Trial By Error: PACE Team Stages a Comeback Tour

By David Tuller, DrPH

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Professors Peter White, Trudie Chalder and Michael Sharpe seem to have embarked on what could be called the PACE Rehabilitation Tour.

This is an apparent effort to salvage their reputations and save professional face now that the UK’s National Institute for Health and Care Excellence (NICE) has officially rescinded its previous recommendations for graded exercise therapy and cognitive behavior therapy as treatments for what the agency currently calls ME/CFS. It is also an effort by these professors to gain a foothold in the long Covid marketplace. They hope their crumbling GET/CBT treatment paradigm for ME/CFS can revive its fortunes in a post-coronavirus world.

Last week, HealthSense, a UK watchdog group formerly called HealthWatch, posted Professor White’s umpteenth defense of the £5.000,000 PACE trial, which he co-led with Professors Sharpe and Chalder. The trial purported to show that GET and CBT were effective treatments. Professor White’s article was a feeble response to a cogent HealthSense commentary by Caroline Struthers, a Senior EQUATOR Research Fellow at Oxford University (also a friend and colleague), called “It is not only drugs and devices that can harm.”

And yesterday, The Guardian published a letter from the PACE trio in response to a compelling personal account of long Covid from Ravi Veriah Jacques, a 23-year-old who has been disabled from the illness. In discussing ME/CFS, Veriah Jacques included information about the debunking of the PACE trial findings. He also mentioned the publication last fall by NICE of new clinical guidelines for the illness, which reversed the agency’s earlier position. (Apparently, the letter was in The Observer, The Guardian‘s Sunday sister paper, but it was published on The Guardian‘s website, so from my perspective that means it was published by The Guardian as well, whatever The Observer‘s editorial role.)

In their response, the PACE trio suggested that Veriah Jacques was “misinformed” about the trial. (This is their routine response to criticism—it is based on a misunderstanding or miscommunication or on mistaken assumptions or on the other person’s failure to have read the article in question.) They acknowledged that NICE no longer recommends the treatments. (The guidelines allow for CBT as supportive care.) Their counter-argument was that objections to the NICE decision were raised by four trade groups of doctors. Since these trade groups essentially serve as campaigners and lobbyists for advancing physicians’ professional and financial interests and preserving their status, their testimony is not necessarily convincing, especially when they argue against the evidence.

(In the UK, such trade groups are grandiosely referred to as “royal colleges.” The groups appear to believe, for unclear reasons, that they are owed some particular deference and should be seen as objective and above reproach in all matters.)

The PACE investigators ended their letter to The Guardian with an explicit appeal to extend their domain to long Covid. “CBT and GET may help some sufferers from long Covid but, unless we fund research to test them, we will never know for certain,” they write.

Let’s pause to reflect on that statement. It was clear from the start of the pandemic to anyone who was paying attention to this arena of activity that the long-term sequelae of Covid-19 would likely be the new frontier for the GET/CBT ideological brigades. Now here it is. They see research with long Covid patients as the means to revive the fortunes of the PACE approach.


A methodological and ethical disaster

It cannot be stated often enough that the PACE trial was a methodological and ethical disaster—a case of egregious research misconduct, in my opinion.

Its failures are now widely known. It has been taught in Berkeley graduate epidemiology seminars as a case study of how NOT to conduct a clinical trial. Its findings have been refuted effectively in a re-analysis in BMC Psychology. (I was a co-author.) A 2018 letter to The Lancet, signed by more than 100 experts from around the world, referenced the trial’s “unacceptable methodological lapses.” The letter triggered coverage in The Times and BMJ, disseminating news of international dismay about the PACE trial to the general public.

After years of having their study lauded as a “thing of beauty” (Professor Sir Simon Wessely) and “a great, great” trial (Professor Esther Crawley), Professor White and his colleagues appear to find it difficult to adjust to the new reality. Perhaps like President Trump, they are surrounded by like-minded believers who reinforce their biases and delusions. I’ve been rebutting their claims since 2015, so I’m not going to bother doing it again here.

Anyway, the PACE investigators’ admirable persistence can’t change the fact that the trial they are defending is indefensible on multiple levels. I want to highlight one issue that has been generally overlooked. They promised in their protocol to adhere to the Declaration of Helsinki—and they violated that promise. The Declaration of Helsinki, an international convention created to protect human research subjects, includes a mandate that investigators must disclose to trial participants “any possible conflicts of interest.”

Although the declaration has been revised over the years, this mandate was already part of the document at the start of the PACE trial. It is explicit and very clear. The phrase “any possible conflicts of interests” means what it says. There is little wiggle room.

The PACE trial was launched in 2005. At that time, the lead investigators had advisory and/or financial ties with leading insurance companies. For decades, they have told insurers that the treatments being tested in PACE could get people back to work. These links certainly should have fallen under anyone’s interpretation of “any possible conflicts of interests.”

