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Questions of ethics arise as the age of gene-edited humans looms – IOL

Posted: February 29, 2020 at 11:30 pm

By Chelsea Geach 15h ago

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According to American technology futurist and Hacking Darwin author Jamie Metzl, its inevitable science will soon be advanced enough to make human gene editing, not only possible, but widespread.

The difficult question is whether humans will be able to use this power fairly and ethically.

We happen to be born in a time when our species suddenly has the ability to remake all of life on earth. Its this awesome responsibility, Metzl said.

He addressed UCT medical students at Groote Schuur Hospital this week as part of his work on the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. The panel was established to advise the World Health Organisation (WHO) on how to chart an ethical way forward into the age of gene-edited humans, which has already begun.

At the end of 2018, Chinese scientist He Jiankui announced that he had created the worlds first gene-edited babies. As a result, the WHO gathered a committee of 20 experts from around the world, including two South Africans: Justice Edwin Cameron, who is chair of the committee, and associate professor of bioethics Jantina de Vries, from UCT.

We are increasingly developing the tools to rewrite our code of life, Metzl said. The reason our committee is here is because we dont yet have rules of the road to figure out how can we optimise the good stuff and minimise the harms.

Whatever we do, this science is moving forward extremely rapidly. Were in the middle of a revolution.

Metzl believes that it will soon be commonplace for every baby born in a hospital to have its entire genome sequenced. From this information, parents may be advised on what diseases or genetic conditions their child is at higher risk for, and what attributes and aptitudes the child could possess.

Soon, whole genome sequencing will just be a normal part of being born in any kind of legitimate hospital, Metzl said.

But even before birth, the existing technologies of in vitro fertilisation and embryo screening could offer parents the unprecedented choice of selecting gene edits to be done before the embryo is implanted in the mothers uterus.

I believe were going to see a greater shift towards conception through science, because conception through sex brings with it the bugginess of human biology, he said

If you were a prospective mother, and you were given the option to choose from a range of your own fertilised embryos to implant in your uterus, youd probably choose one that wont result in your child being at high risk of dying young from a genetic disease.

This seems obviously beneficial, but it doesnt end there: it would also be possible to select for certain traits that the parent decides are desirable.

Professor Ntobeko Ntusi, head of the department of medicine at UCT, said it is precisely this line that becomes difficult to draw.

If you are a mother who wants to have a child who is tall, or has red hair, or is intelligent, or can play the violin - where do we draw the line? Where do you consider it appropriate to interfere with embryos where the consequences will affect generations ad infinitum?

Ntusi said the technology could have clear benefits in conditions such as sickle cell anaemia, which is caused by a mutation on a single gene and could potentially be eradicated through editing.

Its clear to many that the promise of genomic editing has a huge value to society. It can change lives and reduce suffering for many. But the long-term effects remain unknown. We cannot gain informed consent from our patients if we do not know the long-term consequences.

Ntusi also warned about the devastating disparities it could cause if only the wealthy had access to creating children free of genetic disease and edited for the most desirable traits.

Metzl agreed on this risk.

The consequences of unequal access could be huge, he said.

Weekend Argus

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Biogen and Sangamo Announce Global Collaboration to Develop Gene Regulation Therapies for Alzheimer’s, Parkinson’s, Neuromuscular, and Other…

Posted: at 11:30 pm

DetailsCategory: More NewsPublished on Saturday, 29 February 2020 09:44Hits: 471

CAMBRIDGE, MA and BRISBANE, CA, USA I February 27, 2020 I Biogen Inc. (Nasdaq: BIIB) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that they have executed a global licensing collaboration agreement to develop and commercialize ST-501 for tauopathies including Alzheimers disease, ST-502 for synucleinopathies including Parkinsons disease, a third undisclosed neuromuscular disease target, and up to nine additional undisclosed neurological disease targets. The companies will leverage Sangamos proprietary zinc finger protein (ZFP) technology delivered via adeno-associated virus (AAV) to modulate the expression of key genes involved in neurological diseases.

As a pioneer in neuroscience, Biogen will collaborate with Sangamo on a new gene regulation therapy approach, working at the DNA level, with the potential to treat challenging neurological diseases of global significance. We aim to develop and advance these programs forward to investigational new drug applications, said Alfred Sandrock Jr., M.D., Ph.D., Executive Vice President, Research and Development at Biogen.

There are currently no approved disease modifying treatments for patients with many devastating neurodegenerative diseases such as Alzheimers and Parkinsons, creating an urgency for the development of medicines that will not just address symptoms like the current standards of care, but slow or stop the progression of disease, said Sandy Macrae, CEO of Sangamo. We believe that the promise of genomic medicine in neuroscience is to provide a one-time treatment for patients to alter their disease natural history by addressing the underlying cause at the genomic level.

Sangamos genome regulation technology, zinc finger protein transcription factors (ZFP-TFs), is currently delivered with AAVs and functions at the DNA level to selectively repress or activate the expression of specific genes to achieve a desired therapeutic effect. Highly specific, potent, and tunable repression of tau and alpha synuclein has been demonstrated in preclinical studies using AAV vectors to deliver tau-targeted (ST-501) and alpha synuclein-targeted (ST-502) ZFP-TFs.

The combination of Sangamos proprietary zinc finger technology, Biogens unmatched neuroscience research, drug development, and commercialization experience and capabilities, and our shared commitment to bring innovative medicines to patients with neurological diseases establishes the foundation for a robust and compelling collaboration, said Stephane Boissel, Head of Corporate Strategy at Sangamo. This collaboration exemplifies Sangamos commitment to our ongoing strategy to partner programs that address substantial and diverse patient populations in disease areas requiring complex clinical trial designs and commercial pathways, therefore bringing treatments to patients faster and more efficiently, while deriving maximum value from our platform.

