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Libertarianism Was Born In Westminster And Other Historical Party Facts – Colorado Public Radio

Posted on August 7, 2017 by Danzig

Libertarian party founderDavid Nolan.

(CourtesyFran Holt of DuPage Libertarians)

In 1977, the condensed version of the party's platform was described in this fashion by Nolan:

1. We favor the abolition of damn near everything.

2. We call for drastic reductions in everything else.

3. And we refuse to pay for what's left!

The Libertarian party has grown to have somewhere around half a million registered voters nationwide. There's a new project to document its history, led by Caryn Ann Harlos, Libertarian Party of Colorado communications director and Region 1 representative on the Libertarian National Committee. Harlos has been cataloging and digitizing party documents, photos and artifacts at LPedia.org.

Here's a look at some of the things Harlos has unearthed:

A poster for the party's first presidential ticket with John Hospers as president and Theodora "Tonie" Nathan as vice president. Nathan the first woman in U.S. history to get an electoral vote in the electoral college.

(Courtesy Libertarian Party of Colorado)

Harlos found issues of the Libertarian Party News, or the LP News, and early newsletters that she says "give a snapshot of what was going on at the time."

(Courtesy Libertarian Party of Colorado)

There's also this abridged history of the party.

(Courtesy Libertarian Party of Colorado)

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Libertarianism Was Born In Westminster And Other Historical Party Facts - Colorado Public Radio

Why the Liancourt Rocks Are Some of the Most Disputed Islands in the World – Cond Nast Traveler

Posted on August 7, 2017 by Danzig

The Liancourt Rocks sound French, but that's just because they're named for a French whaling ship that almost ran aground there in 1849, the first European vessel to see the little islands. They're actually in East Asia, almost exactly halfway between Japan and South Korea and thereby hangs a tale. We still call them the Liancourt Rocks today because these two Asian powers can't agree on who owns the rocks, or what they should be called, or even what the sea around them is named.

It's the little things that matter.

The craggy island grouptwo small islets and ninety surrounding rocks and reefscovers only 47 acres of land in total, the size of New York's Grand Central Terminal . Visitors coming ashore there must brave a cliff stairway so steep that it's almost vertical; food and freight get transported to the top by a pulley system. But despite the islands' small size and inaccessibility, they've become a huge point of contention between Japan and South Korea.

Bamboo Island or Solitary Island?

The Liancourt Rocks were uninhabited before the twentieth century, and historical texts referring to their first settlers are ambiguous. After World War II, the final version of the Allies' peace treaty with Japan failed to mention the Liancourt Rocks among the islands Japan was specifically returning to Korea, so both countries still claim the islands today. Japan calls the island group Takeshima ("bamboo island"); in Korea, it's Dokdo ("solitary island"). Even the name of the sea where the islands sit is different. Often, mapmakers call that body of water the Sea of Japan; on Korean maps it's the "East Sea."

It takes a village to support one fisherman.

The only two civilian residents of the island are a Korean octopus fisherman and his wife. But almost fifty government personnel live there as well, because the South Korean Coast Guard has administered the islands since 1954. In recent years, "Dokdo" has been a big point of pride in the Korean media, inspiring patriotic propaganda and almost 100,000 tourist visits a year. Tourists hop off the ferry, wave flags, and take photos for twenty minutes, and then head back. The Japanese government objects to these visits, since to them visiting "Takeshima" is an international vacation.

The struggle for these islands isn't about the islands.

Predictably, North Korea has jumped into the strained Japan-South Korea relations over the hot spot as well. "Dokdo island has been the sacred territory of North Korea since ancient times," their official state news agency proclaimed in 2012. It doesn't look like any of the three governments will be ceding their claim to the Liancourt Rocks anytime soon. On paper, the dispute is about fishing rights and possible natural gas deposits, but the underlying issue is one of national prestige and not losing face. The real-world stakeslike everything else about these rocksare pretty small.

Explore the world's oddities every week with Ken Jennings, and check out his book Maphead for more geography trivia.

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Why the Liancourt Rocks Are Some of the Most Disputed Islands in the World - Cond Nast Traveler

NASA Spots extra-Tropical Depression Nalgae near Kuril Islands – Phys.Org

Posted on August 7, 2017 by Danzig

August 7, 2017 by Rob Gutro On August 7, NASA's Aqua satellite passed over the Northwestern Pacific Ocean and captured an image of extra-tropical storm Nalgae near the Kuril Islands north of Japan. Credit: NASA Goddard MODIS Rapid Response Team

On August 7, NASA's Aqua satellite passed over the Northwestern Pacific Ocean and captured an image of extra-tropical storm Nalgae near the Kuril Islands north of Japan.

On Sunday, August 6 at 11 a.m. EDT (1500 UTC) the Joint Typhoon Warning Center issued their final advisory on Tropical depression Nalgae. At the time of the last advisory, Nalgae was located near 36.0 degrees north latitude and 161.4 degrees east longitude, about 805 miles north-northeast of Minami Tori Shima Atoll. Nalgae was moving to the north-northwest at 20 mph (18 knots/33 kph) and maximum sustained winds were down to 28.7 mph (25 knots/46.3 kph).

On August 7, when Aqua passed over the Northwestern Pacific Ocean, the Moderate Resolution Imaging Spectroradiometer or MODIS instrument that flies aboard captured a visible-light image of the storm. Extra-tropical storm Nalgae was just east of the Kuril Islands. The Kuril Islands of Russia's Sakhalin Oblast region are a volcanic archipelago northeast of Hokkaido, Japan that covers about 810 miles (1,300 km) and stretches to Kamchatka, Russia. The archipelago separates the Sea of Okhotsk from the North Pacific Ocean.

In the image, Nalgae had already transitioned to an extra-tropical storm, but still showed a circulation.

When a storm becomes "extra-tropical" it means that a tropical cyclone has lost its "tropical" characteristics. The National Hurricane Center defines "extra-tropical" as a transition that implies both poleward displacement (meaning it moves toward the north or south pole) of the cyclone and the conversion of the cyclone's primary energy source from the release of latent heat of condensation to baroclinic (the temperature contrast between warm and cold air masses) processes. Some cyclones can become extratropical and still retain winds of hurricane or tropical storm force, but Nalgae's winds were below 28.7 mph (25 knots/46.3 kph).

Explore further: NASA spies wind shear still affecting Tropical Storm Nalgae

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NASA Spots extra-Tropical Depression Nalgae near Kuril Islands - Phys.Org

Ferry service in the San Juan Islands suffers another breakdown – KING5.com

Posted on August 7, 2017 by Danzig

Jason Sillman, KING 4:52 AM. PDT August 07, 2017

The brand new, 144-car Samish ferry on the Anacortes/San Juan Islands route went into service for the first time on June 14, 2015. (Photo: Chris Teren / http://www.terenphotography.com/)

An engine problem has taken the Washington State Ferry boatSamish out of service causing severe travel delays on the Anacordes/San Juan Islands route.

WSF said they will start an emergency four-boat schedulestarting Monday until another vessel can be dispatched to the route.

Travelers took to social media Sunday said they had been waiting in line all day to board a ferry.

In the ferry line since 0900 on Lopez...100 cars have left the island since, now 730p Just make a plan and communicate!!!@wsferries @king5

@KING5Seattle @wsferries 200+ cars stuck on lopez island since last 8 hours waiting for ferry to anacortes, with kids,no restrooms,no food

@wsferries stuck in lopez island for 8 hrs to get a ferry to Anacortes. No clear schedule updates given.. #bigfail

This is just the latest in what has been a series of breakdowns that have plagued the popular summer travel route.Just last month, one of their regular vessels was taken out of service followed by the only backup ferry the state has in the fleet.

2017 KING-TV

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Ferry service in the San Juan Islands suffers another breakdown - KING5.com

You’ll Want to Explore These Hidden Barrier Islands Off the Mid-Atlantic Coast – Washingtonian.com

Posted on August 7, 2017 by Danzig

The wind is shrill and gusty. And here comes some spitting rain. A noreaster is on tap before the weekend is out. What better time for some open-boat coastal sightseeing?

Assuring us its more uncomfortable than unsafe, Captain Meriwether Payne of Seaside Ecotours backs her skiff out of its Wachapreague, Virginia, slip. The wife and I huddle in our rain gearexcitement trumping apprehensionas we swing in-to Bradford Bay. Our destination: an unprepossessing line of scrub some four miles in the distance, barely discernible amid the whitecaps. Cedar Island.

