For Erin McGowan, who expects her sixth child around New Year's, volunteering for a trial of the H1N1 flu vaccine was a no-brainer.
Not only did she volunteer, but she enrolled all but her youngest child in a pediatric trial of the swine flu vaccine.
In the H1N1 flu pandemic, she says, a pregnant mother and five "itty-bitty kids" -- her oldest is 6 -- are "a recipe for disaster."
McGowan, 33, a stay-at-home mom in St. Louis who holds a doctorate in psychology, has read about how pregnant women are among the high-risk groups for complications from H1N1.
As of Sept. 3, 6% of confirmed deaths from the H1N1 flu have been pregnant women, the Centers for Disease Control and Prevention says. And among people infected with H1N1, pregnant women are more likely to be hospitalized than the general population, says the National Institute of Allergy and Infectious Diseases.
"You like to test vaccines in people who need them the most," says Sharon Frey, a professor of internal medicine who is overseeing the pregnancy trial at Saint Louis University, where McGowan received her first dose on Monday. Five other centers also are enrolling pregnant women in the trial, which is to recruit up to 120.
Trepidation in testing
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 obstetrician/gynecologist 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.
Manufacturers have shied away from pregnant women for fear of harming their fetuses. That same concern leaves many pregnant women nervous about taking any kind of medicine, even though uncontrolled chronic conditions such as asthma could harm both mothers and babies.
With the H1N1 trial, "my first reaction was I have to talk to my doctor about it and see what she thinks, because I was hesitant," says Katie Watts, 26. Watts is due to deliver her first child Dec. 15. "She definitely recommended that I do participate."
Though there's no guarantee, Watts says, she's reassured that testing in non-pregnant women shows the H1N1 vaccine is "pretty safe." Like McGowan, she says she values the chance to be first in line for it. Watts is enrolled in the trial at Vanderbilt University, where she works in development and alumni relations.
Kathryn Edwards, a pediatrics professor who's overseeing the H1N1 pregnancy trial at Vanderbilt, notes that "we've known for a long time" that garden-variety seasonal flu increases the risk of hospitalization during the last trimester four- or five-fold.
Yet, she says, only about 15% of pregnant women get vaccinated against seasonal flu. "One very positive aspect of this whole H1N1 pandemic may be that people are a little more comfortable getting seasonal flu vaccine."
A frightening specter
Blame thalidomide for the nervousness about vaccines and medications in pregnancy. In the 1950s and early 1960s, thousands of pregnant women in dozens of countries who took the drug for morning sickness gave birth to babies with severe birth defects, such as missing limbs.
Although the Food and Drug Administration never approved thalidomide to treat morning sickness in the USA, the drug galvanized debate about the wisdom of pregnant women taking any kind of medication.
Three years ago, anticipating a pandemic caused by bird flu, the University of Pittsburgh recruited Richard Beigi, an OB/GYN and infectious-disease specialist, to set up a biopreparedness program for pregnant women.
One of the first drugs on the agenda was Tamiflu. It's one of two antivirals the CDC recommends for treating H1N1 influenza patients who are hospitalized or belong to a high-risk group.
Although the government has stockpiled enough Tamiflu to treat millions of Americans, Beigi says, the drug has never been tested in pregnant women.
"Pregnancy has the potential to change the pharmacokinetics of many drugs," he notes. Pregnant women absorb, metabolize and eliminate drugs differently than other women, leading doctors to speculate that they might need higher doses.
Pitt is one of five medical centers that make up the 5-year-old Obstetrics Pharmacology Research Network, funded by the Eunice Shriver National Institute for Child Health and Human Development. Starting next month, Beigi and researchers at two other network sites plan to begin enrolling a total of 90 to 100 pregnant women in a Tamiflu study. Only women who are already taking Tamiflu for H1N1 flu will participate.
Perhaps Beigi and his collaborators will find more women who share McGowan's view on participating in a research trial: "Anything that I can do to keep myself and this new baby healthy is the most important thing."
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