225690 H1N1, fear, and maternal bioethics

Tuesday, November 9, 2010

Ruth Farrell, MD, MA, FACOG , Departments of Bioethics and OB/GYN, Cleveland Clinic, Cleveland, OH
The H1N1 pandemic raises awareness of the ethical challenges of emergency planning for diverse members of the population. Pregnant patients are one such group as they present policymakers with the task of protecting the health and wellbeing of the individual woman, the developing fetus, and the greater public.

Antiviral medications are at the core of a pandemic planning scheme. Formulations currently approved for the H1N1 virus are Category C, indicating potential fetal effects from in utero exposure to the drug. It is regarded that the benefits of oseltamivir and zanamivir for mother and fetus outweigh the potential risks of exposure. However the influenza virus carries the potential for drug resistance, raising concerns about the need for development and use of experimental drugs in the midst of pandemic.

Policymakers must develop pandemic plans that consider the unique state of the maternal-fetal dyad, including an ethical framework protecting pregnant women's ability to participate in clinical trials. Practices that exclude pregnant women from the initial phases of clinical trials prioritize fears of fetal harm over the interests of the woman. Although potential for harm to fetuses is a concern, there may be more harm done than good by such an approach. Exclusion from clinical trials results in drugs with inadequate safety information and fosters ethically problematic practices. Carefully crafted health policy will ensure that a woman's autonomy, in addition to her health and the health of the fetus, is preserved during the time of a pandemic.

Learning Areas:
Ethics, professional and legal requirements
Protection of the public in relation to communicable diseases including prevention or control
Public health or related laws, regulations, standards, or guidelines
Public health or related organizational policy, standards, or other guidelines
Public health or related public policy

Learning Objectives:
At the end of the presentation, attendees should be able to: 1)Identify the ethical challenges of andemic planning for pregnant women. 2)Discuss the importance of involving pregnant women in clinical trials of experimental antiviral agents. 3)Describe pandemic planning strategies that promote outcomes for pregnant women and the developing fetus.

Keywords: Bioethics, Pregnancy Outcomes

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am an obstetrician/gynecologist and bioethicist who performs outcome research
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.