Taboo Trades

Today’s guest is the Israeli sociologist, Hagai Boas, a four-time organ transplant recipient and the author of The Political Economy of Organ Transplantation, published by Routledge. Hagai is the second transplant recipient on the podcast (Sally Satel, an earlier guest, has received two kidney transplants), but I’ve never met anyone before who has been transplanted *four* times, or who has purchased an organ on the black market, as Hagai did with his third transplant. Boas is the director of the Science, Technology, and Society unit at Van Leer Jerusalem Institute. He is also a senior lecturer in the Department of Politics and Government at Ben-Gurion University. 

Today, I'm joined by two fabulous guests: Marielle Gross, Assistant Professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of Pittsburgh, and renaissance man, Brian Frye, the Spears-Gilbert Professor of Law at the University of Kentucky. 

Marielle provides clinical care at UPMC Altoona and her research focuses on the application of technology and elimination of bias as a means of promoting evidence-basis, equity and efficiency in women’s healthcare. Today, we’re discussing heny, Inc., a start up that Marielle founded that utilizes NFTs to allow breast cancer patients to remain connected to their biopsy results. When patients participate in research studies, their names and identifying features are taken off of their samples – in other words, they are deidentified. What this means is that if researchers find medically relevant information, they can’t pass that on to the patient. Nor can patients share in any of the profits that research on their tissue might generate. As we discuss in this episode, Marielle was inspired by the infamous Henrietta Lacks case to create a non-fungible NFT-like token that allows breast cancer patients to track and learn about research on their donated tumor and tissues. 

That’s where Brian Frye comes in: he teaches courses on patent and intellectural property law, and has published widely about NFTs. Many of his articles are linked in the show notes. Brian is also a filmmaker. He produced the documentary Our Nixon (2013), which was broadcast by CNN and opened theatrically nationwide. His short films and videos have shown in the 2002 Whitney Biennial, the New York Film Festival, and the San Francisco International Film Festival, among other venues, and are in the permanent collection of the Whitney Museum of American Art. If you don’t get enough of Brian in this episode, then make sure to listen to my earlier bonus episode: The Plagiarism Taboo with Brian Frye. 

Further reading and listening:

Marielle S Gross, MD; Amelia J Hood, MA; Robert C Miller Jr, BA, Nonfungible Tokens as a Blockchain Solution to Ethical Challenges for the Secondary Use of Biospecimens: Viewpoint, JMIR Bioinform Biotech 2021;2(1):e29905) doi: 10.2196/29905; https://bioinform.jmir.org/2021/1/e29905

This Pitt professor’s startup applies NFTs to bioethics, Technical.ly, Sept. 13, 2022; https://technical.ly/startups/heny-nfts-bioethics-marielle-gross/

The Plagiarism Taboo with Brian Frye, https://www.buzzsprout.com/1227113/episodes/11050801

Frye, Brian L., NFTs & the Death of Art (April 19, 2021). Available at SSRN: https://ssrn.com/abstract=3829399 or http://dx.doi.org/10.2139/ssrn.3829399

Frye, Brian L., How to Sell NFTs Without Really Trying (September 25, 2021). 13 Harvard Journal of Sports and Entertainment Law 113 (2022), Available at SSRN: https://ssrn.com/abstract=3930430

Frye, Brian L., After Copyright: Pwning NFTs in a Clout Economy (November 25, 2021). 45 Colum. J.L.& Arts 341 (2022), Available at SSRN: https://ssrn.com/abstract=3971240 or http://dx.doi.org/10.2139/ssrn.3971240

Frye, Brian L., The Art of the Token (March 16, 2022). Stanford Journal of Blockchain Law & Policy, Available at SSRN: https://ssrn.com/abstract=4059574

 And so concludes another season of the Taboo Trades podcast,
courtesy of me, Kim Krawiec, and the fabulous students at the University of Virginia. But never fear, I have some wonderful bonus episodes lined up over the coming months, with interesting guests, and I’ve invited some very special colleagues to join me as guest co-hosts.   

In this episode, Holly Fernandez Lynch and I continue our discussion of clinical research ethics with co-hosts Rahima Ghafoori and Caroline Gozigian (UVA Law '23). In this Part 2 of our interview, we focus on questions of payment, exploitation, and trust. As a reminder, in Part I, Holly introduced the basic regulatory framework governing clinical trials, with a focus on laws and rules impacting payment. She also discussed the benefits of and concerns about human challenge studies, and shared some historical examples. 

Holly Fernandez Lynch, JD, MBE, is Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine (PSOM), University of Pennsylvania. She has a secondary appointment as an Assistant Professor of Law at the University of Pennsylvania Carey Law School.

