Category Archives: Human Genetic Engineering

Enlarge / Scanning electron micrograph of a human T cell.

For the first time, the Food and Drug Administration has approved a therapy that involves genetically engineering a patients own cells, the agency announced Wednesday.

The therapy, called Kymriah (tisagenlecleucel) by Novartis, will be used to reprogram the immune cells of pediatric and young adult patients with a certain type of leukemia, called B-cell acute lymphoblastic leukemia. During a 22-day out-of-body retraining, patients immune cellsspecifically T cells that patrol the body and destroy enemiesget a new gene that allows them to identify and attack the leukemia cells.

Such therapies, called CAR-T therapies, have shown potential for effectively knocking back cancers in several trials, raising hopes of researchers and patients alike. But they come with severe safety concernsplus potentially hefty price tags.

Nevertheless, the FDA announced its approval with fanfare and optimism, calling it a historic action. In the announcement, FDA Commissioner Scott Gottlieb said:

Were entering a new frontier in medical innovation with the ability to reprogram a patients own cells to attack a deadly cancer. New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses. At the FDA, were committed to helping expedite the development and review of groundbreaking treatments that have the potential to be life-saving.

Like all CAR-T therapies, Kymriah involves reprograming body-guard T cells to contain a gene that codes for a protein called chimeric antigen receptor or CAR. This protein allows the T cells to recognize and attack cells that have a protein called CD19 hanging off themwhich leukemia cells do.

In the Kymriah procedure, researchers first harvest T cells from a patient and then send them to a manufacturing center. There, researchers insert the CAR gene into the immune cells using a virus. The process takes 22 days, Nature reported.

In an earlier trial, 52 of 63 participants (82.5 percent) achieved overall remission after undergoing the therapy. The trial is unpublished and lacked controls, so its not possible to determine Kymriahs influence. But trials of other CAR-T therapies have shown similarly high rates of remission. And the early results were enough to sway an external panel of FDA scientific advisors in July. In a unanimous vote on July 12, the panel recommended that the FDA approve Kymriah.

This is a major advance and is ushering in a new era, panel member Malcolm Smith, a pediatric oncologist at the US National Institutes of Health in Bethesda, Maryland, told Nature at the time.

But, the story isnt all rosy. CAR-T therapies are known to cause life-threatening immune responses called cytokine storms or cytokine release syndrome (CRS). This can lead to systemic full body inflammation, with organ failure, seizures, delirium, and brain swelling. Several trials of therapies similar to Kymriah have reported deaths.

In the Kymriah trial, 47 percent of patients experienced some level of CRS, but none died. Novartis reported that it was able to manage all the cases of CRS.

The FDA noted the risk in todays announcement and also revealed that it had expanded the approved use of a drug called Actemra, which treats CRS, so it can be used in patients who receive CAR-T therapy. The FDA also approved Kymriah with a risk evaluation and mitigation strategy or (REMS). This involves additional safeguards such as extra training and protocols for healthcare providers.

For now, though, Kymriah is only approved for use in patients aged 25 or younger who have failed conventional therapies or relapsed since undergoing those therapies. Of the roughly 3,100 patients aged 20 or younger who are diagnosed each year with acute lymphoblastic leukemia, about 15 to 20 percent will fail treatment. For these patients, Kymriah may be a literal life-saver, as there are few alternatives.

But along with the frightening side effects, gene therapy may also come with a hefty price tag. UK experts have appraised one round of therapy at $649,000. Its still unclear what the actual cost will be and what patients will end up having to pay.

In a press release, Novartis announced that its working with Centers for Medicare and Medicaid Services to come up with outcomes-based pricing. Also in the release, Bruno Strigini, CEO of Novartis Oncology, added:

We are so proud to be part of this historic moment in cancer treatment and are deeply grateful to our researchers, collaborators, and the patients and families who participated in the Kymriah clinical program. As a breakthrough immunocellular therapy for children and young adults who desperately need new options, Kymriah truly embodies our mission to discover new ways to improve patient outcomes and the way cancer is treated.

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First genetic engineering therapy approved by the FDA for leukemia - Ars Technica

There are two ways to upgrade a human - tinker with biology or augment with technology. So when the time comes to upgrade to human 2.0, should we become Bioshock-style splicers or Halo-esque spartans?

This week we look at the science behind a genetic boost.

