CHIMERAS AND OTHER FEARSOME CREATURES, 2016


http://www.npr.org/sections/health-shots/2016/08/04/488387729/nih-plans-to-lift-ban-on-research-funds-for-part-human-part-animal-embryos

NIH Plans To Lift Ban On Research Funds For Part-Human, Part-Animal Embryos
Rob Stein
August 4, 2016 9:01 AM ET

Photograph -- Pablo Ross of the University of California, Davis, inserts human stem cells into a pig embryo as part of experiments to create chimeric embryos.
Rob Stein/NPR
SHOTS - HEALTH NEWS -- In Search For Cures, Scientists Create Embryos That Are Both Animal And Human, Jeannie Phan for NPR


“The federal government announced plans Thursday to lift a moratorium on funding of certain controversial experiments that use human stem cells to create animal embryos that are partly human.

The National Institutes of Health is proposing a new policy to permit scientists to get federal money to make embryos, known as chimeras, under certain carefully monitored conditions.

The NIH imposed a moratorium on funding these experiments in September because they could raise ethical concerns.

One issue is that scientists might inadvertently create animals that have partly human brains, endowing them with some semblance of human consciousness or human thinking abilities. Another is that they could develop into animals with human sperm and eggs and breed, producing human embryos or fetuses inside animals or hybrid creatures.

But scientists have argued that they could take steps to prevent those outcomes and that the embryos provide invaluable tools for medical research.

Jeannie Phan for NPR

For example, scientists hope to use the embryos to create animal models of human diseases, which could lead to new ways to prevent and treat illnesses. Researchers also hope to produce sheep, pigs and cows with human hearts, kidneys, livers, pancreases and possibly other organs that could be used for transplants.

To address the ethical concerns, the NIH's new policy imposes several restrictions.

The policy proposes prohibiting the introduction of certain types of human cells into embryos of nonhuman primates, such as monkeys and chimps, at even earlier stages of development than what was currently prohibited.

The extra protections are being added because these animals are so closely related to humans.

But the policy would lift the moratorium on funding experiments involving other species. Because of the ethical concerns, though, at least some of the experiments would go through an extra layer of review by a new, special committee of government officials.

That committee would, for example, consider experiments designed to create animals with human brain cells or human brain tissue. Scientists might want to create them to study neurological conditions such as Alzheimer's and Parkinson's diseases. But the experiments would undergo intensive scrutiny if there's any chance there might be a "substantial contribution" or "substantial functional modification" to an animal's brain.

In addition, the NIH would even consider experiments that could create animals with human sperm and human eggs since they may be useful for studying human development and infertility. But in that case steps would have to be taken to prevent the animals from breeding.

"I am confident that these proposed changes will enable the NIH research community to move this promising area of science forward in a responsible manner," Carrie Wolinetz, the NIH's associate director for science policy, wrote in a blog post.

"At the end of the day, we want to make sure this research progresses because its very important to our understanding of disease. It's important to our mission to improve human health," she said in an interview with NPR. "But we also want to make sure there's an extra set of eyes on these projects because they do have this ethical set of concerns associated with them."

Several scientists said they are thrilled by the new policy. "It's very, very welcome news that NIH will consider funding this type of research," says Pablo Ross, a developmental biologist at the University of California, Davis, trying to grow human organs in farm animals. "We need funding to be able to answer some very important questions."

But critics denounced the decision. "Science fiction writers might have imagined worlds like this — like The Island of Dr. Moreau, Brave New World, Frankenstein," says Stuart Newman, a biologist at New York Medical College. "There have been speculations. But now they're becoming more real. And I think that we just can't say that since it's possible then let's do it."

The public has 30 days to comment on the proposed new policy. NIH could start funding projects as early as the start of 2017.”



http://osp.od.nih.gov/under-the-poliscope/2016/08/next-steps-research-using-animal-embryos-containing-human-cells

Next Steps on Research Using Animal Embryos Containing Human Cells
August 4, 2016

Biomedical researchers have created and used animal models containing human cells for decades to gain valuable insights into human biology and disease development. For example, human tumor cells are routinely grown in mice to study cancer disease processes and to evaluate potential treatment strategies. To advance regenerative medicine, it is common practice to validate the potency of pluripotent human cells – which can become any tissue in the body – through introducing them into rodents.

With recent advances in stem cell and gene editing technologies, an increasing number of researchers are interested in growing human tissues and organs in animals by introducing pluripotent human cells into early animal embryos. Formation of these types of human-animal organism, referred to as “chimeras”, holds tremendous potential for disease modeling, drug testing, and perhaps eventual organ transplant. However, uncertainty about the effects of human cells on off-target organs and tissues in the chimeric animals, particularly in the nervous system, raises ethical and animal welfare concerns.

