Recognizing when “protecting patient privacy” is mere excuse for not sharing data

In bringing up “protecting patient privacy”  in refusing to release the PACE trial data published in PLOS One, King’s College, London is doing the Shuck ‘N’ Jive.

garfunkel shuck

To hear Art Garfunkel’s Mr Shuck ‘N’ Jive click here

King's college LondonAs covered in a recent blog post, King’s College London issued a press release reiterating their refusal to release the PACE PLOS One data. A close read of the press release reveals the PACE investigators have suspended attacking the character and motives of those who request data that they promised as a condition for publishing  in PLOS One. They instead now focus on conditions which they argue must be met in terms of “protecting patient privacy” before they release the data.

“We stand by our decisions to decline two recent applications for trial data as we believe that they did not meet these requirements.”

Under some specific circumstances, the need to protect the privacy of research participants is of course a reasonable justification to withhold data even in the face of government pressure. Avoiding harm to research participants, particularly when they were recruited from vulnerable populations, might be seen as a preemptive objection to sharing data, even when the data had been promised.

The circumstances can be anticipated and safeguards can be built into a study so that research participants can be protected while anonymitized data can still be shared with other researchers. For instance, my colleagues and I were concerned about the biological fathers of low income pregnant women subpoenaing information concerning the women’s mental health to be used against them in child custody proceedings. We requested a Certificate of Confidentiality from the National Institute of Health Office of Extramural Research for our study that allowed us to refuse such subpoenas but still make data available when we publish papers.

What if safeguards were not built into a study? BMJ has provided an authoritative guide:

Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. BMJ (CR)-print. 2010 Jan 29;340(8):c181.

The BMJ article notes:

how to prepare raw clinical data for sharing

ivan-oranskyAmong others, Ivan Oransky, the Co-Founder of Retraction Watch emailed me and queried whether King’s College had requested that I sign a confidentiality agreement. Of course they had not asked me to sign any agreement.

After I gave the same answer to another inquiry, the other person replied:

They should have at least offered you to sign a confidentiality agreement, not turn it into a FOIA request and then reject it with insults.

I am not sure why a confidentiality agreement would be needed to provide the data from the PLOS article to me or anyone else who requests it.

In this blog post I present my analysis of why raising the issue of protecting patients as it has been raised in the press release is simply a distraction. When you finish the brief analysis, you may be tempted to consider King’s College raising the issue of protecting patients in this context as hypocritical and sanctimonious.

The “PACE investigators” group needs to be unpacked as the specific professionals who will are doing unprofessional things. The seven authors of the PLOS One article  who are not living up to their promise to share data are Paul McCrone, Michael Sharpe, Trudie Chalder, Martin Knapp, Anthony Johnson, Kimberley Goldsmith, Peter White.

To summarize my analysis of the PACE investigators citing “protecting patient privacy” as a reason for continuing to withhold the data:

  • The larger PACE investigator group recklessly endangered patient privacy with careless practices, that at least in the United States, could subject them to harsh penalties and legal action by participants in the PACE trial.
  • The claim that PACE investigators have already shared data with “independent” investigators refers to a situation in which they share data with close cronies in a manner in which they could control presentation and interpretation of the data consistent with their previously stated objective of protecting their reputations from scrutiny of their work.

Unlocked drawers and a serious data breach: Patients are already potentially harmed by carelessness of PACE investigators

The press release from King’s College suggests that due care has been taken to ensure the confidentiality of patient data.

We are however also concerned for the rights and welfare of trial participants. Participants did not give consent to the public release of their data when they entered the trial. In particular we are concerned to ensure that there is no risk of misuse of the data such as through inadvertent personal identification. The scientists who have already received data have all signed a formal confidentiality agreement, approved by the independent PACE Trial Steering Committee, which required that they respect the confidential nature of the data, and keep them secure, as agreed with trial participants when they consented to take part.

However, a shocking instance of data being stolen from an unlocked drawer reveals both the bad research practices of the PACE trial and a casual attitude towards patient data being leaked to unknown persons.

Margaret Williams, whom I do not know, left the following information as a comment on my previous blog post. The official documentation of the incident is available here.

Professor Peter White is claiming that he promised to keep patients’ data securely; has he forgotten that some of this data was not held securely? The following extract comes from “Magical Medicine: How to make a disease disappear” (p256):

http://www.meactionuk.org.uk/magical-medicine.pdf

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”.

It seems that the patients involved were not warned that confidential information about them had been stolen.
………………
Additional note: The data stolen were not backed up. The same letter from Peter White to the MREC makes this clear:

The DAR “contained six sessions recorded with five participants which had not been downloaded at this time, and therefore is not available for review.”

