Blog: "Even the Ethics Committee says the PACE authors should share the patient-level data, so why does PLOS ONE not enforce its regulations...

[Andy]

Full title: Even the Ethics Committee says the PACE authors should share the patient-level data, so why does PLOS ONE not enforce its regulations and compel them to? by some bloke called @JohnTheJack

In 2012 a cost-effectiveness analysis of the PACE trial was published by PLOS ONE. One of the conditions of publication was an agreement by the authors ‘to make freely available any materials and data described in their publication that may be reasonably requested for the purpose of academic, non-commercial research’.

A number of requests have been made to the authors for the patient-level data. These requests have been rejected.

PLOS ONE has issued an Expression of Concern, but has not obliged the authors to make the data available. In response, the authors state they are ‘surprised by and question the decision by the journal to issue this Expression of Concern’. They continue to reject all requests for patient-level data. In their Statement, they make it clear why:

‘During negotiations with the journal over these matters, we have sought further guidance from the PACE trial R[esearch] E[thics] C[ommittee]. They have advised that public release, even of anonymised data, is not appropriate.’

https://johnthejack.com/2019/02/17/...t-enforce-its-regulations-and-compel-them-to/

 

[Andy]

I'm guessing there is an "l" missing here, "was a pubic document"?

 

[RuthT]

I'm guessing there is an "l" missing here, "was a pubic document"?

Been reported & sorted.

 

[Barry]

During negotiations with the journal over these matters, we have sought further guidance from the PACE trial REC. They have advised that public release, even of anonymised data, is not appropriate. As a consequence, we are unable to publish the individual patient data requested by the journal. However, we have offered to provide key summarised data, sufficient to provide an independent re-analysis of our main findings

A really good FOI requesty @JohnTheJack.

This is so very true to form. The authors only mentioning the bit of the REC response they want people to know about, and nothing at all about the bit they don't want anyone to know about. The FOI act was made for these sort of people. So the REC also said:

"It is suggested that the researchers and the patient interest group should between them agree upon an academic institution (or possibly an independent researcher) whom both sides would trust. That institution would then receive the anonymised data and produce a report."

Given their track record for obfuscation and misleading, I would never trust the authors themselves to summarise data for subsequent reanalysis.

 

[JohnTheJack]

A really good FOI requesty @JohnTheJack.

This is so very true to form. The authors only mentioning the bit of the REC response they want people to know about, and nothing at all about the bit they don't want anyone to know about. The FOI act was made for these sort of people. So the REC also said:

"It is suggested that the researchers and the patient interest group should between them agree upon an academic institution (or possibly an independent researcher) whom both sides would trust. That institution would then receive the anonymised data and produce a report."

Given their track record for obfuscation and misleading, I would never trust the authors themselves to summarise data for subsequent reanalysis.

Thanks, Barry. Yes, I thought their quoting of the REC was very partial and indeed misleading.

 

[JohnTheJack]

I'm guessing there is an "l" missing here, "was a pubic document"?

Hehe. Oops.

 

[Barry]

Thanks, Barry. Yes, I thought their quoting of the REC was very partial and indeed misleading.

It is what I see over and over in so many of these ME/CFS BPS proponents, and is a form of deception I have seen in other people. Telling partial truth in order to strongly imply untruth; it seems second nature to many such people, and allows them to say they have not actually stated an untruth. It is why in a court of law the oath is to tell the truth, the whole truth, and nothing but the truth.

An imaginary example I sometimes use is if someone goes round accusing a person of deliberately swerving their car onto the pavement and injuring their dog, observing that person never liked their dog anyway. A very effective smear campaign could be waged with that, and it could be completely true. But what if they deliberately withheld from telling people that a child ran into the road, and was only saved by the car swerving onto the pavement. Lying by omission is very real, and it's not about listeners being gullible, but simply about them being trusting.

 

[Sly Saint]

Not directly related to @JohnTheJack s excellent piece but just a reminder;

It is nearly 6 months since the MRC wrote

"We hope to include the PACE trial on the CSDR portal within the next 6-12 months. This will allow researchers to apply to the CSDR Independent Review Panel to gain access to the dataset for their own analyses."
https://mrc.ukri.org/news/browse/criticism-of-the-pace-trial/

https://www.clinicalstudydatarequest.com

Has anyone asked what, if any, progress has been made on this?

 

[Barry]

It is suggested that the researchers and the patient interest group should between them agree upon an academic institution (or possibly an independent researcher) whom both sides would trust. That institution would then receive the anonymised data and produce a report.

Are we planning to follow this is up in some way? Because the more MS and Co strive to block independent analysis of PACE data, the more suspicious I get there is stuff the authors are absolutely desperate to keep hidden away.

If the REC's suggestion were followed up on, and the authors still resisted even engaging in the process, that would be a big tell in itself, for all to see.

A hypothetical question, but I see as really important to understand. Just supposing (and remember I'm saying hypothetical), that one or two PACE participants had bad reactions to GET let's say, and that these data were recorded, but not adequately pulled into the statistical analysis. That would be vitally important to assessing the veracity of the PACE author's analysis of their finding, but would also have the potential to indirectly identify those people even if the data were anonymized, given only one or two of them. Yet if the data made publicly available data were only summarised, would the crucial information then get lost? Is it possible to achieve the required anonymity, whilst still achieving the necessary information content regarding the harm, in this example. There could of course be all manner of such outlier data that might be invaluable to analyses, but be an issue for indirectly compromising anonymity.

