Kidneys and Livers, Made to Order?

By Seán Finan

Last week, Organovo might just have revolutionised the pharmaceutical industry. The San Diego-based company specialises in producing structures that mimic the behaviours and functions of human tissue, using 3D bioprinting. They announced last week that they were beginning the commercial manufacture and sale of their ExVive Kidney. The product models the proximal tubule of the human kidney and holds significant promise for clinical trials of new drugs. The commercialization of the ExVive Kidney follows the release of ExVive Human Liver Tissue in 2014.

In essence, Organovo is using 3D printing technology to produce samples of “human” tissue that can be used to test the toxicity of new drugs. The printing process, known as 3D bioprinting, involves extracting human cells, culturing them and suspending them in a solution. The resulting “bioink” is fed through a modified 3D printer. Layer by layer, the printer deposits cells, producing a mass with a similar structure and density to a sample of, for example, human liver. Just like “organ on a chip” technology, these synthetic liver and kidney samples present significant advantages over traditional clinical testing.

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NIH Announces Plans for new Rules for Funding Chimera Research (Human-Animal Mixtures)

As reported by Science, today the NIH announced plans to lift a preemptive year long moratorium on funding chimera research – that which mixes human and animal cells, often at the embryonic stage.

Here is a snippet from the Science article about the new proposed NIH process:

According to two notices released today, NIH is proposing to replace the moratorium with a new agency review process for certain chimera experiments. One type involves adding human stem cells to nonhuman vertebrate embryos through the gastrulation stage, when an embryo develops three distinct layers of cells that then give rise to different tissues and organs. The other category is studies that introduce human cells into the brains of postgastrulation mammals (except rodent studies, which won’t need extra review).

These proposed studies will go to an internal NIH steering committee of scientists, ethicists, and animal welfare experts that will consider factors such as the type of human cells, where they may wind up in the animal, and how the cells might change the animal’s behavior or appearance. The committee’s conclusions will then help NIH’s institutes decide whether to fund projects that have passed scientific peer review.

The devil will, of course, be in the details. It will be interesting to see how much NIH takes a more categorical approach as opposed to more case-by-case rule making like in the Institutional Review Board or ESCRO setting. Continue reading

NOW ONLINE! Oxford Union Debating Society DNA Manipulation Debate

DNA fingerprints.The Oxford Union Debating Society at Oxford University has published full video of its DNA Manipulation Debate, filmed on May 26. The Motion under debate was, “This House Believes the Manipulation of Human DNA is an Ethical Necessity.” Oxford billed its DNA Manipulation Debate as “historic” in a year when rapid advances in gene editing and genome synthesis suddenly confront humans with the possibility of being able to write, edit, re-write, and ultimately control their own genetic destinies.

The team supporting the Motion was led by Sir Ian Wilmut, famous for cloning Dolly the Sheep and now Chair of the Scottish Centre for Regenerative Medicine at the University of Edinburgh, and included Oxford’s noted moral philosopher Julian Savulescu and Oxford student debater Lynda Troung, a fast-rising star in RNA research.

The team opposing the Motion included Dr. Norman Fost, professor emeritus of pediatrics and director of the medical ethics program at the University of Wisconsin; Professor Barbara Evans, Director of the Center for Biotechnology & Law at the University of Houston Law Center and a frequent participant in Petrie-Flom conferences; and Oxford student debater Dr. Rahul Gandhi, a young medical doctor and monk focusing on rural healthcare, who is pursuing an MBA at Oxford this year as a prelude to seeking an MPH at Harvard next year.

