

 

The PACE study was publicly funded by the Medical Research Council, the Department for Work and Pensions, the Department of Health for England and the Scottish Chief Scientific Office with a combined cost of nearly £5million. Furthermore, the authors of PACE used over £220,000 of money from Queen Mary University of London to resist the FoI Act request for the raw data. Effectively PACE authors have mis-used public funds. This is financial fraud.  [COMPLAINT – Fraud Act 2006 – Fraud by failing to disclose information and Fraud by abuse of position]

 

 

The Evidence Base

 

The evidence base for these allegations can be found in the August 2017 Journal of Health Psychology Vol 22 Number 9.  http://journals.sagepub.com/toc/hpqa/22/9  [Reference 8]. In addition to comments in this complaint letter, I further submit Reference 8 in its entirety as part of my complaint concerning the PACE authors.

 

This journal published a commentary on the released PACE raw data by Dr Keith Geraghty. With access to such, Dr Geraghty pointed out that the PACE trial was seriously flawed in many ways concluding that:

 

“Lead authors overstated the effectiveness of CBT and GET therapy by lowering thresholds they used to determine improvement. Patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient………”

[COMPLAINT - Fraud Act 2006 – Fraud by abuse of position] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

In particular Geraghty wrote:

 

…….the trial investigators had altered assessment thresholds after the start of the trial…

[COMPLAINT - Fraud Act 2006 – Fraud by abuse of position] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

……...had applied a broad inclusion criteria, rather than strict sampling criteria.

[COMPLAINT - Fraud Act 2006 – Fraud by abuse of position] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

…….and contaminated the trial by promoting the success of CBT and GET in newsletters to trial participants during the course of the trial.

[COMPLAINT - Fraud Act 2006 – Fraud by abuse of position] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT – CR ‘Sharing information’, paragraphs 4-6] [COMPLAINT – CR ‘Give information in a way people can understand’, paragraphs 7-8]

 

…….some  of the PACE team were in fact [also] the Cochrane reviewers [of the PACE paper].

Within days of the [PACE data] release……It quickly became apparent that the improvements reported by White et al were much reduced when the original protocol thresholds were applied. ………..the effectiveness of CBT and GET fell from the reported 59 and 61 percent to just 20 and 21 percent respectively……the added benefit fell to 10 and 11 per cent respectively [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27 – some PACE authors were their own reviewers] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated]

 

…….initial gains reported at trial end (52 weeks) mostly disappeared between groups at follow up (2.5 years)………

[COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

……trial authors had favoured subjective self report measurement instruments over objective tests of physical function.

[COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated]

 

……..the PACE team lowered the threshold for improvement and recovery from a score of 85 on SF-36 to a score of 60 at the analysis stage. This change meant some trial participants had reached the level required to be classified as improved or recovered at trial entry, before they had even taken any treatment course.

[COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated]

 

 

….Much of the reported benefits in the PACE trial rested on patients’ perceptions of mood and fatigue, rather than measurements of their physical improvement

[COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position – ie the results of PACE are falsely stated]

 

The PACE team were invited to respond to the Geraghty critique and these two papers were held by the journal Editor David Marks who then invited commentaries from 40 academic groups with equal numbers on both sides of the debates. Marks published those of quality. This is an important point for the GMC to appreciate because this journal has effectively undertaken all the necessary investigation and peer reviewed analyses of PACE and subsequent commentaries.

 

The combined conclusion of those commentaries as summarised by David Marks was:

 

 “we should question the wisdom of spending £5million of public money on what can only be described as a poorly designed and scientifically flawed study.”

[COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Some examples of the peer reviewed comments from the Journal of Health Psychology are as follows. These are only examples and the GMC investigators are encouraged to read all comments laid out in Reference 8.

 

Editor -David Marks - page 1103

The PACE TRIAL investigators’ defence of the trial was in a template form that failed to engage with critics

 

PACE authors refused proper debate with their peers. [COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

 

On the question of conflict of interest, the PACE authors themselves appear to hold strong allegiances to CBT and GET – treatments they developed for ME/CFS.