Science fiction isnt afraid to mess with genetics. Bioshocks ADAM is a syrup of stem cells augmented with plasmids that carry superhuman genetic traits. Preys Neuromod enhances cognitive abilities by splicing alien genetics into viruses delivered directly into the brain through the eyes. And Prototype's Blacklight gets in to cells and tweaks their genetic code, activating and editing dormant sequences.

So how close are we to game-changing genetic upgrades?

(Image: I.C. Baianu et al.)

The genetic revolution started in the 1950s with two wily Cambridge scientists. With data nabbed from colleagues in London, Watson and Crick deciphered the structure of DNA and opened Pandoras box. Since then, the field has moved fast, and it's littered with Nobel Prizes.

By the mid 1970s, scientists had discovered DNA-snipping molecular scissors known as restriction enzymes, and DNA-stitching enzymes called ligases. It became possible to cut and splice the genetic code, stitching components from different organisms to create recombinant DNA.Bacteria were turned into factories, churning out molecules that they were never intended to make, and genetic engineering began in ernest.

(Image: Bethesda)

In the 1980s, everything sped up. Polymerase chain reaction (PCR) was invented, allowing chunks of DNA to be copied millions of times in a matter of hours. And DNA sequencing became automated, enabling the genetic code to be read faster than ever before.

And the next logical step once you can read the genetic code? Read all of it.

In 2003, the Human Genome Project was completed , revealing the recipe for a human in its entirety. All three billion letters and over 20,000 genes. And, what took an international team decades can now be repeated in days.

We've got the manual to make a human being. We have the tools to read, write and edit DNA. Time to get creative.

(Image: Irrational Games/2K Games)

Interested in making fire with your fingers? Bioshock-style plasmids are already here. Every day scientists stuff them with genes and jam them into cells to give them new abilities.

Real-world plasmids are loops of DNA most often found in bacteria, where they carry genes for useful traits like antibiotic resistance. They replicate independently of the main bacterial genetic code and can be swapped between cells like trading cards that upgrade the microbes' abilities.

And, with a molecular toolkit, they can be cut open and edited, carrying thousands of letters of genetic code like miniature trojan horses.

(Image: Minestrone Soup )

Plasmids can force cells to make new molecules or switch the behaviour of their existing genes. Bacteria will make infinite copies of them on demand. And, they can be frozen down and stored for years.

But, they tend stay out of chromosomes, floating about in the cell and never meshing with the host unless some serious selective pressure is applied.

They're good for a temporary upgrade, but maybe not for a permanent human 2.0 changes. Maybe thats why splicers need a constant ADAM or EVE fix to keep their abilities topped up.

(Image: 2K Games)

Looking for something a little more permanent than a plasmid? Augments in Prey are delivered by viruses, a step up in terms of persistence.

Retroviruses (like HIV) stitch their own genetic code into the code of the cells they infect, permanently merging with their host to ensure that their genes remain active generation after generation. Every time the cell copies its own DNA, it copies the viral genes too.

So, scientists stripped them out, snipping away the genes that cause disease and turning them into empty genetic transport vessels.

(Image: Bethesda Softworks)

Like plasmids, these 'viral vectors' can be stuffed with genetic code, but this time theyll stitch the new genes straight into the cell, adding the new trait permanently. This is the tech is used in Prey to deliver alien genetics into human brains.

Trouble is, viruses aren't that picky about where they choose to integrate. And, if they tuck their DNA right in the middle of something important, they can ruin a crucial gene and destroy the cell they've infected. Worse still, inserting into some genes can cause cancer.

Then there's the problem of getting them to infect the right cells. If you want fire at your fingertips, you'd need a virus that knew the difference between a hand and a foot.

Scientists are working on improving the usability of viral vectors, but to achieve true human 2.0 without the unpredictable side effects, we'll probably need a more targeted approach. Enter CRISPR.

(Image: Thomas Splettstoesser)

Bioshock or Prey-style approaches to gene editing work well, but they're fuzzy and they take time. CRISPR delivers precision genetic manipulation, fast.

Here's how it works.

Viruses, known as bacteriophages, inject their genetic code into bacteria, turning the microbes into miniature virus factories. But the bacteria evolved a way to fight back.

When they come under attack, they store strips of viral genetic code in a CRISPR reference library so that they'll have a head start if the virus returns. When it attacks again, they check the library and an enzyme called Cas9 chops out any matching code, stopping the infection in its tracks.