However, the investigators failed to disclose these business interests to potential participants during the process of obtaining their consent for being in the trial. That means participants gave their consent without knowing key information—that the lead investigators had compelling reasons apart from scientific curiosity to prove that GET and CBT were effective.

In other words, the consent obtained from participants by the PACE investigators was not informed consent per their own promise to adhere to the Declaration of Helsinki. That everyone involved in research oversight in the UK has ignored this very, very serious issue is extremely disturbing. Despite all that money invested in PACE, no one bothered to ensure that the the lead investigators followed their own protocol promise to disclose “any possible conflicts of interest” to potential participants. And no one seems to care after-the-fact about this unexplained breach of an international human rights document. I have found it hard to understand this dereliction of responsibility when it comes to ensuring that human research subjects have been provided with all appropriate and required information.

The list of derelicts in this instance includes the Medical Research Council and the other funders, the research ethics committee or committees that approved the consent forms, the various trial-affiliated committees stuffed with allies of the PACE team, and the journals that published PACE results obtained without legitimate informed consent. And this violation of the Declaration of Helsinki is just one of the many problems with the trial.

Lancet editor Richard Horton, who presents himself as the scourge of bad science, has never acknowledged publicly that PACE was a debacle. He’s a very smart guy. He can’t possibly believe at this point that he was right to champion the 2011 paper.

Or maybe he does. We all have blind spots.

In any event, every day The Lancet does not address this embarrassment, it is failing to perform its basic function–safeguarding the medical literature and the public from crap.

12 thoughts on “Trial By Error: PACE Team Stages a Comeback Tour”

  1. Alicia Butcher Ehrhardt, PhD

    Someone official has to go after these people, and scour the record of their garbage.

    Is there no way to file criminal charges? Based on the number of people harmed?

    I still hear of new people – ME and long covid – who are being offered NOTHING for their illness but CBT and GET from these people. New one yesterday.

    And there is NOTHING being made ready for the long covid types, of whom I recently saw a doctor say ‘met the criteria for ME.’

  2. The PACE trial is a dead horse stinking to high heaven, but it *still* awaits a proper autopsy. Trial investigators have never released all the requested trial data, and with good reason. I assert that a proper review of the data, including recorded therapy sessions, will reveal a massive coverup of harms reported by the trial participants.

    It is clear from various anecdotes scattered across the internet that participants tried to report adverse events and were brushed aside. How many? We don’t know. Might be good to find out.

    That is what they have been hiding for a decade. It’s not too late to properly deal with PACE. Society has a duty to the trial participants to investigate the conduct of the PACE trial and bring criminal indictments against those responsible. Participants put their neck on the line in the hope that effective treatments would be found. They were betrayed and those who were harmed deserve compensation.

    For a hundred years the psychiatrists have enjoyed their power to condemn patients to locked wards, harmful treatments, and poverty (by denying social benefits) but now we are fighting back. And they don’t like it one bit. They won’t stop until they are thoroughly humiliated in public and held to account by a court of law.

    ME is only one battle in a huge power struggle involving patients and their advocates against the psychobabblers and most of the medical industry. The rot at Cochrane extends far beyond their dumbass ME treatment reviews. The Royal Colleges clearly need someone to yank their chains, and hard.

    The era when doctors could bully nurses, patients, and families is coming to an end, but not soon enough. Even now parents of young people with ME and now Long Covid live in fear of “experts” who somehow have the legal power to force treatments on young people and remove them from home.

    It has been slow going for ME patient advocates over the past few decades. We have been too few in number and too sick to make much progress. Policies only change when the social cost of maintaining them gets too high. That is now happening with the huge numbers of medical professionals who have Long Covid.

    It was easy enough for the medical industry to dismiss and drive out one or two physicians with ME. The number of people with Long Covid is now too big to simply dismiss and ignore.

    It’s great to have lots of new allies. It is devastating that they are as sick as we are, and that there are no known likely effective treatments, thanks in part to all that useless and harmful psychobabble research.

  3. Janet M Masleid

    Are these same arrogant, incompetent people still inflicting moral injury on the M.E. patient population? Now universities are expected to embrace these credentialed purveyors of disinformation and malpractice. Unbelievable.
    At some point, there will be a price to pay for allowing this bad influence to contaminate any real progress being made for Long Covid sufferers. We already know how this story ends.
    These people may be politely tolerated by their peers and the heretofore naive, but the rest of the intelligent world certainly doesn’t have to put up with this non-evidence based hideous behavior. Can someone PLEASE keep them far away from the Long Covid sphere of influence before they contaminate policy with their self-serving fog of concern?
    United States

  4. There are people in the US who don’t appear to have let PACE go either. It pays to be aware of just how far this desperate rehabilitation tour thing might go.

    Could the Academy of Consultation-Liaison Psychiatry (ACLP) be viewed as a non-exclusive but America-based version of a pro-PACE royal college/”trade group” as David describes them, I wonder?

