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‘Care in the absence of data’

For two years, a group of world-class scientists pitched their idea for a new biotech company to investors: a startup focused on a promising therapy for preeclampsia, a serious pregnancy complication that can be life-threatening. It was cutting-edge science, backed by a Nobel laureate, a Harvard kidney specialist, a leading chemist, and a biologist with both expertise and personal experience.

Eventually, they gave up – not on the science and not on preeclampsia – but on the investors.

“We talked to so many different venture capitalists and other companies. The scientists and doctors would get excited,” said Melissa Moore, a University of Massachusetts Medical School scientist. “But as soon as their lawyers heard ‘sick, pregnant women,’ nothing happened,” Moore said. “There’s such a sense of liability.”

This experience highlights a persistent problem in medical research. Basic understanding of pregnancy itself is full of gaping holes, mysteries that include how the placenta forms and what controls the timing of birth.

Stephanie Hinze holds her son Harrison, 2, at home in Gainesville, Ga. Hinze, who suffers from spina bifida, is five months pregnant with her third child. (Elijah Nouvelage/The Washington Post)

The default assumption has long been that it’s essential to protect pregnant women from research, rather than ensure they benefit from it. But concerted pressure from scientists and advocates is slowly beginning to change policy and research culture.

In January, an updated federal policy officially removed pregnant women from being listed as “vulnerable to coercion or undue influence,” alongside children and “mentally disabled” people.

Activists successfully pushed for more women to be included in medical research in the 1990s, but pregnant and lactating women have largely been left behind. Now, another round of activism is pushing new thinking. High maternal mortality rates in the U.S. have intensified the focus and there is a growing awareness that conditions during pregnancy can affect a baby’s risk of developing chronic conditions late in life.

“Probably most people think pregnancy is a time-limited experience and, therefore … we don’t need to invest that many resources in it …,” said Diana Bianchi, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. “But … there are these dual opportunities to both understand what lies ahead for the pregnant woman and also, by doing research that ensures a healthy pregnancy, we’re contributing to the long-term health of the nation.”

Absence of data

The medical attitude toward pregnancy was shaped more than half a century ago by the thalidomide crisis, which helped launch the modern era of U.S. drug regulation. Pregnant women, however, are typically left out of such research.

One study found that the risks to human pregnancy were “undetermined” in 98 percent of prescription drugs approved between 2000 and 2010. An analysis showed it took nearly three decades to get more precise risk information, despite the fact that 90 percent of the 6 million women in the U.S. who are pregnant each year take at least one medication.

Anne Drapkin Lyerly, a bioethicist and obstetrician at the University of North Carolina at Chapel Hill, said taking women out of the vulnerable category is long-overdue.

“If you don’t do these studies … you’re providing care in the absence of data,” said Catherine Spong, chief of maternal-fetal medicine at the University of Texas Southwestern Medical Center.

Another teaching moment came last year when an HIV drug called dolutegravir was flagged as potentially causing birth defects.

“The dolutegravir finding … oriented the whole HIV research community toward research in pregnancy.” Lyerly said.

Doing nothing not an option

For people who are pregnant or hope to conceive, the unknowns extend far beyond what drugs women can safely take. The National Institutes of Health began spending on pregnancy, maternal health and breast-feeding in 2017.

Stephanie Hinze makes chocolate chip cookies with her son Ethan, 3. (Elijah Nouvelage/The Washington Post)

Stephanie Hinze, 37, of Atlanta, suffers from spina bifida and has used a wheelchair since she was 8 years old. When she and her husband decided to conceive, little information was there – except for an informal network of other women with disabilities who had already had children. Concerns included whether it was safe to carry a child at all; fertility questions; whether she was gaining weight at the right rate; and what to do when she couldn’t feel the baby moving due to a decreased lack of sensation in her abdomen.

Hinze, who has two sons, one adopted, is pregnant for the second time. She says she was lucky – her first pregnancy went smoothly and her medical team supportive. But at each step, they were solving new puzzles.

“My doctor didn’t know everything to expect. As things happened during the pregnancy, he’d say, ‘Let’s deal with this issue and let’s figure this out.’ ” Hinze said. “You don’t want to go in and your doctor’s not entirely sure what the solution will be for what’s going on.”

NIH last year partnered with the CDC to survey how disabled women experience pregnancy.

“We don’t know,” said Alison Cernich, director of the National Center for Medical Rehabilitation Research, about the evidence gap around disability. Women’s health is often overlooked, many disabled women belong to ethnic groups that do not receive optimal care due to bias, many disabled people experience poverty, and disabilities are often stigmatized.

The basic science of pregnancy is also getting a closer look; NIH has funded $76 million in research projects to study the placenta. The recent discovery that it is possible to grow a miniature version in a lab may help scientists understand fundamental questions about how it develops, in part in response to secretions from the uterus.

“We don’t know what’s in the secretions that the future of the human species depends on,” said Graham Burton, a professor of the physiology of reproduction at the University of Cambridge.

The placenta is necessary for a successful pregnancy, but it also affects the pregnant woman. Preeclampsia, which causes maternal high blood pressure, is caused in part by proteins released from the placenta. There is no treatment for preeclampsia, which ends only when the woman delivers the baby – and the placenta.

Surendra Sharma, a professor of pediatrics at Brown University, has been trying to learn the science behind an alarming observation: women with preeclampsia appear to be at increased risk for dementia, heart disease and stroke decades later. The idea that treating preeclampsia could help both mothers and babies adds urgency to the quest of Moore and colleagues.

Last year, Moore and colleagues demonstrated a therapy’s promise in treating a baboon version of preeclampsia and hope to develop the drug through a nonprofit model.