Its easy to view the Mid-Atlantic coastfrom Rehoboth to Virginia Beachas an endless stretch of taffy stands and sun-blanched condos. Yet the region is also home to one of the countrys longest undeveloped strings of barrier islands. Assateague, the pony-inhabited National Seashore straddling Maryland and Virginia, is part of it. But you can drive there. For the true desert-island experience, you must head into the less trampled corner of the Delmarva Peninsulain Virginiaand take to the waves.

The waters off Wachapreagueself-proclaimed flounder capital of the worldcan teem with recreational anglers, but not today. (Anyone else of a certain age remember seafood dinners at Silver Springs old Wachapreague Restaurant?) Bird life is abundant: Arctic-bound whimbrels fattening up on fiddler crabs, red-billed American oystercatchers furtively pairing off in the marsh grass, terns and gulls wheeling overhead.

After some bumpy open-water stretches, Payne gingerly runs the boat into Cedars sands and we step off. Dry land. Well, for now. Erosion is whittling away the island. Nearly 30 beach houses stood here in 1997. The last one slipped into the surf in 2014.

Today, ours are the only footprints to be seen. What is visible is a beachcombers fever dream of shells and driftwood. Intact whelks are everywhere. We fill our pockets and revel in the exhilarating wildness.

During clement conditions, you could hunt shells for hours, spread a towel, crack open a picnic basket. On this day, were a bit weather-beaten after 90 minutes.

Soon after, were reflecting on it all at Wachapreagues waterfront Island House restaurant, where the Bloody Marys are strong and the island views come warm and dry.

Seaside Ecotours, 34 Atlantic Ave., Wachapreague, Va.; 757-710-2454. Tours: $100 for the first hour, $25 each additional hour. Beach-taxi drop-off on Cedar Island with later pickup: $125.

Many of Virginias nearly two dozen barrier is-lands are under Nature Conservancy purview. For visitation rules, go to nature.org.Rent a boat or kayak on the mainland and head that way.

This article appears in the August2017 issue of Washingtonian.

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You'll Want to Explore These Hidden Barrier Islands Off the Mid-Atlantic Coast - Washingtonian.com

Virgin Islands follow Puerto Rico into the debt day of reckoning – R Street

Posted on August 7, 2017 by Danzig

What do Puerto Rico and the U.S. Virgin Islands have in common? They are both islands in the Caribbean, they are both territories of the United States and they are both broke.

Moreover, they both benefited (or so it seemed in the past) from a credit subsidy unwisely granted by the U.S. Congress: having their municipal bonds be triple-tax exempt everywhere in the country, something U.S. states and their component municipalities never get. This tax subsidy helped induce investors and savers imprudently to overlend to both territorial governments, to finance their ongoing annual deficits and thus to create the present and future financial pain of both.

Puerto Rico, said a Forbes article from earlier this yearas could be equally said of the Virgin Islandscould still be merrily chugging along if investors hadnt lost confidence and finally stopped lending. Well, of course: as long as the lenders foolishly keep making you new loans to pay the interest and the principal of the old ones, the day of reckoning does not yet arrive.

In other words, both of these insolvent territories experienced the Financial Law of Lending. This, as an old banker explained to me in the international lending crisis of the 1980s, is that there is no crisis as long as the lenders are merrily lending. The crisis arrives when they stop lending, as they inevitably do when the insolvency becomes glaring. Then everybody says how dumb they are for not having stopped sooner.

Adjusted for population size, the Virgin Islands debt burden is of the same scale as that of Puerto Rico. The Virgin Islands, according to Moodys, has public debt of $2 billion, plus unfunded government pension liabilities of $2.6 billion, for a total $4.6 billion. The corresponding numbers for Puerto Rico are $74 billion and $48 billion, respectively, for a total $122 billion.

The population of the Virgin Islands is 106,000, while Puerto Ricos is 3.4 million, or 32 times bigger. So we multiply the Virgin Islands obligations by 32 to see how they compare. This gives us a population-adjusted comparison of $64 billion in public debt, and unfunded pensions of $83 billion, for a total $147 billion. They are in the same league of disastrous debt burden.

What comes next? The Virgin Islands will follow along Puerto Ricos path of insolvency, financial crisis, ultimate reorganization of debt, required government budgetary reform and hoped for economic improvements.

A final similarity: The Virgin Islands economy, like that of Puerto Rico, is locked into a currency union with the United States from which, in my opinion, it should be allowed to escape. This would add external to the imperative internal adjustment, as the debt day of reckoning arrives.

Image byPeter Hermes Furian

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Virgin Islands follow Puerto Rico into the debt day of reckoning - R Street

Japan investigating projects on Kuril Islands – Windpower Monthly (subscription)

Posted on August 7, 2017 by Danzig

The Bogdan Khmelnytsky volcano on Iturup in the Kuril Islands

The Kurils are located in the Sakhalin Oblast region of far-eastern Russia. There are 56 volcanic islands stretching 1,300 kilometres between Kamchatka in Russia and Hokkaido, northern Japan.

It is planned that future plants will be primarily built on Iturup Island, which has the best geographical conditions of the archipelago for the establishment of wind projects. Other options may also include Kunashir.

Planned capacities of wind farms are not disclosed, however, according to some sources close to the Sakhalin Oblast region, they may reach 50MW at the initial stage with the possibility of expansion in due course.

Future power will be supplied both to mainland Russia and Japan.

It is thought that the contract between Japanese business for the building of new wind power plants may be signed during the Eastern Economic Forum (6-7 September) business event held in Russia for local and Asian-Pacific companies.

Everglades animals stranded and dying on tree islands – MyPalmBeachPost

Posted on August 7, 2017 by Danzig

High water levels in the Everglades have stranded animals on levees and tree islands, triggering emergency measures last week by water managers to drain flooded areas.

The U.S. Army Corps of Engineers was allowed to change its water storage rules to temporarily allow for more water to be held in a conservation area west of Palm Beach and Broward counties through the fall and into the dry season.

The move will restrict water flowing into an area farther south where the water has risen nearly two feet above whats recommended for flora and fauna to survive. When water levels stay too high for too long, animals can drown and run out of food on the tree islands. Plants submerged under too much water can die for lack of sun.

RELATED: See all of The Palm Beach Posts coverage on Lake Okeechobee

This buys us a little time, said John Campbell, a spokesman for the corps. We are seeing recession, and that is a promising sight, but we really need to get some extended dry weather.

A National Weather Service report released Thursday said preliminary data shows the past two months were the wettest June and July on record with an average of 23.45 inches of rain across a 16-county region managed by the South Florida Water Management District.

On Friday, the district announced it had installed three temporary pumps to reduce water levels. The pumps will run non-stop until the water is back to acceptable levels.

Check The Palm Beach Post radar map

Last weeks actions are the second time this summer officials were forced to make emergency changes to account for the high water levels caused by the heavy rainfall.

In June, the U.S. Fish and Wildlife Service agreed reluctantly to allow water to be released from one area into another that was being used as a nesting ground for the nearly extinct Cape Sable seaside sparrow. There are between 2,000 and 3,000 endangered Cape Sable seaside sparrows left in the Everglades. If their population drops much below 300, they likely will become extinct. Sparrow nesting season ended mid-July.

RELATED: Active hurricane season forecast holds, 61 percent chance of a Florida landfall

These kind of water management decisions are a distinctly Florida dilemma, born of mans reroute of the states natural plumbing that traditionally drained through channels around the sparrows, which nest on higher ground. The diversion from natural drainage also causes backups in the northern Everglades and Lake Okeechobee while areas to the south, such as Florida Bay, are dying from a lack of freshwater.

This is another example of why Everglades restoration needs to happen faster, USFWS state supervisor Larry Williams said last month.

In the bloated water conservation areas, threatened species include the snail kite, wood storks and indigo snakes. Threatened is a lower concern level than endangered, but still means a species is likely to become endangered in the future. More common wildlife such as deer and raccoon also suffer when there is too much water.

Download the Palm Beach Post WeatherPlus app here

Florida Fish and Wildlife Commissioner Alligator Ron Bergeron sent a detailed letter to the corps last week describing the conditions of animals marooned on the tree islands, levees and spoil islands.

He said huddled on higher ground, their preferred food sources are limited. They have less to eat, and eat less nutritious food, which increases stress.

