Black and white photo of a line of dominoes toppling over

The (Possible) “Dark Side” of Gene Editing Technologies

By Shelly Simana

Gene editing technologies enable people to directly change their DNA sequence by adding, removing, or replacing DNA bases. Today, for the first time, as Jennifer Doudna and Samuel Sternberg announced in their book, A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution, people “possess the ability to edit not only the DNA of every living human but also the DNA of future generations” (p. xvi). The emergence of new gene editing tools, such as CRISPR-Cas9prime editing, and dubbed SATI, has led to momentous advances in biotechnology as the new tools make gene editing faster, easier, less expensive, and more precise than ever before.

While gene editing technologies offer great promise, they may also introduce risks with far-reaching consequences. This post focuses on the possible “dark side” of gene editing technologies and addresses some threats that the technologies might pose to human lives. While nowadays some of those risks would be deemed “science fiction,” they should be in the back of our minds as we ponder the potential impact of gene editing technologies.

Gene Editing as a Weapon of Mass Destruction Read More

Photograph of a green cow statue in a field

Exploring the Future of Meat: Academy of Food Law & Policy 2nd Annual Conference at Georgia State University, Dec. 10, 2019

By Nicole Negowetti

Sustainably feeding a growing population with healthy diets is a pressing global challenge. The role of meat in such diets is a deeply contentious issue that has public health, animal welfare, food systems, farming, and environmental experts and advocates weighing in on the issue. As we learn more about the impacts of meat production and consumption on human and environmental health and animal welfare, meat consumption is changing. In North America, eaters are heeding recommendations to reduce, replace, or eliminate meat in their diets; however, global meat production and consumption continues to rise.

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Close up of a mosquito sucking blood on human skin. This mosquito is a carrier of Malaria, Encephalitis, Dengue and Zika virus.

Malaria Eradication: For Africa as America

There is a page in the history books waiting to be written for the eradication of malaria. In recent years, malaria has killed more people globally than war—it’s killed predominately children, and predominately in sub-Saharan Africa. Despite being curable, and eliminated from most developed countries, malaria is the fifth deadliest infectious disease in the world.

A team of scientists in Italy is looking to write that history. Read More

Pig lagoons in North Carolina

Hurricane Florence and the health effects of climate change

Among the coverage of the aftermath of Hurricane Florence, news stories about the overflowing waste from North Carolina pig lagoonswere among the most stomach-turning. North Carolina is home to a slew of concentrated animal feeding operations, or CAFOs, and these industrial livestock farming operations often involve storing massive volumes of pig manure in contained “lagoons.”The driving rain from Hurricane Florence caused at least 110 of these lagoons to swell over. CAFOs are, in themselves, a topic of concern among public health and environmental justice advocates. But this specific example of what happens when CAFOs and extreme weather patterns collide provides an opportunity to reflect on the unique relationship between public health and climate change.

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Orcas, Dolphins, and Whales: non-human persons and animal rights

With few exceptions, most cultures put homo sapiens at the center or the apex of creation. Humans, it is generally believed, are distinguished from other animals by our self-awareness and our ability to use tools, to think, reason, and construct meaning and representations about life. The Abrahamic religious traditions are most notable in their anthropocentric vision of human purpose in creation; and although the metaphysics and teleology are sometimes challenged by advances in science and technology, the fact remains that human beings remain the paradigmatic case against which other animals or even artificial intelligence is measured. As a Muslim and a theist, I avow my belief in the unique status of humans; however, as someone who also believes in science and is keenly attuned to the environment, I have a great love for nature and the animal world, and a great desire to protect them.

It is with this, then, that I want to propose to put ethics before metaphysics in considering the moral status of what legal scholars and ethicists call “non-human persons.” In particular, I want to look at cetacean intelligence of orcas, dolphins, and whales to understand the way in which we might classify them as non-human persons which would be given certain rights and protections. Doing so, I argue, would enable us to collapse the bifurcations that influences much of Western thought thereby ushering in a more holistic, ecological and relational approach to ethics and being.

