Monday, December 05, 2022

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 Abstract

Excerpted From: Myrisha S. Lewis, How Analogizing Socio-legal Responses to Organ Transplantation Can Further the Legalization of Reproductive Genetic Innovation, 74 SMU Law Review 665 (Fall, 2021) (357 Footnotes) (Full Document)

 

MyrishaSLewisMORAL panic often accompanies innovation, especially in medicine. Generally, “[a] moral panic [results when] a specific group [is] viewed as threatening those around them; without action, they risk destroying society as a whole.” It may be hard to believe today, but zippers, for example, were once criticized for facilitating sex.

Moral panic has described society's reactions to other commonplace goods and services such as life insurance, which was once “berated as a 'speculation repugnant to the law of God and man.”’

Moral panic is often accompanied or signaled by the invocation of science fiction. After the first heart transplant, a 1968 Saturday Evening Post editorial entitled Frankenstein in South Africa observed that “the idea of a dead man's heart continuing to beat inside someone else is only one degree short of that ultimate goal of the hero of Gothic science fiction, the transplanting of the brain.” Today, this possibility is largely disregarded (and not even considered by most Americans) because organ transplantation is widespread and perceived as a social good. Beyond surgical procedures, moral panic or the “Yuck Factor,” is also associated with “techno-anxiety,” which describes science-related fears including fears related to organ and tissue transplantation and in vitro fertilization (IVF). A recent article in The New York Times observed:

Louise [Brown, the first baby born using in vitro fertilization,] was widely, glibly and incorrectly called a “test-tube baby.” The label was enough to throw millions of people into a moral panic, for it filled them with visions of Dr. Frankenstein playing God and throwing the natural order of the universe out of kilter.

Moral panic has accompanied several issues related to reproduction including surrogacy, Safe Haven Laws, responses to the maternal consumption of certain substances during pregnancy, and IVF.

A present-day moral panic surrounds techniques involving genetic innovation in reproduction. In this article, the term “reproductive genetic innovation” includes mitochondrial transfer, cytoplasmic transfer, and heritable gene editing, which are reproductive techniques that combine IVF with genetic modifications or substitutions. Mitochondrial transfer, a technique that changes approximately 0.1% of DNA, could prevent the transmission of harmful genetic disease. But this promising technique has been sensationalized as “three-parent” IVF, a characterization that scientists oppose because the third party would be a donor who would contribute only a trivial amount of genetic material. Media coverage of cytoplasmic transfer, a technique similar to mitochondrial transfer, has been accompanied by headlines such as “[t]he girl with three biological parents.” Similarly, dystopian references to movies like Gattaca and novels like Aldous Huxley's Brave New World commonly arise as observers expect that reproductive genetic innovation will lead to a “brave new world” full of children created with pre-ordained roles in furtherance of social stability.

Although few people realize it, and no one invokes Huxley over it, individuals' DNA can change naturally or because of routine medical procedures:

1. A woman's blood donation revealed that she had two blood types because she had “acquired” the DNA of her twin in the womb;

2. A man experienced several DNA changes years after receiving a bone marrow donation as part of his leukemia treatment. The DNA in his blood is solely the donor's DNA, the DNA in his saliva and cheeks is both his original DNA and the donor's DNA, and his semen contains only the donor's DNA;

3. Medical testing for a woman in need of a kidney transplant revealed that the children she conceived and gave birth to were not her genetic children;

4. Women have acquired the genomes of their children after pregnancy; and

5. Studies have revealed that blood transfusions sometimes transfer DNA from donor to recipient.

These genetic changes occur after commonly accepted medical experiences and are accompanied by sensational news coverage, yet there are no cries for the end of pregnancy, bone marrow transplantation, or organ transplantation. Instead, these occurrences and procedures are commonly accepted by society (although still newsworthy) as indicated by insurance coverage and the lack of any significant social outcry.

It may come as a surprise given its widespread acceptance today, but organ transplantation sparked controversy at its inception. Controversy surrounding organ transplantation culminated in discussions of the definition of death, prosecutorial scrutiny of surgeons, wrongful death suits by “donors” against the surgeons who transplanted loved ones' organs into recipients, and the eventual passage of brain death statutes. These brain death statutes, the passage of the Uniform Anatomical Gift Act in all fifty states, and other federal legislation facilitated the acceptance of organ transplantation and increased availability of organs. Thus, much of the controversy related to the legality of organ transplantation and the proper role of physicians and surgeons in “experimental” techniques has dissipated, and today organ transplantation enjoys societal acceptance. Organ transplantation is still accompanied by bioethical concerns and controversy, including those related to racialdisparities, black-market organ sales, supply and demand limitations, and resource allocation issues, but it enjoys a societal acceptance that has led to a “hands-off” approach in which the technique is permissible, and individuals can decide whether to (try to) avail themselves of the technique as donors, recipients, or nonparticipants.

