Pharmacovigilance and principle of nonmaleficence in sex reassignment

Abstract

Physicians are obliged to provide treatment that is consistent with their commitment to avoid or minimize harm (nonmaleficence) and their commitment to do good (beneficence). Therefore, if patient's desires were contradictory to the primary aim of medicine, the doctor's calling would require him/her to thoroughly analyze the cause of the disease and provide an adequate as well as ethical treatment rather than obediently follow patient's requests. Yet, chemical and surgical sex reassignment is one of the areas where some physicians surrender to the desire of their patients instead of finding out what their real condition is and trying to manage it in a way the essence of medicine would require. The objective of this article was to provide specific pharmacovigilance search details for the evaluation of the current situation and the scientific background of the treatment of gender dysphoria and to analyze its conformity with one of the two main ethical principles of medicine-nonmaleficence. Literature retrieval was accessed through Medline (1979-2011) using the terms "gender dysphoria," "replacement hormonal therapy," and "pharmacovigilance." The article concludes that hormonal and surgical interventions have not proven to be medically justified and could be harmful, not treating the cause, but resulting in irreversible disability. Thus, these interventions contradict the principle of nonmaleficence and goals of basic therapeutics and pharmacovigilance. They are not based on clinical trials and are lacking a thorough follow-up assessment.