Over time, fat reserves become exhausted and malnutrition and death will occur, Bergeron said. Extended duration high water conditions also have detrimental long-term effects on the essential foraging and nesting habitats of federally-listed species such as wood storks and snail kites.

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Everglades animals stranded and dying on tree islands - MyPalmBeachPost

Modification of genes in human embryos could mark turning point in human evolution – The Globe and Mail

Posted on August 7, 2017 by Danzig

It appears, by all accounts, to be a momentous scientific achievement and possibly a turning point in human evolution. In a study released last week, scientists at Oregon Health and Science University confirmed they were able to modify genes in viable human embryos, proving the potential to permanently alter the makeup of a genetic line.

In this case, that meant replacing and repairing a mutated gene that causes a common and deadly heart disorder. But the possibilities heralded by gene-editing technology are endless, the scenarios as divided as they are bold. In some visions, it leads to a population of designer babies or consumer eugenics. Others imagine a utopia of scientific advancement where humans live free of disease, and devastating conditions are eradicated for the betterment of humanity. What direction the technology will take is the topic of much debate.

The big thing which is making the scientific and ethics community get excited, and on the other hand a little bit hot and bothered, is its a mechanism to change genes for multiple generations, says Dr. Alice Virani, a genetic counsellor and director of ethics at British Columbias Provincial Health Services Authority. There are two ways to look at it, the more realistic ramifications and the sci-fi, if-this-was-out-of-control ramifications.

Opinion: Gene editing is not about designer babies

The team at the Oregon universitys Center for Embryonic Cell and Gene Therapy used technology called CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, to repair or edit the gene carrying the heart disorder, seemingly with greater success than previous attempts by scientists in China.

News of the research has been anxiously anticipated by many in the field, both for what it means for the potential eradication of a disease such as hypertrophic cardiomyopathy and for the fundamental questions it raises about human reproduction, health and society.

When the study was leaked days before its publication in the journal Nature, its lead scientist, Dr. Shoukhrat Mitalipov, attributed the release to likely a combination of hot words: CRISPR, gene-editing, and designer babies.

The study and its combination of hot words didnt disappoint.

The New York Times hailed the milestone in research, while The New York Post cried BABE NEW WORLD and described an amazing and slightly terrifying breakthrough. A headline on Vox declared simply, This Is Huge.

Even actor Ashton Kutcher tweeted enthusiastically about the scientific breakthrough, writing: Scientists successfully used CRISPR to fix a mutation that causes disease. This is why I wanted to be a geneticist!

The tweet ignited among his followers the same range of responses that are always so keenly tied to the issue of changing human genes, from hope that devastating conditions such as muscular dystrophy will be eradicated, to fear about the unknown consequences of playing God.

Dr. Timothy Caulfield, a Canada Research Chair in Health Law and Policy and professor at the University of Alberta, says the polarized and dramatic response he has seen in recent days reminds him of early reaction to stem-cell science, where, he says, It was either going to be cloned armies, or we were going to eradicate all disease.

In fact, neither has turned out to be the case, and so it may be with gene editing as well.

We need to be cautious not to hype the benefits and be cautious not to hype the ethical concerns, he says. There are real issues on both sides of the debate but lets make sure our discourse is evidence-formed.

He described the new research as a genuinely exciting area, and said the potential of CRISPR which is used not only in human genetics, but also has potentially revolutionary applications for agriculture, animals, plants and food has introduced both exciting possibilities and reasons for deep policy reflection.

Erika Kleiderman, a lawyer and academic whose work focuses on gene-editing technologies, stem-cell research and regenerative medicine at the Centre of Genomics and Policy at McGill University, says the Oregon teams research is exciting because it confirms the ability of CRISPR technology to repair genetic mutations, and establishes the basic safety of the technique in a research context. And while she said people often go straight to thinking about the potential for manipulating genes to create so-called designer babies, a concept that is cool but also quite frightening, the medical implications could be equally staggering, and are far more likely.

For example, something like Huntington disease, she says. Being able to prevent that or treat that one day, in my opinion, would be a fantastic leap for our scientific knowledge and medical advancement. That being said, people will raise the eugenics argument. Is that a possibility? Yes. Are we close to that? I dont think so.

Canada has strict laws around genetic modification and editing, and altering genes in a way that could be passed on to future generations is a criminal offence under the Assisted Human Reproduction Act, punishable with fines up to $500,000 or 10 years in prison.

But as the technology takes a large step forward, Ms. Kleiderman and Dr. Caulfield and are among a group of Canadian scientists and academics calling for less regulation around genetic science and research in Canada, not more.

Both were involved in the creation of an editorial published in the journal Regenerative Medicine in January calling for new consideration of the issues and ethics involved in gene editing, and a revision of Canadian legal policy.

A criminal ban is a suboptimal policy tool for science as it is inflexible, stifles public debate, and hinders responsiveness to the evolving nature of science and societal attitudes, the editorial read. It was signed by seven other experts and ethicists, and came out of a think tank on the future of human gene editing in Canada held at McGill last summer.

Dr. Caulfield says legal prohibition of certain genetic research doesnt make sense when we dont yet know or understand where the science is going, or what the benefits or harms could be. Instead, he says he believes in regulation in problematic areas, while allowing for studies and trials. He says that some of the slippery slope scenarios people fear such as using genetic modification for human enhancement and to achieve superficial traits such as height remain distant possibilities given the complexity of the science.

That is not to say there are not risks or issues to be addressed as the technology continues to evolve. Ms. Kleiderman says that includes consideration of the potential risk to future generations, the safety of the technology and other irrevocable, if unintended, consequences, although she says those risks are not unique to gene modification but true of all technologies.

When it comes to CRISPR, one of the areas it would be most beneficial is with the treatment of prevention of disease which I think most people would be in agreement with, she says. Of course, we need to be mindful of doing not-so-positive things with it, like going down the enhancement route.

She said other potential issues, such as the preservation of human diversity and individuality, the welfare of children born from this technology and the potential for creating new forms of inequality, discrimination or societal conflict, all require significant consideration and research.

There is time. Although the technology is moving quickly, there is still a long way before gene editing is used in clinical human trials. Even after that, Dr. Virani says for the foreseeable future the technology will most likely be used by a small group of people in specific scenarios related to the prevention of serious genetic disease.

Im not saying we shouldnt be concerned about those potential issues, but sometimes we make that leap too quickly, she said. We dont necessarily [think] that the most likely scenario is that couples will use this technology on a very limited basis if they know their child may potentially have a devastating genetic condition. Thats not something that suddenly everyone is going to start to do. I think theres sometimes that leap to, Oh, we can create designer babies, but I think were very much in the lessening-burden-of-disease phase rather than the designer-baby phase, though thats where peoples minds go.

Dr. Virani said one of her own concerns is the possibility of off-target effects, where changing a gene unexpectedly alters something else in the genome. Other concerns are more social reality than science fiction, including that the technology and the ability to prevent disease may only be available to those who can pay for it. Eradicating a horrible disease is one thing. Eradicating it only for families who can afford it is another.

So is it going to look like just the wealthy are going to be able to afford this type of technology? she asks. Thats very problematic in my eyes from an ethics point of view, and thinking about fairness in society. If only poor people get Huntington disease, then the lobby to support Huntington disease research is greatly diminished. Its kind of like a two-fold negative effect.

On Thursday, the American Journal of Human Genetics ran a policy statement signed by 11 organizations from around the world, including the Canadian Association of Genetic Counsellors, urging a cautious but pro-active approach as the science moves forward. The statement includes an agreement that gene editing should not yet be performed in embryos carried on to human pregnancy. (The embryos used in the Oregon research were created only for the research, and were not developed further.) It also outlines a number of criteria that should be met before clinical trials take place, and supports public funding for the research. The U.S. government does not allow federal funding for genetic research on embryos. The Oregon research was funded by the university.

We dont want it to go speeding ahead, said Kelly Ormond, the lead author of the policy statement and a genetics professor at Stanford University in California. We want people to be very transparent about whats happening and we want things to undergo good ethics review, and for society to actually be engaged in these dialogues now while this research is just starting to happen.

She said she believes its important to be pro-active in talking and thinking about the issues related to the technology, and starting a broader conversation of how gene editing should and will be used.

We can all agree that that world [of eugenics and designer babies] doesnt feel very comfortable, and I think most of us dont want to go there, she said. So we need to find ways to prevent that from happening.

