In what has become his characteristic style, Simon Wessely smears me with innuendo, suggesting I might try to alter the PLOS One PACE data and use the altered data to damage the careers of the investigators. He further argues that any release of the data could hurt the careers of the investigators and he understands their resistance. I say “Nonsense! I should be provided with the data as the investigators promised in publishing in PLOS One.”
Simon Wessely discreetly stays in the shadows, but he’s been very much involved in the struggle over the PACE trial, including whether the data will be released to me. I first learned from Wessely, not PLOS One, that my asking for data promised as a condition for publishing in the journal had somehow been turned into a Freedom of Information Act request.
But before that, Simon and I were in regular contact by direct messages on Twitter. I gave a talk at King’s College on biomarkers in June 2015. Simon and I later discussed getting a drink together because he was not able to be there. Simon established that he’s a wine guy, not one for scotch or beer.
When I first started tweeting about the PACE study months later, Simon contacted me, asking me not to comment on this study until I had spent months familiarizing myself with it. When that strategy didn’t work, he asked me to tone down my criticism of the PACE study. He even suggested that the PACE investigators would meet me in a public debate that Andre Tomlin of Mental Elf was trying to set up. But Andre later confirmed that the PACE investigators had already indicated there was no way that they would debate me.
Simon has continued to work behind the scenes, conveying vague threats to early investigators who criticize PACE in print. Simon’s nudges have been followed up by further threats from the PACE investigators to the universities of these early investigators.
Journalists have also been contacted by Simon who discouraged them in emails marked confidential from commenting on PACE. Tacky and manipulative because Simon’s emails came out of the blue, and Simon was suggesting that the journalists should not tell anyone about them.
Journal editors have been contacted by PACE investigators with efforts to suppress publication of criticism.
Critics have asked Psychological Medicine to publish a letter to the editor reporting the switched scoring of PACE outcomes that had substantially inflated the recovery rates reported in that journal in 2013. The editor, Robin Murray – a close colleague of Simon’s at King’s College, London – rejected the possibility of any letter based only on re-analyses. Rather, any correction would have to be based on an independent replication of the £5 million study in another sample.
Something is rotten in the UK, not just the State of Denmark.
When one highly professional and mild-mannered early career researcher requested a small amount of data from the PACE trial, the PACE investigators did a background check on her and attacked her character. Her request was labeled “vexatious” and refused.
Nonetheless, a group of patients teamed up with an early career investigator. Relying on normative data and reanalysis of the outcomes originally specified in the PACE protocol, they concluded:
None of the changes made to PACE recovery criteria were adequately justified. Further, the final definition was so lax that on some criteria, it was possible to score below the level required for trial entry, yet still be counted as ‘recovered’. When recovery was defined according to the original protocol, recovery rates in the GET and CBT groups were low and not significantly higher than in the control group (4%, 7% and 3%, respectively).
Critics need to be protected from bullying and their efforts to secure the data need to be supported. As I have noted before, the success of attempts to correct the untrustworthiness of the scientific literature depend on critics getting access to data, especially when replications are not feasible. That’s why the situation with the withholding of the PACE data should concern everybody, not just those focused on chronic fatigue syndrome.
It’s been over a year since I requested the PLOS One data. It wasn’t through a Freedom of Information Act request. I’m determined that early in the new year either I will get the data released or the PLOS One paper will be retracted. Stay tuned.
But for now, here is a communication from Simon to a patient who had tweeted about the PACE data back in March 2016. Some of the excuses made for not sharing the data with me were tried out at the UK Lower Tribunal and soundly rejected. Nonetheless, the excuses continue to be made by the PACE investigators to the press through the Science Media Centre London, which orchestrated the team’s unsuccessful effort to get Parliament to exclude university research from Freedom of Information Act requests.
There is international consensus that the usefulness of data sharing will be seriously compromised if those of us who request data are screened for whether the original authors think we have been naughty or nice. We are not asking the original authors to play Santa.
