Tag: IVF

Brews and Views returns, addresses “the science and ethics of IVF and artificial wombs”

Can society and the judicial system keep pace with the technologies of in vitro fertilization (IVF), stem cell biology, artificial wombs, and in vitro gestation?

Simple green line drawing depicting a fetus and its umbilical cord inside a circular womb.

On a Friday evening in late September, there was an obvious energy in the IQ Building atrium as faculty, staff, and researchers gathered for the first in-person Brews and Views event in well over two years. Chris Contag, Director of the Institute for Quantitative Health Science and Engineering, noted this significance as he introduced the session on “Human Reproduction in a Dish: The Science and Ethics of IVF & Artificial Wombs.”

A panel of experts sat facing the audience, ready to share their perspectives on innovations to the science of human reproduction that could dramatically impact reproductive health. These experts were Jennifer Carter-Johnson, PhD, JD, associate professor, College of Law; Leonard Fleck, PhD, professor, Center for Bioethics and Social Justice, College of Human Medicine; Richard Leach, MD, professor and chair, Department of Obstetrics, Gynecology and Reproductive Biology, College of Human Medicine; and Margaret Petroff, PhD, professor, Department of Pathobiology & Diagnostic Investigation, College of Veterinary Medicine.

Dr. Leach, reproductive endocrinologist and infertility specialist, explained new developments in human gamete derivation or in vitro gametogenesis (IVG) for IVF. Citing research on this process that has been successful in mice, he explained a future where it could be possible to create human embryos by taking an adult’s cells and reprogramming them into egg and sperm cells. Asking attendees to consider this possible future, he noted that there are already three companies in the U.S. and Japan related to IVG.

How far are we from this type of assisted reproductive technology (ART) existing? Dr. Margaret Petroff shared that there currently are 2.5 million IVF cycles per year—more than 500,000 babies born each year globally. Dr. Petroff stressed that there is still much to learn about long-term health effects of ART, and that long-term epidemiological studies are needed to learn about impacts of all types of ART.

What is it that makes us human? Dr. Jennifer Carter-Johnson, who is an associate professor of law with a background in microbiology, asked attendees to think about how life is defined—ethically, scientifically, legally. She noted that there is no good definition, that discussing human life is legally ambiguous. In contrast, there is legal precedent about when human life ends. Dr. Carter-Johnson discussed the complexities and unknowns related to the June 2022 Dobbs decision that overturned Roe v. Wade. Individual U.S. states are now making different decisions about access to abortion, and about how a person is defined. If life were to be legally defined as beginning at conception, that would greatly impact the current and future use of IVF and ART.

Philosopher and medical ethicist Dr. Leonard Fleck introduced the idea of an artificial womb and what medical purpose it would serve were it to exist. In theory an artificial womb might be used to save a fetus that was going to be born before viability, or by someone without a uterus. He characterized it as a micro version of a neonatal intensive care unit. The idea of an artificial womb brought up a wide variety of ethical questions related to abortion, who has the right to make decisions about a fetus in an artificial womb, and the high cost of the use of such technology creating access barriers and utilizing limited healthcare resources.

One message from the panelists in the discussion that followed was the importance of thinking about guidelines for this technology now, rather than waiting. The complexity of the topic continued to be apparent—legal, ethical, scientific, safety, health policy, and societal implications.

The question and answer portion brought forth more unique perspectives, demonstrated with both passion and vulnerability from panelists and attendees.

“We can only see a limited distance into the future when trying to assess new technologies,” stated Dr. Fleck. The event generated more questions than answers, but that is the very nature of the mission of Brews and Views. Though the event had officially ended, the room remained abuzz with conversation.

While Brews and Views continued virtually during 2020 and 2021, this event was not only the first in-person offering is years, but also the first that explored a non-COVID topic since the pandemic began. The series is an ongoing collaboration between the Institute for Quantitative Health Science and Engineering (IQ) and the Center for Bioethics and Social Justice, and aims to hold moderated discussions addressing fascinating and provocative areas of bioscience and engineering.

Designing Children: Patents and the Market are not Sufficient Regulation

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Jennifer Carter-Johnson, PhD, JD

In an October report entitled “Breeding Out Disease,” 60 MINUTES correspondent Nora O’Donnell reported on the use of pre-implantation genetic diagnosis (PGD) to screen embryos produced during in vitro fertilization (IVF) procedures.i PGD allows doctors to determine if an embryo contains a gene that will lead to disease or increased risk of disease after birth. PGD currently can be used to screen for diseases caused by a single defective gene. Examples of such diseases include cystic fibrosis, Tay-Sachs, muscular dystrophy, sickle-cell anemia, hemophilia, and Huntington’s disease as well as certain types of cancer and some types of early onset Alzheimer’s. For parents who know that they carry a family risk of these diseases, PGD can relieve fear about some of the diseases that their child will face.

DNA-vials
Source: Flickr Creative Commons

The report also described a relatively newly developed patented process that can be used in concert with PGD. The process, and the company that sells the service, is called GenePeeks. GenePeeks uses DNA profiles from a potential set of parents to determine the likely genetic profiles of children from that couple. Couples can then use that information to determine the diseases towards which to direct any PGD screening. However, the patent for the GenePeeks process is written quite broadly and contemplates screening for not only diseases but also over 500 other traits such as eye shape and color, sex, the ability to roll one’s tongue, social intelligence and cognitive abilities.ii While prospective parents don’t quite have the technology to specifically pick and choose the traits, à la the movie Gattaca,iii they would be able to predict and select either for, or against, genetic traits that the child might possibly naturally inherit.