Follow Jana G. Pruden on Twitter: @jana_pruden

Modification of genes in human embryos could mark turning point in human evolution - The Globe and Mail

New look at archaic DNA rewrites human evolution story – Phys.Org

Posted on August 7, 2017 by Danzig

August 7, 2017 These population trees with embedded gene trees show how mutations can generate nucleotide site patterns. The four branch tips of each gene tree represent genetic samples from four populations: modern Africans, modern Eurasians, Neanderthals, and Denisovans. In the left tree, the mutation (shown in blue) is shared by the Eurasian, Neanderthal and Denisovan genomes. In the right tree, the mutation (shown in red) is shared by the Eurasian and Neanderthal genomes. Credit: Alan Rogers, University of Utah

Hundreds of thousands of years ago, the ancestors of modern humans diverged from an archaic lineage that gave rise to Neanderthals and Denisovans. Yet the evolutionary relationships between these groups remain unclear.

A University of Utah-led team developed a new method for analyzing DNA sequence data to reconstruct the early history of the archaic human populations. They revealed an evolutionary story that contradicts conventional wisdom about modern humans, Neanderthals and Denisovans.

The study found that the Neanderthal-Denisovan lineage nearly went extinct after separating from modern humans. Just 300 generations later, Neanderthals and Denisovans diverged from each other around 744,000 years ago. Then, the global Neanderthal population grew to tens of thousands of individuals living in fragmented, isolated populations scattered across Eurasia.

"This hypothesis is against conventional wisdom, but it makes more sense than the conventional wisdom." said Alan Rogers, professor in the Department of Anthropology and lead author of the study that will publish online on August 7, 2017 in the Proceedings of the National Academy of Sciences.

A different evolutionary story

With only limited samples of fossil fragments, anthropologists assemble the history of human evolution using genetics and statistics.

Previous estimates of the Neanderthal population size are very smallaround 1,000 individuals. However, a 2015 study showed that these estimates underrepresent the number of individuals if the Neanderthal population was subdivided into isolated, regional groups. The Utah team suggests that this explains the discrepancy between previous estimates and their own much larger estimate of Neanderthal population size.

"Looking at the data that shows how related everything was, the model was not predicting the gene patterns that we were seeing," said Ryan Bohlender, post-doctoral fellow at the M. D. Anderson Cancer Center at the University of Texas, and co-author of the study. "We needed a different model and, therefore, a different evolutionary story."

The team developed an improved statistical method, called legofit, that accounts for multiple populations in the gene pool. They estimated the percentage of Neanderthal genes flowing into modern Eurasian populations, the date at which archaic populations diverged from each other, and their population sizes.

A family history in DNA

The human genome has about 3.5 billion nucleotide sites. Over time, genes at certain sites can mutate. If a parent passes down that mutation to their kids, who pass it to their kids, and so on, that mutation acts as a family seal stamped onto the DNA.

Scientists use these mutations to piece together evolutionary history hundreds of thousands of years in the past. By searching for shared gene mutations along the nucleotide sites of various human populations, scientists can estimate when groups diverged, and the sizes of populations contributing to the gene pool.

"You're trying to find a fingerprint of these ancient humans in other populations. It's a small percentage of the genome, but it's there," said Rogers.

They compared the genomes of four human populations: Modern Eurasians, modern Africans, Neanderthals and Denisovans. The modern samples came from Phase I of the 1000-Genomes project and the archaic samples came from the Max Planck Institute for Evolutionary Anthropology. The Utah team analyzed a few million nucleotide sites that shared a gene mutation in two or three human groups, and established 10 distinct nucleotide site patterns.

Against conventional wisdom

The new method confirmed previous estimates that modern Eurasians share about 2 percent of Neanderthal DNA. However, other findings questioned established theories.

Their analysis revealed that 20 percent of nucleotide sites exhibited a mutation only shared by Neanderthals and Denisovans, a genetic timestamp marking the time before the archaic groups diverged. The team calculated that Neanderthals and Denisovans separated about 744,000 years ago, much earlier than any other estimation of the split.

"If Neanderthals and Denisovans had separated later, then there ought to be more sites at which the mutation is present in the two archaic samples, but is absent from modern samples," said Rogers.

The analysis also questioned whether the Neanderthal population had only 1,000 individuals. There is some evidence for this; Neanderthal DNA contains mutations that usually occur in small populations with little genetic diversity.

However, Neanderthal remains found in various locations are genetically different from each other. This supports the study's finding that regional Neanderthals were likely small bands of individuals, which explains the harmful mutations, while the global population was quite large.

"The idea is that there are these small, geographically isolated populations, like islands, that sometimes interact, but it's a pain to move from island to island. So, they tend to stay with their own populations," said Bohlender.

Their analysis revealed that the Neanderthals grew to tens of thousands of individuals living in fragmented, isolated populations.

"There's a rich Neanderthal fossil record. There are lots of Neanderthal sites," said Rogers. "It's hard to imagine that there would be so many of them if there were only 1,000 individuals in the whole world."

Rogers is excited to apply the new method in other contexts.

"To some degree, this is a proof of concept that the method can work. That's exciting," said Rogers. "We have remarkable ability to estimate things with high precision, much farther back in the past than anyone has realized."

Explore further: DNA of early Neanderthal gives timeline for new modern human-related dispersal from Africa

More information: Alan R. Rogers el al., "Early history of Neanderthals and Denisovans," PNAS (2017). http://www.pnas.org/cgi/doi/10.1073/pnas.1706426114

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Having lost their heads, been pulled from their plinths, smashed and even buried, things are at last looking up for some of the unluckiest statues in Christendom.

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New look at archaic DNA rewrites human evolution story - Phys.Org

Rural veterans face long paths to health care – PBS NewsHour

Posted on August 7, 2017 by Danzig

For decades, officials who work with veterans have sympathized with rural residents like Graham, but have had little to offer. Now, by testing new ideas through pilot programs like the van rides provided by Volunteers of America North Louisiana, the VA is developing models and spreading them across the country to get more rural veterans the health care they need.

VA expansion

Just 20 miles from where the dirt road to Grahams driveway begins, in Texarkana, theres a VA outpatient clinic. But the clinic doesnt provide chemotherapy. It, like many local clinics for veterans, provides basic physical and mental health care, but not emergency care or some specialized services.

While there is a general lack of doctors and hospitals in rural areas, the situation is even worse for veterans who rely on the VA, said John Hoellwarth, a spokesperson for American Veterans, the nations largest veterans organization. In recent years, the VA has set up more community-based clinics, and the Obama administration created a program, called Choice, that allows non-VA clinicians to serve rural veterans and receive reimbursement from the VA. But the problem persists.

Many rural veterans rely on a combination of VA health insurance and other forms of insurance, such as private insurance, Medicaid (the joint federal-state health insurance program for the poor and disabled), or Medicare (federal health program for the elderly), according to census data. The number ofveterans enrolled in Medicaidincreased by about 340,000 under the Affordable Care Act, according to an analysis by Families USA, a nonprofit that advocates for high-quality, affordable health care.

For veterans in rural areas, Medicaid could mean the difference between them getting care, and them not getting care, said Andrea Callow, Families USA associate director of Medicaid initiatives.

To improve care for rural veterans, the VA needs to expand both the services it provides and the services it pays others to provide, said Margaret Puccinelli, chairwoman of the Veterans Rural Health Advisory Committee, which makes recommendations to Secretary of Veterans Affairs David Shulkin.

Because of the geographic isolation for many vets that are eligible, you have to approach it as creatively as possible, Puccinelli said.

The U.S. House of Representatives last weekvoted to fund the Choice programfor another six months, which would allow lawmakers more time to agree on changes to the program. The bill now goes to the Senate. The program, which is open to veterans who live more than 40 miles from a VA clinic or hospital or who face long wait times, has been plagued with problems from the start, including difficulty for veterans trying to make appointments, and long wait times for reimbursement.

Medicaid could mean the difference between them getting care, and them not getting care

New approaches

The Volunteers of America North Louisiana program was one of five to receive $2 million from 2014 to 2016 from the VA Office of Rural Health, which develops models for care that can be replicated nationwide.

The idea of shuttling veterans to and from their appointments is not new. The VA has had a transportation program for decades, under which Disabled American Veterans donates vans to the VA that volunteers use to take veterans to medical appointments.

