Patient Safety Commissioner proposal - First Do No Harm IMMDSReview, 2020, Cumberlege et al

The Independent Medicines and Medical Devices Safety Review into three unsafe medicines/medical products aimed at women has now published its report to the UK government (8 July 2020).

The report, First Do No Harm, calls for:

• a new Patient Safety Commissioner to "champion the patient voice"
• a new Redress Agency focused on "avoidable harm looking at systemic failings... [and] using a non-adversarial process. The support or redress offered could be both financial and non-monetary."

"1.18 We heard about the failure of the system to acknowledge when things go wrong for fear of blame and litigation. There is an institutional and professional resistance to changing practice even in the face of mounting safety concerns. There can be a culture of dismissive and arrogant attitudes that only serve to intimidate and confuse. For women there is an added dimension – the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.
...
1.29 ... The failure of the healthcare system to respond to patient concerns is a recurrent theme... Patients often know when something has gone wrong with their treatment. All too often they are the first to know. Their experience must no longer be considered anecdotal and weighted least in the hierarchy of evidence-based medicine."​

A weakness of the review is that the proposed Patient Safety Commissioner and Redress Agency would look at "medicines and medical devices" only. The review does not consider potential harms to patients from other types of medical intervention, such as activity regimens or psychological interventions. There is currently no UK mechanism for recording or monitoring these harms so that patient safety can be improved - as discussed in McPhee et al.'s "Monitoring Treatment Harm in Myalgic encephalomyelitis/chronic Fatigue Syndrome: A Freedom-Of-Information Study of National Health Service Specialist Centres in England" (2019).

 

It is vital that the safety and indeed the effectiveness of psychological and behavioural interventions is covered by a future patient safety commissioner.

There is no rigorous research or long term post-marketing surveillance for non-drug/device interventions. If this were ever done properly, I suspect would also reveal lack of long-term benefit and in many cases evidence of harm. The pervading 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 interventions also cost money and if they don't work, that money is wasted. The powerful establishment proponents of the treatments expend a huge amount of time and energy conducting and then defending the poor science which "proves" these non-drug/device treatments are worth investing in further.

The harm is done by gaslighting patients with (as yet) medically unexplained symptoms and convincing them that the first line of treatment should be psychological or behavioural ones - a nice quick referral and job done. In the case of people with ME, they are coercing into trying Graded Exercise and/or CBT for fear of upsetting doctors blindly following the NICE guidelines and thereby losing recourse to ongoing medical help or benefits if the treatments don't work or make things worse. These patients are being asked to play russian roulette, but most don't realise that's what's happening until it's too late.

I agree that the irreparable damage done in plain sight by mesh, valproate, primodos and other interventions is completely horrific. I hope that this new commitment to protect patients from harm extends to protecting them from non-drug/device treatments where they are not only disbelieved when they report they have been harmed, but also blamed if they don't get better.

 

I have rewritten and expanded the above rant below as it was written in haste (and anger) without consideration of its readability. I will probably put it on my blog in due course too. So please comment to agree, disagree, or suggest improvements.

The Cumberlege report has important implications for people with ME and others who have been thrown into the "MUS" creek without a paddle

But I am worried you will be overlooked again.

It is vital that the safety and also effectiveness (or lack of effectiveness) of psychological and behavioural interventions is covered by a future patient safety commissioner.

At the moment, there is no rigorous research or long term "post-marketing" surveillance for non-drug/device interventions. By post-marketing, I mean when the people who have an interest financial or otherwise in the intervention have already convinced themselves and the regulators, insurance companies etc. that it has merit and can move on to "marketing" it on a grand scale. There is no incentive for developers of any intervention, drug, device. behavioural or psychological - to test their intervention, or to do the post-marketing surveillance properly. PACE was a “show trial” and in the case of GET, the Cochrane review was seen as adequate post-marketing surveillance. No need to listen to patients, or systematically monitor what was happening in practice.

If post-marketing surveillance were ever done properly for non-drug/device interventions, I suspect it would reveal lack of long-term benefit and in many cases, such as for people with ME, evidence of harm. But now, as revealed by the Cumberledge report, it's not even done properly for drugs and devices.

The pervading 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 interventions also cost money, and if they don't work, abd/or cause harm that money is wasted when you carry on prescribing them.

