Key opinion leaders - a critical perspective.

Enormous progress has been made in the field of rheumatology in the past several decades, historically led by publicly funded academic innovators but in more recent times with much greater involvement of the pharmaceutical industry. This shift in resources has created a complex new model for reinvestment in the medical community in which the vast majority of private funds are redirected towards influencing the prescription behaviour of practitioners through 'key opinion leaders', with the main purpose of enhancing and perpetuating profit rather than innovation and critical thinking, and often at the expense of partnerships with scientists (that is, basic and translational researchers) and academic collaborations. This new episteme brings multiple opportunities to rethink approaches to sustaining long-term critical research in the field, ultimately maximizing the return on investment: scientific knowledge for the benefit of patients and society. Central to such strategies should be the rebalancing of academia-industry partnerships towards academic research and the involvement of 'innovation and knowledge leaders', rather than mostly key opinion leaders.

Gender inequality in leadership and academic rank in academic reproductive endocrinology programs.

PURPOSE: To identify gender differences in leadership and academic rank within academic reproductive endocrinology (REI) programs with fellowships in the USA. METHODS: Official institutional websites of the 2017-2018 American Board of Obstetrics and Gynecology (ABOG)-accredited reproductive endocrinology fellowship programs were reviewed, and gender representation at each leadership position and academic rank (Division and Fellowship Director and Full, Associate, and Assistant Professor) was recorded. Univariate comparisons were performed using Chi-square tests, with significance at p < 0.05. RESULTS: Among 49 ABOG-accredited reproductive endocrinology programs, 263 faculty were identified, 129 (49.0%) male and 134 (51.0%) female. Division directors were 69.3% male and 30.7% female (p = 0.006). Similarly, fellowship directors were 65.3% male and 34.6% female (p = 0.03). Full professors (n = 101) were more frequently male (70.3% vs. 29.7%, p < 0.001). There was no difference in gender among associate professors (n = 60, 51.7% male vs. 48.3% female, p = 0.79), while significantly more assistant professors were female than male (n = 102, 73.6% vs. 26.4%, p < 0.001). CONCLUSION: While a majority of residents in obstetrics and gynecology and half of reproductive endocrinology academic faculty are female, women are still underrepresented among leadership positions and full professors in academic reproductive endocrinology programs with fellowship programs.

[Nutricia Code: nutrition and conflict of interest in academia]. / Código Nutricia: nutrición y conflicto de interés en la academia.

To combat malnutrition in all its forms, actions must be integrated from society as a whole. The main interest of the actors involved in these actions should be health. However, there are actors with conflict of interest that interfere in the design, planning, implementation and monitoring of public health nutrition policies. In order to mitigate the adverse effect that result from these conflicts, from evidence generation to the design and implementation of policies, this Code is proposed. It invites the nutrition and health community to adopt it, promote it and subscribe it, and to favor the advancement of actions and policies without industry interference to address the problem of malnutrition.

Para combatir la mala nutrición en todas sus formas es necesario integrar acciones desde la sociedad en su conjunto. El interés superior de los actores involucrados en generar estas acciones debe ser la salud. No obstante, existen actores con conflictos de interés que interfieren en el diseño, planeación, implementación y monitoreo de las políticas derivadas de dichas acciones. A fin de mitigar el efecto adverso que generan estos conflictos desde la etapa de generación de evidencia hasta el diseño e implementación de las políticas, se propone este código. Se invita a la comunidad de nutrición y salud a adoptarlo, promoverlo y sumarse al mismo, para favorecer el avance de las acciones y políticas necesarias sin interferencia de la industria y resolver el problema de la mala nutrición.

Código Nutricia: nutrición y conflicto de interés en la academia / Nutricia Code: nutrition and conflict of interest in academia

Resumen: Para combatir la mala nutrición en todas sus formas es necesario integrar acciones desde la sociedad en su conjunto. El interés superior de los actores involucrados en generar estas acciones debe ser la salud. No obstante, existen actores con conflictos de interés que interfieren en el diseño, planeación, implementación y monitoreo de las políticas derivadas de dichas acciones. A fin de mitigar el efecto adverso que generan estos conflictos desde la etapa de generación de evidencia hasta el diseño e implementación de las políticas, se propone este código. Se invita a la comunidad de nutrición y salud a adoptarlo, promoverlo y sumarse al mismo, para favorecer el avance de las acciones y políticas necesarias sin interferencia de la industria y resolver el problema de la mala nutrición.

Abstract: To combat malnutrition in all its forms, actions must be integrated from society as a whole. The main interest of the actors involved in these actions should be health. However, there are actors with conflict of interest that interfere in the design, planning, implementation and monitoring of public health nutrition policies. In order to mitigate the adverse effect that result from these conflicts, from evidence generation to the design and implementation of policies, this Code is proposed. It invites the nutrition and health community to adopt it, promote it and subscribe it, and to favor the advancement of actions and policies without industry interference to address the problem of malnutrition.

Pushing partnerships: corporate influence on research and policy via the International Life Sciences Institute.