The many things that the PACE investigators have done with their data require forensic exploratory analyses of what the data may be hiding. This is especially important because of the policy implications that they are claiming and the financial benefits they are gaining from ties to the insurance and re-insurance industries.*
…I doubt anyone would actually be surprised to learn that they are not keen on handing anything over to someone who says they are “at war” with the PIs, that they are “coming to get your pathetic little trial” and so on and so forth. Hardly disinterested academic inquiry. But I can tell you they do want to release the data, because they have absolutely nothing at all to hide, but it does come down to trust. I have been suggesting that the sooner they get a robust system set up, which excludes them, the easier life will be for everyone. And I am sorry, but there have to be safeguards. For a start, there are legal obligations on data sharing on any doctor. And these are not easy to fulfil. And there is the issue of consent…you simply cannot just ride over it. And I am afraid some of the tweets do show a total lack of understanding what you can do with data, should you be so inclined. And if you do that, then that becomes a serious charge against whoever gave you that data. And in the weird, paranoid, sulphurous world of ME… I am afraid that fanciful notions of someone trying to do that, just to make life difficult and indeed possibly professionally terminal, for the PIs, is something that they don’t dismiss, and neither would I. so it takes time to get it right. and lawyers are going to be involved – because it’s a very complex area of the law. I have actually written on data confidentiality for the academy of medical sciences, so I know of what I speak. No one is going to hand over any data set these days without a data sharing agreement – I think you do really believe that you get a request, and say “OK, now, where the CD, ah yes, let me put in the post for you”. No academic would ever do that, they would be insane, and would probably also be unemployed fairly quickly
In fact the more intemperate some people become over the this, that just makes it worse, and also makes it easier for the PIs to perfectly legitimately use the current legal framework not to share data, because they are worried about all this, and so would I be, if it was. They are worried about active malice – there are people out there who have downloaded my powerpoints, changed them (guess how) and then circulated false versions to make me look like an ogre – which is why for many years now I never ever allow my powerpoints to be placed in any public place, as usually happens with conferences remember there are people also, and you know as well as I do who they are, who make up quotes claiming they are from me or peter and co – so its not paranoid to worry about what such people might do with a data set.
The other problem is that speaking frankly, I would say that nearly everyone who can analyse large clinical trial datasets, doesn’t have the slightest interest in doing so. They don’t care. PACE looks pretty good to the professionals. I know you don’t believe that, but it does.
Anyway, I have been suggesting quietly that the sooner they rid of the issue – get the Wellcome, MRC or the US centres that provide a data sharing service (there are several by the way) to take this – then they can deal with the data sharing agreements, they can decide if Jim Coyne should get It and give reasons if not, they can police the system, they can check the pre specifcied analytic strategy (which for sure will be required, trust me – no one is going to be permitted just to do random fishing exercises, because we all know that will create utterly spurious results which will do fantastic harm) – but guess what, some of these august bodies are not too keen . I wonder why……
So I think it will happen. Its not been made easier by someone develop an illness I am afraid, which is certainly stress related (when KCL said that they were concerned about the health of their eployees they were spot on). But it will take time. And here I do agree with you – the sooner it taken away from the PACE team the better for everyone.
Because there isn’t a smoking gun. Sorry,…but there isn’t. its just a well conducted huge trial with a rather modest but still useful result that adds to the evidence for the safety and efficacy of CBT and GET, which will remain the treatment of choice until something better comes along. Because there isn’t anything else at the moment.
*Here is the declaration of conflict of interest that accompanied the 2011 article in The Lancet:
PDW has done voluntary and paid consultancy work for the UK Departments of Health and Work and Pensions and Swiss Re (a reinsurance company). DLC has received royalties from Wiley. JB was on the guideline development group of the National Institute for Healthand Clinical Excellence guidelines for chronic fatigue syndrome and myalgic encephalomyelitis and has undertaken paid work for the insurance industry. GM has received royalties from Karnac. TC has done consultancy work for insurance companies and has received royalties from Sheldon Press and Constable and Robinson. MB has received royalties from Constable and Robinson. MS has done voluntary and paid consultancy work for government and for legal and insurance companies, and has received royalties from Oxford University Press. ALJ, BA, HLB, LVC, JCD, KAG, LP, MM, PM, HO, RW, and DW declare that they have no conflicts of interests.