The PACE data have been released (9 Sept 2016)

[Snowdrop]

A good question -- I expect litigating between countries will have it's own problems of course.
I also haven't a clue about how this all works in Canada.

There are sometimes cases that make precedent though. Maybe as a human rights violation (I say not having a clue as to how that would work)

 

[Large Donner]

On this we agree.

You mean you still don't agree with me on what the legal definition of a conspiracy is and that its nothing to do with the DSM?

Its achievable to demonstrate failure here, though difficult. I think we need to go beyond just putting those questions to them, especially since they will deflect them or claim they are already answered. Public questions help, but we need a wider strategy.

I agree.

 

[Large Donner]

How about we work out a way of asking QMUL under FOI for the data of proof of safety of the treatments used in the PACE trial.

They can either claim the evidence exists or it doesn't and supply us with such proven evidence.

 

[alex3619]

You mean you still don't agree with me on what the legal definition of a conspiracy is and that its nothing to do with the DSM?

Straw man. Counter-example.

Its not the definition I disagree with, its the interpretation of what it means. The argument about DSM goes to showing the fallacy of the logic that a criminal conviction on conspiracy proves there was intent. People can be convicted on technical grounds. Intent does not always matter. Proving intent is very very hard, which is another point I keep making.

So, for example, a possible defense against the scientific fraud claim is that they simply made a mistake. A paper showing they knew otherwise, they even published otherwise, proves its no mistake. Further there is a pattern. Was it not admitted they used the wrong comparison data, as in the entire population instead of working age population? Though admitted this was never corrected.

Most medical practice of CBT/GET could be defended on the grounds its supported by official guidelines, and is routine practice. It could be very hard to prove intent, just as its hard to prove harm. We could possibly do so for individual cases, but the history is that such claims are dismissed.

The PACE trial is already going down as one of the worst "scientific" trials in history. That is something its far easier to use to influence public policy and research practices.

 

[alex3619]

How about we work out a way of asking QMUL under FOI for the data of proof of safety of the treatments used in the PACE trial.

They can either claim the evidence exists or it doesn't and supply us with such proven evidence.

I think we would have to cite specific data which it is reasonable they should have. That is, we would have to compile a list of the data collected but not adequately published and ask for that. One thing I want to know is how many who withdrew from the trial cited declining health?

 

[Large Donner]

Straw man. Counter-example.

The argument about DSM goes to showing the fallacy of the logic that a criminal conviction on conspiracy proves there was intent.

You have done it again alex while accusing me of the strawman. If there's is a conviction for conspiracy there has to be proof of intent.

 

[Amused]

Criminality in the UK requires mens rea (intention) and actus reus (an actual act or omission). You have to have both.

This means that people who intend to hurt someone or something but don't actually do it, they aren't criminals (ie thinking how nice it would be to brain the noisy neighbour isn't criminal, until you actually do it).

Also means that people who hurt someone unintentionally aren't criminals (for example if I dropped a brick on your foot - it would be an accident).

Of course that doesn't mean that the brick dropper can't be indicted for something else, like negligence for the brick dropping etc.

So I think they can't be done as criminals, because they didn't intend to hurt anyone and had measures in place for what to do if people deteriorated. Also it's a medical trial, so there are risks inherent in that.

 

[Amused]

I should point out I don't actually go around dropping bricks on people. EVER! mutters not least cos I can't lift em. But also, I'm not a violent person.

 

[Large Donner]

I think we would have to cite specific data which it is reasonable they should have. That is, we would have to compile a list of the data collected but not adequately published and ask for that. One thing I want to know is how many who withdrew from the trial cited declining health?

Yes I understand the point of asking for specific data which is reasonable they should have but the effect of them replying "we have no data that proves the safety of the treatments used in the PACE trial because no such data exists", could be quite damning.

 

[Amused]

Medical negligence might be a possibility if they knowingly inflated Trial results and these were taken at face value and applied. But not sure that crosses international boundaries. And anyway they got permission/ agreement for their changes to the protocol, they didn't just do it willy nilly. So, I don't think that's viable either.

Also, they are medical professionals trying to help people. I honestly don't feel they have in any way tried to hurt people or knowingly influence others to do so.

