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kaszz writes:

A scientist at the University of Wisconsin-Madison published an article in June 2014 revealing that he had taken genes from the deadly human 1918 Spanish Flu and inserted them into the H5N1 avian flu to make a new virus one which was both far deadlier and far more capable of spreading than the original avian strain. In July 2014 it was revealed that the same scientist was conducting another study in which he genetically altered the 2009 strain of flu to enable it to evade immune responses, "effectively making the human population defenseless against re-emergence" In the U.S. alone, biosafety incidents involving pathogens happen more than twice per week. These 'gain-of-function' experiments are accidents waiting to happen, with the possibility of starting deadly pandemics that could kill millions. In 2009, a group of Chinese scientists created a viral strain of flu virus by deliberately mixing the H5N1 bird flu virus, which is highly lethal but not easily transmitted between people, with a 2009 strain of H1N1 flu virus, which is very infectious to humans And got heavily criticized for doing this by senior scientists. 'The growing use of gain-of-function approaches for research requires more careful examination. And the potential consequences keep getting more catastrophic.' The Bulletin has published an article that explores the history of lab created pandemics and outlines recommendations for a safer approach to this type of research.

The possibility of gene mixing in the wild is also a reason to urgently deal with the current outbreak of Ebola in west Africa Which has the possibility to become airborne. Something that has been known since 1986.

Beware list: The SSL deficient journal Cell Host and Microbe is owned by Evilvier, The
Guardian and The independent still hasn't got the message about neither the use of SSL or annoying javascripts (autoscroll to top), thebulletin.org page layout is best viewed in a text only browser.

takyon writes:

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.

takyon writes:

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

Original Submission

takyon writes:

The human embryo editing study first reported by MIT Technology Review last week has been published in Nature. Scientists led by the Oregon Health & Science University's Shoukhrat Mitalipov edited human embryos to remove the MYBPC3 mutation associated with hypertrophic cardiomyopathy:

The experiment corrected the defect in nearly two-thirds of several dozen embryos, without causing potentially dangerous mutations elsewhere in the DNA.

None of the embryos were used to try to create a baby. But if future experiments confirm the techniques are safe and effective, the scientists say the same approach could be used to prevent a long list of inheritable diseases. "Potentially, we're talking about thousands of genes and thousands of patients," says Paula Amato, an associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. She was a member of the scientific team from the U.S., China and South Korea.

[...] Amato and others stress that their work is aimed at preventing terrible diseases, not creating genetically enhanced people. And they note that much more research is needed to confirm the technique is safe and effective before anyone tries to make a baby this way. But scientists hoping to continue the work in the U.S. face many regulatory obstacles. The National Institutes of Health will not fund any research involving human embryos (the new work was funded by Oregon Health & Science University). And the Food and Drug Administration is prohibited by Congress from considering any experiments that involve genetically modified human embryos.

Nevertheless, the researchers say they're hopeful about continuing the work, perhaps in Britain. The United Kingdom has permitted genetic experiments involving human embryos forbidden in the United States. "If other countries would be interested, we would be happy to work with their regulatory bodies," says Shoukhrat Mitalipov, director of the Oregon Health & Science University's Center for Embryonic Cell and Gene Therapy.

Also at NYT, MIT, BBC, Science Magazine, and Scientific American.

Correction of a pathogenic gene mutation in human embryos (open, DOI: 10.1038/nature23305) (DX)

Previously: First Known Attempt at Genetically Modifying Human Embryos in the U.S. is an Apparent Success

Original Submission