(Image: National Human Genome Research Institute (NHGRI) from Bethesda, MD, USA)

The great thing about CRISPR is that it's programmable. Give Cas9 a 20-letter strip of genetic code to guide it, and it'll chew up any DNA you want. These are quick and cheap to make in the lab, and the sequence can be made to match all kinds of different genes. And, when the cell goes to repair the cut, you can swoop in with any new DNA you want to add.

The technique has the scientific community so excited that it was named 'breakthrough of the year' by Science in 2015. But is the world about to be overrun with splicers?

(Image: Ingrid Moen et al. 2012)

Splicers can make fire with their hands, hurl balls of ice and cling to the ceiling like spiders. Morgan Yu can morph into a cup, superheat plasma and create telekinetic shields. What could we do with CRISPR at our disposal?

So far, scientists have repaired a gene that causes muscular dystrophy in mice, and they're trialling the technique to reprogram immune cells in people with cancer. We're now in a CRISPR arms race as scientists across the world rush to be the first to make a gene editing breakthrough.

(Image: Bethesda)

It's early days, but the tech has a lot of potential. We could edit single letter mistakes in genetic code, switch genes off, turn genes on, make genetic tweaks. Or, best of all, we could borrow genes from other species and smash them into our cells to acquire traits we were never supposed to have, glow in the dark jellyfish genes, anyone?

In 2010, scientists created the first synthetic cell. In 2016, they designed and built a genome. In the future, it's possible that we could design brand new genes of our own.

Let's face it, this is still a dream, but the toolkit to make it happen is there.

We still don't know what all of our DNA is for, let alone what changes we'd need to make to improve it. Good luck finding the right genes to edit if you're looking to make yourself taller, smarter or funnier, let alone inventing one that'll give you wings.

And then there's the issue of inheritance. Editing adult, or 'somatic', cells could change a person Bioshock-style, but editing sperm and eggs, or 'germline' cells, could change a whole species.

At the moment, genetic engineering tech is moving faster than the regulation to control it, and it's got scientists worried. We all saw what happened to Rapture when the brakes were taken off scientific advancement.

Gene editing germline cells is restricted in many countries, including the UK, but in July 2017, Chinese scientists got CRISPR working in human embryos for the first time. It was a huge breakthrough, but out of 86 embryos only 28 were successfully edited, and not all of them ended up with the right gene mod at the end.

Rapture, a city where the artist would not fear the censor, where the scientist would not be bound by petty morality, Where the great would not be constrained by the small! And with the sweat of your brow, Rapture can become your city as well.

Luckily, no-one is trying to take edited human embryos all the way though to birth, yet. But, CRISPR opens a whole can of ethical worms, and if youre in any doubt that human modification is coming, watch this.

Pandora's box is open, and we're betting humans of the future will be genetically augmented, but it isn't the only way our species could upgrade. Come back next week when we'll be looking at tech and what it'd take to join the ranks of Halo's Master Chief or Deus Ex's Adam Jensen.

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Genetic engineering: upgrading to human 2.0 - T3

Should we welcome human genetic engineering? Tyler Cowen

If you could directly alter your kids genetic profile, what would you want? Its hard to know how the social debate would turn out after years of back and forth, but I was dismayed to read one recent research paper by psychologists Rachel M. Latham and Sophie von Stumm. The descriptive title of that work, based on survey evidence, is Mothers want extraversion over conscientiousness or intelligence for their children. Upon reflection, maybe that isnt so surprising, because parents presumably want children who are fun to spend time with.

Would a more extroverted human race be desirable, all things considered? I genuinely dont know, but at the very least I am concerned. The current mix of human personalities and institutions is a delicate balance which, for all of its flaws, has allowed society to survive and progress. Im not looking to make a big roll of the dice on this one.

Amazon robots bring a brave new world to the warehouse The Financial Times

Another way to look at US wage growth The Financial Times

The robot tax gains another advocate Wired

Kim got the idea of a robot tax from Bill Gates, who mentioned it in an interview in February. Since then, shes been meeting with stakeholdersunions and business types and the likeabout how San Francisco, and California, might explore such a thing.

Among the issues with a robot tax: What is a robot? Even roboticists have a hard time agreeing. Does AI that steals a job count as a robot? (Nope, but youd probably want to tax it like one if youre going to commit to this.) Were still working on what defines a robot and what defines job displacement, Kim says. And so announcing the opening of the campaign committee is going to also allow us to have discussions throughout the state in terms of what the actual measure would look like.