Cronyism: Yes, the data are available – to family and friends

The press release from King’s College  states

We have supplied requested, anonymised data to independent scientists […] [T]hese include a Cochrane review group who have independently validated the trial findings on the primary outcomes, and who are now undertaking an individual patient data meta-analysis using these data.

Let’s take a look at the proposed “individual patient data meta-analysis”:

 Larun L, Odgaard-Jensen J, Brurberg KG, Chalder T, Dybwad M, Moss-Morris RE, Sharpe M, Wallman K, Wearden A, White PD, Glasziou PP. Exercise therapy for chronic fatigue syndrome (individual patient data) (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD011040.

Note that a number of the PACE investigators are included as authors on this protocol, as well as authors of the sister trial to PACE, the Fatigue Intervention by Nurses Evaluation (FINE) study.

As authors on the resulting systematic review article, the PACE investigators have veto power over what is said and they are among friends and family.

Hmm, comfortably among “friends and family” in a way that invokes Tony Soprano’s uses of the term.

Die_Sopranos_Startseite_2

I’ll have to take up the issue in another blog post, but this Cochrane review group seems to be a serious breach of what has been a long established policy of the Cochrane Collaboration. But more basically, a systematic review by design should attempt to overcome the risks of bias in the individual studies that are included. The Cochrane Collaboration previously gave my colleagues and me the Bill Silverman Award  for an article that caused them to tighten their risk of bias associated with investigator conflict of interest. And we know that systematic reviews and meta-analyses conducted by those with an investment in a particular treatment produce exaggerated and less valid estimates of effect sizes of the investigators.

And the PACE investigators have already engaged in the dodgy practice of altering their primary outcomes for the trial after the start of data collection.  Would you trust meta-analysis of individual patient-level data, knowing that such a bad research practice was associated with their original study and knowing the reluctance to share data with those who seek to independently check their analyses and interpretations?

A loyalty oath required?

The Charter of the UK CFS/ME Research Collaborative states:

“3.2.3 Members will be required to sign a declaration that they will not take part in the harassment or abuse of researchers. Neither will they take part in orchestrated campaigns against those conducting peer-reviewed research.”

I’m not a lawyer, but I am a staunch advocate of academic and intellectual freedom and can recognize a threat when I see it. The phrase “harassment or abuse of researchers” is particularly worrisome because its vagueness and undefined breadth of application. And what does “orchestrated campaigns” encompass – Pubpeer discussion threads that lead to a joint letter to the editor or petition when objections to a study are not addressed?

It’s not a matter of whether this declaration is legally binding or enforceable. But as we’ve seen time and time again in academic disputes, the existence of such a requirement, even if not enforceable, tends to dampen intellectual discussion by all, even by those who have nothing at risk by signing such a declaration.

No one asked me to sign a formal confidentiality agreement, but…

The King’s College press release states

The scientists who have already received data have all signed a formal confidentiality agreement, approved by the independent PACE Trial Steering Committee, which required that they respect the confidential nature of the data, and keep them secure.

I’ve never been asked to sign this agreement, but I would certainly like to show it to readers. I am curious about what rationale is offered for the necessity of the agreement and what other conditions required agreement in signing it.

Other dubious aspects of invoking “protecting patient privacy” as an excuse for not sharing data.

Mr Alem Matthees requested the PACE trial data used in articles in The Lancet and was refused. He disputes whether the original consent forms prohibited sharing of anonymised data and a comment left at my blog.

Arguably the most important statement in the consent forms is this: “You will not be named in any published results from our study. […] The results won’t say who took part or give any details that lead to people being recognised or identified.” It is unlikely that releasing sufficiently anonymised IPD would violate this promise. An extract from the consent forms which is somewhat ambiguous: “And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study.”

The UK Information Commissioners Office has already considered and rejected a detailed presentation of the PACE investigators’ objections to releasing data because of the need to protect patient privacy . This decision is now under appeal.

If the PACE investigators are so protective of patient rights…

Why did they violate the Helsinki Declaration which requires that study participants be “adequately informed” of researchers’ “possible conflicts of interest” and “institutional affiliations”? David Tuller raises this  concern at  Virology blog with what many saw as an evasive  response from the PACE investigators.

Postscript: Having given this whole matter serious thought, I reiterate my request:

Come on, Paul McCrone, Michael Sharpe, Trudie Chalder, Martin Knapp, Anthony L. Johnson, Kimberley A. Goldsmith and Peter D. White, provide me with the data as you said you would.