PACE authors are biased

[COMPLAINT – Fraud Act 2006 –Fraud by abuse of position] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

Page 1103 to 1104

Stark conflicts of interest have been exposed by the commentaries including the PACE authors themselves who hold a double role as advisers to the UK government Dept of Work and Pensions, a sponsor of PACE, while at the same time working as advisers to large insurance companies who have gone on record about the potential financial losses from ME/CFS being declared a long term physical illness.

PACE authors were intellectually and possibly financially compromised. He who pays the piper calls the tune

[COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

Page 1104

PACE authors appeared unwilling to enter into the spirit of scientific debate. They acted with a sense of entitlement not to have to respond to criticism. Two pro-PACE authors even showed disdain for ME/CFS patients, stating: We have no wish to get into debates with patients. This is scientific arrogance

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

 [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession, show respect for patients and treat patients fairly]

 

David Tuller,School of Public Health California page 1118

Once again the PACE authors respond to concern with empty answers:

[their] responses have repeatedly failed to provide satisfactory explanations for the trial’s very serious flaws.  PACE authors refused a proper debate with their peers

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

 

David Tuller page1119

…..the investigators over hauled their definition of “recovery” in ways that boosted the trial’s apparent success rate  p1119

This is scientific fraud

[COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

[COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

13% of the sample met the recovery threshold for physical function at baseline.

Manipulation of the data to achieve a desired outcome

[COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

[COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

Page 1119

The PACE investigators withheld important evidence from the scientific record

Evidence was hidden to cover up for failings

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

[COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

Page 1119

Conscientious editors at journals that mistakenly publish such flawed research would immediately move to correct or retract it. Yet those serving as gate keepers and decision makers at Psychological Medicine……..have yet to acknowledge the glaring and fundamental problems with the PACE trial……….(one of the PACE investigators, Michael Sharpe, is on the Psychological Medicine editorial board).

PACE authors peer reviewed their own research. This is not peer review.

[COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27 – some PACE authors were their own reviewers] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT – Fraud Act 2006 – Fraud by false representation and Fraud by abuse of position]

 

Page 1121

White and his colleagues took 5 million pounds in government funds and promised to bring back apples from the market. Instead they brought back pears, refusing to show anyone the apples they had rejected.

This is scientific and financial fraud

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’]

 

Page 1121

With the release of the trial data, it is no longer enough to have persuaded themselves, Sir Simon Wessely, and other adherents that their methods are sound and the findings robust. The larger scientific world……….has found their reasoning problematic and their intellectual position unsustainable.

Scientific fraud. The PACE team misled themselves.

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

 

Page 1121

Rather than acknowledging the flaws that others now see clearly, the investigators appear determined to persist with their current approach and resist any concession of error.  Given this ill-advised and anti-scientific stance, they should prepare themselves for an even great onslaught of questions and challenges………

The leopards will not change their spots.

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position] [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

 

Steven Lubet, Northwestern Pritzker School of Law Chicago, page1123

Investigator bias and the PACE trial:

Conclusion: the PACE investigators impartiality might reasonably be questioned. In fact they were testing their own theories of the illness

PACE investigators were not impartial……….

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27]

 

Page 1124

The PACE Investigators were deeply committed to the “unhelpful cognitions” theory of ME/CFS which they and…….Simon Wessely  had originated and actively promoted for decades…….they used their positions of power to support their untenable theories.

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27]

 

Page 1124

…..the risk of latent bias was palpable from the onset…..it seems self evident that researchers’ intellectual allegiance to a favoured theory could potentially influence the conduct, design or interpretation of a randomised trial.

Clear intellectual conflict of interest.

This is researcher allegiance.

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27]

 

Caroline Wilshire  School of Psychology  Wellington New Zealand, 1128

The problem of bias in behavioural intervention studies: Lessons from the PACE trial:

PACE was a biased trial

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27]

 

Page 1129

…many relevant procedures and standards were adhered to, but there were some significant departures sufficient to undermine several key conclusions of the study

PACE investigators moved the goal posts to ensure a score

[COMPLAINT – Fraud Act 2006 –Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1130

Unfortunately in PACE, CBT and GET were promoted to patients during therapy as highly effective………....no such information was given to the remaining two groups.

