Washington – For two years, a group of world-class scientists pitched their idea for a hot new biotech company to investors: a start-up focused on a promising therapy for preeclampsia, a serious pregnancy complication that can become 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 who began working on preeclampsia after she suffered from it in 2003 and was put on bed rest for more than a month, only to give birth seven weeks early to a baby girl who weighed less than four pounds (about 1.8kg). "But as soon as their lawyers heard ‘sick, pregnant women,’ nothing happened," Moore said. "There’s such a sense of liability."
Moore and her colleagues’ experience highlights a persistent problem in medical research. About 10 percent of reproductive-age women become pregnant each year in the United States, but far less research is done into pregnancy than into much less common conditions. The effect of medicines on pregnant women and their fetuses is rarely studied.
Basic understanding of pregnancy itself is full of gaping scientific holes, mysteries that include how the placenta forms and what, exactly, controls the timing of birth. Some pregnancy experts call the placenta, an organ that is necessary for all human reproduction, the Rodney Dangerfield of the human body because it gets "no respect."
The default assumption has long been – and, to a large extent, still is – that it’s essential to protect pregnant women from research, rather than ensure they benefit from its rapid progress. But concerted pressure from scientists and advocates is slowly beginning to change policy and research culture.
In January, an updated federal policy that governs protections for human research subjects went into effect, officially removing pregnant women from being listed as "vulnerable to coercion or undue influence," alongside children and "mentally disabled" people.
"We all joke about pregnancy brain, but I was still able to make decisions for myself and my fetus," said Sonja Rasmussen, a pediatrician and clinical geneticist at the University of Florida.
"Once the child is born, only consent of one parent is needed," said Catherine Spong, chief of maternal-fetal medicine at the University of Texas Southwestern Medical Center, who chaired the task force. "Given the autonomy of pregnant women and the evolution of family structure, we really should align that with parental consent for pediatrics."
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 that began a decade ago is pushing new thinking on pregnancy. High maternal mortality rates in the US 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.
Some researchers note that pregnant women are increasingly being studied in their own right – and not just as the environment in which a fetus develops. Recent evidence suggests that pregnancy complications may predict women’s susceptibility to dementia or heart disease decades later.
"Probably most people think pregnancy is a time-limited experience, and therefore, because it lasts only nine months, we don’t need to invest that many resources in it – because it’ll be over soon," said Diana Bianchi, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
"But that’s really a fallacious idea. Pregnancy is a stress test for a woman, and there are these dual opportunities, to both understand what lies ahead for the pregnant woman, but also by doing research that ensures a healthy pregnancy, we’re contributing to the long-term health of the nation."
The Washington Post