Should we try to manage non-financial interests?
BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1240 (Published 12 April 2018) Cite this as: BMJ 2018;361:k1240
All rapid responses
Chatfield summarized the pro and con debate about non-financial conflict of interests (1): a) Wiersma and colleagues argued that we all have non-financial motives that must be managed; b) Rodwin disagreed, financial conflicts of interest are a practical legal tool and redefining them to include intellectual conflicts would reduce their usefulness.(2) This deserves comment, and experiences with financial conflicts provide a framework.
First, the debate must not be about concepts but about real life. Rodwin’s previous book about financial conflicts in medicine, although it was 392 pages, overlooked several key issues about conflicts of interest such as: lobbying, key opinion leaders, disease mongering.(3)
Second, considering “conflicts of interest are a practical legal tool”(2) is a misconception. This is the industry industry’s motto for allowing financial conflicts. Indeed, the Physician Payments Sunshine Act is not about allowing conflicts but a tool for avoiding relying on persons with conflicts. Disclosing conflicts is not dissolving them.(4) Moreover, the Act is too timid with several flaws and the bar should be raised.(4,5) How to overlook the serial scandals and concerns of lay people: A Google search with "integrity " "healthcare" “financial” hits 127 000 000 pages!
Considering that non-financial conflicts are not conflicts is a two decade set back: in 1999, Surgeon General Koop declared before Congress that latex gloves do not cause allergic reactions, and when it was made public he had received $650,000 for consulting work from a manufacturer of latex gloves, he stated: “It never occurred to me it could be a conflict of interest.” ( http://lowninstitute.org/news/the-conflict-denialists-strike-back/ )
Sadly, the worst could be the title of the debate:(2) believing conflicts could be “managed” seems naive pride. It is simpler and wiser to avoid conflicts, all, financial or non-financial.
Last, no need for debate: disclosing non-financial competing interests is Nature’s policy!(5) This concerns authors, reviewers and its staff.
1 Chatfield C. Public health or research—money matters. BMJ 2018;361:k1607
2 Wiersma M, Kerridge I, Lipworth W, , Rodwin R. Should we try to manage non-financial interests? BMJ 2018;361:k1240
3 Braillon A. Book review: Conflicts of interest and the future of medicine: The United States, France and Japan. J Pub Health Pol 2011;32:391–398
4 Braillon A, Bewley S. The Physician Payments Sunshine Act: a smokescreen if no action! Am J Obstet Gynecol2016;215:810-811.
5 Braillon A, Wilson M. The Sunshine Act: Moving Forward. Am J Med 2016;129:e201.
6 Nature. Nature journals tighten rules on non-financial conflicts. Nature 2018;554:6.
Competing interests: No competing interests
Whether or not to regulate conflict-of-interest (COI) of any type, financial or non-financial, is only part of the debate on this subject 1. Another concern is bringing COI to public attention so that its effects on outcomes can be constructively debated. We recently encountered this problem in an attempt to raise the issue of financial COI amongst a guideline development group (GDG).
In its March 19, 2018 issue the Medical Journal of Australia (MJA) published guidelines from the Royal Australian and New Zealand College of Psychiatrists for the long-term management of bipolar disorder 2. We were concerned that the composition of the GDG appeared to violate four of the recommendations from the Institute of Medicine in its 2011 report on the creation of guidelines 3. Specifically, the IOM recommended that members with conflicts of interest (COI) should not be a majority of the guideline development group (GDG), but seven out of the thirteen committee members declared financial links with pharmaceutical companies or other commercial interests. The IOM recommended that the chair not have COI. The first author, and presumably the committee chair, reported COI with nine pharmaceutical companies. The IOM recommended that the GDG should include a current or former patient, and a patient advocate or patient/consumer group representative, but none of the thirteen committee members fulfilled this criterion. Finally, the IOM recommended that the GDG should have methodological experts as members, but all of the committee members appear to have clinical rather than methodological expertise.
We sent a letter to the MJA outlining the points above. The response was that the journal was not the appropriate venue to present our criticisms of the composition of the GDG. When medical journals decline to allow a discussion of COI then regulating them is made that much more difficult.
References
1. Wiersma M, Kerridge I, Lipworth W, et al. Should we try to manage non-financial interests? BMJ 2018;361:k1240.
2. Malhi G, Outhred T, Morris G, et al. Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders: bipolar disorder summary. MJA 2018;208:219-25.
3. Institute of Medicine. Clinical practice guidelines we can trust. Washington, DC, 2011.
Competing interests: In 2015-2017 Joel Lexchin received payment from two non-profit organizations for being a consultant on a project looking at indication based prescribing and a second looking at which drugs should be distributed free of charge by general practitioners. In 2015 he received payment from a for-profit organization for being on a panel that discussed expanding drug insurance in Canada. He is on the Foundation Board of Health Action International. Barbara Mintzes was an expert witness on behalf of plaintiffs in a Canadian class action suit on cardiovascular risks of a testosterone gel.
