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Editorials |

Walking the Tightrope of Academia–Industry RelationshipsAcademia–Industry Relationships FREE

The Editors
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 14 July 2015.


Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.


Ann Intern Med. 2015;163(6):477-478. doi:10.7326/M15-1500
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The New England Journal of Medicine (NEJM) recently opened a debate about the management of physician–industry relationships when its editor in chief, Jeffrey Drazen, questioned whether the divide between academia and industry is in the public's best interest (1). In a series of commentaries, Lisa Rosenbaum, a NEJM national correspondent, questioned whether zealous policies that prohibit people with industry relationships from publishing journal articles really protect patients or merely cloak an anti-industry bias in false scientific virtue (24). Countering those views, authors of a feature essay in the British Medical Journal (BMJ) (all previously employed by NEJM) and BMJ editors condemned the suggestion that journals reconsider policies that preclude researchers with industry relationships from writing articles (56). As editors ourselves, we walk this tightrope daily and want to share how we judge and balance these issues.

Some journals have blanket prohibitions against consideration of specific types of papers written by individuals with industry relationships. For example, BMJ implemented a policy in 2014 that prohibits such authors from publishing "educational articles" (5). Between 1990 and 2002, NEJM precluded anyone who had a financial relationship with industry from writing an editorial (6). Annals of Internal Medicine does not now nor has it ever had a black-and-white policy banning certain types of authors from publishing articles in the journal. The absence of such a policy does not mean, however, that we ignore these relationships or fail to recognize their potential to introduce bias. As Frank Davidoff, Annals editor from 1995 to 2001, wrote in 1997, we know that industry relationships can be an important source of bias (7). Thus, the potential for financial conflict does contribute to the decision not to publish an article. Consequently, the pages of Annals are not teeming with editorials and review articles written by people with a financial stake in their subject.

Why don't we have blanket proclamations about potential conflicts and authorship? Because we simply believe it is impossible to create strict rules about something that is always a judgment call. We agree with Drs. Drazen and Rosenbaum that the mere presence of a relationship with industry does not necessarily mean that an individual is incapable of writing a responsible piece of work that readers will find useful. Conversely, the absence of such relationships does not ensure that the work is balanced, responsible, and educational. Thus, we make decisions on a case-by-case basis.

An ironclad rule applied only to relationships with the pharmaceutical industry is prejudicial reductionism: It naively oversimplifies and promulgates a false sense of security and purity. Everyone—academics, chief executive officers and employees of pharmaceutical companies, clinicians, editors, patients, and government-funded researchers—have biases that shape their perspectives and how they might write or interpret. Responsible discourse in medical science requires that we think critically about all that we read, not just about material written by persons tied to one industry or another.

Annals requires that all authors complete the International Committee of Journal Editors uniform disclosure form, which asks them to disclose relationships that present potential conflicts of interest (8). When making editorial decisions, we consider those relationships. When we think conflicts are present, we make judgments about how they might affect both the possibility of bias and the credibility of the published paper. If we publish such a paper, it is because we believe it contains enough information for our readers to make their own judgments, in part because each article is accompanied by links to the actual disclosure forms that each author completed. If readers think that author relationships undermine the article's credibility, they can skip the article altogether, take its conclusions with a grain of salt, post their concerns as a comment, or combine these options.

We prefer writers without industry relationships for editorials and commentaries, except in specific cases when obtaining an industry perspective is specifically our intent (9). At the other extreme, we never decline to publish a research article simply because an author has industry ties. We avoid narrative reviews that are written solely by authors with industry ties because such reviews provide little information about how the authors searched for, selected, evaluated, and summarized the evidence, which makes it difficult to judge whether the review provides a balanced view of available evidence. High-quality systematic reviews with detailed methods and transparent reporting written by authors with industry ties are never automatically excluded from consideration.

It is common for physicians to work with industry and, although Steinbrook and colleagues imply that the collaboration might not require financial exchange (5), it seems naive to think that academics could (or should) spend time doing work that is not compensated in some manner—either directly to them or indirectly to their institutions. We also think that it is unrealistic to create a sharp divide between evidence generation and its appraisal, as the BMJ editors recommend (5). Good science is iterative, with a constant back and forth between data collection and interpretation.

The elephant in the room that is not addressed in any of the recent commentaries is that BMJ and NEJM, like Annals and all of our parent organizations, sell advertisements and reprints to industry and engage with it in other ways. These activities are very different from the creation of journal content, but if industry can't be trusted, why engage it in any manner? We sell ads because doing so allows us to provide our readers with better services at lower cost.

