THE BLOG
10/21/2014 01:27 pm ET Updated Dec 21, 2014

Pregnant Women Must Be Studied Too

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Imagine being pregnant while having a chronic health condition such as diabetes, hypertension, depression or asthma, or being diagnosed with an illness while pregnant. Amazingly, your doctor may not know exactly what treatments or drugs, or what dose, will work best for you. This is a reality faced by American women every day [1].

The simple fact is, pregnant women get sick and sick women get pregnant. Meanwhile, rates of chronic disease are rising [2] and women are having children at an older age [3]. Stopping medication or avoiding new treatments is not always an option. Significant knowledge gaps exist because pregnant women have historically been excluded from medical research, mainly due to concerns about the effect on the fetus [4]. But even a normal pregnancy has risks.

There is a common belief that medication during pregnancy is unhealthy and unwise, due in part to the effects of certain drugs on pregnant women. For instance, it was found that thalidomide, a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women, can cause birth defects. This history may create a dilemma for many women.

Still, failing to take medication, taking inappropriate doses or not being prescribed a needed treatment can be harmful or fatal for a mother or her unborn child. Today, an American woman will take at least one and on average four medications during her pregnancy [5]. Health care providers, though, often have inadequate information about how a drug works during pregnancy because most medications have not been evaluated in pregnant women [6].

Confronted with this lack of data, a woman who is pregnant or nursing may stop taking drugs or breastfeeding, even though that may not be the best course of action. With more information, she could stay on medications that improve her short-term and long-term health and quality of life while minimizing harm to herself or her baby.

Moreover, newer medications shown to be effective in non-pregnant patients have the potential to improve outcomes in pregnancy, but haven't yet been tested in pregnant women. For example, newer treatments for hepatitis C may help prevent the mother-to-child transmission of hepatitis C, but they need to be studied in pregnancy.

Unfortunately, this lack of new scientific information leads to uncertainty for health care providers about whether to prescribe needed medications and sometimes results in no drug treatment at all for pregnant or breastfeeding patients with an illness [4]. Worse, in the search for answers, many pregnant women turn to the Internet and social media, which often results in conflicting, confusing and just plain wrong advice.

Our nation must do better. Pregnant women should determine what level of risk they are willing to take. A robust, transparent informed consent process can help them make that decision. Pregnant women should not be generally prohibited from deciding if they want to participate in medical research as they are now since most research protocols exclude pregnant or breastfeeding women.

Additionally, we need to improve data collection related to drugs and pregnancy, which is currently inadequate to make informed decisions. For example, the U.S. Food and Drug Administration keeps a list of what are called Pregnancy Exposure Registries that collect health information, mostly about birth defects and infant health, from researchers and drug companies about women who take medicines or vaccines while pregnant.

Existing data should be standardized and easily accessible to support sound decision-making by providers and patients. Pregnancy registries should be required for new drugs, and registries must capture not just adverse events but healthy outcomes to create a baseline of both positive and negative medical information.

The U.S. Office of Management and Budget also should finalize the long-pending FDA Pregnancy and Lactation Labeling Rule, which would provide detailed, updated information about fetal risk, clinical considerations and the quality of studies available for each drug.

Federal policymakers and the medical community must re-evaluate regulations that have led to the near exclusion of pregnant women in medical research [7] and strengthen requirements to collect as much data as possible, including follow-up with women who become pregnant and drop out of a study. Incentives must be created for pharmaceutical companies to perform lab research and clinical trials focusing on pregnancy when seeking approval for new drugs that may be used by pregnant women.

By taking these actions, pregnant women will be better served by medical research. With 62 million women in the United States of childbearing age [8] and 4 million births each year, getting the best possible health care is vitally important now and for generations to come [9].

By:

Martha Nolan, JD, vice president of public policy, Society for Women's Health Research

Vincenzo Berghella, MD, president, Society for Maternal-Fetal Medicine

Katherine L. Wisner, MD, MS, Women's Health Research Institute Leadership Council, Northwestern University

References:

1) Reproductive Health Fact Sheet on Pregnancy Complications, Centers for Disease Control and Prevention (CDC): http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pregcomplications.htm

2) Almanac of Chronic Disease 2009, Partnership to Fight Chronic Disease: http://www.fightchronicdisease.org/sites/fightchronicdisease.org/files/docs/PFCDAlmanac_ExecSum_updated81009.pdf

3) Joyce A. Martin, M.P.H.; Brady E. Hamilton, Ph.D.; Michelle J.K. Osterman, M.H.S.; Sally C. Curtin,M.A.and T.J. Mathews, M.S., Division of Vital Statistics. Births: Final Data for 2012, December 30, 2013: National Vital Statistics Reports, Volume 62, Number 9.

4) David B. Clemow, PhD1, Lode Dewulf, MD, DPM, FFPM2, Debra L. Michaels, MS, RD, LD3, Martha R. Nolan, JD4, Susan A. Cantrell, BS Pharm, RPh3, Andreas M. Kogelnik, MD, PhD5, Gideon Koren, MD, FRCPC, FACMT6,7,8, and J. Stephen Mikita, JD9. A Proposed Framework to Address Needs of Clinical Data for Informed Medication Use in Pregnancy: Therapeutic Innovation & Regulatory Science 2014, Vol. 48(2) 145-154

5) Mitchell AA, Gilboa SM, Werler MM, et al. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol 2011;205:51.e1-8.

6) Phoebe G. Thorpe, Suzanne M. Gilboa, Sonia Hernandez-Diaz, Jennifer Lind, Janet D. Cragan, Gerald Briggs, Sandra Kweder, Jan M. Friedman, Allen A. Mitchell, Margaret A. Honein and The National Birth Defects Prevention Study. Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk (pages 1013-1018): article first published online: 29 JUL 2013 | DOI: 10.1002/pds.3495

7) U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). 2004 Guidance for Industry. Pharmacokinetics in Pregnancy - Study Design, Data Analysis, and Impact on Dosing and Labeling. April 30, 2009. http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm133348.htm (July 7, 2013)

8) Gladys Martinez, Ph.D.; Kimberly Daniels, Ph.D.; and Anjani Chandra, Ph.D., Division of Vital Statistics, Centers for Disease Control and Prevention (CDC). National Health Statistics Report, Number 51. Fertility of Men and Women Aged 15-44 Years in the United States: National Survey of Family Growth, 2006-2010. April 12, 2012.

9) Joyce A. Martin, M.P.H.; Brady E. Hamilton, Ph.D.; Stephanie J. Ventura, M.A.; Michelle J.K. Osterman, M.H.S.; and T.J. Mathews, M.S., Division of Vital Statistics. Births: Final Data for 2011, June 28, 2013: National Vital Statistics Reports, Volume 62, Number 1.