When Janet Woodcock first began practicing medicine nearly 40 years ago, she quickly realized that her training did not prepare her to tackle a common dilemma.
New mothers were being encouraged to breastfeed their babies, but was it safe to do so if they were taking medication? “I didn’t know a word about the condition,” says Woodcock, who now heads the US Center for Drug Evaluation and Research at the Food and Drug Administration (FDA).
Woodcock’s patients, she says, were “frantic” to do what was best for their children. But in the absence of data on how a drug might affect their newborn, mothers were often forced to decide between themselves and their baby’s health. The prevailing medical advice – then and now – was, when in doubt, to stop breastfeeding.
The situation has improved, she said last month at a workshop on drugs and breastfeeding convened by the FDA — but not nearly enough. About 90% of breastfeeding mothers in the United States take some form of medication. For many of those drugs — including drugs commonly used to treat high cholesterol and diabetes — doctors still don’t know how to advise their patients.
In the workshop, the researchers pointed out how little research is done to answer those questions: A search for grants released by the US National Institutes of Health (NIH) on the topic shows only a handful of studies, and mostly on HIV drugs focuses.
The lack of research comes amid renewed large-scale public-health efforts around the world to encourage mothers to breastfeed. Breastfeeding has been linked to fewer infections and less time in the pediatrician’s office, saving parents the worry and health systems cash.
The need is especially acute in countries where the money and clean water to buy and prepare baby formula are limited. For more than a decade in the twenty-first century, whether or not the medications that breastfeeding mothers take are safe is a question that needs more attention.
It is undeniably difficult to do most clinical studies of infants. There are logistical challenges: An exhausted mother may not be eager to attend additional medical visits, and may not wish to reveal the medications she has chosen to take while breastfeeding. There are ethical challenges: for example, clinical trials involving infants are fraught with questions about informed consent. And there are economic challenges as well.
Ethical questions can be addressed through careful study design.
These problems have received little public attention, yet obstacles can be overcome. At the FDA Workshop, several researchers presented their success stories and lessons learned. Seemingly small measures, even changing the nappy or moving the baby while the mother visits the clinic, may encourage women to make an effort to participate in the study.
Ethical questions can be addressed through careful study design, and by focusing on the benefits of additional monitoring for both individual children and mothers. And in 2014, the FDA took a step toward increasing the visibility of the matter by reformulating drug labels to better demonstrate the known — and unknown — of the drug’s safety for breastfeeding mothers and their babies.
Some researchers are already collecting data and building resources. For example, researchers at the University of California, San Diego have launched the Mother’s Milk Human Milk Research Biorepository—the first of its kind, they say.
At first glance, this might not seem like sexy science to a basic researcher: the details of how particular drugs are metabolized lie more in the province of drug developers. And of course the industry has a responsibility to address open questions about the drugs it produces. But basic researchers can contribute, too.
Fascinating research avenues include developmental biology, physiology and the microbiome, all of which can provide relevant information and possibly even a fundamentally advanced field.
Funders such as the NIH have taken commendable steps to address women’s health issues at the level of basic research, by ensuring that animal studies include females when possible and relevant. More researchers and fundraisers should build on that momentum and address the effects of drugs on breastfeeding mothers and their babies.