Under the terms of the collaboration, Biogen has exclusive global rights to ST-501 for tauopathies including Alzheimers disease, ST-502 for synucleinopathies including Parkinsons disease, and a third undisclosed neuromuscular disease target. In addition, Biogen has exclusive rights to nominate up to nine additional undisclosed targets over a target selection period of five years. Sangamo will perform early research activities, costs for which will be shared by the companies, aimed at the development of the combination of proprietary CNS delivery vectors and ZFP-TFs targeting therapeutically relevant genes. Biogen will then assume responsibility and costs for the investigational new drug-enabling studies, clinical development, related regulatory interactions, and global commercialization.

Sangamo will be responsible for GMP manufacturing activities for the initial clinical trials for the first three products of the collaboration and plans to leverage its in-house manufacturing capacity. Biogen will assume responsibility for GMP manufacturing activities beyond the first clinical trial for each of the first three products.

Upon closing of this transaction, Sangamo will receive $350 million comprised of $125 million in a license fee payment and $225 million from the sale of new Sangamo stock, or approximately 24 million shares at $9.21 per share. In addition, Sangamo may receive up to $2.37 billion in other development, regulatory, and commercial milestone payments, including up to $925 million in pre-approval milestone payments and up to $1,445 million in first commercial sale and other sales-based milestone payments. Sangamo will also be eligible to receive from Biogen tiered high single digit to sub-teen double-digit royalties on potential net commercial sales of products arising from the collaboration. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S.

Conference callSangamo will host a conference call at 8:00 a.m. ET tomorrow, Friday, February 28, which will be open to the public via telephone and webcast. During the conference call, Sangamo will discuss the collaboration, review financial results for the fourth quarter and full year 2019, and provide a business update. The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 4609858. Participants may access the live webcast via a link on the Sangamo website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call on Sangamos website. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 4609858.

About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the worlds first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics, and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimers disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology, and pain.

Biogen routinely posts information that may be important to investors on its website at http://www.biogen.com. To learn more, please visit http://www.biogen.comand follow Biogen on social media Twitter, LinkedIn, Facebook, YouTube.

About Sangamo Therapeutics Sangamo Therapeutics is committed to translating ground-breaking science into genomic medicines with the potential to transform patients lives using gene therapy, ex vivo gene-edited cell therapy, and in vivo genome editing and gene regulation. For more information about Sangamo, visit http://www.sangamo.com.

SOURCE: Biogen

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Video: Why labs are printing synthetic copies of the coronavirus genome – Genetic Literacy Project

Posted: at 11:30 pm

Advancements in genetic technology are making it easier, faster, and less expensive for public health experts to understand how the new coronavirus spreads. Time is of the essence for the people on the frontlines of this viral outbreak as the virus has already sickened more than 40,000 people and killed 910.

Researchers got an early win in January. It only took two weeks after public health officials reported the virus to the World Health Organization (WHO) for scientists to isolate the virus and figure out the full sequence of its genetic material. As soon as that sequence was public, biotechnology companies started creating synthetic copies of the virus that could be used in research.

With genetic sequences and synthetic copies, experts were able to quickly develop diagnostic tests for the virus.[February 3], just over a month after the virus was reported, the Centers for Disease Control and Prevention (CDC) started shipping testing kits it developed to labs in the US and internationally. It was also able to start creating vaccines.

In our latestVergeSciencevideo, we take a look at the genetic processes that made these developments possible and how theyre helping in the fight against the coronavirus epidemic.

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A time-travelling musical comedy with lots of flying – Insane Animals arrives at HOME – Manchester Evening News

Posted: at 11:22 pm

They say there's nothing new under the sun, and this week's big opening somehow both proves and disproves the theory.

Insane Animals takes its inspiration from the Epic of Gilgamesh - an ancient poem from Mesopotamia that is widely regarded as the oldest great work of literature yet discovered.

It was written around 1800BC and deals with some pretty weighty themes, not the least of which is immortality. And given we're still talking about Gilgamesh right now, you could say he's gone some way to reaching that goal.

Insane Animals is brought to us by cult cabaret duo and leading lights of the UKs alternative performance scene Bourgeois and Maurice, otherwise known as George Heyworth and Liv Morris. As you can imagine, their work is about as a la mode as it's possible to be.

George said of the subject matter: "It just felt really current. It's a story about survival and attempting to outlive your human body. Its central character and a lot of the themes that it explores feel like they really chime with what's going on in the world at the moment and the people that are running the world at the moment, so we were kind of drawn to it for that reason."

So what can we expect? George again: "Well, we've written quite a lot in this script about things flying in, so that'll be happening.

"Just generally it's a bigger cast. It's us with a cast of eight. The music is bigger, the storytelling is much bigger, just the spectacle of the thing is much bigger.

"We've got some really exciting creatives on the show. Our director is Phillip McMahon, who has just got an amazing vision and ability to see the story.

"So we're going Gothic and we're going big and we're going camp and we're going showbiz."

Liv adds: "It is our biggest show that we have ever made. It's a musical adventure, through the telling of the story of the Epic of Gilgamesh, and looking forward to the future and the idea of some of the themes around survival and immortality that this ancient ancient poem talks about, and these ideas of future tech and transhumanism that we are talking about now.

"All with some funny rhymes and songs."

Insane Animals is an outrageous larger-than-life time-travelling musical comedy in which two hyper-glam aliens arrive from a faraway galaxy to rescue present-day earth from impending political, environmental, and social doom. This epic joyride from the dawn of civilisation to the sequinned near future sees Bourgeois and Maurice on hand to help the human race live forever.

