Case Scenario:
Every day, about 22 people in the United States die while waiting for organ transplants, according to federal statistics (1). Organ transplantation has become an accepted medical treatment for end-stage organ failure. Some people spend years on a transplant list, and others lose their lives while waiting (2). What if we could change that by growing human organs in farm animals (pigs), a process call chimera, in an attempt to solve the donor-organ shortage. A simple explanation of a chimera embryo involves injecting human stem cells in a pig embryo with the expected outcome of the resulting animal growing the intended organ ex pancreas.
Problem
Is the solution to organ shortage lies in incubating our organs in animals?
What if during the process of transposing human stem cell to a foreign animal those cells that still have the capability to differentiate into any cells line end up developing into neuron cells in a pig in addition to the intended organ thus making the pig more human.
Opponents of such methods and then Senator Brownback introduced the Human-Animal Hybrid Prohibition Act to amend title 18, United States Code, to prohibit human-animal hybrids that died in congress. The bill would have banned any pairing of human DNA with animals. As of now the National Institutes of Health would not support studies involving such "human-animal chimeras".
The problem of organ shortage is real; science is making breakthrough regardless in the U.S. or elsewhere.
Policy stream
Proponents of such research are privately funded and by the U.S. Army. University of California, Davis and Stanford have allowed such research programs to be implemented with grant from California Institute of Regenerative Medicine. Restrictions have been implemented to limit the pig embryo gestation at just 28 days (a pig is born in 114 days) which will allow enough growth to see if the implanted gene is developing the intended organ(s).
Opponents start by saying humanness lies in our DNA. When you put human DNA in a non-human animal, you could blur that line between humans and other species.
Political stream
In the area of intellectual property law, practitioners have urged Congress to resolve the debate over which forms of life are patentable. Congress has responded in 2004 with a provision of the federal budget that prohibited the U.S. Patent and Trademark Office (USPTO) from issuing patents on human organisms (4). However, the provision does not prevent scientists from seeking patents for processes to create biological products from USPTO. That provision has not prevented the USPTO to grant patents on animals that have been modified to include a few human genes for the production of a human protein or antibody. The hot question remains: How many human gene sequences are needed for the USPTO to decide that a chimera is human? Furthermore, the FDA has claimed authority over various forms of assisted reproductive technology, although it has not added human-nonhuman chimeras specifically to its jurisdiction. Should this subject be left to the court to sort out or is it up to the congress to delegate the policy to another entity?
The battle in regards to the role of the embryo in U.S. abortion law is already threaded along partisan line in congress, adding the human-nonhuman chimeras to the soup won't help.
Kingdon model
In analyzing those two articles (2,3), it is evident that the issue with organ shortage is real and its inherent burden on the healthcare cost is substantial. 5 people that needed transplant on a CO-OP health plan has bankrupt the plan. People are dying on the transplant list. opponents are against blurring the lines between human and animals. They say the solution lie by with organ donations by giving incentives. Proponents see the real life of personalized medicine at hands' reach where one organ can be made to order within a year at most. Universities have taken the lead by instituting their own policies and guidelines. There is no current federal guideline against chimera products. Issues are being addressed along party ideology while private sector are moving forward. The policy window has already been operational in some private sectors. The policy window need for a national guideline is dire.
References
https://www.organdonor.gov/about/data.html
https://www.cnn.com/2016/06/09/health/human-organs-chimera-irpt/index.html