Three national academy leaders have a new opinion piece in Science on what the community needs to do next regarding human germline editing now that we are most likely in the CRISPR babies era.
Some of us have been wondering what the Academies and their empowered experts really think about this issue and what they are saying outside the public domain. Do some of them disagree with each other? There have been mixed messages.
The new piece, entitled, Wake-up call from Hong Kong, gets a lot of things right in my view, but could have gone much further.
It rightly expresses a sense of urgency about the need for more action. The authors of the piece, Victor Dzau (President of US National Academy of Medicine), Marcia McNutt (President of US National Academy of Sciences), and Chunli Bai (President of Chinese Academy of Sciences) focus on the need for international cooperation and consensus on how to handle this complex area. Waiting 3 years for another (the third) international meeting on human genome editing in 2021 is too passive a route for a complex, quickly evolution situation like this. The authors clearly get that.
I appreciated that this particular statement is also stronger than some of the past:
“To maintain the public’s trust that someday genome editing will be able to treat or prevent disease, the research community needs to take steps now to demonstrate that this new tool can be applied with competence, integrity, and benevolence. Unfortunately, it appears that the case presented in Hong Kong might have failed on all counts, risking human lives as well as rash or hasty political reaction.”
However, overall it seems like this article doesn’t go quite far enough. I also believe that the Academies’ groups of experts/meeting organizers are in some cases themselves causing potential issues in certain ways via their conflicting statements.
For instance, one issue at the recent international human genome editing meeting in Hong Kong was that even in the context of He Jiankui’s statement claiming (we still don’t know if it’s true by the way) production of CRISPR’d babies, some of the meeting organizers spoke about the need not to restrict human germline editing or even seemed to advocate forging ahead quickly. As much as the organizers of this particular meeting collectively then issued a stern statement at the end about how what He did was bad and they discouraged others from following suit, overall they overall sent a mixed message.
There has even been speculation that certain meeting organizers or other experts are secretly happy (or at least have mixed rather than entirely negative feelings) about what He did because it “broke the ice” even if it also caused a lot of commotion and wasn’t done well. I’m not sure I buy this idea, but at the same time we can’t rule it out entirely because of the mixed messages.
“We need to build upon the work done at recent international summits and the guidance provided by numerous organizations to achieve broad agreement on specific standards and criteria for human germline genome editing research and clinical applications—agreement that should include not only the scientific and clinical communities, but also society as a whole.”
But what if academy members and meeting organizers can’t even agree amongst themselves?
Furthermore, what if broad consensus from the wider, diverse community is in favor of a temporary moratorium, but many of the Academy leaders don’t want one? If the Academies go with their few experts over the wider community then I think we have a problem.
On the other hand, perhaps the wider community agrees with the experts on not even wanting a temporary moratorium on implantation of CRISPR’d human embryos? Maybe. I don’t think we have a very clear sense of the broader views on CRISPR babies within the diverse research community yet.
In the end, the scientific community cannot stop a few rogue actors from making more CRISPR babies even with a moratorium, but we can send a much stronger, more consistent message that human germline editing should not be done at least at this time or in the near future.
Why should we do this?
In my view, such a strong stance actually helps CRISPR research overall including that focused on somatic gene therapy where there are already promising clinical trials.
There is also a clear lack of a compelling medical need for CRISPR babies (don’t forget PGD), there are sizable gaps in our understanding of gene editing in human gametes and early embryos that make it very risky at this time, and there are definite known risks such as off target effects and mosaicism that in reality haven’t been resolved and won’t be as soon as 2019.
There are also thorny ethical, societal, and specifically social justice issues related to making heritable mutations in humans via CRISPR. I am definitely glad the Science piece reinforces the need for societal involvement and agreement as that wasn’t stressed by the organizers of the latest meeting.
The “Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine Oviedo,4.IV.1997″states “An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.” This forms part of the overall European Convention on Human Rights, in all its parts “The Convention.”
On the biotech “product” front, which is of course a driver for development activity, “Use” of human embryos, for their own benefit, is written into the established Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 Recital(42) on the legal protection of biotechnological inventions in European states et al and is a foundational document addressing this area. The interpretation of this document has led to the European Patent Office guidelines and appeal rulings.
However, apart from the embryo “use” issue, the Directive (Chapter 6.2.b) specifically states that “processes for modifying the germ line genetic identity of human beings” are prohibited from Patentability.
Fundamentally the underlying principles of the protection of life in the Chapter 1 Article 2 of The Convention doesn’t state explicitly that germ line cells, nor for that matter an embryo or fetus, are to be given specific reserved consideration. This has been tested at the European Court of Human Rights. Should national laws allow in-vitro research on embryos The Convention states in Chapter 5 Article 18 that they should “ensure adequate protection of the embryo” and that “the creation of human embryos for research purposes is prohibited.” This is the general positioning at the European Human Rights level, as a result of the union of culturally diverse member states. As previously indicated, individual countries apply local Laws to their societal ethical positions, which they all do in regard to embryos/ESCs, genetics, IVF & fetal development, considering The Convention. Generally, the principle of human rights & dignity extends to all human beings and for that the definition of a “human being” is central to The Convention’s interpretation. The UN’s Universal Declaration of Human Rights is similarly worded and looks to respect individual human rights, while leaving the question of developing life to individual societies.
The fact that new technological advancements are being designed to address medical needs of those that suffer from, or may fall victim to, potentially treatable biological conditions warrants considered thought as to how best to unify behind the effort to achieve a host of goals in the process. Through public education and the application of successful next generation technology the substance and impact science can have on solving the very issues that divides opinion is possible.
