Trial by Error: Retired PACE Investigator Peter White and Swiss Re

By David Tuller, DrPH

On November 17, 2015, a few weeks after publication of my 15,000-word investigation of the PACE trial, I posted a blog about a talk Peter White gave to Swiss Re employees on the findings from his bogus study. Professor White, of course, was the lead PACE investigator and also served–and apparently still serves–as “chief medical officer” for the insurance company.

Swiss Re has released information about its 2017 “insurance medicine summit,” to be held this coming November. Not surprisingly, Professor White is on the schedule. Although he has retired from his academic position, he apparently continues his work promoting his egregious research to insurers. His talk is called “Burn out, vital exhaustion and chronic fatigue syndrome: Old wine in new bottles?” Presumably he will once more be discussing the false PACE trial results and perhaps the campaign of “harassment” that he claims angry patients have waged against him.

It cannot be repeated often enough that the tribunal decision from last summer, which ordered the release of the raw trial data, dismissed the claims of harassment as baseless. The tribunal found that the only credible evidence of such behavior was that Professor Trudie Chalder was once heckled during a lecture. However, the tribunal’s scathing decision hasn’t prevented these dishonest researchers from continuing their disinformation campaign against the patient community.

Given Professor White’s ongoing role with the Swiss Re, I decided to repost the 2015 blog below. Shortly after I initially posted the blog, the insurance company removed from its website the article touting Professor White’s presentation. Therefore, in this version, I am linking instead to a screen-shot of the “disappeared” page. (Thanks, Anil van der Zee!)

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Trial by Error, Continued: PACE Team’s Work for Insurance Companies Is “Not Related” to PACE. Really?

By David Tuller, DrPH

In my initial story on Virology Blog, I charged the PACE investigators with violating the Declaration of Helsinki, developed in the 1950s by the World Medical Association to protect human research subjects. The declaration mandates that scientists disclose “institutional affiliations” and “any possible conflicts of interest” to prospective trial participants as part of the process of obtaining informed consent.

The investigators promised in their protocol to adhere to this foundational human rights document, among other ethical codes. Despite this promise, they did not tell prospective participants about their financial and consulting links with insurance companies, including those in the disability sector. That ethical breach raises serious concerns about whether the “informed consent” they obtained from all 641 of their trial participants was truly “informed,” and therefore legitimate.

The PACE investigators do not agree that the lack of disclosure is an ethical breach. In their response to my Virology Blog story, they did not even mention the Declaration of Helsinki or explain why they violated it in seeking informed consent. Instead, they defended their actions by noting that they had disclosed their financial and consulting links in the published articles, and had informed participants about who funded the research–responses that did not address the central concern.

“I find their statement that they disclosed to The Lancet but not to potential subjects bemusing,” said Jon Merz, a professor of medical ethics at the University of Pennsylvania. “The issue is coming clean to all who would rely on their objectivity and fairness in conducting their science. Disclosure is the least we require of scientists, as it puts those who should be able to trust them on notice that they may be serving two masters.”

In their Virology Blog response, the PACE team also stated that no insurance companies were involved in the research, that only three of the 19 investigators “have done consultancy work at various times for insurance companies,” and that this work “was not related to the research.” The first statement was true, but direct involvement in a study is of course only one possible form of conflict of interest. The second statement was false. According to the PACE team’s conflict of interest disclosures in The Lancet, the actual number of researchers with insurance industry ties was four—along with the three principal investigators, physiotherapist Jessica Bavington acknowledged such links.

But here, I’ll focus on the third claim–that their consulting work “was not related to the research.” In particular, I’ll examine an online article posted by Swiss Re, a large reinsurance company. The article describes a “web-based discussion group” held with Peter White, the lead PACE investigator, and reveals some of the claims-assessing recommendations arising from that presentation. White included consulting work with Swiss Re in his Lancet disclosure.

The Lancet published the PACE results in February, 2011; the undated Swiss Re article was published sometime within the following year or so. The headline: “Managing claims for chronic fatigue the active way.” (Note that this headline uses “chronic fatigue” rather than “chronic fatigue syndrome,” although chronic fatigue is a symptom common to many illnesses and is quite distinct from the disease known as chronic fatigue syndrome. Understanding the difference between the two would likely be helpful in making decisions about insurance claims.)

The Swiss Re article noted that the illness “can be an emotive subject” and then focused on the implications of the PACE study for assessing insurance claims. It started with a summary account of the findings from the study, reporting that the “active rehabilitation” arms of cognitive behavioral therapy and graded exercise therapy “resulted in greater reduction of patients’ fatigue and larger improvement in physical functioning” than either adaptive pacing therapy or specialist medical care, the baseline condition. (The three intervention arms also received specialist medical care.)