A lawyer and bioethicist by training, Professor Fernandez Lynch’s scholarly work focuses on Food and Drug Administration (FDA) pharmaceutical policy, access to investigational medicines outside clinical trials, clinical research ethics, and the ethics of gatekeeping in health care. Her specific areas of expertise include Institutional Review Board (IRB) quality, payment to research participants, research prioritization, pre-approval access pathways (e.g., Expanded Access, Emergency Use Authorization, and Right to Try), and efforts to balance speed and certainty in drug approvals, including pathways that rely on post-approval trials such as accelerated approval.

 Links:
Lynch HF, Darton TC, Levy J, McCormick F, Ogbogu U, Payne RO, Roth AE, Shah AJ, Smiley T, Largent EA. Promoting Ethical Payment in Human Infection Challenge Studies. Am J Bioeth. 2021 Mar;21(3):11-31. doi: 10.1080/15265161.2020.1854368. Epub 2021 Feb 4. PubMed PMID: 33541252.

Shah SK, Miller FG, Darton TC, Duenas D, Emerson C, Lynch HF, Jamrozik E, Jecker NS, Kamuya D, Kapulu M, Kimmelman J, MacKay D, Memoli MJ, Murphy SC, Palacios R, Richie TL, Roestenberg M, Saxena A, Saylor K, Selgelid MJ, Vaswani V, Rid A. Ethics of controlled human infection to address COVID-19. Science. 2020 May 22;368(6493):832-834. doi: 10.1126/science.abc1076. Epub 2020 May 7. PubMed PMID: 32381590.

Largent EA, Heffernan KG, Joffe S, Lynch HF. Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies. J Clin Oncol. 2020 Feb 20;38(6):532-537. doi: 10.1200/JCO.19.00250. Epub 2019 Jun 14. PubMed PMID: 31199697.

Holly Fernandez Lynch and I discuss clinical research ethics, including challenge trials, research subject payment, and diversity in medical research with co-hosts Rahima          Ghafoori and Caroline Gozigian (UVA Law '23). In this episode, Holly introduces the basic regulatory framework governing clinical trials, with a focus on laws and rules impacting payment. She also discusses the benefits of and concerns about human challenge studies, and shares some historical examples. In the next episode, Part II of our interview, we explore issues of coercion, inducement, and exploitation more explicitly.

Holly Fernandez Lynch, JD, MBE, is Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine (PSOM), University of Pennsylvania. She co-chairs the PSOM Research Ethics and Policy Series (REPS) and serves as Assistant Faculty Director of Online Educational Initiatives in the Department, where she helps lead the Master of Health Care Innovation. She has a secondary appointment as an Assistant Professor of Law at the University of Pennsylvania Carey Law School.

A lawyer and bioethicist by training, Professor Fernandez Lynch’s scholarly work focuses on Food and Drug Administration (FDA) pharmaceutical policy, access to investigational medicines outside clinical trials, clinical research ethics, and the ethics of gatekeeping in health care. Her specific areas of expertise include Institutional Review Board (IRB) quality, payment to research participants, research prioritization, pre-approval access pathways (e.g., Expanded Access, Emergency Use Authorization, and Right to Try), and efforts to balance speed and certainty in drug approvals, including pathways that rely on post-approval trials such as accelerated approval.

Links:
Lynch HF, Darton TC, Levy J, McCormick F, Ogbogu U, Payne RO, Roth AE, Shah AJ, Smiley T, Largent EA. Promoting Ethical Payment in Human Infection Challenge Studies. Am J Bioeth. 2021 Mar;21(3):11-31. doi: 10.1080/15265161.2020.1854368. Epub 2021 Feb 4. PubMed PMID: 33541252.

Shah SK, Miller FG, Darton TC, Duenas D, Emerson C, Lynch HF, Jamrozik E, Jecker NS, Kamuya D, Kapulu M, Kimmelman J, MacKay D, Memoli MJ, Murphy SC, Palacios R, Richie TL, Roestenberg M, Saxena A, Saylor K, Selgelid MJ, Vaswani V, Rid A. Ethics of controlled human infection to address COVID-19. Science. 2020 May 22;368(6493):832-834. doi: 10.1126/science.abc1076. Epub 2020 May 7. PubMed PMID: 32381590.

Largent EA, Heffernan KG, Joffe S, Lynch HF. Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies. J Clin Oncol. 2020 Feb 20;38(6):532-537. doi: 10.1200/JCO.19.00250. Epub 2019 Jun 14. PubMed PMID: 31199697.

In today’s episode, UVA Law 3Ls, Makenna Cherry and Meghana Puchalapalli join me to continue our discussion with Lancaster University professor Stephen Wilkinson. Wilkinson is a Professor of Bioethics, Associate Dean for Research for the Faculty of Arts and Social Sciences, and Chair of the University Research Ethics Committee.

