Pregnancy and the Pharmaceutical Industry
The Movement Towards Evidence-Based Pharmacotherapy for Pregnant Women
Explores the medical, ethical, scientific, and legal rationales behind the movement towards the inclusion of pregnant women in drug studies.
Describes how pharma and biotech companies can safely implement the new FDA guidance and begin to include pregnant women in drug testing.
Shares insider views from the pharmaceutical industry about business risks and the reluctance to implement the new guidance, but also reveals understanding of the ultimate need to include pregnant women in studies and how to do it safely and effectively.
•Published by Elsevier Academic Press, 2019
Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women
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.
Two books are in the works: one on STDs tentatively titled 'My Life in STDs,' and the other on Birth Control, tentatively titled 'The Nurse Practitioner's Guide to Choosing the Right Birth Control Method for You.'