Patient Autonomy versus Physician Paternalism Paul A Sobotka

Patient Autonomy versus Physician Paternalism Paul A. Sobotka, MD Competing ethical standards in regulatory and reimbursement

Conflict of Interest Rox Medical, Inc. Cibiem, Inc Rainbow Medical, Inc. Abbott Ventures Boston Scientific, Inc. Ablative Solutions, Inc. Chief Science Officer Chief Medical Officer Consultant

Hypothesis • Medical ethic has embraced patient autonomy whereas regulatory and reimbursement bias remains firmly enamored with medical paternalism

Autonomy • The personal rule of the self that is free from controlling interferences by others – Autonomous individuals act intentionally, with understanding and without controlling influences • Physicians have the obligation to create the conditions necessary for autonomous choice in others – Individuals come to doctors for guidance in making choices – Physicians educate patients to understand the situation adequately to make informed choice – Explicitly enjoins providers from making decisions for the patient

Beneficence • An action done for the benefit of others • Physicians are expected to refrain from causing harm, but they also have an obligation to help their patients – Ideal Beneficence • Extreme acts of generosity or attempts to benefit others – Obligatory beneficence • Prevent and remove harm

When Autonomy conflicts with Beneficence • Example: a patient who is considering bypass surgery for CAD and continues to smoke cigarettes – As long as the patient meets the criteria for making an autonomous choice (the patient understands the decision and is not basing the decision on delusional ideas) the physician is obligated to respect the patient’s decisions • a patient-centered medical ethics – emphasizes autonomy rights over professional obligations of beneficence when they conflict • Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Third ed. New York: Oxford University Press; 1989

Medical Paternalism • A philosophy that certain health decisions are best left in the hands of those providing health care • Conflict between beneficence and autonomy, such as when a practitioner ignores the choice that a patient makes because he or she feels that more good can be done by the practitioner's judgment. – Hope Savulescu and Hendrick 2008 P. 41

Justifications for Medical Paternalism • The only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. • His own good, either physical or moral, is not a sufficient warrant. Mill 1859 in Hope et al 2008

Paternalism in Regulatory Trials • Mandating identical, or ideal baseline therapy • Excluding non compliant patients • Making explicit decisions of risk: benefit on behalf of patients • Quality Science in Regulatory Trials – Stable baseline – Stable behaviors throughout trial – Ability to analyze interactions between baseline conditions, interval behaviors and intervention of regulatory interest • Risk Benefit analysis is vested in the autonomous patient, not the regulatory body

Inadvertent Outcome of Regulatory Paternalism • Investigators cannot respect patient autonomy – “you cannot participate in this trial if you choose to…. ” • Specific populations are excluded from trials which is reflected in later regulatory decisions – Non compliant patients are excluded – Patients who choose therapy different than “ideal” or “optimal” are excluded from trials and therefore from later regulatory recommendations – Reimbursement decisions are restricted to a subset of patients • Risk benefit determination is made without input from involved patient community

FDA Patient Representative Program (section 1137 FDASIA) • Under MDUFA III, Patient Preference Initiative to provide information, guidance and framework necessary to incorporate patient preferences on benefit-risk tradeoff of medical devices…. . FDA intends to incorporate patient views into the total product life cycle of medical devices) • Recruit patient representatives on an as-needed basis to – Advise the Agency on drugs and devices – Provide input on development and review process – Serve as “special government employee- SGE) to participate • Serve on Advisory Committee • Consultant to review decisions on benefit risk determination • Presenters at FDA meetings

Whats Missing? Oct 10 th 2013 ASH Workshop with FDA W. White and B. Zuckerman • Target: Cardiologists, nephrologists, hypertension experts, FDA device physicians and scientists, cardio-renal drug product physicians and scientists, physicians from public and private insurers, in particular CMS, Blue Cross, Aetna, Cigna, United Health Care, Kaiser Permanent • Experts, Regulators, Payers----

Autonomy in Regulatory Trials • Regulatory trials must embrace current physician moral codes respecting patient autonomy • The critical scientific question must be phrased in a way that respects autonomy – Excluding autonomous patents is not acceptable – Excluding non compliant patients is not acceptable • Regulatory recommendations cannot limit to only patients who accept paternalistic recommendations – Unless an adequately powered, prior defined endpoint identifies an interaction that bears comment • Risk Benefit analysis must be patient based, and neither a paternalistic physician group nor regulatory body owns this analysis