 Note: Although I am one of thousands of academic editors for PLOS One, I have sole responsibility for my blog posts, which cannot be construed as reflecting the opinions of any institutions with which I am affiliated, including PLOS. In requesting the data for an article that appeared in PLOS, I am exercising the same rights to anyone in the world has with respect to this open access journal committed to transparency and data sharing.

Special thanks to the numerous  professionals and patients who provided feedback and documentation for  this post.  All errors and excesses remain my own.

 

 

Advertisements

26 thoughts on “Recognizing when “protecting patient privacy” is mere excuse for not sharing data

  1. Thank you for continuing to pursue this vexed issue and help expose these critical problems.

    “Why did they violate the Helsinki Declaration which requires that study participants be “adequately informed” of researchers’ “possible conflicts of interest” and “institutional affiliations”? David Toler raises this concern at Virology blog…”

    I presume that is supposed to David Tuller.

    http://www.virology.ws/2015/10/21/trial-by-error-i/

    Like

  2. Thanks a lot for highlighting all the flaws in the PACE trial.

    Rona Moss-Morris who participated to the Cochrane review can hardly be seen as an independant reviewer. She often collaborates with Trudie Chalder.

    Few examples:
    Understanding fatigue in paediatric multiple sclerosis: a systematic review of clinical and psychosocial factors Susan Carroll · Trudie Chalder · Cheryl Hemingway · Isobel Heyman · Rona Moss-Morris
    Assessing Cognitive behavioural Therapy in Irritable Bowel (ACTIB): Protocol for a randomised controlled trial of clinical-effectiveness and cost-effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome in adults Hazel Everitt · Sabine Landau · Paul Little · Felicity L Bishop · Paul McCrone · Gilly O’Reilly · Nicholas Coleman · Robert Logan · Trudie Chalder · Rona Moss-Morris
    The most popular terms for medically unexplained symptoms: The views of CFS patients
    Federica Picariello · Sheila Ali · Rona Moss-Morris · Trudie Chalder ·

    Liked by 1 person

    • What better way to make your paper *appear* quality than to get Cochrane to ratify it, and what better way to ensure that happens than to be directly involved, along with your known pals, and control the outcome of Cochrane’s work? It must be highly irregular for Cochrane to allow it, but then this is the latest in a very long list of irregularities with the PACE trial.

      Liked by 3 people

  3. The PACE investigators contend that requests for raw data are an attempt to cause them “reputational damage”. I like to call a spade a spade and would say that they are entirely correct in this contention, but they are correct because they know fine well that the study is fundamentally flawed [along with subsequent rehashes] and that independent scientific analysis will indeed damage their reputations. That is not a valid reason for not releasing the data. Their concern is for themselves, not the anonymity of participants.

    Liked by 4 people

  4. The PACE investigators continue to have a tenuous understanding of reality. I am amazed that they dared to bring up the Cochrane review and claim that it was an “independent” analysis of their study. How could they possibly think that the “Army of Evil M.E. Troublemakers” would not immediately grab this phony claim and proceed to beat them over the head with it?

    That hole they keep digging must be getting close to the Center of the Earth by now. I have a shovel and pick axe they can borrow – I’m no longer well enough to use them myself any more…

    Liked by 1 person

  5. Dear Prof. Coyne, thank you very much for your continued interest in this subject. This article states- “Let’s take a look at the proposed “individual patient data meta-analysis”

    Larun L, Odgaard-Jensen J, Brurberg KG, Chalder T, Dybwad M, Moss-Morris RE, Sharpe M, Wallman K, Wearden A, White PD, Glasziou PP. Exercise therapy for chronic fatigue syndrome (individual patient data) (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD011040.

    Note that a number of the PACE investigators are included as authors on this protocol, as well as authors of the sister trial to PACE, the Fatigue Intervention by Nurses Evaluation (FINE) study. As authors on the resulting systematic review article, the PACE investigators have veto power over what is said and they are among friends and family.”

    While the PACE and FINE authors are authors of the protocol, I’m not sure it would be accurate to state that they are authors of the resulting systematic review article and therefore have veto power over what is said, although I could be wrong. I think the resulting systematic review article is the following-

    Cochrane Database Syst Rev. 2015 Feb 10;2:CD003200.
    Exercise therapy for chronic fatigue syndrome.
    Larun L, Brurberg KG, Odgaard-Jensen J, Price JR.
    http://www.ncbi.nlm.nih.gov/pubmed/25674924

    Like

    • John, The review you link to is a recent update of an old Cochrane systematic review from 2004 which combined aggregated data from different trials. It does not include PACE trialists as authors.
      http://www.ncbi.nlm.nih.gov/pubmed/15266475

      The new review has not been published yet and will combine individual patient data from the trials chosen for review. Although IPD meta-analysis is well regarded, one concern here is that it will include outcomes that first appeared in the Lancet, and not as pre-specified in the PACE protocol published in 2007. PACE and FINE trialists are definitely listed as authors.

