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Science Policy Around the Web January 7th, 2020

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By Ben Wolfson, PhD

Image by mcmurryjulie from Pixabay 

What CRISPR-Baby Prison Sentences Mean for Research

Chinese scientist He Jiankui came to prominence last year after claiming he had used CRISPR/Cas9 to genetically edit human embryos to confer resistance to HIV-1. Twin girls with the mutation were born in October of 2018, and He’s work was confirmed by Chinese investigators in February of 2019.

Now, after a trial held in secret, He has been sentenced to three years in prison for “illegal medical practice” by a Chinese court. Two of He’s colleagues were also charged and given shorter prison sentences. All three were leveled fines, and will be prevented from conducting research using human reproductive technology.

These actions set an important precedent for regulation of human gene editing, however Chinese scientists also worry that they may result in restrictions for research into genetic modification that is not as ethically dubious. They worry that it may become difficult to get approval to use gene editing tools in clinical trials, as well as making funding for these sorts of research experiments more difficult to get. 

Despite these worries, He’s imprisonment is supported by the scientific community, and represents the first big check on clinical gene editing research. Others outside of the mainstream scientific community disagree. In an Op-Ed published by Stat News, Biohacker Josiah Zayner states that as gene-editing of human embryos becomes more common, the perspective on Jiankui will shift and he will no longer be seen as having done anything wrong. 

(David Cyranoski, Scientific American)

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January 7, 2020 at 1:27 pm

Science Policy Around the Web – March 18, 2019

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By: Allison Cross, Ph.D.

Source: Pixabay

Scientists track damage from controversial deep-sea mining method

The extraction of rare and valuable metals and minerals from the deep sea is highly attractive to mining companies.  Scientists, however, have long raised concerns about potential harmful effects of these activities on marine ecosystems.  Next month, the mining company Global Sea Mineral Resources is scheduled to harvest precious metals and minerals on the seafloor in the remote Pacific Ocean for eight days with a team of scientists working alongside them.  The scientists will be using deep-sea cameras and sensors to monitor sediment plumes created by the mining activity.  

Scientists are concerned that sediment plumes created during deep sea mining could extend tens or hundreds of meters above the seafloor and “bury, smother and toxify” the marine communities in these regions.  The research exhibition scheduled for next month is intended to help scientists understand the potential impact of deep-sea mining and inform the development of an international code of conduct for deep-sea commercial mining.  

The code of conduct for deep sea commercial mining will be created by the International Seabed Authority (ISA), an organization founded in 1994 to organize, regulate and control all mining activity in international waters.  The ISA is planning to finalize the code by 2020, allowing companies that have been granted licenses to extract minerals from the deep sea to begin full scale mining in the Pacific Ocean.  

Though the experiment scheduled for next month will provide key insight into how long it takes for sediment plumes to resettle, and how far they can travel, the experiment is just too short to gauge potential long-term effects of mining activities.  Craig Smith, an oceanographer at the University of Hawaii at Manoa in Honolulu cautions “We will not really understand the actual scale of mining impacts until the effects of sediment plumes from full-scale mining are studied for years”.

(Olive Heffernan, Nature Briefing)

U.S. blocks U.N. Resolution on Geoengineering

Last week, during the fourth session of the UN Environment Assembly (UNEA) in Nairobi, the United States, Saudi Arabia, and Brazil joined together to block a resolution aimed at studying the potential risks of geoengineering.  “Geoengineering”, also referred to as climate engineering or climate intervention, aims to mitigate effects of global warming using techniques like solar radiation management and carbon dioxide removal.

Geoengineering technologies are not yet operational and while proponents believe these techniques could help curb the impact of climate change, opponents worry about the potential risks of these techniques on both people and nature. Notably, one proposed method of solar radiation managementinvolves using aerosols to reflect a portion of inbound sunlight back out to space. Research in this area is still in its infancy and some worry that infusing the atmosphere with aerosols could lead to undesired side effects, like severe weather.  

The proposal raised at the UNEA meeting last week, backed by Switzerland and nine other nations, aimed to direct the U.N. Environment Programme to study the implications of geoengineering and compile a report by next year on current scientific research in this area. 

