Continuing the evidence‐based health care debate in 2006. The progress and price of EBM

In Volume 12, Part 3 of the Journal of Evaluation in Clinical Practice, we committed to the international medical literature a deposit of considerable scholarship on the evolution of the evidence-based medicine (EBM) debate and on the nature of evidence for clinical practice (Borry et al. 2006; Couto 2006; Dewhurst 2006; Djulbegovic 2006; Dobre et al. 2006; Geanellos & Wilson 2006; Gupta 2006; Leung & Johnston 2006; Lipman 2006; Loughlin 2006a,b; Kemm 2006; Maier 2006; Malterud 2006; Miettinen 2006; Miles et al. 2006, Porta 2006; Roddy et al. 2006; Sandars & Heller 2006; Stevenson et al. 2006; Tanenbaum 2006; Tonelli 2006; Upshur 2006a; Upton & Upton 2006). In the current issue, Volume 12, Part 4, we publish those articles that for practical reasons of space could not be included in Volume 12, Part 3, but where editorially judged urgency of publication precludes their being delayed until the 10th thematic edition on EBM in early 2007. This Part II of the ninth thematic edition on the progress of the EBM movement therefore augments Part I (Miles et al. 2006) and the previous eight (see Miles et al. 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004). This opus having now been achieved, we again invite contributions to the 10th thematic edition for publication in 2007. Recurrent themes in the contributions to this and previous thematic editions concern the apparent failure on the part of many advocates of EBM to explain and justify their most fundamental assumptions – about the nature of science, rationality and evidence itself, and how these key concepts may be put to work in the formulation of any defensible view about proper medical practice. We believe that it is necessary for any intellectually serious analysis of the phenomena associated with EBM to explore and, if possible, attempt an explanation of this surprising omission on the part of defenders of so influential and pervasive a doctrine. Even the attempt to characterize EBM as a ‘doctrine’ may be challenged (Lipman 2006), but this difficulty in finding any consensus about what EBM is can itself be seen as one of the more puzzling of the phenomena crying out for explanation (Loughlin 2006c). Any author attempting such an analysis must be driven to consider not only contributions to the EBM literature, but also the processes that produce that literature – he must effectively take the debate itself as the object of his study and ask causal questions about how it comes to take the form it does. What forces drive the debate about EBM? What assumptions or interests give rise to or frame that debate? Why are some questions regarded as apparently unworthy of serious consideration and banished to the margins of debate by organs that (by general consensus) may be regarded as defining the ‘mainstream’ in medical discourse? To address these questions, it will be necessary to consider the processes which affect publication practices in certain influential medical journals. In this context, it is therefore appropriate for us to discuss openly the processes which led to the publication of the first two papers in the current issue. One of these (Upshur et al. 2006) poses in our view a necessary and, it would certainly seem, overdue question: ‘Can scholarly journals be in financial conflict of interest situations?’ Readers might imagine such a question to be purely theoretical, even somewhat ludicrous, given the level of trust built up over long years by periodicals of international stature. Recent events at the Journal of the American Medical Association, at the Canadian Medical Association Journal and elsewhere begin, however, to make questions relating to conflicts of interest in general, more than topical and essential to pose. In order to explain the Editor’s rationale in commissioning and publishing such a paper, we would invite the reader to study, firstly, the juxtaposed paper contributed by Buetow et al. (2006). It is now possible to document here that the substance of that particular article (Buetow et al. 2006) was written, initially and relatively speedily, for publication in the British Medical Journal (BMJ), following that journal’s decision to take, intentionally or inadvertently, the same position as the Journal of Evaluation in Clinical Practice (JECP) in publishing a thematic edition on EBM (Straus 2004). But while the JECP has been noted for its impartiality and objectivity in publishing both so-called ‘pro-EBM’ as well as ‘anti-EBM’ articles, thus following the classical intellectual tradition, the thematic edition of the BMJ was characterized principally by its dramatically ‘pro-EBM’ stance. Not believing that the BMJ could possibly simply be paying ‘lip service’ in inviting responses to its thematic edition, the authors (Buetow et al. 2006) submitted their article only to see it very swiftly rejected, despite the fact that it had directly addressed – and contested in lucid intellectual terms – many of the precepts and approbations of EBM that the BMJ had appeared selectively to favour for publication in its thematic edition. Indeed, the thematic edition of the BMJ had published an extensive number of so-called ‘pro-EBM’ views, while the only article expressing ‘concerns’ about the whole conceptual and practical basis of EBM had been relegated to the back of the BMJ and branded under the extraordinary heading Personal View. Buetow et al. (2006) subsequently contested the rejection of their article by the BMJ, understandably requiring, in these days of ‘transparency’ and ‘accountability’ (concepts, it must be noted, that the BMJ itself has seen fit to pioneer), a proper and fully rational account of the basis on which their article had been rejected. ‘Lack of originality’ was the reason given, yet the article had raised a considerable number of objections to the concept and practice