- Repeated signals that The BMJ is moving forward while editors of other key medical journals try to undermine data sharing.
- Institutions are stiffening their resistance to release of the promised PACE trial data from the PLOS One article. This threatens to splinter the movement for routine data sharing.
- But The BMJ continues to support for data sharing and persists in calls for release of PACE data to scientists and patients.
As I have recently noted, activists for routine sharing of data from clinical trials should curb their enthusiasm about 14 medical journals publishing the International Committee of Medical Journal Editors (ICMJE) statement.
No editors wanted to be seen refusing to publish it, particularly when there was ample reassurance that it is only a proposal, merely aspirational, and far from being implemented. But there is distancing and undermining by editors going on.
New England Journal of Medicine editors Dan Longo and Jeffrey Drazen quickly drew ridicule in the social media with their attempts to distance themselves from the ICMJE statement and their raising of the specter of “research parasites.”
”…people who had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited. There is concern among some front-line researchers that the system will be taken over by what some researchers have characterized as ‘research parasites’.”
Old guard Richard Horton, who is committed to “a permanent attack on the present,” exercised his prerogative as editor to cleverly preempt implications of The Lancet publishing the statement. He published a stirring account of a conference on the reproducibility and reliability of biomedical research but notably failed to mention one of the key solutions being considered at the conference was publicly accessible data.
On a more positive note, a recent twitter exchange called renewed attention to a contrasting 2015 The BMJ editorial:
Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ. 2015 May 7;350:h2373.
The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices.The data transparency revolution is gathering pace. Last month, the World Health Organization (WHO) and the Nordic Trial Alliance released important declarations about clinical trial transparency.
The editorial ends on a strong note:
Hoarding data and limiting access to them is inimical to the data sharing society envisioned in the IOM report. Making anonymised patient level data from clinical trials available for independent scrutiny allows other researchers to replicate key analyses, reduces the possibility that studies will be unnecessarily duplicated, and maximises use of the information from trials—an important moral obligation to trial participants. An initial investment of time and money is needed to prepare trial data for sharing, but after the first use there are few additional costs; in essence, the value of the data increases with each use.
What was said on Twitter
You can see the actual exchange and more by following Trish Groves on Twitter. . She indicates that the tweets are her own, but that she is Deputy editor, The BMJ and editor in chief, BMJ Open (qualifications MBBS, MRCPsych).
I was still caught up in the 2013 statement and Trish Groves clarified it had been expanded to all trials.
She gave an example:
Richard Smith, former editor of The BMJ calls for release of the PACE data
Many members of the British establishment ran for cover in the face of Peter White and the PACE investigators’ refusal to release the data to me. Yet, Richard Smith, the former editor of The BMJ responded with a blog post, the title of which says it all:
His concluding statement:
I fear that QMUL and King’s are defending the indefensible and like King Canute failing to stop a tide that is coming in fast.
That was followed up by Richard Lehman, a British primary care physician, academic and author of the regular blog, Richard Lehman’s Journal Review, taking aim at the NEJM editors in Share data or be damned:
Having signed the remarkably radical ICMJE proposal, Jeff Drazen, editor of NEJM, co-authors an editorial simply titled “Data Sharing.” It begins by mocking a delusive biscuit-tin landscape of everybody happily sharing data, moves on to grave warnings about “research parasites” feeding off other people’s hard work, and ends up advocating “research symbiosis,” by which the original researchers collaborate with others in moving beyond the data already gathered. I think they are trying to be witty, and I don’t want to discourage that, but they make it clear that they regard re-analysis and meta-analysis as little better than what a tapeworm gets up to in the bowel, as illustrated on p.234.
Personally, I think we need all the data parasites we can get, as well as symbionts and all sorts of other creatures which this ill-chosen metaphor can’t encompass. What this piece really shows, in my opinion, is how far the authors are from understanding and supporting the true opportunities of clinical data sharing.
The BMJ’s call for greater patient involvement in interpreting research vs the spoiled identity of patients with chronic fatigue syndrome/myalgic encephalomyelitis (ME) or ME/CFS
Peter White and the PACE investigators’ crude, personal, and unprofessional response to my request for data was reflexive. They are accustomed to receiving those requests from patients in a culture where patients should be seen and not heard. They were responding as if I was somehow below them in the hierarchy in which their views should be uncritically accepted with all the deference that colonialists are due. How vexatious of me to challenge the interpretations of their data that they were putting forth…
Once I was cast among the patients, I was subject to the usual smearing and collective punishment for real and imaginary hostile actions of a few patients in a familiar narrative crafted by Simon Wessley’s Science Media Centre . Although I have a stronger publication record than any of the PACE investigators, concerns were raised about releasing data to those who are incapable of analyzing it.