While there is some consensus that issuesof geoengineering technologies need to be explored, countries disagree on who should be overseeing these efforts. It has been reported that the United States prefers questions about geoengineering to be dealt with by the Intergovernmental Panel on Climate Change (IPCC), rather than by UNEA. The IPCC is reported to be assessing geoengineering as a part of its next report set to be published in 2021 or 2022. 

(Jean Chemnick, Scientific America)

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March 19, 2019 at 7:45 pm

Science Policy Around the Web – March 15, 2019

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By: Allison Dennis. B.S.

Image by Gabriela Sanda from Pixabay 

A Genetic Mutation Might Explain Why Birth Control Can Fail

Hormonal contraceptives have been increasingly embraced as an effective tool for family planning since their approval for contraceptive use by the FDA in 1960Fewer than 1 in 100women will get pregnant in a year when using the contraceptive pill correctly, but the cause of the few unintended pregnancies remaines a mystery. 

To ask if there was a genetic reason why hormonal contraceptives might be ineffective at preventing pregnancy for some women, researchers measured the amount of etonogestrel in the blood of women using the etonogestrel contraceptive implant (Nexplanon). While the findings of this small study were not significant, the researchers did observe that women carrying a mutation in their CYP3A7gene had lower concentrations of etonogestrel in their blood. Of the women with mutation, 28% had etonogestrel levels lower than what is needed to suppress ovulation. Only 9% of women without the mutation had critically low levels. The CYP3A7 gene produces a fetal enzyme, responsible for breaking down excessive steroid hormones in the developing fetus. Usually the gene is turned off in adulthood, but genetic mutations can result in it staying active throughout one’s life, possibly leading women with these mutations to break down the etonogestrel being supplied by the Nexplanon implant. 

To begin capturing the ability of particular genetic variants to predict which patients will or will not respond to particular medication, experience adverse events, or need a particular dose, the FDA maintains a list of drugs whose use may be complicated by particular Pharmacogenomic Biomarkers. Only one of the 232 on the list is a hormonal contraceptive, listed because women carrying a particular mutation may respond negatively to one of its inactive ingredients, not because it is less effective for these women. The etonogestrel study is the first to associate particular genetic variants with birth control performance. As researchers delve into the complicated intersection between genetic differences and drug responses their discoveries promise to lead to better outcomes for all those seeking effective family planning options. 

(Megan Molteni, Wired Magazine)

New call to ban gene-edited babies divides biologists

The birth of genetically modified children is now possible thanks to technologies like the genome-editing CRISPR-Cas9which can introduce heritable changes in germline cells, including human sperm, eggs, and embryos. In November 2018, He Jiankui’s demonstrated the technique by orchestrating the birth of two babies whose genomes were altered between in vitro fertilization and implantation. He Jiankui’s experiment may have shown editing the human germline was possible, but it did not address the safety or efficacy of the genetic changes for his two inaugural patients. While many view He Jiankui’s experiment as prematureand possibly illegal, it has undeniably brought discussions of the appropriate use of the technology to a forefront. 

On March 13th, a group of prominent scientists and international specialists published a call for a global moratorium on clinically making genetically modified children. The first step, as they see it should be setting a deadline before which all clinical use of germline editing will be put on hold. They suggest five years from now. During this time, they propose that nations engage in “discussions about the technical, scientific, medical, societal, ethical, and moral issues that must be considered.” Technical issues arise from the need to demonstrate germline editing as safe and efficacious. Scientifically, the long-term effects of specific genetic enhancements or corrections must be understood. Many potential changes imagined to be possible may not be medically necessary. As for societal, ethical and moral considerations, the authors stress the importance of carefully weighing “the appropriateness of altering a fundamental aspect of humanity.” The commentary acknowledges that not all nations will be ready to proceed at the same rate but suggests that any nation that does decide to proceed only do so after consulting broadly with other countries and allowing their public to reach societal consensus that the next step is appropriate. 

The motivation of the authors’ is clear. “We’re trying to force the spotlight on what comes next,” said co-author Eric Lander, President of the Broad Institute. To what extent international consensus can be built surrounding what the National Institutes of Health calls“a crucial moment in the history of science: a new technology offers the potential to rewrite the script of human life”  remains to be seen.

(Jon Cohen, Science Magazine)

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March 15, 2019 at 4:00 pm

Science Policy Around the Web – December 6, 2018

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By: Neetu M. Gulati, Ph.D.

