Call for HHS to Investigate PACE

Share on facebook
Share on twitter
Share on email

Call for HHS to Investigate PACE

Recently, journalist David Tuller, DrPH, published an investigative report outlining serious concerns with the conduct, analyses, and results of U.K.’s £5 million PACE trial for chronic fatigue syndrome. PACE investigated the efficacy of cognitive behavioral therapy (CBT) and graded exercise therapy (GET)
Since then, other researchers and journalists have voiced their own concerns with the fundamental problems in the trial. Most recently, Julie Rehmeyer wrote an excellent overview of the situation in Slate Magazine and six researchers called on The Lancet to “seek an independent re-analysis of the individual-level PACE trial data.”
The PACE treatment approach is based on the theory that the debility of ME/CFS is caused by presumed deconditioning, which is the result of patients’ belief that they have an organic disease and that activity will harm them. CBT and GET is claimed to lead to improvement and even “recovery” by reversing patients’ “illness beliefs,” “fear of activity,” and deconditioning.
PACE is hugely influential in how patients are treated in the media, by society, and especially in medical practice. In the U.S., many ME/CFS clinical guidelines, including those of the Centers for Disease Control and Prevention (CDC), recommend CBT and GET, based in part on the PACE trial. This is true even in medical education and clinical guidelines published since the 2015 Institute of Medicine (IOM) report. The IOM report makes it clear that the problem is not deconditioning. It identifies the hallmark of the disease is a systemic intolerance to exertion, which would be exacerbated by PACE’s treatments.
The impact of PACE is also seen in scientific evidence reviews. In 2014, the U.S. Agency for Healthcare Research and Quality (AHRQ, part of HHS) recommended CBT and GET, based in part on PACE, which it ranked as a “good” study. This is significant because the AHRQ Evidence Review can be used to support CBT and GET recommendations in future journal articles and in the clinical guidelines of any country. This evidence review already has been used for this purpose in at least one U.S. clinical guideline.
Even aside from concerns with the conduct of PACE, the AHRQ Evidence Review recommendation for CBT and GET for all ME/CFS patients is questionable since the review itself acknowledged that PACE’s Oxford definition was overly broad and could include patients who do not have ME/CFS. NIH’s 2015 Pathways to Prevention report felt this was a serious enough problem that it called for the Oxford definition to be retired.
Continuing to use PACE and similar Oxford definition studies to support treatment recommendations for all ME/CFS patients is an issue of grave concern because it confuses doctors on the nature of the disease and results in medical treatment that can harm patients.
Therefore, together with 11 other U.S. ME/CFS organizations, we have called on the CDC and the AHRQ to investigate the concerns raised by Dr. Tuller, other researchers and many patients. Then, we have asked them to take the necessary steps with CDC’s clinical guidelines/medical education and AHRQ’s Evidence Review to best protect patients. The letter to Director Thomas Frieden of the CDC and Director Dr. Richard Kronick of the AHRQ can be found here.
You can add your voice to this request by signing this accompanying petition. While the petition is directed to CDC and AHRQ, their response will affect other countries as well so we encourage people from all countries to sign.

Share on facebook
Facebook
Share on twitter
Twitter
Share on whatsapp
WhatsApp
Share on google
Google+
Share on email
Email

Leave a Comment

Your email address will not be published. Required fields are marked *

Latest News

Sign petition To Fix ME/CFS tracking In US!

In August, we shared with you that we and six other ME/CFS organizations had submitted a proposal to the National Center of Health Statistics (NCHS) to fix the coding of ME/CFS in the US International Classification of Diseases (ICD-10-CM). Today, we are writing with an update on that proposal and asking that you sign the

Read More »

NICE announces roundtable event to ensure implementation of ME/CFS guideline

NICE announced today that it will hold a roundtable in September as the next step in the publication of the ME/CFS guideline. The roundtable will include representatives from patient organisations and charities, relevant professional societies, NHS England and NHS Improvement, NICE and the guideline committee. It aims to, “better understand the issues raised and determine

Read More »

#MEAction & 6 ME Orgs Call for CDC to Change How it Tracks ME/CFS

Together with six other organizations, we have submitted a proposal to the National Center for Health Statistics (NCHS) to add myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) to the neurological chapter of the International Classification of Diseases (ICD-10-CM).  Today, ME/CFS does not exist in the US ICD-10-CM. Instead,  most US doctors assign the code for chronic fatigue

Read More »

Help keep our work going

We rely on donations from people like you to keep fighting for equality for people with ME.

Donate

Get actions alerts and news direct to your inbox

You can choose what you want to be kept up to date on.

Subscribe
Scroll to Top