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A week after a Chinese team reported semi-successful modification of human embryos, Dr. Francis Collins, director of the National Institutes of Health, has said in a statement that his agency will not fund any research involving human germline modification:
The concept of altering the human germline in embryos for clinical purposes has been debated over many years from many different perspectives, and has been viewed almost universally as a line that should not be crossed. Advances in technology have given us an elegant new way of carrying out genome editing, but the strong arguments against engaging in this activity remain. These include the serious and unquantifiable safety issues, ethical issues presented by altering the germline in a way that affects the next generation without their consent, and a current lack of compelling medical applications justifying the use of CRISPR/Cas9 in embryos.
Practically, there are multiple existing legislative and regulatory prohibitions against this kind of work. The Dickey-Wicker amendment prohibits the use of appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed (H.R. 2880, Sec. 128). Furthermore, the NIH Guidelines state that the Recombinant DNA Advisory Committee, "...will not at present entertain proposals for germ line alteration". It is also important to note the role of the U.S. Food and Drug Administration (FDA) in this arena, which applies not only to federally funded research, but to any research in the U.S. The Public Health Service Act and the Federal Food, Drug, and Cosmetic Act give the FDA the authority to regulate cell and gene therapy products as biological products and/or drugs, which would include oversight of human germline modification. During development, biological products may be used in humans only if an investigational new drug application is in effect (21 CFR Part 312).
However, some scientists aren't joining the chorus of "universal" criticism:
George Church, a geneticist at Harvard Medical School in Boston, Massachusetts, disagrees that the technology is so immature. He says that the researchers did not use the most up-to-date CRISPR/Cas9 methods and that many of the researchers' problems could have been avoided or lessened if they had.
Although researchers agree that a moratorium on clinical applications is needed while the ethical and safety concerns of human-embryo editing are worked out, many see no problem with the type of research that Huang's team did, in part because the embryos could not have led to a live birth. "It's no worse than what happens in IVF all the time, which is that non-viable embryos are discarded," says John Harris, a bioethicist at the University of Manchester, UK. "I don't see any justification for a moratorium on research," he adds. Church, meanwhile, notes that many of the earliest experiments with CRISPR/Cas9 were developed in human induced pluripotent stem cells, adult cells that have been reprogrammed to have the ability to turn into any cell type, including sperm and eggs. He questions whether Huang's experiments are any more intrinsically problematic.
(Score: 3, Insightful) by kaszz on Saturday May 02 2015, @03:41PM
So they don't want a family line of Typhoid Marys? :p
In the longer term there's research competition and they will have less inhibitions about what can be researched. This could lead to some countries being left behind. Something that may be hard to catch up with later on. Now it's a good idea to have rules about some things. But one has to be insightful about this and not ideologically driven.
(Score: 0) by Anonymous Coward on Saturday May 02 2015, @04:02PM
We're eventually going to see gene modification used to result in men, and maybe even women, with larger penises. I agree with you, it would be better for the entire world if the Americans possess this technology first.
(Score: 2) by kaszz on Saturday May 02 2015, @04:45PM
The American nation (USA) is not the best there is. But when taken into comparison of nations like Russia and China the choice is not that hard. The Chinese government will likely have less qualms and transparency in growing yes-men-drones.
And of course the option of a synthetic womb is probably within grasp.
(Score: 1, Insightful) by Anonymous Coward on Saturday May 02 2015, @05:40PM
If ever there was a country of yes men drones, it would be America. Most of you are too lazy to even vote and nearly all of those that do keep saying 'yes' to the same 2 groups of idiots.
(Score: -1, Flamebait) by Anonymous Coward on Saturday May 02 2015, @07:21PM
We vote for the first two because the third, fourth, fifth, sixth and beyond are crazier than the first two!
(Score: 0) by Anonymous Coward on Saturday May 02 2015, @07:52PM
Your post implies that the first two are sane.
If the third, fourth, fifth, sixth and beyond are crazier than the first two, then you need more crazy, and less sane.
(Score: 0) by Anonymous Coward on Saturday May 02 2015, @09:05PM
It implies nothing of the sort.
(Score: 0) by Anonymous Coward on Sunday May 03 2015, @04:43AM
No one wants to run apart from those 2 because the rest of the population are yes-men.
(Score: 2) by kaszz on Tuesday May 05 2015, @12:19AM
How to cure yes-men..
-Go kill yourself.
-Yes sir!
;-)
(Score: 1) by dime on Saturday May 02 2015, @06:09PM
You honest think that if amazing technology to modify genes comes out, it will be immediately forced onto the lowest class in order to make them drones? They're already drones. Everyone in the world will be a drone compared to the few (those who already have the influence or money to get this) who have first crack at this technology to breed out health problems and breed in (more) intelligence. Stick with your 1984 brush applies to everything ideology and live a bitter life as new technology and possibly the course of human evolution passes you by.