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Source:Pixabay

 

The CRISPR Baby Scandal Gets Worse by the Day

Ethical concerns and controversy came to the forefront last week when news broke that Chinese scientist He Jiankui had supposedly created genetically edited babies using CRISPR technology: a first in the world. CRISPR/Cas9 technology, or CRISPR as it is more commonly known, is a scientific tool that allows researchers to edit (add, subtract, or change) the expression of genes quickly and precisely. This technology could be used to fix mutations that cause human disease. However, there are also risks, using CRISPR for gene editing may have disastrous side effects such as potentially leading to cancer.

He Jiankui claimed that he used the technology to alter a gene called CCR5 to reduce the risk of of HIV infection in embryos before implanting them in a woman, who then gave birth to twin girls. He claimed another CRISPR baby may be on the way from another pregnant woman. It is unclear if He has actually done what he claimed, and he has not yet published his results in a peer-reviewed journal. Nevertheless, the response to He’s claims have been strongly negative. Many people are concerned that He violated ethical norms by editing human embryos, especially because the overall consensus among scientistsin the field of gene-editing was that “there is a need for caution” and to only use the technology after “much more research to meet appropriate risk/benefit standards.”

Since the public has learned about He’s experiments, numerous scientists, including pioneers in the CRISPR field, have spoken out against He’s actions and have called for a temporary moratorium on similar experiments. Southern University of Science and Technology in China, where He has been on unpaid leave since February, has opened an investigation into He after finding out about his research. China’s National Health Commission is also investigating He.

Amid the backlash, He defended himself and his actions at the Human Genome Editing Summit in Hong Kong, claiming to be “proud” of his work. Dr. He has not been seen since the summit, however, and there are now concerns that he may be missing.

(Ed Yong, the Atlantic)

 

Trump emphasizes workforce training in new vision for STEM education

The White House released a new five-year strategic plan for science, technology, engineering, and mathematics (STEM) education this week, with a vision that “all Americans will have lifelong access to high-quality STEM education and the United States will be the global leader in STEM literacy, innovation and employment.” The report emphasizes workforce training in STEM, focusing primarily on opportunities outside of traditional classroom settings, such as apprenticeships. The plan also highlights the need for more diversity in STEM, such as minorities and women.

Overall the strategic plan focuses on four pathways to success: developing and enriching partnerships between educators, employers, and the community; engaging students in trans-disciplinary learning, including advancing innovation and entrepreneurship education; building computational literacy; and operating with transparency and accountability. The plan put forth by the Trump administration diverges from some of the key priorities of the former administration, including efforts focused on traditional academic environments such as training more teachers, and improving STEM instruction in colleges and universities. Instead, this plan appears more focused on how STEM education prepares students for the years after schooling is completed. “STEM education is absolutely critical to supporting the American worker, and this plan brings together a number of programs that are part of our emphasis on the American worker,” said Michael Kratsios, deputy assistant to the president at OSTP.

(Jeffrey Mervis, Science)

 

NASA’s InSight Mars explorer lands safely on the Red Planet

For only the eighth time in human history, a spacecraft has been landed on Mars. The InSight lander touched down on Martian soil on November 26, 2018 after over six months of space travel.

NASA’s InSight mission aims to gather information about Mars, and is part of the NASA Discovery program for focused solar science missions. InSight will study the crust, mantle, and core of Mars, to allow scientists to learn more about the formation of rocky planets in the solar system.

InSight has already begun taking photos of the surface of Mars, which have been posted on social media accounts such as Twitter. The lander has also set up solar panels, which allows InSight to power its cutting edge instruments. In doing so, the lander set an ‘off-world record,’ generating more electrical power than any previous vehicle on the planet’s surface. InSight project manager Tom Hoffman spoke on the importance of this achievement, “The 4,588 watt-hours we produced during sol 1 means we currently have more than enough juice to perform these tasks and move forward with our science mission.” This almost doubles the energy produced in a Martian day produced by NASA’s Curiosity rover, which previously held the record.

InSight will continue taking pictures of the surface of Mars to study its new surroundings and use its robotic arm to set up instruments to place them on the surface of Mars for the next few weeks. It will take two to three months before the lander begins conducting science on the Red Planet.

