On December 1st – December 3rd 2015, the main scientific body of the United States, that is, the National Academies, held the first international summit on gene editing. To that end, the Academies co-hosted the conference with two other national academies – the Royal Society of London and the Chinese Academy of Sciences.
This brief review will not cover the technological developments in gene editing and, specifically, CRISPR/Cas9, that were reported at the summit – those can be found elsewhere. In fact, discussing the scientific progress was not the aim of the summit.
Over the last few years gene editing became cheaper, more accurate, and more efficient due to the discovery of CRISPR/Cas9 and the meeting was devoted to the discussion of the risks accompanying the future applications of the technology. If you don’t know anything about this amazing technology, below is a short video that describes it very well. The event gathered numerous scientists, physicians, ethicists, policy makers, patient groups, and other stakeholders.
National academies, in general, are not regulatory bodies but rather institutions that consult the governments on scientific matters. It was thus notable that the summit received endorsement from the legislative and executive branches of the US government. The former was embodied through Congressman Bill Foster (D) who calls himself “the last scientist in Congress”, and the latter was represented by John Holdren, who is the director of the White House Office on Science and Technology Policy (OSTP). Foster is on the House Committee on Science, Space, and Technology while Holdren is the senior adviser to Obama on science and technology so both gentlemen have a lot to do with how science policy is shaped in America and both gave opening remarks at the summit recognizing its importance.
The summit started with the context and background of the technology. During his opening remarks, John Holdren was very clear about his words being not just his personal opinion but the stance of the Administration on the topic. The stance is “that altering the human germline for clinical purposes is a line that should not be crossed at this time.” (The original statement from the White House that Holdren reiterated can be found here.
Holdren also referenced the official position of the National Institute of Health (NIH, the primary agency of the government responsible for biomedical and health-related research) expressed by its director Francis Collins saying that “alteration of the human germline in embryos for clinical purposes currently lacks compelling medical justification while at the same time raising serious safety and ethical issues.” (The original NIH statement can be found here).
At the same time, OSTP director noted that “the administration recognizes that the same gene editing technologies that could be used for modifying human germline also have exciting therapeutic uses through somatic cell editing which would only affect the individual being treated” and which the administration generally supports to be further researched and developed under the existing regulatory frameworks.
Ralph Cicerone, the president of the National Academy of Sciences, and others compared the summit to the influential 1975 conference on recombinant DNA – the Asilomar Conference – both in its importance and the participation of general public. David Baltimore, a 1975 Noble Laureate in Physiology or Medicine, who presided over the summit noted that “we are close to being able to alter human heredity” and, among other questions, asked “when will we be prepared to say that we are justified to use editing for genetic enhancement?” Unfortunately, this question was not answered during the summit and given the summit’s conclusion it seems that the scientific community will not be able to answer it too soon.
Ismail Seragelding, the director of the Library of Alexandria and a former World Bank vice president, appeared to address a common anti human enhancement argument of the wrongness of playing god when he said that “we have been playing god ever since we domesticated plants and animals, and we do so every time today when we turn on the lights at night and turn night into day”.
The summit included a detailed history of eugenics by Daniel Kevles. He drew parallels to the current gene editing context and identified several potential dangers similar to those that eugenics bore in the beginning of the 20th century. Among them is “the hazard not of racism as such but of racial genotyping for particular diseases which even if pursued with benign and scientifically neutral intent could lead to new types of stigmatization”. Another danger according to Kevles is the “consumer demand” that requires answering the question of “how couples will respond if CRISPR enables them to select for or even to engineer advantageous traits into their children”. He warned that “biotechnology industry … is a new player in this game compared with the early 20th century” and that if germline editing is “conducted in private laboratories, they are then wholly outside of government control, much as IVF has been outside of government control … for complicated political reasons”. Kevles concluded that “human improvement is a fact of life … because of consumer demand” asking his final question of “How can we expect to deal responsibly with human genetic information in such a culture?”
Scientific summits are no political debates so if you are in for a verbal duel look elsewhere. Still one session got a little heated when John Harris, a bioethicist from Manchester, was followed by Hille Haker, the Chair of Catholic Moral Theology department of the Loyola University Chicago. While Harris effectively suggested, in my opinion, a carte blanche on gene editing research and taking evolution into our own hands, Haker called for a moratorium on basic research for 2 years, securing a ban on germline gene editing for reproductive purposes through the UN and regional bodies, and preparing international binding regulations. Though she did permit the somatic cell editing research with due oversight. Haker was followed by Marcy Darnovsky – the Executive Director at the Center for Genetics and Society – who shared Haker’s concerns (her take on the conference can be read in this Guardian article).
Arguably, the emotional peak of the summit occurred after this very session. During the Q&A, a lady from the American Association of Tissue Banks related a devastating story of her child dying from a fetal birth defect at the age of 6 days each of which was filled with suffering. Trying to hold her tears, she finished with “If you have the skills and the knowledge to fix these diseases, then freaking do it!”
As part of the session on governance at the international level, Indira Nath of the All India Institute of Medical Sciences and the National Academy of Science of India suggested that policies should exceed national borders as people will go wherever the technologies are available. She provided a current medical tourism example of patients traveling abroad “not only for IVF but also with frozen embryos for surrogacy”. She also expressed concern that the services and technologies stemming from CRISPR will be “expensive and affordable only by the rich”.
Gary Marchant, a professor of law from the Arizona State University provided arguments for international regulations, such as the ability to prevent “race to the bottom” (a term for government deregulation of the business environment or taxes in order to attract or retain economic activity in their jurisdictions) attracting researchers to certain countries with no relevant regulations. At the same time, he provided arguments against international regulation, such as the amount of resources that would be needed for such harmonization that could potentially be spent more efficiently by each country to figure out what to do and as such international coordination is very unlikely at any rate.
Finally, security issues were exposed by David Relman of Stanford University and VA Palo Alto Health Care System. One danger presented comes from the growing power of the individual in the life sciences due to falling barriers to entry, reduced costs, more efficient processes, and the ability to outsource some procedures. And as more individuals become capable or conducting corresponding procedures, there is going to also be more ill-intended or irresponsible individuals doing that. Relman provided the story of the second largest university in Iraq – the University of Mosul which is located in the territory currently occupied by ISIS. Mosul University has “a biology department with what seems to be quite respectable competent individuals”. The head of the physics department of Mosul University was reportedly executed by ISIS for refusing to develop bioweapons. “You’d have to be blind to think”, continues Relman, “ that there is no possibility that there are people that are clearly determined to do harm who are not thinking about the possibilities of misusing biology”.
The summit culminated with the release of the official statement which is available here. So when will we witness angry mobs with “Occupy Versalife” signs? Probably not too soon. The final statement essentially reiterated what John Holdren opened the summit with:
- Basic and preclinical research is clearly needed and should proceed, subject to appropriate legal and ethical rules and oversight.
- Clinical use in somatic cells – that is, cells whose genomes are not transmitted to the next generation – can in theory be approved if the existing and evolving regulatory standards are met.
- Clinical use in germline – which will be carried by all of the cells of a resulting child and will be passed on to subsequent generations as part of the human gene pool – would be irresponsible and should not be currently pursued.
- The stakeholders need to keep meeting – including on the international level – to further the discussion.
The statement does not equal guidelines, let alone a policy, so it remains to be seen how scientific institutions, labs, and individual researchers will respond to it. Still, this summit is an important first step on the path to establishing a responsible yet stimulating framework for gene editing in general and using CRSIPR/Cas9.
Watch the Full Coverage for the International Summit on Human Gene Editing Below