Medicine, Professional Practice Guidelines and Ethical Dilemmas

Physicians have a duty to be aware of “Standards of Care”, also known as “Practice Guidelines,” when approaching specific diagnoses. To do so, they rely on clinical “experts” to review the literature, critically evaluate relevant data, and conduct a peer review process before publishing guidelines. Unfortunately, in order to conduct these clinical trials, clinicians and researchers increasingly rely on financial support from pharmaceutical companies. This process can create significant conflicts of interest that may be hidden from physicians, particularly those who do not have the resources to review all of the literature upon which the guidelines were based. This can place serious constraints on a physician’s Duty to Care and patients’ ability to make fully informed decisions about treatment options. Moreover, physicians are often pressured to prescribe these “standard of care” treatments, many of which are exorbitantly priced and patients at risk for financial hardship.

This paper presentation focuses on the ethical dilemmas posed by one such drug, glucarpidase. The FDA approved glucarpidase to treat toxicity from the cancer drug methotrexate but there are no clinical trials that were appropriately designed to demonstrate that this very expensive drug actually decreases severe adverse effects. The presenter will discuss the multiple ethical dilemmas she encountered in relation to the drug’s development, trials, and marketing, and how they impacted her interactions with her patients, other clinicians, and her healthcare institution.