National Academies panel leaves door a crack open to future human genetic modification

Early human embryosA National Academies panel on human genome editing chaired by Alta Charo and Richard Hynes released its report today. While it covered both somatic and germline (heritable) human genetic modification, the latter topic is far more contentious. You can see the National Academies summary of their report here. You can read the full report here.

On germline genetic modification using technologies such as CRISPR, the authors of the report carefully discussed potential benefits and risks to the use of this technology. On my first brief reading of it, the report is mostly appropriately cautious in terms of outlining the potential risks as well as societal and bioethical issues in addition to potential benefits.

As to the more controversial area of potential human germline genetic modification, I appreciate the fact that the report unambiguously says that human germline editing is not ready to be tried and lists numerous hurdles to address first. However, although the report tackles most of the key considerations and risks (and for that the authors should be commended), there is still an interesting undertone to the report’s discussion that seems to strive to justify leaving the door open to potential future use of human germline editing.

For instance, the report makes a point of noting mostly hypothetical instances where existing technologies such as PGD that are far less controversial may hypothetically fall down and so possibly might need to be supplanted by germline editing using techniques like CRISPR, but such instances are now and in the future would continue to be exceedingly rare. Too much weight are placed on these.

The other point that needs to be made is that hypothetical future germline editing in human embryos (or even done earlier developmentally in, for example, germ cells) with reproductive intent would have to be preceded by a great deal of research that involves PGD-like testing of human embryos to monitor efficiency and specificity of editing, chimerism, and other issues so it is not as though germline editing could avoid PGD-related issues or destruction of embryos.

I’m also not convinced that the personal need by some individuals to have a genetically-related offspring should be a major consideration in decisions related to the permissibility of human germline gene editing. The related concept of parental autonomy is given too much weight by the report. While this argument has both aspects that intuitively make good sense, it also has some that could lead to promotion of germline modification.

For instance, what if parents want their kids to have certain traits that become potentially available via germline modification? In this regard, the ability of researchers and policy-makers both in the US and more globally to prevent parents and practitioners from going down the path to use germline human modification for traits rather than strictly health conditions may prove to be quite limited and it’s not clear had to address that risk. The report in some places does not use strong enough language to counter the idea of human germline modification.

On the whole, I have favored a moratorium on germline modification, a step that this report does not take. Of course there are possible problems with a moratorium too including enforceability (lack thereof) and that once you have a moratorium it might be hard to escape it (e.g. if the government follows suit with legal steps) even if down the road the science were to back up getting rid of it. Note that as the report mentions, for at least some months longer, in the US the FDA cannot consider applications for any human embryo genetic modification and then there’s the Dickey-Wicker Amendment that disallows federal funding of anything that involves ‘destruction’ of human embryos and such things as using CRISPR modified embryos to do PCR for research would qualify as destruction. But then there’s loads of private money out there for research as well.

What are your impressions of the report?

For more of my thoughts and concerns on human genetic modification you can read my book GMO Sapiens and watch my TED talk (below).

NAS Human Gene Editing Meeting: Agenda & Public Participation

A draft agenda is now publicly available for the upcoming National Academy of Sciences (NAS) meeting on human gene editing. We now know a lot more about what to expect from this international gathering, which is called the International Summit on Human Gene Editing: A Global Discussion.

The meeting will start on day 1 with context from David Baltimore as well as other scientists from around the world. There will be scientific background on the technology and information on applications. Social Implications will be discussed. Sprinkled throughout the first day will be opportunities for comments and questions from the floor totaling about 2 hours on this day.

Human Gene Editing Meeting

Image from National Academy of Medicine. Oops they made the DNA left-handed.

Day 2 looks to build on the themes of the first day, but now bringing in the issues of governance and more emphasis on international perspectives.

Day 3 will be focused more squarely on societal implications and governance including the crucial issue of commercialization. These days also provide time for comments and questions from the floor.

These windows of time will include opportunities for members of the public to bring their voices into the discussion. I asked a NAS spokesperson about the role of the public in the meeting and received this reply:

“The organizing committee and staff and leadership of the academies have been identifying experts/stakeholders/interested parties from a range of disciplines and perspectives to invite to attend and participate in the summit.  In addition, a general public registration will open next week, it will be open to anyone although seating is limited and dozens of people have already expressed interest in attending.  And yes, public may participate in breakout sessions, and will have an opportunity to speak in public comment sessions as appropriate.”

There will also be other opportunities for involvement according to the spokesperson:

“Also, the video webcast will allow many people to view the proceedings and we expect a lively conversation on social media including at #GeneEditSummit”

Since I will be at the meeting and blogging it live here, I hope that this site will in addition provide a forum for discussion involving a diverse group and boost democratic deliberation on this important topic.