But the Volunteers of America North Louisiana program was different: It used paid drivers, picked rural veterans up at their homes, and transported veterans in wheelchairs, which the other program does not do.

Graham tried using the Disabled American Veterans program in his area. But the pickup location is in Texarkana, and Graham said rides werent available at the times he needed them.

Volunteers of America North Louisiana knew there was a need, but it was overwhelmed by the response, said Gary Jaynes, the organizations director of veteran services. In the two years the program was running, it provided 2,229 rides to veterans, logging nearly 300,000 miles and saving veterans nearly $400,000 in travel expenditures, Jaynes said.

Most of the Office of Rural Healths $250 million budget for programs goes to rolling out promising models in local VA clinics. A few approaches that have stuck include using home-based rehabilitation for veterans who have heart attacks, and using telehealth for patients with HIV or multiple sclerosis.

Like Volunteers of America North Louisiana, the Nebraska Association of Local Health Directors received a $2 million grant. The Nebraska nonprofit used its money to place 10 coordinators in local health departments to spread the word about services available to veterans and teach health workers how to find veterans in need of help. The Nebraska program ended up referring about 600 veterans to services in and out of the VA, and created a statewide network of people working toward the same purpose, said Teri Clark, the projects director.

We didnt reach just a couple veterans, Clark said. Instead, we changed the system.

Telehealth expansion

On the way to the VA, just before crossing into Louisiana, Graham gets the hiccups. His cancer exhausts him, and makes it hard for him to digest food. He rubs his chest, recalling a time he had to drive himself home from chemotherapy.

I got the cold sweats, he said, as Texas ranches flew by outside the car window. I got sick as soon as I pulled up in the yard.

The VA knows that providing telehealth to rural veterans makes many long trips unnecessary.Telehealth makes veterans healthier, reducing hospital admissions by 35 percent, and saves them money about $2,000 per patient each year, according to a 2014 VA study.

In addition to driving veterans to appointments, the Volunteers of America bought a telehealth van equipped with communications equipment and broadband internet, which is used to see patients across state lines.

Graham now feels too sick and tired to work, but he used to be a chef. He cooked at the convention center and a cafe in Shreveport. Then he was kitchen manager at a seafood restaurant in Texarkana. He laughs remembering all the energy he had at opening day in 2013, as he ran around trying to feed a hundred guests at once, with food orders stuffed in his shirt pocket.

A couple years later, he was raking leaves and he got dizzy. When he got to the hospital, they found his cancer. He quit his job, sold his truck and signed up for Medicaid.

On his rides with Volunteers of America North Louisiana, Graham bonded with his drivers and fellow riders. Veterans appreciated the program so much that they started calling their representatives in Congress. Now, clinic officials plan to meet with Jaynes and congressmen to discuss ways to keep the services in operation.

Thomas Klobucar, acting director of the Office of Rural Health, said his office is still evaluating the results of the Volunteers of America North Louisiana program, and will report to Congress by October on its findings.

Continued here:

Rural veterans face long paths to health care - PBS NewsHour

Caretaker for Obamacare? Trump’s health care role may shift – ABC News

Posted on August 7, 2017 by Danzig

With Republicans unable to advance a health care bill in Congress, President Donald Trump's administration may find itself in an awkward role as caretaker of the Affordable Care Act, which he still promises to repeal and replace.

The Constitution says presidents "shall take care that the laws be faithfully executed." So as long as former President Barack Obama's law is on the books, that doesn't seem to leave much choice for Trump, even if he considers "Obamacare" to be "a disaster."

"It's either caretaker or undertaker," quipped economist Joe Antos of the business-oriented American Enterprise Institute. "I think in the end it's going to be 'caretaker' because they'll finally realize nobody is going to blame Obama. Having the thing blow up is going to be considered in the public eye to be Trump's fault."

Every move by Trump's health chief will be scrutinized by Democrats for evidence of "sabotage," a charge they're already making. Meanwhile, the administration will try to use its rule-making power to bend Obama's law toward Republican priorities.

The Trump administration's first sign-up season, for 2018 coverage, starts in about three months, on Nov. 1.

Some things to watch for:

INTENSE SCRUTINY

Consumer organizations, state officials, Democrats, insurers, and groups representing various health care interests will keep close tabs on the actions of Health and Human Services Secretary Tom Price and his deputy, Seema Verma, who runs the federal agency that administers health insurance programs.

"We are going to hold HHS accountable to fully implement the law," said lawyer Mara Youdelman, who heads the Washington office of the National Health Law Program, an advocacy group. "The Affordable Care Act is the law of the land, and everyone who is working for the administration should be committed to upholding the law of the land."

Former Obama administration officials intimately familiar with the program will be looking over the shoulders of the Trump team Twitter accounts at the ready.

Price so far has sent mixed signals. His department recently canceled contracts for community groups to provide sign-up assistance in 18 cities. His official rhetoric about the law has been harsh, maximizing its faults without recognizing the health benefits of 20 million more people with insurance.

But the department did work with Alaska on a waiver that's been praised for helping to stabilize that state's insurance market. And early on, the agency issued a regulation that made several changes insurers had requested to help things run more smoothly.

About 10 million people are signed up for private insurance in subsidized markets, and 11 million more have coverage through expanded Medicaid.

DON'T OVERLOOK THAT COMPUTER SYSTEM

Few things were as damaging to Obama's aura of cool competence as the failure of the HealthCare.gov computer system when it went live in the fall of 2013. Few people managed to sign up that first day, and it took weeks for a technological rescue team to sort through layers of problems, restoring acceptable functionality.

After that chastening experience, Obama administration officials constantly kept tinkering with the website, trying to improve its technical capacity and usability for consumers.

It's unclear what the Trump administration has been doing since he took office in January. No media preview of 2018 open enrollment has been announced.

The administration may have made its own job harder by cutting in half the sign-up season for next year. This time, open enrollment will run from Nov. 1-Dec. 15. Previously, it ran through Jan. 31.

In earlier years, Dec. 15 was a big day for the computer system because it was the last opportunity to sign up for coverage effective Jan. 1. This year the Dec. 15 crunch could be even more overwhelming, because it's also the last chance for most people to sign up for the coming year.

The day falls on a Friday a sort of "Black Friday" for health insurance sign-ups.

"The system has to be ready at the start, and they have to be prepared to detect problems, especially when they hit the end," said Antos.

UNCERTAINTY OVER SUBSIDIES

The clearest signal Trump could send of his administration's good faith would be to remove the uncertainty around billions of dollars in payments to insurers. That money reimburses the insurers for reducing copayments and deductibles for people with modest incomes.

The "cost-sharing" subsidies are called for in the health law, but they are under a legal cloud because of a lawsuit brought earlier by House Republicans, questioning whether the law included a specific instruction for the government to pay the money. The case is on hold before a federal appeals court; the administration has continued making monthly payments.

After the Senate's GOP health bill failed, the president sent out a series of tweets in which he seemed to threaten to stop the payments.

"If a new HealthCare Bill is not approved quickly, BAILOUTS for Insurance Companies...will end very soon!" said one of Trump's Twitter messages.

Experts say the money is not a bailout, but a government obligation. GOP leaders in Congress want the payments continued.

Without a subsidy guarantee from Trump, some insurers have been seeking double-digit premium increases, on top of raises that reflect underlying medical costs.

"This month-to-month uncertainty is just corrosive," said former HHS Secretary Kathleen Sebelius, who served in the Obama administration.

LOSING GROUND?

Obama's law reduced the U.S. uninsured rate to a historic low of about 9 percent.

That was widely seen as an indicator of progress under the health overhaul, and one of the main problems for the recent Republican bills is that they would have significantly increased the number of uninsured people.

Amid confusion about the future of the ACA, there are signs that coverage is already beginning to erode.

A major survey called the Gallup-Sharecare Well-Being Index recently estimated that the number of adults without health insurance grew by about 2 million this year.

What happens next is in the hands of the Trump administration.

Online: http://www.HealthCare.gov

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Caretaker for Obamacare? Trump's health care role may shift - ABC News

Hatch on GOP’s ObamaCare repeal push: ‘They shot their wad on healthcare’ – The Hill

Posted on August 7, 2017 by Danzig

Sen. Orrin HatchOrrin HatchFive tough decisions for the GOP on healthcare GOP debates deep cut to corporate tax rate Overnight Healthcare: GOP states move to cut Medicaid | Senate passes key FDA funding bill MORE (R-Utah) raised some eyebrows when he used a colorful phrase to argue that it was time for Republicans to move from the healthcare debate to tax reform.

