NIH Plans To Lift Ban On Research Funds For Human-Animal Chimera Embryos

NIH Won't Fund Human Germline Modification 21 comments

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.

U.S. Congress Moves to Block Human Embryo Editing 85 comments

AnonTechie writes:

The US House of Representatives is wading into the debate over whether human embryos should be modified to introduce heritable changes. Its fiscal year 2016 spending bill for the US Food and Drug Administration (FDA) would prohibit the agency from spending money to evaluate research or clinical applications for such products.
In an unusual twist, the bill—introduced on June 17—would also direct the FDA to create a committee that includes religious experts to review a forthcoming report from the US Institute of Medicine (IOM). The IOM's analysis, which considers the ethics of creating embryos that have three genetic parents, was commissioned by the FDA.
The House legislation comes during a time of intense debate on such matters, sparked by the announcement in April that researchers in China had edited the genomes of human embryos. The US National Institutes of Health (NIH) moved quickly to remind the public that a 1996 law prevents the federal government from funding work that destroys human embryos or creates them for research purposes.

http://www.scientificamerican.com/article/u-s-congress-moves-to-block-human-embryo-editing/

[Source]: http://www.nature.com/news/us-congress-moves-to-block-human-embryo-editing-1.17858

We covered a related story, Three-Person Babies Could Be Possible in Two Years just over a year ago.

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China's Bold Push into Genetically Customized Animals 22 comments

Phoenix666 writes:

China's western Shaanxi Province is known for rugged windswept terrain and its coal and wool, but not necessarily its science. Yet at the Shaanxi Provincial Engineering and Technology Research Center for Shaanbei Cashmere Goats, scientists have just created a new kind of goat, with bigger muscles and longer hair than normal. The goats were made not by breeding but by directly manipulating animal DNA—a sign of how rapidly China has embraced a global gene-changing revolution.
Geneticist Lei Qu wants to increase goatherd incomes by boosting how much meat and wool each animal produces. For years research projects at his lab in Yulin, a former garrison town along the Great Wall, stumbled along, Qu's colleagues say. "The results were not so obvious, although we had worked so many years," his research assistant, Haijing Zhu, wrote in an e-mail.

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Human-Animal Chimeras are Gestating on U.S. Research Farms 34 comments

AndyTheAbsurd writes:

A radical new approach to generating human organs is to grow them inside pigs or sheep.

(Andy's note: pretty sure it's only "radical" if you discount ideas from science fiction - Technovelgy points out it's been as an idea from at least 2002, and I'm pretty sure earlier examples could be found if one went looking.)

Braving a funding ban put in place by America's top health agency, some U.S. research centers are moving ahead with attempts to grow human tissue inside pigs and sheep with the goal of creating hearts, livers, or other organs needed for transplants.

The effort to incubate organs in farm animals is ethically charged because it involves adding human cells to animal embryos in ways that could blur the line between species.

Last September, in a reversal of earlier policy, the National Institutes of Health announced it would not support studies involving such "human-animal chimeras" until it had reviewed the scientific and social implications more closely.

The agency, in a statement, said it was worried about the chance that animals' "cognitive state" could be altered if they ended up with human brain cells.

[Wikipedia helpfully has articles on Chimera (mythology) (the source of the name) and Chimera (genetics) (the topic of this research). -Ed.]

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Francis Collins Retains Position as Director of the National Institutes of Health 6 comments

takyon writes:

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).

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Mauritius: Safe Haven for Nonhuman Primate Experimentation? 6 comments

takyon writes:

Mauritius, an island nation that is the world's second largest exporter of long-tailed macaques, has moved to allow scientific experimentation on the nonhuman primates locally:

The persistent fight by animal welfare activists to end nonhuman primate research has found its way to Mauritius, an island in the Indian Ocean two-thirds the size of Rhode Island. In the 1700s, Dutch and Portuguese seafarers introduced the long-tailed macaque to the island, where the animals thrived and, in recent decades, formed the basis of an export industry supplying biomedical labs in the developed world. Now, Mauritius has decided to get into the business of nonhuman primate experimentation itself even as such work is becoming increasingly constrained in North America and Europe. Last month the move touched off a heated debate in Mauritius's National Assembly about whether the government could adequately protect the macaques used in research and whether the new industry might endanger a far bigger lifeline for the island—tourism.
The debate is reverberating overseas. Activists, led by London-based Cruelty Free International, see the influence of Mauritius's five monkey breeding companies behind the government's February step allowing licenses to be issued for local research on island-bred macaques. (The new regulations also allow rabbit and rodent studies.) They contend that the companies are alarmed by a successful, high-pressure campaign to discourage commercial airlines from flying nonhuman primates from source countries such as Mauritius to research centers—and are trying to hedge their bets. The London group also argues that the new regulations, which amend the country's Animal Welfare Act, are invalid because they don't further the purpose of the original legislation.

National Institutes of Health 3-Year Ban on Viral "Gain of Function" Studies Lifted 1 comment

takyon writes:

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

Original Submission

Scientists Grow Sheep Embryos Containing Human Cells 8 comments

takyon writes:

Breakthrough as scientists grow sheep embryos containing human cells

Growing human organs inside other animals has taken another step away from science-fiction, with researchers announcing they have grown sheep embryos containing human cells.
Scientists say growing human organs inside animals could not only increase supply, but also offer the possibility of genetically tailoring the organs to be compatible with the immune system of the patient receiving them, by using the patient's own cells in the procedure, removing the possibility of rejection. [...] "Even today the best matched organs, except if they come from identical twins, don't last very long because with time the immune system continuously is attacking them," said Dr Pablo Ross from the University of California, Davis, who is part of the team working towards growing human organs in other species.
[...] Ross and colleagues have recently reported a major breakthrough for our own species, revealing they were able to introduce human stem cells into early pig embryos, producing embryos for which about one in every 100,000 cells were human. These chimeras – a term adopted from Greek mythology – were only allowed to develop for 28 days.
Now, at this week's meeting of the American Association for the Advancement of Science in Austin, Texas, the team have announced that they have managed a similar feat with sheep embryos, achieving an even higher ratio of human to animal cells. "About one in 10,000 cells in these sheep embryos are human," said Ross.

Japan is expected to lift a ban on growing human organs inside of animals.

Here's another article about pig-to-human organ transplants.

Also at The Telegraph.

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