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Stem cell patenting on the other side of the pond

We are pleased to announce a new publication in the International Review of Intellectual Property and Competition Law (IIC). Our paper analyzes new case law in European stem cell patenting and compares these developments with the US situation and International treaties. Further information and an abstract is available below:

Authors: Ana Nordberg & Timo Minssen, University of Copenhagen, Centre for Information and Innovation Law (CIIR)

Title: A “Ray of Hope” for European Stem Cell Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and How it Compares to the US
Journal: IIC – International Review of Intellectual Property and Competition Law, 47(2), 138-177
DOI: 10.1007/s40319-016-0449-x

ABSTRACT:  Continue reading

The Testosterone Rule Strikes Again – New Policy to Address Transgender Athletes

New Guidelines issued by the IOC (International Olympic Committee) offer a new policy for the participation of transgender athletes in sports competitions. According to the new policy, transgender athletes should be given the option to compete without having to undergo genital re-construction surgery. Female to Male (F-M) transgender athletes will be allowed to compete without further limitations, however Male to Female (M-F) transgender athletes would be allowed to compete only after receiving hormonal treatment intended to keep testosterone levels under a fixed threshold for at least a year before the competition. This is a significant change to the previous guidelines, which recommended that transgender athletes be eligible to compete only after a genital re-construction surgery and two years of hormonal therapy. The committee explained that the change of policy was due to “current scientific, social and legal attitudes on transgender issues”. The overriding objective of all policies according to the IOC was ‘fair competition’, so whereas genital appearance was not considered to affect fairness, testosterone levels are still understood to generate a competitive edge.

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Does the NAM Recommendation of Sex Selection for Mitochondrial Replacement Therapy Violate the Equal Protection Clause (Part III on my take on the NAM report)

As I said in one of my earlier posts today one of the most interesting parts of the NAM report on mitochondrial replacement therapy was its recommendation that only male embryos be implanted and not female ones. The argument is that this will eliminate the risks of germ-line transmission of anything untoward. I will leave it to others more versed in the risk factors to discuss whether this is an over-reaction (the UK did not adopt this in their recommendation) or reasonable. In the last post I discussed why politically/ethically this may get them in some hot water, but here  I want to raise a different question. Would such a recommendation be unconstitutional?

If FDA were to adopt this rule it would clearly be state action. It seems to be a state-law that favors one gender (males) over another (females) in that only males can be produced in this way. If that is right, under existing Supreme Court precedent it would be judged under “intermediate scrutiny.” To pass intermediate scrutiny, the challenged law must further an important government interest by means that are substantially related to that interest. Would this rule satisfy that test? Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Continue reading

The Testosterone Rule

Dutee Chand is an Indian athlete that has been in the focus of a recent drama in elite sport. Chand, a gifted athlete and champion, was suspended from participating in competitions by the International Association of Athletics Federations (IAAF), after she was found to have high levels of testosterone. A biological condition called “hyperandrogenism” caused Chand to have three times more testosterone than an average woman athlete, similar to that of men. Chand was given the unappealing alternative of undergoing surgery and hormonal treatments meant to “normalize” her so she could race again, or turning to the Court of Arbitration for Sport (CAS), she chose the latter.

One would think that in a world in which men and women’s sports are so profoundly separated, distinguishing between male and female athletes would be a no-brainer.  Well, it’s not like that at all. Chand’s case can be traced along a history of similar episodes in which female athletes (like South African runner Caster Semanya and others) were suspected for not being “true females,” having to undergo medical scrutiny in order to conclude on the matter. This ambiguity is not special to athletes. It even has a name – “intersex,” an umbrella term describing a range of conditions in which the person’s sex cannot be conclusively determined. To read more on intersex variations click here.

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Ethics for CRISPR and the Big Leap Forward

By Kelsey Berry

This week, a research group in China published a paper describing a significant step forward in one application of the genome editing technique CRISPR: they used it to modify the genome of non-viable human embryos. Now, the scientific community finds itself grasping for ethical and legal foundations in order to evaluate the implications of this work and its possible extensions. Bioethicists and philosophers have been laying these foundations for years. Yet, the key problem, as always, is in translation: as we shift from science fiction to scientific reality, the robust and rigorous literature on the ethics of human population enhancement must find its way to usefully inform the policy debate and scientific practice. Translation between these camps can be thorny, but it must start with convergence on the issues at stake. Here’s a quick primer on the issue:

The spark: A team out of Sun Yat-sen University in Guangzhou led by Junjiu Huang used the CRISPR technique in non-viable human embryos to modify the gene responsible for a potentially fatal blood disorder. Leading journals Science and Nature denied the group publication on ethical grounds; the paper can be found in Protein & Cell. This is the first time that the CRISPR technique has been used to modify the human germline; however, the team specifically selected non-viable embryos in which to conduct the experiment in order to side step some of the most pressing ethical concerns.

