A question
@Valerie Eliot Smith please, which occurred to me whilst looking in
https://www.s4me.info/threads/valerie-eliot-smith-covid-19-nice-and-me-towards-litigation.14984/.
Just to be clear, I have no medical nor legal expertise. Some of the terminology I'm using is probably incorrect therefore, but hopefully gets my point across.
My key issues are:
- Burden of proof of required to demonstrate harms vs burden of proof of required to demonstrate safety.
- Anecdotal evidence of ineffectiveness and harms from patients vs anecdotal evidence of efficacy and safety from the SMES.
My concern is that, in the future, advocates of GET/CBT-a-la-GET (especially SMES) might argue that if we can base evidence of harms on anecdotal evidence (in the form of patient surveys), then it must be equally valid for them to use anecdotal evidence of efficacy and safety, in the form of "clinical experience", and that theirs is based on medical expertise. I don't believe that argument holds water, but would appreciate your input.
As I see it, the burden of proof required to demonstrate adequate safety should be at a much higher threshold than the burden of proof required to demonstrate the potential for harms. I think this is true for something like aircraft safety, where extremely high confidence has to be demonstrated that an aircraft is safe to fly, but a significantly lower confidence threshold required to demonstrate it's potential unsafety and the need for it to be grounded. I see no reason why the same principle should not apply to medical safety.
SMES have clearly stated that ME/CFS is classified as a neurological disorder, which means they simply cannot rely on any supposed evidence from PACE etc, which clearly states is based on the deconditioning and false illness beliefs theory. So instead there have been murmurings from them about "clinical experience" which is effectively anecdotal evidence, but which I see as being prone to all manner of potential biases.
But if we argue that their use of anecdotal evidence is weak and flawed, even though from "experienced clinicians", then they might well seek to argue that our use of anecdotal evidence is equally suspect; why should their anecdotal evidence be unacceptable but our anecdotal evidence valid?
It would be good to have an effective rebuttal to that, and to think about it well beforehand.
Thank you for raising that, Barry. It's a very important point.
All litigation is founded on stories of real life. As such, much of the basis for litigation is anecdotal. This is then often supported by other forms of evidence such as eg. expert/documentary evidence (eg. diaries, emails, financial records etc.).
When it comes to technical specialist areas such as medical evidence, anecdotal evidence is relevant but does not provide so-called "best" evidence as most patients are not medical experts. However, its role in bringing an action is still key to commencing proceedings.
The patient survey would need to be formally produced by a witness (probably by a representative from Forward-ME) as documentary evidence. It then forms part of the case. If the case then went to trial, the judge would assign the appropriate weight to it evidentially. It's not primary evidence in its own right but it is powerful supporting evidence.
As the NICE GDG requested the survey from Forward-ME, this increases the value which should be put on it (despite the fact that NICE appears to have ignored it so far).
In the case of the ME community, the history of neglect, stigma and consequent under-investment in the illness means that there is a severe shortage of expert evidence to support claims surrounding the harms caused by GET. However, this does not mean that anecdotal evidence is simply dismissed. It still forms a fundamental part of the case.
Your concern about claims that the ME community's anecdotal evidence is of little evidential weight is very real. However, with the power balance as it is (ie. the ME community being in an unacceptably weak position through no fault of its own) it still has a vital role to play. We have to use whatever is available to us.
Arguably, in trials such as PACE, subjective reporting is little more than anecdotal evidence.
So - to bring an action against a healthcare provider for prescribing GET, these are some of the initial challenges:
1. A patient/patients who are willing to provide affidavits detailing their treatment and the effects it had on them. This is where diaries are useful (see blog post). Contemporaneous evidence boosts credibility.
2. Patient evidence cannot be anonymous as it will carry very little or no weight. This might be a problem for some people.
3. Finding healthcare professionals who are a) recognised and credible experts b) understand the history/pathology of ME and c) are willing to act on the community's behalf. This is one of the biggest problems, although, as I said in the post, it's not insurmountable.
I'm aware that this only a start in answering your points, Barry. There is more that I could add about standard of proof and rebuttal evidence (ie. your "aircraft safety" point). However, I'm completely out of resources now and I don't think there's much more I can say that would be useful at this point.
Obviously, evidence is something which would have to be carefully considered if any legal action was being contemplated.
