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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:

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

Original Submission

AndyTheAbsurd writes:

(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.)

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

Original Submission

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

Arthur T Knackerbracket has found the following story:

Clinical trials and translational medicine have certainly given people hope and rapid pathways to cures for some of humankind's most troublesome diseases, but now is not the time to overlook the power of basic research, says UC Santa Barbara neuroscientist Kenneth S. Kosik.

In fact, as he points out in an article published in the journal Science -- along with coauthors Terry Sejnowski, Marcus Raichle, Aaron Ciechanover and David Baltimore -- supporting fundamental cell biology research into neurodegeneration may be the key to accelerating understanding of neurodegenerative and so-called "incurable" diseases such as Alzheimer's and Parkinson's.

"My point here is that what we really have to do is take the longer view and get a very fundamental understanding of these diseases to make inroads in treatment," said Kosik, who is UCSB's Harriman Professor of Neuroscience in the Department of Molecular, Cellular and Developmental Biology, and also the director of the campus's Neuroscience Research Institute.

[Continues...]

An Anonymous Coward writes:

The 21st Century Cures Act, a bill to provide billions of dollars of funding to the US National Institutes of Health (NIH), the Federal agency responsible for biomedical research, sailed through the US House of Representatives last week with a rare showing of strong bipartisan support. It is expected to pass the US Senate and to be signed by President Obama, a strong backer, later this month.

The $4.8 billion in funding for NIH is targeted at three areas: cancer research (as in Joe Biden's "cancer moonshot"), brain research (including Alzheimer's, Parkinson's and PTSD) and precision medicine (treatment informed by patient genomes).

However, $3.5 billion in funding of the bill will be redirected from Obamacare's Prevention and Public Health Fund, which is chartered to research Alzheimer's and other infectious diseases, so it could be argued that the bill reduces the Federal government's commitment to Alzheimer's research.

While the NIH employs thousands of researchers, most of the new funds are expected to be distributed to researchers at universities, hospitals, and other external labs.

The bill also authorizes $1 billion to fight the nation's opioid crisis, and $500 million in additional funding for the Federal Drug Administration (FDA).

As part of the compromise needed to attract Republican support, the bill loosens the guidelines on the FDA needed to approve a new drug or medical device; the industry and some patient advocates have complained about red tape in getting new drugs approved. However, the new approach has troubled some doctors who have followed the legislation.

Senators Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) have attacked the bill as a giveaway to the pharmaceutical and medical device industries, at the expense of the health of consumers and patients. Some conservative groups also oppose the bill as a waste of public funds.

Legislation text; political analysis from StatNews.

Original Submission

takyon writes:

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.

Previously: NIH Won't Fund Human Germline Modification
Francis Collins Retains Position as Director of the National Institutes of Health
The Era of Biomedical Research on Chimpanzees in the United States is Effectively Over
2017: Gene Therapy's Milestone Year

Original Submission

takyon writes:

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

Original Submission