Glimpses into the assault on data sharing

…Exempting Universities from the FOIA would achieve that. Exempting scientific research data produced by Universities and other higher educational institutes might be a workable alternative.” – Peter White, Principal Investigator, PACE trial

Little attention is being given to a serious and sustained assault on the sharing of data from research conducted in the UK. Another significant incident has largely gone unreported.

The UK Independent Commission on Freedom of Information issued a call for evidence on October 9, 2015:

…To consider whether there is an appropriate public interest balance between transparency, accountability and the need for sensitive information to have robust protection, and whether the operation of the Act adequately recognises the need for a “safe space” for policy development and implementation and frank advice. The Commission may also consider the balance between the need to maintain public access to information, and the burden of the Act on public authorities, and whether change is needed to moderate that while maintaining public access to information.

Dr. Peter White2Peter White, Principal Investigator of the PACE Chronic Fatigue Syndrome Trial submitted testimony sometime between October 9 and the deadline of December 7, 2015.

He ended his testimony with an impassioned plea that science needs protection from requirement for data sharing:

Section 22a of the Act is insufficient protection for science into controversial subjects, and requires that the research is on-going, so is irrelevant to completed research. We need science in the UK to be protected or it will continue to be damaged as this trial has been (other examples include climate change science, and research into the health effects of tobacco). Exempting Universities from the FOIA would achieve that. Exempting scientific research data produced by Universities and other higher educational institutes might be a workable alternative.”

So, if we accept White’s arguments, his psychotherapy trial data and even data from pharmaceutical trials needs to be protected from the burden that was faced by researchers of climate change and health effects of tobacco. Thus, Peter White places himself on the side of the angels.

He claims damage was done to his trial by the freedom of information act (FOIA) as it is now enforced. His time spent responding to FOIA requests for data could have been better spent doing:

…Further research into the causes and treatments of this debilitating and misunderstood illness [which] has been delayed.

White cites the damage done by two patients who withdrew from the trial:

Perhaps most damaging of all have been requests by two trial ex-participants to “”destroy”” all their data collected on them during the trial because of their concern that the data will not be held securely and confidentially, something we promised them to do as part of their giving informed consent. The first such request was received after we had finished all trial data collection and had started the main analysis. After some months of trying to obtain advice on what to do, we were advised to destroy this ex-participant’s data, which we did (and which took some time to do due to the complexity of the data), but this meant that we had to restart the analysis, which caused several month’s delay in publishing the main results paper in 2011. This paper was important since it showed that there were two treatments for this condition which were safe and moderately effective. It is estimated that some 250,000 people suffer from CFS in the UK.

burglaryI doubt the Independent Commission has the context to evaluate “this most damaging” evidence without a context. We know from other sources that the PACE investigators failed to provide participants in their study with suitable protection of their data. The investigators did not separate data from identifying information and did not have lockable cabinets in which to store data. Furthermore, some audiotapes with unique patient identifiers were stolen from an unlocked desk drawer in a burglary. The PACE investigators did not notify the patients of the breach of data security.

On 31st March 2006 Peter White wrote to the West Midlands Multi‐centre Research Ethics Committee to inform them of the theft of a digital audio recording (DAR) of GET sessions from Centre 03 (which is King’s College, ie. Trudie Chalder’s Centre). This confidential information was stolen from an unlocked drawer in the therapists’ office. Peter White informed West Midland MREC that: “There are no lockable cabinets in any of the therapists’ rooms so the drawer was not locked” (cf SSMC Participant Information Sheet). His letter continued:

The burglary was reported to Southwark police on the day that it happened, which was Wednesday 22nd March 2006. The crime number is 3010018‐06. The therapist was away on leave 22nd‐24th March and therefore the DAR was not found to be missing until Monday 27th March 2006”. It was only after the theft that Professor Trudie Chalder sought advice on how to secure the data properly.

The letter also said: “The Principal Investigator for this centre, Professor Trudie Chalder, is awaiting advice from the Trust R&D as to whether the affected participants should be made aware of the theft”.

The same letter stated that recordings were being downloaded to CD only on a monthly basis, a working methodology that is not compatible with the promises of confidentiality set out in the “Invitation to join the PACE trial” leaflet.

The letter carries a handwritten annotation dated 13th April 2006: “Noted. Sad! No action needed”.

We don’t know how restricting FOIA requests would protect anyone affected by this incident. Perhaps some patients participating in the PACE trial learned that their data had been stolen by way of a FOIA request, after the investigators decided not to inform them. Perhaps the two patients withdrawing from the trial were not directly affected but felt threatened by the disregard of the investigators for the basic rights.

The patients who withdrew from this trial were well within their rights provided by their informed consent agreement. Given the investigators demonstrated such indifference to patient rights, the rational action was for these patients to withdraw.

colonial administratorSo what is Peter White’s point? That we need to seriously restrict the FOIA so that investigators will not be found out?  So  the patients will not withdraw from a trial in which confidentiality has been breached? This seems a very colonial view of patients as “subjects” of researchers, quite contrary to the enlightened view of the World Medical Association Declaration of Helsinki accepted in the UK as elsewhere.