PACE participants were mis-led and this distorted outcomes

[COMPLAINT – Fraud Act 2006 –Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14] [COMPLAINT – CR ‘Sharing information’, paragraphs 4-6] [COMPLAINT – CR ‘Give information in a way people can understand’, paragraphs 7-8]

 

We were able to demonstrate that apparently minor, late changes to the definition of recovery impacted very severely on the observed rates of recovery and on their final conclusions about the effectiveness of treatment

PACE moved the goal posts

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1130

Most of the objectively measurable outcomes did not yield significant treatment effects……

The patients thought they were improved but in fact they were not

[COMPLAINT – Fraud Act 2006 –Fraud by false representation]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1131

……..the PACE investigators did not even report the most worrying results until several years after the publication of the main findings, and when they did they dismissed them as unimportant.

Publish late and hope the fraud is over-looked.

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

 

Page 1131

About three-quarters of participants completed this assessment [15 months after completion of PACE] and at this stage the differences between the treatment groups on self reported measures were no longer statistically reliable. Alleged benefits of CBT and GET were lost in the medium term

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

 

Page1132

….there was no evidence from the [PACE] trial that patients can recover from CFS/ME as a result of either of these treatments

That says it all! £5 million wasted

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

 

Page 1134

Protocols and outcomes for the PACE trial were changed after the start of the trial. These changes made substantial differences, leading to exaggerated claims for the efficacy of CBT and GET in CFS/ME

Scientific fraud

[COMPLAINT – Fraud Act 2006 –Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1138

Patients want their health and independence back…………PACE showed that CBT and GET are ineffective in helping them to achieve this Ergo CFS/ME is not a psychological disease

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1141

PACE trial investigators were not successful in designing and implementing a valid pacing intervention and patient selection ambiguity further compromised the study’s outcome

Scientific fraud

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1147

…….one cannot conclude that these interventions [GET and CBT] are safe and risk free

Actually many patients were worsened by these treatments

[COMPLAINT GMP Domain 2 Safety and Quality] [COMPLAINT GPR ‘Protect from harm’, paragraphs 15-20]

 

Page 1154

PACE team response shows a disregard for the principles of science.

Scientific fraud

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1158

….the flaws are so egregious that it would serve well in an undergraduate textbook as an objective lesson in how not to design a trial. You could not make it up!

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1159

Our analysis indicates that the [PACE] researchers have shown significant bias in their accounts of the literature and may also have overstated the effectiveness of the ….treatments [CBT and GET]

hoc stercus tauri est [COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

[COMPLAINT – GPR ‘Conflicts of Interest’, paragraphs 26-27 – PACE authors have gained fraudulently]

 

Page 1164

PACE-gate is not just an example of flawed research. It is simply the latest in a series of studies which promote one school of thought. We find this hard to reconcile with best practice and evidence-based medicine

CBT and GET have no evidence base and cannot form part of National Guidelines

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Karen D Kirk Independent scholar Page 1168

PACE investigators’ response is misleading regarding patient survey results

PACE misrepresent patients in a way to support PACE recommendations

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1174

…patient survey data provide compellingly consistent evidence….that for most patients GET results in worsening of symptoms, CBT is ineffective……..

Patients know that CBT and GET make them worse…..

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT GMP Domain 2 Safety and Quality] [COMPLAINT GPR ‘Protect from harm’, paragraphs 15-20]

 

Keith Laws, School of Life and Medical Science  Herts UK Page  1179

We also know from the PACE trial itself that around 10% of patients find that CBT makes their condition “much worse” or “very much worse”

……….CBT currently seems to promise no gain but the possibility of some pain.

………….and there is no hope of these treatments resulting in cure.

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT GMP Domain 2 Safety and Quality] [COMPLAINT GPR ‘Protect from harm’, paragraphs 15-20]

 

Graham McPhee Independent scholar Page 1185

[PACE] continuing to rely on subjective measures is potentially misleading  and is rather like using different sets of elastic tape-measures at a Weight-Watchers meeting.

PACE move the goal posts

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Charles Shepherd page 1190

…..the enormous amount of public money spent by the Medical research Council and the Departments of Works and Pensions on funding the PACE trial, along with the legal costs of met by Queen Mary University of London in appealing against the Freedom of Information request, merits a formal inquiry……

PACE financial fraud should be investigated. We need a public inquiry into this abuse of CFS/ME patients

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

 

Bart Stouten Independent Scholar Netherlands page 1195

White et al systematically overestimate the effectiveness of CBT because they focus on subjective rather than objective outcomes

PACE authors chose the outcome which gave them the desired results

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

 

Steven Lubet Northwestern university Chicago page 1201

In defence of the PACE trial Petrie and Weinman employ a series  of misleading or fallacious argumentation techniques, including circularity, blaming the victim, bait and switch, non-sequitur, setting up a straw person, guilt by association, red herring, and the parade of horribles.