Were not going back to healthcare. Were in tax now," Hatch told Politicoon Wednesday in a story published Monday.

"As far as Im concerned, they shot their wad on healthcare and thats the way it is. Im sick of it.

"As few of you were alive during the Civil War, here's a valuable jargon lesson on 'wads' and the shooting of them," Hatch tweeted.

As few of you were alive during the Civil War, here's a valuable jargon lesson on "wads" and the shooting of them. https://t.co/dOYvcfgImO pic.twitter.com/wk9aaNb3s2

Hatch's office linked to an online version of the Oxford dictionary.

While the phrase Hatch used has taken on a sexual connotation, it also has meanings that are far from blue comedian material.

The Oxford dictionary's definition for the phrase is that it means someone has spent all of their money.

Hatch's Civil War reference is a nod to the definition of "wad" described by Merriam-Webster as "a soft plug used to retain a powder charge or to avoid windage especially in a muzzle-loading gun."

The comments come after the GOP plan to repeal and replace ObamaCare collapsed last month.

Some lawmakers are pushing forRepublicans tocontinue their healthcare push in an effortto fulfill their longtime campaign promise to repeal and replace former President Obama's signature domestic achievement.

Others are arguing that Republicans should move on to otheragenda items, such as tax reform.

Senate Majority Leader Mitch McConnellMitch McConnellFive tough decisions for the GOP on healthcare McConnell on healthcare failure: 'Feel better, Hillary Clinton could be president' George Will warns grotesque is becoming normal for GOP MORE (R-Ky.)said this past weekend he doesn't like to "dwell on situations where we come up a little bit short."

Even on the night when we came up one vote short of our dream to repeal and replace ObamaCare, heres the first thing I thought about: feel better, Hillary Clinton could be president," he said during an appearance at a Republican event in Kentucky.

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Hatch on GOP's ObamaCare repeal push: 'They shot their wad on healthcare' - The Hill

Report: Colorado among states with best health care – The Denver Channel

Posted on August 7, 2017 by Danzig

DENVER Colorado has some of the best health care in the country, according to a new report from WalletHub.

The Centennial State landed in 13th place on WalletHubs list of the best states for health care.

What does that mean, exactly?

In its effort to rank each state (and Washington, DC), WalletHub looked at a range of factors, including cost, access and health outcomes. That means states were graded on things like out-of-pocket medical spending, hospital beds per capita, doctors and clinics per capita, the share of insured adults and children, life expectancy and rates of diseases like diabetes, cancer and heart disease.

In essence, the report aims to measure not just availability of health services, but also their value and efficacy, in order to give a more comprehensive picture of health care in each state.

Colorado ranked especially well in certain health issue-related measures, with the fourth-lowest cancer rate in the country and the third-lowest rate of heart disease, according to WalletHub.

Hawaii came in at the top of the list, while Louisiana landed at the bottom.

Here are the top 15 states overall, according to WalletHub:

1. Hawaii 2. Iowa 3. Minnesota 4. New Hampshire 5. District of Columbia 6. Connecticut 7. South Dakota 8. Vermont 9. Massachusetts 10. Rhode Island 11. Maryland 12. Kansas 13. Colorado 14. Maine 15. Utah

To read the full report, log on to wallethub.com.

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Report: Colorado among states with best health care - The Denver Channel

#HITSECURITY Twitter chat to zero-in on state of healthcare cybersecurity – Healthcare IT News

Posted on August 7, 2017 by Danzig

Ahead of Septembers Healthcare Security Forum, Healthcare IT News will be hosting a Twitter chat on Aug. 24 to explore the current healthcare cybersecurity landscape. The discussion will be moderated by Healthcare IT News Associate Editor Jessica Davis (@JessieFDavis).

Kicking off at 3 p.m., the event will feature two security experts:

Last year was a wakeup call for the healthcare sector, with more than 27 million healthcare records stolen in 2016 across 450 reported data breaches. And 26.8 percent of these were caused by ransomware, hacking or malware, according to the 2016 Protenus 2016 healthcare data report.

And this year isnt fairing much better: The latest Protenus reporting found at the current rate 2017 will exceed last year with more than one health data breach per day.

Combined with the U.S. Department of Health and Human Services Health Care Industry Cybersecurity Task Force report that found three out of four healthcare organizations operate without a designated security person, now is the time for healthcare to rapidly improve its cybersecurity posture.

The chat will highlight these challenges and some of the major cybersecurity questions facing the healthcare sector:

RSVP for the event by adding the Twitter chat to your calendar.

Have some pre-chat thoughts and insights of your own? Share on Twitter using #HITSECURITY before the event on Aug. 24.

Twitter:@JessieFDavis Email the writer: jessica.davis@himssmedia.com

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#HITSECURITY Twitter chat to zero-in on state of healthcare cybersecurity - Healthcare IT News

Madhuri Hegde Elected to ACMG Foundation for Genetic, Genomic Medicine Board – India West

Posted on August 7, 2017 by Danzig

The ACMG Foundation for Genetic and Genomic Medicine announced Aug. 4 that Indian American Madhuri Hegde of Waltham, Mass.-based PerkinElmer Inc. was elected to its board of directors.

"We are delighted that Dr. Hegde has been elected to the ACMG Foundation Board of Directors. She has vast experience in genetic and genomic testing and is a longtime member of the college and supporter of both the college and the foundation," said Dr. Bruce R. Korf, president of the ACMG Foundation, in a statement.

Hegde, who will serve a two-year renewable term, joined PerkinElmer in 2016 as vice president and chief scientific officer of global genetics laboratory services. She is also an adjunct professor of human genetics in Emory Universitys human genetics department.

Previously, Hegde served as the executive director and chief scientific officer at Emory Genetics Laboratory in Atlanta, Ga.; professor of human genetics and pediatrics at Emory University; and assistant professor at Baylor College of Medicines Department of Human Genetics in Houston, Texas.

Additionally, Hegde has served on a number of scientific advisory boards for patient advocacy groups including Parent Project Muscular Dystrophy, Congenital Muscular Dystrophy and the Neuromuscular Disease Foundation.

She earned her doctorate from the University of Auckland in Auckland, New Zealand, and completed her postdoctoral fellowship in molecular genetics at Baylor College of Medicine. She also holds a masters from the University of Mumbai in India.

The foundation, a national nonprofit dedicated to facilitating the integration of genetics and genomics into medical practice, is the supporting educational foundation of the American College of Medical Genetics and Genomics.

Board members are active participants in serving as advocates for the foundation and for advancing its policies and programs.

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Madhuri Hegde Elected to ACMG Foundation for Genetic, Genomic Medicine Board - India West

Invitae CEO says the diagnostic company has big plans for genomic medicine – MedCity News

Posted on August 7, 2017 by Danzig

San Francisco-based genetic diagnostics company Invitae has acquired Good Start Genetics and CombiMatrix, expanding Invitaes portfolio to include prenatal and pediatric testing. Its part of their long-term plan to make genomic testing routine.

Were building a company for the coming genomic era that includes genetic capabilities through all phases of life, said Invitae CEO Sean George in a phone interview.

Invitae offers a wide range of genomic panels to detect anomalies that could contribute to heart disease, cancer, neurologic disorders and other conditions. In Good Start, Invitae picks up expertise in carrier screening and preimplantation genetic testing. CombiMatrix also provides preimplantation testing, as well as panels to analyze miscarriages and pediatric developmental disorders.

Invitae is issuing 1.65 million shares of stock, paying $18.3 million in cash and assuming $6 million in debt for privately-held Good Start. CombiMatrix shareholders will receive around $27 million in common stock.

Spun off from Genomic Health in 2012, Invitae initially focused on adult inherited diseases and has gradually expanded their portfolio. They now enter a crowded field that includes LabCorp (which acquired Sequenom last year), Illumina, Progenity and others. George believes Invitaes ability to do the hard things will carry them through these market battles.

We are building a technology engine to win the race of scale, said George. We are looking to the OB market and the perinatal space to extend our platforms capabilities. But more importantly, in order to move the world away from the current disease-by-disease, test-by-test market, its managing genetic information for an individual over the course of their life.

Good Start appealed to Invitae for their cost-effective pre-implantation screening and diagnosis. CombiMatrix brings specific expertise in chromosomal microarrays. In addition, the companies could expand Invitaes marketing reach.