 

(Sarah Kaplan, Washington Post)

 

 

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December 6, 2018 at 5:23 pm

Science Policy Around the Web – November 27, 2018

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By: Allison Dennis, B.S.

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Source: Pixabay

 

California’s Wildfires Could Mean A Generation Of Lung Problems

The acute dangers of uncontrolled wildfires are undeniable, yet chronic dangers remain poorly understood. Changes in air quality due to wildfire smoke may have long-term and widespread health effects that researchers are only beginning to decipher. In 2017, nature provided the near perfect conditions for a much needed experiment. As the Mendocino Complex Fire raged, its smoke drifted over 200 miles to blanket the living space of an outdoor colony of primates bred for research for 10 days. 500 infant rhesus macaques, a commonly used model of human disease, were exposed, allowing respiratory immunologist Lisa Miller to begin an experiment looking for long-term respiratory damage in a pediatric population. Her previous studies of a smaller group of monkeys exposed in 2008 revealed monkeys born in wildfire conditions grew up to have a reduced lung capacity and compromised immune system . Ten years after the fire, monkeys who were infants at the time of the fire have a high incidence of idiopathic pulmonary fibrosis, a fatal human disease associated with environmental pollutants and cigarette smoking. By carefully recreating her impromptu 2008 experiment, Miller is hoping to gain deeper insights into what damage can occur in the developing lung tissue that will lead to possible interventions.

Miller’s research already suggests that a brief exposure to smoke early in life can have a lifetime of consequences. Smoke inhalation is much more widespread than the immediate dangers of fire, and will need to be incorporated into disaster preparedness plans. Financial assistance may be needed to help families temporarily relocate following fires not only due to burned homes, but also to homes blanketed in smoke. Currently, websites like airnow.gov provide up to date measures of air quality and can be used to decide when to limit children’s time outdoors. Parents with other options may need to weigh the potential risks of raising a family in places where wildfires are an annual occurrence.

(Maggie Koerth-Baker, FiveThirtyEight)

 

Genome-edited baby claim provokes international outcry

 

The announcement of the first genome-edited babies is shocking ethicists, scientists, and spectators around the world. He Jiankui of the Southern University of Science and Technology of China in Shenzhen claims to have altered the embryonic DNA of two twin girls born in November 2018 by using CRISPR-cas9 to disable the protein CCR5, known to provide HIV access to human cells. The study has not yet been submitted for publication and will likely undergo extensive peer review for verification. He recruited couples looking to conceive, where the male partner had HIV. The risk of transmission of HIV between father and offspring is very low, and removing semen from sperm before fertilization is commonly used to further mitigate the small risk. However, He thought these would-be parents would especially value the benefits of conferring their child with a lifetime protection against HIV through altered genetics.

Since its first demonstration as a gene-editing technique nearly ten years ago, ethicists have debated the potential application of CRISPR-cas9 to alter human DNA. Because reproductive tissues develop from the edited zygotic cells, it is likely that the twins will pass these changes on to their offspring along with any other possible off-target changes to the genome. While lacking the CCR5 gene has been shown to confer protection against HIV infection, it may subsequently increase the risk of other viral infections. Many still feel that not enough is known about the long-term and generational effects of altering a person’s germ-line using these proteins to justify the risks they could pose over an unborn person’s lifespan. To what extent the institutions that facilitated the experiment were consulted or informed of the true nature of the search remains unclear. The trial was only registered on November 8th, well after the work had begun. However in the race to be first, He appears to understand that any harm to the children arising from the experiment stating these risks are “going to be my own responsibility.”

 

(David Cyranoski, Nature News)

 

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November 27, 2018 at 10:24 am

Science Policy Around the Web – November 28, 2017

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By: Patrice J. Persad, PhD

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source: pixabay

Mental Health

Brain Patterns May Predict People at Risk of Suicide

Suicide is the second common cause of death for adults under 27 years old in the United States. In light of this, being able to identify individuals who are more likely to attempt suicide may transform suicide prevention initiatives’ outcomes.