I doubt much of the scientific community outside of the UK would agree that a FOIA should be required to obtain data from a publicly funded trial. As was seen with the PACE trial, considering requests for data as FOIA requests hopelessly bureaucratize the simple provision of data as requested. There is no limit on the silliness of reasons used to refuse a FOIA request. It then takes time to appeal a refusal to release data to the UK’s Information Commissioner’s Office. Then, the investigators can appeal the decision of the Commissioner against them, delaying release of the data a number of months.

If Peter White is serious about advancing knowledge of “the causes and treatments of this debilitating and misunderstood illness, ” why doesn’t  he simply embrace what the rest of the international scientific community sees as a way of advancing knowledge – availability of data for others to independently evaluate claims that are being made and test their own novel hypothesis?

Hopefully PLOS One will disregard the PACE investigators’ vexatious conversion of my request to a FOIA for data they’ve promised would be available. I look forward to a retraction of their article if they do not provide the data immediately.

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14 thoughts on “Glimpses into the assault on data sharing

  1. > The Commission may also consider the balance between the need to maintain public access to information, and the burden of the Act on public authorities, and whether change is needed to moderate that while maintaining public access to information.

    Emphasis on “maintaining public access to information”. I’m sure it gets tiresome rejecting all those requests for data as vexatious. Fortunately there is an easy solution: publish the data. Since White has never attempted to resolve the problem in this manner and has preferred legal battles his complaints cannot be taken seriously. Looks like White just wants a way to deny data to potential critics without coming across as someone that has something to hide.

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  2. As with everything Peter White says, the devil is in the detail. He is relying on people not looking closely at the underlying facts and just taking his account of things at face value, and his word always portrays himself and his colleagues as the victims and anyone wanting to see the data from his trials as aggressors. This is easy for him to do because he has control of the key information. Unfortunately this has worked very well for him for many years, but I hope now that people are beginning to see the importance of scrutinizing what he says to check if it is right, or not and to do that we must see the PACE trial data. This has implications far beyond just ME/CFS. PACE has been used, and continues to be used, as “evidence” that FOI legislation should be restricted and watered down, but the outcome will not be just for White and his pals, but for all universities.

    The only way to resolve this is to get the PACE data released as it looks likely that it will show certain evidences have been deliberately hidden as they did not support the authors conflicts of interest. Were that to happen PACE would go from being used as “evidence” for why universities should be exempt to being used to show that they absolutely must not be.

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  3. Protocol for PACE trial: Policy for deteriorating participant or one who drops out of treatment
    The following policy will be enacted by the centre leader for any participant who is considered, or considers themselves, to be deteriorating, or has dropped out of treatment. The centre leader or delegated professional will undertake a detailed clinical assessment, at home if necessary, following which they will be offered appropriate help.
    The participants who did not continue with the Trial, were they given the follow up care as per the protocol?

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  4. I would like to hear from the two patients that asked for their data to be destroyed on why they did this. There is often a large discrepancy between what PACE authors say “on behalf of patients” and what patients actually say.

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  5. Once again, a hard-hitting, no nonsense, straight-forward read that gets right to the point. Leaving all the political niceties aside, it is glaringly obvious that these boyos do not want their methods, data and outcomes scrutinized and the simple question is…why not? Even those with the most limited analytical skills can answer that question. None of what they have done will stand up to evidence based scrutiny and thats a fact. They can cry pity me, pity me all they want. They can feign all the outrage and crocodile tears of faux compassion for their patient group all they want – no one believes them anymore and those that are failing to speak out are colluding with them. If I were them I would be planning my exit strategy and taking the lesser of two evils…going quietly into the night and moving over for proper research for this dreadful, dreadful disease. We are not going away you know…

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  6. >>Little attention is being given to a serious and sustained assault on the sharing of data from research conducted in the UK.<>Hopefully PLOS One will disregard the PACE investigators vexatious conversion of my request to a FOIA for data they’ve promised would be available. I look forward to a retraction of their article if they do not provide the data immediately.<<

    The immediate restriction on PLOS One acting against the PACE article is that the article was accepted for publication under the old terms of acceptance http://journals.plos.org/plosone/s/file?id=c4aa/PLOSONE_data_policy_before_2014March.pdf . More substantially however, and this goes to the root of why the PACE authors are automatically judging all requests for data under FOIA terms, is that a judgement in favour of the authors in the current Appeal against the Information Commissioner’s decision https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1560081/fs_50565190.pdf would provide the authors with support for a legal argument that data not required to be released under an FOIA request should not be openly released in any other context. The confidentiality clause http://www.kcl.ac.uk/ioppn/news/records/2015/december/release-of-data-from-the-PACE-trial.aspx demanded by the PACE authors should be read as underlying this approach to ‘closing off’ data.

    So, if we accept White’s arguments, his psychotherapy trial data and even data from pharmaceutical trials needs to be protected from the burden that was faced by researchers of climate change and health effects of tobacco.