PACE techniques are similar to the legal equivalent of a kangaroo court

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession]

 

Susanna Agardy page 1206

….failure of PACE to achieve evidence of recovery through CBT and GET in either self reports of the objective measure of the 6 minutes walking test.

GET and CBT are ineffective

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT GMP Domain 2 Safety and Quality] [COMPLAINT GPR ‘Protect from harm’, paragraphs 15-20]

 

Keith Geraghty 1213

The majority of invited expert commentaries in the Journal of Health Psychology echo the concerns raised by Geraghty (2016).

They are in agreement over the PACE fraud

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT GMP Domain 2 Safety and Quality] [COMPLAINT GPR ‘Protect from harm’, paragraphs 15-20]

 

Page 1212

..the PACE authors abandoned [the recovery threshold originally agreed] mid-trial in favour of an SF-36 score of 60 – roughly around where a patient with congestive heart failure might fall (hardly a good marker of recovery).

PACE moved the posts so much that a heart failure outcome ranked as a success

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT GMP Domain 2 Safety and Quality] [COMPLAINT GPR ‘Protect from harm’, paragraphs 15-20] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Page 1214

PACE is a controversial trial that does not stand up well to close scrutiny. The majority of participants in the trial did not recover and the majority were not substantially functionally improved. Participants in PACE were drawn from milder cases, with more severe cases excluded.

………the benefits of CBT and GET were overstated, the result of changes to the trial protocol.

…..the modest benefit reported in PACE rests on subjective accounts of improvement.

Findings from the trial have been terminally damaged by the way in which the trial was conducted, with a lack of care for treatment fidelity and contamination – so much so, that doctors, commissioners and patients can have little faith in the outcomes reported

Commentaries are agreed that this is scientific fraud. This fraud was funded by public money. This makes the authors of PACE guilty of financial fraud.

[COMPLAINT – Fraud Act 2006 – Fraud by false representation, Fraud by failing to disclose information and Fraud by abuse of position]

[COMPLAINT GPR ‘Honesty and Integrity’, paragraphs 21-25] [COMPLAINT GMP paragraph 67 – ‘act with honesty and integrity’] [COMPLAINT GMP Domain 4, ‘Maintaining Trust’ Maintain trust in the profession] [COMPLAINT GMP Domain 2 Safety and Quality] [COMPLAINT GPR ‘Protect from harm’, paragraphs 15-20] [COMPLAINT - GPR ‘Research Design and Practice’, paragraphs 7-14]

 

Urgent action is required

 

Six years have elapsed between publication of the PACE trial and its exposure as a fraud. It is already clear that many patients have suffered and continue to suffer as a direct result of this fraud. So, I am writing to inform the GMC of this public health hazard so that the GMC can take immediate action to prevent further harm to patients. Indeed, the primary function of the GMC is to protect patients. This quote below is taken from the GMC website:

 

“We are an independent organisation that helps to protect patients….” http://www.gmc-uk.org/about/role.asp

 

In the interim I shall be informing CFS/ME sufferers through social media and other means to get in touch with the GMC directly, by way of example of the harm done by the PACE authors, and to confirm the seriousness of the injuries they have suffered. I shall ask patients to report directly to the GMC in the following categories:

  • Those who have suffered damage as a result of CBT.

  • Those who have suffered damage as a result of GET.

  • Those who have been denied disability benefits because the physical nature of their disease has not been properly recognised and/or they have been told they have a psychological condition.

  • Those who have been denied industrial compensation for their disease because the physical nature of their disease has not been properly recognised and/or they have been told they have a psychological condition.

  • Those who have been denied referral or funding for referral to a physician specialising in the biomedical approach to treating CFS/ME.

 

These patient submissions will also form part of this complaint.

