Trial By Error: Professor Sharpe’s Retraction Requests

I suspect it is intended to protect HRA from any accusation of rocking any boats. It seems to include bits from advisers with different agendas, or maybe as you imply, to pacify everyone. Having been initiated by Parliament it was inevitable that the eminent friends of PACE would get called in.

I don't actually think anyone will notice that PACE has been vindicated in any way at all except the PACE authors and their critics. What I think may be useful is that the MPs involved in the select committee will have learnt a bit more about the complexities of the problem and the need to get the right arguments up front.

 

I suspect there are two issues here though. One is that people are bigots, and always have been and always will be. Injustice will always be with us. That seems to be the lesson of history. However, specific injustices do get addressed along the way. The core problem with this whole episode is that there is an anomaly within medicine that allows therapist-delivered treatments, (along with medical devices and other strange categories) to be used without any regulatory requirements for proof of safety and efficacy. That has been exploited by liaison psychiatry and now neuro-rehabilitation and primary care. The exploitation has led to the growth of a pseudoscientific trial industry. That has now been flagged up.

I think there is also another dynamic coming from left field. That is that this exploitation has led to commercial ventures that are increasingly looking like scams - Lightning Process, Norwegian Mindfulness courses and in fact IAPT. People are writing articles about that. The exploitation has sown the seeds of its own destruction because these things will soon have to be regulated. As Wessely said in his 2016 email to me, PACE has potentially opened a Pandora's box for its inventors.

 

If we win the argument about subjective unblinded trials ,a huge amount of research and medical practice falls apart. That's why they fight so nastily.
@Jonathan Edwards what are medical students and specialist registrars taught about research methodology these days? Or is too much time spent on the " psychology" of illness?

 

https://twitter.com/user/status/1097681352420405248

 

Jonathan, do you mean this is actually in the pipeline or are you just hoping this will be so down the line?

 

Yes. Now of all times is not the time to get complacent. They only have to 'win' with the people they already have the ears of anyway.

 

HRA letter to Lamb said: “We have reviewed the concerns about conflicts of interest that were raised with me at the Committee and have found that the declarations were consistent with the contemporary standards.”

This reminded me of Fiona Watt’s letter to Jeremy Quin MP (to which Jonathan Edwards responded) when she wrote: “However, I do believe that the trial was designed, conducted and overseeen in accordance with accepted standards at the time.”

It is notable that neither Watt nor Montgomery say that the standards at the time were acceptable. In other words, it may be that the standards (particularly in the field of psychological medicine) were unacceptably low but – in their view – nobody is really at fault because they were just doing what everybody else was doing at that time. If we could at least get them to admit that the standards at that time were unacceptably low they would be half-way towards admitting that PACE and a lot of other research involving therapist-delivered interventions is flawed.

——

I’ve just been re-reading the HRA letter. The COI bit is such a confused jumble – mixing up concerns about non adherence to the Declaration of Helsinki with concerns about the DWP’s involvement. It’s not clear to me if the HRA didn’t understand the valid concerns that have been raised, or whether it was just trying to brush them aside with a deliberately confused response.

I am minded to write to Norman Lamb to ask if he can request access to the evidence upon which the HRA made its assessment.

 

Are the standards any higher today? I expect little has changed.

 

Interesting that, I have just had a notice from TfL to tell me that if i drive my car into certain areas of London I will be liable for an emission charge of £12.50 a day. My car is diesel and and gets rewarded with the low road tax rate on the basis that it has exceptional fuel consumption and was therefore for that reason and others deemed more environmentally friendly.

Yet now that the policy has changed I don't just get to write back to Sadiq Khan and say, "sorry mate when I bought the car those were the standards at the time so going forward I get to inflict the previous standards failings onto others going forward".

Actually I might try it!

 

Could be that was the intent. But the words in the document are the words in the document and no reason not to cite them at face value.

 

+1000
And lets not forget the threats received in publishing them

 

And in doing so exposed themselves to liability, as they are basically saying they gave proper approval to deliberately biasing research and cherry-picking.

There is no reasonable explanation for approving lowering the primary endpoint below the entry point and absolutely no reasonable explanation to inventing the concept of "within normal range" that applies to basically 95% of the population. Or that you can basically pick participants to a trial without caring whether they even have the condition at all. It doesn't matter if it's filed with pomp and signed with an old-timey feather, it was blatant cheating.

So HRA basically absorbed some of the blame. That's a temporary reprieve but it will make them have to explain exactly how widespread this practice is and what exactly is it that they are doing when they are fine with blatant cheating and outcome switching, as long as the paperwork is filed. It also exposes them as unfit to check for conflicts of interest. So again the question is: how widespread is that? Because the editors basically do the same: "well, the researchers say it's fine and it's not our job to make that determination", when it is in fact exactly their job.

The HRA letter basically amounts to clearing blatant cheating and shoddy methodology because the simple act of filing the cheating makes the cheating proper. That's a can of worms that won't crawl back any time soon.

 

The ongoing (and largely ignored) crisis of replicability certainly suggests things haven't improved.

In fact, it's critical for the MUS project to succeed that standards be kept as low as possible, as it is not an area of research that can withstand any independent review. PACE has normalized the use of unblinded psychological trials with self-reported (shifting) outcomes having medical significance. This dumbening of science is the only way to push this pile of garbage over the finish line.

 

The problem is those were not part of the primary outcomes that did get approval. The "normal range" analysis, which became the "recovery" thresholds for physical function and fatigue, was post-hoc--so they didn't need committee approval or anything like that. They didn't call their new "recovery" definition post-hoc, although they should have. And they should have gotten approval for changing their definition of recovery for the 2013 paper, but HRA didn't look at that paper. HRA only looked at permission to change the primary outcome for the Lancet paper--which they got. HRA also blessed the decision because it was made before they viewed their data--ignoring the fact that in an open label/subjective outcome trial you don't need to see your data to know which way trends are heading.

Also, remember HRA is a relatively new agency--two years old or so. It wasn't around when these things were done. So it's not really justifying itself or somehow trying to give itself a pass for past work. it was largely created to fix things going forward, as I understand it. It's remit is not really to go backwards and investigate past wrongs.

 

Yikes. That makes for a pretty rough start, then.

 

But I see a document here that looks to me like the HRA was up and running in 2011-2012.

https://assets.publishing.service.g.../uploads/attachment_data/file/246994/0312.pdf

With regards J Montgomery it says:

I feel privileged to have been appointed to Chair the Health Research Authority on 11th June 2012. I have served as a NHS chair for the past fourteen years and I am a passionate supporter of the Service, who wants it to provide the best evidence-based care that it can. My first public appointment was to a local research ethics committee and I am delighted to be involved in this area again. Research Ethics Committees have a crucial role to play in promoting the interests of research participants, including protecting them from unethical research. Our work extends much further, however, and I am excited to be part of the wider agenda of streamlining governance processes so that good research is easy to do and be involved in.

Is this something else?

 

https://twitter.com/user/status/1097888253070491648