Video: Powerball lotteries and the endowment effect Marginal Revolution

3,700-year-old Babylonian tablet rewrites the history of math The Telegraph

Winner-takes-all effects in autonomous cars Benedict Evans

Transcript: Gary Cohn on tax reform and Charlottesville The Financial Times

FT: So what exactly will you have in the tax bill?

GC: On the personal side, we have protected the three big deductions charitable, mortgage and retirement saving. We want to raise the standard deduction caps and get rid of many of the other personal deductions. We want to get rid of death taxes and estate taxes.

On the business side, we are proposing to get rid of many of the deductions that companies can take right now to lower taxable income. At the moment we start with a high corporate tax rate in America but companies use deductions: what we are trying to do is get everyone to pay at a lower rate. This is a big base-broadening exercise.

Revenue may decline in the medium term but it will then explode for the government. When we grow the economy we will see substantial growth in revenue.

The rest is here:
Around the web: Concerns with human genetic engineering, Gary ... - American Enterprise Institute

Should we welcome human genetic engineering? Tyler Cowen

If you could directly alter your kids genetic profile, what would you want? Its hard to know how the social debate would turn out after years of back and forth, but I was dismayed to read one recent research paper by psychologists Rachel M. Latham and Sophie von Stumm. The descriptive title of that work, based on survey evidence, is Mothers want extraversion over conscientiousness or intelligence for their children. Upon reflection, maybe that isnt so surprising, because parents presumably want children who are fun to spend time with.

Would a more extroverted human race be desirable, all things considered? I genuinely dont know, but at the very least I am concerned. The current mix of human personalities and institutions is a delicate balance which, for all of its flaws, has allowed society to survive and progress. Im not looking to make a big roll of the dice on this one.

Amazon robots bring a brave new world to the warehouse The Financial Times

Another way to look at US wage growth The Financial Times

The robot tax gains another advocate Wired

Kim got the idea of a robot tax from Bill Gates, who mentioned it in an interview in February. Since then, shes been meeting with stakeholdersunions and business types and the likeabout how San Francisco, and California, might explore such a thing.

Among the issues with a robot tax: What is a robot? Even roboticists have a hard time agreeing. Does AI that steals a job count as a robot? (Nope, but youd probably want to tax it like one if youre going to commit to this.) Were still working on what defines a robot and what defines job displacement, Kim says. And so announcing the opening of the campaign committee is going to also allow us to have discussions throughout the state in terms of what the actual measure would look like.

Video: Powerball lotteries and the endowment effect Marginal Revolution

3,700-year-old Babylonian tablet rewrites the history of math The Telegraph

Winner-takes-all effects in autonomous cars Benedict Evans

Transcript: Gary Cohn on tax reform and Charlottesville The Financial Times

FT: So what exactly will you have in the tax bill?

GC: On the personal side, we have protected the three big deductions charitable, mortgage and retirement saving. We want to raise the standard deduction caps and get rid of many of the other personal deductions. We want to get rid of death taxes and estate taxes.

On the business side, we are proposing to get rid of many of the deductions that companies can take right now to lower taxable income. At the moment we start with a high corporate tax rate in America but companies use deductions: what we are trying to do is get everyone to pay at a lower rate. This is a big base-broadening exercise.

Revenue may decline in the medium term but it will then explode for the government. When we grow the economy we will see substantial growth in revenue.

Read the rest here:
Around the web: Concerns with human genetic engineering, Gary Cohn on tax reform, and more - American Enterprise Institute

The announcement by researchers in Portland, Oregon that theyve successfully modified the genetic materialof a human embryotook some people by surprise.

With headlines referring to groundbreaking research and designer babies, you might wonder what the scientists actually accomplished. This was a big step forward, but hardly unexpected. As this kind of work proceeds, it continues to raise questions about ethical issues and how we should we react.

For a number of years now we have had the ability to alter genetic material in a cell, using a technique called CRISPR.

The DNA that makes up our genome comprises long sequences of base pairs, each base indicated by one of four letters. These letters form a genetic alphabet, and the words or sentences created from a particular order of letters are the genes that determine our characteristics.

Sometimes words can be misspelled or sentences slightly garbled, resulting in a disease or disorder. Genetic engineering is designed to correct those mistakes. CRISPR is a tool that enables scientists to target a specific area of a gene, working like the search-and-replace function in Microsoft Word, to remove a section and insert the correct sequence.

