New recommendations for human genome editing

Given how controversial genetically modified corn is, it's no wonder that the prospect of genetically modifying humans pushes a lot of people's buttons. But we already have gene therapies, and new technologies are making it faster, safer, and less expensive to modify the human genome in a range of ways. That has the science community and policymakers scrambling to set responsible guidelines for the use of genome editing.

In 2015, the International Summit on Human Gene Editing recommended holding off until the methods could be shown safe and effective, and until there was some public consensus about their use. Last week, the National Academies of Science, Engineering, and Medicine released recommendations that suggested at least some of those criteria had been met.

The bottom line, according to report co-chair Richard Hynes of M.I.T., is this:

In all cases, the panel recommended public input on the appropriate uses of genome editing. But there remain enormous questions - what that public engagement should look like, how consensus might be defined or achieved, and how public opinion would translate into federal - or even international - policy.

Guests:

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National Academy Calls for Public Input on Human Genetic ... - WCAI - WCAI

Last week, an international panel of scientists and ethicists concluded that changing heritable aspects in human genes would be permissible under certain conditions, going further than any previous mainstream group in endorsing the long-term aim of producing gene-edited babies ("Gene-edited babies: From red light to orange... and then green?"; Feb 20).

The most straightforward and unique advantage of genetic engineering is that it prevents the inheritance of devastating genetic diseases, such as cystic fibrosis, beta thalassemia or Huntington's disease.

It could also be used to modify genes to lower the risk of contracting diseases like HIV/AIDS.

However, it may be impossible to draw a line between using this technology for "therapy" and using it for "enhancement".

On practical grounds, genetic enhancement procedures could potentially lead to the widening of the rich-poor divide in society, as the wealthy would be able to engineer smarter, healthier and more attractive children, thus giving them even greater advantages in life.

From an ethical point of view, it is important to consider whether parents or medical professionals have the inherent right to alter a baby before it has been born.

As scientists focus on accomplishments and whether a thing can be done, they must also stop to ask if it should be done.

A baby cannot consent to having his body altered. Genetically engineering a child would be a violation of his fundamental right to bodily integrity.

Another ethical issue to consider would be the loss of individuality in a society that prides itself on conformity. This could open the door to eugenics.

It would be wise to exercise caution on this issue. As scientists focus on accomplishments and whether a thing can be done, they must also stop to ask if it should be done.

International scientific bodies should not only implement stringent regulations on genetic engineering practices, but also engage actively and effectively with politicians and the public to ensure a sturdy legal framework.

Denise Lee Hui Jean (Ms)

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Proceed with caution on genetic engineering - The Straits Times

Consider the work of God; for who can make that straight, which He hath made crooked? Ecclesiastes 7:13 (The Israel Bible)

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New technology enabling scientists to manipulate genes, mixing human genes and organs with those of animals, is a disturbing trend in science which one rabbi believes mirrors the sin that led to global destruction in the generation of Noah.

Last week, the National Academies of Sciences and Medicine released a new report including recommendations to ensure genetic research done in the United States is performed responsibly and ethically. In essence, this report gave the greenlight to gene research, even though funding for such research is currently banned by the government because of the ethical dilemmas it raises.

The new technology bears with it practical risk. Genetic research can take two forms: gene editing to cure or prevent disease, and gene editing to enhance humans. Genetics is uncharted territory and scientists could accidentally introduce a dangerous mutation that will harm future generations, or, in an attempt to create vaccines, inadvertently create a superior form of the disease which could threaten mankind.

Rabbi Moshe Avraham Halperin of the Machon Madai Technology Al Pi Halacha (the Institute for Science and Technology According to Jewish Law) stated in response to the report that there are clear Torah guidelines for this new technology. Rabbi Halperin referred to the Biblical law concerning mixing of species.

Thou shalt not let thy cattle gender with a diverse kind: thou shalt not sow thy field with mingled seed: neither shall a garment mingled of linen and woollen come upon thee. Leviticus 19:19

It is forbidden to create a creature that is a mixture of species, but as long as they are not producing a new creature that has a different form, it is permitted, Rabbi Halperin told Breaking Israel News.

However, he noted, Improving species, even the human race, is not forbidden by Jewish law. Changing the color of the skin or hair is permitted, even more so when it concerns removing genetic maladies. But the process certainly needs oversight.