    There are certainly members of it who seem to support the PACE trial, including of course its past president Michael Sharpe, but also others I believe. Their conference last November looked interesting, with Simon Wessely, Francis Creed, Michael Sharpe, Jeffery Staab (Mayo Clinic) and James Levenson amongst the listed speakers, and I hear there was quite an illuminating workshop on the long-term sequelae of Covid-19, (rather than “Long-Covid”, because patients might believe that they will be ill for a long time and subconsciously decide they won’t get better. )

  5. In the section “A methodological and ethical disaster”, you say:
    “The letter triggered coverage in The Times and BMJ, disseminating news of international dismay about the PACE trial to the general public.”
    but no links to that coverage is provided. Can you provide those links?

  6. It is welcome that David Tuller is reviving PACE’s ethical breach of the Declaration of Helsinki.

    But he fails to cite my March 2021 blog piece, which went much further than his original letter of 2015. He relies on my 2021 piece when he writes: ‘Although the declaration has been revised over the years, this mandate was already part of the document at the start of the PACE trial. It is explicit and very clear. The phrase “any possible conflicts of interests” means what it says.’

    I had an email dialogue with Mr Tuller, substantially on the issue of the ethics of the PACE trial, at the time I published my 2021 piece. He discontinued that dialogue when I pointed out that his past Conflicts of Interest declarations had been incomplete. So far, he has not informed me that he will remedy them voluntarily, and in due course I intend to formally complain to the Editors of the Journal of Health Psychology (JHP).

    If he fails to correct the above piece by citing my 2021 piece on the Declaration of Helsinki, I will complain about his plagiarism to the University of California, Berkeley, and copy that complaint to the JHP.

  7. Pingback: David Tuller, please remedy, and desist from, your plagiarism. | DrNMblog

  8. Dr MacFarlane says he wants PACE retracted. Here’s an idea: don’t attack other people who are advocating for the same result.

  9. Per Lucibee’s reminder, I’ve added links to The Times’ and BMJ’s articles about Virology Blog’s letter to The Lancet.

  10. Surprise Surprise! The Pace Cabal want research done of CBT & GET for Long Covid.

    It’s hilarious that they think we can’t see the ridiculousness of this. They want to waste money that would be better spent on finding biomed treatment for post viral conditions.

    I agree with a comment before, we need a big exposé on these people and the PACE trial. It influenced the medical neglect we pwme have gone through for decades.

    It also influenced how benefit assessors see our illness and has put many of us through hell and poverty.

    The only people who benefit from CBT and GET are the PACE authors and their own secondary gains of insurance work, press coverage and gongs.

  11. Yes, it was clear that Long Covid was going to be next stop for the failed biopsychosocial model of chronic illness. Fortunately, many Long Covid patients have found their way into ME/CFS support groups and communities to ask advice, and you can be sure that the message to them is the dangers of this kind of treatment and these kind of doctors.

    Hopefully that message is feeding back into other parts of the Long Covid support network but is is worrying that even progressive parts of the media such as The Guardian (although with an honourable mention to George Monbiot for his excellent pieces on ME and PACE) are still prepared to give column inches to Sharpe, White and Calder to spin their discredited work.

    Bringing up the conflict of interest is extremely important, as it is obvious that there are reasons for which they continue to promote the ideas behind PACE, when the science of their own research has clearly failed to support it. That the welfare of patients is put at risk for the need of the researchers in question to try and salvage their reputations and access to corporate contracts, rather than admit to what the trial shows, is something that should worry anyone involved in medicine, or who relies on it.

    Thank you, David, for continuing to bang this drum.

  12. I’d love to see a piece of research/just a table totting (estimates if necessary) for each of the ones who managed to elbow their way to the front of the funding queue, just how much they earned from their research, their centres, their books and alongside that their more direct conflict-of-interest jobs such as insurance industry, and other earnings that could be highly related to the ‘rolling stone effect’. A league table so to speak too.

    I think the public knowing that this isn’t about ‘good intentions and beliefs’ but also large sums of money – with ballpark amounts to give a sense of the size – is an important part of the picture missing from most conversations.

    We can safely assume ‘slice of the pie’ theory for those not yet there but happy to follow in footsteps.

    The size of this might explain to people just how so much misinformation becomes published and certain voices pushing that get platform.

    Similar thing is how much funding is going into IAPTS MUS, given it is linked and comes from the same psychosomatic schools push – I read a doc about how much it was going to cost just for one small area to train existing staff (who do mental health IAPTS), noting roll-out would mean hiring more staff and implementation and running costs. It was a lot of money. Scaling up across the areas it has now captured a very big amount of money that isn’t going into hospital depts and other services etc.

    This was in the same presentation I think where CCGs were told ‘it saves money at any cost’ because of their claims about how many appts apparently were all MUS. Whether their latter stats were correct it’s an irrelevant not if, as some research shows, their offering doesn’t reduce GP appts anyway (however many of them there are) so what are they ‘saving’ I couldn’t help but note the sophism in inferring ‘reduce all these appts’ through choosing of what they noted and didn’t – particularly given that doc wasn’t for the first area of this service/a pilot so said ‘savings’ or not must have been possible to have quantified?

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