The nationwide experiment will initially include around 100,000 volunteers.
An international committee says scientists should be allowed to modify human embryos as long as strict oversight criteria are met.
February 15, 2017|
© BRYAN SATALINO
While new gene editing tools like CRISPR/Cas9 have made it easier to modify the genome, whether scientists should be permitted to modify human embryos is a hotly debated subject. One of the biggest concerns is the possibility of passing genetic modifications down to futures generations. Yesterday (February 14), a committee of experts appointed by the U.S. National Academy of Sciences (NAS) and the National Academy of Medicine released a report that broadly supports human germline editing, but only with substantial oversight.
In 2015, NAS organized a summit to discuss the ethics of embryo editing in response to the controversial study published by a Chinese group that attempted to use CRISPR/Cas9 to edit disease genes in embryos. At the time, the Organizing Committee released a statement saying that, “It would be irresponsible to proceed with any clinical use of germline editing unless and until the relevant safety and efficacy issues have been resolved.” That spurred the NAS to form an international committee of researchers, lawyers and ethicists to draw up a report on the scientific and ethical issues around editing the human genome.
The committee came to the conclusion that human embryo editing is acceptable when it can help prevent a baby from inheriting genes known to cause series medical conditions, such as Huntington’s disease and cystic fibrosis, and when there are no other “reasonable alternatives.” The report also recommended that genome editing should not be used for enhancing human traits, such as physical strength or intelligence.
“It’s a very careful, conservative position that’s just a little bit beyond an absolute bar,” Eric Lander, president of the Broad Institute of MIT and Harvard, who was not a part of the committee, told the Washington Post. “And I think that’s the right place to go for now.”
Others, however, feel the committee’s conclusions are far too permissive. “We’re very disappointed with the report,” Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley, California, told Science. “It’s really a pretty dramatic shift from the existing and widespread agreement globally that human germline editing should be prohibited,”
February 15, 2017
I have a question about this. Why? It seems uneconomical to me. I think there is a far better, more economical way. Correct me if I get anything wrong, because I've been scratching my head about something I read on this.
I assume we are talking about using CRISPR, to "help prevent a baby from inheriting genes known to cause series medical conditions,"
So, consider this process... loosely speaking, (1) harvest eggs from the mother, (2) fertilize them, (3) sequence them to analyze the genetic state, (4) develop/use a CRISPR molecule that can change that problem allele/sequence, (5) do the CRISPR process, (6) sequence them again to make sure it worked right, (7) then implant the zygote. Sounds good to me... except for a two things.
First off, why not instead (1) harvest eggs from the mother, (2) fertilize them, (3) sequence them to analyze the genetic state, (4) select a zygote that is not carrying that gene for cystic fibrosis/Huntington’s/Broka/etc., (7) then implant the zygote. Isn't that much simpler and cheaper?
You have two cases - a medical problem that occurs in the heterozygous condition and in the homozygous condition. One that occurs in the heterozygous case, could be removed by simple selection in one generation, because of only one parent had it, only half of the zygotes would have it and only one quarter of the zygotes if both parents carried it. If it is a condition that occurs only in the homozygous state, then it would take two generations to remove it, but it could be neutralized (made heterozygous) in the first generation.
There is far more reason for this approach... I'm quoting a book here called Genetics For A New Human Ecology - https://www.amazon.com/Genetics-Human.../dp/B01MYCC25Q
The author's perspective is two fold on this. First, CRISPR is not likely to help with larger copy errors such as caused by de novo mutations. Really though he has a far more compelling reason. He makes the point that older parents (mainly the mother) means there will be far more de novo mutations. At the same time there has been a huge reduction in natural selection due to a number of factors including medicine, vaccines and especially reduced family size. He argues for promoting large scale pre-natal artificial selection to replace the natural selection that has been removed. CRISPR could never compensate for the genetic problems that natural selection handles in a normal state... at least not economically practically.
