Drug Trials and Pregnant Women
By: Cohen, Placitella & Roth @ Mar 26, 2016
Should pharmaceutical companies perform clinical trials that test drugs on pregnant women? Historically speaking, pregnant women have been off when it comes to drug companies and clinical trials. The idea being to avoid potential injuries or birth defects. However, according to a recent article from Philly.com, this practice might actually be hurting expectant mothers in the long run. Indeed, some drug safety advocates contend that we need to be conducting clinical trials in which pregnant women play a key role as subjects to prevent birth injuries.
Determining Whether Certain Drugs Are Safe for Use in Pregnant Women
When drug companies do not conduct clinical trials that include pregnant women, they are not providing information about whether those medications are likely to be safe for use during pregnancy—both for the expectant mother and for the fetus. Anne Lyerly, an OB-GYN and bioethicist at the University of North Carolina, recalled a situation early in her career in which she had to make a recommendation about using a critical cardiac drug on a dying pregnant patient. Lyerly remembers that she did not know whether the medication would be safe for the fetus, largely because “most medications are never tested in pregnant women.”
Lyerly ultimately advised using the drug to save the patient’s life, but she has discovered that the question posed to her early on in her career is one that continues to arise. To be sure, situations arise with some regularity in which a pregnant patient needs a life-saving drug, but physicians do not know whether the drug could cause injury to the fetus. In some cases, Lyerly contends, “the answer is obvious: a dying woman should get a drug that would save her life, regardless of the risk if might pose to the fetus.” Yet in many situations, Lyerly underscores that the answer is not so cut and dry.
Ethics of Testing Prescription Medications on Expectant Mothers
As the article makes clear, more than 600 prescription drugs received approval from the U.S. Food and Drug Administration (FDA) between 1980 and 2010. Of those medications, however, the article highlights that “91 percent have been so meagerly researched that their safety during pregnancy remains uncertain.” In other words, researchers believe there is an incumbent need to determine whether many of these drugs can be used safety by expectant mothers without compromising the health and safety of the fetus.
Lyerly has taken the lead in pushing for precisely this type of research. She and a small group made up of other bioethicists argue that the long-held belief that we need to protect pregnant women from unnecessary harm has led to a situation in which we have very little knowledge about the types of medications that can be used safely by pregnant women. As Lyerly and others argue, this is a serious disservice to women. And bioethics does not, she explains, preclude the inclusion of pregnant women as subject. Rather, she contends, “ethics requires it.”
It may be difficult to conduct clinical trials in which expectant mothers are subjects, but bioethicists emphasize that we need more knowledge about prescribing drugs for pregnant mothers. With such research, we may be able to prevent dangerous and deadly birth injuries linked to certain medications.
In the meantime, if you gave birth to an infant with a birth defect, you should discuss your case with a dedicated Philadelphia birth injury attorney. You may be able to file a claim for compensation. Contact Cohen, Placitella, & Roth, P.C. to learn more about our services.