HOME / homemcr.org / 0161 200 1500 / Friday, February 2 to Saturday March 14 / 13-27

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What’s Genetic Engineering? | Live Science

Posted: at 11:12 pm

Genetic engineering is the process of using technology to change the genetic makeup of an organism - be it an animal, plant or a bacterium.

This can be achieved by using recombinant DNA (rDNA), or DNA that has been isolated from two or more different organisms and then incorporated into a single molecule, according to the National Human Genome Research Institute (NHGRI).

Recombinant DNA technology was first developed in the early 1970s, and the first genetic engineering company, Genentech, was founded in 1976. The company isolated the genes for human insulin into E. coli bacteria, which allowed the bacteria to produce human insulin.

After approval by the Food and Drug Administration (FDA), Genentech produced the first recombinant DNA drug, human insulin, in 1982. The first genetically engineered vaccine for humans was approved by the FDA in 1987 and was for hepatitis B.

Since the 1980s, genetic engineering has been used to produce everything from a more environmentally friendly lithium-ion battery to infection-resistant crops such as the HoneySweet Plum. These organisms made by genetic engineering, called genetically modified organisms (GMOs), can be bred to be less susceptible to diseases or to withstand specific environmental conditions.

But critics say that genetic engineering is dangerous. In 1997, a photo of a mouse with what looked like a human ear growing out of its back sparked a backlash against using genetic engineering. But the mouse was not the result of genetic engineering, and the ear did not contain any human cells. It was created by implanting a mold made of biodegradable mesh in the shape of a 3-year-old's ear under the mouse's skin, according to the National Science Foundation, in order to demonstrate one way to produce cartilage tissue in a lab.

While genetic engineering involves the direct manipulation of one or more genes, DNA can also be controlled through selective breeding. Precision breeding, for example, is an organic farming technique that includes monitoring the reproduction of species members so that the resulting offspring have desirable traits.

A recent example of the use of precision breeding is the creation of a new type of rice. To address the issue of flooding wiping out rice crops in China, Pamela Ronald, a professor of plant pathology at the University of California-Davis, developed a more flood-tolerant strain of rice seed.

Using a wild species of rice that is native to Mali, Ronald identified a gene, called Sub1, and introduced it into normal rice varieties using precision breeding creating rice that can withstand being submerged in water for 17 days, rather than the usual three.

Calling the new, hardier rice the Xa21 strain, researchers hope to have it join the ranks of other GMOs currently being commercially grown worldwide, including herbicide-tolerant or insect-resistant soy, cotton and corn, within the next year, Ronald said. For farmers in China, the world's top producer and consumer of rice, being able to harvest enough of the crop to support their families is literally a matter of life and death.

Because Ronald used precision breeding rather than genetic engineering, the rice will hopefully meet with acceptance among critics of genetic engineering, Ronald said.

"The farmers experienced three to five fold increases in yield due to flood tolerance," Ronald said at a World Science Festival presentation in New York. "This rice demonstrates how genetics can be used to improve the lives of impoverished people."

Got a question? Email it to Life's Little Mysteries and we'll try to answer it. Due to the volume of questions, we unfortunately can't reply individually, but we will publish answers to the most intriguing questions, so check back soon.

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Is it time to have a national conversation about genetic engineering? – TVNZ

Posted: at 11:12 pm

Were proud to be Nuclear Free. We want to be Predator Free. But what about GE Free?Is it time to have a national conversation about genetic engineering?

Dr Sean Simpson Source: 1 NEWS

As I sit opposite Dr Sean Simpson in his companys high-tech Chicago HQ, I cant help but notice his T-Shirt.

Firstly, because its bright yellow. Secondly because hes worn it before he tells me he owns three, all in various stages of fading. The message on the front however couldnt be clearer Science Doesnt Care What You Believe.

Simpson is a man on a mission to reduce the worlds carbon footprint a mission that began in New Zealand.

It was a very basic set up when he started his company LanzaTech with the late Dr Richard Forster in an Auckland basement back in 2005.

Our first experiments were done with a rotisserie unit bought from The BBQ Warehouse and two defunct refrigeration units from the local dairy, he laughs.

Both scientists, Simpson and Forster set out to make a clean burning fuel, ethanol from waste products i.e. pollution and rubbish. They succeeded - the company is now valued at over $1 billion.

Its understandable then that when LanzaTech announced in 2014 it was relocating its head office from Auckland to Chicago there was a sense that New Zealand had missed a major opportunity to retain this innovative and world-leading company.

Simpson acknowledges that New Zealand is a fantastic place in which to start a business, but one of the key reasons for their move was our stance on genetic engineering.

LanzaTechs process uses microbes that secrete ethanol when they are fed waste gases but by genetically modifying the bugs, they can produce a range of other chemicals i.e. not just ethanol. Those chemicals can be used to make things we need every day without contributing to our carbon footprint, and you can't scale that technology in New Zealand.

The government's interim climate change committee has pointed to that stance (which predominantly confines GE to the lab), as a possible barrier to lowering our carbon emissions.

GE also has potential applications in pest control remember were aiming to be predator free by 2050. However, for now, the rules arent likely to change.

Professor Peter Dearden, the Director of Genomics Aotearoa from the University of Otago says pest control, agriculture and medicine are key areas where Kiwis could benefit from GE technology but that our regulations have had a chilling effect on research as much of it depends on whether companies can take their technology to market.

The result of which is that were not doing critical work we need to do in the laboratory because the chances of it being used are so small".

Dearden believes our position will only change if the issue is personalised the best approach is for us to look at NZ solutions to NZ problems, things like Kauri dieback, invasive wasps. The key thing is making it about people, if you or I see a personal benefit then were much more likely to see it differently".

Ultimately, he says its about weighing up the risks and benefits so the public can decide.

The Minister for the Environment, David Parker, was advised on the matter late last year by officials. His office confirmed on Friday that he is still considering it as it is not a straightforward issue.

