Can CRISPR be used responsibly?

What comes next for CRISPR? It is advancing at an unprecedented pace. In the near future, we could see CRISPR-based treatments for currently incurable diseases, more resilient crops, and even the ability to edit genes before birth to prevent inherited disorders. But, with such power comes a need for caution. So, what regulations are in place to assuage these concerns, and what kind of event could shift the goalposts? Hank Greely chairs the Steering Committee of the Center for Biomedical Ethics at Stanford University.

Hank - The aspect that people are worried about is using CRISPR on human beings. Using CRISPR on human beings is regulated in, I think, every country that has a substantial bioscience infrastructure. There are really two different kinds of uses that are subject to different levels of regulation. One is CRISPR to try to treat diseases of people who've already been born. That's regulated everywhere as a therapeutic and has to be proven safe and effective, whether it's under the FDA in the US or the EMA in the EU. That kind of CRISPR is regulated the way any new drug would be regulated. What people mainly worry about is CRISPR embryos. That seems to be either strongly or weakly illegal in almost every country where it's plausible that it could happen.

Will - It does seem a pretty tough nut to crack in that regard because it is an embryo that cannot consent. Is there any legislation that can be put in place or is that just something you anticipate will just be left alone indefinitely?

Hank - Legislatures have a tendency to be reactive rather than proactive. They tend to react to scandals. Most of the regulatory activity with respect to embryo editing is a result of He Jiankui's CRISPR babies from 2018. Unless or until there's another scandal, I think we're not likely to see another wave of regulation. We live in societies, many of which are built on hype. Science hype is a real thing. Will somebody try to do something with modified babies? Maybe. If so, will there be a reaction? Almost certainly there will be, particularly if the babies turn out to be damaged and disabled in some important respect. The CRISPR babies from China, they're now six-year-olds. We know nothing about them. China has released no information about their health or well-being. That's disconcerting.

Will - What about the question of consent?

Hank - There is this interesting question about what can we do affecting embryos since embryos don't give consent? Is it ethical to do anything with respect to them? The answer is yes, because lots of things we do have effects on embryos. Any kind of food or drug or environmental perturbation could affect a pregnant woman and as a result affect the embryo. We let research go on people who can't consent, whether they're infants or children or people who are intellectually disabled, but we have safeguards for it. Usually we require that a guardian or a next of kin or a court or somebody give consent on their behalf. Yes, it's true that embryos can't consent, but that doesn't mean that they can't be appropriate ethical subjects of research as long as somebody with their interests at heart consents in an informed way for them. I have to tell you, I don't remember the consent form I signed as an embryo that said, I want to be born and I want to be born to these people.

Will - To stay on that and talk about the ethical side of medical treatment, because a lot of CRISPR is cutting edge and as you say, it's not something that a lot of the world is concerned about because it is still quite a complex and expensive procedure to be involved with. That naturally creates a disparity between who has access to these treatments. It sounds callous to say, but do we just think of CRISPR as any other medical treatment where the rich people can afford it and the poor people cannot afford so much of it and it's less of an ethical quandary as an accessibility quandary.

Hank - What accessibility quandary is an ethical quandary. You in the UK with the National Health Service, at least within your country, almost everybody, everybody or almost everybody has access to decent healthcare. My country, I can't say that because we don't have an organised and ethical healthcare system. Even if we did that, that's a long way from guaranteeing access to people living in villages in India or in South America. There are going to be international disparities just as there are international disparities in access to food and education and other good things. Those are big ethical questions. There are also big geopolitical questions for which we don't have good answers. Other than try to make things as even and as fair as we can. We see this sometimes good things happen. So I do think that the rich world ultimately did and has been doing a decent job with respect to HIV drugs. It's not a perfect job by any means, but we have come together to make HIV drugs accessible to people in many poor countries.

Will - And to look at the other side of this, we've been speaking primarily about human CRISPR, but obviously a lot of our food is increasingly coming from genetically modified sources, genetically edited sources. The primary concern, of course, being that we accidentally create a faulty gene down the line when treating genes today. Are there safeguards in place for our food sources as well?

Hank - I actually think that the non-human uses of CRISPR are going to turn out to be much more important and much more interesting than the human uses of CRISPR, in part because we're willing to take a lot bigger risks with non-humans than we are with humans. We're much more worried about harming babies than we are about harming calves or harming baby carrots, and that's appropriate. And so we will use CRISPR much more on non-humans. Our regulation of non-human uses of CRISPR varies enormously from place to place, and I haven't seen any regulatory scheme that I think gets it right. Some are too strong. Europe has, in effect, a ban on genetically modified organisms for agricultural purposes, and I think that's foolish. For plants in the United States, basically it's anything goes. For animals in the United States, the regulatory scheme is very tight. I think it's too loose for plants, too tight for animals. People are approaching it, but I don't think we've yet figured out a good, balanced, nuanced way to approach it. But we shouldn't say, no, no, no, that's not natural. We shouldn't do it. Nothing in our lives is natural. You and I are having this conversation. We are hundreds of miles apart. This is not a natural conversation. This is not my natural fur that I'm wearing as a blue shirt. And I think this naturalist fallacy is strong, particularly with respect to genetic modification, and it is not helpful.

Will - So to look ahead then, as a final question, do you anticipate us being able to shed this idea of everything needing to be natural in order for us to combat the fast approaching issues of increased disease and climate change?

Hank - The most important word in the question you just asked is we. There are 8 billion of us on this planet and we agree on almost nothing. And I think that's going to be true with respect to use of CRISPR. I do think that particularly under the impetus of the most important issue of this century, climate change, a lot of genetic modification is going to end up being allowed and even welcomed. And I hope carefully regulated because the alternative will be hungry, starving people.