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EDITORIALS: Richard Smith Making progress with competing interests BMJ 2002; 325: 1375-1376 [Full text]

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Conflicts of interest

Richard E Ashcroft   (17 December 2002)

The BMJ fails to walk its talk

Max Lagnado, Simone Kohll, General Practitioner, North London   (17 December 2002)

Should editors publish their own original research in the journals they edit?

Richard Smith   (18 December 2002)

The BMJ still fails to walk its talk

Max Lagnado, Dr Simone Kohll, General Practitioner, North London   (19 December 2002)

Grading the Competing Interests

Mangesh A Thorat   (20 December 2002)

Its my Journal and I'll write if I want to

Jonathan O'B Hourihane   (20 December 2002)

Randomised controlled trials: the need for blinding

Philip M Bath, Peter Sandercock.   (24 December 2002)

Avoiding competing interests

Jon N Jureidini, Peter Mansfield   (27 December 2002)

Broadening the concept of competing interests

Ivar S Kristiansen   (3 January 2003)

More than sponsorship bias?

Peter C Arnold, Nil   (4 January 2003)

Conflict of Interest Courtesy of Drug Reps...

Tony Floyd   (5 January 2003)

Surely you jest?

david d derauf   (15 March 2003)

Conflicts of interest 17 December 2002
Richard E Ashcroft, Leverhulme Senior Lecturer in Medical Ethics Imperial College London, Reynolds Building, St Dunstan's Road, London W6 8RP Send response to journal: Re: Conflicts of interest	The BMJ's position on competing interests is admirable and deserves to be widely imitated. What most BMJ readers may not know is that this issue has created controversy outside biomedical research as well. A recent article in the London Review of Books by leading US bioethicist Carl Elliott calls his US colleagues in bioethics to account for the widespread practice of receiving funds for their research, speaking fees, consultancy payments and the like from pharmaceutical and biotechnology industry sources, both as personal payments and as investment in bioethics centres and university departments, without declaring this interest in their publications.(1) Given that much bioethical research has an "advocacy" element, involving not only ethical analysis but also persuasion that a certain position or policy is to be preferred, this is in some ways less alarming than in science, where there is a claim to objective truth. On the other hand, since much bioethical argument turns on the giving of neutral and dispassionate assessments of moral options, there is still some cause for concern. Elliott was responding to a position statement on conflict of interest commissioned, but not adopted, by two major US bioethics associations, and subsequently published in the leading US bioethics journal - where the task force members themselves refused to declare their own interests.(2) Bioethicists - like other academics - need to find funds in support of their work. Sometimes it is appropriate to seek industrial sponsorship. But there is a crying need for clarity about when this is and is not appropriate, and for acceptance of the need to declare interests when publishing. (1) Elliott C "Diary: The Ethics of Bioethics", London Review of Books, 2002: 24(23): 36-7 (2) Brody B, "Bioethics Consultation in the Private Sector", Hastings Center Report, 2002: 32(May/Jun): 14-20 Competing interests:   I am an Associate Editor of the Journal of Medical Ethics, writing in a personal capacity.
The BMJ fails to walk its talk 17 December 2002
Max Lagnado, Medical Director Chameleon Medical Communications, Park House, 111 Uxbridge Road, Ealing, London W5 5LB, Simone Kohll, General Practitioner, North London Send response to journal: Re: The BMJ fails to walk its talk	In his editorial about competing interests Richard Smith quite rightly states, “we still have some way to go to the fully transparent world that is desirable.” [1] In support of this statement he says that revised guidelines on publication ethics by the International Committee of Medical Journal Editors [2] have yet to be widely implemented. As well as stating that authors must disclose all potential conflicts of interest, this document also recommends, “editors should avoid submitting to their own journal reports of original research to which they have contributed as authors.” Presumably the rationale for this latter recommendation is to ensure that the editor’s status does not influence peer reviewers’ assessments. In spite of this guidance we find that Smith initiated, designed, co-wrote and co-authored original research published in the BMJ, [3] the journal he edits. Is it realistic to expect authors to adhere to publication guidelines that journal editors ignore? References 1. Smith R. Making progress with competing interests. BMJ 2002;325:1375–6. 2. Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, Horton R et al. Sponsorship, authorship, and accountability. Lancet 2001;358:854–6. 3. Chaudhry S, Schroter S, Smith R, Morris J. Does declaration of competing interests affect readers’ perceptions? A randomised trial. BMJ 2002;325:1391–2. Competing interests:   ML helps pharmaceutical companies to produce scientific and marketing materials