Even though our GE rules were a factor in LanzaTech heading off-shore, Bruce Jarvis of the governments business support agency, Callaghan Innovation, says it wasnt the only reason as for NZ companies to be successful they have to be close to their market.

In the US most petrol is blended with up to 10 per cent ethanol so theres an enormous opportunity for ethanol producers there.

Jarvis says even though it can be a blow to the Kiwi psyche when a company leaves (especially when its received government start-up funding), there isnt enough focus on their legacy and ongoing benefits to NZ.

He says often whats left behind are highly skilled people who start their own companies and share what theyve learned in terms of commercialisation and thats gold for us.

Its part of the cycle, these people are entrepreneurs, they get bored quickly, this is what they love doing, they love building successful tech companies.

Its an ambition Sean Simpson shares, hes determined to come back to New Zealand for good one day to reinvest his time and talent in other tech start-ups.

In the meantime, although the sentiment behind Seans favourite T-shirt will never change, it could be a lot more faded before theres a significant change to our GE rules.

For the full story on Sean Simpsons incredible journey with LanzaTech, watch SUNDAY, on TVNZ1 at 7:30pm.

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Solution for a scourge? University of Minnesota scientist is progressing with carp-killer tool – Minneapolis Star Tribune

Posted: at 11:12 pm

Sam Erickson followed his love of science to outer space one summer during an internship at NASA. He came away fascinated by seeing into deep space by interpreting interaction between matter and infrared radiation.

Now a full-fledged researcher at the University of Minnesotas College of Biological Sciences, the 25-year-old Alaska native is immersed in something far more earthly: killing carp. His fast-moving genetic engineering project is drawing attention from around the country as a potential tool to stop the spread of invasive carp.

I want to make a special fish, Erickson said in a recent interview at Gortner Laboratory in Falcon Heights.

In short, he plans to produce batches of male carp that would destroy the eggs of female carp during spawning season. The modified male fish would spray the eggs as if fertilizing them. But the seminal fluid thanks to DNA editing would instead cause the embryonic eggs to biologically self-destruct in a form of birth control that wouldnt affect other species nor create mutant carp in the wild.

His goal is to achieve the result in a controlled setting using common carp. From there, it will be up to federal regulators and fisheries biologists to decide whether to translate the technology to constrain reproduction of invasive carp in public waters.

What were developing is a tool, Erickson said. If we could make this work, it would be a total game-changer.

Supervised by University of Minnesota assistant professor Michael Smanski, Erickson recently received approval to accelerate his project by hiring a handful of undergraduate assistants. He also traveled last month to Springfield, Ill., to present his research plan to the 2020 Midwest Fish and Wildlife Conference.

Were pretty excited about where his project is at, said Nick Phelps, director of the Minnesota Aquatic Invasive Species Research Center at the U. Things are sure moving fast. Theres excitement and caution.

Ericksons research has received funding from Minnesotas Environment and Natural Resources Trust Fund. No breeding populations of invasive carp have been detected in Minnesota, but the Department of Natural Resources has confirmed several individual fish captures and the agency has worked to keep the voracious eaters from migrating upstream from the lower Mississippi River. Silver carp, bighead carp and other Asian carps pose a threat to rivers and lakes in the state because they would compete with native species for food and habitat.

Erickson views his birth control project as one possible piece in the universitys integrated Asian carp research approach to keep invasive carp out of state waters. Already the DNR has supported electric barriers and underwater sound and bubble deterrents at key migration points. Another Asian carp-control milestone was closing the Mississippi River lock at Upper St. Anthony Falls in Minneapolis in 2015.

Shooting star

Growing up in Anchorage, Erickson had never heard of Macalester College in St. Paul. But he visited the campus at the urging of a friend and felt like he fit in. He majored in chemistry and worked for a year at 3M in battery technology. But his interests tilted toward the natural world and how to better live in cooperation with nature, he said. Erickson met with Smanski about research opportunities at the university and was hired on the spot.

Smanski, one of the universitys top biological engineers, said carp is not an easy organism to work with and Erickson lacked experience in the field. But he hired the young researcher and assigned him to the carp birth control project because he seemed to have a rare blend of determination and intelligence.

I could tell right away when I was talking to him that he was like a shooting star, Smanski said. If you set a problem in front of him, he wont stop until he solves it Hes taken this farther than anyone else.

In two short years, Smanksi said, Erickson has mastered genetic engineering to the point that his research is starting to bear fruit.

With his new complement of research assistants, Erickson aims to clear his projects first major hurdle sometime this year. The challenge is to model his experiment in minnow-sized freshwater zebrafish. The full genetic code of zebrafish like common carp is already known.

Ericksons task is to make a small change to the DNA sequence of male zebrafish, kind of like inserting a DNA cassette into the fish, he said. During reproduction, the alteration will create lethal overexpression of genes in the embryonic eggs laid by females.

By analogy, Erickson said, the normal mating process is like a symphony with a single conductor turning on genes inside each embryo, Erickson said. But the DNA modification sends in a mess of conductors and the mixed signals destroy each embryo within 24 hours.

In the lab we have to make sure were causing the disruption with no off-target effects, he said. If we can do this in zebrafish, we hope to translate it. They are genetically similar to carp.

Ericksons upcoming experimentation with tank-dwelling live carp could be painfully slow because the fish only mate once a year. But hes working his way around that problem by altering lighting conditions and changing other stimuli in his lab to stagger when batches of fish are ready to reproduce.

The birth control process projected to be affordable for fisheries managers if it receives approval is already proven to work in yeast and insects. And Erickson said the same principles of molecular genetics have been used to create an altered, fast-growing version of Atlantic salmon approved for human consumption in the U.S.