The two together have a pretty good commercial presence in the IVF and reproductive medicine sector, said George. Combined, especially with our capabilities, I think its fair to say we are immediately the number one player in the IVF, reproductive medicine segment for genetic information.

These acquisitions add around 150 people to the Invitae payroll, a 20 percent workforce increase. George notes they are always looking around for potential acquisitions but will probably take a breather to focus on moving new products to market. Ultimately, Invitae wants to be the company that mainstreams clinical genomics.

With the broad capabilities we now have at all stages of life, we expect to get traction in this new age of genomic medicine, where all this information can be brought to bear, said George. The first company to have broad capabilities across all of it and to continue to lower the cost basis and deliver that information is likely in position to truly bring genetics into medicine for everybody.

Photo: mediaphotos, Getty Images

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Invitae CEO says the diagnostic company has big plans for genomic medicine - MedCity News

Gene therapy via skin could treat diseases such as obesity – UChicago News

Posted on August 7, 2017 by Danzig

A University of Chicago-based research team has overcome challenges that have limited gene therapy and demonstrated how their novel approach with skin transplantation could enable a wide range of gene-based therapies to treat many human diseases.

In a study inthe journal Cell Stem Cell, the researchers provide proof-of-concept. They describe gene-therapy administered through skin transplants to treat two related and extremely common human ailments: Type 2 diabetes and obesity.

We resolved some technical hurdles and designed a mouse-to-mouse skin transplantation model in animals with intact immune systems, said study author Xiaoyang Wu, assistant professor in the Ben May Department for Cancer Research at the University of Chicago. We think this platform has the potential to lead to safe and durable gene therapy in mice and, we hope, in humans, using selected and modified cells from skin.

Beginning in the 1970s, physicians learned how to harvest skin stem cells from a patient with extensive burn wounds, grow them in the laboratory, then apply the lab-grown tissue to close and protect a patients wounds. This approach is now standard. However, the application of skin transplants is better developed in humans than in mice.

The mouse system is less mature, Wu said. It took us a few years to optimize our 3-D skin organoid culture system.

This study is the first to show that an engineered skin graft can survive long term in wild-type mice with intact immune systems. We have a better than 80 percent success rate with skin transplantation, Wu said. This is exciting for us.

The researchers focused on diabetes because it is a common non-skin disease that can be treated by the strategic delivery of specific proteins.

They inserted the gene for glucagon-like peptide 1 (GLP1), a hormone that stimulates the pancreas to secrete insulin. This extra insulin removes excessive glucose from the bloodstream, preventing the complications of diabetes. GLP1 can also delay gastric emptying and reduce appetite.

Using CRISPR, a tool for precise genetic engineering, they modified the GLP1 gene. They inserted one mutation, designed to extend the hormones half-life in the blood stream, and fused the modified gene to an antibody fragment so that it would circulate in the blood stream longer. They also attached an inducible promoter, which enabled them to turn on the gene to make more GLP1, as needed, by exposing it to the antibiotic doxycycline. Then they inserted the gene into skin cells and grew those cells in culture.

When these cultured cells were exposed to an air/liquid interface in the laboratory, they stratified, generating what the authors referred to as a multi-layered, skin-like organoid. Next, they grafted this lab-grown gene-altered skin onto mice with intact immune systems. There was no significant rejection of the transplanted skin grafts.

When the mice ate food containing minute amounts of doxycycline, they released dose-dependent levels of GLP1 into the blood. This promptly increased blood-insulin levels and reduced blood-glucose levels.

When the researchers fed normal or gene-altered mice a high-fat diet, both groups rapidly gained weight. They became obese. When normal and gene-altered mice got the high-fat diet along with varying levels of doxycycline, to induce GLP1 release, the normal mice grew fat and mice expressing GLP1 showed less weight gain.

Expression of GLP1 also lowered glucose levels and reduced insulin resistance.

Together, our data strongly suggest that cutaneous gene therapy with inducible expression of GLP1 can be used for the treatment and prevention of diet-induced obesity and pathologies, the authors wrote.

When they transplanted gene-altered human cells to mice with a limited immune system, they saw the same effect. These results, the authors wrote, suggest that cutaneous gene therapy for GLP1 secretion could be practical and clinically relevant.

This approach, combining precise genome editing in vitro with effective application of engineered cells in vivo, could provide significant benefits for the treatment of many human diseases, the authors note.

We think this can provide a long-term safe option for the treatment of many diseases, Wu said. It could be used to deliver therapeutic proteins, replacing missing proteins for people with a genetic defect, such as hemophilia. Or it could function as a metabolic sink, removing various toxins.

Skin progenitor cells have several unique advantages that are a perfect fit for gene therapy. Human skin is the largest and most accessible organ in the body. It is easy to monitor. Transplanted skin can be quickly removed if necessary. Skins cells rapidly proliferate in culture and can be easily transplanted. The procedure is safe, minimally invasive and inexpensive.

There is also a need. More than 100 million U.S. adults have either diabetes (30.3 million) or prediabetes (84.1 million), according the Centers for Disease Control and Prevention. More than two out of three adults are overweight. More than one out of three are considered obese.

Additional authors of the study were Japing Yue, Queen Gou, and Cynthia Li from the University of Chicago and Barton Wicksteed from the University of Illinois at Chicago. The National Institutes of Health, the American Cancer Society and the V Foundation funded the study.

Article originally appeared on Science Life.

Bluebird Bio sees Europe as first market for its gene therapies – FierceBiotech

Posted on August 7, 2017 by Danzig

Bluebird Bio plans to bring its gene therapies to market in Europe before the U.S., thanks to a favorable regulatory pathway.

Bluebird's head of Europe, Andrew Obenshain, told the Daily Telegraph that the company is already in negotiations with the EMA and the U.K.'s Medicine and Healthcare products Regulatory Agency (MHRA) on possible regulatory filings.

The EMA's adaptive pathways processwhich allows new therapies to be approved in stages based on stepwise collection of datais a key part of that decision, as is the fact that the agency "works very closely with companies coming forward with new methodologies," said Morgan. And with Brexit looming, it makes sense to discuss these plans with the MHRA separately.

Two years ago, Bluebirdwhich targets severe genetic diseases and cancerwas hit hard when the NorthStar trial of lead therapy LentiGlobin failed to hit the mark in sickle cell disease and beta thalassemia, mainly because of variable patient responses to the treatment.

In a recent SEC filing, the company said that combined data from Northstar and other trials, including a follow-up Northstar-2 study, "could support the filing of a marketing authorization application in the EU" for transfusion-dependent thalassemiaprovided they all meet the primary objective of freeing patients from the need for regular blood transfusions.

So far, no approved gene therapies have been in the U.S., while Europe has seen two approvals, namely for UniGene's Glybera (alipogene tiparvovec) for lipoprotein lipase deficiency and GlaxoSmithKline's Strimvelis for the ultrarare "bubble boy syndrome," or ADA-SCID.

Even getting approval is no guarantee of success, however. Glybera was taken off the market in April due to a lack of demand for the 1 million (around $1.2 million)-per-year therapy, with only one patient receiving it commercially since its launch in 2012.

GSK, meanwhile, has priced Strimvelis at a lower rate (around $650,000 a year) to try to encourage takeup, but hasn't given any updates and said last week it may put its rare disease unit up for sale. Rare disease head Carlo Russo moved to Italian biotech Genenta in January.

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Bluebird Bio sees Europe as first market for its gene therapies - FierceBiotech

Pioneering gene therapy restores vision to people with rare retinal blindness – Genetic Literacy Project

Posted on August 7, 2017 by Danzig

Three years ago, at a fundraiser near Philadelphia for theCuring Retinal Blindness Foundation, I stood, dumbstruck, as young teen Christian Guardino took the stage and belted outDont Stop Believing. Christian had recently undergone gene therapy that was already beginning to illuminate his darkening world but most in the crowd didnt know that.

Next to me was Dr. Jean Bennett, the physician-scientist who pioneered the gene therapy for what was then called Leber congenital amaurosis type 2. She asked me not to tell anyone about Christians treatment.

The world heard Christian last month when he performed in June on forAmericans Got Talent, singing the Jackson 5s Whos Lovin You.Fox Newsmentioned his blindness in what is perhaps the greatest oversimplification of a biotechnology of all time:When Christian Guardino was young, he learned that he would lose his sight. Fortunately, thanks to some gene therapy, he later regained the gift of sight. In the interim, he turned to music and stuck with it.