 

[alex3619]

Yes I understand the point of asking for specific data which is reasonable they should have but the effect of them replying "we have no data that proves the safety of the treatments used in the PACE trial because no such data exists", could be quite damning.

It would be damning, but they wont do that. This is one case where the question would be correctly classed as vexatious and dismissed - you are asking for data they don't have. So they will just dismiss the claim, not answer it.

 

[Amused]

Yes I understand the point of asking for specific data which is reasonable they should have but the effect of them replying "we have no data that proves the safety of the treatments used in the PACE trial because no such data exists", could be quite damning.

They know how many people dropped out. Didn't one of their papers mention it? And one person aftewards said they couldn't use their data, sot hey had to redo everything (at the time I thought, pah, they should have built their results architecture more flexibly).

However, what has occurred to me, is that I very much doubt they EVER ran the data on the original protocol - cos my impression is they changed the protocol as they were going along, before all the data was available for analysis. And they got permission to change it (though who from I can't remember).

That said, it does seem weird they got permission to change the protocol so you had the overlapping thing where you could be in the trial and get worse but still be counted as recovered. That's just damn strange!

 

[Large Donner]

[QUOTE="Amused, post: 763227, member: 15758"

So I think they can't be done as criminals, because they didn't intend to hurt anyone and had measures in place for what to do if people deteriorated. Also it's a medical trial, so there are risks inherent in that.

So where are the figures for the deteriorated ESPECIALLY FIGURES MATCHING THE ORIGINAL PROTOCOL VERSUS THE PUBLISHED ONE and what where the measures in place to carry out if people did deteriorate?

Remember they have just suddenly given us "improvers" figures after being ordered to release the data requested. So why haven't they done a new analysis of the deteriorated as they did with the "improvers".


If, as it seems, people may have not been included in the data if they dropped out due to deterioration at what point did the investigators introduce such measures other than the treatments put on trial by PACE and if they did put those measures into place how can they claim to know they where safe before they had finished the trial and evaluated the data? Do they have some secret treatments they are not divulging which were the measures?

Secondly was the fraudulent use of £5 million pounds of tax payers money which was put to use in designing a fraudulent study and misreporting the efficacy and outcomes, changing the protocols halfway through, changing the recovery definition to the criteria needed to enter the trial, using a weak definition then going around after the study claiming the results are applicable to all ME definitions even ones that they didn't use, then refusing to share the data just one big accident if it wasn't intentional?

All just one big accident right???!!!

 

[Large Donner]

It would be damning, but they wont do that. This is one case where the question would be correctly classed as vexatious and dismissed - you are asking for data they don't have. So they will just dismiss the claim, not answer it.

Are you sure they have no such data? And lets say that's true then how can the PACE team go around claiming that there are no adverse effects form the chosen treatments?

Patients are entitled to expect such academics to have collected such data so that they can make informed choices when the investigators have been publicly funded to the tune of £5 million.

That line of questioning my be difficult to word under a FOI I accept, but who says that it has to only be put to them under a FOI.

It has to be put to them to them so that its on record either way whether they are entitled to makes claims of the safety of the proclaimed treatments.

Perhaps silence is golden in terms of them not replying or replying whilst not being able to make any claims of the efficacy of safety.

Could such line of questioning be simply put to them with a heading "THIS IS NOT A FOI REQUEST".

Can you imagine a drug company not being able to provide proof of safety for a drug they want to put on the market.

 

[Large Donner]

That said, it does seem weird they got permission to change the protocol so you had the overlapping thing where you could be in the trial and get worse but still be counted as recovered. That's just damn strange!

B I N G O !!!

So why haven't they done an analysis of those potential "worsers" and released it as they have done with the "improvers". Don't they care either way? Or is it even worse, and they have found a number of people have deteriorated and they don't want it known?

Surely the first thing an ethical researcher would want to know is how many people may have got worse comparing the original protocol figures versus the published figures especially when you have mentioned.......

so you had the overlapping thing where you could be in the trial and get worse but still be counted as recovered.

 

[JES]

So why haven't they done an analysis of those potential "worsers" and released it as they have done with the "improvers". Don't they care either way? Or is it even worse, and they have found a number of people have deteriorated and they don't want it known?

