Tuller summarizes issues with PACE in Health Affairs

Share on facebook
Share on twitter
Share on email

David Tuller has published a new article in the Health Affairs blog that summarizes the issues with the conduct of the PACE trial and also examines the ways in which PACE and other studies have impacted the attitudes of doctors and the clinical guidelines used by doctors to treat patients.

Tuller’s series of articles reporting on the flaws in the PACE trial have created an unprecedented level of challenge over PACE’s conduct and conclusions. As Tuller notes, “What makes these public rebukes of PACE so noteworthy is that they take on a well-established treatment paradigm that has, for years, successfully defended itself against vigorous criticism from patients and advocacy groups” despite mounting evidence of serious physiological impairment. And for perhaps the first time, these criticisms are being raised by prominent researchers and clinicians from outside the field. They have requested access to the data and called on Lancet to ensure that an independent review is conducted.

But the PACE story is not just about the conduct of a single trial and it’s not just about research. As Tuller notes, “The PACE results have exerted a major influence on public health policies, clinical treatment guidelines, and societal attitudes, not just in the U.K. but in the U.S. as well.” The U.K.’s National Health Service focuses on CBT and GET while various U.S. clinical guidelines, including those from the CDC, the American Academy of Family Physicians, the Cleveland Clinic, Kaiser Permanente, and UpToDate recommend CBT and GET.

As Tuller notes, these recommendations are based largely on PACE and other Oxford studies. But a recent NIH report said that Oxford could “impair progress and cause harm” and called for it to be retired because it includes patients with other conditions. As I explained to Tuller, “Basing recommendations for ME/CFS on studies like PACE that include patients who do not have ME/CFS is not only bad science but is medically unethical and creates a serious risk of harm” to these patients. 

What is especially significant about UpToDate’s clinical guidelines is that they recommend that the IOM criteria be used for diagnosis but then recommend PACE-style CBT and GET for treatment. But the IOM stated that ME/CFS is not psychological or deconditioning and that it is characterized by a systemic intolerance to even trivial activity. A recommendation for PACE-style CBT and GET is clearly inappropriate and creates a risk of harm for patients.

A basic assumption of evidence-based medicine is that the recommendations are based on studies into the same disease. Until medical education providers stop using evidence from studies in patients with other conditions, doctors are going to continue to be misled on the nature of the disease and patients with ME/CFS are going to continue to be at risk of harm.

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

Waiting for Superman Book on table

Waiting for Superman – UK Book Giveaway and Review

Do you want to win a free copy of Waiting for Superman? We have three copies to give away to people in the UK!  To enter, all you have to do is follow #MEAction UK on Instagram, like and comment on this post. The deadline is 9am (GMT) Monday 8th March! Win a copy! Thank

Read More »
#MEAction activists outside Scottish Parliament

Scottish Election! Ask your MSPs to support people with ME

If you live in Scotland, please join our campaign to ask your MSPs to pledge their support for people with ME. Email your MSPs The Holyrood elections are coming up on 6 May 2021 and we want to make sure that MSPs are aware of ME and the desperate need for support. There are more

Read More »
Terri Wilder - #MEAction Activist Camp

#MEAction’s ACTIVIST CAMP! – the Highlights!

It’s a wrap! Last weekend concluded the final session #MEAction’s first ever ACTIVIST CAMP!, a teach-in series for activists in the United States. We are so proud of this program and what it has accomplished. Congrats to our new grads!  #MEAction ACTIVIST CAMP! aimed to deepen our campers’ engagement with activism – teaching our collective

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