Each year, hundreds of thousands of pregnant women in the US face significant medical illness during their pregnancies. Diabetes and hypertension complicate 40,000+ pregnancies; psychiatric illness complicates an estimated 500,000; cancer and autoimmune diseases are not uncommon, and yet we have surprisingly little data about how to safely and effectively treat these conditions. The pregnant body can substantially change the ways in which drugs are metabolized; and concerns about the safety of taking medication must be balanced against the medical risks — to woman and fetus alike — of undertreating significant medical disease.
In April of 2009, scholars from Georgetown, Johns Hopkins, and Duke held a two-day workshop to make progress in this challenging area. Participation included leaders from the NIH, FDA, as well as from leading academic medical centers. Supported by a Reflective Engagement grantfrom Georgetown, the outcome of 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. Second Wave advocates have also worked over the 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.
Kennedy Institute of Ethics Berman Institute of Bioethics Trent Center for Bioethics Georgetown University Hospital Georgetown University Johns Hopkins University Duke University
Case Statement: Ending the knowledge gap on treating illness in pregnant women
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. ...READ MORE
We believe that the current paucity of research on effective and safe treatment of pregnant women’s illnesses is unethical. It is unfair and irresponsible to continue a system that compels physicians to use therapeutic agents in an uncontrolled experimental situation virtually every time they prescribe for pregnant women, and for women, and the fetuses they carry, to shoulder those risks when pregnancy is complicated by illness. As we learned in pediatric and geriatric research, if a population is going to use a medication, it must be studied in that population. Pregnant women and the children they bear are best protected through responsible inclusion in research, not broad-based exclusion from it.
To this end we urge the following as priorities in the critical task of advancing the health of women during and after pregnancy, as well as the health of the children they bear:
Pursue innovative study designs.
Develop more nuanced research regulations.
Alter labeling to more effectively communicate evidence-based guidance to medication use in pregnancy.
Establish an Institute of Medicine working group to issue a report on the under-representation of pregnant women in research.
Create incentives for inclusion of pregnant women in biomedical research.
In the absence of information about the safety and efficacy of medications, pregnant women and the clinicians who care for them are left with two unsavory options—use a drug with unknown safety and efficacy, or leave the woman and her fetus vulnerable to the consequences of the underlying illness. Women and the children they will bear deserve better. Clinical research with pregnant women is morally challenging, but it is a challenge we must confront. For the alternative to responsible research with pregnant women is relegating pregnant women to second-class medical citizens—something, it turns out, that is good for neither pregnant women nor the fetuses they carry.
An expert committee that advises the World Health Organization (WHO) today updated its guidance on pandemic H1N1 vaccines, recommending a single dose for most age-groups and advising that any of the forms are safe for pregnant women.
At a media briefing today, Dr Marie-Paule Kieny, director of the agency's Initiative for Vaccine Research, said this week's 3-day meeting of the Strategic Advisory Group of Experts (SAGE) on immunizations marked the group's first discussion of the pandemic H1N1 vaccine since mid July, when it took up the vaccine priority question and addressed concerns about low yields with the first vaccine seed strains. ...Read More
Pregnant women are at the front of the queue for swine flu vaccine as distribution starts this month in the US, UK and elsewhere. It is well known that their suppressed immunity puts them at greater risk; less widely recognised is the evidence that flu can harm their babies...
"Mothers think they're protecting their baby by not getting the flu vaccine," says bioethicist Margaret Little of Georgetown University in Washington DC, who specialises in women's medicine. "In fact, the flu is a more dangerous risk than the vaccine." ...Read More
When Sherean Malekzadeh Allen of Marietta, Ga., learned she was pregnant, she was 43, had been married for two years, had gone through two miscarriages and had all but given up hope of having a baby.
But instead of being overjoyed, Ms. Allen was immobilized: panic-ridden, nauseated, listless and thoroughly depressed. She could not rouse herself to go to work in the marketing business she founded and ran, or even get through the newspaper.
And she faced the pregnant woman’s quintessential dilemma: take drugs that might pose a risk to the developing baby, or struggle through an anguishingpregnancy that could harm the baby in other ways? ...Read More
Pregnant women are deluged with advice about things to avoid: caffeine, paint, soft cheese, sushi. Even when evidence of possible harm is weak or purely theoretical, the overriding caveat is, “Don’t take it, don’t use it, don’t do it.” In a few contexts, the admonition is warranted; in most, it is merely inconvenient and anxiety provoking. But in the case of pandemic influenza, it may be deadly. With the second wave of swine flu at hand, and up to 50 percent of the public at risk, the usual mode of thinking about pregnancy and medications threatens to make a worrisome situation worse.