Were not building a new carp from the bottom up but its kind of a whole new paradigm, so we have to get it done right, he said.

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The growing viral threat – The Week

Posted: at 11:12 pm

Infectious disease experts warn that it's inevitable that a virus will jump from animals to humans and kill tens of millions. Here's everything you need to know:

Why are experts worried?Picture a new viral disease like the Wuhan coronavirus, now called COVID-19, that passes easily from person to person and spreads rapidly around the globe. But unlike COVID-19, which kills perhaps 2 or 3 percent of its victims, this virus kills 20 percent of those infected. Or 40 percent. It might sound like a disaster movie premise (and in fact it was, in 2011's Contagion), but viral disease experts are in wide agreement that such a pandemic is coming, and that it will inflict unimaginable devastation. The only question is when it will hit. Last September, the Global Preparedness Monitoring Board (GPMB), a group convened in 2018 by the World Bank and the World Health Organization, warned of "a very real threat" of a pandemic that would kill 50 million to 80 million people, cost $3 trillion, and create "widespread havoc, instability, and insecurity." We need only look to the recent past to see how dire things can get: The Spanish flu of 1918 killed between 50 million and 100 million (including 675,000 Americans), or about 3 percent of the global population.

Where would such a virus come from?The most likely scenario is a pathogen that jumps from animals to humans and can spread through the air. The outbreak of COVID-19 was traced to a live-animal market in Wuhan, China, where a bat virus appears to have added some genetic material from a soldierfish. Many viral diseases have been traced to animals, including HIV (which originated in chimpanzees), MERS (camels), SARS (probably bats and civet cats), and Ebola (unknown, but probably bats). Last year researchers at Johns Hopkins ran a simulation of a hypothetical coronavirus emerging from a Brazilian pig farm: The result was 65 million dead within 18 months. Another concern is a familiar very deadly virus that mutates, allowing it to spread more easily. The avian flu H5N1, for example, has proven highly lethal but not very communicable so far. The intentional or accidental release of a manmade pathogen is another threat; new genetic engineering tools have made them far easier to create. A laptop captured from ISIS in 2014 contained instructions on how to weaponize plague bacteria.

Why is this more of a problem now?Human population growth. People are encroaching on previously wild areas where unknown viruses and bacteria lurk in animals; those who become infected carry the pathogens back to densely packed cities, where disease is easily spread. The 1998 emergence of the Nipah virus, for example, was linked to deforestation in Malaysia that displaced fruit bats and put them near pig farms. Pigs became infected, and the virus then spread to farmworkers. In the past 50 years, more than 300 pathogens have emerged or re-emerged, including Zika and yellow fever. At the same time, climate change has enabled insects and animals that carry disease to expand their habitats to new regions. Human migratory patterns are a factor as well: The surge in international travel allows viruses to spread around the globe quickly. "We've created an interconnected, dynamically changing world that provides innumerable opportunities to microbes," says Richard Hatchett of the Coalition for Epidemic Preparedness Innovations. "If there's weakness anywhere, there's weakness everywhere."

Are we prepared for a major pandemic?Not at all. A report released last October by the Global Health Security Index found glaring gaps in readiness; out of 195 countries surveyed, not one was judged fully prepared to handle a major event. In the U.S. under President Trump, the federal budgets for both research and response preparation have been cut, the National Security Council's global health security unit has been disbanded, and the White House official in charge of pandemic response left his job in 2018 and has not been replaced. We're caught in a "cycle of panic and neglect," World Health Organization Director-General Tedros Adhanom Ghebreyesus said. "We throw money at an outbreak, and when it's over, we forget about it and do nothing to prevent the next one."

What needs to be done?Experts say the U.S. and other countries need to spend vastly more money on pandemic preparedness. We need to develop better diagnostic tools, stockpile drugs and vaccines, and fund research into new treatments and vaccine technologies. Above all, there needs to be an international effort to improve sanitation, medical care, and response capability in poorer countries where new diseases are most likely to arise and spread. All of this requires a major change in mindset, say experts. "The world needs to prepare for pandemics the same way it prepares for war," said Microsoft founder Bill Gates, who's invested tens of millions in viral disease research. Humanity's biggest threat, he says, is "not missiles, but microbes."

It's happened many times beforeEpidemics have been a fact of life since the first human settlements. As humans built cities and trade routes, the capacity for pandemics grew, and history is marred by many devastating outbreaks. The earliest on record dates to 430 B.C., when a pestilence that may have been typhoid fever took root in Athens, killing up to two-thirds of the city's population. In A.D. 541, the Justinian plague spread through the Mediterranean world; recurrences over the next two centuries would kill more than 25 percent of the world's population. In the 14th century, another outbreak of plague, called the Black Death driven by fleas that live on rats but can bite humans claimed over 75 million lives, including some 60 percent of the population of Europe, whose cities were piled with reeking corpses. In the 16th and 17th centuries Native Americans were ravaged by smallpox and other diseases brought by European conquerors and colonists; in some areas as much as 90 percent of native populations were wiped out. The pandemic with the greatest number of casualties in history was the Spanish flu of 1918. It infected some 500 million people worldwide a third of the population and killed as many as 100 million.

This article was first published in the latest issue of The Week magazine. If you want to read more like it, try the magazine for a month here.

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Biobased Plastics and the Sustainability Puzzle – The National Law Review

Posted: at 11:12 pm

Friday, February 28, 2020

As consumer interest in sustainable alternatives to fossil-based plastics continues to grow and food and beverage companies set goals to reduce their environmental footprint, the use of biobased plastics in food packaging is expanding. Revenue for the U.S. biobased plastics manufacturing sector was $177.9 million annually, according to a 2018 report prepared for U.S. Department of Agriculture (USDA), titled,An Economic Impact Analysis of the U.S. Biobased Products Industry.[1]The report also estimates a 4.5% grow rate for the sector over the five years from 2018 through 2023.

