Intended for healthcare professionals

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Cumberlege review exposes stubborn and dangerous flaws in healthcare

BMJ 2020; 370 doi: (Published 06 August 2020) Cite this as: BMJ 2020;370:m3099

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Rapid Response:

It’s not only drugs and medical devices that can cause harm

Dear Editor

The Cumberlege report has far-reaching and welcome implications for much needed change in the way patients are treated.
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” (MUS) 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 option for ME or for other long-term conditions where the cause and perpetuating factors are unknown.

In clinical research, scientists often have a vested interest in the success of an intervention they are investigating. They may have already convinced themselves, their peers, and if higher up the food chain, maybe also politicians, funders, regulators, policy makers, insurance companies, that it has merit. They will then want to move as quickly as possible to “selling” it on a grand scale, and one of the best ways to do this is by conducting a randomised trial. If you can also convince politicians that once a trial has “confirmed” the intervention works as you believe it does, the government will save money in welfare benefits, you might even get some government funding for the trial.

This is not how science should work. Scientists should always be challenging their own hypotheses, not trying to confirm them. If clinical scientists have "equipoise" they will design their research to try to prove that a treatment doesn’t work any better than a placebo or an alternative treatment. If they design their research to genuinely try to do that, and can’t, then there is likely to be a benefit.

There is also no incentive for anyone “invested” financially or otherwise in a treatment, including healthcare providers, to carry out post-marketing surveillance, or - perish the thought - ask patients what’s happening to them in practice. This could pick up problems such as lack of long-term benefit or evidence of harm which would not be found during a trial. With non-drug interventions there is no Yellow Card system to raise the alarm. All we have are systematic reviews, often carried out by, or with input from, proponents of the interventions who have conducted the trials. If post-marketing surveillance were ever done properly for psychosocial and behavioural interventions, I suspect they would often 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 [1]. Now, as revealed by the Cumberledge report, we have confirmation it’s not done properly for drugs and devices either.

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, 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 finding out what causes and perpetuates conditions like ME, and on research to find treatments that do work.

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 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 behavioural or psychological treatments, the only treatments on offer, 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 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.

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 also huge failings in academia, scientific publishing, and the medical establishment which have enabled and compounded these failings, especially in the case of psychosocial and behavioural interventions.

[1] McPhee G, Baldwin A, Kindlon T, Hughes BM. Monitoring treatment harm in myalgic encephalomyelitis/chronic fatigue syndrome: A freedom-of-information study of National Health Service specialist centres in England [published online ahead of print, 2019 Jun 24]. J Health Psychol. 2019;1359105319854532. doi:10.1177/1359105319854532

Competing interests: No competing interests

15 August 2020
Caroline Struthers
Senior Research Fellow
University of Oxford
Oxford, UK