I myself have a few qualms and suspicions on what this may be used for, but the compulsive backlash that articles like this get often remind me of the Ousters from the Hyperion Cantos. Thought of as the evil and barbaric race that we must be protected by our human-preserving hegemony must protect us from. Meanwhile, those who brave into new territories have already evolved beyond regard for those who refuse to adapt.
(Score: 1) by dime on Saturday May 02 2015, @06:15PM
s/by our human-preserving hegemony must protect us from/from by our human-preserving hegemony/
(Score: 0) by Anonymous Coward on Saturday May 02 2015, @07:34PM
I'm worried that these yes-men will have 14" or maybe even 16" penises, all thanks to gene splicing and modification. Doesn't that worry you? It worries the heck out of me.
(Score: 3, Funny) by frojack on Saturday May 02 2015, @06:19PM
Human Gremlins... {spits coffee}
Oh, sorry, coffee first, then read headlines...
No, you are mistaken. I've always had this sig.
(Score: 1, Interesting) by Anonymous Coward on Saturday May 02 2015, @08:07PM
Its give you a warm and fuzzy feeling that you can debate the finer points of this technology and what its merits are, and what it should not be used for. Don't you realize that no one will ask you of your opinion when the time comes. This technology is probably live by now, with modified people running around. Its not for normal people, solving their genetic diseases and such. Its for the elite running the world.
Wait until someone spills the news that modified humans have been running the world for a long time. With all the masters in the New World Order being super-humans. These masters are/will be hyper-intelligent, hyper-psychic, be able to read human minds across time and space. They will then put it on the news and "normal" people will believe what the honest "journalists" will tell them. What is anyone going to do about it? Get angry? There is nothing that can be done about the dictators-for-life until there is human* oversight.
human* = real human, not human-look-alike alien.
(Score: 2) by frojack on Saturday May 02 2015, @09:00PM
Yeah, saw that movie [wikipedia.org] too.
Your conspiracy affliction is running away with you. Back on your med before you hurt yourself.
No, you are mistaken. I've always had this sig.
(Score: 1) by khallow on Saturday May 02 2015, @08:19PM
(Score: 3, Funny) by aristarchus on Saturday May 02 2015, @10:09PM
My solution is completely privatize . . . a large clone army and killing a bunch of people.
Wow, never saw that coming! Especially the privitization part.
(Score: 2) by MichaelDavidCrawford on Saturday May 02 2015, @10:05PM
"fer scientific experimentation".
Just now me and my left hand violated research ethics.
Yes I Have No Bananas. [gofundme.com]
(Score: 3, Insightful) by Anonymous Coward on Sunday May 03 2015, @12:44AM
ethical issues presented by altering the germline in a way that affects the next generation without their consent
Is that really the best reason they have?
Nothing is done with the consent of the next generation until they are old enough to make decisions for themselves. Circumcision, "corrective" sex-change operations, where they live, what they eat, where they are educated, etc. The next generation also doesn't have a chance to consent to muscular dystrophy, cystic fibrosis, or other genetic diseases.
a current lack of compelling medical applications
There are plenty of genetic disorders that are lethal or severely debilitating.
http://en.wikipedia.org/wiki/List_of_genetic_disorders [wikipedia.org]
(Score: 2) by captain normal on Sunday May 03 2015, @03:37AM
I can't believe that 17 comments went by and no one caught the difference between genome and germline. Unless of course, that was what the first post intended. I guess this crew is not too sharp on the weekends.
"It is easier to fool someone than it is to convince them that they have been fooled" Mark Twain
(Score: 2, Informative) by sbgen on Sunday May 03 2015, @04:07PM
The response from NIH's director is in keeping with its policies and is not unexpected. That does not mean it is good. I get a feeling this is the beginning of attempts to place restriction on a research area with the basis mostly outside of science. Something similar happened with stem-cell related research during Bush era but that was confined to work funded by federal grants. Privately funded research was free to go forward. What worries me in this iteration of the same story is the invocation of FDA's powers to regulate any and all research conducted within the USA regardless of the funding source. Implication is that any research on editing of the human germline could be stopped via legal means, perhaps not germane to the actual science.
On a related note, it appears Nature journal has made the commentaries linked in the above summary available to all. One of those commentaries include response from the editor of the journal that published the paper defending the quick review of one day (the author's had submitted with the article the reviewer's comments from the previous journal submissions - Nature and Science) and also a cogent argument from the Science journal why they did not accept the paper. Worth reading them for a better perspective.
Warning: Not a computer expert, but got to use it. Yes, my kind does exist.