Tuesday, 27 February 2018

Yellow Cards & Psycho-Social Therapies

“Why does the yellow card system for reporting medical harms, not extend to psycho-social therapies such as Graded Exercise Therapy (GET) and Cognitive Behaviour Therapy (CBT)?”

This is the question I would like asked of the Health Minister.  I have sent the information below to my MP, and also submitted it to Jeremy Corbyn’s online request for questions.

“Considering that exercise can be medically contraindicated, and that psychological manipulations can be abusive, surely it should be recognised that GET and CBT, when medically applied, could also cause harm, and that such therapies should therefore also be covered by the Yellow Card reporting system.

Details of the Yellow card system are given here: https://yellowcard.mhra.gov.uk/

I became suddenly ill with myalgic encephalomyelitis (ME) in 2012.  I was warned by other patients to avoid the NICE recommended therapies of GET and CBT. Unfortunately, I only heard this after I had suffered harm from attempting to “exercise” on the advice of my GP.

This advice was given by my GP with no cautionary explanations, because GET is recommended in the CG53 NICE guideline for “CFS/ME”. GET and CBT remain as recommended therapies despite repeated calls from patients to have them removed from the guideline. Patient surveys and petitions clearly demonstrate that harms from these therapies are widely recognised in patient circles.

One of the reasons given for leaving GET and CBT in place, is that there is no evidence to show that they cause harm. Yet, there is no means by which harms encountered by patients can be properly reported.  The Yellow Card system for reporting pharmaceutical adverse effects apparently does not apply to therapies such as GET and CBT.

Further, the various trials, that purport to show that these therapies are of benefit, are lax about how “harm” is reported.  Thus without specifically looking for harm, they find “no evidence”.

The PACE trial, and other trials based on the psycho-social premise that ME patients are no longer physically ill, are now being heavily questioned. As you are probably aware, Carol Monaghan MP led a debate in Westminster Hall on 20th February 2018 on the harms caused by the PACE trial (on CBT and GET) to ME patients.

It is time for these psycho-social therapies to be be properly challenged.

Psycho-social therapies must no longer be hidden behind a system that prohibits the proper reporting of the harm they cause. They must be open to the same medical scrutiny as pharmacological treatments.

So please ask:

Why does the yellow card system for reporting medical harms, not extend to psycho-social therapies such as Graded Exercise Therapy (GET) and Cognitive Behaviour Therapy (CBT)?

And:

What possible reason could there be for protecting these psycho-social therapies from scrutiny?

UPDATE: 10/3/18 Jim Shannon MP asked the question about the Yellow cards here:

Top of page 11, question no 98:
https://publications.parliament.uk/pa/cm/cmquestionbook/noq.pdf


Questions tabled on Monday 5 March 2018

"98 Jim Shannon (Strangford): To ask the Secretary of State for Health and Social Care, for what reason the yellow card system for reporting medical harms does not include (a) Graded Exercise Therapy and (b) Cognitive Behaviour Therapy. (130828)"

UPDATE - A further blog post 10/7/18  Yellow Card Confusion