Over time, I’ve gotten to know some of the individuals who have previously requested data, although I have never met them. They impress me as amply qualified to analyze data, and they often analyze data that I report in my blogs, with them asking for no credit. Many of them have been academics or have had other professional achievements. Others were progressing well along in their educational pathways before they were struck by their illness. Still others become citizen-scientists with the capacity to publish peer reviewed letters to the editor as a result of struggling to deal with their misunderstood medical condition.
There is something ugly, pernicious going on here, more fundamental than the question of data sharing. Being a patient with chronic fatigue syndrome/ myalgic encephalomyelitis is what sociologists like Erving Goffman would call a spoiled identity . Being a patient means being stripped of all other significant social identities and being reduced to a common denominator, stigmatized role.
Long after the current crisis about data sharing is resolved, issues about respect for patients that have been uncovered in the UK will remain. These issues are shocking to outsiders. In the United States, they would variously framed as discrimination and even human rights issues. I wouldn’t be surprised if there is not some movement in the UK to identify these issues in the same terms.
But there is also an affront to any conception of patient empowerment. After all, the PACE investigators are making claims that have profound implications for the treatment and well-being of patients.
A recent blog post of mine, What patients should require before consenting to participate in research… argued that patients should refuse to consent to research unless their role is more clearly specified than as mere passive providers of data. I drew heavily on an editorial from The BMJ’s editor-in-chief calling for more explicitly defined patient involvement in the design, implementation and interpretation of research.
More than three million NHS patients took part in research over the past five years. Bravo. Now let’s make sure that patients are properly involved, not just as participants but in trial conception, design, and conduct and the analysis, reporting, and dissemination of results. You may have noticed the new “patient involvement” box in The BMJ’s research articles. Sadly, all too often the text reads something like, “No patients were involved in setting the research question or the outcome measures; nor were they involved in the design and implementation of the study. There are no plans to involve patients in the dissemination of results.” We hope that the shock of such statements will stimulate change.
This is clearly aspirational, and may still be well beyond reach. As an article cited in the editorial stated:
Thornton S. Beyond rhetoric: we need a strategy for patient involvement in the health service. BMJ. 2014 Jun 23;348:g4072. [http://www.bmj.com/content/348/bmj.g4072.short]
UK government is heavy on the hyperbole of empowering patients but lacks a robust strategy.
Respect for a patient’s individual autonomy is an accepted principle in modern medicine. In the past half century, the concept of autonomy has usurped medical paternalism in almost all of its forms and has aspired to promote patients from passive recipients of care to partners in planning their own treatment.1 Now the concept has extended beyond individual autonomy to an expectation of empowerment at the population level.
But the editorial clearly puts the issue on the table in a way that is in sharp contradiction to the way patients are being treated by Peter White and the PACE investigators.
Update: Simon Wessely continues to fight release PACE data
For someone who adamantly proclaims he has no dog in the fight, Simon Wessely is quite active behind the scenes. He sends regular emails and direct messages to players in the struggle for the PACE data, including myself and numerous patients.
Recently he emailed blogger Leonid Schneider signaling that maneuvering to prevent release of the PACE data is set to challenge the legitimacy of having to share data at all.
What is clear is that the general atmosphere around data sharing, especially of sensitive data such as medical information, is in a state of flux. Indeed several reviews are ongoing in this country which are likely to make data linkage and sharing more onerous, and eventually there will be new legal rulings, which again are unlikely to produce a more liberal approach to data sharing/linkage.
Sooner or later I anticipate there will be a collision between the open data movement and the legal framework around data protection, at least in the UK.
As an epidemiologically trained researcher I am anxious about the consequences of this, since I doubt very much it will make data sharing and linkage easier, rather the reverse. I hope I am wrong, but the fallout from care.data has been so toxic that I suspect the direction of travel will be in one direction only. At least in England.
The battle lines are getting more clearly drawn and the stakes are being raised. We need everybody supporting data sharing to unite.
The BMJ and patients with chronic fatigue syndrome/ myalgic encephalomyelitis have an unfortunate history with perceived injustices and wounds on both sides. I see a clear indication The BMJ editorial staff is willing to put that aside. I hope the patients can do similarly.