MSLs are the stewards of medical and scientific information; we develop and maintain peer-level relationships with HCPs and researchers. These relationships, grounded in trust, respect, and integrity, allow MSLs to have thoughtful discussions. These scientific exchanges ought to be truthful, not misleading, and unbiased facilitating in peer relationship development with clinicians and researchers.
Recent events such as the opioid epidemic further disparage the industry as a whole, necessitating extra care in how we navigate ethical relationships. In addition, the COVID 19 pandemic also underscores disparities in the healthcare system and misuse or precious, life-saving resources. These and other examples illustrate the need for clear policies, documentation of MSL communications, and ethical awareness; all of which are essential to managing KOL relationships. The purpose of this article is to start a dialogue on ethics in Medical Affairs, increase our communal awareness, and be able to hit the “pause” button for thoughtful discernment.
- Why is fostering ethical interactions important in the MSL profession?
The regulatory landscape and scrutiny underscore the importance of understanding the MSL role in the context of regulatory mandates and the need for routine compliance updates and training. In addition, well-drafted SOPs, thorough documentation of communication, and experience (i.e. best practice sharing) are critical for Medical Affairs professionals to be successful. However, compliance training is often seen as a prescriptive activity – telling you what you cannot do and how to stay out of trouble.
Understanding the context and principles behind medical ethics can be freeing. For example, scenario-based training on ethical interactions and common compliance scenarios is vital to encourage open dialogue within MSL teams and their organizational leadership. In addition, building a habit of looking through a medical ethics lens, along with SOPs and experience, is essential for navigating the issues Medical Affairs professionals deal with. In this article, we will highlight the four Medical Ethics principles and seven NIH guiding principles for clinical research.
- What are the four principles of Medical Ethics?
Medical Ethics rests on four central pillars: autonomy, beneficence, non-maleficence, and justice. An MSL who is knowledgeable about these principles, compared to someone who lacks this substantive knowledge, is better equipped to ask questions, apply good judgment based on knowledge and expertise, and recognize how and when to escalate a situation. We briefly describe these four pillars below.
- Autonomy: in a clinical trial setting, the study subject has the autonomy of thought, intention, and action when making decisions regarding healthcare procedures. Decisions need to be made free of coercion or coaxing.
- Beneficence: the intent of doing good for the patient i.e. being patient-centric. MSLs play a crucial role in being a fair and balanced conduit of information for the physicians.
- Non-maleficence: simply put, do no harm.
- Justice: ensure that the burdens and benefits of a new experimental treatment must be distributed equally among all groups in society. Encourage fair distribution of scarce resources, competing needs, rights, and obligations – inclusion of minority groups with proper informed consent.
It is inevitable that the principles will conflict in certain cases (i.e. respect for autonomy will lead to one action and non-maleficence will lead to the opposite). Ethicists work on how to balance principles when they may compete against each other. Thankfully, in Medical Affairs we do not have to debate the details of the principles, however, a broad understanding of the principles and working with our Compliance colleagues will help navigate difficult situations. A useful resource to keep handy is the 2018 Global MSL Activity Guidelines which have been reviewed by PhRMA and other regulatory entities to crystalize key concepts related to the MSL role and functions (Hyder et al, 2018, MSLSociety).
- What are the seven guiding principles for clinical trials from the NIH?
In addition, the National Institute of Health (NIH) has published their 7 guiding principles: social and clinical value, scientific validity, fair subject selection, favorable risk-benefit rationale, independent review, informed consent, respect for potential and enrolled subjects. While the seven principles are the NIH’s north star for clinical research, unsurprisingly, there is significant overlap between these 7 principles and the 4 basic principles of medical ethics.
- Importance of experience and building good habits
80% of New Year’s resolutions fail. Every year we set these lofty goals for ourselves and we wonder why they didn’t work out. In his best-selling book, Atomic Habits, the author James Clear writes, “What you repeatedly do (i.e. what you spend time thinking about and doing each day) ultimately forms the person you are, the things you believe, and the personality that you portray.”
In addition to healthcare ethics, it is also crucial to call attention to the importance of learning from peers and building good habits. New MSLs learn from their senior MSLs and managers. By shadowing and observing tenured colleagues, and asking questions, new MSLs make informed choices about their careers. Simultaneously, habits mold our attitudes, dispositions, and character traits. James Clear writes, “Habits are the compound interest of self-improvement. The same way that money multiplies through compound interest, the effects of your habits multiply as you repeat them.” As MSLs, we can make an intentional effort to maintain trustworthiness, veracity, compassion, and integrity, one customer at a time.
In conclusion, this article is an introduction to healthcare ethics – it would be impossible to cover the minutia of the principles. The purpose of this article is to find like-minded individuals and encourage a principles-based approach to compliance, learn from each other’s experiences, and building good habits in our interactions.
Bander Center Consulting Group: https://www.slu.edu/medicine/bander-center/index.php
Belmont Report: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
Common Rule: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
Declaration of Helsinki: https://www.who.int/bulletin/archives/79(4)373.pdf
Nuremberg Code: https://www.nejm.org/doi/full/10.1056/NEJM199711133372006
Veracity in Medicine: https://www.thelancet.com/pdfs/journals/lancet/PIIS0140673603149914.pdf
Guidelines for MSL Activities, 2018, MSL Society: https://www.themsls.org/msl-guidelines/
Disclaimer: The opinions expressed in this presentation are solely those of the author and not necessarily those of Genentech/Roche . Genentech/Roche do not guarantee the accuracy or reliability of the information provided herein.
Cherie Hyder, PharmD
Cherie Hyder is Senior Director, US Head of Medical Affairs, with more than 15 years of MSL experience in the field. She has been involved in research for more than 30 years, starting as a bench researcher in Genetics. She completed a Bachelor of Science degree in Molecular Biology and Chemistry at Iowa State University where she led Genetics research projects for over 5 years. Her education continued at the University of Missouri where she received a Doctor of Pharmacy degree with the intention to devote her career fully to clinical research. She has multiple adjunct faculty appointments and enjoys teaching opportunities. She worked for the FDA for 5 years, focusing on the review of the safety and effectiveness of novel medications.
Her experience in regulatory compliance brought her to Eli Lilly as a Regulatory Scientist and led her to attend law school; she has a business development and in-licensing background as well as experience balancing portfolios for major PhRMA companies; she has been employed by Eli Lilly, Pfizer, Novartis, Regeneron, Solvay, and Avanir in Regulatory and Medical roles supporting new product development. In August 2016, she joined Alimera Sciences, leading the US MSL team, building compliant internal processes, and developing a Medical Affairs infrastructure.
Mitch D’Rozario, Ph.D.
Mitch is a Malignant Hematology MSL at Genentech/Roche. In his MSL career spanning hematology and ophthalmology, Mitch has supported ocular surgical devices, microdosing implants, biologics, antibody-drug conjugates, oral inhibitors, and bispecific antibodies from Phase I-IV. Mitch enjoys advocating for customers and patients, collaborating with internal colleagues, and building strategic tools to make informed business decisions and deliver urgent medical solutions. Mitch earned his Ph.D. from Drexel University and trained as a postdoc at Washington University School of Medicine. In a pre-COVID world, Mitch can be seen keeping pace with his two boys, Francis (2.5 years) and Miles (1 year). In a post-COVID world, he has been busy being a Montessori dad, learning how to bake, and going to OrangeTheory (while maintaining a safe distance) to burn off the said baked goods.
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