 

I give my consent to you to share my complaint and all the attached supporting information with

  • All the named PACE Study doctors and

  • their employers, and

  • other relevant individuals or organisations, where necessary to progress your investigation

 

 

Yours sincerely

 

 

Lead Author:  Dr Sarah Myhill MBBS  office@doctormyhill.co.uk

There are seven other medical doctors who have also signed this letter. However, they are concerned about the impact of such “whistle-blowing” on their future careers within and without the NHS.

We can release the names of these doctors to one named Registrar within the GMC on the understanding that these names are not released to PACE authors and do not get into the public domain. Should this occur then that Registrar will be held personally liable.

 

This letter is being sent by email  - there is also a hard copy in the post.

 

 

References:

 

1.List of PACE Authors

‘Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. (2011)’ Prof PD White, MD

KA Goldsmith, MPH  AL Johnson, PhD L Potts, MSc R Walwyn, MSc JC DeCesare, BSc HL Baber, BSc M Burgess, PhD LV Clark, PhD DL Cox, PhD J Bavinton, BSc BJ Angus, MD

G Murphy, MSc M Murphy, FRCP H O'Dowd, PhD  D Wilks, FRCP[Ed] Prof P McCrone, PhD Prof T Chalder, PhD Prof M Sharpe, MD

The Lancet 377(9768): 823-836

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract

 

2.GMC Thresholds [2016]

http://www.gmc-uk.org/Guidance_GMC_Thresholds.pdf_48163325.pdf

 

3.Good Medical Practice [2013]

http://www.gmc uk.org/guidance/good_medical_practice.asp

4.Good Practice in Research and Consent to Research [2010] [updated 2013]

http://www.gmc uk.org/Good_practice_in_research_and_consent_to_research.pdf_58834843.pdf

 

5.NICE [National Institute for Health and Care Excellence] Clinical Guideline [CG53]

 

https://www.nice.org.uk/guidance/cg53

 

6.Surveillance report 2017 – Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management (2007) NICE guideline CG53

 

https://www.nice.org.uk/guidance/cg53/resources/surveillance-report-2017-chronic-fatigue-syndromemyalgic-encephalomyelitis-or-encephalopathy-diagnosis-and-management-2007-nice-guideline-cg53-4602203537/chapter/Surveillance-decision

 

7.Continuing Medical Educational Programme, Chronic Fatigue Syndrome/Myalgic Encephalomyelitis(CFS/ME) Guidelines for the Disability Analyst: Version 8

 

https://www.whatdotheyknow.com/request/313702/response/770712/attach/html/4/RED%2013%20MED%20S2%20CMEP%200017%20Mod%206%20Chronic%20Fatigue.pdf.html

 

8. August 2017 Journal of Health Psychology Vol 22 Number 9

 

http://journals.sagepub.com/toc/hpqa/22/9

 

9.Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome’

 

http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx

 

10.Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and

pacing treatments: Analysis of a primary survey compared with secondary surveys

 

http://journals.sagepub.com/eprint/hWSxVIBTzDtqisvafkhE/full

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PACE patient support letter

 

Sir Terence Stephenson

General Medical Council
Fitness to Practise Directorate
3 Hardman Street
Manchester, M3 3AW.

 [INSERT DATE]

 

[INSERT ADDRESS and EMAIL OF PATIENT COMPLAINANT]

 

Dear Sir Terence

 

DOCTORS COMPLAINED ABOUT - such authors of the PACE TRIAL ([1] below) as are subject to GMC regulation.

 

BACKGROUND

I am writing in support of the above complaint submitted to yourself by Dr Sarah Myhill et al. This complaint was submitted to the GMC on 14 January 2018.

I am not using your standard form of complaint (https://www.gmc-uk.org/DC6046_Hardcopy_form_52934724.pdf)  as its format does not lend itself to the nature of this supporting letter of complaint.

 

In the last paragraph of her complaint letter, Dr Myhill states that she will be gathering patient support for the issues raised in her letter. Namely, Dr Myhill states that she will be asking ME sufferers to get in touch with the GMC directly, by way of example of the harm done by the PACE authors, to them specifically, and to confirm the seriousness of the injuries they personally have suffered.

 

Dr Myhill asked that such letters of support from ME sufferers, who have personally been harmed by the actions of the PACE authors, should be considered in the following categories:

  • Those who have suffered damage because of CBT.

