David Tuller’s three-installment investigation of the PACE trial for CFS, Trial By Error, received much attention in the press. Although the PACE researchers declined David’s efforts to interview them, they subsequently requested the right to reply. Virology blog posted the response of Professors Peter White, Trudie Chalder and Michael Sharpe to David’s story on 30 October 2015.
Excerpt: In their effort to correct the “misinformation” and “inaccuracies” in my story about the PACE trial, the authors make claims and offer accounts similar to those they have previously presented in published comments and papers. In the past, astonishingly, journal editors, peer reviewers, reporters, public health officials, and the British medical and academic establishments have accepted these sorts of non-responsive responses as adequate explanations for some of the study’s fundamental flaws. I do not.
None of what they have written in their response actually addresses or resolves the core issues that I wrote about last week. They have ignored many of the questions raised in the article. In their response, they have also not mentioned the devastating criticisms of the trial from top researchers from Columbia, Stanford, University College London, and elsewhere. They have not addressed why major reports this year from the Institute of Medicine and the National Institutes of Health have presented portraits of the disease starkly at odds with the PACE framework and approach. Read more
Cort Johnson also commented on the researchers’ response: PACE Trial authors feeling the heat over Chronic Fatigue Syndrome Trial, Oct 30, 2015
Excerpt: The PACE trial authors appear to have done themselves few favors by presenting their side of the argument.
Their responses demonstrated two things:
- Tuller’s critique and the response to it by the patient community has hit home
- they don’t have answers to most of his questions.
If it looks like a duck and walks like a duck – is it a duck?
Notice that every change they made it more possible for the trial to get positive results. Notice how moderate the results were even with these added boosts.
Consider the fact that the researchers were never blinded to the results flooding in. Consider the possibility that they gloamed early on to the fact that things were not going their way and that changes needed to be made.
While the study findings were initially lauded (and misinterpreted) by the press (apparently with Chalder’s help) the controversy over the PACE trial continues to muddy it’s results.
Remember we’re talking about what is surely the most expensive study ever done on ME/CFS. The PACE authors are right. Reputations are at stake. Until they can satisfactorily explain – if that’s possible – the many questions surrounding the trial – it doesn’t appear that the controversy is going to go away.