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participant safety make the thought of research in pregnant women daunting, but it is importantto find ways to test commonly used drugs in pregnant patients. Pregnancy is a commoncondition, even among women who suffer from serious and chronic disease. Researchers must,therefore, design clinical trials for both new and already-approved drugs and therapies that willgenerate data for the safe use of these drugs. Phase IV trials involving careful monitoring ofefficacy and adverse events in pregnant patients who receive approved drugs off-label will alsocontribute to the development of better data on which to base prescribing decisions. This paperwill describe the current status of inclusion of pregnant women in research and will suggest newFDA policies, educational initiatives, and incentives to improve the availability and quality ofdata to support safe drug therapy during pregnancy.Herding WomenDavid Healy, Bangor UniversityIn recent years, a number of authors have advocated the merits of conducting randomizedcontrolled trials (RCTs) of antidepressants in women with nervous disorders during the prenatalperiod, despite growing evidence that these drugs cause birth defects, miscarriages, an increasedrate of voluntary terminations, and possibly lead to increased rates of learning disabilities inchildren born to mothers who take them through pregnancy. This information however is hard tofind. Instead there is a literature extolling the merits of antidepressants and the risks of leavingdepression untreated. It is becoming increasingly clear however that a significant proportion ofliterature like this on the merits of using pharmaceutical agents is ghostwritten. Against thisbackground, ethicists and others making assertions that RCTs are needed risk becoming part ofan apparatus that plays down the hazards of treatment and promotes the use of treatments thatmay be harmful.Antidepressant Use and Depression Screening in Pregnancy: Do BenefitsOutweigh Harm?Barbara Mintzes, University of British Columbia – School of Population and Public Health(Barbara.mintzes@ti.ubc.ca)Modern drug regulation was introduced in response to the thalidomide disaster of 1958-1961. Inthe face of the possible devastating and unpredictable harm, clear evidence of benefit was seen asneeded. For the first time, systematic scientific evidence of effectiveness was required before adrug could be marketed. Thalidomide led to caution with medicine use in pregnancy. Ironically,however, regulatory oversight remains limited, with most drugs used “off-label” in pregnancy.Antidepressants are increasingly used in pregnancy, with rates reaching 8-10% in NorthAmerica. This is despite a growing body of evidence of harm, including miscarriage, cardiacmalformations, poorer neonatal adaptation, and persistent pulmonary hypertension of the129