Should editors publish their own original research in the journals they edit? 18 December 2002
Richard Smith, Editor BMJ Send response to journal: Re: Should editors publish their own original research in the journals they edit?	Dr Lagnado criticises me for publishing a piece of original research in the BMJ. He accuses me of breaching the uniform requirements of the International Committee of Medical Editors. It is true that those requirements state that: "Editors should avoid submitting to their own journal reports of original research to which they have contributed as authors." Dr Lagnado did not, however, quote the next sentence, which says: "If they do so, they should recuse themselves from the editorial process, and delegate editorial decisions on those manuscripts to other members of the editorial staff." This is exactly what I did. The question of whether editors should submit original research to their own journals is vexed. The argument against is that they will have undue influence over the process and possibly be able to get inferior work published. One argument for editors being able to submit to their own journals is particularly strong for editors of specialist journals. They are often selected because they are gifted researchers, and it may be unfair on them if they are not able to publish in what might be the best journal in their specialty. It would also be unfair on the journal if it were forbidden access to some of the best research being done. The argument that is important to the BMJ is that the work we have published--on methods of peer review and competing interests--is undertaken on BMJ readers, authors, and reviewers and is used to determine BMJ policies. It would be odd to publish such work in another journal. We have devised a system for peer reviewing work by BMJ editors that does not include any of the inhouse team. A description of this system will be published on our website very soon. Richard Smith, Editor, BMJ Competing interests:   I am editor of the BMJ.
The BMJ still fails to walk its talk 19 December 2002
Max Lagnado, Medical Director Chameleon Medical Communications, Ealing, London, W5 5LB, Dr Simone Kohll, General Practitioner, North London Send response to journal: Re: The BMJ still fails to walk its talk	We thank Dr Smith for his response [1]. Our intention was not to be critical of him for publishing his original research in the BMJ. Our point was more subtle: if you ask a group of individuals to behave in a certain way, your chances of success rapidly diminish when you start to give reasons why you can behave differently. Although we understand Smith’s point that “it would be odd to publish” work about his journal in another journal, we note that editors from the BMJ [2,3] and other general medical journals such as the Lancet [4] have done this in the past. As Smith correctly points out the revised guidelines on publication ethics [5] state that editors who publish in their own journal should excuse themselves from the peer review process. But this does not negate the preceding guidance from the same document that editors “should avoid submitting to their own journal reports of original research to which they have contributed as authors.” We fully endorse the BMJ’s valiant attempts to bring greater transparency to the publication process. But we fear that the BMJ’s failure to follow the spirit of the International Committee of Medical Journal Editors guidelines may discourage authors from adhering to them. References 1. Smith R. Should editors publish their own original research in the journals they edit? Available from http://bmj.com/cgi/eletters/325/7377/1375#27924. 2. van Rooyen S, Godlee F, Evans S, Smith R, Black N. Effect of blinding and unmasking on the quality of peer review. J Gen Intern Med 1999;14:622–4. 3. van Rooyen S, Godlee F, Evans S, Smith R, Black N. Effect of blinding and unmasking on the quality of peer review: a randomized trial. JAMA 1998;280:234–7. 4. Horton R. The hidden research paper. JAMA 2002;287:2775–8. 5. Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, Horton R et al. Sponsorship, authorship, and accountability. Lancet 2001;358:854–6. Competing interests:   ML helps pharmaceutical companies to produce scientific and marketing materials. He has written this letter in a personal capacity.
Grading the Competing Interests 20 December 2002
