These would shed some light on where the anger and hostility arises when it looks like too much emphasis is being placed on exercise as being the answer.
PACE: The research that sparked a patient rebellion and challenged medicine
by sasusa | Mar 21, 2016 | Study design | 44 comments
https://senseaboutscienceusa.org/pace-research-sparked-patient-rebellion-challenged-medicine/
"
In 2011, researchers announced that PACE, the largest treatment trial in the history of chronic fatigue syndrome, had been a great success. That seemed like great news since there is no known cure for this devastating disease that affects over a million people in the United States alone, including Laura Hillenbrand, the best-selling author of
Seabiscuit, and jazz pianist Keith Jarrett. Exercise and psychotherapy, the researchers said, can significantly improve and sometimes cure chronic fatigue syndrome (CFS), which is also sometimes called myalgic encephalomyelitis (ME). Headlines announced the study finding around the world; it was simple, as
The Independent wrote, “Got ME? Just get out and exercise, say scientists.”
The finding struck many ME/CFS sufferers as preposterous—and their concerns about the way the trial was designed and conducted, after long being dismissed, were suddenly supported in a recent investigative
tour de force by David Tuller, academic coordinator of UC Berkeley’s joint masters program in public health and journalism. In response to his investigation, six scientists from Stanford, Columbia, and elsewhere sent an open letter to the editor of
The Lancet demanding a fully independent investigation into the trial. After three months with no response from
The Lancet, the letter was republished with 42 signatures. After that, The Lancet editor, Richard Horton, emerged from witness protection and invited the group to submit a letter about the concerns for publication. The study is under increasing scrutiny by scientists and science writers about whether its conclusions are valid.
The question of how all this happened and how the criticism is being handled have sent shockwaves through medicine. The results from PACE (including these) have been published in prestigious journals and influenced public health recommendations around the world; and yet, unraveling this design and the characterization of the outcomes of the trial has left many people, including me, unsure this study has any scientific merit. How did the study go unchallenged for five years? And how could journalists have recognized the problems before reporting unqualified, but unjustified, good news?
There were problems with the study on almost all levels, but our goal in this piece is to examine a critical issue that is increasingly being talked about in academic research but less so in the news media, due to its complexity: study design.
... "
and
Editorial: On PACE
by sasusa | Mar 21, 2016 | Study design | 39 comments
https://senseaboutscienceusa.org/editorial-on-pace/
"
...
David Tuller, a journalist who had earned a doctorate in public health, and who ran the University of California Berkeley’s joint program in public health and journalism, believed the sufferers were onto something when they said there was something badly wrong with the way the trial was designed and conducted.
And the thing about patients who either suffer from a rare disease, or a more common and inexplicable one as with ME/CFS, is that they are usually a formidable resource—a network of distributed experts who have sifted and weighed the scientific research with the kind of avidity you would expect, given that their lives depended on it. In pharmacology, rare disease patient groups are highly respected and are seen as partners in research rather than just subjects and consumers of studies.
Tuller dug in the weeds and published his results in a four-part series on the blog Virology. The gravity of his investigation may be gauged by one of the experts he quotes, Ronald Davis, Ph.D., Professor of Biochemistry and Genetics at Stanford University: “The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review.”
Because we believe that study design is a critical issue in science, and because statistics is central to understanding study design, we felt it was important to look at PACE from this perspective.
But we were also spurred by science writer Julie Rehmeyer, who wrote a powerful essay for our series “Epistemically Challenged” (over at Sense About Science USA) about her own experience of ME/CFS, and how it changed her view of science. As Rehmeyer is the most recent recipient of the American Statistical Association’s Excellence in Statistical Reporting Award (an honor we think Joseph Pulitzer would have considered equal to his eponymous prizes given his love of statistics), we took her criticism of PACE as another important alarm.
The conclusion of Rebecca Goldin’s 7,000-word analysis on PACE’s design is this: “The best we can glean from PACE,” concludes Goldin, “is that study design is essential to good science, the flaws in this design were enough to doom its results from the start.”
...
"
Scott