The powerful establishment proponents of behavioural and psychological treatments expend a huge amount of time and energy conducting and then defending the poor science which "proves" these treatments are worth investing in further.

The harm is done by gaslighting patients with (as yet) medically unexplained symptoms and convincing them that the first line of treatment should be psychological or behavioural ones. For doctors with little knowledge or understanding of these conditions, this is a nice quick referral and they can wash their hands of tricky patients – 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. They fear that if they don't do as advised by the professionals, they will lose recourse to further medical help or benefits if the treatments don't work or make things worse.

These patients are being asked to play Russian roulette, but most don't realise that's what's happening until it's too late.

I agree that the irreparable damage done over decades in plain sight by conflicted promoters of mesh, valproate, Primodos and other drug/device interventions is horrific. But I hope that this new commitment to protect patients from harm extends to protecting them from non-drug/device treatments where they are not only disbelieved if they report they have been harmed, but also blamed if they say they are not helped.

 

I like it. The assumption of psychological causes of illness in general is another thing that has I suspect never been adequately shown to be safe or correct. Nobody is really looking for harm related to this even though it's very easy to find patient stories of harm.

People may object to mental illness diagnoses because they are often an instance of bad medicine and bad care. We need less talk about "stigma of mental health" and more genuine efforts to recognize how mental health ideas are harming people.

 

Thank you – it reads well (as did the first version, to my eyes anyway). Haven't the brain function to go into any depth at the moment, but I'd prefer you kept the 'as yet' qualifier on 'medically unexplained symptoms'. It makes it clearer that you're not accepting the term as some kind of diagnosis.

 

Yes. I will blog it, Tweet it, and then think about how to get the message across to authority about psychosocial interventions. Cochrane would theoretically have been a good ally in this... if they had ever highlighted the problems in trials of psychosocial interventions rather than glossing over them. Hey ho.

 

My memory may be playing tricks but was there not , a few years ago, a study into the effects of counselling on post disaster victims which found that those who received the counselling fared worse than those who did not. The counselling somehow fixed (not in the "mended" sense) the trauma.

That would seem to have been a harm of the type discussed here.

 

Yes. I think there may be something more recent too

 

OK - here's the blog - comments very welcome - I haven't Tweeted it yet https://healthycontrolblog.wordpres...rugs-and-medical-devices-that-can-cause-harm/

 

Thank for a clear cogent account.

 

I have taken a few very helpful comments on board and updated it - thanks everyone! Will tweet tomorrow am

 

To me, anything that can have an effect on someone at all, can potentially have either a positive or a negative effect. In a sense you can broadly perceive an effect as being on an analogue scale, ranging from negative through zero to positive. What we think of as benefits would be the positive side of the scale, and detriments/harms on the negative side. The notion that any intervention has an effect range which magically truncates at zero (i.e. lops off the negative side) is nonsensical. If something has the potential to benefit, then it has the potential to have an effect; if it has the potential to have an effect, then it could be anywhere across the whole range. It's just not safe to presume otherwise.

If something has the potential to benefit then it must be assumed it has the potential to harm, no matter what the treatment.

 

Hi Caroline,

Excellent. Just one possible typo and maybe lost text?

Apart from the double commas, not sure if it reads quite right?

 

I would add a call to action: email your MP, write to Matt Hancock, etc.

 

Quite right, everything in life works that way. Even improvements in your situation usually have a few negative aspects.

They do analyses on Pharma research and if the results are too good it is taken as proof that negative studies have been suppressed. The BPS research, with it's universal benefit and no risk of harms, would not pass that test.

 

On the rare occasions when I post here, it tends to be "flyposting": I have to go off to recover for a few weeks after having posted, and don't find out what happened next in the conversation.

It was great to come back on today to find that the brilliant Caroline blogged about non-pharmaceutical harms.

The comments I quoted above from the First Do No Harm report apply so well to our situation:

The continued exposure of UK patients to potentially harmful interventions for M.E. without being warned appropriately of documented risks and evidence of inefficacy shows that those "dismissive and arrogant attitudes" are thriving in the NHS today as much as ever. Patients cannot get back the years or decades that have been taken from us by harmful protocols, but the least we deserve is recognition of what we have endured, protection for M.E. patients in the future, and a system to ensure nothing like this happens again to any group of patients.