First Do No Harm, the Independent Medicines and Medical Devices Safety Review focusing on three drug/devices aimed at women (aka the Cumberlege report) was published on 8 July 2020. It has far-reaching and very welcome implications for much needed change in the way patients are treated.
Two of the review’s proposals are that there be a new Patient Safety Commissioner and Redress Agency established. However, they would only look at harms from “medicines and medical devices”. The review did not consider potential harms to patients from psychosocial and behavioural interventions which are still widely recommended for people with ME, and for an ever-expanding range of patients chucked into the (as yet) “medically unexplained symptoms” swamp. There is currently no UK mechanism for recording or monitoring harms from these types of interventions, or for challenging the assumption that they are an appropriate first-line treatment options for ME or for other long-term conditions where the either the cause or the perpetuating factors are unknown. It is vital that the safety and effectiveness (or lack of effectiveness) of psychological and behavioural interventions is covered by a future Patient Safety Commissioner and Redress Agency.
When people who have a financial or other interest in an intervention of any kind, they have already convinced themselves, and maybe regulators, policy makers, insurance companies etc. that it has merit. They will want to move as quickly as possible to “selling” it on a grand scale. So there is no incentive for makers or developers of any intervention – drug, device, psychosocial or behavioural – to try and prove it doesn’t work. But that is what scientists are trained to do; to try and prove their hypothesis is wrong. If they genuinely try to prove that the intervention doesn’t work better than placebo or an alternative treatment, and they can’t, then it’s likely there is a benefit. There is also no incentive for anyone “invested” in these treatments, including health service providers, to carry out the post-marketing surveillance which may reveal lack of long-term benefit or evidence of harm which would not be picked up in a trial. For example, in the case of treatments for people with ME, The PACE Trial was designed and manipulated as a confirmatory “show trial” by proponents of the interventions, some of whom had connections with insurance companies. In the case of Graded Exercise Therapy (GET), a Cochrane review was published three years later, acknowledging “advice” from the lead PACE investigator. I guess this was what passed as adequate post-marketing surveillance to confirm GET was effective and safe. No need to listen to patients, or systematically monitor what was actually happening in practice.
If post-marketing surveillance were ever done properly for psychosocial and behavioural interventions, I suspect it would reveal lack of long-term benefit, and in many cases, such as for people with ME, evidence of harm. This is discussed in McPhee et al.’s 2019 paper “Monitoring treatment harm in myalgic encephalomyelitis/chronic fatigue syndrome: A freedom-of-information study of National Health Service specialist centres in England” Now, as revealed by the Cumberledge report, we have confirmation it’s not done properly for drugs and devices either.
Powerful establishment proponents of behavioural and psychological treatments have expended a huge amount of time, energy and public funding conducting and then defending the poor science which they say “proves” these treatments are worth investing in further. The assumption that any intervention that isn’t a drug or device probably won’t do any harm, even if it doesn’t work, is preposterous. These types of interventions also cost money, and time and emotional investment from patients. If they don’t work, and/or cause harm, that investment continues to be wasted when they continue to be prescribed. This is public money that could be spent on research to find treatments that do work, and on finding out what causes and perpetuates conditions like ME in the first place.
Harm is done by gaslighting patients with (as yet) medically unexplained symptoms and convincing them that the first line of treatment should be a psychological or behavioural one, that their recovery depends on their engagement with such treatments, and will give them the best chance of recovery. For doctors with little knowledge or understanding of these conditions, this will also lead to a nice quick referral and the ability to get rid of a “tricky” patient – win-win.
In the case of people with ME in the UK and elsewhere, they are essentially coerced into trying Graded Exercise and/or CBT for fear of upsetting their doctors who are following the national treatment guidelines in good faith. Patients have a well-founded fear that if they don’t do as advised by the professionals, they will forfeit further medical help or benefits if and when the treatments don’t work or make things worse. These patients are being forced to play Russian roulette, but most don’t realise that’s what’s happening until it’s too late.
The irreparable damage done over decades in plain sight by the financially and professionally conflicted promoters of pelvic mesh, valproate, Primodos and other drug/device interventions is horrific. There are many cases where interventions are so well established and accepted by the medical establishment, any interest in further trials, such as withdrawal trials, or surveillance studies is past. For non drug or device interventions, there is not even a Yellow card system to raise the alarm.
This new strong commitment to listen to patients and protect them from harm must extend to psychosocial and behavioural treatments. The merit and safety of these interventions is often backed up by poor science which escapes the greater scrutiny given to research on drugs and medical devices. Patients who are treated with psychological or behavioural interventions are disbelieved if they report they have been harmed, and blamed if they don’t get better. They are also labelled anti-science if they point out obvious methodological flaws in the studies which have embedded the assumption that these interventions are effective and safe when they are neither.
The Cumberledge review highlights the failings of regulators and drug and device makers, but there are huge failings in academic institutions and the medical establishment too which have enabled and compounded these failings, especially in the case of behavioural and psychological interventions. It has to stop.
If you haven’t already, please write to your MP, Matt Hancock, NICE, Cochrane, your local GP practice, ME/CFS service – anyone you can think of to help get this message across.