In spite of the peace of mind many prospective parents receive from using these two technologies, a host of ethical and regulatory issues surround them. For instance, the extent to which parents should have the ability to tailor the genetic traits of their children is completely unregulated. Additionally, the disposition of unused embryos is controversial; embryos with disease-causing mutations are usually discarded, and excess embryos are often frozen indefinitely. Other uses for excess embryos, such as stem cell research, are equally fraught with controversy. Beyond such embryonic issues, a cycle of IVF and PGD will cost around 20,000 dollars, making access to this aspect of reproductive technology and disease-screened offspring a luxury. Also, once the DNA of a parent or child is sequenced, the potential exists for insurance companies and employers to discriminate based on genetic profile, and databases of DNA profiles could additionally be matched against forensic data from crime scenes.

In light of these potential problems, Nora O’Donnell interviewed two of the developers and patent owners related to the technology. She independently asked each one what regulations should be in place to keep PGD and GenePeeks limited to disease testing. The responses of the two men interviewed were essentially the same – and essentially wrong. Each explained that due to patent exclusivity few can practice the technology. Both doctors promised to act as gatekeepers for the technology and use it exclusively for screening for disease in embryos and conducting related disease research, rather than crafting designer children – even though such designer activities were explicitly described in the GenePeeks patent. “Trust us,” seemed to be the echoing cry.

However, the number of people who can sell a technology at a given moment has little bearing on whether a technology will need to be regulated. The number of patients GenePeeks and the PGD firm see each year number in thousands. Moreover, patents can be licensed broadly fairly quickly, increasing the reach of the technology even further. Once the patents expire, twenty years after filing, everyone will be free to offer the service for sale. More importantly, and problematically, the issuance of a patent does not indicate that a technology is being used ethically.

Patent law is technologically neutral. In 1980, in the case of Diamond v. Chakrabarty, the Supreme Court determined that “anything under the sun that is made by man” can be patented so long as the new technology is useful, novel and non-obvious. The Chakrabarty case dealt with the patentability of genetically modified bacteria and is credited with ushering in the biotechnology industry.

Furthermore, the same Chakrabarty Court recognized that patents may incentivize technology that needs regulation. In the discussion of the technology underlying genetically modified bacteria, the Chakrabarty Court contemplated a “parade of horribles” that could result if this underlying genetic technology were patented and encouraged. Among the potential problems discussed were the spread of pollution and disease, loss of genetic diversity and a devaluation of human life. The Chakrabarty Court then invited legislatures to pass any laws to regulate this new biotechnology by a “balancing of competing values and interests.”

Congress and various administrative agencies have answered that invitation in a myriad of circumstances and in as many distinct ways. Concerns over cloning and human ownership led Congress to forbid any patents directed toward a human organism.v The development of genetically modified crops and animals resulted in a multi-agency co-operative regulatory regime encompassing the Food and Drug Administration (FDA), the US Department of Agriculture and the Environmental Protection Agency.vi The Genetic Information Nondiscrimination Act (GINA) of 2008 prohibited discrimination in health coverage and employment based on genetic information.vii The FDA has promulgated rules for DNA research and the safety and efficacy of the resulting new biologics as well as the informed consent of volunteers for related clinical trials.  This oversight has not been limited to Federal laws and regulations as state legislatures have dealt with family law issues such as surrogacy agreementsviii and ownership of frozen embryos.ix

As the PGD and GenePeeks technologies develop, so too must the laws and regulations surrounding their use. Recently, the FDA announced new guidelines for proving the safety and accuracy of genetic tests. However, testing accuracy does not address whether the tests should be used in a capacity beyond disease diagnosis. As these technologies demonstrate, inventors and patent owners may be smart, and ethical, but they do not necessarily speak for all segments of society and they are at least in part generally profit-driven. Society needs to consider precisely potential problems beyond technical ability and rather than waiting to react, judiciously guide a growing industry.

References:

i Breeding Out Disease, 60 MINUTES. Last accessed at http://www.cbsnews.com/news/breeding-out-disease-with-reproductive-genetics/.

ii  Method and system for generating a virtual progeny genome, Patent #8620594 (filed Aug 22, 2012).

iii Gattaca, Sony Pictures Entertainment (1997).

iv  Diamond v. Chakrabarty, 447 U.S. 303 (1980).

v America Invents Act of 2011 (Pub. L. 112–29, § 33,Sept. 16, 2011, 125 Stat. 340(enacted September 22, 2011).

vi Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (2003).

vii Genetic Information Nondiscrimination Act of 2008 Pub.L. 110–233, 122 Stat. 881 (enacted May 21, 2008).

viii Guide to State Surrogacy Laws. Last accessed at https://www.americanprogress.org/issues/women/news/2007/12/17/3758/guide-to-state-surrogacy-laws/.

ix  See, e.g., Szafranski v. Dunston, 993 N.E.2d 502 (2013).

Jennifer Carter-Johnson, PhD, Jj-carter-johnsonD, is an Associate Professor of Law in the College of Law at Michigan State University. Dr. Carter-Johnson is a member of the Michigan State Bar and the Washington State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, December 4, 2014. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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