Tag: clinical trial
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An open letter to Psychological Medicine, again!
Last week, Virology Blog posted an open letter to the editors of Psychological Medicine. The letter called on them to retract the misleading findings that participants in the PACE trial for ME/CFS had “recovered” from cognitive behavior therapy and graded exercise therapy. More than 100 scientists, clinicians, other experts and patient organizations signed the letter.…
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A Follow-Up Post on FITNET-NHS
Last week’s post on FITNET-NHS and Esther Crawley stirred up a lot of interest. I guess people get upset when researchers cite shoddy “evidence” from poorly designed trials to justify foisting psychological treatments on kids with a physiological disease. I wanted to post some additional bits and pieces related to the issue. I sent Dr.…
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The Real Data
‘The PACE trial is a fraud.’ Ever since Virology Blog posted my 14,000-essord investigation of the PACE trial last October, I’ve wanted to write that sentence. (I should point out that Dr. Racaniello has already called the PACE trial a “sham,” and I’ve already referred to it as “doggie-poo.” I’m not sure that “fraud” is…
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A request for data from the PACE trial
Mr. Paul Smallcombe Records & Information Compliance Manager Queen Mary University of London Mile End Road London E1 4NS Dear Mr Smallcombe: The PACE study of treatments for ME/CFS has been the source of much controversy since the first results were published in The Lancet in 2011. Patients have repeatedly raised objections to the study’s methodology and…
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PACE Team’s Work for Insurance Companies Is “Not Related” to PACE. Really?
In my initial story on Virology Blog, I charged the PACE investigators with violating the Declaration of Helsinki, developed in the 1950s by the World Medical Association to protect human research subjects. The declaration mandates that scientists disclose “institutional affiliations” and “any possible conflicts of interest” to prospective trial participants as part of the process…
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An open letter to Dr. Richard Horton and The Lancet
Dr. Richard Horton The Lancet 125 London Wall London, EC2Y 5AS, UK Dear Dr. Horton: In February, 2011, The Lancet published an article called “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized trial.” The article reported that two “rehabilitative” approaches, cognitive behavior therapy…
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Why has the PACE Study’s “Sister Trial” Been “Disappeared” and Forgotten?
In 2010, the BMJ published the results of the Fatigue Intervention by Nurses Evaluation, or FINE. The investigators for this companion trial to PACE, also funded by the Medical Research Council, reported no benefits to ME/CFS patients from the interventions tested. In medical research, null findings often get ignored in favor or more exciting “positive”…
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Did the PACE Study Really Adopt a ‘Strict Criterion’ for Recovery?
First, some comments: When Virology Blog posted my very, very, very long investigation of the PACE trial two weeks ago, I hoped that the information would gradually leak out beyond the ME/CFS world. So I’ve been overwhelmed by the response, to say the least, and technologically unprepared for my viral moment. I didn’t even have…
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David Tuller responds to the PACE investigators
David Tuller’s three-installment investigation of the PACE trial for chronic fatigue syndrome, “Trial By Error,” has received enormous attention. Although the PACE investigators declined David’s efforts to interview them, they have now requested the right to reply. Today, virology blog posts their response to David’s story, and below, his response to their response. According to…
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PACE trial investigators respond to David Tuller
Professors Peter White, Trudie Chalder and Michael Sharpe (co-principal investigators of the PACE trial) respond to the three blog posts , published here on 21st, 22nd and 23rd October 2015, about the PACE trial. Overview The PACE trial was a randomized controlled trial of four non-pharmacological treatments for 641 patients with chronic fatigue syndrome (CFS) attending secondary care…
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The Troubling Case of the PACE Chronic Fatigue Syndrome Study (final installment)
A few years ago, Dr. Racaniello let me hijack this space for a long piece about the CDC’s persistent incompetence in its efforts to address the devastating illness the agency itself had misnamed “chronic fatigue syndrome.” Now I’m back with an even longer piece about the U.K’s controversial and highly influential PACE trial. The $8 million…
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The Troubling Case of the PACE Chronic Fatigue Syndrome Study (second installment)
A few years ago, Dr. Racaniello let me hijack this space for a long piece about the CDC’s persistent incompetence in its efforts to address the devastating illness the agency itself had misnamed “chronic fatigue syndrome.” Now I’m back with an even longer piece about the U.K’s controversial and highly influential PACE trial. The $8 million…