The total production volume of bio-based building blocks and polymers (worldwide) was 7.5 million tons in 2018, or about 2% of the production volume of petrochemical polymers, with a growth rate of 4% expected through 2023, according to a report by Nova-Institute GmbH.[2]The potential for significant growth is much higher, but low oil prices and a lack of political support are hampering growth, notes the report.

Examples of the use of biobased plastics in food packaging include Snickerscandy bars with a bio-based film wrapper made from potato starch by-products that were introduced by Mars in 2016 and the soon-to-be-available 20-ounce size Dansani water bottles made with up to 50% of renewable plant-based and recycled PET material beginning in mid-2020. The Coca-Cola Company first launched recyclable bottles made partially from plants (PlantBottle) in 2009 and expanded access to the PlantBottle IP in early 2019 to encourage industry-wide adoption. The new bottle, referred to as HybridBottle, includes recycled PET material in addition to the plant-based material.[3]

Other uses of biobased plastics in food contact articles include bags; containers for fruit, vegetables, eggs and meat; bottles for soft drinks and dairy products; flexible packaging; and coffee pods. Biobased plastics also have been used in food service ware, such as bowls, cups, and straws.

Like most materials that are intended to be used to package or otherwise in contact with food, biobased materials are also subject to the regulatory requirements imposed by several jurisdictions throughout the world. This article will focus on the requirements related to obtaining regulatory approval of biobased food contact materials (FCMs) in the U.S. and the European Union (EU), safety considerations, and future considerations.

Well begin with some definitions. Biobased means related to or based out of natural, renewable, or living sources. Biodegradable means capable of being broken down naturally to basic elemental components (water, biomass, and gas) with the aid of microorganisms. Compostable plastics are a subset of biodegradable plastics that biodegrade under specified conditions and timeframes.

Several international standards are available to determine compostability of plastic packaging. The European Committee for Standardization, standard EN 13432, Requirements for packaging recoverable through composting and biodegradation, is a harmonized European standard and is linked to the EU Directive on Packaging and Packaging Waste (94/62/EC). In the U.S., American Society for Testing and Materials standard ASTM 6400, Standard Specification for Labeling of Plastics Designed to be Aerobically Composted in Municipal of Industrial Facilities, is cited in various regulations. For example, California requires that food and beverage containers labeled as compostable must meet the ASTM D6400 standard.

An important distinction exists between biobased plastics and bioplastics. European Bioplastics defines bioplastics as a plastic material that is either biobased OR biodegradable OR both. On the other hand, biobased plastics are plastics manufactured from renewable biomass, such as vegetable oil, cornstarch, pea starch, and microbiota. Accordingly, a product can be both biobased and biodegradable, but it can also be biobased and not biodegradable, or biodegradable and not biobased.

Bio-based food contact materials (BBFCMs) are derived from biological renewable resources (animal or plant biomass) that consist of polymers directly extracted or removed from biomass, produced by chemical synthesis using renewable bio-based monomers, or produced by microorganisms or genetically modified bacteria, according to the 2019 report,Bio-Based Materials For Use In Food Contact Applications.[4]

The first bioplastics were developed from traditional agricultural resources, such as sugarcane, soy protein, starch, and cellulose. Within this group are polymers directly extracted from biomass and polymers produced by chemical synthesis using renewable biobased monomers. For example, polylactic acid (PLA), which is commonly used as a base material or coating in food packaging, is produced through the polymerization of lactic acid, which can be derived from the fermentation of agri-food wastes such as sugar beets or sugarcane.

PLA exhibits barrier properties comparable to fossil-based plastics, such as low-density polyethylene (PP) and polyethylene (PE), and has been used as a replacement for them, although it has the disadvantage of being more expensive to produce. The first generation of bioplastics also includes polymers produced by microorganisms or microbial fermentation, such as polyhydroxyalkanoate (PHA) and poly-3-hydroxybutyrate.

The second generation of bioplastics that are beginning to be introduced are made from raw materials such as food byproducts, wood, and sawdust, explained Patrick Krieger, Plastics Industry Association, in an interview for the 2018 USDA report mentioned above. He added that the next or third generation of bioplastics, many of which currently are in the laboratory stage, will come from algae and other organisms that are not associated with the production of food. Another area of research is the production of strains of microbes through genetic engineering that can improve yields of biobased polymers.

While biobased plastics offer a myriad of benefits related to sustainability, there are some concerns related to end-of-life issues. A potential disadvantage arising from the use of BBFCMs is the need to ensure effective segregation from fossil-based materials to enable their effective recycling, suggests Fera in the UK Report. For example, the presence of small quantities of PLA can prevent recycling of PET into a transparent product suitable for re-use in food and drink applications. Also, bioplastics produced from polymer blends that include biobased fillers may be difficult to recycle or may adversely affect the existing recycling stream.

Generally speaking, biobased plastics are required to comply with the same regulations with respect to food safety as fossil-based plastics.

In the U.S., the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 301, et seq., provides that any substance, the intended use of which, is reasonably expected to become a component of food (e.g., migrates from packaging into food) must be authorized for such use by the U.S Food and Drug Administration (FDA) through a food additive regulation or in the case of packaging and other food contact materials, a Food Contact Notification (FCN), or the substance must be generally recognized as safe (GRAS), or used in accordance with a sanction or approval issued prior to 1958 by either the U FDA or USDA, among other potentially available exemptions and exclusions.

Polymers cleared for food-contact use through food additives petitions are listed in Title 21 of the Code of Federal Regulations (C.F.R.), Part 177, "Indirect Food Additives: Polymers." This part is further divided by types of polymers. Polymers and other food contact substances can also be cleared through an FCN. FCNs are proprietary and only may be relied on by the notifier/manufacturer and its customers.