We all benefit from health care interventions that would not exist without industry and its collaborators. Rather than treat them as pariahs, we should be grateful to the academics and patients who work with industry to develop and continuously improve these products. Even a "zero tolerance" policy would not guarantee objectivity. With the right checks and balances, we believe that it is possible for us to allow our readers to benefit from the insights that come from some industry relationships. Journals must set guidelines about the disclosure of conflicts and use these disclosures to make responsible editorial decisions. But each and every decision is a delicate balance that weighs expertise against potential conflicts.

References

Drazen JM. Revisiting the commercial-academic interface [Editorial]. N Engl J Med. 2015; 372:1853-4.
PubMed
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Rosenbaum L. Conflicts of interest: part 1: Reconnecting the dots—reinterpreting industry-physician relations. N Engl J Med. 2015; 372:1860-4.
PubMed
CrossRef
 
Rosenbaum L. Understanding bias—the case for careful study. N Engl J Med. 2015; 372:1959-63.
PubMed
CrossRef
 
Rosenbaum L. Beyond moral outrage—weighing the trade-offs of COI regulation. N Engl J Med. 2015; 372:2064-8.
PubMed
CrossRef
 
Steinbrook R, Kassirer JP, Angell M. Justifying conflicts of interest in medical journals: a very bad idea. BMJ. 2015; 350:h2942.
PubMed
CrossRef
 
Loder E, Brizzell C, Godlee F. Revisiting the commercial-academic interface in medical journals [Editorial]. BMJ. 2015; 350:h2957.
PubMed
CrossRef
 
Davidoff F. Where's the bias? [Editorial]. Ann Intern Med. 1997; 126:986-8.
PubMed
CrossRef
 
Drazen JM, deLeeuw PW, Laine C, Mulrow CD, DeAngelis CD, Frizelle FA, et al. Toward more uniform conflict disclosures: the updated ICMJE conflict of interest reporting form [Editorial]. Ann Intern Med. 2010; 153:268-9.
CrossRef
 
Kuntz RE. The changing structure of industry-sponsored clinical research: pioneering data sharing and transparency [Editorial]. Ann Intern Med. 2013; 158:914-5.
CrossRef
 

Figures

Tables

References

Drazen JM. Revisiting the commercial-academic interface [Editorial]. N Engl J Med. 2015; 372:1853-4.
PubMed
CrossRef
 
Rosenbaum L. Conflicts of interest: part 1: Reconnecting the dots—reinterpreting industry-physician relations. N Engl J Med. 2015; 372:1860-4.
PubMed
CrossRef
 
Rosenbaum L. Understanding bias—the case for careful study. N Engl J Med. 2015; 372:1959-63.
PubMed
CrossRef
 
Rosenbaum L. Beyond moral outrage—weighing the trade-offs of COI regulation. N Engl J Med. 2015; 372:2064-8.
PubMed
CrossRef
 
Steinbrook R, Kassirer JP, Angell M. Justifying conflicts of interest in medical journals: a very bad idea. BMJ. 2015; 350:h2942.
PubMed
CrossRef
 
Loder E, Brizzell C, Godlee F. Revisiting the commercial-academic interface in medical journals [Editorial]. BMJ. 2015; 350:h2957.
PubMed
CrossRef
 
Davidoff F. Where's the bias? [Editorial]. Ann Intern Med. 1997; 126:986-8.
PubMed
CrossRef
 
Drazen JM, deLeeuw PW, Laine C, Mulrow CD, DeAngelis CD, Frizelle FA, et al. Toward more uniform conflict disclosures: the updated ICMJE conflict of interest reporting form [Editorial]. Ann Intern Med. 2010; 153:268-9.
CrossRef
 
Kuntz RE. The changing structure of industry-sponsored clinical research: pioneering data sharing and transparency [Editorial]. Ann Intern Med. 2013; 158:914-5.
CrossRef
 

