Thursday, June 17, 2010

Should pregnant women be medical test subjects?

Citing high death rates among pregnant women during the recent H1N1 flu pandemic, researchers spelled out what they believe is an urgent need to perform clinical testing in that group, according an article in the New England Journal of Medicine.

The researchers called pregnant women "therapeutic orphans" because of their virtual exclusion from medical research.

"The importance of studying subpopulations that have previously been excluded from research is undeniable," wrote the authors. "Ironically, the effort to protect the fetus from research-related risks by excluding pregnant women from research places both women and their fetuses at great risk..."

It is both a tough argument and a paradox - and the recent H1N1 pandemic provides an interesting case study.

Pregnant women were hit hard during the pandemic. The virus was more likely to hospitalize and kill pregnant women compared with the general populace. The mantra from public health officials was for pregnant women to get vaccinated - that the potential benefits outweighed the risks - yet many mothers-to-be were worried about how the vaccine might affect the baby, and whether it could cause complications. The stark options were to get vaccinated and, with that, potentially risk the baby's health, or not get vaccinated and risk some impact from the H1N1 virus.

The same paradox exists regarding testing antidepressants on depressed pregnant women. Is it more important to address a mother's depression, which could lead to poor prenatal care - or worse, self-harm by the mother – and poor outcomes for the developing baby? Or is it more important to protect the fetus from possible risks surrounding antidepressants? They are vexing questions for sure.

In the NEJM article, authors attempt to address those questions by presenting ways to circumvent risks for testing pregnant women including, "...waiting to study pregnant women until adequate pre-clinical studies...have been completed...on non-pregnant women..." Or studying pregnant women who have already been prescribed a particular drug by their doctors, so that the only risk remaining would be taking a blood sample.

They say, "The complexity of studying the effects of medications in pregnant women should not stifle efforts to obtain scientifically rigorous data."