Published by Elsevier Academic Press in 2019
The book explores the medical, ethical, scientific, and legal rationales behind the movement towards the inclusion of pregnant women in drug studies. Pharmaceutical industry insider views about perceived business risks reveal their reluctance to implement the new FDA guidance that encourages pregnant women’s enrollment. With in-depth chapters on pharmaceutical industry history, medical vs. business ethics, and current efforts to ensure the safety of drug exposures during pregnancy, the book asserts that quality obstetrical practice relies on accurate data derived from all of the populations for whom the drugs are intended.
The lack of information on the use of medication in pregnant and lactating women has bothered practitioners for decades. The US government is exploring ways to increase research in this area, but there are impediments based on superstition, practical difficulties, and fear of litigation. Kris Shields takes on the issue with a review of the way things are and with practical suggestions for improvement. Dr. Shields has been a health care provider and a researcher for industry in human pregnancy exposures. Her book is a thorough and even-handed exploration of the issues. She does not point fingers or lay blame, and the result is a careful examination that is easy to read. Highly recommended. — Tony S., OB/GYN physician