On the NYMag piece, it's weird to see the tide turning, while the quality of coverage remains poor. It feels dirty, having opinion shifting in our favor, while real understanding remains largely so abysmally low. The understanding will no doubt come, in short or long, it's just a weird transition.
Moving the Goal Posts to Catch the Ball and Other Hazards of A Chronic Fatigue Syndrome Treatment Trial
When it comes to offering patients high-quality care for a poorly understood disease, solid, well-funded research, medical education, and respect go a long way. In a masterful report today in STAT, Julie Rehmeyer sets the record straight on chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME). She specifically covers the many pitfalls in the landmark UK PACE trial. Rehmeyer is far from the only critic of this research.
Today’s publication on Dr. Racaniello’s blog presents the analysis of the recovery outcome data obtained by Alem Matthees. Once again, the mid-stream changes to the study protocol grossly inflated the PACE results.
As the graph from the Matthees paper shows, the PACE authors claimed more than 20% of subjects recovered with CBT and GET. Using the original protocol, however, those recovery rates drop by more than three-fold. Furthermore, there is no statistically significant difference between those who received CBT or GET and those who received standard care or pacing instruction. In other words, the differences among the groups could have easily been the result of chance rather than the result of the therapy delivered.
After some years of litigation, the original data have now been made public, and it turns out that the PACE investigators had overstated their results on two key determinants by factors of three and four. In other words, there is no statistically significant support for the theory that CBT or GET can lead to improvement or recovery.
The details of the re-analysis are reported on the Virology Blog here.
The PACE trial, and the attendant claims of “recovery,” have done enormous damage to ME/CFS patients, and not only by diverting funding and effort away from biomedical research.
BIOWORLD TODAY TM
THE DAILY BIOPHARMACEUTICAL NEWS SOURCE
BIOTECH’S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS
SEPTEMBER 23 , 2016
VOLUME 27, NO. 185
This week, NICE came under pressure from a different quarter, when a grassroots group of experts and patients, using patient data obtained under the U.K.’s Freedom of Information legislation, challenged claims, long unpopular with patients, that exercise and psychotherapy provided benefit to patients with chronic fatigue syndrome, or myalgic encephalomyelitis. The group, #MEAction, has been repeatedly seeking a change in the guidelines since 2012, spokesman Graham McPhee told BioWorld Today by email. The message is finally getting through.
“Inevitably, new evidence accumulates over the years,” Dillon said. “There is pressure for NICE to review that guideline against the new evidence that has accumulated, and we are going to do that.”
Lukewarm reception from AfME, which I don't suppose should surprise us.
Alan Cook, Chair of Board of Trustees, Action for M.E., says, “As a point of principle, Action for M.E. supports the sharing of research data to enable replication and validation. We have supported the release of PACE trial data, and I wrote to QMUL in February to ask it to do so. It is evident that this new preliminary analysis of the data raises a number of questions, and we would welcome publication in a peer-reviewed journal to facilitate the robust scientific debate that is clearly needed.
“Any new evidence that can be replicated and validated concerning the efficacy of symptom-management approaches must be considered in the formulation of treatment guidelines. This includes the guideline published by the National Institute of Health and Care Excellence, which is due to be considered for review next year.”
What's all this "new evidence" stuff from NICE (and, of course, AfME)?
It's not really new evidence, is it. More like suppressed data which demonstrates that the existing 'evidence' base was a sham, as many people have been saying for years. That's rather an important distinction, especially in terms of consequences for those involved (which maybe answers my original question).