Ethical Challenges in Regulatory Medicine: A Christian’s Perspective from the Regulatory Trenches
James Rusthoven, MD, PhD, Medical Officer and Evaluator, Biologics and Genetic Therapies Directorate, Health Canada
The Reformational worldview has been developed out of concern for obedience to the teachings of the Christian Scriptures and for the anormative influence of reductionism on understanding the created order. Understood through this worldview, the created order is expressed subjectively and objectively through at least 15 irreducible aspects (also called functions or ways-of-being). Living and non-living individuals and things as well as relationships between individuals can be envisioned in their fullest expression through these functions.
This worldview can be helpful in understanding various academic and practice-based disciplines. Medicine, for example, can be understood through such functions but one particular function guides the normative expression of other functions and as such distinguishes medicine from businesses, schools, governments, and other societal structures and their relationships. For medicine, this guiding or qualifying function is the ethical function, expressed through the relationships of medicine as the ethic of care. In medical practice, the core relationship involves caregivers and those in need of medical care. Such relationships are founded on bilateral trust. That is, once a care plan and expectations are mutually agreed upon, the person in need trusts the caregiver to exercise an expertise that can provide helpful advice and care while the caregiver trusts that person to communicate the ill effects of treatment while clearly identifying any benefits of recommended treatment.
In regulatory medicine, regulators are commissioned to protect the public by reviewing submitted studies of new interventions and judging whether or not such interventions are both effective and safe enough to be prescribed for patients in specific health states. The relationships in regulatory medicine include regulators and sponsors of new drugs (nearly always pharmaceutical companies), regulators and drug prescribers (usually physicians), and regulators representing different regulatory jurisdictions. In two of these relationships, the qualifying function for both parties is the ethic of care toward improving patient medical needs. By contrast, the relationship between regulators and sponsors is usually founded on conflicting qualifying functions. That is, while regulators identify therapies that improve the health of patients with medical illnesses, pharmaceutical companies are motivated by the economic qualifying function toward the goal of increased profits for shareholders. This economic qualifying function is expressed in various ways in regulatory medicine, from conducting cheaper and less rigorous clinical trials that may improve speed to market to omitting control groups that reduce the confidence in clinical trial results. This conflict of qualifying functions has ethical implications.
This presentation will touch on ethical conflicts that require multilevel vigilance by reviewers. Some conflicts involve unethical behaviour while others involve differences in standards of acceptable efficacy and safety with ethical overtones. The ethical challenges of Christians in this field include improving vigilance to identify unethical behaviour, teaching such vigilance to colleagues, developing and supporting acceptable standards of clinical trial design and criteria for meaningful efficacy, and wisely balancing efficacy against risk in making final regulatory decisions.
This worldview can be helpful in understanding various academic and practice-based disciplines. Medicine, for example, can be understood through such functions but one particular function guides the normative expression of other functions and as such distinguishes medicine from businesses, schools, governments, and other societal structures and their relationships. For medicine, this guiding or qualifying function is the ethical function, expressed through the relationships of medicine as the ethic of care. In medical practice, the core relationship involves caregivers and those in need of medical care. Such relationships are founded on bilateral trust. That is, once a care plan and expectations are mutually agreed upon, the person in need trusts the caregiver to exercise an expertise that can provide helpful advice and care while the caregiver trusts that person to communicate the ill effects of treatment while clearly identifying any benefits of recommended treatment.
In regulatory medicine, regulators are commissioned to protect the public by reviewing submitted studies of new interventions and judging whether or not such interventions are both effective and safe enough to be prescribed for patients in specific health states. The relationships in regulatory medicine include regulators and sponsors of new drugs (nearly always pharmaceutical companies), regulators and drug prescribers (usually physicians), and regulators representing different regulatory jurisdictions. In two of these relationships, the qualifying function for both parties is the ethic of care toward improving patient medical needs. By contrast, the relationship between regulators and sponsors is usually founded on conflicting qualifying functions. That is, while regulators identify therapies that improve the health of patients with medical illnesses, pharmaceutical companies are motivated by the economic qualifying function toward the goal of increased profits for shareholders. This economic qualifying function is expressed in various ways in regulatory medicine, from conducting cheaper and less rigorous clinical trials that may improve speed to market to omitting control groups that reduce the confidence in clinical trial results. This conflict of qualifying functions has ethical implications.
This presentation will touch on ethical conflicts that require multilevel vigilance by reviewers. Some conflicts involve unethical behaviour while others involve differences in standards of acceptable efficacy and safety with ethical overtones. The ethical challenges of Christians in this field include improving vigilance to identify unethical behaviour, teaching such vigilance to colleagues, developing and supporting acceptable standards of clinical trial design and criteria for meaningful efficacy, and wisely balancing efficacy against risk in making final regulatory decisions.