Much of his work is about reproductive ethics and the regulation of reproductive technologies, especially the ethics of selective reproduction. A book on this topic (Choosing Tomorrow’s Children, Oxford University Press) was published in 2010. Since then, particular interests have included ethical issues raised by uterus transplantation, non-invasive pre-natal testing, mitochondrial replacement, new sources of eggs and sperm, genome editing, surrogacy, and public funding for infertility treatment.

Another abiding interest is the commercial exploitation of the human body, which was the subject of his first book, Bodies for Sale (Routledge, 2003), which we discuss in this episode, together with his 2016 article, Exploitation in international paid surrogacy arrangements, which appeared in the Journal of Applied Philosophy. 

Professor Stephen Wilkinson Bio, Lancaster University: https://www.lancaster.ac.uk/ppr/people/stephen-wilkinson

Exploitation in international paid surrogacy arrangements
Wilkinson, S. 05/2016 In: Journal of Applied Philosophy. 33, 2, p. 125-145

Bodies for sale: ethics and exploitation in the human body trade
Wilkinson, S. 2003 New York : Routledge. 248 p. ISBN: 9780415266253 .

My guest today is Lancaster University professor Stephen Wilkinson and I’m joined by two UVA Law 3L co-hosts, Makenna Cherry and Meghana Puchalapalli. Wilkinson is a Professor of Bioethics, Associate Dean for Research for the Faculty of Arts and Social Sciences, and Chair of the University Research Ethics Committee.

Much of his work is about reproductive ethics and the regulation of reproductive technologies, especially the ethics of selective reproduction. A book on this topic (Choosing Tomorrow’s Children, Oxford University Press) was published in 2010. Since then, particular interests have included ethical issues raised by uterus transplantation, non-invasive pre-natal testing, mitochondrial replacement, new sources of eggs and sperm, genome editing, surrogacy, and public funding for infertility treatment.

Another abiding interest is the commercial exploitation of the human body, which was the subject of his first book, Bodies for Sale (Routledge, 2003), which we discuss in this episode, together with his 2016 article, Exploitation in international paid surrogacy arrangements, which appeared in the Journal of Applied Philosophy. 

Professor Stephen Wilkinson Bio, Lancaster University: https://www.lancaster.ac.uk/ppr/people/stephen-wilkinson

Exploitation in international paid surrogacy arrangements
Wilkinson, S. 05/2016 In: Journal of Applied Philosophy. 33, 2, p. 125-145

Bodies for sale: ethics and exploitation in the human body trade
Wilkinson, S. 2003 New York : Routledge. 248 p. ISBN: 9780415266253 .

In today’s episode, UVA Law 3Ls Reidar Composano and Bryan Blaylock join me to continue our discussion with University of Chicago Law professor, Mary Anne Case, about her forthcoming paper, Donorsexuality. The f-bomb is dropped (but for reasons relevant to the paper) and I emphasize (again) that all this Con Law talk is not welcome on my podcast. No one listens to me. 

Case litigated for Paul, Weiss, Rifkind, Wharton & Garrison and was professor of law and Class of 1966 Research Professor at the University of Virginia before joining the Chicago Law School faculty. Her scholarship has concentrated on the regulation of sex, gender, sexuality, religion, and family; and the early history of feminism.

Mary Anne Case faculty bio: https://www.law.uchicago.edu/faculty/case

University of Chicago Law professor, Mary Anne Case, joins me and UVA Law 3Ls Reidar Composano and Bryan Blaylock to discuss her forthcoming paper, Donorsexuality. The f-bomb is dropped (but for reasons relevant to the paper) and I emphasize (again) that all this Con Law talk is not welcome on my podcast. No one listens to me. 

Case litigated for Paul, Weiss, Rifkind, Wharton & Garrison and was professor of law and Class of 1966 Research Professor at the University of Virginia before joining the Chicago Law School faculty. Her scholarship has concentrated on the regulation of sex, gender, sexuality, religion, and family; and the early history of feminism.

Mary Anne Case faculty bio: https://www.law.uchicago.edu/faculty/case

Jonathan Peterson and I continue our discussion of prisons, commodification, and privatization, together with UVA Law 3Ls Ryan Fitzgerald and Mary Talkington.  Peterson is an Associate Professor of Philosophy at Loyola New Orleans and the paper we’re discussing is forthcoming in the Routledge Handbook on Commodification, edited by Elodie Bertrand and Vida Panitch. (As mentioned in the last episode, I have a chapter in the Handbook as well) 

Jonathan’s research specializations are in philosophy of law and political philosophy. His current research focuses on political authority, social justice, criminal law, and punishment. 

Jonathan’s paper is an important read for anyone interested in prison reform. We hope you enjoy this final portion of our discussion. 

Jonathan Peterson's webpage at Loyola New Orleans: http://cas.loyno.edu/philosophy/bios/jonathan-peterson