      Liked by 3 people

  6. Thank you for another terrific post.

    I’m glad you brought up the appalling clause in the CMRC charter. I can’t tell you how hurt and shamed I feel as a patient that an organisation involved in my disease would include such a pointed insult to patients. If I recall correctly, anyone – including any patient – who wants to attend the CMRC conference has to sign up to the charter and agree to this clause.

    It is against the law in the UK to harass someone. There is absolutely no need for a harassment clause to be written into any membership document in the UK.

    I hope the CMRC will reconsider their inclusion of this clause and remove it.

    This narrative of harassment needs tackling.

    Liked by 3 people

  7. Just a reminder of what is deemed harassment by this group – https://www.dropbox.com/s/92m09l9tq55pihh/Behind%20the%20Scenes%20-%20Research%20Collaborative.pdf?dl=0

    Extract:

    In the run-up to the full formation and launch of the Collaborative, a meeting was recorded by the Science Media Centre (SMC)’s outgoing head of Mental Health (details below). In attendance were key persons now involved with the Collaborative. Under their heading ‘Harassment’ (of researchers) they list:

    Freedom of Information Requests
    Complaints to the GMC and various institutions
    Parliamentary Questions

    A series of Action Points include:

    ‘Support4rs – Work with Peter White and Simon Wessely to develop resources for dealing with harassment”

    SMC – Run a press briefing on biosocial illness to improve public understanding.’NB Two sets of written records are kept of Collaborative meetings; one for the Board, another for the public. This should be borne in mind when reading records that are placed online.

    Liked by 2 people

    • “NB Two sets of written records are kept of Collaborative meetings; one for the Board, another for the public. This should be borne in mind when reading records that are placed online.”

      That is getting dangerously close to straight fraud, far as I am concerned. It is certainly cowardly and completely unacceptable.

      Like

  8. Professor Coyne wrote: “A loyalty oath required? I’m not a lawyer, but I am a staunch advocate of academic and intellectual freedom and can recognize a threat when I see it. The phrase “harassment or abuse of researchers” is particularly worrisome because its vagueness and undefined breadth of application. And what does “orchestrated campaigns” encompass – Pubpeer discussion threads that lead to a joint letter to the editor or petition when objections to a study are not addressed? It’s not a matter of whether this declaration is legally binding or enforceable. But as we’ve seen time and time again in academic disputes, the existence of such a requirement, even if not enforceable, tends to dampen intellectual discussion by all, even by those who have nothing at risk by signing such a declaration.”
    .
    Professor Coyne is affiliated to the University of Groningen (RUG), The Netherlands. This implies that professor Coyne is always and at all times required to work for the full 100% according to the VSNU “The Netherlands Code of Conduct for Academic Practice, the Principles of good academic teaching and research”, see http://www.rug.nl/about-us/organization/rules-and-regulations/algemeen/gedragscodes-nederlandse-universiteiten/code-wetenschapsbeoefening-14-en.pdf
    .
    So the VSNU “Code of Conduct (CoC) for Academic Practice” is his loyalty oath. I am hereby inviting the seven authors of the PLOS ONE paper, Paul McCrone, Michael Sharpe, Trudie Chalder, Martin Knapp, Anthony L. Johnson, Kimberley A. Goldsmith and Peter D. White, to read carefully this loyalty oath, and to reflect on all items of this loyalty oath, in particular on the Preamble and on Principle 1. It is for example for professor Coyne mandatory that “Communication regarding research results should be dispassionate and realistic.” So his ‘declaration’ is the VSNU CoC. The VSNU CoC is of course focused around academic and intellectual freedom.
    .
    Furhermore, item 10 of the Preamble of the CoC connects the CoC to the “Regulations for the Protection of Academic Integrity”, see http://www.rug.nl/about-us/organization/rules-and-regulations/algemeen/gedragscodes-nederlandse-universiteiten/wetenschappelijke-integriteit-12-en.pdf So anyone who has serious suspicions that a researcher affilated to any of the 14 Dutch research universities is violating one or more of the rules of the CoC, can just file a complaint. That’s how it works in The Netherlands. I fail to understand why all UK Universities don’t have such a system which is equal for all UK universities.
    .
    http://www.rug.nl/about-us/organization/rules-and-regulations/onderzoek/promotiereglement-14-en.pdf also underlines that the VSNU CoC is a ‘loyalty oath’. Anyone can read in the PhD regulations for RUG that all PhD candidates at RUG need to declare, in public and during the graduation ceremony, that they will always act according to the VSNU CoC. PhD candidates who refuse to declare this in public, are unable to obtain a PhD. Such a declaration during the graduation ceremony is for example also mandatory for all PhD students at Utrecht University (UU). That’s how it works in The Netherlands. Anyone any idea how this is organised in the UK?