The trial’s “key message,” declared the article, was that “pushing the limits in a therapeutic setting using well described treatment modalities is more effective in alleviating fatigue and dysfunction than staying within the limits imposed by the illness traditionally advocated by ‘pacing.’”

Added the article: “If a CFS patient does not gradually increase their activity, supported by an appropriate therapist, then their recovery will be slower. This seems a simple message but it is an important one as many believe that ‘pacing’ is the most beneficial treatment.”

This understanding of the PACE research—presumably based on information from Peter White’s web-based discussion—was wrong. Pacing is not and has never been a “treatment.” It is also not one of the “four most commonly used therapies,” as the newsletter article declared, since it has never been a “therapy” either. It is a self-help method practiced by many patients seeking the best way to manage their limited energy reserves.

The PACE investigators did not test pacing. Instead, the intervention they dubbed “adaptive pacing therapy” was an operationalized version of “pacing” developed specifically for the study. Many patients objected to the trial’s form of pacing as overly prescriptive, demanding and unlike the version they practiced on their own. Transforming an intuitive, self-directed approach into a “treatment” administered by a “therapist” was not a true test of whether the self-help approach is effective, they argued–with significant justification. Yet the Swiss Re article presented “adaptive pacing therapy” as if it were identical to “pacing.”

The Swiss Re article did not mention that the reported improvements from “active rehabilitation” were based on subjective outcomes and were not supported by the study’s objective data. Nor did it report any of the major flaws of the PACE study or offer any reasons to doubt the integrity of the findings.

The article next asked, “What can insurers and reinsurers do to assist the recovery and return to work of CFS claimants?” It then described the conclusions to be drawn from the discussion with White about the PACE trial—the “key takeaways for claims management.”

First, Swiss Re advised its employees, question the diagnosis, because “misdiagnosis is not uncommon.”

The second point was this: “It is likely that input will be required to change a claimant’s beliefs about his or her condition and the effectiveness of active rehabilitation…Funding for these CFS treatments is not expensive (in the UK, around £2,000) so insurers may well want to consider funding this for the right claimants.”

Translation: Patients who believe they have a medical disease are wrong, and they need to be persuaded that they are wrong and that they can get better with therapy. Insurers can avoid large payouts by covering the minimal costs of these treatments for patients vulnerable to such persuasion, given the right “input.”

Finally, the article warned that private therapists might not provide the kinds of “input” required to convince patients they were wrong. Instead of appropriately “active” approaches like cognitive behavior therapy and graded exercise therapy, these therapists might instead pursue treatments that could reinforce claimants’ misguided beliefs about being seriously ill, the article suggested.

“Check that private practitioners are delivering active rehabilitation therapies, such as those described in this article, as opposed to sick role adaptation,” the Swiss RE article advised. (The PACE investigators, drawing on the concept known as “the sick role” in medical sociology, have long expressed concern that advocacy groups enabled patients’ condition by bolstering their conviction that they suffered from a “medical disease,” as Michael Sharpe, another key PACE investigator, noted in a 2002 UNUMProvident report. This conviction encouraged patients to demand social benefits and health care resources rather than focus on improving through therapy, Sharpe wrote.)

Lastly, the Swiss Re article addressed “a final point specific to claims assessment.” A diagnosis of chronic fatigue syndrome, stated the article, provided an opportunity in some cases to apply a mental health exclusion, depending upon the wording of the policy. In contrast, a diagnosis of myalgic encephalomyelitis did not.

The World Health Organization’s International Classification for Diseases, or ICD, which clinicians and insurance companies use for coding purposes, categorizes myalgic encephalomyelitis as a neurological disorder that is synonymous with the terms “post-viral fatigue syndrome” and “chronic fatigue syndrome.” But the Swiss Re article stated that, according to the ICD, “chronic fatigue syndrome” can also “alternatively be defined as neurasthenia which is in the mental health chapter.”

The PACE investigators have repeatedly advanced this questionable idea. In the ICD’s mental health section, neurasthenia is defined as “a mental disorder characterized by chronic fatigue and concomitant physiologic symptoms,” but there is no mention of “chronic fatigue syndrome” as a discrete entity. The PACE investigators (and Swiss Re newsletter writers) believe that the neurasthenia entry encompasses the illness known as “chronic fatigue syndrome,” not just the common symptom of “chronic fatigue.”