of EBM that had not been considered by any of the articles selected for publication in the thematic edition of the BMJ on EBM. The reason for rejection given was therefore not accepted by Buetow et al., who found it unsustainable for the reasons we have outlined. Thus, suspecting that the rejection of their article may have been the product of editorial bias (the potential nature of which we shall turn to below), Buetow et al. (2006) referred their objections to the Ombudsman of the BMJ who, by virtue of such high office, is able to exercise a final decision on such matters. The authors did not find surprising the decision of the BMJ Ombudsman that the initial editorial judgement should stand. The Ombudsman is not an expert in the EBM debate, and therefore is not able to make a judgement on the intellectual content of EBM papers, but effectively an employee of the BMJ with a remit essentially confined to investigating whether proper editorial processes, including the processes of peer review as they are currently defined and understood, have taken place. Now let us draw here a distinction between the processes of what is currently accepted as definitive and ‘established’ peer review and the actual effectiveness of such systems of peer review. Anyone who believes in the possibility of intellectual progress agrees that a prerequisite for such progress is frank and open debate. This implies the possibility of genuine disagreements being aired – different and even contradictory viewpoints being brought to bear upon a controversy in the search for a resolution. Whether one puts the point in Hegelian terms (the necessity of consideration of both thesis and antithesis if a synthesis is to be achieved) or in terms of Mill’s defence of free and open dialogue as ‘the only unfailing and permanent source of improvement’ in any human endeavour (Mill 1991), we take our basic point to be generally understood and accepted. Indeed, if any contributors to the EBM debate think that in this case open dialogue is unnecessary, and that the debate has already been settled, then we invite them to contact us explaining in clear and precise terms the time and manner of its intellectual resolution, since we find no evidence in the literature of any such resolution as having taken place at the time of writing. Certainly, there is ample evidence that scientific progress is stifled where open dialogue is curtailed (Charlton 2000). We therefore regard it as absolutely essential that academic journals do not become partisan in their publishing policies. While it strikes us as wholly acceptable for an editor to have and express a position on a controversial matter (editors have viewpoints like anyone else and we see no virtue in their pretending otherwise), viewpoints contrary to the editorial line of the journal must be given full expression within its pages. Academic journals are the territory in which such debate takes place, and this is why it is so important that they do not become the exclusive property of any given academic ‘club’. They are the intellectual common ground which must not be circumscribed by any specific interests – be they financial, professional or ideological. This is the fundamental conviction underlying the above-mentioned policy of impartial publishing and it is our reason for commissioning commentaries on significant papers published in these pages and inviting the authors of original papers to respond to commentaries where appropriate. Were authors to get the impression that they needed to be ‘on message’ to appear in a ‘credible’ publication, this would, in our view, be immediately indicative of a climate of intellectual repression (Loughlin 2002). To maintain such impartiality, it is necessary to be vigilant against possible abuses (witting or unwitting) of the peer review system. It is well-known that certain journal editors will preferentially select peers who are known to, or can be predicted to hold, given views of a paper or thesis, and if those peers understand they are at liberty to bring those views to bear in the synthesis of their judgement on the paper or thesis, then peer review can actually function to inhibit rather than promote scientific progress. We, at the Journal of Evaluation in Clinical Practice, were greatly troubled by the observation of the rejection by the BMJ of Buetow et al.’s initial paper and have been concerned to examine the circumstances in the necessary detail. Accordingly, we commissioned, and contributed to, an article which set out to reflect on the matter. This brings us to the second paper in this Part II issue of the thematic edition on EBM 2006, the article by Upshur et al. (2006). In that paper, the hypothesis is advanced that some academic medical journals may find themselves in a financial conflict of interest position. In order to advance what might be termed ‘proof of principle’, on which more systematic study might be based, the authors show the sheer extent of financial income that BMJ books, owned for many years until very recently by the British Medical Association (as is the BMJ itself) enjoyed through the commercial sale of a very extensive range of unashamedly ‘pro-EBM’ books and journals. Indeed, the BMJ continues to lend its imprint to the promotion of the recently sold business and thus, we assume, continues to enjoy financial income from the sale of ‘pro-EBM’ books. The authors hypothesize that scholarly journals can find themselves in conflict of interest positions when they operate business strategies which for commercial reasons may militate against the publication of articles which question the usefulness of the products being sold. Moreover, the authors advance the reasoning that the more extensive the merchandizing and the greater the commercial profits, the greater is the potential for conflict of interest. What, then, is the nature of the hypothesis advanced by Upshur et