The ethics of today will give way to the ethics of tomorrow, and so on – it’s nature’s way. Man plays his part in this cycle and uses what is available with intellect and inventiveness. Change is a process of adjustment and one could say that is the will of nature’s law. The only unnatural aspect would be if man himself becomes defined as synthetic, which is, from this writer’s perspective not the goal.
Germ line editing in clinical practice is indeed unnecessary at present until proven otherwise. However, basic research using gene editing technology of germ line cells is necessary, based on clearly defined updated ethical frameworks – with governmental support, if possible.
I have stated previously that the reduction in IVF supernumerary embryo creation should be a stated goal with new specific governance stipulations & authority guidelines over the fertility sector. This I believe is central to a consensus building working model.
More open dialogue is required and opinion sought from all stakeholders. There are too many questions yet unanswered to not search for the clues by all means so one day we may apply that knowledge to human frailty & suffering in developing or developed humans. That goal would be best served by furthering basic research efforts using genetics back to our original cells.
The challenge in establishing regulations in this area will not be easy, but it isn’t insurmountable. A flexible legal & regulatory basis for steps forward in the research is what is required IMO…. Government oversight may be appropriate but the nature of such a flexible system would be best served to have its own adaptation authority once the laws are written.
I don’t believe we’re anywhere near ready yet to implement this technology but progress on the research is indeed warranted imo.
Cheers
Note: Comments made above are extracts from previously published posts on the subject that can be found here: http://msemporda.blogspot.com/2015/05/germline-science-embryo-use-law-scope.html
Dear Admin:
Once many noted scientists (that would include the U.S. National Academy of Sciences) abandoned ethics and advised treating human embryos as if they were not human beings, the present disquieting situation became humanity’s future. Neither the promise of new cures nor new cures themselves can ever be a justification for killing other human beings. Although such horrid acts have and do occur with fully adult humans, history does not regard them as desirable, ethical, or acceptable. Involving younger humans does not purify such acts. Whether professing uncertainty, ambivalence, or uncaring about the humanity of human embryos, this obscuring of biological knowledge and reason was and continues to be a scientifically and socially irresponsible act. Even as some call for a moratorium on implanting gene-edited human embryos and allowing them to come to term and undergo live birth, that moratorium still promotes research that will cause the destruction of many more human embryos. The line that cell and genetic scientists, who motivate research that kills human beings, have arrogantly stepped over is that of the basic regard for the significance of human life to the human species. The scientists who have contributed to the present situation have shown the public that they cannot be trusted to act cautiously or ethically; and furthermore are incapable of doing so. If this situation is to be halted and re-directed to alternative ethical research, it will be the governing bodies of nations that have to do it.
James at Asymmetrex
I am also puzzled about whether some of those who have spoken out are free of personal conflicts.
For example- George Daley, the dean of the Harvard Medical School, whose comments at the Hong Kong meeting were, well, not so negative: “The fact that it is possible that the first instance of human germ-line editing came forward as a misstep should in no way lead us to stick our heads in the sand,” Daley said. “It’s time to … start outlining what an actual pathway for clinical translation would be.” I wouldn’t have called it a “misstep”…I think it was much worse than that.
So, it turns out that Harvard has a project working toward a germ line editing plan of its own:
https://www.technologyreview.com/s/612494/despite-crispr-baby-controversy-harvard-university-will-begin-gene-editing-sperm/
Similarly, George Church, also of Harvard, seems to be even more positive about He’s report.
This concerns me; this is a time when scientists need to send a clear message about where the boundaries are. Just because it’s possible, we don’t have to do it. We’re not in the business to play God.
Let’s be totally clear here, if we are to accept the theory of a ‘God’ and that our intervention in life’s natural plans is to play him, then even smallpox vaccines is to play God. This is highly relevant because medicine relies on the intention to do good, or at least no harm, and the advent of intervening in natural causes.
The ethical debate about CRISPR human embryos relies on the idea that one should not risk the health of the baby and potentially cause suffering. If we apply the exact same criteria to heritable diseases, whose risks are more or less mendelian, with high predictability for causing disease, we would not let many people have kids. Indeed, in many cases the risk of CRISPR is lower if applied to ‘solve’ such diseases.
The ethics of engineering the embryo will force eugenics into debate and it’s not clear how far people will go to ‘prevent harm’.
When we know better we are expected to do better. This is why the ethics on the human CRISPR baby is not yet acceptable; the science isn’t solid enough. Again, applying that logic to heritable diseases, where the science is obvious, we would not let many people reproduce.
I’m not saying we should stop people from having kids. But I am highlighting the fact that nature can be far more hurtful, and we know how to prevent much of that hurt. The ethics about getting between a parent and their intentions for their children is far bigger than CRISPR, but will include CRISPR and more. We do not force those with heritable diseases not to have children — and if they do and choose CRISPR to correct the diseases, what do we tell them? “No, you can only have diseased kids?” It is painful to imagine telling people who want to have healthy kids that we *could* help them and improve the odds, but we won’t.
The reality is that the debate of reproductive ethics is far more complicated and we humans will not find a clear and obvious answer. Those you’ve pointed at critically have also made great points.
Planned genetics will become an extension of planned parenting and human health, just as vaccinations are seen as crucial for disease prevention. Some of us have tried to raise this discussion to create awareness and oversight as research brings the horizon closer. Every reproductive event is an experiment, as is every life. Human life deserves the best we can do.
We’ve been ‘playing God’ for decades. GMO food is safe and the scientific community agrees on that — but when did God give us permission to edit those species?
Food for thought.