UK House of Lords/ House of Commons - relevant people and questions

[ladycatlover]

Yet more free publicity for the damn SMILE trial. And I seem to remember that it was quite difficult to leave the trial - phone calls at home prompting filling in questionnaires.

 

[chrisb]

I am losing track of all this. Does this mean that the obscure placement of the caveat has led to the misleading of Parliament?

 

[MSEsperanza]

Does this mean that the obscure placement of the caveat has led to the misleading of Parliament?

Presumably yes. But first and foremost I think it means that ethics committees have never erred, nor will they err to all eternity.

 

[ladycatlover]

The operating procedure for trials in the UK has inbuilt safeguards designed to protect patients from harm in the event an intervention is ineffective or potentially harmful.

Unless they're psychological interventions where there's no way to officially report harm from an intervention. No yellow card.

 

[Esther12]

I worry that the more people/networks who would be embarrassed by acknowledgement of the problems with SMILE, the less likely it is we're going to be able to make progress. I think that sort of dynamic has played an important role around PACE.

 

[Jonathan Edwards]

This research trial had several limitations as set out in the peer reviewed journal article. This was a very small trial and so it would need to be repeated in a much larger group to demonstrate more generalisable findings. Participants were not blinded so their self-reported outcomes might have been biased, for example participants may have been more likely to report positive outcomes because they knew they were getting additional therapy in the LP group. Of all those eligible to participate in the trial, fewer than 30% agreed to take part. Participants in the trial did not have any serious adverse events attributable to either LP or usual care. LP therapy was given in addition to the usual CFS/ME care as a no-treatment control group was not deemed ethical, therefore it cannot be suggested as a replacement for current specialised medical care.

This section from the health minister is actually quite interesting (mostly the larger type bit). I think it effectively says that LP cannot be approved for NHS care through NICE. For sure it does not actually say that but it says enough to make its use incompatible with any reasonable assessment by NICE. It looks as if the health minister has been primed by the correspondence with Fiona Godlee, which was made available to members of the Commons, including Nicky Morgan.

The caveats have been sanitised but they are there.

 

[Jonathan Edwards]

The interesting question is why, if it is accepted that LP is not currently suitable for use on the NHS that the Health Minister should appear to be minimising the ethical concerns and sanitising the methodological problems.

Nevertheless, the issue of bias has been acknowledged, and a wedge is a wedge however thin the thin end. And it has been acknowledged as a contributory reason to not approving a treatment.

I may point this out to the NICE committee.

 

[Jonathan Edwards]

self-reported outcomes might have been biased, for example participants may have been more likely to report positive outcomes because they knew they were getting additional therapy in the LP group

Now this is crafty.

Participants might have been biased because they knew they were getting additional therapy. So the problem might not apply to trials where nobody got additional therapy, just different therapy? Or just therapy? It seems that the minister has been briefed by someone with a clear agenda in terms of where to steer the language - but perhaps not with much idea how to do that and make sense.

 

[Unable]

So . . . the PACE Trial used Standard Medical Care + additional therapy. Is this a way of saying PACE is also biased? Is that what you mean @Jonathan Edwards ?

 

[Jonathan Edwards]

So . . . the PACE Trial used Standard Medical Care + additional therapy. Is this a way of saying PACE is also biased? Is that what you mean @Jonathan Edwards ?

I had forgotten that. I was implying that PACE was also biased but having forgotten that therapies were in addition to SMC I assumed that the wording from the minister drew attention away from PACE. Maybe whoever did the briefing forgot as well!

 

[dave30th]

I had forgotten that. I was implying that PACE was also biased but having forgotten that therapies were in addition to SMC I assumed that the wording from the minister drew attention away from PACE. Maybe whoever did the briefing forgot as well!

That was my initial thought of what you mean as well, actually. The problem is they could say, well, APT was also "therapy" so there was something different about the "therapies" we liked, i.e. CBT and GET.

 

[Jonathan Edwards]

That was my initial thought of what you mean as well, actually. The problem is they could say, well, APT was also "therapy" so there was something different about the "therapies" we liked, i.e. CBT and GET.

I think we are getting too analytic. Her Majesty's Government has admitted that SMILE might be a tad dodgy. (And the rot might spread.) Seems fair enough to me.

 

[dave30th]

What is the actual role of this question-asking in government policy-making?

 

[NelliePledge]

What is the actual role of this question-asking in government policy-making?

it’s the stated view of the department of health to parliament put out under the ministers name so if they then do something pro LP they will be going against what they’ve told parliament which is bad form

 

[Jonathan Edwards]

What is the actual role of this question-asking in government policy-making?

As far as I know it is purely a means by which members of either House can call the government to account by asking for clarification of policy or intended actions to implement policy.

The situation for the LP is maybe of interest in that the government need have no specific policy relating to LP if it is not provided by government health services. But the government should have a position on the regulation of such treatments in general. I think the answer mentions approval by regulatory bodies with which professionals might be registered. There are of course none for LP - which highlights the fact that therapist-delivered treatments in general are not necessarily regulated in the way drugs are.

 

[Barry]

What is the actual role of this question-asking in government policy-making?

In principle it is a way of getting government officials to formally state on the record their response to the questions asked. It does of course depend on how carefully the questions are framed, and how adept and determined the officials are at avoiding the questions or passing the buck to others. But getting the responses on the official record could be important.

 

[Jonathan Edwards]

I have just discovered that Baroness Blackwood has a history of ME. More recently she has had diagnoses of EDS and POTS.

 

[Trish]

I have just discovered that Baroness Blackwood has a history of ME. More recently she has had diagnoses of EDS and POTS.

Since you have revealed that here, I assume it's public information provided by her. Is there an article about her somewhere?

 

[Jonathan Edwards]

Yes, she put a piece on the net. I just googled her name and EDS.

https://www.oxfordmail.co.uk/news/1...ood-im-battling-a-genetic-mobility-condition/

 

[Sly Saint]

https://www.politicshome.com/news/u...oness-blackwood-6-population-will-be-affected