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.
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Francis Collins to step down as NIH director
National Institutes of Health Director Francis Collins plans to announce his resignation on Tuesday after nearly three decades at the agency, including 12 years at the helm, three sources tell POLITICO.
The 71-year-old physician-geneticist led the agency under three consecutive presidents — making him the first presidentially appointed NIH director to serve in more than one administration and the longest-serving NIH director.
His departure had been in the works for some time, one person familiar said. Officials from NIH, the Department of Health and Human Services and the White House did not immediately respond to requests for comment.
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The Era of Biomedical Research on Chimpanzees in the United States is Effectively Over
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Following a September 3-4 meeting in Manchester, England, the Hinxton Group, "a global network of stem cell researchers, bioethicists, and experts on policy and scientific publishing" has published a statement backing the genetic modification of human embryos, with caveats:
It is "essential" that the genetic modification of human embryos is allowed, says a group of scientists, ethicists and policy experts. A Hinxton Group report says editing the genetic code of early stage embryos is of "tremendous value" to research. It adds although GM babies should not be allowed to be born at the moment, it may be "morally acceptable" under some circumstances in the future. The US refuses to fund research involving the gene editing of embryos. The global Hinxton Group met in response to the phenomenal advances taking place in the field of genetics.
From the statement:
Genome editing has tremendous value as a tool to address fundamental questions of human and non-human animal biology and their similarities and differences. There are at least four categories of basic research involving genome editing technology that can be distinguished: 1) research to understand and improve the technique of genome editing itself; 2) genome editing used as a tool to address fundamental questions of human and non-human animal biology; 3) research to generate preliminary data for the development of human somatic applications; and 4) research to inform the plausibility of developing safe human reproductive applications. These distinctions are important to make clear that, even if one opposes human genome editing for clinical reproductive purposes, there is important research to be done that does not serve that end. That said, we appreciate that there are even categories of basic research involving this technology that some may find morally troubling. Nevertheless, it is our conviction that concerns about human genome editing for clinical reproductive purposes should not halt or hamper application to scientifically defensible basic research.
BBC has this beginner's guide to the designer baby debate.
Related:
The Rapid Rise of CRISPR
NIH Won't Fund Human Germline Modification
Chinese Scientists Have Genetically Modified Human Embryos
UK Approves Three-Person IVF Babies
The National Institutes of Health (NIH) has lifted a ban on research into making certain viruses more deadly, while putting a new review process in place:
More than 3 years after imposing a moratorium on U.S. funding for certain studies with dangerous viruses, the National Institutes of Health (NIH) today lifted this so-called "pause" and announced a new plan for reviewing such research. But federal officials haven't yet decided the fate of a handful of studies on influenza and Middle East respiratory syndrome (MERS) that were put on hold in October 2014.
[...] Concerns over so-called "gain of function" (GOF) studies that make pathogens more potent or likely to spread in people erupted in 2011, when Kawaoka's team and Ron Fouchier's lab at Erasmus Medical Center in Rotterdam, the Netherlands announced that they had modified the H5N1 bird flu virus to enable it to spread between ferrets. Such studies could help experts prepare for pandemics, but pose risks if the souped-up pathogen escapes the lab. After a long discussion, the National Science Advisory Board for Biosecurity (NSABB) decided the two studies should be published and federal officials issued new oversight rules for certain H5N1 studies.
But U.S. officials grew uneasy after the publication of new GOF papers and several accidents in U.S. biocontainment labs. In October 2014, they announced an unprecedented "pause" on funding for 21 GOF studies of influenza, MERS and severe acute respiratory syndrome viruses. (At the time, NIH said there were 18 paused studies.) NIH eventually exempted some studies found to pose relatively little risk. But eight influenza studies and three MERS projects remained on hold.
Also at Nature, NYT, NPR, and Washington Post (archive).
Previously: The Question of Lab Safety when Creating Global Killer Viruses
Related: NIH Won't Fund Human Germline Modification
NIH Plans To Lift Ban On Research Funds For Human-Animal Chimera Embryos
U.S. Human Embryo Editing Study Published
Francis Collins will remain the director of the National Institutes of Health, for now:
Ending weeks of speculation, President-elect Donald Trump has asked National Institutes of Health (NIH) Director Francis Collins to remain in his position. It is not clear for how long. "We just learned that Dr. Collins has been held over by the Trump administration," an NIH spokesperson said in a statement. "We have no additional details at this time."
Collins, a geneticist who has headed the $32 billion NIH for the past 8 years, has been campaigning to keep his job and met with Trump last week. On Wednesday, he told a reporter at the World Economic Forum in Davos, Switzerland, that he still didn't know what his fate would be. But although Collins had the support of key Republicans in Congress, he has been one of several candidates for the NIH post, including Representative Andy Harris (R–MD).
