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Why we were caught unawares and what we should be doing about this

Written by Devang Mehta

The first CRISPRed babies have been born in China, and from all the noise of the past few days my takeaway is that this inevitable development has caught us all shamefully unprepared.

The story began Sunday evening with an article in the MIT Tech Review describing experiments by a scientist in China, Dr. He Jiankui, to make HIV-resistant human embryos by editing the CCR5 gene. Subsequently, rumors spread on Twitter that the embryos had actually been taken to term, confirmed by an AP story stating that a pair of twins (Lulu and Nana) had been born from the CCR5-editing experiment. At about the same time, a series of videos was posted on Youtube by the scientist in question, echoing the story and providing a justification for the choice of CCR5 as a target.

Read More: The CRISPR gene-edited babies: a technological breakthrough or a brave new future?

There are still many unanswered questions, from the role of a PR firm, the actual employment status of Dr. Jiankui, the chain of ethics approvals for his clinical trial (which has been denounced by more than a hundred Chinese scientists, and disavowed by the hospital where the procedure is supposed to have taken place). Or how Jiankui, who has pledged to monitor the health of the twins for the first eighteen years of their life, plans to do so.

Just as disconcerting as this experiment is the response by science journalists, ethicists and other CRISPR scientists…

What we do know is that this experiment clearly flouts ethical standards for human gene editing that have broad agreement in the international scientific and science ethics communities. The choice of gene (CCR5) is suspect, since there are less intrusive, and safer alternatives to treating and preventing HIV; the legal and ethical processes seem aborted; the basic scientific thresholds of producing homozygous edits, resulting in non-mosaic embryos, haven’t been met; and no scientific pre-print or manuscript has yet been circulated to allow peers to assess the experiment itself.

But just as disconcerting as this experiment is the response by science journalists, ethicists and other CRISPR scientists. Scientists and ethicists seem to have resorted to describing the work as, “scary”, “crazy” and “insane”, and journalists have been happy to sensationalize the story, all without truly grappling with the fact that human germline editing is something we all knew was inevitable ever since the first reports of CRISPR-mediated gene editing in late 2012.

The fact that the world has been caught unprepared by Sunday’s announcement is a glaring indictment of the failure of the scientific community to predict, and have policy frameworks ready to deal with, this event.

Consider that even on Monday, at the International Summit on Human Gene Editing in Hong Kong, nearly all the talks sounded like they were written in 2014, instead of in a post-CRISPRed human reality. Feng Zhang, one of the inventors of CRISPR-Cas9 technology gave a TED-style introduction to CRISPR and a group of philosophers and social scientists talked about CRISPRed humans as if this was a faraway possibility instead of something real. And a very vociferous science twitter still featured the same debates between treatment vs. enhancement, or China vs. the West, genetic abnormality vs. genetic integrity.

And the media reports have been just as bad.

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It is now far too late to be simply debating the ethics of human gene editing, or stoking fears of designer babies and a Gattaca-like future. The time to reference Huxley’s Brave New World in every speech and news story is long past.

The good news, however, is that we do in fact have the ethical frameworks needed to guide human-gene editing regulations. These are contained in the impressive report on Human Gene Editing by the National Academies of Science, Engineering and Medicine (NASEM) in the US, and the ethical review by the Nuffield Council on Bioethics in the UK. These documents take a nuanced, in-depth view of the technology and its potential applications. They contain sensible recommendations that answer nearly every question that I’ve seen journalists and scientists agonize over in the last couple of days. Further, they align well with public opinion on human gene editing, in China and the US, and elsewhere.

It’s too bad no one seems to have read them!

What we now need is a path forward: a set of concrete steps that the international scientific community should take so as to redeem the promise of human genome editing from the debacle of Jiankui’s experiments.

1. Develop international policy recommendations.

David Baltimore, the lead organizer of the International Summit on Human Gene-Editing Image source: The National Academies (CC 2.0)

The International Summit on Human Gene Editing currently seems to be a strange mix between a scientific conference and TED-style public presentations. The event has so far featured both highly detailed scientific presentations, and very non-specific talks by social scientists. I think this misses the point: we don’t need more conferences about CRISPR (there are several every year, often featuring the same presenters). Instead, I believe these international summits are a rare opportunity for scientists and bioethicists of varied nationalities and backgrounds to come up with specific policy recommendations to take to their own governments, and potentially the UN.

The organizers of future summits cannot justifiably be a group of opaquely selected scientists…

These recommendations, in my opinion, should draw on the principles laid out in the NASEM report, and be intensely specific. Future summits must be organized into working groups charged with coming up with detailed criteria such as a restrictive list of permitted alleles and traits for human clinical studies, as well as detailed standards for sequencing the products of human gene editing prior to any attempt at implantation, and suggest professional and legal penalties for violating these policies.

And most importantly, the organizers of future summits cannot justifiably be a group of opaquely selected scientists, headed for example, by a scientist who is clearly not representative (based on hands-on expertise, or demographics) of currently working scientists and patients. The current process is now necessarily discredited and has indeed led to a legitimate belief that the scientific community is incapable of self-regulation. The clearest path forward therefore is for concrete legislative policy to be designed and suggested by scientists, ethicists and legal scholars.