At the end of last month, scientists published that machine learning (ML) algorithms were able to yield accurate prognoses by using functional magnetic resonance imaging (fMRI) profiles to differentiate subjects with suicidal thoughts (17 cases) and those without (17 controls) . After being exposed to a display of thirty words classified as positive (some examples: “kindness,” “carefree,” and “innocent”), negative (some examples: “guilty,” “evil,” and “gloom”), or pertaining to suicide (some examples: “lifeless,” “hopeless,” and “apathy”), each participant’s brain activity, or “neural signature”, for each word was captured by fMRI.

The accuracy of predicting individuals who had experienced suicidal thoughts was calculated as 91%. Upon stratifying the cases, a portion of those who had experienced suicidal thoughts were successfully identified as having attempted ending their lives in the past (nine out of 17). From categorizing individuals by suicide attempt status, the ML algorithm’s predictions were 94% accurate. The study’s authors envision clinical applicability, including improving patient surveillance, which could impact the suicide rate and lead to treatment or therapies concentrating on the cerebral areas identified by the algorithm. However, the researchers counsel that the study must be replicated with more subjects, particularly across different demographic groups and including individuals that have been diagnosed with psychiatric disorders but do not experience suicidal thoughts.

Various ethical concerns are raised by the application of this research, including the complications surrounding valid consent and how the life insurance industry could use the data. Classification of potential thoughts by ML may intrude privacy beyond what volunteers may feel they are consenting to when they agree to be recorded by fMRI or similar technologies. Neural signature classification in patients may have secondary uses, which can expand outside of medicine and healthcare areas, and must be evaluated. Misuse by life insurance companies, inviting discrimination against candidate insurance policy holders because of true and false classification of suicide ideation from fMRI, is a hypothetical scenario.

(Jon Hamilton, National Public Radio)

Species Conservation

‘Gene Drives’ Are Too Risky for Field Trials, Scientists Say

Consider the following illustration. On the island of New Zealand, a clan of non-native stoats, short-tailed weasels, are pulverizing numbers of the endemic takahes, flightless birds. Settlers in the 1800s had set stoats free through the terrain to prey on the rabbits, disturbers and unwanted consumers of agricultural crops. Thus, the stoat in this case may have been thought of as posts in a living rabbit-proof fence. Consequently, impacts on the native ecosystem were and are negative underlining the decline in and harm to takahes and other flightless bird species, such as the kiwi, New Zealand’s national bird. This currently heralds the question “How can population sizes of invasive species, such as these stoats, be reduced?”

A proposed solution to the aforementioned question features the germline genome editing system CRISPR to introduce genetic elements designed to undermine the reproductive success of a particular species. The idea of a gene drive system is to increase the inheritance, or frequency, of a particular variation in a gene. The CRISPR system can be applied to introduce variation in a gene essential for a given species’ reproductive system. When an animal carrying a CRISPR edited copy of a gene mates with an animal carrying a functional copy of the gene, their offspring will inherit one altered copy and one regular copy. Eventually, as this genetic variation becomes frequent enough, two individuals carrying the altered copy are likely to mate, producing infertile offspring. Then the number of invasive species’ members, the stoats for example, would drop as a result.

Are there any caveats to the CRISPR-based gene drive system for species conservation? A research team headed by Kevin M. Esvelt, the first proposer of gene drives for wild populations, used population models and stimulations to revealed a vital finding: if several gene-drive-modified organisms of an invasive species came into contact and bred with wild-type organisms of the same species, the population of the species as a whole in its native habitat would decrease over time. In other words, the encounter between a wild-type organism and gene drive organism is inauspicious if mating transpires in the species’ native habitat. Based on these findings, the researchers stressed prudence in initiating this application in field studies, which echoed discussions lead by the National Academy of Sciences in 2016.

One alternative may be to engineer gene drives to deteriorate after a certain number of generations. However, according to Esvelt in the context of eradicating vector-borne diseases, such as malaria, restricted gene drive systems affecting only several generations (out of many) may be ineffective in vector populations.

Although the opening example’s setting is New Zealand, the future development and employment of CRISPR-based gene drive systems depend on international cooperation plus participation because other nations may experience the impact of an ecosystem beyond their designated borders. For formulating proper safeguards before field testing commencement, voices from the scientific community, political arena, general community, and other domains across potentially affected countries must be amplified and heard for maximizing the protection of all species.