Mangesh A Thorat, Research Fellow Tata Memorial Hospital, Dr. E.Borges Marg, Parel, Mumbai - 400012, India Send response to journal: Re: Grading the Competing Interests	Competing interests impact outcome1 and their declaration impacts reader perceptions2. Today, it is very unlikely to find a valid argument against declaration of competing interests. Declaring competing interests must be made mandatory by all biomedical journals, but, will it have an exaggerated impact on reader perceptions? Efforts must be made to ensure that the impact on perceptions is proportional to the competing interests. If we were to develop such a mechanism, then we will have to grade the competing interests. Competing interests can be broadly divided in to 'Project related' and 'Other' competing interests. Project related competing interests, say for example, can be graded as follows: Grade I - Direct professional funding for the project. Grade II - Charitable funding with professional participation like free drug supply. Grade III - Fully charitable (or government agency) funding from organisations whose members are connected (by means of consultancy or stock ownership) with professional organisations. Grade IV - No competing interests. Other competing interests will be the competing interests that are not directly related to the particular project. Asking for declaration of these interests alongwith the financial sums will always be a controversial topic. This controversy can be slightly put aside by not asking for the disclosure of the actual amounts but for the percentage financial dependence. These competing interests can be broadly divided into Research, Academic and Personal interests. The author should disclose the percentage of his/her research funding (for other projects) that comes from a related professional source. He/she should also disclose the percentage of his funding for academic activities (like attending meetings or conferences) that has a related professional source. Consultation payments or stock ownership can be disclosed as the percentage of total personal assets or annual expenditure. This is although a bit complex mechanism, it will probably obviate the need for declaring actual sums, something which majority of the authors will be uncomfortable with. It will also help readers in objectively judging the outcomes. However, competing interests arising out of personal relationships, academic competition and intellectual passion will in all probability remain gray zones for our inability to grade these. Grading financial competing interests will be a step towards bringing some objectivity in our declaration of competing interests without added discomfort. References: 1. Vandenbroucke JP. Competing interests and controversy abut third generation oral contraceptives. BMJ 2000; 320: 381. 2. Choudhary S, Schroter S, Smith R, Morris J. Does declaration of competing interests affect reader perceptions? A randomised trial. BMJ 2002; 325:1391-2. Competing interests:   None declared
Its my Journal and I'll write if I want to 20 December 2002
Jonathan O'B Hourihane, Senior Lecturer, Infection, Inflammation and Repair, Mailpoint 218, Southampton UniversityhHospitals NHS Trust SO16 6YD Send response to journal: Re: Its my Journal and I'll write if I want to	"Richard and colleagues just walked through the door Like a king with his court He says he's had a great idea and surely to publish they ought". Sorry my muse left for the holidays after that. Please feel free to add some more verses.Like other respondents I applaud the BMJs crusade to enlighten readers about the issues of conflicting interests. This work should surely have been submitted to another journal or if not then someone else should have written the editorial for the BMJ. The BMJ's peer journals are not the BMJ itself. Could we be informed as to how long the paper was out at the reviewers and how quickly it got accepted in final version.It has been published with 6 weeks of acceptance. That's nice. I have had work published in the BMJ , on one occasion after the manuscript(and I am quoting directly from the correspondence at the time) "lay in the top drawer" of a staff statistician's desk for 6 months. I doubt that would ever happen to an editor's paper. These are small points but if the BMJ's crusade is to be credible and successful, in-house guidelines about staff submissions should be torn up and replaced by a rule that BMJ related work is only submitted elsewhere. Competing interests:   None declared
Randomised controlled trials: the need for blinding 24 December 2002
Philip M Bath, Stroke Association Professor of Stroke Medicine Division of Stroke Medicine, University of Nottingham, City Hospital campus, Nottingham NG5 1PB, Peter Sandercock. Send response to journal: Re: Randomised controlled trials: the need for blinding	EDITOR- The editorial by Richard Smith on competing interests 1 was very pertinent and timely. Nevertheless, we would like to correct one impression, namely that 'double blind randomised controlled trials are necessary for testing new treatments ...'. Whilst this trial design (where both patient and treating investigator are blinded to treatment) is ideal, it is not always possible. For example, drugs may not be available commercially, or pharmaceutical companies may be unable, or unwilling, to supply academic trials with active and placebo drugs. In trials of surgery and rehabilitation,2,3 it is usually impossible to blind either patient or investigator to treatment. In these cases, the trial must compare active treatment with nothing,2-4 a so-called open-label design. These trials must rely on two other techniques which are potentially far more powerful at minimising bias than double- blinding, namely concealing allocation (so the investigator cannot manipulate the randomisation process, often achieved by randomising centrally), and performing central blinded follow-up, often through administering a questionnaire by post or telephone. So, whilst we support the concept that trials should, ideally, be double-blind this is not essential for a trial to remain of high quality, valid and clinically relevant. Conflicts of interest: PB and PS are principal investigators to academic trials which are (ENOS), or will be (IST-3), open-label with blinded endpoint assessment. References 1. Smith R. Making progress with competing interests. Br Med J 2002; 325:1375-6. 