For plastic packaging materials, FDA regulations generally clear the final polymer, not unreacted starting materials. There are, however, some exceptions where FDA permits certain starting reactants to be used to make a finished polymer. For example, in Part 175.300, "Resinous and polymeric coatings," FDA lists cleared precursor materials since these substances are typically complex and often cross-linked compounds.

In addition, any food-packaging material intended to come in contact with food must comply with FDA's Good Manufacturing Practices (GMP) regulation, found in Title 21 C.F.R. Section174.5. GMP requirements apply to both the use level of an additive as well as to its purity. This means that additives may only be used in an amount necessary to achieve their function or purpose and may not contain impurities at levels sufficiently high as to result in the adulteration of food.

In the EU, the Plastics Regulation, (EU) No. 10/2011, governs the use of plastic materials and articles intended to contact food. It applies to the plastic layers in all multilayer food-contact articles. This regulation includes a positive list of permissible monomers and other starting substances, additives (other than colorants), and some polymer production aids. In contrast to U.S. regulations, the EU Plastics Regulation does not include limits on co-reactants or use levels for starting materials, temperature restrictions, specification of single versus repeated use and food types for specific substances.

Anyone can petition to add a new monomer or additive to the Plastics Regulation's positive list. These petitions are first reviewed by the European Food Safety Authority (EFSA), which will issue a formal opinion on the safety of the substance when intended for use with food and any limitations that should be observed. Once EFSA has issued an opinion, finding a proposed use of a substance to be safe, the European Commission (EC), provided it concurs with the opinion, will add the substance to the list through an amendment to the regulation.

Finally, all FCMs in the EU must comply with the safety criteria set forth in Framework Regulation (EC) No. 1935/2004, which specifies that that food contact materials and articles may not transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food, or bring about a deterioration in the organoleptic characteristic of the food. All food-contact materials must also comply with the Good Manufacturing Practice Regulation, (EC) No 2023/2006.

While certain biobased polymers have been cleared in the U.S. and the EU, such as PHA, there are a number of regulatory issues that need to be considered for new materials or new applications for existing materials. For example, when preparing a submission to obtain clearance of the material, what are the appropriate food simulants to be used to estimate the potential for migration? Likewise, how do you prove to authorities (and to customers) that the substance is stable for an intended application that involves a specific type of food or temperature range?

Also, in some instances, it may be necessary to demonstrate the suitable purity of product with respect to the potential presence of organic matter, such as cellular debris. Possible contamination with naturally produced contaminants (e.g., mycotoxins and algal biotoxins) may also need to be considered. Also, possible contamination with organic compounds (e.g., dioxins and polychlorinated phphenyls) or inorganic compounds (e.g., lead and arsenic), nitrates, pesticide and veterinary medicines residues, and plant toxins may need to be evaluated. In addition, depending on the feedstock and processing conditions, process contaminates such as acrylamide could be formed due to Maillard reactions occurring when complex biomaterials such as food are heated.

Additional questions could result from the inclusion of nanoscale materialsto improve barrier function and to achieve similar or better shelf lifein biobased packaging. There could also be questions about the genetically modified microbial strains, if they are used, to produce the biobased plastic. The UK Food Standards Agency (FSA) report points out that, to date, there have not been any studies that address the presence of genetically modified materials present in the biomass used for the production of BBFCMs.

Another regulatory consideration concerns the use of alternative fiber sources in biobased food packagingan area that is being investigated in both the U.S. and the EU. A potential application for fiber is the addition of bamboo to a polymer backbone for products such re-usable cups. Regulators in the EU are currently considering the use of bamboo in contact with food. With respect to other fiber sources, in the U.S., pulp is listed as generally recognized as safe (GRAS) under 21 C.F.R. Section186.1673 for food packaging uses, including paper production. It is defined as soft, spongy pith inside the stem of a plant such as wood, straw, sugarcane, or other natural plant sources, and therefore gives wide latitude in the potential candidates that could be available for use as alternative pulp sources. In the EU, untreated wood flour and fibers are cleared as additives in the Plastics Regulation. However, in all of these cases, the suitable purity/safety demand of the regulations are still applicable.

Conclusion

The report,Bio-Based Materials for Use In Food Contact Applications, was the result of a review commissioned by the FSA on potential risks and other unintended consequences of replacing fossil-based plastic food contact materials with BBFCMs. The key findings from the study are summarized below.

While the current use of BBFCMs is low, the UK report predicts that their use will grow significantly in response to consumer pressures, manufacturer demand, and increased levels of industrial production. Also contributing to the growth of biobased plastic are new regulations that encourage movement toward sustainable products, especially in the EU, and the development of biobased polymers with increased performance benefits, such as ones that can be used in lighter weight bottles that can hold carbonated pressure longer. Finally, increased demand for biobased products is likely to drive down production costs.

*This article is reprinted with the permission ofFood Safety magazine. It first appeared in theFebruary/March 2020 issue.

[1]The report is available at:https://www.biopreferred.gov/BPResources/files/BiobasedProductsEconomicAnalysis2018.pdf.

[2]See Nova-Institute GmbH press release at:http://news.bio-based.eu/2018-was-a-very-good-year-for-bio-based-polymers-several-additional-capacities-were-put-into-operation/.

[3]The Coca-Cola Company issued a press release on August 13, 2019, on the new HybridBottle, that can be found here:https://www.coca-colacompany.com/press-center/press-releases/dasani-takes-steps-to-reduce-plastic-waste.

[4]This report was prepared by Fera Science Limited (Fera) for the UK Food Standards Agency and is available here:https://www.food.gov.uk/sites/default/files/media/document/bio-based-materials-for-use-in-food-contact-applications.pdf.

