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):

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.


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.