To begin with, I would like to make a distinction clear: I am not claiming that orcas, for example, are morally equivalent to humans, but I am suggesting that we ought to be more cautious with regard to understanding our place in the animal world as a whole, particularly as it relates to the precariousness of life itself. My argument below follows philosophical and ethical reasoning, though this might also be understood in the context of religious texts. The story of Yunus (aka Jonah) and the whale is found in both the Bible and the Qur’an. In short, Yunus felt discouraged that the people of Nineveh did not heed his call to worship God, and so he left in anger. Being cast into the sea, followed by being swallowed by the whale, was ostensibly punishment for his loss of hope and leaving the city without God’s permission; though on another level the exegetical scholars point to the fact of his supplication “O Lord! There is no god but you: Glory to you: I was indeed wrong” (Qur’an 21:87) as instructive of submitting to God’s will and the significance of humility. Indeed, the Qur’an goes on to say elsewhere: “Had he not been of those who exalt God, he would certainly have remained inside the whale until the Day of Resurrection.” (Qur’an 37:143-144). The whale, on this reading, is integral to the Abrahamic worldview insofar as it is the manifestation of God’s power and dominion over creation, as well as his lesson to human beings to remain humble. Read More

Breaking the Mold: Law and Mold Remediation after a Natural Disaster

By Nicolas Wilhelm, JD

We’re in the midst of the hurricane season here on the East Coast, and with hurricanes come a host of health-related concerns from emergency preparedness to the clean-up after a disaster.

One of the issues rarely discussed in the aftermath of hurricanes Katrina and Sandy —two of the costliest natural disasters in US history — is the mold growth that occurred in water-damaged homes. One study indicated that the concentration of mold in flooded areas after Hurricane Katrina was roughly double the concentration in non-flooded areas.

With natural disasters occurring with greater frequency in recent years (there were three times as many natural disasters occurring from 2000 through 2009 than from 1980 to 1989), law may play a role in keeping Americans safe.

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Bold New Policies for The Brave New Biologies: IPRs and Innovation in Synthetic Biology and Gene editing

Research Seminar at the University of Copenhagen debating intellectual property and innovation in synthetic biology, systems biology & gene editing.

New technologies in biology offer a brave new world of possibilities. Promising solutions to some of the most urgent challenges faced by humanity: climate change, environmental protection, growing population, renewable energy and improved health care. Scientific and technological progress has been remarkable. Simultaneously, emerging life science technologies raise outstanding ethical, legal and social questions.

In this research seminar, Prof. Esther Van Zimmeren from the University of Antwerp joins Prof. Timo Minssen, Postdoc Ana Nordberg and Ph.D. Student Jakob Wested from the Centre for Information and Innovation Law, debating bold new policies for intellectual property law and incentive to life science innovation.

Programme

15:00 – 15:10 Welcome
Prof. Timo Minssen, CIIR, Faculty of Law, University of Copenhagen.
15:10 – 15:30 Waiting for the Rumble in the Jungle: – An overview of current CRISPR/CAs9 patent disputes, central legal issues and some thoughts on conditioning the innovation system.
PhD Student Jakob Wested, CIIR, Faculty of Law, University of Copenhagen.
15:30 – 15:50 From FRAND to FAIR for Synthetic and Systems Biology? The Implications of Openness, IP Strategies, Standardization and the Huawei-case.
Prof. Esther van Zimmeren, Faculty of Law, University of Antwerp.
15:50 – 16:10 Keeping up with the technologies: IP Law and Regulation in the age of gene editing.
Postdoc Ana Nordberg, CIIR, Faculty of Law, University of Copenhagen.
16.10 – 17.00 Questions and panel debate

Time: 13 March 2017, 15:00 – 17:00

Venue: Meeting Room 7A-2-04 , Faculty of Law, Njalsgade 76, DK-2300 Copenhagen S

Registration:
The event is free to attend. Registration is mandatory. Please use this registration form no later than Monday, 13 March 2017, 11:00 at the latest.

