The Future of Research and Regulation for Infertility Treatments

Illustration by Clifford Alejandro Illustration by Clifford Alejandro

In our March feature story, Sally Has 2 Mommies + 1 Daddy, life sciences associate editor Rebecca Skloot noted that each year, thousands of women expose themselves and their future children to fertility treatments . Yet most of these treatments have not been tested for safety, and are not subject to regulation. These technologies—like in vitro fertilization (IVF) and the method used for injecting sperm into eggs—have now been connected to a risk of serious birth defects. Though the evidence is far from complete, in the last year, at least 12 studies and articles had appeared in peer-reviewed journals suggesting a potential link between assisted reproductive technologies (ART) and problems like heart defects and genetic disorders, childhood cancer, decreased cognition and more. The government has made little movement toward overseeing ART, but Johns Hopkins University recently established the Genetics as part of their Berman Bioethics Institute, with support from the Pew Charitable Trust. This center—the first of its kind in this country—is positioned to become an ART watchdog with hopes of ensuring the safety of fertility treatments and the health of the children they produce. Recently, Pop Sci talked with Kathy Hudson, director of the new institute, about the Center's goals for the future and the future of ART.



Popular Science: Is it true that ART isn't regulated?



Kathy Hudson: If ART is a big sphere, there are points on that sphere that the existing regulatory system touches, but that sphere isn't enveloped by a coherent whole regulatory framework. It's easy to say, oh, ART is unregulated, it's the wild wild west out there, and that is (a) not true, and (b) it's a really bad starting point if you want to have a productive dialogue. I've been involved in I-can't-tell-you-how-many discussions where the first thing out of somebody's mouth is "You guys are cowboys!" Then you can just see the reproductive practitioners just getting ready to explode as their blood pressure levels rise.



PS: So how is ART regulated?



KH: Well, there are a couple regulatory mechanisms that affect ART. In the beginning, you've got an infertile woman and you inject drugs into her to increase ovulation. Those drugs are all regulated by the Food and Drug Administration.



PS: Are those drugs safe?



KH: Scientifically there are some unanswered questions about the long term consequences those drugs might have on women. There are questions about whether they lead to the production of unhealthy eggs, and whether they pose a cancer risk to the mother. That's an area that we'd the Center hopes to examine.