Rabbi Yosef Berger, rabbi of the Tomb of King David on Mount Zion, stressed that the issue of mixing species had serious Biblical ramifications, noting that the verse forbidding mixing breeds of animals directly preceded a section of the Torah dealing with sexual impropriety.

And whosoever lieth carnally with a woman, that is a bondmaid, betrothed to an husband, and not at all redeemed, nor freedom given her; she shall be scourged; they shall not be put to death, because she was not free. Leviticus 19:20

The rabbi explained the connection between the two distinct commandments.

This is also expressed in the sin of the generation of Noah, which, according to Jewish tradition was the forbidden mixing of animals and man, Rabbi Berger told Breaking Israel News, quoting Genesis.

And Hashem said: I will blot out man whom I have created from the face of the earth; both man, and beast, and creeping thing, and fowl of the air; for it repenteth Me that I have made them. Genesis 6:7

Noahs generation sinned sexually, but it was expressed in the mixing of species, he explained.

This sexual sin could prevent the coming Messianic era as the connection between man and woman is a holy part of the process of bringing geula (redemption). This is the basis of the requirement to be fruitful and multiply: to bring Moshiach (Messiah).

Rabbi Berger stressed that this mitzvah(Torah commandment) requires a proper level of purity. Mixing of species is an improper manifestation of procreation that led to the destruction of the generation of Noah.

Thus, even when saving lives, one of the most important mitzvot, one must be mindful of dangers and limits, Rabbi Berger cautioned.

The limits of science and ethics are indeed being expanded and tested in remarkable ways. In 2015, several groundbreaking experiments took place in genetic engineering. A herd of cloned cattle, genetically engineered with human DNA, were used to incubate antibodies against the Ebola virus. In the same year, scientists at Duke University announced that they had successfully boosted brain size in mice by using human DNA as a catalyst.

Also at Duke, kidneys from aborted human fetuses were transplanted into rats in order to determine if human organs could be grown in animals, solving the problem of organ donations.

In one particularly disturbing case, geneticists in China modified the DNA of human embryos, concentrating on the gene responsible for -thalassaemia, a potentially fatal blood disorder. However, in their final report, the researchers said they found a surprising number of unintended mutations.

These experiments illustrate just some of the astounding areas researchers are exploring. The science involved is staggering, but the ethical considerations are even more perplexing, and less likely to receive clear-cut answers.

Certain areas of research in the United States are stalled until the issue of abortions is resolved, establishing once and for all the legal status of fetuses and embryos. Manipulating genes in utero to eradicate genetic disease can alleviate great suffering, but brushes up against eugenics, the intentional improving of the human race. Negative eugenics were first espoused by the Nazis and other racist ideologies as a method of creating a master race.

The research takes on dark spiritual overtones in the context of the growing transhumanism movement, which believes that the human race can evolve beyond its current physical and mental limitations by means of science and technology.

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Is Genetic Engineering Recreating the Sin of Noah's Generation? - Breaking Israel News

A cancer treatment with genetically engineered cells may change how we think about human modification.

By Michael White

When Mary Shelley wrote Frankenstein 200 years ago, there was no such thing as genetic engineering, and nobody knew what a gene was. But Shelleys sense that it is wrong, even monstrous, to tinker with the building blocks of life haunts genetic engineering today. This is especially true of human genetic engineering, which our popular culture often portrays as an obsession of mad scientists or a totalitarian tool of social control. Weve inherited our views of human genetic engineering from a time when it was just an idea, not a reality. But now that the reality is here, it turns out that widespread human genetic engineering, at least in its initial form, wont look as radical as we thought it would.

One sign that routine human genetic engineering has nearly arrived appeared earlier this month, when the Food and Drug Administration allowed French biotechnology company Cellectis to initiate United States clinical trials for a new cancer therapy. The therapy is based on so-called CAR-T cells (chimeric antigen receptor T cells), which are human immune cells genetically engineered to be cancer fighters. Various forms of CAR-T therapy have been in clinical trials for a few years now, and scientists first started trying to build the cells in the late 1980s. But whats notable about the Cellectis CAR-T cells is that they are the first off-the-shelf version. That is, unlike other CAR-T therapieswhich are custom products made by genetically engineering each patients own cellsCellectis manufactures CAR-T cells from healthy donors. Human genetic engineering is about to become a commodity trade.