    Like

  9. Rona moss Morris is a slippery sort. For her masters and phd she used the database of aucklanders who received our national ME magazine at the time as her sample. Participants weren’t vetted by any Drs as far as I’m aware. I know one participant who subsequently was diagnosed with Parkinson’s . She wouldn’t have known how to recognise a true ME patient if she met one. Her knowledge was scant at best. She transferred from a technical institute to a university. She had done psychology at tech, then somehow , I can’t fathom how, managed to get her phd from the medical school. It was very dodgy to say the least. Her masters and phd aren’t worth the paper they are printed on. That’s my opinion and others would need to check to concur the facts. There was an immense amount of cronyism at Auckland Uni at that time. Her supervisor was a guy called Keith Petrie. Couldn’t get any straight answers out of him either. There is no way that using a dataset of self selected people ( people who paid for the magazine) should have even got ethics comm approval , but somehow it did .

    Like

  10. Professor Coyne wrote: “And what does “orchestrated campaigns” encompass – Pubpeer discussion threads that lead to a joint letter to the editor or petition when objections to a study are not addressed?”
    .
    I propose that Paul McCrone, Michael Sharpe, Trudie Chalder, Martin Knapp, Anthony L. Johnson, Kimberley A. Goldsmith and Peter D. White join the debate at Pubpeer at https://pubpeer.com/publications/22870204 and follow the example of other scientists affilated at UK Universities who also debate at Pubpeer.
    .
    I will give the readers of this blog some examples of long threads at Pubpeer about topics where parties totally disagree with each other.
    .
    1. https://pubpeer.com/publications/B02C5ED24DB280ABD0FCC59B872D04 and https://pubpeer.com/publications/25402426 both refer to a paper in PLOS ONE ( http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0108482 ). Julian Stirling, Philip Moriarty and Raphaël Lévy are affiliated to a UK University. Note that Raphaël Lévy started the second thread when the paper was published. Both threads are very long, and some comments are very harsh, in particular some of the comments of Unreg (an Unregistered Submission, this can be anyone).
    .
    For example: Unreg (February 15th, 2015 12:37am UTC) “Moriarty, you are trying to rewrite history in a way that fits your biased arguments.” Unreg (February 16th, 2015 9:45am UTC) “Anyway, you have been dodging all these facts for a long time; from your attitude it is clear that you will not acknowledge the mistakes. (…). We agree in that Stellacci is an honest man. Fortunately for him, the man is not getting involved in a discussion with scientists that are far below his honesty stature.”
    .
    Julian Stirling also provides feedback why they choose to submit to PLOS ONE: (January 3rd, 2014 11:08pm UTC) “We submitted to PlosONE for a few reasons. First, we (well Philip Moriarty) made some pre-submission enquiries and journals were unwilling to even consider papers which focused on reanalysis of published data (Something which I find very worrying, as questioning everything should be what science is built on!), PlosONE’s response was a breath of fresh air, they were not only open to critical papers (informally as they do not formally respond to pre-submission enquiries) but also have very sensible guidelines for disputes ( http://www.plosone.org/static/editorial#disputing ). Another thing (along with open-access and non-for-profit) was the fact that there is no length limit in PlosONE. We have purposefully put some of the more technical content in supplementary information, but we wanted to be able to present the main content in full without worrying about length and figure restrictions (as there was a lot of work to critique). Either way, as was said above, it is the content not the journal that really matters. Here I want to emphasise one thing. In the interest of openness, all data and analysis code has been provided in full at http://figshare.com/articles/Stripy_nanoparticle_data_FILE_ONE/882904 . This is because openness should be at the heart of science, especially when things become disputed.”
    .
    So these UK scientists likes to debate, they make all the raw research data free available for all, and the debate with all is in public. The topic is heavily disputed, but anyone can read how these people are debating with each other and how the arguments are rebutted (or not). The PLOS ONE paper by Paul McCrone, Michael Sharpe, Trudie Chalder, Martin Knapp, Anthony L. Johnson, Kimberley A. Goldsmith and Peter D. White is also heavily disputed. So join the debate at https://pubpeer.com/publications/22870204 and act like Julian Stirling, Philip Moriarty and Raphaël Lévy in regard to deposit all the raw research data at (for example) Figshare.