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Biobased Plastics and the Sustainability Puzzle - The National Law Review

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Eczema: Definition, Causes, Treatments, and Pictures

Posted: at 10:52 pm

Eczema, also called atopic dermatitis, is a common skin condition marked by itchy and inflamed patches of skin.

Its often seen in babies and young children, appearing on the faces of infants. But eczema can come in a variety of types in children, teens, and adults. Read on to learn what causes the skin condition and how to treat its symptoms.

When people refer to eczema, they usually mean atopic dermatitis, which is characterized as dry, itchy skin that often appears with a red rash. This is the most common and chronic type of eczema.

Other types include:

Contact dermatitis is caused by contact with irritants. Burning, itching, and redness occur. The inflammation goes away when the irritant is removed.

Dyshidrotic dermatitis affects fingers, palms of the hands, and soles of the feet. It causes itchy, scaly patches of skin that flake or become red, cracked, and painful. The condition is more common in women.

Nummular dermatitis causes dry, round patches of skin in the winter months. It usually affects the legs. Its more common in men.

Seborrheic dermatitis causes itchy, red, scaly rashes, particularly on the scalp, on the eyebrows, on the eyelids, on the sides of the nose, and behind the ears.

The main symptom of eczema is itchy, dry, rough, flakey, inflamed, and irritated skin. It can flare up, subside, and then flare up again.

Eczema can occur anywhere but usually affects the arms, inner elbows, backs of the knees, or head (particularly the cheeks and the scalp). Its not contagious, and, in some cases, becomes less severe with age.

Other symptoms include:

Scratching eczema further irritates and inflames the skin. This can cause infections that must be treated with antibiotics.

The cause of eczema is not fully understood. But its believed to be triggered by an overactive immune system that responds aggressively when exposed to irritants.

Eczema is sometimes caused by an abnormal response to proteins that are part of the body. Normally, the immune system ignores proteins that are part of the human body and attacks only the proteins of invaders, such as bacteria or viruses.

In eczema, the immune system loses the ability to tell the difference between the two, which causes inflammation.

An eczema flare-up is when one or more eczema symptoms appear on the skin. Common triggers of eczema flare-ups include:

Several factors can increase your risk of developing eczema.

Eczema is more common in children who suffer from asthma or hay fever, or adults who develop these conditions later, usually before the age of 30.

People with family members who have eczema are also at higher risk of developing the condition.

Theres no specific test that can be used to diagnose eczema. If your doctor has seen the condition before, they may be able to recognize it by looking at your symptoms.

A patch test can pinpoint certain allergens that trigger symptoms, like skin allergies associated with contact dermatitis (a type of eczema).

During a patch test, an allergen is applied to a patch thats placed on the skin. If youre allergic to that allergen, your skin will become inflamed and irritated.

A dermatologist, allergist, or primary care doctor can help you identify the correct treatment for eczema. You may also find it helpful to combine more than one treatment.

Some options include:

Oral over-the-counter (OTC) antihistamines may relieve itching. They work by blocking histamine, which triggers allergic reactions. Examples include:

Several antihistamines can cause drowsiness, so its recommended they be taken when you dont need to be alert.

Cortisone (steroid) creams and ointments can relieve itching and scaling. But they can have side effects after long-term use, which include:

Low-potency steroids, like hydrocortisone, are available over the counter. If your body isnt responding to low-potency steroids, high-potency steroids can be prescribed by a doctor.

In severe cases, a doctor may prescribe oral corticosteroids. These can cause serious side effects, including bone loss.

To treat an infection, a doctor may prescribe a topical or oral antibiotic.

Immunosuppressants are prescription medications that prevent the immune system from overreacting. This prevents flare-ups of eczema. Side effects include an increased risk of developing cancer, infection, high blood pressure, and kidney disease.

Light therapy, or phototherapy, uses ultraviolet light or sunlamps to help prevent immune system responses that trigger eczema. It requires a series of treatments, and can help reduce or clear up eczema. It can also prevent bacterial skin infections.

Stress can trigger or exacerbate symptoms. Ways to reduce stress include:

A cold compress can help alleviate itching, as can soaking for 15 to 20 minutes in a warm or lukewarm bath.

Alternative treatments may help calm the symptoms of eczema. Because of potential side effects, always check with your doctor before using an herbal supplement or beginning an exercise routine. Popular home remedies include:

Lifestyle changes such as stress reduction and improved sleep can reduce the likelihood of an eczema flare-up. Avoid irritants, like rough fabrics, harsh soaps, and detergents. Cold weather can also dry out the skin and trigger flare-ups.

People with atopic dermatitis should avoid scratching. To prevent breaking the skin, it can help to rub rather than scratch the areas that are itchy.

Because dry skin can trigger an eczema flare-up, a dermatologist can recommend an ointment- or cream-based moisturizer that will help soothe your skin.

Theres no cure for eczema, but symptoms can be effectively managed with the right treatments. These may include a combination of lifestyle changes and medications. In some cases, eczema can cause additional health complications.

Skin infections, like impetigo are brought on by constant itching. When scratching breaks the skin, bacteria and viruses can enter.

Neurodermatitis is also caused by frequent itching. It leaves skin thickened, red, raw, and darker in color. This is not a dangerous condition but may result in permanent discoloration and thickening of skin even when eczema is not active. Scratching can also cause scarring.

Many people with eczema report feeling embarrassed and self-conscious about their skin. Receiving proper treatment and getting stress under control can help calm symptoms. Support groups can also help people cope.

Vigorous exercise can be difficult for people with eczema because sweating can bring on a bout of itching. Dress in layers so you can cool down while exercising. You may also want to avoid intense physical activity during an eczema flare-up.

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