An article was released in the June 10, 2010 edition of the well-respected journal, Nature, that raises the question of doing research studies on pregnant women. Women get colds, the flu, infections and other diseases during their pregnancies that have nothing to do with their mom-to-be status. Many women simply “toughen it out” hoping their condition is just a virus that will run its course. Other times, they rely on their obstetrician’s experience with other patients who may have been prescribed an antedote that the physician has used successfully in her/his practice, but has not actually been studied in well-designed research studies that included pregnant women.
Are these women being shortchanged? Are they simply not supposed to get sick through their pregnancy? Here’s a bit of history: It wasn’t until 1994, that the Food and Drug Administration (the regulatory agency that approves drugs for safety and effectiveness) lifted the ban on inclusion of women with childbearing potential from the early clinical trials. This ban had been in place since 1977 and not only excluded pregnant women, but “women who had childbearing potential” and certainly impacted the number of women participating in clinical studies. No wonder our knowledge of sex differences in disease remains inadequate!
An important and legitimate concern, of course, is the safety of a potential fetus. Anyone over age 50 recalls the thalidomide (a drug prescribed for morning sickness) tragedy of the late 50s/early 60s that resulted in far too many babies, especially in Europe, being born with deformities. While this tragedy alerted us to potential in-utero harm, it also slowed the progress we need to be sure tragedies of this nature never happen again while collecting important data on drug use in women. The author of the Nature article provides a logical strategy that should be considered and supported by all women’s health activists. Click Pregnant Women Deserve Better to view article.