Whats striking about CAR-T therapiesboth the custom form and Cellectis off-the-shelf versionis that they are simultaneously a radical departure and an incremental step from existing medical techniques. In practice, CAR-T therapies involve a familiar procedure, the transfer of cells into a patient to treat an illness. The first successful human blood transfusion was performed in 1818 (coincidentally, the year Frankenstein was published), and the first bone marrow transplant to treat leukemia occurred in the 1950s. Seen from this angle, CAR-T therapy is just a new variation on an old theme.

But though CAR-T therapy may look familiar, it is unprecedented. The first CAR-T treatments for cancer may become generally available within the year, despite some recent setbacks. This means that, over the coming years, there will likely be hundreds of thousands, and eventually millions, of people treated with genetically engineered human cells. This is what the first widespread use of human genetic engineering is going to look like.

Scientists have long anticipated this development because the powerful genetic tools that we routinely use to control biology in a petri dish have such obvious medical potential. We shut genes on or off at will, add or subtract them, and even build synthetic genes with new functions. The advantage of genetic engineering for medicine is that, unlike chemical drugs, cells are functioning systems with the ability to sense signals, to make decisions, and to perform complex behaviors. Cellular signal-sensing and decision-making are key built-in features of the cells that make up our immune system; CAR-T technology harnesses those abilities to help the immune system train its tremendous firepower on cancer cells. Genetic engineering is essentially a form of biological reprogramming, and scientists talk about building CAR-T cells with AND, NOT, and OR circuits; feedback control systems; and kill switches. No drug will ever have those capabilities.

Reprogramming human biology like this may sound ethically suspect in the abstract, but when were talking about a life-saving therapy for someones child or grandparent, its hard not to be sympathetic. Human genetic engineering is thus making its entrance to society as a medical treatment that, on the surface, seems incremental, avoiding the drama and questionable ethics that we expected.

There is an upside and downside to this. The obvious benefits of something like CAR-T therapy make it easier to set aside any knee-jerk moral disgust with genetic engineering, and instead think clearly about ethical boundaries. But the risk is that we become too complacent about the ethics, especially as genetic engineering for health purposes comes to seem normal.

For this reason, its fortunate that the U.S. National Academy of Sciences has just released a report laying out ethical guidelines for human genetic engineering. Recognizing that human genetic engineering is no longer just a fantasy, the report lays out two key questions we should ask ourselves as we consider whether particular cases of human genetic engineering are justified.

Most importantly, we should ask: Is the genetic change limited to one person, or will it be passed on to future generations? Patients who receive CAR-T cells dont transmit the genetic edits on to their children, and thus each patient can choose for herself whether to accept any risks posed by genetic engineering. But children who are born from genetically modified embryos will pass on those modifications, together with any associated health risks or social stigmas, to their descendants. The National Academy report therefore argues that we should set a much higher ethical bar for genetic edits to human embryos, only allowing them as a last resort to prevent certain inherited genetic diseases.

The second question to pose is: What is the purpose of the genetic editsto cure disease or to simply enhance human abilities? The report recommends that human genetic engineering should only be aimed at curing disease, and that genome editing for enhancement should not be allowed at this time. That rules out genetic engineering to, say, make someone a better athlete. Why? The report provides two reasons: First, the technology still poses risks that arent outweighed by any benefits of enhancement. And second, the public doesnt seem ready to go there yet. A society in which only the rich have access to genetic enhancements, or, conversely, where everyone is under tremendous social pressure to buy such enhancements, sounds as dystopic as science fiction.

But the question of what qualifies as enhancement is almost certainly going to be a sticking point, because there is a wide range of things you can do between curing cancer and producing super-athletes. What if a company sells a product like CAR-T cells that, rather than fighting cancer, prevents it instead? If you use genetic engineering to lower your cancer risk, is that enhancement? If it is, why should we reject it?

The National Academy report purposely leaves the answer to such questions unanswered, recognizing that there are inevitable differences, rooted in national cultures, that will shape perspectives on whether and how to use these technologies. Our national cultures perspective has been shaped by 200 years of science fiction. But as human genetic engineering becomes realtaking the form of a life-saving cancer treatmentwe will get used to it, and our perspective is likely to change.

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This Is What Real Human Genetic Engineering Looks Like - Pacific Standard