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Consortium: Include More Pregnant Women in Medical Research

Pregnant

Pregnant women face an "'excruciating dilemma'" when making decisions about medical treatment because of a lack of research that involves them, Georgetown community and Congress members say.

January 25, 2012 – A consortium of physicians, scientists and bioethicists – including Georgetown Kennedy Institute of Ethics director – Margaret Little – gained support from 36 Members of Congress today in asking the government to ensure more pregnant women are responsibly involved in medical research.

The U.S. Department of Health and Human Services (HHS) is in the process of revising what is known as its “common rule” regulations on human participation in research.

An original letter from the consortium, called Second Wave, was sent to HHS in October. A second letter from the 36 members of Congress went to HHS Secretary Kathleen Sebelius this afternoon.

Paucity of Information

Second Wave asked that the HHS rules “improve guidance” on research with women who are pregnant.

“Over 500,000 women in the United States face serious medical illness while pregnant, but we have a paucity of information on how to safely and effectively treat them,” the first letter stated.

Georgetown law professor Patricia King as well as Tom Beauchamp and Rebecca Kukla, both Kennedy Institute senior research scholars, are among the 33 Second Wave members who signed the letter.

Proper Treatment

Representatives Nita M. Lowey (D-N.Y.) and Rosa DeLauro (D-Conn.) led the effort resulting in the congressional letter to Sebelius today.

In the late 1980s and early 1990s, Lowey and DeLauro were involved in the “first wave” of this effort, which led to women being included in clinical trials in representative numbers. A decision will be made on the HHS rules in the coming months.

“We urge you to ensure that the regulations being developed follow the lead taken in pediatric research and be fashioned in a way that balances the need for strong patient protections with best practices for gaining and evidence base for proper treatment,” the congressional letter states.

Substantial Health Cost

The Second Wave letter also noted that current HHS regulations contain both vagaries and constraints that make researchers skittish about including pregnant women in their studies.

“This comes at a substantial cost to the health of both women and their newborns,” the letter explains. “...medications needed to treat significant illnesses are often metabolized in very different ways than by the non-pregnant body...”

The letter added that a lack of safety information on such medications and the absence of research in the area leave doctors with insufficient information as they prescribe treatments.

Second Wave

The consortium came out of a Second Wave Workshop that took place at Georgetown in April 2009, sponsored by Little, Anne Lyerly (then an obstetrician and bioethicist at Duke University) and Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics. Lyerly, who has a master’s degree in philosophy from Georgetown, is now associate director of the Center for Bioethics at University of North Carolina at Chapel Hill.

Faden is also a senior research scholar at Georgetown’s Kennedy Institute and is married to Beauchamp.

The initiative, which also included graduate and undergraduate students, was soon after featured in a Time magazine article highlighting the “excruciating dilemma” pregnant women face when forced to make medical decisions without enough evidence.

“Making it possible for more research involving pregnant women to take place has been a three-year effort by Second Wave,” Little said. “We hope that the HHS will take the letter signed by Congress members to heart.”

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