This interpretation, however, appears to be at odds with an ICD rule that illnesses cannot be listed in two separate places—a rule confirmed in an e-mail from a WHO official to an advocate who had questioned the PACE investigators’ argument. “It is not permitted for the same condition to be classified to more than one rubric as this would mean that the individual categories and subcategories were no longer mutually exclusive,” wrote the official to Margaret Weston, the pseudonym for a longtime clinical manager in the U.K. National Health Service.

Presumably, after White disseminated the good news about the PACE results at the web-based discussion, Swiss Re’s claims managers felt better equipped to help ME/CFS claimants. And presumably that help included coverage for cognitive behavior therapy and graded exercise therapy so that claimants could receive the critical “input” they needed in order to recognize and accept that they didn’t have a medical disease after all.

In sum, contrary to the investigators’ argument in their response to Virology Blog, the PACE research and findings appear to be very much “related to” insurance industry consulting work. The claim that these relationships did not represent “possible conflicts of interest” and “institutional affiliations” requiring disclosure under the Declaration of Helsinki cannot be taken seriously.

Update 11/17/15 12:22 PM: I should have mentioned in the story that, in the PACE trial, participants in the cognitive behavior therapy and graded exercise therapy arms were no more likely to have increased their hours of employment than those in the other arms. In other words, there was no evidence for the claims presented in the Swiss Re article, based on Peter White’s presentation, that these treatments were any more effective in getting people back to work.

The PACE investigators published this employment data in a 2012 paper in PLoS One. It is unclear whether Peter White already knew these results at the time of his Swiss Re presentation on the PACE results.

Update 11/18/15 6:54 AM: I also forgot to mention in the story that the three principal PACE investigators did not respond to an e-mail seeking comment about their insurance industry work. Lancet editor Richard Horton also did not respond to an e-mail seeking comment.

Comments on this entry are closed.

  • David Marks

    Thirty years? That time is almost up. Wellesly’s first paper on CFS was in 1989: Wessely S, Powell R: Fatigue syndromes: a comparison of chronic “postviral” fatigue with neuromuscular and affective disorders. J Neurol Neurosurg Psychiatry 1989;52:940–8.

  • To clarify: all ICD-10 terms are known as “legacy terms” in the context of ICD-11.

    A “legacy term” does not mean “retired” but carried forward from ICD-10, as opposed to one of the hundreds of new terms that are being included in ICD-11 for the first time.

    The three G93.3 terms were put back into the public version of the ICD-11 Beta draft platform on March 26, 2017.

    You can view the listing for PVFS, BME and CFS here:

    http://apps.who.int/classifications/icd11/browse/f/en#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f569175314

    As currently stands, both CFS and BME are listed as inclusion terms to Title entity, PVFS. The terms were returned to the draft with the caveat that ICD Revision is still deliberating the most appropriate placing in the classification.

    (PVFS lost its parent class “Other disorders of brain” as this parent class has been retired for ICD-11. This affected several other ICD-10 terms, not just the G93.3 terms.)

    On March 26, Exclusions for CFS and (Benign) ME were inserted under “Fatigue” in the Symptoms, signs chapter.

    WHO/ICD Revision has issued three written clarifications that there is no proposal and no intention to locate the G93.3 terms in the Mental, behavioural and neurodevelopmental chapter.

    However, the proposed “Bodily distress disorder” (which replaces all but one of the ICD-10 Somatoform disorders and Neurasthenia) is problematic.

    A request for Exclusions for the three G93.3 terms under “Bodily distress disorder” was included in the formal proposal submitted by myself and Mary Dimmock on March 27.

    “Bodily distress disorder” as defined by ICD-11 is very close to the DSM-‘s “Somatic symptom disorder” in its characterization, definition and criteria and shares the same problems as SSD.

    Information on our proposal for ICD-11 can be accessed here:

    https://dxrevisionwatch.com/2017/04/03/a-proposal-for-the-icd-10-g93-3-legacy-terms-for-icd-11-part-two/

    Suzy Chapman, Dx Revision Watch

  • It’s the Data Protection Act for access to personal information held:

    https://ico.org.uk/for-the-public/personal-information/

  • Jo Best

    Is it ok to share the link to the IIMEC12 DVD set http://investinme.eu/IIMEC12.shtml#dvd which includes David Tuller’s unmissable pre-conference dinner presentation on the PACE trial (and other matters) along with all the presentations on conference day June 2nd 2017: Ian Gibson (Chair) Ian Charles (Quadram Institute) Vicky Whittemore (NIH) Donald Staines (Griffith University) Nancy Klimas (Nova Southeastern University) Jakob Theorell (Karolinska Institutet) Jo Cambridge (University College London) Simon Carding (Quadram Science) Mady Hornig (Columbia University) Olav Mella, and Ingrid Rekeland on behalf of Øystein Fluge (Haukeland University Hospital) Warren Tate (University of Otago) Ron Davis (Stanford Genome Technology Center) and PhD students Fane Mensah (UCL) Daniel Vipond, Shen-Yuan Hsieh, Fiona Newberry, Katharine Seton (Quadram Science).