    2. Another example. Donald Graft has no affiliation (as far as I am aware). Many of his peers totally disagree with his the ideas. Donald Graft is an couragous scientist. He starts his own thread at Pubpeer about a paper he just published in arXiv ( https://pubpeer.com/publications/E0F8384FC19A6034E86D516D03BB38 ). His posting starts with: “I am interested in feedback about this paper, where I show that (….) To seed the discussion here is a little philosophical background:”. Once again, a very long discussion develops. Professor Richard Gill (Leiden University) is the first one who is responding.
    .
    So Donald Graft is inviting, and in public, all his opponents (including the sometimes very nasty Unregs) to start a scientific dialogue about his paper in arXiv. Excuse me very much, but I totally fail to understand why Paul McCrone, Michael Sharpe, Trudie Chalder, Martin Knapp, Anthony L. Johnson, Kimberley A. Goldsmith and Peter D. White seem unwilling to hold such a debate at Pubpeer with all of their opponents.
    .
    Anyone can read (see also the internal links in the Pubpeer thread about the paper of Donald Graft) that scientists like Richard Gill, Donald Graft, Julian Stirling, Philip Moriarty and Raphaël Lévy are sometimes heavily attacted. All of them always respond with scientific arguments. None of them will say that requests for data (and / or calculations, etc.) are “vexious”, etc. No way. They respond with uploading the data / calculations (etc.).

    Like

  11. Two points merit further consideration: (i) the matter of guaranteed confidential storage of PACE trial data and (ii) the Principal Investigators’ undeclared conflict of interest until after the consent forms were signed by participants.

    The PACE trial Protocol published in BMC Neurology on 8 March 2007 was an abridged version but, as noted by Alem Matthees, the Full Protocol (226 pages) states on page 110:

    “Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study” http://www.meactionuk.org.uk/FULL-Protocol-SEARCHABLE-version.pdf

    What Matthees did not mention was the fact that one of the organisations funding the study was the UK Department for Work and Pensions (DWP). How many participants looked at the funding bodies before signing the consent forms and realising to what they were giving their consent?

    Quite how “confidentiality” could be guaranteed if the DWP had access to the data has never been explained, especially as ME/CFS is known to be a targeted disorder for the withdrawal of state benefits, with patients being harassed by the DWP who required a 60-page form to be completed because the DWP menacingly informed such patients: “We have reason to believe that you are capable of work”.

    If the PACE trial therapists and Investigators deemed a participant “recovered” enough to resume work, then might that participant quickly discover that the DWP stopped paying benefit? The PACE Trial has been described as a “Trojan horse” for the DWP.

    Regarding the secure storage of data, the Full Protocol is unambiguous:

    “Will you keep my details confidential?”

    “Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research”.

    The DWP was not involved in research but still had participants’ signed permission to access their records/data.

    From the outset, recordings were not kept in a locked filing cabinet: some were stolen and thus lost to review (see previous post on 19th December 2015: https://jcoynester.wordpress.com/2015/12/18/kings-college-london-stalls-some-more-reiterating-refusal-to-release-the-pace-trial-data/#comment-1375 ).

    The Consent Form 1 for baseline assessment which participants were required to sign was clear:

    “3. I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research.

    4. I give permission for these individuals to have access to my records.

    …………

    14. I understand that information collected about me for the trial, including my personal details, a copy of this consent form and all of the questionnaires I complete for the trial, will be held securely by the local trial staff and at the PACE trial centre at Queen Mary, University of London. I give permission for this to happen”.

    The PACE PIs obtained participants’ consent on the promise of keeping trial data secure, yet they had made no provision to do any such thing.

    When the PACE Trial had been running for two years, the Participants’ newsletter (Issue 1, June 2006) reaffirmed that the trial data was safe: “The information is being entered onto a large and secure database, designed and maintained by an independent clinical trial unit at King’s College, London”. This was provided for participants even though the PIs knew that trial data had already been stolen (see previous post #comment-1375).