In the last decade, CRISPR has been the primary tool for those seeking to modify genes human and otherwise. Among other things, it has been used in experiments to makemosquitoes resistant to malaria, geneticallymodify plants to be resistant to disease, explore the possibility ofengineered petsandlivestock, and potentially treat some human diseases (includingHIV,hemophiliaandleukemia).

Up until recently, the focus in humans has been on changing the cells of a single individual, and not changing eggs, sperm and early embryos what are called the germline cells that pass traits along to offspring. The theory is that focusing on non-germline cells would limit any unexpected long-term impact of genetic changes on descendants. At the same time, this limitation means that we would have to use the technique in every generation, which affects its potential therapeutic benefit.

Earlier this year, an international committee convened by the National Academy of Sciencesissued a re

portthat, while highlighting the concerns with human germline genetic engineering, laid out a series ofsafeguards and recommended oversight. The report was widely regarded as opening the door to embryo-editing research.

That is exactly what happened in Oregon. Although this is the first study reported in the United States, similar research has beenconducted in China. This new study, however, apparently avoided previous errors weve seen with CRISPR such as changes in other, untargeted parts of the genome, or the desired change not occurring in all cells. Both of these problems had made scientists wary of using CRISPR to make changes in embryos that might eventually be used in a human pregnancy. Evidence of more successful (and thus safer) CRISPR use may lead to additional studies involving human embryos.

We have a ways to go before ordering up desired traits in a future baby. Researchers at Oregon Health and Science University say they worked with single-cell embryos, inserting CRISPR chemicals at the time of fertilization.lunar caustic,CC BY

First, this study did not entail the creation of designer babies, despite some news headlines. The research involved only early stage embryos, outside the womb, none of which was allowed to develop beyond a few days.

In fact, there are a number of existing limits both policy-based and scientific that will create barriers to implanting an edited embryo to achieve the birth of a child. There is afederal ban on fundinggene editing research in embryos; in some states, there are alsototal bans on embryo research, regardless of how funded. In addition, the implantation of an edited human embryos would be regulated under thefederal human research regulations, theFood, Drug and Cosmetic Actand potentially the federal rules regardingclinical laboratory testing.

Beyond the regulatory barriers, we are a long way from having the scientific knowledge necessary to design our children. While the Oregon experiment focused on a single gene correction to inherited diseases, there are few human traits that are controlled by one gene. Anything that involves multiple genes or a gene/environment interaction will be less amenable to this type of engineering. Most characteristics we might be interested in designing such as intelligence, personality, athletic or artistic or musical ability are much more complex.

Second, while this is a significant step forward in the science regarding the use of the CRISPR technique, it is only one step. There is a long way to go between this and a cure for various disease and disorders. This is not to say that there arent concerns. But we have some time to consider the issues before the use of the technique becomes a mainstream medical practice.

Taking into account the cautions above, we do need to decide when and how we should use this technique.

Should there be limits on the types of things you can edit in an embryo? If so, what should they entail? These questions also involve deciding who gets to set the limits and control access to the technology.

Who should be able to use this technology? And who should decide?Johnathan D. Anderson,CC BY-ND

We may also be concerned about who gets to control the subsequent research using this technology. Should there be state or federal oversight? Keep in mind that we cannot control what happens in other countries. Even in this country it can be difficult to craft guidelines that restrict only the research someone finds objectionable, while allowing other important research to continue. Additionally, the use of assisted reproductive technologies (IVF, for example) islargely unregulated in the U.S., and the decision to put in place restrictions will certainly raise objections from both potential parents and IVF providers.

Moreover, there are important questions about cost and access. Right now most assisted reproductive technologies are available only to higher-income individuals. A handful ofstates mandate infertility treatment coverage, but it is very limited. How should we regulate access to embryo editing for serious diseases? We are in the midst of awidespread debate about health care, access and cost. If it becomes established and safe, should this technique be part of a basic package of health care services when used to help create a child who does not suffer from a specific genetic problem? What about editing for nonhealth issues or less serious problems are there fairness concerns if only people with sufficient wealth can access?

So far the promise of genetic engineering for disease eradication has not lived up to its hype. Nor have many other milestones, like the 1996cloning of Dolly the sheep, resulted in the feared apocalypse. The announcement of the Oregon study is only the next step in a long line of research. Nonetheless, it is sure to bring many of the issues about embryos, stem cell research, genetic engineering and reproductive technologies back into the spotlight. Now is the time to figure out how we want to see this gene-editing path unfold.