al. and considered in this Editorial? Are we insinuating wilful corruption on the part of individuals or a crude ‘conspiracy theory’? However carefully we explain our position, some will choose to read us this way and dismiss our argument by knocking down its ‘straw-man’ facsimile. Lipman (2006) argues that EBM cannot be an ‘ideology’ for reasons which include the fact that it was not ‘purposely designed by a sinister group of power-hungry conspirators’. We agree with Lipman that EBM was not the product of any such conspiracy. With regard to such phenomena as apparent biases in publication policies and the general climate of the debate about EBM, we prefer a type of ‘invisible hand’ explanation, owing more in its inspiration to the work of Adam Smith than that of Dan Brown. This does not show that EBM cannot be understood as a sort of ‘ideology’, nor does it imply that such a characterization of EBM can play no useful explanatory role in accounting for the development of the EBM debate. With reference to the extensive literature on how an ideological ‘consensus’ can be ‘manufactured’without any parties ‘conspiring’ to this effect, Upshur et al. (i) provide the theoretical basis for what we will term an ‘ideological conflict of interest’; (ii) show how ideology can be linked to financial and other interests (again, without any crude forms of corruption or conspiracy necessarily coming into play); and (iii) raise the possibility that the current dominance of EBM is an illustrative case of a manufactured consent giving rise to ideological and financial conflicts of interest. Indeed, the authors argue that it would be ‘naïve’ in the extreme to assume that academic journals are axiomatically immune to processes and commercial influences that are known to affect other published media. There are many uses of the terms ‘ideology’ and ‘ideological’ in philosophical and social scientific literature, and it would be absurd for us to declare any one of them the correct usage, labelling all others incorrect. One use of the term ‘ideological’ in the context of the current debate is as follows. To say that a debate has ideological dimensions is to say that the parties bring to it assumptions of a fundamental nature which affect the way that they conceptualize the subject matter under discussion (Loughlin 2002). To say that someone is ‘in the grip of’ an ideology or is in fact an ‘ideologue’ is to say that he is either unable or unwilling to subject his fundamental assumptions to critical attention: The ideologue treats his own basic assumptions as too obvious to need any clear explanation or defence. To such a person, the very fact that someone disagrees with (or even simply questions) his view is evidence that the dissenter has not understood. (Loughlin 2002) This analysis has been applied in the explanation of the ‘quality revolution’ in management theory – a social phenomenon with profound effects upon the working lives of professionals in many areas, including health professionals (Loughlin 2002). Theories were developed that simplistically equated ‘organizational quality’ with the control of professional practice by a managerial class. The initial appeal of these theories no doubt had much to do with the fact that they served the career and political interests of certain groups, and the success of the ‘quality movement’ also owed much to the rhetorical properties of its defining term – for as defenders are never tired of pointing out, no one can be ‘opposed to quality’. For this reason, the ‘drive for quality’ was able to win the vocal support of figures in government, irrespective of any coherent analysis of the real needs of organizations, let alone any sound argument or evidence that the ‘quality movement’ adequately addressed those needs. It serves the interests of politicians to be perceived as allied to ideas that are at once ‘radical’ and unquestionably good. As the movement developed, the assertions that formed its alleged ‘theoretical base’ changed with a rapidity that ought to have shocked anyone in the grip of the idea that this ‘movement’ represented any sort of ‘scientific’ insight into the nature of good organization, as many of its exponents claimed. Yet the more frequently such claims were repeated, and the more people became employed in the design and implementation of ‘quality mechanisms’ based in this purported ‘management science’, the more it seemed to many that the quality movement represented an unquestionable set of truths, such that the questioning of its unproven assumptions started to seem ‘revolutionary’ to some. In some management circles, the ‘quality revolution’ has become so ‘mainstream’ that the attempt to question it strikes its defenders as either frivolous or absurd, such that to do so is to be deemed ‘out of touch’ with the basic realities of life (Loughlin 2002). In this sense, ‘quality management’ has become an ideology: a set of dogmas, lacking in sound evidential or argumentative support, which encourage us to view the world in a certain way, and to practise accordingly – cooperating with every monitoring exercise and implementing whatever is the latest ‘quality mechanism’, without even pausing to question its rationale, because it is presented as an assurance of ‘quality’. This ideology functions to serve the interests of many people: from the authors of the many ‘quality’ guides and handbooks, to politicians, senior managers and the growing army of non-productive employees work or the development and implementation of such we can see how a or of interests can a as the interests become the more and monitoring there the greater the for literature explaining how to such in professional and the more employees will be needed to days and other development events to with these if any of these of ‘quality will regard themselves as parties to a but rather will see the need for quality as too obvious to a serious