Word: pregnants
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Because drugmakers now include women and, thanks to a 2003 law, children in appropriate drug studies, Second Wave organizers are hoping to push federal agencies to gather more data on pregnant women - what they're taking and with what effects - and draw more blood samples so doctors can prescribe an effective dosage rather than winging...
...Everyone thinks, Oh, my God, research on pregnant women! All kinds of ethical flags go up," says Ruth Faden, director of the Berman Institute of Bioethics at Johns Hopkins University. "We don't have to start with high drama." There's enough "low-hanging fruit," she says, "that we could keep lots of medical researchers busy for a long time...
...other end of the attitude spectrum are women like Diane Mello, who was newly pregnant when she learned she had melanoma in 2004. The 21-year-old from New Jersey underwent surgery but took a pass on chemo. Spooked by the lack of data on pregnant women, she chose her baby's health over her own and died when her daughter was 9 months...
Second Wavers know the idea of pharmaceutical research on pregnant women is a moral, not to mention legal, minefield, which is why they advocate starting small by analyzing the amount of medication circulating in the bloodstream of pregnant women who are already taking prescription drugs out of necessity. A program launched in 2004 by the National Institutes of Health (NIH) is doing a few studies of this kind in four cities - Galveston, Texas; Pittsburgh, Pa.; Seattle; and D.C. - where flyers placed in obstetricians' offices seek pregnant women taking prescription drugs who are willing to stay in a hospital...
Researchers could substantially broaden their data pool by piggybacking on the NIH-funded National Children's Study, which is enrolling 100,000 women who are or plan to become pregnant, with the goal of tracking the development of children from before birth to adulthood. Tack on some questions and blood draws and suddenly you've captured a huge number of potential subjects. But expanding the study costs money. Second Wavers like Georgetown bioethicist Maggie Little have begun searching for members of Congress who are willing to take up their cause. "This issue could make somebody on the Hill a hero...