The technology: CRISPR, which stands for “clustered regularly interspaced short palindromic repeats” refers to DNA loci that contain repeated base sequences, separated by other sequences called spacers. These spacers are like memories from previous exposure to a virus, and they tell the biological system which invaders to look out for and destroy – a key part of an adaptive immune system. In 2012, a team led by Doudna and Charpentier showed that CRISPRs could also be used to zero in on DNA sequences of their choosing simply by introducing synthetic guide RNA that matched the DNA sequence they wished to target. The CRISPR system would then slice up the targeted DNA sequence, either knocking out a gene entirely or allowing researchers to insert a “patch,” which if incorporated into the DNA sequence would modify the target gene. Since 2012 this technique has been shown to work in several organisms, including in human cells.

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HLS Health Law Workshop with Matt Lamkin

HLS Health Law Workshop: Matt Lamkin

November 3, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the paper: “Regulating Identity: Medical Regulation as Social Control”

Matt Lamkin is Assistant Professor of Law at the University of Tulsa College of Law. He previously was a Fellow at Stanford Law School’s Center for Law and the Biosciences. Prior to entering academia, he was in private practice in Chicago and Indianapolis, served as a law clerk to a federal judge, and worked as a policy advisor to the Mayor of Indianapolis. Matt’s scholarship explores the intersection of health care, law, and ethics, with a particular focus on how the increasing commercialization of medical care is reshaping our understandings of disease and disability, informed consent and personal responsibility, and the role of government in regulating medical care.

Harvard Effective Altruism: Nick Bostrom, September 4 at 8 PM

[This message is from the students at Harvard Effective Altruism.]

Welcome back to school, altruists! I’m happy to announce our first talk of the semester – from philosopher Nick Bostrom. See you there!

Harvard College Effective Altruism presents:
Superintelligence: Paths, Dangers, Strategies
with Nick Bostrom
Director of the Future of Humanity Institute at Oxford University

What happens when machines surpass humans in general intelligence? Will artificial agents save or destroy us? Professor Bostrom will explore these questions, laying the foundation for understanding the future of humanity and intelligent life. Q&A will follow the talk. Copies of Bostrom’s new book – Superintelligence: Paths, Dangers, Strategies – will be available for purchase. RSVP on Facebook.

Thursday, September 4
8 pm
Emerson 105

Rational Actors and Happy Actors

By Nathaniel Counts

Politics, theoretically at least, is a process designed to enhance the sense of wellbeing of its citizens.  The success of this process, the amount of wellbeing that can be created, is hamstrung by biology – we have basal levels of felt wellbeing that are determined through some amount of nature and nurture, and that are independent of our present circumstances.  Because there is a biological component to it, we may be able to alter an individual’s basal wellbeing before they reach adulthood.  For example, if hypomania, a psychological condition where the individual only experiences the manic part of bipolar disorder, were found to have a definitively genetic etiology, gene therapy could be used on embryos so that they would grow up to experience the constant heightened state of wellbeing associated with the condition (for an interesting article on hypomania and wellbeing, see here).

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The Neuroethics of Unintentional Memory-Modification

By Matthew L Baum

At least since the publication of the President’s Commission on Bioethics’ report in 2003, “Beyond Therapy: Biotechnology and the Pursuit of Happiness”, there has been an ongoing debate about the ethics of using drugs to modify emotional memories.  Rather than focus on the Hollywood-type total memory erasure featured in the Eternal Sunshine of the Spotless Mind, many ground the debate in the molecular neuroscience of memory reconsolidation (for an excellent overview, see here). In the process of memory reconsolidation, a newly reactivated memory triggers certain molecular events that are necessary for it to return to long-term storage; during these events, the memory is temporarily susceptible to disruption by certain drugs like the beta-blocker, propranolol. Further work with people with Post-Traumatic Stress Disorder (PTSD) suggests that using propranolol in this way doesn’t erase a memory, but may blunt the reconsolidation of the memory’s negative emotional content. In the ethical discussion, most agree that 1) it should usually be acceptable to use drugs to modify memories in cases of PTSD where the emotional content of memories becomes debilitating, but 2) the use of memory modifying drugs is usually morally problematic when the target is everyday unpleasant memories, disappointments, and rejections.