The genetic considerations are very complete, even though he says he carefully wrote it to not be technical, because he points out that this is going to effect everyone. He calls it a change in ecology, which puts it an interesting perspective of adaptation as well. He frames the discussion in moral terms too, which is unusual, but seems like a good idea in this day and age. The book is well laid out and very very short, but quite original and compelling. It's something like an hour read. I think it a very original view and well worth a read.
August 9, 2017
The societal relationship between rights and duties in both law and ethics demands that society be willing to ascertain, establish and maintain guidelines as it relates to activities pertinent to its existence. Being proactive regarding genetic editing will have both immediate and long term benefits and assure a queasy public that society’s moral codes are not collapsing.
When the NAS wrote their report “Human Genome Editing: Science, Ethics and Governance” their guidelines were set on basic principles of ethics to include autonomy, informed consent, beneficence and nonmaleficence.
There is to be:
1. An absence of reasonable alternatives.
3. Restriction to editing genes that have been convincingly demonstrated to cause or to strongly predispose to the disease or condition.
4. Restriction to converting such genes to versions that are prevalent in the population and are known to be associated with ordinary health with little or no evidence of adverse effects.
6. Ongoing, rigorous oversight during clinical trials of the effects of the procedure on the health and safety of the research participants.
7. Comprehensive plans for long-term, multigenerational follow-up while still respecting personal autonomy.
8. Maximum transparency consistent with patient privacy.
9. Continued reassessment of both health and societal benefits and risks, with broad, on-going participation and input by the public.
10. Reliable oversight mechanisms to prevent extension to uses other than preventing a
serious disease or condition.
Parenthetical continuity commands the consideration that somatic cell editing is ultimately very minor considering the tumultuous state of genetic alterations made each and every day in human endeavors. Evolution is a moving target and as such microevolution as a change in allele frequencies is due to four different processes: mutation, selection as natural and artificial, gene flow, and genetic drift. Therefore, genetic editing as an artificial form of selection can be considered a part of evolution as much as any other alteration to include breeding, environment, personal habits, and so forth. This the public can understand. But because germline editing is passed to progeny these guidelines take on a different focus. As a facet of genetic editing, germ line editing may be an inevitable scion of genetic editing but the outcome of its use is far too nebulous at this time. But to deny it’s use is self-defeating.
It is important to remember that the legal definition of guideline is a practice that allows leeway in its interpretation. Interpretation, especially in the medical arena, rides a fine line between empirical premise and an ethical slippery slope scenario. To assert that some event must inevitably follow from another without rational argument or means of inevitably is a slippery slope scenario and is a fallacy.
However, an empirical premise as something guided by practical experience and not theory is something that currently cannot be considered a viable option in germ line editing due primarily to the omnibus spending bill H.R. 83 – Consolidated and Further Continuing Appropriations Act, 2015 which prohibits taxpayer funding for “the creation of a human embryo or embryos for research purposes.” Congress has also banned the U.S. Food and Drug Administration from considering a clinical trial of embryo editing. These limit, as noted above, the “Availability of credible preclinical and/or clinical data on risks and potential health benefits of the procedures.”
Therefore, for germ line editing, it is the paucity of compelling cases via clinical trials and the availability of alternate venues of treatment that should command the ethics of the situation for persuasion based on above board, transparent and informative consideration. To say that counseling is of critical importance is moot.
Also, autonomy and informed consent as ethical concerns can be considered questionable regarding the children of germ line editing. This has to be noted as a parenthetical slippery slope scenario because ultimately adults are acting in their best interest. Therefore, 2. Restriction to preventing a serious disease or condition and 3. Restriction to editing genes that have been convincingly demonstrated to cause or to strongly predispose to the disease or condition should be of paramount consideration.
Change is inevitable. It is a relational difference between states. There are expectations which when developed as a working hypothesis are linked to exploratory research and purpose in empirical investigation within a framework for qualitative and quantitative research.