  • Those who have suffered damage because of GET.

 

  • Those who have been denied disability benefits because the physical nature of their disease has not been properly recognised and/or they have been told they have a psychological condition.

 

  • Those who have been denied industrial compensation for their disease because the physical nature of their disease has not been properly recognised and/or they have been told they have a psychological condition.

 

  • Those who have been denied referral or funding for referral to a physician specialising in the biomedical approach to treating CFS/ME.

 

I am writing this letter in support of Dr Myhill’s complaint and am submitting details of my personal case in respect of items [INSERT THE NUMBERS AS ABOVE WHERE PACE HAS HARMED THE SUFFERER]

 

DATES THAT SUCH HARM WAS DONE

 

I am aware that the GMC does not usually investigate concerns about events that took place over 5 years ago.

 

THEN CHOOSE EITHER OF THESE PARAGRAPHS AS APPLICABLE:

 

  • The events that I am describing here took place between the dates to and so fall within the usual five years cut off period.

  • The events that I am describing here took place between the dates to and so do not fall within the usual five years cut off period but I consider the harm done to me to be so serious that the GMC should now review these circumstances. In addition, as per GMC Guidance Notes, I consider that the GMC should review my supporting documentation because I was to raise these issues earlier due to my ill health. Also, the PACE study had not been formally scientifically discredited at that earlier time (even though it was flawed in its design and analysis at its date of publication) and so any case I had put forward at that time for harm caused to me by the PACE authors would not have been so strongly supported by third party evidence. Dr Myhill has detailed the scientific discrediting of PACE in her letter, including full details of third party evidence, and so I shall not repeat it here.

 

DETAILS OF SPECIFIC HARM DONE TO ME

 

  • SUFFERER TO INSERT THEIR PERSONAL DETAILS OF HARM

  • MUST REFER TO THE FACT THAT PACE WAS AT THE ROOT OF THESE PROBLEMS

  • EG I WAS HARMED BY GET AND PACE RECOMMENDED GET AND SO PACE AUTHORS ARE AT FAULT BECAUSE I WAS RECOMMENDED GET BECAUSE OF PACE

  • EG I WAS REFUSED BENEFITS BECAUSE I WAS UNABLE TO PARTICIPATE IN GET/CBT AS RECOMMENDED BY PACE AND SO BENEFITS WERE STOPPED

  •  

 

OTHER INFORMATION

 

THEN CHOOSE EITHER OF THESE PARAGRAPHS AS APPLICABLE:

 

  • I can confirm that I have not complained about this matter before.

  • I have previously complained about the harm done to me by the PACE authors and the nature of my complaint was The outcome of this complaint was

 

I give my consent to you to share my complaint and all the attached supporting information with

  • All the named doctors and

  • their employers, and

  • other relevant individuals or organisations, where necessary to progress your investigation

 

Beneath my signature, I reference links [2,3,4] which confirm the discrediting of PACE and also the harm done to ME sufferers as a result of the recommendations for treatment in PACE. I am submitting these documents in support of my personal complaint because they support, in general terms, the fact that PACE has been discredited and the fact that treatments recommended by PACE have been shown to harm ME sufferers.

 

Your faithfully,

 

 

 

NAME OF SUFFERER

(I am an ME sufferer of [INSERT NUMBER] years]

 

1.List of PACE Authors

‘Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. (2011)’ Prof PD White, MD

KA Goldsmith, MPH  AL Johnson, PhD L Potts, MSc R Walwyn, MSc JC DeCesare, BSc HL Baber, BSc M Burgess, PhD LV Clark, PhD DL Cox, PhD J Bavinton, BSc BJ Angus, MD

G Murphy, MSc M Murphy, FRCP H O'Dowd, PhD  D Wilks, FRCP[Ed] Prof P McCrone, PhD Prof T Chalder, PhD Prof M Sharpe, MD

The Lancet 377(9768): 823-836

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract

 

2. August 2017 Journal of Health Psychology Vol 22 Number 9

 

http://journals.sagepub.com/toc/hpqa/22/9

 

3.Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome’

 

http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx

 

4.Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and

pacing treatments: Analysis of a primary survey compared with secondary surveys

 

http://journals.sagepub.com/eprint/hWSxVIBTzDtqisvafkhE/full

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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