Existing debate has focused on intentional memory modification. But what about those who modify memories in these problematic ways unintentionally? Conspicuously under-discussed is the ethics of continuing to use drugs with potential memory-modifying properties for the treatment of other medical conditions. Propranolol, for example, is on the Department of Veterans Affairs (VA) National Formulary for treatment of patients with severe liver disease (liver cirrhosis). This (not-small) population of people, in theory, risks unintentionally (and pre-emptively) modifying memories every day!

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Inaugural Issue of the new Journal of Law and the Biosciences Now Online (Free Access)

I am very pleased to announce the the first-ever issue of The Journal of Law and the Biosciences is now online. I serve as one of three Editors In Chief (along with Nita Farahany and Hank Greely). The journal is a co-production of Harvard, Duke, and Stanford Law schools and Oxford University Press and is the first peer-reviewed journal of its kind.

Here is the table of contents for the first issue:

Edward S. Dove, Bartha M. Knoppers, and Ma’n H. Zawati, Towards an ethics safe harbor for global biomedical research, J Law Biosci (March 2014) 1 (1): 3-51 doi:10.1093/jlb/lst002

Rebecca Dresser, Public preferences and the challenge to genetic research policy, J Law Biosci (March 2014) 1 (1): 52-67 doi:10.1093/jlb/lst001

Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy, and Julian Savulescu, The regulation of cognitive enhancement devices: extending the medical model, J Law Biosci (March 2014) 1 (1): 68-93 doi:10.1093/jlb/lst003

Timothy Caulfield, Sarah Burningham, Yann Joly, Zubin Master, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, Amy McGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, Helen Wallace, and Ma’n H. Zawati, A review of the key issues associated with the commercialization of biobanks, J Law Biosci (March 2014) 1 (1): 94-110 doi:10.1093/jlb/lst004


Public Lecture at Radcliffe Institute “The Ethicist’s and The Lawyer’s New Clothes: The Law and the Ethics of Smart Clothes” now Available on Youtube

As part of a public lecture series at the Radcliffe Institute on “Smart Clothes” I delivered a public lecture entitled “The Ethicist’s and the Lawyer’s New Clothes: The Law and Ethics of Smart Clothes.” The lecture is now available for viewing on youtube. As the promotional materials described the lecture: “From enhanced exosuits for members of the armed services to clothing that spies on you, I. Glenn Cohen focuses on legal and ethical issues pertaining to the future of smart clothes.” While CNN coverage of the lecture focused on the surveillance aspects of these clothes, I think the discussion of exosuits and enhancements may be more interesting to BOH readers.

Book Review published on SSRN

Three weeks ago I blogged about my recent review of  “Pharmaceutical Innovation, Competition and Patent Law – a Trilateral Perspective” (Edward Elgar 2013). The full review, which is forthcoming in a spring issue of European Competition Law Review (Sweet Maxwell), is now available at SSRN:

DC Circuit Upholds FDA Authority Over Stem Cells

Earlier this week, the D.C. Circuit upheld the FDA’s authority to regulate stem cells (for a good news report see here). The company in question, Regenerative Sciences, had received a warning letter from FDA, which the company challenged claiming that its use of stem cells as therapy was not prohibited by existing federal law and that the FDA lacked authority to regulate it. They lost before the district court and appealed to the D.C. Circuit.

