Dr. Sharon Hillier: Fighting for Research on Medications Used During Pregnancy
Even though over 80% of pregnant women use drugs sometime during their pregnancy, 95% of drugs are never tested in pregnant women
Research ignores pregnant women at their peril, and ours
For generations, research in pregnant women has been considered to be far too risky. But that perception is faulty reasoning that ironically imperils the very population it purports to protect, according to Dr. Sharon Hillier, a senior researcher at Magee-Womens Research Institute.
“Even though over 80% of pregnant women use drugs sometime during their pregnancy, 95% of drugs are never tested in pregnant women. When women become pregnant, physicians have all the same answers the safety, dosage, and effectiveness of products that they have for any other person,” says Hillier, a professor of obstetrics and gynecology and an internationally recognized microbiologist specializing in infectious diseases. “I think the real risk is not doing research in pregnant women.”
Without such research, she argues, women are deprived of the information needed to properly treat them for infection, for depression, and for a whole host of other illnesses, meaning clinicians simply must guess as to drug effectiveness and dosage. Ironically, the very desire to protect pregnant women has the unintended consequence of putting them at risk.
The time lag between studies of new technologies or drugs in men and when the information gleaned from these studies reaches pregnant women is about 15 years, she notes.
In pregnancy, a woman’s blood volume increases, and she experiences changes in her circulation. Dosage needs might change. But without data, the prescribing physician can only guess at the proper dose. Worse yet, doctors may rely instead on studies in men, whose bodies metabolize drugs differently. And given that so many women spend a sizeable number of years either pregnant or breastfeeding, the need for evidence-based answers is obvious, Hillier says.
“The right thing to do is actually evaluate drugs in pregnant women in a very controlled way, so that women are not robbed of the opportunity to use the best kinds of drugs, and women and their providers are not cheated about the information on the safety and efficacy of these drugs,” Hillier says.
To combat the problem, Catherine Chappell, an obstetrician and investigator at MWRI, has been working with Hillier, the U.S. Food and Drug Administration, and the National Institutes of Health to help identify a path for evaluating products for treatment of Hepatitis C during pregnancy.
“So far, the results have been astonishing,” Hillier says. “I like to think that we’re right at the forefront, real pioneers.”