Pictured above: Dr. Katherine L. Kraschel ‘06
By Lily Cao ’21
Staff Writer
On Feb. 9, the biological sciences department invited Dr. Katherine L. Kraschel ’06, an alumna of Mount Holyoke College and the current executive director of the Solomon Center for Health Law and Policy and lecturer in law at Yale Law School, to give a talk on “Regulating the Promises and Perils of Innovation in Reproductive Technologies.” Through this talk, the audience was given the opportunity to learn and ask questions about Kraschel’s research on reproductive technologies.
Before stepping into the field of bioethics and law, Kraschel had previously worked as a research scientist at Pfizer Inc. Before that, she was a student in Mount Holyoke’s biology labs. “What planted the seed and got me so excited about all of this [embryology] was that developmental biology lab, watching the fertilization envelope lift off before my eyes,” Kraschel said, recalling her time taking Professor of Biological Sciences Rachel Fink’s lab course BIOL-200: How Organisms Develop.
The talk began with a brief introduction to in vitro fertilization, the process of fertilizing eggs and sperm with 23 chromosomes each inside a Petri dish in a lab. If IVF proceeds successfully, it becomes a blastocyst with 46 chromosomes and is transferred to the uterus of the patient, resulting in pregnancy.
IVF underwent much evolution from 1992 to 2010 and has become more widely accepted by the general public in the U.S. According to the Centers for Disease Control and Prevention, by the end of 2018, there were 456 reporting IVF clinics in the country.
During the course of her talk, Kraschel touched upon some of the broad concerns surrounding IVF technology in the U.S. today. Preimplantation genetic screening — today called preimplantation genetic testing for aneuploidies — was first introduced in 1990, yet it has been met with growing concern from the scientific community. PGT-A screens for chromosomal abnormalities, such as an addition or lack of a chromosome that is unlikely to lead to a viable embryo or a successful pregnancy. Studies suggest that patients over the age of 35 are more susceptible to such chromosomal errors, a source of pressure for those who dream of becoming genetic parents one day.
Scientists argue that a problem with PGT-A is that only one piece of an embryo is extracted for screening. Given that different parts of the embryo become different parts of an organism, is having chromosomal abnormalities in one piece of the embryo physiologically relevant to the normality of the rest of the embryo? Additionally, there have been cases of IVF patients whose embryos tested positive for chromosomal abnormalities but resulted in successful live births.
Despite concerns about the reliability of PGT-A and its expensive cost unlikely to be covered by insurance, many IVF patients still choose to order them at the recommendation of their physicians. From the viewpoint of the IVF clinics, there are no incentives for them to transplant aneuploidic embryos even if the patients ask them to do so because if they do not result in a pregnancy, then it would not contribute to the clinic’s success rate data.
Concerning the regulatory landscape of the U.S., many say that America is the “Wild West” of innovative reproductive technologies considering barely any regulations exist. Kraschel disagrees and argues that “if it is, it is due to a lack of coordination.”
In 1992, Congress passed the Fertility Clinic Success Rate and Certification Act, the first legislation that dealt specifically with IVF due to a rise in the number of clinics in the U.S. While this legislation is limited in its power, it requires the clinics to report pregnancy rates. It also directs the Food and Drug Administration to screen for infectious diseases but states that the FDA should not interfere with the practice of medicine. An issue arises then, as many IVF clinics argue that the PGT-A technique is a medical practice since it increases their patients’ success rates, and therefore the FDA has no authority over this new standard of care.
The Federal Trade Commission is in charge of filing cases against IVF clinics that purposefully overstate their success rates.
Kraschel suggested that the law doesn’t have to be the only solution. Scientists and embryologists can come to an agreement about certain medical standards and inform the IVF clinics what procedures are and are not necessary for their patients without the interference of law enforcement.