Trial By Error: Do All Clinical Trial Experts Love PACE?
9 JULY 2018
By David Tuller, DrPH
Professor Michael Sharpe blocked me on Twitter many weeks ago but apparently can’t restrain himself from tweeting at me again. Maybe I’ve gotten under his skin.
Yesterday he tweeted what must have felt to him like a slam-dunk question: He wanted to know how many clinical trials I have conducted. The answer is none. But I don’t need to be a clinical trial expert to know that it is impossible to be “recovered” (or “within normal range,” per The Lancet) and “disabled” simultaneously on a primary measure, as happened in PACE. I don’t need to be a clinical trial expert to know that you can’t publish newsletters in which you promote therapies under investigation as already proven to be effective.
Like previous responses to criticism, Professor Sharpe’s challenge has nothing to do with the concerns raised about PACE. I have never positioned myself as a clinical trial expert, so whether I have ever run a clinical trial is irrelevant. I have always made clear that I am a journalist with an interdisciplinary public health doctorate from Berkeley. (Or a public health academic with a journalism background. Whatever.) I have vetted my claims about PACE with many clinical trial experts–including statisticians and epidemiologists at leading institutions. Without exception, they have found Professor Sharpe’s study to be a piece of crap.
Professor Sharpe himself triggered this recent exchange when he wrote, in his briefing for last month’s parliamentary hearing, that none of the public critics quoted in articles about PACE were clinical trial experts. For good measure, he added that such experts, including “the many peer reviewers of the paper when it was published in The Lancet,” regarded PACE as “a high quality trial.” The Lancet has never provided details about the peer review process. We also know that the paper was fast-tracked to publication, which would limit how many reviewers could possibly have scrutinized it. So it is hard to take Professor Sharpe’s comments here at face value.