New Scientist mentions PACE trial "open data" controversy in editorial (9 Feb 2017)

[Sasha]

Wow, surprise...

Just got this week's new issue from the newsagent's and behold, on the first page:

Hearts on our sleeves

We need transparent trials to maintain confidence in medicine

Tens of millions of people took Vioxx for their arthritis between 1999 and 2004. Tens of thousands probably had a heart attack as a result. [...]

Access to data is at the centre of many controversies in modern medicine - not just to do with the usefulness of drugs, but also of treatments (such as exercise for chronic fatigue syndrome) [...Other topics, including trials of statins...]

That has provoked a furious war of words with those who do have access to the data. They say complex ownership and usage conditions mean it can't be released widely. That's a familiar problem: similar issues dogged the release of raw data from the 2011 PACE trial of chronic fatigue syndrome treatments, which a tribunal finally ordered to be released last year. [...]

 

[Jenny TipsforME]

It's online here https://www.newscientist.com/articl...parent-trials-to-keep-confidence-in-medicine/

 

[Sasha]

It's online here https://www.newscientist.com/articl...parent-trials-to-keep-confidence-in-medicine/

Thanks - it hadn't occurred to me that the whole magazine wouldn't be paywalled!

 

[hixxy]

https://www.newscientist.com/articl...parent-trials-to-keep-confidence-in-medicine/

PACE trial is mentioned briefly.

 

[Keith Geraghty]

I would like to think my 'Pace-Gate' Editorial brought some attention in addition to other great works like the re-analysis paper - giving editors and writers fuel to write these short pieces on this controversy - ie we raise our heads above the parapit and then its easier for others too also

 

[Cheshire]

Short answer by Michael Sharpe:

Your leader article criticised the PACE trial of treatments for chronic fatigue syndrome, which I co-led, for not sharing data (11 February, p 3). On behalf of my colleagues, I need to point out that this part of your commentary is misleading. The PACE team has shared data many times with researchers who have agreed to respect its confidentiality, including with a Cochrane Collaboration group who have undertaken a meta-analysis of exercise therapy (which is in review) using individual patient data. We have not voluntarily released data to the general public as we do not have our participants' consent to do this. We suggest that the consent of trial participants must be considered in any discourse about sharing trial data.

https://www.newscientist.com/letter...can-share-data-only-when-rules-are-respected/

 

[slysaint]

We can share data only when rules are respected

that's rich coming from a PACE researcher

 

[user9876]

Short answer by Michael Sharpe:



https://www.newscientist.com/letter...can-share-data-only-when-rules-are-respected/

The tribunal judge pointed out that this attitude is not legal under the DPA (data protection act). If the data is PII and people have not consented for it to be shared then they cannot share it. They did not have explicit consent to share personal data. This means they have either broken the DPA or the data they shared is not PII and there is no confidentiality issue which is what the court rule for the requested set of data. There is a potential gray area with confidentiality and reidentification.

They had also been lying when they claimed that they shared data with independent scientists at the cochrane collaboration as they were involved in the protocol design. They seem to have dropped this claim of independence.

Perhaps we should remember that they have been cherry picking who can see the data to be only those who agree with them.

 

[Barry53]

they have been cherry picking

The PACE authors' stock in trade it would seem.

 

[Sasha]

Response in today's print edition from Michael Sharpe, on the letters page (p. 53) - also online, here:

https://www.newscientist.com/letter...can-share-data-only-when-rules-are-respected/

 

[Tyto alba]

We suggest that the consent of trial participants must be considered in any discourse about sharing trial data.

How/when did PACE trial participants give consent for data to be shared with non-PACE trial researchers?

 

[user9876]

Response in today's print edition from Michael Sharpe, on the letters page (p. 53) - also online, here:

https://www.newscientist.com/letter...can-share-data-only-when-rules-are-respected/

It makes me wonder why the editor is so weak that they are not prepared to defend the criticism that they made.

Sharpe claims they have shared with other scientists (claiming many times) trying to give the impression that it is with many groups but then they can only quote one actual groups who have received data and that is when they were involved in the writing of the analysis protocol. We know others have been turned down and not because they wouldn't respect confidentiality because they weren't asked. It would be interesting for QMUL to release the names of the groups and what data they have shared.

If QMUL really consider the data as personal data then they have broken the law (Data protection act) in sharing since they didn't have explicit permission. This was pointed out in the FoI tribunal ruling. Again here they only managed to quote Cochrane as data recipients and had to drop their claim that they were "independent scientists". The FoI tribunal of course ruled that the small amount of requested data was not PII (Personally Identifiable Information) and hence can be released. If they have shared more with others then there is no reason why they shouldn't share more publicly although there may be arguments over reidentification.

They have of course promised to share data when they published in PLOS - instead PLOS have demonstrated an unwillingness to support their own policies.

 

[TiredSam]

It makes me wonder why the editor is so weak that they are not prepared to defend the criticism that they made.

Sharpe claims they have shared with other scientists (claiming many times) trying to give the impression that it is with many groups but then they can only quote one actual groups who have received data and that is when they were involved in the writing of the analysis protocol. We know others have been turned down and not because they wouldn't respect confidentiality because they weren't asked. It would be interesting for QMUL to release the names of the groups and what data they have shared.

If QMUL really consider the data as personal data then they have broken the law (Data protection act) in sharing since they didn't have explicit permission. This was pointed out in the FoI tribunal ruling. Again here they only managed to quote Cochrane as data recipients and had to drop their claim that they were "independent scientists". The FoI tribunal of course ruled that the small amount of requested data was not PII (Personally Identifiable Information) and hence can be released. If they have shared more with others then there is no reason why they shouldn't share more publicly although there may be arguments over reidentification.

They have of course promised to share data when they published in PLOS - instead PLOS have demonstrated an unwillingness to support their own policies.

They probably have to allow Sharpe a right of reply. Maybe they will also allow publication of a letter replying to Sharpe's drivel which makes the points you've raised?

 

[Esther12]

It makes me wonder why the editor is so weak that they are not prepared to defend the criticism that they made.

I thought that they didn't criticise PACE in the first place, and that seemed very weak. In UK science, people seem afraid to criticise PACE. Seems that they know where the interests of the establishment lie, and they're not willing to challenge that.