Each year, over 400,000 women in the U.S. confront significant medical illness while pregnant: hypertension, diabetes, serious psychiatric illnesses, autoimmune diseases, even cancer. But information about how to treat these conditions in pregnancy is profoundly limited. Despite a 1994 Institute of Medicine report urging that pregnant women be included in appropriately regulated research, researchers and institutional review boards continue to regard pregnancy as a near-automatic cause of exclusion, even in studies carrying no additional risk to the fetus.
The result is a troubling lack of knowledge about how to treat pregnant women’s illnesses, and limited understanding of how illness during pregnancy affects women’s health over time. As a consequence, pregnant women and their doctors face difficult and anxiety-filled decisions about medication use. Without evidence specific to the special state of pregnancy, they must guess about what medications to use, what doses to prescribe or take, and – given concerns about fetal safety – whether to use medications during pregnancy at all.
Katie Watts was just one month pregnant when swine flu first crept across the border into the United States. As the illness spread and the months wore on, a disturbing pattern emerged: pregnant women were four times more likely to be hospitalized from the disease, and about six percent of all swine flu deaths were pregnant women, though they comprise just one percent of the U.S. population. By September, just three months before Katie’s due date, her doctor recommended enrollment in a trial of the H1N1 vaccine.
Like many in her position, Katie was hesitant. Pregnant women are counseled to avoid everything from caffeine to paint fumes out of concern for the developing fetus, and many discontinue prescription medication and shun vaccinations for the same reason. Not only does the culture around pregnancy “tend toward perfectionism and control,” according to Maggie Little, director of the Kennedy Institute of Ethics, but there is a legitimate dearth of clinical information on this front. Concerns about the ethics of performing drug studies on pregnant women have prevented the kind of data-gathering that would enable physicians to make informed decisions about medication during pregnancy.
It’s for this reason that Anne Lyerly, an obstetrician and bioethicist at Duke University, called the trial Katie was considering “a watershed moment in thinking about studying drugs and vaccines in pregnancy.” She sounds a common theme: “we know very, very little about how to treat any diseases during pregnancy, because we don’t study the way that drugs work in pregnant bodies.” Notes Ruth Faden, director of the Berman Institute of Bioethics at Johns Hopkins University, in an interview on NPR, “There is a tremendous reluctance to include pregnant women in research. In fact, there is no group in the United States about which we have less evidence than pregnant women.” The H1N1 trial is an exception proving the general rule, a status quo that harms women and children alike.
“We know very, very little about how to treat any diseases during pregnancy, because we don’t study the way that drugs work in pregnant bodies.”
The status quo is harmful for several reasons. The quality of medical care for pregnant women is compromised. Pregnancy acts as a wild card in how drugs and biologics are processed by the body. Standard doses can be processed so quickly that therapeutic levels are not achieved, leaving woman and fetus exposed to the dangers of the underlying illness. Moreover, inadequate research leaves little data to guide decisions about which medicines are safest for fetuses. Two-thirds of women use prescription medications during pregnancy. Without information about comparative safety, women and their clinicians must guess at the trade-offs involved in managing illness while protecting the fetus – guesses that often miss the mark. More troubling still, in the absence of reassuring data on safety, doctors and patients often discontinue medications, even when the harms of untreated disease outweigh the risks of medication.
But participants of The Second Wave Workshop at Georgetown University are working to change this. The workshop, sponsored by Drs. Little, Lyerly, and Faden, director of the Berman Institute of Bioethics at Johns Hopkins University, and Jason Umans, a physician at Georgetown University, took place in April 2009. Supported by a Reflective Engagement grant from Georgetown, the conference worked toward the responsible inclusion of pregnant women in medical research. Participation included leaders from the NIH, FDA, as well as from leading academic medical centers. The workshop identified barriers, articulated the costs of ignorance, and proposed consensus proposals that can immediately begin to make a difference in pregnant women’s health. The initiative was recently featured in an article in Time magazine, which highlighted the “excruciating dilemma” faced by pregnant women forced to make medical decisions in conditions of extreme uncertainty.
Second Wave advocates worked over the following summer with Members of Congress and their staffs to raise awareness of the issue. Those efforts resulted in inclusion of language in the House Committee Report accompanying the Fiscal 2010 Appropriations for the Departments of Labor, Health and Human Services and Education. They are urging that the Institute of Medicine the health arm of the National Academy of Sciences, convene a group to explore the challenges posed to mothers and their babies by the ethical and regulatory barriers to research at work in the current milieu. The issues are on podiums, too: Drs. Kathy Wisner and Lyerly, Second Wave veterans, will be giving the opening symposium at the 36th Annual Meeting of North American Society for Psychosocial Obstetrics and Gynecology.
If there was ever a time to rewrite the playbook on how to think about drugs, vaccines and pregnancy, this is it. The lives of women and babies depend on it.
In the meantime, however, pregnant women like Katie are left to make hard decisions on their own, faced with tremendous uncertainty — and tremendous risk. In the end, after consulting with her physician, Katie decided to enroll in the trial of the H1N1 vaccine. The outbreak of the flu, and the tragic death of several pregnant women in the U.S., only underscores the urgency of the Second Wave goals. As Little, Lyerly, and Faden argue in The New York Times: If there was ever a time to rewrite the playbook on how to think about drugs, vaccines and pregnancy, this is it. The lives of women and babies depend on it.