Newswise — It may surprise first time pregnant women to know how little the medical community knows about their health when it comes to the use of drugs and vaccines. The reason, according to leading Bioethicists from Johns Hopkins, Duke and Georgetown Universities, is the continued reticence to include pregnant women in medical research. "As a society we are ethically obliged to confront the complex challenges of pregnant women in research, otherwise we relegate all expectant mothers to second-class medical citizens," says Ruth Faden, PhD, MPH, the Philip Franklin Wagley Professor of Biomedical Ethics at Johns Hopkins University and Director of the Johns Hopkins Berman Institute of Bioethics.

Dr. Faden is a contributing author of a paper, to be posted online and later in print in the November edition of the International Journal of Feminist Approaches to Bioethics (IJFAB), in which she and her colleagues argue why more pregnant women must be included in research.

The FDA has only approved a dozen medications for use during pregnancy, all of which are for gestation or birth related issues. That means any other medications used to treat illness during pregnancy, from hypertension and diabetes to depression and cancer, are used "off label" or without approval from the FDA. "Sadly this fact leaves doctors and their patients in very difficult positions when they are faced with making decisions about medications that may or may not harm the mother, the fetus or both," says Dr. Faden.

The paper argues that the price of turning a blind eye to pregnancy in research and research ethics poses a great cost to society. Of the more than 4 million women who give birth in the United States every year, many face medical illnesses and conditions needing clinical treatment during their pregnancies without adequate data to inform their care. Similarly, the paper argues that without information on fetal safety of medications the fetus is at risk as well.

"One of the key messages of this paper is that progress will not happen until we shift the burden of justification from inclusion to exclusion and to an explicit commitment to studying the effects of drugs in pregnancy," says Dr. Faden.

Dr. Faden's co-authors on this paper are Margaret Little, PhD, a philosopher and Senior Research Scholar at Georgetown University's Kennedy Institute of Ethics, and Anne Drapkin Lyerly, MD, an obstetrician/gynecologist and medical ethicist at Duke University's Trent Center for Bioethics.

About the Johns Hopkins Berman Institute of BioethicsOne of the largest centers of its kind in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health, and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, non-governmental organizations, and private sector organizations to address and resolve ethical issues. Institute faculty represent such disciplines as medicine, nursing, law, philosophy, public health, and the social sciences. Their works helps anticipate and inform debates on complex moral challenges; discerns ethically acceptable alternatives in medical, scientific, and public health policy; and helps to prepare the next generation of bioethicists. More information is available at

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International Journal of Feminist Approaches to Bioethics (IJFAB), (Nov-2008)