    In relation to the PIs’ undeclared conflict of interest, one of the pre-trial assessments was at Baseline Visit 1; this set out to collect personal data that seems to have little bearing on a clinical trial but could be of value to the DWP and the permanent health insurance industry because the collected data included not only the customary demographic details, date of birth, age, sex, ethnicity, marital or partner status, years of education, occupation (the latter would obviously afford information about a participant’s earnings) but also very detailed questions about participants’ permanent health insurance payments, for example, questions on page 172 ff of the Full Protocol included the following:

    “Do you currently receive income protection benefit (income protection or total and permanent disability)?”

    “ If yes, how much annually do you receive? £”

    “If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the letter [an alphabetical letter designating an income bracket] that corresponds to the participant’s income”.

    “Do you currently receive a private medical / retirement pension?”

    “If yes, how much weekly do you receive? £
    OR
    If yes, how much monthly do you receive? £
    OR
    If yes, how much annually do you receive? £”

    “If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the (alphabetical) letter that corresponds to the participant’s income”.

    “In the past six months, have you received any one-off payments from income protection or insurance schemes as a result of your health?”

    Such specific questions have no clinical relevance but would be of interest to the Chief PI of the PACE trial in his dual role as the re-insurer Swiss Re’s Chief Medical Officer.

    As detailed by David Tuller, participants could not give fully informed consent because the PIs’ Iong-standing involvement with the permanent health insurance industry was never disclosed to them. Indeed, it appears that this significant conflict of interest was not initially disclosed even to the Trial Steering Committee: at the meeting on 22nd April 2004, all members present were asked to declare any conflict of interest. It was minuted that no financial conflicts of interest were declared and it was agreed that no-one present had any other substantial or material conflict relevant to their work on the PACE Trial. Amongst those present were Professors Peter White, Michael Sharpe and Trudie Chalder, all of whom worked for the permanent insurance industry. There was a brief mention of paid consultancy work done by the PIs in the BMC Neurology version of the Protocol, which was long after signed consent forms had been obtained.

    Like

  12. The stolen audio recordings contain six sessions of GET. It is curious that PACE do not believe voice recordings of individual patients contain any sensitive personal information, [1] yet assert that summarised and (de-identified) scores from questionnaires for fatigue and physical function (etc) are highly confidential and must not be released to the public under any circumstances. While the theft is a serious incident, it should not pose a problem for my FOIA request, as it is unlikely the two can be cross-linked to re-identify individual participants.

    During the ICO’s investigation for FS50565190, [2] QMUL referred to information released from a previous FOIA request, and implied that one participant became concerned about confidentiality as a result and retrospectively withdrew consent from the trial. The FOIA request would not have contained sensitive personal information (otherwise it would have violated the FOIA). This information appears to be mostly related to the trial protocol and amendments to it; there is also mention of “the details of all 50 or so serious adverse events and reactions recorded during the trial” but similar details have been published in the Lancet. [3] It is highly unlikely that the two FOIA requests can be combined to link and re-identify individual participants. The ICO considered QMUL’s evidence and stated that there was insufficient evidence to conclude that further disclosures under the FOIA would have a significant impact on the trial.

    There may be more to the withdrawal case than what is revealed in the ICO decision notice. Any news of the theft of audio recordings would not have helped participants’ confidence that PACE could keep their information private. In David Tuller’s Virology Blog coverage of how PACE trial investigators have violated the Declaration of Helsinki [4] (by failing to declare to trial candidates the investigators’ conflicts of interest with the insurance industry): “Of four participants interviewed, two said the knowledge would have impacted their decision to participate; one retroactively withdrew her consent and forbade the researchers from including her data.”

    Which brings me to the excellent point raised by Margaret Williams. [5] One of the organisations which had access to patients’ personal data was the UK Department for Work and Pensions (DWP). The question asked by Williams is important: “If the PACE trial therapists and Investigators deemed a participant ‘recovered’ enough to resume work, then might that participant quickly discover that the DWP stopped paying benefit?” The participants were also asked specific questions about insurance, which may cause additional concern to patients, more so when it was later revealed the PACE investigators failed to disclose their COIs to trial candidates during recruitment.

