Trial By Error: Happy Tenth Anniversary, PACE Trial!

By David Tuller, DrPH

It’s been ten years since The Lancet published the first results of the PACE trial. Wow!

Ten years ago, I was 54 and still a graduate student in public health at UC Berkeley. I was also busy writing stories for The New York Times about the mouse retrovirus study that had roiled the field of research into chronic fatigue syndrome, the then-standard name for the illness now referred to as ME/CFS by US government agencies. The mouse retrovirus, XMRV, turned out to be a lab contaminant. The story had struck such a nerve at least in part because of long-standing and lingering speculations that a retrovirus could be involved, a position that retains some strong adherents.

At the PACE press conference, Professor Trudie Chalder, one of the three lead investigators, told a blatant untruth. She declared that more than twice as many participants in the cognitive behavior therapy and graded exercise therapy intervention groups got “back to normal.” This statement was a dramatic misrepresentation of the actual findings. As far as I have seen, Professor Chalder has never explained or apologized for this false claim, which led to international headlines touting the success of the trial. Her failure to correct the public record in a timely fashion remains a disgraceful abrogation of her professional responsibilities.

In any event, I had about three hours to write up the PACE story. I produced a problematic article that took the stated findings at face value, more or less. Here are my excuses: I had only recently started covering the illness in depth. I knew nothing about the PACE trial. I’d never heard of Professor Sir Simon Wessely or the three PACE authors–Professors Chalder, Michael Sharpe, and Peter White. I’d never heard of my future BFF, the methodologically and ethically challenged pediatrician from Bristol University, Professor Esther Crawley. (Boy, it’s hard now to remember a time before those names were etched into my consciousness. I wonder if it’s hard for all of them to remember a time when my name wasn’t etched into theirs?)

I remember feeling a bit skeptical when I first glanced at the PACE paper. Psychotherapy? Exercise? Didn’t sound right. But I mean,  this was The Lancet. Why would I have suspected at that point that this august medical journal was publishing such a heap of dung? Only those already familiar with the machinations of the biopsychosocial ideological brigades would have had reason to suspect much amiss.

The New York Times posted my PACE story while I was traveling from the Berkeley campus back to San Francisco on BART, the inter-city train system. By the time I arrived home an hour later, I had received push-back from patients. The story wasn’t wrong or inaccurate, as far as it went, but it parroted the reported results–albeit with more caveats than other major news organizations included in their accounts.

It took a few more years until I had the bandwidth to take a much deeper look at PACE. Virology Blog posted my 15,000-word investigation in October, 2015. I certainly didn’t foresee that it would turn into a long-term project. In truth, I assumed no study could survive the scrutiny to which I and others had subjected the trial. I decided to start organizing the open letters to The Lancet as a way to generate further attention and news media interest. That must have been a smart strategy! It certainly seemed to help heighten awareness of the trial’s egregious and unacceptable flaws.

Even so, I seriously underestimated the power and ability of the biopsychosocial forces to maintain their unjustified hegemony. With help from the misnamed Science Media Centre and other allies, they trashed the critics, most of them patients–as crazy or hysterical. Shamefully, members of my own longstanding profession, journalists, participated willingly in this campaign. (Later on, I received similar treatment from the investigators, journal editors and UK journalists.)

As I recognized the huge resistance being mounted to stave off change, I gradually become obsessed with a core feature of this entire saga: How was it possible that an entire academic and medical establishment could accept as legitimate a study in which participants could be “recovered” on key measures at baseline? How could research with such an anomaly, which would be used as a case study of terrible research in epidemiology classes at Berkeley, be called “a thing of beauty” by one of the most respected physicians in the UK?

The phrase “emperor has no clothes” has always fit this situation perfectly. It is depressing that Professor Wessely and Professor Chalder are still publishing scientifically illiterate CBT propaganda, like their recent paper in the Journal of the Royal Society of Medicine. As I pointed out in a letter co-written with Brian Hughes, a psychology professor at National University of Ireland, Galway, their analysis is deeply flawed; the reported results are essentially meaningless.

Unfortunately, this group of investigators seem to think peer review means being reviewed by peers who think exactly the same way. (Circle jerk, anyone?) The science is moving on and their influence is waning, but they do not appear to have learned anything from the PACE debacle. Nor have their enablers, at journals, universities, and throughout the UK’s academic and medical hierarchy. Pathetic.

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