This Article advocates for viewing reproductive genetic innovation through the lens of organ transplantation instead of the lens of sensationalism. The use of the lens of organ transplantation would apply a medicalized view to these techniques by focusing on their therapeutic uses as opposed to a science-fiction view that focuses on matters such as eugenics-related concerns and sensationalism. In prior works, I have emphasized, as a matter of regulation, the similarities between techniques involving reproductive genetic innovation and assisted reproductive technology (ART), namely IVF and FDA-approved gene therapy products. Framing reproductive genetic innovation in terms of organ transplantation, a societally accepted (and encouraged) practice, could minimize the Yuck Factor's prevalence in discussions of reproductive genetic innovation. Further, as the first expected uses of reproductive genetic innovation are medical uses as opposed to enhancement-based uses, this Article focuses on these therapeutic uses in its analysis.

Despite the promise of reproductive genetic innovation, its use in the United States is severely curtailed by the federal regulatory system that has rendered the techniques unavailable. Moral panic lies at the heart of the overregulation of reproductive genetic innovation. The proscription of these techniques stems from an underlying political and ethical opposition to embryo destruction, broader concern for future generations, and concern about altering the genomes of the future. Reproductive genetic innovation is viewed by many as controversial, based not only on safety and efficacy concerns but also, for many, based on ethical and moral views that are ultimately incorporated into political decisions.

The Article recommends that federal legislators cease renewing the budget rider that prohibits the U.S. Food and Drug Administration (FDA) from considering techniques involving heritable genetic modification. With the continuation of the budget rider, substantive discussion is curtailed, and unlike with organ transplantation, innovation is stymied, and researchers cannot have productive conversations with federal agency members, as evidenced by the FDA's denial of a researcher's request for pre-application meetings because of the rider. Alternatively, the FDA could interpret the budget rider less broadly to encompass fewer techniques used in reproductive genetic innovation, especially since many scientists and physicians disagree with the FDA's current overexpansive interpretation. More broadly, the Article also argues for the removal of federal regulation from reproductive genetic innovation and an emphasis on the role of states in the regulation of reproduction and medicine.

One might question the analogy to organ transplantation as this Article compares techniques that have been classified as products (biologics, drugs, or both) by the FDA and as body parts by the National Organ Transplant Act. While reproductive genetic innovation is often examined singularly through the lenses of bioethics or ART, this Article will show how discussions surrounding organ and tissue donation could be both a useful lens and a helpful analogy to use while examining reproductive genetic innovation. There are many underappreciated similarities between reproductive genetic innovation and organ transplantation, such as the use of foreign biological material, genetic transfer, concerns about allocation, and extensive controversy at inception, along with some dissimilarities and competing analogies. There is robust scholarship on issues involving genetic innovation and genetic modification in reproduction, including articles by a number of scholars (including myself) that focus on scientific acceptance, regulatory choices, and ethical considerations. While the discourse related to reproductive genetic innovation focuses on controversy and “lines that should not be crossed,” organ transplantation is largely neglected in the American and global discourses surrounding techniques involving reproductive genetic modification. This Article fills that gap.

Part II of the Article provides a scientific and regulatory overview of (1) organ and tissue transplantation and (2) reproductive genetic innovation. Part III identifies four important commonalities between organ transplantation and reproductive genetic innovation that make the former a valid frame for considering the latter: (1) the use of foreign biological material, (2) genetic transfer, (3) concerns about allocation, and (4) extensive controversy at inception. Part III also identifies and analyzes the dissimilarities between organ and tissue transplantation and reproductive genetic innovation, which include potential heritable changes, eugenics-related concerns, disparate senses of urgency, and matters of reproductive choice. Despite these dissimilarities, Part IV shows the advantages of applying the organ transplantation lens that emphasizes medical therapy instead of prospective (and often implausible) enhancement to the analysis of reproductive genetic innovation.

[. . .]

Scientists and physicians routinely engage in procedures that result in the genetic modification of a patient that, while once viewed as controversial for safety reasons (or not at all in the realm of natural occurrences), similarly elicited moral panic, albeit to a lesser extent than the amount of moral panic that is accompanying heritable gene editing today. Drawing upon the histories of commonly accepted procedures, including organ transplantation and the United Kingdom's experience in approving clinical trials related to mitochondrial transfer, this Article situates innovative heritable gene editing techniques within the realm of medical procedures. The modifications of genetic composition resulting from these reproductive genetic techniques, by themselves, should be insufficient to hinder their use.


Associate Professor, William & Mary Law School; J.D., Columbia Law School; A.B., Harvard College.


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