OBJECTIVE: There are concerns that some non-profit organisations, financed by the food industry, promote industry positions in research and policy materials. Using Freedom of Information (FOI) requests, we test the proposition that the International Life Sciences Institute (ILSI), one prominent non-for profit in international health and nutrition research, promotes industry positions. DESIGN: U.S. Right to Know filed five FOI from 2015 to 2018 covering communications with researchers at four US institutions: Texas A&M, University of Illinois, University of Colorado and North Carolina State University. It received 15 078 pages, which were uploaded to the University of California San Francisco's Industry Documents Library. We searched the Library exploring it thematically for instances of: (1) funding research activity that supports industry interests; (2) publishing and promoting industry-sponsored positions or literature; (3) disseminating favourable material to decision makers and the public and (4) suppressing views that do not support industry. RESULTS: Available emails confirmed that ILSI's funding by corporate entities leads to industry influence over some of ILSI activities. Emails reveal a pattern of activity in which ILSI sought to exploit the credibility of scientists and academics to bolster industry positions and promote industry-devised content in its meetings, journal and other activities. ILSI also actively seeks to marginalise unfavourable positions. CONCLUSIONS: We conclude that undue influence of industry through third-party entities like ILSI requires enhanced management of conflicts of interest by researchers. We call for ILSI to be recognised as a private sector entity rather than an independent scientific non-profit, to allow for more appropriate appraisal of its outputs and those it funds.

Direct-to-Consumer Advertising for Cancer Centers and Institutes: Ethical Dilemmas and Practical Implications.

In the United States, many cancer centers advertise their clinical services directly to the public. Although there are potential public benefits from such advertising, including increased patient awareness of treatment options and improved access to care and clinical trials, there is also potential for harm through misinformation, provision of false hope, inappropriate use of health care resources, and disruption in doctor-patient relationships. Although patient education through advertising is appropriate, misleading patients in the name of gaining market share, boosting profits, or even boosting trial accrual is not. It is critical that rigorous ethical guidelines are adopted and that oversight is introduced to ensure that cancer center marketing supports good patient care and public health interests. Patients with cancer have been identified as an especially vulnerable population because of fears and anxiety related to their diagnosis and the very real need to identify optimal sources of care. Cancer organizations have a fiduciary duty and a moral and legal obligation to provide truthful information to avoid deceptive, inaccurate claims associated with treatment success. In this article, actionable recommendations are provided for both the oncologist and the cancer center's marketing team to promote ethical marketing of services to patients with cancer. This tailored guidance for the oncology community includes explicit communication on (1) ensuring fair and balanced promotion of cancer services, (2) avoiding exaggeration of claims in the context of reputational marketing, (3) providing data and statistics to support direct and implied assertions of treatment success, and (4) defining eligible patient groups in the context of marketing for research. These recommendations for cancer centers are designed to promote ethical quality marketing information to patients with cancer.

The New 2019 Institutional Review Board Common Rule Update: Implications for Plastic Surgery Research.

Clinical research remains at the forefront of academic practice and evidence-based medicine. Unfortunately, history has shown that human subjects are vulnerable to experimentation without regard for their own dignity and informed decision-making. Subsequently, it is vital for research institutes to uphold safeguards and ethical conscientiousness toward human subjects. The establishment of federal regulations and the development of institutional review boards have set guidance on these processes. On January 21, 2019, final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") went into effect. The purpose of this article is to review changes to the Common Rule and discuss their impact on plastic surgery research.

[Are studies of claims databases reproducible? The hypothesis of an instituted ethical misconduct in public health]. / Les études portant sur les bases de données médico-administratives sont-elles reproductibles ? - L'hypothèse d'une inconduite éthique en santé publique.

Methodological reproducibility refers to the ability to reproduce exactly the same results by reproducing the same study protocol on the same data. The aim of this study was to assess the methodological reproducibility of studies published in the Revue d'Epidémiologie et de Santé Publique between 2008 and 2017 and using data from the national health data system. Our results suggest that only 49% of the studies could be replicated without the help of the authors. The results may reveal a lack of concern about the purpose of public health research. It is difficult to attribute responsibility for this default of reproducibility solely to researchers, so we hypothesize an instituted ethical misconduct.

TITLE: Les études portant sur les bases de données médico-administratives sont-elles reproductibles ? - L'hypothèse d'une inconduite éthique en santé publique. ABSTRACT: La reproductibilité méthodologique fait référence à la capacité à obtenir exactement les mêmes résultats, en reproduisant le même protocole d'étude sur les mêmes données. Nous avons voulu évaluer la reproductibilité méthodologique des études publiées entre 2008 et 2017 dans la Revue d'épidémiologie et de santé publique, qui font appel à des données issues du système national des données de santé. Nos résultats suggèrent que seules 49 % des études portant sur ce système national pourraient être reproduites sans le recours aux auteurs initiaux. L'absence de partage systématique des programmes peut révéler un manque de préoccupation quant à la finalité de la recherche en santé publique. Il est difficile d'attribuer la responsabilité de ce manque de reproductibilité aux seuls chercheurs, et nous faisons donc l'hypothèse d'une inconduite éthique instituée.

LeRoy Walters's Legacy of Bioethics in Genetics and Biotechnology Policy.

LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades.