Medical pharmaceutical and device manufacturers are essential in making products that benefit patients, and collaboration between health care providers and industry is necessary in the design, testing, and manufacture of these medical products. However, health care providers must recognize that their duties and the interests of industry may, at times, diverge. Relationships with industry, even seemingly minor ones, have the potential to shape the decisions made on behalf of patients. The marketing divisions of pharmaceutical and medical device firms view health care providers as a target of their efforts, and some of the interactions that occur between industry and health care providers have the potential to alter decision making in ways that may not necessarily benefit patients. Health care providers have an ethical duty to recognize situations and marketing strategies that are designed to influence their choice of diagnostic and therapeutic options for their patients. Health care providers should be aware of the techniques used to attempt to alter their behavior and guard against them.
The pediatric health care clinician’s primary responsibility is to seek the best interest of his or her patient.1,2 All other interests remain secondary. Professional duties include not only providing high-quality clinical care, but also educating health care professionals in training and advancing the knowledge base of pediatric practice through the conduct of scientifically and ethically sound research.
Health care clinician interactions with industry are often essential to the promotion of these primary professional duties. Research designed and funded by industry is essential to the development and improvement of diagnostic and therapeutic modalities critical to the delivery of quality health care to children. The development of pharmaceutical products and medical devices essential to the care of patients requires interaction with physician experts and investigators at almost every point in the development and research process. Continued progress in drug and device development requires the interaction of physicians and industry.
However, some clinician-industry interactions, even seemingly minor ones, may have the potential to undermine the health care clinician’s duty to seek the best interest of the patient.3–5 Both financial (honoraria, gifts, speakers’ fees, food, travel, lodging, and educational and research grants) and nonfinancial (deference, recognition, enhanced reputation, and publication opportunities) inducements have the potential to influence the decisions health care providers make on behalf of their patients.6,7 The primary challenge posed by interactions with industry is not one of health care providers who are corrupt, but of well-intentioned health care providers who are subtly and subconsciously influenced to make decisions that may not represent the best choice for their patients.8–10 Health care providers may fail to recognize their vulnerability to the methods used by industry to influence their behaviors and decisions.7
Health care providers must conduct their professional duties in a way that allows patients and the public to trust their actions and judgments. Health care providers must recognize that the interests of industry and the duties of the health care clinician may, at times, significantly diverge and that relationships with industry, even seemingly minor ones, have the potential to shape the decisions health care providers make on behalf of patients. Health care providers have an ethical duty to recognize the situations and marketing strategies that are designed to influence their selection of therapeutic options for their patients.
Commercial funding of continuing medical education (CME) has the potential to undermine the objectivity of the educational process and warrants careful scrutiny. Health care providers participating in industry-sponsored CME should recognize the marketing potential of these events.16,17
Health care providers should remain vigilant as they read journal articles and be aware that manuscripts with industry sponsors or authors with conflicts of interests may be subject to biased reporting of data.18
Disclosure of conflicts of interest in education and research is essential but not sufficient. Conflict of interest disclosures should be very clear and include precise descriptions of the industry relationship. Journal articles should include information about who funded a study, who planned and designed the study, who controls the data, who wrote the first draft, and whether final approval was required from an industry sponsor. Nonfinancial conflicts may warrant similar disclosure.
Individuals serving on expert review panels and consensus panels who play a role in crafting final recommendations and authors of review articles in peer-reviewed journals should ideally have no financial relationships with entities that have a stake in the recommendations regarding the topics under discussion. Health care providers should pay close attention to conflicts of interest among members of expert review panels and be aware that recommendations may have been influenced by those relationships.
Offers of ghost authorship should be refused, because the practice is dishonest, is unfair to those who refuse to serve as ghost authors, and are therefore disadvantaged because their promotion packages and reputations appear less robust than those who accept these unethical arrangements, and obscures important information about the paper, including whether industry instigated the study, controlled the data, performed the final data analysis, and had final control over the published draft.19
Douglas S. Diekema, MD, MPH, FAAP
Committee on Bioethics, 2018–2019
Robert Macauley, MD, FAAP, Chairperson
Ratna Basak, MD, FAAP
Gina Marie Geis, MD, FAAP
Naomi Tricot Laventhal, MD, FAAP
Douglas J. Opel, MD, MPH, FAAP
Mindy B. Statter, MD, FAAP
Mary Lynn Dell, MD, DMin; American Academy of Child and Adolescent Psychiatry
Douglas S. Diekema, MD, MPH, FAAP; American Board of Pediatrics
David Shalowitz, MD; American College of Obstetricians and Gynecologists
Nanette Elster, JD, MPH; Legal Consultant
Past Committee Members
William R. Sexson, MD, MAB, FAAP (2017)
Ginny Ryan, MD; American College of Obstetricians and Gynecologists (2017)
Alison Baker, MS
Florence Rivera, MPH
Dr Diekema reviewed the literature, drafted the initial manuscript, reviewed, and revised the manuscript, approves the final manuscript as submitted, and agrees to be accountable for all aspects of the work.
This document is copyrighted and is property of the American Academy of Pediatrics and its board of directors. All authors have filed conflict of interest statements with the American Academy of Pediatrics. Any conflicts have been resolved through a process approved by the board of directors. The American Academy of Pediatrics has neither solicited nor accepted any commercial involvement in the development of the content of this publication.
Policy statements from the American Academy of Pediatrics benefit from expertise and resources of liaisons and internal (AAP) and external reviewers. However, policy statements from the American Academy of Pediatrics may not reflect the views of the liaisons or the organizations or government agencies that they represent.
The guidance in this statement does not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.
All clinical reports from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.