Trial by error, Continued: PACE Team’s Work for Insurance Companies Is “Not Related” to PACE. Really?
By David Tuller, DrPH
David Tuller is academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley.
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 of obtaining informed consent.
The investigators promised in th...
Source: virology blog - November 17, 2015 Category: Virology Authors: Vincent Racaniello Tags: Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behaviour therapy Declaration of Helsinki graded exercise therapy insurance company mecfs PACE specialist medical care The Lancet Source Type: blogs
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 and graded exercise therapy, were effective in treating chronic fatigue syndrome, also known as myalgic encephalomyelitis, ME/CFS and CFS/ME. The study received international attention and has had widespread infl...
Source: virology blog - November 13, 2015 Category: Virology Authors: Vincent Racaniello Tags: Commentary Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behaviour therapy graded exercise therapy mecfs PACE specialist medical care The Lancet Source Type: blogs
Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?
By David Tuller, DrPH
David Tuller is academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley.
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” results. In this vein, the FINE trial seems to have vanished from the public discussion over ...
Source: virology blog - November 9, 2015 Category: Virology Authors: Vincent Racaniello Tags: Commentary Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behavior therapy Dave Tuller exercise Fatigue Intervention by Nurses Evaluation FINE graded exercise therapy mecfs myalgic encep Source Type: blogs
Trial By Error, Continued: Did the PACE Study Really Adopt a ‘Strict Criterion’ for Recovery?
By David Tuller, DrPH
David Tuller is academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley.
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 a photo on my Twitter profile until yesterday.
Given the speed at which events are unfolding, I thought it made sense to ...
Source: virology blog - November 4, 2015 Category: Virology Authors: Vincent Racaniello Tags: Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behavior therapy Dave Tuller exercise graded exercise therapy mecfs myalgic encephalomyelitis outcome PACE trial recovery Source Type: blogs
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 the communications department of Queen Mary University, the PACE investigators have been receiving abuse on social media as a result of David Tuller’s posts. When I published Mr. Tuller’s articles, my intent was to provide a...
Source: virology blog - October 30, 2015 Category: Virology Authors: Vincent Racaniello Tags: Commentary Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behavior therapy Dave Tuller exercise graded exercise therapy mecfs myalgic encephalomyelitis outcome PACE trial recovery Source Type: blogs
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 by David Tuller, 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 clinics in the United Kingdom (UK) (http://www.wolfson.qmul.ac.uk/current-projects/pace-trial) The trial found that individually delivered cognitive behaviour therapy (CBT) and graded exercise therapy (GET) were more effecti...
Source: virology blog - October 30, 2015 Category: Virology Authors: Vincent Racaniello Tags: Commentary Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behavior therapy Dave Tuller exercise graded exercise therapy mecfs myalgic encephalomyelitis outcome PACE trial recovery Source Type: blogs
TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study (final installment)
In conclusion, they wrote in their Psychological Medicine response, cognitive behavior therapy and graded exercise therapy “should now be routinely offered to all those who may benefit from them.”
***
Each published paper fueled new questions. Patients and advocates filed dozens of freedom-of-information requests for PACE-related documents and data with Queen Mary University of London, White’s institutional home and the designated administrator for such matters.
How many PACE participants, patients wanted to know, were “recovered” according to the much stricter criteria in the 2007 protocol? How many participants...
Source: virology blog - October 23, 2015 Category: Virology Authors: Vincent Racaniello Tags: Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behavior therapy Dave Tuller exercise graded exercise therapy mecfs myalgic encephalomyelitis outcome PACE trial recovery Source Type: blogs
TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study (second installment)
By David Tuller, DrPH
David Tuller is academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley.
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 study, funded by British government agencies, purportedly proved that patients could “recover” ...
Source: virology blog - October 22, 2015 Category: Virology Authors: Vincent Racaniello Tags: Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behavior therapy Dave Tuller exercise graded exercise therapy mecfs myalgic encephalomyelitis outcome PACE trial recovery Source Type: blogs
TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study
By David Tuller, DrPH
David Tuller is academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley.
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 study, funded by British government agencies, purportedly proved that patients could “recover” fr...
