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)?”

[Latest update at end of this post - question has now been asked :) ]

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)"


14 comments:

  1. Well done, Sally. If you start a petition, let me know. And remember some of us who read your blog are not in the UK - would our signatures help or hurt?

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    1. Thanks Alicia. I think there are probably enough petitions on the go at the moment. However I am hoping that the question might get asked . I would be good if the Yellow card system extended to these psycho-social therapies wouldn’t it!

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  2. Similar problems with poor harm reporting apply in Australia. They have just taken action here against pelvic mesh, but they have not changed the system for managing harms from non-drug therapies.

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    1. Similar problems world over with these therapies it seems Penelope. Hoping that when change comes (as it surely must) that it will happen world over too. ;)

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  3. I was also harmed by several doctors advising and scolding me to exercise. I have had many problems with benefit claims, every GP I have seen in my area, and with adult social care which continues to be threatened on the principle that I "can do far more than I am doing and am not trying to exercise and go out regularly. There is a rigid schedule if what and when they give me carers, and with fluctuating severe pain and fatigue and IBS, dizziness, etc. I need to allow myself to say no sometimes. I can't even get a knowledgeable advocate as I am housebound and mostly bed bound, and all charities say they don't provide proactive advocacy for this situation by a volunteer who knows about these types of illnesses and the system. The social care managers are cutting back everyone's care plans in my area, and they see me as getting far more than I deserve. I actually need more, especially practical tasks I can't do. I have no family or friends anywhere close. I know there are thousands like me. It was such a blow to see that the CBT and GET recommendations were going to remain in place for at least a few more years! I think petitions and strategic attention getting programmes in the media really need to ramp up a lot. I struggle every day to keep some hope. The worst is that with the current system of financial contributions for social care, we still have to pay the same amount they determine we can afford out of our benefits income, while having the type and amount of social care we get cut back. So they can deprive me of evening meal preparation and domestic tasks, and I don't have enough money to pay for it privately. And if I decline the social care package they choose to give me, I can't afford to provide enough money from my benefits plus insurance provision for hiring a carer even part time. They have to be accredited and insured and be able also to provide backup in case they can't cover my daily calls. The situation is impossible. I don't know what to do. Now awaiting their requested details from my GP who is totally unsupportive and uninformed. If it goes in my favour that would be an unbelievable miracle. We need urgent, intensified action to get the NICE guidelines changed ASAP. I really hope we can.

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    1. I am really disheartened to hear of your situation Budgiefriend. It seems that these therapies are all linked to cost cutting everywhere. I too am horrified that NICE are refusing to address the harms of CBT and GET remaining on their guidelines during the review process. I can see no reason for them to be lift in place - except if NICE are hoping they might remain after the review. And that worries me. As patients we need to report the harms every way we can. I have written to the GMC via Dr Myhill’s campaign. I hope many others will too.

      Change cannot come soon enough for the many many people with ME like yourself who are being denied appropriate care. I don’t know enough to be able to advise you on a way forwards. If you are on FaceBook there is a good group that helps with benefit applications for ME folk. It’s called the UK M.E. Chronic Illness Benefits Advice Group. Hope that helps.

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  4. Great - I will contact my MP too.
    Re a petition, There are currently three petitions atm, the one to UK parliament ending on 13 march, the global one started by Robin Brown, and the global Unrest petition by MEaction. It can be very confusing so people dont sign all three as think they have already signed.
    Could be an idea to wait a bit.
    Just a thought!

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    1. I agree re the petition timing. There are enough of them running right now. And it would probably take quite an effort to get another new one off the ground. Perhaps in a while... but I wasn’t really thinking of one to be honest. :)

      Lots going on. Let’s hope we can keep momentum up for real change soon. Xx

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    2. Thank you Sally 👏💑🔶 great idea the yellow card,. I do have evidence of GET harm.. On my MRI scan, from gentle yoga exercise from my bed, with a yoga expect, said to stop. she was very good with me.. I agree with petition, re. Lots going on atm.. I too am struggling with care package and social care 😭 TLC to you All 💝 💞 💌

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    3. Take care Debra xx
      I hope with all that is going on - including Dr Myhill's complaint to the GMC, that things will change soon. It seems surreal that it hasn't already to be honest.
      Onwards...

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  5. Brilliant!! Could you please send it as an email to all the MPs known to be sympathetic to our cause too? These include:

    Carol Monaghan, Jim Shannon, Jim Cunningham, Alex Sobel, Rachael Maskell, John Howell, John Lamont, Layla Moran, Alison Thewliss,
    Nicky Morgan, Luke Pollard, Helen Whately, Paul Blomfield, Vince Cable.

    You can find their addresses here: http://www.parliament.uk/mps-lords-and-offices/mps/

    Also I have a related petition, you could help to publicise?
    https://www.change.org/p/nice-stop-harming-me-cfs-patients-remove-cbt-get-out-of-nice-now

    And this petition will hopefully help to take down PACE itself, the foundation of CBT and GET:
    https://www.change.org/p/the-general-medical-council-i-am-showing-my-support-for-dr-myhill-s-complaint-to-the-gmc-about-the-pace-authors

    Thank you!
    Robin Brown

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    1. I need to update the post. My MP Jim Shannon has now asked about the Yellow Card system. It will be interesting to see the answers.

      Please also check my blog post after this one, "Supporting Dr Myhill's PACE Trial complaint to the GMC" where I have given both petitions a mention. :)

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  6. Excellent blog "What possible reason could there be for protecting these psycho-social therapies from scrutiny?” Other medical interventions such as pharmaceuticals, medical devices and vaccines are all highly regulated including procedures for harm reporting, rapid recall/cessation of intervention, extensive traceability and full accountability of harms including personal fines and imprisonment if appropriate. All this structure exists already, but psycho-social GET/CBT treatment has none of these patient safety mechanisms in place, as you say...why is that? Psycho-social treatments should be regulated using the same procedures as the MHRA orange guide.

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    1. Interesting. I had to Google the Orange Guide. https://www.gov.uk/government/news/new-essential-orange-and-green-guides-2017-out-now--2

      It is time that patient complaints of harm from GET & CBT were taken seriously. No reason not to surely!

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