The average woman is exposed to four medications during her pregnancy and over 80 percent of medications haven't been studied in a like population,' said Byers.īyers stated this 'forces pregnant women to take medications on an 'off-label' basis. 'Excluding them is a problem because women don't stop getting sick or stop having chronic medical conditions just because they are pregnant. More: Fact check: Thalidomide, COVID-19 vaccine comparisons are misleadingĪs prevailing as Lynch's opinion that research on pregnant women is 'unethical,' there has been a paradigm shift since the late 2000s with some ethicists and health care professionals arguing exclusion, instead being protective, is disadvantageous to prenatal care and women's health in general. This vulnerable classification dates back to the 1940s after diethylstilbestrol, or DES, prescribed from the 1940s to 1970s to prevent miscarriage, gave rise to generations of women born with an increased risk for gynecological cancers. Additionally, thalidomide, prescribed in Europe and other countries during the 1950s for morning sickness, was found to cause birth defects, though it was never approved in the U.S. So many investigators choose to exclude them, even if they might benefit from the study intervention,' she said.

Also, the lack of data about what pregnant women can safely be exposed to leads to more uncertainty. 'In addition, pregnant women are still classified as a 'vulnerable' population for all research studies, so investigators must take additional steps to enroll them to ensure minimum risk. Food and Drug Administration reversed its 1977 policy banning women of child-bearing potential, Byers stated exclusion of pregnant women remains persistent. 'Historically, women in general were excluded from clinical trials because men were thought to be a more homogenous group without hormonal cycles and other sex-based variables that might impact the medical conditions under study,' she said in a January 2019 interview with Stanford's Scope.ĭespite increased inclusion of women since 1993, when the U.S. Heather Byers, a clinical assistant professor in pediatrics at Stanford, women were considered too medically complex, potentially complicating research studies.

While the Facebook comment Lynch shared is correct - Moderna has advised male and female trial participants to abstain 'from all activities that could result in pregnancy' - the exclusion of pregnant women from clinical research is not atypical.Īccording to Dr. Why are pregnant women excluded from clinical trials?

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