I really do think that given the REC have themselves suggested a way for independent analysis of further PACE data, there should be some endeavours to pursue that.

 

[Hoopoe]

Are we planning to follow this is up in some way? Because the more MS and Co strive to block independent analysis of PACE data, the more suspicious I get there is stuff the authors are absolutely desperate to keep hidden away.

The records for adverse reactions could be interesting. The safety claims could be just as false as the improvement and recovery claims.

The adverse reaction assessment was done by people who believed that the intervention couldn't do harm and that patients were merely reacting hysterically to ordinary postexertional tiredness. We also know that the criteria for adverse reactions were tightened after the trial had started.

 

[JohnTheJack]

Not directly related to @JohnTheJack s excellent piece but just a reminder;

It is nearly 6 months since the MRC wrote

"We hope to include the PACE trial on the CSDR portal within the next 6-12 months. This will allow researchers to apply to the CSDR Independent Review Panel to gain access to the dataset for their own analyses."
https://mrc.ukri.org/news/browse/criticism-of-the-pace-trial/

https://www.clinicalstudydatarequest.com

Has anyone asked what, if any, progress has been made on this?

My understanding is that the MRC is still working on this and is expecting that it will be available this year.

 

[JohnTheJack]

Are we planning to follow this is up in some way? Because the more MS and Co strive to block independent analysis of PACE data, the more suspicious I get there is stuff the authors are absolutely desperate to keep hidden away.

If the REC's suggestion were followed up on, and the authors still resisted even engaging in the process, that would be a big tell in itself, for all to see.

I really do think that given the REC have themselves suggested a way for independent analysis of further PACE data, there should be some endeavours to pursue that.

I think this may open the door to something and and am mulling over doing something about it.

I also have a couple of FOI requests for the data in fairly advanced positions.

 

[rvallee]

Are we planning to follow this is up in some way? Because the more MS and Co strive to block independent analysis of PACE data, the more suspicious I get there is stuff the authors are absolutely desperate to keep hidden away.

They will never allow an independent reanalysis for that reason. Furthermore, that's not how any of this works. Scientists can't cherry-pick people to "independently" analyse their work. That makes a mockery of the scientific method and is a sure display of consciousness of guilt. This is exactly like Trump calling Mueller's investigation a "witch hunt", it's obvious guilty behavior.

Truth is they have no reason whatsoever to deny making the data available to any academic and the data that were already shared have only lead to one outcome: proving they exaggerated and misrepresented their work. Nothing else happened other than their dishonesty being revealed. We have the trial meeting group notes in which they specify that they allocated the resources to make the data available, properly anonymized. The work has already been done to make it available (unless their own notes are misleading).

Tuller's letter signed by 100 academics and clinicians already made the call for independent reanalysis. It has been rejected, as prior requests have been. The HRA letter doesn't really change that, although obviously the demand should be reiterated but with notice that this is the nth demand to do so. It is absolutely not normal for scientists to spend so much effort hiding their data and this should be strongly emphasized.

But PACE authors will never agree to anyone "we" could propose. I'm not even sure how that would work in the first place, who would make the selection of an independent panel. "We" are not organized enough to make that so the HRA's position is a bit bizarre in that regard, since it doesn't really translate well on the circumstances. Independent academics have made the request and they were arbitrarily rejected. This is bad enough on its own to rouse all the suspicions.

That and their paper at PLOSOne already contractually obligates them to share the data anyway.

 

[ME/CFS Skeptic]

I can't seem to open pdf-file. Anyone else has this problem or a way to fix it? Many thanks in advance

 

[Barry]

I can't seem to open pdf-file. Anyone else has this problem or a way to fix it? Many thanks in advance

I had the same trouble, but was OK if I downloaded it first then opened it from disc. Attaching it here anyway, assuming this is the one you mean.

Edit: You will still need to download first by the look of it, or maybe try a different browser, I'm using Chrome.

 

[ME/CFS Skeptic]

I had the same trouble, but was OK if I downloaded it first then opened it from disc

Thanks, Barry.

I usually open pdf's in chrome instead of adobe reader and think that might've got something to do with it. When I opened it with Adobe and downloaded/accepted the Flash content, all went fine.

 

[Adrian]

This is so very true to form. The authors only mentioning the bit of the REC response they want people to know about, and nothing at all about the bit they don't want anyone to know about. The FOI act was made for these sort of people. So the REC also said:

"It is suggested that the researchers and the patient interest group should between them agree upon an academic institution (or possibly an independent researcher) whom both sides would trust. That institution would then receive the anonymised data and produce a report."

Given their track record for obfuscation and misleading, I would never trust the authors themselves to summarise data for subsequent reanalysis.

I think the REC are setting a dangerous precedent in that is say a drug company were to have a questionable drug then they could whip up some controversy and then claim that its to controversial to share data. But I guess the REC isn't like a court with case law instead they just pick and choose the ethics to fit their views.

Of course transparency is a good way of dealing with controversy and keeping data hidden like the REC recommends is probably the worst thing they could do in helping create trust.

When reading this we should remember that the HRA gave PACE a clean bill of health over transparency. I can't help thinking that the HRA are misleading parliament in their letter.