The dangers of this mentality became frighteningly apparent this summer, when a study in The Lancet reported strikingly high rates of death and of complications like pneumonia in pregnant women with H1N1 influenza. Pregnancy meant a fourfold risk of hospitalization, sometimes with a tragic outcome; all the pregnant women who died had been relatively healthy to begin with.
The Centers for Disease Control and Prevention have since put pregnant women at the top of the priority list for the vaccine, and have recommended that pregnant women start antiviral medications as soon as possible after exposure to the virus and after the onset of flu symptoms....READ MORE
Earlier today, President Obama nominated Regina Benjamin to become surgeon general. He pointed out that Benjamin hails from the small Alabama fishing village of Bayou La Batre with a mixture of whites, blacks, and Asians, a "diverse but poor rural community."
Besides describing the down-and-out health clinic she runs—destroyed by two hurricanes and a recent fire—Benjamin recounted her family's sad medical history in a Rose Garden statement following the nomination announcement: a mother who died of smoking-related lung cancer; an older brother, her only sibling, dead from HIV; a father befallen by diabetes and high blood pressure. "My family isn't here today because of preventable diseases," she said. ...Read More
With a $3 billion investment by the federal government, the National Children’s Study (NCS) recently began recruitment. The NCS is a golden—and potentially missed—opportunity to study one of the most underrepresented populations in clinical research: pregnant women. As the nation’s largest ever study of children’s health, the NCS will examine the effects of the environment on children from before birth to 21 years of age, with participants sampled primarily through women during pregnancy. Thus the NCS presents a rare opportunity to study the health of women during and after pregnancy, in addition to the health of their children. On both moral and policy grounds, we make the case for inclusion of women’s health outcomes in the NCS ...Read More
Testing the vaccine in pregnant women makes sense, but that doesn't make the trial any less remarkable.
"I might go so far as to call this a watershed moment in thinking about studying drugs and vaccines in pregnancy," says Anne Lyerly, a Duke University OB-GYN and bioethicist. "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."
Of the thousands of drugs sold in the USA, only about a dozen have been tested in and approved for pregnant women, Lyerly says....Read More
Abstract Though much progress has been made on inclusion of non-pregnant women in research, thoughtful discussion about including pregnant women has lagged behind. We outline resulting knowledge gaps and their costs and then highlight four reasons why ethically we are obliged to confront the challenges of including pregnant women in clinical research. These are: the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access to benefits of research participation. Going forward requires shifting the burden of justification from inclusion to exclusion and developing an adequate ethical framework that specifies suitable justifications for excluding pregnant women from research. ...READ MORE
Any pregnant woman who has ever cracked open a medicine cabinet is familiar with the warnings against using nearly every kind of medication, including those sold over the counter, from the moment of conception onward. Yet each year in the U.S., some 500,000 pregnant women battle psychiatric illness, cancer, autoimmune disease, influenza and other conditions that require treatment. Leaving aside for a moment the issue of whether the benefits of certain drugs outweigh the risks to the baby, what is the appropriate dosage for a mom-to-be? Given the shifts in her metabolism, how much she should take is often anyone's guess. ...READ MORE
When diseases like swine flu hit, pregnant women are especially at risk. And yet we know surprisingly little about how to treat them. In its guidelines for the antiviral drugs Tamiflu and Relenza, the Centers for Disease Control and Prevention says that pregnant women infected or at high risk for infection should take the recommended adult dosage: "Pregnancy should not be considered a contraindication" to taking the drugs, because the benefits of treatment "likely outweigh the theoretical risks of antiviral use."
But we don’t know whether this is true. Concerns about the ethics of performing drug studies on pregnant women mean we know far less about how to treat them. It is perfectly possible that the standard adult dose of antivirals will not work in the pregnant body....Read More
In the 1990s, amidst reports that women were underrepresented in clinical research, a key issue in science policy was whether women's health interests were being adequately addressed. In response, the federal government established the Women's Health Initiative to prioritize attention to women's health needs and commissioned the Institute of Medicine to study the ethical and legal issues of including women in clinical studies. Much progress ensued: today, a majority of participants in clinical research are women. ...Read More
You still can use many medicines when you are pregnant or nursing. Use this guide and talk to your doctor, nurse, or pharmacist about keeping you and your baby safe.
Know the Facts
If you're not pregnant yet, you can help your chances for having a healthy baby by planning ahead. You can make choices about which medicines to use before you get pregnant. Always talk to your doctor, nurse, or pharmacist first! It's very important that you keep getting treatment for any health problems. ...Read More