Jessica Berg teaches Health Policy, Food and Drug Law, Public Health Law and Ethics, Bioethics and Law, and Research Regulation at Case Western Reserve University.

A version of this article was originally published on the Conversations website as Editing human embryos with CRISPR is moving ahead nows the time to work out theethics and has been republished here with permission.

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It's time to talk about the ethics of CRISPR-edited human embryos - Genetic Literacy Project

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On Aug. 3, the scientific article in Nature finally gave us some facts about the much-hyped experiments that involved editing the genomes of human embryos at the Center for Embryonic Cell and Gene Therapy at Oregon Health and Science University. The story had broken in late July in Technology Review, spurring profuse hand-wringing and discussion. But until we saw the scientific paper, it was not clear what cells and methods were used, what genes were edited, or what the results were.

Now we know more, and while the paper demonstrates the possibility of genome editing of human embryos, it raises more questions than it answers. It is a useful demonstration of technical promise, though not an immediate prelude to the birth of a genome-edited baby. But the process by which the news emerged is also an ominous harbinger of the discombobulated way the debate about genetically altering human embryos is likely to unfold. We need open, vigorous debate that captures the many, often contradictory, moral views of Americans. Yet what we are likely to get is piecemeal, fragmented stories of breakthroughs with incomplete details, more sober publication in science journals that appear later, news commentary that lasts a few days, and very little systematic effort to think through what policy should be.

The science underlying this news cycle about human genome editing builds on a technique first developed six years ago by studying how bacteria alter DNA. CRISPR genome editing is the most recent, and most promising, way to introduce changes into DNA. It is faster, easier, and cheaper than previous methods and should eventually be more precise and controllablewhich is why it may one day be available for clinical use in people.

Though headlines about the study discussed designer babies, researchers prefer to emphasize how these techniques could help stop devastating genetic disorders. The Oregon experiments with human embryo cells corrected disease-associated DNA variants associated with heart muscle wasting that can cause heart failure. The treated embryos were alive for only a few days and were never intended to become a human baby. They were, however, human embryos deliberately created for the research.

U.S. guidance in this area is sparse and reflects the lack of societal consensus. In 1994, when the federal government was contemplating funding for research involving human embryos, the NIH Embryo Research Panel concluded that just this kind of experiment was ethically appropriate. But within hours of that reports release, then-President Bill Clinton announced he did not agree with creating embryos in order to do research on them.

The United States currently has just two policies relevant to genomic editing of human embryos. The first blocks federal funding: On April 28, 2015, Francis Collins, director of the National Institutes of Health, stated, NIH will not fund any use of gene-editing technologies in human embryos. This is not embedded in statute or formal executive order, but members of Congress are fully aware of it and it is, in effect, a federal policy. NIH can (and does) fund genome editing of nonembryonic cells that might be used to treat cancer and for other possible therapeutic purposes, but not embryonic cells that would have their effect by creating humans with germline alterations.

Second, Congress has prohibited the Food and Drug Administration from reviewing research in which a human embryo is intentionally created or modified to include a heritable genetic modification. This language comes from a rider to FDAs annual appropriations. Yet use of human embryonic cells for treatment should be subject to FDA regulation. So this language in effect means alterations of embryonic cells cannot be done in the United States if there is any intent to treat a human being, including implantation of an altered embryo into a womans uterus. This will remain true so long as the rider is included in FDAs annual appropriations. The federal government thus has two relevant policies, both of which take federal agencies out of the action: One removes NIH funding, and the other precludes FDA oversight of genome-edited human embryos.

This leaves privately funded research that has no direct therapeutic purpose, such as with the Oregon experiments. The funding came from OHSU itself; South Korean Basic Research Funds; the municipal government of Shenzhen, China; and several private philanthropies (Chapman, Mathers, Helmsley, and Moxie). The research complies with recommendations to study the basic cellular processes of genome editing, keeping an eye on possible future clinical use but only so long as the work does not attempt to create a human pregnancy.