(Carl Zimmer, New York Times)

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November 28, 2017 at 7:03 pm

Science Policy Around the Web – June 10, 2017

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By: Allison Dennis, BS

Source: pixabay

Animal Testing

Lack of Clarity Puts Chemical Safety and Animal Welfare at Odds

In the lineup of American stereotypes, the health-nut who cares about the chemicals in his shampoo is often the same person who cares if that shampoo was tested on animals or not. However, a bill signed June 22, 2016, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, may be placing those two views at odds. The bill requires the U.S. Environmental Protection Agency (EPA) to implement a risk-based process to evaluate the safety of chemical substances currently being used in the marketplace and approve the use of new chemicals before their introduction. The bill was passed with bipartisan support and offered EPA the new-found power to fully regulate the use of well-known carcinogens like asbestos.

Yet the pathway forward for the EPA is daunting. More than 62,000 substances find their way into and onto our bodies through the products we use and our environment. While many of these substances have become associated with disease over time, how can the EPA certify the risks associated with different exposures to varying amounts of each substance on such an extensive list? The Act itself suggested that once the EPA has evaluated the existing information on the 62,000 substances currently in use, it spend the next twelve months triaging chemicals according to their potential risk. Next, the highest priority chemicals will be evaluated on a three-year deadline to develop knowledge of their toxicity and guidelines for their regulation. Ultimately, by clearly cataloging the risk of common chemicals the Frank R. Lautenberg Chemical Safety for the 21st Century Act promises to greatly reduce the amount of animal testing needed in the long-term.

In the meantime, however, the companies that use to-be-regulated substances in their products may be inclined to undertake independent toxicity testing, collecting enough data to guarantee that their favorite substances meet the low-risk criteria and avoid a drawn-out evaluation. Defining toxicity requires careful experimentation, which can sometimes be carried out in human cells outside of the body, but often require evaluation in animals. Animal rights groups like the Human Society find concern with the lack of transparency in the pre-prioritization process. They fear the eagerness of companies to provide data without any clear guidelines about how that data will be evaluated or what substances will require extensive evaluation could result in extensive and unnecessary animal testing. Further they suggested that the EPA require any new pre-approval data obtained by companies to be collected using non-animal methods. (Maggie Koerth-Baker, FiveThirtyEight)

CRISPR

Small Study may Reveal Big Concerns over CRISPR-Based Therapy

A one-page letter published in Nature Methods last week reports unexpectedly high levels of unintended changes to the genomes of mice that underwent a CRISPR-based therapy. Since it’s renaissance as a therapeutic tool in 2012, CRISPR has occupied the imaginations of scientists, doctors, patients, investors, and ethicists. CRISPR technology provides a relatively straight-forward and reproducible means to gene editing on the cellular level, but its applications to create heritable mutations in the human germ line is on hold until more is understood about the long-term effects such treatments would have.

The original study sought to explore potential long-term effects of germline manipulation by CRISPR in a mouse model. Guide RNA along with the Cas9 enzyme were injected into mouse zygotes, which introduced a correction in a mutation in the rd1 gene of otherwise blind mice. Initiating this change before the first cell division enabled this corrected mutation to be inherited by all cells arising in the developing mouse, consequently restoring the ability for the eyes to develop normally. In a follow-up experiment described in their one page letter, the researchers looked for mutations in the genomic DNA of two CRISPR-treated adult mice compared with a control mouse, revealing over 2,000 unintended mutations following CRISPR treatments. None of these mutations appeared to affect the mice, suggesting that deep genomic sequencing may be required to reveal unanticipated changes in an outwardly healthy mouse. Further, the nature of these unintended mutations offered few clues explaining how they might have occurred.

This result stands in contrast with other reports quantifying the extent of these unintended changes, which found CRISPR to be highly specific. While the CRISPR-Cas9 system has been observed to sometimes alter off-target regions of the genome, this activity can usually be curbed through the careful design and evaluation of the guide RNA. The limitations of this small study have been discussed extensively since its publication. However, the findings have sparked the need for further investigation into the long-term-whole-animal effects of germline-editing by CRISPR. As human germline-editing creeps closer to reality, the FDA will be tasked with developing an entirely new means of evaluating the safety of such technologies (Megan Molteni, Wired)

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June 10, 2017 at 11:33 am