Organizer: Copenhagen Biotech & Pharma Forum, at CIIR, Faculty of Law, University of Copenhagen

Chimeras with benefits? Transplants from bioengineered human/pig donors

By Brad Segal

In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.

The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises  questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:

“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”

I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Read More

The Once and Future Regulation of Biotechnology

By Seán Finan

whitehouse_slideOn 16th September, 2016, the White House released two documents jointly authored by the FDA, the EPA and the USDA. Together, the “Update to the Coordinated Framework for the Regulation of Biotechnology” (the “Update”) and the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” (the “Strategy”) will form the basis for the federal government’s regulatory policy for biotech for the foreseeable future. So, where did these documents come from? What do they contain?

Background

Last year, the federal government asked the FDA, the EPA and the USDA to

  1. Clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
  2. Develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
  3. Commission an expert analysis of the future landscape of biotechnology products

(Source)

14 months, three public meetings and 900 responses to a Request for Information later, the two documents were released. The Update sets out to respond to the first of the above prompts and the Strategy aims to respond to the second. An answer to the third is still in the pipeline.

Aims

The underlying policy is made explicit in the first paragraph of the Strategy’s Executive Summary (p4):

The policy of the United States Government is to seek regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers

Apart from clarifying the current roles of the FDA, EPA and USDA and setting out the path for future developments, both documents make it clear that they aim

  • to help the public understand how the safety of biotechnology products is evaluated and
  • to help businesses navigate the current regulatory structure.

Read More

Initial Quick Thoughts on the Announcement of the Birth Through Mitochondrial Replacement in Mexico

The science media is abuzz about the birth of a child using mitochondrial replacement techniques in Mexico to Jordanian parents at the hands of NY Doctors. A few quick reactions (I am heading to this unrelated NAS/IOM Committee meeting tomorrow evening so may have some more thoughts when that settles down).

  • This is the first time this particular technique has been used to produce a live, but I am not sure from an ethical standpoint the arguments are all that different. That said, for those deeply interested in the more philosophical question of harm to children and the propriety of best interests argument in light of Parfit’s Non-Identity Problem (my take here and here) it may matter whether mitochondrial replacement is done through Pronuclear Transfer or Maternal Spindle Transfer as argued quite well here.
  • The fact that the doctors are from New York, the Patients are from Jordan, and the procedure took place in Mexico is not insignificant. This is a form of medical tourism, a topic I wrote a book on, most similar to cases of fertility and stem cell therapy tourism I cover in the latter half of the book. Absent making domestic prohibitions extraterritorial, something that I argue is permitted by international law and justified in some instances, there is very little that a home country can do about this. The going abroad is likely in part at least a function of some U.S. laws on the subject Eli Adashi and I wrote about for JAMA prohibiting FDA from considering approval of the technology.
  • As I wrote on this blog in February in relation to the IOM report “whatever the US policy in a world where medical tourism is possible and other countries adopt their own systems, so long as not everyone adopts the approach of the US some of these problems will manifest no matter what. So this is about harm reduction not harm avoidance.” This was a bit quicker than even I thought, but is not surprising. More generally if your concern about MRT is harm to offspring and transmission to future generations, people born elsewhere through the technology will inevitably enter the United States and/or marry, and procreate with U.S. citizens who themselves become U.S. citizens. To sound a bit X-Files about it “THEY WILL BE AMONG US!” This is a great example of the limits of unilateral regulation in a world of globalized health care.
  • Interesting that it was a male birth. This may be coincidence or in keeping with the IOM recommendation that only male embryos be transferred (to get rid of germ line transmission). Eli Adashi and I raised some ethical questions in Nature about whether that was an ethically problematic form of sex selection or not but in the reporting I have seen so far it has not been clear that they used only male embryos on purpose.
  • I wish we could stop calling it in the media “Three Parent IVF” or “Three Parent Reproduction.” That assumes the answer to what I think of as a subtle and interesting set of questions — is the mitochondrial donor a “parent” and what sense of the word do we mean.

More soon, I hope!