    Being falsely declared “fit for work” is also a troubling possibility, particularly when the PACE trial report based on the revised recovery criteria was quite misleading and may inflate the estimated recovery rates by up to several fold (6 times when using FINE trial data! [6]). This may be another aspect of the Declaration of Helsinki which has been violated, as the declaration states that researchers are responsible for the completeness and accuracy of their reports. [7]

    The revised recovery criteria was far too lax, contains significant flaws, and the deviations from the recovery criteria specified in the published trial protocol were poorly or erroneously justified. [8,9] The publication on “recovery” contains multiple factual errors which undermine the reliability and interpretation of the results. [10] QMUL were informed in detail about these issues in June 2014, but there has been no corrections in Psychological Medicine, despite that Cambridge Journals expect authors to alert editors of errors and comply with any actions taken. [11]

    PACE assert that “We are however also concerned for the rights and welfare of trial participants.” [12] Then please address the serious concerns over the revised recovery criteria, as exaggerated claims about clinical trial results threaten the rights and welfare of all patients. Greatly inflated expectations of recovery are detrimental to patients, particularly with controversial welfare reform.

    PACE are now seeking advice from patients over releasing data, [12] but they have given no details about which patients and how the issue is being framed to them. QMUL/PACE have substantially exaggerated the risk of re-identification of data subjects from sufficiently anonymised individual patient data that is stripped of all personal identifiers. This could create a self-fulfilling prophecy by unnecessarily distressing trial participants. While I take patient confidentiality seriously, consent is generally not necessary to anonymise patient data, and the issue of openly resolving the PACE trial controversy goes beyond any individual. The FINE trial (sister to PACE) has already released anonymised individual patient data to the public, without the fear tactics. [13]

    Perhaps PACE can ask patients whether they agree that a “strict criterion for recovery” should overlap which trial eligibility criteria for severe disabling fatigue?

    1. https://dl.dropboxusercontent.com/u/23608059/PDW-re-theft.pdf
    2. http://www.meaction.net/wp-content/uploads/2015/05/fs_50565190.pdf
    3. http://www.thelancet.com/cms/attachment/2001013463/2003813673/mmc1.pdf
    4. http://www.virology.ws/2015/10/21/trial-by-error-i/
    5. https://jcoynester.wordpress.com/2015/12/22/recognizing-when-protecting-patient-privacy-is-mere-excuse-for-not-sharing-data/#comment-1414
    6. http://forums.phoenixrising.me/index.php?threads/new-paper-on-fine-in-plos-therapist-effects-and-the-impact-of-early-therapeutic-alliance.41827/page-2#post-679544
    7. http://www.wma.net/en/30publications/10policies/b3
    8. http://www.bmj.com/content/350/bmj.h227/rr-16
    9. http://www.virology.ws/2015/10/30/david-tuller-responds-to-the-pace-investigators/
    10. https://www.whatdotheyknow.com/request/selected_data_on_pace_trial_part#outgoing-364900
    11. http://journals.cambridge.org/action/stream?pageId=6728&level=2
    12. http://www.qmul.ac.uk/media/news/items/smd/168729.html
    13. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0144623

    Like

    • Mr Matthees,
      Thank you for your persistent efforts to get the data released. The “Berlin Wall” surrounding the PACE trial is developing large cracks, and your work is playing an important role in exposing the blatant fraud.

      Grateful patients are cheering you on!

      Like

      • Thankyou jimells! Just doing what I can to help resolve the PACE trial controversy with open data, and provide the patient community with the answers they deserve about the trial results.

        Minor clarification for my longer post: “overlap which trial eligibility criteria” should be “overlap *with* trial eligibility criteria”.

        Like

  13. Thank you Prof Coyne for continuing to persue this. As a clin psych treating clients with CFS in Australia (well away from the debate) I just want to know what is best for my clients. It is incomprehensible to me that the deidentified data is not available for scrutiny. Surely the only reason for conducting the trial is to get information about what treatment works, release of the data allows the research community to come to a robust view about what the results mean. As it stands now there have been sufficient questions raised about the data interpretation to make it difficult for practicing clin psych to know what is best for clients ie as it stands the results are already suspect. Release the data and clear it up so we can confidently treat clients the best we can.

    Liked by 1 person

  14. Regarding the letter about the theft of the audio recorder.

    I note that the letter refers to the “therapists’ office”. This is the plural form. How many people shared this room and how many people people were routinely going in and out of this room, possibly in the absence of the therapist responsible for the recordings? If the office was shared there is even more reason that the recorder and any other trial material should have been properly secured. I also wonder how many were sharing the office as the therapist was absent but someone else must have had access to discover the crime on the first day. The fact the room was locked did not prevent the crime being discovered. Presumably there was also access to the room for cleaners and other site staff who were not part of the trial team.

    Doesn’t the participants voice on a recording constitute personally identifiable information?

    Do we have any idea if the loss of these recordings changed the usable data and had any effect on the published results? Is it possible that this loss of the recordings could have biased the trial result in favour of the investigators’ preferred outcome?

    Like

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s