Currently, the 2009 NIH Guidelines for Human Stem Cell Research specifically prohibit introducing human pluripotent cells into nonhuman primate blastocysts and the breeding of animals into which human pluripotent cells may have contributed to the germ line (egg or sperm cells). Given the direction of the science, however, NIH felt that it was an appropriate time to consider whether further policy provisions regarding other chimera models were needed before making funding decisions. Therefore, as I wrote about last fall, NIH instituted a funding moratorium in September 2015 (NOT-OD-15-158) for research proposing to introduce human pluripotent cells into animal embryos prior to gastrulation stage—the beginning of development of the three germ layers.

Since the moratorium was issued, NIH has reviewed the state of the science and also convened a workshop in November 2015 to bring together leading experts in the field of chimera research and animal welfare. Today, NIH has published in the Federal Register and the NIH Guide to Grants and Contracts a proposal to make two changes to our policy in this area, for which we are seeking public comment (a table summarizing the proposed changes also appears at the end of the blog to assist stakeholders.) First, NIH is establishing an internal NIH steering committee to provide programmatic input to NIH Institute and Center Directors in making funding decisions for two areas of research in which:

human pluripotent cells are introduced into non-human vertebrate embryos, up through the end of gastrulation stage, with the exception of non-human primates, which would only be considered after the blastocyst stage, or

human cells are introduced into post-gastrulation non-human mammals (excluding rodents), where there could be either a substantial contribution or a substantial functional modification to the animal brain by the human cells.

NIH is seeking public comment on the proposed scope of the chimera research to be considered by the NIH steering committee. The committee will focus on the experimental design and likely nature of the chimeric animal model. The committee’s work will be independent of the peer review process. This committee will also monitor new developments in this field and provide analysis and advice to NIH leadership as needed.

NIH is also seeking comment on modifications to the NIH Guidelines for Human Stem Cell Research, where we propose to slightly expand the current prohibition on the introduction of human pluripotent cells into non-human primate embryos to include the preblastocyst stage, and to clarify that NIH will not fund research involving the breeding of animals where the introduction of any type of human cell may result in human egg or sperm development.

These actions are consistent with recently updated guidelines from the International Society for Stem Cell Research (ISSCR), which suggest that a specialized review of certain types of chimera research is appropriate. The ISSCR guidelines also contain useful suggestions of best practices for experimental design, which I encourage the research community to consider.

I am confident that these proposed changes will enable the NIH research community to move this promising area of science forward in a responsible manner. I encourage those interested in this field to provide comments on these proposals referred to in the related links. While NIH awaits public comment, the moratorium on NIH funding for such research (NOT-OD-15-158) will remain in effect.

Draft Chimera Policy Framework
Key Embryonic Stages of Development
Fertilized Egg → Preblastocyst (Morula) → Blastocyst → Gastrula

Proposed Expansion of NIH Guidelines for Human Stem Cell Research

Current Stem Cell Prohibitions
Proposed Stem Cell

Expanded Prohibitions Nonhuman primate embryos
No human embryonic stem cells or iPS cells (derived from adult tissues) into non-human primate blastocyst-stage embryos Expanded to include the restriction on earlier stage (pre-blastocyst) of non-human primate embryos
Breeding No breeding of animals where the introduction of human hESC or iPS cells may contribute to germ line (i.e. make human egg or sperm) Expanded to no breeding of animals where any human cells may contribute to germ line

Proposed Scope of Chimera Research Considered by new NIH Steering Committee

Early Embryos
Neural Contribution/Effect

Research in which human pluripotent cells are introduced into non-human vertebrate embryos, up through end of gastrulation stage*

*Note that NIH will not fund research introducing human pluripotent cells into non-human primate embryos through the blastocyst stage, per stem cell guidelines, but committee would consider introduction of human cells into non-human primate gastrula stage embryos.

Research in which human cells are introduced into post-gastrulation non-human mammals (excluding rodents) where there could be:

substantial contribution to animal brain or
substantial functional modification to animal brain




In medicine, science, business, policing, government, and in fact, everything, we do need laws. People simply can’t be trusted to always "do the right thing,” even if they do actually know what that is. As one scientist Stuart Newman in the article above said,"There have been speculations. But now they're becoming more real. And I think that we just can't say that since it's possible then let's do it."