It helps no one when scientists, the one group of people who still have a large claim on the public’s trust, respond to events wildly…

It’s worth emphasizing that there are indeed numerous ethical concerns with implementing human gene editing, but these are also entirely solvable. Again, the NASEM report should be the first reference for anyone who has an ethical question related to human genome editing, whether it’s the morality of editing non-lethal diseases, editing in disease resistance, access and availability etc.

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2. Communicate responsibly.

It helps no one when scientists, the one group of people who still have a large claim on the public’s trust, respond to events wildly, using expletives, and characterizing the work of a scientist (who by several accounts is an intelligent person cognizant of the impact of his research) as “crazy” or “insane”.

This is especially bad when the scientists in question have rival interests, or are simply unversed in the ethical reports that should be shaping regulation around human gene editing.

 

Restrictions on human germline editing (NASEM, 2017)

So many scientists, for instance, seem completely unaware of the careful delineation the NASEM report makes between human genetic enhancement and gene editing for disease prevention, or that it recommends a series of restrictions on human germline editing.

It is hardly a surprise then, that when scientists in general are so unaware of the ethical frameworks in existence, that one of our number would perform an experiment so patently unethical. It is irresponsible in my view to call a scientist “rogue”, merely for being first at accomplishing a project (details aside) that many other scientists have already embarked upon.

The same of course, applies to journalists, who seem to be picking up the most volatile quotes and resorting to old, debunked tropes. The stories I’ve read in the last couple of days, even from respected outlets like the New York Times have all been poorly researched, often sacrificing nuance for sensationalism. Antonio Relagado, the journalist who first broke the story, for example, tweeted an incredibly insensitive poll essentially mocking the two children who will be born with edited genomes.

Media reports have also chosen to quote old warnings about a slippery slope (as the NYT put it) to “designer babies”, without mentioning the fact that this is a line that even He Jiankui has agreed not to cross. Or that using CRISPR for “designer babies” (i.e. physical, cosmetic, enhancements) is an idea that has been soundly rejected by several scientific bodies researching the ethics of human gene editing.

All this hyperbole does is to cause panic among readers, without, in fact, informing them.

 

3. Recognize that human germline editing is here to stay

A lot of scientists and journalists seem to be laboring (or tweeting) under the assumption that human germline editing will magically disappear tomorrow if it’s disparaged enough.

The fact, of course, is that this development is here, and it’s not going anywhere. Yes, the technology is banned in some countries but this is not sustainable, nor desirable, in a world where some countries might, legitimately, decide to allow it under tight regulation. A failure to obtain international agreement on regulating this technology will lead to a world with gene-editing tourism, and consequently even greater inequity in accessing gene-editing therapies.

Indeed, as I’ve said before, banning human genome-editing would be an ethical tragedy, depriving several disadvantaged communities the opportunity to control the passing on of lethal, un-treatable genetic diseases such as sickle-cell anemia, or Huntington’s disease to their children. We know for example, that due to the vagaries of history, not every population has an equally scarred genome. Groups of people in Finland, in South Asia, and Ashkenazi Jews bear a disproportionate burden of genetic disease, and germline genome-editing could help them evade their unfair genetic inheritances. It also bears repeating that the public, in the US, in the UK and in China, is clearly in favor of germline editing for disease prevention and treatment, but not for enhancement.

4. A global, collaborative project to edit the human germline

The next clinical trial of human germline editing should be an international, collaborative, multi-stakeholder endeavor

What we now need to do in order to redeem CRISPR technology is start a single long-term, wide-ranging project to treat one genetic disorder using germline editing. This project should be structured like the Human Genome Project (or the more recent Synthetic Yeast project), be funded solely through public funding, and be as consultative as possible.

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A serious attempt to edit the human genome in order to treat a genetic disorder like sickle-cell, involving multiple stakeholders who will get a say on everything from target, study design, participation etc., is the only way to ensure that individual “rogue” experiments don’t endanger more lives.

Such a project will also allow the scientific and other communities to proactively engage with the scientific, ethical, legal and social hurdles bound to crop up along the way. It will force legislators to deal with the new scientific reality seriously, instead of contemplating bans and toothless moratoria.

Imagine how different the Summit from this week would have been if we had such frameworks in place, and an actual globally acceptable plan to carefully perform human gene-editing, instead of having to react to a single experiment taking place out of the world’s eyes.

Wishful thinking that germline editing can be stopped in perpetuity, worldwide, is neither productive nor realistic now.

The next clinical trial of human germline editing (and there are likely several in the offing) must occur under circumstances very different from this one. And it must occur within a globally acceptable legislative framework.

Wishful thinking that germline editing can be stopped in perpetuity, worldwide, is neither productive nor realistic now. Nor is it ethical in my view to demand such a ban. We must not allow one case of heedless science to stymie all progress in this field. And the first step has to be developing legislative policies in accordance with the scientific and ethical consensus, allowing scientists to eradicate the genetic disorders that imperil so many lives.

 

Dr. Devang Mehta is a post-doctoral researcher at the University of Alberta, Canada, and employs genome editing technology in plants. Devang obtained his PhD (with a certificate in Science & Policy) from the Department of Biology, ETH Zurich, Switzerland.

 

Disclaimer: All opinions expressed in the article are those of the Devang Mehta alone, and not of his employer.  These opinions do not necessarily represent those of PLOS, the community, and the editors.

 

 





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