defence. The of the line and the or of the since the driven by the to to the of the the the time and the intellectual to think about how to the needs of the not to those needs they to We believe that a very has the extraordinary success of EBM. one is to of EBM and without equated clinical evidence with evidence from certain As the movement developed the assertions that formed its alleged ‘theoretical base’ changed with a rapidity that ought to have 2006), yet many by the nature of the fundamental Porta the of interests that has developed what to be an idea so as to be question – that medicine should be on it is the that can to As a the which are and to and politicians in a that to the and EBM forms the basis for to a and are but very through are to the final As and get more But the to on will based on more will have to be in more and so of have been built on of in an and see how much into a world has in which EBM and its following of and clinical have themselves to a and in 2006) the on the part of its defenders that fundamental claims evidential EBM has the support of politicians, to be associated with an idea that to a critical at once and unquestionably good. with ‘quality EBM has been as a of health policy & As with the ‘quality we have seen that of EBM are not even to consider the possibility that about their theories might be Indeed, we have noted their of and their to in debate, and have in such a position as both and The of the of EBM to in scholarly debate takes two (i) they to to published articles which and with fundamental for them to their (ii) they never the published of their in their own one of the and most of EBM, for As an extraordinary and a in the of clinical he is if by the of EBM, an observation when one that one of the alleged of EBM is to search for and all It is the ideological nature of the of EBM that would see the work of and that of many other published in the Journal of Evaluation in Clinical Practice, as EBM are preferentially content to and never to those of their et al. such are if at as to the debate, without that they are or or as too to an We have at a in intellectual when of ideas can be not because they have been but because those with the to and control because they or work for that the in which ideas are or in some they own the itself) regard these as simply to our (Loughlin 2002). We ought to be a more about this than many current appear to The cannot be defined with reference to the interests of any person, group or a debate or of should to be circumscribed by such this its as a for at the In a world where the of evidence and the are we must be vigilant in the distinction between an impartial for the and a Yet the current for EBM has led us to product in the pages of journals (Upshur et al. 2006), the of some for the of EBM not its other labelling they do in practice as and others unashamedly publishing books which in the and in the content and the There is no it is that such have dramatically commercial We are some scholarly journals so in the of the EBM as to their as impartial for open debate? commercial forces to the intellectual common questions cannot be immediately and certainly not in the of an editorial and such questions can be only raised at this the time of all we have are the that it has been possible to the that may be based on them and the to for more systematic study of the that are advanced both here and in some of the papers of this issue. the reader may to reflect carefully on what has been and here in to the ideological and financial basis of the EBM The reader is referred to the Editor’s on In the paper of this Part II thematic edition on EBM, we to a from that of EBM, the of In his of – or (2006) argues that in the EBM has enjoyed development and health While we agree that EBM has enjoyed and has had we do not agree that it has professionals and it has most certainly not despite its very questions whether we should this or should the content and of whether EBM is ‘the only way to view medicine in the and whether and extensive EBM with may be the to in order uses and of With these questions and in (2006) the concept of which he to with as an that might be into the of medical reasoning and decision in order to examine more original we two editorial commentaries on his article and publish these immediately following In the first of Upshur on the concept of which this author of to his given the between the EBM movement and the so-called Indeed, he the growing of literature the and of EBM, despite the fact that EBM has itself and thus of its own of he its or to address the of serious intellectual and clinical that have been against While finding much of interest in Upshur views this work as of the within the EBM Indeed, the author that there is now no of for a view of what EBM is or is not and, as a we have a of many of what EBM may As Upshur these are by no then, are the of EBM? for Upshur the difficulty as it to of he is to that has no The second (Loughlin up on of and in the use of his own key terms and in the nature of the thesis being The brings out the to between work on EBM and work on ‘quality’ in management that EBM is the to in medicine and and that its is more than But having advanced these the author immediately by questions as to what EBM is and what the of EBM by can that we have EBM as one of the to practise we should if it and how it is it that he can then on to ask – having that EBM is one of the to practise medicine – our more from the EBM than from its and our EBM than those under any The thesis to be that while EBM is it is by no certain what EBM is – a somewhat puzzling work may be seen to provide an of the processes considered in the first part of this is to raise serious questions about EBM. to appear or and to being absurd or in his he to all questions about the of EBM with an of its has in where

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