Should we test drugs on pregnant women?
June 21, 2010 12:37 PM Subscribe
Should we start doing medical research on pregnant women?
posted by KathrynT (22 comments total)
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In the wake of the H1N1 epidemic, in which pregnant women had a disproportionately higher risk of death
, the question of including pregnant women in clinical trials has begun to be tentatively breached.
Ever since the thalidomide catastrophe
, pregnant women have been virtually excluded from clinical research. But at what cost? Pregnant women end up gritting their teeth and toughing it out without medication through conditions ranging from the common cold and morning sickness to migraines and mental illnesses, and physicians operate largely in the dark when it comes to managing more serious conditions. We can do animal studies, but they aren't always useful; pregnant mammal studies were done with thalidomide and found no problems, for example. (Thalidomide has two optical isomers, one of which is teratogenic and one of which is not. Humans are one of a small number of species which easily converts one isomer to the other in vivo
.) We can use computer modeling, a field called computational pharmacokinetics
, but the results of such modeling are only as accurate as our models -- and gaining accurate data about human placental transfer is as fraught with ethical minefields as anything else related to human pregnancy. The FDA uses a piecemeal approach to grade drugs for safety in pregnancy, combining cohort studies
and animal trials, resulting in a "best guess" system
in which very few drugs are identified as truly dangerous (class X) but even fewer are identified as genuinely safe (class A). The New England Journal of Medicine offers another solution
, outlining a possible ethical framework for including pregnant women in double-blind clinical trials.