Source: virology blog - October 21, 2015 Category: Virology Authors: Vincent Racaniello Tags: Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behavior therapy Dave Tuller exercise graded exercise therapy mecfs myalgic encephalomyelitis outcome PACE trial recovery Source Type: blogs
TBT: Blind to women’s sexual health
Today’s TBT post ran over two years ago and addressed female dysfunction. Given the FDA’s recent approval of flibanserin, a pill that aims to increase a woman’s desire for sex, we thought it would be helpful to review some of the early conversations on the issue.
A recent article published in partnership with The Investigative Fund and Newsweek questioned the existence of “female dysfunction,” as if to say, who cares about women’s sexual health? If you can’t “see” it, apparently it doesn’t exist. This is one-sided, inaccurate and disparaging of women.
Why is it that when men are impotent it ...
Source: Disruptive Women in Health Care - August 20, 2015 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Aging Choice gender Women's Health Flibanserin Food and Drug Administration Sexual desire Sexual dysfunction Source Type: blogs
TWiV 345: How a vaccine got the nod
On episode #345 of the science show This Week in Virology, the TWiVonauts review how the weather affects West Nile virus disease in the US, benefit of B cell depletion for ME/CFS patients, and an autoimmune reaction induced by influenza virus vaccine that leads to narcolepsy.
You can find TWiV #345 at www.twiv.tv. (Source: virology blog)
Source: virology blog - July 12, 2015 Category: Virology Authors: Vincent Racaniello Tags: This Week in Virology antibody autoimmunity B cell chronic fatigue syndrome hypocretin influenza vaccine influenza virus mecfs meterological conditions myalgic encephalitis narcolepsy pandemrix rituximab viral weather West Source Type: blogs
B cell depletion benefits ME/CFS patients
Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) showed clinical improvement after extended treatment with the anti-B-cell monoclonal antibody rituximab. This result suggests that in a subset of patients, ME/CFS might be an autoimmune disease.
Rituximab is a monoclonal antibody against a protein on the surface of B cells known as CD20. When the antibody is given to patients, it leads to destruction of B cells, which are the producers of antibodies, proteins that are made by the immune system to counter infections. The drug has been approved by the US Food and Drug administration to treat diseas...
Source: virology blog - July 10, 2015 Category: Virology Authors: Vincent Racaniello Tags: Basic virology Information autoimmune disease B cell chronic fatigue syndrome mecfs monoclonal antibody myalgic encephalomyelitis rituximab viral virus Source Type: blogs
You can never be prepared for a diagnosis of breast cancer
November of last year found me living as best I could with several health issues, the most debilitating of which stems from never having recovered from a serious viral infection in 2001. I’ve been diagnosed with chronic fatigue syndrome, a little understood and much-misunderstood illness. It keeps me virtually housebound. For the most part, I’ve made peace with feeling sick all the time. In fact, recently I’d been thinking that I could be OK with the prospect of spending the rest of my life with flu-like symptoms as my constant companions.
Then, totally unexpectedly, I was diagnosed with breast cancer. It was discov...
Source: Kevin, M.D. - Medical Weblog - July 6, 2015 Category: Journals (General) Authors: Toni Bernhard, JD Tags: Patient Cancer Source Type: blogs
Lyme Disease: The Great Imitator
Spring is my favorite season. Warmer weather, budding flowers and lots of greenery in yards, gardens and parks encourages outside activities and fills me with energy. The spring season also brings out lots of crawling and flying critters like bees, butterflies, and hummingbirds, as well as some of the more unpleasant pests like ticks and mosquitos. If you enjoy spending time outside like I do, hiking, gardening or walking the dog, be aware that ticks and their bites can be not only annoying, but dangerous.
Jana’s Experience
Jana Braden found out how dangerous tick bites can be the hard way. She enjoyed the outdoors a...
Source: Disruptive Women in Health Care - May 13, 2015 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Chronic Conditions Source Type: blogs
So what were they saying about Wheat Belly being another low-carb diet?
Linnea shared these photos and comments from her mom, who describes an impressive recovery from multiple health problems, including a life-threatening side effect of an intravenous drug used to “treat” autoimmune diseases:
“85 lbs lost. Severe debilitating rheumatoid arthritis in compete remission, medication induced liver failure reversed, high blood pressure reversed, no more IBS, chronic headaches or migraines, chronic urticaria (hives) gone, chronic pain and pain flares gone, chronic fatigue mood swings and depression gone, and many more milder issues resplved.
“Was on 17 medications including ...
Source: Wheat Belly Blog - May 3, 2015 Category: Cardiology Authors: Dr. Davis Tags: News & Updates Source Type: blogs
