A new campaign aims to get the government to put mechanisms in place for reporting harms caused by controversial medical treatments. You’d be forgiven for thinking something like this already exists. Except that it doesn’t – at least not for non-pharmaceutical treatments like exercise therapy. So, the campaign wants to change things. And the implications of this could be far-reaching – not least for long Covid patients.
The campaign founder’s specific area for the government to look at is the disease known as ME.
Years of harm
For years, myalgic encephalomyelitis (ME) patients have reported that non-pharmaceutical treatments have harmed them (some people refer to ME as chronic fatigue syndrome, CFS). This has often been from two treatments: graded exercise therapy (GET) and cognitive behavioural therapy (CBT). Recently, the National Institute for Health and Care Excellence (NICE) updated its treatment guidelines for ME. It removed GET as a recommended treatment. It said this was because:
the committee considered the benefits and harms associated with graded exercise therapy that had been reported with ME/CFS across the quantitative and qualitative evidence, alongside their own experiences.
NICE also downgraded the use of CBT. But some doctors groups were unhappy about NICE removing GET and downgrading CBT, and there’s concern that doctors will still offer exercise as a treatment.
Now, Sally Callow who founded the not-for-profit ME Foggy Dog has decided enough is enough. She has launched a campaign to pressure the government to create a proper, centralised reporting system for patients to log harm caused by things like GET and CBT. And it’s already gaining traction.
Callow told The Canary:
Since the guideline was published by NICE in October 2021, it has been very clear to me that… the harm from these non-pharmaceutical ‘treatments’ wouldn’t stop.
In the absence of adherence to NICE’s guideline, patients need a reporting system that is official and centralised so reports of harm can be collated and counted.
For decades, patients have complained to their NHS Trust, GP practice… and sent anecdotal ‘evidence’ to ME/CFS charities, but the complaints have not lead to change. The harmful ‘treatments’ continue to be recommended to ME/CFS patients across the UK today.
There is research evidence that backs up Callow’s assertion.
A 2011 paper by researcher and person with ME Tom Kindlon reviewed various studies into the use of GET and CBT for ME patients. It found that across various pieces of research, people’s physical and mental health worsened after both treatments. The extent of patients reporting worsening in health varied. One study found that 78.7% of people ‘deteriorated’ after a form of graded exercise. Another put the figure at 33.1% for GET and 27% for CBT. Overall, when Kindlon pooled all the research he included, the data showed:
- GET (or similar) harmed 51.24% of 4,338 patients – with the range varying between 28.1-82%.
- CBT harmed 19.91% of 1,808 patients – with the range varying between 7.1-38%.
Kindlon concluded in his 2011 report that:
It is hoped that this paper will lead to a greater focus on the reporting of harms in ME/CFS, not just those that might be associated with GET or CBT, but from any posited treatment. Interventions should not be presumed to be harmless when there exists evidence of potential harm and there have not been well-planned systematic methods to track and assess harms both within and outside trials.
Sadly, ten years later little has changed.
The NHS: ‘it’s up to the individual’
One example is in the form of an email from late November Callow gave to The Canary. It’s from the assistant to the CEO of NHS England Amanda Pritchard. Callow asked how patients could report harm caused by ME treatments and also in the case of long Covid. The CEO’s assistant said:
The NHS has a patient/public reporting route for patient safety incidents. However, given the therapy will depend to a large degree on the individual’s own situation and tolerance, it may not be appropriate to use this for CFS/ME. If a patient believes that a treatment they have received has not been effective or has had side effects, their normal first route to report this should be to the organisation that provided the treatment through the Patient Advice and Liaison Service (PALS). This should enable adjustment of the treatment. It also provides feedback to that organisation that may enable them to adjust the treatment they offer for other similar patients.
