Biological hazard sticker on the doors to cell culture laboratory. Biohazard is a biological substance that poses a threat to the health of living organisms, primarily humans.

Biosafety Labs, Public Safety, and Politics

By Barbara Pfeffer Billauer

On May 25, 2023, merely six weeks before the Wuhan Biosafety lab lost its NIH funding amid the controversy of possible lab leaks and connection with COVID-19, the United States proudly opened the doors of the National Bio and Agro-Defense Facility (NBAF), the 14th biosafety level 4 lab in the U.S., and the first here that is capable of handling large animals.

The purpose: to research highly contagious diseases affecting animals and humans, such as foot and mouth disease. The NBAF will also feature a Biologics Development Module (BDM) to develop pilot vaccines and other countermeasures, and accelerate technology transfer to industry.

The location of this lab? Manhattan. Don’t be alarmed; it’s only Manhattan, Kansas, albeit adjacent to Kansas State University.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Pig Hearts for Humans and the FDA

By Jacob Balamut

David Bennett, a man who recently underwent the world’s first successful xenotransplantation organ surgery, died last month after a sudden and as yet unexplained period of rapid deterioration.

Bennett, who was 57 years old, had been suffering from end-stage heart disease. With limited options for treatment, he underwent an experimental emergency procedure to replace his damaged heart with a genetically modified pig’s heart. The pig was genetically modified to limit the likelihood that Bennett’s immune system would reject the heart.

Many researchers and clinicians alike see the potential for genetically modified animal organs to serve as a solution to our organ transplant and supply issues. The Health Resources and Services Administration estimates that 17 people die per day on the candidate waiting list. These deaths are the result of a lack of supply of organs, which has been a longstanding issue within the United States.

However, currently, the U.S. Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use”). The lack of approved xenotransplantation products stems from a lack of safety data and concerns regarding the potential for cross-species infections to occur.

In 2016, the FDA updated previously existing guidance for xenotransplantation. The purpose of the guidance was to inform the industry of how the FDA would be handling xenotransplantation applications and to provide recommendations.  In order for xenotransplantation products to be approved, the following process must occur.

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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

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

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

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

Violations of federal antifraud provisions alleged against two hepatitis B treatment producers

By Wendy S. Salkin

Two investor class-action suits have been filed within days of one another against two different California-based pharmaceutical companies both of which produce hepatitis B treatments, Dynavax Technologies and Arrowhead Pharmaceuticals. The named plaintiffs in both shareholder class-action suits, David Soontjens and Yaki J. Meller, are represented by counsel at Pomerantz, LLP.[1]

Meller v. Arrowhead Pharmaceuticals, Inc., et al., complaint filed (C. D. Cal. Nov. 15, 2016)

On November 15th, named plaintiff Yaki J. Meller filed a Class Action Complaint in the United States District Court for the Central District of California against Pasadena-based Arrowhead Pharmaceuticals, Inc., its President and CEO (Christopher Anzalone), and its CFO (Kenneth Myszkowski). Arrowhead is a biopharmaceutical company that, according to its website, “develops medicines that treat intractable diseases by silencing the genes that cause them.”

Among its clinical stage drugs are ARC-520 and ARC-521, which “are designed to treat chronic hepatitis B virus infection by reducing the expression and release of new viral particles and key viral proteins with the goal of achieving a functional cure.” ARC-520 is the drug at issue. According to the Complaint, Arrowhead knew but failed to disclose that ARC-520 “could be fatal at its higher doses and that the FDA was unlikely to approve the treatment as a result.”[2] In particular, the Complaint alleges that Arrowhead:

made false and/or misleading statements and/or failed to disclose that: (i) the Company’s ARC-520 was unsafe at certain doses and caused deaths in an ongoing primate toxicology study; and (ii) as a result, Arrowhead’s public statements were materially false and misleading at all relevant times.

According to Meller’s Complaint, in so doing, Arrowhead violated Sections 10(b) (“Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting.”) and 20(a) (“Liability to contemporaneous traders for insider trading.”) of the Securities Exchange Act of 1934, “Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting” and “Liability to contemporaneous traders for insider trading,” respectively, and Securities and Exchange Commission Rule 10b-5, “Employment of manipulative and deceptive devices.”

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