There's a growing group out there, mainly in small towns or rural areas, who call themselves "Sovereign Citizens." Their feeling is that the law shouldn't restrict anything that we want to do. Their views are so often against our system of civil rights for all. They depart so far from a normal, sensible, responsible, humane way of looking at the world that they are dangerous.

One such person was in the news fifteen or twenty years ago for taking a dislike to a city clerk about his being asked to pay taxes and took a shot at her. Another, in Texas I think, didn't like a man in the neighborhood and left a live rattlesnake in his mailbox. They aren't just insane. They're hostile. In other words, they need to be in either a prison or a locked ward. Being insane and walking around the streets that way is not illegal, but it isn't being treated as an illness, either. The law says that if they are “a danger to themselves or others” they can be (not must be) committed involuntarily to a locked ward until they recover. Pardon me for saying so, but SOME scientists are also “nuts.” People can be brilliant and insane at the same time.

It seems clear to me that, if it is cruel and unthinkable to allow a fetus so mentally or physically damaged that it will never be viable to be born, then no scientist should create a total misfit which can only be killed after the experimentation is over. We are facing this issue now with the Zika virus. Likewise, to make a creature which would only be usable for scientific experimentation, and certainly couldn’t ever take a place in either human or animal society; that would/should be absolutely illegal and punishable by a lengthy prison term. My memories go back to the ‘50s when people were still frequently talking about things that Hitler’s doctors and “scientists” did in the name of knowledge.

I did look at the proposed changes to the NIH rules and two, especially, would be disturbing to me. That is the insertion of human cells into an animal brain to enhance its’ function. That seems to imply going beyond the fetus stage or that result couldn’t be tested, though the articles don’t say how old the scientists would allow a fetus to be before the cells were destroyed.

I’ve seen photographs at least twice of bizarre “creatures” – first, a mouse with a human ear growing out of its’ side; and second, a “jellyfish rat.” (http://thehightechsociety.com/jellyfish-rat-chimera-ddzd6pxthg38/.) That makes headlines, and I’m sure it represents an advance in our knowledge and technical expertise, but it is truly repulsive to me, and it doesn’t look useful either. I’m not one to ban all science that isn’t immediately useful, because I know that one piece of new information often leads to another, with perhaps only the last stages being “useful.” I believe that scientists should contribute to the knowledge of the universe, and that, to me, is the final test of the value of their work, rather than merely the creation of new inventions, but in so doing, they should consciously avoid doing unethical work. "Do no harm."

I don’t think the proposed goal (see the second article above) of “Research in which human cells are introduced into post-gastrulation non-human mammals (excluding rodents) where there could be: substantial contribution to animal brain, or substantial functional modification to animal brain.” If we make an ape or monkey that can keep house or nurse the sick, what will our society begin to look be like. The really excellent sci-fi films Planet of the Apes and Return to Planet of the Apes, plus a great sci-fi TV drama called “Murder and the Android” spring to my mind. And finally, “Greystoke, the Legend of Tarzan, Lord of the Apes.” I know, that kind of sci-fi is farfetched, but it tells an important truth.

We are not the only “worthwhile” creature on this Earth. When a sentient being is relegated to a position of pain due to its’ place in life or being little more than a pincushion for testing, it is very sad indeed. A mouse, I’m pretty sure doesn’t have longings of any kind, or sensitive emotion. If, however, its’ brain were to be enhanced to the point that it does have emotion as we know it, then having that horrible electrode sticking out of its’ skull would feel to it as terrible as it looks to me. So, take care, scientists.

I’m afraid that we, as a society, need to go back to that time period of Hitler’s rule in Europe, and study the things that unfolded then. We have forgotten about them and are "backsliding" to an unethical society these last 10 or so years. I don’t exactly believe that there are “souls” separable from the body, even in humans, but I do know that sentient beings do feel physical and emotional pain if they are as intelligent as a dog or a cat, and CERTAINLY a primate. This lies within the range that I tend, in my Unitarian way, to call “sin” and “evil.” It’s one of the primary symptoms of sociopathy to have no awareness or concern about the pain of others (yes, even “animals”). We forget that all life forms that are not plants are animals, and that includes us. There’s an old Southern Black phrase that is very meaningful: “God don’t make trash!” In short, I do not approve of this kind of research, unless it uses ONLY tissue or a very small embryo, and not a whole living being with nerves and a brain. What happened to scientists using tissue culture instead of basically cruel animal treatment for such experiments? Please don’t go this route unless it is really necessary.

“The public has 30 days to comment on the proposed new policy. NIH could start funding projects as early as the start of 2017.”