Response to Letter to the Editor: “Unwitting Accomplices: Endocrine Disruptors Confounding Clinical Care”
Year: 2020
Type: letter
Abstract: We appreciate the response from Napierska and Schettler (1). The authors raise several important points, including the fact that the presence of endocrine-disrupting chemicals (EDCs) in medical devices has been known for decades. While evidence that these chemicals disrupt endocrine systems continues to expand, this knowledge underscores the urgency to act through revised regulatory practices that have heretofore neglected healthcare-associated exposures in the United States. Importantly, this can be done. As referenced in their letter, Medical Devices Regulation for the European Union now mandates justification for the use of chemicals with endocrine-disrupting activity, expands disclosure requirements, and requires assessment of alternatives (2). In the United States by contrast, the Center for Drug Evaluation and Research has recommended that di(2-ethylhexyl) phthalate and dibutyl phthalate be avoided as excipients in drugs and biologic products (3); however, these recommendations are nonbinding, and there is no national policy or requirement to follow this recommendation. While disappointing, the policy advancements in Europe provide an initial framework to begin to escape this inertia and improve regulations in the United States and elsewhere by reducing healthcare-associated EDC exposures in order to protect patient safety. Importantly, however, the nature of global trade means that regulatory improvements in one country or region are insufficient. A universal global standard must be established in order to protect patients across the globe from healthcare-associated EDCs by preventing exposures arising from medications and medical devices supplied by countries with less restrictive regulations. Built upon the ethical principle of social justice within the context of healthcare and the environment, regulatory agencies in Europe, the United States, and elsewhere must work together to develop unified regulations to ensure that global supplies of medications and medical equipment maximize endocrine safety. This commitment would acknowledge the fact that justice in healthcare means that we must help populations around the world avoid preventable illness and injury related to healthcare delivery whenever possible. To do otherwise is a willful act of negligence. Importantly, it is hoped that the impetus for such action can be aided by addressing the persistent knowledge gaps regarding EDCs among healthcare providers and thereby empowering them to advocate for their own patients as well as patients around the world. Finally, implicit in Napierska and Schettler’s letter is the importance of nongovernmental organizations (NGOs) like Health Care Without Harm in promoting patient safety (4). Functioning as independent arbiters of science and prioritizing patient wellbeing, such NGOs are critical advocates for ensuring that medications and medical devices are free from EDCs. While our manuscript neglected NGOs in our proposed ethical framework, we firmly believe that collaboration among patients, physicians, and these advocacy organizations is essential for bringing about the systemic change necessary for improving the endocrine safety of healthcare across the globe. This work was supported by the National Institute of Environmental Health Sciences (P30 ES027792 to RMS). Disclosure Summary: R.M.S. declares that he has received honoraria from CVS/Health and the American Medical Forum.
Institution: University of Illinois Chicago
Language: English
Subfield: Health, Toxicology and Mutagenesis
Field: Environmental Science
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W3092402970