    The scale of Peter White’s proposals should not be underestimated. Commercially sensitive data is already protected under the UK’s FOIA, a weakness that freely permits inadequate exposure of pharmaceutical data and which does not ensure that harms data such as related to the effects of tabacco and asbestos, would be openly available even today. What White is proposing is even more draconian, it would allow not just that publicly funded research at public Universities could be obsucured for eternity, it would allow via the NIHR http://www.nihr.ac.uk/ , that research at a public University supported by funds from the NHS and utilising NHS patient data, could be obsucured for all eternity. This doesn’t just take us back to 2006 before the FOIA was brought in, it takes us back to before 1986 and the worst abuses of Crown Immunity http://hansard.millbanksystems.com/commons/1986/jun/09/lifting-of-all-crown-immunity

    The especial relevance of the NIHR to White’s proposals is that while the orginal PACE trial was funded largely by the MRC, the most consistent funder of psychosocial research including the PACE follow up papers has been the NIHR. The tactics of the PACE trial authors in closing out examination of their data shouldn’t be seen as a simple attempt at cover up, even if that does happen to be a convenient side effect. What is in play is a concerted defensive approach whose origins lie not so much in the climate change or tabacco research invoked by White, but in the area of animal testing and the sustained often violent opposition that primarily psychology researchers have faced. White and those who share his views may be profoundly wrong, but they are motivated by anxiety that itself is not without foundation, something which underwrites their determination to continue with a campaign against open data. There are much larger questions involved than the simple intransigence of the PACE trial authors.

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  7. My immediate reaction to: “After some months of trying to obtain advice on what to do…but this meant that we had to restart the analysis, which caused several month’s delay in publishing the main results paper in 2011” is that if they’d just got on with accepting that the two participants’ data needed to be taken out instead of faffing around for “some months” waiting for advice, they wouldn’t have had the publication delay! (Or at least, not nearly as much of one).

    But seriously, no matter what reasoning the participants had for wanting to back out, it was their right to do so, and having to recalculate the analysis due to drop-outs is a risk that all medical trial researchers take. This does not validate Peter White in his role as a martyr to the FOIA; it puts him in the exact same position as every other researcher.

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  8. A question I would like to see answered is how many patients had to withdraw because they could not continue the pushed exercise regime. Years ago my insurance company made me undergo a series of seemingly simple tasks run by an occupational therapist – walk up and down about 5 steps, kneel for 15 minutes, sit for 15 minutes, handwrite something, type something – ridiculously easy, right? I was high-functioning at the time, and even I thought it was ridiculously easy. But I blacked out halfway through the second day. I awoke to find the therapist nudging me on the floor with her foot. She said she had to leave, and it was time for me to get up. I told her to call my husband – who was fortunately in the same town. He came with a colleague; he took me and the colleague drove my car home.

    All the therapist wrote down was that I “quit.” Later she explained to my husband that that was the instructions of the insurance company.

    I am in the US, but in touch via internet with a number of patients in the UK. Several told me at the time that they hard participated in early studies of GET and had to withdraw. I went back and read the studies – and there was no mention of the patients who had been forced to withdraw because the exercise was making them worse.

    An article explaining the way the PACE study was to be conducted stated that the authors expected at least a 10% withdrawal rate. How did they handle the withdrawals? Apparently by reducing the size of the sample when they compiled the study data. As far as I know, there was no variable for “patient withdrew because he/she said the exercise was making him/her worse.” In fact, as far as I know, there was no variable for “patient withdrew; we don’t know why.”

    Many definitions of “ME/CFS” include or even require the presence of “post-exertional malaise.” The recent study by the Institute for Open Medicine on behalf of NIH concluded that this symptom was so much a hallmark of the disorder that they put it in a suggested new name, “Systemic Exertional Intolerance Disease.” They meant that the impact of too much effort (mental as well as physical) set off a multi-system response – the “exertional intolerance” was thus “systemic.” PEM is a requirement in the Ramsay (1986) definition of M.E., it is an option in the CDC’s Fukuda (1994) definition of CFS. The Oxford definition, used by the PACE study investigators, requires only the presence of unexplained fatigue for 6 months. But surely they were familiar with the other definitions; surely an impartial researcher would have included a variable to note the presence of PEM. Clearly they did not. And – as far as I can tell – they did not even include a variable for patients who “quit,” whatever the reason.

    Elsewhere, Peter White wrote that up to 40% of patients in smaller studies of ME or CFS did “quit,” so they had embedded an expectation of a 10% withdrawal rate. Under the circumstances, I find it highly improbable that no patients withdrew from the study.

    When a patient withdraws from a study such as this, you have to know why, and that has to be included in the study – you can’t pretend they weren’t in the study in the first place. As far as I can tell – and I may have missed something – there is no information in the original description of the completed the study (Lancet, 2011) about whether or not any patients did not complete the program.. So I would like to see how many patients “quit,” and how they handled the results.

    Thank you.
    Mary M. Schweitzer, Ph.D.

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