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

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Academia–Industry Relationships: how long a spoon to sup with the devil?
Posted on October 14, 2015
Alain Braillon (a), David B Menkes (b), Philippe Nicot (c), Susan Bewley (d)
a Senior Consultant, University Hospital, Amiens. France. b Associate Professor of Psychiatry, University of Auckland, Hamilton. New Zealand. c General practice in private office, 75 Avenue Léon
Conflict of Interest: AB and DBM are members of Healthy Skepticism, a non-profit organisation aiming to improve health by reducing harm from misleading health information (www.healthyskepticism.org/). AB and SB are members of HealthWatch-UK, a charity (#1003392) promoting evidence-based science and integrity in healthcare since 1991 (www.healthwatch-uk.org/).
The Annals editors’ argument (1) that physician–industry relationships can be managed by relying on authors’ conflict of interest disclosures is inadequate, in part because they fail to acknowledge the many distorted claims arising from clinical trials and driven by career advancement or commercial interests.(2) Moreover, the editors might have answered their own question “if industry can't be trusted, why engage it in any manner?” if they had taken into account the staggering criminal record of the industry as a whole.(3)
The fundamental tension between altruism and self-interest remains. There is, as yet, no reliable database for investigating conflict of interest. The US has made a step forward with the Sunshine Act but important exclusions from its scope are numerous. Small payments (e.g. for pizza) miss the larger problems.(4)
The shabby story of Study 329 illuminates the solution. Le Noury et al re-analysed the primary data (5) and produced results contrasting sharply with Keller et al's original claim that "paroxetine is generally well tolerated and effective for major depression in adolescents."(6) Seven years ago, major concerns were raised about Study 329’s ethics and validity.(7) In 2011, the Dean of Brown University’s Medical School, responding to a letter suggesting that the flawed and misleading study be retracted, wrote that the University took such matters “seriously” with a “confidential” internal investigation. Four more years of silence and inaction followed.(www.healthyskepticism.org/global/soapbox/entry/to_brown, braillon.net/alain/media/fus.pdf) Similarly, the journal that published Keller’s paper has failed to provide a rationale for refusing retraction.(8)
GlaxoSmithKline, Brown University, the American Academy of Child and Adolescent Psychiatry and its journal must each investigate its role in the Study 329 travesty, share responsibility to redress the damage caused, and take public steps to ensure there is no recurrence.
It is clear that there is no spoon long enough to edulcorate industry control of clinical research. The solution is simple: access to primary data after genuine publication. In the field of medical discovery, claims of enduring property rights regarding patient data are unethical and unacceptable.

1 The Editors. Walking the tightrope of Academia–Industry relationships. Ann Intern Med 2015;163:477-478.
2 Sox HC, Rennie D. Research misconduct, retraction, and cleansing the medical literature: lessons from the Poehlman case. Ann Intern Med 2006;144:609-13.
3 Braillon A. Drug industry is now biggest defrauder of US government. BMJ 2012 10;344:d8219.
4 Morain SR, Flexner C, Kass NE, Sugarman J. Forecast for the Physician Payment Sunshine Act: partly to mostly cloudy? Ann Intern Med 2014;161:915-6.
5 Le Noury J, Nardo JM, Healy D et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320.
6 Keller MB, Ryan ND, Strober M, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 2001;40:762-72.
7 Jureidini J, McHenry L, Mansfield P. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Saf Med 2008;20:73-81.
8 Doshi P. No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility. BMJ 2015;351:h4629.

Comment
Posted on March 18, 2016
Benjamin Moncada, MD
Universidad Autonoma, Mexico
Conflict of Interest: None Declared
Regarding the paper: “Walking the tightrope of academia-Industry relationships” (AIR) ( 1) it touch a point challenging the dogma of precluding publications from an author that may have ties with the Industry and I think that the considerations made in that paper are very proper
In that sense I would like to comment a point that to the best of my knowledge it has not been attended before, that is The disclosure of information about relationship between the Editor of a journal and the industry, that I think it should be implemented as a routine piece of information the same way nowadays is the case for the authors. Going beyond, the same proposal should be exerted for the people selected as reviewers of the material in consideration for publication. This disclosure would be enforced only for paper that in some way have to do with the Industry.
I wander whether the editors of major medical journal (yours, NEJM BMJ international committee of medical journals editors (ICMJE), etc) have periodic reunions to treat issues of your work because if that were the case it could be an appropriate forum to treat the aforementioned proposal.
About 15 years ago We sent for publication to a prestigious journal in our country a paper titled “The medical student and the pharmaceutical industry” and it was rapidly rejected in less time than average for that particular journal. Neither letters from the reviewers giving explanation for the rejection were sent, which is a common practice in this matter. I realize that the rejection could be correct but suspicious can arouse about whether the relationship that the Editor may have with the industry (and apparently he did) had to do with the rejection.
1.-Ann of intern med.2015;163:477-478. Doi:10.7326/M15-1500
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