Wiersma and colleagues argue convincingly that non-financial interests in medicine can and should be managed. Unfortunately, Rodwin’s intended contrary argument gets diverted by a useful but not wholly relevant legalistic description of interests (mainly pecuniary) that can properly constitute “conflicts of interest” (1).
The emphasis on financial conflicts in biomedical journals has important unintended consequences, including the fact that authors now increasingly describe their relationships with industry with euphemisms such as “unpaid consultant” or “non-financial support”. These often amount to faux disclosures, which are fundamentally misleading as they often signal, but do not explain, a variety of benefits derived from industry involvement (2).
So what disclosures should journals require from authors? I suggest the following hierarchy of reportable conflicts: 1) direct financial payments or interests, 2) indirect benefits with obvious financial value, such as meals, accommodation, travel, conference expenses, research funding, and 3) unpaid but financially relevant involvement, such as serving on a for-profit company’s advisory board.
Expanding the range and required detail of disclosures is hardly likely to solve the problem completely (3), but would provide readers with the means to fairly appraise potential sources of bias that might not be evident from an author’s discipline or previous publications. For some purposes, such as treatment guideline preparation, it may be necessary to eliminate rather than manage such conflicts (4).
1. Wiersma M, Kerridge I, Lipworth W, Rodwin M. Should we try to manage non-financial interests? BMJ 2018;361:k1240.
2. Menkes DB, Masters JD, Broring A, Blum A. What Does 'Unpaid Consultant' Signify? A Survey of Euphemistic Language in Conflict of Interest Declarations. J Gen Intern Med 2018;33:139-41.
3. Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012;307:669-70.
4. Menkes DB, Bijl D. Credibility and trust are required to judge the benefits and harms of medicines. BMJ 2017;358:j4204.
Competing interests: No competing interests
Most non-financial interests are not competing interests
The debate about whether or not to manage non-financial (competing) interests is timely and compelling because so much confusion is being created around the topic.1 We agree that competing interests other than financial can unduly influence professionals’ objectivity, as in the example provided by Miriam Wersma and colleagues.1 But the key question to be elucidated here is what is understood by non-financial conflicts of interest. Besides the legal arguments provided by Marc Rodwin,1 the new rules of Nature for non-financial conflicts give us a clue: “Non-financial competing interests can include a range of personal and/or professional relationships with organizations and individuals”.2 This statement implies that the competing (secondary) interest is that of a third party (outside interest), and that is the nub of the issue.
Then, it would be helpful to clarify what is not a non-financial competing interest. And this is highly important because many authors claim that conflicts of interest may be external (financial or non-financial) and internal (e.g. personal interest in reputation or career advancement),3 as Wiersma et al. do.1 However, internal interest, like personal beliefs or ambition, cannot create a conflict of interest. And this is so, not only because the direction of potential biases arising from internal interests is unpredictable and their magnitude and spread insignificant compared with those from outside—mainly financial—interest4—prompted by the sense of obligation and reciprocity to the third interested party—but also and most important because internal interests (identity, personal beliefs, education, profession, reputation, career advancement, and so on) are, by nature, generally aligned with the researchers’ primary interest. Put in simple words by Marion Nestle: “Hypothesis driven science depends on having a point of view, which is invariably informed by values and culture”.5 One thing is to have a political ideology or a particular religious belief and quite another is to be a member of a political party or an active member of a religious organization, like the Opus Dei, which requires from their members a kind of commitment that may be incompatible with research objectivity.
Setting clear boundaries for non-financial conflicts of interest will help to avoid situations that, in our view, push the limit to the absurd, such as considering a ‘strong’ point of view an intellectual conflict of interest6 or forcing authors to declare about their personal, religious or political beliefs, as it appears to be the case in the ICMJE Uniform Disclosure Form for Potential Conflicts of Interest (http://www.icmje.org/conflicts-of-interest/), a notion that goes against a fundamental right enshrined in all constitutions in democratic states of law.
References
1. Wiersma M, Kerridge I, Lipworth W, Rodwin M. Should we try to manage non-financial interests? BMJ 2018;361:k1240.
2. Nature journals tighten rules on non-financial conflicts. Nature 554, 6 (2018). doi: 10.1038/d41586-018-01420-8.
3. Stead, WW. The complex and multifaceted aspects of conflicts of interest. JAMA 317, 1765-1767 (2017). doi: 10.1001/jama.2017.3435.
4. Bero, L.A. & Grundy. Q. Why having a (nonfinancial) interest is not a conflict of interest. PLoS Biol. 14, e2001221 (2016). doi: 10.1371/journal.pbio.2001221.
5. Schwab T. Dietary disclosures: how important are non-financial interests? BMJ 2018;361:k1451.
6. Lenzer, J. When is a point of view a conflict of interest? BMJ 355, i6194 (2016). doi: 10.1136/bmj.i6194.
Competing interests: No competing interests