UK Biologist Asks to Make GM Human Embryos For Research

Earlier this year, a research team in China crossed a scientific line for the first time in history by using gene editing technology called CRISPR-Cas9 to make genetically modified (GM) human embryos. Other researchers around the world including now one in the UK according to Reuters have expressed interest in creating GM human embryos too as a means to learn more about early human development.

Kathy Niakan

Dr. Kathy Niakan, Francis Crick Institute Photo

In many countries around the world the creation of human embryos for any research purpose is not permitted, but the use of embryos left over from IVF procedures is in some cases allowed. However, in the UK genetic modification of any human embryos (even such left over human embryos) is not currently permitted with the exception of three-person IVF (aka mitochondrial transfer) for the purpose of trying to prevent mitochondrial disease.

Now Dr. Kathy Niakan of the Francis Crick Institute has asked the UK government for permission to make and study the development of GM human embryos.

Although us biologists know a great deal about the development of many organisms including other mammals, surprisingly little is known directly about human embryonic development. That gap is a problem and a roadblock to prevention and treatment of human diseases, particularly developmental disorders. Dr. Niakan has done some impressive, very important research and her studies of gene edited human embryos could in theory prove equally valuable.

Gene editing to produce GM human embryos even solely for laboratory studies is nonetheless very controversial so from a societal perspective there are complexities here beyond the scientific challenges. An international gathering of scientists organized by the US National Academy of Sciences (NAS) will meet in Washington, D.C. on December 1-3. On the agenda is a healthy discussion of these issues with the goal being to come up with policy recommendations for how best to navigate the road ahead related to human genetic modification. One possible outcome is a consensus for a moratorium on clinical use of human gene editing technology. I favor that, but with specific allowance for some embryo editing research in the lab.

This NAS meeting was organized in an impressively short period of time made all the more important by the sense that there will be an increasing number of researchers such as Professor Niakan seeking to making gene edited human embryos for research purposes. It also seems probable that others may aim to go much further to relatively quickly try to deploy genetic modification technology in the clinic such as for reproductive purposes, which would be a big mistake.

For more on the request by Dr. Niakan and background, I recommend this excellent Science piece by Gretchen Vogel.

Best case in favor of germline human genetic modification?

Human genetic modification

Flying out of Portland Airport yesterday, I saw these magazines side by side.

Hmmm.

That’s a humorous juxtaposition and the two covers are oddly similar in design.

It go me thinking…

Could using germline human genetic modification be a wise thing to do in some cases?

After all, humanity in many ways has serious flaws. Could we try to make Homo sapiens a better species via, for instance, CRISPR’ing embryos for “better” traits and removing possibly negative traits?

Of course attempts at making “better” people could yield worse results than already naturally occur.

So have I been wrong about supporting a moratorium against heritable human modification?

I don’t think so.

Still, this peculiar pairing of magazine covers made me laugh and think.

Why interview Steven Pinker on my blog if I strongly disagree with him?

blog ethosEarlier this week I posted an interview with Steven Pinker on CRISPR, human germline modification, and bioethics.

With only a few exceptions, I strongly disagree with Pinker’s philosophy in these areas and I knew going into the interview that his answers would likely go against my own views. I also expected the interview would anger some people. That is exactly what happened and I heard from a few upset people, although most feedback was positive on having done the interview.

Still, why give a forum and a large audience to someone with whom I strongly disagree?

Part of the mission of this blog is to spark discussion on important issues related to innovative medicine and biotechnology. Discussion amongst a circle of people who largely agree can be somewhat useful and I suppose it “feels good” in terms of a sort of mutual self-validation. However, discussion and dialogue inclusive of people with very distinct opinions is far more valuable and educational for a community. That kind of diverse discussion can be quite uncomfortable at times or even make people angry, but its unique value is worth that risk. Of course discussions are not simply binary or even ternary as shown in the image above. The point is to get people engaged with each other even if they differ strongly on key issues.

Just related to CRISPR-Cas9 and human germline modification you can read widely different views in interviews here with Jennifer Doudna, George Church, Nita Farahany, Maria Konovalenko, Natasha Vita-More, and now Steven Pinker. Stay tuned for more in this area and expect additional, very distinct views. I’m not aware of any place else (websites, journals, etc.) that has had as wide a scope of scholarly discussions on human germline modification. Hopefully this will greatly aid in the expeditious development of wise policies on this crucial issue.

More broadly, part of the mission of this blog is to have a diversity of participants whether it is in the comments, guest posts, or interviews. This embrace of inclusion of diverse views extends to other topics well beyond human germline modification and historically has focused on the area of how to best balance innovation and regulation/safety in new stem cell and regenerative medicine treatments. Over the years this has meant interviewing leading influencers in that arena including some controversial figures such as the people running stem cell clinics selling non-FDA approved “treatments”. At times that has been a wild ride, but overall it has served the community well by boosting transparency and providing a place for dialogue that has happened nowhere else. I also press people with difficult, probing questions. No puff interviews.

Let’s keep the conversations going.