2. European Carotid Surgery Trialists' Collaborative Group. Endarterectomy for moderate symptomatic carotid stenosis: interim results from the MRC European Carotid Surgery Trial. Lancet 1996; 346: 1591-3. 3. Walker MF, Gladman JRF, Lincoln NB, Siemonsma P, Whiteley T. Occupational therapy for stroke patients not admitted to hospital: a randomised controlled trial. Lancet 1999; 354: 278-80. 4. International Stroke Trial Collaborative Group. The International Stroke Trial (IST); a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. Lancet 1997; 349: 1569-81. Philip Bath - Stroke Assoication Professor Stroke Medicine, University of Nottingham Peter Sandercock - Professor of Clinical Neurology, University of Edinburgh Competing interests:   PB and PS are principal investigators to academic trials which are (ENOS), or will be (IST-3), open-label with blinded endpoint assessment.
Avoiding competing interests 27 December 2002
Jon N Jureidini, Head, Dept Psychological Medicine Women's and Children's Hospital, North Adelaide, 5006, Australia, Peter Mansfield Send response to journal: Re: Avoiding competing interests	We congratulate you for showing leadership for all medical journals by publishing the competing interests of your editors, editorial board, and group executive (1). However we are concerned that your suggestion that “there isn’t anything wrong in having competing interests” might be taken out of the context provided by your comments about human vulnerability. We agree that there is nothing automatically wrong with competing interests. Even drug company employees can do great research if they take care to minimize bias. However the evidence suggests that competing interests are often harmful (2, 3) and that perceptions of personal invulnerability are a major source of error (4). As you wrote, “bias is pervasive and acts on us unconsciously”. Consequently, anyone who claims to be immune from the adverse effects of competing interests should be treated with healthy skepticism. Competing interests vary. We are proud to disclose our interest in advancing Healthy Skepticism Inc (www.healthyskepticism.org). However, we are not proud to have accepted gifts from drug companies in the past. We now feel that doing so was a mistake. Consequently, we have signed the NoFreeLunch pledge (www.nofreelunch.org) to reduce our dependence on drug companies. Doctors can do better than just declaring competing interests; many competing interests can be avoided altogether. 1. Smith R. Making progress with competing interests. BMJ 2002; 325: 1375-1376. 2. de Laat E, Windmeijer F Douven R. How does pharmaceutical marketing influence doctors’ prescribing behaviour? Centraal Planbureau Netherlands’ Bureau for Economic Policy Analysis. The Hague March 2002. www.cpb.nl/eng/pub/bijzonder/38 (accessed 27th Dec, 2002). 3. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373-80 4. Sagarin BJ, Cialdini RB, Rice WE, Serna SB. Dispelling the Illusion of Invulnerability: The Motivations and Mechanisms of Resistance to Persuasion. Journal of Personality & Social Psychology. 2002; 83:526- 541 Competing interests:   Both authors are members of Healthy Skepticism Inc
Broadening the concept of competing interests 3 January 2003
Ivar S Kristiansen, Senior researcher, MD PhD MPH Institute of Public Health, University of Southern Denmark, DK-5000 Odense, Denmark Send response to journal: Re: Broadening the concept of competing interests	The BMJ should be congratulated for its efforts to avoid bias in the reporting of scientific work (1). Asking editors and authors to explicitly state competing interests reduces the likelihood of bias. As Richard Smith rightly states, however, we still have some way to go to the fully transparent world. Much of the discussion of conflict of interest may leave the impression that the problem lies in commercial sponsorship, in particular from the pharmaceutical and tobacco industries. The problem may be more widespread, however. Could researchers in a public health institute be influenced by political pressures when the institute is financed directly by the ministry of health? Will the pressure become stronger when the research institute is placed within the ministry? Can researchers who receive honoraria for advising government and courts on tobacco issues be influenced by the fees they receive? If researchers can be influenced by commercial sponsorship, and the evidence here is convincing, why should researchers be immune to influence from other sponsors? Nevertheless, it is not unusual that research financed by government and other non-commercial sources is presented without warning the reader that there is a potential conflict of interest. My point is not that bias from commercial sponsorship should be belittled, but rather to emphasise that the problem is greater than the BMJ editorial may indicate. Policies to avoid bias in the conduct and reporting of research should be guided by scientific principles, not by moralism or prejudice. 1. Smith R. Making progress with competing interests. BMJ 2002;325(7377):1375-6. Competing interests:   The author has received salary and honoraria from several public institutions and honoraria from several pharmaceutical firms. He has not received honoraria from the tobacco industry.