  • Rivka Solomon

    Excellent piece when you first published it, and still excellent now. Is there no researcher ethic review board we can bring this case to?

  • For an expansion on how PDW plays fast and loose with WHO’s ICD terminology, see:

    http://forums.phoenixrising.me/index.php?threads/icd-11-status-reports-g93-3-legacy-terms-pvfs-bme-cfs.49549/page-9#post-834454

    The PDF at the end of this Phoenix Rising post contains a partial transcript of Prof Peter White’s presentation at the Royal Society of Medicine CFS Conference, London, April 28, 2008 during which he discussed his views on the utility of what he refers to as the “ICD-10 criteria” for ME and CFS.

    After running through a list of possible terms he claims one might pick from in ICD-10, he concludes:

    “So ICD-10 is not helpful and I would not suggest, as clinicians, you use ICD-10 criteria. They really need sorting out; and they will be in due course, God willing.”

    In this post I set out that several of the terms cited by White as ICD-10 terms, don’t exist in ICD-10 or are little used historical terms and that he is scraping the barrel in his bid to discourage the use of ICD-10.

  • PDW is (or has been) a member of IMEG:

    https://www.gov.uk/government/organisations/independent-medical-expert-group/about/membership

    What we do

    The Independent Medical Expert Group advises the Minister for Defence
    Personnel and Veterans on medical and scientific aspects of Armed Forces
    Compensation Scheme (AFCS) and related matters.

    IMEG is an advisory non-departmental public body, sponsored by the Ministry of Defence.

    https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/583356/20170111_IMEG_Register_of_Members_Interests_-_FINAL.pdf

    Independent Medical Expert Group

    Transparency data

    Register of Members Interests (for Chair and Members)

    1. Professor Sir Anthony Newman Taylor

    2. Professor Linda Luxon

    3. Professor James Ryan

    4. Professor David Snashall

    5. Professor Peter White

    6. Doctor John Scadding

    Members of the Independent Medical Expert Group (IMEG) are required to
    declare any personal, political or business interests that could (or
    could be seen to) influence their judgement.

    (…)

    5. Professor Peter White (Medical member)

    Other public appointments held at present:

    Professor of Psychological Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London.

    European Association for Psychosomatic Medicine (Advisory Board member).

    [Ed: Now Emeritus Professor of Psychological Medicine, having retired from QMUL
    at the end of 2016. Also retired in 2016 as honorary consultant
    liaison psychiatrist at St Bartholomew’s hospital and the co-lead of the
    East London chronic fatigue syndrome (CFS) service.]

    Personal and business interests:

    Consultancy to Swiss Re re-insurance company.

    Director, Added Value Advisory Services Ltd.

    Previous public appointments held within the last 5 years:

    Member London Region NIHR Research for Benefit research panel.

    Member of Department of Health’s advisory
    group to expand IAPT programme to include medically unexplained symptoms
    and long term health conditions.

    Honorary consultant liaison psychiatrist to the East London Foundation NHS trust and Barts Health NHS trust.

    Member MRC CFS/ME expert working group to encourage biomedical research.

    Political activity: None.

    (…)

  • freecell0sd

    It seems that, just as Swiss Re removed their page detailing White’s presentation to them on the PACE trial’s after you had blogged about it, so to have they now removed him from the page you link to in this blog. Did anyone save a copy of the page which described him as one of Swiss Re’s Chief Medical Officers?

  • Barry
  • They are clowns and have caused the patient population immeasurable harm. A tragedy that we as patients have had to suffer so much – especially those who are now *more* disabled as a result of GET – before this cabal and its supporters were finally exposed to the wider world for what they are.

  • John Leslie Whiting

    Yes, I have the page saved

  • Barry

    I posted links to cached pages showing the information before it was deleted. But it’s been deleted as Spam, which it was not – it was my post. Maybe someone reported it as spam who did not want the information made available?

  • freecell0sd

    Hopefully someone will notice and it will be restored?

  • freecell0sd

    Are they available anywhere on-line?

  • freecell0sd
  • John Leslie Whiting

    No, I haven’t posted it. I have it in pdf format. I don’t know the rules about posting something like this. Maybe someone could advise me?

  • Barry

    These cached pages have now been updated as well so no PW there either.

  • freecell0sd

    Thanks Barry. After I asked about this someone else sent me saved copies of the pages too, so they are now archived off-line too.