They did, PACE investigators published a paper on adverse effects and deterioration in 2014 (link). I haven't read it, but if you were to question them regarding safety, I assume they would refer to this paper. Also they have probably published similar papers before regarding CBT/GET, which they can refer to. Most of these people have been researching the same things for the last 20 years.

Also I think that the data that was released last week will give a good picture regarding possible worsening, since it included most of the physical measures of the trial. We just have to wait and see until it gets re-analyzed, I can't see much of a point in requesting anything else at the current moment because most of the information can already be deduced from the raw data.

 

[alex3619]

Can you imagine a drug company not being able to provide proof of safety for a drug they want to put on the market.

Data proving safety on much of psychopsychiatry is simply absent, and especially psychogenic psychiatry. I personally think psychogenic psychiatry is most likely damaging in a high percentage of cases, but proving it is another issue.

They can just deflect by saying you have no proof its doing harm. One of the issues with psychopsychiatry is they get a general exemption from critical scrutiny. I think this is a big blind spot in medicine. You are asking a field of psychiatry to be rigorous and logical which rests on poor data, poor conclusions, and fallacious reasoning, and is treated in many respects as dogma not science. Critics have been trying to hammer that point home since the late 19th century!

You can ask for specific data, but if you ask them to interpret it for you they will most likely dismiss the request. Its up to you to take data and demonstrate a conclusion, or some other team of scientists, statisticians, etc.

So we need to select highly specific data in a request, and if it does not exist then the request would be vexatious. They will almost certainly capitalize on that.

However we can ask public questions and ask about why data is not available. If as a result we learn about data not published, just as we did about fitness data when they finally did publish 4 years later, then we have grounds for an FOI at that point. Once they admit to the existence of data we can request it. If the data is not admitted to we can ask why it is not available outside of an FOI.

One way to do this is to look at deterioration in the 6mwt data and ask why this was not interpreted as harm. I think a good place to start would be to reread Tom Kindlon's harms paper, and then go back to the PACE trial publications. Indeed someone could write a follow-up paper, if the evidence warrants it, to show harm based on the released data. Then we can ask more pointed questions.

Meanwhile would could use all the anonymized data, not just a subset of data. If it comes out in drips and drabs it might be harder to compile it properly.

I am particularly interested in the high and low outcomes, that is claims of recovery and how many deteriorated. They need to start by releasing the data requested by James Coyne. There is a lot of data still kept secret.

 

[Large Donner]

They did, PACE investigators published a paper on adverse effects and deterioration in 2014 (link). I haven't read it, but if you were to question them regarding safety, I assume they would refer to this paper. Also they have probably published similar papers before regarding CBT/GET, which they can refer to. Most of these people have been researching the same things for the last 20 years.

Also I think that the data that was released last week will give a good picture regarding possible worsening, since it included most of the physical measures of the trial.

I mean why haven't they reanalyzed the data for "worsers" NOW as they did last week for improvers, not in 2014, that's 2 years ago and there is now more relevance since they are matching original protocol to the published results after being forced to release data.

Also just referring us to previous papers is no defense to accusations of PACE being a fraud.

We just have to wait and see until it gets re-analyzed, I can't see much of a point in requesting anything else at the current moment because most of the information can already be deduced from the raw data.

I can see your point here but at the same time if we did make requests of them now it could potentially show them to be utterly negligent and incapable of analyzing such data for if they try to avoid obvious issues that we may be able to confirm once the data that was ordered to be released can be analysed.

In the future we then could then potentially have a record of "look this is what they where still claiming right upto reanalysis their own data and even after they reanalyzed the improvers they had no interest in reanalyzing the "worsers" in the same way".

Or maybe I should just shut up and go to bed.

 

[alex3619]

Could such line of questioning be simply put to them with a heading "THIS IS NOT A FOI REQUEST".

Yes, but they, in error or vexatiously, treated Coyne's request for data as an FOI even though it clearly wasn't.

I think this debate with the PACE researchers is best done as very public questions. They love to deflect or not answer questions and we should make a public statement when that happens.

Meanwhile the momentum is growing regarding questions about the PACE trial. More of the media is finally waking up, and we have many mainstream scientists and academics getting involved now. They can see something is wrong and some of them are not going away until this gets resolved.

 

[Kati]

Can anyone confirm that Alem Matthees is in possession of the data?