In a unanimous decision (by judge Griffith for himself, Judge Srinivasan and Edwards) the D.C. Circuit affirmed this decision. Here are some key passages: Continue reading

Now Available: Bioethical Prescriptions by Frances M. Kamm

Bioethical Prescriptions: To Create, End, Choose, and Improve Lives

By Frances M. Kamm, Littauer Professor of Philosophy and Public Policy at Harvard’s Kennedy School of Government, Professor of Philosophy in the Harvard University Faculty of Arts and Sciences, and Petrie-Flom Academic Fellow alumna

This book is a collection of Frances M. Kamm‘s articles on bioethics, which have appeared over the last twenty-five years and which have made her among the most influential philosophers in this area. Kamm is known for her intricate, sophisticated, and painstaking philosophical analyses of moral problems generally and of bioethical issues in particular. This volume showcases these articles – revised to eliminate redundancies — as parts of a coherent whole. A substantive introduction identifies important themes than run through the articles. Section headings include Death and Dying; Early Life (on conception and use of embryos, abortion, and childhood); Genetics and Other Enhancements (on cloning and other genetic technologies); Allocating Scarce Resources; and Methodology (on the relation of moral theory and practical ethics).

Livestream of Sessions from the 2013 International Neuroethics Society Annual Meeting

The Petrie-Flom Center is pleased to host a live webstream of sessions from the International Neuroethics Society‘s 2013 Annual Meeting on Friday, November 8, in the Petrie-Flom Center conference room (302) at 23 Everett St. on the Harvard Law School campus. Participants are encouraged to submit questions directly to the panels via email ( and Twitter (@NeuroethicsInfo).

12:15-2:15pm: “The Science and Ethics of Moral Enhancement”

Can we create a morality pill?  Neuroscientists are discovering how hormones and brain chemicals shape aspects of social behavior relevant for morality, including empathy, cooperation, aggression, trust, and altruism. This work opens potential avenues for pharmacological manipulation of ethical values. In this session, speakers will review studies demonstrating how neuromodulators shape moral decisions, evaluate the evidence for and challenges facing the development of moral-enhancing interventions, and discuss the ethical implications of shaping human morality.

Format:  20-minute presentations and 60 minutes of Q & A

Moderator:  Barbara Sahakian, University of Cambridge


  • Julian Savulescu, University of Oxford
  • Patricia Churchland, Univ of California-San Diego
  • Molly Crockett, University of Zurich

4:30-6:30pm, “States of Consciousness: Neuroethics in impairments of consciousness, brain-machine interfacing and end of life decisions?”

Recent brain-imaging studies detected covert awareness in a small proportion of patients in vegetative or minimally conscious state. In rare cases patients were even able to answer yes or no questions. Brain stimulation can lead to behavioral improvements of the minimal conscious. What are the ethical and legal implications of these findings for withdrawal of life-sustaining treatment or food and fluid? How reliable is communication via a brain-computer interface especially when it comes to end of life decisions? This panel will discuss a broad range of clinical challenges as well as ethico-legal implications with four renowned experts in the field.

Format:  Brief statements of 5 – 8 minutes followed by discussion among the panel and 60  minutes of Q & A

Moderator:  Jens Clausen, University of Tubingen


  • Lisa Claydon, University of Manchester
  • Joe Fins, Weill Cornell Medical College
  • John Pickard, University of Cambridge
  • Niko Schiff, Weill Cornell Medical College

This event is free and open to the public. For more information, contact us at or 617-496-4662.

Announcing the New Journal of Law and Biosciences

The Petrie-Flom Center and Harvard Law School are delighted to announce our partnership with Duke University, Stanford University, and Oxford University Press to launch a new peer-reviewed, open access, online journal in 2014: Journal of Law and the Biosciences (JLB).

JLB will become the preeminent outlet to publish cutting-edge scholarship wherever law and the biosciences intersect. The journal will take a broad and interdisciplinary view of these areas, publishing articles on topics generally considered part of bioethics or neuroethics, such as the ethical, legal, and social implications of reproductive technologies, genetics, stem cell research, neuroscience, or human biological enhancement.  At the same time, JLB will be a home for work that speaks directly to legal issues where the biosciences can be involved, such as food and drug regulation, biosciences patent law, scientific evidence, and criminal responsibility.

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