Faculty Opinions recommendation of First genetically modified mosquitoes released in the United States.

Author(s):  
Michael Lassner
2021 ◽  
Author(s):  
Corbin E. Goerlich ◽  
Bartley P. Griffith ◽  
John A. Treffalls ◽  
Tianshu Zhang ◽  
Avneesh K. Singh ◽  
...  

Abstract There are 5.7 million people in the United States with heart failure, which is life-limiting in 20% of patients.1 While data is most robust in the United States for this cohort, it is known to be a global problem with over 23 million people carrying the diagnosis.1 For end-stage heart failure, many require a heart transplantation, however, there is a shortage in the supply of organ donors. Cardiac xenotransplantation has been proposed to “bridge the gap” in supply for these patients requiring transplantation. Recent pre-clinical success using genetically modified pig donors in baboon recipients has demonstrated survival greater than 6 months.2–5 First-in-human transplantation of a genetically modified pig kidney demonstrated 54 hour rejection-free function when perfused by a deceased human recipient, demonstrating the feasibility of cross-species transplantation and invigorating enthusiasm further to utilize this new organ source for a population that would otherwise die waiting for a human organ.6 While this human study demonstrated proof-of-principle of overcoming hyperacute rejection, further regulatory oversight by Food and Drug Administration (FDA) may be required with pre-clinical trials in large animal models of xenotransplantation with long-term survival. These studies not only require a multi-disciplinary team and expertise in orthotopic transplantation (cardiac surgery, anesthesia and cardiopulmonary bypass), immunology and genetic engineering; but also, specifically handling large animal recipients that cannot communicate their symptoms. Here we detail our approach to pig-to-primate large animal model of orthotopic cardiac xenotransplantation perioperatively and in the months thereafter in long-term surviving animals. We also detail xenograft surveillance methods and common issues that arise in the postoperative period specific to this model and ways to overcome them.


2021 ◽  
pp. 112-133
Author(s):  
Alasdair R. Young

This chapter presents the EU’s responses with respect to three closely related policies: the approval of genetically modified (GM) crops for sale and (separately) for cultivation and efforts to lift member state bans on EU-approved GM varieties. These most similar cases differ in outcome; with the EU resuming approvals for sale (a change sufficient to placate Argentina and Canada, but not the United States), but not for cultivation and failing to address member state bans despite very permissive decision rules. In these cases, no tariffs were threatened and there was no exporter mobilization. Commission trade officials did push to accelerate approvals. The Commission, which was more favorably disposed toward biotechnology than most of the member states, was able, with the help of very a permissive decision rule, to overcome opposition to approvals for sale, but not for cultivation, reflecting greater concern among regulators about the environmental impacts of GM cultivation than about the safety of GM varieties. The member state governments also balked at forcing their peers to change their policies. There is little evidence that the WTO’s adverse ruling affected any of the protagonists’ preferences.


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