Related: NIH Won't Fund Human Germline Modification
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U.S. scientists have genetically modified human embyros using CRISPR and have apparently avoided the worst of the off-target effects that have plagued previous efforts. The results are unpublished and the team is not commenting yet:
The first known attempt at creating genetically modified human embryos in the United States has been carried out by a team of researchers in Portland, Oregon, Technology Review has learned.
The effort, led by Shoukhrat Mitalipov of Oregon Health and Science University, involved changing the DNA of a large number of one-cell embryos with the gene-editing technique CRISPR, according to people familiar with the scientific results.
Until now, American scientists have watched with a combination of awe, envy, and some alarm as scientists elsewhere were first to explore the controversial practice. To date, three previous reports of editing human embryos were all published by scientists in China.
Now Mitalipov is believed to have broken new ground both in the number of embryos experimented upon and by demonstrating that it is possible to safely and efficiently correct defective genes that cause inherited diseases.
Although none of the embryos were allowed to develop for more than a few days—and there was never any intention of implanting them into a womb—the experiments are a milestone on what may prove to be an inevitable journey toward the birth of the first genetically modified humans.
Also at STAT News.
Previously: Chinese Scientists Have Genetically Modified Human Embryos
NIH Won't Fund Human Germline Modification
Group of Scientists and Bioethicists Back Genetic Modification of Human Embryos
The International Summit on Human Gene Editing
UK Scientist Makes the Case for Editing Human Embryos
Second Chinese Team Reports Gene Editing in Human Embryos
Scientists Keep Human Embryos Alive Longer Outside of the Womb
Francis Collins Retains Position as Director of the National Institutes of Health
A team of researchers led by Junjiu Huang at the Sun Yat-sen University in Guangzhou have reported human germline modification using CRISPR:
In a world first, Chinese scientists have reported editing the genomes of human embryos. The results are published in the online journal Protein & Cell and confirm widespread rumours that such experiments had been conducted — rumours that sparked a high-profile debate last month about the ethical implications of such work.
In the paper, researchers led by Junjiu Huang, a gene-function researcher at Sun Yat-sen University in Guangzhou, tried to head off such concerns by using 'non-viable' embryos, which cannot result in a live birth, that were obtained from local fertility clinics. The team attempted to modify the gene responsible for β-thalassaemia, a potentially fatal blood disorder, using a gene-editing technique known as CRISPR/Cas9. The researchers say that their results reveal serious obstacles to using the method in medical applications.
[...] A Chinese source familiar with developments in the field said that at least four groups in China are pursuing gene editing in human embryos.
While some embryos were successfully edited, the use of CRISPR/Cas9 was not nearly as reliable as desired:
The team injected 86 embryos and then waited 48 hours, enough time for the CRISPR/Cas9 system and the molecules that replace the missing DNA to act — and for the embryos to grow to about eight cells each. Of the 71 embryos that survived, 54 were genetically tested. This revealed that just 28 were successfully spliced, and that only a fraction of those contained the replacement genetic material. "If you want to do it in normal embryos, you need to be close to 100%," Huang says. "That's why we stopped. We still think it's too immature."
The National Institutes of Health (NIH) is planning to lift its moratorium on chimeric embryo research:
The National Institutes of Health is proposing a new policy to permit scientists to get federal money to make embryos, known as chimeras, under certain carefully monitored conditions. The NIH imposed a moratorium on funding these experiments in September because they could raise ethical concerns.
[...] [Scientists] hope to use the embryos to create animal models of human diseases, which could lead to new ways to prevent and treat illnesses. Researchers also hope to produce sheep, pigs and cows with human hearts, kidneys, livers, pancreases and possibly other organs that could be used for transplants.
To address the ethical concerns, the NIH's new policy imposes several restrictions. The policy prohibits the introduction of any human cells into embryos of nonhuman primates, such as monkeys and chimps, at their early stages of development. Previously, the NIH wouldn't allow such experiments that involved human stem cells but it didn't address the use of other types of human cells that scientists have created. In addition, the old rules didn't bar adding the cells very early in embryonic development. The extra protections are being added because these animals are so closely related to humans. But the policy would lift the moratorium on funding experiments involving other species. Because of the ethical concerns, though, at least some of the experiments would go through an extra layer of review by a new, special committee of government officials.
You can submit a response to the proposal here up until the end of the day on September 4.
Related: NIH Won't Fund Human Germline Modification
U.S. Congress Moves to Block Human Embryo Editing
China's Bold Push into Genetically Customized Animals
Human-Animal Chimeras are Gestating on U.S. Research Farms
(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.
The Musk/Trump interview appears to have been hacked, but not a DDOS hack...more like A Distributed Denial of Reality.
(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.