A Long Time Coming

Christian didnt just order up gene therapy like a side of fries.

The first clinical trial of gene therapy for a single-gene disease in the U.S. was in 1990. The publication of the phase 3 clinical trial data for the gene therapy for RPE65-mediated inherited retinal dystrophy, the disease that Christian has, bestows the name Luxturna, and FDA acceptance ofSpark TherapeuticsBiologics License Application (BLA) with priority review. These are giant steps forward in achieving the companys mission statement to challenge the inevitability of genetic disease.

Corey Haas owes his vision to the gene therapy he received at age 8.

Corey Haas owes his vision to the gene therapy he received at age 8. He is 14 in the accompanying photo, and will turn 17 in September.

The decade-long story of the clinical trial for the inherited blindness frames my history of gene therapy, published in 2012.The Forever Fix: Gene Therapy and the Boy Who Saved It(St. Martins Press, 2012) follows Corey Haas, the same age as Christian, who had his first eye treated in 2008 and sees so well that he goes fishing and turkey hunting. Without gene therapy, his world would be dark. Since the book came out Ive followed families whose children are having gene therapy for a variety of conditions right here atDNA Science.

The phase 3 findings for the blindness, published inThe Lancet, evaluate 21 patients in the treatment group and 10 others randomized to the control group who continued to have their vision evaluated the same way that the treated patients did (because sham surgery isnt ethical). A year later, all of the controls had the procedure too. And all have done great as have others in the earlier clinical trials.

The crux of the research, and part of what took so long, was the invention of a mobility course to evaluate a persons ability to navigate obstacles on a winding pathway under low light conditions. A test of real life, its a crucial complement to standard assessments of visual field, visual acuity, and imaging the layers of the retina.

Ill never forget watching Corey at his two-year check-up at Childrens Hospital of Philadelphia (CHOP) tackle the mobility course after just one eye had been treated. Covering that eye, the boy wobbled and careened, Dr. Jean offering her hand when he teetered too far of course. Yet covering his still-blind eye, he zipped through the maze.

Q&A withDr. Katherine High

The media largely ignored the blindness gene therapy news last week, perhaps because a few days earlier came news of an FDA advisory committees thumbs up for chimeric antigen receptor (CAR) technology to treat a form of leukemia. Two genetics news stories in one week? Nah.

I was frustrated. CAR, although widely described asgene therapybecause it sticks DNA into viruses, isnt really. Instead, it creates a double-whammy drone-like not-seen-in-nature immune response; it doesnt bolster a deficient enzyme. And a cancer is not at all like a single-gene disease.

So I believe that Luxturna to treatRPE65blindness will still be the first actual gene therapy approval.Katherine High, MD, president, chief scientific officer and a founder ofSpark Therapeutics, agrees. I spoke with her earlier this week about the recent progress. An excellent interview about her background ishere.

Ricki Lewis:How will patients be selected to receive Luxturna? Is newborn screening plausible?

Katherine High:Its for symptoms of vision loss in people with two autosomal recessive mutations in the geneRPE65. Initial licensing will be for children 3 years of age through adults. All of our work was done in children aged 3 or older, because treating younger children would require innovations in surgical technique.

RL:Can you describe the protocol?

KH:The first eye is done and within 6 to 18 days, the second eye is done. So it takes about 2 weeks. The protocol provides a chance to make sure the first eye is healing and that the person has the opportunity to get the patch off.

RL:What will Luxturna cost? Will savings on no-longer-needed treatments and aids be considered?

KH:Cost is under discussion. Part of the organization that Spark is building is to make sure that anybody who is a candidate for the therapy will have access to it. Were talking to key stakeholders the patient community, payers, health care providers, and policy makers. Its different in Europe, where all social services and educational services and so forth required for people with impaired vision comes out of the same pot, whereas in the US those kinds of services are separate from the payers. So cost, and cost savings, will involve a more complicated algorithm.

RL:Spark is also developing gene therapy forhemophilia B, with interim findings recently presented at the International Society for Thrombosis and Hemostasis meeting in Berlin. Youve been working on that condition a long time! Update?

KH: Its hard to imagine what its like to take clotting factor once or twice a week for your whole life and then not to have to. Individuals with hemophilia are always planning around when they last had an infusion of factor IX. Do the infusion, the level of clotting factor peaks, and then it slowly comes down until the next infusion. As its coming down, the patient is at risk for bleeds. So people always have to think about it.Id like to go to the gym, and the last infusion was 40 hours ago. Can I? I want to take the kids down to the park. When was my last infusion?

RL:Another hemophilia B clinical trial uses the oldest form of genome editing,zinc finger nucleases. Are the two approaches in competition? (Gene therapy adds a gene; gene editing can swap a functioning gene for a mutant one.)

KH:They both could work. Clinical experience with gene editing is much earlier and it can take time in clinical development to uncover challenges and work through them. With these complex biologics, only a certain amount can be learned from the animal models. Then in clinical investigation you have to look at results and understand what they mean and possibly modify a protocol or institute a course correction. That was true for monoclonal antibodies, for bone marrow transplants, and for straight gene therapy. Will gene editing have a shorter path? Perhaps.

RL:Where will gene therapy be in five years?

KH:Clinical development timelines will become shorter. We started the clinical work for voretigene (aka Luxturna) in 2007, but I began working on it, with Jean Bennett and Al Maguire, in 2005. We initiated the trial in 2007. We paused along the way to discuss with regulators the best way to proceed. We had to do a natural history study, for example, and we had to evaluate the mobility test. We had to build the infrastructure for studying this ultrarare form of inherited retinal dystrophy.

We will continue to see proof-of-concept of gene therapy demonstrated in different target tissues. Were seeing promising results in gene delivery to the liver and the central nervous system. I hope we will see continued accumulation of successful clinical results in a range of target tissues and continued progress in bringing gene therapy products to licensing. One of the challenges in my career has been interesting physicians in learning more about gene therapy. When gene therapy products are licensed, there will be increased interest in the medical community, and that will help to expand opportunities.

RL:Your attempt to catalyze interest in gene transfer goes back pretty far, as does gene therapy itself. And of course the field had to overcome the setbacks of the turn of the century Jesse Gelsingers death and the boys who developed leukemia.

KH:Back in the 1990s when I worked with a gene therapy company in northern California, I kept telling them they should work on this gene,RPE65. They declined because of the small patient population, and I said its a great proof-of-concept idea and its probably going to work. (Its a straightforward enzyme replacement via genetic instructions to an accessible tissue.)

After the high profile adverse events and everyone pulling out of gene therapy, Childrens Hospital of Philadelphia gave us the resources to set up vector production in-house. Dr. Steven Altschuler, then CHOP CEO and now chairman of the board at Spark, said well help, but you cant just commit the resources all to hemophilia. You have to work on a genetic disease that affects children. I said I know exactly what Im going to do, and I went and talked to Jean Bennett.

CHOP gave us the luxury of working without worrying how big the market was. I will always be grateful to Dr. Altschuler for having had the courage to make that decision when things didnt look very good for gene therapy. The other important decision he made was to spin out Spark. We were discussing many possibilities, including partnering with biotech or pharma, but most of them knew very little about gene therapy. And I was concerned about what would happen to the program for gene therapy for this ultrarare disease if put in the hands of a big company and they have a bad year.

(Spark Therapeutics formed in March 2013, the month my book came out in paperback.)

RL:So when will ophthalmologists be able to save young people like Corey Haas and Christian Guardino from living in darkness?

KH:FDA has accepted the Biologics License Application for priority review. That means that they have 6 months to decide. So there will be much back and forth with requests for additional information, and then typically for a novel therapy like this they would arrange an advisory committee meeting.

RL:So 2018 will likely be the year for Luxturna to challenge the inevitability of this one genetic disease. Its a giant first step to achieving Sparks vision:A world where no life is limited by genetic disease.

A version of this article was originally published on the PLOSwebsite as Luxturna: A Giant Step Forward For Blindness Gene Therapy A Conversation with Dr. Kathy High and has been republished here with permission.

Ricki Lewis has a PhD in genetics and is a genetics counselor, science writer and author of Human Genetics: The Basics. Follow her at her website or Twitter @rickilewis.

Pioneering gene therapy restores vision to people with rare retinal blindness - Genetic Literacy Project

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