By coincidence, on the same day the Nature paper came out, the American Journal of Human Genetics also published a thoughtful 10-page position statement about germline genome editing from the American Society for Human Genetics endorsed by many other genetic and reproductive medicine organizations from all over the world. It reviews recommendations of the National Academies of Sciences, Engineering, and Medicine, several international and U.S.-based organizations and commissions, and makes several recommendations of its own, concluding it is inappropriate to perform germline gene editing that culminates in human pregnancy, but also there is no reason to prohibit in vitro germline genome editing on human embryos and gametes, with appropriate oversight and consent from donors, to facilitate research on the possible future clinical applications. Indeed, the statement argues for public funding. Finally, it urges research to proceed only with compelling medical rationale, strong oversight, and a transparent public process to solicit and incorporate stakeholder input.

So is there a problem here? It is truly wonderful that medical and scientific organizations have addressed genome editing. It is, however, far from sufficient. Reports and scientific consensus statements inform the policy debate but cannot resolve it. All of the reports on genome editing call for robust public debate, but the simple fact is that embryo research has proven highly divisive and resistant to consensus, and it is far from clear how to know when there is enough thoughtful deliberation to make policy choices. Its significant that none of the reports have emerged from a process that embodied such engagement. The Catholic Church, evangelical Christians, and concerned civic action groups who view embryo research as immoral are not likely to turn to the National Academies of Sciences, Engineering and Medicine, the American Society for Human Genetics, the Hinxton Group, the Nuffield Council on Bioetics, or other scientific and medical organizations for their primary counsel. They may well listen to scientists, but religious and moral doctrine will get greater weight. Yet religious groups highly critical of embryo research are part of the political systemand whether we embrace this sort of genome editing in the United States is a political question, not a purely technical one.

Reports and scientific consensus statements inform the policy debate but cannot resolveit.

Addressing the political questions will be extremely difficult. The U.S. government is poorly positioned to mediate the policy debate in a way that recognizes and addresses our complex moral pluralism. NIH and FDA are two of the most crucial agencies, but current policies remove them from line authority, and with good reason, given that engaging in this debate could actually endanger the agencies other vital missions. International consensus about genome editing of human embryos remains no more likely than about embryo research in general: Some countries ban it while others actively promote and fund it. Private foundations dont have the mandate or incentive to mediate political debate about a controversial technology that rouses the politics of abortion. What private philanthropic organization would willingly take on such a thankless and politically perilous task, and what organization would be credible to the full range of constituencies?

So who can carry out the public engagement that everyone seems to agree we need? The likely answer is no one. This problem occurs with all debate about fraught scientific and technical innovations, but its particularly acute when it touches on highly ossified abortion politics.

The debate about genomic editing of human embryos is unlikely to follow the recommendations for systematic forethought proposed by illustrious research bodies and reports. Given the reactions weve seen to human embryonic stem-cell research in the past two decades, we have ample reason for pessimism. Rather, debate is more likely to progress by reaction to events as researchers make newsoften with the same lack of information we lived with for the last week of July, based on incomplete media accounts and quotes from disparate experts who lacked access to the details. Most of the debate will be quote-to-quote combat in the public media, leavened by news and analysis in scientific and medical journals, but surrounded by controversy in religious and political media. It is not what anyone designing a system would want. But the recommendations for robust public engagement and debate feel a bit vacuous and vague, aspirations untethered to a concrete framework.

Our divisive political system seems fated to make decisions about genomic editing of human embryos mainly amidst conflict, with experts dueling in the public media rather than through a thoughtful and well-informed debate conducted in a credible framework. As the furor over the Oregon experiments begins to dissipate, we await the event that will cause the next flare-up. And so it will continue, skipping from news cycle to news cycle.

History shows that sometimes technical advances settle the issues, at least for most people and in defined contexts. Furor about in vitro fertilization after Louise Brown, the first test tube baby, was born in 1978 gave way to acceptance as grateful parents gave birth to more and more healthy babies and welcomed them into their families. Initial revulsion at heart transplants gave way in the face of success. Anger about prospects for human embryonic stem-cell research might similarly attenuate if practical applications emerge.

Such historical examples show precisely why reflective deliberation remains essential, despite its unlikely success. Momentum tends to carry the research forward. Yet at times we should stop, learn more, and decide actively rather than passively whether to proceed, when, how, and with what outcomes in mind. In the case of genome editing of human embryos, however, it seems likely that technology will make the next move.

This article is part of Future Tense, a collaboration among Arizona State University, New America, and Slate. Future Tense explores the ways emerging technologies affect society, policy, and culture. To read more, follow us on Twitter and sign up for our weekly newsletter.

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Listening for the Public Voice - Slate Magazine