More than sponsorship bias? 4 January 2003
Peter C Arnold, retired GP Sydney, Australia, Nil Send response to journal: Re: More than sponsorship bias?	May I suggest that the issue of competing or conflicting interests1 goes beyond the question of financial sponsorship by pharmaceutical companies or other entities? An opinion piece on health care reform was published recently in another peer reviewed medical journal2. The author was identified as an adjunct professor at the Faculty of Medicine at Sydney University. Mention was not made of his immediately prior position as Director-General of Health of the State of NSW. The editor kindly published my concern that readers, especially overseas, would have been better informed on the import of the article if editorial mention had been made of this fact. In his response3, the editor poses the question “Arnold wishes to move to a higher plane through disclosure of relevant areas of contributors' life stories, presumably to alert readers to the potential for bias. But might not the publication of a contributor's relevant career prejudice the response of the reader?” Here, indeed, is a dilemma for editors. However, in this era of "career-hopping" between industry, government and academia, do not readers, if they are to intelligently interpret an OPINION piece, need to know more than merely the present position held by the author. 1 Smith R. Making progress with competing interests BMJ 2002;325:1375-1376 2 Reid MA. Reform of the Australian Health Care Agreements: progress or political ploy? Med J Aust 2002; 177: 310-312. 3 Van Der Weyden MB. Med J Aust 2002 177 (10): 576-576 Competing interests:   None declared
Conflict of Interest Courtesy of Drug Reps... 5 January 2003
Tony Floyd, Medical Student Newcastle University, Australia 2308 Send response to journal: Re: Conflict of Interest Courtesy of Drug Reps...	Richard Smith's editorial(1) has raised some interesting points. As poignantly put by RS himself (who has never bought me lunch): "bias is pervasive and acts on us unconsciously" Given that fact(2): Why then do the doctors that I've spent time with even allow drug reps to sit in their office and give their spiel? I am not blind to the commercial realities of the world, and am quite OK with companies promoting their wares, but doctors should choose the best treatment option for their patients supported by the latest unbiased research. If the marketing money had to be redirected to researching better drugs because doctors started to insist on making only evidence-based decisions well so be it. Now there's a 'win-win-win' for free enterprise/doctors/patients. Perhaps all doctors should take http://www.nofreelunch.org/'s version of the CAGE questionnaire. (For those who are not members of the med-speak cognoscenti, the real CAGE questionnaire is normally used to screen people for alcohol abuse.) Have you ever prescribed Celebrex? Annoyed by the people who complain about drug lunches & free gifts? Is there a medication loGo on the pen you are using right now? Do you drink your morning Eye-opener out of a Lipitor coffee mug? If you answered YES to 2 or more of the above, you may be drug company dependent. Don't despair!!! Click for HELP References: (1) Smith, R. Making progress with competing interests. EDITORIAL. BMJ 2002; 325: 1375-1376 (2) Both quoting the Editor in BOLD, and irrevocably designating the statement to be fact is clearly obsequious and a conflict of interest, although I am a student so this may be considered acceptable(?). Competing interests:   A sense of humour.
Surely you jest? 15 March 2003
david d derauf, Clinical Director Kokua Kalihi Valley, Honolulu, Hawaii 976817 Send response to journal: Re: Surely you jest?	Richard Smith's otherwise cogent article on "Competing Interests" seems to me seriously marred by his blanket statement: "There isnt anything wrong in having competing interests". First I thought, "Surely he means: 'There isn't anything <i>neccesarily</i> wrong in having competing interests'" but he then goes on to describe the apparent ubiquity of the the (bad) practice of doctors receiving gifts, lunches and travel as somehow proof that "there is nothing wrong" except if they are not declared. Can he really mean this? Surely the question of whether or not these practices are "wrong" is one that is subject to vigourous debate, much more cautious consideration, and a lot less selfish interest on the part of all of us. Competing interests:   None declared