“Not trying hard enough”
Responding to that email, Callow told The Canary:
Patients have been complaining to their NHS Trust… and PALS for decades. Treatments are not ‘adjusted’ for other similar patients. Clinics are resistant to negative feedback and insist that the patient simply is not trying hard enough or doing it correctly. With GET or any ‘therapy’ that involves increasing activity levels, patients do not experience ‘side-effects’ – many are left house or bedbound for months, years, or even decades. Patients tend to not want to return for more ‘treatment’ once their health has deteriorated to that degree of severity.
In my opinion, the status quo allows the NHS (and ‘partners’) to mark their own homework with regards to ME/CFS, they have been giving themselves an undeserved A* for too long and too many patients have been harmed.
So, it seems that change is sorely needed within the NHS. This is where Callow’s campaign comes in.
Shake It Up
She’s launched a campaign called Shake It Up. It began with Callow emailing the Medicines and Healthcare Products Regulatory Agency (MHRA). She said:
I am writing to ask if you would consider creating a reporting mechanism for anything that is heralded as a ‘treatment’ or ‘cure’ by the NHS, in this particular case GET and CBT. A mechanism in which patients to log their name, address, the date, and healthcare professional/clinic that recommended these treatments as well as the effects of these ‘treatments’ – somewhere to scan appropriate paperwork if possible.
Now, she’s broadened the campaign. There’s a petition people can sign. Callow also wants people to write to/email their MP to ask them to support the campaign. She says you can additionally contact lord Kamall, parliamentary under-secretary at the Department of Health and Social Care (DHSC). So, what would a harm reporting system look like?
A “Yellow Card” scheme
The purpose of the scheme is to provide an early warning that the safety of a medicine or a medical device may require further investigation. It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about. The MHRA will review the issue and if necessary, take action to minimise risk and maximise benefit to the patients.
Yet nothing exists for non-pharmaceutical treatments. Currently, if an ME patient is harmed by exercise therapy prescribed by a doctor, then all they can do is complain. This means there is no central database of everyone who has reportedly been harmed by the treatment. So, it’s this which Callow wants the MHRA and government to change.
Not just ME
This issue is not confined to ME. Callow told The Canary:
ME/CFS patients are not alone in being harmed by non-pharmaceutical ‘treatments’, some of the petition signatures have come from other patient groups who have also experienced harm. This campaign is tackling the widespread false belief that non-pharmaceutical ‘treatments’ cannot, and do not, harm patients. This is simply not true.
Long Covid is another example. As The Canary previously reported:
medical professionals are still using exercise therapy in post-viral illness – namely post-and-long Covid. There are already clinics that are using this treatment – one using GET is funded directly by Public Health England.
And it’s not just ME and long Covid where doctors use non-pharmaceutical treatments on patients. Fibromyalgia and the Ehlers-Danlos syndromes all have exercise therapy as an NHS recommended treatment. Medically unexplained symptoms (MUS) has CBT.
A very economic problem?
Callow thinks she knows why some of the medical establishment might be against a harms reporting mechanism. She told The Canary:
I believe that much of the resistance to acknowledging non-pharmaceutical harms has origins in economics. Non-pharmaceutical often means cheap and cost-effective for medical organisations who would rather offer exercise and CBT to patients than invest in biomedical research that could lead to pharmaceutical treatments and possibly a cure.
I’m hopeful that my Shake It Up campaign will lead to positive social change for a number of patient groups, including ME/CFS and long Covid, who are also offered GET and CBT despite many experiencing post-exertional malaise – the reason GET and CBT are not to be recommended for ME/CFS.
So far, Callow’s petition has nearly 5,000 signatures. She’s also had a response from Kamall. Callow asked her MP Penny Mordaunt to contact Kamall to ask if the DHSC would implement the harm reporting system. But his response failed to even mention Callow’s question about harm reporting – effectively ignoring the issue:
It seems unfathomable that there is currently no centralised mechanism to report harms from non-pharmaceutical treatments. Yet that is the reality. Despite the prevelance of exercise therapy, it does cause people harm. This is not just an ME problem either. Therefore, anyone affected by the issues raised in Callow’s campaign would do well to put their full-weight behind Shake It Up. Change is needed – and quickly.
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