By David Tuller, DrPH
This morning (Wednesday) I gave an informal online talk about the piece of crap known as the PACE trial to a small group of UK doctors, researchers and others. The group had been pulled together by Paul Garner, a physician and professor of infectious diseases at Liverpool School of Tropical Medicine. Garner has written several widely read blog posts for BMJ about his struggles with profound exhaustion and other long-Covid symptoms.
In those posts, Garner has expressed sympathy for the plight of people with ME and their challenges in finding adequate medical treatment. Those experiences triggered his interest in the PACE saga–about which I know a little bit.
As sometimes happens, I got a bit, uh, energized while I discussed the PACE trial. It’s possible I dropped a four-letter word as I explained how the outcome thresholds were weakened so much that people could get worse on key measures and still be considered €œrecovered.€ (Or €œback to normal,€ as one of the PACE investigators falsely declared at the 2011 press conference presenting the first results.)
In the talk, I expressed dismay that the study remains in the medical literature even though 13% of participants met a primary outcome threshold at baseline. If disclosed before publication, that bizarre statistical anomaly would or should have caused immediate rejection of any manuscript. I said the paper, in my opinion, qualified as research misconduct, something I would say about any paper in which the investigators did not disclose that 13% of their participants had met an outcome threshold at baseline.
That a study including this feature passed peer review is hard to understand. Lancet editor Richard Horton, who professes outrage at bad research published in other journals yet thinks highly of PACE, has refused to disclose anything about the reviews. I assume they would, if released, cause some embarrassment, given the many flaws that marred the published paper. Two years ago, more than 100 experts from around the world signed Virology Blog‘s open letter to Horton, which cited the study’s “unacceptable methodological lapses” and requested an independent investigation.
I suggested some of the logic on display in the defense of PACE had a Trumpian quality to it. I also suggested that science can’t work if people who raise legitimate concerns–such as that participants in PACE could be “disabled” and “recovered” simultaneously on key measures–are dismissed as hysterics and dangerous climate-change deniers. I noted that MP Carol Monaghan had called PACE “one of the biggest medical scandals of the 21st* century.” I said I thought it was likely one of the biggest medical scandals of the millennium–although it’s kind of early for a definitive assessment. [*I originally wrote 20th century. Oops! Time flies!]
I didn’t prepare a slide presentation–just sent out a one-pager with a few salient details and thoughts. We didn’t discuss the PACE authors’ extensive ties to disability insurance companies and government agencies, I meant to bring it up, but I forgot! So I made sure to highlight these conflicts of interest in a follow-up e-mail.
The one-pager I sent the participants concluded with the following points:
*Why have all levers of authority in UK science endorsed this study, journals, NHS, Cochrane, etc.? Why hasn’t it been dealt with? Why have patients been so poorly treated?
*Other themes: gaslighting, research misconduct, €œeminence-based medicine€