Booties on the ground

In his excellent review of Annie Murphy Paul's new book, Origins: How the Nine Months Before Birth Shape the Rest of Our Lives in the New York Times Book Review on Sunday, physician/author Dr. Jerome Groopman wrote:

Of necessity, research on fetal development involves observing pregnant women in their daily lives; no one would purposefully have one group eat in a possibly risky way or be exposed to a potentially dangerous substance, and compare outcomes with an unperturbed control group. We have, at best, only correlations between a mother’s lifestyle and her child’s future health, not clear causation.

And, in "The Case Against Breast-Feeding," Hanna Rosin's 2009 article in The Atlantic, she wrote, "An ideal study would randomly divide a group of mothers, tell one half to breast-feed and the other not to, and then measure the outcomes. But researchers cannot ethically tell mothers what to feed their babies."

Really? Why not? Both Groopman and Rosin are writing about how vulnerable observational studies are to being tainted by hidden variables. Controlled trials are a better system for testing what works and what doesn't.

But if I am reading their statements correctly, Groopman and Rosin are saying that we cannot even think about practicing actual, rigorous science if babies and fetuses are involved.

Building up a body of "evidence-based medicine" around a segment of the population that is exempted from clinical trials — depending entirely on observational research, that is — seems unwise to me. We don't need to wonder what a worst-case scenario involving babies would look like;  we have the 50-year-old thalidomide catastrophe as a demonstration. Thousands of children around the world were born with deformed limbs after their mothers took the drug.

Subjecting drugs and behaviors that can affect unborn children to standard scientific trials that include pregnant women might save the population from potentially massive damage from those behaviors, and from the drugs once they are put on the market. This is especially true now that we suspect the experience in the womb has a huge influence on the course of an individual's life — the subject of Paul's book, Origins.

Now I understand why the medical ethicist Ruth Macklin, writing in The Lancet last winter, called for the inclusion of pregnant women in drug trials, and retaining women who get pregnant in such trials. Conventional wisdom seems to have rendered the concept so unthinkable that a call for change is necessary.

What do you think about including pregnant women in clinical trials? I would love to read your comments.

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