Response to Adam Jacobs
15 November 2011
Thank you for raising the issue of consent for publication of the pathology grading sheets.
We did not obtain consent for publication in this case. In deciding to take this course we took into consideration our own patient confidentiality policy, advice from our ethics committee, relevant law, the interests of the patients in question and the public interest in the publication of the grading sheets. Having weighed all these considerations, we concluded that the right thing to do would be to publish the grading sheets, specifically to enable readers and the wider public to test and judge for themselves the merits of the competing arguments put forward by David Lewis, Brian Deer and the reviewers based upon the contents of the grading sheets.
In terms of how we went about carrying out this balancing exercise, the first point to observe is that the patients in question are not identifiable from the grading sheets as published, certainly no more so than they already were in consequence of the public GMC proceedings involving Andrew Wakefield and John Walker-Smith and the media coverage of the case. We specifically obscured the patients’ hospital numbers given on the sheets to ensure that this was so. Provided that living individuals are not identifiable in material that we are considering for publication, there is no obligation to obtain consent, whether as a matter of our own patient confidentiality policy (http://www.bmj.com/about-bmj/resources-authors/forms-policies-and-checkl...) or the law (i.e. the Data Protection Act).
The second point is that, even if we had concluded that we were obliged to obtain consent, we reasonably anticipated that we would have been unable to obtain it. The BMJ is not and never has been in contact with the patients or their families to the extent that, apart from one parent who has written to us, we don't know their identities. Furthermore, given (a) the fact that most of the families of the patients in question are known to be dedicated supporters of Andrew Wakefield and opponents of Brian Deer and his work and (b) the tenor of the articles that we were proposing to publish alongside David Lewis’s letter, we reasonably believed that even if we could establish contact with the patients or their families, we would not obtain consent.
Third, we considered that there was an overwhelming public interest in publication of the grading sheets and the data they contained, most particularly for the reason given above. With respect to the issue of public interest, it is also worth bearing in mind the circumstances in which the grading sheets came to our attention in the first place. As you are aware we were sent the grading sheets by David Lewis who had been given them by Andrew Wakefield. We reasonably took the view, having regard to our communications with David Lewis, that the grading sheets were likely to be published by him on the National Whistleblower Center website and quite possibly more widely in support of an ill-founded and misinformed campaign to exonerate Wakefield, undermine the BMJ’s work in exposing Wakefield's research misconduct, and thereby to further mislead the public about the validity of Wakefield’s research. Having in mind the whole sorry history of the MMR scare, we were in no doubt about the damage that such publication might cause if left unanswered. In order to answer Lewis’s argument with the cogency it warranted, we felt we had no option but to publish the grading sheets at the heart of the debate.
Competing interests: I am the Editor of the BMJ and responsible for all it contains
BMJ, London WC1H 9JR, UK
Click to like: